|
1
|
Klosko RC, Whitson B, Lampert B, McLaughlin E, Orzel L. Safety of enoxaparin in patients implanted with continuous flow left ventricular assist devices. Artif Organs 2025; 49:639-648. [PMID: 39601155 PMCID: PMC11974480 DOI: 10.1111/aor.14908] [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: 07/22/2024] [Revised: 10/22/2024] [Accepted: 11/01/2024] [Indexed: 11/29/2024]
Abstract
BACKGROUND The objective of this study is to determine the incidence of major bleeding events in patients implanted with continuous flow left ventricular assist devices (CF-LVADs) bridged with enoxaparin (LMWH) compared to intravenous unfractionated heparin (IV UFH) for a subtherapeutic INR on warfarin. METHODS A single-center, retrospective, cohort study was conducted including patients with CF-LVADs implanted between January 1, 2012 and July 1, 2020 who received at least one inpatient dose or outpatient prescription for LMWH or IV UFH at least 60 days after CF-LVAD implantation. The primary endpoint was the incidence of major bleeding. RESULTS In total, 176 orders were screened and 90 orders in 62 unique patients were included. Major bleeding and thromboembolic events occurred in 1 (2.5%) versus 4 (10.0%) orders (p = 0.36) and 3 (7.5%) versus 1 (2.5%) orders (p = 0.62) in the LMWH and IV UFH groups, respectively. One patient had a fatal thromboembolic event in each group. More patients receiving IV UFH had minor bleeding events (10 [25.0%] vs. 3 [7.5%]; p = 0.03). CONCLUSIONS There was no difference between bleeding and thromboembolic events in patients implanted with CF-LVADs prescribed LMWH or IV UFH for bridging of subtherapeutic INRs. Larger prospective randomized data are needed to validate these findings.
Collapse
Affiliation(s)
- Rachel C. Klosko
- Department of Pharmacy PracticeBinghamton University School of Pharmacy and Pharmaceutical SciencesJohnson CityNew YorkUSA
| | - Bryan Whitson
- Division of Cardiac SurgeryThe Ohio State University Wexner Medical CenterColumbusOhioUSA
| | - Brent Lampert
- Division of Cardiovascular MedicineThe Ohio State University Wexner Medical CenterColumbusOhioUSA
| | - Eric McLaughlin
- Center for BiostatisticsThe Ohio State UniversityColumbusOhioUSA
| | - Libby Orzel
- US Clinical Development, Medical and Regulatory AffairsNovonordiskRochesterMinnesotaUSA
| |
Collapse
|
|
2
|
Iyengar A, Weingarten N, Song C, Rekhtman D, Shin M, Helmers MR, Wald J, Cevasco M, Atluri P. Outcomes and quality of life in patients receiving durable left ventricular assist device with biventricular support. Artif Organs 2024; 48:1476-1483. [PMID: 39118457 DOI: 10.1111/aor.14835] [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: 09/20/2023] [Revised: 05/25/2024] [Accepted: 07/22/2024] [Indexed: 08/10/2024]
Abstract
BACKGROUND Patients requiring biventricular support (BIVAD) face higher morbidity than those undergoing durable left ventricular assist device (LVAD) implantation alone. The goal of the current study was to evaluate quality of life (QOL) of patients with LVAD therapy in the modern era, stratified by use of biventricular support. METHODS All patients undergoing LVAD at our center were reviewed between October 2017 and September 2021. Patients were stratified by perioperative use of BIVAD. Patients were administered a telephone survey consisting of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) as well as free-responses regarding satisfaction surrounding their operation. Outcomes included survival, KCCQ-12 metrics, and thematic analysis of free response questions. RESULTS 92 patients were identified, of whom 26 (28%) received BIVAD support. BIVAD patients had more preoperative ECMO use (54% vs. 12%, p < 0.001) and lower INTERMACS scores (Category 1: 46% vs. 14%, p = 0.001). Three-year survival was 73.8% among LVAD-alone patients and 50.1% among BIVAD patients (log-rank p = 0.022). Median composite KCCQ-12 score was 78 (57-88). No differences in composite or any component scores were noted between groups. 76% of patients report they would be moderately or extremely like to go through surgery again if given repeat choice. The most common themes expressed were overall gratitude (24%) and disappointment with device-related restrictions (20%). CONCLUSIONS Patients requiring BIVAD therapy have more advanced shock, longer associated hospital courses, and lower long-term survival. However, those that survive enjoy similar overall quality of life, and many endorse positive outlooks on their surgical course. Continued assessments of quality of life are important in providing patient-centered LVAD care.
Collapse
Affiliation(s)
- Amit Iyengar
- Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Noah Weingarten
- Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Cindy Song
- Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - David Rekhtman
- Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Max Shin
- Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Mark R Helmers
- Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Joyce Wald
- Division of Cardiovascular Medicine, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Marisa Cevasco
- Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Pavan Atluri
- Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| |
Collapse
|
|
3
|
Tropea I, Cresce GD, Sanesi V, Salvador L, Zoni D. Outcome Through the Years of Left-Ventricular Assist Devices Therapy for End-Stage Heart Failure: A Review. J Clin Med 2024; 13:6622. [PMID: 39518766 PMCID: PMC11546408 DOI: 10.3390/jcm13216622] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2024] [Revised: 10/24/2024] [Accepted: 11/02/2024] [Indexed: 11/16/2024] Open
Abstract
Heart transplantation remains the gold standard surgical treatment for advanced heart failure. Over time, medical therapies have achieved remarkable outcomes in terms of survival and quality of life, yet their results may be insufficient, even when maximized. The limited availability of organ donors and the selective criteria for heart transplant eligibility have led to a significant rise in the utilization of long-term mechanical circulatory support, including left ventricular assist devices. Patients receiving LVADs often present with multiple comorbidities, constituting a highly vulnerable population. Individuals living with LVADs may experience various long-term complications, such as bleeding, driveline infections, neurological events, and right ventricular dysfunction. Fortunately, the development of increasingly biocompatible LVAD devices in recent years has resulted in a notable reduction in these complications. This review aims to summarize the principal complications encountered by patients with LVADs throughout their treatment and the associated daily management strategies.
Collapse
Affiliation(s)
- Ilaria Tropea
- Cardiovascular Department, S. Bortolo Hospital, 36100 Vicenza, Italy; (G.D.C.); (V.S.); (L.S.)
| | | | | | | | - Daniele Zoni
- Cardiovascular Department, S. Bortolo Hospital, 36100 Vicenza, Italy; (G.D.C.); (V.S.); (L.S.)
| |
Collapse
|
|
4
|
Cikes M, Yuzefpolskaya M, Gustafsson F, Mehra MR. Antithrombotic Strategies With Left Ventricular Assist Devices. J Card Fail 2024; 30:1489-1495. [PMID: 39154903 DOI: 10.1016/j.cardfail.2024.07.024] [Citation(s) in RCA: 7] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/18/2024] [Accepted: 07/19/2024] [Indexed: 08/20/2024]
Abstract
Long-term outcomes of patients with advanced heart failure treated with durable left ventricular assist devices (LVADs) have been augmented due to improved durability and hemocompatibility on the backbone of pump engineering enhancements. The incidence of hemocompatibility-related adverse events (pump thrombosis, stroke and nonsurgical bleeding events) are device specific and vary by type of engineered pump. A fully magnetically levitated rotor containing LVAD in concert with use of antithrombotic therapy has successfully overcome an increased risk of pump thrombosis and stroke-risk, albeit with only modest reduction in bleeding events. Modifications to antithrombotic strategies have focused on reduced-dose vitamin K antagonist use or use of direct oral anticoagulants with demonstration of safety and progress in reduction of mucosal bleeding episodes with elimination of antiplatelet agents. This review outlines the current landscape of advances in anticoagulation management in LVAD patients, highlighting the need for ongoing research and cautious application of emerging therapies and technologies.
Collapse
Affiliation(s)
- Maja Cikes
- Department of Cardiovascular Diseases, University of Zagreb School of Medicine, University Hospital Center Zagreb, Zagreb, Croatia
| | - Melana Yuzefpolskaya
- Department of Cardiology, New York Presbyterian Hospital, Columbia University, New York, New York
| | - Finn Gustafsson
- Department of Cardiology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark
| | - Mandeep R Mehra
- Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
| |
Collapse
|
|
5
|
Worku B, Mack C, Gambardella I. Commentary: Flow is fundamental. J Thorac Cardiovasc Surg 2024; 168:147-148. [PMID: 37574005 DOI: 10.1016/j.jtcvs.2023.08.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/07/2023] [Accepted: 08/08/2023] [Indexed: 08/15/2023]
Affiliation(s)
- Berhane Worku
- Department of Cardiothoracic Surgery, Weill Cornell Medical College, New York, NY; Department of Cardiothoracic Surgery, New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY.
| | - Charles Mack
- Department of Cardiothoracic Surgery, Weill Cornell Medical College, New York, NY; Department of Cardiothoracic Surgery, New York Presbyterian Queens Hospital, Queens, NY
| | - Ivancarmine Gambardella
- Department of Cardiothoracic Surgery, Weill Cornell Medical College, New York, NY; Department of Cardiothoracic Surgery, New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY
| |
Collapse
|
|
6
|
Kuriki S, Tsujii Y, Saiki H, Amano T, Uema R, Kato M, Yoshihara T, Hayashi Y, Hikita H, Takehara T. Endoscopic submucosal dissection for early gastric cancer in a patient after left ventricular assist device implantation: A case report. DEN OPEN 2024; 4:e316. [PMID: 38023666 PMCID: PMC10644325 DOI: 10.1002/deo2.316] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 07/20/2023] [Revised: 10/22/2023] [Accepted: 10/31/2023] [Indexed: 12/01/2023]
Abstract
The use of left ventricular assist device (LVAD) implantation has increased in recent years. Here, we report the first case of gastric endoscopic submucosal dissection (ESD) following LVAD implantation. A 69-year-old man who previously underwent LVAD implantation for severe heart failure underwent esophagogastroduodenoscopy, which revealed a 15-mm flat-elevated cancerous lesion at the greater curvature of the gastric angle. Before ESD, antithrombotic drugs were discontinued and replaced with 10,000 units of heparin. However, on the second day, the patient experienced dysarthria and right upper-extremity movement disorder despite a prothrombin time/international normalized ratio (PT-INR) of 2.01. On the fifth day, computed tomography revealed a low-density area extending from the left corona radiata to the basal ganglia, leading to a diagnosis of acute cerebral infarction. Aspirin and warfarin were immediately restarted, while the heparin infusion was discontinued after confirming recovery of PT activity. Thereafter, the neurological abnormalities did not aggravate and a trend toward symptomatic improvement was observed. Two months later, ESD was performed under continuous warfarin administration (PT-INR, 2.62) without heparin replacement, and the lesion was curatively resected without complications. The patient was discharged without adverse events. This case report provides useful information on the feasibility and perioperative management of ESD in patients with LVAD.
Collapse
Affiliation(s)
- Shinji Kuriki
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Yoshiki Tsujii
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Hirotsugu Saiki
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Takahiro Amano
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Ryotaro Uema
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Minoru Kato
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Takeo Yoshihara
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Yoshito Hayashi
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Hayato Hikita
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| | - Tetsuo Takehara
- Department of Gastroenterology and HepatologyOsaka University Graduate School of MedicineOsakaJapan
| |
Collapse
|
|
7
|
Tsiouris A, Slaughter MS, Jeyakumar AKC, Protos AN. Left ventricular assist devices: yesterday, today, and tomorrow. J Artif Organs 2024:10.1007/s10047-024-01436-0. [PMID: 38451441 DOI: 10.1007/s10047-024-01436-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/11/2023] [Accepted: 01/21/2024] [Indexed: 03/08/2024]
Abstract
The shortcomings of expense, power requirements, infection, durability, size, and blood trauma of current durable LVADs have been recognized for many years. The LVADs of tomorrow aspire to be fully implantable, durable, mitigate infectious risk, mimic the pulsatile nature of the native cardiac cycle, as well as minimize bleeding and thrombosis. Power draw, battery cycle lifespan and trans-cutaneous energy transmission remain barriers to completely implantable systems. Potential solutions include decreases in pump electrical draw, improving battery lifecycle technology and better trans-cutaneous energy transmission, potentially from Free-range Resonant Electrical Energy Delivery. In this review, we briefly discuss the history of LVADs and summarize the LVAD devices in the development pipeline seeking to address these issues.
Collapse
Affiliation(s)
- Athanasios Tsiouris
- Department of Surgery, Division of Cardiac Surgery, University of Mississippi Medical Center, 2500 N State St, Jackson, MS, 39216, USA.
| | - Mark S Slaughter
- Department of Cardiovascular and Thoracic Surgery, University of Louisville, 201 Abraham Flexner Way, Louisville, KY, 40202, USA
| | - Ashok Kumar Coimbatore Jeyakumar
- Department of Surgery, Division of Cardiac Surgery, University of Mississippi Medical Center, 2500 N State St, Jackson, MS, 39216, USA
| | - Adam N Protos
- Department of Surgery, Division of Cardiac Surgery, University of Mississippi Medical Center, 2500 N State St, Jackson, MS, 39216, USA
| |
Collapse
|
|
8
|
Mullens W, Dauw J, Gustafsson F, Mebazaa A, Steffel J, Witte KK, Delgado V, Linde C, Vernooy K, Anker SD, Chioncel O, Milicic D, Hasenfuß G, Ponikowski P, von Bardeleben RS, Koehler F, Ruschitzka F, Damman K, Schwammenthal E, Testani JM, Zannad F, Böhm M, Cowie MR, Dickstein K, Jaarsma T, Filippatos G, Volterrani M, Thum T, Adamopoulos S, Cohen-Solal A, Moura B, Rakisheva A, Ristic A, Bayes-Genis A, Van Linthout S, Tocchetti CG, Savarese G, Skouri H, Adamo M, Amir O, Yilmaz MB, Simpson M, Tokmakova M, González A, Piepoli M, Seferovic P, Metra M, Coats AJS, Rosano GMC. Integration of implantable device therapy in patients with heart failure. A clinical consensus statement from the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC). Eur J Heart Fail 2024; 26:483-501. [PMID: 38269474 DOI: 10.1002/ejhf.3150] [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: 04/20/2023] [Revised: 10/27/2023] [Accepted: 01/15/2024] [Indexed: 01/26/2024] Open
Abstract
Implantable devices form an integral part of the management of patients with heart failure (HF) and provide adjunctive therapies in addition to cornerstone drug treatment. Although the number of these devices is growing, only few are supported by robust evidence. Current devices aim to improve haemodynamics, improve reverse remodelling, or provide electrical therapy. A number of these devices have guideline recommendations and some have been shown to improve outcomes such as cardiac resynchronization therapy, implantable cardioverter-defibrillators and long-term mechanical support. For others, more evidence is still needed before large-scale implementation can be strongly advised. Of note, devices and drugs can work synergistically in HF as improved disease control with devices can allow for further optimization of drug therapy. Therefore, some devices might already be considered early in the disease trajectory of HF patients, while others might only be reserved for advanced HF. As such, device therapy should be integrated into HF care programmes. Unfortunately, implementation of devices, including those with the greatest evidence, in clinical care pathways is still suboptimal. This clinical consensus document of the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) describes the physiological rationale behind device-provided therapy and also device-guided management, offers an overview of current implantable device options recommended by the guidelines and proposes a new integrated model of device therapy as a part of HF care.
Collapse
Affiliation(s)
- Wilfried Mullens
- Ziekenhuis Oost-Limburg, Department of Cardiology, Genk, Belgium
- UHasselt, Biomedical Research Institute, Faculty of Medicine and Life Sciences, LCRC, Diepenbeek, Belgium
| | - Jeroen Dauw
- Ziekenhuis Oost-Limburg, Department of Cardiology, Genk, Belgium
- UHasselt, Doctoral School for Medicine and Life Sciences, LCRC, Diepenbeek, Belgium
| | - Finn Gustafsson
- The Heart Center, University Hospital of Copenhagen, Copenhagen, Denmark
| | - Alexandre Mebazaa
- Université de Paris, UMR Inserm - MASCOT; APHP Saint Louis Lariboisière University Hospitals, Department of Anesthesia-Burn-Critical Care, Paris, France
| | - Jan Steffel
- Hirslanden Heart Clinic and University of Zurich, Zurich, Switzerland
| | - Klaus K Witte
- Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany
| | - Victoria Delgado
- Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands
- Hospital University Germans Trias i Pujol, Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Spain
| | - Cecilia Linde
- Karolinska Institutet, Department of Medicine, Karolinska University Hospital, Heart Vascular and Neurology Theme, Stockholm, Sweden
| | - Kevin Vernooy
- Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands
| | - Stefan D Anker
- Division of Cardiology and Metabolism, Department of Cardiology (CVK) and Berlin-Brandenburg Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany
| | - Ovidiu Chioncel
- Emergency Institute for Cardiovascular Diseases 'Prof. C.C. Iliescu', University of Medicine Carol Davila, Bucharest, Romania
| | - Davor Milicic
- University of Zagreb School of Medicine, Zagreb, Croatia
| | - Gerd Hasenfuß
- University Medical Center Göttingen (UMG), Department of Cardiology and Pneumology, German Center for Cardiovascular Research (DZHK), Partner Site Göttingen, Göttingen, Germany
| | - Piotr Ponikowski
- Department of Heart Diseases, Wroclaw Medical University, Wrocław, Poland
| | | | - Friedrich Koehler
- Medical Department, Division of Cardiology and Angiology, Centre for Cardiovascular Telemedicine, Charité-Universitätsmedizin Berlin, Berlin, Germany
| | - Frank Ruschitzka
- Clinic of Cardiology, University Heart Centre, University Hospital, Zurich, Switzerland
| | - Kevin Damman
- University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands
| | - Ehud Schwammenthal
- Leviev Cardiothoracic and Vascular Center, Sheba Medical Center, Tel Hashomer, and Tel Aviv University, Ramat Aviv, Israel
| | - Jeffrey M Testani
- Division of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA
| | - Faiez Zannad
- Centre d'Investigations Cliniques Plurithématique 14-33, Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Université de Lorraine, Nancy, France
| | - Michael Böhm
- Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin III, Saarland University, Kardiologie, Angiologie und Internistische Intensivmedizin, Homburg, Germany
| | - Martin R Cowie
- Royal Brompton Hospital, Guy's & St Thomas' NHS Foundation Trust, and School of Cardiovascular Medicine and Sciences, Faculty of Lifesciences & Medicine, King's College London, London, UK
| | - Kenneth Dickstein
- University of Bergen, Bergen, Norway; and Stavanger University Hospital, Stavanger, Norway
| | - Tiny Jaarsma
- Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia; Department of Health, Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden
| | - Gerasimos Filippatos
- National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Athens, Greece
| | | | - Thomas Thum
- Institute of Molecular and Translational Therapeutic Strategies (IMTTS), Hannover Medical School, Hannover, Germany and Fraunhofer institute for Toxicology and Experimental Medicine, Hannover, Germany
| | - Stamatis Adamopoulos
- Heart Failure and Transplant Unit, Onassis Cardiac Surgery Centre, Athens, Greece
| | - Alain Cohen-Solal
- Department of Cardiology, University Hospital Lariboisière, AP-HP, Paris, France; INSERM UMR-S 942, MASCOT, Université Paris Cité, Paris, France
| | - Brenda Moura
- Armed Forces Hospital, Porto, and Faculty of Medicine of Porto, Porto, Portugal
| | - Amina Rakisheva
- Cardiology Department, Scientific Institute of Cardiology and Internal Medicine, Almaty, Kazakhstan
| | - Arsen Ristic
- Universi Faculty of Medicine, University of Belgrade, and Serbian Academy of Arts and Sciences, Belgrade, Serbia
| | - Antoni Bayes-Genis
- Heart Institute, Hospital Universitari Germans Trias i Pujol, CIBERCV, Badalona, Spain
| | - Sophie Van Linthout
- Berlin Institute of Health (BIH) at Charité - Universitätmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Berlin, Germany; German Center for Cardiovascular Research (DZHK), Partner site Berlin, Berlin, Germany
| | - Carlo Gabriele Tocchetti
- Cardio-Oncology Unit, Department of Translational Medical Sciences (DISMET); Center for Basic and Clinical Immunology Research (CISI), Interdepartmental Center for Clinical and Translational Research (CIRCET), Interdepartmental Hypertension Research Center (CIRIAPA); Federico II University, Naples, Italy
| | - Gianluigi Savarese
- Department of Medicine, Karolinska Institutet and Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
| | - Hadi Skouri
- Division of Cardiology, Internal Medicine Department, American University of Beirut Medical Center, Beirut, Lebanon
| | - Marianna Adamo
- Cardiology and Cardiac Catheterization Laboratory, ASST Spedali Civili Brescia and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy
| | - Offer Amir
- Hadassah Medical Center, Faculty of Medicine, Hebrew University, Jerusalem, Israel
| | | | | | | | - Arantxa González
- Program of Cardiovascular Diseases, CIMA Universidad de Navarra, and IdiSNA, Navarra Institute for Health Research, Pamplona, Spain; CIBERCV, Carlos III Institute of Health, Madrid, Spain
| | - Massimo Piepoli
- Clinical Cardiac Unit, Policlinico San Donato, University of Milan, Milan, Italy
| | - Petar Seferovic
- Universi Faculty of Medicine, University of Belgrade, and Serbian Academy of Arts and Sciences, Belgrade, Serbia
| | - Marco Metra
- Cardiology and Cardiac Catheterization Laboratory, ASST Spedali Civili Brescia and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy
| | | | | |
Collapse
|
|
9
|
Llerena-Velastegui J, Santafe-Abril G, Villacis-Lopez C, Hurtado-Alzate C, Placencia-Silva M, Santander-Aldean M, Trujillo-Delgado M, Freire-Oña X, Santander-Fuentes C, Velasquez-Campos J. Efficacy and Complication Profiles of Left Ventricular Assist Devices in Adult Heart Failure Management: A Systematic Review and Meta-Analysis. Curr Probl Cardiol 2024; 49:102118. [PMID: 37802165 DOI: 10.1016/j.cpcardiol.2023.102118] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2023] [Accepted: 09/30/2023] [Indexed: 10/08/2023]
Abstract
Left ventricular assist devices (LVADs) have marked a milestone in the evolution of treatment for patients with end-stage heart failure. Their popularity and use are steadily rising. This systematic review and meta-analysis aimed to evaluate the effectiveness of LVADs in improving the survival rate of patients with end-stage heart failure and to identify the complications or adverse events associated with LVAD use. Articles for this systematic review and meta-analysis were sourced from PubMed, Google Scholar, and the Cochrane Library databases. Only studies that met the predefined PICOS eligibility criteria were analyzed. LVADs significantly improved the 6, 12, 18, and 24-month survival rates in patients with end-stage heart failure compared to no LVAD or other therapies: OR 1.87 (95%CI [1.27-2.76]), OR 2.29 (95%CI [1.61-3.26]), OR 2.07 (95%CI [0.61-6.61]), and OR 1.73 (95%CI [0.88-3.41]) for 6, 12, 18, and 24 months, respectively. The incidence of adverse events was significantly higher in the LVAD group than in the non-LVAD treatments: bleeding OR 12.53 (95%CI [2.60-60.41]), infections OR 4.15 (95%CI [1.19-14.45]), stroke OR 2.58 (95%CI [1.38-4.82]), and arrhythmia OR 2.81 (95%CI [1.64-4.80]). Overall, complications were higher in the LVAD group compared to those without LVAD treatment. Hospital readmissions due to adverse events were significantly more frequent in the LVAD group, OR 2.98 (95%CI [1.38-6.43]). Despite the elevated risk of adverse events associated with LVADs, these devices have demonstrated a notable enhancement in the survival outcomes for patients with end-stage heart failure.
Collapse
Affiliation(s)
| | | | | | | | | | | | | | - Ximena Freire-Oña
- Regional Autonomous University of Los Andes, Medical School, Ambato, Ecuador
| | | | | |
Collapse
|
|
10
|
Bart NK, Robson D, Muthiah K, Jansz PC, Hayward CS. How do mechanical circulatory support patients die? Autopsy findings for left-ventricular assist device/total artificial heart nonsurvivors. J Heart Lung Transplant 2023; 42:1753-1763. [PMID: 37422144 DOI: 10.1016/j.healun.2023.07.001] [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: 02/07/2023] [Revised: 06/03/2023] [Accepted: 07/02/2023] [Indexed: 07/10/2023] Open
Abstract
BACKGROUND Although life saving for end-stage heart failure patients, permanent mechanical circulatory support (MCS) is often the proximate cause of death in those that do not survive to transplant. Autopsy remains the gold standard for diagnosing causes of death and a vital tool for better understanding underlying pathology of nonsurvivors. The aim of this study was to determine the frequency and outcomes of autopsy investigations and compare these with premortem clinical assessment. METHODS The autopsy findings and medical records of all patients who underwent left ventricular assist device (LVAD) or total artificial heart (TAH) insertion between June 1994 and April 2022 as a bridge to transplant, but subsequently died pre-heart transplantation were reviewed. RESULTS A total of 203 patients had a LVAD or TAH implanted during the study period. Seventy-eight patients (M=59, F=19) died prior to transplantation (age 55 [14] years, INTERMACS=2). Autopsies were conducted in 26 of 78 patients (33%). Three were limited studies. The leading contributor to cause of death was respiratory (14/26), either nosocomial infection or associated with multiorgan failure. Intracranial hemorrhage was the second most common cause of death (8/26). There was a major discrepancy rate of 17% and a minor discrepancy rate of 43%. Autopsy study added a total of 14 additional contributors of death beyond clinical assessment alone (Graphical Abstract). CONCLUSIONS Over an observational period of 26years, the frequency of autopsy was low. To improve LVAD/TAH patient survival to transplant, better understanding as to cause of death is required. Patients with MCS have complex physiology and are at high risk of infection and bleeding complications.
Collapse
Affiliation(s)
- Nicole K Bart
- St Vincent's Hospital, Sydney, New South Wales, Australia; Victor Chang Cardiac Research Institute, Sydney, New South Wales, Australia; University of New South Wales, Sydney, New South Wales, Australia; Notre Dame University, Sydney, New South Wales, Australia.
| | - Desire Robson
- St Vincent's Hospital, Sydney, New South Wales, Australia
| | - Kavitha Muthiah
- St Vincent's Hospital, Sydney, New South Wales, Australia; Victor Chang Cardiac Research Institute, Sydney, New South Wales, Australia; University of New South Wales, Sydney, New South Wales, Australia
| | - Paul C Jansz
- St Vincent's Hospital, Sydney, New South Wales, Australia; Victor Chang Cardiac Research Institute, Sydney, New South Wales, Australia; University of New South Wales, Sydney, New South Wales, Australia
| | - Christopher S Hayward
- St Vincent's Hospital, Sydney, New South Wales, Australia; Victor Chang Cardiac Research Institute, Sydney, New South Wales, Australia; University of New South Wales, Sydney, New South Wales, Australia
| |
Collapse
|
|
11
|
Schroeder SE. Mechanical Circulatory Support Therapy in the Cardiac Intensive Care Unit. Nurs Clin North Am 2023; 58:421-437. [PMID: 37536790 DOI: 10.1016/j.cnur.2023.05.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/05/2023]
Abstract
Mechanical circulatory support (MCS) includes temporary and durable mechanical devices used for two sets of indications: 1. acute heart failure (HF) secondary sepsis, a myocardial infarction, or pulmonary emboli, and 2. for chronic end-stage HF secondary to worsening cardiomyopathy despite guideline driven medical treatment. This article is to aide cardiac intensive care unit (ICU) nurses in understanding the history of MCS therapy, the care of the MCS patient in the cardiac ICU, the critical and collaborative role of transplant teams with MCS therapy, educational needs for a successful discharge, and implications for education and shared decision-making when placing these devices.
Collapse
Affiliation(s)
- Sarah E Schroeder
- Mechanical Circulatory Support Nurse Practitioner and Program Manager, Bryan Heart, 1600 South 48th Street, Suite 600, Lincoln, NE 68506, USA.
| |
Collapse
|
|
12
|
Tsukiya T, Nishinaka T. Numerical simulation of the leakage flow of the hydrodynamically levitated centrifugal blood pump for extracorporeal mechanical circulatory support systems. J Artif Organs 2023; 26:176-183. [PMID: 35907152 DOI: 10.1007/s10047-022-01351-2] [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: 01/25/2022] [Accepted: 07/07/2022] [Indexed: 10/16/2022]
Abstract
Extracorporeal centrifugal pumps are widely used in various forms of mechanical circulatory support, including extracorporeal membrane oxygenation and ventricular assist device. A durable centrifugal pump was developed by implementing a new hydrodynamic bearing design that prevents the impeller from touching to the casing wall and provides sufficient washout through the pump to prevent thrombus formation in the pump. The hydrodynamic bearings of the pump are composed of dual annular paths located on both sides of the impeller. Computational fluid dynamics analyses were performed on the flow field inside the pump to estimate the leakage flow through the gap and its impact on the pump efficiency and biocompatibility. The calculations were performed for motor speeds from 3000 to 5000 rpm and flow rates from 1.0 to 9.0 L/min. The leakage flow increased linearly with increasing pressure head of the pump, and the total leakage flow ranged from 2.0 to 27.3% of the total flow. The average wall shear stresses in the casing bottom ranged from 10.6 to 40.9 Pa. The leakage flow of the centrifugal pump with the hydrodynamically levitated impeller had a measurable impact on hydraulic energy losses while enhancing the washout flow to achieve good anti-thrombogenicity.
Collapse
Affiliation(s)
- Tomonori Tsukiya
- Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, 6-1 Kishibe-Shinmachi, Suita, Osaka, 5648565, Japan.
| | - Tomohiro Nishinaka
- Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, 6-1 Kishibe-Shinmachi, Suita, Osaka, 5648565, Japan
| |
Collapse
|
|
13
|
Krishnarao K, Krim SR. Management of hypertension in patients supported with continuous flow left ventricular assist devices. Curr Opin Cardiol 2023; 38:281-286. [PMID: 36927690 DOI: 10.1097/hco.0000000000001042] [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] [Indexed: 03/18/2023]
Abstract
PURPOSE OF REVIEW Hypertension remains one of the most common clinical problems leading to devastating postleft ventricular assist device (LVAD) implant complications. This study reviews the pathophysiology of hypertension in the setting of continuous flow LVAD support and provides an update on currently available antihypertensive therapies for LVAD patients. RECENT FINDINGS The true prevalence of hypertension in the LVAD population remains unknown. Effective blood pressure (BP) control and standardization of BP measurement are key to prevent suboptimal left ventricular unloading, pump malfunction and worsening aortic regurgitation. Angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), beta blockers and mineralocorticoid receptor antagonists (MRA) are the preferred antihypertensive agents because of their additional potential benefits, including optimization of haemodynamics, prevention of stroke, gastrointestinal bleed and in some patients myocardial recovery. Angiotensin receptor-neprilysin inhibition (ARNI) may be a well tolerated and effective therapy for BP control especially among CF-LVAD patients with resistant hypertension. Similarly, sodium glucose co-transporter 2 inhibitors (SGLT2i) should be considered in the absence of contraindications. SUMMARY Hypertension is very common post-LVAD implant. Heart failure guideline directed medical therapies, including ACEI, ARB, beta blockers and MRA, are the preferred antihypertensive agents to improve post-LVAD outcomes.
Collapse
Affiliation(s)
- Krithika Krishnarao
- Section of Cardiomyopathy & Heart Transplantation, John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation
- The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, Los Angeles, USA
| | - Selim R Krim
- Section of Cardiomyopathy & Heart Transplantation, John Ochsner Heart and Vascular Institute, Ochsner Clinic Foundation
- The University of Queensland School of Medicine, Ochsner Clinical School, New Orleans, Los Angeles, USA
| |
Collapse
|
|
14
|
Bonde R, Bonde P. Futuristic perspectives: novel MCS devices. Indian J Thorac Cardiovasc Surg 2023; 39:190-197. [PMID: 37525706 PMCID: PMC10387008 DOI: 10.1007/s12055-023-01519-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/01/2022] [Revised: 04/06/2023] [Accepted: 04/11/2023] [Indexed: 08/02/2023] Open
Abstract
Treatment of heart failure needs a firm understanding of anatomy and physiology of the circulatory system and the heart. Ancient India takes credit for the "modern concepts" of human circulation. This short review encompasses futuristic perspectives on mechanical circulatory devices (MCS). The heart is a complex structure which has evolved over millennia both in its structure and mechanical functionality. Evolving from a simple tube with peristaltic action such as in annelids, it evolved rapidly to form a more complexity as animals evolved from oceanic to terrestrial adaptation. The major advance is the innovation of placing the actuation mechanism within the blood flow path, such as in continuous flow technology (axial or centrifugal) when contrasted to the positive displacement pumps. We present novel concepts but also touch upon what we would consider as fundamental problems or paradigms that need to be addressed to move this field ahead. Finally, we propose what would be termed a "futuristic" MCS device.
Collapse
Affiliation(s)
- Riya Bonde
- Bonde Artificial Heart Lab, Division of Cardiac Surgery, Yale School of Medicine, 204 Boardman 330 Cedar Street, New Haven, CT 06510 USA
| | - Pramod Bonde
- Bonde Artificial Heart Lab, Division of Cardiac Surgery, Yale School of Medicine, 204 Boardman 330 Cedar Street, New Haven, CT 06510 USA
| |
Collapse
|
|
15
|
Sohn SH, Kang Y, Hwang HY, Chee HK. Optimal timing of heart transplantation in patients with an implantable left ventricular assist device. KOREAN JOURNAL OF TRANSPLANTATION 2023; 37:79-84. [PMID: 37435145 PMCID: PMC10332290 DOI: 10.4285/kjt.23.0015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/15/2023] [Accepted: 03/28/2023] [Indexed: 07/13/2023] Open
Abstract
Heart transplantation (HTPL) has been established as the gold-standard surgical treatment for end-stage heart failure. However, the use of a left ventricular assist device (LVAD) as a bridge to HTPL has been increasing due to the limited availability of HTPL donors. Currently, more than half of HTPL patients have a durable LVAD. Advances in LVAD technology have provided many benefits for patients on the waiting list for HTPL. Despite their advantages, LVADs also have limitations such as loss of pulsatility, thromboembolism, bleeding, and infection. In this narrative review, the benefits and shortcomings of LVADs as a bridge to HTPL are summarized, and the available literature evaluating the optimal timing of HTPL after LVAD implantation is reviewed. Because only a few studies have been published on this issue in the current era of third-generation LVADs, future studies are needed to draw a definite conclusion.
Collapse
Affiliation(s)
- Suk Ho Sohn
- Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
| | - Yoonjin Kang
- Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
| | - Ho Young Hwang
- Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
| | - Hyun Keun Chee
- Department of Thoracic and Cardiovascular Surgery, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, Korea
| |
Collapse
|
|
16
|
Noda K, Koga M, Toyoda K. Recognition of Strokes in the ICU: A Narrative Review. J Cardiovasc Dev Dis 2023; 10:182. [PMID: 37103061 PMCID: PMC10145112 DOI: 10.3390/jcdd10040182] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/25/2023] [Revised: 04/14/2023] [Accepted: 04/17/2023] [Indexed: 04/28/2023] Open
Abstract
Despite the remarkable progress in acute treatment for stroke, in-hospital stroke is still devastating. The mortality and neurological sequelae are worse in patients with in-hospital stroke than in those with community-onset stroke. The leading cause of this tragic situation is the delay in emergent treatment. To achieve better outcomes, early stroke recognition and immediate treatment are crucial. In general, in-hospital stroke is initially witnessed by non-neurologists, but it is sometimes challenging for non-neurologists to diagnose a patient's state as a stroke and respond quickly. Therefore, understanding the risk and characteristics of in-hospital stroke would be helpful for early recognition. First, we need to know "the epicenter of in-hospital stroke". Critically ill patients and patients who undergo surgery or procedures are admitted to the intensive care unit, and they are potentially at high risk for stroke. Moreover, since they are often sedated and intubated, evaluating their neurological status concisely is difficult. The limited evidence demonstrated that the intensive care unit is the most common place for in-hospital strokes. This paper presents a review of the literature and clarifies the causes and risks of stroke in the intensive care unit.
Collapse
Affiliation(s)
- Kotaro Noda
- Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan
- Department of Neurology and Neurological Science, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo 113-8519, Japan
| | - Masatoshi Koga
- Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan
| | - Kazunori Toyoda
- Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan
| |
Collapse
|
|
17
|
Melendo-Viu M, Dobarro D, Raposeiras Roubin S, Llamas Pernas C, Moliz Cordón C, Vazquez Lamas M, Piñón Esteban M, Varela Martínez MÁ, Abu Assi E, Pita Romero R, Legarra Calderón JJ, Íñiguez Romo A. Left Ventricular Assist Device as a Destination Therapy: Current Situation and the Importance of Patient Selection. Life (Basel) 2023; 13:1065. [PMID: 37109593 PMCID: PMC10144236 DOI: 10.3390/life13041065] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2023] [Revised: 04/16/2023] [Accepted: 04/19/2023] [Indexed: 04/29/2023] Open
Abstract
Advanced heart failure is a growing problem for which the best treatment is cardiac transplantation. However, the shortage of donors' hearts made left ventricular assist devices as destination therapy (DT-LVAD) a highly recommended alternative: they improved mid-term prognosis as well as patients' quality of life. Current intracorporeal pumps with a centrifugal continuous flow evolved in the last few years. Since 2003, when first LVAD was approved for long-term support, smaller device sizes with better survival and hemocompatibility profile were reached. The most important difficulty lies in the moment of the implant. Recent indications range from INTERMACS class 2 to 4, with close monitoring in intermediate cases. Moreover, a large multiparametric study is needed for considering the candidacy: basal situation, with a special interest in frailty, comorbidities, including renal and hepatic dysfunction, and medical background, considering every prior cardiac condition, must be evaluated. In addition, some clinical risk scores can be helpful to measure the possibility of right heart failure or morbi-mortality. With this review, we sought to summarize all the device improvements, with their updated clinical results, as well as to focus on all the patient selection criteria.
Collapse
Affiliation(s)
- María Melendo-Viu
- Cardiology Department, University Hospital Álvaro Cunqueiro, 36213 Vigo, Spain
- Health Research Institute Galicia Sur, 36312 Vigo, Spain
- Faculty of Medicine, University Complutense of Madrid, 28040 Madrid, Spain
| | - David Dobarro
- Cardiology Department, University Hospital Álvaro Cunqueiro, 36213 Vigo, Spain
- Health Research Institute Galicia Sur, 36312 Vigo, Spain
| | - Sergio Raposeiras Roubin
- Cardiology Department, University Hospital Álvaro Cunqueiro, 36213 Vigo, Spain
- Health Research Institute Galicia Sur, 36312 Vigo, Spain
| | - Carmen Llamas Pernas
- Anaesthesiology Department, University Hospital Álvaro Cunqueiro, 36312 Vigo, Spain
| | - Candela Moliz Cordón
- Nephrology Department, Regional University Hospital of Málaga, 29010 Málaga, Spain
| | - Miriam Vazquez Lamas
- Anaesthesiology Department, University Hospital Álvaro Cunqueiro, 36312 Vigo, Spain
| | | | | | - Emad Abu Assi
- Cardiology Department, University Hospital Álvaro Cunqueiro, 36213 Vigo, Spain
- Health Research Institute Galicia Sur, 36312 Vigo, Spain
| | - Rafael Pita Romero
- Anaesthesiology Department, University Hospital Álvaro Cunqueiro, 36312 Vigo, Spain
| | | | - Andrés Íñiguez Romo
- Cardiology Department, University Hospital Álvaro Cunqueiro, 36213 Vigo, Spain
- Health Research Institute Galicia Sur, 36312 Vigo, Spain
| |
Collapse
|
|
18
|
Noly PE, Wu X, Hou H, Grady KL, Stewart JW, Hawkins RB, Yang G, Kim KD, Zhang M, Cabrera L, Aaronson KD, Pagani FD, Likosky DS, and the Michigan Congestive Heart Failure Investigators. Association of Days Alive and Out of the Hospital After Ventricular Assist Device Implantation With Adverse Events and Quality of Life. JAMA Surg 2023; 158:e228127. [PMID: 36811897 PMCID: PMC9947806 DOI: 10.1001/jamasurg.2022.8127] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2022] [Accepted: 10/27/2022] [Indexed: 02/24/2023]
Abstract
Importance There is a need to better assess the cumulative effect on morbidity and mortality in patients undergoing durable left ventricular assist device (LVAD) implantation. This study evaluates a patient-centered performance metric (days alive and out of hospital [DAOH]) for durable LVAD therapy. Objective To determine the incidence of percent of DAOH before and after LVAD implantation and (2) explore its association with established quality metrics (death, adverse events [AEs], quality of life). Design, Settings, and Participants This was a retrospective national cohort study of Medicare beneficiaries implanted with a durable continuous-flow LVAD between April 2012 and December 2016. The data were analyzed from December 2021 to May 2022. Follow-up was 100% complete at 1 year. Data from The Society of Thoracic Surgeons Intermacs registry were linked to Medicare claims. Main Outcomes and Measures The number of DAOH 180 days before and 365 days after LVAD implantation and daily patient location (home, index hospital, nonindex hospital, skilled nursing facility, rehabilitation center, hospice) were calculated. Percent of DAOH was indexed to each beneficiary's pre- (percent DAOH-BF) and postimplantation (percentage of DAOH-AF) follow-up time. The cohort was stratified by terciles of percentage of DAOH-AF. Results Among the 3387 patients included (median [IQR] age: 66.3 [57.9-70.9] years), 80.9% were male, 33.6% and 37.1% were Interfaces Patient Profile 2 and 3, respectively, and 61.1% received implants as destination therapy. Median (IQR) percent of DAOH-BF was 88.8% (82.7%-93.8%) and 84.6% (62.1-91.5%) for percent of DAOH-AF. While DAOH-BF was not associated with post-LVAD outcomes, patients in the low tercile of percentage of DAOH-AF had a longer index hospitalization stay (mean, 44 days; 95% CI, 16-77), were less likely to be discharged home (mean. -46.4 days; 95% CI, 44.2-49.1), and spent more time in a skilled nursing facility (mean, 27 days; 95% CI, 24-29), rehabilitation center (mean, 10 days; 95% CI, 8-12), or hospice (mean, 6 days; 95% CI, 4-8). Increasing percentage of DAOH-AF was associated with patient risk, AEs, and indices of HRQoL. Patients experiencing non-LVAD-related AEs had the lowest percentage of DAOH-AF. Conclusions and Relevance Significant variability existed in the percentage of DAOH within a 1-year time horizon and was associated with the cumulative AEs burden. This patient-centered measure may assist clinicians in informing patients about expectations after durable LVAD implantation. Validation of percentage DAOH as a quality metric for LVAD therapy across centers should be explored.
Collapse
Affiliation(s)
- Pierre-Emmanuel Noly
- Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor
- Now with the Montreal Heart Institute, Université de Montréal, Quebec, Montréal, Canada
| | - Xiaoting Wu
- Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor
| | - Hechuan Hou
- Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor
| | - Kathleen L. Grady
- Division of Cardiac Surgery, Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
| | - James W. Stewart
- Division of Cardiac Surgery, Yale School of Medicine New Haven, Connecticut
| | - Robert B. Hawkins
- Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor
| | - Guangyu Yang
- Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor
| | - K. Dennie Kim
- Strategy, Ethics, and Entrepreneurship, Darden School of Business, University of Virginia, Charlottesville
| | - Min Zhang
- Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor
| | - Lourdes Cabrera
- Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor
| | - Keith D. Aaronson
- Division of Cardiovascular Medicine, Department of Internal Medicine, Michigan Medicine, University of Michigan, Ann Arbor
| | - Francis D. Pagani
- Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor
| | - Donald S. Likosky
- Department of Cardiac Surgery, Michigan Medicine, University of Michigan, Ann Arbor
| | | |
Collapse
|
|
19
|
Abstract
Mechanical circulatory support (MCS) devices provide temporary or intermediate- to long-term support for acute cardiopulmonary support. In the last 20 to 30 years, tremendous growth in MCS device usage has been seen. These devices offer support for isolated respiratory failure, isolated cardiac failure, or both. Initiation of MCS devices requires the input from multidisciplinary teams using patient factors and institutional resources to guide decision making, along with a planned "exit strategy" for bridge to decision, bridge to transplant, bridge to recovery, or as destination therapy. Important considerations for MCS use include patient selection, cannulation/insertion strategies, and complications of each device.
Collapse
Affiliation(s)
- Suzanne Bennett
- Department of Anesthesiology, University of Cincinnati College of Medicine, 2139 Albert Sabin Way, Cincinnati, OH 45267-0531, USA.
| | - Lauren Sutherland
- Columbia University Irving Medical Center, 622 W 168(th) Street, New York, NY 10032, USA
| | - Promise Ariyo
- Johns Hopkins University, 1800 Orleans Street, Baltimore, MD 21287, USA
| | - Frank M O'Connell
- Anesthesiology, Atlanticare Regional Medical Center, 65 W Jimmie Leeds Road, Pomona, NJ 08240, USA
| |
Collapse
|
|
20
|
Outcomes of Patients Referred for Cardiac Rehabilitation After Left Ventricular Assist Device Implantation. ASAIO J 2023; 69:304-308. [PMID: 35920751 DOI: 10.1097/mat.0000000000001799] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/02/2022] Open
Abstract
A single-center continuous-flow left ventricular assist device (LVAD) cohort (n = 503) was reviewed for patients with information on cardiac rehabilitation (CR) participation (n = 273) over a 13-year period. The analysis was then limited LVAD recipients who fit into three main CR categories: those who graduated CR (n = 138), those who were able to but declined participation (n = 61), and those who were too sick to complete or start CR (n = 28). To assess the association between CR categories and mortality and hospitalizations on LVAD support, multivariate cox regression and negative binomial regression analyses were performed, respectively. Among those who started CR and had the opportunity to finish (enough follow-up time, insurance coverage), 79% graduated. Those who graduated CR had a 96% survival at 1 year (95% confidence interval [CI], 91-98). Compared with the graduated group, those in the too sick group had an increased hazards rate of mortality (hazard ratio, 2.85; 95% CI, 1.49-5.44; p < 0.01) and an increase in the incidence rate of hospitalizations (incidence rate ratio, 1.74; 95% CI, 1.14-2.66, p = 0.01). This study is the largest to date to report outcomes of LVAD recipients referred for CR. The lower readmission rates and high survival in the group that graduated CR provides further evidence for the safety of CR in LVAD recipients.
Collapse
|
|
21
|
Neurologic Complications in Patients With Left Ventricular Assist Devices. Can J Cardiol 2023; 39:210-221. [PMID: 36400374 PMCID: PMC9905352 DOI: 10.1016/j.cjca.2022.11.004] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2022] [Revised: 11/10/2022] [Accepted: 11/10/2022] [Indexed: 11/16/2022] Open
Abstract
Left ventricular assist device (LVAD) use has revolutionised the care of patients with advanced heart failure, allowing more patients to survive until heart transplantation and providing improved quality for patients unable to undergo transplantation. Despite these benefits, improvements in device technology, and better clinical care and experience, LVADs are associated with neurologic complications. This review provides information on the incidence, risk factors, and management of neurologic complications among LVAD patients. Although scant guidelines exist for the evaluation and management of neurologic complications in LVAD patients, a high index of suspicion can prompt early detection of neurologic complications which may improve overall neurologic outcomes. A better understanding of the implications of continuous circulatory flow on systemic and cerebral vasculature is necessary to reduce the common occurrence of neurologic complications in this population.
Collapse
|
|
22
|
The Jarvik 2000 Left Ventricular Assist Device: Results of the United States Bridge to Transplant Trial. ASAIO J 2023; 69:174-182. [PMID: 35421002 DOI: 10.1097/mat.0000000000001750] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023] Open
Abstract
The Jarvik 2000 bridge to transplant investigational device exemption study was a multicentered, prospective study of 150 UNOS status I patients implanted with the Jarvik 2000 between 2005 and 2012. During the study period, there were numerous modifications of the system that included converting from pin to cone bearings. Results were analyzed for three cohorts: total (n = 150), pin (n = 128), and cone (n = 22). Baseline demographics included age (52 ± 13), gender (79% male), size (BSA 1.98), and etiology (37% idiopathic dilated cardiomyopathy; 43% Ischemic). Seventy percent of patients were either INTERMACS 1 or 2. The primary endpoint-defined as successful transplantation or listing at 180 days (prespecified at 65%; 95% lower CI: 57%)-was successfully achieved for the total cohort (67.3%; 95% CI: 59.5%-74.3%; p = 0.006). In subgroup analysis of the more contemporary, cone-bearing group, the primary endpoint was met in 91% (95% CI: 72%-97.5%; p = 0.001). Compared with pin patients, cone-bearing patients had less hemolysis as well as decreased end-organ dysfunction. Functional and quality of life scores improved after implantation independent type of bearing. In conclusion, despite a particularly sick patient population, the Jarvik 2000 was shown to be effective in supporting the advanced HF patient.
Collapse
|
|
23
|
Sato D, Koizumi S, Umekawa M, Kioyofuji S, Ando M, Ono M, Saito N. Controversies and challenges of coil embolization for intracranial aneurysm in a continuous-flow LVAD implanted patient: A case report. Surg Neurol Int 2023; 14:34. [PMID: 36895216 PMCID: PMC9990801 DOI: 10.25259/sni_1101_2022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2022] [Accepted: 01/12/2023] [Indexed: 01/28/2023] Open
Abstract
Background Continuous-flow left ventricular assist device (CF-LVAD) technology has rapidly developed to support the failing heart refractory to standard medical treatments. Although the expected prognosis has improved dramatically, ischemic and hemorrhagic strokes are possible complications and the leading causes of death in the CF-LVAD population. Case Description We encountered a case of an unruptured large internal carotid aneurysm in a patient with a CF-LVAD. Following a detailed discussion of his expected prognosis, the risk of aneurysm rupture, and the inherited risk of aneurysm treatment, coil embolization was performed without adverse events. The patient remained recurrence-free for 2-year postoperatively. Conclusion This report illustrates the feasibility of coil embolization in a CF-LVAD recipient and emphasizes the necessity of vigilant consideration of whether to intervene in an intracranial aneurysm after CF-LVAD implantation. We confronted several challenges during the treatment: optimal endovascular technique, management of antithrombotic drugs, safe arterial access, desirable perioperative imaging modalities, and prevention of ischemic complications. This study aimed to share this experience.
Collapse
Affiliation(s)
- Daisuke Sato
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Satoshi Koizumi
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Motoyuki Umekawa
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Satoshi Kioyofuji
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Masahiko Ando
- Department of Cardiac Surgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Minoru Ono
- Department of Cardiac Surgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Nobuhito Saito
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| |
Collapse
|
|
24
|
Off-pump implantation of left ventricular assist device via minimally invasive left thoracotomy: Our single-center experience. TURK GOGUS KALP DAMAR CERRAHISI DERGISI 2023; 31:37-44. [PMID: 36926145 PMCID: PMC10012981 DOI: 10.5606/tgkdc.dergisi.2023.23370] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Subscribe] [Scholar Register] [Received: 01/27/2022] [Accepted: 08/23/2022] [Indexed: 03/18/2023]
Abstract
Background The aim of this study was to compare our experience of left ventricular assist device implantation via minimally invasive left thoracotomy with off-pump versus on-pump technique. Methods Between June 2013 and April 2020, nine patients (8 males, 1 female; mean age: 47±11.9 years; range, 30 to 61 years) who underwent off-pump left ventricular assist device implantation and nine patients (8 males, 1 female; mean age: 47±11.4 years; range, 29 to 60 years) who underwent on-pump minimally invasive left thoracotomy were retrospectively analyzed. Postoperative outcomes and mid-term results of both groups were evaluated. Results Outflow graft was anastomosed to the ascending aorta with J-sternotomy in all patients. The median duration of intubation and intensive care unit stay were one (IQR: 1.5) day and eight (IQR: 6.5) days in the off-pump group, respectively and one (IQR: 0) day and seven (IQR: 7) days in the on-pump group, respectively. Intra-aortic balloon pump was needed during the weaning of cardiopulmonary bypass in one (11%) of the patients in both groups. Postoperative right ventricular failure was observed in two (22%) patients in the offpump group who were treated medically and recovered. There was no need for revision due to bleeding or postoperative extracorporeal membrane oxygenator implantation in either group. In the off-pump group, three patients underwent heart transplantation after median 854 (IQR: 960) days. Three patients died one month, two and four years after implantation. Three patients were still alive with left ventricular assist device and were being uneventfully followed for 365, 400, and 700 days after implantation. Conclusion Off-pump technique is safe and feasible option for implantation of left ventricular assist device via minimally invasive left thoracotomy.
Collapse
|
|
25
|
Current status of adult cardiac surgery-part 2. Curr Probl Surg 2023; 60:101245. [PMID: 36642488 DOI: 10.1016/j.cpsurg.2022.101245] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2022] [Accepted: 10/13/2022] [Indexed: 12/13/2022]
|
|
26
|
Chaudhry S, DeVore AD, Vidula H, Nassif M, Mudy K, Birati EY, Gong T, Atluri P, Pham D, Sun B, Bansal A, Najjar SS, for the Future Leaders In Growing Heart Failure Therapies (FLIGHT) Investigators. Left Ventricular Assist Devices: A Primer For the General Cardiologist. J Am Heart Assoc 2022; 11:e027251. [PMID: 36515226 PMCID: PMC9798797 DOI: 10.1161/jaha.122.027251] [Citation(s) in RCA: 22] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Durable implantable left ventricular assist devices (LVADs) have been shown to improve survival and quality of life for patients with stage D heart failure. Even though LVADs remain underused overall, the number of patients with heart failure supported with LVADs is steadily increasing. Therefore, general cardiologists will increasingly encounter these patients. In this review, we provide an overview of the field of durable LVADs. We discuss which patients should be referred for consideration of advanced heart failure therapies. We summarize the basic principles of LVAD care, including medical and surgical considerations. We also discuss the common complications associated with LVAD therapy, including bleeding, infections, thrombotic issues, and neurologic events. Our goal is to provide a primer for the general cardiologist in the recognition of patients who could benefit from LVADs and in the principles of managing patients with LVAD. Our hope is to "demystify" LVADs for the general cardiologist.
Collapse
Affiliation(s)
- Sunit‐Preet Chaudhry
- Division of CardiologyAscension St. Vincent Heart CenterIndianapolisIN,Ascension St. Vincent Cardiovascular Research InstituteIndianapolisIN
| | - Adam D. DeVore
- Department of Medicine and Duke Clinical Research InstituteDuke University School of MedicineDurhamNC
| | - Himabindu Vidula
- Division of Heart Failure and TransplantUniversity of Rochester School of Medicine and DentistryRochesterNY
| | - Michael Nassif
- Division of Heart failure and TransplantSaint Luke’s Mid America Heart InstituteKansas CityMO
| | - Karol Mudy
- Division of Cardiothoracic SurgeryMinneapolis Heart InstituteMinneapolisMN
| | - Edo Y. Birati
- The Lydia and Carol Kittner, Lea and Benjamin Davidai Division of Cardiovascular Medicine and SurgeryPadeh‐Poriya Medical Center, Bar Ilan UniversityPoriyaIsrael
| | - Timothy Gong
- Center for Advanced Heart and Lung DiseaseBaylor Annette C. and Harold C. Simmons Transplant Institute, Baylor University Medical CenterDallasTX
| | - Pavan Atluri
- Division of Cardiovascular SurgeryUniversity of PennsylvaniaPhiladelphiaPA
| | - Duc Pham
- Center for Advanced Heart FailureBluhm Cardiovascular Institute, Northwestern University, Feinberg School of MedicineChicagoIL
| | - Benjamin Sun
- Division of Cardiothoracic Surgery, Abbott Northwestern HospitalMinneapolisMN
| | - Aditya Bansal
- Division of Cardiothoracic Surgery, Department of SurgeryOchsner Clinic FoundationNew OrleansLA
| | - Samer S. Najjar
- Division of Cardiology, MedStar Heart and Vascular InstituteMedstar Medical GroupBaltimoreMD
| | | |
Collapse
|
|
27
|
Rubinstein G, Lotan D, Moeller CM, DeFilippis EM, Slomovich S, Oren D, Yuzefpolskaya M, Sayer G, Uriel N. Sex differences in patients undergoing heart transplantation and LVAD therapy. Expert Rev Cardiovasc Ther 2022; 20:881-894. [PMID: 36409479 DOI: 10.1080/14779072.2022.2149493] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
INTRODUCTION Left ventricular assist device (LVAD) and heart transplantation (HT) are the two life-sustaining therapies that have revolutionized the management of end-stage heart failure (HF). Yet, significant sex differences exist with respect to their use and effects. AREAS COVERED This review summarizes sex differences in the utilization, outcomes, and complications of LVAD and HT. Particular emphasis is placed on leading clinical trials in the field, historical and recent large registries-based analyses, as well as contemporary technological and policy changes affecting these differences. EXPERT OPINION Women with advanced HF remain under-treated with guideline-directed medical therapy and are less likely to be referred for consideration for LVAD and HT. This remains true despite newer LVAD technology and the new heart transplant allocation system. Community outreach, education, as well as increased representation of women in clinical research may reduce inequities.
Collapse
Affiliation(s)
- Gal Rubinstein
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Dor Lotan
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Cathrine M Moeller
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Ersilia M DeFilippis
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Sharon Slomovich
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Daniel Oren
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Melana Yuzefpolskaya
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Gabriel Sayer
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| | - Nir Uriel
- Division of Cardiology, Center of Advance Cardiac Care, Columbia University Irving Medical Center/New York-Presbyterian Hospital New York, New York, NY, USA
| |
Collapse
|
|
28
|
Daubenspeck DK. Mechanical circulatory support devices: historical overview and modern approach. Int Anesthesiol Clin 2022; 60:1-7. [PMID: 35972151 DOI: 10.1097/aia.0000000000000376] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Affiliation(s)
- Danisa K Daubenspeck
- Department of Anesthesia and Critical Care, University of Chicago, Chicago, Illinois
| |
Collapse
|
|
29
|
Cormican DS, Madden C, Rodrigue MF. Mechanical circulatory support: complications, outcomes, and future directions. Int Anesthesiol Clin 2022; 60:72-80. [PMID: 35960687 DOI: 10.1097/aia.0000000000000373] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Affiliation(s)
- Daniel S Cormican
- Cardiothoracic & Transplant Anesthesiology and Surgical Critical Care, Anesthesiology Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
| | - Claire Madden
- Surgical Critical Care, Surgery Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
| | - Marc F Rodrigue
- Cardiothoracic Anesthesiology, Anesthesiology Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
| |
Collapse
|
|
30
|
El Nihum LI, Manian N, Arunachalam P, Al Abri Q, Guha A. Renal Dysfunction in Patients with Left Ventricular Assist Device. Methodist Debakey Cardiovasc J 2022; 18:19-26. [PMID: 36132586 PMCID: PMC9461688 DOI: 10.14797/mdcvj.1146] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/08/2022] [Accepted: 07/14/2022] [Indexed: 11/08/2022] Open
Abstract
Late-stage heart failure and renal dysfunction are often seen in conjunction. Cardiorenal syndrome (CRS) describes the complex interaction between the two disease states. Early literature described the pathophysiology of CRS as related only to reduced cardiac output and decreased renal perfusion. Recent literature suggests a more multifaceted mechanism. Left ventricular assist devices (LVAD), used as bridge-to-transplant and destination therapy in patients with heart failure, impact not only cardiac function but also renal function, especially in those patients with preoperative renal dysfunction. The mechanism by which LVAD implantation affects renal function is complex and understated in early literature. In this review, we discuss the pathogenesis of CRS, the impact of preoperative renal dysfunction in patients undergoing LVAD implantation, and the effect of LVAD implantation on postoperative renal function.
Collapse
Affiliation(s)
- Lamees I. El Nihum
- Methodist DeBakey Heart & Vascular Center, Houston Methodist, Houston, Texas, US
- Texas A&M College of Medicine, Bryan, Texas, US
| | - Nina Manian
- Methodist DeBakey Heart & Vascular Center, Houston Methodist, Houston, Texas, US
- Texas A&M College of Medicine, Bryan, Texas, US
| | - Priya Arunachalam
- Methodist DeBakey Heart & Vascular Center, Houston Methodist, Houston, Texas, US
- Texas A&M College of Medicine, Bryan, Texas, US
| | - Qasim Al Abri
- Methodist DeBakey Heart & Vascular Center, Houston Methodist, Houston, Texas, US
| | - Ashrith Guha
- Methodist DeBakey Heart & Vascular Center, Houston Methodist, Houston, Texas, US
| |
Collapse
|
|
31
|
Major R, Wilczek G, Więcek J, Gawlikowski M, Plutecka H, Kasperkiewicz K, Kot M, Pomorska M, Ostrowski R, Kopernik M. Hemocompatibile Thin Films Assessed under Blood Flow Shear Forces. Molecules 2022; 27:molecules27175696. [PMID: 36080463 PMCID: PMC9458224 DOI: 10.3390/molecules27175696] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/20/2022] [Revised: 08/23/2022] [Accepted: 09/01/2022] [Indexed: 11/16/2022] Open
Abstract
The aim of this study was to minimize the risk of life-threatening thromboembolism in the ventricle through the use of a new biomimetic heart valve based on metal-polymer composites. Finite volume element simulations of blood adhesion to the material were carried out, encompassing radial flow and the cone and plane test together with determination of the effect of boundary conditions. Both tilt-disc and bicuspid valves do not have optimized blood flow due to their design based on rigid valve materials (leaflet made of pyrolytic carbon). The main objective was the development of materials with specific properties dedicated to contact with blood. Materials were evaluated by dynamic tests using blood, concentrates, and whole human blood. Hemostability tests under hydrodynamic conditions were related to the mechanical properties of thin-film materials obtained from tribological tests. The quality of the coatings was high enough to avoid damage to the coating even as they were exposed up to maximum loading. Analysis towards blood concentrates of the hydrogenated carbon sample and the nitrogen-doped hydrogenated carbon sample revealed that the interaction of the coating with erythrocytes was the strongest. Hemocompatibility evaluation under hydrodynamic conditions confirmed very good properties of the developed coatings.
Collapse
Affiliation(s)
- Roman Major
- Institute of Metallurgy and Materials Science, Polish Academy of Sciences, 25 Reymonta St., 30-059 Cracow, Poland
| | - Grażyna Wilczek
- Institute of Biology, Biotechnology and Environmental Protection, University of Silesia, Bankowa St. 9, 40-007 Katowice, Poland
| | - Justyna Więcek
- Institute of Metallurgy and Materials Science, Polish Academy of Sciences, 25 Reymonta St., 30-059 Cracow, Poland
| | - Maciej Gawlikowski
- Faculty of Biomedical Engineering, Department of Biosensors and Processing of Biomedical Signals, Silesian University of Technology, Roosevelt St. 40, 41-800 Zabrze, Poland
| | - Hanna Plutecka
- Division of Molecular Biology and Clinical Genetics, Faculty of Medicine, Jagiellonian University Medical College, Skawinska St. 8, 31-066 Cracow, Poland
| | - Katarzyna Kasperkiewicz
- Institute of Biology, Biotechnology and Environmental Protection, Faculty of Natural Sciences, University of Silesia in Katowice, Jagiellońska St., 2840-032 Katowice, Poland
| | - Marcin Kot
- Faculty of Mechanical Engineering and Robotics, AGH University of Science and Technology, Al. Mickiewicza 30, 30-059 Cracow, Poland
| | - Małgorzata Pomorska
- Institute of Metallurgy and Materials Science, Polish Academy of Sciences, 25 Reymonta St., 30-059 Cracow, Poland
| | - Roman Ostrowski
- Institute of Optoelectronics, Military University of Technology, Gen. S. Kaliskiego St. 2, 00-908 Warsaw, Poland
| | - Magdalena Kopernik
- Faculty of Metals Engineering and Industrial Computer Science, AGH University of Science and Technology, Al. Mickiewicza 30, 30-059 Cracow, Poland
- Correspondence: ; Tel.: +48-12-617-51-26
| |
Collapse
|
|
32
|
Kawamura S, Koizumi S, Umekawa M, Miyawaki S, Kinoshita O, Ono M, Saito N. Long-Term Benefit of Mechanical Thrombectomy for Acute Ischemic Stroke in Patients with a Left Ventricular Assist Device: A Single-Center Retrospective Study. World Neurosurg 2022; 165:e331-e336. [PMID: 35718273 DOI: 10.1016/j.wneu.2022.06.046] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/27/2022] [Accepted: 06/09/2022] [Indexed: 12/14/2022]
Abstract
OBJECTIVE Left ventricular assist devices (LVADs) are an epoch-making treatment option for patients with severe heart failure; however, the patients occasionally experience severe acute ischemic strokes (AISs). Although mechanical thrombectomy is considered as an effective treatment for severe AIS in patients with LVADs, there remains a paucity of data on the long-term outcomes. This study aimed to investigate the acute-phase efficacy and long-term outcomes of mechanical thrombectomy for AIS patients with LVADs. METHODS We retrospectively reviewed 9 cases in 8 patients with LVADs who developed AIS and underwent mechanical thrombectomy from July 2014 to November 2021 at our hospital. Clinical information, including the National Institutes of Health Stroke Scale score and modified Rankin Scale score before and after thrombectomy, the details of procedures, and the long-term outcomes after thrombectomy, was retrospectively reviewed and statistically analyzed. RESULTS Effective recanalization was achieved in 89% of the 9 cases. The median National Institutes of Health Stroke Scale score improved from 12 (range, 8-29) to 5 (range, 0-29) after mechanical thrombectomy. The median total follow-up duration was 1327 (range, 78-2659) days. Of the 8 patients, 3 patients underwent heart transplantation, and the LVAD was removed after recovery of the patient's heart function. One patient awaited heart transplantation. CONCLUSIONS This study revealed the long-term benefit of mechanical thrombectomy for AIS in patients with LVADs, eventually achieving 50% of independence from LVADs.
Collapse
Affiliation(s)
- Shinji Kawamura
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Satoshi Koizumi
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan.
| | - Motoyuki Umekawa
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Satoru Miyawaki
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Osamu Kinoshita
- Department of Cardiac Surgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Minoru Ono
- Department of Cardiac Surgery, The University of Tokyo Hospital, Tokyo, Japan
| | - Nobuhito Saito
- Department of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan
| |
Collapse
|
|
33
|
Singh M, Krishnan M, Ruiz ME, Sheikh FH. Nontuberculous Mycobacterial Infections Associated With Left Ventricular Assist Devices in 3 Patients. Tex Heart Inst J 2022; 49:483734. [PMID: 35838643 DOI: 10.14503/thij-20-7498] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
Durable left ventricular assist devices (LVADs) provide circulatory support in patients with end-stage heart failure; however, complications include infection of the driveline exit site. Nontuberculous mycobacterial infections are rare in patients with LVADs, but they should be considered in those who have undergone device exchanges and have bacterial infections with driveline exit-site discharge but no fever or leukocytosis. We reviewed the charts of patients who had an LVAD implanted at our institution from January 2009 through December 2019, to identify those with a device-related nontuberculous mycobacterial infection. Collected data included patient demographics, premorbid conditions, infection type, previous device complications, treatment, and outcomes. We identified infections in 3 patients (mean age, 41 yr): Mycobacterium abscessus in 2 and M. chimaera in 1. All had a HeartMate II device and had undergone device exchanges for pump thrombosis or for driveline fault or infections. All presented with driveline exit-site discharge without fever or leukocytosis. The mean time between initial device implantation and diagnosis of a nontuberculous mycobacterial infection was 55 months. All 3 patients were treated with antibiotics and underwent localized surgical débridement; one underwent an additional device exchange. The M. abscessus infections disseminated, and both patients died; the patient with M. chimaera infection continued to take suppressive antibiotics. Nontuberculous mycobacterial infections are associated with high morbidity and mortality rates, warranting prompt diagnosis and treatment.
Collapse
Affiliation(s)
- Manavotam Singh
- Division of Cardiology, MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
| | - Mrinalini Krishnan
- Division of Cardiology, MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
| | - Maria Elena Ruiz
- Section of Infectious Diseases, Department of Medicine, MedStar Washington Hospital Center, Washington, DC
| | - Farooq H Sheikh
- Division of Cardiology, MedStar Heart and Vascular Institute, MedStar Washington Hospital Center, Washington, DC
| |
Collapse
|
|
34
|
Girfoglio M, Ballarin F, Infantino G, Nicoló F, Montalto A, Rozza G, Scrofani R, Comisso M, Musumeci F. Non-intrusive PODI-ROM for patient-specific aortic blood flow in presence of a LVAD device. Med Eng Phys 2022; 107:103849. [DOI: 10.1016/j.medengphy.2022.103849] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2021] [Revised: 06/23/2022] [Accepted: 07/10/2022] [Indexed: 10/17/2022]
|
|
35
|
George TJ, Aldrich A, Smith RL, Ryan WH, DiMaio JM, Kabra N, Afzal A, Rawitscher DA. Development of a non‐transplant left ventricular assist device program. J Card Surg 2022; 37:3188-3198. [DOI: 10.1111/jocs.16790] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2022] [Revised: 05/19/2022] [Accepted: 06/20/2022] [Indexed: 11/28/2022]
Affiliation(s)
- Timothy J. George
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| | - Allison Aldrich
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| | - Robert L. Smith
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| | - William H. Ryan
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| | - J. Michael DiMaio
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| | - Nitin Kabra
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| | - Aasim Afzal
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| | - David A. Rawitscher
- Department of Advanced Heart Failure and MCS, Baylor Scott and White The Heart Hospital Plano Texas USA
| |
Collapse
|
|
36
|
Worku B, Naka Y. Right ventricular failure after thoracotomy left ventricular assist device; the role of pericardial restraint. J Card Surg 2022; 37:3082-3083. [PMID: 35842795 DOI: 10.1111/jocs.16767] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/01/2022] [Accepted: 07/04/2022] [Indexed: 11/29/2022]
Affiliation(s)
- Berhane Worku
- Department of Cardiothoracic Surgery, New York Presbyterian Weill Cornell Medical Center, New York, New York, USA.,Department of Cardiothoracic Surgery, New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, USA
| | - Yoshifumi Naka
- Department of Cardiothoracic Surgery, New York Presbyterian Weill Cornell Medical Center, New York, New York, USA
| |
Collapse
|
|
37
|
Zheng X, Pan Y, Zhang Y, Meng K, Zhou J, Wang X, Cui Y, Li J, Li Y, Chen H. Interventional Microbubble Enhanced Sonothrombolysis on Left Ventricular Assist Devices. ADVANCED SCIENCE (WEINHEIM, BADEN-WURTTEMBERG, GERMANY) 2022; 9:e2201291. [PMID: 35615977 PMCID: PMC9313509 DOI: 10.1002/advs.202201291] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 03/05/2022] [Revised: 04/27/2022] [Indexed: 06/15/2023]
Abstract
The left ventricular assist device (LVAD) is often used in the treatment of heart failure. However, 4% to 9% implanted LVAD will have thrombosis problem in one year, which is fatal to the patient's life. In this work, an interventional sonothrombolysis (IST) method is developed to realize the thrombolysis on LVAD. A pair of ultrasound transducer rings is installed on the shell of LVAD, and drug-loaded microbubbles are injected into the LVAD through the interventional method. The microbubbles are adhere on the thrombus with the coated thrombus-targeted drugs, and the thrombolytic drugs carried by the bubbles are brought into the thrombus by the cavitation of bubbles under the ultrasound. In a proof-of-concept experiment in a live sheep model, the thrombus on LVAD is dissolved in 30 min, without damages on LVADs and organs. This IST exhibits to be more efficient and safer compared with other thrombolysis methods on LVAD.
Collapse
Affiliation(s)
- Xiaobing Zheng
- State Key Laboratory of Tribology, Department of Mechanical Engineering, Tsinghua University, Beijing, 100084, China
| | - Yunfan Pan
- State Key Laboratory of Tribology, Department of Mechanical Engineering, Tsinghua University, Beijing, 100084, China
| | - Yuan Zhang
- School of Mechanical Engineering, University of Science and Technology Beijing, Beijing, 100083, China
| | - Kuilin Meng
- State Key Laboratory of Tribology, Department of Mechanical Engineering, Tsinghua University, Beijing, 100084, China
| | - Jianye Zhou
- Animal Experiment Center, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100037, China
| | - Xin Wang
- Animal Experiment Center, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100037, China
| | - Yongchun Cui
- Animal Experiment Center, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100037, China
| | - Jiang Li
- School of Mechanical Engineering, University of Science and Technology Beijing, Beijing, 100083, China
| | - Yongjian Li
- State Key Laboratory of Tribology, Department of Mechanical Engineering, Tsinghua University, Beijing, 100084, China
| | - Haosheng Chen
- State Key Laboratory of Tribology, Department of Mechanical Engineering, Tsinghua University, Beijing, 100084, China
| |
Collapse
|
|
38
|
Chivukula VK, Loera G, Dragoljic D, Martinez J, Beckman JA, Li S, Mahr C, Aliseda A. A Computational Hemodynamics Approach to Left Ventricular Assist Device (LVAD) Optimization Validated in a Large Patient Cohort. ASAIO J 2022; 68:932-939. [PMID: 34743140 DOI: 10.1097/mat.0000000000001606] [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: 11/26/2022] Open
Abstract
With increasing use of left ventricular assist devices (LVAD) it is critical to devise strategies to optimize LVAD speed while controlling mean arterial pressure (MAP) and flow according to patient physiology. The complex interdependency between LVAD speed, MAP, and flow frequently makes optimization difficult under clinical conditions. We propose a method to guide this procedure in silico, narrowing the conditions to test clinically. A computational model of the circulatory network that simulates HF and LVAD support, incorporating LVAD pressure-flow curves was applied retrospectively to anonymized patient hemodynamics data from the University of Washington Medical Center. MAP management on 61 patient-specific computational models with a target of 70 mm Hg, resulting flow for a given LVAD speed was analyzed, and compared to a target output of 5 L/min. Before performing virtual MAP management, 51% had a MAP>70 mm Hg and CO>5 L/min, and 33% had a MAP>70 mm Hg and CO<5 L/min. After changing systemic resistance to meet the MAP target (without adjusting LVAD speed), 84% of cases resulted in CO higher than 5 L/min, with a median CO of 6.79 L/min, using the computational predictive model. Blood pressure management alone is insufficient in meeting both MAP and CO targets, due to the risk of hypervolemia, and requires appropriate LVAD speed optimization to achieve both targets, while preserving right heart health. Such computational tools can narrow down conditions to be tested for each patient, providing significant insight into the pump-patient interplay. LVAD hemodynamic optimization has the potential to reduce complications and improve outcomes.
Collapse
Affiliation(s)
| | - Gavin Loera
- Department of Biomedical Engineering, University of North Texas, Denton, Texas
| | - Dina Dragoljic
- Department of Biomedical Engineering, Florida Institute of Technology, Melbourne, Florida
| | - Jasmine Martinez
- Department of Biomedical Engineering, Florida Institute of Technology, Melbourne, Florida
| | | | - Song Li
- Division of Cardiology, University of Washington, Seattle, Washington
| | - Claudius Mahr
- Division of Cardiology, University of Washington, Seattle, Washington
| | - Alberto Aliseda
- Department of Mechanical Engineering, University of Washington, Seattle, Washington, USA
| |
Collapse
|
|
39
|
Salerno CT, Hayward C, Hall S, Goldstein D, Saeed D, Schmitto J, Kaczorowski D, Molina E, Zimpfer D, Tsui S, Soltesz E, Pham DT, Mokadam NA, Kilic A, Davis E, Feller E, Lorts A, Silvestry S, Slaughter MS, Potapov E, Atluri P, Cowger J, Pagani FD. HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations. J Thorac Cardiovasc Surg 2022; 163:2120-2127.e5. [PMID: 35341579 DOI: 10.1016/j.jtcvs.2021.11.085] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/07/2021] [Revised: 11/09/2021] [Accepted: 11/10/2021] [Indexed: 11/29/2022]
Abstract
The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices.
Collapse
Affiliation(s)
| | | | - Shelley Hall
- Departments of Cardiology and Transplantation, Baylor University Medical Center, Dallas, Tex
| | - Daniel Goldstein
- Department of Cardiothoracic Surgery, Montefiore Medical Center, New York, NY
| | - Diyar Saeed
- Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany
| | | | - David Kaczorowski
- Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pa
| | - Ezequiel Molina
- Department of Cardiac Surgery, MedStar Washington Hospital Center, Washington, DC
| | - Daniel Zimpfer
- Department of Cardiac Surgery, Medical University Vienna, Vienna, Austria
| | - Steven Tsui
- Department of Cardiothoracic Surgery, Royal Papworth Hospital, Cambridge, United Kingdom
| | - Edward Soltesz
- Department of Cardiothoracic Surgery, Cleveland Clinical Hospital, Cleveland, Ohio
| | - Duc Thin Pham
- Division of Cardiac Surgery, Northwestern University Feinberg School of Medicine, Chicago, Ill
| | - Nahush A Mokadam
- Division of Cardiac Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio
| | - Arman Kilic
- Division of Cardiothoracic Surgery, Medical University of South Carolina, Charleston, SC
| | - Erin Davis
- Division of Cardiothoracic Surgery, University of Utah, Salt Lake City, Utah
| | - Erika Feller
- Divison of Cardiovascular Medicine, University of Maryland, Baltimore, Md
| | - Angela Lorts
- Division of Pediatric Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
| | | | - Mark S Slaughter
- Department of Cardiovascular and Thoracic Surgery, University of Louisville School of Medicine, Louisville, Ky
| | - Evgenij Potapov
- Department of Thoracic and Cardiovascular Surgery, German Heart Centre, Berlin, Germany
| | - Pavan Atluri
- Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pa
| | - Jennifer Cowger
- Cardiovascular Medicine, Henry Ford Medical Center, Detroit, Mich
| | - Francis D Pagani
- Department of Cardiac Surgery, University of Michigan, Ann Arbor, Mich.
| |
Collapse
|
|
40
|
Tam CW, Shen L, Zeidman AD, Srivastava A, Ivascu NS. Mechanical Circulatory Support: Primer for Consultant Specialists. Clin J Am Soc Nephrol 2022; 17:890-901. [PMID: 35595531 PMCID: PMC9269658 DOI: 10.2215/cjn.13341021] [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: 01/08/2023]
Abstract
Mechanical life support therapies exist in many forms to temporarily replace the function of vital organs. Generally speaking, these tools are supportive therapy to allow for organ recovery but, at times, require transition to long-term mechanical support. This review will examine nonrenal extracorporeal life support for cardiac and pulmonary support as well as other mechanical circulatory support options. This is intended as a general primer and overview to assist nephrologist consultants participating in the care of these critically ill patients who often experience acute renal injury as a result of cardiopulmonary shock and from their exposure to mechanical circulatory support.
Collapse
Affiliation(s)
- Christopher W. Tam
- Department of Anesthesiology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Liang Shen
- Department of Anesthesiology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | | | - Ankur Srivastava
- Department of Anesthesiology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| | - Natalia S. Ivascu
- Department of Anesthesiology, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, New York
| |
Collapse
|
|
41
|
Monteagudo-Vela M, Krasopoulos G, Athanasiou T, Tsui S, Kourliouros A. Impact of third-generation left ventricular assist devices on quality of life: Scoping review and meta-analysis. Artif Organs 2022; 46:1012-1018. [PMID: 35132647 DOI: 10.1111/aor.14186] [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: 06/15/2021] [Revised: 12/19/2021] [Accepted: 01/14/2022] [Indexed: 11/29/2022]
Abstract
OBJECTIVES Development in device technology and the scarcity of donor's hearts have increased the number of patients with advanced heart failure receiving durable left ventricular assist devices (LVADs) as a bridge to transplantation and destination therapy, with improved prognosis compared with guideline-directed medical therapy. We sought to examine the impact of modern durable LVADs on the quality of life (QoL) of the recipients. METHODS We carried out a systematic review of articles on QoL following the implantation of third-generation LVADs published between January 2010 and February 2021. Included studies were critically analyzed and evidence synthesis was carried out into a meta-analysis. RESULTS The systematic search yielded 269 articles, 11 of which met the search predefined criteria. Three of them reported results of randomized trials and eight were retrospective and registry studies. Statistically significant QoL improvement from baseline was observed in all published reports. When using the EuroQol 5L questionnaire (scale 0-100) as a QoL tool 6 months post-LVAD implantation, a meta-analysis of four included studies demonstrated a mean difference increase of 28.9 points (95% confidence interval: 26.71-31.14). CONCLUSIONS Third-generation LVADs confer a significant improvement in QoL and their use can be supported not only for prognosis but also for symptom control. Although methodological limitations should be considered, the available QoL outcomes can be a useful tool in patient selection and the decision-making process.
Collapse
Affiliation(s)
| | - George Krasopoulos
- Department of Cardiothoracic Surgery, Oxford University Hospitals, Oxford, UK
| | - Thanos Athanasiou
- Department of Cardiothoracic Surgery, Imperial College Healthcare, Hammersmith Hospital, London, UK
| | - Steven Tsui
- Department of Cardiothoracic Surgery, Royal Papworth Hospital, Cambridge, UK
| | | |
Collapse
|
|
42
|
HVAD to HeartMate 3 Left Ventricular Assist Device Exchange: Best Practices Recommendations. Ann Thorac Surg 2022; 113:1770-1777. [PMID: 35341592 DOI: 10.1016/j.athoracsur.2021.11.078] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/07/2021] [Accepted: 11/10/2021] [Indexed: 11/22/2022]
Abstract
The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices.
Collapse
|
|
43
|
Pourtau L, Beneyto M, Porterie J, Roncalli J, Massot M, Biendel C, Fournier P, Itier R, Galinier M, Lairez O, Delmas C. Prevalence, management, and outcomes of haemorrhagic events in left ventricular assist device recipients. ESC Heart Fail 2022; 9:1931-1941. [PMID: 35338605 PMCID: PMC9065835 DOI: 10.1002/ehf2.13899] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/15/2021] [Revised: 02/07/2022] [Accepted: 03/02/2022] [Indexed: 01/12/2023] Open
Abstract
AIMS Left ventricular assist devices (LVADs) have reduced the mortality of patients with advanced heart failure both as bridge-to-transplant and as destination therapy. However, LVADs are associated with various complications, including bleedings, which affect the prognosis. The aim of the study was to explore the prevalence, management, and outcomes of haemorrhagic adverse events in LVAD recipients. METHODS AND RESULTS We conducted a retrospective, single-centre, cohort study including all patients who received an LVAD from January 2008 to December 2019 in our tertiary centre (Rangueil University Hospital, Toulouse, France). Bleeding events, death, and heart transplantation were collected from electronic medical files. Eighty-eight patients were included, and 43 (49%) presented at least one bleeding event. Gastrointestinal (GI) bleeding was the most frequent (n = 21, 24%), followed by epistaxis (n = 12, 14%) and intracranial haemorrhage (n = 9, 10%). Bleeding events were associated with increased mortality [hazard ratio (HR) 3.8, 95% confidence interval (CI) 1.5-9.3, P < 0.01], particularly in case of intracranial haemorrhage (HR 14.6, 95% CI 4.2-51.1, P < 0.0001). GI bleedings were associated with a trend towards increased mortality (HR 3.0, 95% CI 0.9-9.3, P = 0.05). Each bleeding episode multiplied the risk of death by 1.8 (95% CI 1.2-2.7, P < 0.01). Finally, only early bleedings (<9 months post-implantation) had an impact on mortality (HR 4.2, 95% CI 1.6-11.1, P < 0.01). Therapeutic management was mainly based on temporary interruption of anticoagulation and permanent interruption of antiplatelet therapy. Invasive management was rarely performed. CONCLUSIONS Haemorrhagic events in LVAD recipients are frequent and associated with increased mortality. GI bleedings are the most frequent, and intracranial haemorrhages the most associated with mortality. Management remains empirical requiring more research.
Collapse
Affiliation(s)
- Laetitia Pourtau
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
| | - Maxime Beneyto
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
| | - Jean Porterie
- Department of Cardiovascular SurgeryRangueil University HospitalToulouseFrance
| | - Jerome Roncalli
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
- Medical School of ToulousePaul Sabatier UniversityToulouseFrance
| | - Montse Massot
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
| | - Caroline Biendel
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
| | - Pauline Fournier
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
| | - Romain Itier
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
| | - Michel Galinier
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
- Medical School of ToulousePaul Sabatier UniversityToulouseFrance
| | - Olivier Lairez
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
- Medical School of ToulousePaul Sabatier UniversityToulouseFrance
- Department of Nuclear MedicineRangueil University HospitalToulouseFrance
| | - Clement Delmas
- Department of CardiologyRangueil University Hospital1 avenue Jean Poulhès, TSA 50032Toulouse31059France
- Medical School of ToulousePaul Sabatier UniversityToulouseFrance
| |
Collapse
|
|
44
|
Li Y, Wang H, Xi Y, Sun A, Deng X, Chen Z, Fan Y. A New Mathematical Numerical Model to Evaluate the Risk of Thrombosis in Three Clinical Ventricular Assist Devices. Bioengineering (Basel) 2022; 9:bioengineering9060235. [PMID: 35735478 PMCID: PMC9219778 DOI: 10.3390/bioengineering9060235] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/17/2022] [Revised: 05/17/2022] [Accepted: 05/25/2022] [Indexed: 11/24/2022] Open
Abstract
(1) Background: Thrombosis is the main complication in patients supported with ventricular assist devices (VAD). Models that accurately predict the risk of thrombus formation in VADs are still lacking. When VADs are clinically assisted, their complex geometric configuration and high rotating speed inevitably generate complex flow fields and high shear stress. These non-physiological factors can damage blood cells and proteins, release coagulant factors and trigger thrombosis. In this study, a more accurate model for thrombus assessment was constructed by integrating parameters such as shear stress, residence time and coagulant factors, so as to accurately assess the probability of thrombosis in three clinical VADs. (2) Methods: A mathematical model was constructed to assess platelet activation and thrombosis within VADs. By solving the transport equation, the influence of various factors such as shear stress, residence time and coagulation factors on platelet activation was considered. The diffusion equation was applied to determine the role of activated platelets and substance deposition on thrombus formation. The momentum equation was introduced to describe the obstruction to blood flow when thrombus is formed, and finally a more comprehensive and accurate model for thrombus assessment in patients with VAD was obtained. Numerical simulations of three clinically VADs (CH-VAD, HVAD and HMII) were performed using this model. The simulation results were compared with experimental data on platelet activation caused by the three VADs. The simulated thrombogenic potential in different regions of MHII was compared with the frequency of thrombosis occurring in the regions in clinic. The regions of high thrombotic risk for HVAD and HMII observed in experiments were compared with the regions predicted by simulation. (3) Results: It was found that the percentage of activated platelets within the VAD obtained by solving the thrombosis model developed in this study was in high agreement with the experimental data (r² = 0.984), the likelihood of thrombosis in the regions of the simulation showed excellent correlation with the clinical statistics (r² = 0.994), and the regions of high thrombotic risk predicted by the simulation were consistent with the experimental results. Further study revealed that the three clinical VADs (CH-VAD, HVAD and HMII) were prone to thrombus formation in the inner side of the secondary flow passage, the clearance between cone and impeller, and the corner region of the inlet pipe, respectively. The risk of platelet activation and thrombus formation for the three VADs was low to high for CH-VAD, HVAD, and HM II, respectively. (4) Conclusions: In this study, a more comprehensive and accurate thrombosis model was constructed by combining parameters such as shear stress, residence time, and coagulation factors. Simulation results of thrombotic risk received with this model showed excellent correlation with experimental and clinical data. It is important for determining the degree of platelet activation in VAD and identifying regions prone to thrombus formation, as well as guiding the optimal design of VAD and clinical treatment.
Collapse
|
|
45
|
Malone G, Abdelsayed G, Bligh F, Al Qattan F, Syed S, Varatharajullu P, Msellati A, Mwipatayi D, Azhar M, Malone A, Fatimi SH, Conway C, Hameed A. Advancements in left ventricular assist devices to prevent pump thrombosis and blood coagulopathy. J Anat 2022; 242:29-49. [PMID: 35445389 PMCID: PMC9773170 DOI: 10.1111/joa.13675] [Citation(s) in RCA: 16] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/23/2021] [Revised: 04/01/2022] [Accepted: 04/06/2022] [Indexed: 12/25/2022] Open
Abstract
Mechanical circulatory support (MCS) devices, such as left ventricular assist devices (LVADs) are very useful in improving outcomes in patients with advanced-stage heart failure. Despite recent advances in LVAD development, pump thrombosis is one of the most severe adverse events caused by LVADs. The contact of blood with artificial materials of LVAD pumps and cannulas triggers the coagulation cascade. Heat spots, for example, produced by mechanical bearings are often subjected to thrombus build-up when low-flow situations impair washout and thus the necessary cooling does not happen. The formation of thrombus in an LVAD may compromise its function, causing a drop in flow and pumping power leading to failure of the LVAD, if left unattended. If a clot becomes dislodged and circulates in the bloodstream, it may disturb the flow or occlude the blood vessels in vital organs and cause internal damage that could be fatal, for example, ischemic stroke. That is why patients with LVADs are on anti-coagulant medication. However, the anti-coagulants can cause a set of issues for the patient-an example of gastrointestinal (GI) bleeding is given in illustration. On account of this, these devices are only used as a last resort in clinical practice. It is, therefore, necessary to develop devices with better mechanics of blood flow, performance and hemocompatibility. This paper discusses the development of LVADs through landmark clinical trials in detail and describes the evolution of device design to reduce the risk of pump thrombosis and achieve better hemocompatibility. Whilst driveline infection, right heart failure and arrhythmias have been recognised as LVAD-related complications, this paper focuses on complications related to pump thrombosis, especially blood coagulopathy in detail and potential strategies to mitigate this complication. Furthermore, it also discusses the LVAD implantation techniques and their anatomical challenges.
Collapse
Affiliation(s)
- Grainne Malone
- Tissue Engineering Research Group (TERG)Department of Anatomy and Regenerative Medicine, RCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | - Gerges Abdelsayed
- School of MedicineRCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | - Fianait Bligh
- School of MedicineRCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | - Fatma Al Qattan
- Tissue Engineering Research Group (TERG)Department of Anatomy and Regenerative Medicine, RCSI University of Medicine and Health Sciences, Dublin 2DublinIreland,School of Pharmacy and Biomolecular SciencesRCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | - Saifullah Syed
- School of MedicineRCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | | | - Augustin Msellati
- School of MedicineRCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | - Daniela Mwipatayi
- School of MedicineRCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | - Maimoona Azhar
- Department of SurgerySt. Vincent's University Hospital, Dublin 4DublinIreland
| | - Andrew Malone
- Tissue Engineering Research Group (TERG)Department of Anatomy and Regenerative Medicine, RCSI University of Medicine and Health Sciences, Dublin 2DublinIreland
| | - Saulat H. Fatimi
- Department of Cardiothoracic SurgeryAga Khan University HospitalKarachiPakistan
| | - Claire Conway
- Tissue Engineering Research Group (TERG)Department of Anatomy and Regenerative Medicine, RCSI University of Medicine and Health Sciences, Dublin 2DublinIreland,Trinity Centre for Biomedical Engineering (TCBE)Trinity College Dublin (TCD)DublinIreland
| | - Aamir Hameed
- Tissue Engineering Research Group (TERG)Department of Anatomy and Regenerative Medicine, RCSI University of Medicine and Health Sciences, Dublin 2DublinIreland,Trinity Centre for Biomedical Engineering (TCBE)Trinity College Dublin (TCD)DublinIreland
| |
Collapse
|
|
46
|
Outcomes in Smaller Body Size Adults after HeartMate 3 Left Ventricular Assist Device Implantation. Ann Thorac Surg 2022; 114:2262-2269. [PMID: 35452663 DOI: 10.1016/j.athoracsur.2022.03.071] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2021] [Revised: 02/21/2022] [Accepted: 03/28/2022] [Indexed: 11/23/2022]
Abstract
BACKGROUND Outcomes in patients with smaller body size following HeartMate 3 Left Ventricular Assist Device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs. larger BSA patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort. METHODS The analysis cohort included 1015 HM3 patients divided into 2 groups: BSA≤1.70 m2 (small patients, n=82) and BSA>1.70 m2 (large patients, n=933). The composite primary endpoint was survival at 2-years free of disabling stroke or reoperation to replace or remove a malfunctioning device. Adverse events were compared between groups. RESULTS Smaller patients were more frequently women (56.1% vs. 17.7%, P<.001), had lower prevalence of diabetes (28.1% vs. 43.9%, P=.005) and hypertension (51.2% vs. 71.9%, P<.001), larger median indexed LVEDD (normalized by BSA, 40 vs. 33 mm/m2, P<.001), and lower median serum creatinine (1.1 vs. 1.3 mg/dl, P<.001). The proportion of patients achieving the composite endpoint at 2-years was 77% in both groups (adjusted HR = 1.14 [95% confidence interval: 0.68-1.91], P=.62). Two-year adverse event rates were also similar between groups except for sepsis (6.1% vs. 14.9%, P=.029) and cardiac arrhythmias (24.4% vs. 35.3%, P=.005), which were higher in the larger patients. CONCLUSIONS Outcomes following HM3 implantation were comparable between small and large patients. Smaller body size should not be used to deny HM3 implantation in patients who are otherwise suitable durable MCS candidates.
Collapse
|
|
47
|
Ono M, Yamaguchi O, Ohtani T, Kinugawa K, Saiki Y, Sawa Y, Shiose A, Tsutsui H, Fukushima N, Matsumiya G, Yanase M, Yamazaki K, Yamamoto K, Akiyama M, Imamura T, Iwasaki K, Endo M, Ohnishi Y, Okumura T, Kashiwa K, Kinoshita O, Kubota K, Seguchi O, Toda K, Nishioka H, Nishinaka T, Nishimura T, Hashimoto T, Hatano M, Higashi H, Higo T, Fujino T, Hori Y, Miyoshi T, Yamanaka M, Ohno T, Kimura T, Kyo S, Sakata Y, Nakatani T. JCS/JSCVS/JATS/JSVS 2021 Guideline on Implantable Left Ventricular Assist Device for Patients With Advanced Heart Failure. Circ J 2022; 86:1024-1058. [PMID: 35387921 DOI: 10.1253/circj.cj-21-0880] [Citation(s) in RCA: 12] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Affiliation(s)
- Minoru Ono
- Department of Cardiac Surgery, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
| | - Osamu Yamaguchi
- Department of Cardiology, Pulmonology, Hypertension & Nephrology, Ehime University Graduate School of Medicine
| | - Tomohito Ohtani
- Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
| | - Koichiro Kinugawa
- Second Department of Internal Medicine, Faculty of Medicine, University of Toyama
| | - Yoshikatsu Saiki
- Department of Cardiovascular Surgery, Tohoku University Graduate School of Medicine
| | - Yoshiki Sawa
- Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
| | - Akira Shiose
- Department of Cardiovascular Surgery, Graduate School of Medical Sciences, Kyushu University
| | - Hiroyuki Tsutsui
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University
| | - Norihide Fukushima
- Department of Transplant Medicine, National Cerebral and Cardiovascular Center
| | - Goro Matsumiya
- Department of Cardiovascular Surgery, Chiba University Graduate School of Medicine
| | - Masanobu Yanase
- Department of Transplant Medicine, National Cerebral and Cardiovascular Center
| | - Kenji Yamazaki
- Advanced Medical Research Institute, Hokkaido Cardiovascular Hospital
| | - Kazuhiro Yamamoto
- Department of Cardiovascular Medicine and Endocrinology and Metabolism, Faculty of Medicine, Tottori University
| | - Masatoshi Akiyama
- Department of Cardiovascular Surgery, Tohoku University Graduate School of Medicine
| | - Teruhiko Imamura
- Second Department of Internal Medicine, Faculty of Medicine, University of Toyama
| | - Kiyotaka Iwasaki
- Cooperative Major in Advanced Biomedical Sciences, Graduate School of Advanced Science and Engineering, Waseda University
| | - Miyoko Endo
- Department of Nursing, The University of Tokyo Hospital
| | - Yoshihiko Ohnishi
- Department of Anesthesiology, National Cerebral and Cardiovascular Center
| | - Takahiro Okumura
- Department of Cardiology, Nagoya University Graduate School of Medicine
| | - Koichi Kashiwa
- Department of Medical Engineering, The University of Tokyo Hospital
| | - Osamu Kinoshita
- Department of Cardiac Surgery, The University of Tokyo Hospital
| | - Kaori Kubota
- Department of Transplantation Medicine, Osaka University Graduate School of Medicine
| | - Osamu Seguchi
- Department of Transplant Medicine, National Cerebral and Cardiovascular Center
| | - Koichi Toda
- Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
| | - Hiroshi Nishioka
- Department of Clinical Engineering, National Cerebral and Cardiovascular Center
| | - Tomohiro Nishinaka
- Department of Artificial Organs, National Cerebral and Cardiovascular Center
| | - Takashi Nishimura
- Department of Cardiovascular and Thoracic Surgery, Ehime University Hospital
| | - Toru Hashimoto
- Department of Cardiovascular Medicine, Kyushu University Hospital
| | - Masaru Hatano
- Department of Therapeutic Strategy for Heart Failure, Graduate School of Medicine, The University of Tokyo
| | - Haruhiko Higashi
- Department of Cardiology, Pulmonology, Hypertension & Nephrology, Ehime University Graduate School of Medicine
| | - Taiki Higo
- Department of Cardiovascular Medicine, Kyushu University Hospital
| | - Takeo Fujino
- Department of Cardiovascular Medicine, Kyushu University Hospital
| | - Yumiko Hori
- Department of Nursing and Transplant Medicine, National Cerebral and Cardiovascular Center
| | - Toru Miyoshi
- Department of Cardiology, Pulmonology, Hypertension & Nephrology, Ehime University Graduate School of Medicine
| | | | - Takayuki Ohno
- Department of Cardiovascular Surgery, Mitsui Memorial Hospital
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Graduate School of Medicine and Faculty of Medicine, Kyoto University
| | | | - Yasushi Sakata
- Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
| | | | | |
Collapse
|
|
48
|
Berardi C, Bravo CA, Li S, Khorsandi M, Keenan JE, Auld J, Rockom S, Beckman JA, Mahr C. The History of Durable Left Ventricular Assist Devices and Comparison of Outcomes: HeartWare, HeartMate II, HeartMate 3, and the Future of Mechanical Circulatory Support. J Clin Med 2022; 11:2022. [PMID: 35407630 PMCID: PMC9000165 DOI: 10.3390/jcm11072022] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2022] [Revised: 03/25/2022] [Accepted: 03/31/2022] [Indexed: 12/13/2022] Open
Abstract
The utilization of left ventricular assist devices (LVADs) in end-stage heart failure has doubled in the past ten years and is bound to continue to increase. Since the first of these devices was approved in 1994, the technology has changed tremendously, and so has the medical and surgical management of these patients. In this review, we discuss the history of LVADs, evaluating survival and complications over time. We also aim to discuss practical aspects of the medical and surgical management of LVAD patients and future directions for outcome improvement in this population.
Collapse
Affiliation(s)
- Cecilia Berardi
- Division of Cardiovascular Medicine, Baystate Medical Center, Springfield, MA 01199, USA;
| | - Claudio A. Bravo
- Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA 98195, USA; (C.A.B.); (S.L.); (J.A.); (S.R.); (J.A.B.)
| | - Song Li
- Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA 98195, USA; (C.A.B.); (S.L.); (J.A.); (S.R.); (J.A.B.)
| | - Maziar Khorsandi
- Division of Cardiothoracic Surgery, Department of Surgery, University of Washington, Seattle, WA 98195, USA; (M.K.); (J.E.K.)
| | - Jeffrey E. Keenan
- Division of Cardiothoracic Surgery, Department of Surgery, University of Washington, Seattle, WA 98195, USA; (M.K.); (J.E.K.)
| | - Jonathan Auld
- Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA 98195, USA; (C.A.B.); (S.L.); (J.A.); (S.R.); (J.A.B.)
| | - Sunny Rockom
- Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA 98195, USA; (C.A.B.); (S.L.); (J.A.); (S.R.); (J.A.B.)
| | - Jennifer A. Beckman
- Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA 98195, USA; (C.A.B.); (S.L.); (J.A.); (S.R.); (J.A.B.)
| | - Claudius Mahr
- Division of Cardiology, Department of Medicine, University of Washington, Seattle, WA 98195, USA; (C.A.B.); (S.L.); (J.A.); (S.R.); (J.A.B.)
| |
Collapse
|
|
49
|
Atti V, Narayanan MA, Patel B, Balla S, Siddique A, Lundgren S, Velagapudi P. A Comprehensive Review of Mechanical Circulatory Support Devices. Heart Int 2022; 16:37-48. [PMID: 36275352 PMCID: PMC9524665 DOI: 10.17925/hi.2022.16.1.37] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2021] [Accepted: 12/07/2021] [Indexed: 08/08/2023] Open
Abstract
Treatment strategies to combat cardiogenic shock (CS) have remained stagnant over the past decade. Mortality rates among patients who suffer CS after acute myocardial infarction (AMI) remain high at 50%. Mechanical circulatory support (MCS) devices have evolved as novel treatment strategies to restore systemic perfusion to allow cardiac recovery in the short term, or as durable support devices in refractory heart failure in the long term. Haemodynamic parameters derived from right heart catheterization assist in the selection of an appropriate MCS device and escalation of mechanical support where needed. Evidence favouring the use of one MCS device over another is scant. An intra-aortic balloon pump is the most commonly used short-term MCS device, despite providing only modest haemodynamic support. Impella CP® has been increasingly used for CS in recent times and remains an important focus of research for patients with AMI-CS. Among durable devices, Heartmate® 3 is the most widely used in the USA. Adequately powered randomized controlled trials are needed to compare these MCS devices and to guide the operator for their use in CS. This article provides a brief overview of the types of currently available MCS devices and the indications for their use.
Collapse
Affiliation(s)
- Varunsiri Atti
- Division of Cardiovascular Diseases, West Virginia University Heart and Vascular Institute, Morgantown, WV, USA
| | | | - Brijesh Patel
- Division of Cardiovascular Diseases, West Virginia University Heart and Vascular Institute, Morgantown, WV, USA
| | - Sudarshan Balla
- Division of Cardiovascular Diseases, West Virginia University Heart and Vascular Institute, Morgantown, WV, USA
| | - Aleem Siddique
- Division of Cardiothoracic Surgery, University of Nebraska Medical Center, Omaha, NE, USA
| | - Scott Lundgren
- Division of Cardiovascular Diseases, University of Nebraska Medical Center, Omaha, NE, USA
| | - Poonam Velagapudi
- Division of Cardiovascular Diseases, University of Nebraska Medical Center, Omaha, NE, USA
| |
Collapse
|
|
50
|
Gyoten T, Rojas SV, Fox H, Deutsch MA, Ruiz-Cano M, Hakim-Meibodi K, Gummert JF, Morshuis M, Schramm R. The HeartWare Ventricular Assist Device (HVAD): A Single Institutional 10-Year Experience. Thorac Cardiovasc Surg 2022; 70:482-492. [PMID: 35235989 DOI: 10.1055/s-0042-1742779] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
OBJECTIVES The aim of this study was to analyze our 10-year experience with the HVAD in a real-world scenario in a high-volume German heart center. METHODS We retrospectively analyzed outcomes of adults (≥18 years) with terminal heart failure (HF), who underwent HVAD implantation for durable LVAD therapy in our center between October 2009 and March 2020. Primary and secondary end points were all-cause death after implantation and LVAD-associated complications, respectively. We focused the distinct analyses on risk profiles at the time of implantation and implant strategies, i.e., bridge-to-transplant (BTT) or destination therapy (DT). RESULTS A total of 510 patients were included, with 229 and 281 individuals in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1 (45%) and 2 to 4, respectively. Median follow-up was 26 months (IQR: 5-54 months). Overall survival at 1, 3, and 5 years after HVAD implantation was 66% (95% CI; 61.7-70%), 49.4% (95% CI; 44.9-53.8%), and 37.4% (95% CI; 32.8-42%), not censored for LVAD exchange, LVAD explantation, or heart transplantation. INTERMACS level 1 and peri-operative temporary right heart assistance were independent risk factors for survival. Survival was best in BTT patients undergoing heart transplantation at any time during follow-up. The INTERMACS level at time of HVAD implantation did not affect survival after heart transplantation. Freedom from the combined end point of any device-associated severe complication and death was 44.5% (95% CI; 40-48.8%) at 1-year after implantation. CONCLUSION The HVAD is a reliable pump for durable mechanical circulatory support even in high-risk patients. Still, heart transplantation outperforms durable MCS therapy for a superior long-term survival.
Collapse
Affiliation(s)
- Takayuki Gyoten
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - Sebastian V Rojas
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - Henrik Fox
- Clinic for Interventional Cardiology, Heart and Diabetes Centre North Rhine Westphalia, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - Marc-Andre Deutsch
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - Maria Ruiz-Cano
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - Kavous Hakim-Meibodi
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - Jan F Gummert
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - Michiel Morshuis
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| | - René Schramm
- Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany
| |
Collapse
|