Original Article

Cardiac Perforation From Implantable Cardioverter-

Defibrillator Lead Placement
Insights From the National Cardiovascular Data Registry
Jonathan C. Hsu, MD, MAS; Paul D. Varosy, MD; Haikun Bao, PhD;
Thomas A. Dewland, MD; Jeptha P. Curtis, MD; Gregory M. Marcus, MD, MAS

Background—Cardiac perforation is a feared complication of implantable cardioverter-defibrillator (ICD) lead implantation

because of the potential for significant morbidity and mortality. Predictors of perforation and the severity of associated
adverse events have not been well studied. We sought to identify predictors of cardiac perforation from ICD lead
implantation and subsequent outcomes.
Methods and Results—We studied 440 251 first-time ICD recipients in the ICD Registry implanted between January 2006
and September 2011. Using hierarchical multivariable logistic regression adjusting for patient, implanting physician,
and hospital characteristics, we examined the predictors of perforation and the association of perforation with other
major complications, length of stay, and in-hospital mortality. Cardiac perforation occurred in 625 patients (0.14%).
After multivariable adjustment, older age, female sex, left bundle branch block, worsened heart failure class, higher left
ventricular ejection fraction, and non–single-chamber ICD implant were associated with a greater odds of perforation.
Conversely, atrial fibrillation, diabetes mellitus, previous cardiac bypass surgery, and higher implanter procedural volume
were associated with a lower odds of perforation (all P<0.05). After adjustment, ICD recipients with perforation had
greater odds of other associated major complications (odds ratio, 27.5; 95% confidence interval, 19.9–38.0; P<0.0001),
postprocedural hospital stays >3 days (odds ratio, 16.3; 95% confidence interval, 13.7–19.4; P<0.0001), and in-hospital
death (odds ratio, 17.7; 95% confidence interval, 12.2–25.6; P<0.0001).
Conclusions—In a large population of ICD recipients, specific patient and implanter characteristics predicted cardiac
perforation risk. Cardiac perforation was associated with a substantially increased risk of other major complications,
prolonged hospital stays, and death.  (Circ Cardiovasc Qual Outcomes. 2013;6:582-590.)
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Key Words: adverse events complication ◼ cardiac perforation ◼ complication ◼ defibrillators, implantable

◼ mortality ◼ national registry

C ardiac perforation is a feared complication of transvenous

pacemaker and implantable cardioverter-defibrillator
(ICD) lead implantation because of the potential for signifi-
cant morbidity and mortality.1 Small studies and registries with
older lead technologies have estimated the prevalence of car-
diac perforation to be 0.1% to 0.8% for pacemakers and 0.6%
to 5.2% for ICDs,2–5 but no large-scale study has evaluated
the prevalence of cardiac perforation during implantation of
modern-day ICDs. Importantly, predictors of cardiac perfora-
tion from ICD implantation and the severity of adverse events
that result from the complication have not been well studied.
We analyzed data from the ICD Registry of the National
Cardiovascular Data Registry (NCDR), a national registry
of ICD implantations that captures detailed clinical patient,
physician, and hospital information as well as in-hospital out-
comes. By assessing a large population of ICD recipients, we
sought to examine predictors of cardiac perforation from ICD
implantation and the magnitude of associated adverse events.
Methods
Data Source
The NCDR ICD Registry was created in 2006 to meet the require-
ments of the Center for Medicare & Medicaid Services’ Coverage
with Evidence Development decision.6 The Heart Rhythm Society
and American College of Cardiology collaborated to establish a na-
tional registry of ICD implantations funded by a combination of hos-
pital fees and grants from payers and device companies. Hospitals
are mandated to provide data on Medicare beneficiaries receiving an
ICD for primary prevention of sudden cardiac death; however, 71.5%

Received April 13, 2013; accepted August 13, 2013.

From the Section of Cardiac Electrophysiology, Division of Cardiology, Department of Medicine, University of California, San Diego, CA (J.C.H.);
Section of Cardiac Electrophysiology, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA (T.A.D., G.M.M.); VA
Eastern Colorado Health Care System, University of Colorado, Denver, CO (P.D.V.); the Colorado Cardiovascular Outcomes Research Group, Denver, CO
(P.D.V.); and the Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT (H.B., J.P.C.).
This manuscript was handled independently by Sana Al-Khatib, MD, MHS, as a Guest Editor. The Editors had no role in the evaluation of this manuscript
or in the decision about its acceptance.
Correspondence to Jonathan C. Hsu, MD, MAS, University of California, San Diego, 9444 Medical Center Dr, MC7411, La Jolla, CA 92037. E-mail
Jonathan.Hsu@ucsd.edu
© 2013 American Heart Association, Inc.
Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org DOI: 10.1161/CIRCOUTCOMES.113.000299

582
 Hsu et al   Cardiac Perforation and ICD Adverse Events   583
WHAT IS KNOWN
• It is known that cardiac perforation is a complica-
tion that may occur during implantable cardioverter-
defibrillator implantation.
• It is known that cardiac perforation may be associ-
ated with increased morbidity and mortality, but the
magnitude of this association has never been studied.
WHAT THE STUDY ADDS
• The prevalence of cardiac perforation during
modern-day implantable cardioverter-defibrillator
implantation is 0.14%.
• Specific patient and implanter characteristics pre-
dict cardiac perforation risk; older age, female sex,
left bundle branch block, worsened heart failure
class, higher left ventricular ejection fraction, and
non–single-chamber implantable cardioverter-defi-
brillator implant are associated with a greater odds
of perforation, whereas atrial fibrillation, diabetes
mellitus, previous cardiac bypass surgery, and higher
implanter procedural volume are associated with a
lower odds of perforation.
• Cardiac perforation from implantable cardioverter-
defibrillator implantation is associated with a sub-
stantially increased risk of other major in-hospital
complications, prolonged hospitalization, and death.
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of the 1375 participating hospitals are providing data on all patients
undergoing ICD implantation, and these hospitals submit 88.4% of
all ICD implants included in the registry.6 This study included all eli-
gible patients enrolled in the ICD Registry after January 2006, which
included Versions 1.0 and 2.0 data. ICD Registry data have under-
gone data quality standard testing, including an auditing program to
confirm completeness and verify accuracy, as previously detailed.6,7
Study Population
All patients with implant data submitted to the registry between
January 1, 2006, and September 30, 2011, were considered for analy-
sis (n=747 795). Patients implanted with a previous ICD or cardiac
resynchronization therapy with defibrillator (n=246 731), those with
a previous pacemaker (n=53 970), and those with an epicardial lead
placed during the index procedure (n=6843) were excluded from the
analysis, leaving 440 251 patients.
Definition of Cardiac Perforation
Cardiac perforation was defined in data coding as puncture or migra-
tion of a lead through the myocardium that may or may not have been
self-sealing or symptomatic and could have occurred between the
start of the procedure until hospital discharge. To account for poten-
tial variations in data coding, patients who experienced cardiac tam-
ponade (fluid in the pericardial space compromising cardiac filling
and requiring intervention at any occurrence between the start of the
procedure until discharge) were also considered to have experienced
a cardiac perforation.
Adverse Outcomes
The first adverse outcome of interest was the occurrence of any as-
sociated major in-hospital complication during or after ICD implan-
tation. An associated major complication was defined as a plausibly
related complication to cardiac perforation and included cardiac ar-
rest, myocardial infarction, or infection requiring antibiotics. The
second outcome was duration of hospitalization from device implant
to discharge. For analytic purposes, length of hospital stay was di-
chotomized to >3 days or ≤3 days based on the distribution of the
cohort. The third outcome was the occurrence of in-hospital death
during or after ICD implantation.
Statistical Analysis
Normally distributed continuous variables are expressed as means and
SDs, whereas continuous variables with skewed distributions are ex-
pressed as medians and interquartile ranges. Baseline patient, implant-
ing physician, and hospital characteristics were compared between
patients with and without cardiac perforation using the χ2 test for cat-
egorical variables and t tests or Wilcoxon rank-sum test for continuous
variables, as appropriate. Independent associations of various charac-
teristics with the outcome of cardiac perforation were identified using
a hierarchical logistic regression model to account for clustering of pa-
tients within hospitals. Covariates selected for the multivariate analy-
ses were chosen based on the plausibility that they could be associated
with cardiac perforation. In the next stage of the analysis, hierarchical
logistic regression models were developed to assess the independent
association of cardiac perforation with adverse outcomes, again by
accounting for clustering of patients within hospitals in multivariable
models.8 Covariates in the multivariable models assessing adverse out-
comes included patient demographics (age, sex, race, insurance payer),
comorbidities (congestive heart failure, New York Heart Association
class, syncope, ventricular tachycardia, cardiac arrest, atrial fibrilla-
tion, nonischemic cardiomyopathy, ischemic heart disease, previous
myocardial infarction, previous coronary artery bypass graft surgery,
previous percutaneous coronary intervention, cerebrovascular disease,
chronic lung disease, diabetes mellitus, hypertension, end-stage renal
disease), diagnostic information (indication for implantation, device
type, left ventricular ejection fraction [LVEF], QRS duration, blood
urea nitrogen level), implanter characteristics (implanter specialty train-
ing, implanter volume), and hospital characteristics (profit type, region,
size, teaching status). We performed an exploratory subset analysis in
patients with only Version 2.0 (after April 1, 2010) data that included
right ventricular endocardial defibrillation lead information to assess
a potential association of right ventricular lead characteristics (largest
lead diameter and active versus passive fixation) and the risk of cardiac
perforation. In this subset analysis, lead characteristics were added to
the covariates included in the main analytic multivariable models to
assess for an independent association between lead characteristics and
cardiac perforation. We also performed a prespecified subgroup adjust-
ed analysis to determine specific groups at higher or lower risk of any
associated complication or in-hospital death from cardiac perforation,
including tests for interactions. Statistical tests were 2-sided and con-
sidered significant if they yielded a P<0.05. Analyses were performed
using the SAS Statistical Package Version 9.2 (SAS Institute, Cary,
NC). The Yale University Human Investigation Committee approved
analysis of data from the ICD Registry.
Results
Cardiac perforation occurred in 625 patients (0.14%). Base-
line characteristics of ICD recipients with and without cardiac
perforation are presented in Table 1.9 In unadjusted analysis,
variables associated with cardiac perforation included older
age, female sex, worsened New York Heart Association heart
failure class, and nonischemic cardiomyopathy. Cardiac per-
foration occurred less often in ICD recipients with a history
of atrial fibrillation, ischemic heart disease, previous myocar-
dial infarction, previous coronary artery bypass surgery, and
diabetes mellitus. Recipients of cardiac resynchronization
therapy with defibrillator were more likely to experience car-
diac perforation compared with single- or dual-chamber ICD
recipients. Clinical characteristics associated with cardiac per-
foration included a left bundle-branch block. Among implant-
ing physician and hospital characteristics, lower physician
 584   Circ Cardiovasc Qual Outcomes   September 2013

Table 1.  Unadjusted Baseline Characteristics of Patients With and Without Cardiac Perforation
From ICD Implantation
Characteristic Cardiac Perforation (n=625) No Cardiac Perforation (n=439 626) P Value
Patient demographic characteristics
 Age, y 70.1±12.3 66.1±13.2 <0.0001
 Female sex 54.2% 27.6% <0.0001
 Race 0.5500
  
White 81.1% 80.7%
  
Black 13.0% 14.4%
  
Asian 1.4% 1.2%
  
Other 4.5% 3.7%
 Hispanic ethnicity 5.6% 5.6% 0.3865
 Congestive heart failure 80.6% 76.9% 0.0793
 NYHA class <0.0001
  
I 10.6% 13.3%
  
II 28.3% 36.6%
  
III 56.3% 46.1%
  
IV 4.6% 3.8%
 Atrial fibrillation/atrial flutter 22.9% 28.5% 0.0066
 Nonischemic dilated cardiomyopathy 48.3% 33.4% <0.0001
 Ischemic heart disease 48.0% 63.0% <0.0001
 Previous myocardial infarction 37.3% 51.8% <0.0001
 Previous CABG 2.6% 31.6% <0.0001
 Hypertension 74.2% 76.9% 0.2446
 Diabetes mellitus 28.2% 37.7% <0.0001
 Cerebrovascular disease 12.5% 14.3% 0.3701
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 End-stage renal disease 3.8% 3.9% 0.7813

Patient diagnostic data
 LVEF, % 28.3±12.1 28.1±11.3 0.6881
 LBBB 46.7% 25.9% <0.0001
 BUN level, mg/dL 23.5±13.2 23.5±13.5 0.9827
Device characteristics
 ICD type <0.0001
  
Single-chamber ICD 13.9% 25.0%
  
Dual-chamber ICD 41.3% 43.1%
  
CRT-D 44.3% 31.8%
Implanter characteristics
 Implanting physician training 0.5033
  
Board-certified EP 54.7% 58.2%
  
Board-eligible EP 9.1% 7.8%
  
HRS guidelines 9.0% 8.2%
  
Surgery boards 1.1% 1.4%
  None of the above 8.0% 6.9%
  
Unknown 18.1% 17.4%
 Implanting physician volume 91.3±88.9 103.5±99.0 0.0007
Hospital characteristics
 Hospital type 0.7871
  
Public 10.1% 9.5%
  
Not-for-profit 72.8% 74.1%
  
Private 14.2% 13.2%
(continued)
 Hsu et al   Cardiac Perforation and ICD Adverse Events   585

Table 1.  Continued.

Characteristic Cardiac Perforation (n=625) No Cardiac Perforation (n=439 626) P Value

  
Unknown 2.9% 3.2%
 Teaching hospital 58.4% 57.6% 0.6703
Categorical variables are reported as proportions (%); continuous variables are reported as mean±SD. Implanting physician
volume reflects average number of cases reported to the ICD Registry by implanters during the time period studied. Board-
eligible EP physicians are physicians who have completed a formal cardiac EP training program before passing the American
Board of Internal Medicine certification examination in cardiac EP. Heart Rhythm Society (HRS) guidelines represent an
alternative training pathway to EP board eligibility/certification for implantation of ICDs.9 BUN indicates blood urea nitrogen;
CABG, coronary artery bypass grafting; CRT-D, cardiac resynchronization therapy with defibrillator; EP, electrophysiology;
ICD, implantable cardioverter-defibrillator; LBBB, left bundle branch block; LVEF, left ventricular ejection fraction; and NYHA,
New York Heart Association.

volume was associated with cardiac perforation, whereas
physician training, hospital profit type, and teaching hospitals
were not associated with cardiac perforation.
After multivariable adjustment, older age, female sex, wors-
ened New York Heart Association heart failure class, non–sin-
gle-chamber ICD, higher LVEF, and left bundle branch block
were independently associated with a greater odds of cardiac
perforation (Table 2). Conversely, a history of atrial fibrillation/
atrial flutter, diabetes mellitus, previous coronary artery bypass
surgery, and higher implanting physician procedural volume
were associated with a lower odds of cardiac perforation.
In a subset analysis restricted to the cohort of ICD recipi-
ents implanted after April 2010 with available right ventric-
ular lead characteristics (n=99 472 total patients with 144
cardiac perforations [0.14%]), a smaller lead diameter was
associated with cardiac perforation, but there was no sig-
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the right ventricular lead characteristics along with variables
plausibly associated with cardiac perforation, a smaller lead
diameter remained associated with an increased cardiac per-
foration risk. When right ventricular lead diameter was instead
categorized by incremental French size, the greater adjusted
odds of cardiac perforation in both <7F (odds ratio, 1.51; 95%
confidence interval, 0.43–5.24; P=0.5185) and 7F to 8F (odds
ratio, 1.55; 95% confidence interval, 0.81–2.97; P=0.1840)
leads were not statistically different than >8F leads.
Association of Cardiac Perforation With Other
Procedural Complications
As shown in Table 4, the crude risk of any other associated
major procedural complication (defined as cardiac arrest,
myocardial infarction, or infection requiring antibiotics) was
higher in those with cardiac perforation (7.4%) than in those

nificant difference in cardiac perforation based on the lead without (0.3%). Most of the other complications listed on the
fixation type (Table 3). In multivariable models that included ICD Registry forms, including pneumothorax, hemothorax,

Table 2.  Statistically Significant Predictors Associated With Cardiac Perforation From ICD Implantation
After Multivariable Adjustment
Variable Adjusted Odds Ratio 95% Confidence Interval P Value
Age (per 10 y increase) 1.37 1.28–1.47 <0.0001
Female sex 2.18 1.86–2.57 <0.0001
NYHA class
 I Reference …
 II 1.10 0.82–1.48 0.5261
 III 1.42 1.05–1.93 0.0231
 IV 1.49 0.94–2.38 0.0923
ICD type
 Single-chamber ICD Reference …
 Dual-chamber ICD 1.52 1.19–1.94 0.0008
 CRT-D 1.30 0.98–1.73 0.0694
LVEF (per 5% increase) 1.05 1.01–1.09 0.0189
LBBB 1.80 1.48–2.19 <0.0001
Atrial fibrillation/atrial flutter 0.71 0.59–0.87 0.0006
Diabetes mellitus 0.72 0.61–0.86 0.0003
Previous CABG 0.06 0.04–0.10 <0.0001
Implanting physician volume 0.99 0.98–1.00 0.0064
The adjusted odds ratio reported for implanting physician volume is per 10 ICD implant procedures performed during the time
period studied. CABG indicates coronary artery bypass grafting; CRT-D, cardiac resynchronization therapy with defibrillator; ICD,
implantable cardioverter-defibrillator; LBBB, left bundle branch block; LVEF, left ventricular ejection fraction; and NYHA, New York
Heart Association.
 586   Circ Cardiovasc Qual Outcomes   September 2013

Table 3.  Subset Analysis of Right Ventricular Defibrillation Lead Characteristics and Association With Cardiac Perforation From
ICD Implantation
Adjusted Odds Ratio
Right Ventricular Lead Cardiac Perforation No Cardiac Perforation for Cardiac Perforation
Characteristic (n=144) (n=99 328) P Value (95% CI) P Value
Largest diameter of lead, 8.1±0.3 8.2±0.3 0.0008 1.88 (1.24–2.84) 0.0028
French size (per 1F size
unit decrease)
Type of lead fixation 0.2412
 Passive 7.6% 5.4% Reference …
 Active 92.4% 94.6% 0.95 (0.47–1.96) 0.8988
Categorical variables are reported as proportions (%); continuous variables are reported as mean±SD. The adjusted odds ratio reported for largest diameter of lead
is per 1F unit size decrease. CI indicates confidence interval; and ICD, implantable-cardioverter defibrillator.

transient ischemic attack or stroke, peripheral embolus, con-
duction block, and valve injury, were also significantly more
common in those with cardiac perforation (Table 4). Those
with cardiac perforation had a significantly greater odds of
any other associated major procedural complication in both
unadjusted and multivariable adjusted analyses (Figure 1).
We did not find evidence that the association between cardiac
perforation and any associated major procedural complication
was significantly different for any prespecified subgroup of
patients (P>0.05 for all interaction terms; Figure 2A).
Association of Cardiac Perforation With Length of
Hospital Stay
The median length of hospital stay for the entire cohort was 1
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bound of the interquartile range observed in those with cardiac
perforation approached 7 days compared with 2 days in those
without cardiac perforation. In both unadjusted and multivari-
able adjusted analyses, ICD recipients with cardiac perfora-
tion had a greater odds of hospital stay >3 days compared with
those without cardiac perforation (Figure 1).
Association of Cardiac Perforation With
In-Hospital Death
The crude risk of in-hospital death was significantly higher
in those with cardiac perforation (5.6%) compared with those
without cardiac perforation (0.4%; Table 4). ICD recipients
with cardiac perforation experienced a greater odds of in-
hospital death in unadjusted and multivariable adjusted analy-

day (interquartile range, 1.0–2.0), and the total length of hos- ses (Figure 1). We did not find evidence that the association
pital stay was ≤4 days in 90% of patients. The median length between cardiac perforation and in-hospital death was sig-
of stay was significantly longer in ICD recipients with cardiac nificantly different for any prespecified subgroup of patients
perforation than those without (Table 4). The largest upper (P>0.05 for all interaction terms; Figure 2B).

Table 4.  Adverse Events and Specific Complications Associated With Cardiac Perforation From
ICD Implantation
Adverse Event Cardiac Perforation (n=625) No Cardiac Perforation (n=439 626) P Value
Any associated major complication* 7.4% 0.3% <0.0001
Length of stay (implant to discharge), d 4.0 (2.0–7.0) 1.0 (1.0–2.0) <0.0001
In-hospital death 5.6% 0.4% <0.0001
Specific associated complication
 Cardiac arrest 6.88% 0.28% <0.0001
 Myocardial infarction 0.32% 0.03% <0.0001
 Infection requiring antibiotics 0.32% 0.04% 0.0006
 Pneumothorax 2.40% 0.41% <0.0001
 Hematoma 1.76% 0.65% 0.0006
 Hemothorax 1.60% 0.06% <0.0001
 Transient ischemic attack or stroke 0.96% 0.06% <0.0001
 Peripheral embolus 0.32% 0.02% <0.0001
 Conduction block 0.32% 0.03% 0.0001
 Valve injury 0.16% 0.00% <0.0001
 Drug reaction 0.00% 0.08% 0.4779
 Peripheral nerve injury 0.00% 0.00% 0.9005
Categorical variables are reported as proportions (%); continuous variables are reported as median (interquartile range). ICD indicates
implantable-cardioverter defibrillator.
*Any associated major complication is defined as cardiac arrest, myocardial infarction, or infection requiring antibiotics.
 Hsu et al   Cardiac Perforation and ICD Adverse Events   587

Figure 1. Unadjusted (white boxes) and multivariable adjusted (black boxes) odds ratios (ORs) of any associated major complication,
length of hospital stay >3 days, and in-hospital mortality among implantable-cardioverter defibrillator (ICD) recipients with cardiac
perforation (defined as cardiac perforation or pericardial tamponade). The reference group for each analysis is ICD recipients without
cardiac perforation. The horizontal error bars denote 95% confidence intervals (CIs). *Adjusted for patient demographics (age, sex,
race, insurance payer), comorbidities (congestive heart failure, New York Heart Association class, syncope, ventricular tachycardia,
cardiac arrest, atrial fibrillation, nonischemic cardiomyopathy, ischemic heart disease, previous myocardial infarction, previous coronary
artery bypass graft surgery, previous percutaneous coronary intervention, cerebrovascular disease, chronic lung disease, diabetes
mellitus, hypertension, end-stage renal disease), diagnostic information (indication for implantation, device type, left ventricular ejection
fraction, QRS duration, blood urea nitrogen level), implanter characteristics (implanter specialty training, implanter volume), and hospital
characteristics (profit type, region, size, teaching status).

Discussion
In a large, national sample of first-time ICD recipients, we
identified several patient and implanter characteristics that
predicted cardiac perforation risk. Patients who experienced
cardiac perforation had a substantially increased risk of
adverse events both before and after adjustment for potential
confounders, including a >26-fold increased odds of any other
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perforation and may be related to force on the lead tip from
early, dyssynchronous right ventricular wall activation with
subsequent late left ventricular activation. Worsened New
York Heart Association heart failure class was independently
associated with an increased cardiac perforation risk that may
be related to overall frailty that affords susceptibility to com-
plications. Apparently incongruous with these results was our

associated major complication, 16-fold increased odds of pro-
longed hospital stay >3 days, and 15-fold increased odds of
in-hospital death.
Previous studies examining the incidence and predictors of
cardiac perforation from lead implantation were small, stud-
ied older leads and included pacemaker lead implantation.4,5,10
In a study by Mahapatra et al,11 active fixation leads, steroid
drug use, and temporary pacing wire use were associated with
postimplant pericardial effusion in patients undergoing per-
manent pacemaker lead insertion. A large-scale study evaluat-
ing several potential predictors of cardiac perforation in ICD
recipients has not been reported. Although cardiac perfora-
tion is recognized as a serious complication from ICD lead
implantation, this is the first study to quantify the magnitude
of the association between cardiac perforation and in-hospital
adverse events. We found the prevalence of cardiac perfora-
tion in modern-day ICD implants to be relatively infrequent at
0.14%. However, with >600 cardiac perforation events, this is
the largest study of its kind, enabling comprehensive analyses
of predictors and outcomes of this important complication.
In multivariable adjusted analysis, several patient and
implanter characteristics were associated with cardiac per-
foration risk. Although our study was not equipped to iden-
tify the underlying mechanisms of these associations, several
plausible explanations exist. Both older age and female sex
have anecdotally been associated with an increased perfora-
tion risk.12 In both populations, a thinner myocardial wall
more susceptible to puncture may be responsible for an
increased perforation risk. The presence of left bundle branch
block was also associated with an increased risk of cardiac
finding that an increased LVEF was associated with a higher
risk of perforation. Although speculative, it is possible that
a smaller right ventricular volume or some as yet unknown
factor associated with a normal LVEF (such as a more frag-
ile right ventricle in arrhythmogenic right ventricular cardio-
myopathy) may be responsible for an increased perforation
risk. Alternatively, a higher LVEF may result in more force-
ful myocardial contractions against a lead tip, predisposing to
cardiac perforation. Consistent with previous studies, devices
with more leads were associated with more risk of cardiac
perforation.13,14 Of interest, although the unadjusted analyses
suggested an incrementally increased risk of perforation with
each additional lead (more for cardiac resynchronization ther-
apy with defibrillators than dual-chamber ICDs), the multivar-
iate analysis suggests that perforation risk increases primarily
with non–single-chamber devices as a group.
Several characteristics were protective against cardiac per-
foration. Atrial fibrillation/atrial flutter was associated with a
decreased cardiac perforation risk, which may be because of
atrial enlargement from the arrhythmia, more atrial fibrosis,
or less forceful contraction of the fibrillating atrium against
the lead tip. A history of diabetes mellitus was also protec-
tive against cardiac perforation and may afford protection
from myocardial wall puncture because of myocardial fibro-
sis seen in this patient population.15 Previous coronary artery
bypass graft surgery dramatically reduced the risk of cardiac
perforation, likely from surgically induced pericardial fibrosis
decreasing clinically meaningful or detectable cardiac perfo-
ration. Although teaching hospital status and implanting phy-
sician training were not associated with perforation, greater
 588   Circ Cardiovasc Qual Outcomes   September 2013

Figure 2. The adjusted odds

ratios for any associated major
complication (A) and in-hospital
death (B) are shown for various
prespecified subgroups among
those with cardiac perforation
compared with those without
cardiac perforation. All odds
ratios are adjusted for the
same covariates listed in
Figure 1. The dashed vertical
line in each panel represents
the adjusted odds ratio of
the adverse outcome for
the entire cohort, and the
horizontal error bars denote
95% confidence intervals. All
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interaction P values exceeded

0.05. CRT-D indicates cardiac
resynchronization therapy with
defibrillator; ICD, implantable
cardioverter-defibrillator;
and LVEF, left ventricular
ejection fraction.

implanter experience was protective against cardiac perfo-
ration risk, the latter being consistent with previous studies
evaluating complications during ICD implantation.16
Because the ICD Registry began collecting lead char-
acteristics only after April 1, 2010, we were limited in our
investigation of the association between right ventricular
defibrillation lead characteristics and cardiac perforation. In
multivariable analysis, implantation with a smaller diameter
right ventricular lead was associated with an increased cardiac
perforation risk. It is plausible that a smaller diameter lead tip
results in more force per unit area of myocardium, predispos-
ing to myocardial perforation. Interestingly, no differences
by fixation type (active versus passive) were observed. These
findings suggest that the design and composition of the right
 Hsu et al   Cardiac Perforation and ICD Adverse Events   589
ventricular lead may be an independent determinant of car-
diac perforation risk, apparently driven primarily by the lead
diameter.
The absolute difference in major associated complications
and mortality between ICD recipients with cardiac perforation
versus those without perforation was profound (7.4% versus
0.3% and 5.6% versus 0.4%, respectively), suggesting that
many acute problems associated with new ICD implantation
may ultimately be related to cardiac perforation. Consistent
with these findings, the median length of stay was markedly
longer in those with perforation (4 days versus 1 day). The con-
siderably greater odds of adverse events in those with cardiac
perforation was consistent across all 3 outcomes studied, per-
sisted despite adjustment for potential confounders, and was
not different across prespecified subgroups. These increased
risks have important ramifications relevant to patients and
practicing physicians, particularly as such major complications
and longer hospital stays likely adversely affect patient quality
of life and translate into increased healthcare utilization and
costs. If indeed cardiac perforation is at the core of the major-
ity of acute complications that occur in new ICD implants
and the lead characteristics influence that risk, these data may
inform lead manufacturers to be even more vigilant in ensur-
ing the safety of lead implant procedures. In addition, knowl-
edge that cardiac perforation is associated with a considerably
increased risk of adverse events may allow for more aggres-
sive treatment in those who experience the complication (such
as intensive care unit monitoring) to avert further morbidity
and mortality. By distinguishing easily recognizable predic-
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tors of cardiac perforation identified in this study, implanters
may be better able to counsel patients about their risks, better
able to quantify that risk, and may alter their approach (such
as placing fewer total leads) in those most vulnerable. Further
research into the mechanisms of novel predictors found to be
associated with cardiac perforation in our study is warranted,
particularly on the association of left bundle branch block and
increased LVEF with a higher cardiac perforation risk, as well
as the association of atrial fibrillation and diabetes mellitus
with a lower cardiac perforation risk. Specifically, now that
these covariates have been identified, other device registries
as well as prospective studies might consider special efforts to
make sure these covariates are included on case report forms.
Although some of these effects may be specific to ICDs, it is
likely that the mechanisms may extend to pacemakers (and
therefore studies of pacemakers) as well.
Study Limitations
Our study has several limitations. First, our analyses were
limited to adverse events during the index hospitalization
and may not be generalizable to patients who experience late
cardiac perforations after leaving the hospital. However, pre-
vious studies have shown that the majority of complications
from ICD implantation are recognized before discharge.17
Second, cardiac perforation occurred in a small proportion
(0.14%) of all ICD recipients but included >600 patients,
providing ample power to perform the analyses described.
In addition, a lack of power should not result in spurious
false-positive associations. Third, we do not have intraproce-
dural or postprocedural information about the type/implant
location of the lead that caused the cardiac perforation. That
dual-chamber ICD and cardiac resynchronization therapy
with defibrillator systems were associated with a higher
perforation risk than single-chamber ICD systems suggests
that atrial and coronary sinus leads were responsible for at
least part of the cardiac perforation risk. Furthermore, the
nature of the ICD Registry, with limited data fields, did not
allow further investigation into the means of cardiac perfo-
ration detection or the clinical presentation of the compli-
cation. Fourth, also because of the limitations inherent to
the ICD Registry, we were not able to assess the impact of
several covariates previously associated with cardiac perfo-
ration during pacemaker implantation, including echocardia-
graphic parameters, specific procedural characteristics such
as fluoroscopy times, and use of a temporary pacemaker.11
Fifth, although body mass index may theoretically be impor-
tant, this covariate was not available in the majority of the
cohort, and our previous analysis focusing on body mass
index failed to detect a statistically significant association
with cardiac perforation.18 Sixth, we cannot rule out report-
ing bias as an explanation for the association found between
cardiac perforation and other associated complications; for
example, hospitals more likely to report cardiac perfora-
tion as a complication may also be more apt to report other
complications. Finally, as with any observational study, we
cannot exclude the possibility that residual confounding
explains our results. However, our extensive multivariable
adjustment did not meaningfully change any of our results,
and it seems unlikely that an unmeasured confounder could
explain the magnitude of the adverse events associated with
cardiac perforation.
Conclusions
In a large, national registry of first-time ICD recipients, specific
patient and implanter characteristics predicted an increased
cardiac perforation risk. Cardiac perforation from implanta-
tion was associated with a substantially increased risk of other
major in-hospital complications, prolonged hospitalization,
and death. These findings help to inform implanting physi-
cians about readily identifiable baseline characteristics that
may predispose to cardiac perforation and therefore warrant
cautionary measures. These results also highlight and quan-
tify the magnitude of specific adverse events associated with
cardiac perforation.
Sources of Funding
This research was supported by the American College of Cardiology
Foundation’s National Cardiovascular Data Registry. The views ex-
pressed in this article represent those of the authors and do not nec-
essarily represent the official views of the NCDR or its associated
professional societies identified at www.ncdr.com. The ICD Registry
is an initiative of the American College of Cardiology Foundation and
the Heart Rhythm Society.
Disclosures
Dr Dewland has received educational travel grants from Medtronic
and Boston Scientific. Dr Curtis has modest ownership in Medtronic
and receives salary support from the American College of Cardiology
NCDR. Dr Marcus receives research support from Medtronic. The
other authors report no conflicts.
 590   Circ Cardiovasc Qual Outcomes   September 2013
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