Transcatheter Pulmonary Valve Implantation With the Alterra Adaptive Prestent and SAPIEN 3 Transcatheter Heart Valve: 3-Year Pooled Outcomes of the ALTERRA Trials.

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.