In the largest propensity-score-matched comparison to date of patients who underwent valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) and those who underwent redo surgical aortic valve replacement (SAVR) for degenerated bioprostheses, ViV-TAVR was associated with a lower rate of all-cause mortality at 30 days but similar long-term mortality.
Bioprosthetic aortic valves are frequently favored over mechanical valves in SAVR despite durability issues. Over time, the risk of valve degeneration increases, with many patients requiring re-intervention. Until recently, that would often require redo SAVR, which is associated with high morbidity and mortality. With the advent of TAVR, patients with prior SAVR now have a minimally invasive alternative with acceptable short-term outcomes.
In this study, Pierre Deharo, PhD, of CHU Timone and Aix-Marseille University, France, and co-investigators compared short- and long-term outcomes in patients undergoing ViV-TAVR to those undergoing redo SAVR for the treatment of degenerated aortic bioprostheses. They used the French Programme de Médicalisation des Systèmes d' Information (PMSI) database, which tracks all TAVR and SAVR performed in France.
Deharo and colleagues reported their findings in a manuscript published in the Aug. 4 issue of the Journal of the American College of Cardiology, which was posted online Monday.
This was a longitudinal cohort study from 2010 through 2019 of 4,327 patients with prior bioprosthetic SAVR who underwent either ViV-TAVR (n=2,554) or redo SAVR (n=1,773) in France. Outcomes of interest included all-cause death, cardiovascular death, all-cause stroke, rehospitalization for heart failure, myocardial infarction, major or life-threatening bleeding, new-onset atrial fibrillation, and pacemaker implantation. The authors retrospectively compared 1,434 patients who underwent either ViV-TAVR (n=717) or redo SAVR (n=717) using propensity-score matching.
Unmatched ViV-TAVR patients were older men with more co-morbidities than those who underwent redo SAVR. Propensity-score-matched patients who underwent ViV-TAVR had a lower mortality rate at 30 days (3.6%) than patients who underwent redo SAVR (7.3%) (odds ratio [OR], 0.48; 95% confidence interval [CI], 0.30-0.78). New-onset atrial fibrillation was less common in patients who underwent ViV-TAVR (0.6%) than in patients who underwent redo SAVR (4.0%) (OR, 0.13; 95% CI, 0.05-0.38). Permanent pacemaker implantation was more common in patients who underwent ViV-TAVR (16.7%) than in patients who underwent redo SAVR (4.6%) (OR, 4.20; 95% CI, 2.91-6.07). Rates of stroke, myocardial infarction, or major bleeding did not differ between the groups. The composite of major clinical events was lower in patients who received ViV-TAVR (8.2%) than in those who underwent redo SAVR (12.6%) (OR, 0.62; 95% CI, 0.44-0.88).
The mean follow-up in these matched patients was 794 days. All-cause mortality did not differ between patients who received ViV-TAVR (10.9%) and those who received redo-SAVR (9.5%) (OR, 1.14; 95% CI, 0.91-1.44). Additional outcomes examined during 30-day follow-up also did not differ at long-term follow up.
Michael A. Borger, MD, PhD, of the Leipzig Heart Center, Germany, and colleagues wrote an accompanying editorial to the study. They acknowledge the growing number of patients with failed bioprostheses worldwide. They state that traditional redo SAVR is fraught with complications in both the short and long term. Over the last decade, TAVR has become a feasible, less-invasive option for patients with failed bioprosthetic SAVR, and several retrospective studies demonstrate improved short-term outcomes compared to redo SAVR.
This study reinforces results from prior retrospective studies, but the editorialists are quick to point out that all the available data, including this study, are retrospective. Despite propensity-score matching, other confounders, such as selection bias for one particular treatment based on anatomy or clinical characteristics, can impact the integrity of the conclusions. Additionally, follow-up in this study may not have been long enough, as the composite outcome survival curves appear to cross during follow-up favoring redo SAVR, although this did not reach statistical significance. The same has been demonstrated in smaller retrospective studies. Borger and colleagues speculate that this higher mortality in the long term may be due to patient-prosthesis mismatch, a phenomenon that appears to occur more commonly in patients receiving ViV-TAVR.
Despite numerous retrospective studies, a multicenter randomized clinical trial is needed to clarify the ideal treatment for patients with failed aortic bioprostheses.
“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,” Borger and colleagues conclude.
Deharo P, Bisson A, Herbert Julien, et al. Transcatheter Valve-in-Valve Aortic Valve Replacement as an
Alternative to Surgical Re-Replacement. J Am Coll Cardiol 2020;76:489-99. DOI: 10.1016/j.jacc.2020.06.010
Borger MA, Raschpichler M, Makkar R. Repeat Aortic Valve Surgery or Transcatheter Valve-in-Valve Therapy: We Need a Randomized Trial. J Am Coll Cardiol 2020;76:500-2. DOI: https://doi.org/10.1016/j.jacc.2020.06.049