New Surveillance Definitions for VAP

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New Surveillance Definitions for VAP 2012 Critical Care Canada Forum Toronto Dr. John Muscedere Associate Professor of Medicine, Queen s University Kingston, Ontario

Presenter Disclosure Dr. J. G. Muscedere The following relationships with commercial interests related to this presentation have occurred during the past 3 years: No Conflicts to Disclose

Outline Background Impact of VAP Problems with current definition of VAP Proposed new surveillance paradigm VAC ivac New Data on the morbidity, mortality and preventability of VAC, ivac and VAP

Studies Studies Why focus on VAP? Increased Morbidity Increased ICU LOS (5-9 days) Increased Hospital LOS (up to 12 days) Increased Vent. Duration (4-8 days) ICU LOS VAP Control Weight Association measure Study ID Year n[e]/m[e]/sd[e] n[c]/m[c]/sd[c] (%) with 95% CI Papazian Papazian 1996 85/32.9/26.4 85/24.59/16.6 10.00% 8.31 (1.68 to 14.94) Bercault Bercault 2001 135/31/19 135/26/17 12.00% 5 (0.7 to 9.3) Rello Rello 2002 842/11.7/11 2243/5.6/6.1 14.00% 6.1 (5.32 to 6.88) Leone Leone 2002 58/22.7/2.9 58/16.8/2.9 14.00% 5.9 (4.84 to 6.96) Kallel Kallel 2005 57/24.5/18 57/12.3/8 12.00% 12.2 (7.09 to 17.31) Cocanour Cocanour 2005 70/21.6/2.2 70/6.4/1.1 14.00% 15.2 (14.62 to 15.78) Nseir Nseir 2005 77/26/17 77/15/13 12.00% 11 (6.22 to 15.78) Cavalcanti Cavalcanti 2006 62/20/14 62/14/18 11.00% 6 (0.32 to 11.68) META-ANALYSIS: n=1386 n=2787 100% 8.74 (4.51 to 12.97) Vent. Duration VAP Control Weight Association measure Study ID Year n[e]/m[e]/sd[e] n[c]/m[c]/sd[c] (%) w ith 95% CI Papazian 1996 85/27.3/23.7 85/19.7/14.7 12.00% 7.6 (1.67 to 13.53) Rello 2002 842/14.3/15.5 2243/4.7/7 15.00% 9.6 (8.51 to 10.69) Leone 2002 58/11.6/1.7 58/9.4/1.3 16.00% 2.2 (1.65 to 2.75) Kallel 2004 57/13/8.4 57/8.3/4.3 15.00% 4.7 (2.25 to 7.15) Cocanour 2005 70/17.7/2 70/5.8/1 16.00% 11.9 (11.38 to 12.42) Nseir 2005 77/24/15 77/13/11 14.00% 11 (6.85 to 15.15) Cavalcanti 2006 62/17/14 62/11/16 13.00% 6 (0.71 to 11.29) META-ANALYSIS: N= 1251 n= 2652 100% 7.57 (3.09 to 12.04) 0 5 10 15 20 MD 8.7 days Muscedere et al, CID, 2010 0 5 10 15 20 MD 7.6 days

Why the focus on VAP? Increased Mortality Depends on population Relative: 4-6% of ICU Mortality Absolute: 1 1.5% Mortality Adequacy and timeliness of antibiotic treatment Melsen et al, SR and MA of 52 Obs. studies, 17,000 patients RR 1.27 (1.15,1.39) Melsen et al, Crit Care Med, 2009 Baekert et al, AJRCCM, 2011

Why the focus on VAP? Empiric and definitive treatment for VAP drives antibiotic utilization Estimated that a large percentage of antibiotics prescribed in ICU given for VAP Increased hospital costs >$10,000 US in additional costs >$11,000 Cdn using Canadian data Safdar et al, Crit Care Med, 2005 Muscedere et al, J. Crit Care, 2008

Why the focus on VAP? VAP is a preventable disease 0.67 (0.50, 0.88) ETT with Subglottic Secretion Drainage Chlorhexidine Labeau et al, Lancet ID, 2011 Muscedere et al, CCM, 2011

VAP as a patient safety metric Because of impact on patients and the health care system regarded as a patient safety metric Mandatory reporting in many jurisdictions Canada- Public reporting in Ontario US 32 states

Paradigm for Diagnosis of VAP + Clinical + Chest X-Ray Microbiology Purulent secretions Increasing oxygen requirements Core temp > 38.0 o or < 34 o C WBC <3.5 or > 11.0 Pathogenic Bacteria New or Persistent Infiltrates

Correlation between Clinical Diagnosis and Pathological Diagnosis Tejerina et al comparison histological diagnosis of VAP in 253 patients with: Clinical Diagnosis (CXRay + 2/3: Temp, WBC and Purulent Secretions) Rigorous Clinical Diagnosis (CXRay + 3/3: Temp, WBC and Purulent Secretions) Rigorous Clinical Diagnosis plus pathogenic bacteria in ETA Tejerina, JCC 25: 62-68

Correlation between Clinical Diagnosis and Pathological Diagnosis Tejerina, JCC 25: 62-68

Current VAP diagnostic paradigm as a quality metric Subjective Non-specific Inconsistent association with patients outcomes Proposed new surveillance definitions in the ICU

An alternative approach to surveillance Broaden the focus from pneumonia alone to the syndrome of ventilator complications in general More accurate description of what can be reliably determined using surveillance definitions Emphasizes the importance of preventing all complications of mechanical ventilation, not just pneumonia Streamline the definition using quantitative criteria Reduce ambiguity Improve reproducibility Enable electronic collection of all variables

VAC New and sustained respiratory deterioration ventilator-associated condition IVAC New respiratory deterioration with Infection-related concurrent infection ventilator-associated complication Possible pneumonia Probable pneumonia

VAC ivac Possible Pneumonia Probable Pneumonia New respiratory deterioration VAC+ evidence of infection IVAC + possible respiratory source IVAC + probable respiratory source Sustained PEEP or FiO2 after 2 days of stable or PEEP or FiO2 Abnormal temp or WBC AND 4 days of new antibiotics Sputum/BAL polys OR Pathogenic culture Sputum/BAL polys AND Pathogenic culture

An alternative paradigm for surveillance: Ventilator Associate Conditions (VAC) Definition: 2 days of stable or decreasing daily minimum PEEP or FiO2 followed by Rise in daily minimum PEEP 3 cm H 2 O sustained 2 days or Rise in daily minimum FiO2 20 points sustained 2 days Slated for implementation in NHSN in January 2013

An alternative paradigm for surveillance: Infection Related Ventilator Associate Conditions (ivac) Definition: VAC associated with alterations in WBC (< to 4 or 12) or temperature (< 36 or 38 o C) within 2 days and Prescription of antibiotics continued 4 days

What is known to date about VAC, ivac? Most cases of VAC are caused by 4 conditions: Pneumonia ARDS Pulmonary edema Atelectasis VAC, ivac associated with increased morbidity and mortality VAC associated with increased duration of mechanical ventilation No data to date demonstrating preventability No data on relationship to VAP PLoS ONE 2011;6(3): e18062 Critical Care Medicine 2012; online Clinical Infectious Disease 2012; in press

Study Objectives Compare the incidence and agreement of VAC, ivac and VAP Compare attributable morbidity and mortality of VAC, ivac vs. VAP Assess the responsiveness of VAC vs. VAP to a multifaceted quality improvement initiative

Study Design Secondary analysis of the ABATE study dataset ABATE: 2 year, prospective, multifaceted education program to increase implementation of VAP guidelines in 11 academic and community ICUs Each site enrolled the first 30 patients ventilated >48 hours in each of four data collection periods Baseline, 6 months, 15 months, 24 months Tracked guideline concordance and clinical measures for all enrolled patients VAP rigorously adjudicated at multiple levels

Interventions Implemented were as per the Canadian VAP Guidelines Prevention Recommendations ETT with subglottic secretion drainage Semi-recumbent positioning ( 45 ) Oral care with Chlorhexidine Oral route of intubation Closed suctioning system New ventilator circuit for each patient Ventilator circuit changes only if soiled or damaged Heated humidifier changes every 5-7 days Change suctioning system only if blocked or damaged Muscedere et al, JCC 2008

Patient characteristics (N = 1320) Age (mean ± std dev) 59.6 ± 17.2 Male 60% APACHE II on admission (mean ± std dev) 23.0 ± 7.5 Ventilator days (median, IQR) 8.6 days (4.6, 28.6) ICU days Hospital days 13.6 days (7.4, und) 51.3 days (20.5, und) Mortality (hospital) 34%

Occurrence of VAC, ivac and VAP VAC occurred in 139 (10.5%) ivac occurred in 65 (4.9%) or 47.7% of VAC VAP occurred in 148 (11.2%) Agreement between VAP and VAC was: Κ = 0.18 Agreement between VAP and ivac was: Κ = 0.19 VAP VAP (n = 148) 109 VAC (n=139) 13 39 (26.4%) 26 39 ivac ivac (n=65) VAC 26 22 (17.6%)

Clinical Outcomes: Mortality *p < 0.0001 **p = 0.07 ***p = 0.83 49.6 ** * 44.6 ** *** *** 33.0 32.9 31.7 31.8

Clinical Outcomes: ICU LOS *, **, ***p < 0.0001 ** 18.9 22.0 *** 17.8 * ** *** 9.0 9.3 9.0

Clinical Outcomes: Hosp LOS 31.7 34.6 ** *, **, ***p < 0.0001 *** 30.9 * ** *** 21.8 22.5 22.2

Clinical Outcomes: MV Days *, **, ***p < 0.0001 16.9 ** *** 15.4 13.6 * ** *** 6.2 6.4 6.2

Guideline concordance- preventive measures CHG HOB

Aggregate prevention guideline concordance Aggregate overall and prevention guideline concordance rose throughout the study Concordance with all VAP CPG recommendations (%) Concordance with VAP CPG preventive measures (%) Baseline n = 330 6 Months n = 330 15 Months n = 330 24 Months n =330 p values 53.1% 57.1% 57.7% 65.4% 0.009 46.2% 50.3% 52.2% 54.2% 0.004

VAC, ivac and VAP rates over time

Risk factors for VAC (multivariate model) Variable Odds Ratio (95% CI) P-value APACHE II score 0.92 (0.82, 1.04) 0.17 Hospital days to ICU admission 1.09 (0.99, 1.20) 0.09 % ventilator days with SBTs 0.97 (0.94, 1.01) 0.10 % ventilator days with SATs 0.93 (0.99, 1.04) 0.05 % ventilator days with CHG oral care 1.02 (0.99, 1.04) 0.18

Conclusions VAC and VAP rates similar but agreement is very low Likely measure different pathophysiological processes VAC strongly associated with increased length of stay and hospital mortality A multifaceted quality improvement initiative was associated with VAC rates but ivac rates did not change. SATs and SBTs may be protective against VAC

Thank You Questions?

NHSN surveillance definition for VAP Patient must fulfill each of the three categories below: Chest Radiograph Systemic Signs Pulmonary Signs Any one of the following: 1. New, progressive, or persistent infiltrate 2. Consolidation 3. Cavitation Any one of the following: 1. Temperature >38 C 2. WBC <4,000 or >12,000 WBC/mm 3 3. For adults 70 years old, altered mental status with no other recognized cause Any two of the following: 1. New onset of purulent sputum, or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements 2. New onset or worsening cough, or dyspnea, or tachypnea 3. Rales or bronchial breath sounds 4. Worsening gas exchange, increased oxygen requirements, or increased ventilation demand

Interobserver agreement in VAP surveillance 50 ventilated patients with respiratory deterioration IP 1 (11 VAPs) 3 1 7 IP 2 (20 VAPs) 0 7 3 5 Kappa = 0.40 IP 3 (15 VAPs) Klompas, AJIC 2010:38:237

% of patients with positive cultures Impact of diagnostic technique on VAP rates 53 patients with clinically suspected VAP 100 80 60 40 20 0 Endotracheal aspirate (any growth) Endotracheal aspirate >10 6 CFU/ml Bronchoalveolar lavage >10 4 CFU/ml 30 24 18 12 6 0 VAPs per 1000 ventilator-days Morris, Thorax 2009;64:516

Ways to lower VAP rates Without meaningfully changing patient care 1. Narrowly interpret subjective clinical signs 2. Narrowly interpret radiographs 3. Seek consensus between multiple IP s 4. Allow clinicians to veto surveillance determinations 5. Increase use of quantitative BAL for diagnosis Klompas, Clin Infect Dis 2010:51:1123-26 Klompas, Am J Infect Control 2012;40:408-10

National VAP rates United States, 2004-2010 SICUs MICUs Source: CDC NNIS and NHSN

International VAP Rates Source: CDC Europe and CDC USA

Increasing gap between clinical and surveillance VAP rates 15% of ICU pts on VAP Rx on cross-sectional surveys Thomas et al. Am Surgeon 2011;77:998 Skrupky et al. Crit Care Med 2012;40:281 Koulenti et al. Crit Care Med 2009;37:2360 Vincent et al. JAMA 2009;302:2323

VAP Rates: Are they a true measure of reality? Prospective study: 134 patients receiving MV: Diagnostic Criteria (n=134) VAP Rate Clinical Diagnosis 22% ACCP 29% CPIS 25% NNIS (active) 31% NNIS (passive) 2% CONCLUSION: Despite increasing support for public disclosure of nosocomial infection rates, the optimal criteria to diagnose VAP are controversial. This is illustrated by the low correlation between the four strategies most commonly used to diagnose VAP. These data highlight how dramatically VAP rates are affected by the choice of diagnostic criteria and the intensity of VAP surveillance. Morrow et al, Chest 2006