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Journal of Electrocardiology 49 (2016) 530 – 535
www.jecgonline.com

Risk of early mortality after placement of a temporary-


permanent pacemaker
Farah Z. Dawood, MD, MS, a,⁎ Andrew Boerkircher, DO, b Bryon Rubery, MD, a Don Hire, BS, c
Elsayed Z. Soliman, MD, MSc, MS a, d
a
Department of Internal Medicine- Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, NC
b
Department of Internal Medicine- General Medicine, Wake Forest School of Medicine, Winston-Salem, NC
c
Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC
d
Epidemiological Cardiology Research Center (EPICARE), Wake Forest School of Medicine, Winston-Salem, NC

Abstract Background: Temporary-permanent pacemakers [TPPM] are externally placed permanent


generators attached to active fixation transvenous leads. TPPM can be used as an alternative to
standard temporary pacing leads when placement of a permanent pacemaker is contraindicated. We
sought to determine the incidence and risk factors for early (within 6 months) mortality after
placement of a TPPM.
Methods: Electronic medical records were used to extract baseline characteristics for 152 patients
from Wake Forest Baptist Medical Center who had a TPPM placed between the years 2007 and
2012. Multivariable adjusted Cox proportional hazard models were used to estimate hazard ratios
[HR] and 95% confidence intervals [C]) for baseline characteristics [age, sex, race, hypertension,
diabetes, heart failure, coronary artery disease, smoking, dyslipidemia, chronic kidney disease
[CKD], and indication for pacemaker] on early mortality.
Results: Of the 152 patients [mean age 68.9 years; 57.2% female; 86.8% white], 45 [29.6%] died
within the first 6 months after TPPM placement. No deaths occurred as a direct result of TPPM
placement, and only 1 patient experienced documented non-fatal complications. Maximum time to
PPM from the date of insertion of TPPM was 336 days. Using a backward multivariable adjusted
hazard regression model, independent risk factors for early mortality were pre-existing CKD [HR
(95% CI): 2.240 (1.002–5.010) for eGFR 30–59 and 7.645 (3.594–16.263) for eGFR b 30 compared
to eGFR N 60] and history of smoking [HR (95% CI): 2.015 (1.099–3.696)]. Surprisingly,
dyslipidemia was protective of early mortality [HR (95%CI): 0.470 (0.240–0.924)].
Conclusion: TPPM placement is a safe procedure with rare direct complications. CKD and smoking
are predictive of increased risk for early mortality in patients undergoing TPPM placement.
© 2016 Elsevier Inc. All rights reserved.
Keywords: Temporary pacemaker; Heart pacing; Risk of mortality

Introduction another procedure. The efficacy and safety of traditional


temporary transvenous pacing with passive fixation and later
Temporary-permanent transvenous pacing (TPPM) via a
via active fixation leads and an externalized re-usable
permanent external generator attached to active fixation
permanent pacemaker has been previously explored
transvenous leads can be a lifesaving procedure in a variety
[1–11]. Case reports have highlighted complications asso-
of cardiac arrhythmias including sinus node and atrioven-
ciated with temporary pacemaker and TPPM placement
tricular (AV) node dysfunction. It is a well-established
[6–8,12–14] and earlier studies found a low complication
method to restore normal cardiac rhythm when placement of
rate associated with the transvenous pacing [9–11].
a permanent pacemaker is contraindicated for a variety of
Temporary transcutaneous pacemaker is important while
reasons including active infection, transient conduction
bridging to permanent pacemakers in the setting of
abnormalities, perioperative period, or prophylaxis for
hemodynamically significant AV block, the evolving
⁎ Corresponding author at: Department of Internal Medicine, Section on
transcutaneous techniques for cardiac valves replacement
Cardiovascular Medicine, Wake Forest School of Medicine, Medical Center
due to increase in the rate of bundle branch blocks and
Boulevard, Winston-Salem, NC 27157. infection [13,15,16]. Over the years, advances in cardiac
E-mail address: fdawood@wakehealth.edu pacing devices came with greatly improved pacemaker lead
http://dx.doi.org/10.1016/j.jelectrocard.2016.05.004
0022-0736/© 2016 Elsevier Inc. All rights reserved.
F.Z. Dawood et al. / Journal of Electrocardiology 49 (2016) 530–535 531

insulation and tip materials. Rastan et al. first reported Contraindication to placement of a permanent pacemaker
utilization of active-fixation leads attached to pacemaker included active infection from any source, emergent placement
generators as a bridging therapy and Braun et al. compared due to hemodynamic instability, perioperative period, transient
passive vs active fixation leads [16,17] in 2005. The symptoms (often caused by spinal cord injury), prophylaxis for
utilization of active fixation leads during temporary transcatheter aortic valve replacement (TAVR), or other
transcutaneous pacemaker insertion increased the effective- correctable causes including electrolyte abnormalities, respira-
ness and reliability of temporary pacemakers by avoiding tory failure, drug overdose, or treatable diseases not expected to
frequent loss of capture and under-sensing. require permanent pacing.
Though temporary-permanent transvenous pacing is proven
to be a useful procedure, it is not without risk. Understanding
Statistical analysis
which population of patients may be at an increased risk for
complications may change clinical management. Given ad- Baseline characteristics of the patients were tabulated and
vances in cardiac pacing devices, improvements in temporary compared by survival status within 6 months. Multivariable
pacemaker placement, and expanding indications for temporary adjusted Cox proportional hazard regression models were
pacing, it would be worth revisiting the immediate complication used to estimate hazard ratios and 95% confidence intervals
rate and early mortality rate (within 6 months) in the general for baseline demographics and clinical factors on early
adult population presenting with contraindications to permanent all-cause mortality. Variables included in the model are age,
pacemaker placement. sex, race (white vs non-white), hypertension, diabetes,
congestive heart failure, coronary artery disease, smoking
(current or past), dyslipidemia, chronic kidney disease, and
pacing indication (SA node disease, AV node disease,
Methods
others). Backward selection multivariable adjusted hazard
Data were collected from the electronic medical records regression model was used to identify independent risk
(EMR, Epic and Carecast) of 152 patients who received a factors for early mortality. Survival probability was
temporary pacemaker with external generator for any estimated using Kaplan Meier method and compared by
indication from 2007 to 2012 at Wake Forest Baptist levels of the factors identified by the backward selection
Medical Center. Records were reviewed for age, sex, race, regression model using log-rank test. Statistical significance
pre-existing conditions (diabetes, hypertension, coronary for all analyses was p b 0.05. Analyses were conducted
artery disease, congestive heart failure, smoking history), using SAS 9.2 [SAS Institute, Cary, NC].
temporary pacemaker indication (sinus node disease, AV
node disease defined as type II second degree or third degree
AV block or other high grade block), date of temporary
Results
implant, complication from implant, contraindication to
permanent pacemaker placement, and time to permanent Of the 152 total patients (mean age 68.9 years ± 16.4;
pacemaker placement (if indicated). Patients discharged 57.2% female; 86.8% white), 45 (29.6%) died within the first
were set up for follow up for device check to assess the need 6 months after TPPM placement. No deaths occurred as a
for PPM according to standard protocol followed by most direct result of pacemaker placement, and only 1 (0.7%)
US hospitals. patient experienced documented non-fatal complication
Active fixation leads (Medtronic 5076) and Medtronic related to tamponade. Mean and median time to PPM
external re-usable permanent pacemaker were used that were implantation was 9.7 and 21 days respectively. Maximum
secured with sterile dressing technique. Pacing lead time to PPM, if indicated, from the date of insertion of TPPM
threshold at implantation was considered acceptable if was 336 days. Approximately 35 patients were discharged
1.0 V at a pulse width of 0.5 ms, as were sensing amplitudes with TPPM and 15 patients had the system in place for more
of ≥ 5 mV for the R-wave and ≥ 1 mV for the P-wave. than 30 days. Patients' early mortality was related to
Wound check, chest X-ray and device interrogation were multiple conditions including cardiovascular disease
performed during the first 24 h after implantation. Patients were (CVD), ventricular fibrillation (VF)/pulseless electrical
discharged home or to a nursing care facility once clinically activity (PEA) arrest, NSTEMI and abdominal aortic
stable with TTPM system until PPM can be implanted. aneurysm (AAA) rupture (10 patients), respiratory failure
Time to PPM if indicated or death was recorded and all-cause (9 patient), neurological related death including stroke and
mortality data was collected by reviewing the EMR for date of subdural hematoma (5 patients), sepsis (8 patients), post
death and cause (if documented). Mortality was only recorded if bowel surgery complications (2 patients) and unknown for
the patient died within one year of receiving a temporary the remaining 11 patients.
pacemaker. A small subset (n = 12) was lost to follow up, About 30.9% of the participants had diabetes, 64.4% had
therefore date and cause of death were not determined. hypertension, 38.2% had coronary heart disease, 24.3% had
Complications related to placement of the temporary heart failure, 38.2% had dyslipidemia and 35.5% were
pacemaker were defined as any documented adverse smokers. Table 1 shows the patients characteristics stratified
outcome of the procedure including mechanical damage by occurrence of early mortality. As shown, patients with
caused by placement of the pacing lead, or infection of the early mortality were more likely to have history of chronic
pacing system. kidney disease and congestive heart failure.
532 F.Z. Dawood et al. / Journal of Electrocardiology 49 (2016) 530–535

Table 1 Table 3
Patients characteristics stratified by early morality. Independent risk factors of early mortality using backward selection
modeling.
Variable [n (%) or Alive at Died before p-value
mean ± SD] 6 months (n = 107) 6 months (n = 45) Variables⁎ Hazard Lower 95% Upper 95% p-value
ratio⁎ Confidence Confidence
Age (years) 68.8 ± 17 69.1 ± 13.5 0.90
interval interval
Female 65 (60.75) 22 (48.89) 0.18
White race/ethnicity 94 (87.85) 38 (84.44) 0.57 Ever smoker 2.015 1.099 3.696 0.024
Hypertension 73 (68.22 25 (55.56) 0.14 Chronic kidney disease
Diabetes 33 (30.84) 14 (31.11) 0.97 Stage III (vs eGFR N=60) 2.240 1.002 5.010 0.049
Dyslipidemia 45 (42.06) 13 (28.89) 0.13 Stage IV (vs eGFR N=60) 7.645 3.594 16.263 b.001
Ever smoker 33 (30.84) 21 (46.67) 0.06 Dyslipidemia 0.470 0.240 0.924 0.028
Congestive heart 20 (18.69) 17 (37.78) 0.01
eGFR = estimated glomerular filtration rate in mL/min/1.73 m2.
failure ⁎ The starting model included all the variables in Table 2.
Coronary artery 39 (36.45) 19 (42.22) 0.50
disease
Chronic Kidney b .01
Disease Table 2 shows the results of multivariable Cox proportional
Stage I and II 64 (59.81) 11 (24.44) hazards analysis in which all patients' characteristics were
(eGFR N 60)
entered in the model. As shown, only smoking and history of
Stage III 30 (28.04) 13 (28.89)
(eGFR 30–59) CKD (eGFR N 30) were predictive of early mortality.
Stage IV 13 (12.15) 21 (46.67) Using a backward multivariable adjusted hazard regression
(eGFR b 30) model, independent risk factors for early mortality were
Indication of 00.52 pre-existing CKD [eGFR 30–59 and eGFR b 30 compared to
pacemaker
eGFR N 60] and history of smoking. Surprisingly, dyslipidemia
AV nodal disease 46 (42.99) 19 (42.22)
SA nodal disease 42 (39.25) 21 (46.67) was protective of early mortality (Table 3). Figs. 1, 2 and 3 show
Others 19 (17.76) 5 (11.11) Kaplan Meier curves for survival probability by chronic kidney
eGFR = estimated glomerular filtration rate in mL/min/1.73 m2.
disease status, smoking status and dyslipidemia.

The most common indications for pacemaker placement


Discussion
were AV node dysfunction 42.8%, sinus node dysfunction
41.4%, TAVR 6.65%, Mobitz II AV block 4.6%, Mobitz I The two key findings from this study are 1) placement of
AV block 2%, and other 2.6%. TPPM when a permanent implanted pacemaker is contraindi-
The most common site for insertion was the right internal cated is a safe procedure with rare direct complications, and 2)
jugular vein (43.4%), followed by the right axillary vein CKD and smoking are predictive of increased risk of early
(19.7%), right subclavian vein (17.8%), left axillary vein mortality in patients undergoing TPPM placement with maxi-
(9.2%), left subclavian vein (4.6%), left internal jugular vein mum length of time to PPM being shorter as eGFR decreases.
(3.9%), right femoral vein (0.08%), and epicardial (0.08%). Temporary pacing with a conventional external generator
Contraindication to permanent pacemaker placement and temporary pacing wires exposes a patient to additional risks
included active infection (49.3%, n = 75), emergent place- including cardiac perforation, disconnection of wires from the
ment (23.7%, n = 36), perioperative (8.6%, n = 13), TAVR generator, and lead dislodgement [1]. In addition, nursing
(7.9%, n = 12), and other (5.9%, n = 9). expertise is necessary to properly handle and care for a

Table 2
Patients characteristics and risk of early morality.
Hazard ratio⁎ Lower 95% Confidence interval Upper 95% Confidence interval p-value
Age (per year) 1.004 0.984 1.025 0.698
Female (vs. male) 0.762 0.398 1.459 0.412
White (vs. non-white) 0.678 0.267 1.719 0.413
Hypertension 0.589 0.284 1.221 0.155
Diabetes 0.587 0.276 1.248 0.166
Dyslipidemia 0.549 0.246 1.224 0.143
Ever smoker 1.964 1.006 3.834 0.048
Congestive heart failure 1.797 0.869 3.716 0.114
Coronary artery disease 1.063 0.517 2.188 0.868
Chronic kidney disease
Stage III (vs eGFR N=60) 2.293 0.951 5.528 0.064
Stage IV (vs eGFR N=60) 8.206 3.673 18.332 b.001
Indication of pacemaker
SA nodal disease (vs. AV node disease) 1.216 0.604 2.449 0.584
Others (vs. AV node disease) 0.565 0.198 1.615 0.287
eGFR = estimated glomerular filtration rate in mL/min/1.73 m2 AV = atrioventricular.
⁎ Calculated from multivariable adjusted Cox proportional hazards analysis that included all the variables in the table.
F.Z. Dawood et al. / Journal of Electrocardiology 49 (2016) 530–535 533

Fig. 1. Kaplan Meier curves for survival probability by chronic kidney disease status.

temporary pacemaker to prevent pacing failure [18,19]. Patient permanent pacemaker for an extended time in the setting of a
mobility is also significantly limited while a conventional pacemaker pocket infection has been shown safe [5,20].
temporary pacing lead is in place. Placement of a temporary Overall, we found morbidity associated with the procedure

Fig. 2. Kaplan Meier curves for survival probability by smoking status.


534 F.Z. Dawood et al. / Journal of Electrocardiology 49 (2016) 530–535

Fig. 3. Kaplan Meier curves for survival probability by dyslipidemia status.

was 1.9% with no deaths directly attributed to placement of the In conclusions, although there is a relatively high early
device. Despite having an external generator, with trained mortality within 6 months after placement of a temporary-
operators and sterile technique, there appears to be a very low permanent pacemaker, there appears to be a very low
infection rate. Even among those who were discharged home complication rate associated with the procedure itself. Patients
with the external device in place, there were no documented with a history of CKD and smoking appear to be at a particularly
device infections on follow up. elevated risk of early mortality. Given these results, placement
We have shown that patients undergoing placement of a of a temporary-permanent pacemaker should be viewed as a safe
temporary permanent pacemaker have a high mortality rate and effective procedure but should be used with caution in those
in general, 29.6% at 6 months. Nevertheless, there appears to with renal dysfunction or history of smoking.
be a very low complication rate associated with the
procedure itself. The high mortality rate likely reflects the
complex nature of our patient population with multiple
Disclosures
comorbidities and the degree of illness for which they
initially present. We have shown, however, that there are at None.
least two predictors of increased risk of early mortality; CKD
and smoking. When evaluating a patient for a TPPM, it may
be prudent to consider CKD and smoking as risk factors for References
increased mortality.
[1] López Ayerbe J, Villuendas Sabaté R, García García C, et al.
Our results should be read in the context of certain limitations Temporary pacemakers: current use and complications. Rev Esp
including the relatively small sample size, and mostly white Cardiol 2004;57:1045–52.
male population from a single tertiary care center. We have no [2] Hynes JK, Holmes DR, Harrison CE. Five-year experience with
evidence that this mortality is a complication related to the temporary pacemaker therapy in the coronary care unit. Mayo Clin
procedure and hence our prediction models may be less useful in Proc 1983;58:122–6.
[3] Kornberger A, Schmid E, Kalender G, et al. Bridge to recovery or
the contest of predicting poor outcomes in those undergoing permanent system implantation: An eight-year single-center experi-
TPPM. Nevertheless, since the focus was on early (6-months) ence in transvenous semipermanent pacing. Pacing Clin Electrophysiol
mortality, it is still possible that death could be a 2013;36:1096–103.
procedure-related complication. These limitations may affect [4] Kawata H, Pretorius V, Phan H, et al. Utility and safety of temporary
pacing using active fixation leads and externalized re-usable permanent
generalizability of our results. In addition, given that this was a
pacemakers after lead extraction. Europace 2013;15(9):1287–91.
retrospective study, we were forced to rely on documentation [5] Chihrin SM, Mohammed U, Yee R, et al. Utility and cost effectiveness
provided by previous providers therefore its accuracy cannot of temporary pacing using active fixation leads and an externally
be confirmed. placed reusable permanent pacemaker. Cardiol 2006;98:1613–5.
F.Z. Dawood et al. / Journal of Electrocardiology 49 (2016) 530–535 535

[6] Harrigan RA, Chan TC, Moonblatt S, Vilke GM, Ufberg JW. [13] Murphy JJ. Current practice and complications of temporary
Temporary transvenous pacemaker placement in the emergency transvenous cardiac pacing. BMJ 1996;312:1134.
department. J Emerg Med 2007;32:105–11. [14] Sterliński M, Przybylski A, Maciag A, et al. Subacute cardiac
[7] Silver MD, Goldschlager N. Temporary transvenous cardiac pacing in perforations associated with active fixation leads. Europace
the critical care setting. Chest 1988;93:607–13. 2009;11:206–12.
[8] de Cock CC, Van Campen CM, In't Veld JA, Visser CA. Utility and [15] Boerlage-VAN Dijk K, Kooiman KM, Yong ZY, et al. Predictors and
safety of prolonged temporary transvenous pacing using an active- permanency of cardiac conduction disorders and necessity of pacing
fixation lead: comparison with a conventional lead. Pacing Clin after transcatheter aortic valve implantation. Pacing Clin Electro-
Electrophysiol 2003;26:1245–8. physiol 2014;37:1520–9.
[9] Lepillier A, Otmani A, Waintraub X, Ollitrault J, Le Heuzey J, [16] Rastan AJ, Doll N, Walther T, Mohr FW. Pacemaker dependent
Lavergne T. Temporary transvenous VDD pacing as a bridge to patients with device infection – a modified approach. Cardiothorac
permanent pacemaker implantation in patients with sepsis and Surg 2005;27:1116–8.
haemodynamically significant atrioventricular block. Europace [17] Braun MU, Rauwolf T, Bock M, et al. Percutaneous lead implantation
2012;14:981–5. connected to an external device in stimulation-dependent patients with
[10] Austin JL, Preis LK, Crampton RS, Beller GA, Martin RP. Analysis of systemic infection – a prospective and controlled study. Cardiothorac
pacemaker malfunction and complications of temporary pacing in the Surg 2005;27:1116–8.
coronary care unit. Cardiol 1982;49:301–6. [18] Overbay D, Criddle L. Mastering temporary invasive cardiac pacing.
[11] Costa R, Da Silva KR, Rached R, et al. Prevention of venous Crit Care Nurse 2004;24:25–32.
thrombosis by warfarin after permanent transvenous leads implantation [19] Eiken F. How to care for patients with temporary cardiac pacemakers.
in high-risk patients. Pacing Clin Electrophysiol 2009;32:S247–51. Adv Clin Care 1989;4:18–22.
[12] Aliyev F, Celiker C, Türkoğlu C, Karadağ B, Yıldız A. Perforations of [20] Kornberger A, Schmid E, Kalender G, et al. Bridge to recovery or
right heart chambers associated with electrophysiology catheters and permanent system implantation: An eight-year single-center experi-
temporary transvenous pacing leads. Turk Kardiyol Dern Ars ence in transvenous semipermanent pacing. Pacing Clin Electrophysiol
2011;39:16–22. 2013;36:1096–103.

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