1. Common femoral artery stenosis; is surgery still the best revascularization
Richard F. Neville, MD
Associate Director, INOVA Heart and Vascular Institute
Vice Chairman, Department of Surgery
Director, Vascular Services

2. Scientific Advisory Board:
Richard F. Neville, MD
Disclosures
Scientific Advisory Board:
WL Gore
Graftworx
  Cormatrix
Tissue Analytics

3. Principles for femoral occlusive disease
Endarterectomy has been the gold standard for treating atherosclerotic disease of the CFA.
Endarterectomy alone may be sufficient for patients with disabling claudication
Those with tissue loss and more extensive lesions likely require additional revascularization

4. CFA occlusive disease: contemporary results
65 Common femoral thromboendarerectomy cases
Claudication 68%,
CLI 32%
100% Technical success
95% Hemodynamic success
ABI increase 0.24
5% Complications
Patency
1 year 93%
5 year 91%
Assisted primary 100%
CHF – predictor of re-intervention
Patel V, et al. J Vasc Surg 2008;48(4):872-7

5. CFA endarterectomy Primary patency 90-96% to 8 years follow up
Assisted primary patency 100%
Amputation Free survival
94% 10 years
Complications
Hematoma / seroma
Nerve injury
Pseudoaneurysm
Infection: Prior surgery, drain in place
Ballotta E, et al. Surgery 2010;147(2):
Kechagias A, et al. World J Surg 2008;32(1):51-54

6. CFA endarterectomy: Anatomy
Femoral triangle
Inguinal ligament
Sartorius muscle
Adductor longus
Femoral triangle structures
Nerve
Artery
Vein
Lymphatics

7. CFA endarterectomy: Incision
Longitudinal incision
Easier extension
Transverse incision
Decreased complications
Lateral circumflex femoral
Collateral circulation by way of the geniculate branches

8. CFA endarterectomy: Technique
Track down endpoint
Profundaplasty
Selective
Delayed maximal result
Preserve Lateral circumflex femoral
Runoff impacts patency
Rest pain > tissue loss

9. CFA endarterectomy: patch closure
Vein
Bovine pericardium
PTFE
Dacron
ExtraCellular Matrix (ECM)
Wound closure in layers
No dead space
Incisional VAC ?

10. Extracellular Matrix (ECM) patch
ECM derived from porcine small intestinal submucosa
Structural proteins
Adhesion glycoproteins
Glycosaminoglycans and proteoglycans
Matrix-cellular proteins
Concept
Bio-scaffold
Regeneration into tissue specific reparative tissue
Aortic valve
CEA

11. ECM patch: peripheral trial
Multi-institutional (institutional IRB approval)
N = 100
FDA approval for peripheral application (6 ply)
Prospectively collected data
Follow up
Clinical examination
ABI measured
Duplex ultrasound imaging
Selective angiography
Kayssi A, Adams J, Neville RF. SAWC 2016.

12. ECM patch angioplasty: procedures

13. Iliofemoral endarterectomy: ECM patch
DELETE?

14. ECM patch: procedures
DVP bypass
Hybrid procedure

15. ECM patch: graft revision
Prosthetic grafts
Vein grafts
Proximal anastomosis
REMOVE?
Distal anastomosis

16. Results Follow up Range of 3 to 24 months Mean follow-up of 7.5 months
92% Primary patency
No perioperative acute thrombosis, or infection
Late complications
Wound dehiscence 5
Groin infection 5
Thrombosis 4
Pseudoaneurysm 1
Patch dehiscence 1
5 unrelated mortalities during follow-up

17. ECM Follow up: Femoral endarterectomy
Follow up arteriogram – 8 months
Patch intact, no restenosis

18. ECM Follow up: DVP Bypass
Duplex US surveillance at 6 months
No evidence of stenosis/hyperplasia

19. ECM Follow up: DVP bypass
Anastomotic pseudoaneurysm at four months

20. ECM Histology Histological analysis of the ECM reparative response
Anastomotic tissue harvested during revision of thrombosed bypass grafts at 4 and 6 months
Intima (fibro-intimal proliferation)
Media (no inflammation)
Adventitia (granulation tissue)

21. Post-operative complications after CFA endarterectomy
NSQIP database
1843 patients from
Claudication 64% CLI 36%
Mortality 3.4% (30% post discharge)
Morbidity 11%
Superficial infection 6%,
Deep infection 2%
Dehiscence 0.8%
Independent predictors of morbidity
Obesity
Steroid dependence
Nguyen BN, Neville RF, et al. J Vasc Surg 2015;61(6):

22. Post-operative complications after CFA endarterectomy
60% of morbidity and mortality post-discharge
CFA endarterectomy may not be as “benign as previously believed”
Nguyen BN, Neville RF, et al. J Vasc Surg 2015;61(6):

23. Endovascular therapy for CFA occlusive disease
Higher incidence of technical failure
Poor long-term patency compared with surgical repair
Stent fracture increased in region of high mobility
Plaque typically extends into the profunda femoris
Inhibit future percutaneous access and/or impact open surgical options

24. Endovascular therapy for CFA occlusive disease: success?
Ahn, et al (DFW Vascular Group, Dallas, Texas)
61 patients
19% procedural failures
33% thrombosis at 12 months
Bonvini et al (Bad Krozingen, Germany; Geneva, Switzerland)
360 patients
37% with stenting due to suboptimal PTA
28% restenosis at 1 year
Paris et al (Ochsner Clinic)
29 lesions treated with CFA stenting (10% for hemorrhage)
100% procedural success
93% with symptomatic improvement in follow up

25. Should we change the paradigm for treatment of CFA occlusive disease?
The number of study limitations must be addressed.
Although 1-year results are often acceptable, the long-term outcomes are not as promising.
Kaplan-Meier curves for restenosis and TLR reveal a significant drop-off in patency after 1 year, with frequent need for re-intervention.
5-year primary patency is approximately 50%. These long-term results are inferior to those achieved with endarterectomy and patch angioplasty.
John R. Laird, MD, J Am Coll Cardiol. 2011;58(8):

26. Hybrid procedures: CFA endaterectomy with endovascular Rx
Femoral endarterectomy with proximal/distal endovascular revascularization
Multilevel revascularization through one point
Iliac endovascular interventions possible
Femoral-popliteal interventions possible
Decrease in morbidity and Length of Stay
Doslouglu H, et al, Vasc Endovasc Surg
Sharafuddin MJ, et al. Vasc Endovasc Surg
Chang RW, et al. J Vasc Surg.

27. Summary: CFA endarterectomy in current vascular practice
Common femoral endarterectomy remains the “gold standard” for femoral stenosis
Liberal use of profundaplasty
Liberal use of patch closure
ECM material
Favorable healing, reparative characteristics
Further clinical and basic research is warranted
Hybrid procedures are increasing
Role for endovascular therapy
Patient related: Morbidly obese, infected groin, steroid use
Lesion related: focal, not involving the PFA, thrombus
Device choice: PTA, avoid stenting, Atherectomy/debulking?

28. Thank you