V.A.C.Via Therapy System Monograph

Transcription

1 V.A.C.Via Therapy System Monograph DSL# US

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3 Table of Contents Preface 2 Introduction 3 V.A.C.Via Therapy System 3 V.A.C.Via Therapy System Product Description 3 Optimum Use Conditions 5 Safety Information 5 Contraindications 5 Warnings and Precautions 5 Customer Preference Testing 6 Case Studies 7 Case Study 1: Dehiscence after open reduction internal fixation of tibial fracture 7 Case Study 2. Integra Dermal Regeneration Template Placement 8 Case Study 3. Free radial forearm flap transfer 9 Key Evidence Supporting the Use of V.A.C. Therapy Family of Products 10 Acute Wounds 10 Chronic Wounds 11 Cost Effectiveness of V.A.C. Therapy 12 Cost-Effectiveness Analysis Studies 13 Early vs. Late Use of V.A.C. Therapy 13 Cost-Effectiveness Modeling 13 Summary 17 References 18 V.A.C.Via Therapy System Monograph DSL# US

4 Preface The V.A.C.Via Therapy System is a small, portable and virtually silent addition to the V.A.C. Therapy family of technologies (Figure 1). This document provides a comprehensive introduction of the V.A.C.Via Therapy System and the role it plays on the wound healing continuum of care. This publication will: Describe the V.A.C.Via Therapy unit and its components Suggest optimum use conditions Review the V.A.C. Therapy literature for wounds suitable for V.A.C.Via Therapy Describe clinical outcomes in various case studies Demonstrate potential cost savings such as: - Reducing length of stay (LOS) based on immediate access to a V.A.C. Therapy technology - Transitioning patients sooner from acute to home care - Reducing staff time associated with therapy unit operation and dressing changes - Providing a for sale NPWT system that eliminates much of the administrative challenges (eg, indigent care) around a rental model Figure 1: V.A.C. Therapy Family of Products 2 V.A.C.Via Therapy System Monograph DSL# US (3/11)

5 Introduction The use of negative pressure wound therapy (NPWT) continues to expand across the continuum of care, due to its positive effects in healing a wide variety of wounds. Since the introduction of V.A.C. Therapy in 1997, 1 the number of competing commercialized NPWT devices and dressing combinations has skyrocketed. To date, there have been over 800 publications that have discussed the use of commercial NPWT systems, with 97% (776/801) coming from the use of V.A.C. Therapy. Wound type, size, and severity, as well as treatment cost, and patient mobility have become important considerations when choosing an NPWT system. Given increasing portability of personalized electronic devices (eg, cell phones and computers), patients have come to expect similar trends in medical device technologies. V.A.C. Therapy devices have traditionally been rented, which often causes a delay in initiating therapy, due to the time required to process rental and home care reimbursement paperwork. Faster methods of procurement are now demanded to speed transition from acute care to home care. For example, patients with splitthickness skin grafts (STSGs), who would benefit from immediate application of V.A.C. Therapy, could be immediately transitioned to home care if a V.A.C. Therapy System was available on site in the hospital. What often happens is that patients are required to stay in acute care while waiting for coverage for the V.A.C. Therapy System to be granted for home care use. Patients often remain hospitalized for the single purpose of waiting to receive V.A.C. Therapy treatment, an issue that is increasingly being challenged by hospital administrators. These expanded needs of patients, clinicians and administrators for more portable and immediately available therapy systems prompted the creation of the V.A.C.Via Therapy System (Figure 2) a next generation, ultra-lightweight, portable, single-patientuse V.A.C. Therapy product. The V.A.C.Via Therapy System is an integrated wound management system for use in acute, extended and home care settings. It is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. It is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts. 2 Figure 2: V.A.C.Via Therapy System V.A.C.Via Therapy System V.A.C.Via Therapy System Product Description The V.A.C.Via Therapy System is equivalent to other V.A.C. Therapy Systems in terms of providing the same performance specifications, mechanisms of action (Figure 3), and benefits of traditional V.A.C. Therapy. However, the V.A.C.Via Therapy Unit is a single use, disposable V.A.C. Therapy device designed to be used for low exudating (<80 ml/day), small-to medium-sized wounds, grafts and flaps in all care settings. The V.A.C.Via Therapy delivers continuous subatmospheric pressure (-75mmHg or -125mmHg) to the wound site via a small or medium-sized V.A.C. GranuFoam Spiral Dressing or Dynamic Pressure Control (DPC) Therapy. DPC cycles the negative pressure between 25mmHg to 75 or 125mmHg at the wound site in six minute cycles as shown in Figure 4. By sustaining the negative pressure above 0 mmhg between negative pressure cycles, the level of discomfort is potentially eliminated from the foam dressing expanding when negative pressure returns to 0 mmhg; this also helps minimize possible dressing leaks that can occur in the absence of negative pressure. V.A.C.Via Therapy primarily differs from the other V.A.C. Therapy products in its compact size and 7 day therapy life. In addition, it is available for sale rather than rental to allow for stocking in hospital inventory for immediate use. 3

6 Provides a moist, closed wound healing environment Cell Migration and Proliferation Macrostrain (Draws wound edges together) Tissue Microstrain (Promotes granulation tissue formation) Removes Infectious Materials Promotes Perfusion Reduces Edema Figure 3: Mechanism of Action of the V.A.C. Therapy System of Products The V.A.C.Via Therapy System is comprised of: A single-patient use NPWT unit - Provides 7 days of V.A.C. Therapy - Operates under a rechargeable battery - Weighs 0.7 lbs (0.032 kg) - Simplified user interface n Alarms for blockage and leaks n Indicators for power and therapy life - New Vortis Pump Technology (Figure 5) contained inside the therapy unit makes it the quietest and smallest V.A.C. Therapy unit A sterile single-use 250 ml disposable canister A sterile single-use dressing kit containing: - Medium Spiral GranuFoam Dressing (14.5 x 17 x 1.75 cm) or Small Spiral GranuFoam Dressing (7.7 x 11.2 x 1.75 cm) - V.A.C. Advanced Drape - Interface pad and tubing set with foam quantity record label - 3M Cavilon No-Sting Barrier Film (to help assure dressing seal) - Ruler (for wound measurement) A carrying case and lanyard that provide portability options A product comparison chart for the complete V.A.C. Therapy Upper Setting -25mmHg Figure 4: Dynamic Pressure Control Therapy 4 V.A.C.Via Therapy System Monograph DSL# US (3/11)

7 Current V.A.C. Therapy System Figure 5: Vortis Pump Technology family of products is listed in Attachment 1. Wound Exudate (ml) Clinical Judgement V.A.C.Via Therapy System 80 ml/day Optimum Use Conditions The V.A.C.Via Therapy System is expected to be used most frequently in either of the following situations: As NPWT for low exudating (<80 ml/day), small-tomedium-sized wounds, grafts and flaps in the acute care setting (Figure 6). As a transition therapy for acute care patients who are ready to be released to home care, and who require continuation of NPWT at home. Depending on the clinician s assessment and healthcare agency reimbursement guidelines, treatment may be continued with additional V.A.C.Via Therapy Systems or from a rental therapy unit. For example, in indigent hospital paid placements, V.A.C.Via Therapy is an alternative system that can provide a set number of therapy days after the patient leaves the institution while eliminating the risk of a lost rental therapy unit or unexpected days billed. Safety Information The following safety information is that currently provided in all V.A.C. Therapy Systems. There is no safety information specific to the V.A.C.Via Therapy System. Refer to complete safety information as provided in V.A.C.Via Therapy Instructions for Use Wound Volume (cm 3 ) Figure 6: V.A.C. Therapy System Selection Criteria Warnings and Precautions As with any prescription medical device, failure to carefully read and follow all instructions and safety information prior to use may lead to improper product performance. The following table (Table 1) summarizes all warnings and precautions that should be considered when using the V.A.C.Via Therapy System Contraindications The following are contraindications for the V.A.C.Via Therapy System: Do not place foam dressings of the V.A.C.Via System directly in contact with exposed blood vessels, anastomotic sites, organs or nerves. Do not use on patients with: - Malignancy in the wound - Untreated osteomyelitis - Non-enteric and unexplored fistulas - Necrotic tissue with eschar present NOTE: Refer to appropriate section in Instructions for Use 5

8 Table 1. Warnings and Precautions When Using the V.A.C.Via Therapy System Warnings Precautions Therapy should be used with caution on patients who are at high risk of bleeding complications (ie, weakened or friable blood vessels or organs in or around the wound) or who are without adequate wound hemostasis Therapy should not be used on exposed or superficial vessels (including infected blood vessels) and organs in or around the wound Therapy should be used with caution on patients who are receiving doses of anticoagulants or platelet aggregation inhibitors that are thought to increase the risk for bleeding Therapy should not be used when sharp edges or bone fragments are exposed; they must be eliminated or covered first Therapy should be used with caution on infected wounds, which may require more frequent dressing changes than non-infected wounds Therapy should be used in conjunction with natural tissue, meshed nonadherent material, or bio-engineered tissue over tendons, ligaments, and nerves Therapy unit should not be taken into the MR environment; therapy dressing can typically remain on patients with minimal risk Therapy unit should not be taken into a hyperbaric oxygen chamber Standard precautions for infection control should always be applied to reduce the risk of transmission of bloodborne pathogens Continuous, rather than Dynamic Pressure Control, is recommended over unstable structures in order to help minimize movement and stabilize the wound bed Continuous therapy is generally recommended for patients at increased risk for bleeding, highly exudating wounds, fresh flaps and grafts, and wounds with acute enteric fistulae The size and weight of the patient should be considered when prescribing V.A.C. Therapy In the event a patient experiences autonomic dysreflexia (ie, sudden changes in blood pressure or heart rate in response to stimulation of the sympathetic nervous system), V.A.C. Therapy should be discontinued to help minimize sensory stimulation To minimize the risk of bradycardia, V.A.C. Therapy should not be placed in proximity to the vagus nerve V.A.C. Therapy is not recommended if enteric fistula effluent management or containment is the sole goal of therapy The use of 3M Cavilon No Sting Barrier Film should be considered to protect the periwound skin Use of circumferential dressings should be avoided, except in the presence of anasarca or excessively weeping extremities, where a circumferential drape technique may be necessary to establish and maintain a seal Customer Preference Testing Customer Preference Testing was used to survey the initial V.A.C.Via Therapy placements. Both clinician and patients were given surveys at the start and end of V.A.C.Via Therapy. The intent of the study was to determine which wound types the physicians were treating with this device, average wound dimensions and volume, levels of exudates and ease of use. Table 2 summarizes the results from clinician questionnaires regarding wound types, initial wound dimensions, and level of exudates. Ninety-four percent of physicians did not experience difficulties in placements of the V.A.C.Via Dressing. Reported difficulties were due to leaks caused by the dressing placement location: one dressing could not be placed on the patient s left knee, 3 dressings in the coccyx region, and 3 in the rectal region. Overall, the data reveal positive results for the use of V.A.C.Via Therapy in the treatment of wounds listed in Table 2. Table 2. Customer Preference Testing Results (n=110) Wound Types Surgical wounds Dehisced wounds Traumatic wounds Pressure ulcers Diabetic ulcers Chronic ulcers Venous leg ulcers Arterial ulcer Unknown wounds Average Wound Dimensions Length (cm) Width (cm) Depth (cm) Volume (cm 3 ) Levels of Exudate Low Moderate High Number of Patients % 32% 4% 6 V.A.C.Via Therapy System Monograph DSL# US (3/11)

9 Case Studies Clinical experience with the V.A.C.Via Therapy System is reported in the following case studies. Case Study 1: Dehiscence after open reduction internal fixation of tibial fracture A 71-year-old female presented with increasing pain of the lower extremity. Patient had suffered a grade IIIB tibial fracture for which she underwent open reduction internal fixation (ORIF). She subsequently developed a polymicrobial wound infection, requiring plate replacement and multiple debridements. Patient was placed on a 6-week course of IV antibiotics for osteomyelitis. (Figure 7 A-D). Medical history included peripheral vascular disease (PVD) and type II diabetes. Following irrigation and debridement, NPWT (V.A.C. ATS Therapy) was initiated in the wound to prepare it for STSG closure. After two days of wound bed preparation, the NPWT dressing was removed and an STSG was placed. A non-adherent layer (Adaptic Nonadhering Dressing; Systagenix US, Quincy, MA) was cut slightly larger than the STSG and placed over the skin graft. The V.A.C.Via Granufoam Spiral dressing was trimmed to the size of the nonadherent layer and placed over it. Pressure was initiated at -125 mmhg continuously and the patient was discharged home. B) After two days of NPWT, an STSG was applied On postoperative Day 6, the patient returned to the outpatient clinic and the V.A.C.Via Therapy dressing was removed. There was an approximately 100% graft take with good aesthetic results. Figure 7. Case Study 1: Dehiscence after open reduction of tibia fracture. C) Application of V.A.C.Via Therapy System over STSG A) Wound dehiscence at presentation D) Wound on postoperative Day 6 after V.A.C.Via Therapy dressing was removed As with any case study, the results and outcomes should not be interpreted as a guarantee or warranty of similar results. Individual results may vary depending on the patient s circumstances and condition. 7

10 Case Study 2: Integra Dermal Regeneration Template Placement A 71-year-old male patient presented for evaluation of scalp reconstruction with diagnosis of melanoma Breslow thickness of 5.3mm and with a failed graft (Figure 8 A and B). Wide local excision with sentinel node biopsy was performed and bilaminate skin substitute (Integra Dermal Regeneration Template, Integra LifeSciences, Plainsboro, NJ) was used to cover the defect (Figure 8 C-D). The patient s medical history included diabetes, PVD, and coronary artery disease. A non-adherent layer (Adaptic Non-adhering Dressing; Systagenix US, Quincy, MA), cut slightly larger than the Integra graft, was applied over the skin substitute. A V.A.C.Via Therapy dressing was applied on top of the non-adherent layer and pressure was initiated at -125 mmhg. The patient was discharged home. On postoperative Day 5, the patient returned to the outpatient clinic for follow-up and removal of the V.A.C.Via Therapy dressing. The Integra graft appeared intact and viable. Following availability of final pathology revealing clear margins, an STSG was placed on post operative Day 24. A non-adherent layer and V.A.C.Via Dressing were placed over the STSG. V.A.C.Via Therapy was discontinued 6 days post STSG with 100% take of graft. B) Excision of Integra graft In both instances, patient was discharged home with V.A.C.Via Therapy. Procedures were performed as outpatient and no delays for V.A.C. Therapy approvals were encountered. C) Application of new Integra graft Figure 8. Case Study 2: A) Integra graft failure D) Application of V.A.C.Via Therapy System over Integra As with any case study, the results and outcomes should not be interpreted as a guarantee or warranty of similar results. Individual results may vary depending on the patient s circumstances and condition. 8 V.A.C.Via Therapy System Monograph DSL# US (3/11)

11 Case Study 3: Free radial forearm flap transfer A 62-year-old male patient presented with a fracture to his left leg due to a traffic accident while riding a bicycle. A free radial forearm flap transfer was used to cover the defect. Treatment of the donor site required multiple surgical interventions and subsequent meshed STSG. A V.A.C.Via Therapy dressing was applied at the donor site for 5 days, resulting in good healing of the STSG (Figure 9 A-C). Figure 9. Case Study 3: A) Soft tissue findings after debridement before mesh-graft coverage B) Intraoperative after mesh-graft coverage C) V.A.C.Via Therapy over mesh-graft coverage As with any case study, the results and outcomes should not be interpreted as a guarantee or warranty of similar results. Individual results may vary depending on the patient s circumstances and condition. 9

12 Key Evidence Supporting the Use of the V.A.C. Therapy Family of Products As previously indicated, the V.A.C.Via Therapy Systems is equivalent to other V.A.C. Therapy System in terms of providing the same performance specifications, mechanisms of action and benefits of traditional V.A.C. Therapy. A literature review of V.A.C. Therapy use was conducted based on the types of wounds that would most likely be applicable to V.A.C.Via Therapy. Several published randomized controlled trials (RCTs) and case series are provided for review and can be found in Table 3. Table 3. V.A.C. Therapy Technology Key References Wound Type Acute Wounds Surgical Wounds Number of Articles Number of Articles 109 NPWT is a common method of actively bolstering STSGs in difficult recipient beds. Adjunctive NPWT for 3-6 days has been recommended over STSGs in cases of contoured surfaces, exudative surfaces, surfaces subject to repeated motion, and areas of compromised vascularity. 12, 27 In addition, application of NPWT prevents fluid collection beneath the graft, protects the graft from outside contaminants and shear, and provides positive contact between the bed and newly transplanted skin. Pressure is distributed evenly over contoured surfaces, and the pliability of the dressing allows limited movement of the recipient surface without compromising the graft. 27 NPWT has also Key References Key References 3 Zannis et al 2009 (PCT) 4 Siegel et al 2007 (CRS) 5 Yang et al 2006 (CRS) 6 Moues et al 2004 (RCT) General Trauma 17 7 Machen et al 2007 (CSE) 8 Labler et al 2007 (CST) Grafts 58 9 Blume et al 2010 (RS) 10 Vidrine et al 2005 (CRS) 11 Moisidis et al 2004 (RCT) 12 Scherer et al 2002 (CSE) Diabetic Foot Amputations 9 13 Lavery et al 2008 (RCT-P) 14 Armstrong and Lavery 2005 (RCT) 15 Paola 2010 (RCT) 16 Eginton et al 2003 (RCT) Chronic Wounds Pressure Ulcers Wanner et al 2003 (RCT) 18 Ford et al 2002 (RCT) 19 Joseph et al 2000 (RCT) Diabetic Foot Blume et al 2008 (RCT) Chronic Leg 7 21 Vuerstaek et al 2006 (RCT) CRS: Comparative Retrospective Study; CSE: Case Series; PCT: Prospective Controlled Trial; RCT: Randomized Controlled Trial; RCT-P: Post hoc Analysis of previously published RCT Acute Wounds The effectiveness of early, short-term NPWT in preparing acute wounds for surgical closure is well documented Applied as a temporizing dressing, NPWT has been shown to downstage soft tissue coverage requirements on the reconstructive ladder. 24 The therapy has demonstrated reduced incidence of acute wound infection in high-energy open fractures, 26 compared to gauze dressings. been shown to improve autograft survival as measured by increased qualitative graft take 11, and a reduction in secondary 10, 12, 28 procedures and number of repeated STSGs. An RCT by Armstrong and Lavery investigated the effects of NPWT compared with standard moist wound care (control) in complex wounds secondary to partial foot amputation in diabetic patients. 14 There were 162 patients who were randomly assigned to NPWT (n=77) or control (n=85). All wounds were 10 V.A.C.Via Therapy System Monograph DSL# US (3/11)

13 treated until healing or completion of the 112-day treatment period. The results showed that more patients healed in the NPWT group compared to the control group (43 versus 33, respectively; p=0.04) with faster rates of healing (p=0.005). The NPWT group also reached % granulation faster than the control group (42 days versus 84 days, respectively; p=0.002). The authors concluded that NPWT was a safe and effective treatment for complex diabetic foot wounds. 14 In a more recent published RCT by Paola et al, the authors evaluated the effectiveness of NPWT in improving graft takes of diabetic foot wounds (Study I) and treatment for infected open minor amputations (Study II). 15 In Study I, 70 patients were randomized to NPWT (n=35) or non-adherent gauze (n=35) for coverage of their grafts. The findings revealed that complete graft take was significantly better in the NPWT group than the non-adherent gauze group (80% versus 68%, respectively; p=0.05). In Study II, 130 diabetic patients were randomized to NPWT (n=65) or standard modern wound dressings (n=65) for treatment of their amputations. All patients received a vascular assessment with transcutaneous oxygen pressure measurements. NPWT patients achieved complete closure of the wound in 65±16 days compared to 98±45 days for standard wound dressings (p=0.005). Also, the NPWT group developed wellvascularized granulation tissue over exposed bone significantly faster than the standard wound dressing group (41±8 versus 59±18 days, respectively; p=0.03). Based on these outcomes, use of NPWT resulted in faster wound bed preparation and closure and better graft take rates as compared to standard wound care. 15 Chronic Wounds Adjunctive NPWT has been shown to be effective in different types of chronic wounds, including pressure ulcers (PrUs), diabetic foot ulcers (DFUs), and venous leg ulcers (VLUs), by removing exudate and infectious materials and promoting granulation tissue formation. 20, 29 In addition to irrigation and debridement, mechanisms of action of V.A.C. Therapy assist physicians and clinicians in reducing ulcer size and preparing the wound for closure. Short-term application of V.A.C. Therapy will be most effective in chronic wounds that have been thoroughly debrided and converted to acute wounds. Furthermore, V.A.C.Via Therapy may benefit chronic wound patients who could transition out of the hospital with the immediate provision of an outpatient V.A.C. Therapy device. In the past 10 years, three different RCTs have been conducted for DFUs, PrUs, and VLUs, respectively, comparing the use of V.A.C. Therapy versus the standard care for each wound type. An RCT by Blume et al examined the safety and efficacy of V.A.C. Therapy compared with advanced moist wound therapy (AMWT) for treating diabetic patients with a stage II or III calcaneal, dorsal, or plantar foot ulcer 2 cm 2 in area. 20 All wounds were treated until ulcer closure or completion of the 112-day treatment period. A greater percentage of foot ulcers attained complete closure with V.A.C. Therapy (73/169, 43.2%) compared to AMWT (48/166, 28.9%; p=0.007) within the treatment period. Based on Kaplan-Meier analyses, the median time to complete ulcer closure was 96 days (95% CI, ) for V.A.C. Therapy (p=0.001) and could not be determined for AMWT. Additionally, significantly fewer amputations were reported for V.A.C. Therapy patients compared to AMWT patients (7/169 versus 17/166, respectively; p=0.035). These findings showed that V.A.C. Therapy is as safe as and more efficacious than AMWT in the treatment of DFUs. 20 In a prospective randomized trial by Joseph et al, V.A.C. Therapy was compared to traditional saline-wet-to-moist (WM) dressings for the treatment of chronic wounds. 19 Twenty-four patients with 36 chronic wounds (mostly PrUs) were randomized to receive either V.A.C. Therapy or WM. Blinded, independent wound evaluators measured wounds by volume displacement of alginate impression molds and performed punch biopsies for histology and culture. The results showed a significant difference in volume with a change in depth of 66% for V.A.C. Therapy compared to 20% for WM (p< ). Furthermore, there was granulation tissue formation in 64% of the wounds treated with V.A.C. Therapy. The authors recommended that V.A.C. Therapy be applied to chronic, non-healing wounds that are deep and complicated. In the last RCT, Vuerstaek et al prospectively studied the efficacy of V.A.C. Therapy compared to conventional wound care (control) for the treatment of venous leg ulcers. 21 A total of 60 patients (30 NPWT and 30 Control) were randomized; the primary endpoint was time to complete healing. Data revealed a significantly shorter time to achieve complete healing using V.A.C. Therapy with a median time of 29 days (95% CI, 25.5 to 32.5) for the V.A.C. Therapy group as compared to 45 days (95% CI, 36.2 to 53.8) with control therapy (p=0.0001). Additionally, wound bed preparation was significantly shorter in the V.A.C. Therapy group than the control group (7 days versus 17 days, respectively; p=0.005). The authors recommended that V.A.C. Therapy should be considered as the treatment of choice for chronic leg ulcers owing to its significant advantages in the time to complete healing and wound bed preparation time compared with conventional wound care

14 Cost Effectiveness of V.A.C. Therapy Economic pressures continue to challenge the global healthcare system. Wounds are a major source of patient morbidity and cost to hospitals and community health providers, and wound care costs are closely tied to the individual patient s wound burden In 2005, the US Centers for Medicare and Medicaid Services (CMS) identified chronic wounds as an important issue for longterm study. 36 Chronic wounds (eg, PrU) are difficult to heal and often result in longer lengths of stay (LOS) than acute wounds and require more skilled nursing visits and wound care supplies, 37, 38 which drives up the cost of treatment. In 2007, diabetes and its complications cost the US $174 billion; $116 billion were in direct costs and $58.3 billion in indirect costs, such as loss of productivity, disability, and premature mortality. 67 Diabetic foot problems impose a major economic burden, and costs increase disproportionately to the severity of the condition. The cost of care for patients with a foot ulcer is 5.4 times higher in the year after the first ulcer episode and 2.8 times higher in the second year compared with diabetic patients without foot ulcers. Patients with DFUs require more frequent emergency department visits, are more commonly admitted to hospital, and require longer LOS. 68 In 2008, more than 89 million US patients were treated for wound-related conditions at a cost exceeding $25 billion. 30 In hospitals alone, an estimated 5 million patients have complex chronic wounds that cost the US healthcare system more than $20 billion. 39 Of these chronic wounds, VLUs account for 80% to 90% of all lower extremity ulcerations. It is estimated that over 2.5 million people have VLUs, resulting in a loss of 2 million workdays per year and at an estimated treatment cost of greater than $2.5 billion per year. 40 Furthermore, PrUs and their prevention have become a challenge to both caregivers and healthcare facilities. PrUs account for more than $1.3 billion in healthcare costs per year. The prevalence of PrUs in acute care is between 4% to 34%, with treatment estimates ranging from $2,000 to $70,000, depending on severity, 41 which is particularly onerous to the facilities because the additional costs associated with hospital-acquired PrUs are not reimbursed. Healthcare systems continue to be challenged by a lack of resources and supplies to effectively provide adequate healthcare that results in effective outcomes. One of the major issues in the US healthcare system today is a lack of incentives to manage patients through the continuum of care. In 1983, US legislation was enacted that established set payments per admission that were based on the patient s diagnosis-related group rather than payments based on hospital days and services rendered. 42 The goal of the legislation was to encourage shorter LOS in the hospital and more efficient care; however, the policymakers were concerned about possible growth in readmissions. 43 In 2009, Jencks reported that 19.6% of 11,855,702 Medicare beneficiaries who had been discharged from a hospital were rehospitalized within 30 days, and 24% were rehospitalized within 90 days. Jencks estimated that 10% of readmissions were planned. They also estimated that the cost to Medicare of unplanned rehospitalizations 44, 45 in 2004 was $17.4 billion. Recent healthcare reforms are targeted at managing patient outcomes through the continuum of care. In 2010, Morrison reported that there are two big themes in the new US health reform law, which include: 1) more people will be covered at lower reimbursement and 2) there are changes coming that will shift the game from payment for procedures to payment for outcomes. 46 This will allow healthcare reform laws to better align with provider incentives and to reduce costs through improvement of quality and care coordination. These reforms will also institute value-based purchasing systems for hospitals, voluntary bundled Medicare payment pilot projects, voluntary pilot programs that allows qualifying hospital providers to form accountable care organizations and share in Medicare cost savings, and provides for financial penalties for hospitals with excessive readmissions. 47 Recently, President Barack Obama signed the Patient Protection and Affordable Care ACT (PPACA) into law. This law will make sweeping changes to the Medicare program to strengthen program integrity by increasing the efficiency and quality of medical services. Several provisions of the PPACA are consistent with Medicare Payment and Advisory Commission (MedPAC) recommendations to provide adequate incentives to produce appropriate, high-quality care at an efficient price. 48 For example, PPACA will require the establishment of a national, voluntary pilot program that will bundle physician and hospital payments with the goal of improving patient care and reducing spending. 49 Another provision establishes rewards for healthcare organizations that meet quality-of-care targets and reduce costs per patient relative to a spending benchmark from the share of the savings they achieve for the Medicare program. 42, 49 The Congressional Budget Office (CBO) estimates that this shared savings program will save Medicare $4.9 billion over fiscal years CMS is also looking into the Care Transitions Project within the Quality Improvement Organization (QIO) 9th Statement of Work. This project tasks QIOs in 14 states to coordinate care and promote seamless transitions across care settings, including from hospital to home, skilled nursing care, or home health care agencies. It also targets the reduction of unnecessary readmissions 12 V.A.C.Via Therapy System Monograph DSL# US (3/11)

15 to hospitals that may increase risk or harm to patients as well as Medicare costs. Measures arising from this work are geared towards achieving goals of improved transitions of care and greater coordination among providers. These measures should be breaking down the traditional silos and shifting focus to the continuum of care. 50 Cost-Effectiveness Analysis Studies Today, entities across the continuum of care use the methodology of cost-effectiveness analysis (CEA) to structure the decision making process of healthcare facilities when considering the utilization of existing and new medical technologies. 51 The objective of CEA is to maximize health-related outcomes within budget constraints. The major cost drivers for wound care include time to healing, staff time, LOS in hospital, number of dressings, rate of infections and long waiting time from diagnosis to treatment. 45 Only a small portion of costs involve technical requirements to treat the wound. For instance, the cost of materials (eg, dressings) typically accounts for 10-20% of the 36, 45 total cost of treating a patient. Several studies demonstrate that V.A.C. Therapy can result in fewer hospitalizations, emergent care incidents and complications, reduced amputations, fewer dressing changes, decreased personnel commitments, shorter hospitalization, and reduced treatment times. 5,7-9,37,66 By minimizing the factors that contribute to direct and indirect wound care costs, V.A.C. Therapy has emerged as a cost-effective option for wound healing through the continuum of care (Table 4). These economic studies include several conducted on the benefits of early versus late use of V.A.C. Therapy Early vs. Late Use of V.A.C. Therapy V.A.C.Via Therapy provides for early initiation of NPWT because it can be stored on the shelf, thus avoiding extended delivery times. Baharestani et al examined the impact of early versus late initiation of NPWT on the LOS in home health care for patients with Stage III or IV pressure ulcers or surgical wounds. 54 The data indicated that early intervention of NPWT was related to a reduction in the overall length of home care services. For each day NPWT initiation was delayed, nearly 1 day was added to the total length of stay, potentially resulting in higher costs for wound care treatment. 54 A second study by Kaplan et al demonstrated the success using NPWT early for the treatment of traumatic wounds. 23 Trauma patient records were retrospectively analyzed and divided into early group (on day 1 or 2 of their hospital stay) or late group (on day 3 or later). The results showed that early NPWT use was associated with shorter hospital stays (10.4 versus 20.6 days, p<0.0001), treatment days (5.1 versus 6.0 days, p=0.0498), and ICU stays (5.3 versus 12.4 days, p<0.0001). These reductions translated into lower total costs ($32,175 versus $43, 956, p<0.0001) and variable costs ($15,805 versus $22, 891, p<0.0001) with early intervention of NPWT for these traumatic patients. 23 A third study by de Leon et al and Driver examined the effects 62, 63 of early NPWT use on LOS in a long-term acute care setting. This study retrospectively analyzed patients receiving NPWT early ( 14 days of admission) and late ( 15 days of admission). The findings demonstrated a reduction in mean LOS (35.4 versus 56.4 days, p<0.0001) and a 35% reduction in the mean time to 50% wound closure (22 versus 34 days, p=0.0154) with early NPWT use compared to late NPWT use. These data were also associated with a reduction in total wound costs ($3,194 versus $4,182, p=0.08) with early initiation of NPWT. Cost-Effectiveness Modeling Currently, there are several economic studies that address the 23, 31, 56, 59 costs associated with the use of NPWT in treating wounds. Cost-effectiveness studies, such as Apelqvist et al 56, Flack 64 and Schwien et al 52, use economic models to compare the standard medical costs of traditional wound care dressings with the costs of using NPWT, including hospitalization and additional medical procedures performed, and show total hospital savings between $4,000 and $13,000 per patient episode. Patients with DFUs run the risk of undergoing an amputation. Three published studies have examined the clinical efficacy of V.A.C. Therapy versus traditional wound-care dressings. All three studies showed V.A.C. Therapy to be superior to traditional therapy. Frykberg found V.A.C. Therapy to reduce amputations by 5.8%; 55 Blume displayed 6.1% fewer; 20 and Armstrong showed 8.0% improvement. 20 Amputations, in most cases, require a readmission into an acute facility and cost the healthcare system approximately $45,000 per case. In a recent study by Driver et al comparing the costs of V.A.C. Therapy versus advanced moist wound therapy (AMWT), the authors found that V.A.C. Therapy reduced total inpatient costs by $3,364 per patient for DFU patients. 68 V.A.C. Therapy was shown by Page et al 65 to reduce the risk of readmission by 80% for patients with open wounds with significant tissue defects when compared with saline-soaked gauze. Additionally, Schwien et al retrospectively compared the hospitalization rates for home-care patients with Stage III and IV pressure ulcers treated with V.A.C. Therapy versus other wound care modalities. This study found that the hospitalization rate due to wound complications was lower for patients treated with V.A.C. Therapy (5% versus 14%, p<0.01)

16 Table 4: Literature Summary of V.A.C. Therapy Cost-Effective studies Wound Type # of Patients Costs Basis Outcome Traumatic Wounds 23 Kaplan et al (2009) n=518 early group (day 1 or 2) n=1000 late group (day 3 or later) Pressure Ulcers 52 Schwien et al (2005) n=60 V.A.C. Therapy n=2,288 other 2005 Early group patients had mean lower total ($32,175 vs $43,956; p<0.001) and variable costs ($15,805 vs $22,891; p,0<001) than late group & 2004 V.A.C. Therapy patients had fewer hospital stays (p 0.05), fewer hospitalizations (p<0.01) and fewer wound emergent care encounters (p 0.01) Cost savings estimated $4,209 per episode 53 Philbeck et al (1999) n= to 1998 Cost analysis showed a difference of $8,919 when using NPWT (V.A.C. Therapy) compared to MWT 54 Baharestani et al (2008) n=65 early group (<30 days) n=33 late group (>30 days) 2002 to 2004 Regression analysis indicated that for each day NPWT initiation was delayed almost 1 day was added to the total length of home care (β=0.96, p<0.001) Secondary Amputations 55 Frykberg and Williams (2007) n=12, Medicare patients had lower incidence of amputations (p=0.0077) 56 Apelqvist et al (2008) n=77 V.A.C. Therapy n=85 MWT 2005 Average direct cost per patient treated for 8 weeks: $27,270 (V.A.C. Therapy) versus $36,096 (MWT) Average total cost to achieve healing: $25,954 (V.A.C. Therapy) versus $38,809 (MWT) 57 Flack (2008) Diabetic Foot Ulcer Markov model n= Whitehead et al (2011) Markov model n=1000 Chronic Leg Ulcers NS Demonstrated improved healing rates, more Quality Adjusted Life years and an improved overall cost of care $53,830 per person (V.A.C. Therapy) and $61,757 per person (AMWT dressings) Experienced improved healing rates, more Quality Adjusted Life years and an improved overall cost of care 24,881 per patient/year (V.A.C. Therapy) and 28,855 per patient/year (Advanced Wound Care) 21 Vuerstaek et al (2006) n=60 patients Total wound care costs for hospitalized patients were 25% to 30% lower for V.A.C. Therapy ($3,881) versus stand wound care ($5,452) Full Thickness Wounds 59 Mouës et al (2005) n=54 NS Mean hospitalization costs were 1,788 (V.A.C. Therapy) and 2,467 (conventional therapy) p<0.043 Surgical Wounds 54 Baharestani et al (2008) n=352 early group (<7 days) n=112 late group (>7 days) Regression analysis indicated that for each day NPWT initiation was delayed almost 1 day was added to the total length of stay (β=0.97, p<0.001) 60 Song et al (2006) NS Economic model estimates cost savings of over $7,700 for treatment of dehisced chest wounds with V.A.C. Therapy compared to MWT dressings 61 Page et al (2004) n= Patients treated with NPWT showed a 70% reduction in risk of complications, subsequent foot surgeries, and hospital readmissions NS: Not stated MWT: Moist Wound Treatment AMWT: Advanced Moist Wound Treatment 14 V.A.C.Via Therapy System Monograph DSL# US (3/11)

17 The Vuerstaek et al study of V.A.C. Therapy versus Moist Wound Therapy (MWT) revealed that total nursing time required to treat VLU s was 40% lower for V.A.C. Therapy (232 minutes versus 386 minutes, p=0.001) (Figure 10). 55 The V.A.C.Via System offers an even easier application than our current V.A.C. Therapy products. The V.A.C.Via System has been developed to make the use of our NPWT systems more intuitive for healthcare professionals and for patients. Recently, KCI conducted an internal study comparing the placement times between V.A.C.Via Therapy and InfoV.A.C. Therapy. This study concluded that V.A.C.Via Therapy takes less than 10 minutes to complete product placement, a 19% reduction in placement time compared to InfoV.A.C. Therapy A Randomized Controlled Trial of Hospital Patients with a Variety of Chronic Leg Ulcers % 386 Blume et al 25 retrospectively compared the survival outcomes of STSGs between V.A.C. Therapy and conventional therapy (eg, cotton bolster, sterile compressive, and stainless steel gauze) (Figure 11). Table 5 is a hypothetical economic model that uses the superior clinical outcomes achieved by V.A.C. Therapy in reducing the number of repeat grafts to calculate savings of $ per patient. Additionally, Gabriel et al conducted a small study evaluating the impact of V.A.C.Via Therapy on STSG patients. 66 This study determined that using V.A.C.Via Therapy on STSG patients resulted in a reduction of at least one hospital day per patient. Gabriel et al stated that an affordable, for-sale disposable like V.A.C.Via Therapy may provide earlier transition to the home. 66 As previously indicated the process of obtaining home care placement for medical devices is cumbersome and can take days. Particularly in wounds, such as STSGs, that would benefit from immediate application of NPWT, home care coverage for the NPWT system is typically not granted until after the course of treatment, if at all. Patients often remain hospitalized for the single purpose of receiving NPWT treatment. Gabriel et al s results have also been inputted into a hypothetical model (Table 6) to calculate savings per patient of $1, The total potential savings from these two categories results in $3, per patient (Table 7). The economic model presented above illustrates the potential cost effectiveness of the V.A.C.Via Therapy System on STSG. Additional models can be constructed as clinical evidence is reported for various wound types. 0 V.A.C. Therapy (n=30) Nursing Time (Minutes) Figure 10: Nursing time was reduced by 40% with V.A.C. Therapy versus MWT, Vuerstaek (2006) % 16.0% 14.0% 12.0% 10.0% 8.0% 6.0% 4.0% 2.0% 0.0% Moist Wound Therapy (n=30) Hydrogels and Alginates A 10-year Retrospective Review of STSG Patients Admitted to a Level 1 Trauma Center 3.4% 13.0% V.A.C. Therapy (n=87) % of Repeat Procedures 16.4% Conventional Therapy (n=55) Figure 11: Percentage of failed STSG was reduced 13.0% (3.4% versus 16.4%, p=0.006) with V.A.C. Therapy versus conventional therapy, Blume (2010) 9 15

18 Table 5: V.A.C.Via Therapy hypothetical cost model (100 patient example) of repeated grafts based on Blume (2010) 9 retrospective study (n=142; p=0.009). Category V.A.C.Via Therapy (Assumed same as V.A.C. Therapy) # of Patients a Conventional Therapy V.A.C.Via Therapy Savings % of Repeat Grafts 3.5% 16.4% # of Repeat Grafts b Cost of Materials on Initial Graft $24, $ ($24,662.50) c Cost of Repeat Graft $29, $131, $101, Total Cost $54, $131, $76, Cost per patient $1, $2, $1, a Cotton bolster, sterile compressive, stainless steel gauze b V.A.C.Via Therapy cost: $ per unit (includes $ for the starter kit, with a $100 rebate); Cost of Conventional Therapy is $2.55 for dressings *50 Patients = $ c Cost of a repeated graft is $16,000, and was calculated by averaging the cost of DRGs based on publicly available 2008 HCUP data. The following cost figures were averaged: DRG 573--$23,115; DRG 574--$12,578; DRG 575--$7,366; DRG 576--$29,100; DRG 577--$13,927; DRG 578--$9,734. See Cost of repeated graft per patient for V.A.C.Via Therapy is $16, ($16,000 + $495.00); Cost of repeated graft per patient for Conventional Therapy is $16, ($16, ). The above model uses selected study data to provide an illustration of estimates of costs for use of the V.A.C.Via Therapy System or conventional therapy on STSGs. This model is an illustration and not a guarantee of actual individual costs, savings, outcomes or results. Results are based on selected study data and may not be typical. Individual results may vary. The hospital and/or clinician is advised to use this model as an illustration only to assist in an overall assessment of products and pricing. Table 6: V.A.C.Via Therapy hypothetical cost model (100 patient example) of reduced LOS based on Gabriel et al (2011) 66 prospective small pilot study (n=6). Category V.A.C.Via Therapy a Bolster Dressings # of Patients Average LOS 4.6 b 5.6 a c Cost of LOS $458, $558, $99, Cost per patient $9, $11, $1, a LOS for V.A.C. Therapy was obtained from Blume (2010). 9 Post-STSG LOS: 5.6 days. V.A.C.Via Therapy Savings b LOS for V.A.C.Via TM was calculated by reducing V.A.C. Therapy LOS from 5.6 to 4.6 days based on Gabriel et al s (2011) 66 prospective small pilot study (n=6). Gabriel stated that the purchase, versus rental, model of NPWT procurement was more cost-effective for this otherwise healthy patient population, because hospital stay was reduced by at least one day per patient. c The average cost in 2008 for one day in an Acute facility is $1994, The above model uses selected study data to provide an illustration of estimates of costs for use of the V.A.C.Via Therapy System or conventional therapy on STSGs. This model is an illustration and not a guarantee of actual individual costs, savings, outcomes or results. Results are based on selected study data and may not be typical. Individual results may vary. The hospital and/or clinician is advised to use this model as an illustration only to assist in an overall assessment of products and pricing. Table 7: Total potential savings summary for V.A.C.Via Therapy Reference Category Savings per Patient Blume (2010) Reduced Repeat Grafts vs. Conventional Therapy $1, Gabriel (2010) LOS Reduction vs. V.A.C. R THerapy $1, V.A.C.Via Therapy System Monograph DSL# US (3/11) Total Potential Savings $3,532.15

19 Summary This monograph provided a review of the literature on the use of V.A.C. Therapy over several wound types, as well as providing the V.A.C. Therapy clinical and economic benefits. The V.A.C.Via Therapy System is a simple, easy to use, virtually silent device that has been developed as part of the wound healing continuum of care. V.A.C.Via Therapy will allow for transition of patients from the acute to the homecare setting thereby improving their quality of care and their quality of life. It should be considered as a first line treatment for low exudating (<80 ml/day), small-to-mediumsized wounds, grafts and flaps. In this age in which purchasing practices and policies should ultimately support the founding principles of any healthcare system, this off the shelf disposable product will help improve procurement efficiency and reduce costs associated with duplication of administrative work, delays in delivery of a rental unit, and may reduce the time needed to raise purchase orders. Additional clinical research is still needed to fully understand the scientific, medical and economic impact of the V.A.C.Via Therapy System in providing quality cost effective wound care. 17

20 References (1) Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg 1997 June 1;38(6): (2) V.A.C.Via Negative Pressure Wound Therapy System Instructions for Use. (3) Zannis J, Angobaldo J, Marks M et al. Comparison of fasciotomy wound closures using traditional dressing changes and the vacuumassisted closure device. Ann Plast Surg 2009 April 1;62(4): (4) Siegel HJ, Long JL, Watson KM, Fiveash JB. Vacuum-assisted closure for radiation-associated wound complications. J Surg Oncol 2007 November 12;96(7): (5) Yang CC, Chang DS, Webb LX. Vacuum-assisted closure for fasciotomy wounds following compartment syndrome of the leg. J Surg Orthop Adv 2006 March 1;15(1): (6) Moues CM, Van Den Bemd GJ, Heule F, Hovius SE. A prospective randomized trial comparing vacuum therapy to conventional moist gauze therapy. 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