Trends in ICD Implantations and in-Hospital Outcomes After DOJ Investigation.
| Title: | Trends in ICD Implantations and in-Hospital Outcomes After DOJ Investigation. |
|---|---|
| Authors: | Bourdillon PM; The Division of Internal Medicine, University of Washington, Seattle, Washington.; Parzynski CS; Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, New Haven, Connecticut.; Minges KE; Section of Cardiology, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut; Department of Health Administration and Policy, University of New Haven, West Haven, Connecticut.; Curtis JP; Section of Cardiology, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Desai NR; Section of Cardiology, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut. Electronic address: nihar.desai@yale.edu. |
| Source: | Journal of cardiac failure [J Card Fail] 2022 Jan; Vol. 28 (1), pp. 154-160. Date of Electronic Publication: 2021 Oct 08. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Churchill Livingstone Country of Publication: United States NLM ID: 9442138 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-8414 (Electronic) Linking ISSN: 10719164 NLM ISO Abbreviation: J Card Fail Subsets: MEDLINE |
| Imprint Name(s): | Publication: : Philadelphia, PA : Churchill Livingstone; Original Publication: Naperville, IL : Churchill Livingstone, c1994- |
| MeSH Terms: | Heart Failure*/diagnosis ; Heart Failure*/epidemiology ; Heart Failure*/therapy ; Defibrillators, Implantable* ; Myocardial Infarction*; Death, Sudden, Cardiac/prevention & control ; Primary Prevention/methods ; United States/epidemiology ; Aged ; Hospitals ; Humans ; Medicare ; Registries |
| Abstract: | Background: The Department of Justice (DOJ) investigated implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria, resulting in increased adherence to the NCD criteria. Trends of the specific reasons for patients not meeting the NCD criteria and in-hospital outcomes for those patients are not known.; Methods and Results: We analyzed 300,151 primary-prevention ICDs from 2007-2015 at 1809 hospitals. We calculated the rates of in-hospital adverse events and the proportion of ICDs not meeting the 4 NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Most reductions in the use of devices in patients not meeting NCD criteria were in patients with recently diagnosed heart failure (15.5%-6.8% for settled; 13.5%-7.3% for nonsettled) and who had had a recent myocardial infarction (8.4%-1.3% for settled; 7.4% to 1.5% for nonsettled). Adverse-event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled; P < 0.001; 1.18 for nonsettled; P = 0.001).; Conclusions: After the investigation, there was a rapid reduction in the placement of ICDs in patients with recent acute myocardial infarction or recent diagnosis of heart failure. Patients who did not meet NCD criteria experienced more in-hospital adverse events and higher mortality rates.; (Copyright © 2021 Elsevier Inc. All rights reserved.) |
| Contributed Indexing: | Keywords: CMS (Centers for Medicare & Medicaid Services); DOJ (Department of Justice); ICD (implantable cardioverter defibrillator); NCD; National Coverage Determination; outcomes |
| Entry Date(s): | Date Created: 20211010 Date Completed: 20220228 Latest Revision: 20220907 |
| Update Code: | 20260130 |
| DOI: | 10.1016/j.cardfail.2021.09.010 |
| PMID: | 34628015 |
| Database: | MEDLINE |
Journal Article