Anesthetic Management for TA-BSM in HOCM

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Hypertrophic Cardiomyopathy; Transapical Beating-heart Septal Myectomy
• Intervention / Treatment: Procedure: transapical beating-heart septal myectomy

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2022 to January 2023 was extracted and screened according to the inclusion criteria and exclusion criteria

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TA-BSM; The hypertrophic cardiomyopathy patients received TA-BSM	Procedure: transapical beating-heart septal myectomy; The patients with hypertrophic cardiomyopathy undergoing TA-BSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative information 1	Heart reat	During surgery, when use isoproterenol to provocate
Perioperative information 2	Systolic arterial blood pressure	During surgery, when use isoproterenol to provocate
Perioperative information 3	Diastolic arterial blood pressure	During surgery, when use isoproterenol to provocate
Perioperative information 4	Mean arterial blood pressure	During surgery, when use isoproterenol to provocate
Perioperative information 5	The type of tracheal tube	Immediately after the surgery
Perioperative information 6	The usage of anaesthetic drugs	Immediately after the surgery
Perioperative information 7	The usage of cardiovascular drugs	Immediately after the surgery
Perioperative information 8	Intraoperative infusion volume	Immediately after the surgery
Perioperative information 9	Blood transfusion volume	Immediately after the surgery
Perioperative information 10	Blood loss	Immediately after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative information 1	Extubation time,	Postoperative in 30 days
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
Postoperative information 3	The usagen of analgesic drug	Postoperative in 30 days
Postoperative information 4	Postoperative complications	Postoperative in 30 days
Laboratory tests information 1	The changes of hemoglobin (Hb)	7 days before surgery and 3 days after surgery
Laboratory tests information 2	the changes of creatinine (Cr)	7 days before surgery and 3 days after surgery
Laboratory tests information 3	the changes of albumin (Alb)	7 days before surgery and 3 days after surgery
Laboratory tests information 4	the changes of cardiac uhrasonography findings	7 days before surgery and 3 days after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Wenlong Yao, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: TongjiHospital-Anes QQ03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No