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临床试验/NCT05733988
NCT05733988已完成不适用

Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2021年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
MR recurrency

研究概览

简要总结

The absence of residual mitral regurgitation (MR) after mitral valve repair is of paramount importance for the long term durability of the valve repair. Thus, ideally, after weaning from cardio-pulmonary by-pass (CPB) the trans-esophageal echocardiogram (TEE) should show no (or only trivial) residual MR, good coaptation length and no iatrogenic mitral valve stenosis. However, mild or more residual MR can be present in up to 4% of the patients after the initial mitral valve repair and a second CPB run may be necessary to improve the repair results. Mechanism of residual MR can be dynamic, related to systolic anterior motion (SAM) or to severe left ventricular dysfunction, and anatomical, related to residual prolapse, cleft, and suture or ring dehiscence. In several cases medical therapy can be effective in the management of the intra-operatively detected SAM, and residual cleft or suture dehiscence can be easily corrected during a second CPB run. However, in other cases SAM is not responsive to medical therapy or the residual MR jet would require complex and time-consuming techniques to be addressed, or even worse scenario, a mitral valve replacement could be necessary. In such cases the edge-to-edge (EE) technique can be used as a bail-out procedure. The anatomical characteristics of the mitral valve after an initial sub-optimal repair are certainly not ideal for the edge-to-edge technique, due to a possible significant reduction in the valve area, especially in case of posterior leaflet resection or small ring implanted. Nevertheless, in the short term the edge-to-edge technique used to rescue patients with sub-optimal initial repair resulted effective. However, the very long-term results of the edge-to-edge technique used as bail-out are not known. Thus, the aim of this study is to evaluate the clinical and echocardiographic results of the edge-to-edge technique used to rescue patients with initial sub-optimal mitral repair.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

接受健康志愿者

入选标准

  • Adult patients;
  • Patients underwent mitral valve repair, with more than mild residual MR at the intraoperative TEE after leaving the CPB;
  • Patients in whom EtE alone has been added to the repair already performed, as a technique to reduce residual MR after first attempt of mitral valve repair;
  • Patients operated both in median sternotomy or in minithoracotomy;
  • Patients operated on at the Cardiac Surgery departmet of San Raffaele Hospital since January 1999 to December 2015.

排除标准

  • Patients in whom other techniques have been used as a bailout procedure, concurrently or instead of EtE;
  • Patients where the initial repair has been modified or undone;
  • Patients whose mitral valve has been replaced.

结局指标

主要结局

MR recurrency

时间窗: Up to 22 years

Mortality

时间窗: Up to 22 years

Reintervention for MR recurrency

时间窗: Up to 22 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

研究点 (1)

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