Optimizing self-expandable transcatheter heart valve sizing in patients with small sinus of Valsalva

Abstract

Objectives: To evaluate the feasibility and efficacy of transcatheter aortic valve replacement (TAVR) in patients with small sinus of Valsalva (SOV).

Background: Patients with small SOV are considered unfavorable for TAVR since it carries risk of coronary obstruction after valve implantation. Therefore, these patients with small SOV were excluded from previous clinical trials.

Methods: Between February 2017 and February 2019, a total of 139 consecutive patients with severe aortic stenosis (AS) undergoing TAVR were prospectively enrolled in the Tokai Valve Registry. Patients with small SOV who were treated with smaller size of self-expandable transcatheter heart valve (THV) than expected by perimeter-based sizing were included in this study. Eleven patients (7.9%) were included.

Results: Mean age was 86.5 ± 3.8 years and median STS Score was 8.5% (interquartile range: 6.3-12.3%). Device success was accomplished in all patients and no coronary obstruction was observed. No moderate/severe paravalvular leakage, new onset conduction disturbance, and new permanent pacemaker implantation were noted. At 30-day follow-up, mean aortic valve gradient was 6.9 ± 1.7 mmHg and mean indexed aortic valve area was 0.95 ± 0.16 cm² /m² . Prosthetic valve performance was stable at 12-month follow-up. No severe prosthesis patient mismatch was documented at any time point. No in-hospital, 30-day, and 12-month mortality were observed. The median follow-up was 711 days (IQR: 547-803 days), and no patient was lost to follow-up.

Conclusions: Our preliminary experience suggests favorable safety and efficacy of TAVR utilizing self-expandable THV with intentional down-sizing in patients with severe AS and small SOV in a mid-term follow-up.

Keywords: aortic stenosis; coronary obstruction; transcatheter aortic valve replacement.