Canadian Journal of Cardiology 34 (2018) 1026e1032

Clinical Research
Cardiac Implantable Electronic Device Infection: Detailed
Analysis of Cost Implications
Edouard Gitenay, MD,a Franck Molin, MD,b Sebastien Blais, BAA, MBA,c
Veronique Tremblay, AMA,c Philippe Gervais, MD,d Benoit Plourde, MD,b Frederic Jacques, MD,e
Christian Steinberg, MD,b Jean-François Sarrazin, MD,b Éric Charbonneau, MD,e
Helène Parent, RN,b Gilles E. O’Hara, MD,b Jean Champagne, MD,b and
François Philippon, MDb
a
Service de cardiologie, Hôpital Saint Joseph, Marseille, France
b
Electrophysiology Division, Institut Universitaire de cardiologie et de pneumologie de Que bec, Que bec, Canada
c
Clinical and Organisational Performance Division, Institut Universitaire de cardiologie et de pneumologie de Que bec, Que bec, Canada
d
Infectious Disease Division, Institut Universitaire de cardiologie et de pneumologie de Que bec, Que bec, Canada
e
Cardiac Surgery Division, Institut Universitaire de cardiologie et de pneumologie de Que bec, Que bec, Canada

ABSTRACT 
RESUM 
E
Background: Infections of cardiac implantable electronic devices Introduction : Les infections lie es aux dispositifs cardiaques
(CIED) are associated with significant morbidity and mortality. Despite lectroniques implantables (DCEI) sont associe
e es à une morbidite  et à
many preventive measures, this condition is associated with significant une mortalite  significatives. En de pit des nombreuses mesures
costs for the health care system. preventives, ce problème est associe  à des coûts importants pour le
Methods: We retrospectively analyzed all infection cases referred for système de soins de sante .
lead extraction at a single university hospital over 1 year (2015-2016). Me thodes : Tous les cas d’infection oriente s pour l’extraction de
We then calculated all costs related to the infection episode per pa- sondes d’un seul hôpital universitaire durant 1 an (2015-2016) ont fait
tient using hospital databases and charts review. l’objet d’une analyse re trospective. Nous avons ensuite calcule  tous les
Results: Thirty-eight patients with CIED infections (29% womendmean coûts lies à l’episode d’infection par patient à partir des bases de
age 71
14 years) were referred for lead extraction (27 pocket in- donne es et de la revue des dossiers de l’hôpital.
fections, 11 endocarditis). Devices were mainly pacemakers (60%). Resultats : Trente-huit patients ayant une infection lie e au DCEI (29 %
When the pathogen was identified, Staphylococcus aureus methicillin de femmes, âge moyen de 71
14 ans) ont e  te
 oriente
s pour l’ex-
sensitive was the main cause. Extraction was performed in all but 3 traction de sondes (27 infections de la logette, 11 endocardites). Les
cases (92%). One death occurred in the nonextracted group. Respective dispositifs etaient principalement des stimulateurs cardiaques (60 %).
durations of hospitalization and intravenous and antibiotic administra- Lors de l’identification du pathogène, le staphylocoque dore  sensible à
tion for patients undergoing extraction were 21 and 36 days. The la meticilline repre
sentait la principale cause. Tous les cas subissaient

Infection is a major complication of cardiac implantable
electronic device (CIED) implantation and is associated with
significant morbidity and mortality.1 The incidence and costs
Received for publication February 10, 2018. Accepted May 1, 2018.
Corresponding author: Dr François Philippon, Electrophysiology Divi-
sion, Institut Universitaire de cardiologie et de pneumologie de Quebec, 2725
Chemin Ste-Foy, Quebec, Quebec G1V 4G5, Canada. Tel.: þ1-418-656-
8711; fax: þ1-418-656-4581.
E-mail: francois.philippon@fmed.ulaval.ca
See page 1031 for disclosure information.
associated with CIED infections are growing. Many risk fac-
tors have been identified, such as multiple leads, diabetes,
renal and respiratory failure, chronic steroid use, early rein-
tervention, hematomas, fever in the preceding 24 hours, and
use of a temporary pacing lead.2-4 Patients with chronic im-
plants (more than 1 year after their first implantation) are
usually referred to a specialized extraction team because the
extraction will require special tools and a cardiac surgery
backup in most instances.5
A small number of studies looked at the economic burden
of CIED infection in the United States6 and the United
Kingdom.7 None of these studies included all cost associated

https://doi.org/10.1016/j.cjca.2018.05.001
0828-282X/Ó 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
Gitenay et al.
Cardiac Implantable Electronic Device Infection
calculated mean total cost for CIED infection management was
CAD$29,907 (median: 26,879; range: CAD$4,827-$62,585). Mean
hospital charges were CAD$12,291, accounting for 41% of the total
costs.
Conclusions: This study represents the first analysis of the direct costs
associated with lead extraction in Canada. Device infections are
associated with significant costs and increased morbidity. Any pre-
ventive measure will have a significant impact on the economic burden
of the health care system and patient outcome after lead extraction.
with the infection episode and mainly looked only at hospi-
talization charges.
We aimed to calculate all costs associated with CIED
infection episode management over 1 year in a tertiary care
facility in the province of Quebec (Canada), including costs
related to the hospitalization in the referral hospitals before
and after infection management (medical or extraction).
Methods
Population
All patients with chronic implants referred for lead
extraction/explant for infection at the Institut Universitaire de
cardiologie et de pneumologie de Quebec (IUCPQ) were
retrospectively reviewed from the period of May 2015 to May
2016. Lead extraction was defined according to the 2017
Heart Rhythm Society (HRS) guidelines: “Lead removal
procedure where at least one lead removal required the assis-
tance of equipment not typically employed during lead im-
plantation or at least one lead was implanted for greater than1
year.” Lead explant refers to: “Lead removal procedure where
all leads were removed without tools or with implantation
stylets and all removed leads were implanted for less than 1
year.”5 The lead extraction database was used and cross-linked
with medical records to identify patients referred for device
and/or lead infection. All charts were reviewed by 1 member
of the lead extraction program to ensure proper collection of
the investigation, techniques used, and individual manage-
ment for each patient.
Patients with more than 1 previous intervention on their
pocket and/or cardiac resynchronization procedures (CRT)
were identified as “high risk” individuals.2
Lead extraction
The IUCPQ is the only referral center for lead extraction
for a catchment area of 2.5 M Canadians (Center and East of
the Province of Quebec and some referrals from New
Brunswick). Our lead extraction team performs 70 to 100
cases per year, 30% to 35% of cases being referred for
infection (comparable with others at 30%);4 all other cases are
for lead management issues (vascular access, debulking, advi-
sories, CRT upgrades, etc).
1027
l’extraction, excepte 3 (92 %). Un de cès est survenu dans le groupe
n’ayant pas subi l’extraction. Les dure es d’hospitalisation et d’admi-
nistration d’antibiotiques par voie intraveineuse chez les patients
subissant l’extraction etaient respectivement de 21 et de 36 jours. Les
coûts totaux moyens de la prise en charge des infections lie es aux
DCEI s’elevaient à 29 907 $ CA (me diane : 26 879 $ CA; e tendue :
4 827 $ CA-62 585 $ CA). Les frais hospitaliers moyens e taient de
12 291 $ CA, soit 41 % des coûts totaux.
Conclusions : L’e tude represente la première analyse des coûts di-
rects associes à l’extraction de sondes au Canada. Les infections liees
aux dispositifs sont associe es à des coûts importants et à une mor-
 accrue. Toute mesure pre
talite ventive aura des repercussions impor-
tantes sur le fardeau e conomique du système de soins de sante  et sur
volution de l’e
l’e tat de sante  des patients après la proce dure
d’extraction.
The lead extraction procedure was planned in advance as a
Heart Team approach including the cardiac surgeon on backup,
the electrophysiologist performing the lead extraction, the
anesthesiologist, and the nurse team. All imaging was reviewed
and sometimes additional investigation performed (cardiac
computed tomography, etc). All lead extraction procedures
were performed in a cardiac operating room suite by 1 trained
electrophysiologist with direct access to a cardiac surgery team
(2 trained electrophysiologists performed all lead extractions
during that period). Most procedures were performed under
general anesthesia and transesophageal echocardiography
monitoring and a sternal saw and cardiopulmonary bypass
circuit ready. In some high-risk extraction procedures, the
cardiac surgeon was scrubbed or present in the operating room.
The lead extraction procedure was performed using a stepwise
approach, starting with locking stylets and then moving to laser,
mechanical sheaths, or femoral stations as required.8
Economic data
To determine all the IUCPQ direct charges, a software
solution (MAGIC: “Module d’Aide à la Gestion de l’Infor-
mation Clinique”dcost per patient module; Logibec,
Quebec, Canada) was used. “Module d’Aide à la Gestion de
l’Information Clinique” is a software solution that recreates
the complete clinical and financial portrait of any health care
organization. It works by integrating and linking raw data
from multiple source systems (operating room, ward system,
laboratory, etc) within the hospital. It is also a patient-level
information costing solution that analyzes the relationship
between performed activities and dollars spent. The activity-
based costing methodology used is based on a bottom-up
costing approach that focuses on assigning resource use and
the costs incurred by individual patients. It enables the pro-
duction of a complete patient bill based on the real services
consumption during a specific health-related episode.
We also included costs associated with hospitalization and
investigation before patient transfer to IUCPQ (mostly length
of stay). These costs were calculated by reviewing all medical
charts and obtaining data from referral physicians. For
patients referred from New Brunswick, we assumed compa-
rable per diem costs using Quebec fees.
Physician (MD) fees using the RAMQ (Regie de L’Assurance
Maladie du Quebec) fee schedule included consultations,
1028 Canadian Journal of Cardiology
Volume 34 2018

surgeries, anesthesiology, and echocardiographic and nuclear Table 1. Population characteristics

imaging (positron emission tomography [PET] or tagged leu- N %
cocyte scan) readings. Medical visits were calculated on the basis Population 38 100
of 1 electrophysiology consultation during the index hospitali- Medical conditions
zation and 1 cardiology visit per day. One infectious disease Diabetes 15 39
specialist consultation and one daily visit were included, because Heart failure* 21 52
all patients admitted for a lead extraction related to CIED Mean LVEF (%) 43
14
Renal failurey 15 39
infection are followed by a heart team at our institution Mean creatinine clearance (mL/min/1.73 m2) 68
22
including infectious disease specialists. Anemiaz 20 53
Mean Hb level (g/L) 122
18
Statistical analysis BMI  30 14 37
Mean BMI (kg/m2) 28
5
All results are presented as mean or median numbers with Prior cardiac surgery 12 32
range, confidence intervals, and standard deviations. Costs are Pacemaker dependent 13 34
CIED type
presented in Canadian Dollars. Pacemaker 23 61
ICD 6 16
CRT-P 1 3
Results CRT-D 8 21
Procedure before infection
Population and clinical outcomes Primo implant VVI/DDD 9 24
Primo implant CRT 2 5
From May 2015 to May 2016, 38 patients were referred Generator replacement or repositioning/explant 11 29
for CIED infection. There were 11 women (29%) with a Generator replacement þ lead replacement or 14 37
mean age of 71
14 years. Eleven (29%) had systemic repositioning
CRT upgrade 2 5
infection (bacteremia, positive lead culture or positive nuclear Number of leads
imaging on the leads); the other 27 cases (71%) were pocket 1 3 8
infections. The main characteristics of the population are 2 18 47
summarized in Table 1. The number of leads per patient 3 13 34
ranged from 1 to 5. 4 2 5
5 2 5
Seventy-six percent (76%) of our population was consid-
ered “high risk” for infection. BMI, body mass index; CIED, cardiac implantable electronic devices;
The mean number of procedures before CIED infection CRT, cardiac resynchronization therapy; DDD, dual-chamber pacemaker;
Hb, hemoglobin; ICD, implantable cardioverter defibrillator; LVEF, left
was 2 and median time since last surgery was 268 days (range:
ventricular ejection fraction; VVI, single-chamber pacemaker.
19-5545 days) for pocket infections and 1443 days (range: 37- * LVEF < 50%.
2478 days) for systemic infections. y
Creatinine clearance  60 mL/min.
Staphylococcus aureus methicillin sensitive (34% of all pa- z
Hemoglobin level < 120 g/L.
tients) was the common pathogen in systemic infections, and
coagulase-negative staphylococci were responsible for up to for complex lead and device extraction (97-year-old frail
40% of pocket infections. Streptococci were identified in 4 of woman with severe dementia and 87-year-old patient with
11 patients with sepsis where staphylococci (17/27: 63%) were terminal heart failure, pacemaker dependency, 20-year-old
most often identified in pocket infection cases (Fig. 1A). leads, dual coil, and left ventricular leads who subsequently
Amongst the 11 patients with septicemia, the source of died in palliative care).
infection was the pocket in 2 patients, a newly diagnosed In the “extraction group” (35 patients), median time from
colorectal carcinoma in 1 patient, and remained unknown at first implant was 8.8 years (range: 0.12-41.5 years) and
the time of management in the other 8 patients. Two patients complete extraction could be performed in all but 2 cases
presented with septic shock associated with Staphylococcus (94%). These 2 patients had lead implanted for 12 and 17
aureus methicillin sensitive and streptococcus (salivarius and years before extraction, and only small distal lead fragments
sanguinis) infections. were left in place and were not associated with persistence of
neither infection nor a surgical indication, leading to a clinical
Investigation and management
success of 100%. There was no death in the “extraction”
During the investigation before lead extraction, 42% of the group, whereas 1 of the 3 patients in the “medical” group
38 patients had undergone nuclear imaging (PET or tagged died. Complications observed during the index hospitalization
leucocytes scan). included transient acute renal failure (16%), acute heart fail-
Main management outcomes are depicted in Table 2. ure (5%), systemic embolization (10% dwith half of them
Extraction was performed in all but 3 cases (92%): 1 patient being identified before lead extraction), 1 thrombophlebitis
was treated with antibiotics without extraction. This 77-year- and 1 traumatic severe tricuspid regurgitation requiring open
old patient with pocket erythema, negative blood cultures, heart surgery.
and equivocal PET scan had clinical and radiological resolu- The extraction procedures were performed in a cardiac
tion after 3 weeks of intravenous vancomycin. Interestingly, operating room suite under general anesthesia (82%) and
this patient remained without any clinical event after 14 TEE guidance (79%). Specialized extraction tools were used
months of follow-up. Two patients were deemed noneligible in most patients and are detailed in Figure 1B. The mean
Gitenay et al. 1029
Cardiac Implantable Electronic Device Infection

Table 2. Investigation and outcomes

N %
Population 38 100
Nuclear imaging 16 42
Strategy
Extraction 35 92
No extraction 3 8
Procedural outcomes (Extraction group) 35 100
Death 0 0
Emergency surgery 0 0
Complete extraction 33 94
Incomplete extraction 2 6
Follow-up
Death 1 3
Septic shock 2 5
Epicardial reimplantation 5 13
Temporary wire after extraction 10 26
Acute renal failure 6 16
Acute heart failure 2 5
Systemic embolization 4 10
Tricuspid surgery 1 3
Thrombophlebitis 1 3
Hospitalization duration (mean no. of days)
Total 21
Pocket infections 14
Systemic infections 35
Antibiotic administration (mean no. of days)
Figure 1. (A) Microbiology description. (B) Extraction strategies. Tolls Total 36
required performing lead extraction. GNB, gram negative bacteria; Pocket infections 25
Systemic infections 59
SAMS, staphylococcus methicillin sensitive; SARM, staphylococcus
resistant to methicillin; STAPH COAG NEG OXA R, staphylococcus
coagulase negative resistant to oxacillin; STAPH COAG NEG OXA S,
staphylococcus coagulase negative sensitive to oxacillin; TEE, trans- Costs were higher for implantable cardioverter de-
esophageal echocardiography. fibrillators (ICDs) ($36,296), CRT devices ($35,386), and
systemic infections ($30,579) (Supplemental Fig. S1).
In the high-risk group (29 patients: 76%), the mean total
procedure duration was 71
76 minutes, and the mean
cost was $30,974
$15,896 compared with $26,473

fluoroscopy time and dose were 7.2
10 minutes and 2.2

$12,696 in the low-risk group.
3.2 mGy/m2, respectively.
The mean in-hospital length of stay was 21 days (median
16, range: 7-78 days). The mean duration of antibiotic Discussion
administration was 36 days (median 30, range: 9-126 days, To our knowledge, this study is the first to depict the
including both inpatient and outpatient durations). formal cost analysis of the burden of CIED-related infections
in Canada.
Reimplantation
Comparison to previous related studies
Of the 35 extracted patients, information about reimplant
was available in 28 patients (some were transferred back to Among our population, many had established infection
their regional hospital after extraction). In 7 patients with risk factors including diabetes (39%), renal failure (39%), and
previous sinus node dysfunction and now in permanent atrial systolic heart failure (52%). The last procedure performed
fibrillation, no reimplantation was required. Reimplantation before infection was a generator replacement combined with
was performed after the extraction during the index hospi- right atrial or right ventricular lead repositioning or addition
talization in 17 patients (median time from extraction to in 37%, similar to others.2
reimplant 7.7 days) and reimplantation was performed elec- Complete device/lead extraction was achieved in 33 of 35
tively in 4 cases (mean time from extraction to reimplant 46
patients (94%). Two had minimal residual material left in
16 days). place who never required open heart surgery for recurrent or
uncontrolled infection (clinical success in 100%). These rates
are comparable with the usual outcomes from experienced
Cost analysis
centers using mechanical or laser sheaths.9
The mean total cost for CIED infection management was As extraction was performed in 35 of 38 patients (92%)
$29,907. The median cost was $26,796 with a range from referred, our rate of extraction was higher than the US data-
$4827 to $62,585 (Fig. 2A). bases (59% to 77% according to Sridhar et al.4) and the recent
The main expenditure item (Fig. 2B) was hospitalization Greenspon cohort.10 It could be explained in part by the bias
charges (mean $12,291 per patient), followed by reimplan- to refer only patients for lead extraction at our center. We
tation ($8413), physician fees ($4326), and extraction mate- cannot account for patients not referred and kept under
rial fees ($2247). medical treatment in referral hospitals and for patients with
1030
Figure 2. (A) Individualized costs per patient. Costs for each patient
included in the analysis, in Canadian dollars. (B) Detailed cost anal-
ysis. MD, physician fees.
early infections where the explant could be performed in
nontertiary care centers.
Lead extraction was performed using a stepwise approach
using either mechanical or laser sheaths in up to 80% of our
extraction cases (48.6% for laser sheaths). Even with this high
percentage, only 8% of the total costs in our study were
associated with the use of those tools.8
The average length of stay was 21 days in our population
(14 days for pocket infections and 35 days for systemic in-
fections). In the Sohail et al.1 study in the United States, the
length of stay ranged from 16 to 24 days. Sridhar et al.4
reported a mean of 14 days. Thus, our population is com-
parable with other published cohorts.1,4
Economic burden
Most other studies from the United States or the United
Kingdom reported only on hospitalization costs or incre-
mental costs of an infection but have not analyzed the total
health care cost of an infection episode per patient such as in
our study.6,7,11,12
Our total average cost for CIED infection management per
patient was $29,908. This is significantly lower than previous
studies from the United States (between USD$45,500 and
USD$173,000)1,4 and slightly lower than those from the
Ahsan et al.7 study in the United Kingdom (£30,958). Of
note, Sohail et al.1 reported a cost of USD$45,500 based on
estimated hospital costs derived from reported charges using a
cost-to-charge ratio. This model appears to be more
Canadian Journal of Cardiology
Volume 34 2018
comparable to the Canadian health care system than the
Sridhar model (USD$173,000) where they used hospital
charges billed to the insurer/payer.4 A recent cohort of 5401
Medicare fee-for-service beneficiaries showed a cost of
USD$62,638 when they had a device replacement after
extraction and USD$50,079 when not replaced. Hospitali-
zation was the largest cost driver similar to our study.10
Generalizability
Direct comparison between health care systems is difficult
because reimbursement to hospitals, physician fees, cost of
material to perform lead extraction, and cost for reimplanta-
tion of pacemaker or implantable defibrillator and resynch-
ronization therapy after extraction are quite different. Our
analysis represents the first to calculate all the direct cost
imposed on our hospital budget compared with reimburse-
ment from a private or semiprivate insurance company in
other jurisdictions. Our Heart Team approach could also
explain the high success rate and low mortality observed and
may reduce the overall management costs. Our strategy to
discharge patients earlier with intravenous antibiotic admin-
istration at home (ATIVAD) could also reduce the hospital-
ization costs. Of note, we included the costs associated with
the ATIVAD strategy in our cost calculation.
According to the Canadian Institute for Health Informa-
tion,13 our institute has one of the lowest costs for a standard
hospital stay in Canada. In 2015-2016, the mean Canadian
costs were $6098 and our institution averaged $3967
(Fig. 3A). In comparison with other institutions performing
lead extraction across Canada, our institute also has one of the
lowest costs for a standard hospital stay ($3967 compared
with a range from $3967 to $8229) (Fig. 3B). This could also
impact on the total average cost in our population.
Some costs could not be integrated into our analysis such
as fees for rehabilitation facilities, indirect costs for families,
loss of productivity for patients, and loss of quality of life. In
addition, the mid-term morbidity and mortality after infection
is still increased in this population after 5 years, and these
additional costs were not captured in our study.14
Limitations
Our study has several limitations. First, we present a small
sample size of only 38 patients, and there may be greater cost
variations in larger populations referred for device infections.
Second, our cost calculation is limited to the first 12 months
after the index hospitalization/lead extraction, and it is likely
that ongoing morbidity and mortality may generate more costs
in some individuals. The loss of follow-up of 7 patients may
have resulted in a cost underestimation, as those individuals
could have undergone reimplantation of a CIED at a different
center. However, because our institution is the exclusive ICD
and CRT implanting center for the entire catchment area, those
potential reimplantations would have been standard single- or
dual-chamber pacemakers (less expensive devices). We may
have missed additional costs, for example, fees related to pre-
vious emergency room consultations or appointments with the
family physician. Other costs not included in our calculation
include transfer to a rehabilitation or chronic care facility. Pa-
tient families incurred additional costs that are difficult to
measure and to include in this analysis. It is therefore possible
Gitenay et al.
Cardiac Implantable Electronic Device Infection
Figure 3. (A) Costs of a standard hospital stay/Canadian Institute for
Health Information (CIHI). Costs of a standard hospital stay according
to CIHI for Ontario, Quebec, overall in Canada and IUCPQ (Institut
universitaire de cardiologie et de pneumologie de Quebec). (B) Costs
of a standard hospital stay/CIHI/extracting centers. Costs of a stan-
dard hospital stay according to CIHI for IUCPQ and other comparable
heart centers performing lead extraction in Canada (centers A to G).
that our cost calculation is conservative and that the true costs
for the health care system are higher.
Clinical implications
To our knowledge, this is the first study to report direct
costs associated with lead extraction for infection in the
Canadian health care system. Interestingly, the highest
expenditure goes to the hospitalization and the reimplantation
costs similar to other jurisdictions. In fact, the hospitalization
costs at an average of $12,291 are twice the Canadian costs for
a standard hospital stay ($6098). Thus, strategies to shorten
the length of stay and to prevent CIED infections are most
important to reduce charges and to improve cost effectiveness
and morbidity.
Patients derive important benefits from such technologies
(pacemakers, defibrillators, CRT) decreasing their mortality
and increasing their quality of life. The counterpart is the
increasing risk of infection over time and we should increase
our efforts towards prevention.
Strategies to prevent CIED infections such as incremental
antibiotic regimens (Prevention of Arrhythmia Device Infec-
tion Trial [PADIT] trial, NCT01628666)15 or the use of an
absorbable antimicrobial envelope (World-wide Randomized
1031
Antibiotic Envelope Infection Prevention Trial [WRAP-IT]
trial, NCT02277990)12 will soon be presented and could
have a real impact on the cost burden and morbidity/mortality
associated with device infections.16 Our data can contribute to
the development of cost effectiveness strategies because
knowledge of the cost burden associated with CIED infection
is the most important variable in such models.
Conclusions
CIED infection is associated with significant morbidity
and high cost burden. A conservative cost calculation is at least
$30,000 per patient. The significant morbidity/mortality and
cost burden of CIED infections emphasize the importance
and need of improved strategies to prevent cardiac implantable
device infections.
Funding Sources
The “Fondation de l’Institut Universitaire de cardiologie et
de pneumologie de Quebec” awarded a grant for this work.
Disclosures
The authors have no conflicts of interest to disclose.
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Supplementary Material
To access the supplementary material accompanying this
article, visit the online version of the Canadian Journal of
Cardiology at www.onlinecjc.ca and at https://doi.org/10.
1016/j.cjca.2018.05.001.