Repeat transcatheter aortic valve replacement (TAVR) for the treatment of failed TAVR appears to be safe, with 100% procedural success and overall low rates of all-cause mortality and stroke, at 1-year follow-up, according to study results presented Saturday at the TCT Connect virtual conference.
The long-term durability of TAVR remains in question. While clinicians wait for 10-year follow-up data from the pivotal low-risk TAVR trials, available data have been encouraging so far. As the number of patients receiving TAVR increases, so will the number of failed bioprostheses over time.
When TAVR valves fail, most patients are at prohibitive surgical risk and undergo subsequent TAVR. Outcomes in valve-in-valve (ViV) TAVR for the treatment of failed TAVR valves remain unclear.
Luca Testa, MD, PhD, of Vita-Salute San Raffaele University, Milan, presented results from the TRANSIT (Transcatheter aortic valve replacement for failed transcatheter aortic valves) trial Saturday at TCT. The TRANIST trial was an international registry of patients undergoing a second TAVR for the treatment of degenerated bioprostheses.
The investigators screened high-risk patients who had received their first TAVR as early as 2008. Included were 172 patients who received a second TAVR in 2020. Of these patients, 57 had bioprosthetic stenosis, 97 had bioprosthetic regurgitation, and the remaining 18 had mixed bioprosthetic disease. Time to bioprosthetic failure was 1,343 days with the Edwards SAPIEN valve, 1247 days for the Direct Flow valve, 1,038 days with the LOTUS valve, 996 days for the CoreValve Evolut R, 989 days in the Acurate neo and 289 daysfor the PORTICO valve.
Procedural success was achieved in 100% of patients, with 91.9% undergoing transfemoral TAVR. With regard to complications, one patient had an annular rupture, requiring emergent surgery, and three had major vascular complications.
At 1 year, the rate of all-cause mortality was 10%, hospitalization for heart failure was 11%, myocardial infarction was 1.2% and valve thrombosis was 1.4%. These outcomes did not differ between type of bioprosthetic failure.
Stroke at 1 year occurred in 3.5% of patients with bioprosthetic stenosis, 1.8% of patients with bioprosthetic regurgitation and 16.7% of patients with mixed bioprosthetic disease (p=0.006). Overall, these represent very low clinical event rates, suggesting that there is clinical benefit of repeat TAVR in these patients, who would otherwise would not have had other options.
Testa concluded that the results of this study are encouraging.
For younger patients receiving TAVR going forward who develop bioprosthetic failure, the message, he said, is, “We can do it again, safely and effectively.”