Arrhythmia/Electrophysiology

Trends in Use and Adverse Outcomes Associated with

Transvenous Lead Removal in the United States
Abhishek Deshmukh, MBBS*; Nileshkumar Patel, MD*; Peter A. Noseworthy, MD, FHRS;
Achint A. Patel, MD; Nilay Patel, MD; Shilpkumar Arora, MD; Suraj Kapa, MD, FHRS;
Amit Noheria, MD, SM; Siva Mulpuru, MD, FHRS; Apurva Badheka, MD;
Avi Fischer, MD, FHRS; James O. Coffey, MD, FHRS; Yong Mei Cha, MD, FHRS;
Paul Friedman, MD, FHRS; Samuel Asirvatham, MD, FHRS; Juan F. Viles-Gonzalez, MD, FHRS

Background—Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and
safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable
experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of
hospital volume on complications.
Methods and Results—Using the Nationwide Inpatient Sample, we identified 91 890 TLR procedures. We investigated
common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis),
pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair,
and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International
Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code. We specifically assessed in-hospital
death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%),
open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were
female sex and device infections. Hospital volume was not independently associated with higher complications. There
was a significant rise in overall complication rates over the study period.
Conclusions—The overall complication rate in patients undergoing TLR was higher than previously reported. Female sex and
device infections are associated with higher complications. Hospital volume was not associated with higher complication
rates. The number of adverse events in the literature likely underestimates the actual number of complications associated
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with TLR.  (Circulation. 2015;132:2363-2371. DOI: 10.1161/CIRCULATIONAHA.114.013801.)

Key words: complications ◼ device infection ◼ lead removal

T he number of cardiac implantable electronic devices

implanted in the United States continues to grow.1 With
more leads being used for longer periods of time, there has
been a call for a comprehensive device and lead manage-
ment approach. Transvenous lead removal (TLR) has made
immense progress with respect to technical innovation and is
being performed frequently in many centers across the world.2
Recent lead recalls and increasing rates of cardiac implant-
able electronic device infection have resulted in the growing
use of lead removal procedures and the implementation of
dedicated lead removal programs. Most of the data pertaining
to the safety and efficacy of TLR originated from specialized
centers with extensive experience.3–5
Editorial see p 2357
Clinical Perspective on p 2371
Relatively less is known of the contemporary practice of
TLR in the United States in terms of use and safety outcomes
outside the published literature for TLR. In this descriptive
observational study we sought to explore contemporary
trends in the use of TLR, define the frequency of in-hospi-
tal adverse outcomes, and assess the influence of hospital
experience on the incidence of complications in a nationally
representative sample. Because of the constraints of admin-
istrative data sets, data about procedural techniques (eg, the
use of laser sheaths), the time interval between initial implan-
tation and TLR, the type and number of leads (pacemaker

Continuing medical education (CME) credit is available for this article. Go to http://cme.ahajournals.org to take the quiz.
Received October 17, 2014; accepted September 17, 2015.
From Mayo Clinic, Rochester, MN (A.D., P.A.N., S.K., A.N., S.M., Y.M.C., P.F., S. Asirvatham); University of Miami Miller School of Medicine,
Miami, FL (N.P., J.O.C., J.F.V.-G.); Icahn School of Medicine at Mount Sinai, New York, NY (A.A.P., S. Arora); Yale New Haven Medical Center, New
Haven, CT (A.B.); St. Jude Medical, Sylmar, CA (A.F.); and Saint Peter’s University Hospital/Rutgers University, New Brunswick, NJ (N.P.).
*
Drs Deshmukh and Patel contributed equally.
The online-only Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIRCULATIONAHA.
114.013801/-/DC1.
Correspondence to Abhishek Deshmukh, MBBS, Division of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905. E-mail
deshmukh.abhishek@mayo.edu
© 2015 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.114.013801

2363
 2364  Circulation  December 22/29, 2015
versus implantable cardioverter-defibrillator, single versus
dual coil, active versus passive fixation), anticoagulation
management, and medication use were not available.
Methods
Data Source
The data were obtained from the Nationwide Inpatient Sample (NIS)
data set from 2006 to 2012.6 The NIS is a nationally representative
survey of hospitalizations, conducted by the Healthcare Cost and
Utilization Project in collaboration with the participating states. The
largest all-payer inpatient data set in the United States, it includes a 20%
sample of all US community hospitals. Each entry contains informa-
tion on demographic details, including age, sex, race, insurance status,
primary and secondary procedures, hospitalization outcome, total cost,
and length of stay. The NIS database contains clinical and resource use
information, with safeguards to protect the privacy of patients, physi-
cians, and hospitals. The database results have been shown to corre-
late well with other hospitalization discharge databases in the United
States. It has also been used to explain trends in other acute illnesses
and to evaluate the use and safety of various procedures.7,8
Study Population
Our target population consisted of TLR procedures from the years
2006 to 2012. TLR were identified by International Classification of
Diseases, 9th Revision, Clinical Modification (ICD-9-CM), procedure
code 37.77, 37.79, 37.89, or 37.99.9,10 We excluded all observations
with missing information on age (n=35), sex (n=82), mortality (n=66).
To avoid potential confounding of complications, we further excluded
patients who underwent other invasive procedures during the stay,
for example, catheter ablation (n=1723), diagnostic catheterization
(n=5287), and coronary revascularizations (n=1641) (Figure 1).
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Outcomes
We investigated the commonly described acute in-hospital compli-
cations in the setting of TLR procedures. These complications were
also described in other TLR studies and consensus statements.11
Complications available for this analysis included pericardial; com-
plications (hemopericardium, cardiac tamponade, or pericardio-
centesis), pulmonary complications (pneumothorax, postoperative
respiratory failure, iatrogenic complications), vascular complica-
tion (postoperative hemorrhage, postoperative hemorrhage requir-
ing blood transfusion, vascular complications requiring surgical
repair), open heart surgery, and in-hospital death (online-only Data
Supplement Table I). Procedural complications were further identi-
fied by Patient Safety Indicators, which have been established by the
Agency for Healthcare Research and Quality to monitor preventable
adverse events during hospitalization. These indicators are based on
ICD-9-CM codes and Medicare severity Diagnosis-Related Groups;
each Patient Safety Indicator has specific inclusion and exclusion
criteria. Patient Safety Indicator individual measures of technical
specifications, Version 4.4, March 2012, were used to identify and
define preventable complications, namely, iatrogenic pneumothorax,
postprocedure respiratory failure, accidental puncture, or laceration.
Other procedure-related complications (including postprocedure
hemorrhage or hemorrhage requiring blood transfusion), pericardial
complications requiring open heart surgery, other iatrogenic respira-
tory complications (including ventilator-associated pneumonia, post-
procedure aspiration pneumonia, and other respiratory complications
not elsewhere classified), and other vascular complications were iden-
tified using ICD-9-CM codes (listed in online-only Data Supplement
Table I) in any secondary diagnosis field. Any complications was
defined as the occurrence of ≥1postprocedure complications listed
in online-only Data Supplement Table I.12,13 Complications occurring
beyond the index procedural hospitalization were not available for
the analysis. Complications were analyzed by the fiscal year in which
the procedure was performed to determine trends in complication
rates. We also examined length of stay (LOS) for the procedure and
differences in LOS if there was a complication. TLRs associated with
device infection were defined by septicemia (038.0, 038.10, 038.11,
038.19, 038.2, 038.3, 038.40, 038.41, 038.42, 038.43, 038.44,
038.49, 038.8, 038.9), bacteremia (790.7), shock (785.50), cellulitis
(682.8, 682.9), or fever (780.6) and endocarditis (421.0, 421.1, 421.9,
424.90, 424.91, 424.99).9,10
Definition of Variables
We used NIS variables to identify patient age, sex, and race. We
divided race into whites and nonwhites. We divided age into 5 sub-
groups: 18 to 34 years of age, 35 to 49 years of age, 50 to 64 years of
age, 65 to 79 years of age, and ≥80 years of age. We defined sever-
ity of comorbid conditions by using the Deyo modification of the
Charlson Comorbidity Index, which contains 17 comorbid conditions
with differential weights. The scores range from 0 to 33, with higher
scores corresponding to a greater burden of comorbid diseases. A
facility was considered to be a teaching hospital if it had an American
Medical Association–approved residency program, was a member of
the Council of Teaching Hospitals, or had a full-time equivalent ratio
of interns and residents to patients of 0.25 or higher. Hospital location
(rural/urban) and bed size were also recorded. The bed size cutoff
points into small, medium, and large were done so that approximately
one-third of the hospitals in a given region, location, and teaching
status combination would fall within each bed size category. Annual
hospital volume was determined on a year-to-year basis by using the
unique hospital identification number to calculate the total number
of procedures performed by a particular institution in a given year.
Statistical Analysis
We used the weights provided with the NIS to generate national esti-
mates of the number of admissions each year. We used a χ2 test to
compare categorical variables between procedures with and without
complications. We compared continuous variables like LOS by using
the Wilcoxon rank sum test, because they were not distributed nor-
mally. Hierarchical mixed-effects logistic regression models were
generated to identify the independent multivariable predictors of
postprocedural complications. Two-level hierarchical models (with
patient-level factors nested within hospital-level factors) were cre-
ated, with the unique hospital identification number incorporated
as a random effect within the model. Notation of race was missing
in 22.5% of the population, so we did not include it in the model.
Because 94% of TLR procedures were done in urban hospitals, we did
not include the rural/urban location of hospitals in the model. In all
multivariable models, we included hospital-level variables like hos-
pital bed size, hospital region (Northeast, South, Midwest, with West
as referent), teaching versus nonteaching hospital, and patient-level
variables like age, sex, Deyo modification of Charlson Comorbidity
Index, median household income, and primary payer (with Medicare/
Medicaid considered as a referent). Hospital identification was incor-
porated as a random effect in the model to account for the impact of
hospital clustering (meaning that patients treated at the same hospital
may experience similar outcomes as a result of other processes of
care). We used Stata IC 11.0 (Stata-Corp, College Station, TX) for all
analyses. A P value of <0.05 was considered significant.
The relationship between hospital volume and outcomes was rep-
resented as a nonlinear polynomial function using restricted cubic
spline transformations of the volume measure. The use of splines
is an established method to determine whether nonlinearity exists
between a continuous variable and a dependent outcome by using all
data points to estimate the shape of an association between an expo-
sure (hospital volume) and an outcome (mortality).14
Results
We identified 91 890 TLR procedures performed between
2006 and 2012. Table 1 summarizes demographics of patients
undergoing TLR and hospital characteristics where the proce-
dures were performed. The majority of the procedures were
performed in men (60.8%) and in whites (65.8%), with a
 Deshmukh et al   Complications of Lead Removal   2365
median age of 73 years, in hospitals with a large number of
beds (74.9%), in an urban location (94%), in an academic set-
ting (60.6%), and in the southern region of the United States
(33.7%). The comorbidities present were as follows: conges-
tive heart failure (39.5%), hypertension (59.3%), diabetes mel-
litus (28.2%), and peripheral vascular disease (7.6%) (Table 1).
The primary payers were Medicare (71.4%), Medicaid (5.5%),
private/health maintenance organization (19.5%), and self-pay/
other (3.5%). The median LOS was 4 days, with median hospi-
talization cost of US$18 073 (interquartile range, US $10,557–
35 744). Most patients (59.4%) were discharged home; only
38.1% discharges were to a nursing facility.
The number of procedures increased from 10 991 in the
year 2006 to 12 069 in the year 2012 (Figure 2A). Most of the
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procedures (61.39%) were performed in patients with a non-
infection indication, but the number of infections continued to
increase (Figure 2B). A large proportion of the TLRs (91.6%)
were performed in hospitals with an annual volume of <50
procedures (Table 1).
The overall frequency of complications was 4.9% in 2006
and 10.6% in 2012. There has been a significant overall rise
in complication frequency. The total in-hospital mortality rate
was 2.2% (Table 2). The most common complications included
any hemorrhage requiring blood transfusion (2.6%), followed
by respiratory complications requiring prolonged mechanical
ventilation (2.3%), vascular injury (2.0%), pneumothorax/
hemothorax (1.5%), and pericardial complications (1.4%).
The overall frequency of open heart surgery was 0.2%. The
trends of each complication between the years 2006 and 2012
are depicted in Table 2. All complications apart from pneumo-
thorax/hemothorax showed a significant increase in trend over
the study period. The frequency of upper-extremity deep vein
thrombosis and pulmonary embolism reported from our study
cohort were 3.07% and 1.14%, respectively.
We further examined the complication rates depending
on the reason for removal and infectious versus noninfectious
etiology. TLR related to device infection had a higher over-
all complication rate (9.2% versus 7.8%, P<0.001). The in-
hospital mortality (3.6% versus 1.2%, P<0.001) was higher in
device infection–related TLR. See Tables 3 and 4 for compar-
ison. TLR associated with device infection had longer mean
LOS: 11 days versus 4 days (P<0.001). The total median costs
were higher in TLR associated with device infection ($39 308
versus $14 916)
Figure 1. Study design and patient selection.
ICD-9-CM indicates International Classification
of Diseases, 9th Revision, Clinical Modification;
NIS, Nationwide Inpatient Sample; and TLR,
transvenous lead removal.
Predictors of Adverse Outcomes
Women had overall higher complication rates than men (odds
ratio [OR], 1.19; 95% confidence interval [CI], 1.12–1.26;
P<0.001). There was no difference in younger versus older
women. TLR in hospitalizations associated with a Charlson
Comorbidity Index > 2, (OR, 2.95; 95% CI, 2.02–4.29;
P<0.001), teaching hospitals (OR, 1.37; 95% CI, 1.03–1.82;
P<0.001), and TLR related to device infection (OR, 2.51;
95% CI, 1.93–3.27; P<0.001) were independent predictors of
higher complications. The hospital volume as individual pre-
dictor did not reach statistical significance (Table 5).
In a sensitivity analysis, we found that patients who under-
went TLR at hospitals doing >50 TLRs per year (<50 annual
TLRs versus ≥annual TLRs) were having higher Charlson
Comorbidity Index scores (≥2) (40.6% versus 43.2%,
P<0.001), more likely emergent/urgent admissions (57.5%
versus 71.8%, P<0.001), and more device infections (38.4%
versus 55.1%, P<0.001). We constructed adjusted spline curve
for in-hospital mortality. Hospitals performing >50 procedures
per year had a trend toward lower mortality. For hospitals with
a very large annual volume, because the number of hospitals
is very low, there was a much wider confidence interval and
trend toward higher mortality (Figure 4).
Discussion
Using the largest national hospitalization database in the
United States, herein we report the contemporary use pat-
terns and frequency of complications associated with TLR.
The main findings of our analysis are: (1) overall frequency
of complications was 8.39%; (2) there were ≈2.2% in-hospital
deaths; (3) hemorrhage requiring blood transfusion was the
most frequent adverse outcome, followed by vascular injury,
pericardial complications, and respiratory events; and (4)
female sex and device infection were associated with the over-
all frequency of complications and mortality. This is the larg-
est sample of TLRs analyzed thus far, using unselected data
from across the country.
Multiple studies have reported complication rates follow-
ing TLR, but nearly all of them were conducted at centers
with extensive expertise in TLR and high-volume operators.
Periprocedural complication rates following TLR have ranged
from 1% to 6.7% in smaller studies of high-volume cen-
ters.3,11,15–21 In the world survey of cardiac pacing and cardio-
verter-defibrillators, all 81 centers involved reported major
 2366  Circulation  December 22/29, 2015

Table 1.  Demographics of Patients Undergoing Transvenous Lead Removal

Demographic Variables Overall No Complication Complication P Value
Total No. of lead extraction procedures (%) 91 890 84 128 (92.6) 7763 (8.4)
Patient-level variables
 Age in years, % <0.001
  18–34 2.8 2.7 3.8
  35–49 7.6 7.5 8.8
  50–64 21.2 20.8 27.3
  65–79 38.2 38.3 35.8
  ≥80 30.2 30.7 24.3
 Sex, % <0.001
  Male 60.8 61 58.8
  Female 39.2 39 41.2
 Race, % <0.001
  White 65.8 66.1 62.4
  Black 9 8.8 11.2
  Hispanic 4.9 4.9 5.5
  Others 4.2 4.1 5.6
  Missing 16.1 16.1 15.3
 Comorbidities, %
  Charlson/Deyo Comorbidity Index* <0.001
   0 30.8 31.6 22
   1 28.3 28.3 28.1
   ≥2 40.9 40.1 49.9
  Obesity 7.9 7.91 8.4 0.07
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  History of hypertension 59.8 60.2 55.1 <0.001

  History of diabetes mellitus 28.2 28.2 28.5 0.554
  History of congestive heart failure 39.5 38.2 53.6 <0.001
  History of chronic pulmonary disease 17.8 17.6 20.3 <0.001
  Pulmonary circulation disorder 0.7 0.6 2.1 <0.001
  Peripheral vascular disease 7.6 7.2 11. <0.001
  Fluid-electrolyte abnormalities and or renal failure 28.2 26.5 46.1 <0.001
  Neurological disorder or paralysis 6.5 6.4 7.3 <0.001
  Anemia or coagulopathy 19.4 17.7 37.3 <0.001
 Median household income category for patient’s zip code, % † 0.007
  1. 0–25th percentile 26.2 26.1 27.4
  2. 26–50th percentile 26.3 26.4 24.4
  3. 51–75th percentile 24.3 24.2 24.8
  4. 76–100th percentile 21.4 21.3 21.4
 Primary payer, % <0.001
  Medicare 71.4 67.4 71.1
  Medicaid 5.5 7.3 5.7
  Private including HMO 19.5 19.5 22.1
  Self-pay/no charge/other 3.6 3.8 3.1
 Hospital bed size, % <0.001
  Small 7.4 7.6 5.6
  Medium 16.7 17.1 13.2
  Large 74.9 74.3 80.2
 Hospital region, % <0.001
  Northeast 19.1 19.1 18.5
  Midwest or North Central 21.3 21.1 23.5
(Continued  )
 Deshmukh et al   Complications of Lead Removal   2367

Table 1  Continued.
Demographic Variables Overall No Complication Complication P Value

  South 33.4 33.8 32.7

  West 17.2 17.1 17.9
 Hospital location, % <0.001
  Rural 5.2 3.8 5.1
  Urban 94.1 95.5 94.1
 Hospital teaching status, % <0.001
  Nonteaching 38.6 30.2 37.8
  Teaching 60.7 69.1 61.3
Outcomes
 In-hospital mortality, % 2.2 1.4 10.5 <0.001
 Median length of stay in days (interquartile range) 4 (1–9) 4 (1–8) 11 (6–21) <0.001
 Median cost in $ (interquartile range) 18 073 (10 577–35 744) 16 884 (10 191–32 038) 47 818 (25 002–90 235) <0.001
 Disposition among survivors, %
  Home 59.4 61.4 37.3
  Facility/others 38.1 36.8 51.9
 Hospital volume, % 0.007
  ≤50 91.6 91.79 90.1
  >50 8.4 8.21 9.9
Column percentage might not add up to 100% for all variables because of some missing data. Overall, missing data were <5% except for race for which
we have 15.3% data missing as described in the table. HMO indicates health maintenance organization; and ICD-9-CM, International Classification of
Diseases, Ninth Revision, Clinical Modification.
*Charlson/Deyo Comorbidity Index was calculated as per Deyo classification. Comorbidities were identified by ICD-9-CM code mentioned in any of the
diagnostic fields.
†This represents a quartile classification of the estimated median household income of residents in the patient’s zip code. These values are derived from
zip code–demographic data obtained from Claritas. The quartiles are identified by values of 1 to 4, indicating the poorest to wealthiest populations. Because
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these estimates are updated annually, the value ranges vary by year (http://www.hcup-us.ahrq.gov/db/vars/zipinc_qrtl/nisnote.jsp).

complications in their experience: 63% of centers in <1% of
patients, 27% in 1% to 2%, 7.5% in 2% to 5%, and 2.5% of
centers in >5% of patients. Absence of death was stated by
54% of centers; 36% reported deaths in <0.5%; and 10% expe-
rienced an incidence of death in 0.5% to 2% of patients.22 A
high-volume center report from 1043 TLR procedures found
a 0.48% major complication rate, with no procedure-related
deaths. There were 5 cases of cardiac tamponade, 3 treated
with pericardiocentesis, and 2 requiring urgent sternotomy.23
Another single-center report, comparing outcomes in the oper-
ating room versus the electrophysiology laboratory among 684
TLR procedures, observed a total complication rate of 2.24%
versus 2.84%, respectively. Two patients died of superior vena
cava lacerations (0.29%), 1 in each group. Complications
requiring surgical correction occurred in 6 (0.9%) patients (2
subclavian vein lacerations, 1 tricuspid valve laceration, and 3
tamponades), with subsequently favorable outcomes.24
The Pacing Lead Removal with the Excimer Sheath
(PLEXES) trial, a randomized prospective study comparing
laser with nonlaser TLR, observed a major complication rate
of 1.9%, with an in-hospital death rate of 0.8%.25 The more
contemporary Lead Extraction in the Contemporary Setting
(LEXICON) study, looking at outcomes of TLR by using a
laser sheath, found a rate of 1.4% for major complications.

Figure 2. A, Number of TLRs performed each year. B, Trends in TLR by indication. TLR indicates transvenous lead removal.
 2368  Circulation  December 22/29, 2015

Table 2.  Trends in Complications

Complication Rate
Complications 2006 2007 2008 2009 2010 2011 2012 Overall P Value
Mortality 1.8 1.6 2.2 2.4 2.7 2.2 2.5 2.2 <0.001
Any complications 4.9 6.7 7.9 9.2 10.5 9.4 10.6 8.3 <0.001
Any complications and mortality 5.9 7.8 9.3 10.5 12.1 10.5 12.0 9.7 <0.001
Vascular injury 1.3 1.2 1.5 2.1 2.1 3.0 3.9 2.0 <0.001
Hemorrhage requiring 0.7 1.7 2.2 2.7 4.1 3.7 3.8 2.6 <0.001
transfusion
Pericardial complications 0.7 1.0 1.2 1.7 1.8 1.2 2.2 1.4 <0.001
Hemopericardium 0.3 0.3 0.2 0.3 0.4 0.1 0.4 0.2 0.05
Cardiac tamponade 0.0 0.2 0.7 1.2 1.1 1.0 1.7 0.8 <0.001
Requiring pericardiocentesis 0.6 0.8 0.7 0.9 1.2 0.6 1.1 0.8 <0.001
Requiring open heart surgery 0.0 0.2 0.2 0.4 0.3 0.0 0.0 0.2 <0.001
Any respiratory complication 1.2 1.8 2.3 2.6 2.4 2.9 3.4 2.4 <0.001
Pneumothorax/hemothorax 1.4 1.4 1.8 1.6 1.3 1.5 1.1 1.5 0.99

Overall all-cause in-hospital mortality was 1.86%: 4.3% when
associated with endocarditis; 7.9% when associated with
endocarditis and diabetes mellitus; and 12.4% when associ-
ated with endocarditis and creatinine ≥2.0.26
We report complications from 91 890 TLR procedures,
the largest sample ever reported from the United States. This
cohort is more representative of the real-world TLR beyond
the bias of highly skilled operators and centers. Our find-
ings of in-hospital mortality of 2.2% from all US hospitals
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reported to be between 0% and 2.2%. One element to keep in
mind when interpreting our results on thrombotic complica-
tions is that, in some of these patients that were adjudicated
a thrombotic event during the hospitalization, the occlusion
or thrombosis of the subclavian/axillary venous system itself
might have been the indication for TLR as opposed to a com-
plication of the removal procedure. The information contained
in the database does not allow making this distinction.
Predictors of Morbidity and Mortality

are essentially higher than earlier findings reporting mortality.

Our data, which give a realistic perspective on morbidity and Previous studies have shown that, after controlling for base-
in-hospital mortality related to TLR, have important implica- line and procedural characteristics, factors such as age at TLR,
tions, while explaining the risks and benefits of the procedure. systemic infection, local infection, device upgrade, serum cre-
atinine level, and diabetes mellitus are significant correlates
Complications of mortality.23 In the LEXICON study, predictors of all-cause
Cardiac tamponade, which is the most common life-threat- in-hospital mortality were pocket infections, device-related
ening acute complication seen in patients undergoing TLR, endocarditis, diabetes mellitus, and creatinine at ≥2.0%.26
occurs in a range of 0% to 3% depending on the series.27 Complication rates after TLR have been reported to be higher
Results from our analysis revealed an incidence of 0.8%. in women than in men.28 Our results confirmed this previously
Significant vascular complications such as superior vena cava reported finding.28 Although women are undergoing fewer
tear can be lethal if not addressed promptly by open surgical TLR procedures than men, this sex difference in complica-
vascular repair, although our analysis does not allow for the tions argues for further prospective clinical investigation. As
isolation of the incidence of superior vena cava tear as a sepa-
rate variable. Because the optimum treatment includes open
heart surgery, we report a frequency of open heart surgery of
0.2%. We report a higher combined vascular complication rate
(consisting of hemorrhage/hematoma, vascular complication
requiring surgical repair, and accidental arterial puncture) of
4.1%, along with an increasing trend over the study period.
Patients undergoing TLR often have comorbidities that
increase the risk of venous thrombosis and embolization. A
thromboembolic phenomenon leading to pulmonary emboli or
stroke is a possible serious complication of TLR. The removal
process itself may result in a prothrombotic state, and there
appears to be an increased risk of ipsilateral upper extremity
venous thrombosis. The frequency of upper-extremity deep
vein thrombosis and pulmonary embolism reported from our
study cohort were 3.07% and 1.14%, respectively. The inci- Figure 3. Relationship between operator volume and the
dence of thromboembolism associated with TLR ablation is probability of in-hospital death.
 Deshmukh et al   Complications of Lead Removal   2369

Table 3.  Complications Related to Noninfection Indication for TLR

Without Device Infection
Complications, % 2006 2007 2008 2009 2010 2011 2012 Overall P Value
Mortality 0.8 0.8 1.2 1.3 1.5 1.3 1.4 1.2 <0.001
Any complications 4.0 6.8 7.2 9.6 9.8 8.3 11.2 7.8 <0.001
Any complications and mortality 4.3 7.2 8.0 10.2 10.4 8.9 11.9 8.4 <0.001
Vascular injury 0.7 1.3 1.5 2.3 1.8 2.6 4.1 1.9 <0.001
Hemorrhage requiring 0.5 1.6 1.8 2.4 3.3 3.0 3.5 2.1 <0.001
transfusion
Pericardial complications 0.9 1.3 1.5 2.5 2.7 1.4 3.5 1.8 <0.001
Hemopericardium 0.4 0.4 0.2 0.4 0.8 0.1 0.6 0.3 <0.001
Cardiac tamponade 0.0 0.2 0.8 1.9 1.4 1.3 2.8 1.1 <0.001
Requiring pericardiocentesis 0.7 1.0 0.8 1.2 1.7 0.6 2.0 1.0 <0.001
Requiring open heart surgery 0.0 0.1 0.2 0.4 0.2 0.0 0.0 0.1 0.482
Any respiratory complication 0.5 0.9 1.5 2.0 1.7 1.9 2.9 1.6 <0.001
Pneumothorax/hemothorax 1.7 2.1 2.1 2.6 1.2 1.9 1.4 1.9 0.0155
TLR indicates transvenous lead removal.

suggested in large single-center studies and in the LEXICON
study, we also report that TLRs associated with device infec-
tions have higher complication rates.
Complication rates with TLR directly parallel hospital
and operator experience. Major and minor complications are
reduced by ≈50% with increased operator experience from
20 to 120 cases to >300 cases performed.29,30 We did not find
hospital volume to be significantly associated with adverse
outcomes. Most of the lead removal reports from high-volume
Downloaded from http://ahajournals.org by on February 12, 2019
6–26). Fifty-six per cent performed <20 procedures per year.
Eighty per cent of procedures were performed in the electro-
physiology laboratory, 50% of which had no identifiable sur-
geon or operating theater on standby. Mechanical dissection
sheaths were the most widely used method of removal after
failure of manual traction (63%). The risk of minor complica-
tions was perceived to be ≤4% by the majority of respondents
across the device range. The same measures for major compli-
cations and death were 2% and 1%, respectively.33

centers report lower complication rates.3,31 There is no stan-
dard public reporting for low-volume centers for any high-risk
procedures. Atrial fibrillation ablation and percutaneous coro-
nary intervention experience have suggested that low-volume
centers have worse overall outcomes.7,32 It may be surmised
in the context of lead removals that the low-volume hospitals
are doing simpler removals and may be referring challenging
procedures to a more experienced hospital.
In the recently reported UK experience, the median num-
ber of cases performed per year was 13 (interquartile range,
A multidisciplinary heart-team approach (electrophysi-
ologists and cardiac surgeons) in an environment with appro-
priate training of the supporting staff for early detection and
adequate management of complications associated with TLR
appears to be more important than solely the experience of the
primary operator.11
Limitations
Our study has several limitations. First, the NIS is a deidenti-
fied administrative database, making it impossible to validate

Table 4.  Complications Related to Infection Indication for TLR

With Device Infection
Complications, % 2006 2007 2008 2009 2010 2011 2012 Overall P Value
Mortality 4.5 3.1 3.8 3.6 4.1 3.2 3.5 3.6 0.1859
Any complications 7.3 6.5 9.1 8.6 11.2 10.5 9.9 9.2 <0.001
Any complications and mortality 10.1 8.9 11.6 10.9 14.0 12.3 12.2 11.5 <0.001
Vascular injury 2.7 1.0 1.5 1.8 2.3 3.5 3.6 2.3 <0.001
Hemorrhage requiring transfusion 1.1 1.8 2.6 3.1 4.9 4.6 4.1 3.3 <0.001
Pericardial complications 0.3 0.4 0.9 0.8 0.9 1.0 0.9 0.7 <0.001
Hemopericardium 0.0 0.0 0.3 14.0 0.0 0.1 0.2 0.1 0.0945
Cardiac tamponade 0.0 0.4 0.4 0.6 0.4 0.7 0.6 0.4 <0.001
Requiring pericardiocentesis 0.3 0.4 0.5 0.5 0.6 0.5 0.2 0.4 0.4493
Requiring open heart surgery 0.2 0.3 0.2 0.3 0.4 0 0 0.1 <0.001
Any respiratory complication 3.2 3.5 3.7 3.3 3.2 4.0 3.9 3.6 0.0179
Pneumothorax/hemothorax 0.7 0.2 1.2 0.4 1.4 1.0 0.8 0.8 <0.001
TLR indicates transvenous lead removal.
 2370  Circulation  December 22/29, 2015

Table 5.  Predictors of Adverse Outcomes in Multivariable Conclusion

Analysis In conclusion, our analysis provides perspective on the
Mortality use and adverse outcomes of TLR. TLR-associated com-
plication rates have steadily increased. Besides sex and
Odd Ratio (95% CI) P Value
comorbidities, device infections have emerged as important
Age 1.01 (0.91–1.12) 0.83 factors associated with adverse outcomes. Balancing these
Female 1.19 (1.12–1.26) <0.001 risks may help guide lead management and TLR in the indi-
Charlson Comorbidity Index vidual patient.
 0 Referent
 1 1.85 (1.22–2.79) 0.004 Disclosures
 ≥2 2.95 (2.02–4.29) <0.001 Dr Viles-Gonzalez is a consultant for Medtronic, St Jude Medical,
and Biotronik. Dr Asirvatham reports honoraria/consulting (none sig-
Device infection 2.51 (1.93–3.27) <0.001 nificant) for Abiomed, Atricure, Biotronik, Biosense Webster, Boston
Emergent/urgent admission 2.30 (1.68–3.13) <0.001 Scientific, Medtronic, Medtelligence, St. Jude, Sanofi-Aventis,
Primary payer Wolters Kluwer, Elsevier, Zoll Co-patent holder – may receive future
royalties from: Aegis: Appendage ligation Access Point Technologies:
 Medicare Referent Atrial fibrillation ablation and coagulum reduction during ablation
 Medicaid 0.71 (0.38–1.30) 0.27 Nevro: Use of nerve signal modulation to treat central, autonomic,
 Private insurance including HMO 0.92 (0.64–1.30) 0.62 and peripheral nervous system disorders, including pain Sanovas:
Lung ablation Sorin Medical: Tricuspid valve project. Dr Friedman
 Self-pay 0.73 (0.35–1.53) 0.41 reports research support from St Judes Intellectual Property Rights
Median household income Aegis Medical NeoChord Preventice Sorin Speaker or Consultant
Medtronic Leadex Boston.
 1st quartile Referent
 2nd quartile 0.78 (0.57–1.09) 0.15
 3rd quartile 0.76 (0.55–1.08) 0.13
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Clinical Perspective
Transvenous lead removal has made tremendous progress with respect to innovation, efficacy, and safety. However, limited
data exist regarding trends in the use and adverse outcomes outside the centers of considerable experience for transvenous
lead removal. With the use of an administrative database, we examined use patterns, frequency of adverse in-hospital events,
and influence of hospital volume on complications. The most relevant outcomes were in-hospital death (2.2%), hemorrhage
requiring transfusion (2.6%), vascular (2.0%), pericardial (1.4%), open heart surgery (0.2%), and postoperative respiratory
failure (2.4%).There was a significant rise in overall complication rates over the study period. Women and device infec-
tions were associated with higher complication rates. In this real-world sample, the overall complication rate in patients
undergoing transvenous lead removal was higher than previously reported. Hospital volume was not associated with higher
complication rates. The number of adverse events in the literature likely underestimates the actual number of complications
associated with transvenous lead removal.

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