Daniel J Friedman1, Craig S Parzynski2, Paul D Varosy3, Jordan M Prutkin4, Kristen K Patton4, Ali Mithani5, Andrea M Russo5, Jeptha P Curtis2, Sana M Al-Khatib1. 1. Division of Cardiology, Duke University Hospital, Durham, North Carolina2Duke Clinical Research Institute, Durham, North Carolina. 2. Yale University School of Medicine, New Haven, Connecticut. 3. Veterans Affairs Eastern Colorado Health Care System, Denver5Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora. 4. Division of Cardiology, University of Washington, Seattle. 5. Cooper Medical School of Rowan University, Camden, New Jersey.
Abstract
Importance: Trends and in-hospital outcomes associated with early adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the United States have not been described. Objectives: To describe early use of the S-ICD in the United States and to compare in-hospital outcomes among patients undergoing S-ICD vs transvenous (TV)-ICD implantation. Design, Setting, and Participants: A retrospective analysis of 393 734 ICD implants reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD registry, between September 28, 2012 (US Food and Drug Administration S-ICD approval date), and March 31, 2015, was conducted. A 1:1:1 propensity-matched analysis of 5760 patients was performed to compare in-hospital outcomes among patients with S-ICD with those of patients with single-chamber (SC)-ICD and dual-chamber (DC)-ICD. Main Outcomes and Measures: Analysis of trends in S-ICD adoption as a function of total ICD implants and comparison of in-hospital outcomes (death, complications, and defibrillation threshold [DFT] testing) among S-ICD and TV-ICD recipients. Results: Of the 393 734 ICD implants evaluated during the study period, 3717 were S-ICDs (0.9%). A total of 109 445 (27.8%) of the patients were female; the mean (SD) age was 67.03 (13.10) years. Use of ICDs increased from 0.2% during the fourth quarter of 2012 to 1.9% during the first quarter of 2015. Compared with SC-ICD and DC-ICD recipients, those with S-ICDs were more often younger, female, black, undergoing dialysis, and had experienced prior cardiac arrest. Among 2791 patients with S-ICD who underwent DFT testing, 2588 (92.7%), 2629 (94.2%), 2635 (94.4%), and 2784 (99.7%) were successfully defibrillated (≤65, ≤70, ≤75, and ≤80 J, respectively). In the propensity-matched analysis of 5760 patients, in-hospital complication rates associated with S-ICDs (0.9%) were comparable to those of SC-ICDs (0.6%) (P = .27) and DC-ICD rates (1.5%) (P = .11). Mean (SD) length of stay after S-ICD implantation was comparable to that after SC-ICD implantation (1.1 [1.5] vs 1.0 [1.2] days; P = .77) and less than after DC-ICD implantation (1.1 [1.5] vs 1.2 [1.5] days; P < .001). Conclusions and Relevance: The use of S-ICDs is rapidly increasing in the United States. Early adoption has been associated with low complication rates and high rates of successful DFT testing despite frequent use in patients with a high number of comorbidities.
Importance: Trends and in-hospital outcomes associated with early adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the United States have not been described. Objectives: To describe early use of the S-ICD in the United States and to compare in-hospital outcomes among patients undergoing S-ICD vs transvenous (TV)-ICD implantation. Design, Setting, and Participants: A retrospective analysis of 393 734 ICD implants reported to the National Cardiovascular Data Registry ICD Registry, a nationally representative US ICD registry, between September 28, 2012 (US Food and Drug Administration S-ICD approval date), and March 31, 2015, was conducted. A 1:1:1 propensity-matched analysis of 5760 patients was performed to compare in-hospital outcomes among patients with S-ICD with those of patients with single-chamber (SC)-ICD and dual-chamber (DC)-ICD. Main Outcomes and Measures: Analysis of trends in S-ICD adoption as a function of total ICD implants and comparison of in-hospital outcomes (death, complications, and defibrillation threshold [DFT] testing) among S-ICD and TV-ICD recipients. Results: Of the 393 734 ICD implants evaluated during the study period, 3717 were S-ICDs (0.9%). A total of 109 445 (27.8%) of the patients were female; the mean (SD) age was 67.03 (13.10) years. Use of ICDs increased from 0.2% during the fourth quarter of 2012 to 1.9% during the first quarter of 2015. Compared with SC-ICD and DC-ICD recipients, those with S-ICDs were more often younger, female, black, undergoing dialysis, and had experienced prior cardiac arrest. Among 2791 patients with S-ICD who underwent DFT testing, 2588 (92.7%), 2629 (94.2%), 2635 (94.4%), and 2784 (99.7%) were successfully defibrillated (≤65, ≤70, ≤75, and ≤80 J, respectively). In the propensity-matched analysis of 5760 patients, in-hospital complication rates associated with S-ICDs (0.9%) were comparable to those of SC-ICDs (0.6%) (P = .27) and DC-ICD rates (1.5%) (P = .11). Mean (SD) length of stay after S-ICD implantation was comparable to that after SC-ICD implantation (1.1 [1.5] vs 1.0 [1.2] days; P = .77) and less than after DC-ICD implantation (1.1 [1.5] vs 1.2 [1.5] days; P < .001). Conclusions and Relevance: The use of S-ICDs is rapidly increasing in the United States. Early adoption has been associated with low complication rates and high rates of successful DFT testing despite frequent use in patients with a high number of comorbidities.
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