Rates of and Factors Associated With Infection in 200 909 Medicare Implantable Cardioverter-Defibrillator Implants

Prutkin, Jordan M.; Reynolds, Matthew R.; Bao, Haikun; Curtis, Jeptha P.; Al‐Khatib, Sana M.; Aggarwal, Saurabh; Uslan, Daniel Z.

doi:10.1161/circulationaha.114.009081

Cited by 179 publications

(115 citation statements)

References 42 publications

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“…This technique is similar to previous studies linking patients from registry data sets to insurance claims. 9,10 For comorbidity ascertainment, we further required continuous medical and drug benefit coverage for the 3-month period before the implant date.…”

Section: What the Study Addsmentioning

confidence: 99%

Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks

Turakhia

Zweibel

Swain

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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While potentially life-saving, ICD shocks, both appropriate and inappropriate, can also increase long-term morbidity and mortality. 4,5 Trials of device programming to reduce shocks have been shown to improve survival. 6,7 See Editorial by Borne and PetersonHowever, there is limited information on healthcare utilization (HCU) associated with ICD shocks and whether inappropriate and appropriate shocks have differences in type, intensity, or cost of care. Moreover, detailed knowledge of utilization following an appropriate versus inappropriate shock may elucidate downstream patterns of care and potential mediators of the differences in patient survival following shocks. We therefore evaluated HCU and expenditures after inappropriate and appropriate shock events by linking ICD remote monitoring data to healthcare administrative data. Methods Study Design and Data SourcesWe performed a retrospective cohort study of patients with ICDs from national (United States) implant registration and remote monitoring data linked to healthcare claims. Cohort structure and patient selection are detailed in Figure 1. Data, stripped of personal identifiers of name, date of birth, medical record number, and social security, were first obtained from the Medtronic Data Warehousing and Analytics Service (DWAS; Medtronic plc, Mounds View, MN). DWAS is a device implant record data set containing patient demographics (age, sex, 3-digit zip codes for patient location, and implant site location), implant date, device information (device type, model, and leads), Background-In patients with implantable cardioverter-defibrillators, healthcare utilization (HCU) and expenditures related to shocks have not been quantified. Methods and Results-We performed a retrospective cohort study of patients with implantable cardioverter-defibrillators identified from commercial and Medicare supplemental claims databases linked to adjudicated shock events from remote monitoring data. A shock event was defined as ≥1 spontaneous shocks delivered by an implanted device. Shock-related HCU was ascertained from inpatient and outpatient claims within 7 days following a shock event. Shock events were adjudicated and classified as inappropriate or appropriate, and HCU and expenditures, stratified by shock type, were quantified. Of 10 266 linked patients, 963 (9.4%) patients (61.3±13.6 years; 81% male) had 1885 shock events (56% appropriate, 38% inappropriate, and 6% indeterminate). Of these events, 867 (46%) had shock-related HCU (14% inpatient and 32% outpatient). After shocks, inpatient cardiovascular procedures were common, including echocardiography (59%), electrophysiology study or ablation (34%), stress testing (16%), and lead revision (11%). Cardiac catheterization was common (71% and 51%), but percutaneous coronary intervention was low (6.5% and 5.0%) after appropriate and inappropriate shocks. Expenditures related to appropriate and inappropriate shocks were not significantly different. Conclusions-After implantable cardioverter-defibrillator shock, related ...

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Section: What the Study Addsmentioning

confidence: 99%

Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks

Turakhia

Zweibel

Swain

et al. 2017

Circ: Cardiovascular Quality and Outcomes

Self Cite

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“…More complex systems have a higher infection risk and potential benefits from these systems should be weighed against lower infection risk with more simple systems. 4,18,21 Meticulous pre-operative preparation is necessary. Fever within 24 hours before implant is associated with a 5-6 fold infection risk, and diagnosis and treatment of ongoing infection before implantation is therefore important.…”

Section: Before Implantationmentioning

confidence: 99%

“…19,21,24 In a large, Danish cohort study, number of prior CIED procedures was strongly associated with a higher infection risk (see Figure 2). 18 Careful CIED prescription is important to avoid early need for system upgrade, and should include estimation of left ventricular function prior to implantation.…”

Section: Re-operationmentioning

confidence: 99%

“…Need for CIED upgrade should be evaluated extremely carefully, given the high infection risk. 21 Use of active fixation leads should be advocated -with due consideration for a suspected minor increased risk of cardiac perforation -to reduce risk of lead dislodgement and need for re-operation. 52 Appropriate education and reasonable implant volume for each operator should be assured to decrease risk of lead dislodgements, and complications in general, requiring early re-operations.…”

Section: Re-operationmentioning

confidence: 99%

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Management of Cardiac Electronic Device Infections: Challenges and Outcomes

Kirkfeldt¹,

Johansen²,

Nielsen³

2016

Arrhythmia &Amp; Electrophysiology Review

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Cardiac implantable electronic device (CIED) infection is an increasing problem. Reasons for this are uncertain, but likely relate to an increasing proportion of implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) devices implanted, as well as implantations in ‘higher risk’ candidates, i.e. patients with heart failure, diabetes and renal failure. Challenges within the field of CIED infections are multiple with prevention being the most important challenge. Careful prescription of CIED treatment and careful patient preparation before implantation is important. Diagnosis is often difficult and delayed by subtle signs of infection. Treatment of CIED infection includes complete system removal in centres experienced in CIED extraction and prolonged antibiotic therapy. Meticulous planning and preparation before system extraction and later CIED re-implantation is essential for better patient outcome. Future strategies for reducing CIED infection should be tested in sufficiently powered, multicentre, randomised controlled trials

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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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Rates of and Factors Associated With Infection in 200 909 Medicare Implantable Cardioverter-Defibrillator Implants

Cited by 179 publications

References 42 publications

Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks

Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks

Management of Cardiac Electronic Device Infections: Challenges and Outcomes

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

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