Neurologic Evaluation of Patients After Transapical Beating-Heart Septal Myectomy

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TA-BSM<br>patients received transapical beating-heart septal myectomy | Procedure: Cardiac surgery<br>* 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.<br>|
| Cardiac surgery involving left heart operation<br>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 |