Magnetic Resonance Neurological Evaluation After Right Mini-thoracotomy Mitral Valve Surgery: Trans-thoracic Versus Endoaortic Clamp
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- MR microembolization
研究概览
简要总结
The purpose of this study is to prospectively evaluate major and minor neurologic events in patients undergoing right mini-thoracotomy mitral valve surgery and to compare different aortic clamping techniques; specifically, the endoaortic balloon with retrograde perfusion (Endoreturn) and the transthoracic clamp with retrograde perfusion. Major neurologic events will be evaluate through standard neurologic evaluation; minor neurologic events will be evaluate through magnetic resonance (MR) assessment.
The first aim of the study is to determine the number and impact of microembolic events during right mini-thoracotomy mitral valve surgery on clinical neurological status and on MR evaluation. The investigators also aim to determine if different techniques of aortic clamping may impact on early outcome.
Study hypothesis: despite recent concerns arising about endoaortic balloon with retrograde perfusion, the investigators expect to show equivalence in term of safety and effectiveness of this technique compared with the transthoracic clamp in a selected population.
详细描述
The incidence of neurologic events in right mini-thoracotomy mitral valve surgery compared with that of conventional surgery is a controversial issue and has been extensively studied. In the meta-analysis published by Modi et al, equal occurrence of neurologic events between patients who underwent MIMVS and those who underwent a median sternotomy was found. Conversely, the Thoracic Surgeons Adult Cardiac database and the Cleveland Clinic group concluded that the risk of stroke is significantly higher in the less invasive group.
Moreover, recent data have suggested that retrograde arterial perfusion, particularly in patients with severe arch/ascending aortic atherosclerosis, could be the source of the significant increase in the incidence of cerebral complications. The meta-analysis of Cheng, documents a 1.79 fold increase in the risk of stroke in the right thoracotomy group, but on subgroup analysis this appeared driven by a higher stroke risk in those studies reporting endoaortic balloon occlusion and not transthoracic clamping. Murzi et al. report a 4.28 fold increase in stroke risk with RAP in 1280 primary MIMVS patients. Grossi and colleagues show that the only significant risk factor for neurologic event was the use of retrograde perfusion in high-risk patients with aortic disease.
The purpose of this randomized blinded study is to prospectively evaluate major and minor neurologic events in patients undergoing right thoracotomy mitral valve surgery with retrograde perfusion and endoaortic balloon clamp (Endoreturn) or transthoracic clamp. Major neurologic events will be evaluate through standard neurologic evaluation; minor neurologic events will be evaluate through magnetic resonance assessment.
MR evaluation will be performed by blinded radiologists. MR will be performed with a 3T system (Philips INGENIA 3T). The protocol includes conventional sequences for the morphological and quantitative assessment (3D-FLAIR, 3D-T1-TSE, DWI, T2-FFE) and non conventional sequences for the white matter microstructural evaluation (Diffusion Tensor Imaging - DTI with fractional anisotropy and mean diffusivity). No contrast enhanced will be used.
Patients who have no contraindications will undergo cerebral MR before surgery as baseline assessment. Then, they will be randomized in one of the 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Indication for elective mitral valve surgery +/- tricuspid valve surgery through right mini-thoracotomy.
- •No contraindication for MR
排除标准
- •Neuro-cognitive diseases;
- •Peripheral vascular disease;
- •Atrial fibrillation;
- •PFO o interatrial defect;
- •Previous Stroke;
- •Autoimmune diseases;
- •Neoplastic diseases;
- •Migraine;
- •Celiac disease;
- •Alchool or drug abuse;
- •Contraindication for MR.
结局指标
主要结局
MR microembolization
时间窗: untill 3 days after surgical procedure
To determine the incidence of new lesions on pre-discharge MR in patients undergoing right mini-thoracotomy mitral valve surgery according to different aortic clamping techniques.
Clinical events and MR outcome correlation
时间窗: untill 3 days after surgical procedure
To assess the correlation between clinical neurological peri-procedural events (TIA, Stroke), cognitive / neuropsychological status and the occurrence of new lesions on pre-discharge MR.
次要结局
- Evolution of MR lesions(3 month follow up)
研究者
Cristina Barbero
Cardiothoracic Surgeon
University of Turin, Italy
