Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia.

GUIDELINE SUMMARY: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

Nasal methicillin-resistant Staphylococcus aureus colonization is associated with increased wound occurrence after major lower extremity amputation.

OBJECTIVE: Wound occurrence (WO) after major lower extremity amputation (MLEA) can be due to wound infection or sterile dehiscence. We sought to determine the association of nasal methicillin-resistant Staphylococcus aureus (MRSA) colonization and other patient factors with overall WO, WO due to wound infection, and WO due to sterile dehiscence. METHODS: The medical records of all patients undergoing MLEA from August 1, 2011, to November 1, 2013, were reviewed. Demographic data, hemoglobin A1c level, albumin concentration, dialysis dependence, peripheral vascular disease (PVD), nasal MRSA colonization, and diabetes mellitus (DM) were examined as variables. The overall WO rate was determined, and the cause of WO was categorized as either a sterile dehiscence or a wound infection. RESULTS: Eighty-three patients underwent 96 MLEAs during a 27-month period. The rates of overall WO, WO due to infection, and WO due to sterile dehiscence were 39%, 19%, and 19%, respectively (1% developed a traumatic wound). On univariate analysis, PVD, MRSA colonization, DM, and dialysis dependence were all associated with higher rates of overall WO (P < .05). On multivariate analysis, MRSA colonization was associated with higher rates of overall WO (P = .03) and WO due to wound infection (11% vs 45%; P < .01). DM and PVD were associated with higher rates of overall WO and WO due to sterile dehiscence on both univariate and multivariate analysis (P < .05). CONCLUSIONS: Nasal MRSA colonization is associated with higher rates of overall WO and WO due to wound infection. DM and PVD are associated with higher rates of overall WO and WO due to sterile dehiscence but are not associated with WO due to wound infection. Further studies addressing the effect of nasal MRSA eradication on postoperative wound outcomes after MLEA are warranted.

Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials.

BACKGROUND: Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, is being developed as an adjunct for surgical hemostasis. MATERIALS AND METHODS: Safety and efficacy of Fibrocaps applied directly or by spray device, in combination with gelatin sponge, was compared with that of gelatin sponge-alone in two randomized, single-blind controlled trials: FC-002 US (United States) and FC-002 NL (the Netherlands). A total of 126 adult patients were randomized (Fibrocaps: n = 47 [FC-002 US], n = 39 [FC-002 NL]; gelatin sponge alone: n = 23 [FC-002 US], n = 17 [FC-002 NL). One bleeding site was treated during a surgical procedure (n = 125). Time to hemostasis (primary end point) was measured, with a 28-d safety follow-up. Four surgical indications included hepatic resection (n = 58), spinal procedures (n = 37), peripheral vascular procedures (n = 30), and soft tissue dissection (n = 1). RESULTS: Mean (standard deviation) time to hemostasis was significantly shorter after Fibrocaps treatment than after gelatin sponge alone (FC-002 US: 1.9 [1.3] versus 4.8 min [3.1], P < 0.001; FC-002 NL: 2.2 [1.3] versus 4.4 min [3.1], P = 0.004). The incidence of hemostasis was greater after Fibrocaps compared with that of gelatin sponge alone within 3 min (FC-002 US: 83% versus 35%, P < 0.001; FC-002 NL: 77% versus 53%, P = 0.11), 5 min (94% versus 61%, P = 0.001; 95% versus 71%, P = 0.022), and 10 min (100% versus 78%, P = 0.003; 100% versus 82%, P = 0.025). Adverse events were consistent with surgical procedures performed and patients' underlying diseases and generally similar between treatment arms; most were mild or moderate in severity. Non-neutralizing antithrombin antibodies were detected in 5% of Fibrocaps-treated patients on day 29. CONCLUSIONS: Fibrocaps had good safety and efficacy profiles, supporting continuing clinical development as a novel fibrin sealant.

Duplex ultrasound screening detects high rates of deep vein thromboses in critically ill trauma patients.

OBJECTIVE: American College of Chest Physician (ACCP) guidelines stratify deep venous thrombosis (DVT) risk in trauma patients based on injury pattern and pharmacologic prophylaxis. Screening is only recommended for patients with high-risk injuries who are unable to receive pharmacologic prophylaxis. However, the prevalence of lower extremity DVT (LEDVT) in trauma patients may be higher than reported in previous studies as many studies on DVT screening have not investigated calf vein DVTs (CVDVT) and have not exclusively targeted critically ill patients. Given that current ACCP guidelines recommend treatment of CVDVTs, we investigated the efficacy of duplex ultrasound (DUS) screening in critically ill trauma patients for all LEDVTs, including CVDVT, regardless of injury pattern, risk factors, or pharmacologic prophylaxis. METHODS: Medical records of 264 intensive care unit trauma patients who received DUS screening for LEDVT were retrospectively examined for the presence of injuries conferring high risk for LEDVT, patient specific DVT risk factors, and low molecular weight heparin (LMWH) prophylaxis. RESULTS: Forty (15.2%) patients had LEDVTs found on DUS screening, 24 (60%) were CVDVT, and 30% of all DVTs were diagnosed within 1 week of admission. Patients without high-risk injuries receiving LMWH had a 13.5% DVT rate, which did not differ significantly from the 19.7% DVT rate in high-risk injury patients not receiving LMWH (P = .667). CONCLUSIONS: Lower extremity DVT is common in critically ill trauma patients, particularly in the first week following injury, regardless of injury pattern, DVT risk factors, or pharmacologic prophylaxis. Previous studies have underestimated DVT rates by not investigating CVDVTs and not exclusively targeting critically ill patients. We recommend early and continued DUS DVT screening of all critically ill trauma patients.

Outcomes with retrievable inferior vena cava filters: a multicenter study.

PURPOSE: To retrospectively review the outcomes after placement and retrieval of retrievable inferior vena cava (IVC) filters at two academic medical centers. MATERIALS AND METHODS: All patients who underwent retrievable filter placement between May 2001 and December 2005 were included. Hospital records at both institutions were reviewed, and relevant data were collected concerning the placement and retrieval of all removable filters. RESULTS: A total of 197 patients underwent placement of a retrievable IVC filter. Of those, 143 patients (72.5%) had Günther Tulip filters (GTFs) placed, and 54 patients (27.5%) had Recovery filters placed. A total of 94 patients underwent attempted filter retrieval, accounting for just less than half of all retrievable filters placed during the study period (47.7%). Retrievals were successful in 80 patients (85.1%). Half the retrieval failures (n = 7) were the result of thrombus within the filter, and technical difficulties (eg, filter embedded in IVC wall, tilted filter) were the cause of retrieval failure in the other half. There was no significant difference in retrieval failure rates between the GTF and Recovery filter (16.4% vs 9.5%, respectively). GTFs were removed after a median implantation time of 11 days (range, 1-139 d), whereas Recovery filters were removed after a median implantation time of 28 days (range, 6-117 d). CONCLUSIONS: Placement and retrieval of nonpermanent IVC filters can be performed safely with a high technical success rate. In patients at high risk for venous thromboembolism and contraindication to anticoagulation, retrievable filters may be used aggressively to prevent the potentially devastating outcome of pulmonary embolism.