Infective endocarditis after prosthetic valve replacement
Research type
Research Study
Full title
Infective endocarditis after valve replacement: outcomes after surgical and transcatheter valve implantation and the impact of the NICE 2008 guidelines on prosthetic valve endocarditis
IRAS ID
196230
Contact name
Bernard Prendergast
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Infective endocarditis (IE) is a life-threatening condition caused by infection within the heart, most commonly on a heart valve. IE is much more common in people who have undergone a heart valve replacement. Since 2007 a new keyhole method of heart valve replacement – transcatheter valve implantation (TVI) – has been available, which avoids the need for open heart surgery. TVI is mainly used for patients who are too frail to undergo open heart surgery.
There are very few studies examining the risk of IE after valve replacement by TVI. We want to understand how many patients develop this complication, which patients are affected, and to look at how many patients ultimately survive. We also plan to compare the risk of IE after TVI with the risk of IE after conventional open heart surgery. Finally, we will look at whether the number of heart valve replacement patients who develop IE has changed over time. Specifically, we want to study the numbers of patients with IE before and after 2008, when UK guidelines from NICE advised stopping antibiotics prescriptions for prevention of IE.
The study design is a retrospective cohort analysis. Patients who have undergone TVI will be identified from datasets held by the National Institute for Cardiovascular Outcomes Research (NICOR) - the UK TAVI registry (for transcatheter aortic valve intervention), the National Congenital Heart Disease Audit (for transcatheter pulmonary valve intervention), and the Adult Cardiac Surgery Audit (for surgical valve replacement). These NICOR datasets will then be linked to Hospital Episode Statistics to identify patients who have subsequently developed IE. Linkage will be conducted by the Health and Social Care Information Centre. To obtain information about the diagnosis and management of prosthetic valve IE, the research team will contact the consultant who performed the TVI procedure and request further specific information from the patient's record.
REC name
London - Bromley Research Ethics Committee
REC reference
16/LO/0275
Date of REC Opinion
3 Feb 2016
REC opinion
Favourable Opinion