rates of and factors associated with infection in 200 909 medicare implantable...

Aggarwal and Daniel Z. UslanJordan M. Prutkin, Matthew R. Reynolds, Haikun Bao, Jeptha P. Curtis, Sana M. Al-Khatib, Saurabh

Cardioverter-Defibrillator Implants: Results from the NCDR®Rates of and Factors Associated with Infection in 200,909 Medicare Implantable

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DOI: 10.1161/CIRCULATIONAHA.114.009081

1

Rates of and Factors Associated with Infection in 200,909 Medicare

Implantable Cardioverter-Defibrillator Implants: Results from the NCDR®

Running title: Prutkin et al.; ICD infections in the ICD Registry®

Jordan M. Prutkin, MD, MHS1; Matthew R. Reynolds, MD, MSc2; Haikun Bao, PhD3; Jeptha P.

Curtis, MD3; Sana M. Al-Khatib, MD, MHS4; Saurabh Aggarwal, MD5; Daniel Z. Uslan, MD6

1University of Washington, Seattle, WA; 2Lahey Clinic Medical Center, Burlington, MA; 3Yale University, New Haven, CT; 4Duke Clinical Research Institute, Duke University Medical

Center, Durham, NC; 5Chicago Medical School, North Chicago, IL; 6David Geffen School of

Medicine at UCLA, Los Angeles, CA

Address for Correspondence:

Jordan Prutkin, MD, MHS

Division of Cardiology/Electrophysiology

University of Washington

Box 356422, 1959 N.E. Pacific St.

Seattle, WA 98195

Tel: 206-685-4176

Fax: 206-616-1022

E-mail: [email protected]

Journal Subject Codes: Treatment:[22] Ablation/ICD/surgery, Treatment:[120] Pacemaker, Hypertension:[111] Infectious endocarditis

1University of Washington, Seattle, WA; 2Lahey Clinic Medical Center, Burlington, MA; 3YaYalele UUUninn veveersr itty,y,y, NNew Haven, CT; 4Duke Cliniicacaal l l Research Institute,e,, DDDuke University Medical

CeCeCentnter, DuDuurrrhamam, , NCNC; ; ; 5ChChicicagaggo o MeMedidicacal l ScSchohoololl, NNortrth h ChChicagaggo,o,o IIL;L; 66DaD viid d GeGeffffenen SSchchooo ll ofo

MMeMedididiccicinnee aat UUCUCLA,,, LLLos AnAnAngggellees, CCAA

AdAdAddrdrdresesessss fofoforrr CoCoCorrrrrresesespopopondndndenenencecece:::

JoJordrdanan PPrurutktkinin, MDMD, MHMHSS

by guest on October 1, 2014http://circ.ahajournals.org/Downloaded from



2

Abstract

Background—The rate of implantable cardioverter-defibrillator (ICD) infections has been

increasing faster than that of implantation. We sought to determine the rate and predictors of ICD

infection in a large cohort of Medicare patients.

Method and Results—Cases submitted to the ICD Registry™ from 2006-2009 were matched to

Medicare fee-for-service claims data using indirect patient identifiers. ICD infections occurring

within 6 months of hospital discharge after implantation were identified by ICD-9 codes.

Logistic regression was used to examine factors associated with risk of ICD infection. Out of

200,909 implants, 3,390 patients (1.7%) developed an ICD infection. The infection rate was

1.4%, 1.5%, and 2.0% for single, dual, and biventricular ICD’s, respectively (p<0.001).

Generator replacement had a higher rate compared to initial implant (1.9% vs. 1.6%, p<0.001).

The factors associated with infection were adverse event during implant requiring reintervention

(odds ratio [OR] 2.692, 95% CI, 2.304-3.145), prior valvular surgery (OR 1.525, 95% CI, 1.375-

1.692), reimplantation for device upgrade, malfunction, or manufacturer advisory (OR 1.354,

95% CI, 1.196-1.533), renal failure on dialysis (OR 1.342, 95% CI, 1.123-1.604), chronic lung

disease (OR 1.215, 95% CI, 1.125-1.312), cerebrovascular disease (OR 1.172, 95% CI, 1.076-

1.276), and warfarin (OR 1.155, 95% CI, 1.060-1.257).

Conclusions—Patients who developed an ICD infection were more likely to have had peri-ICD

implant complications requiring early reintervention, prior valve surgery, device replacement for

reasons other than battery depletion, and increased comorbidity burden. Efforts should be made

to carefully consider when to reenter the pocket at any time other than battery replacement.

Key words: infection, infective endocarditis, implantable cardioverter-defibrillator, risk factor, registry

p g p p ( ,, pp ))

The factors associated with infection were adverse event during implant requirinnggg rereeinnnteteervrvrvenenentitiono

odds ratio [OR] 2.692, 95% CI, 2.304-3.145), prior valvular surgery (OR 1.525, 95% CI, 1.375-

1.692)), reimplp antation for device upgrade, malfunction, or manufacturff er advisory (OR 1.354,

95955% % % CCICI, 1.1.19191966-1.1.53533)3 , rer nanal faaililuru e onn diai lyysiss ((OROROR 1.34242, , 95% CICIC , 1.1.12123-3 1.60604)4), , chror nin c c lungg

ddidiseeeasa e (OR 1.1 21212155, 9995%5%5% CCCII,I, 111.1.125255-1-11.3.312122), ccerrrebrooovvvascccuulularar ddisisi eaeaaseee ((OROROR 11.11727272,, 95955% % % CICICI, 1.11.077076---

1.1.2727276)6)6 , , and wawaw rfrfararrinn ((ORORR 1.111555555,, 95955%% % CICII,, 1.1.060660-0 11.22557)7)).

Concnclulu isionons—PaP titienentst wwhoh ddeveveleloped aan n ICICDD ininfecttioion n wewerere morore e lilikek lyy to o hahavev hadad pereri-i-ICI D D

mplp ant compmpmplililicacacatititiononns ss rerer ququuiriririnini g g eaeae rrrlylyl rrreeieintntereervevevenntntioioon,n, ppririiooror vvvalalalvveve suuurgrrgererery,yy, dddevevicicice e rerer plplplaaacement forrr




3

Introduction

The rising rate of cardiovascular implantable electronic device (CIED) infection (permanent

pacemaker and implantable cardioverter-defibrillator [ICD]) has been strikingly out of

proportion to that of device implantation.1-4 Analysis of clinical factors associated with short and

long-term mortality among patients with CIEDs showed that CIED infection was a strong

predictor of death.1, 5 Aging of the population and increases in implant volumes will further

amplify the problem of CIED-related infections in the future. In addition, financial costs

associated with ICD infection can be significant, with an average length of stay for CIED

infection from 8-20 days and total costs from $24,000 to $130,000.3, 4, 6-8

Understanding the reasons for increased infection rate among ICD recipients can lead to

targeted strategies to reduce infection rates. Therefore, we used combined data from the ICD

Registry™ and a large Medicare cohort to determine rates and risk factors for ICD infection.

Methods

Data source

The ICD Registry was created in response to a mandate from the Center for Medicare and

Medicaid Services (CMS) in 2005 after the coverage for primary prevention ICDs was expanded.

Data collection started January 1, 2006, as described previously.9 While the initial requirement

was only for primary prevention ICDs, data from most secondary prevention ICD procedures are

also included by hospitals. Medicare beneficiaries make up 68% of patients in the Registry.10

Most hospitals also submit data on non-CMS patients to the Registry, but they were not included

in this analysis.

Demographic, clinical, procedural, operator, hospital, and device based data are inputted

Understanding the reasons for increased infection rate among ICD recipieieentntsss cacaan n leleleadadad tto

argeted strategies to reduce infection rates. Therefore, we used combined data from the ICD

ReRegigigistststrryry™™™ anannd aa a lalalarrge Medicare cohort to determrmminnne rates and riskskk facactototorrrs for ICD infection.

MeMeMethththodododss

Data source e




4

into the Registry at the time of an initial implant or generator change using a standardized data

collection form. Data are audited periodically by reviewing records at a random sample of sites.9, 11

Patient Population

Merged Registry and MedPAR claims data from 2006-2009 were utilized to identify patients

with ICD infection after initial hospital discharge, as previously described. 12-14 Briefly,

deterministic matching of the Registry and MedPAR claims files was performed using indirect

patient identifiers (age, gender, admission date, ICD procedure date, provider number) found in

both datasets. Using this approach, 70% of Medicare patients have been liked with Registry files.

Patients were initially identified if they had a principal or secondary diagnosis indicating

CIED infection (ICD-9-CM code 996.6 or 996.61) or infective endocarditis (either a DRG for

endocarditis [126] or a principal or secondary diagnosis indicating infective endocarditis [ICD-9-

CM codes 421.0, 421.1, 421.9]). In addition, patients were included if they had both a procedural

code for initial ICD/cardiac resynchronization therapy (CRT) implant (3794, 3795, 3796, 3797,

3798, 0051, 0052), pacemaker or ICD/CRT removal (3789, 3794, 3795, 3796, 3797, 3798, 0051,

0052), or lead removal (3777) as well as having an ICD-9-CM codes for sepsis (038, 785.52,

785.59), bacteremia (790.7), endocarditis (421.0, 421.1, 421.9, 424.90, 424.91), cellulitis

(681.00, 681.1, 682), or fever (780.6) during the same admission.5

Subjects were excluded if the index procedure in the Registry was a reimplant for device

infection, if the implanted ICD type was not known, or if the patient died during the index

hospitalization.

Potential Risk Factors

Potential risk variables evaluated included demographic factors, clinical characteristics,

procedure-related events, and operator and hospital factors available in the Registry. These

CIED infection (ICD-9-CM code 996.6 or 996.61) or infective endocarditis (eitheheer a aa DRDRDRG G G fofofor rr

endocarditis [126] or a principal or secondary diagnosis indicating infective endocarditis [ICD-9-

CMCMM ccodododesess 4442122 .00, , 442421.1, 421.9]). In addition, patttiieienntts were includedeed iff ttthhehey had both a procedura

cooddede for initialal IICDCDCD/c/caaardididiacacac rrreseesynynchchchroroninizzatiiononon theeeraaapyy (((CRCRCRT)T)) iimmpmplalantnt ((337794944, 33737959595, 373737969696,, 377379977,

3777989898, 00000 51511,,, 0000052522),),, ppaacaceememakakerere ooorrr ICICICD/D//CRCRCRTTT reeemomomovavaal l (3(3(37878789,9,9, 33379797 44,4, 33379797 555, 33797996,6,6, 3379797977,7, 33379998,8, 00000551,

0052), or leadadd rremememovovovalalal (((3777777777))) asasas wwwelele l asasas hhhaaavivivingngng aaan n n ICICICD-D-D 9-9-9 CMCMCM cccodododeees s fofofor r r sesesepspsp isisis (((0303038,8,8, 785.52,




5

included age at implantation, gender, race, prior syncope, family history of sudden death, prior

heart failure hospitalization, New York Heart Association (NYHA) class, atrial

fibrillation/flutter, history of ventricular tachycardia, sinus node dysfunction, non-ischemic

cardiomyopathy, ischemic heart disease, prior percutaneous coronary interventional, valvular or

coronary artery bypass graft (CABG) surgery, cerebrovascular disease, chronic lung disease,

diabetes, hypertension, renal failure on dialysis, blood urea nitrogen and creatinine levels,

sodium level, systolic blood pressure, use of warfarin, aspirin, clopidogrel, and ticlopidine,

intraventricular conduction abnormalities, QRS duration, ejection fraction, ICD generator

replacement vs. initial implant, type of ICD, adverse events during implantation, operator

training and volume, hospital teaching status, and hospital coronary artery bypass graft and

coronary catheterization availability.

Statistical Analysis

The patient demographic factors, clinical characteristics, procedure-related events, discharge

medications, and operator and hospital factors were compared between patients with and without

ICD infection. The 2 test and t test were used for categorical variables and continuous variables,

respectively. The specific adverse events during or after the implant procedure until discharge

between ICD infection patients and ICD non-infection patients were examined by 2 or Fisher’s

exact tests. The Kaplan-Meier curve of ICD infection was used to show the survival function of

ICD infection within 6 months of ICD implantation. The missing rates of variables were less

than 0.5% except for ejection fraction percent (4%), hospital beds set up (2.6%), hospital

teaching status (2.6%), cardiac facility (2.6%) and operator type (22%). Multiple imputation

technique was used for the missing values. Then, a hierarchical logistic regression model was

used to examine patient, operator, and hospital factors associated with risk of ICD infection. The

raining and volume, hospital teaching status, and hospital coronary artery bypasssss grgrgrafafftt ananand dd

coronary catheterization availability.

Sttatatatisisistititicacaalll AnAnAnallysysysisis

TThee e pap tient deemomoogggrapaphihicc c fafafactctctoorors,s, clclclinini iiccaaal chhharrracteereriiisticscscs,, prprrocccededurure-e-rerelall tteed d evevevenentststs, , dididiscscchahahargrgeee

memeedididicacacatitiononns,s,s, aandndd ooopepep rraratotoor r annnd dd hohohospspspiititalall fffacacactototorsss wwweeereee comomompapaparered dd bebeetwtwweeeee nnn ppapatitiienene tstst wwwititthhh aanandd d wiwiithththououo t

CD infectioon.n.n. TTThehehe 222 tttesee t ananand dd tt tttesese t t wewewererer uuusesesed d d fofof r rr cacacatetet gogooririricacacalltt vavavarirr ababblelees s s ananand d d cocoonnntititinununuououous variabless,




6

model accounted for clustering of the patients within hospitals through the inclusion of a

hospital-specific random effect. Because of the multiple comparisons used, a p value <0.0012

(p=0.05/42 variables) was considered statistically significant. All analyses were performed on

SAS Version 9.3.

Results

Using the indirect patient matching method, 204,309 ICDs were implanted between 2006-2009

and had CMS claims data available. Of these, 2,197 had a reimplant for device infection, 276 had

a missing ICD type, and 927 had in-hospital death, all of which were excluded. The remaining

200,909 implanted ICDs from 1,348 hospitals were included in the analysis.

A total of 3,390 (1.7%) infections were observed through six months. Infections were

more frequent in the first 45 days, but continued throughout the entire six months (Figure 1).

Baseline characteristics are shown in Table 1. Patients who developed an ICD infection were

more likely to have several medical comorbidities, including heart failure hospitalization, NYHA

class III or IV, atrial fibrillation, abnormal sinus node function, prior ICD, previous CABG or

valvular surgery, cerebrovascular disease, chronic lung disease, diabetes, renal failure on

dialysis, higher creatinine and blood urea nitrogen, abnormal intraventricular conduction with a

wider QRS duration, lower ejection fraction, lower sodium level, and use of warfarin. In

addition, they were less likely to have nonischemic dilated cardiomyopathy.

Patients with a CRT-ICD device were more likely to develop infection than patients with

dual or single chamber devices (2.0% vs. 1.5% vs. 1.4%, respectively, p<0.0001). Infection rates

were higher regardless of whether the left ventricular lead was placed transvenously in the

coronary sinus or epicardially. The infection rate was also higher if the most recent procedure

200,909 implanted ICDs from 1,348 hospitals were included in the analysis.

A total of 3,390 (1.7%) infections were observed through six months. Infections were

momorerere fffrrerequququenenent t innn ttthhehe first 45 days, but continueddd ttthrrroughout the enenntiree sssixixix months (Figure 1).

BBasseseline charaactcttereriistitiicccs aaarerere ssshohohownwnn iiinn n TaTaTable 1.. Paattieeentsss wwwhohoo dddeveveeloopopededed aann ICICCDD D ininfefef ctctc ioioion wwewerrere

momoorerer lllikiki elely y y tototo hhaavaveee seseeveveeraral mmmedididicacacalll cocoomomomorbrbrbididitititieiesss, iincnccluluudididinngng hhheaeaarttt fffaiaia luluurree hhhoosospipipitataallilizzzatiiiononn,, NNYNYHHHA

class III or IV,V,V, aaatrtrriaiaiall l fififibrbrb illalalatitiiononon,, ababa nonon rmrmrmalalal sssiinununus s nononodeded ffunununctctctioioion,n,n, pppriororor IIICDCDCD,, prprp evevevioioioususus CCCABG or




7

was a device upgrade or battery change, versus initial implant (1.9% vs. 1.6%, p<0.0001).

Several operator and hospital factors were also associated with infection, including non-

electrophysiology trained operators, those with lower implant volume, implant at a non-teaching

hospital, and a hospital that did not perform coronary artery bypass graft surgery.

Those with an ICD infection were significantly more likely to have had an adverse event

at the time of the most recent procedure (5.4% vs. 1.9%, p<0.001). When examining specific

adverse events, hematoma and lead dislodgement requiring early reoperation were significantly

associated with future device infection (Table 2).

On multivariate analysis, factors found to be significantly associated with the development

of ICD infection included adverse event during implant requiring reintervention, prior valvular

surgery, reimplantation for device upgrade, malfunction, or manufacturer advisory, renal failure on

dialysis, chronic lung disease, cerebrovascular disease, and warfarin use (Table 3).

Since 1.47% of patients received more than one implant during the time period, we

conducted a sensitivity analysis where one implant was randomly selected and combined with

those patients who had only one implant. These results were not significantly different than the

main analysis.

The six month mortality was 12.0% in those with ICD infection and 6.5% in those

without (p<0.0001).

Discussion

In this study, the largest of ICD infections in Medicare patients, we have shown the six month

rate of ICD infection after the last procedure was 1.7%. Infection rates were higher if there was a

periprocedural adverse event, prior valve surgery, reimplantation for device upgrade,

of ICD infection included adverse event during implant requiring reintervention, prprriooor rr vavaalvlvlvulululararar

urgery, reimplantation for device upgrade, malfunction, or manufacturer advisory, renal failure ontt

diialallysysysisisis, chchchroror nnnic c lululunng disease, cerebrovascular disisseaeae sse, and warfarrininn usesee (((TTTable 3).

Since 1.1 4744 %% % ofofo pppatatatiieientntntss rereecececeivivededd moooreee thaanan onenee iimpmpplalaantnt dduururininggg thhhee tititimmeme ppperere ioioiod,dd wwwee

coondndnducucuctetedd a aa sesensnssittivivi itityy aananala ysysysisiss wwwheheherere oonenene iiimpmpmpllanannt wawaas rararandnndomomomlylyly ssselele ececcteeed d ananand dd cocoombmbm innneddd wwiitithh h

hose patientsts wwwhohoo hhhadadd ooonlllyyy onoo e e e imimimplplp anannt.t. TTThehehesesese rrresessuuultlts wewewererere nnnototot ssigggnininififificacacannntltltly y dididifffffferererenenent than the




8

malfunction, or manufacturer advisory, and increased comorbidities.

Prior studies have reported infection rates in a similar range. While small studies have

suggested an infection rate of 0.03-7.9%,15 multicenter registries have had rates of 0.3-2.2%.7, 16-

21 A retrospective analysis of Medicare data from 2002-2005 examined 8,581 patients

undergoing ICD implantation.22 The infection rate was 0.7% during the index hospitalization,

1.6% at 30 days, and 2.2% at 90 days. Using the Nationwide Inpatient Sample, which reports on

approximately 20% of all inpatient hospitals, the rate of ICD and pacemaker infection was 1.61%

between 1993 and 2008.4 From 2006-2008, which is similar to our time period, there was an

increase in infection rate from 1.7% to 2.4%. Variability in these studies may be due to

differences in patient comorbidities, duration of follow-up, inclusion of pacemakers as well as

ICDs, presence of epicardial systems and/or abdominal generators, or different definitions of

infection.

Postoperative complications, especially hematoma, have been seen in several studies as a

risk factor. 19, 23-25 Hematoma is only defined in the Registry if the patient required reoperation or

transfusion. Since lead dislodgement was also a risk factor, it is probable that early reoperation is

the most important risk factor for ICD infection. The exact reason for this is not clear. Several

studies have demonstrated that a lead addition or generator change, including re-entering for

manufacturer advisory, leads to a higher risk of infection compared to initial implantation.7, 19, 20,

23, 25-30 It is thought that bacteria can colonize a pocket after initial implantation but do not lead to

clinical infection, as they are in equilibrium with the host immune response.31 Disrupting the

pocket with a re-do procedure may affect the interaction between the organism and host, leading

to a CIED infection. In fact, several studies have demonstrated up to a 42% presence of bacteria

cultured from asymptomatic pockets at the time of generator change.32, 33 Re-entering a pocket

differences in patient comorbidities, duration of follow-up, inclusion of pacemakakkeersss asss wwwelelell l l asas

CDs, presence of epicardial systems and/or abdominal generators, or different definitions of

nnfefeectctctioioionn.

Postoppereraata iiivee cocompmpmpliliicacaatitiononnss,s, eespsppeciaaalllyy heeemmmatooommama, , hahaaveve bbeeeen n ssseenen iiin n seseveveeraaal l sststududdiieiesss aaas a

iisksksk fffacacactotor.r. 19,19,19, 2323-2-225 HHememmaatatomoma aa isiss ooonlnlnlyy ddedefififinenenedd ininin tthhehe RRegege isisistrtrtryyy iiif f f ththhee papapatitiienennt t rereequququirirededed rrreooopepeeraratitiionnn or

ransfusion. SSininincecece llleaeae d d d didd slsllodododgegeememem ntntnt wawawasss alalalsososo aaa rrrisissk k k faf ctctctororor,,, ititi iiis s s prpp obobobababablelele ttthahah t t eaeaearlrlrly y y rerereoperation iiss




9

for other reasons such as device upgrade, malfunction, and manufacturer advisory was a risk

factor, while re-entering for a battery change was not, suggesting a possible time-dependence

influence on infection risk.

In addition, hematomas may also influence risk because they impair wound healing or

lead to wound dehiscence, or because the presence of blood in the pocket is conducive to

bacterial growth. Warfarin use was associated with an increase risk, as seen in some prior

studies,20 though not all.19, 23, 27 Warfarin may have increased the number of hematomas that did

not require reintervention which would not be counted as an adverse event in our study.

Similar to prior studies, renal dysfunction, especially hemodialysis, was a potent risk

factor in our study.4, 20, 23, 34 Not only is there altered immunity in those with kidney disease on

hemodialysis, but patients have frequent vascular access, indwelling catheters, and increased risk

of bacteremia. 35, 36

Prior valve surgery increases risk of ICD infection since there is a 50-fold higher rate of

endocarditis in those with prosthetic valves compared to native valves.37 If there is a valvular

vegetation, especially with S. aureus or fungi, the ICD is thought to be infected also even if no

vegetation is seen on the ICD leads.38 That said, not all have found that prosthetic valves

increases risk of ICD infection. 29, 39

One study showed a correlation of an increase in respiratory failure with CIED infection

but no multivariate analysis was completed,4 while another did not find this.39 Cerebrovascular

disease appears to be a novel risk factor for ICD infection. It is unlikely that these are directly

causative but more likely reflects unknown or unmeasured associated factors.

The c-statistic for the multivariable model, even though it included a large number of

predictive variables, was quite poor. The patient, operator, and hospital characteristics which

factor in our study.4, 20, 23, 34 Not only is there altered immunity in those with kidndnneyeyy ddisisiseaaeasesese ooon n

hemodialysis, but patients have frequent vascular access, indwelling catheters, and increased riskr

off bbbacacacteteterereemimimiaaa. 355,, 36636

Prior vavalvlvlvee suurrrgeerery y ininnccrcreaeaseses ss s rriiskkk of f ICCCD iininffecttitioonon sssinnncece thheherere iiis aa ff 50500--f-folold dd hihihighghherrr rratatteee ooof

enndodod cacacardrdititisisis iiinn ththhoososee wwiwiththt pprorooststthehehetititiccc vavaalvvveseses comomomppaparrered d tooo nnnaatativvve ee vvavalvlvlvesese ..377 IIf f thththerereree iisis aaa vvaalvvuvulalaar

vegetation, esespepepeciciialalallylyly wwwith h h S.S.S. aururureueueusss orrr ffununungigigi,, thththeee ICICICD D isisis ttthohohougugughththt to o o bebebe iiinfnfnfecececteteed d d alalalsososo eeeven if no




10

were examined represented variables that have previously been examined, as well as novel

factors. Other papers which have used multivariable models have not included the c-statistic, so

direct comparison of model strengths cannot be completed.19, 23, 27, 29, 34, 39, 40 Regardless, even

with a large number of patients and predictive variables, this study suggests that there are

important unknown clinical and patient characteristics that influence ICD infection.

Limitations

The main limitation of this study is the use of administrative coding to define ICD infections, as

we could not validate diagnoses with chart review. Several studies have used ICD-9 codes and

administrative databases, including MedPAR and the National Hospital Discharge Survey, to

look at CIED infections.1, 2, 4, 6, 41, 42 As noted by other investigators,2, 41 while the practice of

coding for complications of CIEDs may be subject to bias, it is more likely that there is

undercoding versus overcoding, and it is likely that any undercoding would be random and not

prone to bias in any one direction. Undercoding would also lead to an underestimation of the true

risk of infection.

The data regarding infection risk of devices are predominantly affected by the duration of

follow-up in studies. We have only been able to determine the six month rate of ICD infection,

and the true incidence over the lifetime of a Medicare beneficiary is unknown.

In addition, the information obtained from this study is only applicable to the Medicare

population and may not be valid in other patient groups (i.e., younger patients, private insurance,

etc). Because of the large sample size, some variables may be statistically significant, but may

actually be surrogates for other variables that could not be tested in this study due to lack of

available information in the Registry. We could not assess several factors seen in prior studies,

such as use of skin cleansing agent, antibiotics in solution used to irrigate the ICD pocket, fever

ook at CIED infections.1, 2, 4, 6, 41, 42 As noted by other investigators,2, 41 while thheee prprpraccctititicecece ooof ff

coding for complications of CIEDs may be subject to bias, it is more likely that there ist

unndededercrccodododinininggg vversrssuusus overcoding, and it is likely thththatat any undercoddinini g wowowouuuld be random and not

pronnne to bias inin aaannyy oonnene dddiririrececectititionon.. UUnUnddederrcodddinnng wowowouldd d aalalsosoo lleaead d tooo anan uunndndererresestitimamamatititionon oof ff thththeee tttrue

iisksksk oooff f ininfefeectctctiioion.n.

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11

within 24 hours of implant, use of a temporary pacing wire, presence of a central venous

catheter, abdominal versus pectoral generator, and procedure duration. 16, 19, 23, 41, 43 Similarly,

other potentially relevant variables could not be assessed, such as open pocket time, removal of

the ICD capsule at the time of generator change, or duration of post-procedural antibiotics.

Conclusion

Merging ICD Registry and Medicare data in over 200,000 patients, we demonstrated an overall

ICD infection rate of 1.7% within six months. The presence of an adverse event, especially

where there was early reoperation for hematoma or lead dislodgement, greatly increased the rate

of infection. In addition, reentering an ICD pocket for an upgrade, manufacturer advisory, or

malfunction also increased infection rates. Efforts should be made to prevent the need for early

reintervention during the peri-implant time period and carefully consider when to reenter the

pocket for reasons other than battery replacement.

Funding Sources: The study was partially funded by a grant from the American Heart

Association to one of the authors (DZU). In addition, this research was supported by the

American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR).

Conflict of Interest Disclosures: Dr. Reynolds has received consulting fees from Medtronic.

Dr. Curtis has received salary support under contract with the American College of Cardiology

(ACC) to provide data analytic services for the ICD registry and has significant stock holdings in

Medtronic, a maker of ICDs. No other disclosures are reported. Disclaimer: The views expressed

in this manuscript represent those of the authors, and do not necessarily represent the official

views of the NCDR or its associated professional societies identified at www.ncdr.com.

Additional Information: The ICD Registry™ is an initiative of the American College of

Cardiology Foundation and the Heart Rhythm Society.

of infection. In addition, reentering an ICD pocket for an upgrade, manufacturer r adaddvivisososoryryry, ,, ororo

malfunction also increased infection rates. Efforts should be made to prevent the need for early

eeininntetetervrvrvenenntititiononn ddurururiining the peri-implant time periododod aaand carefully cconoo siidedederr r when to reenter the

pocckket for reaasosonnsns oothththererr tthahahann n babbatttterere yy y rreeppplacememementt.

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AsAssosociciatatioionn toto oonene ooff ththee auauththororss (D(DZUZU)) IInn adaddidititionon ththisis rreseseaearcrchh wawass susupppporortetedd byby tthehe




12

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14

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3388. BBaddour LMLMM, EpEpEpststeiiinnn AEAEAE,,, ErEricicickksksoonn CC,C,, KKKnigghghtt BPPP,,, LeLeeviviisosonnn MMEME, LoLoLockckkhahahartrt PPPB,B,B, MMMasssoououddid FFAOOOkuumum EJ, WWili soonn WRWRR, BBeererrmmman n LBBB, , BoBoBolgeerr AAAF, EEsstetes s s NANANA, 333rd,, GGGewiittzz MMM, NNNewe bbburrgrgeeer JJW,, ScSchrhrh ononon EEB,B,B, TTTauaubbebertrtr KKKAA.A. UUpdpddatatteee ononon ccaarardididiovovovassscucuculalaar r imimmplplplanananttatablblblee elele ececectrtrt oooniicic dddevevevicici e e ininnffeccctiooonsns anndnd heiir r mmananaggemement:: A A scieentn ifficic statatet menntt frfromom tthehe amemeriricacan n hehearrt t asassosociatatioion.n CiCircululaatioonn.

2010;121:458588-4-4477777..




16

43. Mela T, McGovern BA, Garan H, Vlahakes GJ, Torchiana DF, Ruskin J, Galvin JM. Long-term infection rates associated with the pectoral versus abdominal approach to cardioverter- defibrillator implants. Am J Cardiol. 2001;88:750-753.




17

Table 1. Baseline characteristics of patients with ICD infection versus those without infection.

No Infection (N=197519)

Infection(N=3390) P value

Demographic Age, mean (SD), y 75.3 ( 6.4 ) 75.3 ( 6.4 ) 0.63 Male, % 74.2 75.5 0.07 Race, % White non-Hispanic 86.2 85.0 Black non-Hispanic 7.3 8.1 0.054 Hispanic 3.9 4.5 Other 2.6 2.3 Clinical Characteristics Syncope, % 20.1 19.3 0.26 Family History Sudden Death, % 3.5 3.0 0.09 Heart Failure Hospitalization, % No 55.3 49.4 Yes-Hospitalized 6 months 22.0 26.3 <.001 Yes-Hospitalized > 6 months 22.7 24.3 NYHA Class , % I 11.3 8.8 II 34.1 29.9 <.001 III 50.4 56.3 IV 4.2 5.1 Atrial Fibrillation/Atrial Flutter, % 42.1 48.7 <.001 Ventricular Tachycardia, % 41.6 40.2 0.09 Sinus Node Function, % Normal 65.6 60.0 <.001 Abnormal 34.4 40.0 Non-Ischemic Dilated Cardiomyopathy, % 25.5 24.1 0.05 Ischemic Heart Disease, % 73.2 74.4 0.12 Previous ICD, % 28.7 32.0 <.001 Previous MI, % 58.1 56.9 0.17 Previous CABG, % 42.3 46.5 <.001 Previous PCI, % 34.3 33.4 0.26 Previous Valvular Surgery, % 8.5 14.1 <.001 Cerebrovascular Disease, % 17.7 21.2 <.001 Chronic Lung Disease, % 24.3 29.1 <.001 Diabetes, % 37.7 40.1 0.005 Hypertension, % 79.1 80.1 0.12 Renal Failure-Dialysis, % 3.7 5.4 <.001 Intraventricular conduction, % Normal 32.5 28.1) Abnormal-LBBB 26.4 25.4 <.001 Abnormal-RBBB 7.4 7.6 Other 33.6% ) 38.9

Yes-Hospitalized 6 months 22.0 26.3 <<.0.00101 Yes-Hospitalized > 6 months 22.7 24.3

NYHA Class , % I 11.3 8.8 II 34.1 29.9 <.001 IIIIIII 50.4 556.3 IVIVIV 44.4.222 5.11

AAtririiala Fibrillatatioion/n/AtAtririalll FFFlluluttttteerer, %%% 44242.1.1 4848.7.77 <<<.0.0001011 VVeVenntntricular TaTachhhyyccardddiaaa, %% 414141.6.6.6 4040.2.2 0.0009 SiSinununus s NoNoN dedede FFFununccctiioion,n,, %%% Noormrmal 6565.66 6060.00 << 0.0010 Abnormal 343434.4.44 404040.0.0

NoNonn IsIschchememicic DDililatateded CCarardidiomomyoyopapaththyy %% 2255 55 2424 11 00 0055




18

Ejection Fraction, mean (SD), % 28.4 ( 10.8 ) 28.0 ( 10.5 ) 0.04 QRS duration, mean (SD), ms 135.1 ( 35.7 ) 139.4 ( 37.0 ) <.001 Creatinine, mean (SD), mg/dL 1.4 ( 1.0 ) 1.5 ( 1.1 ) <.001 BUN, mean (SD), mg/dl 26.5 ( 14.3 ) 28.1 ( 15.7 ) <.001 Sodium, mean (SD), mg/dL 138.7 ( 3.6 ) 138.3 ( 3.7 ) <.001 Systolic Blood Pressure, mean (SD), mm Hg 132.5 ( 22.7 ) 132.0 ( 23.2 ) 0.17 Procedure factors Reimplantation, % No 71.3 68.0 Yes-Device upgrade, malfunction, manufacturer advisory 6.7 9.8 <.001 Yes-Battery change 22.1 22.2 ICD type, % Single chamber 16.1 13.3 Dual chamber 37.0 31.8 <.001 Biventricular-LV lead (coronary sinus) 44.2 51.5 Biventricular-LV lead (epicardial/other) 2.7 3.4 Multiple ICDs during admission, % 0.2 0.3 0.02 Adverse events, % 1.9 5.4 <.001 Operator factors EP operator ICD training, % Unknown 22.6 23.8 <.001 Board-certified EP/EP fellowship 61.9 58.2 Surgery board 1.8 2.1 Other 13.8 15.9 Physician volume, mean (SD) 87.2 ( 79.0 ) 84.5 ( 80.6 ) 0.049 Teaching status, % COTH 30.2 27.6 Teaching 28.0 27.7 <.001 Other 41.8 44.8 Cardiac facility, % CABG availability 86.9 84.9 Coronary catheterization 3.2 4.0 0.002 Other 9.9 11.1 Number beds set up and staffed, mean (SD) 455.0 ( 270.0 ) 447.9 ( 270.9 ) 0.13 Medications Warfarin, % 33.2 39.6 <.001 Aspirin, % 66.8 65.2 0.06 Clopidogrel, % 23.1 23.1 0.96 Ticlopidine, % 0.3 0.3 0.98 Abbreviations: BUN, blood urea nitrogen; CABG, coronary artery bypass graft; COTH, Council of Teaching Hospitals; EP, electrophysiology; ICD, Implantable cardioverter-defibrillator; LBBB, left bundle branch block; LV, left ventricular; MI, myocardial infarction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; RBBB, right bundle branch block.

Multiple ICDs during admission, % 0.2 0.3 0.0.0202 Adverse events, % 1.9 5.4 <<.<.00000011Operator factors EP operator ICD training, %Unknk own 22.6 23.8 <.001 BoBooararard-dd-ceceertrtrtififified d EEPEP/EP fellowship 61.9 558.2 SuSuSurrgrgery boboarara d d 11.1.888 2.11

tOtthher 1133.8.88 1515.9.99 PhPhPhysysysician voolulummeme,, meeanann (SDSDD) ) ) 8787.2.22 ((( 77799.9 000 ) 8444.555 (( 88000.66 ) 0.044999 TeTeacacachihihingngng ssstatatattutus,s,, %%% COOTHTH 3030.22 2727.66 Teaching 282828.0.00 272727.7.7 <.001 OtOtheherr 4141 88 4444 88




19

Table 2. Adverse events during implant hospitalization.

Adverse Event No Infection (N=197519)

Infection(N=3390) P value

AV Fistula 7 ( 0.004% ) 2 ( 0.059% ) 0.01 Cardiac Arrest 174 ( 0.088% ) 2 ( 0.059% ) 0.99 Cardiac Perforation 146 ( 0.074% ) 2 ( 0.059% ) 0.99 Conduction Block 60 ( 0.030% ) 2 ( 0.059% ) 0.28 Coronary Venous Dissection 244 ( 0.124% ) 2 ( 0.059% ) 0.45 CVA/Stroke 106 ( 0.054% ) 1 ( 0.029% ) 0.99 Drug Reaction 155 ( 0.078% ) 3 ( 0.088% ) 0.75 Hematoma 1828 ( 0.925% ) 127 ( 3.746% ) <.001 Hemothorax 173 ( 0.088% ) 7 ( 0.206% ) 0.03 Lead Dislodgement 1884 ( 0.954% ) 56 ( 1.652% ) <.001 Myocardial Infarction 46 ( 0.023% ) 0 ( 0.000% ) 0.99 Pericardial Tamponade 194 ( 0.098% ) 3 ( 0.088% ) 0.99 Peripheral Embolus 49 ( 0.025% ) 0 ( 0.000% ) 0.99 Peripheral Nerve Injury 10 ( 0.005% ) 0 ( 0.000% ) 0.99 Phlebitis - Deep 51 ( 0.026% ) 1 ( 0.029% ) 0.59 Phlebitis - Superficial 64 ( 0.032% ) 2 ( 0.059% ) 0.31 Pneumothorax 954 ( 0.483% ) 17 ( 0.501% ) 0.88 TIA 37 ( 0.019% ) 0 ( 0.000% ) 0.99 Abbreviations: AV, arteriovenous; CVA, cerebrovascular accident; TIA, transient ischemic attack

Table 3. Multivariable predictors of ICD infection.

Effect OR (95% CI) P-value Clinical Characteristics Previous Valvular Surgery 1.525 ( 1.375 - 1.692 ) <.0001 Cerebrovascular Disease 1.172 ( 1.076 - 1.276 ) .0003 Chronic Lung Disease 1.215 ( 1.125 - 1.312 ) <.0001 Renal Failure-Dialysis 1.342 ( 1.123 - 1.604 ) .0012 Procedure factors Reimplantation No Reference Yes-Device upgrade, malfunction, manufacturer advisory 1.354 ( 1.196 - 1.533 ) <.0001 Yes-Battery change 1.090 ( 0.992 - 1.198 ) Adverse events 2.692 ( 2.304 - 3.145 ) <.0001 Medications Warfarin 1.155 ( 1.060 - 1.257 ) 0.001 C-statistic for model 0.676. Abbreviations: BUN, blood urea nitrogen; CABG, coronary artery bypass graft; EP, electrophysiology; ICD, Implantable cardioverter-defibrillator; LBBB, left bundle branch block; LV, left ventricular; MI, myocardial infarction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; RBBB, right bundle branch block

Peripheral Embolus 49 ( 0.025% ) 0 ( 0.000%% ))) 0.0.0 999999 Peripheral Nerve Injury 10 ( 0.005% ) 0 ( 0.000%% ))) 00.0 999999 Phlebitis - Deep 51 ( 0.026% ) 1 ( 0.029% ) 0.59 Phlebitis - Superficial 64 ( 0.032% ) 2 ( 0.059% ) 0.31Pnneueuumomomothththorororaxaxa 959595444 (( 0.483% ) 11777 ((( 0.501% ) 0.88TITIIAAA 37377 ((( 0.001919% % ) 00 ((( 0.0 00000%0% ))) 0.0.9999 AAAbbbrreve iations: AAV,V,V arrrterrioioioveeenononouusus; ;; CVCVCVAA,A, ccerereebebrroovasscucular aacccciidennnt;; TITIA,A,A ttrarannsnsieentnt iiiscscschheemiic cc aatattatackckk

TaTaablblblee e 3.3 MMululultittivavaariiiababllee ppprerediiictctc ororors s ofofof IICDCDCD iinnfnfeccctitioonn.

Effect OOOR R R (9(9(95%5%5% CCCI)I)I) P-value ClClininicicalal CChahararactctererisistiticscs




20

Figure Legend:

Figure 1. Kaplan-Meier curve of survival free of ICD infection.



rates of and factors associated with infection in 200 909 medicare implantable...

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