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Adams HSL, Prendergast B, Redwood S. BIOVALVE: A New Self-Expanding Supra-Annular TAVR System. JACC Cardiovasc Interv 2020; 13:167-169. [PMID: 31629747 DOI: 10.1016/j.jcin.2019.09.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/20/2019] [Accepted: 09/04/2019] [Indexed: 11/24/2022]
Affiliation(s)
- Heath S L Adams
- Department of Cardiology, St Thomas' Hospital, London, United Kingdom; Faculty of Health Science, University of Tasmania, Hobart, Tasmania, Australia
| | | | - Simon Redwood
- Department of Cardiology, St Thomas' Hospital, London, United Kingdom.
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2
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He C, Xiao L, Liu J. Safety and efficacy of self-expandable Evolut R vs. balloon-expandable Sapien 3 valves for transcatheter aortic valve implantation: A systematic review and meta-analysis. Exp Ther Med 2019; 18:3893-3904. [PMID: 31602250 PMCID: PMC6777306 DOI: 10.3892/etm.2019.8000] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/31/2019] [Accepted: 09/09/2019] [Indexed: 12/12/2022] Open
Abstract
The aim of this study was to systematically search literature and conduct a meta-analysis comparing the clinical efficacy and safety of Evolut R and Sapien 3 valves for transcatheter aortic valve implantation (TAVI). The PubMed, Biomed Central, Scopus, Cochrane library and Google scholar databases were searched for articles published up to June, 2019. A total of 5 studies were included. In total, 795 patients underwent TAVI with Evolut R, while 665 patients received the Sapien 3 valve in the included studies. Overall device success with Evolut R was 95.7% and with Sapien 3 was 94.2%. Pooled data indicated no significant differences between the 2 valves (OR, 1.12; 95% CI, 0.66–1.89; P=0.68; I2=0%). No significant differences were observed in the incidence of none to mild paravalvular leakage between the 2 groups (OR, 1.71; 95% CI, 0.83–3.54; P=0.14; I2=0%). Both mean [random; mean difference (MD) = −3.96; 95% CI, −4.61 to −3.31; P<0.00001, I2=0%] and peak (random; MD = −6.85; 95% CI, −8.22 to −5.48; P<0.00001, I2=0%) aortic valve gradients were significantly lower with Evolut R. No significant differences were observed in the 30-day mortality (OR, 1.32; 95% CI, 0.45–3.87; P=0.62; I2=0%) or 30-day stroke outcomes (OR, 0.76; 95% CI, 0.32–1.81; P=0.54; I2=0%) between the 2 devices. On the whole, the findings of this study indicate that Evolut R and Sapien 3 valves may be comparable in terms of device success and short-term complications. The differences between the 2 devices for post-operative moderate to severe paravalvular leak and permanent pacemaker implantation remain unclear. There is thus a need for a large multi-center randomized controlled trial to provide stronger evidence on this subject.
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Affiliation(s)
- Chenglin He
- Department of Cardiovascular Medicine, Hanchuan People's Hospital, Hanchuan, Hubei 431600, P.R. China
| | - Lang Xiao
- Department of Haematology, Hanchuan Hospital of Traditional Chinese Medicine, Hanchuan, Hubei 431600, P.R. China
| | - Junli Liu
- Department of Critical Care Medicine, Hanchuan People's Hospital, Hanchuan, Hubei 431600, P.R. China
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3
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Reichenspurner H, Schaefer A, Schäfer U, Tchétché D, Linke A, Spence MS, Søndergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol 2019; 70:3127-3136. [PMID: 29268926 DOI: 10.1016/j.jacc.2017.10.060] [Citation(s) in RCA: 39] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/31/2017] [Revised: 10/15/2017] [Accepted: 10/17/2017] [Indexed: 11/17/2022]
Abstract
BACKGROUND The CENTERA transcatheter heart valve (THV) is a low-profile, self-expanding nitinol valve made from bovine pericardial tissue that is 14-F compatible with a motorized delivery system allowing for repositionability. OBJECTIVES The pivotal study evaluated safety and efficacy of this THV in high-surgical-risk study patients with severe symptomatic aortic stenosis. METHODS Implantations were completed in 23 centers. Clinical and echocardiographic outcomes were assessed at baseline, discharge, and 30 days. Major events were adjudicated by an independent clinical events committee. Echocardiograms and computed tomography scans were reviewed by core laboratories. The primary endpoint was all-cause mortality at 30 days. RESULTS Between March 25, 2015 and July 5, 2016, 203 patients with severe symptomatic aortic stenosis and increased surgical risk, as determined by the heart team, were treated by transfemoral THV implantation (age 82.7 ± 5.5 years, 67.5% female, 68.0% New York Heart Association functional class III/IV). At 30 days, mortality was 1%, disabling stroke occurred in 2.5% of patients, and New York Heart Association functional class I/II was observed in 93.0% of patients. Effective orifice area increased from 0.71 ± 0.20 cm2 to 1.88 ± 0.43 cm2 (p < 0.001). Mean aortic transvalvular gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days post-procedure (p < 0.001). Paravalvular aortic regurgitation at 30 days was moderate or higher in 0.6% of patients. A new permanent pacemaker was implanted in 4.5% of patients receiving the THV (4.9% for patients at risk). CONCLUSIONS The herein described THV is safe and effective at 30 days with low mortality, significant improvements in hemodynamic outcomes, and low incidence of adverse events. Of particular interest is the low incidence of permanent pacemaker implantations. (Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).
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Affiliation(s)
- Hermann Reichenspurner
- Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany.
| | - Andreas Schaefer
- Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany
| | - Ulrich Schäfer
- Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany
| | - Didier Tchétché
- Cardiologie Générale et Interventionelle, Clinique Pasteur, Toulouse, France
| | - Axel Linke
- Department of Internal Medicine/Cardiology, Heart Center and Leipzig Heart Institute, University of Leipzig, Leipzig, Germany
| | - Mark S Spence
- Cardiology Department, Royal Victoria Hospital, Belfast, United Kingdom
| | | | - Hervé LeBreton
- Centre cardio-pneumologique, Centre Hospitalier Universitaire Pontchaillou, Rennes, France
| | - Gerhard Schymik
- Department of Cardiology, Medical Clinic IV, Municipal Hospital Karlsruhe, Karlsruhe, Germany
| | | | - Jonathon Leipsic
- Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada
| | - Darren L Walters
- Department of Cardiology, The Prince Charles Hospital, Chermside, Queensland, Australia
| | - Stephen Worthley
- Department of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
| | - Markus Kasel
- Department of Cardiology, German Heart Center Munich, Munich, Germany
| | - Stephan Windecker
- Department of Cardiology, Bern University Hospital (Inselspital), Bern, Switzerland
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4
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Meng S, Mao J, Rouse EN, Le-Bel G, Bourget JM, Reed RR, Philippe E, How D, Zhang Z, Germain L, Guidoin R. The Red Kangaroo pericardium as a material source for the manufacture of percutaneous heart valves. Morphologie 2019; 103:37-47. [PMID: 30638803 DOI: 10.1016/j.morpho.2018.12.004] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2018] [Accepted: 12/06/2018] [Indexed: 11/28/2022]
Abstract
BACKGROUND The kangaroo pericardium might be considered to be a good candidate material for use in the manufacture of the leaflets of percutaneous heart valves based upon the unique lifestyle. The diet consists of herbs, forbs and strubs. The kangaroo pericardium holds an undulated structure of collagen. MATERIAL AND METHOD A Red Kangaroo was obtained after a traffic fatality and the pericardium was dissected. Four compasses were cut from four different sites: auricular (AUR), atrial (ATR), sternoperitoneal (SPL) and phrenopericardial (PPL). They were investigated by means of scanning electron microscopy, light microscopy and transmission electron microscopy. RESULTS All the samples showed dense and wavy collagen bundles without vascularisation from both the epicardium and the parietal pericardium. The AUR and the ATR were 150±25μm thick whereas the SPL and the PPL were thinner at 120±20μm. The surface of the epicardium was smooth and glistening. The filaments of collagen were well individualized without any aggregation, but the banding was poorly defined and somewhat blurry. CONCLUSION This detailed morphological analysis of the kangaroo pericardium illustrated a surface resistant to thrombosis and physical characteristics resistant to fatigue. The morphological characteristics of the kangaroo pericardium indicate that it represents an outstanding alternative to the current sources e.g., bovine and porcine. However, procurement of tissues from the wild raises supply and sanitary issues. Health concerns based upon sanitary uncertainty and reliability of supply of wild animals remain real problems.
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Affiliation(s)
- S Meng
- Chongqing Key Lab of Catalysis and Functional Organic Molecules; College of Environment and Biotechnology, Chongqing Technology and Business University, Chongqing, PR China
| | - J Mao
- Axe Médecine Régénératrice, Centre de Recherche du CHU and Département de Chirurgie, Faculté de Médecine, Université Laval, Québec Canada
| | - E N Rouse
- Department of Comparative Medicine, College of Veterinary of Tennessee, Knoxville, TN, USA
| | - G Le-Bel
- Axe Médecine Régénératrice, Centre de Recherche du CHU and Département de Chirurgie, Faculté de Médecine, Université Laval, Québec Canada
| | - J M Bourget
- Axe Médecine Régénératrice, Centre de Recherche du CHU and Département de Chirurgie, Faculté de Médecine, Université Laval, Québec Canada
| | - R R Reed
- Department of Comparative Medicine, College of Veterinary of Tennessee, Knoxville, TN, USA
| | - E Philippe
- Axe Médecine Régénératrice, Centre de Recherche du CHU and Département de Chirurgie, Faculté de Médecine, Université Laval, Québec Canada
| | - D How
- Peninsula College of Medicine and Dentistry (PCMD), Plymouth, Devon, UK
| | - Z Zhang
- Axe Médecine Régénératrice, Centre de Recherche du CHU and Département de Chirurgie, Faculté de Médecine, Université Laval, Québec Canada
| | - L Germain
- Axe Médecine Régénératrice, Centre de Recherche du CHU and Département de Chirurgie, Faculté de Médecine, Université Laval, Québec Canada
| | - R Guidoin
- Axe Médecine Régénératrice, Centre de Recherche du CHU and Département de Chirurgie, Faculté de Médecine, Université Laval, Québec Canada.
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5
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Kim U, Blanke P, Windecker S, Kasel AM, Schäfer U, Walters D, Linke A, Le Breton H, Schymik G, Spence MS, Søndergaard L, Abdel-Wahab M, Worthley S, Tchétché D, Reichenspurner H, Ohana M, Sellers SL, Leipsic JA. Computed tomography-based oversizing and incidence of paravalvular aortic regurgitation and permanent pacemaker implantation with a new-generation self-expanding transcatheter heart valve. EUROINTERVENTION 2018; 14:e511-e518. [PMID: 29741486 DOI: 10.4244/eij-d-17-01040] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
AIMS We aimed to evaluate the relationship between CT-based annular perimeter oversizing and the incidence of paravalvular aortic regurgitation (PAR) and permanent pacemaker (PPM) implantation in patients treated with the new self-expanding CENTERA transcatheter heart valve (THV) for severe aortic stenosis. METHODS AND RESULTS One hundred and ninety-eight patients in the CENTERA-EU trial were stratified a priori into four groups based on the perimeter oversizing (2.5-10%, 10-15%, 15-20% and >20%). PAR at 30 days was moderate or higher in 0.6% of patients. The frequency of PPM implantation was 4.9%. The mean perimeter oversizing was 16.2±5.6%. For patients with a perimeter oversizing >10%, an inverse relationship between oversizing and ≥mild PAR was observed (43.3% for 10-15% oversizing; 37.7%, 15-20%; 33.3%, >20%). No association between oversizing and effective orifice area was observed. The optimal cut-off value of perimeter oversizing for the prediction of ≥mild PAR was 15.9% (AUC 0.718, 95% CI: 0.576, 0.860). No annular ruptures were observed. CONCLUSIONS The CENTERA THV appears to have a wide range of sizing tolerance. The degree of oversizing to mitigate PAR is relatively low compared to other self-expanding transcatheter devices. There appears to be no compromise between occurrence of PAR and PPM across this wide range of oversizing.
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Affiliation(s)
- Ung Kim
- St. Paul's Hospital, Vancouver, BC, Canada
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6
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Hatoum H, Yousefi A, Lilly S, Maureira P, Crestanello J, Dasi LP. An in vitro evaluation of turbulence after transcatheter aortic valve implantation. J Thorac Cardiovasc Surg 2018; 156:1837-1848. [PMID: 29961588 DOI: 10.1016/j.jtcvs.2018.05.042] [Citation(s) in RCA: 70] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/27/2017] [Revised: 04/17/2018] [Accepted: 05/13/2018] [Indexed: 01/20/2023]
Abstract
BACKGROUND This study aimed at assessment of post-transcatheter aortic valve (TAV) replacement hemodynamics and turbulence when a same-size SAPIEN 3 (Edwards Lifesciences Corp, Irvine, Calif) and Medtronic Evolut (Minneapolis, Minn) were implanted in a rigid aortic root with physiological dimensions and in a representative root with calcific leaflets obtained from patient computed tomography scans. METHODS TAV hemodynamics were studied by placing a SAPIEN 3 26-mm and an Evolut 26-mm in rigid aortic roots and representative root with calcific leaflets under physiological conditions. Hemodynamics were assessed using high-fidelity particle image velocimetry and high-speed imaging. Transvalvular pressure gradients (PGs), pinwheeling indices, and Reynolds shear stress (RSS) were calculated. RESULTS (1) PGs obtained with the Evolut and the SAPIEN 3 were comparable among the different models (10.5 ± 0.15 mm Hg vs 7.76 ± 0.083 mm Hg in the rigid model along with 13.9 ± 0.19 mm Hg vs 5.0 ± 0.09 mm Hg in representative root with calcific leaflets obtained from patient computed tomography scans respectively); (2) more pinwheeling was found in the SAPIEN 3 than the Evolut (0.231 ± 0.057 vs 0.201 ± 0.05 in the representative root with calcific leaflets and 0.366 ± 0.067 vs 0.122 ± 0.045 in the rigid model); (3) higher rates of RSS were found in the Evolut (161.27 ± 3.45 vs 122.84 ± 1.76 Pa in representative root with calcific leaflets and 337.22 ± 7.05 vs 157.91 ± 1.80 Pa in rigid models). More lateral fluctuations were found in representative root with calcific leaflets. CONCLUSIONS (1) Comparable PGs were found among the TAVs in different models; (2) pinwheeling indices were found to be different between both TAVs; (3) turbulence patterns among both TAVs translated according to RSS were different. Rigid aortic models yield more conservative estimates of turbulence; (4) both TAVs exhibit peak maximal RSS that exceeds platelet activation 100 Pa threshold limit.
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Affiliation(s)
- Hoda Hatoum
- Department of Biomedical Engineering, The Ohio State University, Columbus, Ohio
| | - Atieh Yousefi
- Department of Biomedical Engineering, The Ohio State University, Columbus, Ohio
| | - Scott Lilly
- Department of Surgery, The Ohio State University, Columbus, Ohio
| | - Pablo Maureira
- Department of Cardiovascular Surgery, CHU de Nancy, Nancy, France
| | - Juan Crestanello
- Department of Surgery, The Ohio State University, Columbus, Ohio
| | - Lakshmi P Dasi
- Department of Biomedical Engineering, The Ohio State University, Columbus, Ohio; Department of Surgery, The Ohio State University, Columbus, Ohio.
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7
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Young MN, Elmariah S. A Decade Later, Continued Transformation of Transcatheter Aortic Valve Replacement. US CARDIOLOGY REVIEW 2018. [DOI: 10.15420/usc.2017:25:2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Abstract
The emergence of transcatheter aortic valve replacement as an effective treatment option in appropriately selected patients with severe aortic valve stenosis has proven to be revolutionary to the fields of interventional cardiology and cardiac surgery. As percutaneous technologies continue to mature and indications for transcatheter valve therapy concurrently expand, the contemporary management of valvular heart disease necessitates a multidisciplinary heart team approach that considers the indication, multimodality imaging, anesthetic and procedural strategy, and selection of the appropriate valve prosthesis for each patient. We provide an overview of the historical development of transcatheter aortic valve replacement, commercially available and investigative devices, landmark clinical trial data, and developments on the horizon that aim to further advance the care of patients with aortic valve disease.
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8
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Transcatheter heart valve for aortic valve implantation: republication of the article published in the Japanese Journal of Artificial Organs. J Artif Organs 2018; 21:125-131. [PMID: 29426997 DOI: 10.1007/s10047-017-1015-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2017] [Accepted: 12/27/2017] [Indexed: 10/18/2022]
Abstract
This review was created based on a translation of the Japanese review first reported in the Japanese Journal of Artificial Organs in 2015 (vol. 44, no. 3, pp. 136-140), with some modifications.
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New Valves May Overcome Weaknesses of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2017; 70:3137-3139. [PMID: 29268927 DOI: 10.1016/j.jacc.2017.10.074] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2017] [Accepted: 10/30/2017] [Indexed: 11/21/2022]
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10
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Schäfer U, Deuschl F, Schofer N, Frerker C, Schmidt T, Kuck K, Kreidel F, Schirmer J, Mizote I, Reichenspurner H, Blankenberg S, Treede H, Conradi L. Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol 2017; 232:247-254. [DOI: 10.1016/j.ijcard.2017.01.010] [Citation(s) in RCA: 61] [Impact Index Per Article: 7.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/19/2016] [Revised: 12/25/2016] [Accepted: 01/03/2017] [Indexed: 10/20/2022]
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Metaxa S, Ioannou A, Missouris CG. Transcatheter aortic valve implantation: new hope in the management of valvular heart disease. Postgrad Med J 2017; 93:280-288. [PMID: 28104807 DOI: 10.1136/postgradmedj-2016-134554] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/01/2016] [Revised: 12/19/2016] [Accepted: 12/29/2016] [Indexed: 12/17/2022]
Abstract
Severe calcific aortic stenosis is relatively common, and unless treated with valve replacement it carries an adverse prognosis. A large number of patients, however, are denied surgery due to their advanced age or coexistent medical conditions that increase perioperative cardiovascular risks. Transcatheter aortic valve implantation (TAVI), a technique in which a bioprosthetic valve is inserted via a catheter and implanted within the diseased native aortic valve, is a new therapeutic modality for treatment of older patients with severe symptomatic aortic stenosis and other comorbidities, who have an inherently high surgical risk. This review will provide an overview of the pivotal trials in the development of TAVI; while also investigating important complications and limitations of the procedure and evaluating how new valves are being designed and clinically evaluated, with the ultimate goal of reducing potential complications and expanding the use of TAVI to lower-risk patient cohorts.
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Affiliation(s)
| | | | - Constantinos G Missouris
- Frimley Health NHS Foundation Trust, London, UK.,University of Cyprus Medical School, Nicosia, Cyprus
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12
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Athappan G, Gajulapalli RD, Tuzcu ME, Svensson LG, Kapadia SR. A systematic review on the safety of second-generation transcatheter aortic valves. EUROINTERVENTION 2017; 11:1034-43. [PMID: 26788706 DOI: 10.4244/eijv11i9a211] [Citation(s) in RCA: 40] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
AIMS To review the outcomes of studies and the safety of newer transcatheter aortic valves (THV). METHODS AND RESULTS All studies reporting on second-generation THV were identified and pooled using the systematic review guidelines. Twenty-four reports on 1,708 patients and eight THV were included in the analysis. The pooled 30-day event rate for mortality after transcatheter aortic valve implantation (TAVI) was 5.7% (95% CI: 4.0-7.8), myocardial infarction (MI) was 1.7% (95% CI: 1.1-2.6), stage 3 acute kidney injury (AKI) was 3.4% (95% CI: 2.0-5.6), life-threatening bleeding was 5.1% (95% CI: 3.3-7.8), major vascular complications was 4.9% (95% CI: 3.5-6.6%), major bleeding was 10.5% (95% CI: 5.1-20.4), major stroke was 2.4% (95% CI: 1.7-3.4), permanent pacemaker utilisation was 13.5% (95% CI: 10.8-16.9), and coronary obstruction was 1.2% (95% CI: 0.6%-2.4%). Moderate or severe aortic insufficiency (AI) after TAVI was 4.2% (95% CI: 2.0-8.5). The pooled 30-day mean gradient and effective orifice area (EOA) were 11.63 mmHg (95% CI: 10.19-13.07) and 1.60 cm2 (95% CI: 1.5-1.7), respectively. All estimates compare favourably to events reported for first-generation valves. CONCLUSIONS Our findings suggest that the new THV have a low risk of TAVI-related short-term complications.
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Affiliation(s)
- Ganesh Athappan
- Department of Cardiovascular Medicine, Mount Sinai Hospital, New York, NY, USA
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13
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Sawaya FJ, Spaziano M, Lefèvre T, Roy A, Garot P, Hovasse T, Neylon A, Benamer H, Romano M, Unterseeh T, Morice MC, Chevalier B. Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: A single-center experience. World J Cardiol 2016; 8:735-745. [PMID: 28070241 PMCID: PMC5183973 DOI: 10.4330/wjc.v8.i12.735] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2016] [Revised: 09/19/2016] [Accepted: 10/24/2016] [Indexed: 02/06/2023] Open
Abstract
AIM To investigate the clinical outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (S3-THV) vs the SAPIEN XT valve (XT-THV).
METHODS We retrospectively analyzed 507 patients that underwent TAVI with the XT-THV and 283 patients that received the S3-THV at our institution between March 2010 and December 2015.
RESULTS Thirty-day mortality (3.5% vs 8.7%; OR = 0.44, P = 0.21) and 1-year mortality (25.7% vs 20.1%, P = 0.55) were similar in the S3-THV and the XT-THV groups. The rates of both major vascular complication and paravalvular regurgitation (PVR) > 1 were almost 4 times lower in the S3-THV group than the XT-THV group (major vascular complication: 2.8% vs 9.9%, P < 0.0001; PVR > 1: 2.4% vs 9.7%, P < 0.0001). However, the rate of new pacemaker implantation was almost twice as high in the S3-THV group (17.3% vs 9.8%, P = 0.03). In the S3 group, independent predictors of new permanent pacemaker were pre-procedural RBBB (OR = 4.9; P = 0.001), pre-procedural PR duration (OR = 1.14, P = 0.05) and device lack of coaxiality (OR = 1.13; P = 0.05) during deployment.
CONCLUSION The S3-THV is associated to lower rates of major vascular complications and PVR but higher rates of new pacemaker compared to the XT-THV. Sub-optimal visualization of the S3-THV in relation to the aortic valvular complex during deployment is a predictor of new permanent pacemaker.
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14
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Gunning PS, Saikrishnan N, Yoganathan AP, McNamara LM. Total ellipse of the heart valve: the impact of eccentric stent distortion on the regional dynamic deformation of pericardial tissue leaflets of a transcatheter aortic valve replacement. J R Soc Interface 2016; 12:20150737. [PMID: 26674192 DOI: 10.1098/rsif.2015.0737] [Citation(s) in RCA: 43] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
Abstract
Transcatheter aortic valve replacements (TAVRs) are a percutaneous alternative to surgical aortic valve replacements and are used to treat patients with aortic valve stenosis. This minimally invasive procedure relies on expansion of the TAVR stent to radially displace calcified aortic valve leaflets against the aortic root wall. However, these calcium deposits can impede the expansion of the device causing distortion of the valve stent and pericardial tissue leaflets. The objective of this study was to elucidate the impact of eccentric TAVR stent distortion on the dynamic deformation of the tissue leaflets of the prosthesis in vitro. Dual-camera stereophotogrammetry was used to measure the regional variation in strain in a leaflet of a TAVR deployed in nominal circular and eccentric (eccentricity index = 28%) orifices, representative of deployed TAVRs in vivo. It was observed that (i) eccentric stent distortion caused incorrect coaptation of the leaflets at peak diastole resulting in a 'peel-back' leaflet geometry that was not present in the circular valve and (ii) adverse bending of the leaflet, arising in the eccentric valve at peak diastole, caused significantly higher commissure strains compared with the circular valve in both normotensive and hypertensive pressure conditions (normotension: eccentric = 13.76 ± 2.04% versus circular = 11.77 ± 1.61%, p = 0.0014, hypertension: eccentric = 15.07 ± 1.13% versus circular = 13.56 ± 0.87%, p = 0.0042). This study reveals that eccentric distortion of a TAVR stent can have a considerable impact on dynamic leaflet deformation, inducing deleterious bending of the leaflet and increasing commissures strains, which might expedite leaflet structural failure compared to leaflets in a circular deployed valve.
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Affiliation(s)
- Paul S Gunning
- Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland Galway, Galway, Republic of Ireland
| | - Neelakantan Saikrishnan
- Cardiovascular Fluid Mechanics Laboratory, Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, GA, USA
| | - Ajit P Yoganathan
- Cardiovascular Fluid Mechanics Laboratory, Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, GA, USA
| | - Laoise M McNamara
- Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland Galway, Galway, Republic of Ireland
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15
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Kong WK, van Rosendael PJ, van der Kley F, de Weger A, Kamperidis V, Regeer MV, Marsan NA, Bax JJ, Delgado V. Impact of Different Iterations of Devices and Degree of Aortic Valve Calcium on Paravalvular Regurgitation After Transcatheter Aortic Valve Implantation. Am J Cardiol 2016; 118:567-71. [PMID: 27328953 DOI: 10.1016/j.amjcard.2016.05.053] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/13/2016] [Revised: 05/23/2016] [Accepted: 05/23/2016] [Indexed: 10/21/2022]
Abstract
The iterations of the SAPIEN prosthesis might impact the incidence and grade of paravalvular regurgitation (PVR). The aim of this study was to assess the impact of iterations of balloon-expandable valves (SAPIEN, SAPIEN XT, and SAPIEN 3) and degree of aortic valve calcification (AVC) on the severity of PVR after transcatheter aortic valve implantation (TAVI). Comprehensive echocardiographic examinations and multidetector computed tomography (MDCT) were performed in 272 patients (127 men, 81 ± 7 years old, logistic EuroScore of 21 ± 13%) who underwent TAVI with 23- and 26-mm balloon-expandable valves. The degree of AVC was assessed with MDCT. PVR grade was assessed with echocardiography. The cover index was calculated as (prosthesis area - MDCT annulus area)/prosthesis area. SAPIEN, SAPIEN XT, and SAPIEN 3 prostheses were implanted in 103 patients (38%), 105 patients (38.5%), and 64 patients (23.5%), respectively. Significant PVR (≥moderate) occurred in 14%, 10%, and 0% of patients receiving the SAPIEN, SAPIEN XT, and SAPIEN 3, respectively (p = 0.010). Across the groups, the aortic annulus size, degree of calcification, and cover index were comparable. Larger burden of AVC was independently associated with significant PVR (odds ratio 3.48, p = 0.006) after adjusting for age, body surface area, gender, aortic annulus area, cover index, and prosthesis iteration. SAPIEN 3 was associated with lower frequency of significant PVR (odds ratio 0.31, p = 0.002). In conclusion, the incidence of significant PVR significantly decreased over time with improvement in valve design. SAPIEN 3 was associated with less significant PVR after TAVI independently of the AVC burden.
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16
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Zamorano J, Gonçalves A, Lancellotti P, Andersen KA, González-Gómez A, Monaghan M, Brochet E, Wunderlich N, Gafoor S, Gillam LD, La Canna G. The use of imaging in new transcatheter interventions: an EACVI review paper. Eur Heart J Cardiovasc Imaging 2016; 17:835-835af. [PMID: 27311822 DOI: 10.1093/ehjci/jew043] [Citation(s) in RCA: 38] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/14/2016] [Accepted: 02/15/2016] [Indexed: 01/28/2023] Open
Abstract
Transcatheter therapies for the treatment of valve heart diseases have expanded dramatically over the last years. The new developments and improvements in devices and techniques, along with the increasing expertise of operators, have turned the catheter-based approaches for valvular disease into an established treatment option. Various imaging techniques are used during these procedures, but echocardiography plays an essential role during patient selection, intra-procedural monitoring, and post-procedure follow-up. The echocardiographic assessment of patients undergoing transcatheter interventions places demands on echocardiographers that differ from those of the routine evaluation of patients with valve disease, and there is a need for specific expertise for those working in the cath lab. In the context of the current rapid developments and growing use of transcatheter valve therapies, this document intends to update the previous recommendations and address new advancements in imaging, particularly for those involved in any stage of the treatment of patients with valvular heart diseases.
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17
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Spangenberg T, Budde U, Schewel D, Frerker C, Thielsen T, Kuck KH, Schäfer U. Treatment of acquired von Willebrand syndrome in aortic stenosis with transcatheter aortic valve replacement. JACC Cardiovasc Interv 2016; 8:692-700. [PMID: 25946442 DOI: 10.1016/j.jcin.2015.02.008] [Citation(s) in RCA: 44] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/08/2014] [Revised: 02/02/2015] [Accepted: 02/27/2015] [Indexed: 12/11/2022]
Abstract
OBJECTIVES This study sought to investigate the prevalence of abnormal von Willebrand multimers (AbM) in patients undergoing transcatheter aortic valve replacement (TAVR) and the impact of TAVR on the underlying factor variances. BACKGROUND An association between the acquired von Willebrand syndrome (aVWS) and valvular aortic stenosis (AS) has been established in the past and surgical aortic valve replacement (SAVR) shown to lead to factor recovery. Prevalence and course of AbM in patients treated with TAVR though has not yet been described comprehensively. METHODS Ninety-five consecutive patients underwent TAVR at our institution. Hemostaseologic testing was performed before and up to 1 week after TAVR. Transvalvular and right heart hemodynamics as well as bleeding episodes were recorded and analyzed with descriptive statistics. RESULTS Baseline prevalence of AbM was 42% with an average high-molecular-weight multimer (HMWM) count of 16.2 ± 3.3%. Pressure gradients correlated significantly with the extent of HMWM deficiency (r = -0.63 [p < 0.0001]). Following valve implantation, HMWM increased proportional to the drop in mean pressure gradient and normalized in most of the patients. However, residual aortic regurgitation/leakage led to inferior HMWM recovery but prosthesis-patient mismatch (PPM) was rare and left HMWM uninfluenced. We saw no association of transfusion with AbM and 1-year mortality was unaffected by AbM. CONCLUSIONS AbM in patients with AS undergoing TAVR is frequent. However, TAVR is capable of correcting AbM and therefore possibly aVWS in patients with AS. As opposed to SAVR, bleeding and transfusion requirement in TAVR patients was not associated with severe HMWM deficiency; PPM was rare and HMWM were uninfluenced by the procedure. Aortic regurgitation after TAVR adversely influenced HMWM recovery.
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Affiliation(s)
- Tobias Spangenberg
- Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany.
| | - Ulrich Budde
- Medilys Laborgesellschaft mbH, Hemostaseology, Hamburg, Germany
| | - Dimitry Schewel
- Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany
| | - Christian Frerker
- Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany
| | - Thomas Thielsen
- Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany
| | - Karl-Heinz Kuck
- Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany
| | - Ulrich Schäfer
- Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany; Division of Cardiology, University Heart Center Eppendorf, Hamburg, Germany
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18
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Wiegerinck EMA, Van Kesteren F, Van Mourik MS, Vis MM, Baan J. An up-to-date overview of the most recent transcatheter implantable aortic valve prostheses. Expert Rev Med Devices 2016; 13:31-45. [PMID: 26567756 DOI: 10.1586/17434440.2016.1120665] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Over the past decade transcatheter aortic valve implantation (TAVI) has evolved towards the routine therapy for high-risk patients with severe aortic valve stenosis. Technical refinements in TAVI are rapidly evolving with a simultaneous expansion of the number of available devices. This review will present an overview of the current status of development of TAVI-prostheses; describes the technical features and applicability of each device and the clinical data available.
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Affiliation(s)
- Esther M A Wiegerinck
- a Heart Center, Academic Medical Center , University of Amsterdam , Amsterdam , the Netherlands
| | - Floortje Van Kesteren
- a Heart Center, Academic Medical Center , University of Amsterdam , Amsterdam , the Netherlands
| | - Martijn S Van Mourik
- a Heart Center, Academic Medical Center , University of Amsterdam , Amsterdam , the Netherlands
| | - Marije M Vis
- a Heart Center, Academic Medical Center , University of Amsterdam , Amsterdam , the Netherlands
| | - Jan Baan
- a Heart Center, Academic Medical Center , University of Amsterdam , Amsterdam , the Netherlands
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O'Sullivan CJ, Wenaweser P. Optimizing clinical outcomes of transcatheter aortic valve implantation patients with comorbidities. Expert Rev Cardiovasc Ther 2015; 13:1419-32. [PMID: 26479904 DOI: 10.1586/14779072.2015.1102056] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Abstract
Transcatheter aortic valve implantation (TAVI) has revolutionized the management of high-risk or inoperable patients presenting with symptomatic severe aortic stenosis (AS). There are several factors to consider to optimize patient outcomes from TAVI. Before TAVI, patient selection is key and an understanding the effects of common comorbidities on outcomes after TAVI is critical. Some comorbidities share common risk factors with AS (e.g. coronary artery disease), others are directly or indirectly caused or exacerbated by severe AS (e.g. atrial fibrillation, pulmonary hypertension, mitral regurgitation, tricuspid regurgitation and right ventricular dysfunction), whereas others are not directly related to severe AS (e.g. chronic kidney disease and chronic lung disease). Choice of transcatheter heart valve prosthesis, vascular access route and mode of anesthesia are important considerations during TAVI. New onset conduction disturbances and arrhythmias remain a vexing issue after TAVI. The aim of the present review is to provide an overview of these issues.
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Affiliation(s)
| | - Peter Wenaweser
- b Department of Cardiology , Bern University Hospital , Bern , Switzerland
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20
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Mangieri A, Regazzoli D, Ruparelia N, Colombo A, Latib A. Recent advances in transcatheter aortic valve replacement for high-risk patients. Expert Rev Cardiovasc Ther 2015; 13:1237-49. [PMID: 26414888 DOI: 10.1586/14779072.2015.1093935] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Aortic stenosis is the most common valvular heart disease of old age. Patients with severe aortic stenosis who develop symptoms have a very poor prognosis without valve intervention. Surgical aortic valve replacement has historically been the only treatment option for these patients. However a significant minority are considered inoperable or at high surgical risk and therefore are refused or decline surgery. In recent years, transcatheter aortic valve replacement has emerged as an alternative treatment option in these high-risk patients. The aim of this review is to summarize the current role of transcatheter aortic valve replacement in contemporary clinical practice including recent advances in technological and procedural aspects and then discuss future directions.
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Affiliation(s)
- Antonio Mangieri
- a 1 Interventional Cardiology Unit, Cardiology and Cardiothoracic Surgery Department, San Raffaele University Hospital, Milan, Italy
| | - Damiano Regazzoli
- a 1 Interventional Cardiology Unit, Cardiology and Cardiothoracic Surgery Department, San Raffaele University Hospital, Milan, Italy
| | - Neil Ruparelia
- a 1 Interventional Cardiology Unit, Cardiology and Cardiothoracic Surgery Department, San Raffaele University Hospital, Milan, Italy.,b 2 Imperial College, London, UK.,c 3 Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy
| | - Antonio Colombo
- a 1 Interventional Cardiology Unit, Cardiology and Cardiothoracic Surgery Department, San Raffaele University Hospital, Milan, Italy.,c 3 Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy
| | - Azeem Latib
- a 1 Interventional Cardiology Unit, Cardiology and Cardiothoracic Surgery Department, San Raffaele University Hospital, Milan, Italy.,c 3 Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy
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21
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Abdel-Wahab M, Jose J, Richardt G. Transfemoral TAVI devices: design overview and clinical outcomes. EUROINTERVENTION 2015; 11 Suppl W:W114-8. [DOI: 10.4244/eijv11swa33] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
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22
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Athappan G, Gajulapalli RD, Tuzcu ME, Kapadia SR. Expanding opportunities in interventional cardiology: reducing aortic insufficiencies with transcatheter aortic valve replacement. Interv Cardiol 2015. [DOI: 10.2217/ica.14.54] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
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23
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Jose J, Richardt G, Abdel-Wahab M. Balloon- or Self-Expandable TAVI: Clinical Equipoise? Interv Cardiol 2015; 10:103-108. [PMID: 29588684 DOI: 10.15420/icr.2015.10.2.103] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Abstract
Transcatheter aortic valve implantation (TAVI) has become an effective treatment option for patients with severe aortic stenosis and high surgical risk or contraindications for surgical aortic valve replacement. Most of the currently available prostheses employ either balloon-expandable or self-expandable designs. Presently, there is a paucity of data directly comparing these two widely used prosthesis types. Forthcoming trials will reveal whether newer designs of both technologies translate into fewer complications and better outcomes, with expansion of TAVI indications. This manuscript reviews features and clinical outcomes of balloon- and self-expanding prostheses, summarising current data from registries and trials.
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Affiliation(s)
- John Jose
- Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck and Hamburg), Bad Segeberg, Germany
| | - Gert Richardt
- Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck and Hamburg), Bad Segeberg, Germany
| | - Mohamed Abdel-Wahab
- Heart Center, Segeberger Kliniken GmbH (Academic Teaching Hospital of the Universities of Kiel, Lübeck and Hamburg), Bad Segeberg, Germany
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24
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Chevalier F, Poulin F, Lamarche Y, Viet Le VH, Gallant M, Daoust A, Heylbroeck C, Serri K, Beaulieu Y, Demers P, El-Hamamsy I, Jeanmart H, Pagé P, Schampaert E, Palisaitis D, Généreux P. Excellent Outcomes for Transcatheter Aortic Valve Replacement Within 1 Year of Opening a Low-Volume Centre and Consideration of Requirements. Can J Cardiol 2014; 30:1576-82. [DOI: 10.1016/j.cjca.2014.08.010] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2014] [Revised: 08/19/2014] [Accepted: 08/19/2014] [Indexed: 10/24/2022] Open
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25
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El-Mawardy M, Abdel-Wahab M, Richardt G. Transcatheter aortic valve implantation: technique, complications and perspectives. Expert Rev Cardiovasc Ther 2014; 12:1005-24. [DOI: 10.1586/14779072.2014.929942] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/14/2023]
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26
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Ielasi A, Latib A, Tespili M. Current and new-generation transcatheter aortic valve devices: an update on emerging technologies. Expert Rev Cardiovasc Ther 2014; 11:1393-405. [PMID: 24138525 DOI: 10.1586/14779072.2013.837702] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
Transcatheter aortic valve implantation (TAVI) has become an accepted treatment option for patients with symptomatic severe aortic stenosis who are at high risk for traditional surgical aortic valve replacement. In particular, TAVI has been shown to reduce mortality in a randomized comparison with medical treatment and to be non-inferior to surgical aortic valve replacement in 'high-risk operable' patients. From its early stages it became apparent that TAVI has tremendous potential and thus considerable efforts were made to design new devices and advance valve technology in order to improve outcomes and increase TAVI applications in complex anatomies and in patients with multiple co-morbidities. In this review, we present the advances in transcatheter aortic valve technology and discuss the current evidence on the new-generation TAVI devices.
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Affiliation(s)
- Alfonso Ielasi
- Cardiology Division, Azienda Ospedaliera "Bolognini", Seriate (BG), Italy
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27
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Abstract
Transcatheter aortic valve replacement emerged ≈20 years ago and changed the landscape of structural interventional cardiology. The first experiments in animal models provided proofs of the concept and the substrate for the first percutaneous valve implantation in patients. The initial promising results in a clinical setting drew the attention of the industry and of the scientific community, and an effort was made for the past 12 years to address the limitations of the technology, facilitate the procedure, minimize the risk of complications, and broaden the applications of transcatheter aortic valve replacement. This article reviews the evolution of transcatheter aortic valve replacement, presents the first steps in this field, cites the evidence from registries and clinical trials, highlights the limitations of this treatment, and discusses the future perspectives and the developments proposed to address the current pitfalls.
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Affiliation(s)
- Christos V. Bourantas
- From the Department of Interventional Cardiology, ThoraxCenter, Erasmus Medical Center, Rotterdam, The Netherlands (C.V.B., P.W.S.); and International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom (P.W.S.)
| | - Patrick W. Serruys
- From the Department of Interventional Cardiology, ThoraxCenter, Erasmus Medical Center, Rotterdam, The Netherlands (C.V.B., P.W.S.); and International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom (P.W.S.)
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28
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Kumar R, Latib A, Colombo A, Ruiz CE. Self-expanding prostheses for transcatheter aortic valve replacement. Prog Cardiovasc Dis 2014; 56:596-609. [PMID: 24838135 DOI: 10.1016/j.pcad.2014.03.002] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic valve replacement in patients who are considered high surgical risk or inoperable due to advanced age and comorbidities. Randomized trial and registry data have demonstrated the safety and efficacy of TAVR in such patients. Currently available transcatheter heart valves (THVs) employ either balloon-expandable or self-expanding designs, and several new designs have shown promising early results. Differences in valve design may offer specific advantages for accurate deployment and minimizing complications. This article reviews several designs of self-expanding THVs that are currently available or have undergone successful implantation in humans. Additional studies are required to compare the relative performance of these devices.
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Affiliation(s)
- Robert Kumar
- Division of Cardiology, Sharp Rees-Stealy Medical Group, San Diego, CA
| | - Azeem Latib
- Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
| | - Antonio Colombo
- Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
| | - Carlos E Ruiz
- Department of Structural and Congenital Heart Disease, Lenox Hill Heart and Vascular Institute, North Shore/LIJ Health System, New York, NY.
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29
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Abstract
Treatment of aortic stenosis in high-risk surgical patients has been modified in the past 10 years owing to the introduction of transcatheter aortic valve implantation (TAVI). Several issues affecting outcomes with implantation of the first-generation TAVI devices remain unresolved, including haemorrhagic and vascular complications, neurological events, rhythm disturbances, and paravalvular leakage. Further technological improvements are, therefore, required before the indications for TAVI can be extended to young and low-risk patients with aortic stenosis. Many new-generation TAVI devices are currently in the early stages of clinical evaluation. Modifications in the new devices include the ability to reposition the valve before final deployment, features to reduce paravalvular leakage, and the introduction of low-profile delivery systems. The aim of this Review is to provide an overview of the new-generation transcatheter valvular technologies, including initial clinical reports.
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30
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Chiam PTL, Ewe SH. An update on complications associated with transcatheter aortic valve implantation: stroke, paravalvular leak, atrioventricular block and perforation. Future Cardiol 2013; 9:733-47. [DOI: 10.2217/fca.13.43] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023] Open
Abstract
Transcatheter aortic valve implantation (TAVI) has become an alternative therapeutic option for patients with symptomatic severe aortic stenosis at high surgical risk and the standard of care in patients who are inoperable for open aortic valve replacement. With technological evolution and increasing experience, the procedure has become more predictable. Complications of TAVI, however, are not infrequent, and can range from minor to life-threatening events. Stroke, paravalvular leak, various forms of atrioventricular block, including the need for permanent pacemakers and aortic annular and ventricular perforation will be the focus of the present review. Other complications associated with TAVI (such as vascular injury, acute kidney injury, coronary obstruction, valve malpositioning or migration) are clinically important, but are beyond the scope of this article. Understanding the occurrence and pathophysiology of these complications may provide insights into the improvement of the transcatheter devices and techniques, and aid in extending the application of TAVI to a broader population.
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Affiliation(s)
- Paul TL Chiam
- Department of Cardiology, National Heart Centre Singapore, 17 Third Hospital Avenue, Mistri Wing, 168752 Singapore.
| | - See Hooi Ewe
- Department of Cardiology, National Heart Centre Singapore, 17 Third Hospital Avenue, Mistri Wing, 168752 Singapore
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31
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Costopoulos C, Naganuma T, Latib A, Colombo A. Aortic regurgitation after transcatheter aortic valve implantation. Expert Rev Cardiovasc Ther 2013; 11:1089-92. [PMID: 23944936 DOI: 10.1586/14779072.2013.824688] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Affiliation(s)
- Charis Costopoulos
- Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy and Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, 48 Via M. Buonarroti, 20145 Milan, Italy and Imperial College London, London, UK
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