Anesthetic Management for TA-BSM in HOCM
- Conditions
- AnesthesiaHypertrophic CardiomyopathyTransapical Beating-heart Septal Myectomy
- Interventions
- Procedure: transapical beating-heart septal myectomy
- Registration Number
- NCT06397092
- Lead Sponsor
- Tongji Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Patients with hypertrophic cardiomyopathy
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Undergoing TA-BSM
- Cardiopulmonary bypass was used to assist the surgery.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TA-BSM transapical beating-heart septal myectomy The hypertrophic cardiomyopathy patients received TA-BSM
- Primary Outcome Measures
Name Time Method Perioperative information 1 During surgery, when use isoproterenol to provocate Heart reat
Perioperative information 3 During surgery, when use isoproterenol to provocate Diastolic arterial blood pressure
Perioperative information 7 Immediately after the surgery The usage of cardiovascular drugs
Perioperative information 5 Immediately after the surgery The type of tracheal tube
Perioperative information 2 During surgery, when use isoproterenol to provocate Systolic arterial blood pressure
Perioperative information 4 During surgery, when use isoproterenol to provocate Mean arterial blood pressure
Perioperative information 6 Immediately after the surgery The usage of anaesthetic drugs
Perioperative information 8 Immediately after the surgery Intraoperative infusion volume
Perioperative information 9 Immediately after the surgery Blood transfusion volume
Perioperative information 10 Immediately after the surgery Blood loss
- Secondary Outcome Measures
Name Time Method Postoperative information 1 Postoperative in 30 days Extubation time,
Postoperative information 3 Postoperative in 30 days The usagen of analgesic drug
Laboratory tests information 1 7 days before surgery and 3 days after surgery The changes of hemoglobin (Hb)
Laboratory tests information 2 7 days before surgery and 3 days after surgery the changes of creatinine (Cr)
Postoperative information 2 Postoperative in 30 days Postoperative pain score: Pain score evaluation was performed after surgery ( 0-10 stands for the degree of the pain, 0 for painless and 10 for twinge).
Postoperative information 4 Postoperative in 30 days Postoperative complications
Laboratory tests information 3 7 days before surgery and 3 days after surgery the changes of albumin (Alb)
Laboratory tests information 4 7 days before surgery and 3 days after surgery the changes of cardiac uhrasonography findings
Trial Locations
- Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
🇨🇳Wuhan, Hubei, China