long-term mortality following transvenous lead...
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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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aan Antonio Military Medical Center, Fort Sam Houston, TX
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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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o aort of consecutive patients undergoing transvenous lead extra
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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
up information was available by at least one method for all in
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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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mmon indication was infection (50%; 18% systemic infectio
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
CIED patientss w w ww www
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other indications. In multivariable analysis, age, diabetes me
and local infection and device system upgrade were the stron
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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
ciated co morrrrrrrbibbbbbb
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emic and local) and device system upgrade. CIED infection i
tion and venous obstruction with the need for system upgrad
g to the 2009 HRS Expert Consensus on Transvenous Lead E
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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:
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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
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yiannis WT Gornick CC Almquist AK Kallinen LM Deat
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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.
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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
published online February 23, 2012;Circ Arrhythm Electrophysiol.
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