Isuru Ranasinghe, MBChB, MMed(ClinEpi), PhD; Clementine Labrosciano, BSc, BHlthSc(Hons); Dennis Horton, BCompSci(Hons); Anand Ganesan, MBBS, PhD; Jeptha P. Curtis, MD; Harlan M. Krumholz, MD, SM; Andrew McGavigan, MBChB, MD; Sadia Hossain, PhD; Tracy Air, BA(Hons), MBiostat; Saranya Hariharaputhiran, MD
Grant Support: By grant IRUA2015149 from The Hospitals Contribution Fund (HCF) Research Foundation, with additional funding from the National Heart Foundation of Australia and The Hospital Research Foundation.
Disclosures: Dr. Ranasinghe reports grants from The HCF of Australia Research Foundation, National Heart Foundation of Australia, and The Hospital Research Foundation during the conduct of the study. Dr. Ganesan reports personal fees from Bayer outside the submitted work. Dr. Curtis reports salary support from the Centers for Medicare & Medicaid Services (CMS) for measure development and from the American College of Cardiology for analytic services, and equity ownership in Medtronic, outside the submitted work. Dr. Krumholz reports personal fees from UnitedHealth, IBM Watson Health, Element Science, and Aetna; ownership in Hugo; contracts with CMS; and grants from Medtronic and the U.S. Food and Drug Administration and from Medtronic and Johnson & Johnson, outside the submitted work. Dr. McGavigan reports personal fees from Abbott and Boston Scientific and grants from Biotronik and Medtronic, 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=M18-2810.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive 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. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor, Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available from Dr. Ranasinghe (e-mail, email@example.com).
Corresponding Author: Isuru Ranasinghe, MBChB, MMed(ClinEpi), PhD, DX 465701, Basil Hetzel Institute, 28 Woodville Road, Woodville South, South Australia 5011, Australia; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Ranasinghe, Hossain, and Hariharaputhiran; Ms. Labrosciano; Mr. Horton; and Ms. Air: DX 465701, Basil Hetzel Institute, 28 Woodville Road, Woodville South, South Australia 5011, Australia.
Drs. Ganesan and McGavigan: Flinders Medical Centre, GPO Box 2100, Adelaide 5001, South Australia, Australia.
Drs. Curtis and Krumholz: Center for Outcomes Research and Evaluation, 1 Church Street, Suite 200, New Haven, CT 06510.
Author Contributions: Conception and design: I. Ranasinghe, C. Labrosciano, D. Horton, A. McGavigan, S. Hossain, S. Hariharaputhiran.
Analysis and interpretation of the data: I. Ranasinghe, D. Horton, A. Ganesan, H.M. Krumholz, A. McGavigan, T. Air.
Drafting of the article: I. Ranasinghe, C. Labrosciano, S. Hossain, T. Air, S. Hariharaputhiran.
Critical revision for important intellectual content: I. Ranasinghe, C. Labrosciano, D. Horton, A. Ganesan, J.P. Curtis, H.M. Krumholz, A. McGavigan, S. Hossain, T. Air, S. Hariharaputhiran.
Final approval of the article: I. Ranasinghe, C. Labrosciano, D. Horton, A. Ganesan, J.P. Curtis, H.M. Krumholz, A. McGavigan, S. Hossain, T. Air, S. Hariharaputhiran.
Statistical expertise: D. Horton.
Obtaining of funding. I. Ranasinghe.
Administrative, technical, or logistic support: I. Ranasinghe, S. Hossain.
Collection and assembly of data: I. Ranasinghe, D. Horton, S. Hossain, T. Air.
Cardiovascular implantable electronic devices (CIEDs) are associated with procedure-related complications, yet little is known about variation in complication rates among institutions that may suggest disparities in care quality.
To assess institutional variation in risk-standardized complication rates (RSCRs) for CIED.
174 hospitals in Australia and New Zealand, 98 of which implanted at least 25 CIEDs during the study period.
81 304 patients older than 18 years (mean, 74.7 years [SD, 12.4]; 37.9% female) who received a new CIED (65 711 permanent pacemakers [PPMs] and 15 593 implantable cardioverter-defibrillators [ICDs]) in 2010 to 2015.
RSCRs and frequencies of major device-related complications during hospitalization or within 90 days of discharge.
Of the cohort, 6664 patients (8.2%) had a major complication. Although complication rates were higher for ICDs than PPMs (10.04% vs. 7.76%), 76.5% of all complications were attributable to PPMs (5098 vs. 1566 for ICDs). Among hospitals that implanted at least 25 CIEDs, the median RSCR was 8.1%; however, rates varied from 5.3% to 14.3%, with 22 hospitals identified as having RSCRs that differed significantly from the national average. Similar variation was observed when RSCRs for PPM implantation (n = 96 hospitals) (median RSCR, 7.6% [range, 5.4% to 12.9%]) were considered separately from those for ICD placement (n = 68 hospitals) (median RSCR, 9.7% [range, 6.2% to 16.9%]) and persisted when only elective procedures were assessed (n = 88 hospitals) (median RSCR, 7.4% [range, 4.7% to 13.0%]).
Possible unmeasured confounding from the use of administrative data.
CIED complications are common and vary among hospitals, suggesting institutional variation in CIED care quality. Concerted clinical and policy interventions are needed to address CIED-related complications. These efforts should preferentially target PPMs, because most CIED complications are attributable to these devices.
The Hospitals Contribution Fund Research Foundation.
Ranasinghe I, Labrosciano C, Horton D, Ganesan A, Curtis JP, Krumholz HM, et al. Institutional Variation in Quality of Cardiovascular Implantable Electronic Device Implantation: A Cohort Study. Ann Intern Med. [Epub ahead of print 30 July 2019]:. doi: 10.7326/M18-2810
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Published: Ann Intern Med. 2019.
Cardiology, Hospital Medicine, Rhythm Disorders and Devices.
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