MEDTRONIC Open Pivot主动脉瓣机械瓣置换术后早中期临床结果

Early and Mid-term Outcome of Aortic Valve Replacement With the Mechanical MEDTRONIC Open Pivot Valve

目的:回顾性分析MEDTRONIC Open Pivot主动脉瓣机械瓣置换术后早中期临床结果。方法:连续收集2016年1月至2019年12月在中国医学科学院阜外医院使用MEDTRONIC Open Pivot主动脉瓣机械瓣行瓣膜置换术的患者348例,回顾性分析患者的基线临床资料、手术结果、早中期生存率和并发症发生情况。结果:348例患者中,男性283例(81.3%),平均年龄(49.4±11.2)岁。围术期无患者死亡和二次手术。共333例(95.7%)患者完成随访,平均随访(1.9±0.8)年(最长3.36年,共计627人年)。随访期间,11例(3.3%)患者死亡,术后第1、2、3、4年分别死亡3例、2例、5例、1例;5例死于心力衰竭,1例死因为人工瓣膜功能障碍,1例因脑出血死亡,4例为其他非心脑血管原因死亡。术后1年、2年、3年累积生存率分别为99.0%、98.1%、93.5%。随访期间,14例(4.2%)患者出现人工瓣膜功能障碍,发生率为2.23%/人年;6例(1.8%)患者出现瓣周漏,发生率为0.96%/人年;2例(0.6%)患者因严重瓣周漏需二次接受手术。17例(5.1%)患者发生主要不良事件,其中心肌梗死1例(0.3%),脑出血2例(0.6%),脑栓塞1例(0.3%),其他严重出血事件13例(3.9%)。结论:MEDTRONIC Open Pivot主动脉瓣机械瓣有效、耐用,置换术后死亡率及并发症发生率低,是主动脉瓣膜置换的可靠选择之一。

Objectives:To retrospectively analyze the early and mid-term postoperative clinical results of the aortic valve replacement with the mechanical MEDTRONIC Open Pivot valve.Methods:From January 2016 to December 2019,348 patients underwent aortic valve replacement with the mechanical MEDTRONIC Open Pivot valve.The medical records were retrospectively reviewed to evaluate the clinical characteristics,operative findings and the early and mid-term postoperative outcomes in these patients.Results:There were 283(81.3%)males and the mean age was(49.4±11.2)years in this cohort.There were no perioperative deaths or perioperative reoperation in these patients.333(95.7%)patients completed follow-up([1.9±0.8]years).The overall operative mortality was 3.3%(11 cases),including 3 deaths in the first year after surgery,2 deaths in the second year,5 deaths in the third year,and 1 death in the fourth year postoperatively.Causes of death were as follows:heart failure(n=5),artificial valve dysfunction(n=1),cerebral hemorrhage(n=1),and non-cardiovascular and cerebrovascular causes(n=4).The cumulative survival at 1,2 and 3 years follow-up were 99.0%,98.1%,and 93.5%,respectively.Postoperative prosthetic valve dysfunction occurred in 14(4.2%)cases during follow-up,the incidence rate was 2.23%/patient-year.Postoperative paravalvular leakage occurred in 6(1.8%)cases during follow-up,the incidence rate was 0.96%/patient-year.Two(0.6%)patients received reoperation for severe paravalvular leakage during follow up.Severe adverse events were observed in 17(5.1%)patients during follow-up,including 1(0.3%)myocardial infarction,2(0.6%)cerebral hemorrhage,1(0.3%)cerebral embolism,and 13(3.9%)other serious bleeding events.Conclusions:MEDTRONIC Open Pivot is effective and durable mechanical valve,with low mortality and complication rate.It serves as one of the reliable options for heart valve replacement.