The Clinical Trial Outcomes of Med-Zenith PT-Valve in the Treatment of Patients With Severe Pulmonary Regurgitation

Frontiers in Cardiovascular Medicine

article

Xiaoke Shang¹  Nianguo Dong²  Changdong Zhang²  Yanggan Wang¹ 

[1] Department of General Medicine and Geriatrics, Zhongnan Hospital of Wuhan University, Wuhan University;Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology;Medical Research Institute of Wuhan University, Wuhan University

关键词: transcatheter pulmonary valve;    native right ventricular outflow tract;    pulmonary regurgitation;    Tetralogy of Fallot;    coronary artery compression;   

DOI  :  10.3389/fcvm.2022.887886

学科分类：地球科学(综合)

来源: Frontiers

【 摘 要 】

Objective Nearly 2/3 of patients with dilated right ventricular outflow tract (RVOT) were excluded from pulmonary valves transplantation due to the lack of size-matched valves. Here, we explored the safety and efficacy of the Med-Zenith PT-Valve for the treatment of patients with severe pulmonary regurgitation. Methods 22 Patients with severe PR (grade 3+,4+) were enrolled based on the anatomical features of native RVOT and the valve design. The immediate, 3-months and 1-year post-procedural follow-up data were analyzed. Results The baseline mean systolic diameters in the distal main pulmonary artery (MPA), MPA sinus junction, MPA sinus, pulmonary annulus, RVOT aneurysm and muscular outlet measured with computed tomography were 33.6 ± 6.1, 34.0 ± 5.8, 37.9 ± 6.0, 32.4 ± 7.3, 41.9 ± 9.3, and 34.4 ± 8.0 mm, respectively. The PT-Valve landing zone was set within these levels. Successful valve implantations were achieved in all patients without noticeable device malposition, coronary artery compression, pulmonary branch obstruction or paravalvular leak during follow-ups. Post-procedural pulmonary artery diastolic pressure increased from 5.8 ± 3.1 to 11.3 ± 2.5 mmHg. In the 3-month and 1-year follow-up, the right ventricular end diastolic volume index reduced from the baseline 181.6 ± 29.0 to 143.7 ± 29.7 ml/m 2 and 123.4 ± 31.2 ml/m 2 , and the trans-pulmonary valve gradient decreased from 25.6 ± 22.2 to 10.64 ± 3.54 mmHg and 11.16 ± 3.0 mmHg, respectively. The 6-min walk distance increased from 416.6 ± 97.9 to 455.9 ± 64.6 m and 467.8 ± 61.2 m, respectively. Conclusion This clinical trial revealed favorable outcomes for the safety, efficacy and feasibility of the Med-Zenith PT-Valve in the treatment of severe PR with significantly enlarged RVOT.

【 授权许可】

CC BY