经导管三尖瓣置换术治疗电极导线相关三尖瓣反流临床疗效的多中心回顾性队列研究

Clinical efficacy of transcatheter tricuspid valve replacement in cardiac implantable electronic lead-related tricuspid regurgitation:A multi-center retrospective cohort study

目的分析经导管三尖瓣置换术(transcatheter tricuspid valve replacement,TTVR)治疗电极导线相关三尖瓣反流(tricuspid regurgitation,TR)的临床疗效。方法回顾性纳入2020年6月—2021年8月国内9家医疗单位接受LuX-Valve TTVR的重度TR患者。根据术前是否接受植入式心脏电子装置(cardiac implantable electronic device,CIED)分为CIED组和非CIED组。手术成功定义为瓣膜安全植入,输送器完整退出。预后改善定义为TR等级下降至≤2+级,心功能改善≥2个等级。比较两组患者手术成功率及术后预后情况。结果共纳入190例患者,其中男50例、女140例,平均年龄(66.2±7.8)岁。CIED组29例,非CIED组161例。CIED组28例患者植入永久起搏器,1例患者植入心律转复除颤器。两组患者术前心功能分级、TR程度、左心室射血分数、三尖瓣环收缩期位移、心脏风险评分差异均无统计学意义(P>0.05)。术后所有患者TR降低至≤2+级,两组瓣周漏发生率差异无统计学意义(P=0.270),CIED组患者术后复查CT可见瓣膜在位,电极导线无明显挤压、扭曲、偏移。两组患者在院死亡率分别为10.3%和1.9%,差异有统计学意义(P=0.047)。此外,两组患者术后心功能改善情况、随访1年和2年死亡率差异均无统计学意义(P>0.05)。结论TTVR对CIED植入患者可行且安全有效,电极导线对治疗效果无显著影响。

Objective To analyze the clinical efficacy of transcatheter tricuspid valve replacement(TTVR)in cardiac implantable electronic lead-related tricuspid regurgitation(TR).Methods The patients with severe TR who underwent LuX-Valve TTVR in 9 Chinese medical centers from June 2020 to August 2021 were retrospectively enrolled.They were divided into a cardiac implantable electronic device(CIED)group and a non-CIED group based on whether they had pre-existing CIED implantation.Success of the procedure was defined as safe implantation of the LuX-Valve and complete withdrawal of the delivery system.Prognostic improvement was defined as a decrease of TR grade to≤2+and an improvement of cardiac function by≥2 grades.Surgical success and postoperative prognosis were compared between the two groups.Results A total of 190 patients were collected,including 50 males and 140 females with a mean age of 66.2±7.8 years.There were 29 patients in the CIED group,and 161 patients in the non-CIED group.In the CIED group,28 patients were implanted with a permanent pacemaker and 1 patient with a cardioverter-defibrillator.Preoperative New York Heart Association(NYHA)cardiac function class,TR degree,left ventricular ejection fraction,tricuspid annular plane systolic excusion,and cardiac risk scores were comparable between the two groups(P>0.05).Postoperative TR was reduced to≤2+in all patients,and there was no statistical difference in the incidence of perivalvular leakage between the two groups(P=0.270).Postoperative CT of CIED patients showed the valve was in place,and the lead was not extruded,twisted,or deflected.The in-hospital mortality of the two groups were 10.3%and 1.9%,respectively,and the difference was statistically significant(P=0.047).In addition,there was no statistical difference between the two groups in terms of postoperative improvement of cardiac function and mortality in the 1-and 2-year follow-up.Conclusion TTVR is feasible,safe,and effective in patients with CIED implantation,and the pre-existing lead has no significant effect on the clinical efficacy.