Transcatheter aortic valve replacement with new-generation devices

A systematic review and meta-analysis

Marco Barbanti, Sergio Buccheri, Josep Rodés-Cabau, Simona Gulino, Philippe Genereux, Gerlando Pilato, Danny Dvir, Andrea Picci, Giuliano Costa, Corrado Tamburino, Martin B. Leon, John G. Webb

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Objective The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤ 30 days) major outcomes after (TAVR) with second-generation devices. Methods A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. Results A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n = 5423, 45.9%), Lotus Valve (n = 3007, %), Portico (n = 130, 1.1%), JenaValve (n = 345, 2.9%), Symetis Acurate (n = 1314, 11,1%), and Evolut R (n = 1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). Conclusions Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with < 2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.

Original languageEnglish (US)
Pages (from-to)83-89
Number of pages7
JournalInternational Journal of Cardiology
Volume245
DOIs
StatePublished - Oct 15 2017

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Meta-Analysis
Equipment and Supplies
Aortic Valve Insufficiency
Prostheses and Implants
Stroke
Blood Vessels
Transcatheter Aortic Valve Replacement
Databases
Hemorrhage
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Barbanti, Marco ; Buccheri, Sergio ; Rodés-Cabau, Josep ; Gulino, Simona ; Genereux, Philippe ; Pilato, Gerlando ; Dvir, Danny ; Picci, Andrea ; Costa, Giuliano ; Tamburino, Corrado ; Leon, Martin B. ; Webb, John G. / Transcatheter aortic valve replacement with new-generation devices : A systematic review and meta-analysis. In: International Journal of Cardiology. 2017 ; Vol. 245. pp. 83-89.
@article{7c5f551ef37946e9adf911f1de6c4e96,
title = "Transcatheter aortic valve replacement with new-generation devices: A systematic review and meta-analysis",
abstract = "Objective The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤ 30 days) major outcomes after (TAVR) with second-generation devices. Methods A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. Results A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n = 5423, 45.9{\%}), Lotus Valve (n = 3007, {\%}), Portico (n = 130, 1.1{\%}), JenaValve (n = 345, 2.9{\%}), Symetis Acurate (n = 1314, 11,1{\%}), and Evolut R (n = 1603, 13.6{\%}). Thirty-day all-cause and cardiovascular 30-day death were 2.2{\%} (95{\%} CI: 1.6{\%} to 2.8{\%}) and 1.6{\%} (95{\%} CI: 0.9{\%} to 2.3{\%}), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6{\%} (95{\%} CI: 2.0{\%} to 3.3{\%}) and 0.9{\%} (95{\%} CI: 0.2{\%} to 1.6{\%}), respectively; life-threatening bleeding, 3.9{\%} (95{\%} CI: 2.9{\%} to 5.0{\%}); major vascular complications, 4.5{\%} (95{\%} CI: 3.7{\%} to 5.4{\%}); pacemaker implantation, 16.2{\%} (95{\%} CI: 12.7{\%} to 19.6{\%}); more than mild aortic regurgitation, 1.6{\%} (95{\%} CI: 0.9 to 2.3). Conclusions Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with < 2{\%} of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.",
author = "Marco Barbanti and Sergio Buccheri and Josep Rod{\'e}s-Cabau and Simona Gulino and Philippe Genereux and Gerlando Pilato and Danny Dvir and Andrea Picci and Giuliano Costa and Corrado Tamburino and Leon, {Martin B.} and Webb, {John G.}",
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Barbanti, M, Buccheri, S, Rodés-Cabau, J, Gulino, S, Genereux, P, Pilato, G, Dvir, D, Picci, A, Costa, G, Tamburino, C, Leon, MB & Webb, JG 2017, 'Transcatheter aortic valve replacement with new-generation devices: A systematic review and meta-analysis', International Journal of Cardiology, vol. 245, pp. 83-89. https://doi.org/10.1016/j.ijcard.2017.07.083

Transcatheter aortic valve replacement with new-generation devices : A systematic review and meta-analysis. / Barbanti, Marco; Buccheri, Sergio; Rodés-Cabau, Josep; Gulino, Simona; Genereux, Philippe; Pilato, Gerlando; Dvir, Danny; Picci, Andrea; Costa, Giuliano; Tamburino, Corrado; Leon, Martin B.; Webb, John G.

In: International Journal of Cardiology, Vol. 245, 15.10.2017, p. 83-89.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Transcatheter aortic valve replacement with new-generation devices

T2 - A systematic review and meta-analysis

AU - Barbanti, Marco

AU - Buccheri, Sergio

AU - Rodés-Cabau, Josep

AU - Gulino, Simona

AU - Genereux, Philippe

AU - Pilato, Gerlando

AU - Dvir, Danny

AU - Picci, Andrea

AU - Costa, Giuliano

AU - Tamburino, Corrado

AU - Leon, Martin B.

AU - Webb, John G.

PY - 2017/10/15

Y1 - 2017/10/15

N2 - Objective The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤ 30 days) major outcomes after (TAVR) with second-generation devices. Methods A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. Results A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n = 5423, 45.9%), Lotus Valve (n = 3007, %), Portico (n = 130, 1.1%), JenaValve (n = 345, 2.9%), Symetis Acurate (n = 1314, 11,1%), and Evolut R (n = 1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). Conclusions Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with < 2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.

AB - Objective The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤ 30 days) major outcomes after (TAVR) with second-generation devices. Methods A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. Results A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n = 5423, 45.9%), Lotus Valve (n = 3007, %), Portico (n = 130, 1.1%), JenaValve (n = 345, 2.9%), Symetis Acurate (n = 1314, 11,1%), and Evolut R (n = 1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). Conclusions Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with < 2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.

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