Trial success for less invasive life-saving cardiac procedure

A nationwide study led by Leicester academics has shown that a less invasive procedure to treat a common heart problem is just as effective as open-heart surgery.

Funded by the National Institute for Health Research (NIHR), the £3million trial compared Transcatheter Aortic Valve Implantation (TAVI) with surgical aortic valve replacement in patients with severe aortic stenosis (a narrowing of the aortic valve) who were at increased risk from surgery.

Given the current constraints on theatre-based surgical procedures and risks to patients during hospitalisation during the COVID-19 pandemic, TAVI can be performed with a minimally-invasive approach, local anaesthesia and rapid mobilisation and discharge.

In this major UK trial, involving 913 patients, the rates of death (from any cause) and other important clinical outcomes such as stroke at one year were similar between the TAVI group and the surgery group.

TAVI patients spent less time in hospital after the procedure and less time in intensive care. They were also more likely to be discharged directly home. There was greater improvement in symptoms, functional capacity and quality of life at six weeks in the patients who received TAVI although the improvement was similar between the two groups at one year.

Professor William Toff, Professor of Cardiology in the University of Leicester’s Department of Cardiovascular Sciences and the NIHR Leicester Biomedical Research Centre said: “TAVI offers an alternative and less invasive treatment option for patients who are at increased risk from open-heart surgery.

“This trial confirms the effectiveness of the TAVI strategy in a real-world setting - it wasn’t only conducted at the best centres or limited to a particular valve under ideal conditions. This was TAVI as it is in the real world compared with surgery as it is in the real world.”

The TAVI procedure involves threading a new valve through a small tube into an artery in the groin, upper arm or chest. TAVI patients had a lower risk of major bleeding but a higher rate of vascular complications and aortic regurgitation (back-flow through or around the valve) after the procedure. They were also more likely to need a pacemaker fitted. The researchers plan to continue to track outcomes for a minimum of five years.

Professor Toff continued: “The results from our trial are encouraging, but it’s essential that we continue to follow the patients in the longer term to ensure that the clinical benefits are sustained and that no late differences between the groups emerge.

“We need to know more about the long-term implications of the increased risk of aortic regurgitation after TAVI and to confirm the long-term durability of the TAVI valves. In the meantime, treatment recommendations should continue to be made by a multi-disciplinary heart team. Patients need to be fully informed about the alternative treatment options and their advantages and disadvantages.

“Notwithstanding the need for long-term outcome data, the findings are particularly reassuring during the current COVID-19 pandemic, when there are major constraints on theatre-based surgical procedures and risks to patients during hospitalisation. TAVI can be performed with a minimally-invasive approach, local anaesthesia and rapid mobilisation and discharge.”

The results of the UK TAVI trial were presented in the Annual Scientific Sessions of the American College of Cardiology, combined with the World Congress of Cardiology. The trial was funded by the NIHR Health Technology Assessment Programme and supported by the NIHR Leicester Biomedical Research Centre.

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