Anesthetic Management for TA-BSM in HOCM

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06397092
• Other study ID #: TongjiHospital-Anes QQ03
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with hypertrophic cardiomyopathy

• American Society of Anesthesiologists (ASA) physical status classification I-III

• Undergoing TA-BSM

Exclusion Criteria:

• Cardiopulmonary bypass was used to assist the surgery.

Related Conditions & MeSH terms

• Anesthesia
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Procedure:
• transapical beating-heart septal myectomy
The patients with hypertrophic cardiomyopathy undergoing TA-BSM

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative information 1	Heart reat	During surgery, when use isoproterenol to provocate
Primary	Perioperative information 2	Systolic arterial blood pressure	During surgery, when use isoproterenol to provocate
Primary	Perioperative information 3	Diastolic arterial blood pressure	During surgery, when use isoproterenol to provocate
Primary	Perioperative information 4	Mean arterial blood pressure	During surgery, when use isoproterenol to provocate
Primary	Perioperative information 5	The type of tracheal tube	Immediately after the surgery
Primary	Perioperative information 6	The usage of anaesthetic drugs	Immediately after the surgery
Primary	Perioperative information 7	The usage of cardiovascular drugs	Immediately after the surgery
Primary	Perioperative information 8	Intraoperative infusion volume	Immediately after the surgery
Primary	Perioperative information 9	Blood transfusion volume	Immediately after the surgery
Primary	Perioperative information 10	Blood loss	Immediately after the surgery
Secondary	Postoperative information 1	Extubation time,	Postoperative in 30 days
Secondary	Postoperative information 2	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 in 30 days
Secondary	Postoperative information 3	The usagen of analgesic drug	Postoperative in 30 days
Secondary	Postoperative information 4	Postoperative complications	Postoperative in 30 days
Secondary	Laboratory tests information 1	The changes of hemoglobin (Hb)	7 days before surgery and 3 days after surgery
Secondary	Laboratory tests information 2	the changes of creatinine (Cr)	7 days before surgery and 3 days after surgery
Secondary	Laboratory tests information 3	the changes of albumin (Alb)	7 days before surgery and 3 days after surgery
Secondary	Laboratory tests information 4	the changes of cardiac uhrasonography findings	7 days before surgery and 3 days after surgery