Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy
Language English Country United States Media print-electronic
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
29157723
DOI
10.1016/j.hrthm.2017.11.020
PII: S1547-5271(17)31360-7
Knihovny.cz E-resources
- Keywords
- Defibrillation testing, Hypertrophic cardiomyopathy, Implantable cardioverter–defibrillator,
- MeSH
- Global Health MeSH
- Defibrillators, Implantable * MeSH
- Electrocardiography MeSH
- Cardiomyopathy, Hypertrophic mortality physiopathology therapy MeSH
- Incidence MeSH
- Single-Blind Method MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate trends MeSH
- Death, Sudden, Cardiac epidemiology prevention & control MeSH
- Prognosis MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) are considered to be at high risk for elevated defibrillation thresholds, periprocedural complications, and failed appropriate shocks. OBJECTIVE: The purpose of this study was to determine the value of defibrillation testing (DT) in HCM patients undergoing implantable cardioverter-defibrillator (ICD) insertion. METHODS: Defibrillation thresholds, perioperative complications, and long-term outcomes were compared between patients with HCM and those with ischemic cardiomyopathy (ICM) or dilated cardiomyopathy (DCM) enrolled in the SIMPLE (Shockless IMPLant Evaluation) trial (Clinialtrials.gov Identifier: NCT00800384). In patients with HCM, outcomes were also compared between those randomized to DT vs no DT. RESULTS: Adequate defibrillation safety margin without system change was achieved in 46 of 52 (88.5%) HCM and 948 of 1047 (90.5%) ICM/DCM patients (P = .63). Perioperative complications occurred in 1 of 52 (1.9%) HCM patients with DT compared to 67 of 1047 (6.4%) ICM/DCM patients with DT (P = .37) or 3 of 42 (7.1%) HCM patients without DT (P = .32). During follow-up, there was no significant difference between HCM vs ICM/DCM patients in terms of all-cause mortality (adjusted hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.45-2.34), composite of arrhythmic death or failed appropriate shock (adjusted HR 0.33, 95% CI 0.04-2.42), inappropriate shocks (adjusted HR 1.64, 95% CI 0.69-3.89), or system complications (adjusted HR 1.93, 95% CI 0.88-4.27). All-cause mortality (HR 0.26, 95% CI 0.03-2.20), appropriate (HR 0.24, 95% CI 0.03-2.05), and inappropriate shocks (HR 2.13, 95% CI 0.51-8.94) were similar in HCM patients without or those with DT. CONCLUSION: We did not find any difference in intraoperative defibrillation efficacy, perioperative complications, and long-term outcomes between patients with HCM and those with ICM/DCM. DT did not improve intraoperative or clinical shock efficacy in HCM patients.
Centre Hospitalier Universitaire Rennes France
Hospital de Santa Creu i Sant Pau Barcelona Spain
Institut Universitaire de Cardiologie et de Pneumologie de Québec Quebec Canada
Institute for Clinical and Experimental Medicine Prague Czech Republic
Karolinska Institute Stockholm Sweden
Klinikum Kassel Kassel Germany
Leiden University Medical Center Leiden the Netherlands
Leviev Heart Center Sheba Medical Center Tel Hashomer Israel
McMaster University Hamilton Ontario Canada
Population Health Research Institute Hamilton Ontario Canada
University Hospital Frankfurt Goethe University Frankfurt Germany
References provided by Crossref.org
ClinicalTrials.gov
NCT00800384