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Original Article
Outcomes 1 Year After Implantable Cardioverter–
Defibrillator Lead Abandonment Versus Explantation
for Unused or Malfunctioning Leads
A Report from the National Cardiovascular Data Registry
Emily P. Zeitler, MD, MHS; Yongfei Wang, MS; Kumar Dharmarajan, MD, MBA;
Kevin J. Anstrom, PhD; Eric D. Peterson, MD, MPH; James P. Daubert, MD;
Jeptha P. Curtis, MD; Sana M. Al-Khatib, MD, MHS
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Background—Patients with an unused or malfunctioning implantable cardioverter–defibrillator (ICD) lead may have the
lead either abandoned or explanted; yet there are limited data on the comparative acute and longer-term safety of these
2 approaches.
Methods and Results—We examined in-hospital events among 24 908 subject encounters using propensity score 1:1
matching for ICD lead abandonment or explantation in the National Cardiovascular Data Registry (NCDR) ICD Registry
(April 2010 to June 2014). Relative to patients undergoing lead abandonment, patients undergoing lead explantation
had more in-hospital procedure-related complications: 2.19% (n=273) versus 3.77% (n=469; P<0.001), respectively.
Similarly, patients undergoing lead explantation had slightly higher rates of in-hospital death: 0.21% (n=26) versus
0.64% (n=80; P<0.001), respectively. At 1 year in a Medicare subset for survival, there was a trend of increased mortality
in the explantation group (11% versus 8%; P=0.06). In the Medicare subset analyzed for postprocedure complications,
there was no difference with respect to 6-month bleeding (4.80% in both the groups), tamponade (0.38% versus 0.58%),
infection (1.34% versus 3.07%), upper extremity thrombosis (0.77% versus 0.96%), pulmonary embolism (0.38% versus
0.96%), or urgent surgery (1.15% for both the groups; P>0.05 for all).
Conclusions—After matching, patients undergoing removal of an unused or malfunctioning ICD lead had slightly higher
in-hospital complications and deaths than those with a lead abandonment strategy. Although the 1-year mortality risk was
slightly higher in the lead explantation group, this difference was not statistically significant and may be explained by
chance. (Circ Arrhythm Electrophysiol. 2016;9:e003953. DOI: 10.1161/CIRCEP.116.003953.)
Key Words: implantable cardioverter defibrillator ◼ medicare ◼ survival analysis
T
he implantable cardioverter–defibrillator (ICD) prevents
sudden cardiac death in patients with a history of sudden
cardiac arrest and in patients with heart failure and reduced ejection fraction.1–4 Since the widespread adoption of ICD therapy
for primary prevention, the number of patients with ICDs has
risen substantially with nearly 150 000 new implants in 2009
alone (the most recent data available).5 Device infection remains
a common reason for system revision and one that usually
necessitates system explantation,6,7 but when lead replacement is
indicated for other reasons (eg, lead fracture), there are 2 potential approaches to managing the existing lead: explantation or
abandonment. To date, data comparing management strategies
of unused or malfunctioning ICD leads have been limited to
single-center studies some of which examined lead explantation
and lead abandonment in isolation,8–11 whereas others compared
these strategies to one another.12–15 Thus, in the absence of a
large, multicenter comparison of real-world outcomes, the relative risks and benefits of each approach remain unclear.
Using data from the National Cardiovascular Data
Registry (NCDR) ICD Registry (the Registry) and the Centers
for Medicare and Medicaid Services, we conducted a study to
compare characteristics of patients, providers, and facilities
associated with abandonment or explantation of an unused or
malfunctioning ICD lead and examine both acute and longerterm outcomes associated with these different management
strategies.
Received January 26, 2016; accepted May 17, 2016.
From the Duke Clinical Research Institute, Durham, NC (E.P.Z., K.J.A., E.D.P., J.P.D., S.M.A.-K.); Department of Medicine, Duke University Medical
System, Durham, NC (E.P.Z., E.D.P., J.P.D., S.M.A.-K.); Center for Outcomes Research and Evaluation, Yale New Haven Health Services Corporation, CT
(Y.W., K.D., J.P.C.); and Department of Medicine, Yale University School of Medicine, New Haven, CT (Y.W., K.D., J.P.C.).
Guest Editor for this article was Gerhard Hindricks, MD.
The Data Supplement is available at http://circep.ahajournals.org/lookup/suppl/doi:10.1161/CIRCEP.116.003953/-/DC1.
Correspondence to Sana M. Al-Khatib, MD, MHS, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715. E-mail [email protected]
© 2016 American Heart Association, Inc.
Circ Arrhythm Electrophysiol is available at http://circep.ahajournals.org
1
DOI: 10.1161/CIRCEP.116.003953
2 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
WHAT IS KNOWN
• Patients
with an unused/malfunctioning implantable cardioverter defibrillator (ICD) lead
undergoing revision may have the unused/malfunctioning lead either abandoned or explanted.
• ICD leads are revised based on weighing upfront
risks of explantation against later risks of lead
abandonment, but comparative safety data between these two revision strategies are limited.
WHAT THE STUDY ADDS
• Compared
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with lead abandonment, patients
undergoing lead explantation of an unused/
malfunctioning ICD lead had slightly higher
in-hospital complications and deaths.
• One year after lead revision in a Medicare population, mortality risk was higher in lead the
explantation patients compared with abandonment patients, but the difference did not meet
statistical significance.
Methods
Data Sources
Data for this investigation were acquired from 2 sources: the NCDR
ICD Registry and the Centers for Medicare and Medicaid Services.
The NCDR ICD Registry has been described previously.16 Briefly, it
was launched in 2005 by the American College of Cardiology and the
Heart Rhythm Society to meet a Centers for Medicare and Medicaid
Services mandate requiring data submission on all Medicare beneficiaries receiving a primary prevention ICD. Since launching of this
Registry, a large majority of participating hospitals submit data on all
ICD implants. In 2010, a leads only data collection form was added
to capture characteristics of ICD procedures not involving generator placement or replacement. Registry data are submitted via a secure Website and are subject to rigorous electronic quality checks.
Although there is significant variability between data elements, formal auditing of data entered into the Registry demonstrated overall
raw data accuracy of 91.2%.17
Medicare data include inpatient and outpatient claims and the
corresponding denominator files for 2010 through 2011. We linked
the Registry data to Medicare claims using a combination of indirect
identifiers including age, sex, admission date, procedure date, and
hospital identification for the examination of postprocedure survival
and complications.
Study Population
To study procedural complications, we included all patient encounters involving either defibrillator lead abandonment or explantation
in the NCDR ICD Registry from April 2010 to June 2011 (n=43 232;
Figure 1). We use the term explantation rather than extraction because
we were not able to exclude procedures involving simple traction
techniques versus true extraction. Many pace-sense lead procedures
are also captured in the Registry, so all lead models had to be characterized manually as a transvenous pacing only lead versus a transvenous defibrillator lead versus other (eg, epicardial and coronary sinus)
to capture abandonment or explantation of transvenous defibrillator
leads only. Procedures were assigned to the lead abandonment versus
explantation groups based on the management of the defibrillator lead
regardless of whether any other leads were involved in the procedure.
Patient encounters were excluded if they involved a procedure that
included both abandonment and explantation (n=143) or if there was
Figure 1. Development of the 3 analysis cohorts from the National Cardiovascular Data Registry (NCDR) implantable cardioverter–defibrillator (ICD) Registry and Medicare claims. CIED indicates cardiac implantable electronic device.
3 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
evidence of definite or presumed ICD infection because this would
generally be an indication for system explantation (n=4259). Patient
encounters with the procedure performed by a cardiothoracic surgeon
were excluded (n=1990) because it was assumed that lead explantation was predetermined in these cases. This resulted in an analysis
cohort of 36 840 patient encounters in 1241 facilities.
To study postprocedure survival, we limited our analysis to those
patients who could be matched to Medicare enrollment files that include postdischarge information on all fee-for-service Medicare beneficiaries aged ≥65 years. Patient data in the Registry were merged
with Medicare Part A inpatient claims, matching by patients’ age,
admission date or procedure date, sex, and hospital. As a result, we
identified 1985 patient encounters from 1980 patients who were
Medicare eligible at any time during follow-up for a survival analysis.
Finally, to evaluate complications ≤6 months post discharge, we
excluded 201 patient encounters from the Medicare cohort in which
the patient was not insured by Medicare either at the time of the procedure or over the course of the 6-month follow-up because we could
not confirm capture of complications without this consistency in
Medicare insurance. This analysis included 1784 patient encounters
in 1780 unique Medicare patients.
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Outcomes
The primary outcome for this analysis was in-hospital procedurerelated complications or death from the NCDR ICD Registry from
April 2010 through June 2014. Each outcome was examined individually and by severity (major versus minor) as has been done previously.18 Secondary outcomes for Medicare patients included (1) all-cause
mortality at discharge, 90 days, and 1 year; patients with no record
of death in the denominator file were considered alive as of May 3,
2012 or the date at which the patient was no longer enrolled in Part
A and Part B fee-for-service Medicare, whichever came first and (2)
incidence of bleeding, tamponade, infection, need for urgent surgery,
upper extremity thrombosis, and pulmonary embolism at 6 months
as determined by relevant International Classification of Diseases
Ninth Revision codes (Data Supplement). Six-month complication
outcomes were chosen to reflect the period of time during which a
complication could reasonably be attributed to the abandonment or
explantation procedure.
Statistical Analysis
We compared baseline characteristics between the lead abandonment
and lead explantation groups. Most baseline characteristics were available directly from the Registry; however, the number of high-voltage
coils on the defibrillator lead undergoing revision is not included in
the Registry, but this characteristic has been established as critical.
Accordingly, for each lead model recorded in the data set, coil number
was determined manually through a combination of searching manufacturer Websites and catalogs, and, when necessary, through direct
telephone contact with manufacturer customer support. Continuous
variables were compared using T tests, and categorical variables were
compared with the χ2 test. Summaries of these descriptive analyses
are reported as percentages for categorical variables and as means and
SDs for continuous variables. The standardized difference for each
variable, defined as the absolute difference in means (or proportions)
divided by the average SD, is also reported for each variable.
In-hospital death, in-hospital procedural complications, and
in-hospital death or procedure events were compared between unmatched groups using logistic regression models. Categories of independent variables were added into the model in the following order:
none, medical history, procedural characteristics, hospital characteristics, and operator characteristics.
Significant and important differences between the lead abandonment and explantation patients were expected in this nonrandomized cohort. A preliminary examination of the data confirmed this.
As such, a 1:1 matched-patient analysis was planned and performed
according to the methods described by Rosenbaum and Rubin.19
Briefly, a propensity model was built using logistic regression in
which the dependent variable was an indicator of whether each
patient was from the abandonment or explantation group, and the
independent variables were baseline variables regarded as potentially clinically important. Independent variables included those
listed in 1 and 2. Of note, because we could not differentiate implant
duration for the lead being revised from other indwelling leads, we
included the maximum lead implant duration in our model. Missing
values for the covariates were rare (<2%) except for ICD indication
(24%) and final device type (24%), so these were imputed to the
most common values for categorical variables and to the median for
continuous variables in the model analyses. In addition, for the ICD
indication and the final device type variables, dummy variables indicating the presence of a missing value were added into the model.
The number of patients in the lead abandonment group was larger than the lead explantation group, so patients were selected from
the lead abandonment group to match those in the lead explantation
group in a 1:1 ratio based on the propensity models. An estimated
probability of being an explantation patient (propensity score) and a
corresponding logit (loge[p/(1−p)]) was calculated for each patient.
For a given explantation patient, all abandonment patients were considered whose logit differed from the explantation patient’s logit by
less than the caliper width (0.6×SD of the logit); among these patients, the abandonment patient with the closest logit from the explantation patient was selected as the match. Each abandonment patient
was matched at most once for each analysis. Differences in procedural complications between the matched groups of patients were assessed using the χ2 test.
The matching process was repeated for the Medicare subgroup
to obtain matched groups for a comparison of device-related complications at 6 months as well as mortality predischarge, 90 days, and
1 year. Unadjusted all-cause mortality event rates were summarized
with Kaplan–Meier survival curves. Six-month complications were
compared between groups using the χ2 statistic for categorical variables. Results were considered statistically significant when 2-sided
P value is <0.05. All analyses were performed with SAS version 9.3
(SAS Institute, Cary, NC).
Results
Baseline Characteristics
Baseline characteristics for the overall lead abandonment and
explantation cohorts before and after matching are listed in
Tables 1 and 2. The Medicare 6-month complications cohort
was similar to the Medicare survival cohort (Data Supplement). Before matching in the NCDR cohort, there were 36 840
patient encounters including 20 918 and 15 922 in the abandonment and explantation groups, respectively. Before matching in
the Medicare cohort, there were 1985 total patient encounters
for the survival analysis (1239 abandonment and 746 explantation) and 1784 patient encounters for the 6-month complications analysis (1121 abandonment and 663 explantation).
In all 3 of the analysis cohorts, compared with patients
in the explantation group, those in the abandonment group
were older, had a greater burden of comorbid conditions,
were more likely to have a primary prevention ICD, and were
treated at hospitals with less experience in lead explantation;
facility and provider characteristics were similar for patients
in the explantation and abandonment groups. Maximum lead
implant duration was significantly longer in the abandonment
group (6.5 versus 5.0 years in the overall cohort, 5.5 versus 4.1
years in the Medicare survival cohort, and 5.4 versus 4.1 years
in the Medicare 6-month complications cohort). Severity of
heart failure as measured by New York Heart Association
functional class and rates of important comorbidities including history of coronary artery bypass grafting surgery, lung
disease, and diabetes mellitus were similar between groups.
4 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
Table 1. Baseline Characteristics With Standardized Difference Before and After Matching in the Overall NCDR ICD Registry Cohort
Before Matching
Description
All
Lead Abandonment (No. [%]
or Mean [SD])
20 918 (100)
Lead Explantation (No.
[%] or Mean [SD])
After Matching
ASD*
15 922 (100)
Lead Abandonment (No.
[%] or Mean [SD])
12 454 (100)
Lead Explantation (No.
[%] or Mean [SD])
ASD
12 454 (100)
Demographics
Age, y
68.20 (12.70)
62.57 (14.34)
42
65.40 (13.23)
64.97 (12.79)
Female sex
5587 (26.71)
4753 (29.85)
7
3479 (27.93)
3504 (28.14)
0
16 948 (81.02)
12 857 (80.75)
1
9980 (80.13)
10 033 (80.56)
1
14 711 (70.33)
9953 (62.51)
7
8508 (68.32)
8380 (67.29)
2
Class I
3984 (19.05)
3175 (19.94)
2
2363 (18.97)
2444 (19.62)
2
Class II
7402 (35.39)
4847 (30.44)
11
4138 (33.23)
4074 (32.71)
1
Class III
6758 (32.31)
4702 (29.53)
6
3995 (32.08)
3941 (31.64)
1
White (non-Hispanic)
3
Medical history
Heart failure
NYHA Functional Classification†
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Class IV
390 (1.86)
265 (1.66)
2
245 (1.97)
224 (1.80)
1
Nonischemic dilated cardiomyopathy
6051 (28.93)
4882 (30.66)
11
3859 (30.99)
3857 (30.97)
1
Atrial fibrillation/Flutter
7471 (35.72)
4702 (29.53)
8
4066 (32.65)
4012 (32.21)
0
Ventricular tachycardia
9527 (45.54)
6284 (39.47)
6
5266 (42.28)
5243 (42.10)
0
Hemodynamic instability
2801 (13.39)
1908 (11.98)
3
1560 (12.53)
1536 (12.33)
2
History of cardiac arrest
2356 (11.26)
1630 (10.24)
0
1285 (10.32)
1274 (10.23)
0
Previous CABG
6197 (29.63)
3540 (22.23)
13
3239 (26.01)
3173 (25.48)
1
Primary valvular heart disease
1892 (9.04)
1369 (8.60)
1
1122 (9.01)
1087 (8.73)
1
Cerebrovascular disease
2982 (14.26)
1652 (10.38)
9
1491 (11.97)
1455(11.68)
1
Lung disease
3960 (18.93)
2407 (15.12)
7
2158 (17.33)
2109(16.93)
1
Diabetes mellitus
6992 (33.43)
4493 (28.22)
6
3961 (31.81)
3887 (31.21)
1
14 571 (69.66)
9580 (60.17)
11
8219 (65.99)
8154 (65.47)
0
Hypertension
Most recent LVEF, %
33.80 (14.06)
34.19 (14.69)
3
33.72 (14.32)
33.78 (14.27)
0
Hemoglobin
13.25 (1.88)
13.29 (1.96)
2
13.28 (1.91)
13.30 (1.94)
1
138.77 (4.05)
138.53 (4.92)
5
138.76 (3.57)
138.55 (5.09)
5
1.30 (1.05)
1.26 (1.05)
4
1.28 (1.06)
1.28 (1.04)
1
Sodium
Creatinine
Procedural factors
Primary prevention
11 178 (53.44)
7455 (46.82)
13
6473 (51.98)
6446 (51.76)
0
Lead only
3819 (18.26)
4824 (30.30)
29
2823 (22.67)
2941 (23.61)
2
Routine coumadin therapy
6591 (31.51)
4414 (27.72)
8
3650 (29.31)
3636 (29.20)
0
Lead implant duration, y‡
6.52 (2.92)
4.95 (3.08)
52
5.73 (2.40)
5.57 (2.92)
6
Single-coil lead§
6363 (30.42)
6579 (41.32)
23
4482 (35.99)
4536 (36.42)
1
20 128 (96.22)
14 348 (90.11)
25
11 847 (95.13)
11 823 (94.93)
1
Teaching
6129 (29.30)
4183 (26.27)
7
3503 (28.13)
3477 (27.92)
0
No. of lead explantations in the hospital
29.45 (54.44)
101.54 (121.45)
80
33.58 (61.04)
94.44 (110.39)
68
15754 (75.31)
12 685 (79.67)
10
9800 (78.69)
9819 (78.84)
0
Dual-coil lead§
Hospital characteristics
Physician training
Board-certified electrophysiologist
Other baseline characteristics used in the propensity model included: history of syncope, family history of sudden death, previous myocardial infarction, previous percutaneous
coronary intervention, electrophysiology study, QRS duration, systolic blood pressure, diastolic blood pressure, BUN (blood urea nitrogen; mean), potassium (mean), procedure
type (initial generator vs generator change vs lead only), coumadin held for procedure, final device type (single chamber vs dual chamber vs cardiac resynchronization therapy),
number of leads in the procedure, discharge medications (angiotensin converter enzyme inhibitor, angiotensin receptor blocker, aspirin, β-blocker, diuretic, and warfarin),
hospital ownership (public vs private vs not-for-profit), hospital setting (division, micro, metro, and rural), number of staffed hospital beds, hospital teaching status, ability to
perform advanced cardiac procedures, and hospital geographic region. ASD indicates absolute standardized difference; CABG, coronary artery bypass grafting; ICD, implantable
cardioverter–defibrillator; LVEF, left ventricular ejection fraction; NCDR, National Cardiovascular Data Registry; and NYHA, New York Heart Association.
*ASD defined as the absolute difference in means (or proportions) divided by the average SD.
†NYHA categories do not add up to total because of some missingness.
‡When >1 lead was present, the maximum lead implant duration was used.
§These groups are not mutually exclusive. Many subjects in this cohort had >1 indwelling ICD lead and the presence of any single-coil or dual-coil lead is reported here.
5 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
Table 2. Baseline Characteristics With Standardized Difference Before and After Matching of the Medicare Survival Cohort
Before Matching
Description
All
Lead Abandonment (No.
[%] or Mean [SD])
Lead Explantation (No.
[%] or Mean [SD])
1239 (100)
746 (100)
76.25 (6.74)
74.77 (5.97)
After Matching
ASD*
Lead Abandonment (No.
[%] or Mean [SD])
588 (100.00)
Lead Explantation (No.
[%] or Mean [SD])
ASD
588 (100.00)
Demographics
Age, y
Female sex
White (non-Hispanic)
23
75.30 (6.60)
75.04 (5.94)
4
315 (25.42)
196 (26.27)
2
155 (26.36)
150 (25.51)
2
1127 (90.96)
670 (89.81)
4
538 (91.50)
533 (90.65)
3
964 (77.80)
582 (78.02)
8
460 (78.23)
464 (78.91)
2
Medical history
Heart failure
NYHA Functional Classification†
Class I
193 (15.58)
102 (13.67)
5
82 (13.95)
81 (13.78)
0
Class II
448 (36.16)
262 (35.12)
2
221 (37.59)
215 (36.56)
2
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Class III
525 (42.37)
304 (40.75)
3
234 (39.80)
242 (41.16)
3
Class IV
23 (1.86)
26 (3.49)
11
17 (2.89)
17 (2.89)
0
Nonischemic dilated cardiomyopathy
309(24.94)
214 (28.69)
11
155 (26.36)
166 (28.23)
5
Atrial fibrillation/Flutter
547 (44.15)
325 (43.57)
2
254 (43.20)
267 (45.41)
5
Ventricular tachycardia
604 (48.75)
295 (39.54)
16
254 (43.20)
244 (41.50)
3
Hemodynamic instability
145 (11.70)
74 (9.92)
7
53 (9.01)
57 (9.69)
2
History of a cardiac arrest
133 (10.73)
57 (7.64)
10
51 (8.67)
52 (8.84)
1
Previous CABG
515 (41.57)
283 (37.94)
5
228 (38.78)
231 (39.29)
1
Primary valvular heart disease
145 (11.70)
101 (3.54)
7
72 (12.24)
71 (12.07)
0
Cerebrovascular disease
205 (16.55)
131 (17.56)
5
92 (15.65)
103 (17.52)
5
Lung disease
275 (22.20)
157 (21.05)
1
119 (20.24)
123 (20.92)
2
Diabetes mellitus
466 (37.61)
281 (37.67)
3
228 (38.78)
227 (38.61)
0
Hypertension
Most recent LVEF, %
Hemoglobin
Sodium
Creatinine
950 (76.67)
557 (74.66)
2
447 (76.02)
444 (75.51)
0
33.56 (13.25)
31.54 (12.96)
15
32.11 (13.02)
32.51 (13.43)
3
13.06 (1.73)
13.03 (1.84)
2
13.06 (1.71)
13.10 (1.84)
2
138.55 (4.83)
138.68 (3.11)
3
138.45 (6.16)
138.69 (3.15)
4
1.37 (0.90)
1.36 (0.87)
1
1.36 (1.01)
1.35 (0.84)
0
Procedural factors
Primary prevention
782 (63.12)
472 (63.27)
0
389 (66.16)
375 (63.78)
5
96 (7.75)
111 (14.88)
23
62 (10.54)
73 (12.41)
6
Routine coumadin therapy
474 (38.26)
276 (37.00)
2
225 (38.27)
226 (38.44)
1
Lead implant duration, y‡
5.45 (2.91)
4.07 (2.18)
52
4.49 (1.84)
4.43 (2.09)
3
Single-coil lead§
254 (20.50)
195 (26.14)
14
140 (23.81)
133 (22.62)
3
1196 (96.53)
694 (93.03)
16
563 (95.75)
564 (95.92)
1
Lead only
Dual-coil lead§
Hospital characteristics
Teaching
No. of lead explantations in the hospital
402 (32.45)
30.25 (55.97)
227 (30.43)
4
187 (31.80)
99.55 (119.04)
81
33.92 (64.85)
611 (81.90)
16
477 (81.12)
182 (30.95)
2
91.45 (111.21)
63
473 (80.44)
2
Physician training
Board-certified electrophysiologist
931(75.14)
Other baseline characteristics used in the propensity model included: history of syncope, family history of sudden death, previous myocardial infarction, previous
percutaneous coronary intervention, electrophysiology study, QRS duration, systolic blood pressure, diastolic blood pressure, BUN (blood urea nitrogen; mean), potassium
(mean), procedure type (initial generator vs generator change vs lead only), coumadin held for procedure, final device type (single chamber vs dual chamber vs cardiac
resynchronization therapy), number of leads in the procedure, discharge medications (angiotensin converter enzyme inhibitor, angiotensin receptor blocker, aspirin,
β-blocker, diuretic, and warfarin), hospital ownership (public vs private vs not-for-profit), hospital setting (division, micro, metro, and rural), number of staffed hospital
beds, hospital teaching status, ability to perform advanced cardiac procedures, and hospital geographic region. ASD indicates absolute standardized difference; CABG,
coronary artery bypass grafting; LVEF, left ventricular ejection fraction; and NYHA, New York Heart Association.
*ASD defined as the absolute difference in means (or proportions) divided by the average SD.
†NYHA categories do not add up to total because of some missingness.
‡When >1 lead was present, the maximum lead implant duration was used.
§These groups are not mutually exclusive. Many subjects in this cohort had >1 indwelling implantable cardioverter–defibrillator lead and the presence of any singlecoil or dual coil-lead is reported here.
6 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
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After matching, there were 24 908 patient encounters in
the overall cohort matched 1:1 between abandonment and
explantation; in the survival and 6-month complications
Medicare cohorts, there were 1176 and 1042 patient encounters, respectively. Propensity score matching resulted in
improved similarity between groups in all 3 analysis cohorts
with the absolute standardized difference in all measured
variables not >8% except for center explantation volume that
remained poorly matched (Tables 1 and 2). Notably, after
matching in the overall cohort, lead implant duration averaged 5.7 and 5.6 years in the abandonment and explantation
groups, respectively. In the matched Medicare survival and
6-month complication cohorts, lead implant duration was 4.5
and 4.4 years in the abandonment and explantation groups,
respectively.
As noted above, we were not able to exclude those
explantation procedures, involving simple traction techniques versus true extraction. However, only 7.2% of procedures in the overall cohort involved leads with a maximum
lead implant duration of <1 year, and in many instances leads
with a dwell time of ≥1 year are more likely to be removed
with extraction.
Table 3. In-Hospital Complications (Overall Population)
Description
N
In-hospital death
Lead
Abandonment
Lead
Explantation
N (%)
N (%)
P Value
12 454 (100.00)
12 454 (100.00)
…
26 (0.21)
80 (0.64)
0.0000
Death or Procedure events
286 (2.30)
500 (4.01)
0.0000
Any intra or Postprocedure
events
273 (2.19)
469 (3.77)
0.0000
Major complications
103 (0.83)
227 (1.82)
0.0000
Cardiac arrest
18 (0.14)
56 (0.45)
0.0000
Cardiac perforation
10 (0.08)
54 (0.43)
0.0000
Cardiac valve injury
0 (0.00)
2 (0.02)
0.0000
Coronary venous
dissection
8 (0.06)
15 (0.12)
0.1444
9 (0.07)
24 (0.19)
0.0090
Pericardial tamponade
17 (0.14)
75 (0.60)
0.0000
Pneumothorax
48 (0.39)
49 (0.39)
0.9183
Hemothorax
Myocardial infarction
1 (0.01)
4 (0.03)
0.1797
In-Hospital Complications
TIA or Stroke (CVA)
4 (0.03)
7 (0.06)
0.3657
In-hospital complications were evaluated in the 1:1 matched
overall cohort. In the lead abandonment group, 286 (2.30%)
patients experienced an intra or postprocedural event or
death before discharge compared with 500 (4.01%) in the
lead explantation group (P<0.001; Table 3). Compared with
abandonment patients, explantation patients were more likely
to die (26 [0.21%] versus 80 [0.64%] deaths, respectively;
P<0.001) or to experience a complication before discharge
(273 [2.19%] versus 469 [3.77%] events, respectively;
P<0.001). When examined by type of event, explantation
patients were more likely to experience cardiac arrest, cardiac
perforation, cardiac valve injury, hematoma requiring intervention, hemothorax, infection requiring antibiotics, lead
dislodgement, pericardial tamponade, peripheral embolus,
venous obstruction, and urgent cardiac surgery (P≤0.02 for
all; Table 3). There was no statistically significant difference in the rate of drug reaction, conduction block, coronary
venous dissection, myocardial infarction, pneumothorax, set
screw problem, or stroke/transient ischemic attack (P>0.05
for all), and the only complication that was numerically more
common in the lead abandonment group was set screw problem (P=0.06). When examined by the severity of event, major
complications were experienced by 103 patients (0.83%) in
the lead abandonment group and 227 patients (1.82%) in
the lead explantation group (P<0.001). Minor complications
occurred in 166 (1.33%) and 262 (2.10%) patients, respectively (P≤0.001).
In a logistic regression model performed on the matched
overall cohort, the odds ratio of an explantation patient experiencing an in-hospital complication or death compared with
an abandonment patient was 1.73 (95% confidence interval, 1.53–1.95; P<0.001). This odds ratio was essentially
unchanged after adjusting for demographic, medical history,
procedural, hospital, and operator characteristics.
Urgent cardiac surgery
13 (0.10)
59 (0.47)
0.0000
166 (1.33)
262 (2.10)
0.0000
Minor complications
Conduction block
1 (0.01)
6 (0.05)
0.0588
Drug reaction
10 (0.08)
5 (0.04)
0.1967
Hematoma requiring
reoperation, evacuation,
or transfusion
42 (0.34)
67 (0.54)
0.0157
Infection requiring
antibiotics
9 (0.07)
24 (0.19)
0.0090
Lead dislodgement
96 (0.77)
138 (1.11)
0.0054
Peripheral embolus
0 (0.00)
11 (0.09)
0.0000
Set screw problem
6 (0.05)
1 (0.01)
0.0588
Venous obstruction
5 (0.04)
26 (0.21)
0.0002
CVA indicates cerebrovascular accident; and TIA, transient ischemic attack.
Mortality
Mortality risk was assessed in the 1:1 matched Medicare cohort.
The mean follow-up was approximately 14.7 months in both the
lead abandonment and explantation groups. There was numerically greater mortality in the explantation group compared with
the abandonment group at each time point assessed: in-hospital,
90 days post discharge, and 1 year post discharge (Table 4).
There were only 7 total in-hospital deaths in this cohort, including 2 in the abandonment group and 5 in the explantation group
(P=0.26). Within 90 days of discharge, there were 19 (3.23%)
and 24 (4.08%) deaths (P=0.44), and within 1 year, there were
48 (8.16%) and 67 (11.39%) deaths (P=0.06), respectively, in
the lead abandonment and explantation groups (Table 4). Allcause mortality is summarized with Kaplan–Meier survival
curves in Figure 2 and demonstrates no statistically significant
difference during the course of follow-up (P=0.16).
7 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
Table 4. In-Hospital, 90-Day, and 1-Year Mortality in Lead Abandonment and Explantation
Medicare Patients
Lead Abandonment
Lead Explantation
N=588
N=588
N (%)
N (%)
Description
P Value
Follow-up months from procedure for death (mean, SD)
14.7
4.2
14.7
4.7
0.91
Survival months from procedure (mean, SD)
7.5
5.4
6.8
4.9
0.42
In-hospital death
2
0.34
5
0.85
0.26
Death within 90 d
19
3.23
24
4.08
0.44
Death within 1 y
48
8.16
67
11.39
0.06
Total death
63
10.71
78
13.27
0.18
Six-Month Complications
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There were 1042 subjects enrolled in Medicare at the time of
the procedure and for the subsequent 6 months that could be
matched 1:1 to assess differences in six-month complications
occurring after discharge between lead abandonment and
explantation (Figure 1). There were no differences observed
between groups in regard to bleeding, pericardial tamponade,
infection requiring antibiotics, urgent surgery, upper extremity thrombosis, or pulmonary embolism at 6 months (P>0.05
for all; Table 5), although event rates were low for most of
these outcomes.
Discussion
There are 3 major findings from our analysis of outcomes of
patients undergoing lead revision of noninfected ICD leads
from the NCDR ICD registry: first, procedural complications
and death are low but occur slightly more frequently in patients
undergoing explantation compared with abandonment. Second,
in the Medicare subgroup, there was a trend toward greater
mortality in the explantation group, but both groups had relatively high rates of 90-day and 1-year mortality with nearly 1 in
10 patients dead within a year. Finally, in Medicare patients, differences in complication rates including death in the year after
hospital discharge were not statistically significantly different
for patients undergoing lead explantation versus abandonment.
Previous cohort studies and case series have found rates
of periprocedural mortality from an unused or malfunctioning
ICD lead extraction to be in the range of 0.3% to 0.6%.10,20
The in-hospital mortality rate in the overall cohort in our
analysis was 0.64% in the explantation group and 0.21% in
the abandonment group (P<0.001). In a Medicare subgroup,
in-hospital mortality was 0.85% (explantation) and 0.34%
(abandonment), but this was based on only 5 and 2 events,
respectively (P=0.26).
Both the lead management strategies studied here
were associated with low procedural risk with 2.19% of
Figure 2. Kaplan–Meier survival curves
for Medicare patients undergoing lead
abandonment vs explantation.
8 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
Table 5. Six-Month Complications From Lead Abandonment
vs Explantation in a Medicare Subgroup After Hospital
Discharge
Description
Bleeding
Lead
Abandonment
Lead
Explantation
N=521
N=521
N (%)
N (%)
P Value
25 (4.80)
25 (4.80)
1.0000
Pericardial tamponade
2 (0.38)
3 (0.58)
0.6539
Infection
7 (1.34)
16 (3.07)
0.0577
Urgent surgery
6 (1.15)
6 (1.15)
1.0000
Upper extremity thrombosis
4 (0.77)
5 (0.96)
0.7378
Pulmonary embolism
2 (0.38)
5 (0.96)
0.2552
Downloaded from http://circep.ahajournals.org/ by guest on June 14, 2017
abandonment patients in the overall cohort experiencing an inhospital complication compared with 3.77% of explantation
patients (P<0.001). This absolute difference of 1.58% corresponds to a number needed to harm of 63. It is noteworthy
that the time period studied (2010–2011) was one in which
the Medtronic Sprint Fidelis (Medtronic, Minneapolis, MN)
recall was underway. Indeed, a majority of revised leads in
our analysis were manufactured by Medtronic, and the majority of leads were revised in response to an advisory or recall
(Data Supplement). Explantation of the Sprint Fidelis lead by
experienced operators is generally considered to be less complicated than explantation of other leads (eg, Riata),21 so the
overall procedural risk observed in this cohort is likely conservative compared with contemporary experience. Moreover,
actual or anticipated lead failures in the context of this recall
may have encouraged lead revision of relatively young leads;
average lead implant duration was approximately 5.5 years
in all matched groups. Because lead implant duration is well
known to correlate with lead explantation complications, this
may also contribute to a conservative estimate of complications in the lead explantation cohorts.
Tear of the superior vena cava is an important and potentially lethal complication of lead explantation, but it is not
captured in the NCDR ICD Registry. Instead, urgent cardiac
surgery is considered a reasonable surrogate. Therefore, it
is intriguing that the number of in-hospital deaths in the
explantation group (80) exceeded the number of urgent cardiac surgeries (59). This is consistent with evidence in the
literature.10,22,23 There are 3 potential explanations for this
finding. First, explantation procedures taking place outside
the cardiothoracic operating room complicated by a vascular tear or cardiac avulsion may result in death before
urgent surgery can be undertaken. In this case, urgent cardiac surgery is considered a reasonable surrogate for vascular tear because the latter complication is not captured
in the ICD Registry. Second, complications more common
in the explantation group (eg, stroke) that do not require
surgical intervention may contribute substantially to the
mortality rate, and third, those complications occurring at
similar rates in explantation and abandonment patients (eg,
myocardial infarction) may be more deadly in explantation
patients. As such, data on cause of death may help further
explain this slight difference in mortality; however, these
data are unavailable.
After discharge, all-cause mortality to 1 year in the
Medicare cohort was slightly higher in the explantation group
compared with the abandonment group (8.16 compared with
11.39%, respectively [P=0.06]). Although not statistically
significant, the trend shows greater mortality in the explantation group with numerically more deaths at each time point
measured (in hospital, 90 days post discharge, and 1 year post
discharge). The Medicare subgroup was >10× smaller than
the overall cohort, and as a result, had lower statistical power
to identify mortality and safety differences between groups.
However, the overall sample size represents the largest published cohort to date. Although the numeric difference in mortality between these groups of older patients seems to widen
with increasing time (Figure 2), it remains unknown how outcomes would differ beyond 1 year. Even if a difference exists
in outcomes beyond 1 year, it is unclear how much of this difference is because of differences in comorbidities that could
not be captured from observational data (when compared with
a randomized trial).
In other investigations of outcomes after sterile lead
extraction, mortality was lower.10,24,25 For example, Maytin
et al25 reported outcomes of patients undergoing lead extraction at a single, high volume institution and found that among
patients with extraction of sterile leads, 1-year mortality was
8.4%. However, our clinical practice cohort was older (mean,
75 years versus 56 years), had a higher burden of comorbid
illness, especially diabetes mellitus, and had a greater range of
center and provider volume that are known to make a difference in outcomes.26,27
The 1-year mortality rate for patients undergoing lead
abandonment in this analysis was relatively high, despite low
rates of ICD-related complications (Table 4). Interestingly,
this mortality rate and the mortality rate in the explantation
group are similar to that seen in an all-comer NCDR ICD
Registry cohort undergoing elective generator replacement in
which a 9.8% 1-year mortality was observed and only 6.2% of
subjects underwent concomitant lead revision.28 This suggests
that in clinical practice, lead revision decisions are often made
in older patients with multiple comorbidities such that the risk
of any procedure increases with increasing comorbidity burden and competing risks of death. Indeed, choosing a revision
strategy involves complex decision making. For example, in
our prematched cohorts, maximum lead implant duration was
significantly longer in abandonment patients compared with
explantation patients that likely reflects healthcare providers’
awareness that longer implant duration increases the risks of
explantation. Although this difference was balanced with propensity matching, other differences between groups may be
less well captured in the Registry.
To assess outcomes beyond the index hospitalization, we
had to limit our cohort to those patients enrolled in Medicare.
In this subgroup, we assessed complications within 6 months
of hospital discharge and found no difference between the
explantation and abandonment groups for any outcome.
This means that although there were differences in the overall cohort between groups in regard to infection, tamponade,
venous obstruction, and urgent surgery before discharge, there
9 Zeitler et al Outcomes in Lead Abandonment Versus Explantation
were no differences seen at 6 months in these outcomes in
the Medicare subgroup. Notably, complications from lead
abandonment are more difficult to capture than those from
explantation, especially from claims data in which some outcomes (eg, asymptomatic venous occlusion) may not be captured. Moreover, whether they are captured in claims data or
not, complications from lead abandonment may be expected
to accrue over a much longer time period than 1 year. Thus,
longer-term complications of abandonment may be more relevant in a younger cohort in whom leads that may someday
need extraction are left to dwell longer as comorbidities and
age accumulate.
On the basis of these results, and consistent with previous
work, although lead explantation is a riskier procedure in the
short term, both lead explantation and lead abandonment are
associated with relatively few deaths and complications. At 1
year, explantation does not seem to provide benefit over lead
abandonment in a Medicare population.
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Limitations
The decision to explant or abandon an unused or malfunctioning ICD lead involves numerous considerations many of
which are not included in our analysis: perceived surgical
risk, life expectancy, and patient preferences to name a few.
In addition, outcomes in our analysis were limited to those
in the ICD Registry and in the Centers for Medicare and
Medicaid Services administrative database; other outcomes
(eg, asymptomatic venous occlusion), intermediate-term outcomes in non-Medicare patients, and outcomes outside of the
2010 to 2011 window during which the Sprint Fidelis lead
recall was underway were not available, and so our results
may not apply to all patients or more current procedures or
leads. We used propensity score matching by including an
extensive list of clinically relevant variables to reduce the bias
of healthier patients undergoing lead explantation; this process leaves some patients unmatched, so our results may not
apply to patients with the highest level of comorbidity burden
or other outlier characteristics. In particular, we were unable
to match well on the variable of center explantation volume
(absolute standard difference >60%) such that patients undergoing explantation were treated in centers with a much greater
average number of explants per year, which has 2 potential
implications: (1) these findings may underestimate complication rates at centers with lower explantation volume and
(2) this may represent a referral bias; patients undergoing
explantation may have more commonly been referred to an
explantation center specifically for explantation making their
revision strategy “predetermined”. In addition, propensity
score matching cannot account for every clinical scenario,
so the differences in outcomes between lead abandonment
and lead explantation patients in our analysis may not apply
to all propensity-matchable patients. For example, although
we matched patients based on long-term warfarin usage to
account for risks of procedural bleeding, this does not take
into account how perceived risks of warfarin discontinuation influenced lead revision decisions, and although procedural bleeds associated with warfarin continuation through a
procedure would be well captured in this analysis, embolic
strokes occurring after discharge would not be. Finally, we
could not exclude explantation procedures involving simple
traction techniques versus true extraction. Although the number of procedures (7.2%) involving leads with the dwell time
of <1 year is too small to have a large impact on the overall
outcomes, it should be acknowledged that some leads with the
dwell time of ≥1 year can be removed with simple traction,
and as a result, 7.2% likely underestimates the true number of
leads that were removed with simple traction.
Clinical Implications
In this study, management of unused or malfunctioning ICD
leads was associated with <1% in-hospital mortality and <5%
overall in-hospital complications regardless of the adopted strategy. After hospitalization for lead management, mortality was
somewhat higher at discharge, 90 days, and 1 year among Medicare-aged patients undergoing explantation versus abandonment,
but 6-month device-related complications seemed to be similar
between the 2 groups. Future longitudinal studies will hopefully
provide better understanding of the longer-term outcomes of lead
abandonment and explantation, especially in younger patients.
However, only adequately powered randomized prospective trials with long-term follow-up can provide the most meaningful
guidance to patients and physicians facing the decision to abandon or explant an unused or malfunctioning lead.
Acknowledgments
We thank Sean Pokorney, MD MBA, for his tremendously helpful
assistance in collecting and confirming lead characteristics.
Sources of Funding
This research was supported by the American College of Cardiology’s
National Cardiovascular Data Registry (NCDR). The views expressed
in this article represent those of the author(s) and do not necessarily
represent the official views of the NCDR or its associated professional societies identified at CVQuality.ACC.org/NCDR.
Disclosures
Dr Zeitler was funded by National Institutes of Health (NIH) T-32
training grant 2 T32 HL 69749-11 A1. Dr Dharmarajan is supported
by grant K23AG048331-02 from the National Institute on Aging
and the American Federation for Aging Research through the Paul
B. Beeson Career Development Award Program. However, no relationships exist related to the analysis presented. Dr Daubert reports
modest honoraria from Biotronik, Boston Scientific, Medtronic, and
St. Jude Medical; moderate to significant research grant and fellowship support to his institution from Biotronik, Boston Scientific, St.
Jude Medical, and Medtronic. The other authors report no conflicts.
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CIRCOUTCOMES.111.000054.
Outcomes 1 Year After Implantable Cardioverter−Defibrillator Lead Abandonment
Versus Explantation for Unused or Malfunctioning Leads: A Report from the National
Cardiovascular Data Registry
Emily P. Zeitler, Yongfei Wang, Kumar Dharmarajan, Kevin J. Anstrom, Eric D. Peterson,
James P. Daubert, Jeptha P. Curtis and Sana M. Al-Khatib
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Circ Arrhythm Electrophysiol. 2016;9:
doi: 10.1161/CIRCEP.116.003953
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Supplemental Material
1
Table 1. ICD-9-CM codes used to identify 6-month complications in Medicare patients undergoing lead abandonment versus explantation
Outcome
Bleeding
Tamponade
Infection
Codes and description
998.11 (hemorrhage complicating a procedure), 998.12 (hematoma complicating a procedure), major bleeding (430
through 432 [intracerebral], 578.X [gastrointestinal tract], 719.1X [hemarthrosis], 423.0 [hemopericardium], 599.7
[hematuria], 626.2, 626.6, 626.8, 627.0, 627.1 [vaginal], 786.3 [hemoptysis], 784.7 [epistaxis], or 459.0 [hemorrhage not
otherwise specified]), V58.2 (blood transfusion without reported diagnosis), or 99.00 (P: perioperative autologous
transfusion of whole blood or blood components), 99.03 (P: other transfusion of whole blood), 99.04 (P: transfusion
procedure)
423.0 (hemopericardium), 423.3 (hemopericardium), 423.9 (unspecified disease of pericardium previously used for
tamponade), 37.0 (pericardiocentesis)
996.6 (infection and inflammation because of internal prosthetic device, implant, or graft), 996.61; (infection and
inflammation because of cardiac device, implant, or graft), 424.9 (endocarditis valve unspecified, within 6 months of the
procedure), 790.7 (bacteremia, within 6 months of the procedure)
Upper extremity
thrombosis
453.7x (chronic venous embolism and thrombosis), 453.81-7 (acute venous embolism and thrombosis), 453.9 (embolism
and thrombosis of unspecified site)
Pulmonary
embolism
415.1-3, 415.19 (pulmonary embolism), 416.2 (chronic pulmonary embolism)
Urgent surgery
998.11 (hemorrhage complicating a procedure), 998.12 (hematoma complicating a procedure), 998.2 (Accidental puncture
or laceration during a procedure, not elsewhere classified), 39.31 (P: suture of an artery), 39.41 (P: control of hemorrhage
following vascular surgery), 39.49 (P: other revision of vascular procedure), 39.53 (P: repair of arteriovenous fistula), 39.56
to 39.59 (P: repair of blood vessel with tissue patch, synthetic patch, unspecified patch graft), 39.79 (P: other endovascular
procedures on other vessels)
2
Table 2. Baseline characteristics with standardized difference before and after matching of the Medicare 6-month complications
cohort
Description
All
Demographics
Age, yrs
Gender: Female
White (non-Hispanic)
Medical History
Heart Failure
NYHA Functional Classification†
- Class I
- Class II
- Class III
- Class IV
Non-ischemic dilated cardiomyopathy
Atrial Fibrillation/Flutter
Ventricular Tachycardia
Hemodynamic Instability
History of a Cardiac Arrest
Prior CABG
Primary Valvular Heart Disease
Cerebrovascular disease
Lung disease
Before Matching
Lead
Lead
Abandonment Explantations
[# (%) or
[# (%) or
mean (std)]
mean (std)]
ASD*
After Matching
Lead
Lead
Abandonment
Explantations
[# (%) or
[# (%) or
mean (std)]
mean (std)]
ASD
521 (100)
521 (100)
24
2
3
75.09 (6.36)
144 (27.64)
74.92 (5.93)
139 (26.68)
474 (90.98)
473 (90.79)
3
2
1
508 *76.62)
6
402 (77.16)
406 (77.93)
2
183 (16.32)
404 (36.04)
477 (42.55)
15 (1.34)
289 (25.78)
94 (14.18)
239 (36.05)
265 (39.97)
16 (2.41)
187 (28.21)
424 (43.18)
439 (48.08)
130 (11.60)
114 (10.17)
456 (40.68)
132 (11.78)
180 (16.06)
248 (22.12)
279 (42.08)
252 (38.01)
63 (9.50)
50 (7.54)
243 (36.65)
89 (13.42)
108 (16.29)
135 (20.36)
6
0
5
8
9
1
18
11
8
5
7
3
2
72 (13.82)
196 (37.62)
213 (40.88)
11 (2.11)
140 (26.87)
225 (43.19)
217 (41.65)
53 (10.17)
42 (8.06)
210 (41.31)
62 (11.90)
81 (15.55)
116 (22.26)
81 (15.55)
185 (35.51)
217 (41.65)
11 (2.11)
149 (28.60)
231 (44.34)
207 (39.73)
53 (10.17)
44 (8.45)
200 (38.39)
70 (13.44)
93 (17.85)
111 (21.31)
5
4
2
0
4
2
4
0
1
4
5
6
2
1121 (100)
663 (100)
76.18 (6.68)
292 (26.05)
1018 (90.81)
74.64 (5.97)
179 (27.00)
597 (90.05)
868 (77.43)
3
Diabetes mellitus
Hypertension
Most Recent LVEF %
Hemoglobin
Sodium
Creatinine
Procedural Factors
Primary Prevention
Lead only
Routine coumadin therapy
Lead implant duration, yrs‡
Single coil lead§
Dual coil lead§
Hospital Characteristics
Teaching
Number of lead explantations in the hospital
Physician training
Board-certified EP
419 (37.38)
856 (76.36)
33.85 (13.31)
13.12 (1.71)
138.59 (4.89)
1.34 (0.88)
251 (37.86)
490 (73.91)
31.97 (13.08)
13.14 (1.75)
138.76 (3.05)
1.30 (0.72)
4
2
14
1
4
5
206 (39.54)
388 (74.47)
32.50 (12.93)
13.07 (1.69)
138.55 (6.27)
1.32 (1.05)
201 (38.58)
389 (74.66)
32.43 (13.310)
13.18 (1.77)
138.74 (3.05)
1.29 (0.66)
2
1
1
7
4
3
718 (64.05)
86 (7.67)
409 (36.49)
5.42 (2.91)
233 (20.79)
1084 (96.70)
419 (63.20)
100 (15.08)
251 (37.86)
4.05 (2.10)
168 (25.34)
616 (92.91)
2
24
3
52
11
18
336 (64.49)
55 (10.56)
188 (36.08)
4.54 (2.07)
124 (23.80)
499 (95.78)
337 (64.48)
59 (11.32)
208 (39.92)
4.43 (1.99)
123 (23.61)
497 (95.39)
0
3
8
5
0
2
370 (33.01)
29.43 (54.90)
197 (29.71)
101.15 (120.41)
7
84
164 (31.48)
31.42 (58.61)
161 (30.90)
94.76 (113.21)
1
70
842 (75.11)
547 (82.50)
18
414 (79.46)
419 (80.42)
2
Other baseline characteristics used in the propensity model included: history of syncope, family history of sudden death, prior myocardial
infarction, prior percutaneous coronary intervention (PCI), electrophysiology study, QRS duration, systolic blood pressure, diastolic blood
pressure, BUN (mean), potassium (mean), procedure type (initial generator vs generator change vs lead only), coumadin held for procedure,
final device type (single chamber versus dual chamber versus cardiac resynchronization therapy), number of leads in the procedure, discharge
medications (ACE inhibitor, angiotensin receptor blocker, aspirin, beta blocker, diuretic, and warfarin), hospital ownership (public vs private vs
not-for-profit), hospital setting (division, micro, metro, rural), staffed hospital beds, hospital teaching status, ability to perform advanced cardiac
procedures, and hospital geographic region.
*ASD = absolute standardized difference defined as the absolute difference in means (or proportions) divided by the average standard deviation
†NYHA categories do not add up to total due to some missingness
‡When more than one lead was present, the maximum lead implant duration was used
§These groups are not mutually exclusive. Many subjects in this cohort had more than one indwelling ICD lead and the presence of any single
coil or dual coil lead is reported here.
4
Table 3. Lead characteristics by management strategy in the overall matched cohort*
Total
Description
All
Lead Implant Duration
Lead
Lead
Abandonment
Explantation
P
#
%
#
%
#
%
25281
100.00
12613
100.00
12668
100.00
2057.38
978.91
2088.97
880.37
2025.99
1066.96
0.0000
Reason for lead revision

Abnormal lead function
14233
56.30
7640
60.57
6593
52.04
0.0000

Advisory/Recall
13885
54.92
6883
54.57
7002
55.27
0.2617
0.0000
Manufacturer

Biotronik Inc

Boston Scientific

ELA Medical

Guidant

Medtronic
649
2.57
345
2.74
304
2.40
272
1.08
92
0.73
180
1.42
31
0.12
22
0.17
9
0.07
2051
8.11
1044
8.28
1007
7.95
16729
66.17
8473
67.18
8256
65.17
5549
21.95
2637
20.91
2912
22.99
 St. Jude Medical
*Lead characteristics shown here for the overall cohort are nearly identical to those in the one-year and six-month Medicare matched cohorts.
5