Mate Vamos1, Jeff S Healey2, Jia Wang3, Stuart J Connolly4, Philippe Mabo5, Lieselot Van Erven6, Josef Kautzner7, Michael Glikson8, Jorg Neuzner9, Gilles O'Hara10, Xavier Vinolas11, Frederik Gadler12, Stefan H Hohnloser13. 1. University Hospital Frankfurt, Goethe University, Frankfurt, Germany. 2. McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada. 3. Population Health Research Institute, Hamilton, Ontario, Canada. 4. McMaster University, Hamilton, Ontario, Canada. 5. Centre Hospitalier Universitaire, Rennes, France. 6. Leiden University Medical Center, Leiden, the Netherlands. 7. Institute for Clinical and Experimental Medicine, Prague, Czech Republic. 8. Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Israel. 9. Klinikum Kassel, Kassel, Germany. 10. Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, Canada. 11. Hospital de Santa Creu i Sant Pau, Barcelona, Spain. 12. Karolinska Institute, Stockholm, Sweden. 13. University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: hohnloser@em.uni-frankfurt.de.
Abstract
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.
RCT Entities:
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/DCMpatients (P = .63). Perioperative complications occurred in 1 of 52 (1.9%) HCM patients with DT compared to 67 of 1047 (6.4%) ICM/DCMpatients 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/DCMpatients 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.
Authors: Gerrit Frommeyer; Florian Reinke; Dietrich Andresen; Thomas Kleemann; Stefan G Spitzer; Joachim Jehle; Johannes Brachmann; Christoph Stellbrink; Matthias Hochadel; Jochen Senges; Lars Eckardt Journal: Clin Res Cardiol Date: 2019-07-31 Impact factor: 5.460