Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results
Why the study?
Do new-generation ICDs with novel discrimination algorithms and modern programming strategies prevent inappropriate shocks in patients with an indication for ICD implantation?
Population
2790 patients with approved indication for ICD implantation
Design
Cohort
Follow-up
mean 22 months (minimum 12 months)
Authors
Discussion
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Member takes
Implication
Modern ICD programming supports low inappropriate shock rates in practice; leaves open randomized confirmation of chamber-specific differences.
Key Points
- The study aimed to evaluate new-generation implantable cardioverter-defibrillators using advanced discrimination algorithms to reduce inappropriate shocks.
- Prospective, multicenter clinical trial enrolled 2790 patients indicated for ICD implantation.
- Patients followed for at least 12 months, with a mean follow-up of 22 months.
- Primary endpoint was percentage of patients free of inappropriate shocks at 1 year, analyzed for both dual/triple and single-chamber ICDs.
- Inappropriate shock rate at 1 year was 1.5% for dual/triple-chamber ICDs and 2.5% for single-chamber devices.
- Two years postimplant, inappropriate shock rate was 2.8% for dual/triple and 3.7% for single-chamber ICDs.
- Most inappropriate shocks were due to atrial fibrillation or flutter.
Structured PICO
Do new-generation ICDs with novel discrimination algorithms and modern programming strategies prevent inappropriate shocks in patients with an indication for ICD implantation?
P
Population
2790 patients with approved indication for ICD implantation (79% male, mean age 65 years; 69% primary prevention indication, 27% single-chamber ICD, 33% replacement or upgrade)
I
Intervention
New-generation implantable cardioverter-defibrillators (ICDs) with novel discrimination algorithms (SmartShock Technology) and modern programming strategies
O
Outcome
Percentage of patients remaining free of inappropriate shocks at 1 year postimplantsafety
The adoption of novel enhanced detection algorithms and modern programming strategies in ICDs leads to very low inappropriate shock rates at 1 and 2 years.
Cite This Study
Auricchio et al. (2015) studied this question.