The Team Approach to Amputation Prevention

Transcription

1 UCSF Vascular Symposium 2012 Diabetic Foot/Limb Preservation George Andros, MD The Team Approach to Amputation Prevention Medical Director, Amputation Prevention Center Valley Presbyterian Hospital Van Nuys, California The Case for an APC Li Y, Burrows N, Gregg E, Albright A, Geiss L Diabetes Care 35(2): Feb

2 Lancet November 15, 2005 DFCon March,

3 The Global Burden of Diabetes For the first time in the history of mankind non-communicable diseases have become the leading cause of global mortality and morbidity (60%) Diabetes is now responsible for 3.2 million deaths each year and it has overtaken HIV/Aids which is responsible for 3 million deaths per year (WHO 11 May 2004) Demography is Destiny Marshall McLuhan Canadian Social Scientist & Demographer BMJ 2009;339:b2857 The Case for an APC The Case for an APC In 2007, $116 billion attributed to the treatment of diabetes, at least 33% of those costs linked to the treatment of foot ulcers Driver et al JAPMA 2011 Driver et al JAPMA

4 A Profile of Amputation All-encompassing data reporting PAD, DFU and amputation are incomplete and unavailable (USA) Major amputations approximate K/yr Minor amputations approximate 60-80K/yr Major are declining and minor increasing 80-90% both major and minor and minor amputations are diabetics: non-diabetics are a small minority of amputation patients The majority of diabetics do not have CLI but neuro-ischemia complicated by infection 1/3 of diabetics are undiagnosed Pathophysiologic Factors of Diabetic Foot Ulceration ISCHEMIA Revascularize The Spectrum of Pedal Neuro-ischemia NEUROPATHY Offloading SEPSIS Debridement and antibiotics Neuropathic NEURO- ISCHEMIA Ischemi a DEFORMITY Offloading REPETITIVE TRAUMA Offloading Younger Higher incidence of DM I DM II Smokers Hypertensio n ESRD 4

5 Hemodynamics and Probability of Healing of Diabetic Foot Ulcer Probability of Healing FLOW TOE Ankle pressure Toe Pressure TcPO mmhg Healing is unlikely if toe pressure < 55 mmhg Rogers, et al. JVS 2011 Basic Valley Presbyterian Hospital Van Nuys, California Intermediate Center of Excellence Rogers, et al. JVS

6 Entrance to the Amputation Prevention Center Valley Presbyterian Hospital DFCon Walk of Fame Edward James Olmos Award Winners Amputation Prevention Center (VPH) Statistics Total number of patients Average days to complete healing Prevention of major amputation Average number of visits 8.9 Average number of surgeries 2.9 Use of NPWT (VAC) 60% Length of stay? Scheduled readmissions High Unscheduled readmissions? (very low) Amputation Prevention Center (VPH) Statistics Diabetes mellitus present in 90% of patients Neuro-ischemics 60% 50% Revascularized + ulcer care 10% Ulcer care only 35% open revascularization 15% endoluminal End Stage Renal Disease 21% of patients with ulcers YEAR 1 YEAR 2 Toe Ray 2 6 Transmetatarsal 3 7 Chopart s 0 7 Below-the-knee 6 2 Above-the-knee % reduction in major amputations Rogers, Bevilacqua JAPMA

7 Hi-Lo Amputation Ratio Paper work HiLo ratio National Average Year 1 Year 2 Rogers, Bevilacqua JAPMA 2010 Virtual Network EURODIALE STUDY: DIFFERENCES ACROSS EUROPE Study in 14 European hospitals in 10 countries 1229 new diabetic foot ulcer patients included More non-plantar ulcers seen (52%): PVD in 49%, Infection in 58%: 31% both infection and PVD. Severity of diabetic foot ulcers greater than previously reported Those with PVD + infection more likely to have other serious co-morbidities.. Prompers et al, Diabetolgia 2007;50:18. 7

8 EURODIALE STUDY: MINOR AMPUTATIONS Study in 14 European hospitals in 10 countries Amputation rate varied from 2.4% - 34% across centres Predictors of major amputations included * Male sex * Ulcer depth * Peripheral Arterial Disease * Infection Earlier referral to foot centres might reduce amputation rates Van Buttam et al, Diabetic Med 2011;28:199. The Importance of a Registry The VSSGNNE is a procedure-based registry The DFU/APC registry will be disease-based. Diabetes as a Risk Factor for Peripheral Vascular Surgery: Data from the Vascular Surgery Study Group of Northern New England Nolan, B, Elrdrup-Jorgensen, J, Stanley, AC, Goodney, PP, Beck, AW, and Cronenwett, JL. Presented at the 19th Annual Winter Meeting of the Peripheral Vascular Surgery Society, Steamboat Springs CO, January 30, 2010 Interdisciplinary Wound Clinic Evolution of Diabetic Foot Service Diabetic Foot Clinic Operations centre Acute Diabetic Foot Service Vascular reconstruction Charcot reconstruction 8

9 Outcome of Diabetic Foot Inpatients in Japan ー Clinical Study in National Hospitals ー Prevalence of PAD in Major Amputees Outcome of Footcare (Kyoto Medical Center, Foot Center ) Prevalence of PAD in amputees ~ ~ ~ n=84 Prevalence of PAD in Minor Amputees n=37 n=33 Amputation 30.1% 21% 21% Major Amputation 18% 9% 5% Footcare Clinic Footwear Clinic Dermatology Foot Clinic Foot center Vascular Surgery Clinic Long-term Prognosis of the Diabetic Foot Patients -Cardiovascular disease- Outcome of Diabetic Foot Inpatients in Japan ー Multi-center Study of National Hospital Organization ー Ischemic Heart Disease Stroke Change of Amputation Rate なし 67.4% あり 32.6% なし 76.7 % あり 23.3 % 37% 19% 9

10 Most Feared Complications? (%) Cambodia (%) Philippines Neuroischemic DFU and Vascular Intervention Drop out n=5 All patients n = 1151 (%) Indonesia (%) Vietnam (%) Thailand Drop out n = 14 No Angiography n = 345 (30%) Angiography n = 801 (70%) Medical treatment n = 297 (26% *, 37% **) PTA n = 314 (27% *, 39% **) Reconstructive surgery n = 190 (17% *, 24%**) Drop out n = 14 Drop out n=14 Drop out n=4 Apelqvist, Elqzyri, Löndahl et al J Vasc Surg 2011 Outcome 79% Healing Rate Without Major Amputation In Surviving Patients (N=1151) 8.6% Drop out withdrawals 1.1% Not healed 27.5 % Deceased unhealed 11.1% Major Amputation 12.7% Minor Amputation 39.8% Primary healing Apelqvist, Elgzyri, löndahl et al J Vasc Sur 2011On Line/In Press Apelqvist et al. JVS (6):

11 Barriers to Prevent Diabetes Related Amputations Availability of health care -Demographics Patient and wound characteristics -Treatment strategies and tradition -Recognition -Attitudes and beliefs of staff Patient related factors Health Care system Resources Reimbursement Multidisciplinary Team Diabetologists Interventional Radiologists Nurses Orthotist Patient Podiatrist s No conflicting advice ULCER Multivariate Risk Factors for: Self care Absent Monofilaments Absent pulses Callus Prior ulcer Foot deformity Male Insulin use High/mod risk score Diabetes duration Serum creatinine HbA1c Microalbuminuria Proteinuria Retinal Disease AMPUTATION Self care Absent Monofilaments Absent pulses Callus Prior ulcer Foot deformity Male High/Mod risk score Systolic BP Diabetes duration Serum creatinine HbA1c Microalbuminuria Proteinuria Retinal Disease Community based study (3719 patients, followed up mean 1.2years) Leese et al, Diab Med

12 Factors Related To Major Amputation In Neuroischaemic/Ischaemic Ulcers Duration of diabetes >23 years Odds ratio 95% CI p value Uraemia Oedema Foot deformity Toe pressure <30 mmhg Intermittent claudication Rest pain Multiple ulcers Non-compliant Male sex What is Happening in England? England Hospital episode statistics (HES) data 21,675 fem-pop bypass 3,458 fem-distal bypass Amputations in England Putting Feet First The report outlines the recommended care pathway in three stages: Immediate care Intermediate care Continuing Specialist Care at 0-4 hours from admission at 4-48 hours from admission after 48 hours 12

13 Neuropathic Charcot Neuroischaemic Critical ischaemic Acutely ischaemic Reporting Standards for Diabetic Limb Salvage Clinical stratification (SVS) Hemodynamic (vascular lab) criteria Ulcer classification (UTWC) Infection (IDSA) Neuropathy Arteriographic anatomic classification COMPARISON ACROSS CENTERS Reporting Standards for Diabetic Limb Salvage Calcification (CTA-MIP views) Salient co-morbidities Arteriosclerotic risk factors Disease specific QOL instrument Appropriate measure of outcomes and endpoints --- primary and secondary Wound healing completeness and timing --- must be achieved and specified TLR and amputation-free survival are unacceptable endpoints Neuropathy Sensory Loss of protective sensation (pain) Pressure (repetitive trauma, e.g. walking) Proprioception Temperature Pain Motor Muscle atrophy Intrapedal weakness causing deformity of foot and toes Abnormally high pedal-plantar pressures Combined sensory/motor Autonomic neuropathy Auto sympathectomy causing dry skin, fissures and cracks AV shunting resulting in decreased perfusion and edema 13

14 Neuropathic Diabetic Foot Ulcers Andrew J.M. Boulton, M.D., Robert S. Kirsner, M.D., and Loretta Vileikyte, M.D. A score (for both feet) of 6 or greater is predictive of foot ulceration. The annual risk of ulceration is 1.1 percent if the score is less than 6 and 6.3 percent if it is greater than or equal to 6. If a patient walks into your clinic with an ulcer on his foot and he doesn t limp, he has neuropathy. Paul Brand, MD NEJM 351;1 July 1, 2004 Progression of Infection in Chronic Wounds Increased amount of exudate New onset pain Odour Wound breakdown Increased insulin requirement/loss of BS control 14

15 A Systematic Review of Scoring Systems for Diabetic Foot Ulcers 11 scoring systems, 6 validated Three systems in widest use: UTSA PEDIS WAGNER All combine neuropathy, ischemia and infection Properly done DFU staging allows comparison of data from different centers Diabet Med May;27(5): Karthikesalingam A, Holt PJ, Moxey P, Jones KG, Thompson MM, Hinchliffe RJ. Diabetic Foot Care Team (Boulton) A New Diabetic Foot Care Paradigm Amputation Prevention Center Primary Care Nurses Primary Care Physician / General Practitioner Diabetologist Diabetes Nurse Specialist Diabetic Podiatrist TOE Vascular FLOW Hospital Nurses Patient Orthotist Orthopaedic Vascular Chiropodist or Podiatrist Plaster Technician 15

16 A New Diabetic Foot Care Paradigm Patient with Diabetic Foot Ulcer A New Diabetic Foot Care Paradigm Primary Care Physician / General Practitioner Nurse Practitioners Infectious Disease Specialist Insurance Company Orthopaedic Well-Meaning, Misguided Friend Amputation Prevention Center Diabetic Podiatrist TOE Cardiologist Vascular FLOW Patient with Diabetic Foot Ulcer Vascular Podiatrist Diabetologist Cardiac Diabetes Nurse Specialist General Interventional Radiologist Wound Care Nurse IPA HMO Nephrologist A New Diabetic Foot Care Paradigm Diabetologist Nephrologist A New Diabetic Foot Care Paradigm Diabetologist Nephrologist Infectious Disease Specialist Cardiologist Interventional Radiologist Orthopaedic Amputation Prevention Center Xxx Infectious Disease Specialist Cardiologist Interventional Radiologist Orthopaedic Amputation Prevention Center Podiatrist Vascular Xxx Wound Care Nurse Podiatrist Patient with Diabetic Foot Ulcer Wound Care Nurse Patient with Diabetic Foot Ulcer Vascular 16

17 Charcot Foot Ulceration over bony prominence on the plantar surface of a rocker-bottom deformity (Charcot foot) 17

18 HODFU Study: Sweden Well-designed placebo-controlled, double-blinded RCT Chronic neuro-ischaemic or ischaemic foot ulcers 94 patients, 5 treatments/week, up to 40 sessions, HBO or HBA Complete healing 52 VS 29% overall (p=0.03): in those having >35 dives, 61 VS 27% (p=0.009) No major side effects HBO may be a useful adjunctive therapy in selected diabetic foot ulcers. Courtesy: Mark Granick Londahl et al, Diabetes Care 2010;33:998 HODFU Follow-Up Study. Three year mortality rates of 75 patients (38:HBO, 37:P) from the original HODFU study No differences in co-morbidities between groups Mortality rates: 10.5% (HBO) vs 29.7 (P): p=0.04 Median age of deceased 79 vs 75y: p=ns HBO may improve survival in this patient population Londahl et al, J Vasc Surg 2011;53:1582 Modified from Löndahl et al Curr Diab Rep

19 Hyperbaric Oxygen in Diabetic Foot Ulcers The HODFU-study Acute (Inpatient) Rehab ** ** An essential component of the APC Patients are severely de-conditioned and require general rehabilitation and Rehabilitation for ambulation More than 10% of our APC reconstructed neuro-ischemic patients spend > 2 weeks in acute rehab A higher percentage of patients leave the hospital walking than walked in Löndahl et al, Diabetes Care 2010 * p<0,05 ** p<0,01 A New Diabetic Foot Care Paradigm Diabetologist Nephrologist Infectious Disease Specialist Cardiologist Interventional Radiologist Orthopaedic Wound Care Nurse Amputation Prevention Center Podiatrist Vascular Patient with Diabetic Foot Ulcer Home Walking Acute Rehabilitation Home Walking Nursing Home Multidisciplinary Management Multidisciplinary management has been associated with improved healing rate and reduction of amputation rate in comparative studies (McCabe Diab Med 1998, Dargis Diab c 1999, Krishnan 2008, Zayed 2009 ) No difference in results from centers which focus on a surgical vs medical approach (Frykberg Diab res Clin Pract 1997) Multidisciplinary approach associated with a decrease in amputation rate (Int consensus Diabetic Foot 2003,2007,2011, Apelqvist Diab/Metab 2001, Aydin K 2010 ) 19

20 Amputation Incidence as a Marker of Quality of Care Future analyses and comparisons will not be meaningful unless the methods used are optimized and harmonized Amputation incidence must be qualified by measures of co-morbidity, operative indication as well as level of amputation ( Schaper et al 2012) Amputation incidence must be compared to a cohort with equivalent morbidity and mortality who do not undergo amputation Jeffcoate & Van Houtum 2004 Closing Thoughts Commit with passion. If you don t have passion, no one else will This is a long term experiment and needs long term support Without the support of administration you are dead! Be prepared to have the center break even but you will contribute substantially to the bottom line with in patient work. Make the center fit your talents and personnel --- use the TOE/FLOW paradigm If Cancer Centers can improve cancer care then APCs can reduce the number of amputations and improve quality of life for Diabetics Thank you. 20