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Published on: February 28, 2012
Long-Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter-Defibrillator: UMBRELLA
Sem Briongos-Figuero1,2, Arcadio García-Alberola3, Jerónimo Rubio4
1Hospital Universitario Infanta Leonor Madrid Spain.
Insights
This large study shows contemporary implantable cardioverter-defibrillator (ICD) patients with heart failure have similar risks for life-saving interventions and death. Current ICD programming guidelines require better implementation for improved patient outcomes.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Research
Background:
- Large-scale studies on contemporary implantable cardioverter-defibrillator (ICD) populations are scarce.
- Understanding real-world outcomes in diverse ICD patient groups is crucial.
Purpose of the Study:
- To analyze arrhythmia incidence, device interventions, and mortality in a broad spectrum of real-world ICD patients.
- To evaluate risk factors associated with ICD therapies and mortality across different heart conditions.
Main Methods:
- Prospective, multicenter, nationwide UMBRELLA study with remote monitoring and blinded arrhythmia episode review.
- Follow-up of 4296 patients over a median of 46.6 months.
- Analysis of demographic data, cardiac diagnoses, ICD therapies, and mortality.
Main Results:
- Sustained ventricular arrhythmia occurred in 31.3% of patients; appropriate ICD therapy in 27.3%.
- Ischemic cardiomyopathy, dilated cardiomyopathy, and valvular heart disease increased risk for appropriate ICD therapies and mortality.
- Hypertrophic cardiomyopathy and Brugada syndrome showed lower risks for appropriate ICD therapies.
- Delayed high-rate detection and single-zone programming correlated with lower risk of first appropriate ICD therapy.
- Inappropriate shocks were low (6%) and reduced with SmartShock-capable devices.
Conclusions:
- Contemporary ICD patients with heart failure-related disorders share similar risks for life-saving interventions and mortality.
- Implementation of current ICD programming recommendations is essential for optimizing patient care.
- Device programming strategies, like delayed high-rate detection, may reduce unnecessary therapies without increasing mortality.
Abstract:
Background Large-scale studies describing modern populations using an implantable cardioverter-defibrillator (ICD) are lacking. We aimed to analyze the incidence of arrhythmia, device interventions, and mortality in a broad spectrum of real-world ICD patients with different heart disorders. Methods and Results The UMBRELLA study is a prospective, multicenter, nationwide study of contemporary patients using an ICD followed up by remote monitoring, with a blinded review of arrhythmic episodes. From November 2005 to November 2017, 4296 patients were followed up. After 46.6±27.3 months, 16 067 episodes of sustained ventricular arrhythmia occurred in 1344 patients (31.3%). Appropriate ICD therapy occurred in 27.3% of study population. Patients with ischemic cardiomyopathy (hazard ratio [HR], 1.51; 95% CI, 1.29-1.78), dilated cardiomyopathy (HR, 1.28; 95% CI, 1.07-1.53), and valvular heart disease (HR, 1.94; 95% CI, 1.43-2.62) exhibited a higher risk of appropriate ICD therapies, whereas patients with hypertrophic cardiomyopathy (HR, 0.72; 95% CI, 0.54-0.96) and Brugada syndrome (HR, 0.25; 95% CI, 0.14-0.45) showed a lower risk. All-cause death was 13.4% at follow-up. Ischemic cardiomyopathy (HR, 3.09; 95% CI, 2.58-5.90), dilated cardiomyopathy (HR, 3.33; 95% CI, 2.18-5.10), and valvular heart disease (HR, 3.97; 95% CI, 2.25-6.99) had the worst prognoses. Delayed high-rate detection was enabled in 39.7% of patients, and single-zone programming occurred in 52.6% of primary prevention patients. Both parameters correlated with lower risk of first appropriate ICD therapy, with no excess risk of mortality. The rate of inappropriate shocks at follow-up was low (6%) and did not differ among type of ICD but was lower in SmartShock-capable devices. Conclusions Irrespective of the cause, contemporary ICD patients with heart failure-related disorders had a similar risk of ICD life-saving interventions and death. Current ICD programming recommendations still need to be implemented. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NTC01561144.
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