25 FAPA Congress 2014
Transcript of 25 FAPA Congress 2014
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
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