Author + information
- Received April 15, 2019
- Revision received August 28, 2019
- Accepted August 28, 2019
- Published online October 30, 2019.
- Seyed Mohammadreza Hosseini, MDa,b,∗,
- Guy Rozen, MD, MHAa,b,∗,
- M. Ihsan Kaadan, MD, MSa,b,
- Jennifer Galvin, PA-Ca and
- Jeremy N. Ruskin, MDa,b,∗ ()
- aCardiac Arrhythmia Service, Massachusetts General Hospital, Boston, Massachusetts
- bDepartment of Medicine, Harvard Medical School, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Jeremy N. Ruskin, Cardiac Arrhythmia Service, Massachusetts General Hospital, 55 Fruit Street, Boston, Massachusetts 02114.
Objectives The aim of this study was to investigate the safety and in-hospital outcomes of transcutaneous lead extraction (TLE) associated with device-related infection (DRI) in the United States from 2003 to 2015.
Background DRI remains the most serious complication and the most common indication for lead extraction in patients with cardiac implantable electronic devices. The rates of DRI and associated lead extraction have been growing in line with the increasing number of cardiac implantable electronic device implantations worldwide.
Methods Data for this study were drawn from the National (Nationwide) Inpatient Sample. The International Classification of Diseases-Ninth Revision-Clinical Modification coding system was used to identify hospitalizations with TLE for DRI and to investigate the rates of major adverse events.
Results From a total of approximately 100 million unweighted hospitalizations over the 13-year study period, 12,257 unweighted observations were identified. This represents 59,082 (95% confidence interval [CI]: 58,982 to 59,182) patients who underwent TLE for DRI during the study period. A large majority of patients (75%) were older than 60 years. Patients were predominantly male (70%) and Caucasian (76%), and 80% had at least 1 comorbidity. The median length of stay was 8 days (interquartile range 5 to 14 days). At least 1 major adverse event occurred in 10.42% of procedures. The all-cause in-hospital mortality rate was 4.11%. Independent predictors of mortality were weight loss (adjusted odds ratio [aOR]: 4.02; 95% CI: 3.13 to 5.17), congestive heart failure (aOR: 3.28; 95% CI: 2.48 to 4.34), chronic kidney disease (aOR: 2.09; 95% CI: 1.70 to 2.56), pericardial complications (aOR: 2.87; 95% CI: 1.79 to 4.61), and procedure-related pulmonary injury (aOR: 2.06; 95% CI: 1.25 to 3.40).
Conclusions These results reflect the high rate of complications and mortality for TLE due to DRI in real-world experience, highlighting the importance of comorbidities, especially congestive heart failure and chronic kidney disease, as significant predictors of mortality in these patients.
- cardiac implantable electronic device
- device-related infection
- transvenous lead extraction
↵∗ Drs. Hosseini and Rozen contributed equally to this work and are joint first authors.
This work was conducted with support from Harvard Catalyst, The Harvard Clinical and Translational Science Center (National Center for Research Resources; the National Center for Advancing Translational Sciences, National Institutes of Health award UL1 TR001102); and financial contributions from Harvard University and its affiliated academic health care centers. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic health care centers, or the National Institutes of Health. Dr. Rozen is a scientific advisory board member for Medtronic. Dr. Ruskin is a consultant or scientific advisory board member for Acesion Pharma, Advanced Medical Education, Cala Health, Element Science, InCarda Therapeutics, InfoBionic, Janssen, Lantheus, NewPace Medical, and Medtronic; is a steering committee member for Pfizer; and holds equity or options in Portola, Element Science, NewPace, Gilead, and InfoBionic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received April 15, 2019.
- Revision received August 28, 2019.
- Accepted August 28, 2019.
- 2019 American College of Cardiology Foundation
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