Long-Term Mortality Following Transvenous Lead Extractioncircep.ahajournals.org/content/circae/early/2012/02/22/CIRCEP.111... · Long-Term Mortality Following Transvenous Lead Extraction

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Long-Term Mortality Following Transvenous Lead Extraction

Running title: Maytin et al.; Long-Term Mortality Following TLE

Melanie Maytin, MD1; Samuel O. Jones, MD, MPH2; Laurence M. Epstein, MD1

1Brigham & Women’s Hospital, Boston, MA;

2San Antonio Military Medical Center, Fort Sam Houston, TX

Corresponding Author:

Melanie Maytin, MD

Brigham & Women’s Hospital

75 Francis Street

Boston, MA 02115

Tel: 857 307 1947

Fax: 857 307 1944

E-mail: [email protected]

Journal Subject Codes: [22] Ablation/ICD/surgery; [120] Pacemaker; [27] Other Treatment

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Abstract:

Background - The number of cardiovascular implantable electronic devices (CIED) has risen

progressively and has led to an increased need for transvenous lead extraction (TLE). Multiple

reports of TLE procedural outcomes exist, however data regarding post-procedural and long-

term mortality are limited.

Methods and Results - We performed a retrospective study of consecutive patients undergoing

TLE at a single, high-volume center. Patient characteristics, indications and outcomes were

analyzed. Multivariable Cox regression model was developed to identify factors associated with

mortality. Between January 2000-December 2010, 985 patients underwent 1043 TLE

procedures. The cohort was 68% male with a mean age of 63 years (15-95) and LVEF of

40±17%. Indications included systemic infection (18%), pocket infection (32%), lead

malfunction (30%) and other (device upgrade, venous occlusion, advisory leads 20%). There

were no procedure related deaths. The mean follow-up was 3.7 years (range, 0.1-11.3). Kaplan-

Meier analysis demonstrated a cumulative mortality of 2.1% at 30 days, 4.2% at 3 months, 8.4%

at 1 year and 46.8% at ten years. In multivariable analysis, systemic infection (HR 3.52 [1.95,

6.38], p<0.0001), local infection (HR 2.70 [1.55, 4.67], p=0.0004), device system upgrade (HR

2.14 [1.07, 4.25], p=0.03; indication compared to a reference group of extraction for lead

malfunction), diabetes mellitus (HR 1.71 [1.25, 2.35], p=0.0009), increasing age (HR 1.05 [1.04,

1.07], p<0.0001) and serum creatinine (HR 1.16 [1.01, 1.35], p=0.04) were significant correlates

of increased mortality risk.

Conclusions - While TLE procedural mortality is exceedingly low at high volume centers, post-

procedural and long-term mortality remain high in certain patient populations such as the elderly

and those undergoing TLE for infectious indications and device system upgrade. Information

regarding TLE long-term outcomes may help guide CIED and lead management.

Key words: lead extraction, cardiovascular implantable electronic device, mortality, lead management, infection

Abbreviations: CIED: cardiovascular implantable electronic device; ICD: implantable cardioverter-defibrillator; TLE: transvenous lead extraction; PPM: pacemaker; CRT-P: cardiac resynchronization therapy-pacemaker; CRT-D: cardiac resynchronization therapy-defibrillator; CTS: countertraction sheath; AF: atrial fibrillation; DM: diabetes mellitus; CHF: congestive heart failure; CAD: coronary artery disease; EF: ejection fraction; Q1, Q3: interquartile range; HRS: Heart Rhythm Society

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onstrated a cumulative mortality of 2.1% at 30 days, 4.2% at

at ten years. In multivariable analysis, systemic infection (H

cal infection (HR 2.70 [1.55, 4.67], p=0.0004), device system

=0.03; indication compared to a reference group of extraction


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Introduction

The number of active cardiovascular implantable electronic devices (CIED) has risen

progressively over the past decade1, 2 with a parallel increase in the demand for transvenous lead

extraction (TLE).3 Transvenous lead extraction is associated with inherent intra-procedural risks

and even mortality. Observational registries of experienced, high volume extractionists have

consistently demonstrated high success rates (>99%) with exceedingly low major complication

(<1.0%) and mortality rates (<0.3%).4-6 However, data regarding post-procedural and long-term

mortality are limited.7-9 This study examined the experience at a single high-volume extraction

center with regard to post-procedural and long-term mortality following TLE in addition to

evaluating potential correlates of mortality.

Methods

We identified a cohort of consecutive patients undergoing transvenous lead extraction at a single,

high volume referral center between January 2000 and December 2010 and retrospectively

analyzed patient characteristics, procedural indications and outcomes and mortality. Indications

for extraction were categorized as systemic infection (bacteremia and/or endocarditis), local

infection (pocket infection or erosion), lead malfunction, CIED system upgrade and other.

Examples of indications included in the “other” category include venous thrombosis, severe

chronic pain at site of device or lead, advisory leads and need for either radiation therapy or MR

imaging.

A stepwise approach to lead extraction was implemented in every case with the goal of

complete success utilizing the least amount of tools as has been described previously.4 Complete

removal of infected tissue and foreign material is mandatory in cases of CIED infection. If

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ipsilateral reimplantation is planned, ipsilateral venous access is attempted under fluoroscopic

guidance with or without the aid of intravenous contrast. If the vein is successfully cannulated

and a wire could be passed into the inferior vena cava or if ipsilateral reimplantation is not

planned, lead removal with simple traction is attempted. If this proves unsuccessful, the lead is

cut and a locking stylet with #5 silk is introduced and traction reattempted. If lead removal still

proves unsuccessful, a nonpowered or powered sheath is employed. Sheath selection is

determined by the operator’s preference and experience. If the lead is not retrievable from the

implant vein or lead disruption occurs, transfemoral retrieval is performed.

The operator is well versed in all extraction modalities with a large volume of experience

(>100 lead extractions/year). Patient characteristics and the indications and outcomes for TLE

were examined. Survival was assessed by both review of the electronic medical record and

search of the Social Security Death Index for those individuals following up outside the

institution. Follow-up information was available by at least one method for all individuals. For

patients undergoing multiple TLE procedures, length of follow-up and outcomes are relative to

most recent procedure.

Outcomes were based upon the most recent Heart Rhythm Society lead management

consensus10 and defined as follows: 1) complete procedural success if all targeted leads and lead

material were removed from the vascular space; 2) clinical success if all targeted leads and lead

material were removed but with retention of a small portion of the lead that does not negatively

impact on outcome goals; and, 3) failure if neither complete procedural nor clinical success

could be achieved. Major complications were defined as those that threaten life, require

significant surgical intervention, cause persistent or significant disability or result in death.

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vival was assessed by both review of the electronic medical r

Security Death Index for those individuals following up outs

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Complications that do not meet the major complication criteria are classified as minor

complications.10

Means, medians, or proportions for baseline clinical variables were calculated for the

entire cohort. Continuous variables were expressed as mean ± SD or median and the first and

third quartiles (Q1, Q3). Fisher exact tests were used to compare categorical variables.

Continuous variables were compared across multiple groups using ANOVA. Cox regression was

performed to identify correlates of mortality and to correct for possible confounders. Variables in

the multivariable Cox regression model included age at extraction; gender; indication for

extraction (systemic infection, local infection, lead malfunction, device upgrade or other

indication); CIED type (pacemaker, ICD or biventricular device); the presence of atrial

fibrillation (AF), diabetes mellitus (DM), congestive heart failure (CHF), coronary artery disease

(CAD), pacemaker (PPM) dependence or steroid use; renal function as estimated by serum

creatinine; number of leads extracted, lead implant duration; the use of countertraction sheath

assistance (CTS) during TLE; and, the presence of more than one TLE procedure. Age at

extraction, serum creatinine, number of leads extracted and implant duration were modeled as

continuous variables after the linearity assumption was tested. TLE indication was categorized

systemic infection, local infection, lead malfunction, device system upgrade and other TLE

indications (e.g. SVC syndrome, advisory ICD lead, etc.). Lead malfunction was chosen

arbitrarily as the reference group for the variable TLE indication. Similarly, the nominal variable,

device type, was categorized as pacemaker, ICD and cardiac resynchronization therapy (either

pacemaker or defibrillator) with pacemaker arbitrarily chosen as the reference group. All tests of

significance were two sided, and a p-value of <0.05 was considered significant. Statistical

analysis was performed using SAS version 9.2 (SAS Institute, Cary, NC, USA).

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(PPM) dependence or steroid use; renal function as estimated

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abetes mellitus (DM), congestive heart failure (CHF), corona

(PPM) dependence or steroid use; renal function as estimated

of leads extracted, lead implant duration; the use of countertr


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Results

Between January 2000 and December 2010, 1043 transvenous lead extraction procedures were

performed in 985 patients. The cohort was 68% male with a mean age of 62 years (range, 15-95

years). Co-morbidities present were as follows: coronary heart disease, 45%; congestive heart

failure, 43%; atrial fibrillation, 33%; and, diabetes mellitus, 25%. The mean ejection fraction

(EF) was 40 ± 17% (median 38%, Q1, Q3: 25, 55%) and the mean creatinine was 1.3 ± 0.8

mg/dL (median 1.1 mg/dL, Q1, Q3: 0.9, 1.4 mg/dL). Pacemaker dependence was present in 36%

of patients, and 35% had prior cardiac surgery. A comparison of baseline characteristics

according to TLE indication is reported in Table 1.

The most common indication was infection (50%; 18% systemic infection and 32% local

infection), lead malfunction (30%), followed by CIED system upgrade (8%) and other

indications (12%). During the study period, 57 patients underwent repeat TLE. Indications for

repeat procedures included all aforementioned TLE indications with 19 patients (34%)

undergoing a second procedure for the same initial indication (e.g. infection and infection or lead

malfunction and lead malfunction). Of the 21 patients with initial infectious indications (local or

systemic) for lead extraction undergoing a repeat procedure, 10 patients (48%) underwent

another TLE procedure for infection at a mean of 21.4 ± 22.6 months following the initial

procedure (range, 1.3-52.9 months). While of the 36 repeat procedures performed for an initial

indication other than infection, 10 patients (28%) underwent a subsequent lead extraction

procedure for infection at a mean of 5.7 ± 13.0 months (range, 0.9-41.5 months). During the

study period, 21 repeat procedures were performed for the removal of an advisory ICD lead

(Sprint Fidelis®, Medtronic, Inc., Minneapolis, MN) either due to lead malfunction or

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function (30%), followed by CIED system upgrade (8%) and

During the study period, 57 patients underwent repeat TLE. In


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prophylactically.

The total number of leads removed was 1951 leads with a mean of 1.9 ± 0.9 leads per

procedure. Mean implant duration was 70.8 ± 59.2 months (median 52.9 months, Q1, Q3: 30.1,

98.2 months); the oldest lead was in place for 398.0 months. Complete procedural success was

achieved in 95.2% of patients with a 99.4% clinical success rate. Extraction was achieved with

simple traction in 696 leads (36%, Figure 1). Powered CTS assistance was employed with the

Excimer Laser System (Spectranetics, Colorado Springs, CO) in 1137 leads (58%) and the

Evolution device (Cook Medical, Bloomington, IN) in 51 leads (2.6%). Transfemoral

extraction with the Byrd Workstation (Cook Medical, Bloomington, IN) was employed in 67

cases (3.4%). A 0.48% major complication rate was observed and there were no procedure

related deaths. There were five cases of cardiac tamponade, three treated with pericardiocentesis

and two requiring urgent sternotomy. Procedural characteristics are reported in Table 2.

Patients were followed until study endpoint (i.e. death) was reached or a minimum of 8

months (range of follow up 4 days to 135.2 months). The mean follow-up time was 3.4 2.7 years

and the median follow-up time was 2.7 years [Q1, Q3: 1.3, 5.1]. Kaplan-Meier survival analysis

of the entire cohort demonstrated a survival probability of 97.9% at 1 month, 95.8% at 3 months,

93.5% at 6 months, 91.6% at one year, 84.3% at two years, 68.6% at five years and 53.2% (262

deaths) at ten years. Five patients died in-hospital an average of 15 days post-TLE (range, 4-43

days). All 5 individuals had infectious indications for TLE (4 systemic, 1 local). Of the four

patients with systemic infection, 3 died of multi-organ failure secondary to overwhelming sepsis

with methicillin-sensitive Staphylococcus aeurus. The fourth patient died of a complication of

second procedure performed during the index hospitalization (exsanguinating retroperitoneal

hemorrhage following renal biopsy). The one patient with local CIED infection who died in-

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hospital succumbed to progressive heart failure four days following TLE.

If the survival data are divided according to lead extraction indication, a survival

difference is noted among the groups. There is a marked initial decline in survival in the

immediate period following lead extraction that is most pronounced in those referred for

infectious indications or device system upgrade (Figure 2). Breaking down the survival data by

groups at different time points, it becomes apparent that early mortality is higher in certain

groups. Among patients referred for lead extraction for systemic CIED-associated infection,

unadjusted one-year mortality approaches 25% in comparison to a 1.6-2.4% one-year mortality

among patients referred for TLE for lead malfunction or other indications. In fact, patients with

systemic infection were observed to have the poorest outcomes with an unadjusted one-month

survival rate of 90.3%. In comparison, patients referred for TLE for all other indications had

unadjusted survival rates in excess of 99% at one month.

Multivariable analysis of correlates of mortality by Cox regression identified several

correlates of mortality (Table 3). After controlling for baseline and procedural characteristics,

age at TLE, systemic infection, local infection, device upgrade, serum creatinine and diabetes

mellitus remained significant correlates of mortality. Instantaneous mortality rate increases by

5% per each year of patient age (HR 1.05, 95% CI [1.04, 1.07])and by 16% for each mg/dL

increase in serum creatinine (HR 1.16 [1.01, 1.35]). The presence of diabetes mellitus increases

the rate of death by 71% (HR 1.71, 95% CI [1.25, 2.35]). The indication for lead extraction has

the most significant impact on survival. Patients with systemic and local infection have a 3.5-fold

(HR 3.52, 95% CI [1.95, 6.38]) and 2.7-fold (HR 2.70, 95% CI [1.55, 4.67]) increased rate of

death, respectively; while, patients undergoing TLE for device upgrade have an approximate 2-

fold (HR 2.14, 95% CI [1.07, 4.25]) increased instantaneous mortality rate.

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Discussion

While TLE intra-procedural mortality may be low in the hands of high-volume extraction

centers, post-procedural (30-day) and long-term mortality remain significant. In a large,

heterogeneous, unselected cohort, we observed significant unadjusted mortality rates of 2.1% at

30-days, 4.2% at 3 months and 8.4% at one year. If the survival data are further categorized

according to lead extraction indication, long-term mortality following TLE is significantly higher

in certain patient populations. There is a marked initial decline in survival in the immediate post-

operative period that is sustained and most pronounced in those CIED patients with systemic

infection. The survival curves for patients undergoing TLE for local infection and CIED system

upgrade diverge at approximately 2 years post-procedure from those following extraction for

lead malfunction or other indications. In multivariable analysis, age, diabetes mellitus, serum

creatinine, systemic and local infection and device system upgrade were the strongest correlates

of mortality.

These findings are consistent with and extend those from prior reports. Henrikson and

colleagues9 recently described mid-term mortality rates among 67 patients undergoing TLE for

infectious indications with an approximate even distribution of local and systemic infection.

They observed a 30% mortality rate over the follow-up period (range, 6-55 months). There were

no procedure-related deaths and an overall mortality risk of 44% with systemic infection. On

univariate analysis, bacteremia was the only correlate for mortality in this report. Our findings

are in keeping with these observations and identified other correlates of mortality including local

infection, patient age, elevated serum creatinine and the presence of diabetes mellitus. Hamid et

al.7 published a series of 183 patients undergoing TLE with a similar observed 30-day mortality

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rate of 2.7%. In contrast to our observations, Hamid et al. observed a modest mortality rate on

long-term follow-up of 6.6% at an average follow-up of 965 days. While on univariate analysis,

C-reactive protein, prior valve surgery, systemic infection and echocardiographic evidence of

vegetations were associated with increased mortality, on multivariable analysis, the only

identified correlate of mortality was median C-reactive protein level, likely a result of sample

size limitations. In a cohort of 100 patients with CIED-related endocarditis, Grammes et al. 8

observed a 10% 30-day mortality rate, also in keeping with our experience.

High long-term mortality rates following transvenous lead extraction are likely a

reflection the severity of the underlying disease process and associated co-morbidities.

Interestingly, one strong correlate of risk is the indication for lead extraction, specifically

infection (both systemic and local) and device system upgrade. CIED infection is a class I

indication for extraction and venous obstruction with the need for system upgrade is a class IIa

indication according to the 2009 HRS Expert Consensus on Transvenous Lead Extraction10. It is

reasonable to hypothesize that the mortality rates for these extraction indications might be even

higher in the absence of these recommendations. Although we do not have data regarding the

time delays between diagnosis of infection and treatment (i.e. TLE), another plausible hypothesis

for the increased mortality rate is that the mortality was higher among patients in which there

was significant delay in the time to definitive treatment. Mortality rates in these situations may

be modifiable with early recognition and prompt treatment. The first presentation of patients with

CIED infections is frequently to non-electrophysiologists. Thus, the education of emergency

room physicians, primary care providers, infectious disease specialists and general cardiologists

regarding the diagnosis of CIED infection and the need for urgent complete removal of all

hardware may reduce the associated mortality risk. In addition, these findings demonstrate that

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despite a successful extraction procedure, mortality remains high for CIED infection. This

includes both system and local infection. This highlights the need to reduce the incidence of

CIED-related infections. For example, careful consideration should be given prior to implanting

transvenous devices in those at high risk of recurrent bacteremia and infection, such as renal

dialysis patients.

The vast majority of patients (78%) undergoing “upgrade” were for cardiac

resynchronization. This would result in a selection bias towards patients with advanced heart

failure. Although data regarding mode of death are not available for the cohort, progressive heart

failure may explain the observed increased mortality following extraction for system upgrade to

biventricular devices.

Limitations

This study is a retrospective analysis and thus is subject to bias and the other well-known

limitations of non-experimental designs. The cohort was limited to a single, high-volume,

academic center and the experience may differ at other types of institutions. Additionally, the

details regarding mode of death were not available. Thus, definitive conclusions regarding the

cause of the observed differences cannot be drawn.

Conclusion

With expanded CIED utilization and indications for device therapy, the need for device system

revisions and observed complications will continue to increase in parallel. Although procedural

mortality is exceedingly low at high-volume centers, post-procedural and long-term mortality

remain high in certain patient populations. Specifically, patients with advanced age and those

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undergoing lead extraction for infectious indications and device system upgrade have

significantly higher long-term mortality rates. Knowledge of these risks may help guide CIED

and lead management. Future studies aimed at identifying potential interventions that modify

long-term mortality are warranted.

Conflict of Interest Disclosures: Dr. Epstein is a consultant for Boston Scientific, GE

Healthcare, Medtronic, Spectranetics and St. Jude Medical; and has equity in and served as a

board member for Carrot Medical.

References:

1. Hammill SC, Kremers MS, Kadish AH, Stevenson LW, Heidenreich PA, Lindsay BD, Mirro MJ, Radford MJ, McKay C, Wang Y, Lang CM, Pontzer K, Rumsfeld J, Phurrough SE, Curtis JP, Brindis RG. Review of the icd registry's third year, expansion to include lead data and pediatric icd procedures, and role for measuring performance. Heart Rhythm. 2009;6:1397-1401.

2. DeFrances CJ, Lucas CA, Buie VC, Golosinskiy A. 2006 national hospital discharge survey. Natl Health Stat Report. 2008:1-20.

3. Hauser RG, Katsiyiannis WT, Gornick CC, Almquist AK, Kallinen LM. Deaths and cardiovascular injuries due to device-assisted implantable cardioverter-defibrillator and pacemaker lead extraction. Europace. 2010;12:395-401.

4. Jones SO, Eckart RE, Albert CM, Epstein LM. Large, single-center, single-operator experience with transvenous lead extraction: Outcomes and changing indications. Heart Rhythm.2008;5:520-525.

5. Bongiorni MG, Soldati E, Zucchelli G, Di Cori A, Segreti L, De Lucia R, Solarino G, Balbarini A, Marzilli M, Mariani M. Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: High success rate and safety in more than 2000 leads. Eur Heart J. 2008;29:2886-2893.

6. Kennergren C, Bjurman C, Wiklund R, Gabel J. A single-centre experience of over one thousand lead extractions. Europace. 2009;11:612-617.

7. Hamid S, Arujuna A, Ginks M, McPhail M, Patel N, Bucknall C, Rinaldi C. Pacemaker and defibrillator lead extraction: Predictors of mortality during follow-up. Pacing Clin Electrophysiol. 2010;33:209-216.

enennenennenrerererererereicicicicicicich h h h hhh PAPAPAPAPAPAPA, , ,,,,, LiLiLiLiLiLiLindndndndndndndmsfeldldldldldldld J J J J J J J, ,, ,,,, PhPhPhPhPhPhPhurururururururrorororrorr u

iew of the icd registr 's thi d i t incl de leadu

u sp

yiannis WT Gornick CC Almquist AK Kallinen LM Deat

iew of the icd registry's third year, expansion to include leadures, and role for measuring performance. Heart Rhythm. 20

ucas CA, Buie VC, Golosinskiy A. 2006 national hospital disport. 2008:1-20.

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8. Grammes JA, Schulze CM, Al-Bataineh M, Yesenosky GA, Saari CS, Vrabel MJ, Horrow J, Chowdhury M, Fontaine JM, Kutalek SP. Percutaneous pacemaker and implantable cardioverter-defibrillator lead extraction in 100 patients with intracardiac vegetations defined by transesophageal echocardiogram. J Am Coll Cardiol. 2010;55:886-894.

9. Henrikson CA, Zhang K, Brinker JA. High mid-term mortality following successful lead extraction for infection. Pacing Clin Electrophysiol. 2011;34:32-36.

10. Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH, 3rd, Epstein LM, Friedman RA, Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM. Transvenous lead extraction: Heart rhythm society expert consensus on facilities, training, indications, and patient management. Heart Rhythm. 2009;6:1085-1104.


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Table 1. Baseline Characteristics

Characteristic

SystemicInfection(n=186)

Local Infection(n=334)

LeadMalfunction

(n=311)Device Upgrade

(n=82)Other

(n=130) p-value Gender – no. of patients (%) <0.0001

Male 126 (68%) 249 (75%) 189 (61%) 63 (77%) 80 (62%) Female 60 (32%) 85 (25%) 122 (39%) 19 (23%) 50 (38%)

Age (years) 67 14 70 15 54 18 66 14 54 16 <0.0001 Device type <0.0001

PPM 93 (50%) 150 (45%) 84 (27%) 61 (74%) 16 (12%) CRT-P 2 (1%) 2 (<1%) 1 (<1%) 0 (0%) 0 (0%) ICD 74 (40%) 144 (43%) 197 (63%) 21 (26%) 98 (75%) CRT-D 17 (9%) 37 (1%) 29 (9%) 0 (0%) 16 (12%)

Serum creatinine (mg/dL) 1.9 1.5 1.2 0.6 1.0 0.3 1.4 0.8 1.0 0.3 <0.0001Hemodialysis – no. of patients (%) 5 (3%) 4 (1%) 0 (0%) 2 (2%) 0 (0%) 0.011DM – no. of patients (%) 89 (48%) 78 (23%) 46 (15%) 25 (30%) 25 (19%) <0.0001CHF – no. of patients (%) 85 (46%) 139 (42%) 99 (32%) 72 (88%) 57 (44%) <0.0001EF (%) 42 17 39 16 42 18 28 12 41 16 <0.0001CAD – no. of patients (%) 100 (54%) 174 (52%) 94 (30%) 50 (61%) 47 (36%) <0.0001AF – no. of patients (%) 72 (39%) 127 (38%) 68 (22%) 39 (48%) 34 (26%) <0.0001PPM dependent – no. of patients (%) 46 (25%) 133 (40%) 193 (33%) 54 (66%) 35 (27%) <0.0001Steroid use – no. of patients (%) 10 (5%) 4 (1%) 2 (<1%) 2 (2%) 2 (2%) 0.007 Repeat TLE procedure – no. of patients (%) 5 (3%) 14 (4%) 16 (5%) 5 (6%) 17 (13%) 0.003 *Plus-minus values are means SD. TLE: transvenous lead extraction; ICD: implantable cardioverter-defibrillator; CRT-P: cardiac resynchronization therapy-pacemaker; CRT-D: cardiac resynchronization therapy-defibrillator; EF: ejection fraction; CHF: congestive heart failure; CAD: coronary artery disease; AF: atrial fibrillation; PPM: pacemaker; CTS: countertraction sheath assistance.

Table 2. Procedural Characteristics

Characteristic Systemic Infection

(n=186)

Local Infection (n=334)

Lead Malfunction

(n=311) Device Upgrade

(n=82) Other

(n=130) p-value Implant duration (months) 72.3 69.3 82.5 63.4 71.4 52.1 66.5 52.4 51.2 41.2 <0.0001 No. of leads removed 2.1 0.8 2.2 0.9 1.6 0.8 1.7 0.9 1.5 0.9 <0.0001 Complete success 95.6% 95.5% 92.9% 96.3% 98.5% 0.14 Procedural success 99.5% 99.1% 99.4% 100% 100% 0.76 Major complications 0.5% 0.6% 0.3% 1.2% 0% 0.66 CTS use during TLE 65% 79% 82% 79% 65% <0.0001 *Plus-minus values are means SD. CTS: countertraction sheath assistance; TLE: transvenous lead extraction.

0 0 0 0 0 0 0 (0(0(0(0(0(0(0%)%)%)%)%)%)%) 66664666 ( ( ( ( ( ( (15151515151515%)%)%)%)%)%)%)

999999 (3(3(3(3(3(3( 2%2%2%2%2%2%2%))))))85 (46%) 139 (42%) 99 (32%)

72 (39%) 127 (38%) 68 (22%) 46 (25%) 133 (40%) 193 (33%) 10 (5%) 4 (1%) 2 (<1%)

85 (46%) 139 (42%) 99 (32%) 42 17 39 16 42 18

100 (54%) 174 (52%) 94 (30%) 72 (39%) 127 (38%) 68 (22%) 46 (25%) 133 (40%) 193 (33%) 10 (5%) 4 (1%) 2 (<1%)


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15

Table 3. Adjusted Hazard Ratio for Death

Characteristic Hazard Ratio [95% CI] p-value Male Gender 0.94 [0.64, 1.39] 0.77Age (years) 1.05 [1.04, 1.07] <0.0001TLE indication* 0.04

Systemic infection 3.52 [1.95, 6.38] Local infection 2.70 [1.55, 4.67] Device upgrade 2.14 [1.07, 4.25] Other 1.15 [0.45, 2.92]

Device Type** 0.73 ICD 1.08 [0.69, 1.68] CRT-P/CRT-D 1.074 [0.60, 1.94]

Serum creatinine (mg/dL) 1.16 [1.01, 1.35] 0.04EF (%) 0.99 [0.98, 1.00] 0.08Diabetes mellitus 1.71 [1.25, 2.35] 0.0009 CHF 1.43 [0.99, 2.07] 0.05CAD 0.97 [0.68, 1.40] 0.88AF 1.26 [0.93, 1.72] 0.14PPM dependent 0.85 [0.60, 1.21] 0.36Steroid use 1.15 [0.52, 2.53] 0.73Repeat TLE procedure 1.35 [0.74, 2.47] 0.33Implant duration (months) 1.00 [0.99, 1.00] 0.07No. of leads removed 0.94 [0.77, 1.14] 0.51CTS use during TLE 1.01 [0.69, 1.48] 0.96*TLE indication categories are compared to a reference group of extraction for lead malfunction.**Device type categories are compared to a reference group of patients with single or dual chamber pacemakers. TLE: transvenous lead extraction; ICD: implantable cardioverter-defibrillator; CRT-P: cardiac resynchronization therapy-pacemaker; CRT-D: cardiac resynchronization therapy-defibrillator; EF: ejection fraction; CHF: congestive heart failure; CAD: coronary artery disease; AF: atrial fibrillation; PPM: pacemaker; CTS: countertraction sheath assistance.

Figure Legends:

Figure 1. Successful method of lead extraction.

Figure 2. Overall Kaplan-Meier survival curves according to TLE indication.

0] 000000022222] ]]]]]] 0000000] 00

1 15 [0 52 2 53] 0en

g

1.15 [0.52, 2.53] 0e 1.35 [0.74, 2.47] 0nths) 1.00 [0.99, 1.00] 0

0.94 [0.77, 1.14] 01.01 [0.69, 1.48] 0

gories are compared to a reference group of extraction for lead


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Melanie Maytin, Samuel O. Jones and Laurence M. EpsteinLong-Term Mortality Following Transvenous Lead Extraction

Print ISSN: 1941-3149. Online ISSN: 1941-3084 Copyright © 2012 American Heart Association, Inc. All rights reserved.

Dallas, TX 75231is published by the American Heart Association, 7272 Greenville Avenue,Circulation: Arrhythmia and Electrophysiology

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