Awareness of smoking cessation amongst German vascular surgeons.

Background: Smoking represents the well-known enemy of vascular well-being. Numerous previous studies emphasised the important role of smoking on the development and progression of atherosclerotic cardiovascular disease. The current study aimed to identify hurdles and barriers for an insufficient implementation of secondary prevention in the treatment of lower extremity peripheral arterial disease (PAD). Methods: All members of the German Society for Vascular Surgery and Vascular Medicine (DGG) with valid email addresses were invited to participate in an electronic survey on smoking. Results are descriptively presented. Results: Amongst 2716 invited participants, 327 (12%) submitted complete responses, thereof 33% women and 80% between 30 and 59 years old (87% board certified specialists). 83% were employed by hospitals (56% teaching hospital, 14% university, 13% non-academic) and 16% by outpatient facilities. 6% are active smokers (63% never) while a mean of five medical education activities on smoking cessation were completed during the past five years of practice. Only 27% of the institutions offered smoking cessation programs and 28% of the respondents were aware of local programs while a mean of 46% of their patients were deemed eligible for participation. 63% of the respondents deemed outpatient physicians primarily responsible for smoking cessation, followed by medical insurance (26%). Conclusions: The current nationwide survey of one scientific medical society involved in the care of patients with vascular disease revealed that smoking cessation, although being commonly accepted as important pillar of comprehensive holistic care, is not sufficiently implemented in everyday clinical practice.

A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.

BACKGROUND: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. METHODS: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. FINDINGS: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). INTERPRETATION: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy. FUNDING: UK National Institute of Health Research Health Technology Programme.

Impact of geriatric nutritional risk index on prognosis in peripheral artery disease patients undergoing endovascular therapy.

The prevalence of peripheral artery disease continues to rise, with major amputations and mortality remaining prominent. Frailty is a significant risk factor for adverse outcomes in the management of the vascular disease. The geriatric nutritional risk index has been used to predict adverse outcomes in lower extremity peripheral artery disease and is a nutrition-based surrogate for frailty. The authors recruited 126 patients with peripheral artery disease who underwent endovascular stent implantation. As in previous reports, malnutrition was diagnosed by the geriatric nutritional risk index. The authors used Kaplan-Meier and multivariate Cox proportional hazards regression analyses to analyze the risk of major adverse limb events, which included mortality, major amputation, and target limb revascularization. There were 67 major adverse limb events during a median follow-up of 480 days. Malnutrition on the basis of the geriatric nutritional risk index was present in 31% of patients. Cox regression analysis showed that malnutrition based on the geriatric nutritional risk index was an independent predictor of major adverse limb events. Kaplan-Meier analysis showed that major adverse limb events increased with worsening malnutrition. Our single-center, retrospective evaluation of geriatric nutritional risk index (as a synonym for body health) correlates with an increased risk of major adverse limb events. Future directions should focus not only on identifying these patients but also on modifying risk factors to optimize long-term outcomes.

Prevention of arterial and venous thrombotic events in symptomatic peripheral arterial disease patients after lower extremity revascularization in the VOYAGER PAD trial: Dual anticoagulant/antiplatelet regimen vs antiplatelet therapy alone.

BACKGROUND: Vascular disease burden after lower extremity revascularization (LER) comprises more than the first event, more vascular beds than the local arteries, and more than one clinical event type. OBJECTIVES: Assess total arterial and venous thrombotic burden after LER for symptomatic peripheral artery disease (PAD) and effect of low-dose anticoagulation added to low-dose antiplatelet therapy. PATIENTS/METHODS: VOYAGER PAD randomized 6564 symptomatic PAD patients undergoing LER to rivaroxaban 2.5 mg twice-daily or placebo on aspirin background. Marginal proportional-hazards models used to generate treatment hazard ratios and associated 95% CIs for first and total events; non-thrombotic deaths treated as competing terminal events. Incidence rates calculated as number of events per 100 patient-years follow-up. RESULTS: Over 2.5 years (median), first and total thrombotic event rates: 7.1 and 10.3 events/100 patient-years, respectively, in placebo group. Two-thirds (925/1372) of total thrombotic events (arterial 95%, venous 5%) were nonfatal first events. Nearly one-third of patients with first event had a second arterial or venous thrombotic event. Rivaroxaban plus aspirin reduced first and total arterial and venous thrombotic events to 5.4 and 7.9 events/100 patient-years, respectively, a reduction in total thrombotic events over aspirin of 23% (HR: 0.77, 95%CI: 0.67-0.89, p = .0005), preventing 6.1 total arterial and venous thrombotic events at 3 years. CONCLUSIONS: Assessing total arterial and venous thrombotic events, not just first events, provides more complete information about disease burden and absolute on-treatment impact. Following LER, judicious modulation of more than one coagulation pathway can provide broader benefit than intensifying inhibition of one hemostatic system component.

Multi-Level Lower Extremity Arterial Revascularization Via Retrograde Pedal Access Under Local Anesthesia in a Patient With Severe Cardiopulmonary Comorbidities: A Case Report.

BACKGROUND: Chronic limb-threatening ischemia is a severe form of peripheral artery disease that leads to high rates of amputation and mortality if left untreated. Bypass surgery and antegrade endovascular revascularization through femoral artery access from either side are accepted as conventional treatment modalities for critical limb ischemia. The retrograde pedal access revascularization is an alternative treatment modality useful in specific clinical scenarios; however, these indications have not been well described in literature. This case report highlights the use of retrograde pedal access approach as primary treatment modality in a patient with an extensive comorbidities precluding general anesthesia nor supine positioning. CASE PRESENTATION: The patient is a 60-year-old female with multiple severe cardiopulmonary comorbidities presenting with dry gangrene of the right great toe. Her comorbidities and inability to tolerate supine positioning precluded her from receiving open surgery, general anesthesia or monitored sedation, or percutaneous femoral access. Rather, the patient underwent ankle block and retrograde endovascular revascularization via dorsalis pedis artery access without post-operative complications. DISCUSSION: The prevalence of comorbidities related to peripheral artery disease is increasing and with it the number of patients who are not optimal candidates for conventional treatment methods for critical limb ischemia. The retrograde pedal access revascularization as initial treatment modality offers these patients an alternative limb salvaging treatment option.

Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial.

BACKGROUND: Patients with peripheral artery disease requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. The VOYAGER PAD trial (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) demonstrated that rivaroxaban significantly reduced this risk. The efficacy and safety of rivaroxaban has not been described in patients who underwent surgical LER. METHODS: The VOYAGER PAD trial randomized patients with peripheral artery disease after surgical and endovascular LER to rivaroxaban 2.5 mg twice daily plus aspirin or matching placebo plus aspirin and followed for a median of 28 months. The primary end point was a composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction major bleeding. International Society on Thrombosis and Haemostasis bleeding was a secondary safety outcome. All efficacy and safety outcomes were adjudicated by a blinded independent committee. RESULTS: Of the 6564 randomized, 2185 (33%) underwent surgical LER and 4379 (67%) endovascular. Compared with placebo, rivaroxaban reduced the primary end point consistently regardless of LER method (P-interaction, 0.43). After surgical LER, the primary efficacy outcome occurred in 199 (18.4%) patients in the rivaroxaban group and 242 (22.0%) patients in the placebo group with a cumulative incidence at 3 years of 19.7% and 23.9%, respectively (hazard ratio, 0.81 [95% CI, 0.67-0.98]; P=0.026). In the overall trial, Thrombolysis in Myocardial Infarction major bleeding and International Society on Thrombosis and Haemostasis major bleeding were increased with rivaroxaban. There was no heterogeneity for Thrombolysis in Myocardial Infarction major bleeding (P-interaction, 0.17) or International Society on Thrombosis and Haemostasis major bleeding (P-interaction, 0.73) on the basis of the LER approach. After surgical LER, the principal safety outcome occurred in 11 (1.0%) patients in the rivaroxaban group and 13 (1.2%) patients in the placebo group; 3-year cumulative incidence was 1.3% and 1.4%, respectively (hazard ratio, 0.88 [95% CI, 0.39-1.95]; P=0.75) Among surgical patients, the composite of fatal bleeding or intracranial hemorrhage (P=0.95) and postprocedural bleeding requiring intervention (P=0.93) was not significantly increased. CONCLUSIONS: The efficacy of rivaroxaban is associated with a benefit in patients who underwent surgical LER. Although bleeding was increased with rivaroxaban plus aspirin, the incidence was low, with no significant increase in fatal bleeding, intracranial hemorrhage, or postprocedural bleeds requiring intervention. Registration: URL: http://www.clinicaltrials.gov; Unique Identifier: NCT02504216.

[Antithrombotic therapy after peripheral revascularization]. / Antithrombotische Therapie nach peripherer Revaskularisation.

Patients with lower extremity arterial disease are at increased risk for cardiovascular events. Antithrombotic therapy improves prognosis in these patients especially after peripheral revascularization. After endovascular revascularization duale anti-platelet therapy with Aspirin and Clopidogrel is used for up to 3 months in most cases, although there is only little evidence for this practice. Following peripheral bypass grafting most guidelines recommend single anti-platelet therapy. In some patients, anticoagulation with Vitamin K antagonists or dual anti-platelet therapy is indicated. But this practice is also based on small studies. The Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease (VOYAGER PAD) study is the largest randomized trial concerning antithrombotic therapy after peripheral revascularization. In total 6564 patients were included after successful surgical or endovascular lower-extremity revascularization. Rivaroxaban 2.5 mg twice daily plus Aspirin 100 mg reduced cardiac and peripheral events compared with Aspirin 100 mg alone with increased risk for relevant but not for critical bleeding complications. In addition to antithrombotic medication risk factor management and regular follow-up examinations are important improve long-term prognosis after peripheral revascularization.

Hybrid-based iliofemoral endarterectomy for severe and complete iliofemoral occlusive disease.

OBJECTIVE: Primary endovascular approaches are now the dominant modality for the treatment of iliac occlusive disease. However, stenting of the external iliac artery is plagued with high in-stent restenosis rates. This hybrid approach with fluoroscopic, retrograde iliofemoral endarterectomy combined with stenting was previously demonstrated to be both a safe and effective alternative to bypass and primary stenting alone for TransAtlantic Inter-Society Consensus (TASC) II C and D lesions. In this study, early outcomes and hemodynamic improvements of this hybrid approach are evaluated with an expanded patient population. METHODS: This was a single-institution, retrospective review of all hybrid-based retrograde iliofemoral endarterectomies from the common femoral artery extending to the proximal external iliac artery from January 1, 2010, to November 15, 2017. Data were collected from the electronic medical record and analyzed using standard quantitative statistical techniques. All preprocedure and postprocedure imaging was independently reviewed by two vascular surgeons. Variables included patient demographics, degree of ischemia, and stent characteristics. The primary outcomes were mortality and freedom from amputation, with secondary outcomes including changes in the ankle-brachial index and toe pressure. RESULTS: The procedure was performed on 63 limbs in 51 total patients. In 33 limbs, the indication was critical limb ischemia (tissue loss/gangrene = 17, rest pain = 16) and 30 for lifestyle-limiting claudication. The cohort consisted of 84% TASC D and 16% TASC C. External iliac stenting was required in 68% (modal diameter, 10 mm) and ipsilateral common iliac stenting was completed in 75% (modal diameter, 9 mm). The ankle-brachial index significantly improved from 0.42 ± 0.25 to 0.73 ± 0.27 (P < .001) as did toe pressure from 29 ± 27 mm Hg to 59 ± 34 mm Hg (P < .001). Thirteen limbs ultimately required an infrainguinal procedure. One patient experienced an intraoperative iliac perforation that resolved with stenting. One death occurred within 90 days. Ninety-five percent of patients remained free from amputation. CONCLUSIONS: Extensive hybrid-based, retrograde iliofemoral endarterectomy with stenting is a safe and efficacious approach to severe iliac arterial occlusive disease, with excellent early outcomes. This series promulgates the hypothesis that extensive endarterectomy with selective iliac stenting yields superior results to external iliac stenting alone. Given the superb hemodynamic improvements in a larger patient population, this hybrid-based, extensive iliofemoral endarterectomy should be recommended as a minimally invasive, first-line treatment for severe iliac occlusive disease.

The Society for Vascular Surgery Alternative Payment Model Task Force report on opportunities for value-based reimbursement in care for patients with peripheral artery disease.

The Society for Vascular Surgery Alternative Payment Model (APM) Taskforce document explores the drivers and implications for developing objective value-based reimbursement plans for the care of patients with peripheral arterial disease (PAD). The APM is a payment approach that highlights high-quality and cost-efficient care and is a financially incentivized pathway for participation in the Quality Payment Program, which aims to replace the traditional fee-for-service payment method. At present, the participation of vascular specialists in APMs is hampered owing to the absence of dedicated models. The increasing prevalence of PAD diagnosis, technological advances in therapeutic devices, and the increasing cost of care of the affected patients have financial consequences on care delivery models and population health. The document summarizes the existing measurement methods of cost, care processes, and outcomes using payor data, patient-reported outcomes, and registry participation. The document also evaluates the existing challenges in the evaluation of PAD care, including intervention overuse, treatment disparities, varied clinical presentations, and the effects of multiple comorbid conditions on the cost potentially attributable to the vascular interventionalist. Medicare reimbursement data analysis also confirmed the prolonged need for additional healthcare services after vascular interventions. The Society for Vascular Surgery proposes that a PAD APM should provide patients with comprehensive care using a longitudinal approach with integration of multiple key medical and surgical services. It should maintain appropriate access to diagnostic and therapeutic advancements and eliminate unnecessary interventions. It should also decrease the variability in care but must also consider the varying complexity of the presenting PAD conditions. Enhanced quality of care and physician innovation should be rewarded. In addition, provisions should be present within an APM for high-risk patients who carry the risk of exclusion from care because of the naturally associated high costs. Although the document demonstrates clear opportunities for quality improvement and cost savings in PAD care, continued PAD APM development requires the assessment of more granular data for accurate risk adjustment, in addition to largescale testing before public release. Collaboration between payors and physician specialty societies remains key.

[Modern strategy to improve remote results of surgical treatment of peripheral artery disease]. / Sovremennaia strategiia uluchsheniia otdalennykh rezul'tatov khirurgicheskogo lecheniia zabolevanii perifericheskikh arterii.

Treatment of patients presenting with peripheral artery disease requires a comprehensive approach: correction of risk factors, drug therapy and, if necessary, an endovascular/hybrid/open intervention. Reconstructive operation may effectively improve a patient's quality of life in intermittent claudication, save the limb and life in case of severe ischaemia. Discussed in the article are advantages and disadvantages of various types of surgical interventions for peripheral artery disease, the concept PLAN (Patient risk, Limb severity, and ANatomic complexity) and the new Global Anatomic Staging System (GLASS). Good remote results may be ensured by adequate medicamentous therapy. Variations of antithrombotic therapy are versatile and debatable. Long-term dual antithrombotic or systemic anticoagulant therapy with administration of vitamin K antagonists are not indicated for peripheral artery disease. In this connection, the findings of the COMPASS and VOYAGER PAD studies are analysed. The VOYAGER PAD trial showed that in patients with peripheral artery disease who underwent revascularization of lower limbs, the addition of rivaroxaban at a dose of 2.5 mg twice daily to aspirin decreased the risk of lower-extremity unfavourable ischaemic events and major adverse cardiovascular events by 15%. The obtained findings open new possibilities of conservative therapy having a significant role in decreasing the risk for development of limb-threatening conditions.

Dual Pathway Inhibition for Vascular Protection in Patients with Atherosclerotic Disease: Rationale and Review of the Evidence.

Despite advances in secondary prevention strategies in patients with cardiovascular disease, the residual risk of recurrent atherothrombotic events remains high. Dual-antiplatelet therapy is the standard of care for secondary prevention in patients with acute coronary syndrome (ACS), whereas single antiplatelet therapy, generally with aspirin, is the standard of care for secondary prevention in stable patients with coronary artery disease (CAD), peripheral artery disease (PAD), or cerebrovascular disease. However, atherosclerotic plaque disruption not only triggers platelet activation but also results in thrombin generation because of tissue factor exposure. Therefore, blocking both pathways by combining antiplatelet therapy with an anticoagulant, or dual pathway inhibition (DPI), has the potential to be more effective than inhibiting either pathway alone. The benefit of DPI has been demonstrated in the ATLAS ACS 2-TIMI 51, COMPASS, and VOYAGER PAD trials, where the combination of rivaroxaban vascular dose (2.5 mg twice daily) plus aspirin significantly reduced the risk of atherothrombotic events compared with aspirin across a broad range of patients, including those with recent ACS, those with chronic CAD and/or PAD, and patients with PAD who have undergone peripheral revascularization. This article provides the rationale for this regimen in more detail, including why the DPI regimen with the rivaroxaban vascular dose was developed for vascular protection in a broad spectrum of patients with atherosclerotic disease.

Rivaroxaban in Peripheral Artery Disease after Revascularization.

BACKGROUND: Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain. METHODS: In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome. RESULTS: A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007). CONCLUSIONS: In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).

Utilization and Outcomes of Local Anesthesia and Peripheral Nerve Block for Hybrid Lower Extremity Revascularization.

Purpose: To investigate the utilization of local anesthesia or peripheral nerve block with monitored anesthesia care (LPMAC) and its impact on the perioperative outcomes of hybrid lower extremity revascularization (LER) compared with general anesthesia (GA). Materials and Methods: A search of the ACS-NSQIP database between 2005 and 2017 identified 9430 patients who underwent hybrid LER for peripheral artery disease. Excluding 449 ineligible cases left 8981 hybrid LER patients for analysis. The patients were dichotomized based on the anesthetic technique: 8631 (96.1%) GA and 350 (3.9%) LPMAC. The GA patients were matched 3:1 based on propensity scores to patients in the LPMAC group based on gender, age, race, functional status, transfer status, chronic obstructive pulmonary disease (COPD), dialysis status, American Society of Anesthesiologists (ASA) class, emergent surgery, preoperative sepsis, indication, and type of open and endovascular procedure. Outcomes including complications, mortality, procedure time, and hospital length of stay were compared between the matched groups (801 GA vs 267 LPMAC). Results: Comparing the unmatched groups, those treated under LPMAC were older (72.7±9 vs 68±8.4 years, p<0.001) and had higher rates of COPD (24.3% vs 17%, p=0.001), dialysis dependence (8.1% vs 4.2%, p=0.002), preoperative sepsis (6.6% vs 4.2%, p=0.029), and ASA class ≥IV (29.1% vs 24.1%, p=0.036) than in the unmatched GA cohort. In the matched comparison, LPMAC was associated with lower overall morbidity (25.5% vs 32.3%, p=0.042) and shorter operating time (202.7±98 vs 217.7±102 minutes, p=0.034) compared with GA. The rate of myocardial infarction was lower (1.1% vs 2.4%) and ventilator use for >48 hours was less frequent (0.4% vs 2.6%) for LPMAC patients, though statistical significance was not reached. There was no difference in mortality or hospital length of stay. Conclusion: LPMAC is an infrequent anesthetic technique for hybrid LER and is primarily used for patients with a high burden of comorbidities. LPMAC is associated with reduced overall morbidity and operating time. Further studies are needed to identify which patients undergoing hybrid LER benefit most from LPMAC.

Effectiveness and Safety of Rivaroxaban Compared to Acenocumarol after Infrainguinal Surgical Revascularization.

BACKGROUND: Optimal antithrombotic therapy after lower limb infrainguinal revascularization remains a controversial topic. The use of anticoagulants, alone or in combination with antiplatelet drugs, can potentially improve patency rate and limb salvage, particularly in patients with risk factors for early thrombosis. Bleeding is the main complication of long-term anticoagulant use. New oral anticoagulants can represent an attractive alternative to the standard vitamin K antagonists. The objective of the study is to evaluate the effectiveness (bypass occlusion and major amputation) and safety (major bleeding and all-cause mortality) of rivaroxaban compared to acenocumarol after infrainguinal lower limb surgical revascularization. MATERIAL AND METHODS: Retrospective cohort study of patients with peripheral arterial disease submitted to lower limb infrainguinal bypass revascularization with vein or expanded polytetrafluoroethylene conduit, who were anticoagulated with acenocumarol or rivaroxaban after hospital discharge. Patients with proximal revascularization, revascularization due to any pathology other than peripheral arterial disease, coagulation disorder, stroke or acute myocardial infarction in less than 30 days, glomerular filtration rate <15 mL/min, or on hemodialysis were excluded. RESULTS: One hundred nine patients were included (78.9% male), with a mean age of 64.8 years. After hospital discharge, 40 patients (36.7%) were medicated with rivaroxaban and 69 patients (63.3%) with acenocumarol. At 1 year of follow-up, patients under rivaroxaban and acenocumarol presented comparable major amputation rates (12.5 % vs. 10.1%, P = 0.756), bypass occlusion (22.5% vs. 24.6 %, P = 0.769), and mortality rate (10% vs. 8.7%, P = 0.756). Major bleeding occurred in 13.8% of patients. Patients with renal dysfunction had significantly higher bleeding risk with acenocumarol (45.5% vs. 0%, P = 0.028) compared to rivaroxaban, while patients with normal renal function presented similar bleeding rates with both anticoagulants (6.1% vs. 6.4%, P = 0.953). CONCLUSIONS: Rivaroxaban has equivalent effectiveness to acenocumarol after infrainguinal bypass revascularization, with similar occlusion, major amputation, and mortality rates. Rivaroxaban has an improved safety profile in patients with moderate renal dysfunction due to a significantly lower incidence of major bleeding. In patients with normal renal function, rivaroxaban and acenocumarol present equivalent major bleeding rates.

The use of local anesthesia to perform lower limb revascularization in the fragile patient with critical limb ischemia.

Patients with critical limb ischemia are usually compromised, frequently making administration of general or regional anesthesia problematic. We treated 3 fragile patients presenting contraindications to undertake traditional anesthetic techniques for lower limb revascularization, in whom local anesthesia with conscious sedation was used to complete the operation. An axillo-bifemoral, a unilateral axillo-femoral and a femoro-femoral bypass were performed. Procedure was uneventful in all three cases despite the coexistence of specific surgical challenges (distal anastomosis at the profunda in two cases, redo surgery and scarred groin in the third). Surgical revascularization under local anesthesia may be considered in selected high risk patients.

In Patients with Severe Peripheral Arterial Disease, Revascularization-Induced Improvement in Lower Extremity Ischemia Can Be Detected by Laser Speckle Contrast Imaging of the Fluctuation in Blood Perfusion after Local Heating.

BACKGROUND: We previously reported the utility of the perfusion value (PV) fluctuation slope for detecting severe ischemia in the lower limb. Our approach was based on a thermal load test mimicking the well-known physiological reaction termed "cold-induced vasodilation," which is known to occur as a 3-phase phenomenon. The slope parameter quantifies the decrease in PVs accompanying the relative cooling (third phase) following the transient increase in blood flow (second phase) induced by the applied thermal load. This phenomenon of "relative" cold-induced vasodilation (rCIVD) can be monitored using laser speckle contrast imaging (LSCI) after applying the thermal load (LTL test). Here, we aimed to determine whether the slope parameter obtained via the LTL test also reflects the improvement in hemodynamics after revascularization. METHODS: The study enrolled 16 patients (18 limbs), who underwent revascularization for peripheral arterial disease (PAD). The measurements were performed at 2 sites in each limb (in total, 34 sites; 2 sites in one patient were excluded because of significant movement during the measurement). For each site, we recorded the slope describing the behavior of PVs (decrease or plateau) in the third phase of rCIVD, following the initial, heating-induced increase in perfusion (second phase of rCIVD). The plateau group (group P), which included patients with an abnormal rCIVD, and the decrease group (group D), which included patients with a normal rCIVD, were defined based on perfusion slope values of <0.20 and ≥ 0.20 perfusion units/min, respectively. We also quantified the transient increase in perfusion (from baseline to peak) as a descriptor of perfusion behavior during the second phase of rCIVD. RESULTS: In group P, the change in median values (25-75%) of the slope, transcutaneous oxygen tension, and ankle-brachial index (ABI) from before to after operation was (-0.02 [-0.04 to 0.02]; 4 [1-11]; and 0.08 [0-0.27]) to (0.39 [0.32-0.59]; 46 [37-54]; and 0.81 [0.72-0.90]). Conversely, in group D, the change in the median values of the slope, transcutaneous oxygen tension, and ABI between before and after operation was (0.38 [0.32-0.49]; 40.5 [35-45]; and0.58 [0.57-0.65]) to (0.44 [0.30-0.64]; 52 [43-56]; and 0.92 [0.81-0.99]). Sites exhibiting perfusion pattern of group D in the third phase of rCIVD showed no significant change in slope after revascularization (P = 0.21), whereas the slope in group P increased significantly after revascularization, becoming similar to the postoperative slopes in group D (P = 0.81). The amount of transient increase in perfusion, which quantified the behavior in the second phase of rCIVD, showed a similar behavior. Preoperatively, all patients in group P had rest pain and/or ulcer of the foot, whereas only few patients in group D had such symptoms. CONCLUSIONS: Normal rCIVD response in the LTL test indicates less-than-severe ischemia, while abnormal rCIVD response measured via the LTL test indicates severe ischemic symptoms, such as critical limb ischemia. Notably, patients with an abnormal rCIVD response can develop a normal rCIVD response following revascularization, thereby reflecting an improvement in blood flow. The LTL test assessing rCIVD response can be useful for detecting severe limb ischemia, such as critical limb ischemia (CLI), and determining the departure from severe limb ischemia by revascularization.

Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions.

OBJECTIVE: The objective of this study was to assess 1-year safety, efficacy, and invasiveness outcomes of endovascular stent grafting of symptomatic long lesions (≥10 cm) in the superficial femoral artery (SFA) as a substitute for above-knee open bypass surgery. METHODS: This prospective, multicenter (15 hospitals) study assessed heparin-coated stent grafts for the treatment of long SFA lesions in Japanese subjects with peripheral arterial disease. Inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), ankle-brachial index ≤0.9, and color flow duplex ultrasound-assessed SFA lesions with cumulative length ≥10 cm and ≥50% stenosis. Main efficacy and safety outcomes were primary assisted patency and adverse events, respectively. Secondary outcomes included primary patency using the surgical bypass definition, that is, blood flow through a device without requiring target lesion revascularization (TLR) to maintain or to restore flow. For comparison with prior endovascular studies, primary patency-interventional was defined as peak systolic velocity ratio <2.5 without TLR in treated lesions. Other outcomes included freedom from TLR and Vascular Quality of Life questionnaire scoring. General anesthesia avoidance and hospitalization duration were compared with historical data from 68 consecutive patients (n = 51 Rutherford 2/3 claudicants and 17 Rutherford 4/5 subjects) who underwent above-knee bypass surgery at study sites between 2002 and 2012 and met study enrollment criteria. RESULTS: Of 103 enrollees (74.2 ± 7.0 years old; 17.5% female; 97.1% claudicants), 100 subjects were evaluated through postoperative 12 months. Average lesion length was 21.8 ± 5.8 cm, and 65.7% were totally occluded. The whole-cohort Kaplan-Meier estimated primary assisted patency rate was 94.1% (95% confidence interval [CI], 87.3%-97.3%) at 12 months. The primary patency-surgical rate was 92.1% (95% CI, 84.8%-96.0%), the primary patency-interventional rate was 88.1% (95% CI, 80.0%-93.1%), and freedom from TLR was 93.1% (95% CI, 86.1%-96.7%). Mean ankle-brachial index increased from 0.64 ± 0.12 to 0.98 ± 0.12 at 1 month after intervention and 0.94 ± 0 .17 at 12 months (P < .0001 at both follow-ups). Target vessel revascularization, major amputation, or death did not occur through postoperative 30 days. No life- or limb-threatening intraoperative or perioperative adverse events and no acute limb ischemia cases were observed during follow-up. Vascular Quality of Life questionnaire score increased from 58.6% ± 15.7% to 72.9% ± 18.6% at 12 months (P < .0001). No stent fractures were detected. No stent graft participant required general anesthesia, and median postoperative hospital stay was 2.0 days (mean, 3.4 ± 2.9 days) in the Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) claudicant subgroup, values that were significantly lower than the 76.5% general anesthesia rate (P < .0001) and 11.0 days median hospitalization stay (mean, 12.7 ± 5.3 days; P < .0001) in the 51 open bypass claudicant subjects. CONCLUSIONS: Stent grafting appears to be a safe and less invasive alternative to above-knee bypass surgery, providing 88% to 92% primary patency at 12 months in long, complex lesions.

The efficacy of a multidisciplinary team approach in critical limb ischemia.

The aim of the present study was to clarify the characteristics of Japanese critical limb ischemia (CLI) patients and analyze the rates of real-world mortality and amputation-free survival (AFS) in all patients with Fontaine stage IV CLI who were treated with/without revascularization therapy by an intra-hospital multidisciplinary care team. All consecutive patients who presented with CLI at Showa University Fujigaoka Hospital between April 2008 and March 2014 were prospectively registered. The intra-hospital committee consisted of cardiologists, plastic surgeons, dermatologists, diabetologists, nephrologists, cardiovascular surgeons, and vascular technologists. The primary endpoint of this study was all-cause mortality and AFS during the follow-up period. The present study included 145 patients with Fontaine stage IV CLI. The mean age was 76.5 ± 10.2 years. The all-cause mortality rate during the follow-up period (15.5 ± 16.1 months) was 21.4 %. The AFS rate during the follow-up period (14.1 ± 16.4 months) was 58.6 %. A multivariate Cox proportional hazards regression analysis found that age >75 years and hemodialysis were significantly associated with all-cause mortality; and that age >75 years, Rutherford 6, and wound infection were significantly associated with AFS. A multidisciplinary approach and comprehensive care may improve the outcomes and optimize the collaborative treatment of CLI patients. However, all-cause mortality remained high in patients with Fontaine stage IV CLI and early referral to a hospital that can provide specialized treatment for CLI, before the occurrence of major tissue loss or infection, is necessary to avoid primary amputation.