Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

A Prospective Cohort Study of Neurologic Evaluation in Patients Recevied Transapical Beating-heart Septal Myectomy or General Cardiac Surgery

The goal of this prospective cohort study is to evaluate the neurologic changes in patients that received transapical beating-heart septal myectomy. The main questions are: whether this novel operation way would cause neurologic impairment; whether this novel operation way have similar neurologic lesions, compared to other cardiac surgery ways. Participants will undergo detailed neurologic and cognitive assessment at baseline, after procedure, and at 30 days. Researchers will compare the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e. Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) to assess the safety of transapical beating-heart septal myectomy on nervous system.

Study Overview

• Status: Recruiting
• Conditions: Hypertrophic Obstructive Cardiomyopathy \(HOCM\); Neurologic Evaluation; Magnetic Resonance Imaging \(MRI\); Transapical Beating-Heart Septal Myectomy; Cardiac Surgery Involving Left Heart Operation
• Intervention / Treatment: Procedure: Cardiac surgery

Detailed Description

Nervous system complication is one of the common complications caused by cardiac surgery, including ischemic stroke, encephalopathy, neurocognitive dysfunction, which can increase the mortality of patients, hospitalization cost and lead to long-term quality of life impairment. At present, embolism is considered to be the main mechanism of postoperative nervous system complication. Imaging studies have confirmed that 30% to 50% of perioperative strokes are caused by brain embolism larger than 200 μm. For example, a study using diffusion-weighted magnetic resonance imaging (DW-MRI) found that 66% of patients who received aortic valve replacement had a new cerebral infarction with a brain injury volume of about 126 mm3. Recently, our team have invented a novel surgical method called transapical beating-heart septal myectomy (TA-BSM) to cure hypertrophic obstructive cardiomyopathy (HOCM). To date, this novel therapy displayed ideal effectiveness on these patients, however, whether this novel operation way would cause neurologic impairment is unclear. In this study, researchers will compare TA-BSM with cardiac surgery involving left heart operation, and analyze the clinically relevant manifestations and brain lesions measured by cognitive evaluation forms of the nervous system (i.e., Montreal cognitive assessment) and diffusion-weighted magnetic resonance imaging (DW-MRI) in these patients received above therapies. This study is to assess the safety of TA-BSM on nervous system and contributes the further improvement of this novel cardiac surgery.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Xiang Wei, M.D.; Phone Number: +8613995525956; Email: xiangwei@tjh.tjmu.edu.cn
• Study Contact Backup: Name: Yue Chen, M.D.; Phone Number: +8615623410310; Email: chenyue@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiang Wei, M.D.; Phone Number: +8613995525956; Email: xiangwei@tjh.tjmu.edu.cn
      • Contact: Jing Fang, M.D.; Phone Number: +8613296640596; Email: jingfang@hust.edu.cn

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

patients suffer from hypertrophic obstructive cardiomyopathy or the other cardiovascular disease and have to receive cardiac surgery involving left heart operation.

Description

Inclusion Criteria:

meets indications for transapical beating-heart septal myectomy procedure or these cardiac surgery involving left heart operation, such as hypertrophic obstructive cardiomyopathy, mitral valve prolapse, and ventricular septal defect; willing to comply with protocol-specified follow-up evaluations.

Exclusion Criteria:

severe brain infarction, such stroke and cerebral hemorrhage recently; the implantation of metal materials, including Pacemaker; not able to undergo MRI examination; peptic ulcer or recent gastrointestinal bleeding (<6 months); the history of myocardial infarction; cognitive impairment in the past; not able to finish nervous system evaluation scale.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TA-BSM; patients received transapical beating-heart septal myectomy	Procedure: Cardiac surgery; The TA-BSM group will undergo transapical beating-heart septal myectomy and the group of cardiac surgery involving left heart operation will udergo patients received cardiac surgery involving left heart operation, such as valvuloplasty, valve replacement, repair of auricular septal defect, repair of auricular/ventricular septal defect.
Cardiac surgery involving left heart operation; patients received cardiac surgery involving left heart operation, such as valvuloplasty, valve replacement, repair of auricular septal defect, repair of auricular/ventricular septal defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of diffusion-weighted MRI lesions	the number (n) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months	3 months
The volume of new brain lesions measured by diffusion-weighted MRI	the volume (mL) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurologic injury	The number of participants (n) with neurological events and cognitive dysfunction following transapical beating-heart septal myectomy	7 days and 3 months
all-cause and cardiovascular mortality	all-cause and cardiovascular mortality following transapical beating-heart septal myectomy	7 days and 3 months
montreal cognitive assessment	montreal cognitive assessment evaluating mild cognitive impairment, ranging from 0 to 30, in which higher scores mean a better outcome.	7 days and 3 months
national Institute of Health stroke scale	national Institute of Health stroke scale evaluating mild cognitive impairment, ranging from 0 to 42, in which higher scores mean a worse outcome.	7 days and 3 months
modified rankin scale	modified rankin scale evaluating mild cognitive impairment, ranging from 0 to 6, in which higher scores mean a worse outcome.	7 days and 3 months
symbol digit modalities test	symbol digit modalities test evaluating mild cognitive impairmentt, ranging from 0 to 90, in which higher scores mean a better outcome.	7 days and 3 months
trail-making-test	trail-making-test evaluating mild cognitive impairment, in which the longer time mean a worse outcome.	7 days and 3 months

Collaborators and Investigators

• Sponsor: Xiang Wei
• Investigators: Study Chair: Xiang Wei, M.D., Tongji Hospital

Publications and helpful links

General Publications

• Fang J, Wang R, Liu H, Su Y, Chen J, Han X, Wei Y, Chen Y, Cheng L, Wei X. Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):303-311. doi: 10.1093/icvts/ivz249.

Helpful Links

• Transapical septal myectomy in the beating heart via a minimally invasive approach: a feasibility study in swine

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 2023-S034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the conclusive participant data, after removing the individual information of privacy, will be uploaded as supporting information when publishing the current study
• IPD Sharing Time Frame: After the current study is published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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