The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicenter registry designed to collect long term system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009.
- 1000 patients followed for 5 years post implant
- Includes both retrospective and prospective patients implanted since 2009
- Centers to be included from all current commercial countries
- QOL sub-study (not yet reported at the time of this interim analysis)
- ≥ 18yrs at time of consent*
- Eligible for implantation of an S-ICD System per local clinical guidelines or currently implanted with a S-ICD System
- Participation in any other investigational study that may interfere with interpretation of the study results
- Pace-terminable VT
- Previously implanted unipolar pacemakers
Definition of Complications
- Type I: caused by the S-ICD System
- Type II: caused by the S-ICD System user’s manual or labeling of the S-ICD System
- Type III: not caused by the S-ICD System but would not have occurred in the absence of the implanted S-ICD System
The interim results were published online in the European Heart Journal in March 2014.
Complications were defined as clinical events where mitigation required an invasive procedure. There were no electrode failures, no systemic blood infections related to the S-ICD System or Procedure and no endocarditis. Complications occurred in 29 patients giving a patient complication event rate of 6.4% at an average follow-up of 558 days. In 14 patients (3%) complications occurred in the first 30-day post implant, for a peri-operative complication-free rate of 97%.
Implant conversion testing
Of 393 patients with complete data, in all but 1 patient VT/VF was successfully converted (99.7%). Implant testing with shock energy of ≤65J was successful in 95% of patients.
Spontaneous Conversion Efficacy
Time to Therapy
|Included||15.1± 3.7 sec.|
|Spontaneous||17.5 ± 4.4|
- Therapy withheld in 13% of patients and 46% of stored episodes due to longer time to therapy
Inappropriate shocks were recorded in 32 patients over an average follow-up of 18 months (360 day inappropriate shock rate of 7%).
Dual zone programming (patients programmed with a conditional shock zone that applies SVT discrimination algorithms) had a 6.4% inappropriate shock rate (23/357) at an average follow-up of 558 days, while single zone programming had a 12% rate (9/74) [P = 0.09].
Inappropriate Shocks by Programming
One inappropriate therapy due to VF/SVT discrimination error within the conditional zone.