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临床试验/NCT06397092
NCT06397092已完成不适用

Anesthetic Management for Transapical Beating-heart Septal Myectomy (TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM):A Retrospective Analysis

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月1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
120
试验地点
1
主要终点
Perioperative information 5

研究概览

简要总结

To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these patients.

详细描述

Hypertrophic obstructive cardiomyopathy is an inherited cardiomyopathy. Such patients have significantly reduced mobility and quality of life, and are prone to sudden death in severe cases. According to conservative estimates, there are about 2 to 5 million patients with hypertrophic heart disease in China, and about 15 to 20 million patients in the world, which seriously threatens human health. The traditional surgical treatment is partial ventricular septal myectomy through thoracotomy, which is traumatic and difficult, with poor efficacy and high operative mortality in hospitals with little experience.

In order to solve this problem, professor Wei's team invented and developed a beating-heart myectomy device, and established the first transapical beating-heart septal myectomy (TA-BSM) with the aid of this device through the apical minimally invasive incision under the guidance of esophageal ultrasound. With the help of echocardiography, the position of the rotator can be monitored in real time, and the angle and thickness of the rotator can be determined to ensure the safe removal of the hypertrophic ventricular septum, so as to solve the problem of left ventricular outflow tract obstruction.

The team firstly completed 47 clinical trials from April to September 2022, with a surgical success rate of 97.9%. At 3-month follow-up, the median maximum pressure gradient of left ventricular outflow tract decreased from perioperational 86 mmHg to postoperational 19 mmHg , and 45 participants (95.7%) had complete remission of mitral regurgitation. All patients showed significant improvement or even disappearance of symptoms, and exercise capacity and quality of life were significantly improved.

Since TA-BSM is a new surgical method, there is no unified standard for anesthesia management and lack of evidence-based evidence. Therefore, the aim of this study is to retrospectively analyze the preoperative, intraoperative and postoperative anesthetic management of participants with hypertrophic cardiomyopathy undergoing TA-BSM, so as to provide clinical basis for formulating reasonable and standardized perioperative anesthesia programs for these patients.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with hypertrophic cardiomyopathy
  • American Society of Anesthesiologists (ASA) physical status classification I-III
  • Undergoing TA-BSM

排除标准

  • Cardiopulmonary bypass was used to assist the surgery.

结局指标

主要结局

Perioperative information 5

时间窗: Immediately after the surgery

The type of tracheal tube

Perioperative information 7

时间窗: Immediately after the surgery

The usage of cardiovascular drugs

Perioperative information 8

时间窗: Immediately after the surgery

Intraoperative infusion volume

Perioperative information 1

时间窗: During surgery, when use isoproterenol to provocate

Heart reat

Perioperative information 3

时间窗: During surgery, when use isoproterenol to provocate

Diastolic arterial blood pressure

Perioperative information 2

时间窗: During surgery, when use isoproterenol to provocate

Systolic arterial blood pressure

Perioperative information 4

时间窗: During surgery, when use isoproterenol to provocate

Mean arterial blood pressure

Perioperative information 6

时间窗: Immediately after the surgery

The usage of anaesthetic drugs

Perioperative information 9

时间窗: Immediately after the surgery

Blood transfusion volume

Perioperative information 10

时间窗: Immediately after the surgery

Blood loss

次要结局

  • Postoperative information 1(Postoperative in 30 days)
  • Postoperative information 3(Postoperative in 30 days)
  • Laboratory tests information 1(7 days before surgery and 3 days after surgery)
  • Laboratory tests information 2(7 days before surgery and 3 days after surgery)
  • Postoperative information 2(Postoperative in 30 days)
  • Postoperative information 4(Postoperative in 30 days)
  • Laboratory tests information 3(7 days before surgery and 3 days after surgery)
  • Laboratory tests information 4(7 days before surgery and 3 days after surgery)

研究者

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

Wenlong Yao (101480)

Associate professor and deputy chief physician

Tongji Hospital

研究点 (1)

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