Disclosures. Outpatient NPWT Options Free up Hospital Beds, but Do They Work? Objectives. Clinically Effective: Does it Work?

Transcription

1 4/16/16 Disclosures Consultant, Volcano Corporation Outpatient Options Free up Hospital Beds, but Do They Work? UCSF Vascular Symposium 16 Jonathan Labovitz, DPM Medical Director, Foot & Ankle Center Associate Professor, College of Podiatric Medicine Western University of Health Sciences Objectives 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 Zhang, et al. 14 Dumville, et al. 13 Ravari, et al. 14 Proportion healed RR 1.5, p <.1 RR 1.47, p <.1 7% vs. 3.76% (Moist) Area reduction Change in depth SMD.89, p = cm, p =. Moist cm, p =.1 vs. Moist p=.3 Healing time SMD -1.1, p=.3 HR 1.85, p <.1 Secondary LEA RR.35, p =.6 RR.35, p =.6 Major LEA Minor LEA RR.37, p = mm, p =.7 Moist +3 mm, p =.5 vs. Moist p =. RR.14, p =.3 Major.% vs. 38.5% Minor.% vs. 7.69% vs. Moist p =.3 Adverse events RR 1.1, p =.683 RR.9, p >.5 Patient satisfaction 76.9% vs. Moist 3.1% p =.4 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., 14 Data from the two largest included studies suggested that may be an effective treatment in terms of healing debrided foot ulcers and postoperative 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., 13 1

2 4/16/16 sufficient evidence to conclude that healing of diabetes associated chronic lower extremity wounds can be accelerated with use of. - Xie et al., 1 Although the number of patients in this study was limited, the results obtained 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., 14 Moderate quality evidence suggests that s 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., 14 Recommendations for use CLINICAL INTERNATIONAL GUIDELINES EXPERT PANEL RECOMMENDATIONS (INDUSTRY SPONSORED) Canadian A Must Diabetes considered Association, as 13 advanced therapy for Univ. Texas Grade or 3 post-op DM feet No w/out Recommendation ischemia AInsufficient Achieve evidence healing for by any secondary recommendation intention for routine DFU management Some evidence for post-op use after extensive debridement B Stop when wound healing progressed so wound can be healed by surgical means AHRQ, 1 (United States) B Consider in an attempt to prevent amputation or re-amputation May increase complete wound closure compared to standard wound dressings Associated with lower risk secondary to infections IDSA, 1 (Infectious Disease) Consider for selected DFU slow to heal consider using NWPT NHMRC, 11 (Australian) Use in specialist centers as part of comprehensive wound program NICE, 11 (United Kingdom) Clinical trials and rescue therapy (when amputation only option) - Not used routinely SIGN, 1 (Scottish) Consider in active DFU or post-operative wounds Grade C Weak (level), Low (quality) Grade B Low Quality Grade B Cost Outcomes Cost Effective? Cost Outcomes Cost Effective? DRIVER ET AL., 14 HUTTON ET AL., 11 Cost-effective non-healing wounds 1 weeks Lower resource utilization Lower procedure expenditures DFU treatment 16 weeks Higher efficiency = Cost effectiveness Recalcitrant wounds, high efficiency, > 1 home health visits = fewer amputations, more QALYs at lower costs WHITEHEAD ET AL., 1 COST-EFFECTIVENESS MARKOV MODEL Improved healing rates ulcer free months, QALYs, cost/patient Cost sensitive to hospital stay, # infected DFU = lower costs w/ additional QALYs and fewer LEA

3 4/16/16 AHRQ HTA: Technologies, June 14 OUTPATIENT USE Most studies care setting is vague If inpatient & outpatient population, unable to analyze separately Time to heal Closure Moist P value 1% 96 days Undeterminable.1 75% 58 days 84 days.14 PRESSURE ULCERS Randomized patients, 35 ulcers in 6 week trial (n=) Healthpoint topical gel (n=15) Ford et al., PRESSURE ULCERS Schwien et al., 5 Home health records database stage III/IV non-healing ulcers (n = 6) No (n =,88) 5% 4% 3% % 1% % 35% 48% Admission rate 5% 14% Admission No % 8% Emergent care 1% 8% 6% 4% % % 43.% 8.9% vs. Moist Therapy for Stage or 3 DFU Moist therapy 6.1% 51.% 4.1% Complete healing 75% healing Secondary LEA Adverse events Outpatient therapy days greater efficacy, fewer secondary amps than moist therapy BLUME ET AL., DIABETES CARE 8 1.% 13.6% 16.9% 89.5% 95.3% OUTPATIENT CARE SETTING RCT, 16 weeks therapy or complete healing DFU S/P partial foot amputation DRESSING CHANGES APELQVIST ET AL., AM J SURG 8 (n=77) Moist wound therapy (n=85) 4.1% home care 4.4% inpatient 18.3% outpatient clinic Outpatient vs. Moist Therapy Moist Therapy p < p < Clinic visits Dressing 8% done by professionals % done by non-professionals ALL CARE SETTINGS APELQVIST ET AL., AM J SURG 8 35% of patients 8 weeks therapy had inpatient care Outpatient costs unknown Cost analysis not by care setting Total therapy days 89.1% outpatient % of patients % healed Therapy days (% of total days) Cost difference Dressing changes All costs Staff time vs. Moist Therapy, All Care Settings 7 Re-amputation Major re-amputation Abx costs Procedures Moist Therapy $6. $38.8 Cost in USD (x1,) 3

4 G 4/16/16 Resource Use and Economic Costs with Instillation Treatment of diabetic patients with postamputation wounds using 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 APELQVIST ET AL., AM J SURG 8 + INSTILLATION = BENEFICIAL 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 + Instillation = adjunctive therapy All studies are based on inpatient care or undefined populations Gupta et al. Int Wound J 16 ; Kim et al., Plast Reconstr Surg 13; Kim et al., Plast Reconstr Surg 14; Gabriel et al., Int Wound J 1; Timmers et al., Wound Rep Reg 9 Is it Safe Outpatient? MAUDE - Manufacturer and User Facility Device Experience, Accessed April 8, 16 Medicare LCD: Ulcers & Wounds Home Setting ADVERSE EVENTS BY EVENT TYPE TOTAL ADVERSE EVENTS BY EVENT TYPE, April 11-Mar 1 April 1-Mar April 13-Mar April 14-Mar 15 April 15-Mar Death Injury Malfunction NA Other TOTAL FDA REPORTED ADVERSE EVENTS ASSOCIATED WITH OVER 5 YEAR PERIOD (11-16) April 11-Mar 1 April 1-Mar 13 April 13-Mar 14 April 14-Mar 15 April 15-Mar 16 Grand Total ULCER & WOUND TYPES Stage III or IV pressure ulcer Neuropathic Venous or arterial insufficiency Chronic, mixed etiology (present > 3 days) Must have tried or considered & ruled out complete wound therapy program described by Criterion 1 and Criteria, 3, or 4 Criterion 1 Criteria, 3, or 4 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. Stage III or IV pressure Turned & positioned appropriately Group 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 4

5 4/16/16 Outpatient PROVIDING VALUE IN DOES IT WORK? Outpatient : Does it Work? Complete healing Rate of healing Area reduction Fewer LEA Increased satisfaction $ Costs Maybe Pressure ulcers Appears to be clinically effective, safe, and cost effective Increased QALY at lower cost = Improved value Unable to draw firm conclusions about efficacy or safety for chronic wound care Though has been used across the wound care spectrum, significant research gaps remain. RHEE ET AL., AHRQ HTA: IN HOME SETTING, 14 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 appears to be clinically effective, safe, and cost effective 5