None listed
Conditions
Brief summary
Traditionally, the only treatment options for patients diagnosed with severe aortic stenosis were relatively invasive interventions such as surgical aortic heart value replacement (SAVR) or balloon aortic valvuloplasty (BAV), or non-invasive treatment such as medical therapy. The preferred treatment option for patients with severe aortic stenosis has long-been surgical aortic value replacement (SAVR) due to the superior outcomes over medical therapy, however, a number of patients, such as those in advanced age with additional diseases, have not been suitable for surgery, often due to the considerable risks associated with surgical procedures in these patients. More recently, there has been the development of a procedure known as transcatheter aortic heart value implantation (TAVI) which is a less invasive surgical procedure than the standard surgical aortic valve replacement (SAVR) and has allowed doctors to treat patients with severe aortic stenosis who have previously not been suitable for the surgical intervention. This TAVI procedure could therefore be beneficial to many patients with severe aortic stenosis who have been considered too high-risk to undergo the standard surgical procedure and have had to rely on medical therapy alone. What we therefore aim to do in this study is to find out the value of the TAVI procedure in comparison to other treatment options, both surgical and non-surgical, by looking at patient outcomes, patient quality of life and cost effectiveness of those undergoing each of the treatment options.
Interventions
The primary comparison of this observational study is between patients receiving transcatheter aortic valve replacement (TAVR) and those not receiving any form of aortic value replacement. The secondary comparison of this observational study is between patients receiving transcatheter aortic valve replacement and surgical aortic valve replacement. Retrospective data will be used along with a small subset of eligible patients who will be prospectively recruited when placed on waiting lists for th
The primary comparison of this observational study is between patients receiving transcatheter aortic valve replacement (TAVR) and those not receiving any form of aortic value replacement. The secondary comparison of this observational study is between patients receiving transcatheter aortic valve replacement and surgical aortic valve replacement. Retrospective data will be used along with a small subset of eligible patients who will be prospectively recruited when placed on waiting lists for these procedures. This will enable completion of quality of life assessments (EQ-5D) at baseline and 12 months for quality of life modelling for health economic analysis. As such, prospective eligible patients will be reviewed when placed on the waiting list for procedures and will be recruited if eligible prior to any potential TAVI/SAVR procedures. This will enable completion of quality of life assessments (EQ-5D) at baseline and 12 months for quality of life modelling for health economic analysis. For prospective patients, the data will be collected until 12 months post-enrolment (as per the date of last data collection). For retrospective patients, data may be collected for up to 5 years prior to the date of last data collection.
Sponsors
Prof Derek Chew
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 65 years and above with clinical symptoms consistent with aortic stenosis, being syncope, exertional angina and congestive cardiac failure. 2. Echocardiographic evidence of severe aortic stenosis defined as an estimated aortic valve area of <1.0cm2
Exclusion criteria
1. Advanced malignancy defined as untreatable disease with a life-expectancy of <12 months, as determined by the treating oncology specialist. 2. Prior aortic valve surgery. 3. Aortic stenosis resulting from a congenital bicuspid aortic valve. 4. Patients already classified as requiring high-level care in a nursing home. 5. Cardiac Surgery requiring double (aortic and mitral) valve replacement.
Outcome results
None listed