Aortic valve replacement in high risk patients: conventional surgery compared with catheter-based techniques

Completed

• Conditions: Severe aortic valve stenosis; Circulatory System; Nonrheumatic aortic valve disorders

• Registration Number: ISRCTN45792044
• Lead Sponsor: St George's Healthcare NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 657

Inclusion Criteria

1. After a multidisciplinary meeting, patients (both males ane females) with expected mortality >15% (Euroscore) and/or >10% (Society of Thoracic Surgeons Mortality Risk [STS] score)
2. Severe aortic stenosis, confirmed by trans-thoracic echocardiography using a combination of measurements of valve area and flow dependent indices (mean gradient >50 mmHg). Low dose dobutamine echocardiography is useful to differentiate between severe and the rare 'pseudo-severe' aortic stenosis in patients with low left ventricular ejection fraction and low gradient.
3. Severe aortic stenosis, +/- one vessel coronary artery disease amenable to percutaneous intervention
4. Age >70 (if age <70, need to have other significant comorbidities)
5. Symptomatic patients with New York Heart Association (NYHA) grade >II
6. Patients who are able to give consent
7. If it is thought that risks of mortality and morbidity with surgery outweigh the benefits, the patients will be randomised into cohort B

Exclusion Criteria

1. Aortic regurgitation
2. Patient preference - TAVI is not recommended for patients who simply refuse surgery on the basis of personal preference
3. Aortic annulus <18 or >25 mm for balloon expandable and <20 or >27 mm for self-expandable devices
4. Bicuspid aortic valve
5. Present of asymmetric heavy valvular calcification
6. Aortic root dimensions >4.5 cms
7. Presence of apical left ventricular thrombus
8. Evidence of acute myocardial infarction <30 days
9. Hypertrophic cardiomyopathy
10. Life expectancy <1 year due to non-cardiac causes

Specific contraindications for transfemoral approach:
1. Iliac arteries with severe calcification tortuousity and small diameter (6-9 mm), previous aorto-femoral bypass
2. Severe angulation of aorta and atheroma of the outcome and coaptation, aneurysm of the abdominal aorta with mural thrombus
3. Presence of bulky atherosclerosis of the ascending aorta and arch

Specific contraindications for the transapical approach:
1. Previous surgery of the left ventricle using a patch such as the Dor procedure
2. Calcified pericardium
3. Severe respiratory insufficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death within the first year

Secondary Outcome Measures

Name	Time	Method
The following will be assessed at 1, 3, 6 and 12 months for the first year, then 6-monthly until the end of 3rd year:<br>1. Evidence of prosthetic valve dysfunction<br>2. Postoperative bleeding<br>3. Freedom from major adverse cardiac and cerebrovascular complications <br>4. Heart block and need for pacemaker implantation<br>5. Conversion from TAVI, emergency valve surgery<br>6. Length of hospital stay and discharge to rehabilitation centre or home<br>7. Length of hospital stay <br>8. Improved quality of life, assessee by SF-36® Health Survey and Six-Minute Walk test