Bioprosthetic valve dysfunction less common in TAVR vs. surgery at 5 years
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In a pooled analysis of two trials comparing self-expanding transcatheter aortic valve replacement with surgical AVR, bioprosthetic valve dysfunction was less common with TAVR at 5 years, researchers reported.
The analysis, presented by Steven J. Yakubov, MD, interventional cardiologist and director of the MidWest Cardiology Research Foundation, Riverside Methodist, OhioHealth, at Cardiovascular Research Technologies, included 2,099 patients (mean age, 81 years; 55% men) who received TAVR with a self-expanding valve (CoreValve or Evolut, Medtronic) or surgical AVR in the CoreValve US Pivotal and SURTAVI trials.
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“Long-term bioprosthetic valve performance is a critical consideration when evaluating the durability of TAVR, particularly in younger, low-risk patients with longer life expectancies,” Yakubov said during a presentation. “Limited data exist on the incidence and clinical importance of all components of valve performance after TAVR and surgery from large-scale, multicenter and randomized clinical trials. The objective was to evaluate the incidence, outcomes and predictors of long-term valve performance, as assessed by 5-year bioprosthetic valve dysfunction, in patients undergoing supra-annular, self-expanding TAVR or surgery.”
Bioprosthetic valve dysfunction was defined as structural valve deterioration, characterized as mean gradient increase of at least 10 mm Hg from discharge/30 days to last echocardiogram and at least 20 mm Hg at last echo or new onset/increase of at least moderate intraprosthetic aortic regurgitation; nonstructural valve deterioration, characterized as severe prosthesis-patient mismatch at discharge/30 days or severe paravalvular regurgitation at 5 years; clinical valve thrombosis; or endocarditis according to the modified Duke criteria.
The 5-year rate of bioprosthetic valve dysfunction was 14.2% in the surgery group and 7.8% in the TAVR group (HR = 0.5; 95% CI, 0.38-0.66; P < .001), Yakubov said during the presentation.
The results were driven by lower rates in the TAVR group of structural valve deterioration (HR = 0.46; 95% CI, 0.27-0.68; P = .004) and nonstructural valve deterioration (HR = 0.48; 95% CI, 0.33-0.68; P < .001), Yakubov said, noting that the rate of severe prosthesis-patient mismatch was three times lower in the TAVR group (HR = 0.29; 95% CI, 0.19-0.43; P < .001).
In patients with small annular diameters (< 23 mm), the 5-year rate of bioprosthetic valve dysfunction was 8.6% in the TAVR group and 19.7% in the surgery group (HR = 0.5; 95% CI, 0.38-0.66; P < .001), whereas in patients with larger annular diameters ( 23 mm), the rates were 8.1% in the TAVR group and 12.6% in the surgery group (HR = 0.6; 95% CI, 0.43-0.82; P = .002), he said.
In both the surgery and TAVR groups, patients who had bioprosthetic valve dysfunction at 5 years had worse clinical outcomes — including all-cause mortality, CV mortality and hospitalization for valve disease or worsening HF — than those who did not, he said.
Preprocedural predictors of bioprosthetic valve dysfunction at 5 years included higher body surface area and worse renal impairment, whereas lower risk for bioprosthetic valve dysfunction at 5 years was observed in older patients, men, those with higher baseline left ventricular ejection fraction and higher baseline aortic valve area, according to the researchers.
“The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the only transcatheter valve to demonstrate superior valve performance at 5 years compared with surgery in randomized clinical trials,” Yakubov said during the presentation. “This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes, resulting in a near 1.5-fold increased risk for death and hospitalization for valve disease or worsening heart failure.”
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Yakubov SJ, et al. Late-Breaking Trials | Session Three. Presented at: Cardiovascular Research Technologies; Feb. 25-28, 2023; Washington, D.C.
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