Comparison of Results in Endovascular Interventions for Infrainguinal Lesions: Claudication versus Critical Limb Ischemia

2005 ◽  
Vol 71 (6) ◽  
pp. 474-480 ◽  
Author(s):  
Susan M. Trocciola ◽  
Rabih Chaer ◽  
Rajeev Dayal ◽  
Stephanie C. Lin ◽  
Naveen Kumar ◽  
...  

This study analyzed clinical success, patency, and limb salvage after endovascular repair in patients treated for chronic limb ischemia presenting with claudication versus critical limb ischemia. Between October 2001 and August 2004, 115 patients (mean age 71) underwent endovascular treatment for infrainguinal arterial disease. Techniques included subintimal angioplasty and transluminal angioplasty with or without stents. Lesions were classified according to Transatlantic InterSociety Consensus. Follow-up (mean 11 months) included physical exam, ankle-brachial index, and duplex ultrasound. Patency rates were determined using Kaplan-Meier and compared by log-rank analysis. One hundred ninety-nine lesions were treated in 121 limbs using percutaneous techniques. Comorbidities were similar except higher rates of diabetes mellitus (67% vs 41%, P < 0.001) and chronic renal insufficiency (22% vs 7%, P < 0.05) were found in critical limb ischemia patients. Primary patency for claudicants was 100 per cent, 98 per cent, and 85 per cent at 3, 6, and 12 months and 89 per cent, 80 per cent, and 72 per cent for critical limb ischemia, respectively ( P = 0.06). Limb salvage was 91 per cent at 12 months for critical limb ischemia patients. Morbidity was similar between groups, and there was no perioperative mortality. Percutaneous intervention for both claudication and critical limb ischemia provides acceptable 12-month patency with limited morbidity.

Vascular ◽  
2006 ◽  
Vol 14 (2) ◽  
pp. 63-69 ◽  
Author(s):  
Marc Bosiers ◽  
Joseph P. Hart ◽  
Koen Deloose ◽  
Jurgen Verbist ◽  
Patrick Peeters

Endovascular strategies for the treatment of critical infrageniculate peripheral arterial occlusive disease exist and are becoming the primary methodology for such lesions at many centers. Although technically feasible for experienced operators, the evidence to support this strategy for below the knee (BTK) interventions is still evolving. We studied the 6-month and 1-year outcomes of percutaneous transluminal angioplasty (PTA) alone, PTA with stenting, and excimer laser recanalization for BTK lesions in patients with critical limb ischemia. Between September 2002 and June 2005, 443 patients (355 Rutherford category 4, 82 category 5, 6 category 6) underwent intervention for 681 BTK lesions. Follow-up was performed at 6-month intervals after index intervention: limb salvage data were recorded and duplex ultrasonography was performed to measure the patency of treated areas. The primary patency and limb salvage rates of the entire population were 85.2% and 97.0% and 74.2% and 96.6% at 6 months and 1 year, respectively. Stratified for the treatment strategy (PTA alone in 79, PTA with stenting in 300 patients, and excimer laser in 64), 1-year primary patency rates were 68.6%, 75.5%, and 75.4%, whereas the limb salvage rates were 96.7%, 98.6%, and 87.9% for each modality, respectively. Endovascular intervention will become the primary treatment for BTK lesions in patients with critical limb ischemia, with 1-year primary patency and limb salvage rates that compare favorably with published surgical data. Prospective, randomized, multicenter trials will be needed to further establish the role of endovascular intervention in this challenging patient group.


2019 ◽  
Vol 103 (9-10) ◽  
pp. 509-515
Author(s):  
Toshiya Nishibe ◽  
Kiyohito Yamamoto ◽  
Kayo Toguchi ◽  
Yoshimasa Seike ◽  
Naoki Ito ◽  
...  

The purpose of this study was to describe the vascular surgeons' experience with an endovascular-first approach for critical limb ischemia (CLI) due to arteriosclerotic disease involving infrapopliteal vessels. From April 2006 to September 2013, 55 limbs with CLI in 45 consecutive patients who had undergone infrapopliteal percutaneous transluminal angioplasty (PTA) were evaluated. All limbs presented with ulcers or gangrenes (Rutherford 5 or 6), and were treated with infrapopliteal PTA as the initial treatment. Clinical outcomes of major adverse limb event (MALE) + perioperative death (POD), amputation-free survival (AFS), limb salvage, and survival were analyzed with the Kaplan–Meier method. Multivariable perioperative predictors of MALE + POD and AFS were identified using the stepwise Cox proportional hazards regression model. The technical success rate was 95% (52/55). Clinical success was attained in 37 of 55 limbs (67%). Freedom from MALE + POD, AFS, limb salvage, and survival were 89%, 84%, 92%, and 92% at 6 months, respectively, and 82%, 68%, 89%, and 78% at 12 months, respectively. Clinical success (HR, 0.06; 0.01–0.50; P = 0.009) was associated with freedom from MALE + POD. Rutherford 6 (HR, 3.0; 95% CI, 1.1–8.3; P &lt; 0.004) and clinical success (HR, 0.19; 95% CI, 0.07–0.49; P &lt; 0.0007) were associated with AFS. These results suggest that infrapopliteal PTA can be offered as a first therapeutic option for a significant proportion of patients with CLI. Vascular surgeons must embrace and validate endovascular technology if they are to remain competitive in treatment of peripheral artery disease.


2017 ◽  
Vol 24 (3) ◽  
pp. 311-316 ◽  
Author(s):  
Marc Bosiers ◽  
Joren Callaert ◽  
Koen Keirse ◽  
Jeroen M. H. Hendriks ◽  
Patrick Peeters ◽  
...  

Purpose: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. Methods: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0–58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). Results: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. Conclusion: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.


2021 ◽  
pp. 20210215
Author(s):  
Nikolaos Galanakis ◽  
Thomas G Maris ◽  
Georgios Kalaitzakis ◽  
Nikolaos Kontopodis ◽  
Nikolas Matthaiou ◽  
...  

Objectives: To emerge hypoperfusion of lower limbs in patients with critical limb ischemia (CLI) using Intravoxel Incoherent Motion microperfusion magnetic resonance imaging (IVIM-MRI). Moreover to examine the ability of IVIM-MRI to differentiate patients with severe peripheral arterial disease (PAD) from normal subjects and evaluate the percutaneous transluminal angioplasty (PTA) results in patients with CLI. Methods: Eight patients who presented with CLI and six healthy volunteers were examined. The patients underwent IVIM-MRI of lower extremity before and following PTA. The imaging protocol included sagittal diffusion-weighted (DW) sequences. DW images were analyzed and color parametric maps of the micro-circulation of blood inside the capillary network (D*) were constructed. The studies were evaluated by two observers to define interobserver reproducibility. Results: Technical success was achieved in all patients (8/8). The mean ankle-brachial index increased from 0.35 ± 0.2 to 0.76 ± 0.25 (p < 0.05). Successful revascularization improved IVIM microperfusion. Mean D* increased from 279.88 ± 13.47 10−5 mm2/s to 331.51 ± 31 10−5 mm2/s, following PTA, p < 0.05. Moreover, PAD patients presented lower D* values as compared to healthy individuals (279.88 ± 13.47 10−5 mm2/s vs 332.47 ± 22.95 10−5 mm2/s, p < 0.05, respectively). Good interobserver agreement was obtained with an ICC = 0.84 (95% CI 0.64–0.93). Conclusions: IVIM-MRI can detect differences in microperfusion between patients with PAD and healthy individuals. Moreover, significant restitution of IVIM microperfusion is found following successful PTA. Advances in knowledge: IVIM-MRI is a safe, reproducible and effective modality for evaluation of lower limb hypoperfusion in patients with PAD. It seems also to be a helpful tool to detect changes of tissue perfusion in patients with CLI following revascularization.


2016 ◽  
Vol 22 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Caitlin W Hicks ◽  
Alireza Najafian ◽  
Alik Farber ◽  
Matthew T Menard ◽  
Mahmoud B Malas ◽  
...  

Both open surgery and endovascular peripheral interventions have been shown to effectively improve outcomes in patients with peripheral artery disease, but minimal data exist comparing outcomes performed at and below the knee. The purpose of this study was to compare outcomes following infrageniculate lower extremity open bypass (LEB) versus peripheral vascular intervention (PVI) in patients with critical limb ischemia. Using data from the 2008–2014 Vascular Quality Initiative, 1-year primary patency, major amputation, and mortality were compared among all patients undergoing LEB versus PVI at or below the knee for rest pain or tissue loss. Overall, 2566 patients were included (LEB=500, PVI=2066). One-year primary patency was significantly worse following LEB (73% vs 81%; p<0.001). One-year major amputation (14% vs 12%; p=0.18) and mortality (4% vs 6%; p=0.15) were similar regardless of revascularization approach. Multivariable analysis adjusting for baseline differences between groups confirmed inferior primary patency following LEB versus PVI (HR 0.74; 95% CI, 0.60–0.90; p=0.004), but no significant differences in 1-year major amputation (HR 1.06; 95% CI, 0.80–1.40; p=0.67) or mortality (HR 0.71; 95% CI, 0.44–1.14; p=0.16). Based on these data, we conclude that endovascular revascularization is a viable treatment approach for critical limb ischemia resulting from infrageniculate arterial occlusive disease.


Vascular ◽  
2016 ◽  
Vol 24 (5) ◽  
pp. 515-522 ◽  
Author(s):  
E Tartaglia ◽  
A Lejay ◽  
Y Georg ◽  
M Roussin ◽  
F Thaveau ◽  
...  

Aim Infrapopliteal occlusive arterial lesions mostly characterize diabetic patients arteriopathy. Diabetic patients are prone to multiple comorbidities that make them candidates for low-invasive therapeutic options. The aim of this study was to evaluate the safety of infrapopliteal angioplasty in high-risk diabetic patients. Methods We undertook a study (retrospective study of a prospectively collected database) of all infrapopliteal endovascular revascularizations performed for critical limb ischemia in high-risk (≥3 major comorbidities) diabetic patients in our institution between 2008 and 2010. Study end points were safety, technical success rate, healing rate, overall 1-year survival, primary patency, secondary patency and limb salvage rates. Results A total of 101 high-risk diabetic patients (160 arterial lesions: 94 stenosis and 66 occlusions) underwent infrapopliteal endovascular surgery. No major adverse cardiovascular or cerebrovascular event was recorded within 30 days. Two major adverse limb events (two thromboses requiring major amputation) and seven minor adverse events were recorded. Technical and healing rates were, respectively, 83% and 78%. The 1-year survival, primary patency, secondary patency and limb salvage rates were, respectively, 86%, 67%, 83% and 84%. Conclusion Infrapopliteal angioplasty can be considered as a safe and feasible option for high-risk diabetic patients with critical limb ischemia.


Vascular ◽  
2020 ◽  
pp. 170853812096612 ◽  
Author(s):  
Nicola Troisi ◽  
Giovanni De Blasis ◽  
Mauro Salvini ◽  
Stefano Michelagnoli ◽  
Carlo Setacci ◽  
...  

Objectives Guidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE). Methods From January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan–Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. Results Patients were predominantly male ( n = 332, 77.6%) with a mean age of 73.3 years (range 39–95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1–5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1–60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively. Conclusions Preliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes.


2018 ◽  
Vol 5 (6) ◽  
pp. 2039
Author(s):  
Asser Abd El Hamid Goda

Background: Critical limb ischemia (CLI) occurs due to progressive obstructive nature of atherosclerosis disease.  Nowadays, there is widespread use of endovascular revascularization procedures for restoration of blood flow in CLI. The aim this study is evaluation of the efficacy of endovascular intervention for multilevel arterial disease in patients with critical limb ischemia.Methods: This prospective study was included CLI patients due to multilevel arterial disease who underwent endovascular revascularization between January 2016 and January 2017 in our institution. Study end points were limb salvage and wound healing. Results: The mean age of patients was (61.7±7.47) years, with 13 (61.9%) men. Eight limbs were identified as Rutherford category 4 (38.1%), ten limbs as Rutherford category 5 (47.6%), and three limbs as Rutherford category 6 (14.3%). Limb salvage rate was (90.5%) at 1 year. Wound healing rate was 80.9%.Conclusions: This study proved that endovascular revascularization of multilevel arterial disease for patients with critical limb ischemia is effective.


2017 ◽  
Vol 24 (3) ◽  
pp. 321-330 ◽  
Author(s):  
Gagan D. Singh ◽  
Ellen K. Brinza ◽  
Justin Hildebrand ◽  
Stephen W. Waldo ◽  
T. Raymond Foley ◽  
...  

Purpose: To analyze the relationship between the new TransAtlantic Inter-Society Consensus (TASC II) infrapopliteal classification and limb outcomes among patients with critical limb ischemia (CLI). Methods: A single-center retrospective study was performed on 166 consecutive CLI patients (mean age 71 years; 113 men) undergoing endovascular treatment of 244 infrapopliteal lesions from 2006 to 2013. Patient, procedural, angiographic, and limb outcomes were compared for the new TASC A/B vs C/D classification for infrapopliteal lesions. Binary restenosis was determined by a peak systolic velocity ratio >2.0 by duplex ultrasound on follow-up at 1, 3, 6, and 12 months. Results: Seventy-two (43.4%) patients had TASC A/B lesions, while 94 (56.6%) had TASC C/D patterns of infrapopliteal disease. Baseline demographics and tissue loss (93% vs 94%, p=0.59) were similar between the groups. TASC A/B lesions were shorter (53±35 vs 170±83 mm, p<0.001), less severely stenosed (77%±24% vs 93%±14%, p<0.001), had a larger target vessel diameter (2.9±0.5 vs 2.6±0.5 mm, p<0.001), and were less frequently chronic total occlusions (24% vs 64%, p<0.001) compared with the TASC C/D group. Three-year freedom from both amputation (85% vs 67%, p=0.02) and major adverse limb events (79% vs 61%, p=0.02) were significantly higher in the TASC A/B group. Technical success rates (95% vs 80%, p<0.001) and 1-year primary patency (58% vs 51%, p=0.04) were higher in the A/B group. Overall 3-year survival was similar between the groups (96% A/B vs 88% C/D, p=0.2). Conclusion: TASC C/D infrapopliteal lesions are associated with higher amputation and major adverse limb events rates and lower primary patency compared with TASC A/B infrapopliteal lesions. Further studies are needed to assess the association between TASC C/D infrapopliteal lesions and clinical outcomes in patients with CLI.


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