The International SubcutaneouS Implantable Cardioverter Defibrillator Registry (iSuSI)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Device-related complication rate [immediately after the intervention/procedure/surgery"]
Rate of complications pertaining to the device
- DFT impact [2 year]
Impact of defibrillator function test (DFT) on long term arrhythmia outcome or mortality
- Rate of replacements [2 year]
Generator replacements
- 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
- Rate of device upgrades [through study completion, an average of 2 year]
need for device upgrade due to pacing needs
Eligibility Criteria
Criteria
Inclusion Criteria:
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Implantation of an S-ICD, regardless of the technique
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At least 1 month of follow up
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinic for Rhythmology | Luebeck | Schleswig Holstein | Germany | 23538 |
Sponsors and Collaborators
- University of Luebeck
- Prof. Jürgen Kuschyk, M.D
- Giovanni Forleo, M.D.
- Mauro Biffi, M.D.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISuSI 1.0