Balloon Angioplasty in Chronic Critical Limb Ischemia: Factors Affecting Clinical and Angiographic Outcome

2002 ◽  
Vol 9 (4) ◽  
pp. 403-410 ◽  
Author(s):  
Hannes Balmer ◽  
Felix Mahler ◽  
Dai-Do Do ◽  
Jürgen Triller ◽  
Iris Baumgartner
Keyword(s):  
Balloon Angioplasty ◽  
Critical Limb Ischemia ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Factors Affecting ◽  
Chronic Critical Limb Ischemia ◽  
Endpoint Event ◽  
Artery Disease

Purpose: To assess factors that affect clinical and angiographic outcome in chronic critical limb ischemia (CLI) 12 months after primary, technically successful balloon angioplasty (BA) in infrainguinal arteries. Methods: Sixty consecutive patients (37 women; mean age 75 ± 10 years, range 53–99) with technically successful BA in 66 limbs were followed for 12 months or until death, for major amputation, or repeat target lesion revascularization (TLR). Assessment at baseline and 1 day and 12 months after BA or at an endpoint event, if feasible, was performed with angiography or duplex ultrasound (above-knee revascularization only). Mortality, limb prognosis, and restenosis rate were correlated with cardiovascular risk factors, hemodynamic measures, and angiographic features. Results: Mortality was 25% at 1 year; compared to survivors, nonsurvivors more often had coronary artery disease (93% versus 44% for survivors, p<0.001), bilateral CLI (60% versus 29%, p=0.033), and higher fibrinogen levels (5.1 g/L versus 4.3 g/L, p=0.049). CLI resolved in more than half (35, 53%) of the limbs without repeat TLR. The major amputation rate was 6%. Limb prognosis correlated with ankle pressures after BA. Restenosis rates were 65% at the femoropopliteal and 56% at the infrapopliteal level (NS); these correlated with the length of the treated arterial segment (8.7 cm with restenosis versus 4.0 cm without, p<0.001). Conclusions: High mortality in CLI was associated with an extensive, clinically manifest arteriosclerotic process and high fibrinogen levels. Limb prognosis and restenosis after BA were primarily influenced by local hemodynamic and technical factors. Despite considerable restenosis, more than 90% of survivors avoided major amputations.

scholarly journals Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study

2019 ◽  
Vol 26 (3) ◽  
pp. 305-315 ◽  
Author(s):  
Michel M. P. J. Reijnen ◽  
Iris van Wijck ◽  
Thomas Zeller ◽  
Antonio Micari ◽  
Pierfrancesco Veroux ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Major Amputation ◽  
Limb Amputation ◽  
Post Hoc Analysis ◽  
Kaplan Meier ◽  
Global Study ◽  
Post Hoc ◽  
Drug Coated Balloon

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). Materials and Methods: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). Results: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. Conclusion: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

scholarly journals Association of comorbid depression with inpatient outcomes in critical limb ischemia

2019 ◽  
Vol 25 (1) ◽  
pp. 25-32 ◽  
Author(s):  
Greg J Zahner ◽  
Abigail Cortez ◽  
Erin Duralde ◽  
Joel L Ramirez ◽  
Sue Wang ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Critical Limb Ischemia ◽  
Multivariable Analysis ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Comorbid Depression ◽  
Surgical Quality ◽  
Inpatient Outcomes ◽  
Artery Disease ◽  
End Stage

There is a growing body of evidence that peripheral artery disease (PAD) may be impacted by depression. The objective of this study is to determine whether outcomes, primarily major amputation, differ between patients with depression and those without who presented to hospitals with critical limb ischemia (CLI), the end-stage of PAD. A retrospective cohort of patients hospitalized for CLI during 2012 and 2013 was identified from the National Inpatient Sample (NIS) using ICD-9 codes. The primary outcome was major amputation and secondary outcomes were length of stay and other complications. The sample included 116,008 patients hospitalized for CLI, of whom 10,512 (9.1%) had comorbid depression. Patients with depression were younger (64 ± 14 vs 67 ± 14 years, p < 0.001) and more likely to be female (55% vs 41%, p < 0.001), white (73% vs 66%, p < 0.001), and tobacco users (46% vs 41%, p < 0.001). They were also more likely to have prior amputations (9.8% vs 7.9%, p < 0.001). During the hospitalization, the rate of major amputation was higher in patients with comorbid depression (11.5% vs 9.1%, p < 0.001). In multivariable analysis, excluding patients who died prior to/without receiving an amputation ( n = 2621), comorbid depression was associated with a 39% increased odds of major amputation (adjusted OR 1.39, 95% CI 1.30, 1.49; p < 0.001). Across the entire sample, comorbid depression was also independently associated with a slightly longer length of stay (β = 0.199, 95% CI 0.155, 0.244; p < 0.001). These results provide further evidence that depression is a variable of interest in PAD and surgical quality databases should include mental health variables to enable further study.

Evolution of Major Amputation Risk in Patients Hospitalized in France for Critical Limb Ischemia: The COPART Registry

Angiology ◽  
2020 ◽  
pp. 000331972097682
Author(s):  
Alice Coudene ◽  
Francois-Xavier Lapébie ◽  
Ileana Desormais ◽  
P Lacroix ◽  
Valerie Aurillac ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Major Amputation ◽  
The Past ◽  
Significant Difference ◽  
Before And After ◽  
Secondary Outcomes ◽  
Artery Disease ◽  
Peripheral Arterial

Over the past decade, improvements in medical treatment and revascularization techniques have been beneficial for patients with peripheral artery disease in the late stage of critical limb ischemia (CLI). We evaluated the putative reduction in the number of major amputees in the Cohorte des Patients ARTeriopathes (COPART) cohort over time. Patients were selected from this multicenter cohort, from 2006 to 2016, for CLI according to Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease II criteria. Patients included before and after 2011 were compared. Patients were followed for 1 year. Primary outcome was the rate of major amputations. Secondary outcomes were minor amputations, deaths from all causes, cardiovascular deaths; 989 patients were included, 489 before 2011 and 450 after 2011. There was a significant decrease in rates of major amputation after 2011 (17% vs 25%), confirmed in multivariate analysis (odds ratio [OR]: 1.5 [1.1-2.2]), an increase in revascularization, particularly distal angioplasty (OR: 2.7 [1.7-4.4]) and increased statin intake (OR: 1.6 [1.1-2.1]). For secondary outcomes, there was no significant difference. Limb prognosis of CLI patients has improved over the past decade, possibly due to more revascularizations, particularly distal ones, and increased statin use.

Combined Superficial and Deep Venous Arterialization in No-Option Critical Limb Ischemia: Case Report

2021 ◽  
pp. 153857442198986
Author(s):  
Tammam Harfouch ◽  
Andrei Tarus ◽  
Elena-Teodora Agafitei ◽  
Raluca Ozana Chistol ◽  
Grigore Tinica
Keyword(s):  
Critical Limb Ischemia ◽  
Varicose Veins ◽  
Treatment Options ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Poor Quality ◽  
High Rate ◽  
Viable Option ◽  
Artery Disease

The management of peripheral artery disease with no revascularization options can be challenging due to the very limited treatment options available and the high rate of major amputation which is linked to increased mortality and poor quality of life. Using a distal venous bed as an alternative bypass runoff seems to be a viable option when arterial reconstruction is not feasible. We report our experience with distal venous arterialization for limb salvage in non-reconstructable critical limb ischemia and describe the configuration used to achieve venosome directed revascularization in a patient with concomitant varicose veins.

scholarly journals CURRENT TRENDS IN CRITICAL LIMB ISCHEMIA - REVIEW

2020 ◽  
pp. 1-3
Author(s):  
Puneet Kumar Agarwal ◽  
Vikram Vasuniya
Keyword(s):  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Major Amputation ◽  
Primary Treatment ◽  
Ischemic Pain ◽  
Therapeutic Goals ◽  
Current Trends ◽  
Drug Eluting ◽  
Artery Disease

Critical limb ischemia (CLI) is considered the most severe clinical manifestation of peripheral artery disease (PAD). These patients carry high risk of amputation and mortality. CLI patientfaces may problems like restriction of movement, starvation of services and depression. Therapeutic goals in treating these patients include relieving ischemic pain, reducing cardiovascular risk factors, preventing major amputation, improving quality of life and increasing survival.Revascularization is the primary treatment strategy in critical limb ischemia patients. Many patients are not treatable by conventional techniques.This review article provides a comprehensive summary that includes current trends in the management of Critical limb ischemia like endovascular revascularization,gene and cell based therapies and drug eluting stents (DESs) etc.

scholarly journals One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia

2017 ◽  
Vol 24 (3) ◽  
pp. 311-316 ◽  
Author(s):  
Marc Bosiers ◽  
Joren Callaert ◽  
Koen Keirse ◽  
Jeroen M. H. Hendriks ◽  
Patrick Peeters ◽  
...  
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Duplex Ultrasound ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Primary Patency ◽  
Drug Eluting Stent ◽  
Lesion Length ◽  
Imaging Data ◽  
Stent System

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.

scholarly journals Successful limb salvage by endovascular treatment for critical limb ischemia subsequent to acute limb ischemia

2019 ◽  
Vol 2019 (10) ◽  
Author(s):  
Tetsuya Nomura ◽  
Satoshi Tasaka ◽  
Kenshi Ono ◽  
Yu Sakaue ◽  
Naotoshi Wada ◽  
...  
Keyword(s):  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Major Amputation ◽  
Sudden Onset ◽  
Acute Limb Ischemia ◽  
Below The Knee ◽  
Tibial Arteries ◽  
Chronic Critical Limb Ischemia ◽  
Peripheral Arterial

Abstract Recently, there have been increasing opportunities to treat patients with peripheral arterial disease. Of those patients, both pathological conditions, such as acute limb ischemia (ALI) and chronic critical limb ischemia (CLI), are closely associated with high risks of major amputation, disability and death. We encountered a very rare case of CLI subsequent to ALI. An 83-year-old male showed the sudden onset of ALI, probably due to thromboembolism from an abdominal aortic aneurysm during an operation for gastric cancer. The patient was referred to another hospital for Fogarty thrombectomy. About 1 month after ALI onset, necrosis of the left first toe gradually progressed. On angiography of the left lower limb, we noted occlusions of both anterior and posterior tibial arteries. Then, we successfully conducted balloon angioplasty for the below-the-knee arteries. Thereby, favorable blood flow was achieved, which led to successful wound healing without amputations.

New techniques for endovascular treatment of peripheral artery disease with focus on chronic critical limb ischemia

VASA ◽  
2009 ◽  
Vol 38 (1) ◽  
pp. 3-12 ◽  
Author(s):  
Zeller ◽  
Sixt ◽  
Rastan
Keyword(s):  
Limb Salvage ◽  
Critical Limb Ischemia ◽  
Limb Ischemia ◽  
Arterial Disease ◽  
Limb Loss ◽  
Infrapopliteal Artery ◽  
Below The Knee ◽  
Chronic Critical Limb Ischemia ◽  
Artery Disease ◽  
Peripheral Arterial

Chronic critical limb ischemia (CLI) represents the most advanced stage of peripheral arterial disease. CLI is associated with a high risk for limb loss and revascularization, either by surgical or endovascular means, is absolutely mandatory. With traditional techniques such as balloon angioplasty, limb salvage was reported in 80 to 90%. However, in case of failed revascularization attempt, limb loss was 40 to 50% and mortality approximately 20%. This review summarizes new developments in endovascular techniques which increase the acute and chronic success rate of endovascular procedures and therefore potentially further improve limb salvage rates. Special crossing and re-entry devices designed for femoro-popliteal application may even facilitate recanalization of long chronic occlusions. Improved stent design, atherectomy devices and drug coated balloons improve patency rates and may result in improved wound healing rates. Moreover, downsizing the catheter tools for infrapopliteal artery disease opens new horizons also for the treatment of complex below-the-knee lesions representing an increasing patient population due to the increasing prevalence of diabetes and end-stage renal failure.

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