Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
Wuhan, Hubei, 430030, China
NCT Number: NCT06397092
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.
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Observational
Wuhan, Hubei, 430030, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients with hypertrophic cardiomyopathy undergoing TA-BSM
Time frame: During surgery, when use isoproterenol to provocate
Heart reat
Time frame: During surgery, when use isoproterenol to provocate
Systolic arterial blood pressure
Time frame: During surgery, when use isoproterenol to provocate
Diastolic arterial blood pressure
Time frame: During surgery, when use isoproterenol to provocate
Mean arterial blood pressure
Time frame: Immediately after the surgery
The type of tracheal tube
Time frame: Immediately after the surgery
The usage of anaesthetic drugs
Time frame: Immediately after the surgery
The usage of cardiovascular drugs
Time frame: Immediately after the surgery
Intraoperative infusion volume
Time frame: Immediately after the surgery
Blood transfusion volume
Time frame: Immediately after the surgery
Blood loss
Time frame: Postoperative in 30 days
Extubation time,
Time frame: 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).
Time frame: Postoperative in 30 days
The usagen of analgesic drug
Time frame: Postoperative in 30 days
Postoperative complications
Time frame: 7 days before surgery and 3 days after surgery
The changes of hemoglobin (Hb)
Time frame: 7 days before surgery and 3 days after surgery
the changes of creatinine (Cr)
Time frame: 7 days before surgery and 3 days after surgery
the changes of albumin (Alb)
Time frame: 7 days before surgery and 3 days after surgery
the changes of cardiac uhrasonography findings
Tongji Hospital
Other
Anesthetic Management for Transapical Beating-heart Septal Myectomy (TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM):A Retrospective Analysis
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