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Does transcatheter aortic valve implantation mean the end of surgical aortic valve replacement?

ABSTRACT: Although the results of the early TAVI experience are promising, longer-term follow-up is necessary before the procedure can be extended to lowerrisk patients. Many issues are not yet resolved, including the long-term effects of paravalvular leaks (which occur in most TAVI patients), the true stroke rate in TAVI patients (which is probably in the range of 5% to 6%), and the need for permanent pacemaker implantation (which ranges from 5% to 40% in TAVI patients, depending upon the device used). As the procedure is extended into the lower-risk population, these issues will assume greater import than they have in the population currently in treatment—very elderly, high-risk patients with limited life expectancy. As in the coronary-revascularization paradigm of percutaneous coronary intervention versus coronary artery bypass grafting, there will be increasing adoption of the transcatheter approach. Just as the rumors of the demise of surgical bypass were premature, conventional AVR will continue to be the predominant technique for the treatment of aortic stenosis during at least the next decade. Although the percentage of patients treated by a transcatheter approach will continue to increase, regulatory and reimbursement factors are likely to be the primary determinants of the rate of adoption.

SUBMITTER: Mack MJ

PROVIDER: S-EPMC3014148 | biostudies-other | 2010

REPOSITORIES: biostudies-other

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Does transcatheter aortic valve implantation mean the end of surgical aortic valve replacement?

Mack Michael J MJ

Texas Heart Institute journal 20100101 6

Although the results of the early TAVI experience are promising, longer-term follow-up is necessary before the procedure can be extended to lowerrisk patients. Many issues are not yet resolved, including the long-term effects of paravalvular leaks (which occur in most TAVI patients), the true stroke rate in TAVI patients (which is probably in the range of 5% to 6%), and the need for permanent pacemaker implantation (which ranges from 5% to 40% in TAVI patients, depending upon the device used). A ...[more]

PMID: 21224936

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Project description:ObjectivesTo date the reported outcomes of surgical aortic valve replacement (SAVR) are mainly in the settings of trials comparing it with evolving transcatheter aortic valve implantation. We set out to examine characteristics and outcomes in people who underwent SAVR reflecting a national cohort and therefore 'real-world' practice.DesignRetrospective analysis of prospectively collected data of consecutive people who underwent SAVR with or without coronary artery bypass graft (CABG) surgery between April 2013 and March 2018 in the UK. This included elective, urgent and emergency operations. Participants' demographics, preoperative risk factors, operative data, in-hospital mortality, postoperative complications and effect of the addition of CABG to SAVR were analysed.Setting27 (90%) tertiary cardiac surgical centres in the UK submitted their data for analysis.Participants31 277 people with AVR were identified. 19 670 (62.9%) had only SAVR and 11 607 (37.1%) had AVR+CABG.ResultsIn-hospital mortality for isolated SAVR was 1.9% (95% CI 1.6% to 2.1%) and was 2.4% for AVR+CABG. Mortality by age category for SAVR only were: <60 years=2.0%, 60-75 years=1.5%, >75 years=2.2%. For SAVR+CABG these were; 2.2%, 1.8% and 3.1%. For different categories of EuroSCORE, mortality for SAVR in low risk people was 1.3%, in intermediate risk 1% and for high risk 3.9%. 74.3% of the operations were elective, 24% urgent and 1.7% emergency/salvage. The incidences of resternotomy for bleeding and stroke were 3.9% and 1.1%, respectively. Multivariable analyses provided no evidence that concomitant CABG influenced outcome. However, urgency of the operation, poor ventricular function, higher EuroSCORE and longer cross clamp and cardiopulmonary bypass times adversely affected outcomes.ConclusionsSurgical SAVR±CABG has low mortality risk and a low level of complications in the UK in people of all ages and risk factors. These results should inform consideration of treatment options in people with aortic valve disease.

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.

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Does transcatheter aortic valve implantation mean the end of surgical aortic valve replacement?

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Does transcatheter aortic valve implantation mean the end of surgical aortic valve replacement?

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