■由于缺乏大小匹配的瓣膜,近2/3的右室流出道(RVOT)扩张的患者被排除在肺动脉瓣移植之外。这里,我们探讨了Med-ZenithPT-瓣膜治疗重度肺反流患者的安全性和有效性.
■22例重度PR患者(3级以上,4)根据天然RVOT的解剖特征和瓣膜设计进行登记。立即,分析术后3个月和1年的随访数据。
■远端主肺动脉(MPA)的基线平均收缩直径,MPA窦交界处,MPA窦,肺环,计算机断层扫描测量的RVOT动脉瘤和肌肉出口分别为33.6±6.1、34.0±5.8、37.9±6.0、32.4±7.3、41.9±9.3和34.4±8.0mm,分别。PT-Valve着陆区设置在这些水平内。所有患者均成功植入瓣膜,无明显的设备错位,冠状动脉压迫,随访期间肺支梗阻或瓣周漏。术后肺动脉舒张压从5.8±3.1上升至11.3±2.5mmHg。在3个月和1年的随访中,右心室舒张末期容积指数从基线181.6±29.0降至143.7±29.7ml/m2和123.4±31.2ml/m2,经肺动脉瓣梯度从25.6±22.2降至10.64±3.54mmHg和11.16±3.0mmHg,分别。6分钟步行距离从416.6±97.9米增加到455.9±64.6米和467.8±61.2米,分别。
■这项临床试验显示了对安全性有利的结果,Med-ZenithPT瓣膜治疗重度PR伴RVOT明显增大的疗效和可行性。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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/m2 and 123.4 ± 31.2 ml/m2, 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.
UNASSIGNED: 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.