25 th FAPA Congress 2014

Transcription

1 HPO th FAPA Congress 2014 Risk factors of pacemaker implantation infection: a single centre experience Izzati tiabdul Hli Halim Zaki Zki 1, Nor NdihS Nadiah Saat 1, Norah heyon 2, Jalihah h Idris 1, Narwani ihussin 3 3 Liau Siow Yen 13 1,3, Liew Houng Bang 23 2,3 1 Pharmacy Department, 2 Cardiology Department, 3 Clinical Research Centre, Hospital Queen Elizabeth II, Kota Kinabalu

2 Table of contents Introduction Justification idea Objective Methodology Result Discussion Limitation Conclusion

3 Figure 1: Pacemaker news in Malaysia

4 INTRODUCTION

5 Introduction Implantation of permanent pacemaker has been widely implemented worldwide as the treatment of choice for various cardiac rhythm disturbances. 1,2 The rate of PPM infection has been increased proportionately 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 Permanent 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, 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 Consecutive Patients. European Heart Journal,

6 Literature review PPM infection is a serious complication where it may occur either as a surgical site infection (SSI), occurring within 1 year after implantation or as late onset lead endocarditis. 1 Clinical evidence of PPM infection included local signs of inflammation at the generator pocket, kt including erythema, warmth, fluctuance, wound dehiscence, erosion, tenderness, or purulent drainage 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 Consecutive Patients. European Heart Journal, Sohail, M. R., Uslan, D. Z., Khan, A. H., Friedman, P. A., Hayes, D. L., Wilson, W. R., et al. (2007). Management and Outcome of Permanent Pacemaker and Implantable Cardioverte-Defibrilllator Infection. Journal of The American College of Cardiology,

7 Several factors associated with a greater risk of PPM infection such as previous PPM infection, malignancy, long term corticosteroid t id use, multiple device revisions, and a lack of antibiotic prophylaxis at the time of PPM placement. 1,2 Use of antibiotic prophylaxis p prior to PPM implantation 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, 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 Consecutive Patients. European Heart Journal,

8 Justification idea Recently, there are 224% increased number of infection after PPM implantation. 1,2 This research is done to evaluate any possible risk factor that may contribute to the infectious i complication after PPM implantation. The findings of the research should help to the development of strategies to minimize the modifiable 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 Cardiology Today. Retrieved from

9 Objective To determine the associated factors of pacemaker implantation infection.

10 METHOD

11 Study design Case control study Study period March h2013 August t2013 Subject All 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:

12 Inclusion and Exclusion Criteria Inclusion criteria Patients underwent pacemaker implantation between January 2011 July 2013 Exclusion criteria None Table 1

13 Sample size requirement α = 0.05 β = 80% p 0 = ψ = 13.9 m = 5 2 Sample size 3 = 17 case and 85 control p 0 = 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, 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, Dupont WD, Plummer WD: "Power and Sample Size Calculations: A Review and Computer Program", Controlled Clinical Trials 1990; 11:

14 Variables DEPENDENT Host related Preoperative INDEPENDENT Procedure related Postoperative Existence of infection at Day 10 postimplantation age sex weight renal profile DM COPD CHF, LVEF <35% hypothyroidism malignancy immunosuppressive drugs indication corticosteroid usage anticoagulant usage antiplatelet usage fever 24H before procedure CRP leucocyte count temporary PM implants/ replacement heparin/clexane type of pacemaker pre op antibiotic time of antibiotic given time of skin incision time procedure start time procedure end pocket hematoma time of infection to occur clinical infection wound inspection Table 2

15 RESULT

16 Demographic data Variable Case, n=12 (%) Control, n=100 (%) P value a Mean age (SD) 66 (10.45) 63 (015.00) Gender Indication Concurrent medications Male 7 (12.96) 47 (087.04) Female 5 (08.62) 53 (091.38) Complete AV block 5 (08.33) 55 (091.67) Sick Sinus Syndrome 5 (11.36) 39 (088.64) Brady Tachy Syndrome 1 (16.67) 67) 5 (083.33) 33) Others 1 (50.00) 1 (050.00) Coticosteroid usage 0 (00.00) 2 (100.00) Anticoagulant usage 2 (16.67) 10 (083.33) Antiplatelet usage 6 (10.71) 50 (089.29) Table 4 NOTE. Data are no. (%) of patients, unless otherwise indicated. a Fisher s exact test

17 Variable Case, n=12 (%) Control, n=100 (%) P value a Concurrent/recent smoker (<30 days) 1 (06.25) 15 (093.75) Hypertension 9 (10.23) 79 (089.77) Dyslipidemia 7 (11.29) 55 (088.71) Family history of premature CAD 0 (00.00) 20 (100.00) Concurrent illness Obesity 1 (07.14) 13 (092.86) Diabetes mellitus 4 (10.81) 33 (089.19) COPD 1 (20.00) 00) 4 (080.00) 00) CHF (LVEF <35%) 0 (00.00) 3 (100.00) Hypothyoidism 0 (00.00) 5 (100.00) Malignancy 0 (00.00) 1 (100.00) 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

18 Antibiotic Usage Figure 4: Types of antibiotic used preoperative Figure 5: Types of antibiotic used postoperative

19 Logistic Regression analysis Simple logistic regression Variables Crude OR (95% CI OR) X² stat. (df) a P value a Postoperative antibiotics Amoxicillin/Clavulanic Acid (1.107; ) (1) Cefazolin (1.417; ) (1) Cefoperazone (0.050; ) (1) Duration of procedure (1.004; ) (1) a Likelihood Ratio (LR) test Table 6

20 Logistic Regression analysis Multiple logistic regression Variables ibl Adj. OR (95% CI OR) ) X² stat. (df) a P value a Postoperative antibiotics Cefazolin (0.046; 0.842) (2) Duration of procedure (1.003; 1.029) (1) Adj. OR = Adjusted odds ratio a Likelihood Ratio (LR) test Table 7

21 DISCUSSION

22 Longer procedural duration was associated with implant infections consistent with a study done in 2003 by Oliveira et al¹ Similar with a study done by Bertaglia et. al, our study also found that cefazolin used postoperatively had a protective effect against pacemaker infection. Infections may be associated with procedural complexity, operator experience and choice of antibiotics 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, 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,

23 LIMITATION

24 Retrospective study have inherent limitation Incomplete secondary data Variation between various pacemaker devices

25 CONCLUSION

26 Longer procedural duration of the implantation is associated with the pacemaker infection Postoperatively usage of cefazolin has a protective effect against pacemaker infection Hl Help to the development of strategies t to minimize i i pacemaker infections at our centre. Identify patients who are at increased risk of developing infection

27 THANK YOU