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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06397092
Enrollment
120
Registered
2024-05-02
Start date
2022-04-01
Completion date
2024-03-31
Last updated
2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Hypertrophic Cardiomyopathy, Transapical Beating-heart Septal Myectomy

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.

Interventions

The patients with hypertrophic cardiomyopathy undergoing TA-BSM

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perioperative information 10Immediately after the surgeryBlood loss
Perioperative information 2During surgery, when use isoproterenol to provocateSystolic arterial blood pressure
Perioperative information 3During surgery, when use isoproterenol to provocateDiastolic arterial blood pressure
Perioperative information 4During surgery, when use isoproterenol to provocateMean arterial blood pressure
Perioperative information 5Immediately after the surgeryThe type of tracheal tube
Perioperative information 6Immediately after the surgeryThe usage of anaesthetic drugs
Perioperative information 7Immediately after the surgeryThe usage of cardiovascular drugs
Perioperative information 8Immediately after the surgeryIntraoperative infusion volume
Perioperative information 9Immediately after the surgeryBlood transfusion volume
Perioperative information 1During surgery, when use isoproterenol to provocateHeart reat

Secondary

MeasureTime frameDescription
Postoperative information 2Postoperative in 30 daysPostoperative 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 3Postoperative in 30 daysThe usagen of analgesic drug
Postoperative information 4Postoperative in 30 daysPostoperative complications
Laboratory tests information 17 days before surgery and 3 days after surgeryThe changes of hemoglobin (Hb)
Laboratory tests information 27 days before surgery and 3 days after surgerythe changes of creatinine (Cr)
Laboratory tests information 37 days before surgery and 3 days after surgerythe changes of albumin (Alb)
Laboratory tests information 47 days before surgery and 3 days after surgerythe changes of cardiac uhrasonography findings
Postoperative information 1Postoperative in 30 daysExtubation time,

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026