Performance of ePTFE-covered endograft in patients with occlusive disease of the superficial femoral artery: a three-year clinical follow-up study.
OBJECTIVE
Feasibility of ePTFE-covered endoprosthesis for treatment of atherosclerotic stenosis or occlusions of the SFA. This was a prospective follow-up study on intention-to-treat basis. ePTFE-covered endoprosthesis were used.


METHODS
From November 2001 to December 2006, 96 patients were treated for invalidating claudication, critical ischemia or gangrene. ABI and ischemia severity score according to Rutherford were defined. Morphology of the lesions was classified according to the Trans-Atlantic InterSociety Consensus. Clinical outcome was investigated by ABI, Duplex-ultrasound, and luminal diameter measurements inside grafts. Follow-up visits were conducted at six weeks and six months, and yearly thereafter.


RESULTS
Significant clinical improvement was achieved in all patients. ABI increased to normal, and did not fall during three-year follow-up. Kaplan-Meier estimates for primary patency were 76% (N.=77), 70% (N.=56) and 67.7% (N.=40), and for secondary patency 86.9% (N.=85), 82.2 (N.=63) and 79.8% (N.=45) at 1, 2, and 3 years. Intraluminal graft diameters did not decrease significantly during follow-up. Graft occlusion was seen in 21/96 endografts; 20 patients underwent additional PTAs, only three patients had intragraft stenosis. Occluded grafts did not show reduction of luminal diameters on follow-up examinations before occlusion.


CONCLUSIONS
ePTFE-covered endografts have excellent properties for treatment of SFA stenosis or occlusions. There was no intimal hyperplasia inside endografts, and graft occlusion occurred due to progression of atherosclerotic disease outside the graft.
Department of Vascular Surgery, Isala Clinics, Zwolle, The Netherlands. w.m.fritschy@isala.nl
W M
WM
Fritschy
R R
RR
Kruse
T G
TG
Frakking
A A W
AA
Van Geloven
A M
AM
Blomme
D000368:Aged; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000628:therapy; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
D011138:Polytetrafluoroethylene