Clinical Research
Heart Rhythm Disorders
Developing a Risk Model for In-Hospital Adverse Events Following Implantable Cardioverter-Defibrillator Implantation: A Report From the NCDR (National Cardiovascular Data Registry)

https://doi.org/10.1016/j.jacc.2013.09.079Get rights and content
Under an Elsevier user license
open archive

Objectives

To better inform patients and physicians of the expected risk of adverse events and to assist hospitals’ efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry.

Background

ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications.

Methods

We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry. The study group was divided into a derivation (70%) and a validation (30%) cohort. Multivariable logistic regression was used to identify factors associated with in-hospital adverse events (complications or mortality). A parsimonious risk score was developed on the basis of beta estimates derived from the logistic model. Hierarchical models were then used to calculate risk-standardized complication rates to account for differences in case mix and procedural volume.

Results

Overall, 4,388 patients (1.8%) experienced at least 1 in-hospital complication or death. Thirteen factors were independently associated with an increased risk of adverse outcomes. Model performance was similar in the derivation and validation cohorts (C-statistics = 0.724 and 0.719, respectively). The risk score characterized patients into low- and-high risk subgroups for adverse events (≤10 points, 0.3%; ≥30 points, 4.2%). The risk-standardized complication rates varied significantly across hospitals (median: 1.77, interquartile range 1.54, 2.14, 5th/95th percentiles: 1.16/3.15).

Conclusions

We developed a simple model that predicts risk for in-hospital adverse events among patients undergoing ICD placement. This can be used for shared decision making and to benchmark hospital performance.

Key Words

complication
implantable cardioverter-defibrillator
quality of care
registry

Abbreviations and Acronyms

CI
confidence interval(s)
CRT-D
cardiac resynchronization therapy with defibrillation
ICD
implantable cardioverter-defibrillator(s)
OR
odds ratio(s)
SCD
sudden cardiac death

Cited by (0)

This research was supported by the American College of Cardiology Foundation’s NCDR (National Cardiovascular Data Registry). The views expressed in this manuscript represent those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies identified at www.ncdr.com. Dr. Dodson was supported by a Training Grant in Epidemiologic Research on Aging (#T32 AG000158-24) from the National Institutes of Health/National Institute on Aging and a Clinical Research Loan Repayment Award from the National Institutes of Health/National Heart, Lung, and Blood Institute during the writing of this manuscript and is currently supported by the National Institute on Aging grant (#R03AG045067) and a T. Franklin Williams Scholarship Award (funding provided by: Atlantic Philanthropies, Inc.; the John A. Hartford Foundation; the Alliance for Academic Internal Medicine-Association of Specialty Professors; and the American College of Cardiology). Dr. Reynolds has received consulting fees from Medtronic. Dr. Peterson has received honoraria from Janssen, Eli Lilly, and Boehringer Ingelheim. Dr. Kremers has received consulting fees from Medtronic; has served on the Speakers’ Bureau of Boston Scientific; and owns equity in Boston Scientific. Dr. Mirro has received consulting fees from Zoll Medical, iRhythm, and McKesson; and has received grant support from St. Jude Medical. Dr. Curtis receives salary support from the American College of Cardiology National Cardiovascular Data Registry. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. ICD Registry is an initiative of the American College of Cardiology Foundation and the Heart Rhythm Society.