Mortality after major amputation in elderly patients with critical limb ischemia

Summary: Background: Isolated femoral artery revascularisation (iFAR) represents a well-established surgical method in the treatment of peripheral arterial disease (PAD) involving common femoral artery disease. Data for iFAR in multilevel PAD are inconsistent, particularly in patients with critical limb ischemia (CLI). The aim of the study was to evaluate the outcome of iFAR in CLI regarding major amputation and reintervention and to identify associated risk factors for this outcome. Patients and methods: The data used have been derived from the German Registry of Firstline Treatment in Critical Limb Ischemia (CRITISCH). A total of 1200 patients were enrolled in 27 vascular centres. This sub-analysis included patients, which were treated with iFAR with/without concomitant iliac intervention. For detection of risk factors for the combined endpoint of major amputation and/or reintervention, selection of variables for multiple regression was conducted using stepwise forward/backward selection by Akaike’s information criterion. Results: 95 patients were included (mean age: 72 years ± 10.82; 64.2% male). Of those, 32 (33.7%) participants reached the combined endpoint. Risk factor analysis revealed continued tobacco use (odds ratio [OR] 2.316, confidence interval [CI] 0.832–6.674), TASC D-lesion (OR: 2.293, CI: 0.869–6.261) and previous vascular intervention in the trial leg (OR: 2.720, CI: 1.037–7.381) to be associated with reaching the combined endpoint. Conclusions: iFAR provides a reasonable, surgical option to treat CLI. Lesion length (TASC D) seems to have a negative impact on outcome. Further research is required to better define the future role of iFAR for combined femoro-popliteal lesions in CLI – best in terms of a randomised controlled trial.

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Abstract P380: The Cardiovascular Fate in Patients with Amputation or Revascularization for Critical Limb Ischemia

Circulation ◽

10.1161/circ.129.suppl_1.p380 ◽

2014 ◽

Vol 129 (suppl_1) ◽

Author(s):

Paola De Rango ◽

Massimo Lenti ◽

Enrico Cieri ◽

Alessandro Marucchini ◽

Luca Farchioni ◽

...

Keyword(s):

Cardiovascular Mortality ◽

Critical Limb Ischemia ◽

Strong Predictor ◽

Limb Ischemia ◽

Major Amputation ◽

Mortality And Morbidity ◽

Primary Amputation ◽

All Cause Mortality ◽

And Gender ◽

Cox Analysis

Background: Critical limb ischemia (CLI) continues to be a significantly morbid disease for the aging population with high likelihood of cardiovascular mortality and morbidity. Objective: To analyze incidence and timing of all cause and cardiovascular mortality (CM) in patients who survived after intervention for CLI. Methods: Patients consecutively discharged with diagnosis of CLI during the period 2006-2008 were re-evaluated for cardiovascular morbidity after 2 years. Patients receiving revascularization either open or endovascular and those with primary major amputation were compared with Kaplan-Meier analyses. The effect of treatment on outcome was analyzed with Cox analysis. Results: There were 257 patients (171 men, aged 74.12y), 39 treated by primary major amputation and 218 by revascularization. During a mean follow-up of 37months, 81 patients died for all cause mortality and 35 for CM. Mean survival time was 57.4months. More than half deaths (n=44) occurred by 15 months with 21 patients dying in the first 6 months and 33 within the first 12 months. Thirty-five myocardial infarctions and 15 strokes occurred. Cumulative survival rate at 60 months was 54% for all cause mortality and 79% for CM. There was significantly worse survival in patients with primary amputation when compared to those receiving revascularization: rates for all cause mortality were 45% vs. 75% (p=0.001) and rates for CM were 68% vs. 90% (p<0.0001), in primary amputation and revascularization group respectively at 42 months. Unadjusted odd ratios for all cause and cardiovascular mortality in patients with primary amputation vs. revascularization were 3.07 (95%CI 1.5-6.1, p=0.002) and 5.25 (95%CI 2.3-11.6, p<0.0001), respectively. After adjusting for age and gender, primary amputation persisted as independent predictor of all cause (HR 2.76, p<0.0001) and cardiovascular mortality (HR 5.11; p<0.0001). Conclusion: Mortality and CM after 2 years in patients surviving from CLI procedures are high. Primary amputation is a strong predictor of poor prognosis in the mid-long term for patients with CLI. Most deaths occur in the first 15 months after treatment. This data may question the benefits of revascularization.

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NATIONWIDE TRENDS OF SURGICAL AND ENDOVASCULAR REVASCULARIZATION PROCEDURES FOR HOSPITAL ADMISSION, COST UTILIZATION, ALL-CAUSE MORTALITY, AND MAJOR AMPUTATION AMONG ADULTS WITH CRITICAL LIMB ISCHEMIA FROM 2003-2012

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(16)32262-8 ◽

2016 ◽

Vol 67 (13) ◽

pp. 2261

Author(s):

Shikhar Agarwal ◽

Karan Sud ◽

Mehdi Shishehbor

Keyword(s):

Hospital Admission ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

Major Amputation ◽

Endovascular Revascularization ◽

All Cause Mortality ◽

Cost Utilization ◽

Revascularization Procedures

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Abstract 14293: Time to Wound Healing and Major Adverse Limb Events in Patients With Critical Limb Ischemia Treated With Endovascular Therapy

Circulation ◽

10.1161/circ.132.suppl_3.14293 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Grant W Reed ◽

Negar Salehi ◽

Pejman Raeisi-Giglou ◽

Umair Malik ◽

Rami Kafa ◽

...

Keyword(s):

Wound Healing ◽

Endovascular Therapy ◽

Critical Limb Ischemia ◽

Proportional Hazards ◽

Limb Ischemia ◽

Major Amputation ◽

Cox Proportional Hazards ◽

Time Dependent ◽

Kaplan Meier

Introduction: There have been few studies evaluating the influence of time to wound healing on outcomes in patients with critical limb ischemia (CLI) after endovascular therapy. Methods: In this prospective study, patients with CLI treated with endovascular therapy were assessed for comorbidities, presence of wounds, wound healing, and major adverse limb events (MALE; major amputation, surgical endartectomy, or bypass) over time. The incidence of MALE was compared across patient and wound characteristics by Kaplan-Meier analysis. Associations between these variables and MALE were determined by Cox proportional hazards analysis. Results: A total of 252 consecutive patients with CLI were treated between November 1, 2011 and April 1, 2015; 179 (71%) had wounds, of which 97 (54%) healed. During median follow-up of 12.7 months (interquartile range 3.9 - 23.9 months), 46 (18%) had MALE. Wounds were associated with a greater risk of MALE (Hazard Ratio [HR] 3.5; 95% Confidence Interval [CI] 1.4-8.9; p=0.008). As a time-dependent covariate, wound healing was associated with less MALE (HR 0.23; 95% CI 0.10-0.53; p<0.001), and MALE was more frequent in patients with unhealed wounds (23% vs 11%; p<0.0001) (Figure - A). There was significantly less MALE in patients whose wounds healed within 4 months (24% vs 10%; p=0.032) (Figure - B), and less major amputation in those with healed wounds within 3 months (16% vs 5%; p=0.033). After multivariate adjustment for age, presence of diabetes, renal function, wound size, and procedural failure, independent predictors of MALE were wound healing as a time-dependent covariate (HR 0.18; 95% CI 0.08 - 0.40; p<0.0001), and creatinine ≥ 2 (HR 2.3; 95% CI 1.3-4.2; p=0.005). Conclusions: A shorter time to wound healing is associated with less MALE in patients with CLI after endovascular therapy. Efforts should be made to achieve wound healing as quickly as possible in this population, especially in those with renal dysfunction.

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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

Journal of Endovascular Therapy ◽

10.1177/1526602819839044 ◽

2019 ◽

Vol 26 (3) ◽

pp. 305-315 ◽

Cited By ~ 7

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.

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Below-knee endovascular interventions have better outcomes compared to open bypass for patients with critical limb ischemia

Vascular Medicine ◽

10.1177/1358863x16676901 ◽

2016 ◽

Vol 22 (1) ◽

pp. 28-34 ◽

Cited By ~ 10

Author(s):

Caitlin W Hicks ◽

Alireza Najafian ◽

Alik Farber ◽

Matthew T Menard ◽

Mahmoud B Malas ◽

...

Keyword(s):

Critical Limb Ischemia ◽

Multivariable Analysis ◽

Limb Ischemia ◽

Major Amputation ◽

Primary Patency ◽

Tissue Loss ◽

Vascular Intervention ◽

Below The Knee ◽

Endovascular Interventions ◽

One Year

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.

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Real-Time Quantitative Measurements of Foot Perfusion in Patients With Critical Limb Ischemia

Vascular and Endovascular Surgery ◽

10.1177/1538574419833223 ◽

2019 ◽

Vol 53 (4) ◽

pp. 310-315 ◽

Cited By ~ 3

Author(s):

O. Mironov ◽

R. Zener ◽

N. Eisenberg ◽

K.T. Tan ◽

Graham Roche-Nagle

Keyword(s):

Wound Healing ◽

Real Time ◽

Critical Limb Ischemia ◽

Ankle Brachial Index ◽

Microvascular Disease ◽

Limb Ischemia ◽

Major Amputation ◽

Rest Pain ◽

Quantitative Measurements ◽

Patients Experience

Introduction: Current methods of evaluating adequacy of endovascular procedures are imperfect and do not always predict which patients will do well. The purpose of this study was to evaluate the role of real-time quantitative measurements of perfusion among patients with critical limb ischemia. Materials and Methods: Thirty-four patients with critical limb ischemia undergoing endovascular treatment were recruited. Perfusion Images of the foot were obtained pre and post successful angioplasty using an SPY Elite System (Novadaq Technologies, Ontario, Canada). Patients were followed for 6 months. Subsequently a logistic regression was performed to determine whether intraprocedural perfusion parameters predicted the odds of wound healing. Results: Twenty-nine patients had successful angioplasty. Median age was 69.5% ± 8.3; 75% were men and 64% were diabetic. Rutherford stages were (4%-39%, 5%-57%, 6%-4%), and the average target limb ankle–brachial index (ABI) was 0.58 (SD 2.24). There was no significant correlation between the ABI and perfusion parameters. Inflow perfusion rate correlated significantly with Rutherford stage (Spearman rho 0.398, P = .036). After successful angioplasty 39% had a decrease in inflow rate and 57% had a decreased total inflow. In all, 25 patients completed 6 months of follow-up. Resolution of rest pain and/or healing of the ischemic wound occurred in 10 (40%) patients at 1 month, 4 (16%) at 3 months, and 2 (8%) at 6 months. One patient underwent a major amputation at 2 months. Eight (32%) patients never healed or had persistent rest pain. None of the real-time perfusion variables were significant predictors of wound healing. Conclusion: Many patients experience a paradoxical decrease in perfusion following successful angioplasty suggesting perfusion may not correlate with angiographic outcome, possibly due to microemboli, microvascular disease, or vasospasm. Real-time perfusion imaging following intra-arterial infusion of indocyanine green does not predict the odds of wound healing.

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