Patients who received transcatheter aortic valve replacement with a balloon-expandable valve, especially using the transfemoral access route, had low risk for stroke and paravalvular leak and high survival rates at 1 year, according to results presented at EuroPCR.
“These ‘real-world’ outcomes with the SAPIEN 3 valve (Edwards Lifesciences) in a commercial setting continue to support the compelling clinical case for [TAVR], and one again, demonstrate consistency in clinical practice between pivotal studies and global commercial experience,” Olaf Wendler, MD, PhD, FRCS, professor of cardiac surgery at King’s College Hospital in London, said in a press release.
Researchers for the SOURCE 3 study analyzed outcomes in 1,946 patients (mean age, 82 years; 48% women) who received the balloon-expandable valve either through the transfemoral (n = 1,694) or transapical (n = 251) access routes in 80 centers across 10 countries between July 2014 and October 2015. Follow-up occurred 30 days after implantation and annually for 5 years.
At 1 year, patients who underwent TAVR using the transfemoral method had a survival rate of 88.2%. Those in the transfemoral group saw low rates for mortality (11.8% and disabling stroke (1.1%) vs. those in the transapical group (18.5% and 3.6%, respectively).
Among patients who died (n = 245) within 1 year, more than half were CV-related (62%). Among patients who died of a CV cause, the most common cause of death at 30 days was vascular injury (18.8%), while HF (25%) was the most common cause of death between 31 days and 1 year.
Severe paravalvular leak was not observed in both groups, and 2.6% of patients experienced moderate cases. The majority of patients (90%) were in NYHA class I or II at 1 year (P < .001).
“The clinical outcomes of SOURCE 3 highlight the improvements of [TAVR] treatment in general and the SAPIEN 3 [transcatheter heart valve] in particular,” Wendler said in the presentation. “The similarities of 30-day and 1-year outcomes of the global experience may indicate that the present balloon-expandable technology has become less dependent of operator variability.” – by Darlene Dobkowski
Wendler O, et al. TAVI registries and durability – Sessions comprising selected EuroPCR 2017 late-breaking trial submissions. Presented at: EuroPCR; May 16-19, 2017; Paris.
The study was funded by Edwards Lifesciences. Wendler reports consulting for Edwards Lifesciences.