The PULSTA transcatheter pulmonary valve achieved 98.3% procedural success, with 93.8% having mild or less pulmonary regurgitation at 4.1 years and 98.2% freedom from reintervention at 5 years.
Does the PULSTA self-expanding transcatheter pulmonary valve improve hemodynamics and maintain safety in patients with right ventricular outflow tract dysfunction?
The PULSTA transcatheter pulmonary valve demonstrates high procedural success, durable valve function, and sustained hemodynamic benefits at a median follow-up of 4.1 years.
p-value: p=<0.001
BACKGROUND: Patients with congenital or acquired right ventricular outflow tract dysfunction frequently require pulmonary valve replacement and are exposed to repeated surgical interventions due to prosthetic valve degeneration. The PULSTA self-expanding transcatheter pulmonary valve was designed to address a broad spectrum of native and surgically repaired right ventricular outflow tract anatomies. This study reports the midterm safety, hemodynamic performance, and durability outcomes of the prospective, multinational PULSTA CE approval trial (PULSTA Carpentier Edwards). METHODS: This premarket, multicenter, nonrandomized study enrolled 58 patients across 11 centers in 6 countries. Successful PULSTA implantation was achieved in 57 patients (98.3%), including 4 valve-in-valve procedures. Patients were followed for a median duration of 4.1 years. Primary end points included procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function. RESULTS: <0.001). Valve performance remained stable throughout follow-up, with 93.8% of patients exhibiting mild or less pulmonary regurgitation at 4.1 years. Freedom from reintervention was 98.2% at 5 years. One patient required a PULSTA-in-PULSTA implantation due to paravalvular leakage, and one case of infective endocarditis was successfully managed with antibiotic therapy. No stent fractures or structural valve deterioration were observed. CONCLUSIONS: The PULSTA transcatheter pulmonary valve demonstrated high procedural success, durable valve function, and sustained hemodynamic benefits. Its adaptability to diverse right ventricular outflow tract anatomies and favorable safety profile supports its role as an effective therapeutic option for patients with right ventricular outflow tract dysfunction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03983512.
Lee et al. (Thu,) conducted a other in Right ventricular outflow tract dysfunction (n=58). PULSTA self-expanding transcatheter pulmonary valve was evaluated on Procedural or device-related serious adverse events, hemodynamic improvement, and sustained valve function (p=<0.001). The PULSTA transcatheter pulmonary valve achieved 98.3% procedural success, with 93.8% having mild or less pulmonary regurgitation at 4.1 years and 98.2% freedom from reintervention at 5 years.