- Email: [email protected]
Outcomes of Standard Permanent Active Fixation Leads for Temporary Pacing
JACC: CLINICAL ELECTROPHYSIOLOGY
VOL.
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ª 2020 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER
Outcomes of Standard Permanent Active Fixation Leads for Temporary Pacing Ralph Cipriano, MD,a Ashwani Gupta, MBBS,a Faiz Subzposh, MD,a James A. McCaffrey, MD,a Eduard Koman, MD,a David Fridman, MD,a Heath Saltzman, MD, FHRS,a Steven P. Kutalek, MD, FHRSa ABSTRACT OBJECTIVE This study investigated the performance of Temporary Pacing via an Externalized Active-Fixation (TPEAF) lead. BACKGROUND The incidence of cardiac implantable electronic device infections is increasing, which necessitates the need for transvenous lead extraction (TLE). Pacemaker-dependent patients require temporary pacing during the guidelinerecommended waiting period before reimplantation. Data regarding safety and efficacy of TPEAF leads are very limited. METHODS We evaluated patients implanted with TPEAF leads post-TLE at our center between April 2004 and December 2017. RESULTS TPEAF leads were placed in 158 patients. The mean age was 74 11 years. The median duration of the temporary lead was 6 days (range 1 to 29). There were 4 procedural complications (2.5% incidence): 1 patient had cardiac arrest from hyperkalemia, 2 developed cardiac tamponade, and 1 had profuse bleeding from the entry point of the leads. There were 13 complications post-implantation (8.2% incidence): 8 lead dislodgments, 1 elevated pacing threshold, 2 vegetations on the temporary lead, 1 pneumothorax, and 1 loss of capture due to the generator “safety switch”. All dislodgements occurred within 24 h, except 1 on day 3. Sixteen patients died during the hospital stay: 10 due to septic shock, 2 due to hyperkalemic cardiac arrest, 3 due to ventricular tachycardia, and 1 due to a massive cerebrovascular accident. CONCLUSION The use of TPEAF leads is safe and efficacious in pacemaker-dependent patients post-TLE. Dislodgement can occur within the first 24 h. The presence of persistent fever and positive blood cultures should raise concern for vegetation on the temporary lead. (J Am Coll Cardiol EP 2020;-:-–-) © 2020 by the American College of Cardiology Foundation.
T
he incidence of Cardiac Implantable Elec-
especially lead dislodgement (6). Because of this,
tronic Device (CIED) infection has been
our center uses Temporary Pacing via an Externalized
constantly increasing due to increased im-
Active Fixation (TPEAF) lead connected to an exter-
plantation rates (1–3). Current guidelines recommend
nalized pulse generator as the standard practice.
a complete removal of the infected CIED system,
Data regarding the efficacy and outcomes of this prac-
along with the appropriate antibiotic therapy (4).
tice are very limited. We report a single, high-volume
The total duration of antibiotic therapy usually
center experience with the implantation of TPEAF
ranges between 2 and 6 weeks; however, the implan-
leads after transvenous lead extraction (TLE).
tation of a new CIED system is usually delayed for at least 72 h for localized pocket infection and up to
METHODS
14 days for systemic infection with evidence of a valvular vegetation (5). Temporary pacing is required
Our institution maintains a comprehensive database
in pacemaker-dependent patients during this waiting
of all patients who undergo device lead extraction.
period. The traditional balloon-tipped pacing cathe-
We queried our database and identified all patients
ters are associated with high complication rates,
requiring TPEAF lead implantation after TLE at our
From the aDepartment of Cardiology, Drexel University College of Medicine, Philadelphia, Pennsylvania. Dr. Kutalek is a consultant for Spectranetics Corp., St Jude Medical, Boston Scientific, Medtronic, and Sorin. Dr. Saltzman has received speaking/ training honoraria from Boston Scientific, Biosense Webster, Sorin, and Zoll. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page. Manuscript received April 1, 2019; revised manuscript received October 28, 2019, accepted October 31, 2019.
ISSN 2405-500X/$36.00
https://doi.org/10.1016/j.jacep.2019.10.022
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ABBREVIATIONS
center between April 2004 and December
was performed in all of the patients after TLE, unless
AND ACRONYMS
2017. All leads used were active fixation, bi-
contraindicated. An infectious disease evaluation was
polar leads. The patients defined as ‘pace-
obtained for all of the patients to aid antibiotic choice
maker dependent’ were those with complete
and duration, as well as decisions regarding timing
heart block, high-grade atrioventricular (AV)
and reimplantation of the new device.
AV = atrioventricular CIED = cardiac implantable electronic device
block, or patients with marked sinus brady-
PPM = permanent pacemaker
cardia.
RV = right ventricle
The
data
regarding
patient
de-
mographics, procedural details, efficacy and
TAVR = transcatheter aortic
complications of active-fixation leads, and
valve replacement
patient follow-up were collected retrospec-
TEE = trans-esophageal
tively.
echocardiogram
The
Institutional
Review
Board
approved the study.
TLE = transvenous lead extraction
PROCEDURE. After
TPEAF = temporary pacing via an externalized active fixation
VT = ventricular tachycardia
ANALYSIS. All data were entered in Microsoft Excel
(Redmond, Washington) and analyzed using SPSS (v22, SPSS, Chicago, Illinois). Continuous variables are expressed as mean standard deviation, median, or range. Categorical variables are displayed as frequency or proportions. Chi-square test or Fisher exact test was used to analyze categorical variables.
CIED
Continuous variables were compared using Student’s
infection was made per the current guide-
t-test for parametric data and Kruskal-Wallis rank test
lines (4), complete extraction of the system
for non-parametric data.
a
diagnosis
of
was undertaken in the electrophysiology
VF = ventricular fibrillation
laboratory. The choice of anesthetic modality
RESULTS
and agents was left to the discretion of the anesthesiologist. Femoral venous and arterial access was
A total of 158 patients (12.4% of total 1,275 proced-
obtained in all patients. In patients with complete
ures) underwent TPEAF lead implantation after TLE.
heart block, high-degree AV block, or significant sinus
Patient and device characteristics are shown in
node
was
Table 1. The mean age was 74 11 yrs (range 25 to 91
advanced under fluoroscopic guidance via a femoral
yrs). Mean implant duration of the extracted leads
venous sheath into the right ventricular (RV) apex for
was 68.1 59.7 months (range 1 to 309 months). The
pacing during the extraction procedure. A threshold
average number of leads extracted per procedure was
of less than 1 V was considered acceptable.
2.79 0.92 (median 3). Sixty-five patients (41.1%) had
dysfunction,
a
quadripolar
catheter
Vascular access site for the TPEAF lead placement
documented
bacteremia.
Seventy-five
patients
was determined at the operator’s discretion. A 7-
(47.5%) had undergone instrumentation in the device
French peel-away sheath was placed after obtaining
pocket within the year prior to TLE. Complete pro-
venous access and a TPEAF lead was advanced into
cedural success was achieved in 154 patients (97.5%).
either the right ventricle (Central Illustration) or right
Excimer laser was used in 51 patients (32.3%) and for
atrium. In this study, 98.7% of leads were placed in the
23.3% of leads. Four patients had complications dur-
right ventricle and 1.3% of leads were placed in the
ing the procedure: 1 patient had cardiac arrest due to
right atrium. The lead was secured with non-
hyperkalemia requiring cardio-pulmonary resuscita-
absorbable sutures to the skin and connected to
tion (and died 12 h after the procedure), 2 patients
either the recently removed pulse generator or a pre-
developed cardiac tamponade during the extraction
viously removed and sterilized pulse generator that
procedure (1 required pericardiocentesis only and 1
was required to have at least 6 months of projected
required thoracotomy), and 1 patient had profuse
battery longevity and no evidence of electrical mal-
bleeding from the entry point of the leads requiring
function. The selection of pacemaker leads was left to
repair by a vascular surgeon. Inotropic/pressor sup-
the operator’s discretion. The device was mostly pro-
port was required in 19 (12.0%) patients.
grammed to a VVI or VOO mode at 70 beats/min with
The most common access site for the TPEAF lead
an output of 5 V at a pulse width of 1 ms. The pace-
was the right internal jugular vein (96.8% patients).
maker pulse generator was usually sutured and
All the leads were placed in the RV apical septum,
anchored to the skin as well. The exposed lead and the
except for 2 cases, which required lead placement in
pulse generator were covered with Tegaderm dress-
the right atrial appendage for sick sinus syndrome
ings (Central Illustration). In all of the cases, the pa-
with intact AV nodal conduction. Median duration of
tient was transferred to the cardiac care unit for
the TPEAF lead was 6 days (range 1 to 29 days). There
further observation and management. All patients
was no periprocedural mortality related to the im-
remained hospitalized until device replacement.
plantation of TPEAF leads. However, there were 13
Blood cultures were drawn in all patients prior to
complications from these leads (8.2%; Table 2). Eight
the initiation of antibiotic therapy as well as after lead
patients had lead dislodgment (5 radiologically
extraction. A transesophageal echocardiogram (TEE)
confirmed lead dislodgements and 3 leads pulled out
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C ENTR AL I LL U STRA T I O N Temporary Active-Fixation Lead
Cipriano, R. et al. J Am Coll Cardiol EP. 2020;-(-):-–-.
(Left) Chest X-Ray (anterior-posterior view) demonstrating a temporary active-fixation lead implanted in the right ventricle via the right internal jugular vein access, and attached to an external pulse generator. (Right) Image demonstrating a temporary active-fixation lead inserted via the right internal jugular vein and attached to an external, sterilized pulse generator.
by delirious patients) resulting in loss of capture
reimplantation, 134 were endocardial (84.8%) and 12
requiring transcutaneous pacing. All lead dislodge-
were epicardial (7.6%). Twelve patients (7.6%) did not
ments except 1 occurred within the first 24 h post-
undergo reimplantation during the index hospitaliza-
procedure (1 patient had dislodgement on day 3).
tion. Of the 12 patients who did not undergo reim-
One patient developed elevated pacing threshold
plantation, 8 died prior to discharge, 1 was transferred
without lead dislodgement and 1 patient developed
back to the referring hospital with temp-wire in place, 1
pneumothorax requiring chest tube placement. Two
had removal of temp-wire prior to discharge due to
patients had persistent fever and bacteremia and
fungemia, 1 had removal of temp-wire due to dissem-
were found to have developed a vegetation on the
inated intravascular coagulation (DIC) and recurrent
TPEAF lead, which was seen by repeat TEE. One pa-
pocket hematomas precluding replacement of pace-
tient developed loss of capture on day 1 post-
maker, and 1 had removal of temp-wire with no plan to
implantation. Chest X-ray and cardiac fluoroscopy
replace pacemaker. Median hospital stay was 12 days
showed no evidence of lead dislodgment. Persistent
(range 1 to 168). Ninety-eight (62%) patients were dis-
capture at low threshold was obtained using the
charged to home, 23 (14.6%) to skilled nursing facility,
pacing system analyzer. On further device interro-
18 (11.4%) to a rehabilitation facility, and 16 (10.1%)
gation, it was found that the “safety switch” feature
patients died during the hospital stay. Ten patients
was programmed to “on” at the time of implantation.
died due to multi-organ failure due to septic shock, 3
The device (Insignia I Ultra, model # 1290, Boston
patients had ventricular tachycardia (VT)/ventricular
Scientific, Marlborough, Massachusetts) reverted to
fibrillation (VF) arrest, 2 patients had hyperkalemic
unipolar pacing due to variation in the lead imped-
cardiac arrest, and 1 patient died due to a massive ce-
ance and could not consistently capture due to an
rebrovascular accident. Of the 16 patients who died, 7
external pulse generator. The “safety switch” feature
underwent reimplantation prior to their death. Data
was then programmed to “off” and subsequently the
regarding long-term follow-up was limited given the
pacemaker began functioning without issue, elimi-
retrospective nature of the study. One hundred ten
nating the need to replace the unit. This event was
(69.6%) patients were alive at 30 days, however, 28
associated with no clinical consequences.
(17.7%) patients were lost to follow-up. Eighty-four
A new device was reimplanted in 146 patients (92.4%).
In
the
patients
who
underwent
(51.9%) patients were alive at 1 year, however, 42 (26.6%) patients by this point in time were lost to
3
4
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T A B L E 1 Patient and Device Characteristics
T A B L E 2 Complications From the Active-Fixation Lead
Patients (n ¼ 158)
Age (yrs)
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74.1 11.1
Race
Patients (n ¼ 158)
Lead dislodgement
8
Elevated pacing threshold
1
Caucasian
86.7
Vegetation on temporary lead
2
African American
12.7 0.6
Loss of capture due to reversion of device to unipolar configuration (safety switch)
1
Hispanic
Pneumothorax
1
Gender Male Female Body mass index (kg/m2)
70.9 29.1 27.1 5.8
Device type
(3.1%) had septic shock, 3 (1.9%) had gastrointestinal bleed, 3 (1.9%) had deep venous thrombosis, 3 (1.9%)
Single-chamber pacemaker
4.5
Dual-chamber pacemaker
45.2
Dual-chamber ICD
10.8
had pulseless electrical activity arrest, 3 (1.9%) had VT/ VF arrest, and 2 (1.3%) each had multi-organ failure,
3.2
pneumothorax, hyperkalemic cardiac arrest, or acute
Biventricular ICD
36.3
respiratory distress syndrome. The remaining com-
Total leads extracted
438
plications occurred once in the study population:
Biventricular pacemaker
Lead implant duration (months)
68.1 59.7
Temporary lead location Right atrium
Clostridium difficile colitis, hepatic encephalopathy, cardiogenic shock, cerebral vascular accident, aspira-
1.3
Right ventricle
98.7
Abandoned leads
18.1
Pocket site Left
84.2
Right
10.8
Both
5.1
tion pneumonia, genitourinary bleed, hemodialysis graft-related complications, DIC, pulmonary hemorrhage, cholangitis, severe tricuspid regurgitation, and anoxic encephalopathy.
DISCUSSION
Pocket location Prepectoral
94.9
The complication rate of the traditional balloon-
Subpectoral
5.1
tipped temporary pacing catheter has been reported
Previous lead extraction
5.7
Patient characteristics Diabetes mellitus
34.2
to be as high as 46%, with lead dislodgments being 1 of the most frequent culprits (6). Data regarding safety
Coronary artery disease
55.1
and efficacy of TPEAF leads are very limited. Epstein
Ischemic cardiomyopathy
39.2
et al. (7) reported no complications from leads in 62
Non-ischemic cardiomyopathy
20.9
patients. However, only 27 leads were implanted in
42.7 17.7
infected patients and only 13 leads were implanted
Hypertension
72.8
post-TLE. The risk of complications may be higher in
Peripheral vascular disease
15.8
Dyslipidemia
49.4
Chronic kidney disease (GFR <60 ml/kg/min)
48.1
Left ventricular ejection fraction (%)
GFR
60 31.4
these patients. Two publications in 2013 addressed the use of TPEAF leads post-extraction (8,9). However, these were small studies with 17 and 23 patients,
End-stage renal disease
8.2
respectively. They did not report any lead dislodge-
Prior cardiac surgery
36.7
ment and reported development of a vegetation on
Coronary artery bypass grafting
24.7
the temporary lead in 1 patient. Braun et al. (6) re-
Prosthetic valve
13.9
ported 1 lead dislodgement, 1 loss of sensing, and 1
Atrial fibrillation/flutter
55.7
Chronic obstructive pulmonary disease
25.9
patient with an elevated threshold of 23 patients
Obstructive sleep apnea
10.1
Left ventricular assist device Liver cirrhosis
0.6% 1.3
implanted with an active-fixation lead. Chihrin et al. (10) reported 1 patient with loss of capture 2 weeks after implantation of their first 20 patients. Thus far, data published on the use of TPEAF leads have been
Values are mean SD or n%. ICD ¼ implantable cardioverter-defibrillator; GFR ¼ glomerular filtration rate.
limited by small sample size. We report the largest series regarding the safety and efficacy of TPEAF leads implanted post-TLE. Our
follow-up. Complications, not procedure related,
series reports an 8.2% complication rate from these
occurred in 20.8% of patients during the hospital stay.
leads, which is higher than previously reported. Lead
Most patients had more than 1 complication. Apart
dislodgement was the most common complication
from death, 5 (3.1%) patients had acute kidney injury, 5
with an incidence of 5.1%, which is higher than
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published data with permanently placed leads (1.2%
anesthesia. Adequate nursing supervision must be
to 3.3% in various studies) (11,12) and was compared
provided during the recovery from anesthesia to
with dislodgement rates of 10% to 37% for balloon-
avoid this complication, especially in elderly patients
tipped catheters (6,8,13). However, 3 of the 8 dis-
who are more prone to delirium. One patient devel-
lodgments were caused by delirious patients pulling
oped loss of capture due to reversion to unipolar
out their temporary leads and, although they count
pacing from the “safety switch”. This feature detects
toward our dislodgment rate, they were not a proce-
changes in the lead impedance and reverts to a uni-
dural issue. The overall reduced incidence of lead
polar pacing configuration if any significant change is
dislocation using the TPEAF lead as compared with a
detected. Lead impedance changes are common
balloon-tipped pacing catheter, which has been re-
during the first few days after lead implantation and
ported in various studies (6,8,13) and confirmed in
reversion to unipolar pacing can occur, which will
our study, is 1 of the main advantages of this system
lead to loss of capture due to an external pulse
and lends support to it being the superior method of
generator. This feature must be programmed to “off”
temporary pacing in the pacemaker-dependent pa-
at the time of implantation.
tient. In addition, TPEAF leads can sometimes be more
cost-effective
than
traditional
From our experiences, several interventions un-
temporary
dertaken by the operator reduced the risk of
transvenous pacing by decreasing intensive care unit
dislodgement in our patients. We allowed for signif-
length of stay (10).
icant lead slack in the atrium in addition to the 3 to 4
The authors do recognize that these leads require an
coils of lead outside the body, which were then
implanting physician competent in the use of IS-1
secured with multiple layers of transparent adhesive
active fixation leads, whereas a balloon-tipped lead
dressing. Initially, we implanted the pulse generator
might be implanted by a broader range of physicians.
near the neck region, however, it allowed for more
However, it is likely that most patients undergoing
movement and we subsequently started positioning
TLE will be under the care of physicians who are
the pulse generator in the supraclavicular fossa to
comfortable with IS-1 active fixation lead implantation
minimize movement of the generator. The pulse
and all other equipment and personnel will usually be
generator is also sutured in place to reduce move-
available.
ment. The lead was secured to the skin with sutures
Patients with systemic infection requiring lead
around suture sleeves and the lead insertion site was
extraction and implantation of a temporary lead have
secured with a separate Biopatch at the insertion site.
a relatively low incidence of developing vegetations
In
addition
to
its post-extraction indication,
on the temporary lead. In our series, 2 patients
TPEAF leads have additional applications. These
developed vegetations on the temporary lead of a
include
total of 65 patients with bacteremia (3.1%). One pa-
(TAVR), for periprocedural bradyarrhythmia support,
transcatheter
aortic
valve
replacement
tient had persistent Methicillin-sensitive Staphylo-
transient bradyarrhythmia of other etiology, and
coccus aureus bacteremia. On post-operative day 2,
patients who require permanent pacemaker (PPM)
the patient underwent TEE that demonstrated vege-
implantation but have an active infection. Tempo-
tations on the temporary lead as it entered the right
rary pacing leads serve important procedural roles in
atrium and another large vegetation on the tricuspid
TAVR procedures, including support of periproce-
valve. The Cardiothoracic Surgery department was
dural conduction disturbances as well as rapid pac-
subsequently consulted and they placed an epicardial
ing for deployment of balloon-expandable valves
lead. The patient had a long and complicated hospital
(14,15). Webster et al. (16) reported on 25 patients (13
course that eventually ended with his decision to
TAVRs, 11 electrophysiologic procedures, and 1
pursue hospice care. The second patient developed
balloon aortic valvuplasty) who required temporary
persistent fevers on post-operative day 5 with Strep-
pacing as a procedural adjunct or periprocedural
tococcus mitis bacteremia. He also underwent epicar-
pacing support. Technical feasibility was achieved in
dial lead placement and eventually decided on the
23 cases (92%); 2 patients had unsuitable anatomy.
hospice route given multi-organ failure and poor
They reported no device-related complications or
prognosis. Persistent bacteremia or recurrent high-
failure to pace. This study used BioTrace Medical’s
grade fever should raise the suspicion of this
novel Tempo lead (BioTrace Medical, Menlo Park,
complication and a repeat TEE should be performed.
California)and a relatively small number of patients
We also report 2 complications that have not
had prolonged Tempo lead implantation (beyond 24
yet been reported in the published data. Three
h) (16). Leong et al. (17) described the use of tradi-
patients pulled out the TPEAF leads despite adequate
tional active-fixation mechanism in their TAVR
dressings and protection while recovering from
population who required temporary pacing as a
5
6
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result of conduction abnormalities post-TAVR who did not meet the conventional criteria for PPM placement. In their experience, 67 patients had TPEAF leads placed for conduction abnormalities other than irreversible AV block. These temporary leads were in place for 2.3 2.4 days. There were no procedure-related complications including infection, lead dislodgements, or perforation noted. DeCock et al (18) investigated the outcomes of TPEAF leads in their 36-patient cohort who required temporary pacing for infection, medication washout, myocardial infarction, postoperative pacing after aortic valve surgery, multi-organ failure, or prolonged asystole after a subarachnoid bleed. Their cohort was compared with a comparable passive-fixation cohort. The dislocation rate was significantly lower in the TPEAF lead group (5.5 vs. 33%; p < 0.001). There were 11 (31%) pacing-related adverse events in the TPEAF group versus 21 (58%) in the passive-fixation group (p < 0.01).
PERSPECTIVES COMPETENCY IN MEDICAL KNOWLEDGE: Implantation of active-fixation leads for temporary pacing has become the usual practice due to the high dislodgement rate of conventional balloon-tipped pacing catheters. However, data regarding outcomes of these active-fixation leads are very limited. This report shows good efficacy of these leads in 158 patients after TLE of infected device systems. However, we report a complication rate of 8.2%, which is lower than balloontipped catheters, but higher than previously reported. Lead dislodgement was the most common complication (incidence 5.1%) and most dislodgements occurred within the first 24 h, except 1 on day 3. Two patients developed vegetation on the temporary lead, 3 patients pulled out the lead while recovering from anesthesia, and 1 patient had loss of capture due to the “safety switch” feature. This report confirms that active-fixation leads should be used for temporary
STUDY LIMITATIONS. There are various limitations
pacing. However, knowledge of these complications
to our study. First, it is a single-center study and may
will help the clinicians in taking better care of patients
not be representative of the general population. Sec-
with active-fixation temporary pacing leads. Lead
ond, it is a retrospective study, potentially leading to
dislodgement can occur with these leads and patients
recording bias.
should be monitored in the cardiac care unit for at least 48 to 72 h. Patients can pull out these leads while recovering from anesthesia and close monitoring is
CONCLUSIONS
critical to prevent this complication. Persistence or
TPEAF lead implantation after TLE in pacemaker-
recurrence of fevers and positive blood cultures could
dependent patients with CIED infection is safe for
suggest development of vegetation on these tempo-
both short- and long-term pacing while patients un-
rary leads and repeat TEE is warranted. Also, the “safety
dergo appropriate antibiotic treatment. The risk of
switch” feature must be confirmed to be programmed
complication appears lower than the conventional
to “off” at the time of the implantation of these leads.
balloon-tipped pacing catheters. However, our series reports a higher complication rate than previously
TRANSLATIONAL OUTLOOK: In addition to the
published smaller series with higher dislodgement
traditional screw-in active fixation leads, there are
rates than are reported for transvenous leads placed
emerging alternatives such as BioTrace Medical’s
with PPMs. Although lead dislodgement can occur at
Tempo lead. The Tempo lead is a radiopaque, poly-
any time, in our study most occurred within the first
meric lead featuring active fixation, bipolar elec-
24 h. Adequate supervision must be provided to
trodes, and a soft tip. The design replaces the
prevent inadvertent pulling of the lead by patients
standard metallic electrode tip with an atraumatic
recovering from anesthesia. Persistent fevers and
distal tip to reduce the risk of cardiac perforation. In
inability to clear bacteremia, despite adequate anti-
addition, the Tempo lead contains a handle-actuated
biotic therapy, should raise the suspicion of devel-
fixation mechanism aimed at enhancing myocardial
opment of vegetation on the temporary lead. Lastly,
attachment using novel active-fixation loops to
the “safety switch” feature must be programmed to
maintain stable pace capture. An elastomeric balloon,
“off” at the time of implantation. ADDRESS
FOR
CORRESPONDENCE:
between the electrodes, inflates to aid passage of the
Dr.
Ralph
Cipriano, Drexel University College of Medicine, 245 North 15th Street, MS 470, Philadelphia, Pennsylvania 19102. E-mail: [email protected].
which is mounted asymmetrically on the lead body lead into the right ventricle as well as enhancing wall apposition of the stabilizing loops. The system is designed for temporary transvenous intracardiac pacing for up to 7 days (16).
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9. Kawata H, Pretorius V, Phan H, et al. Utility and safety of temporary pacing using active fixation leads and external re-usable permanent pacemakers after lead extraction. Europace 2013;15: 1287–91. 10. Chihrin SM, Mohammed U, Yee R, et al. Utility and cost effectiveness of temporary pacing using active fixation leads and an externally placed reusable permanent pacemaker. Am J Cardiol 2006;98:1613–5. 11. Ghani A, Delnoy PPHM, Misier ARR, et al. Incidence of lead dislodgement, malfunction and perforation during the first year following device implantation. Neth Heart J 2014;22:286–91. 12. Cheng A, Wang Y, Curtis JP, Varosy PD. Acute lead dislodgements and in-hospital mortality in
study. Pacing Clin Electrophysiol 2006;29:875–9.
patients enrolled in the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator registry. J Am Coll Cardiol 2010;56:1651–6.
7. Epstein LM, Eckart RE. Modified temporary cardiac pacing using transvenous active fixation
13. Orsbourn G, Lever N, Harding SA. Use of tunnelled active fixation leads allows reliable
2016;9:2189–99. 15. Mauri V, Reimann A, Stern D, et al. Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3. J Am Coll Cardiol Intv 2016;9:2200–9. 16. Webster M, Pasupati S, Lever N, Stiles M. Safety and feasibility of a novel active fixation temporary pacing lead. J Invasive Cardiol 2018;30:163–7. 17. Leong D, Sovari A, Ehdaie A, et al. Permanenttemporary pacemakers in the management of patients with conduction abnormalities after transcatheter aortic valve replacement. J Interv Cardiac Electrophysiol 2018;52:111–6. 18. DeCock C, Van Campen C, In’T Veld J, Visser C. Utility and safety of prolonged temporary transvenous pacing using an active-fixation lead: comparison with a conventional lead. Pacing Clin Electrophysiol 2003;26:1245–8. KEY WORDS active-fixation lead, lead extraction, lead dislodgement, pacemaker dependent, safety switch, temporary pacing
7
VOL.
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ª 2020 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER
Outcomes of Standard Permanent Active Fixation Leads for Temporary Pacing Ralph Cipriano, MD,a Ashwani Gupta, MBBS,a Faiz Subzposh, MD,a James A. McCaffrey, MD,a Eduard Koman, MD,a David Fridman, MD,a Heath Saltzman, MD, FHRS,a Steven P. Kutalek, MD, FHRSa ABSTRACT OBJECTIVE This study investigated the performance of Temporary Pacing via an Externalized Active-Fixation (TPEAF) lead. BACKGROUND The incidence of cardiac implantable electronic device infections is increasing, which necessitates the need for transvenous lead extraction (TLE). Pacemaker-dependent patients require temporary pacing during the guidelinerecommended waiting period before reimplantation. Data regarding safety and efficacy of TPEAF leads are very limited. METHODS We evaluated patients implanted with TPEAF leads post-TLE at our center between April 2004 and December 2017. RESULTS TPEAF leads were placed in 158 patients. The mean age was 74 11 years. The median duration of the temporary lead was 6 days (range 1 to 29). There were 4 procedural complications (2.5% incidence): 1 patient had cardiac arrest from hyperkalemia, 2 developed cardiac tamponade, and 1 had profuse bleeding from the entry point of the leads. There were 13 complications post-implantation (8.2% incidence): 8 lead dislodgments, 1 elevated pacing threshold, 2 vegetations on the temporary lead, 1 pneumothorax, and 1 loss of capture due to the generator “safety switch”. All dislodgements occurred within 24 h, except 1 on day 3. Sixteen patients died during the hospital stay: 10 due to septic shock, 2 due to hyperkalemic cardiac arrest, 3 due to ventricular tachycardia, and 1 due to a massive cerebrovascular accident. CONCLUSION The use of TPEAF leads is safe and efficacious in pacemaker-dependent patients post-TLE. Dislodgement can occur within the first 24 h. The presence of persistent fever and positive blood cultures should raise concern for vegetation on the temporary lead. (J Am Coll Cardiol EP 2020;-:-–-) © 2020 by the American College of Cardiology Foundation.
T
he incidence of Cardiac Implantable Elec-
especially lead dislodgement (6). Because of this,
tronic Device (CIED) infection has been
our center uses Temporary Pacing via an Externalized
constantly increasing due to increased im-
Active Fixation (TPEAF) lead connected to an exter-
plantation rates (1–3). Current guidelines recommend
nalized pulse generator as the standard practice.
a complete removal of the infected CIED system,
Data regarding the efficacy and outcomes of this prac-
along with the appropriate antibiotic therapy (4).
tice are very limited. We report a single, high-volume
The total duration of antibiotic therapy usually
center experience with the implantation of TPEAF
ranges between 2 and 6 weeks; however, the implan-
leads after transvenous lead extraction (TLE).
tation of a new CIED system is usually delayed for at least 72 h for localized pocket infection and up to
METHODS
14 days for systemic infection with evidence of a valvular vegetation (5). Temporary pacing is required
Our institution maintains a comprehensive database
in pacemaker-dependent patients during this waiting
of all patients who undergo device lead extraction.
period. The traditional balloon-tipped pacing cathe-
We queried our database and identified all patients
ters are associated with high complication rates,
requiring TPEAF lead implantation after TLE at our
From the aDepartment of Cardiology, Drexel University College of Medicine, Philadelphia, Pennsylvania. Dr. Kutalek is a consultant for Spectranetics Corp., St Jude Medical, Boston Scientific, Medtronic, and Sorin. Dr. Saltzman has received speaking/ training honoraria from Boston Scientific, Biosense Webster, Sorin, and Zoll. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page. Manuscript received April 1, 2019; revised manuscript received October 28, 2019, accepted October 31, 2019.
ISSN 2405-500X/$36.00
https://doi.org/10.1016/j.jacep.2019.10.022
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ABBREVIATIONS
center between April 2004 and December
was performed in all of the patients after TLE, unless
AND ACRONYMS
2017. All leads used were active fixation, bi-
contraindicated. An infectious disease evaluation was
polar leads. The patients defined as ‘pace-
obtained for all of the patients to aid antibiotic choice
maker dependent’ were those with complete
and duration, as well as decisions regarding timing
heart block, high-grade atrioventricular (AV)
and reimplantation of the new device.
AV = atrioventricular CIED = cardiac implantable electronic device
block, or patients with marked sinus brady-
PPM = permanent pacemaker
cardia.
RV = right ventricle
The
data
regarding
patient
de-
mographics, procedural details, efficacy and
TAVR = transcatheter aortic
complications of active-fixation leads, and
valve replacement
patient follow-up were collected retrospec-
TEE = trans-esophageal
tively.
echocardiogram
The
Institutional
Review
Board
approved the study.
TLE = transvenous lead extraction
PROCEDURE. After
TPEAF = temporary pacing via an externalized active fixation
VT = ventricular tachycardia
ANALYSIS. All data were entered in Microsoft Excel
(Redmond, Washington) and analyzed using SPSS (v22, SPSS, Chicago, Illinois). Continuous variables are expressed as mean standard deviation, median, or range. Categorical variables are displayed as frequency or proportions. Chi-square test or Fisher exact test was used to analyze categorical variables.
CIED
Continuous variables were compared using Student’s
infection was made per the current guide-
t-test for parametric data and Kruskal-Wallis rank test
lines (4), complete extraction of the system
for non-parametric data.
a
diagnosis
of
was undertaken in the electrophysiology
VF = ventricular fibrillation
laboratory. The choice of anesthetic modality
RESULTS
and agents was left to the discretion of the anesthesiologist. Femoral venous and arterial access was
A total of 158 patients (12.4% of total 1,275 proced-
obtained in all patients. In patients with complete
ures) underwent TPEAF lead implantation after TLE.
heart block, high-degree AV block, or significant sinus
Patient and device characteristics are shown in
node
was
Table 1. The mean age was 74 11 yrs (range 25 to 91
advanced under fluoroscopic guidance via a femoral
yrs). Mean implant duration of the extracted leads
venous sheath into the right ventricular (RV) apex for
was 68.1 59.7 months (range 1 to 309 months). The
pacing during the extraction procedure. A threshold
average number of leads extracted per procedure was
of less than 1 V was considered acceptable.
2.79 0.92 (median 3). Sixty-five patients (41.1%) had
dysfunction,
a
quadripolar
catheter
Vascular access site for the TPEAF lead placement
documented
bacteremia.
Seventy-five
patients
was determined at the operator’s discretion. A 7-
(47.5%) had undergone instrumentation in the device
French peel-away sheath was placed after obtaining
pocket within the year prior to TLE. Complete pro-
venous access and a TPEAF lead was advanced into
cedural success was achieved in 154 patients (97.5%).
either the right ventricle (Central Illustration) or right
Excimer laser was used in 51 patients (32.3%) and for
atrium. In this study, 98.7% of leads were placed in the
23.3% of leads. Four patients had complications dur-
right ventricle and 1.3% of leads were placed in the
ing the procedure: 1 patient had cardiac arrest due to
right atrium. The lead was secured with non-
hyperkalemia requiring cardio-pulmonary resuscita-
absorbable sutures to the skin and connected to
tion (and died 12 h after the procedure), 2 patients
either the recently removed pulse generator or a pre-
developed cardiac tamponade during the extraction
viously removed and sterilized pulse generator that
procedure (1 required pericardiocentesis only and 1
was required to have at least 6 months of projected
required thoracotomy), and 1 patient had profuse
battery longevity and no evidence of electrical mal-
bleeding from the entry point of the leads requiring
function. The selection of pacemaker leads was left to
repair by a vascular surgeon. Inotropic/pressor sup-
the operator’s discretion. The device was mostly pro-
port was required in 19 (12.0%) patients.
grammed to a VVI or VOO mode at 70 beats/min with
The most common access site for the TPEAF lead
an output of 5 V at a pulse width of 1 ms. The pace-
was the right internal jugular vein (96.8% patients).
maker pulse generator was usually sutured and
All the leads were placed in the RV apical septum,
anchored to the skin as well. The exposed lead and the
except for 2 cases, which required lead placement in
pulse generator were covered with Tegaderm dress-
the right atrial appendage for sick sinus syndrome
ings (Central Illustration). In all of the cases, the pa-
with intact AV nodal conduction. Median duration of
tient was transferred to the cardiac care unit for
the TPEAF lead was 6 days (range 1 to 29 days). There
further observation and management. All patients
was no periprocedural mortality related to the im-
remained hospitalized until device replacement.
plantation of TPEAF leads. However, there were 13
Blood cultures were drawn in all patients prior to
complications from these leads (8.2%; Table 2). Eight
the initiation of antibiotic therapy as well as after lead
patients had lead dislodgment (5 radiologically
extraction. A transesophageal echocardiogram (TEE)
confirmed lead dislodgements and 3 leads pulled out
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C ENTR AL I LL U STRA T I O N Temporary Active-Fixation Lead
Cipriano, R. et al. J Am Coll Cardiol EP. 2020;-(-):-–-.
(Left) Chest X-Ray (anterior-posterior view) demonstrating a temporary active-fixation lead implanted in the right ventricle via the right internal jugular vein access, and attached to an external pulse generator. (Right) Image demonstrating a temporary active-fixation lead inserted via the right internal jugular vein and attached to an external, sterilized pulse generator.
by delirious patients) resulting in loss of capture
reimplantation, 134 were endocardial (84.8%) and 12
requiring transcutaneous pacing. All lead dislodge-
were epicardial (7.6%). Twelve patients (7.6%) did not
ments except 1 occurred within the first 24 h post-
undergo reimplantation during the index hospitaliza-
procedure (1 patient had dislodgement on day 3).
tion. Of the 12 patients who did not undergo reim-
One patient developed elevated pacing threshold
plantation, 8 died prior to discharge, 1 was transferred
without lead dislodgement and 1 patient developed
back to the referring hospital with temp-wire in place, 1
pneumothorax requiring chest tube placement. Two
had removal of temp-wire prior to discharge due to
patients had persistent fever and bacteremia and
fungemia, 1 had removal of temp-wire due to dissem-
were found to have developed a vegetation on the
inated intravascular coagulation (DIC) and recurrent
TPEAF lead, which was seen by repeat TEE. One pa-
pocket hematomas precluding replacement of pace-
tient developed loss of capture on day 1 post-
maker, and 1 had removal of temp-wire with no plan to
implantation. Chest X-ray and cardiac fluoroscopy
replace pacemaker. Median hospital stay was 12 days
showed no evidence of lead dislodgment. Persistent
(range 1 to 168). Ninety-eight (62%) patients were dis-
capture at low threshold was obtained using the
charged to home, 23 (14.6%) to skilled nursing facility,
pacing system analyzer. On further device interro-
18 (11.4%) to a rehabilitation facility, and 16 (10.1%)
gation, it was found that the “safety switch” feature
patients died during the hospital stay. Ten patients
was programmed to “on” at the time of implantation.
died due to multi-organ failure due to septic shock, 3
The device (Insignia I Ultra, model # 1290, Boston
patients had ventricular tachycardia (VT)/ventricular
Scientific, Marlborough, Massachusetts) reverted to
fibrillation (VF) arrest, 2 patients had hyperkalemic
unipolar pacing due to variation in the lead imped-
cardiac arrest, and 1 patient died due to a massive ce-
ance and could not consistently capture due to an
rebrovascular accident. Of the 16 patients who died, 7
external pulse generator. The “safety switch” feature
underwent reimplantation prior to their death. Data
was then programmed to “off” and subsequently the
regarding long-term follow-up was limited given the
pacemaker began functioning without issue, elimi-
retrospective nature of the study. One hundred ten
nating the need to replace the unit. This event was
(69.6%) patients were alive at 30 days, however, 28
associated with no clinical consequences.
(17.7%) patients were lost to follow-up. Eighty-four
A new device was reimplanted in 146 patients (92.4%).
In
the
patients
who
underwent
(51.9%) patients were alive at 1 year, however, 42 (26.6%) patients by this point in time were lost to
3
4
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T A B L E 1 Patient and Device Characteristics
T A B L E 2 Complications From the Active-Fixation Lead
Patients (n ¼ 158)
Age (yrs)
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74.1 11.1
Race
Patients (n ¼ 158)
Lead dislodgement
8
Elevated pacing threshold
1
Caucasian
86.7
Vegetation on temporary lead
2
African American
12.7 0.6
Loss of capture due to reversion of device to unipolar configuration (safety switch)
1
Hispanic
Pneumothorax
1
Gender Male Female Body mass index (kg/m2)
70.9 29.1 27.1 5.8
Device type
(3.1%) had septic shock, 3 (1.9%) had gastrointestinal bleed, 3 (1.9%) had deep venous thrombosis, 3 (1.9%)
Single-chamber pacemaker
4.5
Dual-chamber pacemaker
45.2
Dual-chamber ICD
10.8
had pulseless electrical activity arrest, 3 (1.9%) had VT/ VF arrest, and 2 (1.3%) each had multi-organ failure,
3.2
pneumothorax, hyperkalemic cardiac arrest, or acute
Biventricular ICD
36.3
respiratory distress syndrome. The remaining com-
Total leads extracted
438
plications occurred once in the study population:
Biventricular pacemaker
Lead implant duration (months)
68.1 59.7
Temporary lead location Right atrium
Clostridium difficile colitis, hepatic encephalopathy, cardiogenic shock, cerebral vascular accident, aspira-
1.3
Right ventricle
98.7
Abandoned leads
18.1
Pocket site Left
84.2
Right
10.8
Both
5.1
tion pneumonia, genitourinary bleed, hemodialysis graft-related complications, DIC, pulmonary hemorrhage, cholangitis, severe tricuspid regurgitation, and anoxic encephalopathy.
DISCUSSION
Pocket location Prepectoral
94.9
The complication rate of the traditional balloon-
Subpectoral
5.1
tipped temporary pacing catheter has been reported
Previous lead extraction
5.7
Patient characteristics Diabetes mellitus
34.2
to be as high as 46%, with lead dislodgments being 1 of the most frequent culprits (6). Data regarding safety
Coronary artery disease
55.1
and efficacy of TPEAF leads are very limited. Epstein
Ischemic cardiomyopathy
39.2
et al. (7) reported no complications from leads in 62
Non-ischemic cardiomyopathy
20.9
patients. However, only 27 leads were implanted in
42.7 17.7
infected patients and only 13 leads were implanted
Hypertension
72.8
post-TLE. The risk of complications may be higher in
Peripheral vascular disease
15.8
Dyslipidemia
49.4
Chronic kidney disease (GFR <60 ml/kg/min)
48.1
Left ventricular ejection fraction (%)
GFR
60 31.4
these patients. Two publications in 2013 addressed the use of TPEAF leads post-extraction (8,9). However, these were small studies with 17 and 23 patients,
End-stage renal disease
8.2
respectively. They did not report any lead dislodge-
Prior cardiac surgery
36.7
ment and reported development of a vegetation on
Coronary artery bypass grafting
24.7
the temporary lead in 1 patient. Braun et al. (6) re-
Prosthetic valve
13.9
ported 1 lead dislodgement, 1 loss of sensing, and 1
Atrial fibrillation/flutter
55.7
Chronic obstructive pulmonary disease
25.9
patient with an elevated threshold of 23 patients
Obstructive sleep apnea
10.1
Left ventricular assist device Liver cirrhosis
0.6% 1.3
implanted with an active-fixation lead. Chihrin et al. (10) reported 1 patient with loss of capture 2 weeks after implantation of their first 20 patients. Thus far, data published on the use of TPEAF leads have been
Values are mean SD or n%. ICD ¼ implantable cardioverter-defibrillator; GFR ¼ glomerular filtration rate.
limited by small sample size. We report the largest series regarding the safety and efficacy of TPEAF leads implanted post-TLE. Our
follow-up. Complications, not procedure related,
series reports an 8.2% complication rate from these
occurred in 20.8% of patients during the hospital stay.
leads, which is higher than previously reported. Lead
Most patients had more than 1 complication. Apart
dislodgement was the most common complication
from death, 5 (3.1%) patients had acute kidney injury, 5
with an incidence of 5.1%, which is higher than
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published data with permanently placed leads (1.2%
anesthesia. Adequate nursing supervision must be
to 3.3% in various studies) (11,12) and was compared
provided during the recovery from anesthesia to
with dislodgement rates of 10% to 37% for balloon-
avoid this complication, especially in elderly patients
tipped catheters (6,8,13). However, 3 of the 8 dis-
who are more prone to delirium. One patient devel-
lodgments were caused by delirious patients pulling
oped loss of capture due to reversion to unipolar
out their temporary leads and, although they count
pacing from the “safety switch”. This feature detects
toward our dislodgment rate, they were not a proce-
changes in the lead impedance and reverts to a uni-
dural issue. The overall reduced incidence of lead
polar pacing configuration if any significant change is
dislocation using the TPEAF lead as compared with a
detected. Lead impedance changes are common
balloon-tipped pacing catheter, which has been re-
during the first few days after lead implantation and
ported in various studies (6,8,13) and confirmed in
reversion to unipolar pacing can occur, which will
our study, is 1 of the main advantages of this system
lead to loss of capture due to an external pulse
and lends support to it being the superior method of
generator. This feature must be programmed to “off”
temporary pacing in the pacemaker-dependent pa-
at the time of implantation.
tient. In addition, TPEAF leads can sometimes be more
cost-effective
than
traditional
From our experiences, several interventions un-
temporary
dertaken by the operator reduced the risk of
transvenous pacing by decreasing intensive care unit
dislodgement in our patients. We allowed for signif-
length of stay (10).
icant lead slack in the atrium in addition to the 3 to 4
The authors do recognize that these leads require an
coils of lead outside the body, which were then
implanting physician competent in the use of IS-1
secured with multiple layers of transparent adhesive
active fixation leads, whereas a balloon-tipped lead
dressing. Initially, we implanted the pulse generator
might be implanted by a broader range of physicians.
near the neck region, however, it allowed for more
However, it is likely that most patients undergoing
movement and we subsequently started positioning
TLE will be under the care of physicians who are
the pulse generator in the supraclavicular fossa to
comfortable with IS-1 active fixation lead implantation
minimize movement of the generator. The pulse
and all other equipment and personnel will usually be
generator is also sutured in place to reduce move-
available.
ment. The lead was secured to the skin with sutures
Patients with systemic infection requiring lead
around suture sleeves and the lead insertion site was
extraction and implantation of a temporary lead have
secured with a separate Biopatch at the insertion site.
a relatively low incidence of developing vegetations
In
addition
to
its post-extraction indication,
on the temporary lead. In our series, 2 patients
TPEAF leads have additional applications. These
developed vegetations on the temporary lead of a
include
total of 65 patients with bacteremia (3.1%). One pa-
(TAVR), for periprocedural bradyarrhythmia support,
transcatheter
aortic
valve
replacement
tient had persistent Methicillin-sensitive Staphylo-
transient bradyarrhythmia of other etiology, and
coccus aureus bacteremia. On post-operative day 2,
patients who require permanent pacemaker (PPM)
the patient underwent TEE that demonstrated vege-
implantation but have an active infection. Tempo-
tations on the temporary lead as it entered the right
rary pacing leads serve important procedural roles in
atrium and another large vegetation on the tricuspid
TAVR procedures, including support of periproce-
valve. The Cardiothoracic Surgery department was
dural conduction disturbances as well as rapid pac-
subsequently consulted and they placed an epicardial
ing for deployment of balloon-expandable valves
lead. The patient had a long and complicated hospital
(14,15). Webster et al. (16) reported on 25 patients (13
course that eventually ended with his decision to
TAVRs, 11 electrophysiologic procedures, and 1
pursue hospice care. The second patient developed
balloon aortic valvuplasty) who required temporary
persistent fevers on post-operative day 5 with Strep-
pacing as a procedural adjunct or periprocedural
tococcus mitis bacteremia. He also underwent epicar-
pacing support. Technical feasibility was achieved in
dial lead placement and eventually decided on the
23 cases (92%); 2 patients had unsuitable anatomy.
hospice route given multi-organ failure and poor
They reported no device-related complications or
prognosis. Persistent bacteremia or recurrent high-
failure to pace. This study used BioTrace Medical’s
grade fever should raise the suspicion of this
novel Tempo lead (BioTrace Medical, Menlo Park,
complication and a repeat TEE should be performed.
California)and a relatively small number of patients
We also report 2 complications that have not
had prolonged Tempo lead implantation (beyond 24
yet been reported in the published data. Three
h) (16). Leong et al. (17) described the use of tradi-
patients pulled out the TPEAF leads despite adequate
tional active-fixation mechanism in their TAVR
dressings and protection while recovering from
population who required temporary pacing as a
5
6
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result of conduction abnormalities post-TAVR who did not meet the conventional criteria for PPM placement. In their experience, 67 patients had TPEAF leads placed for conduction abnormalities other than irreversible AV block. These temporary leads were in place for 2.3 2.4 days. There were no procedure-related complications including infection, lead dislodgements, or perforation noted. DeCock et al (18) investigated the outcomes of TPEAF leads in their 36-patient cohort who required temporary pacing for infection, medication washout, myocardial infarction, postoperative pacing after aortic valve surgery, multi-organ failure, or prolonged asystole after a subarachnoid bleed. Their cohort was compared with a comparable passive-fixation cohort. The dislocation rate was significantly lower in the TPEAF lead group (5.5 vs. 33%; p < 0.001). There were 11 (31%) pacing-related adverse events in the TPEAF group versus 21 (58%) in the passive-fixation group (p < 0.01).
PERSPECTIVES COMPETENCY IN MEDICAL KNOWLEDGE: Implantation of active-fixation leads for temporary pacing has become the usual practice due to the high dislodgement rate of conventional balloon-tipped pacing catheters. However, data regarding outcomes of these active-fixation leads are very limited. This report shows good efficacy of these leads in 158 patients after TLE of infected device systems. However, we report a complication rate of 8.2%, which is lower than balloontipped catheters, but higher than previously reported. Lead dislodgement was the most common complication (incidence 5.1%) and most dislodgements occurred within the first 24 h, except 1 on day 3. Two patients developed vegetation on the temporary lead, 3 patients pulled out the lead while recovering from anesthesia, and 1 patient had loss of capture due to the “safety switch” feature. This report confirms that active-fixation leads should be used for temporary
STUDY LIMITATIONS. There are various limitations
pacing. However, knowledge of these complications
to our study. First, it is a single-center study and may
will help the clinicians in taking better care of patients
not be representative of the general population. Sec-
with active-fixation temporary pacing leads. Lead
ond, it is a retrospective study, potentially leading to
dislodgement can occur with these leads and patients
recording bias.
should be monitored in the cardiac care unit for at least 48 to 72 h. Patients can pull out these leads while recovering from anesthesia and close monitoring is
CONCLUSIONS
critical to prevent this complication. Persistence or
TPEAF lead implantation after TLE in pacemaker-
recurrence of fevers and positive blood cultures could
dependent patients with CIED infection is safe for
suggest development of vegetation on these tempo-
both short- and long-term pacing while patients un-
rary leads and repeat TEE is warranted. Also, the “safety
dergo appropriate antibiotic treatment. The risk of
switch” feature must be confirmed to be programmed
complication appears lower than the conventional
to “off” at the time of the implantation of these leads.
balloon-tipped pacing catheters. However, our series reports a higher complication rate than previously
TRANSLATIONAL OUTLOOK: In addition to the
published smaller series with higher dislodgement
traditional screw-in active fixation leads, there are
rates than are reported for transvenous leads placed
emerging alternatives such as BioTrace Medical’s
with PPMs. Although lead dislodgement can occur at
Tempo lead. The Tempo lead is a radiopaque, poly-
any time, in our study most occurred within the first
meric lead featuring active fixation, bipolar elec-
24 h. Adequate supervision must be provided to
trodes, and a soft tip. The design replaces the
prevent inadvertent pulling of the lead by patients
standard metallic electrode tip with an atraumatic
recovering from anesthesia. Persistent fevers and
distal tip to reduce the risk of cardiac perforation. In
inability to clear bacteremia, despite adequate anti-
addition, the Tempo lead contains a handle-actuated
biotic therapy, should raise the suspicion of devel-
fixation mechanism aimed at enhancing myocardial
opment of vegetation on the temporary lead. Lastly,
attachment using novel active-fixation loops to
the “safety switch” feature must be programmed to
maintain stable pace capture. An elastomeric balloon,
“off” at the time of implantation. ADDRESS
FOR
CORRESPONDENCE:
between the electrodes, inflates to aid passage of the
Dr.
Ralph
Cipriano, Drexel University College of Medicine, 245 North 15th Street, MS 470, Philadelphia, Pennsylvania 19102. E-mail: [email protected].
which is mounted asymmetrically on the lead body lead into the right ventricle as well as enhancing wall apposition of the stabilizing loops. The system is designed for temporary transvenous intracardiac pacing for up to 7 days (16).
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Standard Permanent Active Fixation Leads
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leads and external re-sterilized pulse generators. J Am Coll Cardiol 2006;47:1487–9.
temporary pacing over prolonged periods. Intern Med J 2008;38:735–8.
8. Pecha S, Aydin MA, Yildirim Y, et al. Transcutaneous lead implantation connected to an externalized pacemaker in patients with implantable cardiac defibrillator/pacemaker infection and
14. Fadahunsi OO, Olowoyeye A, Ukaigwe A, et al. Incidence, predictors, and outcomes of permanent pacemaker implantation following transcatheter aortic valve replacement: analysis from the U.S Society of Thoracic Surgeons/American College of Cardiology TVT Registry. J Am Coll Cardiol Intv
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Europace
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9. Kawata H, Pretorius V, Phan H, et al. Utility and safety of temporary pacing using active fixation leads and external re-usable permanent pacemakers after lead extraction. Europace 2013;15: 1287–91. 10. Chihrin SM, Mohammed U, Yee R, et al. Utility and cost effectiveness of temporary pacing using active fixation leads and an externally placed reusable permanent pacemaker. Am J Cardiol 2006;98:1613–5. 11. Ghani A, Delnoy PPHM, Misier ARR, et al. Incidence of lead dislodgement, malfunction and perforation during the first year following device implantation. Neth Heart J 2014;22:286–91. 12. Cheng A, Wang Y, Curtis JP, Varosy PD. Acute lead dislodgements and in-hospital mortality in
study. Pacing Clin Electrophysiol 2006;29:875–9.
patients enrolled in the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator registry. J Am Coll Cardiol 2010;56:1651–6.
7. Epstein LM, Eckart RE. Modified temporary cardiac pacing using transvenous active fixation
13. Orsbourn G, Lever N, Harding SA. Use of tunnelled active fixation leads allows reliable
2016;9:2189–99. 15. Mauri V, Reimann A, Stern D, et al. Predictors of permanent pacemaker implantation after transcatheter aortic valve replacement with the SAPIEN 3. J Am Coll Cardiol Intv 2016;9:2200–9. 16. Webster M, Pasupati S, Lever N, Stiles M. Safety and feasibility of a novel active fixation temporary pacing lead. J Invasive Cardiol 2018;30:163–7. 17. Leong D, Sovari A, Ehdaie A, et al. Permanenttemporary pacemakers in the management of patients with conduction abnormalities after transcatheter aortic valve replacement. J Interv Cardiac Electrophysiol 2018;52:111–6. 18. DeCock C, Van Campen C, In’T Veld J, Visser C. Utility and safety of prolonged temporary transvenous pacing using an active-fixation lead: comparison with a conventional lead. Pacing Clin Electrophysiol 2003;26:1245–8. KEY WORDS active-fixation lead, lead extraction, lead dislodgement, pacemaker dependent, safety switch, temporary pacing
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