Long-Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter-Defibrillator: UMBRELLA Study Final Results

J Am Heart Assoc. 2021 Jan 5;10(1):e018108. doi: 10.1161/JAHA.120.018108. Epub 2020 Dec 25.


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.

Trial registration: ClinicalTrials.gov NCT01561144.

Keywords: all‐cause death; appropriate implantable cardioverter‐defibrillator therapy; implantable cardioverter‐defibrillator; inappropriate shock; sustained ventricular arrhythmia.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cohort Studies
  • Defibrillators, Implantable* / adverse effects
  • Defibrillators, Implantable* / classification
  • Defibrillators, Implantable* / statistics & numerical data
  • Electric Countershock* / adverse effects
  • Electric Countershock* / instrumentation
  • Electric Countershock* / methods
  • Electric Countershock* / statistics & numerical data
  • Equipment Failure Analysis
  • Female
  • Heart Diseases / classification
  • Heart Diseases / complications
  • Heart Diseases / mortality
  • Heart Diseases / therapy
  • Heart Failure / complications
  • Heart Failure / mortality
  • Heart Failure / therapy
  • Humans
  • Male
  • Middle Aged
  • Mortality
  • Needs Assessment
  • Preventive Health Services / methods
  • Preventive Health Services / statistics & numerical data
  • Risk Assessment
  • Spain / epidemiology
  • Survival Analysis
  • Tachycardia, Ventricular* / epidemiology
  • Tachycardia, Ventricular* / therapy

Associated data

  • ClinicalTrials.gov/NCT01561144