Cardiac Surgery Involving Left Heart Operation, Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Magnetic Resonance Imaging \(MRI\), Neurologic Evaluation, Transapical Beating-Heart Septal Myectomy
Conditions
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.
Interventions
PROCEDURECardiac 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.
Sponsors
Xiang Wei
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of diffusion-weighted MRI lesions | 3 months | the number (n) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months |
| The volume of new brain lesions measured by diffusion-weighted MRI | 3 months | the volume (mL) of new brain lesions measured by diffusion-weighted magnetic resonance imaging (DW-MRI) in 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| montreal cognitive assessment | 7 days and 3 months | montreal cognitive assessment evaluating mild cognitive impairment, ranging from 0 to 30, in which higher scores mean a better outcome. |
| national Institute of Health stroke scale | 7 days and 3 months | national Institute of Health stroke scale evaluating mild cognitive impairment, ranging from 0 to 42, in which higher scores mean a worse outcome. |
| neurologic injury | 7 days and 3 months | The number of participants (n) with neurological events and cognitive dysfunction following transapical beating-heart septal myectomy |
| symbol digit modalities test | 7 days and 3 months | symbol digit modalities test evaluating mild cognitive impairmentt, ranging from 0 to 90, in which higher scores mean a better outcome. |
| trail-making-test | 7 days and 3 months | trail-making-test evaluating mild cognitive impairment, in which the longer time mean a worse outcome. |
| modified rankin scale | 7 days and 3 months | modified rankin scale evaluating mild cognitive impairment, ranging from 0 to 6, in which higher scores mean a worse outcome. |
| all-cause and cardiovascular mortality | 7 days and 3 months | all-cause and cardiovascular mortality following transapical beating-heart septal myectomy |
Countries
China
Contacts
Primary ContactXiang Wei, M.D.
Backup ContactYue Chen, M.D.
Outcome results
None listed