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临床试验/NCT07831811
NCT07831811尚未招募不适用

Transient Mitral Regurgitation Following Septal Myectomy: A Retrospective Echocardiographic Study

University Health Network, Toronto0 个研究点目标入组 150 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
≥ moderate MR on intraoperative post-bypass TEE that improves to ≤ mild MR on predischarge transthoracic echocardiography (TTE)

研究概览

简要总结

Mitral regurgitation (MR) following septal myectomy for hypertrophic obstructive cardiomyopathy may persist despite relief of systolic anterior motion and left ventricular outflow tract obstruction. Clinical observations suggest that a subset of postoperative MR may be transient and related to posterior leaflet restriction rather than structural mitral valve abnormality.

We will perform a retrospective single-centre cohort study of patients undergoing septal myectomy between 2022 and 2025. Intraoperative post-bypass transesophageal echocardiograms and predischarge transthoracic echocardiograms will be independently reviewed to assess MR severity and mechanism.

We hypothesize that a substantial proportion of moderate-or-greater postoperative MR resolves before discharge, supporting a conservative approach to mitral valve intervention and improving intraoperative echocardiographic decision-making.

详细描述

Hypertrophic obstructive cardiomyopathy (HOCM) is characterized by asymmetric septal hypertrophy and dynamic LVOT obstruction. Septal myectomy is the standard surgical therapy for symptomatic patients refractory to medical management.

Mitral regurgitation (MR) in HOCM is classically related to systolic anterior motion (SAM) of the anterior leaflet. Following myectomy, relief of LVOT obstruction typically reduces SAM-associated MR. However; intraoperative transesophageal echocardiography (TEE) frequently demonstrates persistent or new MR following separation from cardiopulmonary bypass.

Clinical observation suggests that a subset of this MR may be due to transient posterior leaflet restriction, potentially related to incomplete myocardial protection in hypertrophied myocardium. This may result in MR that resolves prior to discharge without requiring mitral valve intervention. Misinterpretation of this transient phenomenon may lead to unnecessary surgical procedures.

There is currently limited systematic evaluation of the mechanism and natural history of MR observed immediately following myectomy. This study aims to address this knowledge gap using retrospective echocardiographic review.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years)
  • Undergoing septal myectomy for HOCM
  • Availability of intraoperative post-cardiopulmonary bypass TEE images
  • Availability of predischarge TTE

排除标准

  • Concomitant primary mitral valve disease due to structural abnormalities, prior ischemic MR or previous MV intervention (repair or replacement)
  • Inadequate echocardiographic image quality precluding MR assessment
  • Patients without paired TEE and TTE studies

研究组 & 干预措施

Patients who underwent septal myectomy at Toronto General Hospital between 2022 and 2025

We enroll into the study all patients who underwent septal myectomy at Toronto General Hospital between January 1, 2022 and December 31, 2025.

结局指标

主要结局

≥ moderate MR on intraoperative post-bypass TEE that improves to ≤ mild MR on predischarge transthoracic echocardiography (TTE)

时间窗: From January 1, 2022 to December 31, 2025

To determine the proportion of patients with ≥ moderate MR on intraoperative post-bypass TEE that improves to ≤ mild MR on predischarge transthoracic echocardiography (TTE).

次要结局

未报告次要终点

研究者

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

Marcus Salvatori

Staff Anesthesiologist

University Health Network, Toronto

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