title: In-hospital complications associated with reoperations of implantable cardioverter defibrillators.
abstract: Repeat implantable cardioverter defibrillator (ICD) procedures are increasing and may be associated with higher risks for complications. To provide more information for clinical decision making, especially in light of recent defibrillator advisories, we examined a large national cohort to characterize repeat ICD procedural outcomes. Using data from the National Cardiovascular Data Registry (ICD Registry), we compared patient characteristics, reasons for ICD implantation, and associated in-hospital adverse events among 92,751 patients receiving their first device and 81,748 patients who underwent repeat procedures with (n = 31,057) and without (n = 50,691) lead involvement. Hierarchical multivariable logistic regression was used to determine the predictors of in-hospital complications. Complication rates were higher in those who underwent repeat ICD procedures with lead involvement (lead implantation or revision), compared with patients who underwent initial implants (3.2% vs 2.6%, p <0.001) or versus those with pocket-only (e.g., generator change only) procedures (3.2% vs 0.6%, p <0.001). There were significantly more in-hospital deaths, lead dislodgements, and infections requiring antibiotics in the lead involvement cohort. Compared with those who had a pocket-only procedure, the multivariable adjusted odds ratio of any complication were increased at 4.20 (95% confidence interval: 3.66 to 4.82, p <0.001) in patients who underwent repeat procedures with lead involvement excluding lead extraction or 7.11 (95% confidence interval: 5.96 to 8.48, p <0.001) in procedures involving lead extractions. In conclusion, repeat ICD procedures, when involving the addition or revision of a lead with or without concurrent lead extraction, are associated with higher complication rates compared with initial implants and with those who underwent pocket-only procedures.
authors.affiliation: Section of Cardiac Electrophysiology, Department of Cardiology, University of Colorado, Aurora, Colorado.
authors.forename: David A
authors.initials: DA
authors.lastname: Steckman
authors.affiliation: Section of Cardiac Electrophysiology, Department of Cardiology, University of Colorado, Aurora, Colorado; University of Colorado Denver, VA Eastern Colorado Health Care System, Denver, Colorado; Colorado Cardiovascular Outcomes Research (CCOR) Group, Denver, Colorado.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Varosy
authors.affiliation: Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Craig S
authors.initials: CS
authors.lastname: Parzynski
authors.affiliation: Colorado Cardiovascular Outcomes Research (CCOR) Group, Denver, Colorado.
authors.forename: Frederick A
authors.initials: FA
authors.lastname: Masoudi
authors.affiliation: Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Jeptha P
authors.initials: JP
authors.lastname: Curtis
authors.affiliation: Section of Cardiac Electrophysiology, Department of Cardiology, University of Colorado, Aurora, Colorado.
authors.forename: William H
authors.initials: WH
authors.lastname: Sauer
authors.affiliation: Section of Cardiac Electrophysiology, Department of Cardiology, University of Colorado, Aurora, Colorado. Electronic address: duy.t.nguyen@ucdenver.edu.
authors.forename: Duy T
authors.initials: DT
authors.lastname: Nguyen
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000628:therapy*; D003430:Cross-Sectional Studies; D017147:Defibrillators, Implantable; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007297:Inpatients; D007902:Length of Stay / Q000639:trends; D008297:Male; D016017:Odds Ratio; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D019919:Prosthesis Implantation / Q000009:adverse effects*; D012042:Registries; D012086:Reoperation / Q000009:adverse effects; D012189:Retrospective Studies; D012307:Risk Factors; D014481:United States / Q000453:epidemiology