Sudden Cardiac Death
Conditions
Keywords
subcutaneous implantable cardioverter defibrillator
Brief summary
The entirely subcutaneous implantable defibrillator (S-ICD) (Emblem, Boston Scientific, Marlborough, MA, USA) was introduced as a new therapeutic alternative to the conventional transvenous ICD in 2009 and implantations are rapidly expanding since then.1 Implantation of the S-ICD seems to reduce implant-related perioperative complications such as pneumothorax, hematoma and cardiac tamponade. The aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting.
Detailed description
The S-ICD has a CE mark and is FDA approved since 2012 and is mentioned as a potential therapy strategy in the current AHA guidelines on the management of patients with ventricular arrhythmias.2 However, although implant-related complications seem to be reduced by the S-ICD in randomized controlled trials, the rate of inappropriate shocks remains high in S-ICD patients (10-13%).3-5 The most common reason for inappropriate shocks is cardiac oversensing, mostly due to T-wave oversensing or low amplitude of the subcutaneous signal, which not commonly found in patients with transvenous ICDs. Data on the role of the Defibrillation Threshold Testing (DFT), the rate of infectious complications (lead or device complications), the use of the S-ICD in children and adolescents, and the outcome of patients with an S-ICD according to their underlying cardiac substrate are sparse. The aim of this multicenter registry is thus to assess the outcome of patients following an S-ICD implantation in a real-world setting with a special focus on perioperative complication rate, the role of DFT testing in S-ICD, the use of the S-ICD in cohorts that are underrepresented in clinical studies (adolescents and geriatrics), the outcome and risk factors of ineffective, inappropriate and appropriate shocks and the differences in outcomes according to the underlying cardiac disease.
Interventions
None listed
Sponsors
Prof. Jürgen Kuschyk, M.D
Giovanni Forleo, M.D.
Mauro Biffi, M.D.
University of Luebeck
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Implantation of an S-ICD, regardless of the technique * At least 1 month of follow up * At least 1 post-implantation assessment, in accordance to the routine clinical practice of every center (e.g. in person visit or remote follow up)
Exclusion criteria
\- none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall complication rate | through study completion, an average of 2 years | combination of device related complications and inappropriate shocks |
| Rate of appropriate shocks | through study completion, an average of 2 years | Appropriate therapies delivered by the devices |
| Rate of inappropriate shocks | through study completion, an average of 2 years | Inappropriate therapies delivered by the devices |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Role of Gender in primary outcomes | through study completion, an average of 2 year | Analysis of the potential role of gender on the primary outcomes |
| Device-related complication rate | immediately after the intervention/procedure/surgery | Rate of complications pertaining to the device |
| Rate of device upgrades | through study completion, an average of 2 year | need for device upgrade due to pacing needs |
| DFT impact | 2 year | Impact of defibrillator function test (DFT) on long term arrhythmia outcome or mortality |
| Rate of replacements | 2 year | Generator replacements |
Countries
Germany
Contacts
Primary ContactJulia Vogler, Dr.
Backup ContactCornelia Wolf
Outcome results
None listed