Surgical and Transcatheter treatment of PIVSD
Research type
Research Study
Full title
Comparison of surgical and transcatheter repair of post infarct ventricular septal rupture: an observational study of UK cases
IRAS ID
293741
Contact name
Joel P Giblett
Contact email
Sponsor organisation
Liverpool Heart and Chest Hospital
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Post infarct ventricular septal rupture is a rare complication (0.2%) of a heart attack where dying heart muscle between the two main pumping chambers of the hear tears, and creates a hole between them. The complication is fatal if left untreated with a mortality of more than 95% at one month. The traditional treatment for this is open heart surgery to repair the defect, but even with this the mortality is between 30 and 60%.
An alternative treatment is a transcatheter repair. Here a device is inserted using a keyhole technique from the groin and deployed in the defect to close the hole. In recent years increasingly advanced devices have been developed for this purpose, and the risk of this procedure has been similar to surgery in case series. No head to head data has ever been compared, and given the rarity of the condition it is challenging to design a randomised trial to compare the techniques. The largest case series published includes just 52 patients.
This study involves gathering demographic, procedural and outcome data for all patients who have undergone a surgical or transcatheter repair of a post infarct ventricular septal rupture in the UK since 2000. All data is already in the existing patient notes and no contact with patients will be required. The aim is to compare in hospital mortality, and long term survival for "all comers" to help guide decision making regarding which patients may benefit from which treatment.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0079
Date of REC Opinion
24 Mar 2021
REC opinion
Favourable Opinion