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Transcatheter Valve Repair for Mitral Regurgitation
Study Questions:
What are the 30-day outcomes among patients under transcatheter mitral valve repair using the PASCAL transvenous leaflet repair device?
Methods:
Eligible patients had grade 3+ or 4+ mitral regurgitation (MR) despite optimal medical therapy, ejection fraction (EF) >30%, New York Heart Association (NYHA) class III/IV symptoms, and noncommissural primary MR and no secondary jet. The primary efficacy endpoint was procedural and clinical success (one device deployed and delivery system retrieved, MR reduction <2+, and no other surgical intervention post-procedure). The primary safety endpoint was major adverse event (MAE) rate at 30 days (cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications).
Results:
A total of 62 patients were enrolled. Mean age was 76.5 years and 51.6% of patients were in NYHA class III/IV with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5% with all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in NYHA class I/II (p < 0.0001).
Conclusions:
The PASCAL mitral repair system shows short-term feasibility and safety as a treatment choice for a select group of patients with severe MR on optimal medical therapy.
Perspective:
The CLASP study is the first clinical study using the PASCAL repair system and shows feasibility and safety of the device among patients with mixed etiology, severe MR on optimal medical therapy. Patients had significant reduction in quantity of MR (86% had ≤1% MR at 30 days) and notable functional improvement. Adverse event rates were low and procedural success rate was 95%. Pending long-term outcome data, these results suggest that the PASCAL device may be another option for percutaneous treatment of MR.
Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Cardiology Interventions, Heart Failure, Heart Valve Diseases, Hemorrhage, Mitral Valve, Mitral Valve Insufficiency, Myocardial Infarction, Stroke Volume
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