Clinical trial NCT06397092: Anesthetic Management for TA-BSM in HOCM
Official title: Anesthetic Management for Transapical Beating-heart Septal Myectomy (TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy (HOCM)：A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Transapical Beating-heart Septal Myectomy
Hypertrophic Cardiomyopathy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perioperative information 1
timeFrame: During surgery, when use isoproterenol to provocate
measure: Perioperative information 2
timeFrame: During surgery, when use isoproterenol to provocate
measure: Perioperative information 3
timeFrame: During surgery, when use isoproterenol to provocate
measure: Perioperative information 4
timeFrame: During surgery, when use isoproterenol to provocate
measure: Perioperative information 5
timeFrame: Immediately after the surgery
measure: Perioperative information 6
timeFrame: Immediately after the surgery
measure: Perioperative information 7
timeFrame: Immediately after the surgery
measure: Perioperative information 8
timeFrame: Immediately after the surgery
measure: Perioperative information 9
timeFrame: Immediately after the surgery
measure: Perioperative information 10
timeFrame: Immediately after the surgery
Secondary outcomes:
measure: Postoperative information 1
timeFrame: Postoperative in 30 days
measure: Postoperative information 2
timeFrame: Postoperative in 30 days
measure: Postoperative information 3
timeFrame: Postoperative in 30 days
measure: Postoperative information 4
timeFrame: Postoperative in 30 days
measure: Laboratory tests information 1
timeFrame: 7 days before surgery and 3 days after surgery
measure: Laboratory tests information 2
timeFrame: 7 days before surgery and 3 days after surgery
measure: Laboratory tests information 3
timeFrame: 7 days before surgery and 3 days after surgery
measure: Laboratory tests information 4
timeFrame: 7 days before surgery and 3 days after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wenlong Yao
role: PRINCIPAL_INVESTIGATOR
References: