Alejandro J. Torres

BACKGROUND: The COMPASSION S3 trial (Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional Transcatheter Heart Valve) was designed to evaluate the safety and effectiveness of the SAPIEN 3 transcatheter heart valve (THV) for transcatheter pulmonic valve replacement in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position. Here, 5-year clinical and hemodynamic outcomes for patients in the main cohort and the continued access protocol are reported. METHODS: The COMPASSION S3 trial was a single-arm, multicenter study enrolling patients with either moderate-to-severe pulmonic regurgitation, a mean RVOT gradient ≥35 mm Hg, or both. The primary end point was THV dysfunction at 1 year, a nonhierarchical composite of RVOT reintervention, ≥moderate total pulmonic regurgitation, and mean RVOT gradient >40 mm Hg. Clinical and echocardiographic outcomes were assessed at baseline, discharge, 30 days, 6 months, 1 year, and then annually to 5 years. RESULTS: Between 2016 and 2020, 69 patients were enrolled and successfully implanted with the SAPIEN 3 THV. The mean patient age was 32.1 years, and most patients (70.8%) had a conduit as the most recent prior intervention. At 5 years, the rate of THV dysfunction was 12.0%: 3 patients required reintervention, 2 patients had ≥moderate pulmonic regurgitation, and 1 patient had a mean gradient >40 mm Hg. There were 3 cases of device-related endocarditis (4.4%). One death occurred on postoperative day 560 due to cardiogenic shock. No cases of tricuspid valve injury, stent fractures, or valve malposition were reported. Post-transcatheter pulmonic valve replacement, mean gradients were low and stable through 5-year follow-up. Through 5 years, >95% of patients had ≤mild total pulmonic regurgitation, and 97.9% of patients had none/trace paravalvular regurgitation. CONCLUSIONS: Five-year results from the COMPASSION S3 trial demonstrate that the SAPIEN 3 THV provides durable RVOT relief with low rates of reintervention or endocarditis, supporting the device as a safe and versatile option for transcatheter pulmonic valve replacement across diverse anatomies and clinical scenarios. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02744677.

BACKGROUND: The Alterra Adaptive Prestent provides a landing zone for implantation of the 29 mm SAPIEN 3 transcatheter heart valve (THV) in patients with a dysfunctional right ventricular outflow tract (RVOT) to treat pulmonary regurgitation (PR). Here, we report 3-year outcomes from a pooled analysis of patients who underwent Alterra/SAPIEN 3 THV implantation enrolled in the ALTERRA pivotal trial, Continued Access Protocol, and Pulmonic Delivery System Registry. METHODS: This multicenter, prospective trial enrolled patients with moderate or greater PR and RVOT/pulmonary valve anatomy suitable for implantation. The nonhierarchical composite end point of THV dysfunction was examined at 6 months: RVOT/pulmonary valve reintervention, moderate or greater PR, and mean RVOT/pulmonary valve gradient ≥35 mm Hg. Individual components of the composite, as well as additional clinical and echocardiographic outcomes were examined up to 3 years. RESULTS: The Alterra/SAPIEN 3 THV system was implanted in 118 patients at 14 sites. At 6 months, THV dysfunction was 3.5% (4/113). At 3 years, 97.3% of patients in the valve implant population had freedom from reintervention, 100% of patients had a mean RVOT/pulmonary valve gradients <35 mm Hg, and 93.3% of patients had mild or lesser total PR. The Kaplan-Meier estimate of all-cause mortality was 3.5% at 3 years. There were no cases of coronary artery compression, hemopericardium, or endocarditis. CONCLUSIONS: This analysis reports the longest follow-up in the largest cohort of patients from the ALTERRA trials. The Alterra Adaptive Prestent with the SAPIEN 3 THV system has shown excellent procedural outcomes and is effective in reducing PR at 3-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03130777.