Edge-To-Edge Treatment with PASCAL: Are There Sex-Specific Differences?

Mitral regurgitation (MR) is a common valve disease associated with heart failure, hospitalizations, and mortality. 

In women, it is often overlooked and some analyses have linked it to less favorable outcomes after surgical valve repair.

Mitral transcatheter edge-to-edge repair (M-TEER) has been shown safe and effective in high-risk patients, with favorable results at follow-up. However, available data comparing women vs men’s outcomes remain limited.

A CLASP IID analysis included patients with inoperable symptomatic degenerative MR grade 3+ or 4+. A total of 294 patients were analyzed, and 102 were women. PASCAL or PASCAL ACE devices were used. Major adverse events (MAE) were defined as the composite of cardiovascular death, myocardial infarction, stroke, need for dialysis, severe bleeding, and reintervention (percutaneous or surgical).

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Mean population age was 81. The STS risk was 4% for repair and 5% for replacement. Hypertension prevalence was 88%, diabetes 13%, renal insufficiency 37%, peripheral vascular disease 7%, and COPD 34%. Coronary artery disease and prior PCI were more common in men.

MR was 4+ in 75% of cases, with effective regurgitant orifice area (EROA) 0.45 cm², 70 ml regurgitant volume, and 0.65 cm²vena contracta.

Implantation success rate was 99%. The number of implanted devices was lower in women (1.4 vs. 1.6; p=0.009), while men more frequently received two or three devices.

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At 30 days, there were no differences in MAE (5% in women vs. 9% in men), nor in cardiovascular death, myocardial infarction, stroke, need for dialysis, severe bleeding, or reintervention. During the same period, a significant reduction in MR was observed in both groups: 97% had MR ≤2+ and 85% had MR ≤1+, with low gradients.

At 1-year follow-up, there were also no differences in MAE (14%) or cardiovascular mortality (5%), or other events, reintervention, or rehospitalization, which remained low in both groups. Freedom from death was 92.1% in women and 90.9% in men (p=0.754), while freedom from heart failure hospitalization was 91.7% and 94.4% respectively (p=0.366).

MR reduction remained stable in both groups, with 95% of patients having MR ≤2+ and 75% MR ≤1+, with mean gradient of 4 mmHg. In addition, there was a significant reduction in left ventricular end-diastolic and end-systolic volumes, decreased pulmonary artery systolic pressure and left atrial diameter, and increased left ventricular stroke volume. These echocardiographic improvements translated into better functional class and quality of life for both women and men.

Conclusión

This CLASP IID Study showed women and men treated with transcatheter mitral edge-to-edge repair high 1-year survival had low incidence of major adverse events and rehospitalization for heart failure together with improved echocardiographic, functional, and quality-of-life. These results confirm that women achieve effective and safe outcomes comparable to men’s, with contemporary mitral edge-to-edge repair.

Original Title: Sex-Specific Outcomes of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation: Results From the CLASP IID Trial. 

Reference: Molly Szerlip, et al Journal of the Society for Cardiovascular Angiography & Interventions 4 (2025) 103713.