Presentation Abstract

Session: AOS.505.01-Heart Failure: Pacing, Outcomes and Future Device Interventions
Presentation: 9542 - Do ICDs Prevent Hip Fractures or Are Physicians Selecting Appropriate Candidates for ICDs?
Pres Time: Monday, Nov 18, 2013, 11:15 AM -11:30 AM
Location: Hall B-7
Pres. Time: Monday, Nov 18, 2013, 11:15 AM -11:30 AM
Specialty: +505. Heart Failure: Pacing and Other Therapeutic Devices
Keywords: Heart failure; Implantable cardioconvert defibrillator; Comparative effectiveness; Elderly; Outcomes
Authors: Soko Setoguchi, Duke Univ, Durham, NC; Lynne Warner Stevenson, Garrick G Stewart, Deepak L Bhatt, Brigham and Women's Hosp, Boston, MA; Andrew E. Epstein, Univ of Pennsylvania, Philadelphia, PA; Manisha Desai, Stanford Univ Sch of Med, Palo Alto, CA; Lauren Williams, Chih-Ying Chen, Brigham and Women's Hosp, Boston, MA
Abstract: Background: In real world practice, treatments are not randomly allocated but selected based on indications and other considerations. If not taken into account, these selection factors can impact comparative effectiveness estimates in observational studies.
Objective: To assess the potential contribution of unmeasured general health status to patient selection in assessing clinical effectiveness of ICDs for primary prevention.
Methods: Linking CMS ICD registry, National Cardiovascular Data Registry (NCDR®) ICD Registry™, a heart failure (HF) registry, and Medicare files (2005-2009), we identified HF patients ≥66 years who were eligible for primary prevention ICDs. We compared the risk of nontraumatic hip fracture, skilled nursing facility (SNF) admissions, and 30-day mortality between hospitalized HF patients with and without ICDs. Crude and adjusted hazard ratios were estimated by Cox proportional hazards regression.
Results: Compared with 17,853 patients without ICDs, 11,573 patients with ICDs were younger and had lower ejection fractions and more cardiac hospitalizations, but fewer noncardiac hospitalizations and comorbid conditions. Patients with ICDs had greater freedom from unrelated events: hip fracture (HR 0.39; 95% CI, 0.37-0.41, Figure), SNF admission (HR 0.53 95% CI, 0.50-0.55), and 30-day mortality (HR 0.10; 95% CI, 0.09-0.12%). After adjustment for multiple measured patient characteristics, risks in the two groups were less disparate but still substantially lower in ICD patients (HRs ranged from 0.20 to 0.84).
Conclusion: The lower risks of these outcomes likely reflect unmeasured differences in comorbidity burden and frailty. These findings highlight potential pitfalls of observational comparative effectiveness research. The findings also support that physicians in clinical practice consider general health status in selecting patients for ICD implantation, avoiding implantation in patients who are less likely to benefit.
Disclosures:   S. Setoguchi, Novartis, Affymax, Modest,Consultant/Advisory Board; Johnson and Johnson, Significant,Research Grant; L. Warner Stevenson, None; G.G. Stewart, None; D.L. Bhatt, Amarin, Significant,Research Grant; AstraZeneca, Significant,Research Grant; Bristol-Myers Squibb, Significant,Research Grant; Eisai, Significant,Research Grant; Ethicon, Significant,Research Grant; Medtronic, Significant,Research Grant; Sanofi Aventis, Significant,Research Grant; American College of Cardiology (Editor, Clinical Trials, Cardiosource), Significant,Honoraria; Duke Clinical Research Institute (clinical trial steering committees), Significant,Honoraria; Slack Publications (Chief Medical Editor, Cardiology Today‚Äôs Intervention), Significant,Honoraria; WebMD (CME steering committees), Significant,Honoraria; Elsevier Practice Update Cardiology, Modest,Consultant/Advisory Board; A.E. Epstein, Medtronic, Modest,Honoraria; Biotronik, Significant,Research Grant; Boston Scientific, Significant,Research Grant; Medtronic, Significant,Research Grant; St Jude Medical, Significant,Research Grant; Boston Scientific, Significant,Honoraria; St Jude Medical, Significant,Honoraria; M. Desai, None; L. Williams, None; C. Chen, None.



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