Dataset Information

One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.

ABSTRACT:

Aims

To evaluate 1-year outcome after transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (S3) prosthesis with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety" proposed by the updated Valve Academic Research Consortium (VARC-2).

Methods and results

Four hundred and two consecutive patients undergoing transfemoral TAVI with the S3 were enrolled. Mean age was 81 ± 6 years, 43% were female and median logistic EuroSCORE I was 12% [8-19]. Device success was achieved in 93% (374/402) with moderate or severe paravalvular leakage (PVL) in 2%. At 1 year all-cause mortality was 8.9% [95% CI 6.4-12.2] and new permanent pacemaker implantation rate was 16% [95% CI 12.7-20.4]. The composite endpoint time-related valve safety occurred in 29% with structural valve deterioration, defined as elevated gradients or more than moderate PVL, occurring in 13%. The clinical efficacy endpoint after 30 days was observed in 37% of patients with the main contributor symptom worsening with New York Heart Association functional class III + in 17% of cases.

Conclusions

For the first time, VARC-2-defined composite endpoints at 1 year are reported and reveal a considerable proportion of patients experiencing the endpoint of time-related valve safety (29%) and clinical efficacy after 30 days (37%).

SUBMITTER: Pellegrini C

PROVIDER: S-EPMC6805964 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.

Pellegrini Costanza C Rheude Tobias T Trenkwalder Teresa T Mayr N Patrick NP Joner Michael M Kastrati Adnan A Schunkert Heribert H Husser Oliver O Hengstenberg Christian C

Clinical research in cardiology : official journal of the German Cardiac Society 20190502 11

<h4>Aims</h4>To evaluate 1-year outcome after transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (S3) prosthesis with emphasis on the composite endpoints "clinical efficacy after 30 days" and "time-related valve safety" proposed by the updated Valve Academic Research Consortium (VARC-2).<h4>Methods and results</h4>Four hundred and two consecutive patients undergoing transfemoral TAVI with the S3 were enrolled. Mean age was 81 ± 6 years, 43% were female and median logistic EuroSCOR ...[more]

PMID: 31049679

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Project description:ImportanceBioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high-surgical risk patients.ObjectiveTo assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement.Design, setting, and participantsIn this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data.ExposuresMitral valve-in-valve for degenerated bioprosthetic mitral valves.Main outcomes and measuresThe primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association-defined heart failure, and mitral valve performance.ResultsA total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg.Conclusions and relevanceTranscatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

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Project description:BackgroundTranscatheter mitral valve implantation (TMVI) for native mitral valve pathology with severe mitral annular calcification has emerged as an alternative treatment option to conventional mitral valve surgery. The objective of this study was to evaluate patients who were referred for TMVI with severe mitral annular calcification and their procedural outcomes.MethodsRetrospective analysis of patients from 2017 to 2020 referred for TMVI was carried out. Demographic characteristic details; surgical strategy; perioperative complications; and hospital stay, including 30-day and 1-year mortality, were analyzed.ResultsEleven patients were referred for consideration of TMVI. The 8 patients who underwent TMVI had a median age of 74 years (range, 57-80 years), the median Society of Thoracic Surgeons score was 4.6 (range, 2.4-10.9), and European System for Cardiac Operative Risk Evaluation II score was 5.2% (2%-10.1%). The median cardiopulmonary bypass time and crossclamp times were 170 minutes (range, 150-248 minutes) and 152 minutes (range, 118-214 minutes), respectively. The median hospital stay was 29 days (range, 2-40 days). Thirty-day in hospital mortality was 12%, whereas 1-year mortality was 25%. There was symptomatic improvement with downgrade of New York Heart Association functional class from III or IV to I or II. The 3 patients who were turned down had a median age of 73 years, median Society of Thoracic Surgeons score was 13.4, and median European System for Cardiac Operative Risk Evaluation II score was 5.72%. They were alive at 12 months follow-up from the date of surgical assessment; however, all with New York Heart Association functional class III or IV symptoms.ConclusionsWe describe a series demonstrating the technical consideration and capability of transatrial TMVI to treat mitral annular calcification and native mitral valve disease. Our results are favorable when compared with TMVI global registry data for transseptal or transapical approach.

Dataset Information

One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.

Aims

Methods and results

Conclusions

Publications

One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.

Similar Datasets

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