1-Year Outcomes of PT-Valve for Pulmonary Regurgitation in Native Outflow Tract

Abstract

Background

Severe pulmonary regurgitation (PR) in patients with postoperative congenital heart disease is often accompanied by extensive variability of right ventricular outflow tract (RVOT) anatomy, which limited the wide application of existing transcatheter pulmonary valves device.

Objectives

This study sought to evaluate 1-year safety and efficacy of the PT-Valve in the treatment of PR patients presenting with native RVOT from a multicenter, single-arm clinical trial.

Methods

We enrolled 130 patients of moderate or greater PR. One-year clinical outcomes are reported.

Results

Within the cohort (mean age 30 ± 16 years; 52% men), 124 (95%) were diagnosed with tetralogy of Fallot. The procedure success rate was 98.5%. Early explants occurred to 2 device malpositions and 1 pulmonary branch obstruction. At 1 year, there were no procedure- or device-related mortality. Device-related adverse events included 2 arrhythmias, 1 pulmonary thromboembolism, 2 endocarditis, and 1 vascular access complication. Echocardiography examinations showed that 125 (99%) patients had none/trace and mild PR, and no greater than mild paravalvular leak at 1-year visit. The mean peak pulmonary gradient was 20.0 ± 17.4 mm Hg and 16.0 ± 7.8 mm Hg at baseline and 1 year after implantation, respectively. The right ventricular end-diastolic volume index was reduced from 176.3 ± 28.4 mL/m² at baseline to 121.1 ± 20.7 mL/m² at 1 year (P < 0.001).

Conclusions

The PT-Valve demonstrated a high success rate of implantation and favorable safety and efficacy in the treatment of PR through 1 year. This device is anatomically suitable for more than 90% of PR patients with native RVOT. (Prospective, Single Arm, Multi-Center Clinical Study on the Safety And Efficacy of the Sterile Transcatheter Pulmonary Valve and Delivery System; ChiCTR2100043367)