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Complex Transcatheter Edge-to-Edge Mitral Repair
Quick Takes
- A high implant success rate and an adverse event rate comparable to prior M-TEER studies was seen using the PASCAL system in high-risk degenerative MR patients with complex mitral valve anatomy.
- Furthermore, significant MR reduction was achieved at 6 months, as assessed by the echocardiographic core laboratory, with symptomatic improvement.
- Additional prospective studies of larger patient populations are needed to characterize patients most likely to benefit from this procedure given limitations of the current analysis.
Study Questions:
What are the clinical outcomes with the PASCAL system in prohibitive-risk patients with significant symptomatic degenerative mitral regurgitation (DMR) and complex mitral valve anatomy?
Methods:
The investigators conducted the PASCAL IID registry, which assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive-risk patients with significant symptomatic DMR and complex mitral valve anatomy. Patients in the prospective, multicenter, single-arm registry had grade 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. Kaplan-Meier estimates were used to analyze time-to-event variables, and the exponential Greenwood method was used to calculate SE.
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% of 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 authors report that the outcomes of this registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy.
Perspective:
This prospective multinational registry to evaluate mitral valve transcatheter edge-to-edge repair (M-TEER) outcomes using the PASCAL system in high-risk DMR patients with complex mitral valve anatomy reports a high implant success rate in this group and an adverse event rate comparable to prior M-TEER studies. Furthermore, significant MR reduction was achieved at 6 months, as assessed by the echocardiographic core laboratory, with symptomatic improvement. Of note, the limited sample size and lack of blinding to treatment preclude meaningful analysis correlating specific anatomic characteristics to treatment outcomes. Additional prospective studies of larger patient populations with complex mitral valve anatomies are needed to characterize patients most likely to benefit from this procedure.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation
Keywords: Cardiac Surgical Procedures, Echocardiography, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Mitral Valve Insufficiency, Mitral Valve Prolapse, Quality of Life, Risk, Treatment Outcome
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