Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Devices

Background:

• The PASCAL Precision transcatheter valve repair system is a new option for patients with severe degenerative mitral regurgitation (DMR) who are at high risk for surgery.
• Degenerative mitral regurgitation (DMR) significantly impacts patient quality of life and increases morbidity and mortality.

Purpose of the Study:

• To evaluate the early U.S. commercial experience and outcomes of the PASCAL Precision system for DMR treatment.
• To assess the safety and effectiveness of the PASCAL Precision system in a real-world patient population.

Main Methods:

• Analysis of 1,995 patients with DMR treated with the PASCAL Precision system in the U.S. from the STS/ACC TVT Registry.
• Assessment of procedural success, clinical outcomes, echocardiographic results, functional status, and quality of life up to 30 days post-procedure.
• Site-assessed outcomes including echocardiographic evaluations were utilized.

Main Results:

• Successful device implantation in 97.7% of patients.
• Significant reduction in mitral regurgitation (MR) at 30 days: 94.2% achieved ≤moderate MR and 72.6% achieved ≤mild MR.
• Marked improvements in functional status and quality of life, with 84.6% in NYHA functional class I/II and a 21.0-point increase in KCCQ score.
• Low rates of mitral valve reintervention (0.4%), single-leaflet device attachment (0.5%), all-cause mortality (2.2%), cardiovascular mortality (1.2%), and heart failure readmission (2.6%) at 30 days.

Conclusions:

• Early U.S. commercial experience from the STS/ACC TVT Registry demonstrates the safety and effectiveness of the PASCAL Precision system.
• The PASCAL Precision system is a viable treatment option for a diverse population of real-world DMR patients, including those with complex anatomy.
• The findings support the use of the PASCAL Precision system for transcatheter mitral valve repair in high-risk patients.