One of the current challenges in TAVR is bicuspid aortic valves (BAV), because of their anatomical complexity, calcification, raphe presence, aortic dilation and associated calcification, large annuli and BAV type, according to Sievers classification.
Several studies have shown inconsistent results, mainly because they were conducted using first generation valves and less experienced operators, compared to present operator capabilities and current more advanced devices, better adapted for these cases.
This was an observational, retrospective, multicenter, international study carried out between 2016 and 2023, including 955 patients with Sievers type 1 BAV, defined using AngioCT.
Choosing the type of valve, be it balloon-expandable (BEV) used in 421 patients (44%) or self-expanding (SEV), was left to operator criteria.
The primary end point was a composite of all-cause death, neurological events and hospital readmission for cardiac failure, according to VARC-3 criteria, at long term.
Seeing as the groups were not homogeneous, patients were matched using propensity score, which resulted in 301 patients in each group.
Mean patient age was 78, with 2.5% STS. 63% were men, 70% presented hypertension, 18% diabetes, 6% prior pacemaker, 35% heart disease, 26% atrial fibrillation, 8% peripheral vascular disease and 17% COPD. Mean glomerular filtration was 65 ml/min/m².
On EKG, 17% presented first degree atrioventricular block, 8% right bundle branch block, and another 8% left bundle branch block.
Ejection fraction was preserved with 0.7 cm² AVA and 47 mmHg mean gradient.
CT scans did not show differences in asymmetry, raphe location, annulus diameter or area, or calcifications.
Technical implantation success resulted similar in both groups (95%).
At 30 days, there were no differences in all-cause mortality (1% in both groups, p=0.928) or neurological events (3.5% vs. 3.4%, p=0.721). However, the need for pacemaker implantation was higher in the SEV group (18.2% vs. 9.1%, p=0.002), as was the presence of moderate or greater paravalvular regurgitation (8.8% vs. 1.7%, p=0.001). On the other hand, BEV presented higher prosthetic mismatch (5.4% vs. 1.7%, p=0.045). As regards AVA, it was higher with SEV, and mean gradient was lower. There were no significant differences in bleeding events.
Mean follow-up was 1.3 years (range: 0.6 to 4 years). There were no differences in primary end point (15.7% vs. 20.3%; HR: 0.75; CI 95%: 0.49-1.16; p=0.200) between BEV and SEV. No significant differences were observed in all-cause mortality (10.8% vs. 14.8%; p=0.372), cardiovascular mortality (4.9% vs. 6.4%; p=0.491), neurological events (4.5% vs. 5.1%; p=0.442) or rehospitalization for cardiac failure (2.4% vs. 2.7%; p=0.844).
Conclusion
This generation BEV and SEV presented similar technical success and efficacy at mid-term in the treatment of Sievers 1 bicuspid valves. Compared against SEV, BEV were associated to lower need for pacemaker implantation and lower moderate or greater paravalvular regurgitation, even though they presented more prosthetic mismatch.
Original Title: Balloon-Expandable vs Self-Expanding Valves for Transcatheter Treatment of Sievers Type 1 Bicuspid Aortic Stenosis.
Reference: Andrea Buono, et al. ARTICLE IN PRESS. JACC Cardiovasc Interv. 2024.
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