Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

Abstract Background There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and...

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Main Authors: Marko P. O. Virtanen, Markku Eskola, Mikko Savontaus, Tatu Juvonen, Matti Niemelä, Teemu Laakso, Annastiina Husso, Maina P. Jalava, Tuomas Tauriainen, Tuomas Ahvenvaara, Pasi Maaranen, Eeva-Maija Kinnunen, Sebastian Dahlbacka, Mika Laine, Timo Mäkikallio, Antti Valtola, Peter Raivio, Stefano Rosato, Paola D’Errigo, Antti Vento, Juhani Airaksinen, Fausto Biancari
Format: Article
Language:English
Published: BMC 2020-06-01
Series:Journal of Cardiothoracic Surgery
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13019-020-01203-1
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author Marko P. O. Virtanen
Markku Eskola
Mikko Savontaus
Tatu Juvonen
Matti Niemelä
Teemu Laakso
Annastiina Husso
Maina P. Jalava
Tuomas Tauriainen
Tuomas Ahvenvaara
Pasi Maaranen
Eeva-Maija Kinnunen
Sebastian Dahlbacka
Mika Laine
Timo Mäkikallio
Antti Valtola
Peter Raivio
Stefano Rosato
Paola D’Errigo
Antti Vento
Juhani Airaksinen
Fausto Biancari
author_facet Marko P. O. Virtanen
Markku Eskola
Mikko Savontaus
Tatu Juvonen
Matti Niemelä
Teemu Laakso
Annastiina Husso
Maina P. Jalava
Tuomas Tauriainen
Tuomas Ahvenvaara
Pasi Maaranen
Eeva-Maija Kinnunen
Sebastian Dahlbacka
Mika Laine
Timo Mäkikallio
Antti Valtola
Peter Raivio
Stefano Rosato
Paola D’Errigo
Antti Vento
Juhani Airaksinen
Fausto Biancari
author_sort Marko P. O. Virtanen
collection DOAJ
description Abstract Background There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. Methods In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. Results A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. Conclusions The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome. Trial registration ClinicalTrials.gov Identifier: NCT03385915 .
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spelling doaj.art-9eafbf4404c848eda0920a32daa8fa592022-12-21T17:59:37ZengBMCJournal of Cardiothoracic Surgery1749-80902020-06-011511910.1186/s13019-020-01203-1Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosisMarko P. O. Virtanen0Markku Eskola1Mikko Savontaus2Tatu Juvonen3Matti Niemelä4Teemu Laakso5Annastiina Husso6Maina P. Jalava7Tuomas Tauriainen8Tuomas Ahvenvaara9Pasi Maaranen10Eeva-Maija Kinnunen11Sebastian Dahlbacka12Mika Laine13Timo Mäkikallio14Antti Valtola15Peter Raivio16Stefano Rosato17Paola D’Errigo18Antti Vento19Juhani Airaksinen20Fausto Biancari21Heart Hospital, Tampere University HospitalHeart Hospital, Tampere University HospitalHeart Center, Turku University Hospital, and Department of Surgery, University of TurkuHeart and Lung Center, Helsinki University HospitalDepartment of Internal Medicine, Oulu University HospitalHeart and Lung Center, Helsinki University HospitalHeart Center, Kuopio University HospitalHeart Center, Turku University Hospital, and Department of Surgery, University of TurkuDepartment of Surgery, Oulu University Hospital and Research Unit of Surgery, Anesthesia and Intensive Care, Faculty of Medicine, University of OuluDepartment of Surgery, Oulu University Hospital and Research Unit of Surgery, Anesthesia and Intensive Care, Faculty of Medicine, University of OuluHeart Hospital, Tampere University HospitalHeart and Lung Center, Helsinki University HospitalHeart and Lung Center, Helsinki University HospitalHeart and Lung Center, Helsinki University HospitalDepartment of Internal Medicine, Oulu University HospitalHeart Center, Kuopio University HospitalHeart and Lung Center, Helsinki University HospitalNational Centre of Global Health, Istituto Superiore di SanitàNational Centre of Global Health, Istituto Superiore di SanitàHeart and Lung Center, Helsinki University HospitalHeart Center, Turku University Hospital, and Department of Surgery, University of TurkuHeart Center, Turku University Hospital, and Department of Surgery, University of TurkuAbstract Background There is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis. Methods In a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality. Results A total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts. Conclusions The Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome. Trial registration ClinicalTrials.gov Identifier: NCT03385915 .http://link.springer.com/article/10.1186/s13019-020-01203-1Aortic valve stenosisAortic valve replacementTAVRSAVR
spellingShingle Marko P. O. Virtanen
Markku Eskola
Mikko Savontaus
Tatu Juvonen
Matti Niemelä
Teemu Laakso
Annastiina Husso
Maina P. Jalava
Tuomas Tauriainen
Tuomas Ahvenvaara
Pasi Maaranen
Eeva-Maija Kinnunen
Sebastian Dahlbacka
Mika Laine
Timo Mäkikallio
Antti Valtola
Peter Raivio
Stefano Rosato
Paola D’Errigo
Antti Vento
Juhani Airaksinen
Fausto Biancari
Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis
Journal of Cardiothoracic Surgery
Aortic valve stenosis
Aortic valve replacement
TAVR
SAVR
title Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis
title_full Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis
title_fullStr Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis
title_full_unstemmed Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis
title_short Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis
title_sort mid term outcomes of sapien 3 versus perimount magna ease for treatment of severe aortic stenosis
topic Aortic valve stenosis
Aortic valve replacement
TAVR
SAVR
url http://link.springer.com/article/10.1186/s13019-020-01203-1
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