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

Figures

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  Figure 1. Patient Flow in Selection and Follow-Up Period In the patient selection phase, we screened 193 patients with pulmonary regurgitation (PR) with native right ventricular outflow tract (RVOT) initially, and 63 patients were excluded. A total of 130 patients underwent catheterization, and 127 patients remained implanted for more than 1 month. 126 patients completed the 1-year follow-up. TPVR = transcatheter pulmonary valve replacement.

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  Figure 2. Diagram of the PT-Valve The PT-Valve is a porcine pericardial tissue valve mounted on a dumbbell-shaped nitinol frame fully covered by porcine pericardium. The proximal and distal flares are symmetrically identical. The device has 5 sizes. The diameter of the outflow/inflow flare ranges from 28 to 44 mm, and the overall length varies from 38 to 54 mm. The diameter of the valve in the middle portion is 20, 23, or 26 mm, and the length of the valve segment ranges from 10 to 15 mm.

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  Figure 3. The Ideal Result of PT-Valve Implantation Ideally, the PT-Valve is intended to land between the middle plane of the main pulmonary artery (MPA) and the middle right ventricular outflow tract (RVOT), and eventually anchored by distal flare of the stent located in mid-MPA. The main anchoring mechanism relies on the frame suspended at the anatomically narrow ring to sustain the fixation of the device.

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  Figure 4. NYHA Functional Classification at Baseline and 1-Year Follow-Up The NYHA functional classification at 1-year follow-up was significantly improved compared with baseline. Values reported are proportions. P value is calculated from the Stuart-Maxwell test to compare the proportions of NYHA functional classification between preimplant and 1 year. A value of P < 0.05 was considered significant.

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  Figure 5. 1-Year Hemodynamic Outcomes: Echocardiography Assessment Echocardiography assessment of pulmonary regurgitation (A), paravalvular leak (B), peak transpulmonary gradient (C) and tricuspid regurgitation (D) through 1 year. At 1 year, 99% of patients had none/trace and mild pulmonary regurgitation, and no paravalvular leak greater than mild. The average peak transpulmonary gradient was similar to baseline. The proportion of patients with moderate and severe tricuspid regurgitation had decreased. Assessment of pulmonary regurgitation included both central and paravalvular regurgitation. ∗Pulmonary regurgitation grade in this bar is moderate to severe. Values are reported as proportions or mean ± SD. In C, the box is centered around the median, with the mean depicted by a blue cross. Upper and lower bounds of the box represent the IQR. Whiskers represent the minimum and maximum.

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  Figure 6. 1-Year Paired CMR Data Pulmonary regurgitation (PR) fraction (A), right ventricular end-diastolic volume index (RVEDVI) (B), and right ventricular ejection fraction (RVEF) (C) at baseline and 1 year. Available data from 37 patients were reported. CMR data showed significant reductions in PR fraction and RVEDVI, with no significant change in RVEF. Values are mean ± SD. The difference in PR fraction between preimplant and 1 year was calculated using the Mann-Whitney U test. The P values for RVEDVI and RVEF were calculated from paired Student’s t-test. P < 0.05 was considered significant.

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  Central Illustration. The PT-Valve and its 1-Year Outcomes for Pulmonary Regurgitation (Top) The PT-Valve is a novel self-expanding percutaneous pulmonary valve. A total of 130 patients received the implantation of PT-Valve and 126 patients completed the 1-year follow-up. (Bottom) The procedure success rate was 98.5%. The 1-year outcomes showed no procedure- or device-related mortality events; 125 (99%) patients had none/trace and mild PR, and no greater than mild paravalvular leak.