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Purpose: We describe the feasibility and early results of iliac stenting using a physician-modified endograft (PMEG) to preserve a transplant renal artery in patient with iliac occlusive disease. Case Report: A 70-year-old male patient, with sub-occlusive left common iliac artery stenosis at the level of the transplanted kidney arterial anastomosis, presented with left critical limb ischemia (CLI) and pseudo-transplant renal artery stenosis (pseudo-TRAS) symptoms. He was treated with a physician-modified fenestrated covered stent introduced percutaneously via ipsilateral femoral artery after failure of simple angioplasty (percutaneous transluminal angioplasty, PTA). The modified graft was created by performing a square fenestration graftotomy on a Medtronic iliac limb stent graft (Medtronic Cardiovascular, Santa Rosa, CA, USA). The procedure was technically successful with no intraoperative complications. Procedural time was 110 minutes, including 35 minutes for device modification. On short-term follow-up, the patient had early improvement of renal function and resolution of CLI. The iliac and transplant renal artery remained patent with no sign of stent migration or kinking on 6 months surveillance computed tomography angiography and 1 year color Doppler ultrasonography. Conclusion: Use of PMEG to preserve visceral branches in occlusive iliac disease is a feasible endovascular technique with encouraging technical success and satisfying early results.

Purpose The gold standard for the treatment of complex (TASC II C and D) atherosclerotic aortoiliac lesions is still open surgical repair. Endovascular techniques have a lower mortality and morbidity rate but this comes at the cost of worse patency rates when compared with open repair. Improved short- and mid-term results have been reported using the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. The aim of this study was to report our initial experience with the CERAB technique and report long-term patency rates. Materials and Methods All patients treated with the CERAB technique between 2012 and 2018 were prospectively registered in an institutional database and included in this study. Patient demographics, characteristics, symptoms, procedural, and follow-up details were collected and analyzed retrospectively. Perioperative complications and reinterventions were also identified. The Kaplan-Meier survival method was used to assess cumulative rates of patency. Results A total of 44 patients were treated with the CERAB technique and included in this study. The majority of the treated aortoiliac occlusions were classified as complex: TASC II C (n=7; 15.9%) or TASC II D (n=25; 56.8%). Primary patency rate at 60 months was 83.3%, assisted primary patency was 90.9% and secondary patency 95%. No significant differences were found in patency rates comparing noncomplex (TASC II A and B) and complex (TASC II C and D) aortoiliac lesions. Seven patients (15.9%) required at least one additional procedure to maintain either assisted primary patency or secondary patency during follow-up. The 30-day complication rate in this series was 20.5% (n=9), of which 55.6% (n=5) were minor complications. All major 30-day complications (n=4) occurred during or directly after the CERAB procedure. Thirty-day mortality was 0%. No limb occlusions occurred within 30 days of the procedure. Conclusion Good long-term patency rates can be achieved with the CERAB technique to treat aortoiliac stenosis or occlusions while maintaining advantages associated with endovascular interventions. This remains true even when a CERAB is used to treat complex aortoiliac lesions. An endo-first approach to treat complex aortoiliac lesions seems viable.

Purpose: The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI. Materials and Methods: PRESTIGE is a pilot prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Endpoints were adverse event-free survival at 1 month, technical success rate, primary tibial patency at 6 months, limb salvage success, target lesion revascularization (TLR), and amputation free survival (AFS). Results: A total of 25 patients were included. There were 17 (68.0%) males; mean age, 63.7±9.73 years. CLTI severity was based on the Rutherford scale (R5=25/25; 100.0%). Significant comorbidities included diabetes mellitus (n=22; 88.0%) and end-stage renal failure (n=11; 44.0%). A total of 33 atherosclerotic lesions were treated (TASC II D=15 (45.5%)). Mean lesion length treated was 191±111 mm. Technical success was 100%. Primary tibial patency at 6 months was 22/27 (81.5%) and freedom from clinically driven TLR was 25/30 (83.3%). AFS was 21/25 (84.0%; 3 deaths and 1 major lower extremity amputation). Mean Rutherford score improved from 5.00 at baseline to 1.14±2.10 (pConclusions: Selution SLR drug-eluting balloon is a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure. Technical and clinical success rates are high and 6-month target lesion patency and AFS are more than satisfactory.

Purpose: To assess the midterm safety and effectiveness of the Gore Viabahn Balloon-Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of patients with de novo or restenotic aortoiliac lesions. Materials and Methods: The prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study ( ClinicalTrials.gov identifier: NCT02080871) evaluated 134 patients (mean age 66±9.5 years; 79 men) up to 3 years after treatment with the VBX Stent-Graft. A total of 213 lesions were treated with 234 stent-grafts. The primary safety endpoint was a composite of major adverse events (MAEs), which were evaluated through 30 days and 9 months. Secondary outcomes collected through 3 years included freedom from target lesion revascularization (TLR), target vessel revascularization (TVR), clinically-driven TLR (CD-TLR), and CD-TVR as well as Rutherford category, resting ankle-brachial index (ABI), and functional status. A univariate analysis determined any correlation between baseline variables and TLR. Results: The observed composite percentage of MAEs was 2.3%, well below the 17% performance goal (pConclusion: The VBX Stent-Graft is a robust and durable treatment option for aortoiliac occlusive disease as evidenced by the sustained 3-year safety and effectiveness outcomes.

Purpose: To evaluate the safety and efficacy of a next-generation balloon-expandable stent-graft for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries. Methods: A prospective, multicenter, single-arm safety and efficacy study ( ClinicalTrials.gov identifier: NCT02080871) of the VBX Stent Graft for treatment of de novo or restenotic lesions in the iliac arteries was conducted under an Investigational Device Exemption at 26 US sites and 1 New Zealand center. The study eligibility criteria were established with the aim of enrolling more “real-world” patients compared with previous iliac stent studies supporting Food and Drug Administration approval. The study enrolled 134 patients (mean age 66±9.5 years; 79 men) with 213 iliac lesions. Three-quarters of the population (101, 75.4%) had Rutherford category 3 ischemia, and 43 (32.1%) patients presented with TASC II C/D lesions. The primary endpoint was a composite of device- or procedure-related death within 30 days, myocardial infarction within 30 days, target lesion revascularization (TLR) within 9 months, and amputation above the metatarsals in the treated leg within 9 months. Results: In all, 234 devices were implanted in 213 lesions with 100% technical success; 57 (42.5%) patients received kissing stents at the aortic bifurcation. No devices exhibited a discernable change in length after final deployment as determined by independent core laboratory quantitative angiographic analysis. At 9 months, 3 (2.3%) of 132 patients (1 lost to follow-up, 1 unrelated death) experienced a major adverse event (3 TLRs) related to the primary endpoint. At 9 months, there were no device-related serious adverse events or unanticipated adverse device effects. Conclusion: The next-generation balloon-expandable stent-graft demonstrated notable 9-month safety and efficacy in treating iliac occlusive disease in patients reflecting common clinical practice.

Purpose: To evaluate the efficacy and outcome of thrombolysis and thrombectonny for thronnbosed polytetrafluoroethylene stent-grafts inserted in the superficial femoral artery (SFA) for occlusive disease. Methods: A retrospective review was conducted of 79 consecutive patients with a thrombosed SFA endograft between November 2001 and December 2011. Of these, 46 (58%) were treated with thrombolysis (n=40, 87%) or thrombectomy 13%) and form the study group (33 men; median age 66.8 years, range 30-80). Median time from stent-graft insertion to thrombosis was 3 months (range 0-53). Results: Thrombolysis was successful in 38 (95%) patients over a mean 24 hours (range 3 48); one patient had failed lysis and another died during lytic treatment. Thrombectomy was successful in all 6 patients. Thrombosis without a causal lesion was significantly more common in occlusions that presented Conclusion: Thronnbolysis and thrombectonny of thrombosed endografts in the SEA is effective and safe. Patency rates after treatment are moderate, but prolonged secondary patency can be achieved.

To evaluate the efficacy and outcome of thrombolysis and thrombectomy for thrombosed polytetrafluoroethylene stent-grafts inserted in the superficial femoral artery (SFA) for occlusive disease.A retrospective review was conducted of 79 consecutive patients with a thrombosed SFA endograft between November 2001 and December 2011. Of these, 46 (58%) were treated with thrombolysis (n=40, 87%) or thrombectomy (n=6, 13%) and form the study group (33 men; median age 66.8 years, range 30-80). Median time from stent-graft insertion to thrombosis was 3 months (range 0-53).Thrombolysis was successful in 38 (95%) patients over a mean 24 hours (range 3-48); one patient had failed lysis and another died during lytic treatment. Thrombectomy was successful in all 6 patients. Thrombosis without a causal lesion was significantly more common in occlusions that presented30 days after insertion (p=0.01). Over a median follow-up of 14 months (range 1-69), reinterventions were performed for restenosis in 12 patients and reocclusion in 14 patients, all within 18 months after thrombolytic treatment. More than a third of patients (16/45) had definitive failures (2/6 from the thrombectomy group); 4 were treated conservatively (no/minor symptoms) and 12 had bypass grafts. Three (7%) patients eventually required a major amputation. The primary, assisted primary, and secondary patency rates of thrombolysis at 6 months were 56%, 56%, and 68%, respectively. Secondary patency for the entire cohort was 58% at 1 year.Thrombolysis and thrombectomy of thrombosed endografts in the SFA is effective and safe. Patency rates after treatment are moderate, but prolonged secondary patency can be achieved.

To review emerging evidence regarding the use of bare metal (BMS) vs. drug-eluting stents (DES) in the treatment of infrapopliteal occlusive disease.A systematic review of the literature was undertaken to identify all studies comparing stent treatments of infragenicular vessels in patients with chronic lower limb ischemia. Validated methods to assess the methodological quality of the included studies were applied. Outcome data were pooled, and combined overall effect sizes were calculated using fixed or random effects models. The search identified 4 randomized clinical trials and 2 observational studies reporting on 544 patients (287 treated with DES and 257 treated with BMS). Data are presented as the odds ratio (OR) with 95% confidence interval (CI) and the number-needed-to-treat (NNT).Primary patency, freedom from target lesion revascularization, and clinical improvement at 1 year were significantly higher in the DES recipients compared to patients treated with BMS (OR 4.511, 95% CI 2.897 to 7.024, p0.001, NNT 3.5; OR 3.238, 95% CI 2.019 to 5.192, p0.001, NNT 6.0; and OR 1.792, 95% CI 1.039 to 3.090, p=0.036, NNT 7.3, respectively). No significant differences in limb salvage and overall survival at 1 year were identified between the groups (OR 2.008, 95% CI 0.722 to 5.585, p=0.181; OR 1.262, 95% CI 0.605 to 2.634, p=0.535, respectively). Sensitivity analyses investigating the potential effects of study design and type of DES on the combined outcome estimates validated the results.Our analysis has demonstrated superior short-term results with DES compared with BMS, expressed by increased patency and freedom from target lesion revascularization. The influence of this finding on clinical surrogate endpoints, such as limb salvage, remains unknown.

Purpose: To evaluate the 4-year results of polytetrafluoroethylene (PTFE)-covered stents in the treatment of iliac artery occlusive disease.Methods: Between January 2003 and September 2010, PTFE-covered stents were implanted in 115 iliac arteries of 87 patients (73 men; mean age 60 11 years) in a single center. The lesions were classified as TASC II A (n=40), B (n=41), C (n=7), and D (n=27). There were 69 primary endograft placements, while 46 procedures were performed after previous bare metal stent placement (reintervention group). Follow-up consisted of clinical investigation, ankle-brachial index (ABI) measurement, and duplex ultrasound scanning. In this retrospective analysis, outcomes were reported on a per-limb basis.Results: The median Rutherford classification decreased from category 3 at baseline to 0 after the procedure (pConclusion: The use of PTFE-covered stents for occlusive disease in the iliac arteries is related to satisfactory limb patency rates and high freedom from TLR. Previous stent placement was related to a lower primary patency rate. Additional studies are indicated to establish subgroups that may specifically benefit from covered stents. J Endovasc Ther. 2012;19:797-804

To evaluate the 4-year results of polytetrafluoroethylene (PTFE)-covered stents in the treatment of iliac artery occlusive disease.Between January 2003 and September 2010, PTFE-covered stents were implanted in 115 iliac arteries of 87 patients (73 men; mean age 60 ± 11 years) in a single center. The lesions were classified as TASC II A (n=40), B (n=41), C (n=7), and D (n=27). There were 69 primary endograft placements, while 46 procedures were performed after previous bare metal stent placement (reintervention group). Follow-up consisted of clinical investigation, ankle-brachial index (ABI) measurement, and duplex ultrasound scanning. In this retrospective analysis, outcomes were reported on a per-limb basis.The median Rutherford classification decreased from category 3 at baseline to 0 after the procedure (p0.001) and the ABI increased from 0.66 ± 0.24 to 0.89 ± 0.21 (p0.001). The primary limb patency was significantly higher in the primary treatment group (p=0.03): 88.7% at 1 year, 86.4% at 2 years, and 71.5% at 4 years compared to the reintervention group (77.9%, 72.1%, and 53.0%, respectively). Univariate analysis revealed prior stent placement as the only factor associated with loss of primary patency. The freedom from target lesion revascularization (TLR) in the primary treatment group was 95.2% at 1 year, 89.6% at 2 years, and 74.4% at 4 years, which did not differ significantly from rates in the reintervention group (88.0%, 82.3%, and 63.8%, respectively).The use of PTFE-covered stents for occlusive disease in the iliac arteries is related to satisfactory limb patency rates and high freedom from TLR. Previous stent placement was related to a lower primary patency rate. Additional studies are indicated to establish subgroups that may specifically benefit from covered stents.

To report the 6-month outcomes from a prospective multicenter study investigating the use of cryoplasty (cold balloon angioplasty) to treat below-knee occlusive disease in patients with critical limb ischemia (CLI).Between August 2004 and October 2005, 108 patients (77 men; mean age 73+/-12 years, range 41-101) with CLI involving 111 limbs were enrolled in a prospective multicenter trial (Below-the-Knee Chill Study), which was conducted at 16 institutions. The primary study endpoints were acute technical success, defined as the ability to achieveor =50% residual stenosis and continuous inline flow to the foot, and absence of major (above or below-knee) amputation of the target limb 180 days post procedure.Acute technical success was achieved in 108 (97.3%) of the 111 limbs treated, with only 1 (0.9%) clinically significant dissection (or =type C) and 2 residual stenoses50%. During the 180-day follow-up, 15 (13.9%) of the initial 108 patients either withdrew or were lost to follow-up. Five (4.6%) deaths occurred, leaving 88 (81.5%) patients with 91 (82.0%) treated limbs available for 180-day assessment. The rate of freedom from major amputation at 180 days was 93.4%. Amputation-free survival was 89.3% at 180 days (5 deaths, 6 major amputations). Stratifying data by diabetics (n=71) versus non-diabetics (n=34), the 180-day death and amputation rates were 4.9% and 10.0%, respectively, for diabetics versus 6.7% and 0.0%, respectively, for non-diabetics.Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent acute outcomes and a high rate of limb salvage in patients with CLI. Study outcomes support the use of cryoplasty therapy as a primary treatment option for patients with CLI secondary to below- knee disease.

Despite advancement in stent-graft technology, access-related problems continue to occur during endovascular repair of aortic aneurysms. Various techniques have been adopted to overcome difficult access situations, however. To survey these developments in arterial access, we performed a systematic literature review from 1994 through 2005 to identify relevant articles pertaining to endovascular access techniques and complications. Excessive iliac tortuosity, circumferential vessel wall calcification, significant occlusive disease, and small caliber vessels account for the majority of access problems, most of which are readily apparent with adequate baseline imaging. Even with careful preoperative assessment, however, some access problems may not be foreseen; nonetheless, the majority can be overcome using today's array of ancillary procedures, such as an iliac conduit, a brachiofemoral wire, or arterial reconstruction. Alternatively, other approach routes, such as the common carotid artery or direct aortic access, may be used to facilitate endovascular aneurysm repair.

To report our initial experience with a bifurcated endoprosthesis in the management of aortoiliac occlusive disease.From May 2001 to February 2004, 112 patients were referred to our institution for the management of aortoiliac disease. Among these, 5 (6%) patients (3 men; mean age 57.8 years) with severe ischemia owing to TASC C or D iliac occlusions were selected for endovascular treatment with a bifurcated stent-graft. An Excluder stent-graft was placed after preliminary recanalization (thrombolysis and/or balloon dilation) the day before. The patients were followed clinically and ultrasonographically every 3 months during the first year and semiannually thereafter.Technical success was achieved in all patients. Endovascular aortoiliac bifurcation reconstruction restored iliac artery flow immediately in all cases. There were no procedure-related complications. The mean ankle-brachial index (ABI) was significantly improved, from 0.66+/-0.04 before the procedure to 0.94+/-0.06 immediately after the procedure (p0.01). The aortoiliac reconstructions remained patent during the mean 17-month follow-up (range 3-36), and the ABIs were stable. There was no mortality or amputation required in this series.Endovascular placement of a bifurcated stent-graft appears to be technically feasible, effective, and safe in the management of aortoiliac occlusive disease.

Purpose: To evaluate the patency rates of femorofemoral grafts performed in conjunction with aortomonoiliac or aortomonofemoral (AMI/F) endografts. Methods: Over the past 8 years, 110 patients (98 men; mean age 77 ± 7 years, range 57–90) underwent aortoiliac aneurysm repair with an AMI/F endograft. Follow-up data in these patients were prospectively collected for a mean 2.3 years (range 1–68 months). Results: There were 2 early (Conclusions: Femorofemoral bypasses with AMI/F endografts for aneurysmal disease are durable procedures and have better patency than femorofemoral grafts used to treat occlusive disease. Femorofemoral bypass patency rates alone are not a disadvantage of aortomonoiliac endografts.

Purpose: To evaluate the midterm clinical outcome of patients treated with a balloon-expandable polytetrafluoroethylene (ePTFE) endograft for long-segment occlusive disease of the femoropopliteal segment. Methods: Eighty-nine patients (68 men; median age 69 years, range 43–81) with disabling claudication (n=73) or critical ischemia (n=16) were treated with an ePTFE endograft (mean length 29 cm) for 7 stenosis (mean length 9 cm) and 82 occlusions (mean length 19 cm) in the femoropopliteal segment. The follow-up protocol included Doppler ankle-brachial pressure measurement and duplex scanning or angiography of the endograft at 6-month intervals. Primary and secondary patency rates were analyzed. Results: At the last examination, the endograft was patent in 52 patients (median 17 months, range 7–50) and occluded in 35 (median 7 months, range 0–40);2 patients died of nonvascular causes with a patent endograft at 6.5 and 7 months. At follow-up, the primary and secondary endograft patency rates were 71% and 83% at 6 months, 57% and 69% at 1 year, 45% and 49% at 2 years, and 30% and 44% at 3 years, respectively. Conclusions: The midterm success of this new ePTFE endograft is limited; therefore, the device needs to be refined if this minimally invasive technique is to compete with conventional bypass surgery.

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.