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.
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