Dataset Information

Incidence of Bleeding-Related Complications During Primary Implantation and Replacement of Cardiac Implantable Electronic Devices.

ABSTRACT:

Background

Use of cardiac implantable electronic devices (CIEDs) is increasing. The incidence of bleeding-related complications during CIED procedures and the association with subsequent infection risk have been studied in trial settings but not in nonrandomized "real-world" populations.

Methods and results

This retrospective database analysis of US insurance claims from the Truven MarketScan database (2009-2013) evaluated the incidence of bleeding complications during, or in the 30 days following, a CIED procedure and the association between bleeding and subsequent infection in days 31 to 365 of follow-up. This study identified 42 606 patients who had a primary or replacement CIED procedure and met all inclusion criteria. Incidence of bleeding ranged from 0.58% to 2.81% by type of pharmaceutical therapy. Incidence of infection during days 31 to 365 of follow-up was significantly higher among patients with a bleeding complication in the first 30 days versus those without (6.56% vs 1.24%, P<0.001), with results upheld in multivariate analysis (HR=2.97, 95% CI 1.94-4.54, P<0.001).

Conclusions

This study provides a lower bound of the real-world incidence of bleeding complications following a CIED procedure within the coding limitations of an insurance claims database. Results confirm the association between bleeding in the pocket and risk of subsequent infection. Further research is needed to precisely identify the costs associated with bleeding in the pocket.

SUBMITTER: Nichols CI

PROVIDER: S-EPMC5523626 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Publications

Incidence of Bleeding-Related Complications During Primary Implantation and Replacement of Cardiac Implantable Electronic Devices.

Nichols Christine I CI Vose Joshua G JG

Journal of the American Heart Association 20170122 1

<h4>Background</h4>Use of cardiac implantable electronic devices (CIEDs) is increasing. The incidence of bleeding-related complications during CIED procedures and the association with subsequent infection risk have been studied in trial settings but not in nonrandomized "real-world" populations.<h4>Methods and results</h4>This retrospective database analysis of US insurance claims from the Truven MarketScan database (2009-2013) evaluated the incidence of bleeding complications during, or in the ...[more]

PMID: 28111362

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Project description:Background To date, limited population-level studies have examined the impact of sex on the acute complications of cardiac implantable electronic devices ( CIED) , including permanent pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy devices. Methods and Results We studied all patients aged >18 years from 2010 to 2015 who were a resident of Australia or New Zealand, undergoing a new permanent pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy implant. Standardized variables were collected including patient demographic characteristics, primary and secondary diagnoses, procedures performed and discharge status. Diagnoses and procedures were coded as per the International Classification of Diseases, Tenth Revision ( ICD-10) and the Australian Classification of Health Interventions. The primary end point was the incidence of major CIED -related complications in-hospital or within 90 days of discharge, with the effect of sex evaluated using multiple logistic regression. A total of 81 304 new CIED (61 658 permanent pacemakers, 12 097 implantable cardioverter defibrillators, 7574 cardiac resynchronization therapy) implants were included (38% women). Overall, 8.5% of women and 8.0% of men experienced a CIED complication ( P=0.008). Differences between women and men remained significant after adjustment for age, procedural acuity, and comorbidities (odds ratio 1.10, 95% CI: 1.04-1.16, P<0.001). Differences in CIED complication rates were primarily driven by excess rate of in-hospital pleural drainage (1.2% women versus 0.6% men, P<0.001; adjusted odds ratio 1.86, 95% CI: 1.59-2.17, P<0.001) and pericardial drainage (0.3% women versus 0.1% men, P<0.001; adjusted odds ratio 2.17, 95% CI: 1.48-3.18, P<0.001). Conclusions Women are at higher risk of acute CIED complications. Improvements in implant technique and technologies are required to minimize the risk of implant-related complications in women.

Dataset Information

Incidence of Bleeding-Related Complications During Primary Implantation and Replacement of Cardiac Implantable Electronic Devices.

Background

Methods and results

Conclusions

Publications

Incidence of Bleeding-Related Complications During Primary Implantation and Replacement of Cardiac Implantable Electronic Devices.

Similar Datasets

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