Increase In Ankle-brachial Index Research Articles

Outcomes of covered vs bare metal stents for the treatment of aortoiliac occlusive disease

ObjectiveWe retrospectively compared the clinical outcomes of self-expanding covered stents (CSs) and bare metal stents (BMSs) in the treatment of aortoiliac occlusive disease (AIOD) at a single center between 2016 and 2022. MethodsAll patients with AIOD receiving endovascular therapy at a single center from January 2016 to October 2022 were continuously analyzed, including patients with lesions of all classes according to the Trans-Atlantic Inter-Society Consensus II (TASC-II). Relevant clinical and baseline data were collected, and propensity score matching was performed to compare CSs and BMSs in terms of baseline characteristics, surgical factors, 30-day outcomes, 5-year primary patency, and limb salvage. The follow-up results were analyzed by Kaplan-Meier curves. Cox proportional hazard models were used to identify predictors of primary patency. ResultsA total of 209 patients with AIOD were enrolled in the study, including 135 patients (64.6%) in the CS group and 74 patients (35.4%) in the BMS group. Surgical success rates (100% vs 100%; P = 1.00), early (<30-day) mortality rates (0% vs 0%; P = 1.00), cumulative surgical complication rate (12.0% vs 8.0%; P = .891), 5-year primary patency rate (83.4% vs 86.9%; P = .330), secondary patency rate (96% vs 100%; P = .570), and limb salvage rate (100% vs 100%; P = 1.00) did not exhibit significant differences between the two groups. Patients in the CS group had a lower preoperative ankle-brachial index (0.48 ± 0.26 vs 0.52 ± 0.19; P = .032), more cases of complex AIOD (especially TASC D) (47.4% vs 9.5%; P < .001), more chronic total occlusive lesions (77.0% vs 31.1%; P < .001), and more severe calcification (20.7% vs 14.9%; P < .036). After propensity score matching, 50 patients (25 with CS and 25 with BMS) were selected. The results showed that only severe calcification (32.0% vs 8.0%; P = .034) and ankle-brachial index increase (0.45 ± 0.15 vs 0.41 ± 0.22; P = .038) were significantly different between the groups. In terms of surgical factors, patients in the CS group had more use of bilateral femoral or combined brachial artery percutaneous access (60.0% vs 12.0%; P < .001), more number of stents used (2.3 ± 1.2 vs 1.3 ± 0.7; P < .001), longer mean stent length (9.3 ± 3.3 vs 5.8 ± 2.6 cm; P < .001), and more catheter-directed thrombolysis treatment (32.0% vs 4.0%; P = .009). Multivariate Cox survival analysis showed that severe calcification (hazard ratio, 1.32; 95% confidence interval, 1.04-1.85; P = .048) was the only independent predictor of the primary patency rate. ConclusionsAll patients with AIOD who underwent endovascular therapy were included and achieved good outcomes with both CSs and BMSs. The influence of confounding factors in the two groups was minimized by propensity score matching, and the 5-year patency rates were generally similar in the unmatched and matched cohorts. Postoperative hemodynamic improvement was more obvious in patients in the CS group. For more complex lesions, CS is recommended to be preferred. Especially for severe calcification lesions, which is the only independent predictor of primary patency, CS showed obvious advantages. Further studies with more samples are needed to investigate the role of stent types in AIOD treatment.

The Vascular Quality Initiative assessment of the Bard Lifestent for the treatment of popliteal artery occlusive disease

ObjectiveThe Bard LifeStent self-expanding stent is approved for the treatment of occlusive disease involving the superficial femoral artery and proximal popliteal artery. We conducted a post-market trial of treatment of the popliteal artery above and below the knee (P1, P2, and P3 segments) within the Society for Vascular Surgery Vascular Quality Initiative (VQI) Peripheral Vascular Intervention registry. MethodsA single-arm, prospective trial was conducted at 29 VQI sites in the United States, enrolling 74 patients from November 2016 to May 2019. The primary safety outcome was freedom from major adverse events including device-/procedure-related mortality and major amputation at 1 year. The primary efficacy outcomes were freedom from target vessel revascularization and freedom from target lesion revascularization at 1 year. Secondary outcomes included lesion success; procedural success; primary, primary-assisted, and secondary patency; and sustained clinical (improvement in Rutherford class) and hemodynamic success (increase in ankle brachial index >0.10). Outcomes were assessed by Kaplan-Meier analysis. Arteriogram of patients undergoing target lesion revascularization were assessed for stent fracture by a core laboratory. ResultsThe mean age was 71 years, with 63.5% male and 55% with diabetes. The indication was claudication 28% and chronic limb-threatening ischemia in 72%. The superficial femoral artery-popliteal artery was stented in 38% and the popliteal artery alone in 62%. The majority of stents were placed in the P1 + P2 (39%) or P1 + P2 + P3 (37%) segments of the popliteal artery. The composite primary endpoint of freedom from major adverse events was 82% and 74% at 1 and 2 years, respectively. Freedom from mortality was 100% and 97%, and freedom from major amputation was 100% and 90% at 1 and 12 months, with all deaths and major amputations occurring in patients with chronic limb-threatening ischemia. freedom from target lesion revascularization was 86%, and freedom from target vessel revascularization was 84% at 12 months. At discharge, lesion treatment success was 99%, and procedural success was 82%. Primary patency was 80% and 72%, primary-assisted patency was 80% and 72%, and secondary patency was 89% and 82% at 12 and 24 months. Sustained clinical success was 98% and 95%, and sustained hemodynamic success was 100% and 79% at 12 and 24 months. ConclusionsIn this multi-center, registry-based, single-arm prospective study the Bard LifeStent self-expanding stent demonstrated favorable performance in the challenging anatomy of the P2 and P3 popliteal segment. Post-market studies for label expansion of peripheral vascular intervention devices can be successfully conducted within the Society for Vascular Surgery VQI registry.

The Efficacy of Nano-Silver Alginate Dressing Combined with Tibial Transverse Transport for Stage III–IV Diabetic Foot Treatment

To effectively treat severe diabetic foot (DF) and reduce amputation risk, we explored nano-silver alginate (Ag/Alg) dressings and tibial transverse transport (TTT) to improve circulation and suppress inflammatory responses in lower limbs. First, Ag/Alg dressings were biocompatible without affecting L-929 cell activity, and they had better hygroscopic properties when compared with conventional dressings. Ag/Alg dressing also markedly inhibited Gram+/Gram− bacterial activity. We also retrospectively analyzed clinical data from DF patients at our hospital and divided them into control and TTT groups according to treatment modality; the latter group was treated with TTT and Ag/Alg dressings as conventional therapy. We then compared cytokines, inflammatory responses, blood supply to the foot, and ulcer healing characteristics between pre- and post-treatments. TTT patients displayed significantly higher angiogenesis-related cytokine levels and more effective inflammation control after treatment when compared with patients receiving conventional therapy. Additionally, more significant increases in ankle-brachial index and skin temperature, and a greater decrease in the visual analog scale were observed in TTT patients. In terms of surface ulcer healing, TTT patients showed better healing, with healing times, amputation rates, and ulcer recurrence rates significantly reduced. Therefore, Ag/Alg dressings combined with TTT showed great potential for severe DF therapy.

СОВЕРШЕНСТВОВАНИЕ ТЕХНИКИ ВЫПОЛНЕНИЯ ШУНТИРУЮЩИХ ВМЕШАТЕЛЬСТВ НА БЕДРЕННОПОДКОЛЕННОМ СЕГМЕНТЕ У ПАЦИЕНТОВ С ХРОНИЧЕСКОЙ АРТЕРИАЛЬНОЙ НЕДОСТАТОЧНОСТЬЮ НИЖНИХ КОНЕЧНОСТЕЙ

Background: Despite the increasing number of X-ray endovascular operations on infrainguinal lesions of lower limb arteries open surgery remains highly relevant. The operating time of open surgeries cannot be considered satisfactory, especially when combined shunts are used in the infrainguinal position. Research objective is to improve the results of shunt operations at atherosclerotic lesions of the femoropopliteal segment by advancing the technique of determining the required extent and applying the autotransplant material. Material and methods. 72 patients were involved in the research. All the patients underwent the femoropopliteal shunt procedure. The instruments designed by us (autovenous shunt length meter and the device for tunnel formation and for applying the shunt into the tissues) were used in the first group. Patients from the second group were operated on with the use of the classical technique and equipment. Results. No combined shunts were used in the first group of patients in comparison with the second group (n=5). Statistically significant results (p&lt;0.05) between the studied groups were obtained according to such criteria as number of cases of intraoperative shunt torsion (p=0.0171), length of unused autograft material (p=0.0001), ankle brachial index increase (p=0.024), the number of early postoperative complications (p=0.028), the number of shunt dysfunctions (p=0.0203) and shunt functioning duration (p=0.013). Conclusions. The use of the patented instruments when performing femoropopliteal shunting allows to determine precisely the required amount of autotransplanted material and to provide its more convenient applying in the subcutaneous tunnel. The use of the patented instruments when performing femoropopliteal shunting with a reversed autovein made it possible to improve the technique of this revascularization operation: to accurately determine the required amount of autograft material which excluded the presence of patients with combined shunt in the first group, as well as to perform the simultaneous creation of a tunnel in the soft tissues of the thigh, shin and reliable shunt placement, excluding it’s rotation along the axis. The use of the patented instruments when performing femoropopliteal shunting allowed to get positive results in the first group, in comparison with second group of patients both in the early and late postoperative periods.

Gene therapy for diabetic foot ulcers: Interim analysis of a randomised, placebo-controlled phase 3 study of VM202 (ENGENSIS), a plasmid DNA expressing two isoforms of human hepatocyte growth factor.

To evaluate the status of a 7-month phase 3 study conducted to test the effect of intramuscular injections of VM202 (ENGENSIS), a plasmid DNA encoding human hepatocyte growth factor, into the calf muscles of chronic nonhealing diabetic foot ulcers with concomitant peripheral artery disease. The phase 3 study, originally aimed to recruit 300 subjects, was discontinued because of slow patient recruitment. An unprespecified interim analysis was performed for the 44 subjects enrolled to assess the status and determine the future direction. Statistical analyses were carried out for the Intent-to-Treat (ITT) population and separately for subjects with neuroischemic ulcers, using a t-test and Fisher's exact test. A logistic regression analysis was also conducted. VM202 was safe and potentially should have benefits. In the ITT population (N = 44), there was a positive trend toward closure in the VM202 group from 3 to 6 months but with no statistical significance. Levels of ulcer volume or area were found to be highly skewed between the placebo and VM202 groups. Forty subjects, excluding four outliers in both arms, showed significant wound-closing effects at month 6 (P = .0457). In 23 patients with neuroischemic ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4, and 5 (P = .0391, .0391, and .0361). When two outliers were excluded, a significant difference was evident in months 3, 4, 5, and 6 (P = .03 for all points). A potentially clinically meaningful 0.15 increase in Ankle-Brachial Index was observed in the VM202 group at day 210 in the ITT population (P = .0776). Intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in the treatment of chronic neuroischemic diabetic foot ulcers (DFUs). Given the safety profile and potential healing effects, continuing a larger DFU study is warranted with modifications of the current protocol and expansion of enrolling sites.

Prediction of the infrainguinal revascularizing surgery outcomes in patients with diseases of the lower limb arteries

The progressive course of lower extremity arterial disease (LEAD) inevitably leads to the development of intermittent claudication, critical ischemia, and gangrene. If a patient shows signs of critical ischemia and trophic disorders, he should undergo revascularization surgery. The development of reocclusion may be observed in the early period following the surgery. The aim of the work was to develop and validate a prognostic model of the results of revascularizing surgeries below the inguinal ligament. The study involved 133 patients with chronic arterial insufficiency of stages II B, III and IV according to Fontaine-Pokrovsky classification. 92 patients underwent open surgeries and 41 underwent endovascular surgeries. To build a prognostic model, 244 criteria were analyzed. The final model was built on the basis of such criteria as surgery type, levels of total cholesterol, homocysteine, cysteinylglycine, ankle brachial index increase, and diameter of the common femoral artery. This prognostic model has the following characteristics: Se = 85.71%, Sp = 82.56%, Acc = 83.33%

A Novel Angiography Scoring System Predicts Improvement After Isolated Common Femoral Endarterectomy With Profundaplasty

Numerous angiography-based peripheral arterial disease classification schemes have been developed to stratify severity of preoperative patient disease, but few studies have correlated angiography-based anatomic classification schemes to postoperative outcomes. This study examined whether a proposed pre-operative angiography scoring system was predictive of outcomes after isolated common femoral endarterectomy with profundaplasty (CFEP). A retrospective review was conducted of patients treated with isolated CFEP for claudication and/or rest pain at a single institution from 2016-19. Pre-operative angiograms were assessed quantitatively by 4 blinded surgeons across 3 domains: profunda stenosis, profunda disease length, and outflow disease severity. Table I describes the proposed angiography scoring system. Internal consistency reliability of rater scores was calculated using Cronbach alpha. Outcomes included clinical improvement, further interventions, major amputations, mortality, and mean increase in ankle-brachial index (ABI) at 30 days, and 6 months. McNemar tests, between-group t-tests, Pearson correlations, and linear regression were used. Clinical Outcomes 88% of patients (n=22) had clinical improvement at 30 days; the remaining 12% of patients (n=3) required further interventions. One patient (4%) required major amputation between 30 days and 6 months for recurrence of rest pain that had initially resolved after isolated CFEP. There was 0% mortality during the study period. Mean ABI increased by 0.15 ± 0.21 at 30 days, and by 0.06 ± 0.21 at 6 months. Angiography Scoring System Profunda stenosis score was associated with clinical improvement at 6 months (P = 0.04). A profunda stenosis score of ≥2.6 was strongly associated with 6-month clinical improvement (64% of those ≥ 2.6 improved, versus 15% of those <2.6, P = 0.15). Profunda stenosis score was associated with ABI improvement at 30 days (r=0.73, P = 0.01) and 6 months (r=0.82, P = 0.007). Profunda disease length score was associated with clinical improvement at 30 days (P = 0.002). 100% of patients with a profunda disease length score of ≥1.5 clinically improved at 30 days, versus 67% of those with <1.5 (P = 0.04). Angiography scores were not found to be associated with further intervention, major amputation, or mortality. Cronbach alpha for profunda stenosis, profunda disease length, and outflow severity scores were 0.90, 0.90, and 0.79, respectively, indicating strong internal consistency. This institutional angiography scoring system successfully predicts clinical improvement following CFEP. Higher profunda stenosis and profunda disease length scores were most predictive of operative success within 6 months.Future validation studies will investigate these outcomes in a larger population, and over a longer period.

Nutritional status and outcomes of superficial femoral artery stenting due to intermittent claudication

The pathogenesis of in-stent restenosis is still not clear. The aim of this study was to determine the nutritional status of patients with lower limb ischemia and the risk of target lesion revascularization (TLR) after superficial femoral artery (SFA) stenting. Numerous parameters of nutritional status assessment were compared between 70 patients undergoing SFA endovascular intervention with a self-expandable plane stent due to life-limiting intermittent claudication and 40 patients undergoing carotid artery stenting (CAS). All subjects were followed up for at least 1 year in relation to outcomes such as clinically driven TLR occurrence. Patients undergoing SFA stenting had a lower prevalence of overweight and obesity than those who underwent CAS (51.43% vs. 72.50%; P=0.031). An increase in Ankle-Brachial Index of >0.15 after SFA stenting (early end-point) was positively associated with greater handgrip strength (HGS), fat-free mass, skeletal muscle mass and waist-to-hip ratio. Freedom from TLR (late end-point) was significantly related to a higher waist-to-height ratio (WHtR), HGS and Geriatric Nutritional Risk Index (GNRI) Score. The 1-year risk of TLR for patients with a WHtR of ≥61.39 amounted to odds ratio; 95% confidence interval: 0.21; 0.05-0.25; P=0.021. Parameters of nutritional status assessment were associated with early and late outcomes of SFA stenting in patients with intermittent claudication. Abdominal fat distribution and higher HGS and GNRI scores lowered the 1-year risk of TLR. Further study is needed to determine the pathomechanism of the obesity paradox, sarcopenia and undernutrition in relation to outcomes of endovascular interventions.

A2102 Association between high normal ankle-brachial index and incident hypertension

Objectives: We hypothesized that the increase in ankle-brachial index (ABI) with age occurs as a result of increasing arterial stiffness and wave reflection. The aim of this study is to investigate the relationship between ABI and incident hypertension in a screened cohort. Methods: We analyzed the data of 1344 participants without hypertension at baseline who underwent ABI measurement by an automatic oscillometric method at least twice with an interval of over a period of 36 months at health checkup, the baseline measurement in 2008–2010 and the second one in 2011–2015. Participants with ABI ≤0.9 (n = 3) and ABI ≥1.4 (n = 1) were excluded. Hypertension was defined as systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg in the supine position and/or use of antihypertensive medications. Results: Mean age of participants was 51 ± 10 yeas, with a range of 19–80 years, and 55% were women. ABI was lowest in participants aged less than 40 years, and increased with age in both sexes. At the second visit (median 47 months follow-up period), 224 (17%) participants developed hypertension. Baseline ABI was positively correlated with the rates of change in brachial systolic pressure and incident hypertension. Compared with participants with the lowest quartile of baseline ABI, the adjusted odds ratio for incident hypertension was higher in participants with the highest quartile of baseline ABI before and after multivariate adjustment for age, sex, baseline systolic pressure, heart rate, brachial-ankle pulse wave velocity (baPWV), BMI, prevalence of diabetes, dyslipidemia, and low eGFR (<60 ml/min/1.73m2) (odds ratio 2.1, 95% confidence interval 1.19 to 3.61, P = 0.010). Conclusion: Baseline ABI was positively and independently associated with the rate of SBP change and incident hypertension.

Early versus late thrombolysis in acute arterial occlusion of lower extremity

BackgroundAcute arterial occlusion in lower extremity is an urgent condition which occurs when there is an abrupt interruption of blood flow into an extremity. Reperfusion through early intervention can increase limb salvage and decrease mortality. There was no common agreement when is the best to start thrombolysis in treating acute arterial occlusion. This study was designed to study the efficacy of an early thrombolysis compared with a late thrombolysis. MethodWe identified all patients discharged from the Gwangju Veterans hospital with a diagnosis of acute arterial occlusion between 2006 and 2014. 72 patients were eligible, and every patient had treated with catheter-directed thrombolysis on the day or 1day after admission. Among them, 42 patients had undergone an early thrombolysis (less than 7days after the onset of symptoms) and the other 30 patients had undergone a late thrombolysis (more than 7days after the onset of symptoms). The primary outcome was amputation rate at 6months. The secondary outcomes were all cause mortality at 6months and increase of ankle brachial index (ABI). ResultsAmputation rate at 180days in the early thrombolysis group was 7.1% as compared with 30% in the late thrombolysis group. All cause mortality at 6months and increase of ABI were not different between two groups. In multivariable Cox-regression analysis, late thrombolysis was independent predictor of amputation at 6months. ConclusionEarly thrombolysis was superior in preventing amputation than late thrombolysis.

The Mid-Term Clinical Follow-Up Using Drug-Eluting Balloons on Tibial Artery "De Novo" Lesions in Patients With Critical Limb Ischemia: A Cohort Study.

Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has been the rationale for the clinical applications of drug-eluting stents and drug-eluting balloons (DEBs). The purpose of this study was to evaluate the clinical and instrumental efficacy of DEBs versus simple percutaneous transluminal angioplasty (PTA) in patients affected by chronic limb ischemia (CLI) with tibial artery "de novo" lesions. A retrospective analysis was performed and included all consecutive patients who underwent endovascular treatment for CLI in our centers between January 2011 and March 2013. Inclusion criteria were (1) "de novo" tibial artery stenosis and (2) Rutherford class >4. Lesions were further divided by TransAtlantic Inter-Societal Consensus (TASC) classification into groups A, B, C, and D. Between January 2010 and March 2013, a total of 138 patients underwent simple PTA or DEB for CLI, and the groups were clinically and demographically homogenous. We decided to use DEBs in 70 cases. An improvement in the Rutherford Scale in cumulative and single TASC lesions classification was better in the DEB group (74% vs 51%; P = .024) at 24 months than in the PTA group. In the DEB group, the increase in ankle-brachial index was significantly higher than in the PTA group (P = .039). Our experience in addition to the existing literature supports the use of DEB in patients with CLI Rutherford class >3.

The Effect of Prostaglandin Therapy on Ankle Brachial Index in Non- Reconstructable Symptomatic Peripheral Artery Disease Patients- Retrospective Analysis

Background: Prostaglandin E1 has been reported to benefit patients with significant peripheral vascular disease and limb threatening ischemia. The present retrospective study attempts to assess the effect of Prostaglandin E1 on ankle brachial index in non reconstructable symptomatic peripheral artery disease patients. Objectives: To study the effect of Prostaglandin E1 on ankle brachial index in non reconstructable symptomatic peripheral artery disease patients. Methods: Case records of 40 patients who had completed at least six cycles of injection were obtained from medical records of vascular surgery. The demographic data and the ankle brachial index of these patients were recorded at baseline and at the end of six cycles of the drug. Results: The average ABI of both the limbs changed significantly from baseline to the end of study after six cycles of Prostaglandin E1 injection (p<0.05). There was significant increase in Ankle brachial index for the symptomatic limb from baseline whereas the contra lateral limb did not show a significant change. There was a significant increase in Ankle brachial index of both limbs as well as the average Ankle brachial index in the patients without any co-morbidities conditions than those with the presence of co-morbidities. Conclusion: Prostaglandin E1 therapy increases the ankle brachial index in symptomatic limb of patients with non reconstructable symptomatic peripheral artery disease patients.

Ultrasound-Accelerated versus Standard Catheter-Directed Thrombolysis in 102 Patients with Acute and Subacute Limb Ischemia

PurposeTo compare the safety and efficacy of ultrasound-accelerated thrombolysis (UAT) and standard catheter-directed thrombolysis (CDT) in patients with acute and subacute limb ischemia. Materials and MethodsMedical records of all patients treated with thrombolysis for acute and subacute limb ischemia between August 2005 and January 2012 were reviewed. Coprimary (increase in ankle-brachial index, degree of lysis) and secondary endpoints (technical success, distal embolization, bleeding complications, need for additional interventions) were assessed. UAT was performed in 75 patients, and CDT was performed in 27 patients. Patients’ baseline demographic and clinical parameters and procedure details, including lytic drug infusion rate (P = .704 and P = .987), total infusion time (P = .787 and P = .377), and use of adjunctive procedures (P = .457), did not differ significantly between the two groups. ResultsComplete lysis was achieved in 72.0% (UAT) and 63.0% (CDT) of patients (P = .542); hemodynamic success was achieved in 91.8% (UAT) and 92.3% (CDT) (P = .956). Overall major and minor bleeding complications were observed in 6.9% (UAT) and 3.9% (CDT) of patients. Major (P = .075) and minor (P = .276) bleeding independently did not differ between UAT and CDT. Major and minor bleeding combined was lower: 6.7% (UAT) versus 22.2% (CDT) (P = .025). Overall target vessel patency after 8.0 months (range, 1.5–20.5 mo) was 73.5%; target vessel patency for UAT was 75.9% versus 64.3% for CDT (P = .379). Median long-term survival was not significantly different between UAT and CDT: 3.6 years (range, 2.42–5.33 y) versus 1.8 years (range, 1.33–4.92 y) (P = .061). ConclusionsBoth UAT and CDT are safe and efficient treatment modalities for patients with acute and subacute limb ischemia. The observed lower risk of total bleeding for UAT versus CDT may warrant prospective comparative trials.

The Effect of Iloprost on Renal Function in Patients with Critical Limb Ischemia

BackgroundIloprost, which has efficacy in the microvascular space, is shown to have beneficial effects on the kidney, which has an extensive microvascular network. ObjectiveWe aimed to evaluate the effect of iloprost treatment on kidney functions in patients with critical limb ischemia. MethodsForty-eight patients with critical limb ischemia who were not suitable for revascularization and who were treated with iloprost were evaluated prospectively in our clinic between September 2010 and December 2012. The patients were divided into 2 groups as patients with chronic renal dysfunction (Group I) and patients with normal renal function (Group II). Urine albumin:creatinine ratio and glomerular filtration rate (GFR) calculated using serum creatinine and serum cystatin C (GFRcyc) were used to establish the presence of renal dysfunction. The decrease analgesic requirement, walking distance, reduction in ulcer diameter, the increase in ankle-brachial index, and changes in The Society of Vascular Surgery/International Society of Cardiovascular Surgery criteria were used in the evaluation of treatment response. ResultsOpioid analgesic requirement and decubitus pain disappeared after treatment in 58.3% (n = 28) of subjects. Walking distance increased in 66.6% (n = 32). Iloprost treatment significantly increased ankle-brachial index (P < 0.01). In Group I the levels of serum urea, creatinine, and cystatin C significantly decreased (P < 0.05), whereas GFRcyc and GFR calculated using the equation of the Chronic Kidney Disease Epidemiology Collaboration (ie, GFR expressed for specified race, sex, and serum creatinine in milligrams per deciliter) was increased significantly compared with pretreatment levels (P < 0.05). No significant change was observed in urine albumin:creatinine ratio (P > 0.05). ConclusionsThe use of iloprost in critical limb ischemia can slow down the progress of early stage renal damage. GFRcyc and cystatin C, which are indicators of early stage chronic renal dysfunction, can be used for the evaluation of treatment response.

Change of ankle-brachial index and progression of atherosclerosis

Change of ankle-brachial index and progression of atherosclerosis

PS110. Catheter-Directed Thrombolysis as First Line Treatment of Acute Nontraumatic Upper Extremity Ischemia

Methods: Peer-reviewed published studies on open and endovascular treatment for AIOD since 1989 were identified in PubMed, Medline, and EBSCOHost. Reports were thoroughly analyzed, and those not meeting the pre-defined inclusion criteria were excluded. Results: Thirty-seven open studies with 6,618 patients and 31 endovascular studies with 1,932 patients were included in our analysis. Mean age was 60.7 years for open and 60.5 years for endovascular patients. More patients presented with critical limb ischemia in the open group (35.5% vs. 23.6%, Odds Ratio [OR]: 1.8, p 0.001) than with claudication (65.6% vs. 76.2%, OR: 0.6, p 0.001). Mean overall follow-up time in months was greater in the open than endovascular group (42.2 vs. 26.2, p 0.001). Poor preoperative runoff was greater in the open group (47.1% vs. 25.0%, OR: 2.8, p 0.001). No differences in length of hospital stay (LOS) or increase in ankle-brachial index were detected. The open group experienced more systemic (9.5% vs. 3.5%, OR: 2.9, p 0.001) than local complications (4.6% vs. 13.3%, OR: 0.3, p 0.001). Mortality was greater in the open group (2.6% vs. 0.5%, OR: 5.3, p 0.001), and secondary procedures were required less frequently (4.1% vs. 8.5%, OR: 0.5, p 0.001). Primary patency rates at 1, 3, and 5 years were greater in the open group (94.8% vs. 85.7%, OR: 3.0, p 0.001; 87.7% vs. 78.9%, OR: 1.6, p 0.001; 86.2% vs. 69.5%, OR: 2.4, p 0.001, respectively). Conclusions: To our knowledge, this is the first systematic review comparing open and endovascular treatment options for AIOD. These results demonstrate superior durability and equivalent LOS for open treatment with an increased risk for systemic complications and mortality when compared to the endovascular approach. Further clinical studies are necessary to better characterize these two treatment options.

Phase I/IIa Clinical Trial of Therapeutic Angiogenesis Using Hepatocyte Growth Factor Gene Transfer to Treat Critical Limb Ischemia

To evaluate the safety and feasibility of intramuscular gene transfer using naked plasmid DNA-encoding hepatocyte growth factor (HGF) and to assess its potential therapeutic benefit in patients with critical limb ischemia. Gene transfer was performed in 22 patients with critical limb ischemia by intramuscular injection of HGF plasmid, either 2 or 4 mg, 2 times. Safety, ankle-brachial index, resting pain on a 10-cm visual analog scale, wound healing, and walking distance were evaluated before treatment and at 2 months after injection. No serious adverse event caused by gene transfer was detected over a follow-up of 6 months. Of particular importance, no peripheral edema, in contrast to that seen after treatment with vascular endothelial growth factor, was observed. In addition, the systemic HGF protein level did not increase during the study. At 2 months after gene transfer, the mean ± SD ankle-brachial index increased from 0.46 ± 0.08 to 0.59 ± 0.13 (P<0.001), the mean ± SD size of the largest ischemic ulcers decreased from 3.08 ± 1.54 to 2.32 ± 1.88 cm (P=0.007), and the mean ± SD visual analog scale score decreased from 5.92 ± 1.67 to 3.04 ± 2.50 cm (P=0.001). An increase in ankle-brachial index by >0.1, a reduction in ulcer size by >25%, and a reduction in visual analog scale score by >2 cm at 2 months after gene transfer were observed in 11 (64.7%) of 17 limbs, 18 (72%) of 25 ulcers, and 8 (61.5%) of 13 limbs, respectively. Intramuscular injection of naked HGF plasmid is safe and feasible and can achieve successful improvement of ischemic limbs as sole therapy.

Common femoral artery occlusive disease: Contemporary results following surgical endarterectomy

Proliferation of endovascular techniques with perceived reduction in treatment morbidity repetitively question the precept that surgical endarterectomy is the preferred treatment for occlusive disease of the common femoral artery (CFA). This study details a contemporary experience with common femoral endarterectomy (CFE) with and without concomitantly performed endovascular therapies. Technical, hemodynamic, and clinical success of CFE performed between 2002 and 2005 were determined according to the Society of Vascular Surgery reporting standards. Primary and assisted patencies of the CFA segment, freedom from reintervention in the ipsilateral limb, and survival were assessed using Kaplan-Meier life-table analysis. Multivariate analysis was performed to evaluate factors associated with patency and survival. CFE was performed on 65 limbs in 58 patients (mean age 71 +/- 10; male 77%; diabetes 28%; creatinine >/= 1.5 mg/dL 19%). Forty-four cases (68%) were performed for claudication, and 21 cases (32%) for critical limb ischemia. Thirty-seven cases (57%) were performed as a hybrid procedure wherein concomitant endovascular interventions were performed. Twenty iliac (TASC II A-30%; B-35%; C-20%; D-15%) and 25 femoropopliteal (TASC II A-24%; B-60%; C-12%; D-4%) lesions were treated. Technical success was achieved in 100% of the cases. Hemodynamic success was achieved in 95% of the cases with mean postoperative increase in ankle-brachial index (ABI) of 0.24 +/- 0.24. All but one patient (98.5%) had improvement in symptoms and/or ABI. Average hospital stay was 3.2 days (range 1-12 days). There were 3 (5%) major complications requiring reintervention (early failure secondary to untreated inflow lesion, hematoma, and wound infection), six (9%) minor complications which were treated conservatively (five wound infections, one lymph leak), and no perioperative mortality. With a mean follow-up period of 27 months (range 1-58 months), 1- and 5-year primary patencies were 93% and 91%, respectively. Assisted patency was 100% at both time points. There was no difference in patencies between CFE performed alone or as a hybrid procedure. Multivariate analysis showed congestive heart failure (CHF) as the only predictor of primary failure (odds ratio [OR] 18.5 [2.6-142.9]; P = .004). Freedom from reintervention in the ipsilateral limb was 82% at 1 year and 78% at 5 years, with CHF again as the only predictor of reintervention (OR 5.3 [1.4-19.6]; P =.012). Survival was 89% at 1 year and 70% at 5 years. There were no amputations. These data suggest CFE should remain the standard of care for occlusive disease of the CFA. Its safety and efficacy establish a standard for comparison with emerging endovascular therapies.

Incidence and clinical significance of distal embolization during percutaneous interventions involving the superficial femoral artery

Distal embolization of plaque or thrombus may cause organ ischemia following percutaneous peripheral interventions. The purpose of this study was to evaluate the incidence and clinical significance of particulate embolization during percutaneous superficial femoral artery (SFA) intervention by monitoring with continuous Doppler ultrasound. The rate and timing of embolization at various phases of intervention such as guidewire crossing, balloon angioplasty, stent deployment, and directional atherectomy were analyzed and compared. Sixty patients underwent SFA intervention. Of these 60 patients, 10 patients underwent percutaneous transluminal angioplasty (PTA) alone, 40 patients underwent PTA with stenting, and 10 patients underwent plaque excision with the SilverHawk atherectomy device (8) or Spectranetics excimer laser (2) with or without additional PTA or stent placement. A 4-MHz Doppler probe was used for continuous monitoring in the ipsilateral popliteal artery. Distal embolization was registered as embolic signals (ES). ES were quantitatively assessed during critical portions of the procedure including guidewire crossing, balloon angioplasty, stent deployment and/or atherectomy. ES during different phases of intervention were compared using analysis of variance (ANOVA). ES was noted in every patient during wire crossing, angioplasty, stent deployment and atherectomy. The average number of ES noted during guidewire crossing was 8, PTA was 12, stent deployment was 28, SiverHawk atherectomy was 49, and Spectranetics excimer laser was 51. The frequency of ES was statistically higher during stent deployment vs wire crossing or balloon angioplasty but equivalent to that generated by plaque excision. ES was observed more frequent during balloon angioplasty than during wire crossing. In one patient who was treated with the excimer laser, a single runoff vessel was occluded with embolic debris but patency was restored angiographically after thrombolysis. The patient went on to require below knee amputation. During follow-up, all patients with claudication reported improved symptoms and those with ulcers or gangrene demonstrated healing. The average increase in ankle-brachial index following intervention was 0.31. While ES were recorded at each step of SFA intervention, the frequency was greatest during stent deployment. Despite the frequency of these events, only one patient developed angiographically and clinically significant embolization. Thus, our findings do not support the routine use of protection devices during percutaneous SFA intervention.

Abstract 678: Administration of Intravenous High Density Lipoprotein Leads to Acute Changes in Human Atherosclerotic Plaque In Vivo

Introduction High density lipoprotein (HDL) is an inverse predictor of cardiovascular events. Recent studies have shown a reduction in plaque volume and change in plaque ultrasound characteristics after 4 infusions of reconstituted HDL (r HDL CSL-111) given weekly over 1 month. Whether rHDL infusion leads to acute changes in plaque composition in vivo is not known. Methods Patients with symptom limiting claudication planned for percutaneous superficial femoral artery (sfa) revascularisation were randomised in a double blind manner to either placebo or IV r HDL (80mg/Kg given over 4 hrs). Prior to the treatment bloods were taken for measurement of lipid levels and inflammatory markers. 5–7 days following the infusion patients returned, repeat bloods were taken for lipids and inflammatory markers and revascularisation was performed including atherectomy (Foxhollow CA) to excise plaque from the sfa. Results 10 patients (9 male) average age 65 ± 10 yrs (mean ± sd) were recruited. 7 had a history of documented coronary artery disease and all patients were on aspirin and 8 on statins. 6 of the patients received r HDL and 4 placebo. There was a significant increase in Ankle brachial index in both groups after atherectomy (0.57 ± 0.22 to 0.92 ± 0.12 (p &lt; 0.01) in HDL gp, 0.58 ± 0.1 to 0.93 ± 0.05 (p &lt; 0.01) in placebo gp.) There were no significant differences in LDL, HDL or CRP after the infusion in either group. In the SFA plaque there was significantly less Vascular Cell Adhesion Molecule 1(VCAM1) staining (23 ± 8.7% vs 41.8 ± 2.7% p &lt; 0.05) and evidence of oxygen free radicals (31.5 ± 12.0 vs 90.3 ± 24.3 p &lt; 0.05 (arbitrary units)) in the HDL treated subjects compared to placebo. The amount of lipid in the plaque tended to be lower in the HDL group. Conclusion Intravenous infusion of 1 dose of reconstituted HDL leads to acute changes in plaque with a reduction in measures of inflammation and oxidised free radicals in subjects with peripheral vascular disease. These changes may explain the presumed cardioprotective effects of HDL.