Pilot HICD version 1
Research type
Research Study
Full title
Pilot study of Hypertrophic cardiomyopathy & Implantable Cardioverter Defibrillator: subcutaneous vs transvenous
IRAS ID
328127
Contact name
Syed Ahsan
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Hypertrophic cardiomyopathy (HCM) is a disorder that affects the heart muscle and can increase the risk of sudden cardiac death. Implantable cardioverter defibrillators (ICDs) are commonly used to prevent arrhythmic sudden cardiac death in high-risk patients with HCM. While both subcutaneous (SICD) and transvenous ICDs (TV ICD) have been shown to be effective in reducing the risk of sudden cardiac death through multi-center registries and two randomized control trials, there is limited evidence comparing the potential adverse complications of this modern approach in patients with HCM. The HCM population is unique due to the inherited nature of the disease, presenting in younger patients compared to previously studied cohorts of mostly ischaemic heart disease patients. HCM patients are generally more active and likely to achieve higher heart rates, increasing the chance of inappropriate ICD therapy, which is known to be a major limitation of device therapy in this cohort. Furthermore, younger patients require device therapy for a longer period, compounding the benefit of the SICD’s lack of transvenous lead positioning. Transvenous leads produce a higher risk of sepsis if they are infected and if there is a failure of the lead, extraction procedure carries a mortality risk.
The use of both devices is supported in the ESC guidance on management of HCM patients who need and ICD, but the level of evidence is low. Thus, adoption of the SICD has been limited due to the low level of evidence. The access to SICD therapy could prove to be beneficial to HCM patients if complications and inappropriate shocks are equivalent to TV ICD. We intend to add to this evidence to determine wither SICD therapy produces similar complications in the short term and should be considered alongside TV ICD for the protection of arrhythmic sudden death.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
23/NE/0218
Date of REC Opinion
19 Dec 2023
REC opinion
Further Information Favourable Opinion