VIV TAVR or Repeat Aortic Valve Surgery? Research Shows More Randomized Trials Needed
Valve-in-valve (VIV) TAVR may be associated with better short-term outcomes than redo SAVR for failed surgically implanted bioprosthetic aortic valve, according to a study published July 27 in the Journal of the American College of Cardiology. However, major cardiovascular outcomes may not be different between the two treatments during long-term follow-up.
Pierre Deharo, PHD, et al., analyzed the outcomes of VIV TAVR vs. redo SAVR at a nationwide level in France. Based on the French administrative hospital-discharge database, the study collected information from 4,327 patients treated for aortic bioprosthesis failure with isolated VIV TAVR or redo SAVR between 2010 and 2019. After propensity-score matching, there were 717 patients in each group.
Results showed that at 30 days, VIV TAVR was associated with lower rates of the composite of all-cause mortality, all-cause stroke, myocardial infarction, and major or life-threatening bleeding (odds ratio, 0.62; 95% confidence interval [CI], 0.44 to 0.88; p=0.03).
However, during a median follow-up of 516 days, the combined endpoint of cardiovascular death, all-cause stroke, myocardial infarction or rehospitalization for heart failure was not different between the two groups (odds ratio, 1.18; 95% CI, 0.99 to 1.41; p=0.26).
Furthermore, the researchers found that rehospitalization for heart failure and pacemaker implantation were more frequently reported in the VIV TAVR group. The researchers also reported a time-dependent interaction between all-cause and cardiovascular mortality following VIV TAVR.
"Randomized trials are needed to determine the optimum approach to degenerated surgically implanted aortic valve bioprostheses, but the continued evolution of TAVR technology is likely to influence the comparative outcomes," the researchers conclude.
In a related editorial comment, Michael A. Borger, MD, PHD, et al., note that "when two therapy options exist with markedly different hazard functions, properly designed prospective randomized trials are mandatory in order to guide clinical decision making."
They add, "Whether there is enough clinical equipoise within the cardiovascular community to perform a randomized trial comparing redo SAVR with VIV with adequate follow-up is arguable. However, the available data suggest that we would serve our patients best with such a randomized trial, particularly in younger, lower-risk patients presenting with failed aortic bioprostheses."
Keywords: Bioprosthesis, Propensity Score, Aortic Valve, Decision Making, Patient Discharge, Prospective Studies, Transcatheter Aortic Valve Replacement, Myocardial Infarction, Stroke, Heart Failure, Hemorrhage
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