Impact of timing of device removal on mortality in patients with cardiovascular implantable electronic device infections

doi:10.1016/j.hrthm.2011.05.015

Heart Rhythm

Volume 8, Issue 11, November 2011, Pages 1678-1685

https://doi.org/10.1016/j.hrthm.2011.05.015 Get rights and content

Background

Cardiovascular implantable electronic device (CIED) infections are associated with increased mortality. However, detailed analyses of the impact of device removal on mortality have been limited.

Objective

This study sought to evaluate the impact of timing device removal on mortality in patients with CIED infections.

Methods

We retrospectively reviewed all cases of CIED infections seen at Mayo Clinic Rochester between 1991 and 2008. The impact of device removal on 30-day and 1-year mortality was evaluated using Cox proportional hazards models.

Results

Of 416 patients with CIED infection, 23 (5.5%) died by 30 days and 61 (14.6%) died by 1 year. Forty-four (12.0%) developed complications related to device removal, and 3 (0.8%) died. Complete procedural success was achieved in 341 (81.9%) and clinical success in 391 (93.9%) cases. In multivariate analysis, antimicrobial therapy without device removal was associated with a 7-fold increase in 30-day mortality (hazard ratio [HR] 6.97, 95% confidence interval [CI] 1.36 to 35.60). Although device removal complications were associated with increased mortality at 30 days (HR 4.33, 95% CI 1.47 to 12.70) and at 1 year (HR 3.77, 95% CI 1.88 to 7.55), immediate device removal, when compared to delay in device removal in favor of initial conservative therapy with antimicrobials alone, and no device removal, was associated with a 3-fold decrease in 1-year mortality (HR 0.35, 95% CI 0.16 to 0.75).

Conclusion

Although device removal resulted in fatal complications in a few patients, the mortality associated with a delay in device removal was significantly higher. Therefore, early and complete device removal was associated with improved outcomes.

Introduction

Implantation of cardiovascular implantable electronic devices (CIED) has rapidly increased in the United States over the past 2 decades.1, 2, 3 However, increased rates of CIED infection have been observed, and have been out of proportion to implantation rates.4, 5

Based on high relapse rates among patients managed with antimicrobial therapy alone,6, 7, 8, 9, 10, 11, 12 experts have recommended combined treatment of CIED infections consisting of antimicrobials and complete device removal.8, 9, 10, 11 However, device removal is often delayed in favor of initial trials of antimicrobial therapy in clinical practice.¹³ Yet, beyond a few descriptive studies that suggest no significant impact of timing of device removal on patient outcomes and highlight the mortality associated with device removal complications,7, 12 an in-depth analysis of this issue is lacking and discrepancies between expert guidelines and clinical practice continues. The purpose of the current investigation was to evaluate the impact of device removal on 30-day and 1-year mortality among patients with CIED infections.

Section snippets

Methods

We retrospectively reviewed all cases of CIED infection at Mayo Clinic Rochester (MCR) between January 1, 1991, and December 31, 2008. Cases were identified from the Mayo Clinic Heart Rhythm Device Database, the surgical index, and the computerized central diagnostic index. All patients consented to the use of their medical records for research. The Mayo Foundation Institutional Review Board approved the study protocol.

Definitions

CIED infection was defined and further classified as pocket infection, bloodstream infection, or CIED-related infective endocarditis (IE) as previously described by our group.7, 14, 15

Host- and device-related variables

We obtained host- and device-related variables at the time of presentation with CIED infection for potential predictors of mortality. An adjustment was included for statistically significant univariate predictors when the effects of management strategies on mortality were examined. High-risk device removal status was defined as documentation of concern for a patient's age, comorbid conditions, and procedural risks when therapy without device removal was recommended.

Management interventions

We profiled frequencies and duration of primary (>50% of treatment duration) antimicrobial regimens administered by outlying medical centers before transfer to MCR, and at MCR before device removal. Furthermore, the common pathogen-directed antimicrobial therapies were summarized.

Next, approaches to device removal management at MCR were examined, including timing of device removal, reasons for device retention, lead removal methods, and patient outcomes. Device removal was primarily performed

Results

CIED infections were predominately seen in elderly white men. Implantation indications primarily included heart block, sinus node disease, or ventricular arrhythmia. Most infected systems were permanent pacemakers and involved initial implantations that were in the left chest. Of 416 patients with CIED infection, 23 (5.5%) died by 30-day and 61 (14.6%) by 1-year follow-up. Those who died were older, had more comorbid conditions, had their original devices implanted for a longer time, and were

Discussion

Despite management guidelines8, 9, 10, 11 that recommend both antimicrobial therapy and complete device removal in patients with CIED infection, a delay in or lack of device removal in favor of an initial trial of antimicrobial therapy alone continues to occur. The consequences of sustained infection despite appropriate antimicrobial therapy and infection relapse are both well recognized. However, the impact of device removal, including timing of device removal, on mortality has not been

Conclusion

In conclusion, although complete device removal was associated with an apparent mortality risk, death of complications due to device removal was rare. Early and complete device removal was critical in the management of CIED infection and was associated with improved survival.

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Low Utilization of Lead Extraction Among Patients With Infective Endocarditis and Implanted Cardiac Electronic Devices
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Cardiac implantable electronic device (CIED)-associated infections are associated with substantial morbidity, mortality, and costs. Guidelines have cited endocarditis as a Class I indication for transvenous lead removal/extraction (TLE) among patients with CIEDs.
The authors sought to study utilization of TLE among hospital admissions with infective endocarditis using a nationally representative database.
Using the Nationwide Readmissions Database (NRD), 25,303 admissions for patients with CIEDs and endocarditis between 2016 and 2019 were evaluated on the basis of International Classification of Diseases-10th Revision, Clinical-Modification (ICD-10-CM) codes.
Among admissions for patients with CIEDs and endocarditis, 11.5% were managed with TLE. The proportion undergoing TLE increased significantly from 2016 to 2019 (7.6% vs 14.9%; P trend < 0.001). Procedural complications were identified in 2.7%. Index mortality was significantly lower among patients managed with TLE (6.0% vs 9.5%; P < 0.001). Presence of Staphylococcus aureus infection, implantable cardioverter-defibrillator, and large hospital size were independently associated with TLE management. TLE management was less likely with older age, female sex, dementia, and kidney disease. After adjustment for comorbidities, TLE was independently associated with significantly lower odds of mortality (adjusted OR: 0.47; 95% CI: 0.37-0.60 by multivariable logistic regression, and adjusted OR: 0.51; 95% CI: 0.40-0.66 by propensity score matching).
Utilization of lead extraction among patients with CIEDs and endocarditis is low, even in the presence of low rates of procedural complications. Lead extraction management is associated with significantly lower mortality, and its use has trended upward between 2016 and 2019. Barriers to TLE for patients with CIEDs and endocarditis require investigation.
Early Lead Extraction for Infected Implanted Cardiac Electronic Devices: JACC Review Topic of the Week
2023, Journal of the American College of Cardiology
Infection remains a serious complication associated with the cardiac implantable electronic devices (CIEDs), leading to substantial clinical and economic burden globally. This review assesses the burden of cardiac implantable electronic device infection (CIED-I), evidence for treatment recommendations, barriers to early diagnosis and appropriate therapy, and potential solutions. Multiple clinical practice guidelines recommended complete system and lead removal for CIED-I when appropriate. CIED extraction for infection has been consistently reported with high success, low complication, and very low mortality rates. Complete and early extraction was associated with significantly better clinical and economic outcome compared with no or late extraction. However, significant gaps in knowledge and poor recommendation compliance have been reported. Barriers to optimal management may include diagnostic delay, knowledge gaps, and limited access to expertise. A multipronged approach, including education of all stakeholders, a CIED-I alert system, and improving access to experts, could help bring paradigm shift in the treatment of this serious condition.
Transvenous lead extraction in patients with systemic cardiac device–related infection—Procedural outcome and risk prediction: A GALLERY subgroup analysis
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Transvenous lead extraction (TLE) has evolved as one of the most crucial treatment options for patients with cardiac device–related systemic infection (CDRSI).
The aim of this study was to characterize the procedural outcome and risk factors of patients with CDRSI undergoing TLE.
A subgroup analysis of patients with CDRSI of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was performed. Predictors for complications, procedural failure, and all-cause mortality were evaluated.
A total of 722 patients (28.6%) in the GALLERY had “systemic infection” as extraction indication. Patients with CDRSI were older (70.1 ± 12.2 years vs 67.3 ± 14.3 years; P < .001) and had more comorbidities than patients with local infections or noninfectious extraction indications. There were no differences in complete procedural success (90.6% vs 91.7%; P = .328) or major complications (2.5% vs 1.9%; P = .416) but increased procedure-related (1.4% vs 0.3%; P = .003) and all-cause in-hospital mortality (11.1% vs 0.6%; P < .001) for patients with CDRSI. Multivariate analyses revealed lead age ≥10 years as a predictor for procedural complications (odds ratio [OR] 3.23; 95% confidence interval [CI] 1.58–6.60; P = .001). Lead age ≥10 years (OR 2.57; 95% CI 1.03–6.46; P = .04) was also a predictor for procedural failure. We identified left ventricular ejection fraction <30% (OR 1.70; 95% CI 1.00–2.99; P = .049), age ≥75 years (OR 2.1; 95% CI 1.27–3.48; P = .004), chronic kidney disease (OR 1.92; 95% CI 1.17–3.14; P = .01), and overall procedural complications (OR 5.15; 95% CI 2.44–10.84; P < .001) as predictors for all-cause mortality.
Patients with CDRSI undergoing TLE demonstrate an increased rate of all-cause in-hospital, as well as procedure-related mortality, despite having comparable procedural success rates. Given these data, it seems paramount to develop preventive strategies to detect and treat CDRSI in its earliest stages.
Open Chest Approach Lead Extraction in a Patient with a Large Vegetation: The Importance of Multidisciplinary Approach, Advanced Imaging, and Procedural Planning
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: This work was supported by the Edward C. Rosenow Endowed Professorship Internal Medicine Residency Award (to Dr. Le), and the Mayo Foundation Career Development Award (to Dr. Sohail).

: All disclosures are for <$10,000. P.A.F. has received honoraria or is a consultant for Medtronic, Guidant, and Astra Zeneca; has conducted sponsored research for Medtronic, Astra Zeneca via Beth Israel, Guidant, St. Jude, and Bard; and has intellectual property rights with Bard EP, Hewlett Packard, and Medical Positioning, Inc. D.Z.U. has conducted research for the American Heart Association, and has received honoraria or is a consultant for Biotronik, Cubist, and Medtronic. D.L.H. has received honoraria for Medtronic, Boston Scientific, St. Jude Medical, ELA Medical, and Biotronik; has received royalty payments for UpToDate and Wiley-Blackwell; is on the medical advisory board for Boston Scientific, St. Jude Medical, and Pixel Velocity; and is a steering committee member for Medtronic and St. Jude Medical. L.M.B. has received royalty payments from UpToDate; holds an editorship for the Massachusetts Medical Society (Journal Watch Infectious Diseases), and is an ACP/PIER editorial consultant. M.R.S. has received honoraria and is a consultant for TyRx Pharma, Inc. Other authors have no disclosures.

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ClinicalDeviceImpact of timing of device removal on mortality in patients with cardiovascular implantable electronic device infections

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Methods

Definitions

Host- and device-related variables

Management interventions

Results

Discussion

Conclusion

Am J Cardiol

J Am Coll Cardiol

Am Heart J

J Am Coll Cardiol

Heart Rhythm

Cardiol Clin

Heart Rhythm

Mayo Clin Proc

J Chron Dis

Chest

Crit Care Clin

Heart Rhythm

Implantable cardioverter-defibrillators: expanding indications and technologies

JAMA

Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006

Pacing Clin Electrophysiol

Clinical
Device
Impact of timing of device removal on mortality in patients with cardiovascular implantable electronic device infections