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Research

Real world effectiveness of primary implantable cardioverter defibrillators implanted during hospital admissions for exacerbation of heart failure or other acute co-morbidities: cohort study of older patients with heart failure

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h3529 (Published 14 July 2015) Cite this as: BMJ 2015;351:h3529
  1. Chih-Ying Chen, postdoctoral fellow1,
  2. Lynne Warner Stevenson, professor2,
  3. Garrick C Stewart, instructor2,
  4. Deepak L Bhatt, professor2,
  5. Manisha Desai, associate professor3,
  6. John D Seeger, assistant professor1,
  7. Lauren Williams, research assistant1,
  8. Jessica J Jalbert, postdoctoral fellow1,
  9. Soko Setoguchi, associate professor4
  1. 1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02120, USA
  2. 2Division of Cardiovascular Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02115, USA
  3. 3Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, CA 94305, USA
  4. 4Duke Clinical Research Institute, Durham, NC 27705, USA
  1. Correspondence to: S Setoguchi soko.setoguchi{at}duke.edu
  • Accepted 16 June 2015

Abstract

Objectives To examine the effectiveness of primary implantable cardioverter defibrillators (ICDs) in elderly patients receiving the device during a hospital admission for exacerbation of heart failure or other acute co-morbidities, with an emphasis on adjustment for early mortality and other factors reflecting healthy candidate bias rather than the effect of the ICD.

Design Retrospective cohort study.

Setting Linked data from the Centers for Medicare and Medicaid Services and American College of Cardiology-National Cardiovascular Data Registry ICD registry, nationwide heart failure registry, and Medicare claims data 2004-09.

Population 23 111 patients aged ≥66 who were admitted to hospital for exacerbation of heart failure or other acute co-morbidities and eligible for primary ICDs.

Main outcome measures All cause mortality and sudden cardiac death. Latency analyses with Cox regression were used to derive crude hazard ratios and hazard ratios adjusted for high dimension propensity score for outcomes after 180 days from index implantation or discharge.

Results Patients who received an ICD during a hospital admission had lower crude mortality risk than patients who did not receive an ICD (40% v 60% at three years); however, with conditioning on 180 day survival and with adjustment for high dimension propensity score, the apparent benefit with ICD was no longer evident for sudden cardiac death (adjusted hazard ratio 0.95, 95% confidence interval 0.78 to 1.17) and had a diminished impact on total mortality (0.91, 0.82 to 1.00). There were trends towards a benefit with ICD in reducing mortality or sudden cardiac death in patients who had had a myocardial infarction more than 40 days previously, left bundle branch block, or low serum B type natriuretic peptide; however, these trends did not reach significance.

Conclusion After adjustment for healthy candidate bias and confounding, the benefits of primary ICD therapy seen in pivotal trials were not apparent in patients aged 66 or over who received ICDs during a hospital admission for exacerbation of heart failure or other acute co-morbidities. Future research is warranted to further identify subgroups of elderly patients who are more likely to benefit from ICDs. Recognition of those patients whose dominant risk factors are from decompensated heart failure and non-cardiac co-morbidities will allow better focus on ICDs in those patients for whom the device offers the most benefit and provides meaningful prolonging of life.

Footnotes

  • We thank Jeptha Curtis of Yale School of Medicine and Yale-New Haven Hospital, Sherri Dodd of Medtronic, Kenneth Ellenbogen of Virginia Commonwealth University School of Medicine, Marcel E Salive of the National Institute of Aging at National Institutes of Health, and Lynette Voshage-Stahl of Boston Scientific for the guidance and expertise they contributed to this project by serving on the technical expert panel. We also thank Drew Pratt of the National Cancer Institute at the National Institutes of Health for his review of the manuscript. The views expressed in this article are those of the authors and do not represent opinions of the panel members.

  • This article was presented in part at the AHA Scientific Sessions 2013 on 18 November 2013 in Dallas, TX, and at the 2014 International Conference of Pharmacoepidemiology on 25 October 2014 in Taipei, Taiwan.

  • The views expressed in this article are those of the authors and do not represent policies of the AHRQ, CMS or the US DHHS. This manuscript was prepared while CYC was employed at Brigham and Women’s Hospital/Harvard Medical School. CYC is now a visiting scientist at the Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration. The opinions expressed in this work are the author’s own and do not reflect the view of the Food and Drug Administration, the Department of Health and Human Services, or the US government.

  • Contributors: SS and LWS contributed to the acquisition of the data. C-YC, SS and LWS developed the study design. C-YC, SS, and MD contributed to the analysis of the data. C-YC and SS drafted the manuscript. All authors contributed to the interpretation of the data and the revision of the work, and all approved the final version to be published. CYC and SS are the guarantors. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the US Department of Health and Human Services.

  • Funding: This project is funded by contract No HHSA290-2005-0016-I -TO3 from the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services (DHHS) as part of the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) program, IAA Contract 500-2010-00001I TO6 and CEA Contract 500-2010-00001I TO2 from the Centers for Medicare and Medicaid Services (CMS), US DHHS. The funding agency had no role in the design and conduct of the study and in the collection, analysis, and interpretation of the data. The manuscript was based on a report done under contract to AHRQ; AHRQ had the draft report reviewed by independent peer reviewers before acceptance of the final report.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work. SS is supported by a mid-career development award grant K02-HS017731 from the AHRQ, US DHHS. She also reported receiving research support from Johnson and Johnson and receiving personal income for consulting from Sanofi-Aventis. SS has made available online a detailed listing of financial disclosures (http://www.dcri.duke.edu/about-us/conflict-of-interest/). JDS is a paid consultant to Optum Insight and WHISCON. DBL discloses the following relationship— advisory board: Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; board of directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; chair: American Heart Association Get With The Guidelines Steering Committee; data monitoring committees: Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Population Health Research Institute; honorariums: American College of Cardiology (senior associate editor, Clinical Trials and News, ACC.org), Belvoir Publications (editor in chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (editor in chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (associate editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), WebMD (CME steering committees); other: Clinical Cardiology (deputy editor); research funding: Amarin, AstraZeneca, Biotronik, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi Aventis, St. Jude Medical, The Medicines Company; trustee: American College of Cardiology; unfunded research: FlowCo, PLx Pharma, Takeda.

  • Ethical approval: This study was approved by the institutional review board of Brigham and Women’s Hospital (IRB No 2009P002819).

  • Transparency: The lead authors, CYC and SS, affirm that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

  • Data sharing: No additional data available.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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