Dataset Information

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.

ABSTRACT:

Objectives

This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement.

Methods

Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Association (NYHA) functional class were also evaluated.

Results

A total of 1118 patients have received the Avalus valve; 564 have completed the 5-year follow-up. The median follow-up was 4.85 years (4810 patient-years total follow-up). At baseline, the mean age was 70.2 ± 9.0 years; 75.1% of patients were male. The Society of Thoracic Surgeons predicted risk of mortality was 2.0 ± 1.4%. Most patients were in NYHA functional class II (46.8%) or III (40.3%). At the 5-year follow-up, the overall Kaplan-Meier survival rate was 88.1% (85.9-90.0%). The Kaplan-Meier event rates were 5.6% (4.3-7.2%) for thromboembolism, 4.4% (3.2-6.0%) for endocarditis, 0.2% (0.0-0.7%) for a major paravalvular leak and 3.2% (2.3-4.6%) for reintervention. There were no cases of SVD. The mean gradient decreased from 42.1 ± 17.1 mmHg at baseline, to 13.1 ± 4.7 mmHg at discharge and remained stable at 12.5 ± 4.6 mmHg at 5 years. More than 95% of patients were in NYHA functional class I/II 5 years after surgery.

Conclusions

The findings of a high survival rate, excellent safety, no SVD and stable haemodynamic performance and functional status through 5 years of follow-up are encouraging. Additional follow-up is needed to assess the long-term durability of this contemporary surgical bioprosthesis.

SUBMITTER: Klautz RJM

PROVIDER: S-EPMC9346377 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.

Klautz Robert J M RJM Dagenais François F Reardon Michael J MJ Lange Rüdiger R Moront Michael G MG Labrousse Louis L Weissman Neil J NJ Rao Vivek V Patel Himanshu J HJ Liu Fang F Sabik Joseph F JF

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20220801 3

<h4>Objectives</h4>This analysis evaluated the safety, durability and haemodynamic performance of a stented bovine pericardial valve through 5 years of follow-up in patients with an indication for surgical aortic valve replacement.<h4>Methods</h4>Kaplan-Meier analysis was used to estimate the incidence of survival and valve-related thromboembolism, major paravalvular leak, endocarditis, structural valve deterioration (SVD) and reintervention. The mean aortic gradient and New York Heart Associati ...[more]

PMID: 35789382

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Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

Project description:BACKGROUND:Two large, randomized trials are underway evaluating transcatheter aortic valve replacement (AVR) against conventional surgical AVR. We analyzed contemporary, real-world outcomes of surgical AVR in low-risk patients to provide a practical benchmark of outcomes and cost for evaluating current and future transapical AVR technology. METHODS:From 2010 to 2015, 2,505 isolated AVR operations were performed for severe aortic stenosis at 18 statewide cardiac institutions. Of these, 2,138 patients had a Society of Thoracic Surgeons predicted risk of mortality of less than 4%, and 1,119 met other clinical and hemodynamic criteria as outlined in the PARTNER 3 (The Placement of Transcatheter Aortic Valves) protocol. Patients with endocarditis, end-stage renal disease, ejection fraction of less than 0.45, bicuspid valves, and previous valve replacements were excluded. Outcomes of interest included operative death and postoperative adverse events. RESULTS:The median Society of Thoracic Surgeons predicted risk of mortality for the study-eligible patients was 1.44%, with a median age of 72 years (interquartile range [IQR], 65 to 78 years). Operative mortality was 1.3%, permanent stroke was 1.3%, and pacemaker requirement was 4.2%. The most common adverse events were transfusion of 2 or more units of red blood cells (18%) and atrial fibrillation (28%). The median length of stay was 6 days (IQR, 5 to 8 days). Median total hospital cost was $37,999 (IQR, $30,671 to $46,138). Examination of complications by age younger than 65 vs 65 or older demonstrated a significantly lower need for transfusion (11.2%, p < 0.001) and incidence of atrial fibrillation (17.1%, p < 0.001) but no difference in operative mortality (2.2% vs 0.9%, p = 0.1), major morbidity (10.4% vs 12.6%, p = 0.3), or total hospital costs. CONCLUSIONS:Low-risk patients undergoing surgical AVR in the current era have excellent results. The most common complications were atrial fibrillation and bleeding. These real-world results should provide additional context for upcoming transcatheter clinical trial data.

Dataset Information

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.

Objectives

Methods

Results

Conclusions

Publications

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes.

Similar Datasets

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