FRANCE-TAVI: In retrospective study, balloon-expandable TAVR valves safer than self-expanding
PHILADELPHIA — Balloon-expandable transcatheter aortic valves were associated with less paravalvular regurgitation and mortality compared with self-expanding valves, according to the FRANCE-TAVI retrospective study presented at the American Heart Association Scientific Sessions.
The researchers reviewed data from 12,141 patients (mean age, 84 years; 49% men) from the FRANCE-TAVI nationwide registry who underwent TAVR with a balloon-expandable valve (Sapien family of products, Edwards Lifesciences) or a self-expanding valve (CoreValve family of products, Medtronic) between 2013 and 2015. Since the time of the study, newer generations of both devices have come on the market, Eric Van Belle, MD, PhD, from the department of cardiology, Centre Hospitalier Régional Universitaire Lille in France, said during a presentation.
For the analysis, the researchers used 25 clinical, anatomical and procedural variables as well as date of procedure to match 3,910 patients who received a balloon-expandable valve with 3,910 patients who received a self-expanding valve. The results were simultaneously published in Circulation.
The first coprimary outcome of moderate or worse paravalvular regurgitation and/or in-hospital mortality was higher in the self-expanding group compared with the balloon-expandable group (19.8% vs. 11.9%; RR = 1.68; 95% CI, 1.46-1.91), Van Belle said during the presentation, noting the self-expanding group had higher incidence of both moderate or worse paravalvular regurgitation (15.5% vs. 8.3%; RR = 1.9; 95% CI, 1.63-2.22) and in-hospital mortality (5.6% vs. 4.2%; RR = 1.34; 95% CI, 1.07-1.66).
The second coprimary outcome of 2-year mortality was also higher in the self-expanding group (29.8% vs. 26.6%; RR = 1.17; 95% CI, 1.06-1.29), Van Belle said.
A sensitivity analysis of the entire cohort using inverse probability of treatment weighting did not change the results, he said.
The self-expanding group also had higher incidence of the following in-hospital outcomes: use of a second transcatheter heart valve (RR = 3.79; 95% CI, 2.4-5.99), MI (RR = 2.07; 95% CI, 1.11-3.88) and permanent pacemaker implantation (RR = 2.08; 95% CI, 1.83-2.35), although its median mean gradient was lower than that of the balloon-expandable group (7 mm Hg vs. 10 mm Hg), according to the researchers.
At 2 years, CV mortality was higher in the self-expanding group (23.3% vs. 20.9%; HR = 1.18; 95% CI, 1.03-1.32), driven by events in the first 3 months, Van Belle said.
The differences in the first coprimary outcome were stronger in those who had transfemoral TAVR compared with those who had other access approaches (P for heterogeneity = .004) and in those who had their procedure in 2015 compared with those who had it in 2013 or 2014 (P for heterogeneity = .006), he said.
In a sensitivity analysis of patients treated in 2015, mortality was higher in the self-expanding group at 2 years (17.2% vs. 13.3%; P = .005), he said.
Moderate or worse paravalvular regurgitation predicted mortality in the overall cohort (HR = 1.41; 95% CI, 1.23-1.6), the self-expanding valve cohort (HR = 1.38; 95% CI, 1.15-1.65), the balloon-expandable valve cohort (HR = 1.34; 95% CI, 1.11-1.62), according to the researchers.
“These results suggest that the two most widely used transcatheter heart valve designs may not achieve the same clinical outcomes,” Van Belle said during the presentation. “The present study strongly supports conducting a randomized trial powered to compare head-to-head the most recent iterations of self-expanding and balloon-expandable valves on all-cause mortality.”
“While it seems obvious that a significant proportion of patients can probably be safely treated with either a balloon-expandable valve or a self-expanding valve, we cannot advocate that both device types are equal and can always be used interchangeably,” Holger Thiele, MD, interventional cardiologist at Heart Center Leipzig at the University of Leipzig in Germany, and Mohamed Abdel-Wahab, MD, consultant cardiologist and head of the department of structural heart disease at Heart Center Leipzig, wrote in a related editorial in Circulation. “This is surely different than the coronary stent business.” – by Erik Swain
Van Belle E, et al. Late Breaking Science III: Controversies in Contemporary Management of AS. Presented at: American Heart Association Scientific Sessions; Nov. 16-18, 2019; Philadelphia.
Disclosures: Van Belle, Thiele and Abdel-Wahab report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.