HPO 011

25th FAPA Congress 2014Risk factors of pacemaker implantation 

i f tiinfection: a single centre experience

I ti Abd l H li Z ki1 N N di h S t1 N h E 2 J lih h Id i 1 N i H i 3 Li Si Y 1 3 Li H B 2 3Izzati Abdul Halim Zaki1, Nor Nadiah Saat1, Norah Eyon2, Jalihah Idris1, Narwani Hussin3¸ Liau Siow‐Yen1,3, Liew Houng‐Bang2,31Pharmacy Department, 2Cardiology Department, 3Clinical Research Centre, Hospital Queen Elizabeth II, Kota Kinabalu

Table of contentsTable of contents

IntroductionIntroduction

Justification idea

ObjectiveObjective

Methodology

ResultResult

Discussion

LimitationLimitation

Conclusion

Figure 1: Pacemaker news in Malaysia

INTRODUCTIONINTRODUCTION

IntroductionIntroduction

• Implantation of permanent pacemaker hasImplantation of permanent pacemaker hasbeen widely implemented worldwide as thetreatment of choice for various cardiac rhythmdisturbances.1,2

Th t f PPM i f ti h b i d• The rate of PPM infection has been increasedproportionately to the device placement.1,2

1 Sohail M R Uslan D Z Khan A H A F P Hayes D L Wilson W R et al (2007) Risk Factor Analysis of Permanent1. Sohail, M. R., Uslan, D. Z., Khan, A. H., A, F. P., Hayes, D. L., Wilson, W. R., et al. (2007). Risk Factor Analysis of Permanent Pacemaker Infection. Clinical Infectious Diseases , 166-73.

2. Johansen, J. B., Jorgensen, O. D., Moller, M., Arnsbo, P., Mortensen, P. T., & Nielsen, J. C. (2011). Infection After Pacemaker Implantation: Infection Rates and Risk Factors Associated with Infection in a Population-based Cohort Study of 46299 Consecutive Patients. European Heart Journal , 991-998.

Literature review• PPM infection is a serious complication where itmay occur either as a surgical site infection (SSI),may occur either as a surgical site infection (SSI),occurring within 1 year after implantation or aslate‐onset lead endocarditis.1

• Clinical evidence of PPM infection included locali f i fl ti t th t k tsigns of inflammation at the generator pocket,including erythema, warmth, fluctuance, wounddehiscence erosion tenderness or purulentdehiscence, erosion, tenderness, or purulentdrainage.2

1. Johansen, J. B., Jorgensen, O. D., Moller, M., Arnsbo, P., Mortensen, P. T., & Nielsen, J. C. (2011). Infection After Pacemaker Implantation: Infection Rates and Risk Factors Associated with Infection in a Population-based Cohort Study of 46299 ConsecutivePatients. European Heart Journal , 991-998.

2. Sohail, M. R., Uslan, D. Z., Khan, A. H., Friedman, P. A., Hayes, D. L., Wilson, W. R., et al. (2007). Management and Outcome ofPermanent Pacemaker and Implantable Cardioverte-Defibrilllator Infection. Journal of The American College of Cardiology , 1851-9.

f f• Several factors associated with a greater risk ofPPM infection such as previous PPM infection,

li l t ti t idmalignancy, long‐term corticosteroid use,multiple device revisions, and a lack of antibioticprophylaxis at the time of PPM placement 1,2prophylaxis at the time of PPM placement.1,2

• Use of antibiotic prophylaxis prior to PPMp p y pimplantation had a protective effect. 1,2

1. Sohail, M. R., Uslan, D. Z., Khan, A. H., A, F. P., Hayes, D. L., Wilson, W. R., et al. (2007). Risk Factor Analysis of Permanent Pacemaker Infection. Clinical Infectious Diseases , 166-73.

2. Johansen, J. B., Jorgensen, O. D., Moller, M., Arnsbo, P., Mortensen, P. T., & Nielsen, J. C. (2011). Infection After Pacemaker Implantation: Infection Rates and Risk Factors Associated with Infection in a Population-based Cohort Study of 46299 Consecutive Patients. European Heart Journal , 991-998.

Justification idea• Recently, there are 224% increased number ofinfection after PPM implantation.1,2

• This research is done to evaluate any possible riskf h ib h i f ifactor that may contribute to the infectiouscomplication after PPM implantation.

• The findings of the research should help to thedevelopment of strategies to minimize themodifiable risk variables.

1. Symeon, M., & Dimitris, P. Infections of Permanent Pacemakers and Implantable Cardioverter-Defibrillators. Greece: Aristotle University of Thessaloniki.

2. Patel, J. (2011, June). Infection incidence for pacemaker implants increased from 1993 to 2008. Cardiology Today. Retrieved from http://www.healio.com/cardiology/arrhythmia-disorders/news/print/cardiology-today/%7Bd529f070-4eea-43a8-ae19-401c90c42a1a%7D/infection-incidence-for-pacemaker-implants-increased-from-1993-to-2008

ObjectiveObjective

To determine the associated factors ofpacemaker implantation infectionpacemaker implantation infection.

METHODMETHOD 

• Study design

Case control study

• Study period 

M h 2013 A t 2013March 2013 – August 2013

• Subject

All patient underwent pacemaker implantation fromAll patient underwent pacemaker implantation from January 2011 – July 2013 in Hospital Queen Elizabeth II

• Data collection method

Checklist method

• Sample size 1

17 case and 85 control 

1. Dupont WD, Plummer WD: "Power and Sample Size Calculations: A Review and Computer Program", Controlled Clinical Trials 1990; 11:116-28.

Inclusion and Exclusion Criteria

Inclusion criteria Exclusion criteria

Patients underwent pacemaker implantation between 

January 2011 – July 2013None

January 2011  July 2013

Table 1

Sample size requirementSample size requirementα = 0.05

β = 80%

p0 = 0.02 1

ψ = 13.9

m = 5 2

Sample size3 = 17 case and 85 control 

p0 = probability of exposure in controls

1. Sohail, M. R., Uslan, D. Z., Khan, A. H., A, F. P., Hayes, D. L., Wilson, W. R., et al. (2007). Risk Factor Analysis of Permanent Pacemaker Infection. Clinical Infectious Diseases , 166-73.

2 Oliveira J C Martinelli M Nishioka S A Varejao T Uipe D Pedrosa A A Danik S B (2008) Efficacy of2. Oliveira, J. C., Martinelli, M., Nishioka, S. A., Varejao, T., Uipe, D., Pedrosa, A. A., . . . Danik, S. B. (2008). Efficacy of Antibiotic Prophylaxis Before the Implantation of Pacemakers and Cardioverter-Defibrillators. Circ Arrhythmia Electrophysiol, 29-34.

3. Dupont WD, Plummer WD: "Power and Sample Size Calculations: A Review and Computer Program", Controlled Clinical Trials 1990; 11:116-28.

Variables

DEPENDENTINDEPENDENT 

Host ‐ related PreoperativeProcedure ‐related

Postoperativerelated

• age• sex• weight• renal profile

• fever 24H before procedure• CRP• leucocyte count

• type of pacemaker• pre‐op antibiotic• time of antibiotic given

• pocket hematoma• time of infection to occur• clinical infection

Existence of infection at Day 10 post‐

• renal profile • DM• COPD• CHF, LVEF <35%• hypothyroidism

• leucocyte count• temporary PM• implants/  replacement• heparin/clexane

given• time of skin incision• time procedure start• time procedure end

• clinical infection• wound inspection

10 post‐implantation

• malignancy• immunosuppressive drugs• indication• corticosteroid usagecorticosteroid usage• anticoagulant usage• antiplatelet usage

Table 2

RESULTRESULT

Demographic data

VariableCase, n=12

(%)Control, n=100

(%) P valuea

Mean age (SD) 66 (10.45) 63 (015.00) 0.607

GenderMale 7 (12.96) 47 (087.04)

0.458Female 5 (08.62) 53 (091.38)

Indication

Complete AV block 5 (08.33) 55 (091.67)

0.186Sick Sinus Syndrome 5 (11.36) 39 (088.64)

Brady‐Tachy Syndrome 1 (16 67) 5 (083 33)Brady Tachy Syndrome 1 (16.67) 5 (083.33)

Others  1 (50.00) 1 (050.00)

ConcurrentCoticosteroid usage 0 (00.00) 2 (100.00) 1.000

Concurrent medications

Anticoagulant usage 2 (16.67) 10 (083.33) 0.658

Antiplatelet usage 6 (10.71) 50 (089.29) 1.000

Table 4

NOTE. Data are no. (%) of patients, unless otherwise indicated.a Fisher’s exact test

Table 4

VariableCase, n=12

(%)Control, n=100

(%) P valuea

Concurrent/recent smoker (<30 days) 1 (06.25) 15 (093.75) 0.533

Hypertension  9 (10.23) 79 (089.77) 0.750

Dyslipidemia 7 (11.29) 55 (088.71) 0.826

Family history of premature CAD 0 (00.00) 20 (100.00) 0.087

Ob i (0 ) 3 (092 86) 0 636Concurrent illness

Obesity 1 (07.14)  13 (092.86) 0.636

Diabetes mellitus 4 (10.81) 33 (089.19) 0.981

COPD 1 (20 00) 4 (080 00) 0 439COPD 1 (20.00) 4 (080.00) 0.439

CHF (LVEF <35%) 0 (00.00) 3 (100.00) 1.000

Hypothyoidism 0 (00.00) 5 (100.00) 1.000

Malignancy 0 (00.00) 1 (100.00) 1.000

Table 5

NOTE. Data are no. (%) of patients, unless otherwise indicated. CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; CHF, chronic heart failure.a Fisher’s exact test

Table 5

Antibiotic UsageAntibiotic Usage

Figure 4: Types of antibiotic used preoperative Figure 5: Types of antibiotic used postoperative

Logistic Regression analysisLogistic Regression  analysis

Simple logistic regression

Variables Crude OR (95% CI OR) X² stat. (df) a P valuea

Postoperative antibioticsPostoperative antibiotics

Amoxicillin/Clavulanic Acid 0.264 (1.107; 12.945) 4.552 (1) 0.034

Cefazolin 5.750 (1.417; 23.340) 5.242 (1) 0.014

Cefoperazone 0.198 (0.050; 00.788) 4.637 (1) 0.022

Duration of procedure  1.016 (1.004; 01.028) 6.756 (1) 0.010

a Likelihood Ratio (LR) test

Table 6

Likelihood Ratio (LR) test

Logistic Regression analysisLogistic Regression  analysis

Multiple logistic regression

i bl dj ( ) ²Variables Adj. OR (95% CI OR) X² stat. (df) a P valuea

Postoperative antibiotics

Cefazolin 0.196 (0.046; 0.842) 4.336 (2) 0.028

Duration of procedure  1.016 (1.003; 1.029) 6.756 (1) 0.015

Adj. OR = Adjusted odds ratio   a Likelihood Ratio (LR) test

Table 7

DISCUSSIONDISCUSSION

• Longer procedural duration was associated with• Longer procedural duration was associated withimplant infections consistent with a study done in 2003by Oliveira et al¹y

• Similar with a study done by Bertaglia et. al, our studyalso found that cefazolin used postoperatively had aalso found that cefazolin used postoperatively had aprotective effect against pacemaker infection.

• Infections may be associated with proceduralcomplexity, operator experience and choice ofantibiotics that deserve further studyantibiotics that deserve further study

1. Oliveira, J. C., Martinelli, M., Nishioka, S. A., Varejao, T., Uipe, D., Pedrosa, A. A., . . . Danik, S. B. (2008). Efficacy of Antibiotic Prophylaxis Before the Implantation of Pacemakers and Cardioverter‐Defibrillators. Circ Arrhythmia Electrophysiol, 29‐34.

2. Bertaglia, E., Zerbo, F., Zardo, S., Barzan, D., Zoppo, F., & Pascotto, P. (2006). Antibiotic Prophylaxis with a Single Dose of Cefazolin During Pacemaker Implantation: Incidence of Long‐Term Infective Complications. PACE, 29‐33.

LIMITATIONLIMITATION

• Retrospective study have inherent limitationRetrospective study have inherent limitation 

• Incomplete secondary data 

• Variation between various pacemaker devices  

CONCLUSIONCONCLUSION

• Longer procedural duration of the implantation is i t d ith th k i f tiassociated with the pacemaker infection

• Postoperatively usage of cefazolin has a protective effect against pacemaker infectioneffect against pacemaker infection

H l t th d l t f t t i t i i i• Help to the development of strategies to minimize pacemaker infections at our centre.

• Identify patients who are at increased risk of• Identify patients who are at increased risk of developing infection

THANK YOUTHANK YOU