16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States

Greenspon, Arnold J.; Patel, Jasmine; Lau, Edmund; Ochoa, Jorge; Frisch, Daniel R.; Ho, Reginald T.; Pavri, Behzad B.; Kurtz, Steven M.

doi:10.1016/j.jacc.2011.04.033

Cited by 687 publications

(606 citation statements)

References 20 publications

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“…The incremental financial burden associated with reintervention in our study was $68 000 to treat an infection and $36 000 to treat a mechanical failure, and the average costs for the year before and the year after a complication were elevated if a patient had an infection. This is in consonance with other studies that suggest that the healthcare expenditure associated with infections and reinterventions could be astronomical 22, 23, 24…”

Section: Discussionsupporting

confidence: 92%

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Koneru

Jones

Hammill

et al. 2018

JAHA

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BackgroundThe transvenous implantable cardioverter‐defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database.Methods and ResultsData from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5‐year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications.ConclusionsIncidence of mechanical and infectious complications of transvenous ICD leads over long‐term follow‐up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

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Section: Discussionsupporting

confidence: 92%

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Koneru

Jones

Hammill

et al. 2018

JAHA

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“…Most of these patients will require a subsequent generator change in their lifetime. Although generator replacements are relatively low‐risk procedures, the development of a pocket hematoma and/or infection are two of the most recognized complications of the procedure 1, 2, 3…”

Section: Introductionmentioning

confidence: 99%

Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure

Nichols

Vose

Mittal

2016

JAHA

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BackgroundInadvertent damage to leads for transvenous pacemakers, implantable cardioverter‐defibrillators, and cardiac resynchronization therapy defibrillators is an important complication associated with generator‐replacement procedures. We sought to estimate the incidence and costs associated with transvenous lead damage following cardiac implantable electronic device replacement.Methods and ResultsUsing the Truven Health Analytics MarketScan Commercial Research Database, we identified health care claims between 2009 and 2013 for lead damage following generator replacement. Patients were identified by claims with a procedure code for cardiac implantable electronic device replacement and then evaluated for 1 year. All follow‐up visits for lead damage were identified, and incidence, risk factors, and hospitalization costs were determined. A total of 22 557 patients with pacemakers, 20 632 with implantable cardioverter‐defibrillators, and 2063 with cardiac resynchronization therapy defibrillators met selection criteria. Incidence of lead damage was 0.46% for pacemaker replacement, 1.27% for implantable cardioverter‐defibrillator replacement, and 1.94% for cardiac resynchronization therapy defibrillator replacement procedures (P<0.001). After adjusting for patient characteristics, patients with implantable cardioverter‐defibrillators and cardiac resynchronization therapy defibrillators demonstrated risk of lead damage that was, respectively, double (hazard ratio 2.00, 95% CI 1.57–2.55) and >2.5 times (hazard ratio 2.58, 95% CI 1.73–3.83) that of patients with pacemakers. Lead revision or repair procedures were associated with increased inpatient hospitalization costs (mean $19 959 for pacemaker, $24 885 for implantable cardioverter‐defibrillator, and $46 229 for cardiac resynchronization therapy defibrillator; P=0.048, Kruskal–Wallis test).ConclusionsThese findings establish the first objective assessment of the incidence, risk factors, and economic burden of lead damage following cardiac implantable electronic device replacement in the United States. New care algorithms are warranted to avoid these events, which impose substantial burdens on patients, physicians, and payors.

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“…Biofilms block antibiotic penetration and host immune defenses, resulting in chronic and difficult-to-treat infections (10,11), and provide a reservoir for antibiotic-resistance genes (12,13). The treatment of biofilm-associated infections typically involves reoperations to remove or replace the infected implants and prolonged systemic antibiotic therapy (14)(15)(16), with inpatient costs averaging ∼$100,000 per patient or an annual national healthcare burden exceeding $4 billion in the United States (7,17). Current clinical guidelines for systemic antibiotic treatment of medical device infections recommend combinatorial antibiotic therapy because it is more effective than single antibiotics and decreases the potential development of antibiotic resistance while on therapy (14)(15)(16).…”

mentioning

confidence: 99%

Polymeric nanofiber coating with tunable combinatorial antibiotic delivery prevents biofilm-associated infection in vivo

Ashbaugh

Jiang

Zheng

et al. 2016

Proc. Natl. Acad. Sci. U.S.A.

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Bacterial biofilm formation is a major complication of implantable medical devices that results in therapeutically challenging chronic infections, especially in cases involving antibiotic-resistant bacteria.As an approach to prevent these infections, an electrospun composite coating comprised of poly(lactic-coglycolic acid) (PLGA) nanofibers embedded in a poly(e-caprolactone) (PCL) film was developed to locally codeliver combinatorial antibiotics from the implant surface. The release of each antibiotic could be adjusted by loading each drug into the different polymers or by varying PLGA:PCL polymer ratios. In a mouse model of biofilm-associated orthopedic-implant infection, three different combinations of antibiotic-loaded coatings were highly effective in preventing infection of the bone/joint tissue and implant biofilm formation and were biocompatible with enhanced osseointegration. This nanofiber composite-coating technology could be used to tailor the delivery of combinatorial antimicrobial agents from various metallic implantable devices or prostheses to effectively decrease biofilm-associated infections in patients.nanofiber | biofilm | infection | antibiotic | delivery

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16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States

Abstract: The infection burden associated with CIED implantation is increasing over time and is associated with prolonged hospital stays and high financial costs.

Cited by 687 publications

References 20 publications

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure

Polymeric nanofiber coating with tunable combinatorial antibiotic delivery prevents biofilm-associated infection in vivo

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