Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: mid- term follow-up results. Wronski J. 1), 2) 3), Wilczynski M 1), Gembal P 1), Milik K 1), Dec St 1), Grybos M 1) 1) Department of Vascular Surgery, Regional Hospital Mielec, Poland, 2) Department of Vascular Surgery, District Hospital Lublin, Poland 3) Department of Vascular Surgery and Angiology, Medical University, Lublin, Poland
Disclosure Speaker name: Jacek Wronski I do not have any potential conflict of interest
Valji K. Radiology Key Chapter 8 Origin of study Endovascular treatment of the femoro-popliteal segment is increasingly employed for treatment in patients suffering from PAD Self-expanding nitinol stents implanted to the popliteal artery have demonstrated high percentage of in-stent restenosis, stent occlusions and stent fractures
Tigris,Gore, technical data
Tigris,Gore, technical data
Aim of study The evaluation a 12 -months patency of the hybrid heparin-bonded nitinol and eptfe stent (Tigris, Gore) for treatment of atherosclerotic popliteal artery occlusion in a prospective, single center, analysis.
Study population Enrollment period January 2013 - May 2015 No. of consecutive patients treated by TIGRIS implantation No. of patients included to the study 49 Intermitted claudications or CLI ( Rutherford category) 3,4 ± 0,9 Average lesions lenght of occluded arteries 85 9,38 cm ( 2,5-30 cm) CTO 86% ( 42/49) TASC categories: TASC A 10% ( 5/49 ) TASC B 41% ( 20/49 ) TASC C 24,5% ( 12/49 ) TASC D 24,5% ( 12/49 ) Exclusion criteria No. of patients Lack of follow-up 19 Concomittant other stents implantations 17
Patient demographics Variable Age 70,2±10,56 Male gender 92% ( 45/49) Diabetes mellitus 22% ( 11/49) Cerebral ischemia 10% ( 5/49 ) Cardiac disease 12% ( 6/49) Renal disease 4% ( 2/49 )
Baseline lesions characteristics Anatomical lesion location Distal SFA to P1 30,6 % ( 15/49) Pop P1 14,3% ( 7/49) Pop P2 4% ( 2/49) Pop P3 2% ( 1/49) Pop P1-P2 22,5% ( 11/49) Pop P2-P3 12,2% ( 6/49) Pop P1-P3 14,3% ( 7/49)
Results ( 12-months follow-up overall/occluded popliteal group): Primary patency ( PP ) 68,5%/ 73,3% Freedom from Target Lesion Revascularisation ( TLR ) 81,6% ( 41/49)/ 86,7% Postoperated Rutherford category ( mean) 1,0±0,9 Change in Rutherford category pre/postop. ( mean) 2,4±1,0 Stent s fractures 0,0%
Results Overall the primary patency rates after 1,3,6 and 12 months were 98,0%, 93,8%, 87,5% and 68,5% respectivelly, in CTOs in the popliteal segment rate after 6 and 12 months was 93,3% and 73,3% respectivelly
Results Overall freedom from TLR after 1,3,6 and 12 months was 98,0%, 95,9%, 91,7% and 83,1% respectivelly, in patients with CTOs in popliteal segment after 6 and 12 months was 93,3% and 86,7% respectivelly
Comparision with other studies Study Type of study No. of patients/ occlusions CTO(%) in whole group Average lesions lenght ( mm) Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: midterm follow-up results. Prospective single center analysis n=49/ 42 Twelve-month experience with Gore Tigris Vascular stent in the superficial femoral and popliteal arteries. Piorkowski M et all. J Cardiovasc Surg 2015; 1: 89-95 Retrospective single center analysis Use of a new Hybrid Heparin- Bonded Nitinol Ring Stent in the popliteal artery procedural and mid-term clinical and anatomical outcomes. Parthipun A et all. Cardiovascular Intervent Radiol. 2015; 4: 846-54 Prospective singler center analysis n=32/2 n=48 / legs 50/occl. 37 Tigris Trial data Laird J Viva, September 2016, USA Oral presentation ( VascularNews) Prospective randomised multicenter study n=197/ 83 86% 5% 74,0% 42,1% 119,1±67,0 / 93,8 (25-300 ) Primary patency 68,5% / 73,3% Freedom from TLR 61,6%/ 86,7% 43,1±26 114,2±36,9 107,6±68,6 85,5±6,0% 69,5±6,0% 63% nd 86,1±5,9% nd
Conclusion Implantation of hybrid-heparin bonded nitinol and eptfe stent (GORE TIGRIS Vascular Stent) alleviated the need to perform revascularization in most patients with CTOs in popliteal segment, a lesion that previously had limited treatment options available.
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Hybrid Heparin-Bonded Nitinol and eptfe Stent in the treatment of popliteal artery occlusion: mid- term follow-up results. Wronski J. 1), 2) 3), Wilczynski M 1), Gembal P 1), Milik K 1), Dec St 1), Grybos M 1) 1) Department of Vascular Surgery, Regional Hospital Mielec, Poland, 2) Department of Vascular Surgery, District Hospital Lublin, Poland 3) Department of Vascular Surgery and Angiology, Medical University, Lublin, Poland