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Long-Term Clinical and Echocardiographic Outcomes Following the Ross Procedure: A Post Hoc Analysis of a Randomized Clinical Trial.
JAMA Cardiology ( IF 24.0 ) Pub Date : 2023-11-08 , DOI: 10.1001/jamacardio.2023.4090
Maximiliaan L Notenboom 1 , Giovanni Melina 2 , Kevin M Veen 1 , Fabio De Robertis 3 , Giuditta Coppola 3 , Paolo De Siena 3 , Emiliano M Navarra 2 , Jullien Gaer 3 , Michael E K Ibrahim 4 , Ismail El-Hamamsy 5 , Johanna J M Takkenberg 1 , Magdi H Yacoub 6, 7
Affiliation  

Importance The Ross procedure as treatment for adults with aortic valve disease (AVD) has been the subject of renewed interest. Objective To evaluate the long-term clinical and echocardiographic outcomes following the Ross procedure for the treatment of adults with AVD. Design, Setting, and Participants This post hoc analysis of a randomized clinical trial included adult patients (age <69 years) who underwent a Ross procedure for the treatment of AVD, including those with active endocarditis, rheumatic AVD, decreased ejection fraction, and previous cardiac surgery. The trial, conducted from September 1, 1994, to May 31, 2001, compared homograft root replacement with the Ross procedure at a single center. Data after 2010 were collected retrospectively in November and December 2022. Exposure Ross procedure. Main Outcomes and Measures The primary end point was long-term survival among patients who underwent the Ross procedure compared with that in the age-, country of origin- and sex-matched general population. Secondary end points were freedom from any reintervention, autograft reintervention, or homograft reintervention and time-related valve function, autograft diameter, and functional status. Results This study included 108 adults (92 [85%] male) with a median age of 38 years (range, 19-66 years). Median duration of clinical follow-up was 24.1 years (IQR, 22.6-26.1 years; 2488 patient-years), with 98% follow-up completeness. Of these patients, 9 (8%) had active endocarditis and 45 (42%) underwent reoperations. The main hemodynamic lesion was stenosis in 30 (28%) and regurgitation in 49 (45%). There was 1 perioperative death (0.9%). Twenty-five year survival was 83.0% (95% CI, 75.5%-91.2%), representing a relative survival of 99.1% (95% CI, 91.8%-100%) compared with the general population (83.7%). At 25 years, freedom from any reintervention was 71.1% (95% CI, 61.6%-82.0%); from autograft reintervention, 80.3% (95% CI, 71.9%-89.6%); and from homograft reintervention, 86.3% (95% CI, 79.0%-94.3%). Thirty-day mortality after the first Ross-related reintervention was 0% and after all Ross-related reinterventions was 3.8% (n = 1); 10-year survival after reoperation was 96.2% (95% CI, 89.0%-100%). Conclusions and Relevance This study found that the Ross procedure provided excellent survival into the third decade postoperatively that was comparable to that in the general population. Long-term freedom from reintervention demonstrated that the Ross procedure may be a durable substitute into late adulthood, showing a delayed but progressive functional decline. Trial Registration isrctn.org Identifier: ISRCTN03530985.

中文翻译:

罗斯手术后的长期临床和超声心动图结果:随机临床试验的事后分析。

重要性 罗斯手术治疗成人主动脉瓣疾病 (AVD) 已重新引起人们的兴趣。目的 评估罗斯手术治疗成人 AVD 后的长期临床和超声心动图结果。设计、设置和参与者 这项随机临床试验的事后分析包括接受 Ross 手术治疗 AVD 的成年患者(年龄<69 岁),包括患有活动性心内膜炎、风湿性 AVD、射血分数降低和既往病史的患者。心脏手术。该试验于1994年9月1日至2001年5月31日进行,在单一中心对同种移植牙根置换术与Ross手术进行了比较。2010 年之后的数据于 2022 年 11 月和 2022 年 12 月进行回顾性收集。暴露罗斯程序。主要结果和措施 主要终点是接受罗斯手术的患者与年龄、原籍国和性别匹配的一般人群相比的长期生存率。次要终点是没有任何再干预、自体移植物再干预或同种移植物再干预以及与时间相关的瓣膜功能、自体移植物直径和功能状态。结果 本研究包括 108 名成年人(92 名 [85%] 男性),中位年龄为 38 岁(范围为 19-66 岁)。临床随访的中位持续时间为 24.1 年(IQR,22.6-26.1 年;2488 患者年),随访完整性为 98%。这些患者中,9 例(8%)患有活动性心内膜炎,45 例(42%)接受了再次手术。主要血流动力学损伤为 30 例(28%)的狭窄和 49 例(45%)的返流。围手术期死亡 1 例(0.9%)。25 年生存率为 83.0%(95% CI,75.5%-91.2%),与一般人群(83.7%)相比,相对生存率为 99.1%(95% CI,91.8%-100%)。25 岁时,无需再干预的率为 71.1%(95% CI,61.6%-82.0%);来自自体移植物再干预,80.3%(95% CI,71.9%-89.6%);同种移植物再干预的发生率为 86.3%(95% CI,79.0%-94.3%)。第一次罗斯相关再干预后的 30 天死亡率为 0%,所有罗斯相关再干预后的 30 天死亡率为 3.8% (n = 1);再次手术后10年生存率为96.2%(95% CI,89.0%-100%)。结论和相关性 这项研究发现,Ross 手术在术后 30 年里提供了出色的生存率,与一般人群的生存率相当。长期无需再干预表明,罗斯手术可能是成年晚期的持久替代方案,显示出延迟但渐进的功能衰退。试用注册 isrctn.org 标识符:ISRCTN03530985。
更新日期:2023-11-08
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