Amputation-free Survival In Patients Research Articles

Editor's Choice – Association of Pedal Acceleration Time With Healing and Amputation Free Survival in Patients With Ulceration and Gangrene

Pedal acceleration time (PAT) is a novel non-invasive perfusion measurement that may be useful in the management of patients with ulceration and gangrene. The objective of this study was to report the association between PAT and wound healing, amputation free survival (AFS), and mortality at one year. This prospective observational study reviewed all patients who underwent PAT after presentation with ulceration or gangrene from 1 January 2020 to 30 June 2022. PAT was defined as the time (in milliseconds) from the onset of systole to the peak of systole in the mid artery. The final PAT of a limb was used to assess outcomes (presenting PAT if no revascularisation, or post-revascularisation PAT). Wound healing, major limb amputation, and death at one year were collected. Healing was assessed with Fine-Gray competing risks model, AFS via logistic regression, and survival using Cox proportional hazards model. Overall, 265 patients (307 limbs) were included. The median patient age was 71 years and 74.0% (196/265) had diabetes mellitus. Patient demographics were similar among the final PAT category cohorts. Compared with a final PAT category 1, analysis of one year outcomes showed that the final PAT categories 2- 4 had lower wound healing (category 2, hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.43 - 0.9, p= .012; category 3, HR 0.21, 95% CI 0.08 - 0.58, p= .002; category 4, HR 0.12, 95% CI 0.04 - 0.34, p < .001), lower AFS (category 2, odds ratio [OR] 2.86, 95% CI 1.64 - 5.0, p < .001; category 3, OR 5.1, 95% CI 1.71 - 15.22, p= .003; category 4, OR 12.59, 95% CI 4.34 - 36.56, p < .001), and lower survival (category 2, HR 1.89, 95% CI 1.17 - 3.03, p=.009; category 3, HR2.37, 95% CI 1.05 - 5.36, p= .039; category 4, HR 4.52, 95% CI 2.48 - 8.21, p < .001). The final PAT measurement is associated with wound healing, AFS, and death at one year. PAT may be a valuable tool to assess perfusion of the foot.

Outcomes and predictors of amputation-free survival in patients undergoing below-knee popliteal-distal bypass

ObjectiveThe infrageniculate popliteal artery is a potential source for inflow in lower extremity bypass surgery in patients with isolated tibial artery disease. The objective of our study was to assess the short- and long-term outcomes of popliteal-distal bypasses using data from the Vascular Quality Initiative (VQI). MethodsThe VQI registry was queried between 2003 and 2021 for patients undergoing surgical revascularizations with the below-knee popliteal artery serving as inflow. Demographics, comorbidities, intraoperative characteristics, and postoperative complications were analyzed. Kaplan-Meier models were used to estimate amputation-free survival, survival, and freedom from amputation. Cox regression analysis was conducted to determine factors associated with major amputation or death. ResultsA total of 1884 procedures were analyzed. The mean age of the included patients was 67.7 years. The most frequently observed preoperative comorbidities included insulin-dependent diabetes (52.3%), coronary disease (32.4%), and end-stage renal disease (14.4%). Of all the patients, 670 (35.6%) had a history of ipsilateral endovascular intervention. The procedures were performed for a variety of indications, including tissue loss (84.3%), rest pain (10.9%), and claudication (4.8%). Intraoperatively, the outflow targets were the dorsalis pedis (31.4%), the posterior tibial (24.4%), and the anterior tibial arteries (15.6%). Vein conduit was used in 92.1% of cases. The rate of perioperative myocardial infarction (MI) was 2.4%, and the 30-day mortality was 1.9%. The median length of follow up was 371 days. Amputation-free survival was found to be 85.6% (95% confidence interval [CI], 84.0%-87.2%) at 6 months and 78.6% (95% CI, 76.6%-80.4%) at 12 months. Survival was found to be 93.4% (95% CI, 92.2%-94.5%) at 6 months and 88.6% (95% CI, 87.1%-90.0%) at 12 months. Freedom from amputation was found to be 92.0% (95% CI, 90.7%-93.3%) at 6 months and 89.0% (95% CI, 87.3%-90.4%) at 12 months. Cox regression analysis demonstrated that age greater than 65 years, congestive heart failure, coronary artery disease, and end-stage renal disease were associated with a higher risk of major amputation or death (P < .05). ConclusionsBelow-knee popliteal-distal bypass is a safe and effective approach to treat severe tibial vessel occlusive disease in this challenging patient cohort. Patients exhibited low perioperative complication rates and good amputation-free survival at 1 year.

Amputation-free survival in patients treated with critical limb ischemia

Amputation-free survival in patients treated with critical limb ischemia

Outcomes of Surgical Revascularization for Acute Limb Ischemia in COVID-19 Patients Comparing to Noninfected Cohort: A Single-Center Observational Prospective Study

The purpose of the study was to compare the clinical presentation, management, and outcomes of surgical revascularization for acute limb ischemia (ALI) in 2 groups of patients-with and without SARS-CoV-2 infection. During the 2years (01.01.2020-31.12.2021) all consecutive patients diagnosed with ALI and treated with urgent revascularization were prospectively enrolled. Based on the results of polymerase chain reaction swab for SARS-CoV-2 infection patients were allocated to group A-infected or group B-noninfected. Demographic characteristics, clinical, imaging, laboratory data, and details of treatment were collected prospectively. The composite endpoint of major amputation and/or death at 30days after surgery was defined as main study outcome. The postoperative ankle-brachial index value, reinterventions, complications, and length of hospital stay were considered as secondary outcomes. Overall, 130 patients (139 limbs with ALI) were analyzed-21 patients (23 limbs) in group A and 109 patients (116 limbs) in group B. The anatomical site of arterial occlusion, duration, and severity of ischemia did not differ significantly between the groups. Patients with COVID-19 had significantly shorter time from ALI onset till administration of the first dose of anticoagulant: 8 (2.5-24) hr vs. 15.7 (6-72) hr in group B, P=0.02. Vascular imaging was performed before intervention only in 5 (23.8%) infected patients compared to 78 (71.5%) patients in group B, P<0.001. The main outcome was registered in 38 (29.2%) patients, significantly more frequent in infected cohort: 12 (57.1%) patients in group A versus 26 (23.8%) in group B, P=0.003. Difference was preponderantly caused by high mortality in group A-9 (42.8%) patients, compared to 17 (15.5%) patients in group B, P=0.01. The difference in the rate of limb loss was not statistically significant: 4 (17.3%) limbs were amputated in COVID-19 patients and 12 (10.3%) limbs-in noninfected patients (P=0.3). Combination of ALI and COVID-19 resulted in increased 30-day mortality-risk ratio (RR) 2.7 (95% confidence interval [CI]: 1.42-5.31), P=0.002, but did not lead to significantly higher amputation rate-RR 1.6 (95% CI: 0.59-4.75), P=0.32. In group A initial admission of the patient in the intensive care unit was an independent risk factor for amputation/death. Excepting systemic complications which were more frequently registered among COVID-19 patients: 7 (33%) cases vs. 14 (12.8%) in group B, P=0.04; no differences in other secondary outcomes were observed between the groups. Study demonstrates the significant negative impact of COVID-19 upon the 30-day amputation-free survival in patients undergoing urgent surgical revascularization for ALI. The difference in outcome is influenced by higher rate of mortality among infected patients, rather than by the rate of limb loss. Severity of COVID-19, namely requirement of intensive care, mostly determines the outcome of ALI treatment.

Extravascular incidental findings in computed tomography angiography are associated with lower amputation-free survival in patients with acute lower limb ischaemia.

Emergency computed tomography angiography (CTA) is the most important imaging modality to visualize arterial occlusions in patients with acute lower limb ischaemia (ALI). Extravascular incidental findings (EVIFs) have received less attention. The aims of this study were to evaluate the incidence of EVIFs of immediate clinical relevance in patients with ALI undergoing CTA and evaluate the association between EVIFs and emergency revascularization and amputation-free survival at 1 year. Retrospective cohort study. Emergency CTA in patients with ALI between 2015 and 2018 were independently scrutinized by two senior radiologists. EVIFs were classified into immediate (category I), potential (category II) or no clinical relevance (category III). Multi-variable binary logistic regression analysis was expressed in Odds ratios (OR) with 95% confidence intervals (CI). The intra-class correlation (ICC) coefficient for EVIF category I between the raters was 0.94 (95% CI 0.92-0.96). Among 118 patients with ALI, 78 patients underwent emergency revascularization. Forty-six EVIFs (34 patients) were category I, of which 63% were found in the chest, including pleural effusion (n = 12), pneumonia (n = 8) and cardiac thrombus (n = 4). Ascites (n = 4) and cancer disease (n = 4) were other category I findings. Category I EVIFs were associated with reduced rate of emergency revascularization (OR 0.26, 95% CI 0.10-0.66) and increased rate of combined major amputation/mortality at 1year (OR 2.9, 95% CI 1.1-8.2) in adjusted analysis. It is important to evaluate EVIFs in emergency CTA in patients with ALI since these findings are both common and associated with reduced emergency revascularization and amputation-free survival at 1year.

Prognostic value of C-reactive protein to albumin ratio for long-term outcomes of patients with peripheral arterial disease underwent endovascular treatment.

Peripheral artery disease (PAD) is part of the systemic atherosclerotic process that is highly associated with cardiovascular diseases. Despite successful endovascular treatment (EVT) strategies, mortality and morbidity rates still remain higher in PAD patients. C-reactive protein (CRP) and albumin are biomarkers of inflammation and malnutrition that play key roles in the progression of peripheral arterial disease. In this study, we aimed to investigate the relationship between CRP-to-albumin ratio (CAR) and mortality and amputation-free survival in patients with PAD after successful EVT. Our study enrolled 149 consecutive patients who underwent EVT on atherosclerotic obstruction of iliac, femoral, popliteal and/or below-knee arteries with the clinical features of PAD and/or chronic limb-threatening ischaemia between January 2015 and January 2020. Clinical and prognostic follow-up of patients had been done at the outpatient clinic and were collected from institution's medical records. The mean follow-up period was 22months (14-40). All-cause mortality and amputation rates of patients in the high CAR group were significantly higher than those in the low CAR group (21.3% vs. 6.8% and 18.7% vs. 5.4%, respectively). Kaplan-Meier survival analysis showed significantly better survival for patients in the low CAR group (log-rank p = 0.0058). In multivariate logistic regression analysis, CAR was found to be an independent predictor of amputation and all-cause mortality even after adjusting for other confounding risk factors. ROC curve analysis revealed the optimal cut-off value of CAR for predicting all-cause mortality and amputation to be >1.476 with a sensitivity of 48.5% and specificity of 94.0%. The inflammatory state reflected by CAR levels was strongly associated with all-cause mortality and amputation after EVT in patients with PAD. Furthermore, CAR was found to be an independent predictor of these clinical outcomes after adjusting for other clinically associated parameters.

Validation of ERICVA Risk Score as a Predictor of One Year Amputation-Free Survival of Patients with Critical Limb Ischemia

BackgroundThe ERICVA score was derived to predict amputation-free survival in patients with critical limb ischemia (CLI). It may be a useful tool to stratify patients in trials of novel interventions to treat CLI but, as yet, it has not been externally validated.MethodsA prospective database of CLI patients was developed during prescreening of patients for a phase 1 stem cell therapy clinical trial. The primary outcome was amputation free survival (AFS) at 1 year. Both the full ERICVA scale (11 parameters) and simplified ERICVA scale (5 parameters) were validated. Data analysis was performed by calculation of the area under the receiver operating characteristic (ROC) curve examining the predictive value of the scores. The Chi-square test was used to examine the association between risk group and one-year AFS and the cumulative survival of the three risk groups was compared using Kaplan Meier survival curves.ResultsA series of 179 CLI patients were included in the analysis. The Chi-square test of independence showed a significant association between the risk group (high, medium and low) and one-year AFS outcome (P = 0.0007). Kaplan-Meier survival curve showed significant difference in one-year AFS between the three risk groups (log-rank P < 0.001). The area under the curve (AUC) was found to be 0.63 and 0.61 for the full and simplified score, respectively. The sensitivity of the full score was 0.44 with specificity of 0.84. The simplified score had a sensitivity of 0.28 and specificity of 0.92.ConclusionThe ERICVA risk score system was found to have a fair validity but cannot be considered reliable as a single predictor of one year AFS of CLI patients. The simplified score had an AUC almost identical to the full score and can accordingly replace the full score.

The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease

Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS).

Excimer laser atherectomy in complex peripheral artery disease: a prospective European registry.

This study aimed to investigate performance, effectiveness, and safety of excimer laser atherectomy for the treatment of complex lower limb artery disease in a real-world setting. In our prospective, multicenter registry, consecutive patients with complex lower limb lesions underwent excimer laser atherectomy with optional standard balloon angioplasty, paclitaxel-coated balloon angioplasty, and bailout stenting. Primary outcome was technical success. Secondary outcomes were device performance of the excimer laser system, freedom from target lesion revascularization (TLR), peri-procedural complications, and amputation-free survival in patients with critical limb ischemia (CLI). A total of 294 patients were enrolled at 14 European centers (mean lesion length 109±103 mm, total occlusions 56.8% [167 of 294 lesions], CLI 47.3% [132 of 279 patients]. Adjuvant balloon angioplasty was conducted in 283 (96.3%), and complementary stent implantation in 98 patients (33.3%). Technical success was achieved in 95.3% of patients. Increasing lesion length was associated with decreased laser atherectomy performance (odds ratio [OR] per 10 mm: 0.94 [95% confidence interval [CI] 0.90 to 0.99], P=0.01). A total of 66 patients (22.4%) completed the 12-month follow-up. Freedom from TLR was 83.5% (95% CI: 74.9 to 92.1) at 12 months. Chronic total occlusions were associated with more TLR (OR 5.03 [95% CI: 1.01 to 25.1], P=0.049). Amputation -free survival in patients with CLI was 93.1% (95% CI: 83.9 to 100). Excimer laser atherectomy substantially contributed to technical success of endovascular treatment of complex infra-inguinal lesions. Freedom from 12-month TLR was reasonable.

Editor's Choice – The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease

ObjectivePatients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS).MethodsIn this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI).ResultsIn total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69–0.71) and CLTI (c statistic = 0.69, 95% CI 0.68–0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI.ConclusionThe GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent. Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS). In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69–0.71) and CLTI (c statistic = 0.69, 95% CI 0.68–0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI. The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent.

Geriatric nutritional risk index (GNRI) predicts long-term survival and limb events in patients with peripheral artery disease

Abstract Background Geriatric nutritional risk index (GNRI) was developed as a “nutrition-related” risk index and was reported in different populations as associated with the risk of all-cause and cardiovascular morbidity and mortality. Purpose The purpose of this study was to assess the associations of GNRI with mortality and amputation free survival in patients with peripheral artery disease (PAD). Methods From January 2011 to June 2016, 295 consecutive patients (73.3±9.2 years; 75.6% male) with PAD undergoing endovascular treatment (EVT) in our hospital were retrospectively examined. The GNRI on admission was calculated as follows: 14.89 × serum albumin (g/dl) + 41.7 × body mass index (BMI)/22. Characteristics and mortality were compared between 2 groups: low GNRI (&amp;lt;92, n=110) with moderate or severe nutritional risk; and high GNRI (≥92, n=185) with no or low nutritional risk. Results The median follow up period was 39.4±26.4months. There were 85 deaths (28.8%) and 13 major amputation (4.4%) during the follow-up. Patients in the low-GNRI group were more often higher age, non-ambulatory state, hemodialysis and critical limb ischemia. BMI, serum hemoglobin, albumin, low-density lipoprotein were significantly lower, whereas serum C-reactive protein was significantly higher in the low-GNRI group than the high-GNRI group (P&amp;lt;0.05, respectively). Kaplan–Meier analysis revealed that patients in the low-GNRI group had a significantly lower amputation free survival, compared to those in the high-GNRI group (log-rank test, P&amp;lt;0.001). Conclusion The low GNRI is associated with an increased risk of mortality and limb events in patients with PAD. Amputation-free survival (Kaplan-Meier) Funding Acknowledgement Type of funding source: None

Amputation-free survival in patients with diabetic foot ulcer and peripheral arterial disease: Endovascular versus open surgery in a propensity score adjusted analysis

AimsThe aim of the present study was to compare outcomes of endovascular surgery versus open vascular surgery in patients with diabetic foot ulcer (DFU) and peripheral arterial disease (PAD). MethodsBetween 1984 and 2006, 1151 patients with DFU were admitted to the diabetic foot care team. Three hundred seventy-six patients with 408 limbs were consecutively included at a multidisciplinary foot center, 289 limbs were treated with endovascular surgery and 119 limbs with open vascular surgery first strategy. A propensity score adjusted analysis was performed to compare outcomes for type of revascularization. ResultsMajor amputation rates at 3 years were 17.0% and 16.8% (p = 0.97) and mortality at 3 years were 43.1% and 46.5% (p = 0.55) after endovascular surgery and open vascular surgery, respectively. In the propensity score adjusted analysis, patients undergoing endovascular surgery first had similar outcomes in terms of major amputation, mortality, combined major amputation/mortality compared to those undergoing open vascular surgery. Longer time to intervention (p = 0.003) was associated with increased major amputation rate in the multivariable Cox regression analysis. ConclusionThe endovascular surgery first and open vascular surgery first strategies were associated with similar long-term results in a large cohort of patients with DFU and PAD undergoing revascularization. Rapid revascularization reduces the risk of amputation.

A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID)

BackgroundThe prevalence of diabetes mellitus continues to inexorably rise in the United States and throughout the world. Lower limb amputations are a devastating comorbid complication of diabetes mellitus. Osteomyelitis increases the risk of amputation fourfold and commonly presages death.Antimicrobial therapy for diabetic foot osteomyelitis (DFO) varies greatly, indicating that high quality data are needed to inform clinical decision making. Several small trials have indicated that the addition of rifampin to backbone antimicrobial regimens for osteomyelitis outside the setting of the diabetic foot results in 28 to 42% higher cure rates.Methods/designThis is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for DFO. The study population are patients enrolled in Veteran Health Administration (VHA), ages ≥18 and ≤ 89 years with diabetes mellitus and definite or probable osteomyelitis of the foot for whom an extended course of oral or intravenous antibiotics is planned. The primary endpoint is amputation-free survival. The primary hypothesis is that using rifampin as adjunctive therapy will lower the hazard rate compared with the group that does not use rifampin as adjunctive therapy. The primary hypothesis will be tested by means of a two-sided log-rank test with a 5% significance level. The test has 90% power to detect a hazard ratio of 0.67 or lower with a total of 880 study participants followed on average for 1.8 years.DiscussionVA INTREPID will test if a rifampin-adjunctive antibiotic regimen increases amputation-free survival in patients seeking care in the VHA with DFO. A positive finding and its adoption by clinicians would reduce lower extremity amputations and their associated physical and emotional impact and reduce mortality for Veterans and for the general population with diabetic foot osteomyelitis. Given that rifampin-adjunctive regimens are currently employed for therapy for the majority of DFO cases in Europe, and only in a small minority of cases in the United States, the trial results will impact therapeutic decisions, even if the null hypothesis is not rejected.Trial registrationRegistered January 6, 2017 at ClinicalTrials.gov, NCT03012529.

Comparison of Amputation Free Survival in Patients with Diabetes Mellitus and Peripheral Arterial Disease with Heel Ulcer Treated by Endovascular Versus Open Vascular Surgery

Comparison of Amputation Free Survival in Patients with Diabetes Mellitus and Peripheral Arterial Disease with Heel Ulcer Treated by Endovascular Versus Open Vascular Surgery

Bilateral low systolic toe pressure and toe-brachial index are associated with long-term mortality in patients with peripheral artery disease

ObjectiveBased on our previous reports, ipsilateral systolic toe pressure (STP) and toe-brachial index (TBI) have a strong association with midterm cardiovascular and overall mortality as well as with amputation-free survival in patients with symptomatic lower extremity peripheral artery disease (PAD). The effect of the often overlooked contralateral lower limb on patient outcome remains unknown. This study aimed to resolve the significance of contralateral STP (CL_STP) and contralateral TBI for long-term overall and cardiovascular mortality. MethodsThis is a retrospective cohort study of 727 consecutive patients with symptomatic lower extremity PAD. All patients admitted to the Department of Vascular Surgery at Turku University Hospital for digital subtraction angiography between January 2009 and August 2011 and for whom STP measurements were available were recruited and observed for up to 7 years. Dates and causes of death were collected from the national cause of death registry of Statistics Finland. ResultsIn the study cohort, STP was <30 mm Hg in 67 contralateral limbs and 227 ipsilateral limbs. CL_STP <30 mm Hg resulted in a 60-month estimated freedom from cardiovascular death and overall survival of 39% (standard deviation [SD], 0.57) and 25% (SD, 0.41), respectively, and contralateral TBI <0.25, of 45% (SD, 0.54) and 36% (SD, 0.54), respectively. Cumulative freedom from cardiovascular death and overall survival at 60 months for patients with ipsilateral STP <30 mm Hg varied by CL_STP as follows: CL_STP <30 mm Hg: 41% (SD, 0.58) and 25% (SD, 0.43); CL_STP of 30 to 49 mm Hg: 56% (SD, 0.49) and 44% (SD, 0.49); STP ≥50 mm Hg: 62% (SD, 0.52) and 47% (SD, 0.52), respectively. In Cox regression analysis, low STP or TBI of either extremity was associated with significant (P < .001) risk of death for cardiovascular or any reason. ConclusionsLow STP and TBI of both contralateral and ipsilateral lower extremities are associated with high cardiovascular and overall mortality in symptomatic PAD patients. Bilaterally low STP and TBI are associated with a particularly poor prognosis.

Endovascular-First Treatment Is Associated With Improved Amputation-Free Survival in Patients With Critical Limb Ischemia.

Critical limb ischemia remains a difficult disease to treat, with limited level one data. The BEST-CLI trial (Best Endovascular vs Best Open Surgical Therapy in Patients with Critical Limb Ischemia) is attempting to answer whether initial treatment with open surgical bypass or endovascular therapy improves outcomes, although it remains in enrollment. This study aims to compare amputation-free survival and reintervention rates in patients treated with initial open surgical bypass or endovascular intervention for ischemic ulcers of the lower extremities. Using California nonfederal hospital data linked to statewide death data, all patients with lower extremity ulcers and a diagnosis of peripheral artery disease who underwent a revascularization procedure from 2005 to 2013 were identified. Propensity scores were formulated from baseline patient characteristics. Inverse probability weighting was used with Kaplan-Meier analysis to determine amputation-free survival and time to reintervention for open versus endovascular treatment. Mixed-effects Cox proportional hazards modeling was used to adjust for patient ability to manage their disease and hospital revascularization volume. A total of 16 800 patients were identified. Open surgical bypass was the initial treatment in 5970 (36%) while 10 830 (64%) underwent endovascular interventions. Patients in the endovascular group were slightly younger compared with the open group (70 versus 71 years, ±12 years; P<0.001). Endovascular-first patients were more likely to have comorbid renal failure (36% versus 24%), coronary artery disease (34% versus 32%), congestive heart failure (19% versus 15%), and diabetes mellitus (65% versus 58%; all P values <0.05). After inverse propensity weighting as well as adjustment for patient ability to manage their disease and hospital revascularization experience, open surgery first was associated with a worse amputation-free survival (hazard ratio, 1.16; 95% CI, 1.13-1.20) with no difference in mortality (hazard ratio, 0.94; 95% CI, 0.89-1.11). Endovascular first was associated with higher rates of reintervention (hazard ratio, 1.19; 95% CI, 1.14-1.23). Patients with critical limb ischemia have multiple comorbidities, and initial surgical bypass is associated with poorer amputation-free survival compared with an endovascular-first approach, perhaps due to increased severity of wounds at the time of presentation.

Amputation-free Survival in Patients with Critical Limb Ischemia Treated with Paclitaxel-eluting Stents and Paclitaxel-coated Balloons

The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PESs) and paclitaxel-coated balloons (PCBs) on amputation-free survival in patients with critical limb ischemia (CLI). A retrospective review of all patients with Rutherford stage 5 and 6 limb ischemia undergoing endovascular revascularization with paclitaxel-related technology, both PES and PCB, was carried out over a 4-year period. Clinical grading was determined by Rutherford classification and the Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) scoring system. Clinical and angiographic follow-up was reviewed based on intention-to-treat analysis. The primary endpoint of this study was amputation-free survival at 12months. Secondary endpoints included wound healing, freedom from target lesion revascularization, and patency of target vessels at 12months. Follow-up occurred at 3, 6, and 12months postoperatively. Target lesion patency was defined as <50% stenosis, based on a duplex velocity ratio of less than or equal to 2. Postoperative ankle-brachial index (ABI) and duplex ultrasound were performed to verify successful treatment. Outcomes were evaluated using Kaplan-Meier and Cox proportional-hazards models. A total of 88 limbs were revascularized in 88 patients. Drug-eluting stent (DES) was used as the sole drug technology in 56 patients (60.7% men, median age 70.5years) and drug-coated balloon (DCB) was used as the sole drug technology in 32 patients (46.9% men, median age 66years). Baseline demographics were well matched except for a higher prevalence of occluded target lesions in the DES group (41.1% vs. 12.5%; P=0.004). Limbs were treated for Rutherford stage 5 CLI in 71.6% and stage 6 CLI in 28.4%. Univariate analysis identified no dependent factors affecting limb salvage, except for the use of DCBs. After 12months of follow-up, amputation-free survival was significantly higher in the DES group than in the DCB group (88.5% vs. 71.1%; P=0.0443). Wound healing rates after 1year were also higher in the DES group (83.9% vs. 59.4%; P=0.0198). Freedom from target lesion revascularization was no different between patients treated with DESs and patients treated with DCBs (90.6% vs. 85.7%; P=0.518). Primary patency at 12months in patients treated with DESs was significantly higher than in patients treated with PCBs (80.4% vs. 58.1%; P=0.0255). Overall, drug technology represents a viable option for patients with CLI; a cohort not represented in major randomized trials. In our experience, femoropopliteal lesions treated with DESs have higher primary patency rates than those treated with DCBs. This was found to support higher amputation-free survival rates in patients treated with paclitaxel DESs than those treated with paclitaxel DCB. The use of paclitaxel DESs for CLI was also associated with significantly improved wound healing compared with DCBs. Our data suggest improved outcomes with DESs compared with DCBs; however, these patients represent a nonrandomized, heterogenous group that were treated with the operator's best judgment.

Immediate results of conservative treatment of patients with unreconstructable critical limb ischaemia and trophic changes

The purpose of the study was to comparatively assess efficacy of using agents belonging to the group of prostaglandin E1 in comprehensive conservative treatment of patients with unreconstructable critical limb ischaemia and trophic changes by the frequency of major amputation, amputation-free survival, and total mortality by combinations of the WIfI classification during a 6-month follow up period. Our retrospective multicentre study enrolled a total of 109 patients, including 60 men and 49 women, with a mean age of 70±7.3 years. The patients were subdivided into 2 groups. Group 1 patients (n=58) received standard conservative therapy without prostaglandin E1 and group 2 patients (n=51) received similar treatment with the use of prostaglandin E1. The statistical analysis (chi-squared test, Fisher criterion, log-rank test) was carried out with regard to stratification of the patients in the groups by the WIfI component combinations. No statistically significant differences between the groups in the frequency of amputation and total mortality were revealed (p=0.094 and p=0.925, respectively). The use of the WIfI classification system made it possible to single out a cohort of patients (with a WIfI combination of 130) for whom the results of administering prostaglandin E1 statistically significantly differed by the frequency of amputation (p=0.042) and by amputation-free survival (p=0.017). No significant differences by these outcomes were obtained for other combinations analysed. A conclusion was drawn that using prostaglandin E1 in comprehensive conservative treatment decreased the frequency of amputation and increased amputation-free survival in patients presenting with unreconstructable critical limb ischaemia and referred to the category with a combination of 130 according to the WIfI classification.

Highlights From the Circulation Family of Journals.

Highlights From the Circulation Family of Journals.

Open or endovascular revascularization in the treatment of acute lower limb ischaemia

BackgroundConsensus is lacking regarding intervention for patients with acute lower limb ischaemia (ALI). The aim was to study amputation‐free survival in patients treated for ALI by either primary open or endovascular revascularization.MethodsThe Swedish Vascular Registry (Swedvasc) was combined with the Population Registry and National Patient Registry to determine follow‐up on mortality and amputation rates. Revascularization techniques were compared by propensity score matching 1 : 1.ResultsOf 9736 patients who underwent open surgery and 6493 who had endovascular treatment between 1994 and 2014, 3365 remained in each group after propensity score matching. Results are from the matched cohort only. Mean age of the patients was 74·7 years; 47·5 per cent were women and mean follow‐up was 4·3 years. At 30‐day follow‐up, the endovascular group had better patency (83·0 versus 78·6 per cent; P < 0·001). Amputation rates were similar at 30 days (7·0 per cent in the endovascular group versus 8·2 per cent in the open group; P = 0·113) and at 1 year (13·8 versus 14·8 per cent; P = 0·320). The mortality rate was lower after endovascular treatment, at 30 days (6·7 versus 11·1 per cent; P < 0·001) and after 1 year (20·2 versus 28·6 per cent; P < 0·001). Accordingly, endovascular treatment had better amputation‐free survival at 30 days (87·5 versus 82·1 per cent; P < 0·001) and 1 year (69·9 versus 61·1 per cent; P < 0·001). The number needed to treat to prevent one death within the first year was 12 with an endovascular compared with an open approach. Five years after surgery, endovascular treatment still had improved survival (HR 0·78, 99 per cent c.i. 0·70 to 0·86) but the difference between the treatment groups occurred mainly in the first year.ConclusionPrimary endovascular treatment for ALI appeared to reduce mortality compared with open surgery, without any difference in the risk of amputation.