Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study)

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.

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Pathophysiology of Peripheral Artery Disease, Intermittent Claudication, and Critical Limb Ischemia

Vascular Medicine: A Companion to Braunwald's Heart Disease ◽

10.1016/b978-1-4377-2930-6.00017-3 ◽

2013 ◽

pp. 223-230 ◽

Cited By ~ 4

Author(s):

William R. Hiatt ◽

Eric P. Brass

Keyword(s):

Intermittent Claudication ◽

Peripheral Artery Disease ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Peripheral Artery ◽

Artery Disease

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Differences Between Patients With Intermittent Claudication and Critical Limb Ischemia Undergoing Endovascular Intervention: Insights From the Excellence in Peripheral Artery Disease Registry

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.121.010635 ◽

2021 ◽

Author(s):

Kunal Patel ◽

Yulun Liu ◽

Farshid Etaee ◽

Chirag Patel ◽

Peter Monteleone ◽

...

Keyword(s):

Intermittent Claudication ◽

Peripheral Artery Disease ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Endovascular Intervention ◽

Baseline Risk ◽

Peripheral Artery ◽

Disease Registry ◽

Endovascular Revascularization ◽

Artery Disease

Background: There are limited data on differences in angiographic distribution of peripheral artery disease and endovascular revascularization strategies in patients presenting with intermittent claudication (IC) and critical limb ischemia (CLI). We aimed to compare anatomic features, treatment strategies, and clinical outcomes between patients with IC and CLI undergoing endovascular revascularization. Methods: We examined 3326 patients enrolled in the Excellence in Peripheral Artery Disease registry from 2006 to 2019 who were referred for endovascular intervention for IC (n=1983) or CLI (n=1343). The primary outcome was 1-year major adverse limb events, which included death, repeat target limb revascularization, or target limb amputation. Results: Patients with CLI were older and more likely to have diabetes and chronic kidney disease and less likely to receive optimal medical therapy compared with IC. Patients with IC had higher femoropopliteal artery interventions (IC 87% versus CLI 65%; P <0.001), while below the knee interventions were more frequent in CLI (CLI 47% versus IC 12%; P <0.001). Patients with CLI were more likely to have multilevel peripheral artery disease (CLI 32% versus IC 15%, P <0.001). Patients with IC were predominantly revascularized with stents (IC 48% versus CLI 37%; P <0.001) while balloon angioplasty was more frequent in CLI (CLI 37% versus IC 25%; P <0.001). All-cause mortality was higher in patients with CLI (CLI 4% versus IC 2%; P =0.014). Major adverse limb event rates for patients with IC and CLI were 16% and 26%, respectively ( P <0.001) and remained higher in CLI after multivariable adjustment of baseline risk factors. Conclusions: Patients with IC and CLI have significant anatomic, lesion, and treatment differences with significantly higher mortality and adverse limb outcomes in CLI. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01904851.

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Prospective Trial of Infrapopliteal Artery Balloon Angioplasty for Critical Limb Ischemia: Angiographic and Clinical Results

Journal of Vascular and Interventional Radiology ◽

10.1016/s1051-0443(07)61332-3 ◽

2000 ◽

Vol 11 (8) ◽

pp. 1021-1031 ◽

Cited By ~ 218

Author(s):

Heini K. Söder ◽

Hannu I. Manninen ◽

Pekka Jaakkola ◽

Pekka J. Matsi ◽

Heikki T. Räsänen ◽

...

Keyword(s):

Balloon Angioplasty ◽

Critical Limb Ischemia ◽

Prospective Trial ◽

Limb Ischemia ◽

Clinical Results ◽

Infrapopliteal Artery

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

VASA ◽

10.1024/0301-1526.38.1.3 ◽

2009 ◽

Vol 38 (1) ◽

pp. 3-12 ◽

Cited By ~ 10

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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Characteristics and outcomes of patients with peripheral artery disease undergoing endovascular revascularization: A community hospital perspective

Vascular ◽

10.1177/1708538120958858 ◽

2020 ◽

pp. 170853812095885

Author(s):

S Michael Gharacholou ◽

Zhuo Li ◽

Jonathan J Uy ◽

Lee H Eckstein ◽

Carolyn R Flock ◽

...

Keyword(s):

Intermittent Claudication ◽

Peripheral Artery Disease ◽

Critical Limb Ischemia ◽

Community Hospital ◽

Limb Ischemia ◽

Study Cohort ◽

Acute Limb Ischemia ◽

Peripheral Artery ◽

Endovascular Revascularization ◽

Artery Disease

Background There are limited data on outcomes for patients with peripheral artery disease undergoing endovascular revascularization by multi-disciplinary teams in a community hospital setting. Methods From January 2015 through December 2015, we assembled a multi-disciplinary program comprised of cardiologists, surgeons, radiologists, nurses, and administrative staff for managing patients with peripheral artery disease undergoing endovascular revascularization. Demographic, procedural, and outcomes data were collected with use of a template from the Society for Vascular Surgery Vascular Quality Initiative database. We compared characteristics and outcomes of patients with intermittent claudication and critical limb ischemia. We used Kaplan–Meier methods to estimate the rate of overall survival and freedom from rehospitalization between groups. Results After excluding patients with acute limb ischemia ( n = 5), peripheral intervention to the upper extremity ( n = 6), or abdominal aorta ( n = 11), there were 82 patients in the study cohort; 45 had intermittent claudication and 37 had critical limb ischemia. Baseline and procedural characteristics were similar between groups, although critical limb ischemia patients were more likely to have hyperlipidemia (75.7% vs. 53.3%, P = .42). Procedural success was achieved in 91.3% of cases. Actionable access site bleeding occurred in 2.4% of patients. High rates of aspirin (91.5%) and statin (87.8%) were noted at discharge. After two years of post endovascular revascularization, survival was 57.5% for critical limb ischemia patients and 94.4% for intermittent claudication patients ( P < .001). Freedom from rehospitalization was 32.7% for critical limb ischemia patients and 83.5% for intermittent claudication patients ( P < .001). Conclusions We found that favorable outcomes may be achieved with a multi-disciplinary peripheral artery disease program at community hospitals. The incorporation of quality improvement practices may further help to develop standardized and regionalized approaches to care delivery for patients with peripheral artery disease.

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