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Outcomes of Transcatheter Pulmonary SAPIEN 3 Valve Implantation
Quick Takes
- Transcatheter pulmonary valve implantation with the SAPIEN 3 is associated with a high procedural success rate of 98.5%.
- The rates of endocarditis and pulmonary valve replacement at 6 years were 3.8% and 8%, respectively.
Study Questions:
What are the outcomes of transcatheter pulmonary valve implantation (TPVI) with the SAPIEN 3 valve in patients with right ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD)?
Methods:
An international, multicenter, registry-based study was performed utilizing the EUROPULMS3 registry. Patient-related, procedural, and follow-up outcome data from 35 centers in 15 countries were retrospectively assessed.
Results:
Data for 840 consecutive patients undergoing procedures from 2014–2021 at a median age of 29.2 years were obtained and analyzed. The underlying diagnosis was conotruncal defect in 70.5% of patients, with 50.7% of patients with native or patched RVOT. Valve implantation was successful in 98.5%. The median follow-up was 20.3 (7.1-38.4) months. Infective endocarditis occurred in eight patients, pulmonary valve replacement was required in 11 patients with a lower incidence in those with larger valves, and valve thrombosis in four patients. Cumulative incidences 1, 3, and 6 years after TPVI were endocarditis, 0.5%, 0.9%, and 3.8%; pulmonary valve replacement 0.4%, 1.3%, and 8%; and pulmonary valve thrombosis, 0.4%, 0.7%, and 0.6%, respectively.
Conclusions:
The authors conclude that outcomes of SAPIEN 3 TPVI were favorable in patients with CHD, half of whom had native or patched RVOTs.
Perspective:
This study assessed outcomes for transcatheter pulmonary valve replacement with the SAPIEN 3 valve. The study included a large proportion (approximately half) of patients with native or patched RVOT, as opposed to those with existing conduits or bioprosthetic valves. The rate of serious complications was 3.9%, which included death in 0.6%. These rates are low but not insignificant. The rate of endocarditis of 3.8% compares favorably with previous transcatheter pulmonary valve studies. The study demonstrates that the SAPIEN 3 is an effective option for patients with a variety of RVOT sizes and morphologies (both native and those after intervention).
Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and CHD and Pediatrics, Congenital Heart Disease, CHD and Pediatrics and Interventions, Interventions and Structural Heart Disease
Keywords: Heart Defects, Congenital, Pulmonary Valve, Transcatheter Aortic Valve Replacement
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