Lower Extremity Peripheral Arterial Disease: Its All About the Pulse. Spence M Taylor, M.D.

Transcription

1 Lower Extremity Peripheral Arterial Disease: Its All About the Pulse Spence M Taylor, M.D. President, Greenville Health System Clinical University Senior Associate Dean for Academic Affairs and Diversity University of South Carolina School of Medicine Greenville April 28- May 1, 2016 G H S C l i n i c a l U n i v e r s i t y P a r t n e r s

2 Lower Extremity Peripheral Artery Disease Disclosure Statement World according to Spence Taylor Expert Opinion

3 Critical Limb Ischemia Management 2016 Case Presentation

4 Case Presentation 60yo diabetic presents w/ CLI Sent for A-gram

5 Case Presentation ABI from 0.3 to 0.8 (ankle pressure 90) Discharged home with f/u in clinic-one week With good blood flow, he will do well Comes to the ER at 10 days with a pulse and gas extending to the ankle

6 Lessons Learned Its All About the Pulse G H S C l i n i c a l U n i v e r s i t y P a r t n e r s

7 Wilford Hall USAF Medical Center Greenville Health System Greenville SC

8 Spence Taylor MD & the STS 1992

9 Factors associated with limb loss despite a patent infrainguinal bypass graft. Carsten CG, Taylor SM, Langan EM, Crane MM Am Surg Jan;64(1):33-7 Lower-extremity limb salvage should parallel infrainguinal bypass graft patency. To determine factors associated with limb loss despite a patent bypass, we reviewed 191 consecutive infrainguinal bypasses in 158 patients followed prospectively over 42 months. In this series 191 of Bypasses/ (92%) vein grafts, patients 15 (8%) expanded polytetrafluoroethylene grafts, 122 (64%) tibial artery bypasses, and 170 (89%) bypasses placed for limb salvage, 29 major lower-extremity (above-knee or below-knee) amputations were Mean performed f/u 42 in 29 months patients, 12 because of ischemia after graft thrombosis and 1729 (9% amputations of series) due to progression (17 [9% of soft total tissue series] infection/necrosis w/ patent despite bypass) a functioning bypass. Primary and secondary 36-month vein graft patencies by life-table analysis were 61 per cent and 81 per cent, respectively. When the 17 cases of limb loss were compared to the rest of the series, nonstatistically significant CKD, Diabetic neuropathic ulcers: independent predictors variables included male sex [11 (65%) vs 79 (56%); P = 0.608] and diabetes [12 (71%) vs 80 (57%); P = 0.310]. Statistically significant variables included black race [9 (53%) vs 39 (28%); P = 0.048]; chronic renal failure [6 (35%) vs 12 (9%); P = 0.005], placement to a tibial/pedal artery [15 (88%) vs 107 (62%); P = 0.034], distal anastomosis to the anterior tibial/dorsalis pedis (AT/DP) artery [8 (47%) vs 27 (16%); P = 0.004], and grafts requiring late revision [7 (41%) vs 22 (13%); P = 0.006]. Thirteen (76%) extremities had an intact pedal arch. Nine amputations were performed within 30 days (early group), and eight were performed from 45 days to 20 months

10 It s not about the pulse: More Cull DL, et al. Open versus Endovascular Intervention for Critical Limb Ischemia: A Population-Based Study. J Am Col Surg 2010;210(5):555-63

11 An Assessment Cull DL, et al: SSA 2009 Open Era 1996 n=570 30% Endo Era 2005 n=749 Open/ Endo 75%/25% 50%/50% 1) # of 2 revascularizations doubled (8%-19%) 2) Amputation rate not improved ~ 3years

12 An Assessment Cull DL, et al: SSA 2009 Our shift from open surgery to endovascular, while less invasive, has increased the amount of care without improving outcomes It s not just about endovascular revascularization: There is more

13 Other Lessons Limb salvage is like cancer; complex, multifactorial (not just vascular), prognostically challenging and needs a multidisciplinary approach A standardized treatment approach is needed A standardized diagnostic terminology is needed Precision Medicine: Patient centered outcomes

14 If CLI is like cancer: Multidisciplinary treatment standardization..what is our appetite?

15 Our Observation & a Plan: Seems we get confused about how and when to treat people with PAD. Some perform open surgery for certain problems while others perform angioplasty. Some do nothing. Lets decide to put together a treatment algorithm to help direct how best to treat PAD given various clinical presentations. What do you think? Peter Mackrell MD 1999

16 Its 1999, why do we need to standardize and where is the confusion?

17 Type of Care Rendered? Toyota Corolla Care

18 Peripheral Angioplasty Less invasive Better tolerated Less durable Anatomy/Other: Short lesions Big diameter Good R/O Higher risk pts Open Bypass More invasive Less well tolerated More durable Anatomy/Other: Long lesions More ischemia Good risk pts Diabetics

19 The Lower Extremity Grading System (LEGS) Score Arteriographic Findings Presentation Functional Status Co-morbidities Technical Factors - Aortic - Claudication 5 - Ambulatory 0 - Obesity 2 All Cases < 3 cm aortic stenosis/ - Redo surgery 2 occlusion or 3-5 cm stenosis - Limb threatening - Ambulatory/ - High risk coronary of aorto-iliac bifurcation 8 ischemia 2 at home only 2 artery disease 3 - Redo angioplasty -2 > 3 cm aortic stenosis/ occlusion or > 5 cm stenosis - Non-ambulatory/ - Age Infrainguinal Cases of aorto-iliac bifurcation 0 transfer only 5 > Blind segment target 2 - Iliac - Non-ambulatory 20 > 80 2 TASC A or B 8 - No venous TASC C 2 conduit 6 TASC D 0 or - No vein w/ foot - Fem-pop-tib infection 8 < 5 cm occlusion/stenosis 5 > 5 cm occlusion w/ distal target 0 Isolated common/deep femoral stenosis 0 Possible score: 2-5 Possible score: 0-20 Possible score: 0-7 Possible score: > 5 cm occlusion w/o distal target 6 Recommended Treatment: (sum of total score from each column) * If a heel ulcer and ESRD -0 9 = open surgery are present, double the score Possible score: = endovascular ->20 = primary amputation

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21 Case Like Control a Lead Study Balloon 100pts LEGS v 100pts Contrary *LEGS better outcomes@ 6mos -Patency -Limb salvage -Ambulation We will figure it out as we learn more about endovascular

22 What more can we really learn? Twenty-Year Med Pub Search Endovascular intervention: 32,182 citations Open bypass: 5,369 citations Open bypass vs. Endovascular: 57citations We have looked at the elephant..from about every angle

23 The Oculostenotic Reflex

24 Multidisciplinary treatment standardization..we have a ways to go

25 Glimmers of hope Southern Arizona Limb Salvage Alliance (SALSA)

26 If PAD is like cancer: Standardized Terminology

27 The term CLI lacks specificity

28 Factors influencing amputation risk

29 The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: Risk stratification based on Wound, Ischemia, and foot Infection (WIfI) Mills JL, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G on behalf the Society for Vascular Surgery Lower Extremity Guidelines Committee J Vasc Surg Jan;59(1):

30 WIfI Clinical Stage Ischemia - 0 Ischemia - 1 Ischemia - 2 Ischemia - 3 W-0 VL VL L M VL L M H L L M H L M M H W-1 VL VL L M VL L M H L M H H M M H H W-2 L L M H M M H H M H H H H H H H W-3 M M H H H H H H H H H H H H H H fi-0 fi-1 fi-2 fi-3 fi-0 fi-1 fi-2 fi-3 fi-0 fi-1 fi-2 fi-3 fi-0 fi-1 fi-2 fi-3 WIfI Clinical Stage Amputation Risk at 1 year 1 Very Low (3%) 2 Low (8%) 3 Moderate (25%) 4 High (50%)

31 SVS WIFI CLASSIFICATION GRADE WOUND ISCHEMIA FOOT INFECTION ULCER GANGRENE ABI TP INFECTION 0 None None >0.8 > 60 mm Hg None 1 Shallow None mm Hg Mild 2 Deep Digits only mm Hg Moderate 3 Extensive Extensive <0.39 < 30 mm Hg Severe (SIR) The WIfI classification system grades each factor on a severity scale from 0 to 3. The original document outlines each grade in much greater detail; the basic delineations for each factor are shown above with respect to unaffected, mild, moderate, and severe wound, ischemia, and foot infection grades.

32 Critical Limb Ischemia : Too Simple We need to devise a foot ischemia classification that takes into consideration the degree of foot wound Infection David L Cull M.D

33 Comparison of GCLI and WIfI Grades Greenville CLI Grades Wound Diameter Grade 1 3 Depth Grade 1 3 Type Ulcer/gangrene Location Grade 1 3 Ischemia Grade 1 3 Infection Grade 1-4 WIfI Grades Wound Grade 0 3 Ischemia Grade 0 3 Infection Grade 0-3

34 Prospective Analysis of Wound Characteristics, Degree of Ischemia, and Extent of Infection on Time to Wound Healing and Limb Salvage: An Early Validation of the SVS Lower Extremity Threatened Limb Classification System David L. Cull, MD Ginger Manos, MD Michael C. Hartley, MD Spence M. Taylor, MD Eugene M. Langan, MD John F. Eidt, MD Brent L. Johnson, MS G H S C l i n i c a l U n i v e r s i t y P a r t n e r s

35 Purpose To determine whether the WIfI clinical stage risk stratification estimated by the SVS expert panel compares to actual patient outcomes. To determine whether the WIfI clinical stage is predictive of wound healing.

36 Methods Jan 2008 Dec 2010 patients with a foot wound + revascularization procedure At the intervention the wound/infection grades were assigned by a vascular attending or resident Ischemia grade was assigned after the procedure

37 Results 139 patients/151 limbs/158 index wounds Males- 63% Mean age- 70 yrs Tobacco use- 66% Comorbidities Diabetes mellitus 65% Coronary artery disease 64% End stage renal disease 15%

38 139 patients/151 limbs/158 index wounds WIfI Clinical Stage Predicted Observed Observed Amputation Amputation Non-Healing Stage 1 (n= 40) 3% 3% 8% Stage 2 (n= 64) 8% 10% 19% Stage 3 (n= 46) 25% 23% 30% Stage 4 (n= 8) 50% 40% 63%

39 139 patients/151 limbs/158 index wounds Wound Healing OR Amputation OR (95% CI) (95% CI) WIfI Stage (Referent) 1.00 (Referent) WIfI Stage 2.29 ( ) 4.8 ( ) WIfI Stage 3.15 ( ) 10.8 ( ) WIfI Stage 4.05 ( ) 23.4 ( )

40 Factors Associated with Wound Healing Bivariate Analysis Smoking (p=0.03) Wound size (p=0.004) Wound depth (p=0.001) Ischemia grade (p<0.001) Factors Associated with Limb Amputation Bivariate Analysis Smoking (p=0.027) Wound size (p=0.026) Ischemia grade (p<0.001) Infection grade (p=0.05) Multivariate Analysis Ischemic grade Infection grade Multivariate Analysis Ischemia grade Infection grade Diabetes mellitus 40

41 Conclusions: WIfI promises not only to serve as a tool for comparing treatment modalities but also as a clinical decisionmaking tool to guide treatment

42 Risk of amputation versus SVS WIfI Stage: Compilation of published data Study (year): # limbs at risk Stage 1 Stage 2 Stage 3 Stage 4 Cull (2014): (3%) 63 (10%) 43 (23%) 8 (40%) Zhan (2015): (0%) 50 (0%) 53 (8%) 59 (37%) Darling (2015): (0%) 111 (2%) 222 (6%) 213 (28%) Causey (2016): (0%) 48 (25%) 42 (21%) 49 (31%) Beropoulis (2016): (13%) 42 (19%) 29 (19%) 26 (38%) N = 1189 (weighted average) 131 (4% ) 314 ( 9%) 389 (11%) 355 (31%) Number of limbs at risk in each WIfI Stage with % amputation at 1 year in parentheses Averages in total in bottom row (in parentheses) are weighted

43 If PAD is like cancer: What about precision therapy targeted at each patient? Doctor Knows Best

44 Patient Centered Outcomes: What Does the Patient Want from Intervention? Analysis of 102 Patients; Elective Surgery 66% based decision on surgeon recommendation Success: No need to return to doctor -82% Maintenance of daily activity -65% Maintenance of mobility -61% Relief/avoidance pain -58% Continue hobbies -54% Continue work -12%

45 A Definition of Success Success after Revascularization for CLI According to the Patient All of the following: 1. Maintenance of living independence 2. Maintenance of ambulatory status 3. Control/relief of pain 4. No additional/non-routine physician visits 5. Survival for one year

46 Patient-Centered Outcome of Success Tested on 954 patients Successful Outcome 218/954 combining (23%) all components: Independent Predictors of Failure ESRD (OR 2.21; p=0.006) Impaired ambulation (OR 1.76; p=0.015)

47 A Resident s Observation: The residents, get confused about how and when to treat people with PAD. Some attendings perform open surgery for certain problems while others perform angioplasty. Some do nothing. We have decided to put together a treatment algorithm to help direct how best to treat PAD given various clinical presentations. What do you think? Taylor SM, et al. The LEGS Score: A proposed grading system to direct treatment of chronic lower extremity ischemia. Ann Surg; 2003:

48 Expert Opinion According to Spence Taylor It s not just about the pulse Vascular disease of the lower extremities is as deadly as cancer, why not stage it and treat it like cancer in a multidisciplinary fashion? Let s benchmark and standardize care like the oncologists; Should be easy Right? Maybe Doctor does not know best

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