How many patients with HCM meet the criteria for S/C ICD implant
Research type
Research Study
Full title
Assessment of the proportion of Patients with Hypertrophic Cardiomyopathy who meet the criteria for implantable cardiac defibrillator (ICD) therapy who meet the ECG screening criteria for the new Sub-Cutaneous ICD.
IRAS ID
145072
Contact name
Pier D Lambiase
Contact email
Sponsor organisation
Data and Information Manager
Research summary
The number of victims of sudden cardiac death (SCD) is in excess of 50,000 a year in the UK. The commonest cause of sudden cardiac death in young people is Hypertrophic Cardiomyopathy (HCM). This is a condition where the heart muscle becomes thickened abnormally and flow of blood leaving the heart is obstructed. HCM is the commonest inherited myocardial disease affecting 1 in 500 adults.
In order to prevent sudden cardiac death some patients receive an Implanteable Cardiac Defibrillator(IDC). This can prevent dangerous heart rhythms by delivering energy (a shock) to restart the heart back to normal rhythm. ICDs require a lead or wire that touches the inside surface of the heart via a vein, which is accessed under the collar bone.
Current guidelines recommend implantation of ICDs in HCM patients with a history of sustained ventricular arrhythmia or with clinical features associated with increased risk SCD.
However, these patients are often young and therefore their lifetime risk of device related complication is high. Common device related complication include wound infection, and lead complications including the requirement for implantation of new leads into the heart or removal of a lead from the patient’s heart. This carries significant morbidity to patients as well as a small but not insignificant mortality risk.
Recently newer implantable defibrillators have been developed that can deliver a shock to reset dangerous heart rhythms by siting under the surface of the skin, offering cosmetic and complication related advantages. In order to assess whether a patient is suitable for these newer subcutaneous ICD’s (SC-ICD)an ECG must be performed and its shape is analysed against pre-defined algorithms to assess whether a patient is suitable for the devise. This study will assess what proportion of patients of patients with indications for an ICD would be meet the criteria for SC-ICD.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0163
Date of REC Opinion
21 Feb 2014
REC opinion
Favourable Opinion