mitral valve replacement

二尖瓣置换术
  • 文章类型: Journal Article
    主动脉瓣置换术(AVR)期间中度功能性二尖瓣反流(FMR)的治疗存在争议。本研究旨在评估不同手术策略对接受AVR的中度FMR患者的影响。
    回顾性研究了2010年1月至2019年12月进行AVR的468例中度FMR患者,比较了3种不同的手术策略。即孤立的AVR,AVR+二尖瓣修复术(MVr)和AVR+二尖瓣置换术(MVR)。使用Kaplan-Meier方法估计生存率,并与对数秩检验进行比较,其次是逆概率处理加权(IPTW)分析,以调整组间不平衡。主要结果是总死亡率。
    患者接受孤立性AVR(35.3%),AVR+MVr(30.3%),或AVR+MVR(34.4%)。中位随访时间为27.1个月。与孤立的AVR和AVR+MVr相比,AVR+MVR在早期和随访期间与FMR的更好改善相关(p<0.001)。与孤立的AVR相比,AVR+MVR增加了中期死亡率的风险(风险比[HR]:2.13,95%置信区间[CI]:1.01-4.48,p=0.046),在IPTW分析中保持不变(HR:4.15,95%CI:1.69-10.15,p=0.002)。相比之下,AVR+MVr仅显示出增加随访死亡率风险的趋势(HR:1.63,95%CI:0.72-3.67,p=0.239),这在IPTW分析中更为明显(HR:2.54,95%CI:0.98-6.56,p=0.054)。
    在患有严重主动脉瓣疾病和中度FMR的患者中,隔离的AVR可能比AVR+MVr或AVR+MVR更合理。
    UNASSIGNED: Treatment of moderate functional mitral regurgitation (FMR) during aortic valve replacement (AVR) is controversial. This study aimed to evaluate the effect of different surgical strategies in patients with moderate FMR undergoing AVR.
    UNASSIGNED: A total of 468 patients with moderate FMR undergoing AVR from January 2010 to December 2019 were retrospectively studied comparing 3 different surgical strategies, namely isolated AVR, AVR + mitral valve repair (MVr) and AVR + mitral valve replacement (MVR). Survival was estimated using the Kaplan-Meier method and compared with the log-rank test, followed by inverse probability treatment weighting (IPTW) analysis to adjust the between-group imbalances. The primary outcome was overall mortality.
    UNASSIGNED: Patients underwent isolated AVR (35.3%), AVR + MVr (30.3%), or AVR + MVR (34.4%). The median follow-up was 27.1 months. AVR + MVR was associated with better improvement of FMR during the early and follow-up period compared to isolated AVR and AVR + MVr (p < 0.001). Compared to isolated AVR, AVR + MVR increased the risk of mid-term mortality (hazard ratio [HR]: 2.13, 95% confidence interval [CI]: 1.01-4.48, p = 0.046), which was sustained in the IPTW analysis (HR: 4.15, 95% CI: 1.69-10.15, p = 0.002). In contrast, AVR + MVr showed only a tendency to increase the risk of follow-up mortality (HR: 1.63, 95% CI: 0.72-3.67, p = 0.239), which was more apparent in the IPTW analysis (HR: 2.54, 95% CI: 0.98-6.56, p = 0.054).
    UNASSIGNED: In patients with severe aortic valve disease and moderate FMR, isolated AVR might be more reasonable than AVR + MVr or AVR + MVR.
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  • 文章类型: Journal Article
    背景:对于患有二尖瓣疾病的儿童,修复是优选的;二尖瓣置换(MVR)有时是必要的。我们介绍了15mmSt.Jude机械二尖瓣的多机构研究设备豁免试验的结果。
    方法:从5月开始,2015年3月,2017年,23名年龄在0.4-27.4个月(平均7.8个月;85%<1岁)的儿童,体重2.9-10.9公斤(平均5.5公斤),在15个中心接受了15毫米SJM的MVR(环内45%,超环形55%)。21人(91%)曾进行过心脏手术。跟进直到死亡,瓣膜外植术,或术后五年完成100%。
    结果:前12个月有6例死亡,无瓣膜相关死亡。四名患者需要起搏器(2个上环形,2个环内)。3例患者在术后13、21和35天有血栓形成,需要瓣膜移植。3例患者中有2例接受低分子肝素抗凝治疗,第三个患有因子V莱顿缺乏症。在MVR的4个月内有5例非致命性出血并发症(1年无出血71.0%)。一年和五年无死亡或瓣膜外植术的发生率为71.0%。
    结论:对于患有需要MVR的严重二尖瓣疾病的儿童,15mmSJMMHV可提供令人满意的血流动力学。这些患者的死亡率和并发症并非微不足道。低分子量肝素可能应避免作为主要抗凝药物。最终的瓣膜更换是不可避免的。
    BACKGROUND: Repair is preferable for children with mitral valve disease, but mitral valve replacement (MVR) is occasionally necessary. This report presents the results of a multiinstitutional Investigational Device Exemption trial of the 15-mm St Jude (SJM) mechanical mitral valve (Abbott Structural Heart).
    METHODS: From May 2015 to March 2017, 23 children aged 0.4 to 27.4 months (mean, 7.8 months; 85% <1 year) weighing 2.9 to 10.9 kg (mean, 5.5 kg) at 15 centers underwent MVR with a 15-mm SJM mechanical mitral valve (intraannular, 45%; supraannular, 55%). A total of 21 (91%) of the children had undergone previous cardiac operations. Follow-up until death, valve explantation, or 5 years postoperatively was 100% complete.
    RESULTS: There were 6 deaths, all in the first 12 months; no death was valve related. Four patients required a pacemaker (2 supraannular, 2 intraannular). Three patients had thrombosis requiring valve explantation at 13, 21, and 35 days postoperatively. Two of these 3 patients were receiving low-molecular-weight heparin for anticoagulation, and the third had factor V Leiden deficiency. There were 5 nonfatal bleeding complications within 4 months of MVR (1-year freedom from bleeding, 71.0%). The 1- and 5-year freedom from death or valve explantation was 71.0%.
    CONCLUSIONS: In small children with severe mitral valve disease requiring MVR, the 15-mm SJM mechanical mitral valve provides satisfactory hemodynamics. Mortality and complications in these patients are not trivial. Low-molecular-weight heparin likely should be avoided as primary anticoagulation. Eventual valve replacement is inevitable.
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  • 文章类型: Systematic Review
    目的:继发性二尖瓣反流(SMR)的理想手术干预,左心室的疾病,而不是二尖瓣本身的疾病,仍在辩论。我们进行了一项更新的系统评价和研究水平的荟萃分析,调查了成年SMR患者的二尖瓣修复(MVr)与二尖瓣置换术(MVR)。有或没有冠状动脉疾病(CAD)。
    方法:PubMed,搜索CENTRAL和EMBASE以比较MVr与MVR的研究。随机试验或观察性研究被认为是合格的。主要终点是任何原因的长期死亡率。重建Kaplan-Meier生存曲线,并与Cox线性回归进行比较。分析了界标分析和时变风险比(HR)。敏感性分析包括荟萃回归和单独的子分析。使用随机效应模型。
    结果:纳入了23项研究(MVr=3,727和MVR=2,839)。一项研究是一项随机试验,19项研究进行了调整。平均加权随访时间为3.7±2.8年。在10年随访时,MVR与显著的晚期死亡率相关(HR=1.26;95%CI,1.14-1.39;P<0.0001)。MVR后的前2年有随时间变化的趋势(HR=1.38;95%CI,1.21-1.56;P<0.0001),之后这一差异消失(HR=0.94;95%CI,0.81-1.09;P=0.41)。单独的子分析显示,伴随冠状动脉手术≥90%的患者的长期死亡率相当,左心室射血分数≤40%,瓣膜下器官保存率100%。
    结论:与修复相比,MVR在手术后的前2年内与较高的死亡率相关,之后,两种手术显示出相当的晚期死亡率。
    OBJECTIVE: The ideal surgical intervention for secondary mitral regurgitation (SMR), a disease of the left ventricle not the mitral valve itself, is still debated. We performed an updated systematic review and study-level meta-analysis investigating mitral valve repair (MVr) versus mitral valve replacement (MVR) for adult patients with SMR, with or without coronary artery disease (CAD).
    METHODS: PubMed, CENTRAL and EMBASE were searched for studies comparing MVr versus MVR. Randomized trial or observational studies were considered eligible. Primary endpoint was long-term mortality for any cause. Kaplan-Meier survival curves were reconstructed and compared with Cox linear regression. Landmark analysis and time-varying hazard ratio (HR) were analyzed. Sensitivity analyses included meta-regression and separate sub-analysis. A random effects model was used.
    RESULTS: Twenty-three studies (MVr=3,727 and MVR=2,839) were included. One study was a randomized trial, and 19 studies were adjusted. The mean weighted follow-up was 3.7±2.8 years. MVR was associated with significative greater late mortality (HR=1.26; 95 % CI, 1.14-1.39; P<0.0001) at 10-year follow-up. There was a time-varying trend showing an increased risk of mortality in the first 2 years after MVR (HR=1.38; 95 % CI, 1.21-1.56; P<0.0001), after which this difference dissipated (HR=0.94; 95 % CI, 0.81-1.09; P=0.41). Separate sub-analyses showed comparable long-term mortality in patients with concomitant coronary surgery ≥90 %, left ventricle ejection fraction ≤40 %, and sub-valvular apparatus preservation rate of 100 %.
    CONCLUSIONS: Compared to repair, MVR is associated with higher probability of mortality in the first 2 years following surgery, after which the two procedures showed comparable late mortality rate.
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  • 文章类型: Journal Article
    经皮腔内二尖瓣连合切开术(PTMC)已成为具有良好解剖结构的严重二尖瓣狭窄的护理标准。尽管多年来并发症有所减少,紧急外科救援的需要仍然存在。本研究评估了2013年1月1日至2019年12月31日接受PTMC的24小时内进行手术抢救的结果。在2259名PTMC患者中,22例患者(<1%)需要进行二尖瓣手术抢救。在22名患者中,17例患者(77.27%)出现二尖瓣反流;5例患者(22.7%)出现心包填塞。20例(90.9%)行二尖瓣置换术,而两名患者(9.1%)接受了二尖瓣修复。心脏压塞继发于左心房损伤(9.1%),左心室(4.5%),右心室(9.1%)。3例(13.6%)同时行三尖瓣修复术。术中,二尖瓣前叶撕裂占68.2%,二尖瓣后叶撕裂占9.1%。术后,3名患者(13.6%)需要长时间通气,卒中发生率为4.5%(n=1),住院死亡率为4.5%(n=1).3例患者(13.6%)使用主动脉内球囊反搏,术前。我们得出的结论是PTMC术后并发症很少见,但他们需要紧急手术治疗.
    Percutaneous transluminal mitral commissurotomy (PTMC) has become the standard of care for severe mitral stenosis with favorable anatomy. Although the complications have reduced over the years, the need for emergency surgical rescue persists. This study evaluates the outcomes of surgical rescue performed within 24 h of undergoing PTMC from 1 January 2013 to 31 December 2019. Out of 2259 PTMC patients, 22 patients (< 1%) required rescue mitral valve surgery. Out of 22 patients, 17 patients (77.27%) developed mitral regurgitation; five patients (22.7%) had cardiac tamponade. Mitral valve replacement was performed in 20 patients (90.9%), while two patients (9.1%) underwent mitral valve repair. Cardiac tamponade was secondary to injury of the left atrium (9.1%), left ventricle (4.5%), and right ventricle (9.1%). Concomitant tricuspid valve repair was done in three patients (13.6%). Intraoperatively, anterior mitral leaflet tear was seen in 68.2% while posterior mitral leaflet tear was noted in 9.1%. Postoperatively, three patients (13.6%) required prolonged ventilation, incidence of stroke was 4.5% (n = 1), and in-hospital mortality was 4.5% (n = 1). Intra-aortic balloon pump was used in three patients (13.6%), preoperatively. We conclude that post-PTMC complications are rare, but they require urgent surgical intervention.
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  • 文章类型: Journal Article
    肥厚型心肌病(HCM)影响全球数百万人。在严重的情况下,它会导致危及生命的情况,如左心室流出道(LVOT)梗阻,二尖瓣反流(MR),和心源性猝死,必须进行手术治疗。本研究旨在报告接受间隔肌切除术或二尖瓣置换术(MVR)的HCM患者的长期结果,并比较不同类型手术的结果。
    这是一项针对2005年至2021年在伊朗转诊中心接受手术治疗的HCM患者的回顾性队列研究。根据接受的手术类型将患者分为三组:间隔肌切除术,MVR,或者两种手术的组合。患者特征,手术和超声心动图特征,报告并比较三组的院内和长期结局.
    共纳入102例患者,平均年龄为53.3±16.9。26例患者做了间隔肌切除术,23有MVR,53例进行了室间隔肌切除术和MVR手术。所有手术均与室间隔厚度和LVOT梯度的显着降低有关。经过6.8年的平均随访时间,与其他组相比,行隔离间隔肌切除术的患者的死亡率和主要不良心脑血管事件发生率显著较低.
    隔离间隔肌切除术显示出更好的长期生存率,并且可以纠正HCM相关的MR,而MVR只应保留固有的瓣膜缺陷。需要更广泛的研究来证实这些发现,并获得关于HCM手术治疗的全面指南。
    UNASSIGNED: Hypertrophic cardiomyopathy (HCM) affects millions of individuals worldwide. In severe cases, it can cause life-threatening conditions such as left ventricular outflow tract (LVOT) obstruction, mitral regurgitation (MR), and sudden cardiac death, making surgical treatment necessary. This study aimed to report the long-term outcomes of HCM patients undergoing septal myectomy or mitral valve replacement (MVR) and compare the results between different types of surgeries.
    UNASSIGNED: This was a retrospective cohort study on HCM patients who underwent surgical treatment in an Iranian referral center between 2005 and 2021. Patients were divided into three groups according to the type of surgery received: septal myectomy, MVR, or a combination of both surgeries. Patient characteristics, surgical and echocardiographic features, and in-hospital and long-term outcomes were reported and compared between the three groups.
    UNASSIGNED: A total of 102 patients with an average age of 53.3 ± 16.9 were included. Twenty-six patients had septal myectomy, 23 had MVR, and 53 had combined septal myectomy and MVR surgery. All surgeries were associated with a significant reduction in interventricular septum thickness and LVOT gradients. After a median of 6.8-year follow-up time, patients with an isolated septal myectomy had significantly lower mortality and major adverse cardiac and cerebrovascular events rates than the other groups.
    UNASSIGNED: Isolated septal myectomy showed better long-term survival rates and can correct HCM-related MR, while MVR should be preserved only for intrinsic valve defects. More extensive studies are needed to confirm these findings and achieve a comprehensive guideline on surgical treatment of HCM.
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  • 文章类型: Journal Article
    目的:二尖瓣手术和,最近,经二尖瓣导管边缘对边缘修复术(TEER)是符合条件的患者中严重二尖瓣返流的两种治疗方法。两种疗法的临床比较仍然受到分析的患者数量的限制。这项研究的目的是分析二尖瓣TEER与在法国全国范围内进行孤立的二尖瓣手术。
    方法:基于法国行政医院出院数据库,本研究收集了2012年至2022年期间所有接受单纯TEER或单纯二尖瓣手术治疗的二尖瓣返流患者的信息.倾向评分匹配用于结果分析。
    结果:在数据库中发现总共57030名患者。匹配基线特征后,对每组2160名患者进行了分析。在3年的随访中,TEER与心血管死亡发生率显著降低相关(风险比0.685,95%置信区间0.563-0.832;P=0.0001),起搏器植入,和中风。非心血管死亡(风险比1.562,95%置信区间1.238-1.971;P=.0002),复发性肺水肿,TEER后心脏骤停更频繁。两组在全因死亡方面无显著差异(风险比0.967,95%置信区间0.835-1.118;P=0.65),心内膜炎,大出血,心房颤动,和心肌梗塞。
    结论:我们的结果表明,在长期随访中,TEER治疗重度二尖瓣反流的心血管死亡率低于二尖瓣手术。TEER后起搏器植入和中风的频率较低。
    OBJECTIVE: Mitral valve surgery and, more recently, mitral transcatheter edge-to-edge repair (TEER) are the two treatments of severe mitral regurgitation in eligible patients. Clinical comparison of both therapies remains limited by the number of patients analysed. The objective of this study was to analyse the outcomes of mitral TEER vs. isolated mitral valve surgery at a nationwide level in France.
    METHODS: Based on the French administrative hospital discharge database, the study collected information for all consecutive patients treated for mitral regurgitation with isolated TEER or isolated mitral valve surgery between 2012 and 2022. Propensity score matching was used for the analysis of outcomes.
    RESULTS: A total of 57 030 patients were found in the database. After matching on baseline characteristics, 2160 patients were analysed in each arm. At 3-year follow-up, TEER was associated with significantly lower incidence of cardiovascular death (hazard ratio 0.685, 95% confidence interval 0.563-0.832; P = .0001), pacemaker implantation, and stroke. Non-cardiovascular death (hazard ratio 1.562, 95% confidence interval 1.238-1.971; P = .0002), recurrent pulmonary oedema, and cardiac arrest were more frequent after TEER. No significant differences between the two groups were observed regarding all-cause death (hazard ratio 0.967, 95% confidence interval 0.835-1.118; P = .65), endocarditis, major bleeding, atrial fibrillation, and myocardial infarction.
    CONCLUSIONS: Our results suggest that TEER for severe mitral regurgitation was associated with lower cardiovascular mortality than mitral surgery at long-term follow-up. Pacemaker implantation and stroke were less frequently observed after TEER.
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  • 文章类型: Journal Article
    在二尖瓣置换期间良好地暴露于二尖瓣装置是每个心脏外科医生必须采取的重要决定。这项研究是为了比较简单的经中间隔入路和传统的左心房入路用于二尖瓣手术。评估单纯经中间隔入路在心脏二尖瓣直视手术中的安全性和有效性,因为传统的左心房方法可能无法提供最佳暴露,尤其是在不利的解剖和手术情况下。
    这是一项回顾性研究。已对140名被诊断患有需要二尖瓣置换的心脏病的患者进行了研究。手术在心胸外科进行。二尖瓣手术是在全麻下,在体外循环机上使用冷顺行心脏停搏液通过胸骨正中切口进行的。人口统计数据,术前诊断,术中发现,住院,并发症,记录和修订死亡率。
    本研究纳入了140名患者,中位年龄为39岁,在基线人口统计数据和年龄方面没有显著差异,性别,体重指数(BMI)。共有68例患者通过简单的经中间隔入路进行了二尖瓣置换术,而72例患者通过常规的左心房入路进行了二尖瓣置换术。两组在旁路时间方面差异不显著,再手术率,术后并发症,住院,和死亡率。
    在二尖瓣置换术中的某些困难手术情况下,通过卵圆窝中点的简单经中隔入路可能是传统左心房切开术的安全甚至有利的替代方法。
    UNASSIGNED: Having good exposure to the mitral apparatus during mitral valve replacement is a vital decision every cardiac surgeon must take. This study was conducted to compare the simple transseptal approach and the conventional left atrial approach for mitral valve procedures, to evaluate the safety and efficacy of the simple transseptal approach during open heart mitral valve procedures, as the conventional left atrial approach may not provide optimal exposure, especially in unfavorable anatomical and operative situations.
    UNASSIGNED: This is a retrospective study. It has been conducted on 140 patients who were diagnosed with heart diseases that required mitral valve replacement. Surgeries were performed in the Cardiothoracic Surgery Department. Mitral procedure was done through median sternotomy incision under general anesthesia on a cardiopulmonary bypass machine with cold antegrade cardioplegia. Demographic data, preoperative diagnosis, intraoperative findings, hospital stay, complications, and mortality were documented and revised.
    UNASSIGNED: One hundred and forty patients were enrolled in this study with a median age of 39 years, and no significant differences as regards the baseline demographic data as age, sex, and body mass index (BMI). A total of 68 patients underwent mitral valve replacement through the simple transseptal approach and 72 patients through the conventional left atrial approach. Both studied groups had insignificant differences as regards bypass time, re-operation rate, postoperative complications, hospital stay, and mortality.
    UNASSIGNED: The simple transseptal approach through the midpoint of the fossa ovalis could be a safe and even favorable alternative to the traditional left atriotomy approach in certain difficult operative situations during mitral valve replacement surgery.
    UNASSIGNED:
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  • 文章类型: Multicenter Study
    背景:由于手术风险高或二尖瓣解剖结构不合适,大量重度二尖瓣反流(MR)患者不适合进行手术或经导管边缘到边缘修复。
    目的:本研究的目的是评估HighLife跨间隔二尖瓣置换术(TSMVR)系统在有症状的MR和高手术风险患者中的应用。
    方法:这种前瞻性,多中心,非随机可行性研究评估了HighLifeTSMVR系统在1年随访期间对中度至重度或重度症状性MR患者的安全性和性能.超声心动图数据在独立的核心实验室进行评估。
    结果:30名患者(平均年龄75.6岁,27%的女性,胸外科医师协会评分中位数为5.5%)伴重度MR(90%伴二次MR,左心室射血分数中位数43%)在13个部位接受治疗。在30名患者中的27名,成功植入HighLifeTSMVR系统(技术成功率90%)。30天的装置成功率为83%。一年后,5例(17%)患者死亡。接受植入的患者均不需要二尖瓣再介入。所有接受植入的患者均无或有微量(78%)或轻度(22%)MR,HighLife瓣膜的平均梯度为5.1mmHg,并且没有左心室流出道阻塞的迹象(平均梯度2.0mmHg)。
    结论:HighLifeTSMVR可行性研究的一年结果证明了很高的技术成功率,出色的阀门功能,无左心室流出道梗阻,也不需要二尖瓣再介入.需要额外的患者结果和更长时间的随访来确认这些发现。(中-重度或重度二尖瓣反流和高手术风险患者的HighLife28mm跨间隔导管二尖瓣扩展研究;NCT04029363)。
    A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy.
    The aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk.
    This prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory.
    A total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg).
    The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363).
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  • 文章类型: Journal Article
    新型组织小叶(RESILIA组织)可以改善生物假体心脏瓣膜的耐久性。COMMENCE试验是一项正在进行的前瞻性研究,旨在评估使用RESILIA组织进行的瓣膜置换。本报告描述了COMMENCE二尖瓣队列的中期结局。
    需要二尖瓣置换术的成年患者被纳入前瞻性,在美国和加拿大的17个地点进行的单臂试验。独立的临床事件委员会使用既定指南中的定义来裁定安全事件。血流动力学性能由独立的超声心动图核心实验室进行评估.
    82名患者(中位年龄70岁)成功接受了研究瓣膜的二尖瓣置换术。全因死亡率的五年无事件概率,结构阀门恶化,再次手术率为79.9%,98.7%,和97.1%,分别。在5年的随访期内,血流动力学瓣膜功能测量稳定;很少观察到瓣膜渗漏,主要是临床上不明显/轻度。
    植入RESILIA组织生物假体的二尖瓣置换术患者具有良好的安全性和临床稳定的血流动力学表现。
    UNASSIGNED: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE.
    UNASSIGNED: Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory.
    UNASSIGNED: Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-free probabilities for all-cause mortality, structural valve deterioration, and reoperation were 79.9%, 98.7%, and 97.1%, respectively. Hemodynamic valve function measurements were stable through the 5-year follow-up period; valvular leaks were infrequently observed and primarily clinically insignificant/mild.
    UNASSIGNED: Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance.
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