Implantation of a specially designed transcatheter aortic valve replacement (TAVR) system is feasible and safe in patients with pure aortic regurgitation (AR), with no deaths and only one person needing a permanent pacemaker, a pilot first-in-human study shows.
The Pioneer system (KOKA Lifesciences), a self-expanding pericardial TAVR system designed specifically for the treatment of patients with pure AR, has three controllable locators that help align valves depending on individual anatomy and avoid coronary obstruction.
The study included 10 patients with pure severe AR (four men and six women), mean age 72.5 years, who underwent transfemoral TAVR with the new system at West China Hospital, Chengdu, People’s Republic of China, between January and April 2023.
The mean Society of Thoracic Surgeons score among the 10 patients was 9.7%, and 90% had type 2 bicuspid aortic valve.
The mean procedure duration was 42.0 minutes, the mean intensive care unit stay was 1.3 days, and the mean length of hospital stay was 8.8 days.
None of the patients had died by the 30-day follow-up, and only one patient (10%) had a permanent pacemaker implanted because of complete left bundle branch block (the authors stress that the cohort size is too small to provide detailed analysis regarding need for a permanent pacemaker).
There were no other adverse events, including no myocardial infarctions or hospitalizations for heart failure, and all patients were in New York Heart Association functional class II or lower.
At 30 days, the mean gradient was 10.5 mm Hg, and only one patient had mild paravalvular leak, which the authors write suggests “excellent” hemodynamic performance of the valve.
“The present first-in-human study suggests that the implantation of this novel TAVR system is feasible and safe,” the authors conclude, adding that short-term outcomes “were excellent,” with no mortality, and only one patient receiving a permanent pacemaker.
The study was carried out by Lulu Liu, MD, West China Hospital/West China School of Medicine, Chengdu, People’s Republic of China, and colleagues. It was published online October 4, 2023 as a Research Letter in JACC: Cardiovascular Interventions.
Definitive conclusions regarding study outcomes should not be overinterpreted because the sample size was small; a large multicenter clinical trial is being designed to further assess the mid-term safety and efficacy of this TAVR system.
This study was supported in part by the National Research Foundation of Nature Science, People’s Republic of China, and the 1.3.5 Project for Disciplines of Excellence, West China Hospital, Sichuan University. The authors have no relevant conflicts of interest.
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