Critical Leg Ischemia Research Articles

Neutrophil-to-Lymphocyte Ratio and Systemic Inflammation Index as Predictors of Poor Outcome in Patients with Critical Limb Ischemia Treated with Remote Endarterectomy

Abstract Introduction: Severe ischemia occurring in the lower limbs represents the advanced stage of peripheral artery disease (PAD). Atherosclerosis and inflammatory markers have been intensively studied to identify prognostic tools with a role in the evolution of patients with PAD. The aim of this study is to demonstrate the predictive value of systemic inflammatory markers such as the neutrophil-to-lymphocyte ratio (NLR) and the systemic inflammation index (SII) in the prognosis of patients diagnosed with critical leg ischemia (CLI) undergoing infrainguinal surgical revascularization with remote endarterectomy. Materials and methods: This retrospective study included all patients admitted to the Vascular Surgery Clinic of the County Emergency Clinical Hospital of Târgu Mureș, Romania between January 2018 and December 2021, who had critical limb ischemia Leriche-Fontaine stage III and were treated with endarterectomy. Patients were divided into two groups based on the presence or absence of patency in the lower limbs at 12 months. Results: There was a higher baseline value of neutrophil count (p <0.0001), platelet count (p = 0.006), NLR and SII value (p <0.0001), as well as a lower value of lymphocyte count (p = 0.001) in the group without patency at 12 months. The ROC curve analysis showed that the NLR and SII were associated with the risk of major amputation and primary patency failure at 12 months, while multivariate analysis has shown that arterial hypertension (OR 3.63, p = 0.04), history of myocardial infarction (OR 2.93, p = 0.009), diabetes mellitus (OR 2.20; p = 0.04) and smoking (OR 3.48, p <0.0001) were also predictors of primary patency failure. Conclusions: The results of this study demonstrated the predictive role of NLR and SII regarding poor outcomes among patients with CLI Leriche-Fontaine stage III undergoing infrainguinal surgical revascularization with remote endarterectomy.

Is it justified to search for cancer in patients with peripheral arterial disease?

Cancer is the leading cause of death in European countries, ahead of cardiovascular diseases. Cancer is also the most common co-morbidity among patients hospitalized for the management of cardiovascular diseases. Through an overview, we searched for the frequency and types of cancer associated with peripheral arterial disease (PAD) in order to address the relevance of cancer screening in patients with PAD. We searched in PubMed database from 1996 to 2020 for retrospective and prospective cohort or cross-sectional or randomized studies evaluating the frequency of all types of cancer in patients with PAD excluding patients with aneurysmal disease. The keywords used were: peripheral arterial disease, arterial thrombosis, acute leg ischemia, critical leg ischemia, chronic leg ischemia, intermittent claudication, malignant tumor, cancer. Based on published studies, the frequency of cancer in patients with PAD varied widely from 3.8 to 30.4% depending on study design, population, method used to screen for cancer and study period. In medical records database and registers,cancer prevalence varied from 3,8% to 22,4% in 4 retrospective studies of patients with acute limb ischemia and from 10.5 to 30.4% in 3 prospective studies of patients with acute limb ischemia, critical ischemia or intermittent claudication. In 3 retrospective analyses from 2 population-based cohorts and health insurance claims data, incidence of cancer in patients with intermittent claudication, acute limb ischemia or peripheral arterial disease varied from 8% to 11.7%. The frequency of cancer in PAD patients appeared higher than in the general population. Tobacco-dependent cancers seemed to be the most common cancers in PAD. Cancers were also more frequent in case of anemia, amputation and iterative bypass thrombosis in few studies. Although there is no recommendation for cancer screening in patients with PAD, the high prevalence of cancer raises the question of screening patients at high risk such as those with acute or critical limb ischemia and especially in case of severe tobacco use, anemia, amputation and iterative bypass thrombosis. These results call for further studies with larger sample size and long term follow-up.

Comparison of sympathectomy and cilostazol treatment results in non-revascularized critical leg ischemia

ABSTRACT
 Objective: The aim of this retrospective study is to compare the efficacy of sympathectomy and cilostazol therapy in critical limb ischemia that cannot be revascularized.
 Material and Method: This study was retrospectively conducted on 30 patients who underwent lumbar sympathectomy (Group 1) and received cilostazol treatment (Group 2) between January 2017 and August 2020. Demographic data, comorbidity, complications, wound healing, walking distance, and pain scale records of the patients were determined by examining the hospital registry system and statistical analysis was performed.
 Results: In the study, no significant difference was found between the two groups in terms of walking distance and ischemic pain in the statistical analysis of the data before treatment, at the 3rd, 6th, 12th, and 24th months (p> 0.05). However, a statistically significant difference was found between the pre-treatment data and the data at the 3rd, 6th, 12th, and 24th months in both Group 1 and Group 2 in terms of walking distance and ischemic pain (p˂0.001 ). In the time periods followed in both groups, it was observed that there was an increase in walking distance and a decrease in ischemic pain.
 Conclusion: Cilostazol treatment may be preferred as a good alternative treatment method compared to lumbar sympathectomy in critical leg ischemia.
 Keywords: Critical leg ischemia; sympathectomy; cilostazol

Tips and Tricks in Below-Knee Peripheral Artery Disease Interventions

Critical leg ischemia, which threatens lower extremity and life, is an important form of lower extremity peripheral artery disease. Below-knee peripheral artery disease is an important part of critical leg ischemia. The most important treatment of below-knee peripheral artery disease is endovascular treatment. Knowing the endovascular treatment techniques is very important in increasing the success of the procedure. For this reason, we have presented this mini review called tips and tricks in below-knee peripheral artery disease interventios.

DIGITAL ISCHEMIA: IS EPOPROSTENOL EFFECTIVE FOR CONNECTIVE TISSUE DISEASE-ASSOCIATED INTERSTITIAL LUNG DISEASE?

SESSION TITLE: Medical Student/Resident Diffuse Lung Disease SESSION TYPE: Med Student/Res Case Rep Postr PRESENTED ON: October 18-21, 2020 INTRODUCTION: Epoprostenol (EPO), a prostaglandin analog, has been used for connective tissue disease-associated pulmonary arterial hypertension (PAH) with significant improvement in clinical outcomes, however, the efficacy of prostaglandin analogs in treating digital ulcers associated with dermatomyositis and ILD has conflicting results. We present a patient with ischemic digits and cutaneous ulcerations associated with connective tissue disease and interstitial lung disease (CTD-ILD) that was successfully treated with EPO. CASE PRESENTATION: A 52 years old woman with a history of MDA-5 amyopathic dermatomyositis and CTD-ILD presented with worsening cutaneous skin ulcerations and severe pain in bilateral hands along with findings concerning for digital ischemia [Figure 1-3]. Her previous workup included a chest computed tomography revealing bilateral multiple patchy ground-glass opacities along with interstitial thickening and pulmonary function tests with restrictive lung physiology. During this hospital stay, she continued to develop worsening skin ulcerations (negative arterial dopplers) despite treatment with intravenous immunoglobulins, steroids, mycophenolate, sildenafil, topical nitroglycerin, and botulinum toxin injections. She was therefore, transferred to the intensive care unit for continuous EPO infusion as a last measure to prevent digital necrosis. She tolerated this treatment well with improvement in her pain and prevented digital necrosis. DISCUSSION: In this case, EPO was used to treat severe digital ischemia and pain as a last resort to avoid digital amputation. Prostacyclin analogs used commonly in the USA are EPO and treprostinil. EPO in addition to being a potent vasodilator also has anti-platelet effects, inhibits smooth muscle proliferation, and promotes remodeling response (1). Prostacyclin analogs have been shown to be beneficial for critical leg ischemia, with improvement in digital blood flow and preventing gangrene (1). These medications have an effect on both macro and microcirculation by inducing vasodilation, increasing intracellular cyclic AMP, and by preventing smooth muscle cell proliferation (2). There is limited objective data behind increased blood flow in the digits that correlate with wound healing, however, prostacyclin analogs can help with pain relief due to underlying systemic sclerosis. Currently, very limited data are available for the use of prostacyclin analogs in dermatomyositis associated cutaneous skin ulcerations and digital ischemia. CONCLUSIONS: EPO can potentially be used to prevent the worsening of digital ischemia and pain and associated complications in refractory cases of small vessel vasculitis secondary to dermatomyositis and other connective tissue diseases. Further research and clinical trials are needed to analyze the use of EPO and other prostacyclin analogs for the relief of vascular complications in CTD-ILD. Reference #1: Engel G, Rockson SG. Treprostinil for the treatment of severe digital necrosis in systemic sclerosis. Vasc Med. 2005;10(1):29-32. doi:10.1191/1358863x05vm579cr Reference #2: Rhee RL, Gabler NB, Praestgaard A, Merkel PA, Kawut SM. Adverse Events in Connective Tissue Disease-Associated Pulmonary Arterial Hypertension. Arthritis Rheumatol. 2015;67(9):2457-2465. doi:10.1002/art.39220Kawut, MD, MS Reference #3: Shah AA, Schiopu E, Chatterjee S, et al. The Recurrence of Digital Ulcers in Patients with Systemic Sclerosis after Discontinuation of Oral Treprostinil. J Rheumatol. 2016;43(9):1665-1671. doi:10.3899/jrheum.151437 DISCLOSURES: Advisory Committee Member relationship with GSK Please note: $5001 - $20000 Added 05/22/2020 by Antonio Anzueto, source=Web Response, value=Consulting fee Advisory Committee Member relationship with BI Please note: $1001 - $5000 Added 05/22/2020 by Antonio Anzueto, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Mylan Please note: $5001 - $20000 Added 05/22/2020 by Antonio Anzueto, source=Web Response, value=Consulting fee Advisory Committee Member relationship with AstraZeneca Please note: $1001 - $5000 Added 05/22/2020 by Antonio Anzueto, source=Web Response, value=Consulting fee No relevant relationships by Moeezullah Beg, source=Web Response No relevant relationships by Mahnoor Mir, source=Web Response

Double VEGF/HGF Gene Therapy in Critical Limb Ischemia Complicated by Diabetes Mellitus

Critical leg ischemia (CLI) complicated by diabetes mellitus (DM), which is a very common and dangerous disease, represents the ultimate stage of peripheral arterial disease. Patients are treated with antiplatelet drugs, statins and limb revascularization, but a significant number of patients are not candidate for revascularization. Literature shows that in such cases, gene therapy could be a perfect therapeutic option. The aim of our study was to evaluate efficacy of double vascular endothelial growth factor/hepatocyte growth factor (VEGF/HGF) gene therapy in patients with CLI complicated by DM. We observed that 90 days after administration, serum level of VEGF and ankle-brachial index increased significantly (p < 0.001) and rest pain decreased significantly compared with the control group (p < 0.002). Moreover considerable improvement in vascularization was observed in computed tomography angiography (P = 0.04). Based on the results of this study, we suggest that the therapy with pIRES/VEGF165/HGF bicistronic plasmid administration is a safe and effective method of treatment of patients with both CLI and DM.Graphical abstract

Regional oxygen saturation change rate for detection of leg ischemia in minimally invasive cardiac surgery.

The criteria for placement of distal perfusion cannulas vary among reports. This cohort study aimed to establish a reproducible method to monitor critical leg ischemia during minimally invasive cardiac surgery. We included 121 patients who underwent minimally invasive cardiac surgery via right thoracotomy with right femoral arterial cannulation from 2015 to 2018. The change rate of regional oxygen saturation (ΔrSO2) was calculated as follows: rSO2 (baseline) - rSO2 (actual number)/rSO2 (baseline). Patients were divided into Group N (ΔrSO2 < 40%): 100/121 (83%) and Group H (ΔrSO2 > 40%, <10 minutes if >40%): 21/121 (17%). A distal perfusion cannula was placed when ΔrSO2 was >40% over 10 minutes. No patients experienced significant leg ischemia. Significantly longer cardiopulmonary bypass and aortic cross-clamp times were observed in Group H than in Group N (cardiopulmonary bypass time, 129 ± 36 minutes (Group N) vs. 151 ± 34 minutes (Group H), p = 0.01). ΔrSO2 correlated positively with plasma creatine phosphokinase elevation (R = 0.40, p < 0.001) on postoperative day 1. Serum lactate on intensive care unit admission showed a significant positive correlation (R = 0.40, p < 0.001) with ΔrSO2. ΔrSO2 measurement by near-infrared spectroscopy can facilitate distal leg perfusion monitoring and assist surgeons in preventing critical leg ischemia during minimally invasive cardiac surgery.

The Effects of Spinal Cord Stimulators on End Organ Perfusion: A Literature Review.

Spinal cord stimulators (SCS) have been gaining momentum in the last decade as their role in the management of chronic pain has become more apparent. Our intention was to search, analyze and highlight the effects of spinal cord stimulators on end-organ perfusion. We also looked at vascular diseases of atherosclerotic and nonatherosclerotic nature by examining objective evidence of improved circulation, pain control, limb salvage, and quality of life. We paid specific attention to disease processes such as cerebral hypoperfusion, Chronic-Critical Limb Ischemia, Intractable Angina Pectoris (IAP), Raynaud’s syndrome and Thromboangiitis Obliterans.We performed a Medline database search for medical literature relevant to Spinal cord stimulators encompassing the years 1950 to 2019. Search terms included “Spinal cord stimulator,” plus one of the following search terms: vasculopathy, stroke, cerebral blood flow, angina pectoris, diabetic ulcers, chronic critical leg ischemia, thromboangiitis obliterans and peripheral vascular disease. We included both clinical and experimental human studies that investigated the effect of SCS’s on end-organ perfusion. We also investigated the pathophysiological mechanism of action of SCS’s on the vasculature. We found 497 articles of which 43 more relevant and impactful articles investigating the hemodynamic effects of SCS and its possible mechanism were selected. Animal studies were excluded from the literature review as they provided heterogeneity. In addition to reporting literature supporting the use of stimulators for currently FDA approved uses, we also actively looked for potential future uses. Spinal Cord stimulators showed improvement in cerebral blood flow, increased capillary recruitment, and better quality of life in many studies. Patients also had increased exercise capacity and a significant reduction in the use of narcotic drug use and daily anginal attacks in patients suffering from IAP.

Iloprost treatment on top of infrapopliteal angioplasty accelerates wound healing in critical leg ischemia

Objectives This study aimed to examine the efficacy of the concomitant use of infrapopliteal drug-eluting balloon angioplasty and a medical treatment (iloprost) in the treatment of critical leg ischemia. Methods Eighty-seven patients that underwent infrapopliteal drug-eluting balloon angioplasty for critical leg ischemia were included in this retrospective study. For analyses, patients were allocated into one of the two groups: 55 patients that underwent drug-eluting balloon angioplasty alone (drug-eluting balloon Group), and 32 patients that received intravenous iloprost for one week after drug-eluting balloon (DEB-I Group). Demographic, perioperative and follow-up clinical data were extracted retrospectively and analyzed. Results Duration of hospitalization was significantly longer in the DEB-I group (9.7 vs. 3.1 days, p &lt; 0.001); however, the two groups were similar in terms of other clinical outcomes including early postoperative mortality, and primary patency, wound healing, reintervention, mortality, and amputation rates at one year ( p &gt; 0.05 for all). Primary patency was similar across groups. Wound healing occurred earlier in the DEB-I group when compared to drug-eluting balloon group, in the subgroup of patients with ischemic wound at baseline. Mean time to wound healing was 3.0 ± 0.6 and 4.4 ± 0.6 months in DEB-I and drug-eluting balloon groups, respectively ( p = 0.037). Conclusions Iloprost add-on treatment in patients undergoing drug-eluting balloon angioplasty for critical limb ischemia seems to have additional benefits, at least in terms of accelerated wound healing. Further large prospective studies are warranted.

Treatment of Critical Limb Ischemia by pIRES/VEGF165/HGF Administration

Prognosis of peripheral artery disease (PAD), especially critical limb ischemia (CLI), is very poor despite the development of endovascular therapy and bypass surgery. Many patients result in having leg amputation. We decided to investigate the safety and efficacy of plasmid of internal ribosome entry site/vascular endothelial growth factor (VEGF) 165/hepatocyte growth factor (HGF) gene therapy (GT) in patients suffered from CLI. Administration of plasmid of internal ribosome entry site/VEGF165/HGF was performed in 12 limbs of 12 patients with rest pain and ischemic ulcers due to CLI. Plasmid was injected into the muscles of the ischemic limbs. The levels of VEGF in serum and the ankle-brachial index (ABI) were measured before and after treatment. Mean (±SD) plasma levels of VEGF increased nonsignificantly from 258±81 pg/L to 489±96 pg/L (P>0.05) 2weeks after therapy, and the ABI improved significantly from 0.27±0.20 to 0.50±0.22 (P<0.001) 3months after therapy. Ischemic ulcers healed in 9 limbs. Amputation was performed in 3 patients because of advanced necrosis and wound infection. However, the level of amputations was lowered below knee in these cases. Complications were limited to transient leg edema in 3 patients and fever in 2 patients. Intramuscular administration of plasmid of internal ribosome entry site/VEGF165/HGF is safe, feasible, and effective for patients with critical leg ischemia.

Trends of the treatment of Critical Limb Ischemia during the last two decades.

In this review 14 studies were identified reporting the treatment strategy in 4891 patients with Critical Limb Ischemia (CLI) with the aim to investigate if the strategy of treatment of the first episode of CLI has changed during the last 15-20 years. A computer research has been performed on PubMed and Scopus databases on November 2016. The used terms for the investigation about studies evaluating the strategy of treatment of CLI at the first-time presentation, have been "critical leg ischemia", "critical limb ischemia", "critical lower limb ischemia" along with the terms "placebo", "medical treatment" and/or "conservative" revascularisation, surgical revascularisation, endovascular revascularisation, hybrid revascularisation and primary amputation. Studies were included if they were either retrospective or prospective and reporting the rate of patients who underwent to any form of revascularization, conservative treatment and primary amputation. The one-year limb and life survival rates have been reported as major outcomes. The pooled rate of revascularization was 72.5% (95% CI 80-64.96) of which 54.5%, surgical, 38.3% endovascular and 7.1% hybrid. The bivariate regression of revascularisation procedures has been with not significant increase, from 68% in 1993 to 88% in 2015. The endovascular procedures have shown a significant increase of the trend, from 2% to more the 50% (p 0.007), while surgical and hybrid procedures have not. The pooled rate of conservative treatment was 18% (95% CI 11.6-24.5%) with a not significant increasing trend and primary amputation pooled rate was 8.7% (95% CI 12.0-5,4) with a significant decreasing trend (p 0.009). The one-year limb survival rate was 75,4% (95% CI 81.5-69.3%) and the life survival was 76%. (95% CI 85.4-66.1%) both with a not significant increasing trend. In conclusion, this review highlights how the treatment strategy of the first CLI manifestation has changed over the last 15-20 years. It has shown an increase of the rate of revascularization procedures, particularly for endovascular and a significant reduction of the rate of primary amputations. The rate of patients treated conservatively appears to be unchanged and maybe influencing the rate of limb and life survival, that have remained unchanged.

PP-158 - Femoro-Popliteal Bypass With Local Anesthetic Is Possible?: Case Reports

Peripheral arterial disease (PAH) due to atherosclerosis is seen in 30% of the population over 65 years of age. Acute arterial embolism in chronic PAH is one of the most common causes of emergency in this age group. We aimed to present two patients had critical leg ischemia who underwent femoro popliteal bypass with local anesthesia for emergency acute arterial embolism on chronic PAH.

External Validation and Evaluation of Reliability of the FARP2 Score to Predict Early Graft Failure after Infrainguinal Bypass

To evaluate the accuracy of the FARP2 (female gender [F], bypass after a previous angioplasty [A], Redo bypass [R], and Pedal bypass [P2]) scoring system in predicting early graft failure (EGF) after infrainguinal bypass surgery (IBS). Charts of patients who underwent IBS between January 2014 and January 2017 in 2 tertiary academic centers were evaluated retrospectively. In follow-ups, 1 week after operation, detailed physical examination was done, Doppler ultrasonography was performed 1 month after operation, and integrity of the graft was evaluated. Calculation of FARP2 score was performed by a single surgeon (M.S.) who was well informed regarding FARP2 scoring system. The FARP2 scoring system was evaluated as following: female gender 1 point, bypass after a previous angioplasty 1 point, redo bypass 1 point, and pedal bypass 2 points. Totally, 231 patients (180 men and 51 women) were enrolled in the study. The mean FARP2 score was 0.52±0.73. The graft occlusion occurred in 23 patients (10%). Presence of critical leg ischemia was lower in patients who faced early graft occlusion (P=0.002). On the other hand, Rutherford classification score was significantly higher in patients who did not face graft occlusion (4.1 vs. 3.4, P=0.007). Moreover, unsuccessful angioplasty history and history of previous surgery were more common in that group (P<0.001 and P<0.001, respectively). None of the patients faced acute pulse loss, numbness loss, or ulcerative lesion after unsuccessful angioplasty. The mean interval between unsuccessful angioplasty and bypass was 1±1.2days in our study, which may have a role to prevent undesirable clinical consequences. The FARP2 score was 1.5±1.2 and 0.4±0.6 in patients who faced graft occlusion and in patients without occlusion (P<0.001). Multivariate regression analysis identified that critical leg scheme, presence of unsuccessful angioplasty history, and history of previous bypass operation were found as a predictive factor for EGF (P=0.044, P<0.001, and P=0.003, respectively). Finally, our study demonstrated that patients with FARP2 score 3-4 have 2.88-fold increased graft occlusion risk when compared with patients with FARP2 score 1-2. Our study externally validates that the FARP2 scoring system is related with EGF after IBS. The FARP2 score may be an effective practice in prediction of EGF in patients with peripheral arterial bypass surgery.

Effect of Impulsive Compression Treatment on Postoperative Complications After Open Peripheral Vascular Revascularization (In Situ): Protocol for a Randomized Control Trial

BackgroundIn patients with critical leg ischemia (CLI), the standard operative choice is an in situ bypass to the lower extremity to improve the patients´ prognosis and quality of life. Postoperative complications after surgery occur in 18 % of the patients, prolonging hospitalization and convalescence. The main operative complication is edema. This can be prevented by early mobilization or stimulation of the natural venous pump in the leg.ObjectiveTo investigate whether compression therapy with foot pump reduces postoperative edema, facilitates wound healing of the operation wounds, promotes healing of ischemic ulcers, and shortens hospitalization, increasing and improving the patient’s subjective quality of life faster.MethodsThe protocol is designed as a randomized, unblinded prospective study with 50 patients in each group. Standard postoperative routines after bypass surgery, including short-stretch bandaging of the operated legs, are compared to supportive stimulation of the venous pump by an impulsive compression foot pump. The postoperative edema of the leg is measured 10 cm below the patella and 8 cm proximal to the medial malleolus. Measurements are performed preoperatively, 1 and 4 days postoperatively and at discharge.ResultsThe primary endpoint is reduction of leg edema by at least 50%. The secondary endpoint includes earlier mobilization in the pump group and decreased length of stay in hospital. Quality of life is evaluated through the European Health Related Quality of Life Questionnaire 5 Dimensions (EQ-5D) and Vascular Quality of Life Questionnaire-6 (VascuQol-6) questionnaires. The start of the study is February 1, 2018, and the end of the study is February 1, 2020. First results will be available April 2020.ConclusionsIn orthopedic surgery of the lower extremities, the use of foot pumps has shown a reduction of edema and thrombosis in risk patients. Although important positive effects may be expected after vein bypass surgery, no reports have yet investigated the use of the device in vascular-operated patients and no analysis or meta Cochrane reviews are available in this field.Trial RegistrationClinicalTrials.gov NCT03192982; https://clinicaltrials.gov/ct2/show/NCT03192982 (Archived by WebCite at http://www.webcitation.org/6xMZJ06dw)

A multicenter study of the impella device for mechanical support of the systemic circulation in pediatric and adolescent patients.

The objective was to review the use of Impella devices (Abiomed Inc, Danvers, MA) for temporary circulatory support in pediatric and adolescent patients (age ≤ 21 yrs). Options for minimally invasive circulatory support in children are limited, and published data are confined to case reports and small case series. This was a retrospective, multicenter review of Impella implants in pediatric and adolescent patients from 2009-15, using standardized data collection and INTERMACS definitions. A total of 39 implants were performed in 38 patients from 16 centers. Median age and weight were 16 yrs (4-21 yrs) and 62 kg (15-134 kg). The primary indication for implant was cardiogenic shock in 28 patients (72%). Cardiac allograft rejection, myocarditis, or cardiomyopathy were the underlying diagnosis in 23 patients (59%); 11 patients had congenital heart disease. The median duration of support was 45 hr (1-1224 hr). Indications for explant included ventricular recovery in 16 patients, transition to another device in 12, death in 5, and transplant in 1. Survival was 85% at 7 days and 68% at 30 days. Major adverse events occurred in 8 patients: hemolysis in 3, bleeding in 2, stroke in 1 (unclear if related to Impella), sepsis in 1, and critical leg ischemia in 1. An increase in aortic regurgitation was noted in three patients, with no evidence of valve injury. Temporary circulatory support with Impella devices is feasible in pediatric and adolescent patients, with acceptable risk profiles. More experience and follow up is needed to improve technical performance and patient selection. © 2017 Wiley Periodicals, Inc.

Peripheral Stent Thrombosis Leading to Acute Limb Ischemia and Major Amputation: Incidence and Risk Factors in the Aortoiliac and Femoropopliteal Arteries

PurposeTo report the real-world incidence and risk factors of stent thrombosis in the aortoiliac and femoropopliteal arteries in case of bare nitinol stent (BNS) or covered nitinol stent (CNS) placement from a single-centre retrospective audit.Materials and MethodsMedical records of consecutive patients treated with peripheral stent placement for claudication or critical limb ischemia were audited for definite stent thrombosis defined as imaging confirmed stent thrombosis that presented as acute limb-threatening ischemia. Cases were stratified between aortoiliac and femoropopliteal anatomy. Cox regression analysis was employed to adjust for baseline clinical and procedural confounders and identify predictors of stent thrombosis and major limb loss.Results256 patients (n = 277 limbs) were analysed over a 5-year period (2009–2014) including 117 aortoiliac stents (34 CNS; 12.8 ± 5.0 cm and 83 BNS; 7.8 ± 4.0 cm) and 160 femoropopliteal ones (60 CNS; 21.1 ± 11.0 cm and 100 BNS; 17.5 ± 11.9 cm). Median follow-up was 1 year. Overall stent thrombosis rate was 6.1% (17/277) after a median of 43 days (range 2–192 days) and affected almost exclusively the femoropopliteal segment (12/60 in the CNS cohort vs. 4/100 in the BNS; p = 0.001). Annualized stent thrombosis rates (per 100 person-years) were 12.5% in case of CNS and 1.4% in case of BNS (HR 6.3, 95% CI 2.4–17.9; p = 0.0002). Corresponding major amputations rates were 8.7 and 2.5%, respectively (HR 4.5, 95% CI 2.7–27.9; p = 0.0006). On multivariable analysis, critical leg ischemia and CNS placement were the only predictors of stent thrombosis. Diabetes, critical leg ischemia, femoropopliteal anatomy, long stents and CNS were independent predictors of major amputations.ConclusionsPlacement of long femoropopliteal covered nitinol stents is associated with an increased incidence of acute stent thrombosis and ensuing major amputation. Risks are significantly lower in the aortoiliac vessels and with use of bare nitinol stents.

Therapeutic Benefits and Adverse Effects of Combined Proangiogenic Gene Therapy in Mouse Critical Leg Ischemia

Critical leg ischemia (CLI) represents the ultimate stage of peripheral arterial disease. Despite current surgery advances, patients with CLI have limited therapeutic options. Therapeutic angiogenesis thus appears as a powerful approach, aiming to stimulate vessel formation by angiogenic molecules administration. In this context, combined gene therapy has been proved to be the most efficient. The present study aims to compare, in a preclinical mouse model, the therapeutic benefit of a combination of 2 angiogenic factors fibroblast growth factor 2 (FGF2) and Cyr61 using plasmid and viral vectors, able to generate short- or long-term transgene expression in the leg, respectively. Two therapeutic genes, FGF2 and Cyr61, were introduced into internal ribosome entry site-based expression vectors (FGFiCyr) allowing co-expression of the 2 transgenes. The proangiogenic plasmid pC-FGFiCyr was assessed by intramuscular administration followedby electrotransfer into ischemic legs. To generate long-term transgene expression, the FGFiCyr bicistronic cassette was introduced into an adenoassociated virus-derived vector(rAAV). The rAAV treatment was performed either before or immediately after surgery. Therapeutic effects were analyzed by laser Doppler imaging, clinical score, and angiography. The plasmid pC-FGFiCyr improved revascularization, reperfusion, and clinical score. Surprisingly, when AAV-FGFiCyr was injected 21 or 28days before surgery, the proangiogenic rAAV was drastically deleterious on all measured parameters. In contrast, when administrated shortly after surgery, AAV-FGFiCyr generated therapeutic benefits, with a significantly better clinical score than after treatment with the plasmid. Therapeutic effects of the angiogenic combination FGF2-Cyr61 is observed with short-term transgene expression, but the treatment is significantly more efficient when a long-term expression viral vector is used. However, the rAAV-FGFiCyr generated therapeutic benefit only when injected in an ischemic leg, whereas the same dose of rAAV exhibited deleterious effects when administrated to healthy animals. These data may contribute to the understanding of the moderate success of proangiogenic treatments in CLI gene therapy clinical assays.

OUTBACK catheter for treatment of superficial femoral and iliac artery chronic total occlusion: Experience from two centers.

Purpose:The OUTBACK® catheter is a reentry device that enables reentry into a vessel lumen from the subintimal space during subintimal angioplasty. It is reserved for cases where reentry has not been possible using conventional wire and catheter techniques. We report a two-center experience in recanalization of the chronic total occlusions of the common iliac (CIA) and the superficial femoral artery (SFA) using the OUTBACK® catheter in cases where other techniques were unsuccessful.Material and Methods:All cases where recanalization was performed using the OUTBACK® reentry catheter between January 2010 to January 2015 were retrospectively identified and included in this study. 21 patients were identified. The indication for intervention in these cases included claudication and critical leg ischemia. In all cases, conventional recanalization could not be successfully achieved.Results:The OUTBACK® catheter was used to recanalize 10 SFA occlusion and 9 CIA occlusions. In 19 patients (90%), reentry into true arterial lumen was successfully achieved. 17 patients had their recanalization through the transfemoral approach whereas 2 patients had a transpopliteal artery approach. In 2 patients, reentry into the true lumen could not be achieved using the OUTBACK® catheter due to patient's intolerability for the procedure and severe atherosclerotic calcified plaques. There was 100% patency of the vessel intervened on Duplex ultrasound at 24 months of follow up. 16 patients (84%) remained asymptomatic and 2 patients (10.5%) reported worsening of their symptoms due to the development of new lesions within the arterial system.Conclusion:The OUTBACK® catheter is an effective and safe technique for reentry into the vessel lumen when conventional techniques fail.

Society for Vascular Surgery Calls for Caution in PAD Care

Society for Vascular Surgery Calls for Caution in PAD Care

Sýnýrlý Distal Run-Off’a Sahip Kritik Bacak Ýskemisi Olan Hastalarda Ringli Politetrafloroetilen ile Desteklenen Safen Ven Greftinin Femoro-Femoral Bypass’da Kullanýmý

Sýnýrlý Distal Run-Off’a Sahip Kritik Bacak Ýskemisi Olan Hastalarda Ringli Politetrafloroetilen ile Desteklenen Safen Ven Greftinin Femoro-Femoral Bypass’da Kullanýmý