bundles, bundles, bundles: improving surgical...

Bundles, Bundles, Bundles: Improving Surgical Outcomes

2/19/20

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Saketh R. Guntupalli, MD, FACOG, FACSAssociate Professor and DirectorDivision of Gynecologic Oncology

Department of Obstetrics and GynecologyUniversity of Colorado School of Medicine- Denver

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Disclosures

• I have no relevant disclosures for this talk.

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Surgical Bundles

• A grouping of best practices that individually improve care, but when applied together result in substantially greater improvement.

• Science behind the bundle elements is well established – the standard of care.

• Bundle element compliance can be measured as “ yes/no”for audit

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Surgical Bundles

Key components of bundles and protocols•Easy to implement•Easy to replicate•Compliance rate is high (> 90%)•Easy to identify “failures” or issues with compliance• compliance can be measured as “ yes/no” for audit

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Surgical Bundles- Top 3

The are many different types of bundles but the three that generally have the most impact in surgical practice…

• Prevention of Surgical Site Infections

• Prevention of Catheter Associated Urinary Tract Infection (CAUTI

• Prevention of Venous Thromboembolism

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Surgical Site Infection Control

• Infections are the leading cause of morbidity associated surgery.• These infections have a substantial effect on surgical outcomes• Long term prognosis of the patient• Cost to the health care system

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Surgical Site Infection Control

• Purulent discharge, abscess or spreading cellulitis at surgical site up to one month after surgery.• 3rd most common hospital infection• Incidence : 0.5 – 15%• Incisional • Superficial• Deep

• Organ Space• Generalized (peritonitis)• Abscess

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Risk factors for the development of SSI

• Diabetes mellitus• Hypoxemia• Hypothermia• Leukopenia• Nicotine (tobacco smoking)• Immunosuppression• Malnutrition• Poor skin hygiene

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Surgical Site Infection – Wound Classification

• Class 1 = Clean• Class 2 = Clean contaminated• Class 3 = Contaminated• Class 4 = Dirty infected

Mangram AJ et al. Infect Control Hosp Epidemiol. 1999;20:250-278.

Prophylactic antibiotics indicated

Therapeutic antibiotics

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SSI Definitions2T

Superficial• Purulent drainage from

wound• Positive wound culture• Pain, redness, swelling• Diagnosis by surgeon

Organ Space• Infection in the

surgical cavity (abdomen)

Deep• Purulent drainage

from deep aspect of the wound

• Dehiscence• Abscess on exam or

CT scan

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What are the costs associated with surgical site infection?

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SSI Bundles

• Appropriate preoperative antibiotics given at right time• Surgical clipping of the area• Correct identification of type of

surgery (clean, contaminated etc.)• Appropriate closure of wound

BUNDLES in Electronic Health Record

• Correct type of wound description

• This initiates an order set for antibiotic therapy IF INDICATED

• Drain placement?• Type of wound closure

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Bundles for prevention of surgical site infections-Clipping

• Clipping should always be done outside of the OR whenever possible• Removal of stray hairs from clipping should

be done using current methods (tape and/or suction), while clipping on top of a disposable underpad• Remove and dispose of single-use clipper

head immediately after use and clean the clipper unit according to manufacturer instructions before storing• In cases of excessive amounts of hair, use

vacuum assisted suction device and associated single-use disposable tubing

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Surgical Site infection- antibiotics• Antibiotic therapy forvarious gynecologic procedures• Key to this is using the correct

antibiotics for the right procedure. AND• Continuing the antibiotic for the

right amount of time• Prolonged therapy has its

consequences…..

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Bowel preparation

Redosing and weight-based dosing

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Johns Hopkins Hospital Antibiotic PosterPerioperative Antibiotic Prophylaxis To

Prevent Surgical Site Infection

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Urinary Tract Infection- Background

• Urinary tract infection is the most common health care-associated infection the United States (40% of 1.7 million cases)• 40% of urinary tractions infections are catheter associated urinary

tract infections (CAUTI)• Up to 25% of all hospitalized patients have a urinary catheter at some

point during their stay

Peasah SK, M edicare M edicaid Res Rev. 2013.

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National Costs

• CAUTI increases hospital stay 2-4 days on average• Estimated 13,000 deaths annually

from CAUTI (mortality rate 2.3%)• National economic cost of CAUTI

estimated at $400 million annually • Since 2008 hospitals have been

unable to classify CAUTI within a higher diagnosis related group in order to receive additional reimbursement from Medicare Wald HL, JAM A, 2007.

Klevens RM , Public Health Rep, 2007

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CAUTI Risk Factors

• Prolonged catheterization• Female sex• Older age• Diabetes• Lower training of inserter• Placement of catheter

outside of OR

� Impaired immunity� Renal dysfunction� Orthopedic and neurologic

services� Disconnection of closed drainage

system

Gould, CDC.GOV CAUTI Toolkit

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CAUTI-Prevention

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Study Design –Prevention of CAUTI

• Single-site randomized control trial • Patients enrolled and randomized within 24 hours of surgery• Randomization performed by computer algorithm via RedCap

• Goal enrolment of 100 patients per arm to detect a 50% reduction in UTI rates in the intervention group (alpha 0.05 and power 0.84)

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Treatment Groups

• Arm 1: Standard of Care Technique• Cather placed on surgical field after vaginal prep by resident or attending

physician using standard aseptic technique

• Arm 2: Enhanced Aseptic Technique• Same steps as SOC, with addition of banding the protective plastic sheath to

the catheter and dipping the tip of the catheter in betadine prior to insertion • Plastic sheath remains in place until removal of catheter

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Assessment

• Urine dipstick within 24 hours post-operatively • Urine dipstick and patient satisfaction survey at 2 weeks post-

operative visit • If positive nitrites or leukocyte esterase on urine dipstick, then reflex

to formal laboratory urinalysis and urine culture• UTI defined as 105 of a single bacterial organism on urine culture • Treated with antibiotic of physician’s choice

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OutcomesCharacteristic

Enhanced Aseptic (N=40, 49%)

Standard of Care (N=42, 51%) Total (N=82) p-value

Culture confirmed UTI 0.599

Yes 4 (10%) 6 (14%) 10 (12%)

No 36 (90%) 36 (86%) 72 (88%)

Hysterectomy 0.487

Yes 24 (60%) 22 (52%) 46 (56%)

No 16 (40%) 20 (48%) 36 (44%)

Surgery time (mean minutes) 181.7 (56-349) 204 (86-376) 193.1 (56-376) 0.18

Symptomatic @ 24 hours n/a

Yes 0 (0%) 0 (0%) 0 (0%)

No 40 (100%) 42 (100%) 82 (100%)

(+) UA at 24 hours

Yes 0 (0%) 1 (2%) 1 (1%) 1.00

No 40 (100%) 41 (98%) 81 (99%)

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Bundles to prevent CAUTI

• Ensure patients who don’t need a catheter don’t get one (diagnostic l-scope, simple BSO)• You can always put in a Foley later if your case goes longer• Initiate antibiotic prophylaxis is patient is at high risk• Use sterile technique in placement of Foley catheters

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Venous Thromboembolism Prevention

• 350,000 to 650,000 with VTE per year• 100,000 to > 200,000 deaths per year • About half are hospital related. • VTE is primary cause of fatality in half-of post surgical patients • More than HIV, MVAs, Breast CA combined• Equals 1 jumbo jet crash / day

• 10% of hospital deaths• PE among top sources of preventable hospital related death

• Huge costs and morbidity (recurrence, post-thrombotic syndrome, chronic PAH, anticoagulation)

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Venous Thromboembolism in OBGYN

• Pregnant patients are at particularly high risk for the development of VTE• Hypercoagulable state of pregnancy• Lack of mobility as pregnancy progresses• Prolonged hospitalization if patients are

admitted• Pre-Eclampsia• PPROM• Other chronic conditions

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VTE in Cancer Patients….

• One of the most common causes of mortality from extensive surgical debulking in women with gynecologic cancer continues to be venous thromboembolism (collectively deep venous thrombosis and pulmonary embolism)

• Rates of VTE after surgery for gynecologic cancer are as high as 26% for deep venous thrombosis (DVT) and 9% for pulmonary embolism (PE) without prophylaxis

• Based on this data, the American College of Chest Physicians recommends the use of pre-operative heparin, sequential compression devices (SCD) during surgery, and post-surgical DVT prophylaxis for women undergoing pelvic surgery who are at moderate risk for the development of VTE

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- Classic “3 bucket” model derived from AT8 Low Risk: Minor surgery in mobile patients. Medical patients who are fully mobile. Observation patients with expected hospital stay < 48 hours.

No prophylaxis, reassess periodically, ambulate.

Moderate Risk: Most general, thoracic, open gynecologic or urologic surgery patients. Medical patients, impaired mobility from baseline or acutely ill.

UFH or LMWH prophylaxis*

High Risk: Hip or knee arthroplasty, hip fracture surgery. multiple major trauma, spinal cord injury or major spinal surgery, Abdominal-pelvic surgery for cancer.

IPCD AND LMWH or other anticoagulant*

*For those at moderate or high risk and contraindications to anticoagulation, use IPCD.

Risk Assessment

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VTE Bundle Screening

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VTE Bundles

• Necessary to prevent life threating complications• Easy to use in an electronic health record• Risk stratifying patients is key• Open of MIS surgery?• Cancer or No cancer?• Length of the procedure?• Immobility following the procedure

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Our VTE Bundle

• Bundle used in our practice….(order set in EPIC)• All patients risk stratified as low moderate and high risk• Moderate and high-risk patients

• Sequential compression devices at intubation and throughout case• Preoperative heparin 5000 units SQ at incision• Post operatively

• 5000 units SQ q 8 hours x 24 hours (begin 6-12 hours after surgery completed)• Within 24 hours convert to SQ enoxaparin if H/h stable• If high risk or cancerà continue anticoagulation for 28 days per ACCP recommendations• If moderate riskà tailor to patient

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Study Design• Prospective Randomized Open-Blinded End-point (PROBE) study for safety with

N=400• Previous presentation for interim safety analysis was presented at the 2017 Society of

Gynecologic Oncology annual meeting• This data represents the final report for safety and efficacy• Recruitment occurred at two sites: • University of Colorado Hospital, USA• University of Southern California, USA

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Study Design• Participants were randomized to:• Oral apixaban 2.5 mg tablet BID for 28 days post surgery

OR• Subcutaneous enoxaparin 40 mg QD for 28 days post surgery

• Followed for 90 days post-operatively

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Study Design

Screening Visit •Suspected/confirmed Gyn-Onc malignancy•No history VTE•No bleeding disorders•Not on anticoagulant or NSAIDS or SSRIs

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Study Design

Screening Visit •Suspected/confirmed Gyn-Onc malignancy•No history VTE•No bleeding disorders•Not on anticoagulant or NSAIDS or SSRIs

Gyn. Surgery•5,000 units Heparin SQ •Compression devices •Heparin 5,000 units SQ TID post-op•Observed for no bleeding 12-24 hrs. post-surgery•Epidural had been d/c as intended

Open Cases

MIS(<20%)

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Study Design

Random ization 1:1

Post-surgery day 1-7

Screening Visit •Suspected/confirmed Gyn-Onc malignancy•No history VTE•No bleeding disorders•Not on anticoagulant or NSAIDS/SSRIs

Gyn. Surgery

•5,000 units Heparin SQ •Compression devices •Heparin 5,000 units SQ TID post-op

Open Cases

MIS (<20%)

Apixaban2.5mg BID

28d

Enoxaparin 40mg SQ

28d

Apixaban2.5mg BID

28d

Enoxaparin40mg SQ

28d


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Study Design

Random ization 1:1



Gyn. Surgery


Open Cases

MIS(<20%)

Apixaban2.5mg BIDfor 28 days

Enoxaparin40mg SQ

for 28 days


Enoxaparin 40mg SQ

for 28 days

Visit 3•Post-op check 10-18 days post-surgery•Assessment of bleeding•Wells criteria and physical assessment for VTE•Collection of AEs•Medication adherence


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Study Design

Random ization 1:1



Gyn. Surgery


Open Cases

MIS(<20%)


Enoxaparin 40mg SQ

for 28 days


Enoxaparin40mg SQ

for 28 days

Visit 3•Post-op check 10-18 days post-surgery•Assessment of bleeding•Wells criteria and physical assessment for VTE•Collection of Aes•Medication adherence

Visit 4•Study day 24-32•Assessment of bleeding•Wells criteria and physical assessment for VTE•Collection of AEs•Medication adherence•Satisfaction and QOL


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Study Design

Random ization 1:1



Gyn. Surgery


Open Cases

MIS(<20%)


Enoxaparin40mg SQ

for 28 days


Enoxaparin40mg SQ

for 28 days

Visit 3•Post-op check 10-18 days post-surgery•Assessment of bleeding•Wells criteria and physical assessment for VTE•Collection of AE•Medication adherence

Visit 4•Study day 24-32•Assessment of bleeding•Wells criteria and physical assessment for VTE•Collection of AEs•Medication adherence•Satisfaction and QOL

Visit 5•Study day 76-104•Assessment of bleeding•Wells criteria and physical assessment for VTE•Collection of AEs


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Primary Outcome-Safety Evaluation•One major bleeding event in each arm(0.5% vs. 0.5%, OR=1.05, 95% CI 0.07-16.76, P=1.00) •12 CRNM bleeding events in the apixaban and 19 in the

enoxaparin arm(5.4% vs. 9.7%, OR= 1.88 95%, CI 0.87-4.1, P=0.11)

No significant difference in major bleeding or CRNM

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Secondary Outcome: Venous Thromboembolism

• 5 VTE events occurred during the study period• 2 in the apixaban arm and 3 in the enoxaparin arm• (1.0% vs. 1.5%, OR=1.57 95% CI 0.26-9.50, P=0.68)

• 13 additional patients evaluated for suspected VTE (3.2%)• Underwent lower extremity ultrasonography or CT angiography• All determined to be negative for VTE

No difference in VTE events

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Bundles for Improvement of Quality• Bundles can improve the quality of surgical health care delivery in

selected patients in both obstetrics and gynecology.• Bundles should be implemented in systems that have a high degree of

reproducibility and oversight.• Identification of key quality outcomes for improvement are key to

bundles systems to work.

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Thank you!

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