Outcome prediction in patients with aortic stenosis after TAVI
Research type
Research Study
Full title
Observational study of outcome prediction in patients undergoing transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis (PREDICT-TAVI).
IRAS ID
319698
Contact name
Simon Redwood
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
Aortic stenosis (AS), is a condition in which the aortic valve becomes narrowed as people get older, causing the heart pump (the left ventricle) to struggle to push blood through it, leading to breathlessness, chest pain and blackouts. If left untreated, the prognosis is bleak (similar to lung cancer). Previously the only effective treatment for AS was a valve replacement via open heart surgery, which was too high risk for many patients to undergo, meaning they were left without treatment. Over the last decade transcatheter aortic valve implantation (TAVI) has emerged as a treatment option for most patients with severe symptomatic AS. In TAVI, a new valve is inserted through a small tube, usually in the leg artery, which avoids open heart surgery.
Clinical outcomes after TAVI have significantly improved with the accumulation of operator and institution experience as well as the wide use of newer generation devices. However, a significant minority of patients undergoing TAVI derive little or no benefit from the procedure. Nearly a third describe no improvement in quality of life, or die within the first year. To combat this problem, it is essential we develop more sophisticated means of predicting adverse outcomes related to TAVI, to improve the selection of patients and identify patients where the potential benefit of the procedure is outweighed by unfavourable outcomes.
TAVI-related complications, of which vascular complications are amongst the most common, can critically influence TAVI outcomes. These are associated with increased costs, longer hospitalisation, greater morbidity and mortality. Current means of predicting complications after TAVI are limited.
Assessment of physical recovery and improvement of symptoms and quality of life after TAVI is an important aspect of examining the outcomes of treatment. This is often a more meaningful and relevant treatment goal in the TAVI cohort than ‘hard’ clinical outcomes (like death and stroke) alone. Traditionally, less emphasis has been put on the assessment of the right side of the heart (the right ventricle) in evaluating physical recovery after TAVI.
We propose:
1. A retrospective study to create a tool for predicting the risk of clinical outcomes related to vascular complications in patients treated with TAVI.
2. A prospective study to evaluate the significance of the right side of the heart on the clinical outcomes related to functional recovery in patients undergoing TAVI.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0331
Date of REC Opinion
5 May 2023
REC opinion
Further Information Favourable Opinion