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Reducing Surgical Site Infection in Cardiac Surgery Scott Schubach, MD Chairman, Dept. of Thoracic & Cardiovascular Surgery Winthrop University Hospital Associate Professor, Surgery Stony Brook School of Medicine Presentation sponsored by ConvaTec Introduction Curriculum Vitae Education: – Medical degree from Baylor College of Medicine – Trained in general surgery at Dartmouth Hitchcock Medical Center – Trained in cardiac surgery at University of Pittsburgh Physician at Winthrop University Hospital since 1991 Chairman of Dept. of Thoracic & Cardiovascular Surgery since 2001 Introduction Winthrop University Hospital Teaching hospital Affiliate of SUNY Stony Brook Located in Mineola, NY 520 open heart procedures done annually by group of 4 surgeons 1 Surgical Site Infections (SSI) Defined by CDC At or near operative site Occurs in post-op period Reportable if it occurs within 30 days post-op Three major sources Patient Healthcare Team OR environment Most common pathogens for sternal wound infections1 Staph aureus Staph epidermis 1Singh, K et al, Overview and Management of Sternal Wound Infection, Seminars in Plastic Surgery, Volume 25, Number 1 2011 SSIs: Scope of the Problem Surgical wound infections MOST common infection in surgical patients Common nosocomial infection Associated with substantial morbidity and mortality1 – 60% more likely ICU admit – 2x increase in mortality during perioperative period post-op LOS1 treatment costs1 1Banbury, MK, Experience in prevention of sternal wound infections in nasal carriers of Staphylococcus aureus, Surgery, 2003 Nov SSIs: Scope of the Problem Cardiac Surgery Annual US procedural volume: – >600,000 cardiac procedures1 – 395,000 CABG procedures2 3.5% infection rate postCABG procedures3 Cost to treat mediastinitis estimated to be $40,000 $50,0003 1Elgharably H, et al. First Evidence of Sternal Wound Biofilm Following Cardiac Surgery, PLoS One, 2013 Aug 1;8(8), 2http://www.cdc.gov/nchs/fastats/insurg.htm, 3http://www.infectioncontroltoday.com/articles/2008/03/cabg-infections-are- costly-and-dangerous-staffs-m.aspx 2 Sternal Wound Infections (SWI) Risk Factors Obesity Renal insufficiency Diabetes COPD Peripheral Vascular Disease Existing pre-op infection Steroid use Malnutrition Sternal Wound Infections Incidence of Sternal Wound Infection (SWI): 1-8%1 SWI mortality rates reaching 40%1 Treatment requires:1 – Prolonged antibiotic courses – Repeated surgical interventions – Longer hospital stay Can occur in any procedure requiring median sternotomy 1 Elgharably H, et al. First Evidence of Sternal Wound Biofilm Following Cardiac Surgery, PLoS One, 2013 Aug 1;8(8) Deep Sternal Wound Infections Increased hospital LOS > 2 full weeks compared to any other post-op complication1 Associated with other complications such as:1 – Prolonged ventilation – Bleeding – Renal failure – Atrial fibrillation – Increased rates of stroke – Need for inotropic or mechanical cardiac support 1Atkins, Z, Wolfe, W, Sternal Wound Complications following Cardiac Surgery, www.intechopen.com 3 Reimbursement Challenges No CMS reimbursement for treatment of: SSI, mediastinitis, following Coronary Artery Bypass Graft (CABG) SSI following Cardiac Implantable Electronic Device (CIED) http://www.cms.gov/HospitalAcqCond State Reporting of SSI’s Government Oversight and Physician Data Tracking Twenty one (21)states require hospitals to report surgical site infection, 14 states so far have posted the information publicly Report and data available to public- CA, OR, WA, CO, IL, MO, PA, OH, SC, NJ, NY, MA, VT And NH http://www.ama-assn.org/amednews/2012/04/02/prsb0402.htm Winthrop Story Increased Sternal Wound Infection rate Infection rate is state and patient reportable Hospitals do not get paid for Sternal Wound Infection readmissions Task force formed to reduce incidence of SWI 4 Evaluated Current Practices Operating room team’s sterile technique Hand washing technique Room ventilation Instrument sterilization Operating room traffic Baseline SWI Prevention Strategy Adherence to core pre-operative antibiotic protocols – Administer antibiotics within 1 hour of incision (2 hours for Vancomycin) Approach to SWI Prevention Address all potential sources of infection: Pre-operative Preparation Operating Room Environment Operating Room Team Post-operative Care of Patient and Wounds Patient Co-morbidities 5 Operation Room Environment Limit traffic in and out of OR Operating Room Team 1. 2. 3. Stopped using Avagard gel and returned to practice of scrubbing hands Change gloves more frequently Educated entire team on sterile field Patient 1. 2. 3. 4. Use chlorhexidine to cleanse the skin Apply occlusive dressing, AQUACEL® Ag Surgical, in operating room Dressing left on for 5 days, removed prior to discharge Emphasize at discharge patients can wash over incision with soap and water 6 Considerations When Choosing Surgical Dressing 1. Permeable: – Moist wound environment promotes healing – Excessive moisture predisposed wounds to maceration and blister formation 2. Barrier: – Prevent microbial ingress into wound – Waterproof to allow showering 3. Occlusive: – Creates hypoxic environment – Accelerates angiogenesis National Institute for Health and Clinical Excellence. Surgical Site Infection Guideline. Gauze Dressings Disadvantages Non-Occlusive Require Frequent Changes – Non-optimal wound environment – Exposure of wound – Adhesive can cause skin injury Not waterproof Occlusive Dressings Improved re-epithelialization Increase in collagen synthesis by 2-6x compared to wounds open to the air Lower rate of wound infection (Hutchinson study 1990) – With occlusive dressing 2.6% – With non-occlusive dressing 7.1% Patel C, Surgical Wound Infections. Current Treatment in Infectious Diseases. 2000;2:147-153. Michie D. Influence of Occlusive and Impregnated Dressings on Incisional Healing: Ann Plastic Surg. 1994. Hulten L. Dressings for Surgical Wounds. Am J Surg. 1994. .Xi et al Wound Repair, 2000. Hutchinson, JJ, McGuckin, M, Occlusive dressings: A microbiologic and clinical review, American Journal of Infection Control, Aug 1990 7 AQUACEL® Ag Surgical Dressing Advantages Barrier to pathogen transmission1 Microbicidal effects of silver ion2 Dressing may be left in place up to 7 days – Less potential hospital exposure of wound – Less potential for pain associated with dressing changes Patient satisfaction – Immediate showering 1 Nelson Laboratories Report, Viral Penetration ASTM Method F1671, Procedure Number :ST0062 Rev07, Protocol Detail Sheet No. 200902139 Rev 1, Laboratory no. 483744, 7th August 2009 2 Jones SA, Bowler PG, Walker M, Parsons D. Controlling wound bioburden with a novel silver-containing Hydrofiber dressing. Wound Repair Regen. 2004;12(3):288-294. Advanced Dressings Hydrofiber® Technology Basic component is cellulose Carboxymethylation* process alters the absorption capacity Hydrofiber® technology allows for fluid to be absorbed directly into the fibers A bond is formed with the absorbed fluid to hold it within the fiber Cellulose fragment *Carboxymethylation: addition of sodium carboxymethyl 1Waring MJ, Parsons D. Physico-chemical characterisation of carboxymethylated spun cellulose fibres. Biomaterials. 2001;22:903-912. AQUACEL® Ag Broad-spectrum Antimicrobial Activity Aerobic Bacteria Antibiotic-resistant Bacteria Staphylococcus aureus (NCTC 8532) MRSA (NCTC 10442) Staphylococcus aureus (clinical isolate) MRSA (NCTC 12232) Pseudomonas aeruginosa (clinical isolate, x2 strains) MRSA (clinical isolate, x8 strains) Enterobacter cloacae (clinical isolate) VRE (NCTC 12201) Streptococcus pyogenes (clinical isolate) VRE (clinical isolate, x2 strains) Klebsiella pnuemoniae (clinical isolate, x3 strains) Serratia marcescens (clinical isolate) Enterococcus faecalis (clinical isolate) Pseudomonas aeruginosa (NTC 8506) Escherichia coli (NCIMB 8545) Escherichia coli (NCIMB 10544) Acinetobacter baumannii (NCIMB 9214 Anerobic Bacteria Yeasts Bacteroides fragilis (clinical isolate) Peptostreptococcus anaerobius (clinical isolate) Candida albicans (NCPF 3179) Candida albicans (NCPF 3265) Clostridium ramosum (clinical isolate) Clostridium clostridioforme (clinical isolate) Clostridium cadaveris (clinical isolate) Clostridium perfringens (clinical isolate) Tissierella praeacute (clinical isolate) Jones SA, Bowler PG, Walker M, Parsons D. Controlling wound bioburden with a novel silver-containing Hydrofiber® dressing. Would Repair Regen. 2004;12:288-294. 8 Hydrofiber® Ag Dressing Bacterial Sequestration & Bactericidal Activity T = 2-3 mins T = 20 mins Green = Alive Red = Dead T = Time in minutes T = 40 mins T = 60 mins Confocal microscopy of Pseudomonas aeruginosa on hydrated Hydrofiber® Ag dressing fiber Newman GR, Walker M, Hobot J, Bowler P. Biomaterials. 2006;27(7):1129-1139. Dressing Change Technique Stretching of hydrocolloid portion (like stretching “taffy”) allows gentle adhesive release from skin. Skin traction is avoided AQUACEL® Ag Surgical Dressing CLINICAL RESULTS 9 Rothman Institute Study Results Retrospective study- Journal of Arthroplasty, 2014 1,778 patients undergoing primary THA/TKA – 875 standard gauze dressing – 903 AQUACEL® Ag Surgical dressing 76% reduction in incidence of surgical site infection in AQUACEL® Ag Surgical group Multivariate analysis – no other independent variables such as patient co-morbidities, age, or BMI impacted the reduction in infection Cai J, Karam JA, Parvizi J, Smith EB, Sharkey PF. The Aquacel® Ag Hydrofiber Wound Dressing with Ionic Silver Reduces the Rate of Acute Periprosthetic Joint Infection Following Total Joint Arthroplasty., Poster presented at 22nd annual AAHKS meeting, Nov 2-4, 2012. OrthoCarolina Clinical Trial Results Prospective Randomized Study – American Journal of Orthopedics, 2015 AQUACEL® Ag Surgical vs. Control 300 pts Midterm analysis of 150 TKA (AAOS 2013) Significant reduction in wound complications (p=0.009) Significantly less # dressing changes (p<0.001) Improved patient satisfaction, perception of hygiene Springer, BD, Beaver, W, Griffin, W, Mason, JB, Dennos, A, Odum, S. The Role of Surgical Dressings in Total Knee Arthroplasty: A Randomized Clinical Trial, Poster presented at 2013 AAOS annual meeting; March 19-23, 2013. Winthrop AQUACEL® Ag Surgical Study Began using AQUACEL® Ag Surgical in May 2011 Conducted a study that involved*: – Retrospective look at 503 patients with sternal incisions covered with sterile 4x4 gauze pads and tape – 208 patients with AQUACEL® Ag Surgical dressing Patients included in the study were any patients with a sternotomy incision *Data not yet submitted for publication 10 Study Results Dressing Type # of Deep SWI % Gauze and Tape 17 0 3.4% AQUACEL® Ag Surgical of Deep SWI 0% To date, approximately 500 patients have had the AQUACEL® Ag Surgical dressing applied to their sternal wound with only 1 deep sternal wound infection. Thank You Appendix 11 AQUACEL® Ag SURGICAL Dressing Skin-friendly hydrocolloid technology flexes with the skin during body movement1,3 Patented Hydrofiber® Technology absorbs and locks in fluid, including harmful bacteria.*2 Unique construction enhances extensibility and flexibility Polyurethane film provides waterproof viral and bacterial barrier *3 *As demonstrated in vitro 1Nelson Laboratories Report, Viral Penetration ASTM Method F1671, Procedure Number :ST0062 Rev07, Protocol Detail Sheet No. 200902139, Rev 1, Laboratory no. 483744, 7th August 2009, 2Walker M, Hobot JA, Newman GR, Bowler PG. Scanning electron microscopic examination of bacterial immobilisation in a carboxymethylcellulose (Aquacel) and alginate dressings. Biomaterials. 2003; 24:883-890.8. 3WHRI 3264 Laboratory Test Comparison of AQUACEL® Surgical Dressing ‘New Design’and the Jubilee Method of Dressing Surgical Wounds . 7th Oct 2009 Dressing With Hydrofiber® Technology * Locks in fluid*1 Sequesters bacteria2,3 Traps harmful enzymes*4,5 ® Hydrofiber dressing Alginate dressing Gauze dressing Sequestration test: a simple experiment using fluids of different colors to demonstrate the ability of dressings to lock in fluid 1Waring 2Walker MJ, Parsons D. Biomaterials. 2001;22:903-912; M, Hobot JA, Newman GR, Bowler PG. Biomaterials. 2003;24(5):883-890; GR, Walker M, Hobot J, Bowler P. Biomaterials. 2006;27(7):1129-1139; MJ, Hermans MHE, Richters CD, Dutrieux RP. J Wound Care. 2002;11(2):113-117; M, Bowler PG, Cochrane CA. Ostomy Wound Manage. 2007;53(9):18-25. 3Newman 4Hoekstra 5Walker *as demonstrated in vitro Hydrofiber® Technology w/ Ionic Silver AQUACEL® Ag Dressing Reduction in bioburden to reduce risk of infection is key to optimal wound healing 1 Ionic silver (Ag) has broad spectrum antimicrobial activity2 Hydrofiber® Ag dressing more effective at killing bacteria in vitro on simulated wounds with uneven contours than a nanocrystalline silvercontaining dressing 4 1Bowler PG, Cochrane CA. Ostomy Wound Manage. 2003:49(8)(suppl):S2-S5; J, Denyer SP. London: MEP Ltd, 2006:7-10.; PG, Jones SA, Walker M, Parsons D. J Burn Care Rehabil. 2004;25:192-196; S, Bowler PG, Walker M. Wounds. 2005;17(9):263-270. 2Maillard 3Bowler 4Jones 12 AQUACEL® Ag Broad-spectrum Antimicrobial Activity Aerobic Bacteria Antibiotic-resistant Bacteria Staphylococcus aureus (NCTC 8532) MRSA (NCTC 10442) Staphylococcus aureus (clinical isolate) MRSA (NCTC 12232) Pseudomonas aeruginosa (clinical isolate, x2 strains) MRSA (clinical isolate, x8 strains) Enterobacter cloacae (clinical isolate) VRE (NCTC 12201) Streptococcus pyogenes (clinical isolate) VRE (clinical isolate, x2 strains) Klebsiella pnuemoniae (clinical isolate, x3 strains) Serratia marcescens (clinical isolate) Enterococcus faecalis (clinical isolate) Pseudomonas aeruginosa (NTC 8506) Escherichia coli (NCIMB 8545) Escherichia coli (NCIMB 10544) Acinetobacter baumannii (NCIMB 9214 Anerobic Bacteria Yeasts Bacteroides fragilis (clinical isolate) Peptostreptococcus anaerobius (clinical isolate) Candida albicans (NCPF 3179) Candida albicans (NCPF 3265) Clostridium ramosum (clinical isolate) Clostridium clostridioforme (clinical isolate) Clostridium cadaveris (clinical isolate) Clostridium perfringens (clinical isolate) Tissierella praeacute (clinical isolate) Jones SA, Bowler PG, Walker M, Parsons D. Controlling wound bioburden with a novel silver-containing Hydrofiber® dressing. Would Repair Regen. 2004;12:288-294. Hydrofiber® Ag Dressing Bacterial Sequestration & Bactericidal Activity T = 2-3 mins T = 20 mins Green = Alive Red = Dead T = Time in minutes T = 40 mins T = 60 mins Confocal microscopy of Pseudomonas aeruginosa on hydrated Hydrofiber® Ag dressing fiber Newman GR, Walker M, Hobot J, Bowler P. Biomaterials. 2006;27(7):1129-1139. 13 5/2/2016 Incidence & Burden of Infections Following Cardiac Surgery Gorav Ailawadi, MD Chief, Adult Cardiac Surgery University of Virginia May 2, 2016 Disclosures • • • • • • Convatec Abbott Vascular St. Jude Edwards Mitralign Atricure Outline • Overview of Major Infections Following Cardiac Surgery – Incidence – Cost • DSWI • Pneumonia 1 5/2/2016 Hospital Acquired Infections • 1.7 million individuals acquire HAI • Leads to 100,000 deaths annually • Results in additional $6.5 billion additional health care expenditures Perencevich EN, Pittet D. JAMA 2009; 301: 1285-7. CTSN • Supported by U01 HL088942 Cardiothoracic Surgical Trials Network (CTSN) • Funding Agencies: • National Heart, Lung, and Blood Institute • National Institute of Neurological Disorders and Stroke • Canadian Institutes for Health Research 2 5/2/2016 Investigators • • • • • • • • • • • • • • Data Coordinating Center: InCHOIR Montefiore – Einstein Emory University Duke University Hôpital Laval University of Virginia Health System Montreal Heart Institute University of Pennsylvania Columbia University Medical Center Cleveland Clinic Foundation University of Maryland Brigham and Women's Hospital Sacré-Cœur de Montréal Ohio State University Medical Center • • • • • • • • • • • • • East Carolina Heart Institute Wellstar / Kennestone Baylor Research Institute University of Southern California St. Michael’s Hospital Toronto General Hospital Mission Hospital NIH Heart Center at Suburban Hospital Inova Heart & Vascular Institute University of Alberta Hospital Centre Hospitalier de l'Université de Montréal Sunnybrook Health Sciences Centre Aarhus University Methods • 5,158 patients prospectively enrolled at 10 core CTSN sites • Infections identified and adjudicated up to 65 days after index surgery • 4.6% (237 patients) experienced major infection • SSI (sternum or secondary site), mediastinitis, infectious pericarditis, endocarditis, cardiac device infection, pneumonia, C Diff colitis Frequency, Type and Timing of Infection 3 5/2/2016 Organism Type Organism Type Survival Impact of Major Infection Gelijns AC, et al. J Am Coll Cardiol. 64(4):372-81, 2014. 4 5/2/2016 Sites of Infection • Site of infection N, % Incidence • • • • • • 9 (30%) 8 (26.7%) 5 (16.7%) 4 (13.3%) 1 (3.3%) 1 (3.3%) 5.23% 4.65% 2.90% 2.32% 0.58% 0.58% 30 (100%) 17.42% Bacteremia Sternotomy site infection Infection of vascular catheters Pneumonia Mediastinitis Urinary tract infection • Total Lola, et. Al Journal of Cardiothoracic Surgery2011 6:151 Cost of Infection 5 5/2/2016 Average Cost Per Day With Infection Incremental Costs By Type Center Variability in Infection 6 5/2/2016 Circ Cardiovasc Qual Outcomes. 2014 Jul; 7(4): 567–573 Survival Impact of Infection Circ Cardiovasc Qual Outcomes. 2014 Jul; 7(4): 567–573 DSWI 7 5/2/2016 DSWI Incidence and Impact • Incidence ranges: 0.5% -6.8% • In hospital Mortality: 7-35% • 1 year survivors of DSWI: 15% survival disadvantage • 10 yr survival after CABG: – Without DSWI: 70% – With DSWI: 39%! Cotogni P, et al. World J Crit Care Med. 4(4), 2015. Survival Impact of DSWI Bilal H, et al. Interact Cardiovasc Thorac Surg. 2013 17(3):479-484. Timing of DSWI 8 5/2/2016 Pneumonia CTSN: Pneumonia • • • • 2.4% (123 of 5,158 patients) 40% of all major infections 67% diagnosed during index hospitalization 86% diagnosed within 30 days – 14% developed pneumonia after 1st month Time to Pneumonia 9 5/2/2016 Impact of Pneumonia on Mortality Variable HR (95% CI) P Value Pneumonia 8.89 (5.02, 15.75) <0.001 Age (year) 1.03 (1.01, 1.05) <0.001 Male 0.60 (0.39, 0.91) 0.02 Diabetes* (yes/no) 1.57 (1.03, 2.41) 0.04 Heart Failure (yes/no) 1.86 (1.24, 2.80) 0.003 Creatinine, mg/dL 1.17 (1.06, 1.30) 0.002 Hemoglobin, g/dL 0.85 (0.75, 0.95) 0.005 Conclusions • • • • Increasing patient comorbidities Surgical infections still prevalent Significant financial burden of infections Significant mortality effect from infections Conclusions • • • • Increasing patient comorbidities Surgical infections still prevalent Significant financial burden of infections Significant mortality effect from infections • No consensus on Best Management! 10 5/2/2016 Thank You • Questions? • gorav@virginia.edu 11 5/2/2016 Risk Factors of Infections After Cardiac Surgery Justin Sambol MD FACS Chief, Division of Cardiothoracic Surgery Rutgers-New Jersey Medical School Disclosures Consultant for ConVatec No other disclosures Infections Following Cardiac Surgery Infection following cardiac surgery associated with significant cost Increases hospital LOS Increases Morbidity Increases need for further surgery Increases mortality 1 5/2/2016 Types of Infections After Cardiac Surgery Pneumonia Surgical Site Infections Superficial Sternal Wound Infections Deep Sternal Wound Infections Saphenectomy Site Septicemia Why do Infections Occur? Preoperative Factors Intraoperative Events Postoperative Course Preoperative Risk Factors Age >70 Obesity with BMI >30 kg/m2 Immunosuppression COPD Diabetes (NIDDM as well as IDDM) Renal Insufficiency Critical preoperative status (infections, sepsis, cardiogenic shock) 2 5/2/2016 Intraoperative Risk Factors Prolonged operative time Prolonged bypass time Use of Bilateral Internal Mammary Artery Intraoperative use of blood products Postoperative Risk Factors Prolonged mechanical ventilation Vasopressor support Need for transfusions Reoperation for bleeding (data is variable) From: Management Practices and Major Infections After Cardiac Surgery J Am Coll Cardiol. 2014;64(4):372-381. doi:10.1016/j.jacc.2014.04.052 Table Title: Baseline and Procedure Characteristics Associated With Infection Date of download: 4/12/2016 Copyright © The American College of Cardiology. All rights reserved. 3 5/2/2016 Mitigation of Risk Factors Optimization of blood glucose (HbA1C < 8.0%) Reduce Obesity (BMI <30 kg/m2) Cessation of Cigarette Smoking Optimization of COPD Avoid operative time > 7 hours CPB time <180 min Optimize postoperative cardiac output Minimize bleeding and postoperative transfusion Sajja LR, International Journal of Surgery 16 (2015) 171-178 Bilateral Internal Mammary Artery The use of Bilateral Internal Mammary Artery (BIMA) requires special consideration Emerging data that BIMA improves survival following CABG Increased risk of Deep Sternal Wound Infection??? David P. Taggart et al. Eur Heart J 2010;31:2470-2481 Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2010. For permissions please email: journals.permissions@oxfordjournals.org 4 5/2/2016 Survival to 1 year. David P. Taggart et al. Eur Heart J 2010;31:2470-2481 Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2010. For permissions please email: journals.permissions@oxfordjournals.org Table 3 Adverse event data by randomized group SIMA (n = 1552) BIMA (n = 1542) Relative risk (95% CI) Sternal wound reconstruction No history of diabetes Insulin-dependent diabetes Non-insulin-dependent diabetes MI event at 30 days CVA event at 30 days Revascularization at 30 days 9 (0.6%) 4 2 3 23 (1.5%) 19 (1.2%) 6 (0.4%) MI event at 1 year CVA event at 1 year 1.43) Revascularization at 1 year 31 (2.0%) 29 (1.9%) 15 5 9 22 (1.4%) 15 (1.0%) 11 (0.7%) 3.24 (1.54–6.83) 0.96 (0.54–1.72) 0.79 (0.40–1.56) 1.85 (0.68–4.98) 30 (2.0%) 0.97 (0.59–1.60) 28 (1.8%) 23 (1.5%) 0.83 (0.48– 20 (1.3%) 27 (1.8%) 1.36 (0.77–2.41) Conclusion Infections following cardiac surgery increase cost, morbidity and mortality Risks of Infection are multifactorial Mitigation of these risks, when possible, can significantly reduce the sequeli of these infection The benefits of the use of BIMA should be carefully weighed against the added risk of infection 5
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