scholarly journals Meta-analysis of Individual Patient Data After Kissing Stent Treatment for Aortoiliac Occlusive Disease

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.

2019 ◽  
Vol 26 (5) ◽  
pp. 623-632 ◽  
Author(s):  
Gabriele Piffaretti ◽  
Aaron Thomas Fargion ◽  
Walter Dorigo ◽  
Raffaele Pulli ◽  
Andrea Gattuso ◽  
...  

Purpose: To report the results of endovascular treatment of iliac and complex aortoiliac occlusive disease (AIOD) in a multicenter Italian registry. Materials and Methods: A retrospective, multicenter, observational cohort study analyzed 713 patients (mean age 68±10 years; 539 men) with isolated iliac and complex aortoiliac lesions treated with primary stenting between January 2015 and December 2017. Indications for treatment were claudication in 406 (57%) patients and critical limb ischemia in 307 (43%). According to the TransAtlantic Inter-Society Consensus II (TASC) classification, the lesions were categorized as type A (104, 15%), type B (171, 24%), type C (170, 24%), and type D (268, 37%). Early (<30 days) endpoints included mortality, thrombosis, and major complications. Late major outcomes were primary and secondary patency and freedom from reintervention as estimated by Kaplan-Meier analysis; estimates are given with the 95% confidence intervals (CIs). Associations between baseline variables and primary patency were sought with multivariate analysis; the results are presented as the hazard ratio (HR) and 95% CI. Results: Technical success was achieved in 708 (99%) lesions; in-hospital mortality was 0.6% (n=4). The median follow-up was 11 months (range 0–42). The estimated primary patency rate was 96% (95% CI 94% to 97%) at 1 year and 94% (95% CI 91% to 96%) at 2 years. The estimated secondary patency was 99% (95% CI 97% to 99%) at 1 year and 98% (95% CI 95% to 99%) at 2 years. The estimated freedom from reintervention was 98% (95% CI 96% to 99%) at 1 year and 97% (95% CI 94% to 98.5%) at 2 years. Cox regression analysis demonstrated that the application of a covered stent was associated with an increased need for reintervention (HR 1.4, 95% CI 1.10 to 1.74, p=0.005). Chronic obstructive pulmonary disease was associated with decreased primary patency (HR 3.7, 95% CI 1.25 to 10.8, p=0.018). Conclusion: Endovascular intervention with primary stent placement for aortoiliac occlusive disease achieved satisfactory 2-year patency regardless of the complexity of the lesion. Almost all TASC lesions should be considered for primary endovascular intervention if suitable.


2018 ◽  
Vol 25 (5) ◽  
pp. 632-639 ◽  
Author(s):  
Miklós Vértes ◽  
Ildikó Zsófia Juhász ◽  
Tin Dat Nguyen ◽  
Dániel Sándor Veres ◽  
Artúr Hüttl ◽  
...  

Purpose: To determine the long-term patency of aortoiliac kissing stents and to identify predisposing factors for the development of in-stent restenosis (ISR). Methods: A retrospective analysis was conducted of 105 patients (median age 60.9 years; 64 women) with symptomatic aortoiliac occlusive disease who had kissing stents implanted between 2001 and 2015. The indication for kissing stents was severe claudication in 91 (86.7%) patients and critical limb ischemia in 14 (13.3%). Lesions were TASC A in 52 (49.5%), B in 29 (27.6%), C in 4 (3.8%), and D in 20 (19%) patients. Twenty-five (23.8%) patients had heavily calcified lesions. In all, 210 stents were deployed [180 (85.7%) self-expanding and 30 (14.3%) balloon-expandable]. Follow-up included clinical evaluation, ankle-brachial index measurement, and duplex ultrasonography. Results: The median follow-up was 45 months. The primary patency rates were 93%, 86%, and 77% at 12, 24, and 60 months, respectively. Significant ISR developed in 23 (21.9%) patients (12 unilateral and 11 bilateral). Univariate Cox regression analysis revealed older age [hazard ratio (HR) 0.5, 95% confidence interval (CI) 0.31 to 0.81, p=0.004] and larger aortic diameter (HR 0.42, 95% CI 0.25 to 0.7, p<0.001) to be variables favoring long-term patency, while a longer aortic stent segment (HR 1.56, 95% CI 1.16 to 2.09, p=0.003) and a larger discrepancy between the summed stent diameters and the aortic diameter (HR 1.64, 95% CI 1.01 to 2.65, p=0.043) were associated with ISR development. Multivariate analysis showed a longer aortic stent segment to be the only significant determinant of ISR (HR 1.44, 95% CI 1.02 to 2.01, p=0.035). Conclusion: The kissing stent technique can be performed with good long-term patency. Patients whose iliac stents protrude too far into the aorta need closer follow-up.


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.


2020 ◽  
Vol 27 (5) ◽  
pp. 728-736 ◽  
Author(s):  
Jean M. Panneton ◽  
Jean Bismuth ◽  
Bruce H. Gray ◽  
Andrew Holden

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 (p<0.001). Of the 134 patients in the per protocol analysis, 107 (80%) completed the study. The 1-year Kaplan-Meier estimate of primary patency was 94.5% and primary assisted patency was 99.0%. The estimate of freedom from TLR per-lesion/vessel was 97.6% at 9 months and 91.2% at 3 years. The 9-month estimate of freedom from CD-TLR was 98.6% and the 3-year estimate was 98.1%. The 3-year mean resting ABI was 0.93±0.19, an improvement of 0.17±0.26 from baseline (p<0.001). At 3 years, 82 patients (92.1%) improved ≥1 Rutherford category from baseline, and 77 patients (86.5%) maintained or improved upon their baseline functional status. Conclusion: 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.


Angiology ◽  
2021 ◽  
pp. 000331972199137
Author(s):  
Ender Özgün Çakmak ◽  
Emrah Bayam ◽  
Fatih Yilmaz ◽  
Muzaffer Kahyaoğlu ◽  
Mehmet Çelik ◽  
...  

We report the results of endovascular treatment of Trans-Atlantic Inter-Society Consensus II (TASC) A&B, TASC C, and TASC D aortoiliac lesions in a single vascular center. In this retrospective, observational cohort study, we analyzed 395 patients (mean age 61.2 ± 9.0; 359 men) between January 2015 and December 2017. Technical success was achieved in 96.5%; in-hospital mortality was 1.2% (n = 5). Median follow-up was 36 months (range 24-49 months). After 1 and 5 years, the primary patency rates were 99% and 85% for TASC A&B, 90%, and 78% for TASC C, and 90% and 74% for TASC D. Secondary patency rates were 99% and 90% for TASC A&B, 98% and 65% for TASC C, and 97% and 65% for TASC D. Previous peripheral revascularization (hazard ratio: 1.76, 95% CI: 1.01-3.08, P = .04) was associated with decreased primary patency along with lower age, TASC C, and TASC D class. This analysis reported the acceptable effectiveness and safety of stenting for all types of aortoiliac occlusive disease in a modern setting, with few complications and excellent long-term primary and secondary patency rates.


2021 ◽  
pp. 152660282110250
Author(s):  
Athanasios Saratzis ◽  
Murtaza Salem ◽  
Cezar Sabbagh ◽  
Said Abisi ◽  
Bella Huasen ◽  
...  

Objective This UK multicenter study aims to report early- and medium-term results following covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of aortoiliac occlusive disease (AIOD) in patients with chronic limb threatening ischemia (CLTI) or intermittent claudication (IC). Materials and Methods Retrospective case analysis was performed of patients who underwent CERAB between November 1, 2012 and March 31, 2020 in 6 centers across the United Kingdom. Anatomical data, including degree of plaque calcification, were assessed using preoperative imaging. Outcome measures included mortality, perioperative complications, target lesion reintervention (TLR), and major limb amputation. Primary, assisted primary, and secondary patencies were calculated at set intervals. Results A total of 116 patients underwent CERAB over the study period for the following reasons [48% presenting with CLTI (Rutherford 4–6) and 52% with IC (Rutherford 1–3)]; 82% presented had Trans-Atlantic Inter-Society Consensus (TASC) D AIOD disease. Median age was 65 years (range 42–90 years); 76% of the cohort were male. Severely calcified aortic and iliac lesions were noted in 90% and 80% of patients, respectively. Over a median follow-up of 18 months (range 1–91 months), 2 (1.7%) patients were lost to follow up. In total 5, (4.3%) patients died and 2 (1.7%) had a major amputation. Endovascular TLR was required in 14 (12.1%) patients at last follow up. Surgical TLR was performed in 4 (3.4%) patients at last follow-up. Seven (6%) patients developed an aortic/iliac stent occlusion at last follow-up. The Kaplan-Meier (KM) freedom from TLR at 1 year was 94% and KM 1-year primary patency, assisted primary patency, and secondary patency were 88%, 94%, and 98% respectively. Subanalysis found the following features were associated with need for TLR; TASC D disease (OR = 2.45, 95% CI 1.44 to 3.71), severe aortic calcification (OR = 2.01, 95% CI 1.03 to 2.20), and presence of tissue loss at baseline (OR = 1.43, 95% CI 1.01 to 4.63). Conclusion Perioperative (<30 days) and medium-term morbidity, mortality, and patency rates in this pragmatic cohort of patients with severe AIOD lesions show that CERAB is a valid revascularization option. A direct comparison with surgical treatments for AIOD in a randomized controlled trial is justified.


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.


2016 ◽  
Vol 24 (1) ◽  
pp. 11-18 ◽  
Author(s):  
Andrew Holden ◽  
Stephen Merrilees ◽  
Brendan Buckley ◽  
Brigid Connor ◽  
Frances Colgan ◽  
...  

Purpose: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis. Methods: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated. Results: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months. Conclusion: This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiaoxi Yu ◽  
Xin Zhang ◽  
Zhichao Lai ◽  
Jiang Shao ◽  
Rong Zeng ◽  
...  

Abstract Background Drug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up. Methods This study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI). Results One hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan–Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan–Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint. Conclusion In our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan–Meier estimation was 82.1%.


2011 ◽  
Vol 1 (1) ◽  
pp. 2 ◽  
Author(s):  
Eva Schönefeld ◽  
Susanne Szesny ◽  
Konstantinos P. Donas ◽  
Georgios A. Pitoulias ◽  
Giovanni Torsello

The authors would present the mid-term outcomes with the use of stent-supported angioplasty in the treatment of symptomatic chronic mesenteric ischemia (CMI). The present study is a retrospective analysis of 36 patients undergoing endovascular treatment of symptomatic CMI, between November 2000 and September 2009. Primary study endpoints were defined as primary patency, periprocedural and midterm mortality and complications, and symptom improvement after intervention. Forty-one mesenteric arteries (77.3% stenotic and 22.7% occluded vessels) were treated in 36 patients with 42 stents. In 30 patients (83.3%) one visceral artery and in 6 cases (16.7%) two visceral arteries were treated. Overall mortality was 16.7% (n=6) after a 60-month follow-up (mean follow-up period 30.1 months). Two early (&lt;30-day) deaths were caused by visceral ischemia (n=2: 5.5%). Late death was procedure-related in one patient with re-occlusion of the superior mesenteric artery after 12 months. The other 3 patients died from non procedure-related causes; e.g. twice myocardial infarction. Initial symptom relief was observed in 29 patients (80.5%); 7 patients reported no change. Primary patency was 83.3% after 5 years and secondary patency was 90.5% (38 out of 42 stents) among all patients. Two conversions to open surgery were documented. First-line endovascular approach of CMI is a reasonable strategy. Close follow-up is mandatory due to symptom recurrence and restenosis.


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