Transcatheter Leaflet Repair System for Tricuspid Regurgitation
- Transcatheter leaflet repair for tricuspid regurgitation (TR) is safe and effective in reducing TR severity and improving symptoms in patients with severe TR.
- Sustained reduction in TR was noted in most patients (78%) on echocardiographic follow-up in 3-6 months.
- Early real-world experience is consistent with previously published trial data for transcatheter leaflet tricuspid valve repair for severe TR.
What is the safety and efficacy of transcatheter leaflet repair for tricuspid regurgitation (TR) using the PASCAL and PASCAL Ace device?
This study used a retrospective observational multicenter European registry of patients undergoing implantation of the PASCAL and PASCAL Ace device for transcatheter tricuspid valve (TV) edge-to-edge repair. This is the first report of real-world use in 235 high-risk surgical patients (mean Society of Thoracic Surgeons Risk of Mortality score of 8.6%) since commercial approval of the device in 2019.
Mean age was 78 years and 49% were women. Etiology for TV TR was functional in the majority (87%) of patients. Most patients received 1-2 devices (91%). While early procedural success is reported at 98%, sustained reduction in TR to ≤2 was only noted in 78% on echocardiogram follow-up at approximately 6 months. This reduction in TR coincided with favorable right heart remodeling and symptom improvement (63% were New York Heart Association class I or II). Device failure occurred in 11 patients (6%), of which device embolization occurred in one patient. Overall, 30-day mortality was 2%, four patients underwent redo TV edge-to-edge repair, one underwent direct annuloplasty, and one underwent TV replacement.
In early clinical experience, TV edge-to-edge repair using the PASCAL system appears to be safe and effective.
PASCAL is yet another promising tool in a growing toolkit of transcatheter therapies for right heart disease. While TV disease is widely prevalent, it often co-exists with other valvular disorders and pulmonary vascular disease. The evolving landscape of TV interventional therapies will have to account for interplay amongst these different pathologies. TV repair and replacement continue to evolve, and future work will be critical to refine patient selection and allocation of correct technology to the correct pathology in such patients.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, 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
Keywords: Cardiac Surgical Procedures, Cardiac Valve Annuloplasty, Echocardiography, Embolization, Therapeutic, Geriatrics, Heart Failure, Heart Valve Diseases, Transcatheter Aortic Valve Replacement, Tricuspid Valve Insufficiency, Vascular Diseases
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