Accuracy of Using 2D Transesophageal Echocardiography Compared to Balloon Sizing in Determining Valve Size During Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- accuracy of 2D transesophgeal echocardiography compared to balloon sizining in determining size of valve during TAVI
研究概览
简要总结
The method of transcatheter aortic valve implantation (TAVI) introduced in 2002 by Alain Cribier et al. has offered new prospects for patients with severe aortic stenosis and multiple comorbidities, who are at high operative risk(1).
The PARTNER series of randomized controlled trials has firmly established the role of TAVI with the balloon-expandable Edwards Sapien valve in patients with severe symptomatic aortic stenosis (AS) at prohibitive risk of surgery (PARTNER IA), high risk for surgery (PARTNER IB), and intermediate risk for surgery (PARTNER 2).(2)
Also PARTNER 3 and Evolut Low Risk trial strongly suggest that TAVI is not only a suitable alternative and may be superior to surgical aortic valve replacement ( SAVR) in low-risk patients.(2)
The accurate determination of the size of the implant is dependent on pre-procedural imaging. Annular measurements are important in the TAVI as inaccurate estimation can lead to complications e.g paravalvular leakage .(3) Transthoracic echocardiography (TTE), transoesophageal echocardiography (TOE), multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) have been extensively studied with respect to pre-procedural aortic annular sizing.(3).
However, even with some of the evidence returning a discrepancy in annular measurements between techniques, the literature to date does not clarify whether TOE undersizes inappropriately or appropriately with respect to MDCT.(3) In a recent study, 29.5% of patients would have been deemed ineligible for TAVI because of overestimation of annular measurements by MDCT, a figure reduced to 1.3% with the use of TOE (4)
In a recent small retrospective study, TOE, MDCT and MRI all performed comparatively well with device sizing. (5)
Balloon aortic valvuloplasty (BAV) dilatation before TAVI is considered a mandatory procedural step in the early years of TAVR. BAV is used to confirm annular sizing and to enhance trans-catheter heart valve (THV) deliverability.(6) However till now there is no comparison of annular measurement by 2D transesophgeal echocardiography with balloon sizing.
详细描述
Aim of work To compare accuracy of 2D transesophageal echocardiography versus balloon sizing in determining size of device during transcatheter aortic valve implantation and inhospital outcomes of this approach using 2D TEE and balloon sizing only during TAVI .
Patients and methods. The study will include (100) patients, prospective observational study
All patient will undergo :
1-Written consent. 2-Detailed history including symptoms (NYHA class) ,co morbidities 3-Clinical examination 4-Electrocardiogram (detection of conduction disturbance , ischemic changes). 5-Laboratory investigation (hemoglobin level, creatinine, glomerular filteration rate(GFR)) 6-Risk stratification: using STS score 6- Transthoracic Echocardiography: (7)
1-Assesment of aortic valve by
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
- •1-Patients must have severe degenerative high flow AS (echocardiographic criteria: aortic valve (AV) effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s) in presence of normal ejection fraction (EF).
- •2- Patients must be symptomatic from the AS (dyspnea in NYHA-class II or greater, angina pectoris, or syncope), or asymptomatic but with decreased left ventricular ejection fraction, positive stress test , Pulmonary hypertension (systolic pulmonary artery pressure >60 mmHg).
- •4-Symptomatic patients with severe low-flow, low-gradient (<40 mmHg) aortic stenosis with reduced ejection fraction and evidence of flow (contractile) reserve.
- •3- Patients surviveal time more than one year . 4- Patients have contraindications for open chest surgery, such as :
- •Presence of comorbidities not adequately reflected by risk scores.
- •Procelain aorta
- •Squelae of chest radiation.
- •Severe chest deformation or scoliosis.
- •Previous cardiac surgery
排除标准
- •Evidence of an acute myocardial infarction 30 days before the intended treatment.
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified.
- •Mixed aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+).
- •Hemodynamic or respiratory instability within 30 days of screening evaluation.
- •Need for emergency surgery for any reason.
- •Hypertrophic cardiomyopathy with or without obstruction.
- •Severe left ventricular dysfunction with LVEF <20%.
- •Severe pulmonary hypertension and RV dysfunction.
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation. . 10-A known contraindication to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
- •11-MRI confirmed stroke or transient ischemic attack within 6 months (180 days) of the procedure.
- •12-Renal insufficiency (creatinine >3mg) and / or end stage renal insufficiency requiring chronic dialysis at the time of screening.
- •13-Estimated life expectancy<12 month.
- •. 14-Severe incapacitating dementia 15-Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5 mm), protruding or ulcerated] or narrowing of the abdominal or thoracic aorta, severe tortuosity of the thoracic aorta.
- •Also a minimum iliac or femoral artery diameter of less than 6 mm may be deemed unsuitable for femoral approach.
- •16-Severe mitral regurgitation. 17-Annulus size out of range of available prosthese (<18mm and >29mm). 18-Untreated coronary artery disease requiring revascularization. 19- Elevated risk of coronary ostium obstruction (asymmetric valve calcification, short distance between annulus and coronary ostium less than 10mm.
结局指标
主要结局
accuracy of 2D transesophgeal echocardiography compared to balloon sizining in determining size of valve during TAVI
时间窗: 6 months
accuracy of 2D transesophgeal echocardiography compared to balloon sizining in determining size of valve during TAVI
次要结局
- in hospital outcomes of this approach using 2D TEE and balloon sizing only during TAVI(6 months)
研究者
Marwan Sayed Mahmoud
Assiut university Heart Hospital
Assiut University