Endoluminal Grafting for Aneurysmal and Occlusive Disease in the Superficial Femoral Artery: Early Experience

1995 ◽  
Vol 2 (3) ◽  
pp. 225-239 ◽  
Author(s):  
Edward B. Diethrich ◽  
Konstantine Papazoglou

Purpose: To examine whether endoluminal grafts (ELGs) of radially expandable polytetrafluoroethylene (PTFE) can successfully form durable internal conduits to revascularize lengthy occlusive disease and exclude aneurysms in the femoropopliteal (FP) arteries. Methods: Under protocol, implantation of an unpredilated PTFE tube ELG anchored with Palmaz stents using a low-profile percutaneous delivery system was attempted in 50 symptomatic patients for a variety of pathologies: (1) restenosis; (2) complex lesions unlikely to be treated successfully with other endoluminal therapies; (3) acute angioplasty failure; and (4) aneurysms. There were 37 occlusions, 14 stenoses, and 2 long, combined stenoticaneurysmal lesions in 47 native arteries, 5 FP grafts, and 1 femorotibial (FT) vein graft. Thirty-two percent of the patients had ≤ 1 vessel runoff. The average lesion length was 20.4 ± 11.4 cm (range 1.5 to 40), and the mean preoperative ankle-brachial index (ABI) at rest was 0.53 ± 0.14. Results: In a 20-month period through April 1995, 50 patients (34 males, 16 females; mean age 69.5 years, range 45 to 87) underwent 54 procedures in 53 limbs; 55 ELGs were successfully deployed in 51 limbs; 2 patients were converted to FP bypass owing to technical problems (96% procedural success). There were 18 inhospital complications: 1 distal wire dissection repaired with an additional ELG; 2 hematomas requiring surgical repair; 1 graft collapse; 1 pseudoaneurysm at the site of a mid-ELG leak; 7 minor access sequelae; and 6 acute ELG thromboses, 4 treated with lytic therapy and balloon dilation, 1 with open thrombectomy, and 1 with bypass grafting. The mean postoperative ABI was 1.01 ± 0.10. During the 30-day postprocedure period, 2 ELGs rethrombosed and 2 other limbs (3 ELGs) occluded; 1 thrombosis and 1 rethrombosis were lysed successfully, but the other 2 patients had an FP bypass. Over the mean 8.3 ± 5.5 month follow-up, 6 additional ELGs occluded and 1 reoccluded; 4 were successfully treated by endovascular techniques for a primary patency of 72% and secondary patency of 84% by life-table analysis. Conclusions: Endovascular grafting is a conceptually attractive technique that has the potential to expand the current boundaries of interventional treatment. This preliminary experience attests to the feasibility and safety of ELG deployment in the superficial femoral arteries. Whether such a device can match the durability of classical revascularization techniques remains to be determined in clinical trials when device configurations and deployment techniques have been standardized.

2018 ◽  
Vol 26 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Erik Groot Jebbink ◽  
Suzanne Holewijn ◽  
Michel Versluis ◽  
Frederike Grimme ◽  
Jan Willem Hinnen ◽  
...  

Purpose: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. Materials and Methods: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. Results: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p<0.005). Any previous endovascular intervention (HR 2.52, p=0.02) was the main predictor for loss of secondary patency; history of cardiovascular disease (HR 0.27, p=0.04) was the main predictor of sustained secondary patency. Conclusion: The kissing stent technique has a good safety profile and acceptable patency rates up to 2 years, even in TASC C and D lesions, supporting an endovascular-first approach for AIOD.


Vascular ◽  
2014 ◽  
Vol 23 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Jeffrey Lorne Grenville ◽  
Kong Teng Tan ◽  
Hadas Moshonov ◽  
Dheeraj Kumar Rajan

Purpose: Describe outcomes after endovascular intervention of TransAtlantic Inter-Society Consensus C and D femoro-popliteal disease. Materials and methods: Retrospective cohort study. Patient demographics, ankle-brachial indices, and lesion details were analyzed from a prospectively maintained database. In all, 980 limbs treated with percutaneous transluminal angioplasty ± stenting of the femoro-popliteal segment between 2005 and 2012 were reviewed. Seventy-six patients representing 83 limbs with de novo TransAtlantic Inter-Society Consensus C and D lesions measuring ≥15 cm continuously were identified (mean age 71.3 ± 12.1 years, 62% male). Results: Twenty-five (30.1%) limbs were treated for severe claudication and 58 (69.9%) for critical limb ischemia. The mean pre-procedural ankle-brachial index was 0.47 ± 0.19. The mean lesion length was 22.9 ± 4.82 cm. Seventy patients representing 77 limbs were available for a mean follow-up length of 19.5 months (range 0–79). The mean post-procedural ankle-brachial index was 0.71 ± 0.28. Primary, assisted-primary, and secondary patency rates were 68.1%, 72.7%, and 83.3% at 6 months, 55.3%, 63.6%, and 58.3% at 12 months, and 38.2%, unavailable, and 10.4% at 24 months, respectively. Conclusions: Angioplasty-first strategy for TransAtlantic Inter-Society Consensus C and D lesions of the femoro-popliteal artery can be safely performed. However, patency drastically decreases after 12 months suggesting further improvements are required to achieve longer-term clinical benefit.


VASA ◽  
2013 ◽  
Vol 42 (2) ◽  
pp. 127-133 ◽  
Author(s):  
Ulrich Beschorner ◽  
Hans Krankenberg ◽  
Dierk Scheinert ◽  
Horst Sievert ◽  
Thilo Tübler ◽  
...  

Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. Patients and methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.


2017 ◽  
Vol 24 (3) ◽  
pp. 349-354 ◽  
Author(s):  
Nicola Troisi ◽  
Leonardo Ercolini ◽  
Emiliano Chisci ◽  
Piefrancesco Frosini ◽  
Enrico Barbanti ◽  
...  

Purpose: To evaluate the safety and effectiveness of low-profile 4-F stents for the treatment of atherosclerotic iliac artery lesions. Methods: Between January 2009 and December 2015, 63 patients (mean age 69.3 years; 42 men) received low-profile stents (Astron Pulsar or Pulsar-18) at the discretion of the operator to treat iliac artery occlusive disease. The majority of patients (40, 63.5%) had critical limb ischemia; 36 of 82 lesions were total occlusions. All procedures were performed with 4-F equipment. Outcomes evaluated included mortality, patency (primary, assisted primary, and secondary), absence of target lesion revascularization (TLR), and limb salvage. Associations of patient and procedure variables with patency and TLR outcomes were sought with univariate and multivariate analysis. Results: Via a brachial (n=46/63) or femoral (n=17/63) access, 82 stents were successfully deployed to treat the 82 lesions, with <30% residual stenosis. The overall access-related complication rate was 1.6% (brachial artery occlusion). Mean duration of follow-up was 24.1±22.3 months (range 1–72), during which 3 patients died and 1 major amputation occurred at 10 months. The 4-year Kaplan-Meier estimate of primary patency was 76.9% (95% CI 70.2% to 83.6%); the assisted primary and secondary patency estimates were 79.3% (95% CI 73% to 85.6%) and 91% (95% CI 84.5% to 97.5%). The 4-year freedom from TLR estimate was 73.8% (95% CI 67.4% to 80.2%). On multivariate analysis, the only associations confirmed involved Rutherford category 5/6 with primary patency (hazard ratio [HR] 5.7, 95% CI 4.4 to 7, p=0.02) and assisted primary patency (HR 6.1, 95% CI 4.9 to 7.3, p=0.01). Conclusion: Use of a low-profile 4-F stent in atherosclerotic iliac lesions was safe and effective. At 4 years, the overall patency and the absence of TLR were good. Midterm outcomes were poor in patients with Rutherford category 5/6 ischemia. Finally, the use of stents with a ≥6-mm diameter and postdeployment balloon dilation are recommended in all cases.


Vascular ◽  
2017 ◽  
Vol 26 (1) ◽  
pp. 3-11 ◽  
Author(s):  
Bibombe Patrice Mwipatayi ◽  
Kalpa Perera ◽  
Ali Daneshmand ◽  
Rhys Daniel ◽  
Jackie Wong ◽  
...  

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09–208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37–1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9–98.1) and 88% (95% CI = 75.7–94.5), respectively. The assisted primary was 94% (95% CI = 82.9–98.1) and secondary patency was 96% (95% CI = 85.2–99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83–98%) at 12-month follow-up and 88% (95% CI = 76–94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.


1996 ◽  
Vol 3 (4) ◽  
pp. 369-379 ◽  
Author(s):  
Michel Henry ◽  
Max Amor ◽  
Rafael Beyar ◽  
Isabelle Henry ◽  
Jean-Marc Porte ◽  
...  

Purpose: To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries. Methods: Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% ± 9.9% (range 75% to 100%), and mean lesion length was 45 ± 23 mm (range 20 to 120 mm). Results: Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%). Conclusions: This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.


2020 ◽  
pp. 112972982095474
Author(s):  
Sung-Joon Park ◽  
Hwan Hoon Chung ◽  
Seung Hwa Lee ◽  
Sung Beom Cho ◽  
Tae-Seok Seo ◽  
...  

Purpose: To evaluate the usefulness and feasibility of using a reversible clinch knot with a guidewire in place rather than eliminating the access route during an arteriovenous hemodialysis access (AV access) intervention using the facing sheath technique. Material and methods: From July 2016 to June 2019, we retrospectively studied 78 sessions performed as interventional treatment for arteriovenous (AV) hemodialysis (HD) access using the “facing-sheath technique.” In all sessions, all antegrade sheaths were removed while a 0.035-inch guidewire remained in place with purse-string suture and the clinch knot. Seventy-two sessions were performed in patients with thrombosed AV accesses (69 arteriovenous grafts [AVGs] and three arteriovenous fistulas [AVFs]), and six sessions were carried out to treat non-thrombosed AV accesses (four AVGs and two AVFs). We evaluated whether proper hemostasis and successful reinsertion of the sheath over the wire into the clinch knot was achieved. Clinical success was defined as achieving prompt restoration of blood flow for AV access, and the postintervention primary and secondary patency were also evaluated. Result: In all 87 clinch knots created in 78 total sessions, proper hemostasis was achieved. All clinch knots that required reversal for additional procedures were successfully reopened (55 clinch knots in 50 sessions). The postintervention primary patency rates at 1, 3, and 6 months, and at 1 year were 77.8%, 68.9%, 55.6%, and 33.3%, respectively. The postintervention secondary patency rates at 1, 3, and 6 months, and also at 1 year were 93.3%, 91.1%, 86.7%, and 86.7%, respectively. Conclusion: Our AV access intervention which used a clinch knot with purse-string suture while the guidewire remained in place was both useful and feasible for maintaining temporary hemostasis.


2003 ◽  
Vol 10 (5) ◽  
pp. 987-993 ◽  
Author(s):  
Thomas Zeller ◽  
Ulrich Frank ◽  
Karlheinz Bürgelin ◽  
Uwe Schwarzwälder ◽  
Peter-Christian Flügel ◽  
...  

Purpose: To evaluate the efficacy and safety of a new atherectomy device for the treatment of infragenicular lesions in arteries with a reference diameter of at least 2.5 mm. Methods: Twenty-seven below-the-knee lesions in 17 patients (12 men; mean age 69±12 years) with chronic peripheral arterial occlusive disease were treated with directional atherectomy. The target lesion was in the popliteal artery (segment 3) in 2 (7%) cases, the tibioperoneal trunk in 12 (44%), the peroneal artery in 8 (30%), the anterior tibial artery in 2 (7%), and the posterior tibial artery in 3 (11%). Six (22%) of the lesions were in-stent stenoses. The mean diameter stenosis was 87%±9%, and the mean lesion length was 34±24 mm. Results: All but 2 (7%) of the lesions could be treated successfully (residual stenosis <30%) with the atherectomy catheter (93% technical success) using an average of 5±2 (range 1–10) passes of the device. Six lesions (22%) were treated after predilation and 21 (78%) with primary atherectomy. In 8 (30%) lesions, additional balloon angioplasty was performed. The 2 failures were in heavily calcified lesions through which the device could not pass despite predilation. The mean diameter stenosis after atherectomy was 14%±22% (range 0%–90%); after additional balloon angioplasty, the mean residual stenoses reduced to 12%±21% (range 0%–100%). One (6%) of the 2 patients who failed atherectomy sustained a thrombotic occlusion of the target vessel. This complication was treated successfully with local lysis, but the vessel reoccluded 3 days later; a stent was implanted. The mean ankle-brachial index increased from 0.50±0.27 to 0.86±0.40 before discharge. Conclusions: Below-the-knee native vessel lesions and in-stent restenoses with a diameter of at least 2.5 mm can be treated successfully and safely with this new atherectomy catheter. Additional balloon angioplasty was necessary in only a few cases.


2021 ◽  
pp. 152660282110348
Author(s):  
Grzegorz Halena ◽  
Dainis K. Krievins ◽  
Dierk Scheinert ◽  
Janis Savlovskis ◽  
Piotr Szopiński ◽  
...  

Purpose: This study investigated the 2-year safety and effectiveness of the PQ Bypass DETOUR system as a percutaneous femoropopliteal bypass. Materials and Methods: Seventy-eight patients with 82 long-segment femoropopliteal lesions were enrolled in this prospective, single-arm, multicenter study. The DETOUR system deployed Torus stent grafts directed through a transvenous route. Eligible patients included those with lesions of >10 cm and average of 371±55 mm. Key safety endpoints included major adverse events (MAEs) and symptomatic deep venous thrombosis in the target limb. Effectiveness endpoints included primary patency defined as freedom from ≥50% stenosis, occlusion, or clinically-driven target vessel revascularization (CD-TVR), primary assisted, and secondary patency. Results: Chronic total occlusions and severe calcium occurred in 96% and 67% of lesions, respectively. Core laboratory-assessed total lesion length averaged 371±51 mm with a mean occlusion length of 159±88 mm. The rates of technical and procedural success were 96%, with satisfactory delivery and deployment of the device without in-hospital MAEs in 79/82 limbs. The MAE rate was 22.0%, with 3 unrelated deaths (4%), 12 CD-TVRs (16%), and 1 major amputation (1%). Deep venous thrombosis developed in 2.8% of target limbs, and there were no reported pulmonary emboli. Primary, assisted primary, and secondary patency rates by the Kaplan–Meier analysis were 79±5%, 79±5%, and 86±4%, respectively. Conclusions: The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to femoropopliteal open bypass with favorable results through 2 years. The DETOUR system provides a durable alternative to conventional endovascular modalities and open surgery for patients with long, severely calcified, or occluded femoropopliteal lesions.


2005 ◽  
Vol 71 (11) ◽  
pp. 905-910 ◽  
Author(s):  
Joe H. Morgan ◽  
Charles E. Wall ◽  
D. Benjamin Christie ◽  
Richard L. Harvey ◽  
Maurice M. Solis

The purpose of this study was to evaluate the patentcy rates and physiological effectiveness of angioplasty and stenting as a primary therapy for superficial femoral (SFA), popliteal (POP), and tibial (TIB) arterial occlusive disease. Seventy-eight patients had stents placed in the infra-inguinal vessels between January 1, 2001, and July 31, 2004. We collected data on patient demographics, symptoms, as well as pre- and postprocedure ankle-brachial index (ABI) and angio-graphic findings. Patency rates at 6 months, 12 months, and 24 months were analyzed by life table methods. Thirty-one men and 47 women had a mean age of 68 years (range 36–94 years). Risk factors included diabetes in 50 per cent, hypertension in 79 per cent, smoking in 41 per cent, and end-stage renal disease in 10 per cent. The indications for intervention were claudication in 52 per cent and limb salvage in 48 per cent of patients. Stents were placed in the SFA in 54 patients (69%), in the POP in 15 patients (18%), and in the TIB artery in 6 patients (8%). Average follow-up was 11.2 months. The mean postprocedural increase in ABI was 0.29. The 6-month, 1-year, and 2-year primary patency rates were 83 per cent, 58 per cent, and 47 per cent, respectively. Limb salvage was achieved in 66 per cent of patients treated for limb-threatening ischemia. There was one major and three minor complications. Stenting of the infra-inguinal vessels has a low morbidity, high success rate, and acceptable patency and limb-salvage rates.


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