Disclosures Consultant, Volcano Corporation Outpatient NPWT Options - - PowerPoint PPT Presentation

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Outpatient NPWT Options Free up Hospital Beds, but Do They Work?

UCSF Vascular Symposium 2016

Jonathan Labovitz, DPM

Medical Director, Foot & Ankle Center Associate Professor, College of Podiatric Medicine Western University of Health Sciences

Understand the clinical effectiveness of negative pressure wound therapy Appreciate the cost effectiveness of negative pressure wound therapy Understand potential benefits of negative pressure wound therapy in the outpatient care setting

Disclosures Objectives

Consultant, Volcano Corporation

SYSTEMATIC REVIEWS, META-ANALYSIS

Clinically Effective: Does it Work?

Zhang, et al. 2014 Dumville, et al. 2013 Ravari, et al. 2014 Proportion healed RR 1.52, p < 0.001 RR 1.47, p < 0.001 70% NPWT vs. 30.76% (Moist) Area reduction SMD 0.89, p = 0.003 NPWT -10.7 cm2, p = 0.02 Moist +17.3 cm2, p = 0.1 NPWT vs. Moist p= 0.03 Change in depth NPWT -7.0 mm, p = 0.007 Moist +3 mm, p = 0.5 NPWT vs. Moist p = 0.02 Healing time SMD -1.10, p=0.003 HR 1.85, p < 0.001 Secondary LEA RR 0.35, p = 0.006 RR 0.35, p = 0.006 Major LEA RR 0.14, p = 0.003 Major 0.0% vs. 38.5% Minor 0.0% vs. 7.69% NPWT vs. Moist p = 0.3 Minor LEA RR 0.37, p = 0.837 Adverse events RR 1.12, p = 0.683 RR 0.9, p > 0.05 Patient satisfaction NPWT 76.9% vs. Moist 23.1% p = 0.004 SYSTEMATIC REVIEWS, META-ANALYSIS

Clinically Effective: Does it Work?

“In summary, negative pressure wound therapy appears to be a more effective treatment for diabetic foot ulcers, with a similar safety profile, compared with non-negative pressure wound therapy.” “Future, well-designed clinical trials… are required to provide more convincing evidence for clinical practice.”

• Zhang et al., 2014

“Data from the two largest included studies suggested that NPWT may be an effective treatment in terms of healing debrided foot ulcers and post-

• perative amputation wounds in people with DM.”

Potential change in practice “would need to be informed by clinical experience and acknowledge the uncertainty around this decision due to the quality of the data.”

• Dumville et al., 2013

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SYSTEMATIC REVIEWS, META-ANALYSIS

Clinically Effective: Does it Work?

“…sufficient evidence to conclude that healing of diabetes associated chronic lower extremity wounds can be accelerated with use of NPWT.”

• Xie et al., 2010

“Although the number of patients in this study was limited, the results

• btained from this study and satisfaction of the patients allowed us to

conclude the V.A.C. is a suitable treatment modality in the management of diabetic foot ulcers.”

• Ravari et al., 2014

“Moderate quality evidence suggests that NPWTs improve healing of DFUs and non-healing post-amputation wounds compared to standard wound care.” “Many questions remain regarding the ideal patient population and cost effectiveness.”

• Braun et al., 2014

CLINICAL GUIDELINES INTERNATIONAL EXPERT PANEL RECOMMENDATIONS (INDUSTRY SPONSORED)

Recommendations for use

Canadian Diabetes Association, 2013 No Recommendation

• Insufficient evidence for any recommendation for routine DFU management
• Some evidence for post-op use after extensive debridement

AHRQ, 2012 (United States) Grade C

• May increase complete wound closure compared to standard wound dressings
• Associated with lower risk secondary to infections

IDSA, 2012 (Infectious Disease) Weak (level), Low (quality)

• Consider for selected DFU slow to heal consider using NWPT

NHMRC, 2011 (Australian) Grade B

• Use in specialist centers as part of comprehensive wound program

NICE, 2011 (United Kingdom) Low Quality

• Clinical trials and rescue therapy (when amputation only option) - Not used routinely

SIGN, 2010 (Scottish) Grade B

• Consider in active DFU or post-operative wounds

A Must be considered as advanced therapy for Univ. Texas Grade 2 or 3 post-op DM feet w/out ischemia A Achieve healing by secondary intention B Stop when wound healing progressed so wound can be healed by surgical means B Consider in an attempt to prevent amputation or re-amputation

Cost-effective non-healing wounds ≥12 weeks

Lower resource utilization Lower procedure expenditures

DRIVER ET AL., 2014 HUTTON ET AL., 2011

Cost Effective?

Cost Outcomes

DFU treatment 16 weeks

Higher NPWT efficiency = Cost effectiveness

WHITEHEAD ET AL., 2010 COST-EFFECTIVENESS MARKOV MODEL

Improved healing rates ulcer free months, QALYs, cost/patient Cost sensitive to hospital stay, # infected DFU

NPWT = lower costs w/ additional QALYs and fewer LEA

Recalcitrant wounds, high efficiency NPWT, > 1 home health visits = fewer amputations, more QALYs at lower costs

CONCLUSION

Cost Outcomes

Cost Effective?

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Home health records database stage III/IV non-healing ulcers

NPWT (n = 60) No NPWT (n = 2,288)

Randomized 22 patients, 35 ulcers in 6 week trial

NPWT (n=20) Healthpoint topical gel (n=15) PRESSURE ULCERS PRESSURE ULCERS

Most studies care setting is vague If inpatient & outpatient population, unable to analyze separately

OUTPATIENT NPWT USE

AHRQ HTA: NPWT Technologies, June 2014

Ford et al., 2002 Schwien et al., 2005 35% 5% 0% 48% 14% 8% 0% 10% 20% 30% 40% 50% Admission rate Admission Emergent care NPWT No NPWT

Time to heal

Outpatient efficacy: Is data analysis possible?

43.2% 62.1% 4.1% 13.6% 89.5% 28.9% 51.2% 10.2% 16.9% 95.3% 0% 20% 40% 60% 80% 100% Complete healing 75% healing Secondary LEA Adverse events Outpatient therapy days

NPWT vs. Moist Therapy for Stage 2 or 3 DFU NPWT Moist therapy Closure NPWT Moist P value

100% 96 days Undeterminable 0.001 75% 58 days 84 days 0.014

NPWT greater efficacy, fewer secondary amps than moist therapy

BLUME ET AL., DIABETES CARE 2008

42.1% home care 24.4% inpatient 18.3% outpatient clinic

DRESSING CHANGES

RCT, 16 weeks therapy or complete healing DFU S/P partial foot amputation

• NPWT (n=77)
• Moist wound therapy (n=85)

4 41 11 118 25 50 75 100 125 Clinic visits Dressing ∆

Outpatient NPWT vs. Moist Therapy

NPWT Moist Therapy

≈ 80% done by professionals ≈ 20% done by non-professionals

p < 0.001 p < 0.05

OUTPATIENT CARE SETTING APELQVIST ET AL., AM J SURG 2008

Outpatient efficacy: Is data analysis possible?

Cost difference

Dressing changes

All costs

Staff time

55.8 46 2 $26.0 38.8 54 7 2 $38.8 20 40 60

% healed Therapy days (% of total days) Re-amputation Major re-amputation Cost in USD (x1,000)

% of patients

NPWT vs. Moist Therapy, All Care Settings

NPWT Moist Therapy

35% of patients ≥ 8 weeks therapy had inpatient care Outpatient costs unknown

Cost analysis not by care setting Total therapy days 89.1% outpatient ALL CARE SETTINGS APELQVIST ET AL., AM J SURG 2008

Outpatient efficacy: Is data analysis possible?

Procedures Abx costs

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CONCLUSION Treatment

• f

diabetic patients with post- amputation wounds using NPWT resulted in lower resource utilization and a greater proportion of patients obtaining wound healing at a lower overall cost of care when compared to moist wound healing

Resource Use and Economic Costs

APELQVIST ET AL., AM J SURG 2008

• Adjunctive therapy to cleanse wound bed decreasing bacterial

bioburden

• Indicated for all wound types with bioburden, wound bed debris,

heavy exudate, contaminated/infected wounds

• Improved # of debridement, LOS, length of therapy, time to wound

closure, improved culture results, decreased cost

• NPWT + Instillation = adjunctive therapy
• All studies are based on inpatient care or undefined populations

+ INSTILLATION = BENEFICIAL

NPWT with Instillation

Gupta et al. Int Wound J 2016 ; Kim et al., Plast Reconstr Surg 2013; Kim et al., Plast Reconstr Surg 2014; Gabriel et al., Int Wound J 2012; Timmers et al., Wound Rep Reg 2009

ADVERSE EVENTS BY EVENT TYPE TOTAL ADVERSE EVENTS BY EVENT TYPE, 2011-2016 TOTAL FDA REPORTED ADVERSE EVENTS ASSOCIATED WITH NPWT OVER 5 YEAR PERIOD (2011-2016)

Is it Safe Outpatient?

MAUDE - Manufacturer and User Facility Device Experience, Accessed April 8, 2016

50 100 150 200 250 300 Death Injury Malfunction NA Other

April 2011-Mar 2012 April 2012-Mar 2013 April 2013-Mar 2014 April 2014-Mar 2015 April 2015-Mar 2016

22 736 200 400 600 800 1000 1200 122 104 163 253 398 1040 200 400 600 800 1000 1200 April 2011-Mar 2012 April 2012-Mar 2013 April 2013-Mar 2014 April 2014-Mar 2015 April 2015-Mar 2016 Grand Total

ULCER & WOUND TYPES

Medicare LCD: Ulcers & Wounds Home Setting

Must have tried or considered & ruled out complete wound therapy program described by Criterion 1 and Criteria 2, 3, or 4

Stage III or IV pressure ulcer Venous or arterial insufficiency Neuropathic Chronic, mixed etiology (present > 30 days)

• 2. Stage III or IV pressure

Turned & positioned appropriately Group 2 support surface for extremities Moisture & incontinence managed

• 3. Neuropathic

Comprehensive diabetic mgmt. program Pressure reduced using proper modalities

• 4. Venous

Compression bandages applied consistently Leg elevation and ambulation encouraged

Address, apply, or consider & R/O

Document evaluation, care, wound measurements by licensed professional Apply dressings to maintain moist environment Debride necrotic tissue if present Evaluate and provision for adequate nutritional status

Criterion 1 Criteria 2, 3, or 4

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DOES IT WORK?

PROVIDING VALUE Outpatient NPWT

Increased QALY at lower cost = Improved value

CONCLUSION

Unable to draw firm conclusions about efficacy or safety for chronic wound care “Though NPWT has been used across the wound care spectrum, significant research gaps remain.”

RHEE ET AL., AHRQ HTA: NPWT IN HOME SETTING, 2014

$

Costs

Complete healing Rate of healing Area reduction Fewer LEA Increased satisfaction

Maybe

Pressure ulcers

Appears to be clinically effective, safe, and cost effective

Diabetic foot ulcers

Difficulty Assessing Outpatient Value

Inpatient vs. outpatient rarely defined Unable to isolate outpatient data

In limited studies majority of treatment days are outpatient NPWT appears to be clinically effective, safe, and cost effective

Outpatient NPWT: Does it Work?

IN CONCLUSION