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Chien YN, Lin LY, Lin YC, Hsieh YC, Tu SH, Chiou HY. Taxane/anthracycline combinations reduced incidence of breast cancer recurrence in young women across molecular subtypes: a real-world evidence of Taiwan from 2011 to 2019. Breast Cancer Res Treat 2025; 209:647-658. [PMID: 39487912 DOI: 10.1007/s10549-024-07527-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2024] [Accepted: 10/15/2024] [Indexed: 11/04/2024]
Abstract
PURPOSE Adolescent and young adult (AYA) patients with breast cancer generally have poor prognoses and a higher risk of secondary cancers compared to those at the same cancer stage. Notably, AYA patients in Asia exhibit a higher incidence rate of breast cancer, with Luminal A as the predominant molecular subtype, which contrasts with the trends observed in Western countries. This study aims to compare the efficacy of Taxane/Anthracycline combination-based regimens (TACB) versus Anthracycline-based regimens (AB) in AYA patients with stage I-II breast cancer, focusing on different molecular subtypes. METHODS This study utilized data from the Taiwan National Health Insurance Research Database (NHIRD) and the Taiwan Cancer Registry (TCR) from 2011 to 2019. The study cohort included patients aged 15 to 39 years who were diagnosed with stage I-II breast cancer and received either TACB or AB regimens. Propensity score matching and Cox proportional hazards regression models were used to calculate the hazard ratios (HR) for recurrence. RESULTS The results showed that TACB regimens significantly reduced the risk of recurrence compared to AB regimens across all patients (aHR 0.73, 95% CI 0.55-0.97). Specifically, for low/middle-recurrence risk groups, the aHR was 0.68 (95% CI 0.49-0.96), and for high-recurrence risk groups, it was 0.43 (95% CI 0.21-0.87). The analysis further indicated no significant differences in recurrence risk between AYA and non-AYA patients using TACB regimens. CONCLUSION The TACB regimens showed a more favorable prognosis than AB regimens across all molecular subtypes. Furthermore, TACB regimens not only outperformed AB treatments but also closed the gap in prognostic outcomes between AYA and non-AYA patients. We believe the findings of this study are highly reliable and can provide valuable guidance for physicians in choosing the most appropriate treatment strategies for AYA patients with stage I-II breast cancer.
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Affiliation(s)
- Yu-Ning Chien
- Department of Health and Welfare, University of Taipei, Taipei, Taiwan
| | - Li-Yin Lin
- Department of Leisure Industry and Health Promotion, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
| | - Yi-Chun Lin
- School of Public Health, Taipei Medical University, Taipei, Taiwan
| | - Yi-Chen Hsieh
- The Ph.D. Program for Neural Regenerative Medicine, Taipei Medical University, Taipei, Taiwan
| | - Shih-Hsin Tu
- Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
- Division of Breast Surgery, Department of Surgery, Taipei Medical University Hospital, Taipei, Taiwan.
- Taipei Cancer Center, Taipei Medical University, 250 Wu-Hsing Street, Taipei, 110, Taiwan.
| | - Hung-Yi Chiou
- School of Public Health, Taipei Medical University, Taipei, Taiwan.
- Institute of Population Health Sciences, National Health Research Institutes, No. 35, Keyan Road, Zhunan, Miaoli, 350401, Taiwan.
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2
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Tavazzi G, Colombo CNJ, Klersy C, Dammassa V, Civardi L, Degani A, Biglia A, Via G, Camporotondo R, Pellegrini C, Price S. Echocardiographic parameters for weaning from extracorporeal membrane oxygenation-the role of longitudinal function and cardiac time intervals. Eur Heart J Cardiovasc Imaging 2025; 26:359-367. [PMID: 39441992 DOI: 10.1093/ehjci/jeae274] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2024] [Revised: 10/11/2024] [Accepted: 10/15/2024] [Indexed: 10/25/2024] Open
Abstract
AIMS Limited data exist on echocardiographic predictors of weaning from veno-arterial extracorporeal membrane oxygenation (V-A ECMO). We aimed to test the performance of different echocardiographic indices to predict weaning from V-A ECMO and free survival after weaning. METHODS AND RESULTS Observational study including patients with cardiogenic shock submitted to V-AECMO. Echocardiography was performed after V-AECMO placement and daily during the weaning trial to assess cardiac recovery. Echocardiography data after V-A ECMO implantation and during the last weaning trial before V-A ECMO removal were analysed. Besides traditional parameters, total isovolumic time (t-IVT, a left ventricular performance index) and mitral annular plane systolic excursion (MAPSE) were also tested. Seventy-six patients were included. A greater ventricular velocity time integral (LVOT VTI) at baseline was associated with a five-fold increase in weaning success (P < 0.001) as MAPSE lateral >6.15 mm (P = 0.001) did. TAPSE and S' at tricuspid annulus showed an analogous association. During the weaning trial t-IVT, LVEF, MAPSE, LVOT VTI, and TAPSE all improved significantly (P < 0.001 for all). At regression analysis t-IVT <14.4 s/min (<0.001), LVOT VTI >12.3 cm (P < 0.001), MAPSE > 8.9 mm (P < 0.001), TAPSE > 16 mm (<0.001), and E/e' < 15.5 (P = 0.001) were associated with weaning success and free survival after weaning. LVEF did not predict the weaning success and survival at any time-point (P = 0.230). CONCLUSION Longitudinal function, t-IVT and native ejection, measured with LVOT VTI, are reliable parameters to predict weaning success in V-A ECMO whereas the LVEF, although dynamically changing during weaning trial, it is not.
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Affiliation(s)
- Guido Tavazzi
- Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, VIale Golgi 19, Pavia 27100, Italy
- Anesthesia and Intensive Care, Fondazione Policlinico San Matteo Hospital IRCCS, VIale Golgi 19, Pavia 27100, Italy
| | - Costanza Natalia Julia Colombo
- Anesthesia and Intensive Care, Fondazione Policlinico San Matteo Hospital IRCCS, VIale Golgi 19, Pavia 27100, Italy
- PhD in Experimental Medicine, University of Pavia, Via Ferrata 5, Pavia 27100, Italy
| | - Catherine Klersy
- Unit of Clinical Epidemiology and Biostatistics, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
| | - Valentino Dammassa
- PhD in Experimental Medicine, University of Pavia, Via Ferrata 5, Pavia 27100, Italy
- Adult Intensive Care Unit, Royal Brompton Hospital, London, UK
| | - Luca Civardi
- Anesthesia and Intensive Care, Fondazione Policlinico San Matteo Hospital IRCCS, VIale Golgi 19, Pavia 27100, Italy
| | - Antonella Degani
- Department of Cardiothoracic Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Italy
| | - Alessio Biglia
- Department of Cardiothoracic Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Italy
| | - Gabriele Via
- Cardiac Anesthesia and Intensive Care, Istituto Cardiocentro Ticino, Ente Ospedaliero Cantonale, Lugano, Switzerland
| | - Rita Camporotondo
- Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Carlo Pellegrini
- Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, VIale Golgi 19, Pavia 27100, Italy
- Department of Cardiothoracic Surgery, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, Italy
| | - Susanna Price
- Adult Intensive Care Unit, Royal Brompton Hospital, London, UK
- National Heart and Lung Institute, Imperial College, London, UK
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3
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Schäfer A, Alasnag M, Giacoppo D, Collet C, Rudolph TK, Roguin A, Buszman PP, Colleran R, Stefanini G, Lefevre T, Mieghem NV, Cayla G, Naber C, Baumbach A, Witkowski A, Burzotta F, Capodanno D, Dudek D, Al-Lamee R, Banning A, MacCarthy P, Gottardi R, Schoenhoff FS, Czerny M, Thielmann M, Werner N, Tarantini G. High-risk percutaneous coronary intervention in patients with reduced left ventricular ejection fraction deemed not suitable for surgical revascularisation. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the ESC Working Group on Cardiovascular Surgery. EUROINTERVENTION 2025; 21:22-34. [PMID: 39773827 PMCID: PMC11687390 DOI: 10.4244/eij-d-23-01100] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/27/2023] [Accepted: 10/08/2024] [Indexed: 01/11/2025]
Abstract
This clinical consensus statement of the European Association of Percutaneous Cardiovascular Interventions was developed in association with the European Society of Cardiology Working Group on Cardiovascular Surgery. It aims to define procedural and contemporary technical requirements that may improve the efficacy and safety of percutaneous coronary intervention (PCI), both in the acute phase and at long-term follow-up, in a high-risk cohort of patients on optimal medical therapy when clinical and anatomical high-risk criteria are present that entail unacceptable surgical risks, precluding the feasibility of coronary artery bypass grafting (CABG). This document pertains to patients with surgical contraindication according to the Heart Team, in whom medical therapy has failed (e.g., residual symptoms), and for whom the Heart Team estimates that revascularisation may have a prognostic benefit (e.g., left main, last remaining vessel, multivessel disease with large areas of ischaemia); however, there is a lack of data regarding the size of this patient population. This document aims to guide interventional cardiologists on how to proceed with PCI in such high-risk patients with reduced left ventricular ejection fraction after the decision of the Heart Team is made that CABG - which overall is the guideline-recommended option for revascularisation in these patients - is not an option and that PCI may be beneficial for the patient. Importantly, when a high-risk PCI is planned, a multidisciplinary decision by interventional cardiologists, cardiac surgeons, anaesthetists and non-invasive physicians with expertise in heart failure management and intensive care should be agreed upon after careful consideration of the possible undesirable consequences of PCI, including futility, similar to the approach for structural interventions.
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Affiliation(s)
- Andreas Schäfer
- Cardiac Arrest Center, Department of Cardiology and Angiology, Hannover Medical School, Hanover, Germany
| | - Mirvat Alasnag
- Cardiac Center, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia
| | - Daniele Giacoppo
- Department of Cardiology, Alto Vicentino Hospital, Santorso, Italy
- ISA Research, German Heart Center, Munich, Germany
| | - Carlos Collet
- Department of Cardiology, Cardiovascular Center Aalst, Aalst, Belgium
| | - Tanja K Rudolph
- Department of Cardiology, Heart and Diabetes Center NRW, Ruhr-University, Bad Oeynhausen, Germany
| | - Ariel Roguin
- Department of Cardiology, Hillel Yaffe Medical Center, Hadera, Israel
| | - Piotr P Buszman
- Department of Cardiology, Andrzej Frycz Modrzewski Kraków University, Krakow, Poland and Center for Cardiology and Cardiac Surgery of American Heart of Poland, Bielsko-Biała, Poland
| | - Roisin Colleran
- Department of Cardiology, Mater Private Hospital, Dublin, Ireland
| | - Giulio Stefanini
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy
- IRCCS Humanitas Research Hospital, Rozzano, Italy
| | - Thierry Lefevre
- Hôpital privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France
| | - Nicolas Van Mieghem
- Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands
| | - Guillaume Cayla
- Department of Cardiology, University Hospital Nîmes, University of Montpellier, Nîmes, France
| | - Christoph Naber
- Department of Cardiology and Internal Intensive Care, Wilhelmshaven Hospital, Wilhelmshaven, Germany
| | - Andreas Baumbach
- Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom
- Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom
| | - Adam Witkowski
- Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
| | - Francesco Burzotta
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Davide Capodanno
- Division of Cardiology, AOU Policlinico "G. Rodolico-San Marco", University of Catania, Catania, Italy
| | - Dariusz Dudek
- Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
| | - Rasha Al-Lamee
- Imperial College London, Imperial College Healthcare NHS Trust, London, United Kingdom
| | - Adrian Banning
- Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom
| | | | - Roman Gottardi
- Department of Cardiovascular Surgery, Heart Center Lahr, Lahr, Germany
| | | | - Martin Czerny
- Department of Cardiovascular Surgery, University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany
- Faculty of Medicine, Albert Ludwig University Freiburg, Freiburg, Germany
| | - Matthias Thielmann
- Department of Thoracic and Cardiovascular Surgery, West-German Heart & Vascular Center Essen at University Duisburg-Essen, Essen, Germany
| | - Nikos Werner
- Department of Cardiology, Heart Center Trier, Krankenhaus der Barmherzigen Brüder, Trier, Germany
| | - Giuseppe Tarantini
- Department of Cardiac-Thoracic-Vascular Sciences, University of Padua, Padua, Italy
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Li S, Li A, Beckman JA, Kim C, Granich MA, Mondin J, Sabath DE, Garcia DA, Mahr C. Discordance between aPTT and anti-Xa in monitoring heparin anticoagulation in mechanical circulatory support. ESC Heart Fail 2024; 11:2742-2748. [PMID: 38725133 PMCID: PMC11424350 DOI: 10.1002/ehf2.14816] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/10/2024] [Accepted: 04/02/2024] [Indexed: 09/27/2024] Open
Abstract
AIMS It is unclear whether activated partial thromboplastin time (aPTT) or anti-Xa is more accurate for monitoring heparin anticoagulation in mechanical circulatory support (MCS) patients. This study investigates the relationship between aPTT and anti-Xa in MCS patients and identifies predictors of discordance. METHODS AND RESULTS aPTT and anti-Xa were simultaneously measured in a prospective cohort of MCS patients receiving unfractionated heparin at a tertiary academic medical centre. Therapeutic aPTT and anti-Xa levels were 60-100 s and 0.3-0.7 IU/mL, respectively, and concordance was defined as both levels being subtherapeutic, therapeutic, or supratherapeutic. To identify predictors of discordance, both a machine learning random forest model and a multivariate regression model were applied to patient demographics, device type, and 14 laboratory variables; 23 001 pairs of simultaneously measured aPTT/anti-Xa were collected from 699 MCS patients. aPTT and anti-Xa were concordant in 35.5% of paired observations and discordant in 64.5% (aPTT > antiXa 61.5%; aPTT < antiXa 3.0%). Discordance with a high aPTT relative to anti-Xa (aPTT > antiXa) was associated with high INR, eGFR, and total bilirubin, as well as low platelets, haemoglobin, pre-albumin, white blood cell count, and haptoglobin. Total artificial heart and durable ventricular assist devices were more likely to be associated with aPTT > anti-Xa than temporary MCS devices. CONCLUSIONS aPTT and anti-Xa were frequently discordant in MCS patients receiving heparin anticoagulation. Clinical conditions common in MCS patients such as concurrent warfarin use, malnutrition, haemolysis, and thrombocytopenia, as well as durable type of MCS devices were associated with a high aPTT relative to anti-Xa.
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Affiliation(s)
- Song Li
- Medical City Healthcare, Dallas, TX, USA
| | - Ang Li
- Division of Hematology & Oncology, Baylor College of Medicine, Houston, TX, USA
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5
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Kwon JH, Bentley D, Cevasco M, Blumer V, Kanwar MK, Silvestry SC, Daneshmand MA, Abraham J, Shorbaji K, Kilic A. Patient Characteristics and Early Clinical Outcomes With Impella 5.5: A Systematic Review and Meta-Analysis. ASAIO J 2024; 70:557-564. [PMID: 38386980 DOI: 10.1097/mat.0000000000002169] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/24/2024] Open
Abstract
Data regarding outcomes with Impella 5.5 are limited. The aim of this systematic review and meta-analysis was to summarize patient and treatment characteristics and early clinical outcomes among patients supported by Impella 5.5. A systematic literature search was conducted in PubMed, Scopus, and Cochrane databases from September 2019 to March 2023. Studies reporting outcomes in greater than or equal to 5 patients were included for review. Patient characteristics, treatment characteristics, and early clinical outcomes were extracted. Outcomes included adverse events, survival to hospital discharge, and 30 day survival. Random-effect models were used to estimate pooled effects for survival outcomes. Assessment for bias was performed using funnel plots and Egger's tests. Fifteen studies were included for qualitative review, representing 707 patients. Mean duration of support was 9.9 ± 8.2 days. On meta-analysis of 13 studies reporting survival outcomes, survival to hospital discharge was 68% (95% confidence interval [CI], 58-78%), and 30 day survival was 65% (95% CI, 56-74%) among patients with Impella devices predominantly supported by Impella 5.5 (>60%). There was significant study heterogeneity for these outcomes. Among 294 patients with Impella 5.5 only, survival to discharge was 78% (95% CI, 72-82%) with no significant study heterogeneity. This data present early benchmarks for outcomes with Impella 5.5 as clinical experience with these devices accrues.
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Affiliation(s)
- Jennie H Kwon
- From the Division of Cardiothoracic Surgery, Medical University of South Carolina, Charleston, South Carolina
| | - Dana Bentley
- Principle Scientific Affairs, Abiomed, Danvers, Massachusetts
| | - Marisa Cevasco
- Division of Cardiovascular Surgery, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania
| | - Vanessa Blumer
- Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio
| | - Manreet K Kanwar
- Cardiovascular Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
| | | | - Mani A Daneshmand
- Division of Cardiothoracic Surgery, Emory University, Atlanta, Georgia
| | - Jacob Abraham
- Center for Cardiovascular Analytics, Research and Data Science, Providence Heart Institute, Providence Research Network, Portland, Oregon
| | - Khaled Shorbaji
- From the Division of Cardiothoracic Surgery, Medical University of South Carolina, Charleston, South Carolina
| | - Arman Kilic
- From the Division of Cardiothoracic Surgery, Medical University of South Carolina, Charleston, South Carolina
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6
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Henry CM, Oseran AS, Zheng Z, Dong H, Wadhera RK. Cardiovascular hospitalizations and mortality among adults aged 25-64 years in the USA. Eur Heart J 2024; 45:1017-1026. [PMID: 37952173 PMCID: PMC10972685 DOI: 10.1093/eurheartj/ehad772] [Citation(s) in RCA: 8] [Impact Index Per Article: 8.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/19/2023] [Revised: 10/28/2023] [Accepted: 11/08/2023] [Indexed: 11/14/2023] Open
Abstract
BACKGROUND AND AIMS Declines in cardiovascular mortality have stagnated in the USA since 2011. There is growing concern that these patterns reflect worsening cardiovascular health in younger adults. However, little is known about how the burden of acute cardiovascular hospitalizations and mortality has changed in this population. Changes in cardiovascular hospitalizations and mortality among adults aged 25-64 years were evaluated, overall and by community-level income. METHODS Using the National Inpatient Sample, age-standardized annual hospitalization and in-hospital mortality rates for acute myocardial infarction (AMI), heart failure, and ischaemic stroke were determined among adults aged 25-64 years. Quasi-Poisson and quasi-binominal regression models were fitted to compare outcomes between individuals residing in low- and higher-income communities. RESULTS Between 2008 and 2019, age-standardized hospitalization rates for AMI increased among younger adults from 155.0 (95% confidence interval: 154.6, 155.4) per 100 000 to 160.7 (160.3, 161.1) per 100 000 (absolute change +5.7 [5.0, 6.3], P < .001). Heart failure hospitalizations also increased (165.3 [164.8, 165.7] to 225.3 [224.8, 225.8], absolute change +60.0 (59.3, 60.6), P < .001), as ischaemic stroke hospitalizations (76.3 [76.1, 76.7] to 108.1 [107.8, 108.5], absolute change +31.7 (31.2, 32.2), P < .001). Across all conditions, hospitalizations rates were significantly higher among younger adults residing in low-income compared with higher-income communities, and disparities did not narrow between groups. In-hospital mortality decreased for all conditions over the study period. CONCLUSIONS There was an alarming increase in cardiovascular hospitalizations among younger adults in the USA from 2008 to 2019, and disparities between those residing in low- and higher-income communities did not narrow.
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Affiliation(s)
- Chantal M Henry
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel
Deaconess Medical Center and Harvard Medical School, 375
Longwood Ave, 4th Floor, Boston, MA 02215, USA
- Meharry Medical College, Nashville,
TN, USA
| | - Andrew S Oseran
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel
Deaconess Medical Center and Harvard Medical School, 375
Longwood Ave, 4th Floor, Boston, MA 02215, USA
- Division of Cardiology, Massachusetts General Hospital,
Boston, MA, USA
- Division of Cardiology, Beth Israel Deaconess Medical Center and Harvard
Medical School, 330 Brookline Avenue, Boston, MA
02215, USA
| | - ZhaoNian Zheng
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel
Deaconess Medical Center and Harvard Medical School, 375
Longwood Ave, 4th Floor, Boston, MA 02215, USA
| | - Huaying Dong
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel
Deaconess Medical Center and Harvard Medical School, 375
Longwood Ave, 4th Floor, Boston, MA 02215, USA
| | - Rishi K Wadhera
- Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel
Deaconess Medical Center and Harvard Medical School, 375
Longwood Ave, 4th Floor, Boston, MA 02215, USA
- Division of Cardiology, Beth Israel Deaconess Medical Center and Harvard
Medical School, 330 Brookline Avenue, Boston, MA
02215, USA
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7
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Yeo I, Axman R, Lu DY, Feldman DN, Cheung JW, Minutello RM, Karas MG, Iannacone EM, Srivastava A, Girardi NI, Naka Y, Wong S, Kim LK. Impella Versus Intra-Aortic Balloon Pump in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: An Observational Study. J Am Heart Assoc 2024; 13:e032607. [PMID: 38240236 PMCID: PMC11056174 DOI: 10.1161/jaha.123.032607] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/11/2023] [Accepted: 12/19/2023] [Indexed: 02/07/2024]
Abstract
BACKGROUND Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used for patients with cardiogenic shock. Although Impella or intra-aortic balloon pump (IABP) is frequently used for left ventricular unloading (LVU) during VA-ECMO treatment, there are limited data on comparative outcomes. We compared outcomes of Impella and IABP for LVU during VA-ECMO. METHODS AND RESULTS Using the Nationwide Readmissions Database between 2016 and 2020, we analyzed outcomes in 3 groups of patients with cardiogenic shock requiring VA-ECMO based on LVU strategies: extracorporeal membrane oxygenation (ECMO) only, ECMO with IABP, and ECMO with Impella. Of 15 980 patients on VA-ECMO, IABP and Impella were used in 19.4% and 16.4%, respectively. The proportion of patients receiving Impella significantly increased from 2016 to 2020 (6.5% versus 25.8%; P-trend<0.001). In-hospital mortality was higher with ECMO with Impella (54.8%) compared with ECMO only (50.4%) and ECMO with IABP (48.4%). After adjustment, ECMO with IABP versus ECMO only was associated with lower in-hospital mortality (adjusted odds ratio [aOR], 0.83; P=0.02). ECMO with Impella versus ECMO only had similar in-hospital mortality (aOR, 1.09; P=0.695) but was associated with more bleeding (aOR, 1.21; P=0.007) and more acute kidney injury requiring hemodialysis (aOR, 1.42; P<0.001). ECMO with Impella versus ECMO with IABP was associated with greater risk of acute kidney injury requiring hemodialysis (aOR, 1.49; P=0.002), higher in-hospital mortality (aOR, 1.32; P=0.001), and higher 40-day mortality (hazard ratio, 1.25; P<0.001). CONCLUSIONS In patients with cardiogenic shock on VA-ECMO, LVU with Impella, particularly with 2.5/CP, was not associated with improved survival at 40 days but was associated with increased adverse events compared with IABP. More data are needed to assess Impella platform-specific comparative outcomes of LVU.
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Affiliation(s)
- Ilhwan Yeo
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
- Weill Cornell Cardiovascular Outcomes Research Group (CORG)Weill Cornell MedicineNew YorkNY
- Division of Pulmonary and Critical Care MedicineMayo ClinicRochesterMN
| | - Rachel Axman
- Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
| | - Daniel Y. Lu
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
- Weill Cornell Cardiovascular Outcomes Research Group (CORG)Weill Cornell MedicineNew YorkNY
| | - Dmitriy N. Feldman
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
- Weill Cornell Cardiovascular Outcomes Research Group (CORG)Weill Cornell MedicineNew YorkNY
| | - Jim W. Cheung
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
- Weill Cornell Cardiovascular Outcomes Research Group (CORG)Weill Cornell MedicineNew YorkNY
| | - Robert M. Minutello
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
| | - Maria G. Karas
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
| | - Erin M. Iannacone
- Department of Cardiothoracic Surgery, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
| | - Ankur Srivastava
- Department of Anesthesiology, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
| | - Natalia I. Girardi
- Department of Anesthesiology, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
| | - Yoshifumi Naka
- Department of Cardiothoracic Surgery, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
| | - Shing‐Chiu Wong
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
- Weill Cornell Cardiovascular Outcomes Research Group (CORG)Weill Cornell MedicineNew YorkNY
| | - Luke K. Kim
- Division of Cardiology, Department of Medicine, Weill Cornell MedicineNew York‐Presbyterian HospitalNew YorkNY
- Weill Cornell Cardiovascular Outcomes Research Group (CORG)Weill Cornell MedicineNew YorkNY
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8
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Nathan AS, Reddy KP, Eberly LA, Fanaroff A, Julien HM, Fiorilli P, Wald J, Mutaawe S, Cevasco M, Bermudez C, Kapur NK, Basir MB, Roswell R, Groeneveld PW, Giri J. Racial, Ethnic, Socioeconomic, and Geographic Inequities in Access to Mechanical Circulatory Support. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2024; 3:101193. [PMID: 39131979 PMCID: PMC11307759 DOI: 10.1016/j.jscai.2023.101193] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 09/13/2023] [Revised: 09/26/2023] [Accepted: 09/26/2023] [Indexed: 08/13/2024]
Abstract
Background Hospital admissions for cardiogenic shock have increased in the United States. Temporary mechanical circulatory support (tMCS) can be used to acutely stabilize patients. We sought to evaluate the presence of racial, ethnic, and socioeconomic inequities in access to MCS in the United States among patients with cardiogenic shock. Methods Medicare data were used to identify patients with cardiogenic shock admitted to hospitals with advanced tMCS (microaxial left ventricular assist device [mLVAD] or extracorporeal membranous oxygenation [ECMO]) capabilities within the 25 largest core-based statistical areas, all major metropolitan areas. We modeled the association between patient race, ethnicity, and socioeconomic status and use of mLVAD or ECMO. Results After adjusting for age and clinical comorbidities, dual eligibility for Medicaid was associated with a 19.9% (95% CI, 11.5%-27.4%) decrease in odds of receiving mLVAD in a patient with cardiogenic shock (P < .001). After adjusting for age, clinical comorbidities, and dual eligibility for Medicaid, Black race was associated with 36.7% (95% CI, 28.4%-44.2%) lower odds of receiving mLVAD in a patient with cardiogenic shock. Dual eligibility for Medicaid was associated with a 62.0% (95% CI, 60.8%-63.1%) decrease in odds of receiving ECMO in a patient with cardiogenic shock (P < .001). Black race was associated with 36.0% (95% CI, 16.6%-50.9%) lower odds of receiving ECMO in a patient with cardiogenic shock, after adjusting for Medicaid eligibility. Conclusions We identified large and significant racial, ethnic, and socioeconomic inequities in access to mLVAD and ECMO among patients presenting with cardiogenic shock to metropolitan hospitals with active advanced tMCS programs. These findings highlight systematic inequities in access to potentially lifesaving therapies.
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Affiliation(s)
- Ashwin S. Nathan
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania
| | - Kriyana P. Reddy
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Lauren A. Eberly
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Alexander Fanaroff
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Howard M. Julien
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania
| | - Paul Fiorilli
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania
| | - Joyce Wald
- Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Shafik Mutaawe
- Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Marisa Cevasco
- Division of Cardiac Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Christian Bermudez
- Division of Cardiac Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Navin K. Kapur
- The CardioVascular Center, Tufts Medical Center, Boston, Massachusetts
| | | | - Robert Roswell
- Zucker School of Medicine, Northwell Health, Hofstra University, Hempstead, New York
| | - Peter W. Groeneveld
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania
- Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Jay Giri
- Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia, Pennsylvania
- Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania
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9
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Maigrot JLA, Starling RC, Taimeh Z, Tong MZ, Soltesz EG, Weiss AJ. Association of timing of percutaneous left ventricular assist device insertion with outcomes in patients undergoing cardiac surgery. JTCVS OPEN 2023; 16:430-446. [PMID: 38204614 PMCID: PMC10775102 DOI: 10.1016/j.xjon.2023.10.028] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 10/03/2023] [Accepted: 10/10/2023] [Indexed: 01/12/2024]
Abstract
Objectives The aim of this study was to explore the associations between percutaneous ventricular assist device (pVAD) insertion timing relative to cardiac surgery and patient outcomes. Methods The Nationwide Inpatient Sample was queried for patients undergoing cardiac surgery and pVAD insertion in the same admission from 2016 to 2019. Patients were stratified by timing of pVAD insertion. Preoperative characteristics, postoperative complications, and mortality were compared among groups. Results Overall, 3695 patients underwent cardiac surgery and pVAD insertion during the same hospitalization (pre: 1130, intra: 1690, and post: 875). The distribution of cardiac surgery procedures was similar across groups. Median Elixhauser Comorbidity Index was 13 for pre-, 15 for intra-, and 17 for postoperative pVAD patients (P = .021). Patients who received a postoperative pVAD were associated with increased mortality (pre: 18%, intra: 39%, and post: 54%; P < .01). Increased complication rates were also associated with postoperative pVAD insertion (pre: 61%, intra: 55%, and post: 75%; P < .01). Preoperative pVAD insertion was associated with increase rates of sepsis (pre: 18%, intra: 9.8%, and post: 17%; P = .01) and pneumonia (pre: 38%, intra: 23%, and post: 31%; P < .01). Postoperative pVAD insertion was associated with increased rates of gastrointestinal bleeding (pre: 2.2%, intra: 3.0%, and post: 7.4%; P = .01), renal failure (pre: 10%, intra: 9.2%, and post: 17%; P = .01), and prolonged ventilation (pre: 44%, intra: 41%, and post: 54%; P = .02). Conclusions Postoperative pVAD insertion following cardiac surgery was associated with increased complications and mortality compared with preoperative or intraoperative insertion. Further studies should explore optimal utilization and timing of pVAD insertion in patients undergoing cardiac surgery.
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Affiliation(s)
- Jean-Luc A. Maigrot
- Department of Thoracic and Cardiovascular Surgery, Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio
| | - Randall C. Starling
- Department of Cardiovascular Medicine, Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio
| | - Ziad Taimeh
- Department of Cardiovascular Medicine, Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio
| | - Michael Z.Y. Tong
- Department of Thoracic and Cardiovascular Surgery, Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio
| | - Edward G. Soltesz
- Department of Thoracic and Cardiovascular Surgery, Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio
| | - Aaron J. Weiss
- Department of Thoracic and Cardiovascular Surgery, Kaufman Center for Heart Failure Treatment and Recovery, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio
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10
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Ando T, Nakamaru R, Kohsaka S, Fukutomi M, Onishi T, Tobaru T. Access Site-Stratified Analysis of the Incidence, Predictors, and Outcomes of Impella-Supported Patients With Cardiogenic Shock. Am J Cardiol 2023; 205:198-203. [PMID: 37611410 DOI: 10.1016/j.amjcard.2023.07.134] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/15/2023] [Revised: 07/02/2023] [Accepted: 07/26/2023] [Indexed: 08/25/2023]
Abstract
This study aimed to evaluate the incidence, predictors, and outcomes of Impella-assisted patients with cardiogenic shock, stratified by the access site-transaxillary (TX) or trans-subclavian (TS) versus the conventional transfemoral (TF) approach. For this study, we analyzed the cases entered into the Japanese Percutaneous Ventricular Assist Device registry between February 2020 and December 2021. A multivariable logistic regression analysis was conducted to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) to identify the predictors of the TX/TS approach, with reference to those who received the conventional TF approach. A log-rank test was performed to compare the 30-day mortality between the 2 approaches. A total of 2,564 cases of Impella were included in the study, of which 167 (6.5%) were accessed by way of the TX/TS approach. TX/TS approach cases were younger and had a higher percentage of concomitant use of extracorporeal membrane oxygenation or an intra-aortic balloon pump. The predictors of the TX/TS approach included a presentation with the acute coronary syndrome (aOR 0.32, 95% CI 0.16 to 0.63, p <0.001), cardiac arrest (aOR 0.10, 95% CI 0.02 to 0.36, p = 0.003), cardiogenic shock (aOR 0.51, 95% CI 0.33 to 0.79, p = 0.002), and inotropic use (aOR 1.88, 95% CI 1.08 to 3.49, p = 0.033). The 30-day mortality was comparable between TX/TS and TF approaches (29.3% vs 29.6%, respectively; log-rank, p = 0.64). Our analysis revealed that approximately 6% of the Impella-assisted patients with cardiogenic shock received the TX/TS approach as their first access site. These results suggest that the TX/TS approach may be a viable alternative to the TF approach in certain patients requiring Impella support.
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Affiliation(s)
- Tomo Ando
- Center of Cardiovascular Disease, Kawasaki Saiwai Hospital, Kanagawa, Japan.
| | - Ryo Nakamaru
- Department of Healthcare Quality Assessment, Graduate School of Medicine, University of Tokyo, Tokyo, Japan
| | - Shun Kohsaka
- Department of Cardiology, Keio University School of Medicine, Tokyo, Japan
| | - Motoki Fukutomi
- Center of Cardiovascular Disease, Kawasaki Saiwai Hospital, Kanagawa, Japan
| | - Takayuki Onishi
- Center of Cardiovascular Disease, Kawasaki Saiwai Hospital, Kanagawa, Japan
| | - Tetsuya Tobaru
- Center of Cardiovascular Disease, Kawasaki Saiwai Hospital, Kanagawa, Japan
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11
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Il'Giovine ZJ, Higgins A, Rali AS, Abdul-Aziz AA, Lee R. Training Pathways in Critical Care Cardiology: Competencies and Considerations for Cardiologists. Curr Cardiol Rep 2023; 25:1381-1387. [PMID: 37695412 DOI: 10.1007/s11886-023-01952-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 08/29/2023] [Indexed: 09/12/2023]
Abstract
PURPOSE OF REVIEW Critical care cardiology (CCC) is a rapidly developing field undergoing a renaissance of interest and growth to meet the well-documented population shift in the cardiac intensive care unit (CICU). With this has come the emergence of novel training paradigms that seek to combine specialties with meaningful overlap. RECENT FINDINGS The benefit of having critical care expertise in the CICU has been clearly established; however, there is no formal or uniform CCC training pathway. Contemporary approaches seek to provide appropriate clinical and procedural experience while minimizing opportunity cost. The combination of additional cardiology subspecialties, specifically advanced heart failure or interventional cardiology, has been demonstrated. Educational tracks that integrate critical care training have generated interest but have not yet manifested. CCC training strives to meet the needs of an increasingly sick and diverse patient population while preparing trainees for fulfilling and meaningful careers. The hope is for ongoing development of novel training pathways to satisfy evolving needs.
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Affiliation(s)
- Zachary J Il'Giovine
- Centennial Heart, Tristar Centennial Medical Center, 2400 Patterson St Ste 502, Nashville, TN, 37203, USA.
| | - Andrew Higgins
- Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
| | - Aniket S Rali
- Division of Cardiovascular Diseases, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Ahmad A Abdul-Aziz
- Inova Fairfax Medical Center, Inova Heart and Vascular Institute, Falls Church, VA, USA
| | - Ran Lee
- Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, OH, USA
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12
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Nishimoto Y, Ohbe H, Matsui H, Nakata J, Takiguchi T, Nakajima M, Sasabuchi Y, Sato Y, Watanabe T, Yamada T, Fukunami M, Yasunaga H. Trends in Mechanical Circulatory Support Use and Outcomes of Patients With Cardiogenic Shock in Japan, 2010 to 2020 (from a Nationwide Inpatient Database Study). Am J Cardiol 2023; 203:203-211. [PMID: 37499600 DOI: 10.1016/j.amjcard.2023.06.082] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2023] [Revised: 05/15/2023] [Accepted: 06/24/2023] [Indexed: 07/29/2023]
Abstract
Little is known about the impact of the downgrade of guideline recommendations for intra-aortic balloon pump (IABP) use and the approval of the Impella in Japan, where IABPs have been predominantly used. This study aimed to describe the annual trends in the mechanical circulatory support (MCS) use and outcomes in patients with cardiogenic shock (CS) requiring MCS. Using the Japanese Diagnosis Procedure Combination database from July 2010 to March 2021, we identified inpatients with CS requiring MCS. The patients were stratified into 3 groups: (1) IABP alone, (2) Impella alone, and (3) extracorporeal membrane oxygenation (ECMO), regardless of IABP or Impella use. The patient characteristics and outcomes were reported by the fiscal year. Of the 160,559 eligible patients, 117,599 (73.2%) used IABP alone, 1,465 (0.9%) Impella alone, and 41,495 (25.8%) ECMO. The prevalence of the use of an IABP alone significantly decreased from 80.5% in 2010 to 65.3% in 2020 (p for trend <0.001), whereas the prevalence of the use of an Impella alone significantly increased from 0.0% to 5.0% and ECMO from 19.5% to 29.6% (p for trend <0.001 for both). In-hospital mortality significantly increased from 29.3% in 2010 to 32.6% in 2020 in the overall patients with CS requiring MCS but significantly decreased in those requiring ECMO from 73.7% to 64.1% (p for trend <0.001 for both). In conclusion, there were significant annual changes in the patterns of MCS use and clinical outcomes in patients with CS requiring MCS.
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Affiliation(s)
- Yuji Nishimoto
- Division of Cardiology, Osaka General Medical Center, Osaka, Japan
| | - Hiroyuki Ohbe
- Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan.
| | - Hiroki Matsui
- Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
| | - Jun Nakata
- Division of Cardiovascular Intensive Care and
| | - Toru Takiguchi
- Department of Emergency and Critical Care Medicine, Nippon Medical School, Tokyo, Japan
| | - Mikio Nakajima
- Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan; Emergency Life-Saving Technique Academy of Tokyo, Foundation for Ambulance Service Development, Tokyo, Japan
| | | | - Yukihito Sato
- Department of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan
| | - Tetsuya Watanabe
- Division of Cardiology, Osaka General Medical Center, Osaka, Japan
| | - Takahisa Yamada
- Division of Cardiology, Osaka General Medical Center, Osaka, Japan
| | | | - Hideo Yasunaga
- Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
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13
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Ismayl M, Hussain Y, Aboeata A, Walters RW, Naidu SS, Messenger JC, Basir MB, Rao SV, Goldsweig AM, Altin SE. Pulmonary Artery Catheter Use and Outcomes in Patients With ST-Elevation Myocardial Infarction and Cardiogenic Shock Treated With Impella (a Nationwide Analysis from the United States). Am J Cardiol 2023; 203:304-314. [PMID: 37517125 DOI: 10.1016/j.amjcard.2023.06.117] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2023] [Revised: 05/24/2023] [Accepted: 06/29/2023] [Indexed: 08/01/2023]
Abstract
The role of continuous hemodynamic assessment with pulmonary artery (PA) catheter placement in cardiogenic shock (CS) remains debated. We aimed to assess the association between PA catheter placement and clinical outcomes in patients with CS secondary to ST-elevation myocardial infarction (STEMI) treated with an intravascular microaxial flow pump. We identified patients hospitalized with STEMI complicated by CS on mechanical circulatory support with an intravascular microaxial flow pump (Impella, Abiomed, Danvers, Massachusetts) using the National Inpatient Sample database and compared the outcomes in those treated with and without PA catheters. The primary outcome was in-hospital mortality. The secondary outcomes included in-hospital complications, hospital length of stay, inpatient costs, and temporal trends. The total cohort included 14,635 hospitalizations for STEMI complicated by CS treated with Impella between 2016 and 2020, of whom 5,505 (37.6%) received PA catheters. Over the study period, the use of PA catheters increased significantly from 25.9% to 41.8% (ptrend <0.01). Similarly, the use of Impella increased from 9.9% to 18.9% (ptrend <0.01). After adjustment for baseline characteristics using a multivariate logistic regression analysis, PA catheter use was associated with lower in-hospital mortality (adjusted odds ratio 0.80, 95% confidence interval 0.67 to 0.96, p = 0.01) and similar cardiovascular, neurologic, renal, and hematologic complications; length of stay; and inpatient costs compared with no PA catheter use. In conclusion, PA catheter use in patients with STEMI complicated by CS treated with Impella is associated with reduced in-hospital mortality and similar complication rates. Given the mortality benefit, further research is necessary to optimize PA catheter use in patients with STEMI with CS.
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Affiliation(s)
- Mahmoud Ismayl
- Department of Cardiovascular Medicine, Mayo Clinic School of Medicine, Rochester, Minnesota.
| | - Yasin Hussain
- Department of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut
| | - Ahmed Aboeata
- Department of Cardiovascular Medicine, Creighton University School of Medicine, Omaha, Nebraska
| | - Ryan W Walters
- Clinical Research and Evaluative Sciences, Creighton University School of Medicine, Omaha, Nebraska
| | - Srihari S Naidu
- Department of Cardiovascular Medicine, Westchester Medical Center and New York Medical College, Valhalla, New York
| | - John C Messenger
- Department of Cardiovascular Medicine, University of Colorado School of Medicine, Aurora, Colorado
| | - Mir B Basir
- Department of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan
| | - Sunil V Rao
- Department of Cardiovascular Medicine, NYU Langone Health System, New York, New York
| | - Andrew M Goldsweig
- Department of Cardiovascular Medicine, Baystate Medical Center and University of Massachusetts-Baystate, Springfield, Massachusetts
| | - S Elissa Altin
- Department of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut
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14
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Salter BS, Gross CR, Weiner MM, Dukkipati SR, Serrao GW, Moss N, Anyanwu AC, Burkhoff D, Lala A. Temporary mechanical circulatory support devices: practical considerations for all stakeholders. Nat Rev Cardiol 2023; 20:263-277. [PMID: 36357709 PMCID: PMC9649020 DOI: 10.1038/s41569-022-00796-5] [Citation(s) in RCA: 54] [Impact Index Per Article: 27.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/23/2022] [Indexed: 11/12/2022]
Abstract
Originally intended for life-saving salvage therapy, the use of temporary mechanical circulatory support (MCS) devices has become increasingly widespread in a variety of clinical settings in the contemporary era. Their use as a short-term, prophylactic support vehicle has expanded to include procedures in the catheterization laboratory, electrophysiology suite, operating room and intensive care unit. Accordingly, MCS device design and technology continue to develop at a rapid pace. In this Review, we describe the functionality, indications, management and complications associated with temporary MCS, together with scenario-specific utilization, goal-directed development and bioengineering of future devices. We address various considerations for the use of temporary MCS devices in both prophylactic and rescue scenarios, with input from stakeholders from various cardiovascular specialties, including interventional and heart failure cardiology, electrophysiology, cardiothoracic anaesthesiology, critical care and cardiac surgery.
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Affiliation(s)
- Benjamin S Salter
- Department of Anaesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
| | - Caroline R Gross
- Department of Anaesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | - Menachem M Weiner
- Department of Anaesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | - Srinivas R Dukkipati
- Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | - Gregory W Serrao
- Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai, New York, NY, USA
| | - Noah Moss
- Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai, New York, NY, USA
| | - Anelechi C Anyanwu
- Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA
| | | | - Anuradha Lala
- Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai, New York, NY, USA
- Department of Population Health Science and Policy, Mount Sinai, New York, NY, USA
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15
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Orandi BJ, McLeod MC, MacLennan PA, Lee WM, Fontana RJ, Karvellas CJ, McGuire BM, Lewis CE, Terrault NM, Locke JE. Association of FDA Mandate Limiting Acetaminophen (Paracetamol) in Prescription Combination Opioid Products and Subsequent Hospitalizations and Acute Liver Failure. JAMA 2023; 329:735-744. [PMID: 36881033 PMCID: PMC9993184 DOI: 10.1001/jama.2023.1080] [Citation(s) in RCA: 11] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/03/2022] [Accepted: 01/31/2023] [Indexed: 03/08/2023]
Abstract
Importance In January 2011, the US Food and Drug Administration (FDA) announced a mandate to limit acetaminophen (paracetamol) to 325 mg/tablet in combination acetaminophen and opioid medications, with manufacturer compliance required by March 2014. Objective To assess the odds of hospitalization and the proportion of acute liver failure (ALF) cases with acetaminophen and opioid toxicity prior to and after the mandate. Design, Setting, and Participants This interrupted time-series analysis used hospitalization data from 2007-2019 involving ICD-9/ICD-10 codes consistent with both acetaminophen and opioid toxicity from the National Inpatient Sample (NIS), a large US hospitalization database, and ALF cases from 1998-2019 involving acetaminophen and opioid products from the Acute Liver Failure Study Group (ALFSG), a cohort of 32 US medical centers. For comparison, hospitalizations and ALF cases consistent with acetaminophen toxicity alone were extracted from the NIS and ALFSG. Exposures Time prior to and after the FDA mandate limiting acetaminophen to 325 mg in combination acetaminophen and opioid products. Main Outcomes and Measures Odds of hospitalization involving acetaminophen and opioid toxicity and percentage of ALF cases from acetaminophen and opioid products prior to and after the mandate. Results In the NIS, among 474 047 585 hospitalizations from Q1 2007 through Q4 2019, there were 39 606 hospitalizations involving acetaminophen and opioid toxicity; 66.8% of cases were among women; median age, 42.2 (IQR, 28.4-54.1). In the ALFSG, from Q1 1998 through Q3 2019, there were a total of 2631 ALF cases, of which 465 involved acetaminophen and opioid toxicity; 85.4% women; median age, 39.0 (IQR, 32.0-47.0). The predicted incidence of hospitalizations 1 day prior to the FDA announcement was 12.2 cases/100 000 hospitalizations (95% CI, 11.0-13.4); by Q4 2019, it was 4.4/100 000 hospitalizations (95% CI, 4.1-4.7) (absolute difference, 7.8/100 000 [95% CI, 6.6-9.0]; P < .001). The odds of hospitalizations with acetaminophen and opioid toxicity increased 11%/y prior to the announcement (odds ratio [OR], 1.11 [95% CI, 1.06-1.15]) and decreased 11%/y after the announcement (OR, 0.89 [95% CI, 0.88-0.90]). The predicted percentage of ALF cases involving acetaminophen and opioid toxicity 1 day prior to the FDA announcement was 27.4% (95% CI, 23.3%-31.9%); by Q3 2019, it was 5.3% (95% CI, 3.1%-8.8%) (absolute difference, 21.8% [95% CI, 15.5%-32.4%]; P < .001). The percentage of ALF cases involving acetaminophen and opioid toxicity increased 7% per year prior to the announcement (OR, 1.07 [95% CI, 1.03-1.1]; P < .001) and decreased 16% per year after the announcement (OR, 0.84 [95% CI, 0.77-0.92]; P < .001). Sensitivity analyses confirmed these findings. Conclusions and Relevance The FDA mandate limiting acetaminophen dosage to 325 mg/tablet in prescription acetaminophen and opioid products was associated with a statistically significant decrease in the yearly rate of hospitalizations and proportion per year of ALF cases involving acetaminophen and opioid toxicity.
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Affiliation(s)
- Babak J. Orandi
- University of Alabama at Birmingham Heersink School of Medicine
- Joan & Sanford Weill Medical College of Cornell University, New York, New York
| | | | | | - William M. Lee
- University of Texas Southwestern Medical Center at Dallas
| | | | | | | | - Cora E. Lewis
- University of Alabama at Birmingham School of Public Health
| | - Norah M. Terrault
- University of Southern California Keck School of Medicine, Los Angeles
| | - Jayme E. Locke
- University of Alabama at Birmingham Heersink School of Medicine
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16
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Randomized Trials of Percutaneous Microaxial Flow Pump Devices. J Am Coll Cardiol 2022; 80:2028-2049. [DOI: 10.1016/j.jacc.2022.08.807] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/11/2022] [Accepted: 08/22/2022] [Indexed: 11/16/2022]
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17
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Miller PE, Bromfield SG, Ma Q, Crawford G, Whitney J, DeVries A, Desai NR. Clinical Outcomes and Cost Associated With an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump in Patients Presenting With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA Intern Med 2022; 182:926-933. [PMID: 35849410 PMCID: PMC9295019 DOI: 10.1001/jamainternmed.2022.2735] [Citation(s) in RCA: 63] [Impact Index Per Article: 21.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Importance Intravascular microaxial left ventricular assist device (LVAD) compared with intra-aortic balloon pump (IABP) has been associated with increased risk of mortality and bleeding among patients with acute myocardial infarction (AMI) and cardiogenic shock (CS) undergoing percutaneous coronary intervention (PCI). However, evidence on the association of device therapy with a broader array of clinical outcomes, including data on long-term outcomes and cost, is limited. Objective To examine the association between intravascular LVAD or IABP use and clinical outcomes and cost in patients with AMI complicated by CS. Design, Setting, and Participants This retrospective propensity-matched cohort study used administrative claims data for commercially insured patients from 14 states across the US. Patients included in the analysis underwent PCI for AMI complicated by CS from January 1, 2015, to April 30, 2020. Data analysis was performed from April to November 2021. Exposures Use of either an intravascular LVAD or IABP. Main Outcomes and Measures The primary outcomes were mortality, stroke, severe bleeding, repeat revascularization, kidney replacement therapy (KRT), and total health care costs during the index admission. Clinical outcomes and cost were also assessed at 30 days and 1 year. Results Among 3077 patients undergoing PCI for AMI complicated by CS, the mean (SD) age was 65.2 (12.5) years, and 986 (32.0%) had cardiac arrest. Among 817 propensity-matched pairs, intravascular LVAD use was associated with significantly higher in-hospital (36.2% vs 25.8%; odds ratio [OR], 1.63; 95% CI, 1.32-2.02), 30-day (40.1% vs 28.3%; OR, 1.71; 95% CI, 1.37-2.13), and 1-year mortality (58.9% vs 45.0%; hazard ratio [HR], 1.44; 95% CI, 1.21-1.71) compared with IABP. At 30 days, intravascular LVAD use was associated with significantly higher bleeding (19.1% vs 14.5%; OR, 1.35; 95% CI, 1.04-1.76), KRT (12.2% vs 7.0%; OR, 1.88; 95% CI, 1.30-2.73), and mean cost (+$51 680; 95% CI, $31 488-$75 178). At 1 year, the association of intravascular LVAD use with bleeding (29.7% vs 24.3%; HR, 1.36; 95% CI, 1.05-1.75), KRT (18.1% vs 10.9%; HR, 1.95; 95% CI, 1.35-2.83), and mean cost (+$46 609; 95% CI, $22 126-$75 461) persisted. Conclusions and Relevance In this propensity-matched analysis of patients undergoing PCI for AMI complicated by CS, intravascular LVAD use was associated with increased short-term and 1-year risk of mortality, bleeding, KRT, and cost compared with IABP. There is an urgent need for additional evidence surrounding the optimal management of patients with AMI complicated by CS.
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Affiliation(s)
- P. Elliott Miller
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
| | | | - Qinli Ma
- Enterprise Health Services Research, Anthem Inc, Wilmington, Delaware
| | - Geoffrey Crawford
- Medical Policy & Technology Assessment, Anthem Inc, Indianapolis, Indiana
| | - John Whitney
- Medical Policy & Technology Assessment, Anthem Inc, Indianapolis, Indiana
| | - Andrea DeVries
- Enterprise Health Services Research, Anthem Inc, Wilmington, Delaware
| | - Nihar R. Desai
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut
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18
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Zahid S, Din MTU, Khan MZ, Rai D, Ullah W, Sanchez-Nadales A, Elkhapery A, Khan MU, Goldsweig AM, Singla A, Fonarrow G, Balla S. Trends, Predictors, and Outcomes of 30-Day Readmission With Heart Failure After Transcatheter Aortic Valve Replacement: Insights From the US Nationwide Readmission Database. J Am Heart Assoc 2022; 11:e024890. [PMID: 35929464 PMCID: PMC9496292 DOI: 10.1161/jaha.121.024890] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
BACKGROUND Data on trends, predictors, and outcomes of heart failure (HF) readmissions after transcatheter aortic valve replacement (TAVR) remain limited. Moreover, the relationship between hospital TAVR discharge volume and HF readmission outcomes has not been established. METHODS AND RESULTS The Nationwide Readmission Database was used to identify 30‐day readmissions for HF after TAVR from October 1, 2015, to November 30, 2018, using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD‐10‐CM) codes. A total of 167 345 weighted discharges following TAVR were identified. The all‐cause readmission rate within 30 days of discharge was 11.4% (19 016). Of all the causes of 30‐day rehospitalizations, HF comprised 31.4% (5962) of all causes. The 30‐day readmission rate for HF did not show a significant decline during the study period (Ptrend=0.06); however, all‐cause readmission rates decreased significantly (Ptrend=0.03). HF readmissions were comparable between high‐ and low‐volume TAVR centers. Charlson Comorbidity Index >8, length of stay >4 days during the index hospitalization, chronic obstructive pulmonary disease, atrial fibrillation, chronic HF, preexisting pacemaker, complete heart block during index hospitalization, paravalvular regurgitation, chronic kidney disease, and end‐stage renal disease were independent predictors of 30‐day HF readmission after TAVR. HF readmissions were associated with higher mortality rates when compared with non‐HF readmissions (4.9% versus 3.3%; P<0.01). Each HF readmission within 30 days was associated with an average increased cost of $13 000 more than for each non‐HF readmission. CONCLUSIONS During the study period from 2015 to 2018, 30‐day HF readmissions after TAVR remained steady despite all‐cause readmissions decreasing significantly. All‐cause readmission mortality and HF readmission mortality also showed a nonsignificant downtrend. HF readmissions were comparable across low‐, medium‐, and high‐volume TAVR centers. HF readmission was associated with increased mortality and resource use attributed to the increased costs of care compared with non‐HF readmission. Further studies are needed to identify strategies to decrease the burden of HF readmissions and related mortality after TAVR.
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Affiliation(s)
- Salman Zahid
- Department of Medicine Rochester General Hospital Rochester NY
| | | | - Muhammad Zia Khan
- Division of Cardiology West Virginia University Heart & Vascular Institute Morgantown WV
| | - Devesh Rai
- Department of Medicine Rochester General Hospital Rochester NY
| | - Waqas Ullah
- Department of Cardiovascular Medicine Jefferson University Hospitals Philadelphia PA
| | | | - Ahmed Elkhapery
- Department of Medicine Rochester General Hospital Rochester NY
| | - Muhammad Usman Khan
- Division of Cardiology West Virginia University Heart & Vascular Institute Morgantown WV
| | - Andrew M Goldsweig
- Division of Cardiovascular Medicine University of Nebraska Medical Center Omaha NE
| | | | - Greg Fonarrow
- Division of Cardiovascular Medicine University of California Los Angeles Los Angeles CA
| | - Sudarshan Balla
- Division of Cardiology West Virginia University Heart & Vascular Institute Morgantown WV
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19
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Bjarnason TA, Mentias A, Panaich S, Vaughan Sarrazin M, Gao Y, Desai M, Pandey A, Dhruva SS, Desai NR, Girotra S. Diffusion of Percutaneous Ventricular Assist Devices in US Markets. Circ Cardiovasc Interv 2022; 15:e011778. [PMID: 35904015 PMCID: PMC10797917 DOI: 10.1161/circinterventions.121.011778] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Percutaneous ventricular assist devices (PVADs) have been replacing intra-aortic balloon pumps for hemodynamic support during percutaneous coronary intervention (PCI), even though data supporting a benefit for hard clinical end points remain limited. We evaluated diffusion of PVADs across US markets and examined the association of market utilization of PVAD with mortality and cost. METHODS Using the 2013 to 2019 Medicare data, we identified all patients aged ≥65 years who underwent PCI with either a PVAD or intra-aortic balloon pump. We used hospital referral region to define regional health care markets and categorized them in quartiles based on the proportional use of PVADs during PCI. Multilevel models were constructed to determine the association of patient, hospital, and market factors with utilization of PVADs and the association of PVAD utilization with 30-day mortality and cost. RESULTS A total of 79 176 patients underwent PCI with either intra-aortic balloon pump (47 514 [60.0%]) or PVAD (31 662 [40.0%]). The proportion of PCI procedures with PVAD increased over time (17% in 2013 to 57% in 2019; P for trend, <0.001), such that PVADs overtook intra-aortic balloon pump for hemodynamic support during PCI in 2018. There was a large variation in PVAD utilization across markets (range, 0%-85%), which remained unchanged after adjustment of patient characteristics (median odds ratio, 2.05 [95% CI, 1.91-2.17]). The presence of acute myocardial infarction, cardiogenic shock, and emergent status was associated with a 45% to 50% lower odds of PVAD use suggesting that PVADs were less likely to be used in the sickest patients. Greater utilization of PVAD at the market level was not associated with lower risk mortality but was associated with higher cost. CONCLUSIONS Although utilization of PVADs for PCI continues to increase, there is large variation in PVAD utilization across markets. Greater market utilization of PVADs was not associated with lower mortality but was associated with higher cost.
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Affiliation(s)
- Thorarinn A Bjarnason
- Division of Cardiovascular Medicine (T.A.B, S.P.), Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City
| | - Amgad Mentias
- Department of Cardiovascular Medicine, Heart, Thoracic and Vascular Institute, Cleveland Clinic, OH (A.M., M.D.)
| | - Sidakpal Panaich
- Division of Cardiovascular Medicine (T.A.B, S.P.), Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City
| | - Mary Vaughan Sarrazin
- General Internal Medicine (M.V.S, Y.G.), Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City
- University of Iowa Carver College of Medicine and Center for Access and Delivery Research and Evaluation, Iowa City (M.V.S.)
| | - Yubo Gao
- General Internal Medicine (M.V.S, Y.G.), Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City
| | - Milind Desai
- Department of Cardiovascular Medicine, Heart, Thoracic and Vascular Institute, Cleveland Clinic, OH (A.M., M.D.)
| | - Ambarish Pandey
- Division of Cardiovascular Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (A.P., S.G.)
| | - Sanket S Dhruva
- Department of Medicine, University of California, San Francisco (S.S.D.)
| | - Nihar R Desai
- Center for Outcomes Research and Evaluation and Department of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT (N.R.D.)
| | - Saket Girotra
- Division of Cardiovascular Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (A.P., S.G.)
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20
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Huang YX, Xu ZM, Zhao L, Cao Y, Chen Y, Qiu YG, Liu YM, Zhang PY, He JC, Li TC. Long-term outcomes of high-risk percutaneous coronary interventions under extracorporeal membrane oxygenation support: An observational study. World J Clin Cases 2022; 10:5266-5274. [PMID: 35812664 PMCID: PMC9210891 DOI: 10.12998/wjcc.v10.i16.5266] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/02/2021] [Revised: 12/30/2021] [Accepted: 04/04/2022] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Venoarterial extracorporeal membrane oxygenation (VA-ECMO) offers hemodynamic support for patients undergoing high-risk percutaneous coronary interventions (PCIs). However, long-term outcomes associated with VA-ECMO have not previously been studied.
AIM To explore long-term outcomes in high-risk cases undergoing PCI supported by VA-ECMO.
METHODS In the present observational cohort study, 61 patients who received VA-ECMO-supported high-risk PCI between April 2012 and January 2020 at the Sixth Medical Center of Chinese People’s Liberation Army General Hospital were enrolled. The endpoint characteristics such as all-cause mortality, repeated cardiovascular diseases, and cardiac death were examined.
RESULTS Among 61 patients, three failed stent implantation due to chronic total occlusions with severely calcified lesions. One patient showed VA-ECMO intolerance because of high left ventricular afterload. PCI was successfully performed in 57 patients (93.4%). The in-hospital mortality was 23.0%, and the overall survival was 45.9%, with a median follow-up period of 38.6 (8.6-62.1) mo.
CONCLUSION VA-ECMO can be used as a support in patients undergoing high-risk PCI as it is associated with favorable long-term patient survival.
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Affiliation(s)
- Yi-Xiong Huang
- Medical School of Chinese People’s Liberation Army, Beijing 100853, China
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Zheng-Ming Xu
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Li Zhao
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Yi Cao
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Yu Chen
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Yi-Gang Qiu
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Ying-Ming Liu
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Peng-Yu Zhang
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Jiang-Chun He
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
| | - Tian-Chang Li
- Department of Cardiology, Sixth Medical Center of Chinese People’s Liberation Army General Hospital, Beijing 100048, China
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21
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Hirst CS, Thayer KL, Harwani N, Kapur NK. Post-Closure Technique to Reduce Vascular Complications Related to Impella CP. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2022; 39:38-42. [PMID: 34810113 DOI: 10.1016/j.carrev.2021.10.008] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/22/2021] [Revised: 10/14/2021] [Accepted: 10/18/2021] [Indexed: 01/04/2023]
Abstract
BACKGROUND Use of percutaneous mechanical circulatory support has grown exponentially. Vascular complications remain a growing concern and best practices for device removal do not exist. We describe a novel post-closure technique for the next generation Impella CP removal and immediate hemostasis. METHODS This study is a single center, retrospective, exploratory analysis of 11 consecutive patients receiving an Impella CP for either high-risk PCI or cardiogenic shock and then referred for post-closure compared to 20 patients receiving manual compression for Impella CP removal between 2017 and 2019. RESULTS Mean age range was 62.7-65.4 years and 50-65% male between groups. Average duration of Impella CP treatment ranged from 3.4 to 5.2 days. Patients referred for post-closure had significantly lower rates of all-cause adverse vascular events (0% versus 40%; n = 0/11 versus n = 8/20; p = 0.01). There was no significant difference in BARC 3 or greater bleeding, transfusion requirement, hospitalization duration or intensive care duration between removal strategies. CONCLUSION The novel post-closure technique may significantly reduce vascular complications associated with device removal and may improve clinical outcomes for these critically ill patients.
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Affiliation(s)
- Colin S Hirst
- Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA, United States of America; Ascension Saint John Heart and Vascular Institute, Ascension Saint John Hospital, Detroit, MI, United States of America
| | - Katherine L Thayer
- Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA, United States of America
| | - Neil Harwani
- Tufts University School of Medicine, Boston, MA, United States of America
| | - Navin K Kapur
- Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, MA, United States of America.
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22
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Ritchie C, Walters RW, Ramaswamy S, Alla VM. Impact of delirium on mortality in patients hospitalized for heart failure. Int J Psychiatry Med 2022; 57:212-225. [PMID: 34176306 DOI: 10.1177/00912174211028019] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
OBJECTIVE Heart Failure (HF) is one of the leading causes of hospitalization in the United States accounting for ≈800,000 hospital discharges and $11 billion in annual costs. Delirium occurs in approximately 30% of elderly hospitalized patients and its incidence is significantly higher among those admitted to the critical care units. Despite this, there has been limited exploration of the clinical and economic impact of delirium in patients hospitalized with acute HF. We hypothesized that delirium in HF is associated with excess mortality and hospital costs. METHODS We queried the 2001-2014 Nationwide Inpatient Sample to identify hospitalizations that included a primary discharge diagnosis of HF (ICD-9-CM: 428.xx) and stratified them by presence or absence of delirium (ICD-9-CM: 239.0, 290.41, 293.0, 293.1, 348.31). Differences in in-hospital mortality, length of stay (LOS), and hospital costs were assessed using propensity-score matched cohorts. RESULTS Major predictors of delirium included advanced age, Caucasian race, underlying dementia or psychiatric diagnoses, higher Elixhauser Comorbidity Index, renal failure, cardiogenic shock, and coronary artery bypass surgery. In the propensity-score matched analysis of 76,411 hospitalization with delirium compared to 76,612 without delirium, in-hospital mortality (odds ratio: 1.67, 95% CI: 1.51-1.77), LOS (rate ratio [RR]: 1.47, 95% CI: 1.45-1.51), and hospital costs (RR: 1.44, 95% CI: 1.41-1.48) were all statistically higher in the presence of delirium (all p < 0.001). CONCLUSION In patients hospitalized with HF, delirium is an independent predictor of increased in-hospital mortality, longer LOS, and excess hospital costs despite adjustment for baseline characteristics.
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Affiliation(s)
| | - Ryan W Walters
- Division of Clinical Research and Evaluative Sciences, 12282Creighton University School of Medicine, Department of Medicine, Creighton University School of Medicine, Omaha, NE, USA
| | - Sriram Ramaswamy
- Department of Psychiatry, Creighton University School of Medicine, Creighton University School of Medicine, Omaha, NE, USA
| | - Venkata M Alla
- Division of Cardiology, Department of Medicine, Creighton University School of Medicine, Omaha, NE, USA
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23
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Llaó I, Ariza-Solé A. Cardiogenic shock: approaching the truth. J Geriatr Cardiol 2022; 19:95-97. [PMID: 35317393 PMCID: PMC8915422 DOI: 10.11909/j.issn.1671-5411.2022.02.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/07/2022] Open
Affiliation(s)
- Isaac Llaó
- Cardiology Department, Intensive Cardiac Care Unit, Bellvitge University Hospital, L’ Hospitalet de Llobregat, Barcelona, Spain
| | - Albert Ariza-Solé
- Cardiology Department, Intensive Cardiac Care Unit, Bellvitge University Hospital, L’ Hospitalet de Llobregat, Barcelona, Spain
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24
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Incidence and Timing of Thrombocytopenia in Patients Receiving Impella Ventricular Assist Device Support. ASAIO J 2022; 68:1135-1140. [DOI: 10.1097/mat.0000000000001625] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
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25
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Kim Y, Shapero K, Ahn SS, Goldsweig AM, Desai N, Elissa Altin S. Outcomes of mechanical circulatory support for acute myocardial infarction complicated by cardiogenic shock. Catheter Cardiovasc Interv 2022; 99:658-663. [PMID: 34156755 PMCID: PMC10877703 DOI: 10.1002/ccd.29834] [Citation(s) in RCA: 26] [Impact Index Per Article: 8.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/11/2021] [Revised: 06/03/2021] [Accepted: 06/06/2021] [Indexed: 12/15/2022]
Abstract
BACKGROUND Mechanical circulatory support (MCS) with the Impella device (Abiomed, Danvers, MA) has been associated with higher in-hospital mortality than intra-aortic balloon pump (IABP) in the Premier Healthcare Database and National Cardiovascular Data Registry. METHODS The objective of this retrospective cohort study was to describe trends and outcomes of Impella usage in acute myocardial infarction complicated by cardiogenic shock (AMICS) treated with MCS (Impella or IABP) using real-world observational data from the National Inpatient Sample (NIS) including hospitalizations for AMICS managed with MCS between January 2012 to December 2017. The primary outcomes included in-hospital mortality, transfusion, acute kidney injury, stroke, total costs, and length of stay. Propensity score matching was performed with hierarchical models using risk factor and Elixhauser comorbidity variables. RESULTS AND CONCLUSION We identified 54,480 hospitalizations for AMICS managed with MCS including 5750 (10.5%) utilizing Impella. Throughout the study period, Impella usage increased yearly to 19.9% of AMICS cases in 2017. After propensity score matching, Impella was associated with higher in-hospital mortality (odds ratio [OR] 1.74, 95% confidence interval [CI] 1.41-2.13) and transfusions (OR 1.97, 95% CI 1.40-2.78) than IABP, without association with acute kidney injury or stroke. Impella use was associated with higher hospital costs (mean difference $22,416.80 [95% CI $17,029-27,804]). Impella usage for AMICS increased significantly from 2012 to 2017 and was associated with increased in-hospital mortality and costs. Randomized controlled trials are urgently needed to assess the safety and efficacy of Impella.
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Affiliation(s)
- Yeunjung Kim
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
| | - Kayle Shapero
- Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
| | - Shawn S. Ahn
- Department of Biomedical Engineering, Yale University School of Medicine, New Haven, Connecticut, USA
| | - Andrew M. Goldsweig
- Division of Cardiovascular Medicine, Department of Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA
| | - Nihar Desai
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
| | - S. Elissa Altin
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
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26
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Rali AS, Hall EJ, Dieter R, Ranka S, Civitello A, Bacchetta MD, Shah AS, Schlendorf K, Lindenfeld J, Chatterjee S. Left Ventricular Unloading during Extracorporeal Life Support: Current Practice. J Card Fail 2021; 28:1326-1336. [PMID: 34936896 DOI: 10.1016/j.cardfail.2021.12.002] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/15/2021] [Revised: 11/24/2021] [Accepted: 12/06/2021] [Indexed: 11/29/2022]
Abstract
Veno-arterial extracorporeal life support (VA-ECLS) is a powerful tool that can provide complete cardiopulmonary support for patients with refractory cardiogenic shock. However, VA-ECLS increases left ventricular afterload resulting in greater myocardial oxygen demand, which can impair myocardial recovery and worsen pulmonary edema. These complications can be ameliorated by various LV venting strategies to unload the LV. Evidence suggests that LV venting improves outcomes in VA-ECLS, but there is a paucity of randomized trials to help guide optimal strategy and the timing of venting. In this review, we discuss the available evidence regarding LV venting in VA-ECLS, explain important hemodynamic principles involved, and propose a practical approach to LV venting in VA-ECLS.
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Key Words
- Atrial septal defect, BNP
- Brain natriuretic peptide, CS
- Cardiogenic shock, IABP
- Extracorporeal life support, left ventricular unloading, left ventricular venting, cardiogenic shock, Abbreviations, ASD
- Intra-aortic balloon pump, LA
- Left atrium, LV
- Left ventricle, LVAD
- Left ventricular assist device, MCS
- Mechanical circulatory support, PAC
- Percutaneous ventricular assist device, RV
- Pulmonary artery catheter, PCWP
- Pulmonary capillary wedge pressure, P-VAD
- Right ventricle, VA-ECLS
- Veno-arterial extracorporeal life support
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Affiliation(s)
- Aniket S Rali
- Division of Cardiovascular Diseases, Vanderbilt University Medical Center, Nashville, Tennessee.
| | - Eric J Hall
- Division of Cardiovascular Diseases, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Raymond Dieter
- Division of Cardiovascular Diseases, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Sagar Ranka
- Department of Cardiovascular Diseases, University of Kansas Medical Center, Kansas City, Kansas
| | - Andrew Civitello
- Division of Cardiology, Department of Medicine, Baylor College of Medicine, Houston, Texas; Department of Cardiology, Texas Heart Institute, Houston, Texas
| | - Matthew D Bacchetta
- Division of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Ashish S Shah
- Division of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Kelly Schlendorf
- Division of Cardiovascular Diseases, Vanderbilt University Medical Center, Nashville, Tennessee
| | - JoAnn Lindenfeld
- Division of Cardiovascular Diseases, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Subhasis Chatterjee
- Divisions of General and Cardiothoracic Surgery, Michael E. DeBakey Department of Surgery, Baylor College Medicine, Houston, Texas; Department of Cardiovascular Surgery, Texas Heart Institute, Houston, Texas
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Doll JA, O'Donnell CI, Plomondon ME, Waldo SW. Contemporary Clinical and Coronary Anatomic Risk Model for 30-Day Mortality After Percutaneous Coronary Intervention. Circ Cardiovasc Interv 2021; 14:e010863. [PMID: 34903032 DOI: 10.1161/circinterventions.121.010863] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Percutaneous coronary intervention (PCI) procedures are increasing in clinical and anatomic complexity, likely increasing the calculated risk of mortality. There is need for a real-time risk prediction tool that includes clinical and coronary anatomic information that is integrated into the electronic medical record system. METHODS We assessed 70 503 PCIs performed in 73 Veterans Affairs hospitals from 2008 to 2019. We used regression and machine-learning strategies to develop a prediction model for 30-day mortality following PCI. We assessed model performance with and without inclusion of the Veterans Affairs SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), an assessment of anatomic complexity. Finally, the discriminatory ability of the Veterans Affairs model was compared with the CathPCI mortality model. RESULTS The overall 30-day morality rate was 1.7%. The final model included 14 variables. Presentation status (salvage, emergent, urgent), ST-segment-elevation myocardial infarction, cardiogenic shock, age, congestive heart failure, prior valve disease, chronic kidney disease, chronic lung disease, atrial fibrillation, elevated international normalized ratio, and the Veterans Affairs SYNTAX score were all associated with increased risk of death, while increasing body mass index, hemoglobin level, and prior coronary artery bypass graft surgery were associated with lower risk of death. C-index for the development cohort was 0.93 (95% CI, 0.92-0.94) and for the 2019 validation cohort and the site validation cohort was 0.87 (95% CI, 0.83-0.92) and 0.86 (95% CI, 0.83-0.89), respectively. The positive likelihood ratio of predicting a mortality event in the top decile was 2.87% more accurate than the CathPCI mortality model. Inclusion of anatomic information in the model resulted in significant improvement in model performance (likelihood ratio test P<0.01). CONCLUSIONS This contemporary risk model accurately predicts 30-day post-PCI mortality using a combination of clinical and anatomic variables. This can be immediately implemented into clinical practice to promote personalized informed consent discussions and appropriate preparation for high-risk PCI cases.
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Affiliation(s)
- Jacob A Doll
- VA Puget Sound Health Care System, Seattle, WA (J.A.D.).,University of Washington, Seattle, WA (J.A.D.).,CART Program, Office of Quality and Patient Safety, Veterans Health Administration, Washington DC (J.A.D., C.I.O., M.E.P., S.W.W.)
| | - Colin I O'Donnell
- CART Program, Office of Quality and Patient Safety, Veterans Health Administration, Washington DC (J.A.D., C.I.O., M.E.P., S.W.W.).,Rocky Mountain Regional VA Medical Center, Aurora, CO (C.I.O., M.E.P., S.W.W.)
| | - Meg E Plomondon
- CART Program, Office of Quality and Patient Safety, Veterans Health Administration, Washington DC (J.A.D., C.I.O., M.E.P., S.W.W.).,Rocky Mountain Regional VA Medical Center, Aurora, CO (C.I.O., M.E.P., S.W.W.)
| | - Stephen W Waldo
- CART Program, Office of Quality and Patient Safety, Veterans Health Administration, Washington DC (J.A.D., C.I.O., M.E.P., S.W.W.).,Rocky Mountain Regional VA Medical Center, Aurora, CO (C.I.O., M.E.P., S.W.W.).,University of Colorado School of Medicine, Aurora (S.W.W.)
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Thakkar S, Patel HP, Kumar A, Tan BEX, Arora S, Patel S, Doshi R, Depta JP, Kalra A, Dani SS, Deshmukh A, Badheka A, Widmer RJ, Mamas MA, Rihal CS, Girotra S, Panaich SS. Outcomes of Impella compared with intra-aortic balloon pump in ST-elevation myocardial infarction complicated by cardiogenic shock. AMERICAN HEART JOURNAL PLUS : CARDIOLOGY RESEARCH AND PRACTICE 2021; 12:100067. [PMID: 38559603 PMCID: PMC10978134 DOI: 10.1016/j.ahjo.2021.100067] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/07/2021] [Revised: 10/21/2021] [Accepted: 10/27/2021] [Indexed: 04/04/2024]
Abstract
Background Despite limited randomized trial data demonstrating clinical efficacy, the utilization of Impella in ST-elevation myocardial infarction (STEMI) patients complicated with cardiogenic shock (CS) has increased over time. Methods We identified 75,769 hospitalizations with STEMI complicated by CS between October 2015 and December 2018 using International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. From this cohort, hospitalizations were stratified according to IABP or Impella placement. The primary outcome was all-cause in-hospital mortality. Secondary outcomes were divided into efficacy, safety, and device-related complications. Propensity-score matching was used to account for differences in the baseline characteristics between the groups. Logistic regression was performed to get the odds ratio and confidence intervals. Results Among 75,769 admissions with STEMI and CS, hospitalizations with <18 years old, both IABP and Impella placement, and who underwent ECMO and/or LVAD implantation were excluded. After the exclusion, out of 72,791 admissions, 25,260 (34.70%) hospitalizations received IABP, and 7825 (10.75%) received Impella support. After propensity score-matched analysis, 7345 hospitalizations were included in each group. All-cause in-hospital mortality was higher in the hospitalizations requiring Impella support as compared to IABP (42.10% vs. 31.54%, adjusted OR 1.71; 95% confidence interval (CI) 1.60-1.84, P < 0.0001). Impella was associated with a higher risk of in-hospital complications and hospitalization cost compared with IABP. Conclusion Impella compared with IABP in STEMI patients with CS was associated with higher in-hospital mortality and other adverse clinical and procedural outcomes.
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Affiliation(s)
| | - Harsh P. Patel
- Department of Internal Medicine, Louis A Weiss Memorial Hospital, Chicago, IL, USA
| | - Ashish Kumar
- Section of Cardiovascular Research, Heart, Vascular and Thoracic Department, Cleveland Clinic Akron General, Akron, OH, USA
- Department of Internal Medicine, Cleveland Clinic Akron General, Akron, OH, USA
| | - Bryan E-Xin Tan
- Department of Internal Medicine, Rochester General Hospital, Rochester, NY, USA
| | - Shilpkumar Arora
- Department of Cardiology, Case Western University, Cleveland, OH, USA
| | - Smit Patel
- Department of Internal Medicine, Vassar Brothers Medical Center, Poughkeepsie, NY, USA
| | - Rajkumar Doshi
- Department of Internal Medicine, University of Nevada Reno School of Medicine, Reno, NV, USA
| | - Jeremiah P. Depta
- Sands Constellation Heart Institute, Rochester Regional Health, Rochester, NY, USA
| | - Ankur Kalra
- Section of Cardiovascular Research, Heart, Vascular and Thoracic Department, Cleveland Clinic Akron General, Akron, OH, USA
- Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA
| | - Sourbha S. Dani
- Department of Cardiology, Lahey Hospital & Medical Center, MA, USA
| | - Abhishek Deshmukh
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA
| | - Apurva Badheka
- Heart and Vascular Center, The Everett Clinic, Everett, WA, USA
| | - Robert J. Widmer
- Department of Cardiovascular Medicine, Baylor Scott & White Health, Temple, TX, USA
| | - Mamas A. Mamas
- Keele Cardiovascular Research Group, Institute of Applied Clinical Science, Keele University, Stoke-on-Trent, UK
- Keele Cardiovascular Research Group, Institute of Primary Care and Health Sciences, Keele University, Stoke-on-Trent, UK
| | | | - Saket Girotra
- Department of Cardiology, University of Iowa Carver College of Medicine, IA, USA
| | - Sidakpal S. Panaich
- Department of Cardiology, University of Iowa Carver College of Medicine, IA, USA
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Samsky MD, Morrow DA, Proudfoot AG, Hochman JS, Thiele H, Rao SV. Cardiogenic Shock After Acute Myocardial Infarction: A Review. JAMA 2021; 326:1840-1850. [PMID: 34751704 PMCID: PMC9661446 DOI: 10.1001/jama.2021.18323] [Citation(s) in RCA: 213] [Impact Index Per Article: 53.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
IMPORTANCE Cardiogenic shock affects between 40 000 and 50 000 people in the US per year and is the leading cause of in-hospital mortality following acute myocardial infarction. OBSERVATIONS Thirty-day mortality for patients with cardiogenic shock due to myocardial infarction is approximately 40%, and 1-year mortality approaches 50%. Immediate revascularization of the infarct-related coronary artery remains the only treatment for cardiogenic shock associated with acute myocardial infarction supported by randomized clinical trials. The Percutaneous Coronary Intervention Strategies with Acute Myocardial Infarction and Cardiogenic Shock (CULPRIT-SHOCK) clinical trial demonstrated a reduction in the primary outcome of 30-day death or kidney replacement therapy; 158 of 344 patients (45.9%) in the culprit lesion revascularization-only group compared with 189 of 341 patients (55.4%) in the multivessel percutaneous coronary intervention group (relative risk, 0.83 [95% CI, 0.71-0.96]; P = .01). Despite a lack of randomized trials demonstrating benefit, percutaneous mechanical circulatory support devices are frequently used to manage cardiogenic shock following acute myocardial infarction. CONCLUSIONS AND RELEVANCE Cardiogenic shock occurs in up to 10% of patients immediately following acute myocardial infarction and is associated with mortality rates of nearly 40% at 30 days and 50% at 1 year. Current evidence and clinical practice guidelines support immediate revascularization of the infarct-related coronary artery as the primary therapy for cardiogenic shock following acute myocardial infarction.
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Affiliation(s)
- Marc D Samsky
- Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
| | - David A Morrow
- TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
| | - Alastair G Proudfoot
- Perioperative Medicine Department, Barts Heart Centre, St Bartholomew's Hospital, London, United Kingdom
- Clinic For Anesthesiology & Intensive Care, Charité-Universitätsmedizin Berlin corporate member of Free University Berlin and Humboldt University Berlin, Germany
- Department of Anaesthesiology & Intensive Care, German Heart Centre Berlin, Germany
| | - Judith S Hochman
- Cardiovascular Clinical Research Center, Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York, New York
| | - Holger Thiele
- Department of Internal Medicine/Cardiology, Leipzig Heart Institute, Heart Center Leipzig at University of Leipzig, Leipzig, Germany
| | - Sunil V Rao
- Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
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30
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Takahashi K, Kubo S, Ikuta A, Osakada K, Takamatsu M, Taguchi Y, Ohya M, Shimada T, Miura K, Tada T, Tanaka H, Fuku Y, Kadota K. Incidence, predictors, and clinical outcomes of mechanical circulatory support-related complications in patients with cardiogenic shock. J Cardiol 2021; 79:163-169. [PMID: 34511239 DOI: 10.1016/j.jjcc.2021.08.011] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/15/2021] [Revised: 07/13/2021] [Accepted: 08/04/2021] [Indexed: 01/01/2023]
Abstract
BACKGROUND Mechanical circulatory support (MCS) is essential to maintain the hemodynamics in selected patients with cardiogenic shock (CS). However, little is known about predictors and clinical impact of device-related complications on clinical outcomes in patients with MCS. METHODS We retrospectively reviewed consecutive 477 patients who received veno-arterial extracorporeal membrane oxygenation (VA-ECMO), Impella (Abiomed, Danvers, MA, USA), and intra-aortic balloon pump (IABP) from January 2012 to May 2020. After excluding patients with only VA-ECMO and patients with MCS for procedural support, 403 patients were included in this study. Predictors and clinical outcomes of device-related complications were analyzed. Furthermore, complication rates were compared between Impella and IABP groups in patients with and without VA-ECMO. RESULTS Hemolysis, major bleeding defined by Bleeding Academic Research Consortium type 3 or 5 bleeding, thromboembolic events, and ischemic stroke were observed in 42 (10.4%), 150 (37.2%), 52 (12.9%), and 30 patients (7.4%), respectively. Patients with major bleeding had a higher in-hospital mortality than those without major bleeding (31.2% vs. 56.0%, p<0.001), whereas hemolysis (47.6% vs. 52.4%, p=0.32), thromboembolic events (38.5% vs. 40.7%, p=0.76), and ischemic stroke (48.5% vs. 39.7%, p=0.33) did not increase the in-hospital mortality. In multivariate analysis, both Impella and VA-ECMO were independent predictors of major bleeding and thromboembolic events. However, in-hospital mortality was similar between the Impella and IABP groups irrespective of the VA-ECMO insertion. CONCLUSIONS Among several important complications in CS patients with MCS, major bleeding events most strongly affected the mortality. Implanted MCS type was associated with the device-related complications.
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Affiliation(s)
- Kotaro Takahashi
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Shunsuke Kubo
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.
| | - Akihiro Ikuta
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Kohei Osakada
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Makoto Takamatsu
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Yuya Taguchi
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Masanobu Ohya
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Takenobu Shimada
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Katsuya Miura
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Takeshi Tada
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Hiroyuki Tanaka
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Yasushi Fuku
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
| | - Kazushige Kadota
- Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
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Abstract
PURPOSE OF REVIEW Cardiogenic shock is a complex clinical syndrome of end-organ hypoperfusion due to impaired cardiac performance. Although cardiogenic shock has traditionally been viewed as a monolithic disorder predominantly caused by severe left ventricular dysfunction complicating acute myocardial infarction (AMI), there is increasing recognition of the diverse causes of cardiogenic shock and wide spectrum of clinical severity. The purpose of this review is to describe the contemporary epidemiology of cardiogenic shock, including trends in clinical outcomes and recent efforts to refine risk assessment. RECENT FINDINGS The incidence of cardiogenic shock among patients with AMI has remained remarkably stable at 3-10%; however, the proportion of cardiogenic shock cases related to AMI has decreased over time to ∼30%, while the proportion of cardiogenic shock cases due to acute decompensated heart failure has steadily increased. Estimated in-hospital mortality from cardiogenic shock in contemporary registries is approximately 30-40%, suggesting modest improvement in cardiogenic shock outcomes over the last decade. There is a wide spectrum of clinical severity among patients presenting with cardiogenic shock, which is described by the Society for Cardiovascular Angiography and Interventions clinical staging criteria. SUMMARY Improved clinical characterization and risk assessment of patients with cardiogenic shock may facilitate more effective clinical investigations of this morbid clinical syndrome.
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32
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Clendenen N, Ahlgren B, Robitaille MJ, Christensen E, Morabito J, Grae L, Lyman M, Weitzel N. Year in Review 2020: Noteworthy Literature in Cardiothoracic Anesthesiology. Semin Cardiothorac Vasc Anesth 2021; 25:94-106. [PMID: 33938302 PMCID: PMC10088871 DOI: 10.1177/10892532211013614] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
The year 2020 was marred by the emergence of a deadly pandemic that disrupted every aspect of life. Despite the disruption, notable research accomplishments in the practice of cardiothoracic anesthesiology occurred in 2020 with an emphasis on optimizing care, improving outcomes, and expanding what is possible for patients undergoing cardiac surgery. This year's edition of Noteworthy Literature Review will focus on specific themes in cardiac anesthesiology that include preoperative anemia, predictors of acute kidney injury following cardiac surgery, pain management modalities, anticoagulation strategies after transcatheter aortic valve replacement, mechanical circulatory support, and future directions in research.
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Affiliation(s)
| | - Bryan Ahlgren
- University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Mark J Robitaille
- Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
| | | | - Joseph Morabito
- University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Lyndsey Grae
- University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Matthew Lyman
- University of Colorado Anschutz Medical Campus, Aurora, CO, USA
| | - Nathaen Weitzel
- University of Colorado Anschutz Medical Campus, Aurora, CO, USA
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33
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Racial Disparities in the Utilization and Outcomes of Temporary Mechanical Circulatory Support for Acute Myocardial Infarction-Cardiogenic Shock. J Clin Med 2021; 10:jcm10071459. [PMID: 33918132 PMCID: PMC8037539 DOI: 10.3390/jcm10071459] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2021] [Revised: 03/18/2021] [Accepted: 03/26/2021] [Indexed: 11/17/2022] Open
Abstract
Racial disparities in utilization and outcomes of mechanical circulatory support (MCS) in patients with acute myocardial infarction-cardiogenic shock (AMI-CS) are infrequently studied. This study sought to evaluate racial disparities in the outcomes of MCS in AMI-CS. The National Inpatient Sample (2012–2017) was used to identify adult AMI-CS admissions receiving MCS support. MCS devices were classified as intra-aortic balloon pump (IABP), percutaneous left ventricular assist device (pLVAD) or extracorporeal membrane oxygenation (ECMO). Self-reported race was classified as white, black and others. Outcomes included in-hospital mortality, hospital length of stay and discharge disposition. During this period, 90,071 admissions were included with white, black and other races constituting 73.6%, 8.3% and 18.1%, respectively. Compared to white and other races, black race admissions were on average younger, female, with greater comorbidities, and non-cardiac organ failure (all p < 0.001). Compared to the white race (31.3%), in-hospital mortality was comparable in black (31.4%; adjusted odds ratio (aOR) 0.98 (95% confidence interval (CI) 0.93–1.05); p = 0.60) and other (30.2%; aOR 0.96 (95% CI 0.92–1.01); p = 0.10). Higher in-hospital mortality was noted in non-white races with concomitant cardiac arrest, and those receiving ECMO support. Black admissions had longer lengths of hospital stay (12.1 ± 14.2, 10.3 ± 11.2, 10.9 ± 1.2 days) and transferred less often (12.6%, 14.2%, 13.9%) compared to white and other races (both p < 0.001). In conclusion, this study of AMI-CS admissions receiving MCS devices did not identify racial disparities in in-hospital mortality. Black admissions had longer hospital stay and were transferred less often. Further evaluation with granular data including angiographic and hemodynamic parameters is essential to rule out racial differences.
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34
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Oliveros E, Brailovsky Y, Aggarwal V. Overview of Options for Mechanical Circulatory Support. Interv Cardiol Clin 2021; 10:147-156. [PMID: 33745665 DOI: 10.1016/j.iccl.2020.12.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022]
Abstract
Mechanical circulatory support is used widely in acute setting of myocardial infarction, myocarditis, and cardiogenic shock as well as in chronic scenarios with advanced end-stage heart failure. Different algorithmic approaches can help the clinician decide the type of support required in a high morbidity and mortality setting. It is paramount to emphasize the need for a multidisciplinary approach to make steadfast decisions in the acute settings of cardiogenic shock.
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Affiliation(s)
- Estefania Oliveros
- Division of Cardiology, Department of Medicine, Lewis Katz School of Medicine, Temple University Hospital, 3401 North Broad Street, Philadelphia, PA 19140, USA
| | - Yevgeniy Brailovsky
- Division of Cardiology, Department of Medicine, Sidney Kimmel School of Medicine, Thomas Jefferson University, 833 Chestnut Street, Suite 640, Philadelphia, PA 19107, USA
| | - Vikas Aggarwal
- Division of Cardiology, Department of Internal Medicine, University of Michigan Medical School, 1500 East Medical Center Drive, SPC 5869, Ann Arbor, MI 48109, USA.
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35
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Sohal S, Tayal R. Mechanical Circulatory Support Devices: Management and Prevention of Vascular Complications. Interv Cardiol Clin 2021; 10:269-279. [PMID: 33745675 DOI: 10.1016/j.iccl.2020.12.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Abstract
The use of mechanical circulatory support devices has seen a dramatic rise over the last few years owing to their increased use not only in acute circulatory collapse but also their prophylactic use in high-risk procedures. These devices continue to have their overall benefits marginalized due to the relatively high rates of complications. Vascular complications are the most common and are associated with increased risk of mortality in these patients. Preventive measures at each stage of procedure, frequent monitoring and assessment to recognize early signs of deterioration are the best ways to mitigate the effects of vascular complications.
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Affiliation(s)
- Sumit Sohal
- Division of Cardiovascular Diseases, Department of Medicine, RWJ-Barnabas Heath Newark Beth Israel Medical Center, 201 Lyon Avenue, Newark, NJ 07112, USA
| | - Rajiv Tayal
- Division of Cardiovascular Diseases, Department of Medicine, RWJ-Barnabas Heath Newark Beth Israel Medical Center, 201 Lyon Avenue, Newark, NJ 07112, USA.
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36
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Doshi R, Dave M, Majmundar M, Kumar A, Adalja D, Shariff M, Desai R, Ziaeian B, Vallabhajosyula S. National rates and trends of tobacco and substance use disorders among atrial fibrillation hospitalizations. Heart Lung 2021; 50:244-251. [PMID: 33359929 PMCID: PMC8310779 DOI: 10.1016/j.hrtlng.2020.12.009] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/25/2020] [Revised: 12/14/2020] [Accepted: 12/16/2020] [Indexed: 11/18/2022]
Abstract
BACKGROUND Atrial Fibrillation (AF) has been associated with various behavioral risk factors such as tobacco, alcohol, and/or substances abuse. OBJECTIVE The main objective is to describe the national trends and burden of tobacco and substance abuse in AF hospitalizations. Also, this study identifies potential population who are more vulnerable to these substance abuse among AF hospitalizations. METHODS The National Inpatient Sample database from 2007 to 2015 was utilized and the hospitalizations with AF were identified using the international classification of disease, Ninth Revision, Clinical Modification code. They were stratified into without abuse, tobacco use disorder (TUD), substance use disorder (SUD), alcohol use disorder (AUD) and drug use disorder (DUD). RESULTS Of 3,631,507 AF hospitalizations, 852,110 (23.46%) had TUD, 1,851,170 (5.1%) had SUD, 155,681 (4.29%) had AUD and 42,667 (1.17%) had DUD. The prevalence of TUD, SUD, AUD, and DUD was substantially increased across all age groups, races, and gender during the study period. Female sex was associated with lower odds TUD, SUD, AUD, and DUD. Among AF hospitalizations, the black race was associated with higher odds of SUD, and DUD. The younger age group (18-35 years), male, Medicare/Medicaid as primary insurance, and lower socioeconomic status were associated with increased risk of both TUD and SUDs. CONCLUSION TUD and SUD among AF hospitalizations in the United States mainly affects males, younger individuals, white more than black, and those of lower socioeconomic status which demands for the development of preventive strategies to address multilevel influences.
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Affiliation(s)
- Rajkumar Doshi
- Department of Internal Medicine, University of Nevada Reno School of Medicine, , 1155 Mill St, W-11, Reno, NV 89502, USA.
| | - Mihir Dave
- Department of Internal Medicine, University of Nevada Reno School of Medicine, , 1155 Mill St, W-11, Reno, NV 89502, USA
| | - Monil Majmundar
- Department of Internal Medicine, Metropolitan Medical Center, New York, NY, USA
| | - Ashish Kumar
- Department of Critical Care Medicine, St John's Medical College Hospital, Bengaluru, Karnataka, India
| | - Devina Adalja
- Department of Medicine, GMERS Gotri Medical College, Vadodara, Gujarat, India
| | - Mariam Shariff
- Department of Critical Care Medicine, St John's Medical College Hospital, Bengaluru, Karnataka, India
| | - Rupak Desai
- Department of Cardiology, Atlanta VA Medical Center, Decatur, GA, United States
| | - Boback Ziaeian
- Division of Cardiology, David Geffen School of Medicine at University of California, Los Angeles, CA, USA; Division of Cardiology, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, CA, USA
| | - Saraschandra Vallabhajosyula
- Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA; Center for Clinical and Translational Science, Mayo Clinic Graduate School of Biomedical Sciences, MN, USA
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Nezami FR, Khodaee F, Edelman ER, Keller SP. A Computational Fluid Dynamics Study of the Extracorporeal Membrane Oxygenation-Failing Heart Circulation. ASAIO J 2021; 67:276-283. [PMID: 33627601 PMCID: PMC8130419 DOI: 10.1097/mat.0000000000001221] [Citation(s) in RCA: 23] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022] Open
Abstract
Extracorporeal membrane oxygenation (ECMO) is increasingly deployed to provide percutaneous mechanical circulatory support despite incomplete understanding of its complex interactions with the failing heart and its effects on hemodynamics and perfusion. Using an idealized geometry of the aorta and its major branches and a peripherally inserted return cannula terminating in the iliac artery, computational fluid dynamic simulations were performed to (1) quantify perfusion as function of relative ECMO flow and (2) describe the watershed region produced by the collision of antegrade flow from the heart and retrograde ECMO flow. To simulate varying degrees of cardiac failure, ECMO flow as a fraction of systemic perfusion was evaluated at 100%, 90%, 75%, and 50% of total flow with the remainder supplied by the heart calculated from a patient-derived flow waveform. Dynamic boundary conditions were generated with a three-element lumped parameter model to accurately simulate distal perfusion. In profound failure (ECMO providing 90% or more of flow), the watershed region was positioned in the aortic arch with minimal pulsatility observed in the flow to the visceral organs. Modest increases in cardiac flow advanced the watershed region into the thoracic aorta with arch perfusion entirely supplied by the heart.
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Affiliation(s)
- Farhad Rikhtegar Nezami
- From the Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts
| | - Farhan Khodaee
- From the Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts
| | - Elazer R Edelman
- From the Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts
- Department of Medicine (Cardiovascular Medicine), Brigham and Women's Hospital, Boston, Massachusetts
| | - Steven P Keller
- From the Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts
- Department of Medicine (Pulmonary and Critical Care Medicine), Brigham and Women's Hospital, Boston, Massachusetts
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38
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Khera R, Clark C, Lu Y, Guo Y, Ren S, Truax B, Spatz ES, Murugiah K, Lin Z, Omer SB, Vojta D, Krumholz HM. Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With the Risk of Hospitalization and Death in Hypertensive Patients With COVID-19. J Am Heart Assoc 2021; 10:e018086. [PMID: 33624516 PMCID: PMC8403305 DOI: 10.1161/jaha.120.018086] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Background Despite its clinical significance, the risk of severe infection requiring hospitalization among outpatients with severe acute respiratory syndrome coronavirus 2 infection who receive angiotensin‐converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) remains uncertain. Methods and Results In a propensity score–matched outpatient cohort (January–May 2020) of 2263 Medicare Advantage and commercially insured individuals with hypertension and a positive outpatient SARS‐CoV‐2, we determined the association of ACE inhibitors and ARBs with COVID‐19 hospitalization. In a concurrent inpatient cohort of 7933 hospitalized with COVID‐19, we tested their association with in‐hospital mortality. The robustness of the observations was assessed in a contemporary cohort (May–August). In the outpatient study, neither ACE inhibitors (hazard ratio [HR], 0.77; 0.53–1.13, P=0.18) nor ARBs (HR, 0.88; 0.61–1.26, P=0.48) were associated with hospitalization risk. ACE inhibitors were associated with lower hospitalization risk in the older Medicare group (HR, 0.61; 0.41–0.93, P=0.02), but not the younger commercially insured group (HR, 2.14; 0.82–5.60, P=0.12; P‐interaction 0.09). Neither ACE inhibitors nor ARBs were associated with lower hospitalization risk in either population in the validation cohort. In the primary inpatient study cohort, neither ACE inhibitors (HR, 0.97; 0.81–1.16; P=0.74) nor ARBs (HR, 1.15; 0.95–1.38, P=0.15) were associated with in‐hospital mortality. These observations were consistent in the validation cohort. Conclusions ACE inhibitors and ARBs were not associated with COVID‐19 hospitalization or mortality. Despite early evidence for a potential association between ACE inhibitors and severe COVID‐19 prevention in older individuals, the inconsistency of this observation in recent data argues against a role for prophylaxis.
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Affiliation(s)
- Rohan Khera
- Section of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.,Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT
| | - Callahan Clark
- Research & Development at UnitedHealth Group Minnetonka MN UAS
| | - Yuan Lu
- Section of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.,Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT
| | - Yinglong Guo
- Research & Development at UnitedHealth Group Minnetonka MN UAS
| | - Sheng Ren
- Research & Development at UnitedHealth Group Minnetonka MN UAS
| | - Brandon Truax
- Research & Development at UnitedHealth Group Minnetonka MN UAS
| | - Erica S Spatz
- Section of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.,Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT
| | - Karthik Murugiah
- Section of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.,Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT
| | - Zhenqiu Lin
- Section of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.,Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT
| | - Saad B Omer
- Section of Infectious Diseases Department of Internal Medicine Yale School of Medicine New Haven CT.,Yale Institute for Global Health New Haven CT.,Department of Epidemiology of Microbial Diseases Yale School of Public Health New Haven CT
| | - Deneen Vojta
- Research & Development at UnitedHealth Group Minnetonka MN UAS
| | - Harlan M Krumholz
- Section of Cardiovascular Medicine Department of Internal Medicine Yale School of Medicine New Haven CT.,Center for Outcomes Research and Evaluation Yale-New Haven Hospital New Haven CT.,Department of Health Policy and Management Yale School of Public Health New Haven CT
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Philipson DJ, Cohen DJ, Fonarow GC, Ziaeian B. Analysis of Adverse Events Related to Impella Usage (from the Manufacturer and User Facility Device Experience and National Inpatient Sample Databases). Am J Cardiol 2021; 140:91-94. [PMID: 33147430 DOI: 10.1016/j.amjcard.2020.10.056] [Citation(s) in RCA: 19] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/09/2020] [Revised: 10/25/2020] [Accepted: 10/27/2020] [Indexed: 11/17/2022]
Abstract
Impella devices are increasingly utilized for hemodynamic support in high-risk percutaneous coronary intervention or cardiogenic shock despite a lack of randomized clinical trial data showing clinical benefit and newer observational data suggesting harm. In this retrospective analysis, our aim was to determine the most common adverse events associated with Impella usage reported annually to the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and to estimate via the National Inpatient Sample (NIS) database the number of percutaneous ventricular assist devices utilized and associated with inpatient mortality since introduction of the Impella. Among the 885 complete reports submitted to the MAUDE database from 2008 to 2019 related to Impella usage, there were 1,206 complications coded; 88.2% of reports occurred from 2016 to 2019. Among patients with adverse events reported, bleeding (32.8%), device deployment or retrieval issues (18.2%), vascular complications (15.8%), and death (12.4%) were the most common, and 7.9% of all complications were attributable to operator decision-making or technique. From 2007 to 2017 there was a >100-fold increase in percutaneous ventricular assist devices use with an increase and plateau in in-hospital mortality to 31% from 2012 to 2016 based on NIS data. In conclusion, Impella use has increased substantially over the last decade but remains associated with high inpatient mortality and serious complications based on data from the NIS and MAUDE databases. These findings emphasize the need for high quality randomized controlled trials to determine the clinical utility of Impella in high-risk percutaneous coronary intervention and cardiogenic shock.
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Affiliation(s)
- Daniel J Philipson
- Division of Cardiology, David Geffen School of Medicine at UCLA, Los Angeles, California.
| | - David J Cohen
- University of Missouri-Kansas City, Kansas City, Missouri
| | - Gregg C Fonarow
- Ahmanson-UCLA Cardiomyopathy Center, Division of Cardiology, David Geffen School of Medicine at UCLA, Los Angeles, California
| | - Boback Ziaeian
- Division of Cardiology, David Geffen School of Medicine at UCLA, Los Angeles, California; Division of Cardiology, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California
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Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz AP, Masoudi FA, Messenger JC, Parzynski CS, Ngufor CG, Girotra S, Amin AP, Shah ND, Desai NR. Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA Netw Open 2021; 4:e2037748. [PMID: 33616664 PMCID: PMC7900859 DOI: 10.1001/jamanetworkopen.2020.37748] [Citation(s) in RCA: 68] [Impact Index Per Article: 17.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/17/2023] Open
Abstract
IMPORTANCE Mechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit. OBJECTIVE To examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020. EXPOSURES Therapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only. MAIN OUTCOMES AND MEASURES Use of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use. RESULTS Among the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only. CONCLUSIONS AND RELEVANCE This study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.
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Affiliation(s)
- Sanket S. Dhruva
- University of California, San Francisco School of Medicine, San Francisco
- Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California
| | - Joseph S. Ross
- Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
- Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
| | - Bobak J. Mortazavi
- Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
- Department of Computer Science and Engineering, Texas A&M University, College Station
- Center for Remote Health Technologies and Systems, Texas A&M University, College Station
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Nathan C. Hurley
- Department of Computer Science and Engineering, Texas A&M University, College Station
| | - Harlan M. Krumholz
- Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
- Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Jeptha P. Curtis
- Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Alyssa P. Berkowitz
- Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
| | - Frederick A. Masoudi
- Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora
| | - John C. Messenger
- Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora
| | - Craig S. Parzynski
- Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
| | - Che G. Ngufor
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
- Division of Digital Health Sciences, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota
| | - Saket Girotra
- Division of Cardiovascular Diseases, Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City
- Center for Access & Delivery Research & Evaluation (CADRE), Iowa City Veterans Affairs Medical Center, Iowa City, Iowa
| | - Amit P. Amin
- Cardiovascular Division, Washington University School of Medicine, St Louis, Missouri
| | - Nilay D. Shah
- Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
- Division of Health Care Policy Research, Mayo Clinic, Rochester, Minnesota
| | - Nihar R. Desai
- Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
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Rao SV. Real-World Data on the Intravascular Microaxial Left Ventricular Flow Pump (Impella) in High-Risk Patients. Korean Circ J 2021; 51:487-494. [PMID: 34085421 PMCID: PMC8176068 DOI: 10.4070/kcj.2021.0102] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2021] [Accepted: 04/08/2021] [Indexed: 11/25/2022] Open
Abstract
This narrative review summarizes real-world observational data regarding comparative effectiveness of the Impella device in patients undergoing percutaneous coronary intervention with or without cardiogenic shock. The article also reviews the limitations of the observational studies and addresses the challenges in conducting randomized trials of mechanical circulatory support. While there are ongoing randomized trials of the Impella device that will likely inform clinical practice, the article summarizes recommendations from the recent American Heart Association scientific position statement on invasive management of cardiogenic shock. Mechanical circulatory support (MCS) devices maintain or improve hemodynamic profiles in patients at risk for hemodynamic deterioration during percutaneous coronary intervention (PCI) or those in cardiogenic shock. Clinical trials of MCS have been difficult to complete due to challenges with equipoise; however, there are several “real-world” comparative effectiveness analyses of outcomes of patients undergoing high-risk PCI or cardiogenic shock with different MCS. This review summarizes the real-world data on Impella and intra-aortic balloon pump, 2 of the most commonly used MCS, and provides insight into the limitations of such data and challenges to completing clinical trials.
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Affiliation(s)
- Sunil V Rao
- The Duke Clinical Research Institute, Durham, NC, USA.
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Sanaiha Y, Ziaeian B, Antonios JW, Kavianpour B, Anousheh R, Benharash P. Intraaortic Balloon Pump vs Peripheral Ventricular Assist Device Use in the United States. Ann Thorac Surg 2020; 110:1997-2005. [PMID: 32454014 PMCID: PMC7687352 DOI: 10.1016/j.athoracsur.2020.03.129] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2019] [Revised: 02/26/2020] [Accepted: 03/31/2020] [Indexed: 11/21/2022]
Abstract
BACKGROUND The objective of this study was to characterize practical use trends and outcomes for intraaortic balloon pump (IABP) and percutaneous left ventricular assist device (pVAD) use in cardiogenic shock at a national level. METHODS An analysis of all adult patients admitted nonelectively for cardiogenic shock from January 2008 through December 2017 was performed using the National Inpatient Sample. Trends of inpatient IABP and pVAD use were analyzed using survey-weighted estimates and the modified Cochran-Armitage test for significance. Multivariable regression models and inverse probability of treatment weights were used to perform risk-adjusted analyses of pVAD mortality, a composite of adverse events (AE), and resource use, with IABP as reference. RESULTS Of an estimated 774,310 patients admitted with cardiogenic shock, 143,051 received a device: IABP, 127,792 (16.5%); or pVAD, 15,259 (2.0%). IABP use decreased (23.8% to 12.7%; P for trend <.001), whereas pVAD implantation increased significantly during the study period (0.2% to 4.5%; P for trend <.001). Inverse probability of treatment weights demonstrated significantly higher odds of mortality with pVAD (odds ratio, 1.9; 95% confidence interval, 1.7 to 2.2), but not AE (odds ratio, 1.1; 95% confidence interval, 0.96 to 1.27), compared with IABP. After risk adjustment, pVAD use was associated with an additional $15,202 (P < .001) in cost for survivors and $29,643 for nonsurvivors (P < .001). CONCLUSIONS Over the study period, the rate of pVAD use for cardiogenic shock significantly increased. Compared with IABP, pVAD use was associated with increased mortality, higher costs, and several AEs. Multi-institutional clinical trials with rigorous inclusion criteria are warranted to evaluate the clinical utility of pVADs in the modern era.
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Affiliation(s)
- Yas Sanaiha
- Cardiovascular Outcomes Research Laboratories (CORELAB), David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California
| | - Boback Ziaeian
- Division of Cardiology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California; Division of Cardiology, Veterans Administration Greater Los Angeles Healthcare System, Los Angeles, California
| | - James W Antonios
- Cardiovascular Outcomes Research Laboratories (CORELAB), David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California
| | - Behdad Kavianpour
- Cardiovascular Outcomes Research Laboratories (CORELAB), David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California
| | - Ramtin Anousheh
- Division of Cardiology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California
| | - Peyman Benharash
- Cardiovascular Outcomes Research Laboratories (CORELAB), David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California; Division of Cardiac Surgery, University of California, Los Angeles, Los Angeles, California.
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Fernando SM, Qureshi D, Tanuseputro P, Talarico R, Hibbert B, Mathew R, Rochwerg B, Belley-Côté EP, Fan E, Combes A, Brodie D, Schmidt M, Simard T, Di Santo P, Kyeremanteng K. Long-term mortality and costs following use of Impella® for mechanical circulatory support: a population-based cohort study. Can J Anaesth 2020; 67:1728-1737. [PMID: 32671805 DOI: 10.1007/s12630-020-01755-9] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/02/2020] [Revised: 04/22/2020] [Accepted: 04/27/2020] [Indexed: 12/11/2022] Open
Abstract
PURPOSE The Impella® device is a form of mechanical circulatory support (MCS) used in critically ill adults with cardiogenic shock. We sought to evaluate short- and long-term outcomes following the use of Impella, including mortality, healthcare utilization, and costs. METHODS Population-based, retrospective cohort study of adult patients (≥ 16 yr) receiving Impella in Ontario, Canada (1 April 2012-31March 2019). We captured outcomes through linkage to health administrative databases. The primary outcome was mortality during hospitalization. Secondary outcomes included mortality at 30 days, 90 days, and one year following Impella insertion. We analyzed health system costs in Canadian dollars in the year following the date of the index admission, including the costs of inpatient admission. RESULTS We included 162 patients. Mean (standard deviation) age was 59.2 (14.5) yr, and 73.5% of patients were male. Median [interquartile range (IQR)] time to Impella insertion from date of hospital admission was 2 [1-9] days. In-hospital mortality was 56.8%, and a significant proportion of patients were bridged to a ventricular assist device (67.9%). Mortality at one year was 61.7%. Among hospital survivors, only 38.6% were discharged home independently. Median [IQR] total cost in the year following admission among all patients was $88,397 [32,718-225,628], of which $66,529 [22,789-183,165] was attributed to inpatient care. CONCLUSIONS In-hospital mortality among patients with cardiogenic shock receiving Impella is high, but with minimal increase at one year. While Impella patients accrued substantial costs, these largely reflected inpatient costs, and not costs incurred following hospital discharge.
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Affiliation(s)
- Shannon M Fernando
- Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
- Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.
| | - Danial Qureshi
- ICES, Toronto, ON, Canada
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada
- Bruyère Research Institute, Ottawa, ON, Canada
| | - Peter Tanuseputro
- ICES, Toronto, ON, Canada
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada
- Bruyère Research Institute, Ottawa, ON, Canada
- School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada
- Division of Palliative Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canada
| | - Robert Talarico
- ICES, Toronto, ON, Canada
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada
| | - Benjamin Hibbert
- Division of Cardiology, University of Ottawa Heart Institute, Ottawa, ON, Canada
| | - Rebecca Mathew
- Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canada
- Division of Cardiology, University of Ottawa Heart Institute, Ottawa, ON, Canada
| | - Bram Rochwerg
- Department of Medicine, Division of Critical Care, McMaster University, Hamilton, ON, Canada
- Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada
| | - Emilie P Belley-Côté
- Department of Medicine, Division of Critical Care, McMaster University, Hamilton, ON, Canada
- Division of Cardiology, Department of Medicine, McMaster University, Hamilton, ON, Canada
- Population Health Research Institute, Hamilton, ON, Canada
| | - Eddy Fan
- Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada
- Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada
| | - Alain Combes
- Medical Intensive Care Unit, Assistance Publique-Hôpitaux de Paris (APHP), Hôpital Pitié Salpêtrière, Paris, France
- Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris, France
| | - Daniel Brodie
- Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA
- Center for Acute Respiratory Failure, New York-Presbyterian Hospital, New York, NY, USA
| | - Matthieu Schmidt
- Medical Intensive Care Unit, Assistance Publique-Hôpitaux de Paris (APHP), Hôpital Pitié Salpêtrière, Paris, France
- Institute of Cardiometabolism and Nutrition, Sorbonne Université, Paris, France
| | - Trevor Simard
- Division of Cardiology, University of Ottawa Heart Institute, Ottawa, ON, Canada
| | - Pietro Di Santo
- Division of Cardiology, University of Ottawa Heart Institute, Ottawa, ON, Canada
| | - Kwadwo Kyeremanteng
- Division of Critical Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canada
- Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada
- Division of Palliative Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canada
- Institut du Savoir Montfort, Ottawa, ON, Canada
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Desai R, Hanna B, Singh S, Gupta S, Deshmukh A, Kumar G, Sachdeva R, Berman AE. Percutaneous Ventricular Assist Device vs. Intra-Aortic Balloon Pump for Hemodynamic Support in Acute Myocardial Infarction-Related Cardiogenic Shock and Coexistent Atrial Fibrillation: A Nationwide Propensity-Matched Analysis'. Am J Med Sci 2020; 361:55-62. [PMID: 33008567 DOI: 10.1016/j.amjms.2020.08.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2020] [Revised: 08/04/2020] [Accepted: 08/10/2020] [Indexed: 11/17/2022]
Abstract
BACKGROUND Patients suffering an acute myocardial infarction complicated by cardiogenic shock (AMICS) may experience clinical deterioration with concomitant atrial fibrillation (AF). Recent data suggest that percutaneous ventricular assist devices (pVADs) provide superior hemodynamic support over intra-aortic balloon pump (IABP) in AMICS. In patients with AF+AMICS, however, outcomes data comparing these two devices remain limited. METHODS Using the National Inpatient Sample datasets (2008-2014) and a propensity-score matched analysis, we compared the outcomes of AMICS+AF hospitalized patients undergoing PCI with pVAD vs. IABP support. RESULTS A total of 12,842 AMICS+AF patients were identified (pVAD=468, IABP=12,374). The matched groups (pVAD=443, IABP=443) were comparable in terms of mean age (70.3 ± 12.0 vs. 70.4 ± 11.0yrs, p = 0.92). The utilization of pVAD was higher in whites but lower in Medicare/Medicaid beneficiaries as compared to IABP. The pVAD group demonstrated higher rates of obesity (13.6% vs. 7.8%, p = 0.006) and dyslipidemia (48.4% vs. 41.8%, p = 0.05). There was no difference in the in-hospital mortality (40.5% vs. 36.8%, p = 0.25); however, pVAD group had a lower incidence of post-procedural MI and higher incidences of stroke (7.8% vs. 4.4%, p = 0.03), hemorrhage (5.6% vs. 2.3%, p = 0.01), discharges to home health care (13.5% vs. 10.1%, p<0.001) and to other facilities (29.1% vs. 24.9%, p<0.001) as compared to IABP group. There was no difference between the groups in terms of mean length of stay or hospital charges. CONCLUSIONS All-cause inpatient mortality was similar in AMICS+AF patients undergoing PCI who were treated with either pVAD or IABP. The pVAD group, however, experienced more complications while consuming greater healthcare resources.
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Affiliation(s)
- Rupak Desai
- Division of Cardiology, Atlanta VA Medical Center, Decatur, GA, United States
| | - Bishoy Hanna
- Division of Cardiology, Morehouse School of Medicine, Atlanta, GA, United States
| | - Sandeep Singh
- Division of Clinical Epidemiology, Biostatistics, and Bioinformatics, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
| | - Sonu Gupta
- Division of Cardiology, Morehouse School of Medicine, Atlanta, GA, United States
| | | | - Gautam Kumar
- Division of Cardiology, Atlanta VA Medical Center, Decatur, GA, United States; Division of Cardiology, Emory University School of Medicine, Atlanta, GA, United States
| | - Rajesh Sachdeva
- Division of Cardiology, Atlanta VA Medical Center, Decatur, GA, United States; Division of Cardiology, Morehouse School of Medicine, Atlanta, GA, United States; Division of Cardiology, Emory University School of Medicine, Atlanta, GA, United States; Division of Cardiology, Medical College of Georgia, Augusta University, Augusta, GA, United States
| | - Adam E Berman
- Division of Cardiology, Medical College of Georgia, Augusta University, Augusta, GA, United States; Division of Health Economics and Modeling, Medical College of Georgia, Augusta University, Augusta, GA, United States.
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Khera R, Secemsky EA, Wang Y, Desai NR, Krumholz HM, Maddox TM, Shunk KA, Virani SS, Bhatt DL, Curtis J, Yeh RW. Revascularization Practices and Outcomes in Patients With Multivessel Coronary Artery Disease Who Presented With Acute Myocardial Infarction and Cardiogenic Shock in the US, 2009-2018. JAMA Intern Med 2020; 180:1317-1327. [PMID: 32833024 PMCID: PMC9377424 DOI: 10.1001/jamainternmed.2020.3276] [Citation(s) in RCA: 27] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2020] [Accepted: 06/09/2020] [Indexed: 11/14/2022]
Abstract
Importance Cardiogenic shock after acute myocardial infarction (AMI) is associated with high mortality, particularly among patients with multivessel coronary artery disease. Recent evidence suggests that use of multivessel percutaneous coronary intervention (PCI) may be associated with harm. However, little is known about recent patterns of care and outcomes for this patient population. Objective To evaluate patterns in the use of multivessel PCI vs culprit-vessel PCI in AMI and cardiogenic shock and outcomes in the US from 2009 to 2018. Design, Setting, and Participants This cohort study identified all patients in the CathPCI Registry) with AMI and cardiogenic shock who had multivessel coronary artery disease and underwent PCI between July 1, 2009, and March 31, 2018. Exposures Multivessel or culprit-vessel PCI for AMI and shock. Primary Outcomes and Measures The primary outcome was in-hospital mortality. Temporal trends and hospital variation in PCI strategies were evaluated, while accounting for differences in case mix using hierarchical models. As a secondary outcome, the association of PCI strategy with postdischarge outcomes was evaluated in the subset of patients who were Medicare beneficiaries. Results Of 64 301 patients (mean [SD] age, 66.4 [12.5] years; 20 366 [31.7%] female; 54 538 [84.8%] White) with AMI and shock at 1649 US hospitals, 34.9% had primary multivessel PCI. In the subgroup of 48 943 patients with ST-segment elevation myocardial infarction (STEMI), 31.5% underwent multivessel PCI. Between 2009 and 2018, this percentage increased by 6.7% per year for AMI and 5.8% for STEMI. Overall, multivessel PCI was associated with a greater adjusted risk of in-hospital complications (odds ratio [OR], 1.18; 95% CI, 1.14-1.23) and with greater in-hospital mortality in patients with STEMI (OR, 1.11; 95% CI, 1.06-1.16). Among Medicare beneficiaries, multivessel PCI use was not associated with postdischarge 1-year mortality (51.5% vs 49.8%; risk-adjusted OR, 0.97; 95% CI, 0.90-1.04; P = .37). Significant hospital variation was found in the use of multivessel PCI, with a higher multivessel PCI rate for similar patients across hospitals (median OR, 1.37; 95% CI, 1.33-1.41). Patients at hospitals with high rates of PCI in STEMI use had higher risk-adjusted in-hospital mortality (highest vs lowest hospital multivessel PCI quartile: OR, 1.10; 95% CI, 1.02-1.19). Conclusions and Relevance This cohort study found that multivessel PCI was increasingly used as the revascularization strategy in AMI and shock and that hospitals that used multivessel PCI more, especially among patients with STEMI, had worse outcomes. With recent evidence suggesting harm with this strategy, there appears to be an urgent need to change practice and improve outcomes in this high-risk population.
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Affiliation(s)
- Rohan Khera
- Section of Cardiovascular Medicine, Department of
Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Center for Outcomes Research and Evaluation, Yale-New
Haven Hospital, New Haven, Connecticut
| | - Eric A. Secemsky
- Richard A. and Susan F. Smith Center for Outcomes
Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- Department of Medicine, Harvard Medical School,
Boston, Massachusetts
| | - Yongfei Wang
- Section of Cardiovascular Medicine, Department of
Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Center for Outcomes Research and Evaluation, Yale-New
Haven Hospital, New Haven, Connecticut
| | - Nihar R. Desai
- Section of Cardiovascular Medicine, Department of
Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Center for Outcomes Research and Evaluation, Yale-New
Haven Hospital, New Haven, Connecticut
| | - Harlan M. Krumholz
- Section of Cardiovascular Medicine, Department of
Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Center for Outcomes Research and Evaluation, Yale-New
Haven Hospital, New Haven, Connecticut
| | - Thomas M. Maddox
- Division of Cardiology, Washington University School
of Medicine in St Louis, St Louis, Missouri
- Healthcare Innovation Lab, BJC HealthCare, Washington
University School of Medicine in St Louis, St Louis, Missouri
| | - Kendrick A. Shunk
- Veterans Affairs Medical Center, Division of
Cardiology, University of California, San Francisco
| | - Salim S. Virani
- Michael E. DeBakey Veterans Affairs Medical Center,
Division of Cardiology, Baylor College of Medicine, Houston, Texas
| | - Deepak L. Bhatt
- Department of Medicine, Harvard Medical School,
Boston, Massachusetts
- Division of Cardiology, Brigham and Women’s
Hospital, Boston, Massachusetts
| | - Jeptha Curtis
- Section of Cardiovascular Medicine, Department of
Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Center for Outcomes Research and Evaluation, Yale-New
Haven Hospital, New Haven, Connecticut
| | - Robert W. Yeh
- Richard A. and Susan F. Smith Center for Outcomes
Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- Department of Medicine, Harvard Medical School,
Boston, Massachusetts
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Balloon Pump Counterpulsation Part II: Perioperative Hemodynamic Support and New Directions. Anesth Analg 2020; 131:792-807. [DOI: 10.1213/ane.0000000000004999] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/08/2023]
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Prognostic Impact of Active Mechanical Circulatory Support in Cardiogenic Shock Complicating Acute Myocardial Infarction, Results from the Culprit-Shock Trial. J Clin Med 2020; 9:jcm9061976. [PMID: 32599815 PMCID: PMC7356113 DOI: 10.3390/jcm9061976] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2020] [Revised: 06/11/2020] [Accepted: 06/18/2020] [Indexed: 12/25/2022] Open
Abstract
OBJECTIVES To analyze the use and prognostic impact of active mechanical circulatory support (MCS) devices in a large prospective contemporary cohort of patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). BACKGROUND Although increasingly used in clinical practice, data on the efficacy and safety of active MCS devices in patients with CS complicating AMI are limited. METHODS This is a predefined subanalysis of the CULPRIT-SHOCK randomized trial and prospective registry. Patients with CS, AMI and multivessel coronary artery disease were categorized in two groups: (1) use of at least one active MCS device vs. (2) no active MCS or use of intra-aortic balloon pump (IABP) only. The primary endpoint was a composite of all-cause death or renal replacement therapy at 30 days. RESULTS Two hundred of 1055 (19%) patients received at least one active MCS device (n = 112 Impella®; n = 95 extracorporeal membrane oxygenation (ECMO); n = 6 other devices). The primary endpoint occurred significantly more often in patients treated with active MCS devices compared with those without active MCS devices (142 of 197, 72% vs. 374 of 827, 45%; p < 0.001). All-cause mortality and bleeding rates were significantly higher in the active MCS group (all p < 0.001). After multivariable adjustment, the use of active MCS was significantly associated with the primary endpoint (odds ratio (OR) 4.0, 95% confidence interval (CI) 2.7-5.9; p < 0.001). CONCLUSIONS In the CULPRIT-SHOCK trial, active MCS devices were used in approximately one fifth of patients. Patients treated with active MCS devices showed worse outcome at 30 days and 1 year.
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Intraaortic Balloon Pump Counterpulsation, Part I: History, Technical Aspects, Physiologic Effects, Contraindications, Medical Applications/Outcomes. Anesth Analg 2020; 131:776-791. [DOI: 10.1213/ane.0000000000004954] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2022]
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Kataruka A, Maynard CC, Kearney KE, Mahmoud A, Bell S, Doll JA, McCabe JM, Bryson C, Gurm HS, Jneid H, Virani SS, Lehr E, Ring ME, Hira RS. Temporal Trends in Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting: Insights From the Washington Cardiac Care Outcomes Assessment Program. J Am Heart Assoc 2020; 9:e015317. [PMID: 32456522 PMCID: PMC7429009 DOI: 10.1161/jaha.119.015317] [Citation(s) in RCA: 46] [Impact Index Per Article: 9.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/23/2023]
Abstract
Background Patient selection and outcomes for percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) have changed over the past decade. However, there is limited information on outcomes for both revascularization strategies in the same population. The study evaluated temporal changes in risk profile, procedural characteristics, and clinical outcomes for PCI‐ and CABG‐treated patients. Methods and Results We analyzed all PCI and isolated CABG between 2005 and 2017 in nonfederal hospitals in Washington State. Descriptive analysis was performed to evaluate temporal changes in risk profile and, risk‐adjusted in‐hospital mortality. Over the study period, 178 474 PCI and 36 592 CABG procedures were performed. PCI and CABG volume decreased by 2.9% and 22.6%, respectively. Compared with 2005–2009, patients receiving either form of revascularization between 2014 and 2017 had a higher prevalence of comorbidities including diabetes mellitus and hypertension and dialysis. Presentation with ST‐segment–elevation myocardial infarction (17% versus 20%) and cardiogenic shock (2.4% versus 3.4%) increased for patients with PCI compared with CABG. Conversely, clinical acuity decreased for patients receiving CABG over the study period. From 2005 to 2017, mean National Cardiovascular Data Registry CathPCI mortality score increased for patients treated with PCI (20.1 versus 22.4, P<0.0001) and decreased for patients treated with CABG (18.8 versus 17.8, P<0.0001). Adjusted observed/expected in‐hospital mortality ratio increased for PCI (0.98 versus 1.19, P<0.0001) but decreased for CABG (1.21 versus 0.74, P<0.0001) over the study period. Conclusions Clinical acuity increased for patients treated with PCI rather than CABG. This resulted in an increase in adjusted observed/expected mortality ratio for patients undergoing PCI and a decrease for CABG. These shifts may reflect an increased use of PCI instead of CABG for patients considered to be at high surgical risk.
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Affiliation(s)
- Akash Kataruka
- Division of Cardiology University of Washington Seattle WA
| | - Charles C Maynard
- Department of Health Services University of Washington Seattle WA.,Cardiac Care Outcomes Assessment Program Foundation for Health Care Quality Seattle WA
| | | | - Ahmed Mahmoud
- Division of Cardiology University of Washington Seattle WA
| | - Sean Bell
- Department of Medicine University of Washington Seattle WA
| | - Jacob A Doll
- Division of Cardiology University of Washington Seattle WA.,VA Puget South Health Care System Seattle WA
| | - James M McCabe
- Division of Cardiology University of Washington Seattle WA
| | | | | | - Hani Jneid
- Division of Cardiology Michael E. DeBakey VA& Baylor College of Medicine Houston TX
| | - Salim S Virani
- Division of Cardiology Michael E. DeBakey VA& Baylor College of Medicine Houston TX
| | - Eric Lehr
- Department of Cardiac Surgery Swedish Heart & Vascular Institute Seattle WA
| | | | - Ravi S Hira
- Division of Cardiology University of Washington Seattle WA.,Cardiac Care Outcomes Assessment Program Foundation for Health Care Quality Seattle WA
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Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers with the Risk of Hospitalization and Death in Hypertensive Patients with Coronavirus Disease-19. MEDRXIV : THE PREPRINT SERVER FOR HEALTH SCIENCES 2020. [PMID: 32511481 PMCID: PMC7273249 DOI: 10.1101/2020.05.17.20104943] [Citation(s) in RCA: 29] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
Abstract
BACKGROUND Whether angiotensin-converting enzyme (ACE) Inhibitors and angiotensin receptor blockers (ARBs) mitigate or exacerbate SARS-CoV-2 infection remains uncertain. In a national study, we evaluated the association of ACE inhibitors and ARB with coronavirus disease-19 (COVID-19) hospitalization and mortality among individuals with hypertension. METHODS Among Medicare Advantage and commercially insured individuals, we identified 2,263 people with hypertension, receiving ≥1 antihypertensive agents, and who had a positive outpatient SARS-CoV-2 test (outpatient cohort). In a propensity score-matched analysis, we determined the association of ACE inhibitors and ARBs with the risk of hospitalization for COVID-19. In a second study of 7,933 individuals with hypertension who were hospitalized with COVID-19 (inpatient cohort), we tested the association of these medications with in-hospital mortality. We stratified all our assessments by insurance groups. RESULTS Among individuals in the outpatient and inpatient cohorts, 31.9% and 29.8%, respectively, used ACE inhibitors and 32.3% and 28.1% used ARBs. In the outpatient study, over a median 30.0 (19.0 - 40.0) days after testing positive, 12.7% were hospitalized for COVID-19. In propensity score-matched analyses, neither ACE inhibitors (HR, 0.77 [0.53, 1.13], P = 0.18), nor ARBs (HR, 0.88 [0.61, 1.26], P = 0.48), were significantly associated with risk of hospitalization. In analyses stratified by insurance group, ACE inhibitors, but not ARBs, were associated with a significant lower risk of hospitalization in the Medicare group (HR, 0.61 [0.41, 0.93], P = 0.02), but not the commercially insured group (HR: 2.14 [0.82, 5.60], P = 0.12; P-interaction 0.09). In the inpatient study, 14.2% died, 59.5% survived to discharge, and 26.3% had an ongoing hospitalization. In propensity score-matched analyses, neither use of ACE inhibitor (0.97 [0.81, 1.16]; P = 0.74) nor ARB (1.15 [0.95, 1.38]; P = 0.15) was associated with risk of in-hospital mortality, in total or in the stratified analyses. CONCLUSIONS The use of ACE inhibitors and ARBs was not associated with the risk of hospitalization or mortality among those infected with SARS-CoV-2. However, there was a nearly 40% lower risk of hospitalization with the use of ACE inhibitors in the Medicare population. This finding merits a clinical trial to evaluate the potential role of ACE inhibitors in reducing the risk of hospitalization among older individuals, who are at an elevated risk of adverse outcomes with the infection.
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