Long-Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter-Defibrillator : UMBRELLA Study Final Results
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Journal of the American Heart Association - 10(2021), 1 vom: 05. Jan., Seite e018108 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Briongos-Figuero, Sem [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 18.10.2021 Date Revised 18.10.2021 published: Print-Electronic ClinicalTrials.gov: NCT01561144 Citation Status MEDLINE |
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| doi: |
10.1161/JAHA.120.018108 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM319208028 |
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| 100 | 1 | |a Briongos-Figuero, Sem |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Long-Term Outcomes Among a Nationwide Cohort of Patients Using an Implantable Cardioverter-Defibrillator |b UMBRELLA Study Final Results |
| 264 | 1 | |c 2021 | |
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| 500 | |a Date Completed 18.10.2021 | ||
| 500 | |a Date Revised 18.10.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT01561144 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a all‐cause death | |
| 650 | 4 | |a appropriate implantable cardioverter‐defibrillator therapy | |
| 650 | 4 | |a implantable cardioverter‐defibrillator | |
| 650 | 4 | |a inappropriate shock | |
| 650 | 4 | |a sustained ventricular arrhythmia | |
| 700 | 1 | |a García-Alberola, Arcadio |e verfasserin |4 aut | |
| 700 | 1 | |a Rubio, Jerónimo |e verfasserin |4 aut | |
| 700 | 1 | |a Segura, José María |e verfasserin |4 aut | |
| 700 | 1 | |a Rodríguez, Aníbal |e verfasserin |4 aut | |
| 700 | 1 | |a Peinado, Rafael |e verfasserin |4 aut | |
| 700 | 1 | |a Alzueta, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Martínez-Ferrer, José B |e verfasserin |4 aut | |
| 700 | 1 | |a Viñolas, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a Fernández de la Concha, Joaquín |e verfasserin |4 aut | |
| 700 | 1 | |a Anguera, Ignasi |e verfasserin |4 aut | |
| 700 | 1 | |a Martín, María |e verfasserin |4 aut | |
| 700 | 1 | |a Cerdá, Laia |e verfasserin |4 aut | |
| 700 | 1 | |a Pérez, Luisa |e verfasserin |4 aut | |
| 700 | 0 | |a UMBRELLA Investigators * |e verfasserin |4 aut | |
| 700 | 1 | |a Pavón, Ricardo |e investigator |4 oth | |
| 700 | 1 | |a Arizón, José María |e investigator |4 oth | |
| 700 | 1 | |a Álvarez López, Miguel |e investigator |4 oth | |
| 700 | 1 | |a Alzueta, Javier |e investigator |4 oth | |
| 700 | 1 | |a Díaz Infante, Ernesto |e investigator |4 oth | |
| 700 | 1 | |a Calvo, David |e investigator |4 oth | |
| 700 | 1 | |a Rodríguez, Juan Carlos |e investigator |4 oth | |
| 700 | 1 | |a Rodríguez, Aníbal |e investigator |4 oth | |
| 700 | 1 | |a Álvarez, Luis |e investigator |4 oth | |
| 700 | 1 | |a Olalla, Juanjo |e investigator |4 oth | |
| 700 | 1 | |a Jiménez Díaz, Javier |e investigator |4 oth | |
| 700 | 1 | |a Balaguer, Javier |e investigator |4 oth | |
| 700 | 1 | |a Arias, Miguel Ángel |e investigator |4 oth | |
| 700 | 1 | |a Rubio, Jerónimo |e investigator |4 oth | |
| 700 | 1 | |a Fidalgo, Marisa |e investigator |4 oth | |
| 700 | 1 | |a García, Francisco-Javier |e investigator |4 oth | |
| 700 | 1 | |a Viñolas, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Brugada, Josep |e investigator |4 oth | |
| 700 | 1 | |a Anguera, Ignasi |e investigator |4 oth | |
| 700 | 1 | |a Villuendas, Roger |e investigator |4 oth | |
| 700 | 1 | |a Porro, Rosa |e investigator |4 oth | |
| 700 | 1 | |a Fernández de la Concha, Joaquín |e investigator |4 oth | |
| 700 | 1 | |a Pérez, Luisa |e investigator |4 oth | |
| 700 | 1 | |a García Campo, Enrique |e investigator |4 oth | |
| 700 | 1 | |a Fernández Lozano, Ignacio |e investigator |4 oth | |
| 700 | 1 | |a Villacastín, Julián |e investigator |4 oth | |
| 700 | 1 | |a Arenal, Ángel |e investigator |4 oth | |
| 700 | 1 | |a Muñoz Aguilera, Roberto |e investigator |4 oth | |
| 700 | 1 | |a Hernández, Antonio |e investigator |4 oth | |
| 700 | 1 | |a Peinado, Rafael |e investigator |4 oth | |
| 700 | 1 | |a García Alberola, Arcadio |e investigator |4 oth | |
| 700 | 1 | |a Pérez Lorente, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Basterra, Nuria |e investigator |4 oth | |
| 700 | 1 | |a Arcocha, María Fe |e investigator |4 oth | |
| 700 | 1 | |a Bodegas, Andrés |e investigator |4 oth | |
| 700 | 1 | |a Zumalde, Francisco |e investigator |4 oth | |
| 700 | 1 | |a Martínez Ferrer, José B |e investigator |4 oth | |
| 700 | 1 | |a Porres, José María |e investigator |4 oth | |
| 700 | 1 | |a Moreno Arribas, José |e investigator |4 oth | |
| 700 | 1 | |a Ruiz, Ricardo |e investigator |4 oth | |
| 700 | 1 | |a Quesada, Aurelio |e investigator |4 oth | |
| 700 | 1 | |a Martínez, Juan Gabriel |e investigator |4 oth | |
| 700 | 1 | |a Sancho-Tello, María José |e investigator |4 oth | |
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