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使用柔性带与完整环对退行性二尖瓣疾病患者进行二尖瓣修复的中期结果:一项前瞻性随机研究。

Mid-term results of mitral valve repair using flexible bands versus complete rings in patients with degenerative mitral valve disease: a prospective, randomized study.

作者信息

Bogachev-Prokophiev Alexandr V, Afanasyev Alexandr V, Zheleznev Sergei I, Nazarov Vladimir M, Sharifulin Ravil M, Karaskov Alexandr M

机构信息

Heart Valves Surgery Department, Meshalkin National Medical Research Center Ministry of Health Russian Federation, 15 Rechkunovskaya street, Novosibirsk, Russian Federation, 630055.

出版信息

J Cardiothorac Surg. 2017 Dec 13;12(1):113. doi: 10.1186/s13019-017-0679-0.

Abstract

BACKGROUND

We aimed to compare the outcomes of mitral valve repair with flexible band (FB) versus complete semirigid ring (SR) in degenerative mitral valve disease patients.

METHODS

From September 2011 to 2014, 171 patients were randomized and underwent successful mitral valve repair using a SR (n = 85) or FB (n = 86). There were no significant between-group differences at baseline.

RESULTS

There were no early mortalities. The mean follow up was 24.7 months. The 2-year survival was 96.0 ± 2.3% (95% confidence interval [CI], 88.6-98.7%) and 94.3 ± 2.8% (95% CI, 85.5-97.9%) in the SR and FB groups, respectively (p = 0.899). The left ventricle remodeling was similar between the groups. Higher transmitral peak (8.5 [3.9-17] vs. 6 [2.1-18] mmHg, p < 0.001), mean pressure gradients (3.7 [1.3-8] vs. 2.8 [0.6-6.8] mmHg, p = 0.001), and systolic pulmonary artery pressure (34.5 [20-68] vs. 29.5 [8-48] mmHg, p < 0.001) was observed in the SR group. The 2-year freedom from recurrence of significant mitral regurgitation was significantly higher in the FB group than the SR group (p = 0.002). Residual mitral regurgitation was an independent prognostic factor of recurrence of mitral regurgitation. The 3-year freedom from reoperation was significantly higher in the FB group than the SR group (p = 0.044).

CONCLUSION

Patients with degenerative mitral valve disease may benefit from valve repair with FBs. Residual mitral regurgitation before discharge is an independent risk factor of late insufficiency recurrence.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03278574 , retrospectively registered on 06.09.2017.

摘要

背景

我们旨在比较退行性二尖瓣疾病患者使用柔性带(FB)与完整半刚性环(SR)进行二尖瓣修复的效果。

方法

2011年9月至2014年,171例患者被随机分组,分别使用SR(n = 85)或FB(n = 86)成功进行二尖瓣修复。基线时组间无显著差异。

结果

无早期死亡病例。平均随访24.7个月。SR组和FB组的2年生存率分别为96.0±2.3%(95%置信区间[CI],88.6 - 98.7%)和94.3±2.8%(95%CI,85.5 - 97.9%)(p = 0.899)。两组间左心室重构相似。SR组观察到更高的跨二尖瓣峰值(8.5[3.9 - 17]对6[2.1 - 18]mmHg,p < 0.001)、平均压力梯度(3.7[1.3 - 8]对2.8[0.6 - 6.8]mmHg,p = 0.001)和收缩期肺动脉压(34.5[20 - 68]对29.5[8 - 48]mmHg,p < 0.001)。FB组2年无严重二尖瓣反流复发率显著高于SR组(p = 0.002)。残余二尖瓣反流是二尖瓣反流复发的独立预后因素。FB组3年再次手术率显著高于SR组(p = 0.044)。

结论

退行性二尖瓣疾病患者可能从使用FB进行瓣膜修复中获益。出院前的残余二尖瓣反流是晚期反流复发的独立危险因素。

试验注册

ClinicalTrials.gov NCT03278574,于2017年9月6日进行回顾性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/29e1/5729509/ecd9e51877bf/13019_2017_679_Fig1_HTML.jpg

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