Isuru Ranasinghe, MBChB, MMed, PhD; Craig S. Parzynski, MS; James V. Freeman, MD, MPH; Rachel P. Dreyer, PhD; Joseph S. Ross, MD, MHS; Joseph G. Akar, MD, PhD; Harlan M. Krumholz, MD, MS; Jeptha P. Curtis, MD
This article was published at www.annals.org on 3 May 2016.
Disclaimer: The National Cardiovascular Data Registry (NCDR) Implantable Cardioverter-Defibrillator Registry is an initiative of the American College of Cardiology Foundation with partnering support from the Heart Rhythm Society. The views expressed in this article are those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies (identified at CVQuality.ACC.org/NCDR).
Financial Support: By the National Health and Medical Research Council and the National Heart Foundation of Australia (early career fellowship; Dr. Ranasinghe); the National Heart, Lung, and Blood Institute (grant K23 HL118147-01 to Dr. Freeman and grant 1U01HL105270-03 [Center for Cardiovascular Outcomes Research at Yale–New Haven Hospital] to Drs. Krumholz and Curtis); the National Institute on Aging (grant K08 AG032886; Dr. Ross); the American Federation for Aging Research through the Paul B. Beeson Career Development Award Program (Dr. Ross); and the American College of Cardiology NCDR (salary support; Dr. Curtis).
Disclosures: Dr. Ranasinghe reports grants from the American College of Cardiology Foundation, the National Health and Medical Research Council of Australia, and the National Heart Foundation of Australia during the conduct of the study. Mr. Parzynski reports that the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital is contracted as an analytic center for the American College of Cardiology. Dr. Freeman reports a contract with the NCDR ICD Registry (for Center for Outcomes Research and Evaluation at Yale–New Haven Hospital) during the conduct of the study. Dr. Ross reports grants from the U.S. Food and Drug Administration, Medtronic, Johnson & Johnson, the Centers for Medicare & Medicaid Services, and Blue Cross Blue Shield Association outside the submitted work. Dr. Krumholz reports personal fees from UnitedHealth; other from Johnson & Johnson (Janssen), Medtronic, and the Centers for Medicare & Medicaid Services; and grants from the U.S. Food and Drug Administration outside the submitted work. Dr. Curtis reports grants from the National Heart, Lung, and Blood Institute outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2732.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available from Dr. Ranasinghe (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Isuru Ranasinghe, MBChB, MMed, PhD, Discipline of Medicine, Level 5B, The Queen Elizabeth Hospital, 29 Woodville Road, Woodville South, South Australia 5011, Australia; e-mail, email@example.com.
Current Author Addresses: Dr. Ranasinghe: Discipline of Medicine, Level 5B, The Queen Elizabeth Hospital, 29 Woodville Road, Woodville South, South Australia 5011, Australia.
Drs. Freeman, Dreyer, Ross, Akar, Krumholz, and Curtis and Mr. Parzynski: Center for Outcomes Research and Evaluation, 1 Church Street, New Haven, CT 06510.
Author Contributions: Conception and design: J.P. Curtis, R.P. Dreyer, J.V. Freeman, I. Ranasinghe.
Analysis and interpretation of the data: J.G. Akar, J.P. Curtis, R.P. Dreyer, J.V. Freeman, C.S. Parzynski, I. Ranasinghe, J.S. Ross.
Drafting of the article: R.P. Dreyer, J.V. Freeman, C.S. Parzynski, I. Ranasinghe.
Critical revision for important intellectual content: J.G. Akar, J.P. Curtis, J.V. Freeman, H.M. Krumholz, I. Ranasinghe, J.S. Ross.
Final approval of the article: J.G. Akar, J.P. Curtis, R.P. Dreyer, J.V. Freeman, H.M. Krumholz, C.S. Parzynski, I. Ranasinghe, J.S. Ross.
Statistical expertise: C.S. Parzynski.
Obtaining of funding: H.M. Krumholz, I. Ranasinghe.
Administrative, technical, or logistic support: H.M. Krumholz, I. Ranasinghe.
Collection and assembly of data: J.V. Freeman, I. Ranasinghe.
Ranasinghe I., Parzynski C., Freeman J., Dreyer R., Ross J., Akar J., Krumholz H., Curtis J.; Long-Term Risk for Device-Related Complications and Reoperations After Implantable Cardioverter-Defibrillator Implantation: An Observational Cohort Study. Ann Intern Med. 2016;165:20-29. doi: 10.7326/M15-2732
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Published: Ann Intern Med. 2016;165(1):20-29.
Published at www.annals.org on 3 May 2016
Long-term nonfatal outcomes after implantable cardioverter-defibrillator (ICD) placement are poorly defined.
To determine the long-term risk for ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications, and to assess associated patient and device characteristics.
Observational cohort study of ICD implantations from the National Cardiovascular Data Registry ICD registry linked with Medicare fee-for-service claims data.
1437 U.S. hospitals.
114 484 patients aged 65 years or older (mean, 74.8 years [SD, 6.2]; 72.4% male) receiving an ICD for the first time from 2006 to 2010 (single-chamber, 19.8%; dual-chamber, 41.3%; cardiac resynchronization therapy with a defibrillator [CRT-D], 38.9%).
Rate and cumulative incidence of ICD-related complications requiring reoperation or hospitalization and reoperation for reasons other than complications.
During a median follow-up of 2.7 years (interquartile range, 1.8 to 3.9 years), 40 072 patients died, representing 12.6 (95% CI, 12.5 to 12.7) deaths per 100 patient-years of follow-up. When the risk for death was accounted for, there were 6.1 (CI, 6.0 to 6.2) ICD-related complications per 100 patient-years that required reoperation or hospitalization and 3.9 (CI, 3.8 to 4.0) reoperations per 100 patient-years for reasons other than complications. Overall, 10 patients had complications or reoperation per 100 patient-years of follow-up. Younger age at implantation (65 to 69 vs. >85 years) (hazard ratio [HR], 1.55 [CI, 1.43 to 1.69]), receipt of a CRT-D device (HR, 1.38 [CI, 1.31 to 1.45]) versus a single-chamber device, female sex (HR, 1.16 [CI, 1.12 to 1.21]), and black race (HR, 1.14 [CI, 1.05 to 1.23]) were associated with the greatest increased risks for ICD-related complications.
The analysis was limited to Medicare fee-for-service patients aged 65 years or older.
Patients have a high rate of device-related complications and reoperation for other causes after ICD implantation. Risks of ICD implantation and strategies to reduce them should be actively considered before implantation.
American College of Cardiology Foundation's National Cardiovascular Data Registry.
Tom F Brouwer, MD, Reinoud E Knops, MD.
University of Amsterdam
June 8, 2016
Conflict of Interest:
Disclosure: Knops received personal fees and research grants from Boston Scientific, Medtronic and St. Jude Medical.
Ranasinghe and colleagues' are lauded for their unique analysis of long-term outcomes of implantable cardioverter-defibrillator (ICD) therapy in contemporary cohort of over one-hundred thousand patients.(1) They demonstrated a high rate of complications and reoperations both for complications and for other reasons after transvenous ICD implantation. However, the authors describe that lead-complication occur early with a slow linear increase thereafter, but that generator reoperations increase progressively in the latter years. However, no details are provided about the percentage/rate of leads that are replaced during generator reoperations. In figure 1D generator replacements with and without lead- or pocket-related complications are combined. This seems like a missed opportunity, as lead failures are an important concern for both physicians and patients, as lead failures often result in inappropriate shocks, complications, underdetection of lethal ventricular arrhythmias and inability to treat ventricular arrhythmias. In clinical practice, leads with adequate function are not replaced during generator replacement, but when leads fail the generator may be replaced in the same procedure when the projected longevity would require an additional procedure in the near future. Moreover, specific details about the need for lead replacement during long-term follow-up would be very valuable. Many small observational studies on lead survival have been combined in a meta-analysis of almost 50.000 patients with 136.000 lead-years and a median follow-up between two and three years.(2) They observed an incidence of 0.93 lead failures per 100 lead-years (95% CI 0.88–0.98). In addition, the hazard for lead failure is likely not to be proportional over time. As visually presented by Maisel et al, leads that have been implanted longer are more likely to fail, most likely because older leads have endured more mechanical stress.(3) Ranasinghe and colleagues' study would be more valuable is they could provide more details on the rate and cumulative incidence of lead failure in this long-term metadata cohort. 1. Ranasinghe I, Parzynski CS, Freeman J V, Dreyer RP, Ross JS, Akar JG, et al. Long-Term Risk for Device-Related Complications and Reoperations After Implantable Cardioverter-Defibrillator Implantation: An Observational Cohort Study. Ann Intern Med May 3. [Epub ahead of print]2. Providência R, Kramer DB, Pimenta D, Babu GG, Hatfield L a., Ioannou A, et al. Transvenous Implantable Cardioverter‐Defibrillator (ICD) Lead Performance: A Meta‐Analysis of Observational Studies. J Am Heart Assoc. 2015;4(11):3. Maisel WH, Kramer DB. Implantable cardioverter-defibrillator lead performance. Circulation. 2008;117:2721–3.
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