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TAVR or SAVR for Failed Bioprosthetic Aortic Valves
Quick Takes
- In a retrospective, population-based cohort study based on three statewide administrative databases, intervention for a failed bioprosthetic SAVR with valve-in-valve (ViV) TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years compared to redo SAVR.
- However, ViV TAVR compared to redo SAVR also was associated with higher rates of late mortality and heart failure hospitalization.
- There is a need for prospective, randomized trials to compare outcomes for ViV TAVR compared to redo SAVR for patients undergoing intervention for failed bioprosthetic SAVR.
Study Questions:
How do mortality and morbidity compare after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) versus redo surgical aortic valve replacement (SAVR) for intervention for a failed bioprosthetic SAVR?
Methods:
In a retrospective, population-based cohort study, statewide mandatory administrative databases in California (California Department of Health Care Access and Information), New York (New York Statewide Planning and Research Cooperative System), and New Jersey (New Jersey Discharge Data Collection System) were used to identify patients who underwent January 2015 through December 2020 ViV TAVR or isolated redo SAVR >5 years after bioprosthetic SAVR; excluding out-of-state residents and patients with infective endocarditis. A total of 1,771 patients were identified; propensity matching yielded 375 patient pairs. The primary outcome measure was all-cause mortality. Secondary outcomes were stroke, heart failure hospitalization (HFH), reoperation, major bleeding, acute kidney failure, new pacemaker insertion, and infective endocarditis.
Results:
Median (interquartile range) follow-up was 2.3 (1.1-4.0) years. From 2015 through 2020, the proportion of patients undergoing ViV TAVR versus redo SAVR increased from 159/451 (35.3%) to 498/797 (62.5%). Of 1,771 patients, 653 (36.9%) were female, and mean age was 74.4 ± 11.3 years. Periprocedural mortality and stroke rates were similar between propensity-matched groups. The ViV TAVR group had lower periprocedural rates of major bleeding (2.4% vs. 5.1%, p = 0.05), acute kidney failure (1.3% vs. 7.2%, p < 0.001), and new pacemaker implantation (3.5% vs. 10.9%, p < 0.001). The 5-year all-cause mortality rate was 23.4% (95% confidence interval [CI], 15.7-34.1) in the ViV TAVR group and 13.3% (95% CI, 9.2-18.9) in the redo SAVR group. In a landmark analysis, no difference in mortality was observed up to 2 years (hazard ratio [HR], 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV TAVR was associated with higher mortality (HR, 2.97; 95% CI, 1.18-7.47) as well as a higher incidence of HFH (HR, 3.81; 95% CI, 1.57-9.22). There were no differences in the 5-year incidence rates of stroke, reoperation, major bleeding, or infective endocarditis.
Conclusions:
Compared with redo SAVR, ViV TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2-year follow-up. However, ViV TAVR was associated with higher rates of late mortality and HFH. The authors note that these findings may be influenced by residual confounding and require adjudication in a randomized clinical trial.
Perspective:
The use of TAVR compared to SAVR for severe symptomatic native aortic stenosis has been investigated using prospective, randomized clinical trials, but similar data do not exist for patients undergoing intervention for bioprosthetic SAVR structural deterioration. This retrospective, population-based cohort study based on three statewide administrative databases found that intervention for a failed bioprosthetic SAVR with ViV TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years compared to redo SAVR, but also with higher rates of late mortality and HFH.
With its reliance on administrative data (without access to the type and size of the original and the redo valve prostheses, hemodynamic and other echocardiographic data, or medical management after intervention), it is difficult to be certain whether the findings reflect differences in outcomes based only on the interventional procedure or the presence of residual confounders (including baseline differences between treatment groups, referral bias, selection bias, treatment bias, and patient preference) not addressed by propensity matching. As the authors note, there is a need for prospective, randomized trials to compare outcomes after ViV TAVR compared to redo SAVR.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and VHD
Keywords: Cardiac Surgical Procedures, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement
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