Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397092
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-07
Brief Title:
Anesthetic Management for TA-BSM in HOCM
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
Anesthetic Management for Transapical Beating-heart Septal Myectomy TA-BSM in Patients With Hypertrophic Obstructive Cardiomyopathy HOCMA Retrospective Analysis
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Weis 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 979 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 957 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
In order to solve this problem professor Weis 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 979 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 957 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None