Participation in international data registry: LVADs for recovery
Research type
Research Study
Full title
Participation in an international registry of patients supported with a left ventricular assist device until recovery of natural heart function (VAD WEAN study)
IRAS ID
339534
Contact name
Fernando Riesgo Gil
Contact email
Sponsor organisation
Montefiore Medical Center
Duration of Study in the UK
25 years, 0 months, 1 days
Research summary
A relatively small proportion (approx. 10%) of patients who undergo implantation of amechanical blood pump known as a long term implantable left ventricular assist device (LVAD, artificial heart) as a treatment for end stage heart failure recover natural heart function during LVAD support to a level commensurate with the removal of the LVAD without the concomitant need for a heart transplant. This treatment pathway is referred to as ‘bridging to recovery’. In the UK, individual centres typically implant around 30 long term LVADs per year. As a result, individual centre experience of bridging to recovery is very limited. The assessment of natural heart function during LVAD support is challenging and it has been difficult to identify reliable prognostic indicators of recovery. In spite of these challenges, Harefield Hospital has gained an international reputation for pioneering bridging to recovery practice.
In this initiative, we propose to collaborate with international doctors who share our particular interest in bridging to recovery and pool our experience in the form of a combined link-anonymised registry of patients who have undergone LVAD explantation as a bridge to recovery. We will include relevant clinical metrics including follow up (post-explantation) data in order to assess the durability of recovery. We will also collect prospective data and add this to the registry. This collaborative initiative will increase the statistical power beyond that achievable by individual centres. We anticipate that this will provide insights into the diagnostic utility of natural heart function assessment techniques and may allow us to identify prognostic markers of sustained recovery. Ultimately, we anticipate this will result in improved patient safety and treatment efficacy. We now seek approval by a Research Ethics Committee to allow us to share both retrospective and prospective patient data with the registry.REC name
Wales REC 5
REC reference
24/WA/0319
Date of REC Opinion
17 Oct 2024
REC opinion
Favourable Opinion