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Contact Information: Minkey Wungwattana, PharmD Maine Medical Center – Department of Pharmacy 22 Bramhall Portland, ME 04102 Tel: (207) 662-1008 | Fax: (207) 662-6619 [email protected] Comparison of Peri-Operative Antimicrobial Prophylaxis Regimens in Patients Receiving Ventricular Assist Devices I-wen Wang, MD, PhD IU Health Methodist Hospital – Department of Cardiothoracic Transplantation 1801 N. Senate Blvd, MPC2 Suite 3300 Indianapolis, IN 46202 Tel: (317) 963-1010 | Fax: (317) 962-2659 [email protected] Minkey Wungwattana, PharmD1, Thomas C. Wozniak, MD2, Matthew F. Wack, MD2, David W. Smith, PharmD, BCPS AQ-ID3, Michael J. Latran, PharmD3, Kevin Chen, BS2, Elizabeth M. Amerman, BSN, RN2, Tracie L. Layne, MSN, RN, CCRN2, Courtney A. Sheehan, PharmD3, BCPS, I-wen Wang, MD, PhD2 1Department of Pharmacy, Maine Medical Center, Portland, ME; 2Department of Cardiothoracic Transplantation, IU Health, Indianapolis, IN; 3Department of Pharmacy, IU Health, Indianapolis, IN Background Ventricular assist device (VAD)-associated infections significantly increase morbidity and mortality, having been identified as the primary cause of death in 16% of left ventricular assist device recipients from 2006 to 2009.1 Despite recognizing the need to prevent post-implantation infectious complications, there remains a lack of consensus for the recommended peri-operative antimicrobial prophylaxis for VAD recipients.2,3,4 Various antimicrobial prophylaxis regimens have been described among many VAD implantation centers, varying from single-agent regimens (9.5%) to four-agent regimens (42.9%).1 Table 1. Patient Demographics Basic Demographics Type of Implantation With concerns of multi-drug resistant organisms on the rise, high importance continues to be placed on providing adequate peri-operative antimicrobial prophylaxis while balancing the risk of resistance development. Objective Results Compare clinical outcomes measured by infection rates between a two-drug (TDR) vs. a multi-drug (MDR) (consisting of 3 or 4 agents) antimicrobial prophylaxis regimen among ventricular assist device patients at Methodist Hospital (MH) in Indianapolis, IN. Methods Study Design Inclusion Criteria • Retrospective, non-randomized, single center analysis of VAD recipients at Methodist Hospital in Indianapolis, IN from May 2008 to June 2012. • Age ≥18 years • Implantation of LVAD, RVAD, or BiVAD at MH Exclusion Criteria • Incomplete electronic medical records (with administered peri-operative medications) Primary Endpoint • Surgical site infections rates • Bloodstream, respiratory, urinary, gastrointestinal, cardiovascular, and skin/soft tissue infection rates Secondary Endpoint(s) • Cumulative infection events per patient • Mortality at 1- and 6- months post-op Statistical Analysis • Descriptive statistics for baseline demographics • Student’s t-test for continuous variables, Chi-squared (χ2) for categorical variables • Kaplan-Meier analysis to assess time to first surgical site infection event Multi-Drug Regimen, n = 31 Two-Drug Regimen, n = 56 p Sex: male, frequency (%) 30 (96.8%) 40 (71.4%) 0.004 Age: mean years ± SD 53.4 ± 12.6 53.6 ± 12.4 0.943 BMI: mean ± SD 28.2 ± 4.6 28.7 ± 5.4 Destination Therapy (DT) 9 (29.0%) Bridge to Transplant (BTT) Bridge to Decision (BTD) Device Type Indication for VAD Results (cont.) Figure 3. Time To First Surgical Site Infection Table 3. Isolated Microorganisms MDR, n = 53 TDR, n = 71 p Coagulase-neg staph. 4 6 0.855 0.665 Staphylococcus aureus 14 5 0.003 33 (58.9%) 0.008 Enterococcus spp. 0 10 0.004 20 (64.5%) 20 (35.7%) 0.009 Clostridium difficile 5 1 0.039 2 (6.5%) 2 (3.6%) 0.515 Corynebacterium spp. 1 0 0.245 Streptococci spp. 0 1 0.385 24 (45.3%) 23 (32.4%) -- Gram Positive Open 0 (0%) 1 (1.7%) 0.453 RVAD 0 (0%) 2 (3.6%) 0.293 BiVAD 2 (6.5%) 1 (1.7%) 0.262 Pseudomonas aeruginosa 5 12 0.232 LVAD 29 (93.5%) 53 (94.6%) 0.960 Serratia marcescens 6 4 0.250 Ischemic Heart Disease 14 (45.2%) 27 (48.2%) 0.843 Klebsiella spp. 6 16 0.106 Enterobacter spp. 3 8 0.277 Non-Ischemic Heart Disease 17 (54.8%) 29 (51.8%) 0.851 Escherichia coli 1 2 0.738 Citrobacter spp. 2 1 0.397 Proteus mirabilis 3 3 0.713 Moraxella catarrhalis 1 0 0.245 27 (50.9%) 46 (64.8%) -- 2 (3.8%) 2 (2.8%) 0.766 RVAD = right ventricular assist device, Bi-VAD = bi-ventricular assist device, LVAD = left ventricular assist device Table 2. Types of Infections Multi-Drug Regimen, n = 59 Two-Drug Regimen, n = 71 p 11 (18.6%) 6 (8.5%) 0.085 Surgical Site Infections (SSI) Total Freedom from Surgical Site Infection Gram Negative Total Fungus Blood Stream Infections (BSI) 9 (15.3%) 16 (22.5%) 0.294 Respiratory Tract Infections (RTI) / Pneumonia 16 (27.1%) 20 (28.2%) 0.897 Urinary Tract Infections (UTI) 12 (20.3%) 27 (38.0%) 0.029 Gastrointestinal Tract Infections (GI) 7 (11.9%) 1 (1.4%) 0.014 Cardiovascular System Infections (CVI) 2 (3.57%) 0 (0%) 0.119 Skin and Soft Tissue Infections (SSTI) 2 (3.57%) 1 (1.4%) 0.453 Candida spp. Discussion Overall, we did not detect a significant statistical difference in surgical site infection rates between a multi-drug prophylaxis regimen and a two-drug prophylaxis regimen. Despite a large decrease in fluconazole use prophylactically, there was no difference detected in the rate of fungal infections in VAD recipients. The shift from a MDR to a TDR resulted in a statistically significant increase in UTIs. Nevertheless, we also detected a significant decrease in GI tract infections, the majority of which being Clostridium difficile colitis (75% of all GI infections). While there remains a lack of consensus for ventricular assist device implantation prophylaxis, our study shows that a two-drug regimen may be effective in preventing surgical site infections while limiting exposure to additional antimicrobial agents. Figure 2. Antimicrobial Selection Distribution Figure 1. Patient Allocation References 1. 2. 3. 4. **Note: Second agent in MDR cumulative > 100% due to two patients receiving 5 agents (β-lactam + FQ, as second agent) Walker PC, et al. Surgical infection prophylaxis for left ventricular assist device implantation. J Card Surg 2011 Jul;26(4):440-3. Engleman R, et al. The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part II: Antibiotic Choice. Ann Thorac Surg 2007 Apr;83(4):1569-76. Acharya MN, et al. What is the optimum antibiotic prophylaxis in patients undergoing implantation of a left ventricular assist device? Interact Cardiovasc Thorac Surg 2012 Feb;14(2):209-14. Holman WL, et al. Infection in permanent circulatory support: experience from the REMATCH trial. J Heart Lung Transplant 2004 Dec;23(12):135965. The authors do not have any financial disclosures or conflicts of interest.