Autologous Pericardial Tricuspid Reconstruction of Aortic Valve Leaflets (Ozaki Procedure) in Aortic Valve Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- aortic transvalvular gradient
研究概览
简要总结
Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients. A very promising technique with the potential benefits of dodging oral anticoagulation, foreign material, and suitable for patients with small aortic annuli and in infectious endocarditis.
Performing hemodynamic evaluation, assess the clinical implementation and report preliminary results at follow up .
详细描述
Heart valve disease signifies a severe growing public health problem in developing countries, with aortic valve stenosis being the most common issue. Heart valve disease is commonly initiated by atherosclerotic degenerative processes, congenital anomalies, or rheumatic process. Aortic valve replacement is the gold standard in the treatment of patients with severe aortic stenosis and aortic regurgitation. Mechanical valves are favoured in younger patients (<60 years) owing to longer life-time, whereas biological valves are used for elderly patients in order to evade oral anticoagulation.
Options for aortic valve disease have improved in the last era including replacement, repair, and reconstructive options. A variety of creative techniques including leaflet extensions, neo-leaflet creation, resuspension or plication of prolapsing leaflets, and commissuroplasty to repair valves have been officially become skilled at, specially in pediatric population . In adults, the introduction of trans-catheter aortic valve inserting now permits treatment of degenerative aortic stenosis in the oldest and the highest risk patients. However, surgical treatment choices for pediatric patients with complex congenital aortic valve disease stay restricted.
In recent years, much attention has been given to the Ozaki procedure, an alternative way of repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet reconstruction. Diseased leaflets are removed carefully. The distance between each commissure is measured with invented sizing apparatus. The new leaflet of the size corresponding to the measured value is trimmed with an original template from glutaraldehyde-treated autologous pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with each annulus. Commissural coaptation was secured with additional sutures. The coaptation of three new leaflets were always insured with direct vision.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with AV disease.
- •Documented symptomatic moderate or greater aortic stenosis
- •small aortic annulus patients
- •A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation.
- •Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic valve (especially in paediatric population), and aortic valve cusp perforation from endocarditis.
- •Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.
排除标准
- •Patients with previous aortic valve surgery.
- •missing informed consent
- •Participation in another clinical research.
结局指标
主要结局
aortic transvalvular gradient
时间窗: at follow up frame through one year
analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography
次要结局
- number of patients developed complications(through one year)
- conduction disturbances(6 months post operative)
- Duration of hospitalization(average 5-7 days)
研究者
Mohammed Emad El-Dein Omar
specialist
Assiut University