Lower Extremity Peripheral Arterial Disease: Less is Sometimes More 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
Lower Extremity Peripheral Artery Disease Disclosure Statement World according to Spence Taylor Expert Opinion
3000 Cases/yr Lower extremity ischemia 47.8% of total volume
Standard of Care in 1992 Real opportunity to raise the bar
The case that changed it all
Mrs C. 70 yr old WF-Transferred from out-lying hospital with Lt leg ischemic ulcers blisters from CHF Prolonged course (6 weeks); Home: Died POD # 50 Successful outcome?
Maybe we need to change our approach to the management of critical limb ischemia
Functional outcome not solely determined by limb salvage or reconstruction patency, but by functional, mental, and medical condition at presentation
Claudication CAD Rest Pain Independent Predictors Poor outcome CAD Diabetes ESRD Gangrene Dementia CAD Diabetes ESRD Tissue Loss CAD Diabetes ESRD Gangrene Dementia
Southern Surgical Association 2008 2240 limbs/1732 consecutive patients from Jan. 1998-Dec. 2005 999 limbs/ 663 pts Medically refractory claudication 464 limbs/ 392 pts Rest pain 777 limbs/ 677 pts Tissue loss 60.6% (N=1049) endovascular therapy 38% (N=659) open surgery 1.39% (N= 24) both
Results Secondary Patency
Results Amputation-free Survival
Results Maintenance of Ambulation
Results Maintenance of Independent living
Southern Surgical Association 2008 Implications (General) Outcomes dependent on intrinsic co-morbidities at presentation; not necessarily type of intervention (Endo vs Open) Emphasis: 25% @ 5-yrs Who to treat not How to treat
People go to heaven whether you operate on them or not.. So, when do throw in the towel?
Case Presentation 93 year old female mentally sharp; Prior PTA Assisted living facility; functionally independent Uses legs to transfer; wheelchair bound during the day but very active Baseline congestive heart failure, Diabetes Presents with gangrenous changes, second toe Mrs. H
Case Presentation Slight left knee contracture ABIof 0.39 and a great toe pressure of 13 Triphasic common femoral waveform, superficial femoral artery occlusion with reconstitution of the tibial vessels at midshank Osteomyelitis 2 nd Toe
A Definition of Success Success after Revascularization for Tissue Loss All of the following: 1. Graft patency to the point of wound healing 2. Limb salvage for one year 3. Maintenance of ambulatory status for one year 4. Survival for 6 months Tested on 677 patients (316 endo & 361 open)
Clinical Success Overall = 40.9% Open Bypass = 43.3% Endovascular = 37.0% P =0.06
677 Interventions for Tissue loss Predictors in Probability of Combination Failure (OR) 65-70% Success Impaired ambulation ESRD < 20% Presence of gangrene Success Prior vascular intervention No predictors Independent Predictors Impaired Ambulation, Diabetes, & gangrene Diabetes < 10% Success Impaired Ambulation, ESRD, Diabetes Prior Vasc intervention & Gangrene 35.4% (1.0) 85.2% (10.5) 92.8 (23.7)
Mrs. H: What are my Chances? 70%-80% chance of success (Patency or Limb Salvage) vs. 10%-20% chance of success (Impaired Ambulation, Diabetes, prior PTA & Gangrene > 85% probability of failure [OR 10.5] )
Naysayer s Response: You have to do something. What s the harm in trying endovascular intervention? It is well tolerated and safe, etc, etc, etc.
2015 Medicare Allowable Superficial femoral artery PTA and stent CPT Code Professional Fee Facility Fee 75710-26 75625-26 37226 75960-25 $53.37 $54.14 $506.14 $2,576.46/ or $0 $9,119.70 Total $613.65 $11,696.16 $12,309.81
The Cold Hard Truth Human life is a sexually transmitted disease with a 100% mortality Can not fix a systemic problem with a local operation
If is about the patient and not the anatomy, well consider this 61 year-old man with claudication left leg Cigarette smoker, multiple attempts to quit Seen recently walking around the hospital Works and as informed a contractor, me that likes his to leg hunt is doing well.. Ankle.after brachial index= the balloon.5 angioplasty performed Short segment (5 cm) by his SFA cardiologist occlusion Treatment started exercise & smoking cessation
Where am I missing the boat?
Patients with intermittent claudication have a risk of major amputation of 1% per year and a death rate of 6% per year 6% overall progress to critical limb ischemia Best initial treatment is medical therapy
Claudication - Medical Treatment Stop smoking Exercise program Drug therapy
Claudication - Medical Treatment Exercise Program 34% - can not participate - other ailments 36% - unwilling to participate 30% - participate and do well De La Haye, Vasa, 1992
Mediocrity? At best we help only one-third of our patients with claudication by noninterventional Rx
Summary Self health assessment improved significantly for the overall group, however, the improvement was attributable to the striking improvement in patients with claudication While ambulation and independence rates in patients with CLI exceeded 80% at one year, self health assessment did not improve and amputation-free survival was only 50% Claudication vs. CLI Same pathology; very different diseases
Maybe more is more It s about the patient, not about..
Claudication Do we need to intervene more frequently?
Heresy
1000 Limb Claudication Study Treatment today = predominantly endovascular Rx (> 60%) and safe (< 1% mortality) Symptom resolution = nearly 80%; symptom recurrence = 18% Re-intervention for recurrent symptoms = 6.5%; amputation in this cohort was rare (< 2%)
Secondary Patency n= 1000 93.9% @ 5yrs AIOD better than II
Limb Salvage n= 1000 99% @ 5yrs
Cumulative Survival n=669 77% @ 5yrs
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Critical Acclaim
You have to admire the fact that this group of surgeons keep track of what they do and try report their results. Unfortunately, the way that report the results is not very useful..not stratified by TASC lesion, pre-and post hemodynamic status, or the occurrence of single or multilevel disease. If you are willing to spend a lot of money, you can treat a lot of patients and not hurt them.
Expert Opinion According to Spence Taylor CLI: Don t miss the forest for the trees. Less may be more Human life is a sexually transmitted disease with 100% mortality It s about the patient: Try to understand when enough is enough & not enough Claudication: Beware of the dogma. It will bite you