Transcatheter edge-to-edge repair using the PASCAL system in prohibitive surgical risk patients with complex degenerative mitral regurgitation resulted in 92.4% achieving MR ≤2+ at 6 months.
Observational (n=98)
Yes
Does transcatheter edge-to-edge repair with the PASCAL system improve outcomes in prohibitive surgical risk patients with significant symptomatic degenerative mitral regurgitation and complex mitral valve anatomy?
The PASCAL transcatheter edge-to-edge repair system is safe and effective for reducing mitral regurgitation in prohibitive surgical risk patients with complex degenerative mitral valve anatomy.
p-value: p=<0.001
BACKGROUND Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. OBJECTIVES The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. METHODS Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. RESULTS The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001). CONCLUSIONS The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial CLASP IID NCT03706833).
Hausleiter et al. (Mon,) conducted a observational in Degenerative mitral regurgitation (n=98). PASCAL system was evaluated on MR ≤2+ at 6 months (p=<0.001). Transcatheter edge-to-edge repair using the PASCAL system in prohibitive surgical risk patients with complex degenerative mitral regurgitation resulted in 92.4% achieving MR ≤2+ at 6 months.