Systematic review of hemostatic agents used in vascular surgery.

BACKGROUND: Hemostatic agents are routinely used in vascular surgery to complement proper suture techniques and decrease the risk of perioperative bleeding. A relative lack of comparative research studies have left surgeons with the option of choosing hemostatic agents based on their personal experience. The present review has highlighted the efficacy and safety of hemostatic agents and categorized them according to their primary mechanism of action and cost. METHODS: A systematic search strategy encompassing hemostatic agent products was deployed in the PubMed database. Single-center and multicenter, randomized, controlled trials with >10 patients were included in the present study. RESULTS: We reviewed 12 studies on the efficacy and safety of hemostatic agents compared with manual compression or other hemostatic agents. Using the time to hemostasis as the primary end point, all studies had found hemostatic agents to be significantly more efficient than manual compression. Likewise, adhesives (high pressure sealants) and dual agents (containing biologically active and absorbable components) were found to be more efficient, but costlier, than agents with either biologically active or absorbable components only. Agents with porcine or bovine constituents were found to trigger anaphylactic reactions in rare cases. Additionally, the absence of fibrin stabilizing factor XIII in a brand of fibrin sealant was speculated to reduce the affinity of the fibrin sealant for the expanded polytetrafluoroethylene graft. The cost of agents varied greatly depending on their active ingredient. CONCLUSIONS: Hemostatic agents appear to be highly effective at decreasing the risk of bleeding during surgical procedures. Although some hemostatic agents were demonstrated to achieve hemostasis faster than others, most are able to control bleeding within <10 minutes. Based on the limited data, the least expensive agents might suffice for limited suture lines used in routine procedures.

Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia.

OBJECTIVE: Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX. METHODS: We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR. CONCLUSIONS: In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.

Paclitaxel-Coated Peripheral Arterial Devices are Associated with Reduced Mortality in Younger Patients.

BACKGROUND: Paclitaxel-coated devices have been shown to decrease restenosis when used in the femoropopliteal artery. Recent reports have suggested a possible risk of increased late mortality in patients treated with paclitaxel. It has been suggested that younger patients and those with limited comorbidities may be at higher risk. Our objective was to analyze long-term mortality based on patient age comparing treatment with paclitaxel to uncoated devices. METHODS: We performed a retrospective review of 1,170 consecutive patients who underwent femoropopliteal percutaneous intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. Patients were grouped by age at the time of procedure: <60 years old (n = 244, 20.9%), 60-80 years old (n = 635, 54.3%), and >80 years old (n = 291, 24.9%). Within each group, patients were further divided by use of paclitaxel. The primary outcome measure was survival assessed by Kaplan-Meier analysis. Differences between the groups were analyzed with analysis of variance. Multivariable analysis was performed using Cox proportional hazard models. RESULTS: Of the 1,170 patients who underwent femoropopliteal percutaneous intervention, 654 (55.9%) received a paclitaxel-coated device during treatment and 516 (44.1%) did not. Mean age of the overall patient cohort was 70.4 ± 12.6 years and 663 (56.7%) were male. When comparing the groups by age we found an increase in age but a decrease in the proportion of patients who smoke. The use of paclitaxel-coated devices was similar across the groups (<60 years old, 56.2%; 60-80 years old, 57.0%; >80 years old, 52.6%; P = 0.45). Demographics and comorbidities were similar between the patients treated with and without paclitaxel within each age group except more males in the <60-year-old group treated without paclitaxel and more patients with chronic limb threatening ischemia in the >80-year-old group treated with paclitaxel. In patients <60 and 60-80 years old paclitaxel use was associated with increased survival at 4 years: <60 (80.7% vs. 64.4%; P = 0.04); 60-80 (63.2% vs. 55.1%; P = 0.04). Survival was similar in the >80-year-old group (46.6% vs. 32.8%; P = 0.65). CONCLUSIONS: Our data suggest that the use of paclitaxel-coated arterial devices is not associated with increased mortality. On the contrary, our data show that younger patients treated with paclitaxel show improved survival compared with those treated without paclitaxel. Paclitaxel-coated devices may be used with continued caution especially in patients at high risk for restenosis.

Elevated Neutrophil to Lymphocyte Ratio is Associated with Worse Outcomes after Carotid Endarterectomy in Asymptomatic Patients.

OBJECTIVE: Management of carotid artery stenosis (CAS) remains controversial and proper patient selection critical. Elevated neutrophil to lymphocyte ratio (NLR) has been associated with poor outcomes after vascular procedures. The effect of NLR on outcomes after carotid endarterectomy (CEA) in asymptomatic and symptomatic patients is assessed. MATERIALS AND METHODS: A retrospective review was conducted of all patients between 2010 and 2018 with carotid stenosis >70% as defined by CREST 2 criteria. A total of 922 patients were identified, of whom 806 were treated with CEA and 116 non-operatively with best medical therapy (BMT). Of patients undergoing CEA, 401 patients (290 asymptomatic [aCEA], 111 symptomatic [sCEA]) also had an available NLR calculated from a complete blood count with differential. All patients treated with BMT were asymptomatic and had a baseline NLR available. Kaplan-Meier analysis assessed composite ipsilateral stroke or death over 3 years. RESULTS: In sCEA group, the 3-year composite stroke/death rates did not differ between NLR < 3.0 (22.9%) vs NLR > 3.0 (38.1%) (P=.10). In aCEA group, patients with a baseline NLR >3.0 had an increased risk of 3-year stroke/death (42.6%) compared to both those with NLR <3.0 (9.3%, P<.0001) and those treated with BMT (23.6%, P=.003). In patients with NLR <3.0, aCEA showed a superior benefit over BMT with regard to stroke or death (9.3% vs. 26.2%, P=.02). However, in patients with NLR >3.0, there was no longer a benefit to prophylactic CEA compared to BMT (42.6% vs. 22.2%, P=.05). Multivariable analysis identified NLR >3.0 (HR, 3.23; 95% CI, 1.93-5.42; P<.001) and congestive heart failure (HR, 2.18; 95% CI, 1.33-3.58; P=.002) as independent risk factors for stroke/death in patients with asymptomatic carotid artery stenosis. CONCLUSIONS: NLR >3.0 is associated with an increased risk of late stroke/death after prophylactic CEA for asymptomatic carotid artery stenosis, with benefits not superior to BMT. NLR may be used to help with selecting asymptomatic patients for CEA. The effect of NLR and outcomes in symptomatic patients requires further study. Better understanding of the mechanism(s) for NLR elevation and medical intervention strategies are needed to modulate outcome risk in these patients.

Anatomic criteria in the selection of treatment modality for atherosclerotic carotid artery disease.

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

Elevated neutrophil-lymphocyte ratio predicts mortality following elective endovascular aneurysm repair.

OBJECTIVE: The neutrophil-lymphocyte ratio (NLR) is an inexpensive and useful inflammatory marker that incorporates the balance of the innate (neutrophil) and adaptive (lymphocyte) immune responses. Data exist on the association between NLR and mortality in various coronary diseases and in cancer surgery, but there is a paucity of data on the impact of preoperative NLR on vascular surgical outcomes. The aim of this study was to evaluate the relationship between preoperative NLR and elective endovascular aortic aneurysm repair (EVAR) outcome. METHODS: A retrospective review of all patients who underwent elective EVAR at a single institution between 2010 and 2018 was conducted (n = 373). Only patients who had a preoperative complete blood count with differential within 30 days of their operation were included. The NLR was computed by dividing the absolute neutrophil count by the absolute lymphocyte count. A receiver operating characteristic curve was used to determine the optimal cutoff value of NLR with the strongest association with mortality. NLR was dichotomized so that patients with NLR above the threshold were at increased risk of mortality compared with those below it. Continuous variables were analyzed using Wilcoxon nonparametric signed-rank test and categorical variables with the Fisher exact test. A comparison of NLR and mortality was completed using Kaplan-Meier survival analysis. Cox regression analysis was used to evaluate factors associated with mortality through 5-year follow-up. RESULTS: Overall, 108 patients were included in this study. An NLR ≥ 4.0 was found to be associated with mortality (P < .0001). Thirty-two patients composed the High-NLR (NLR ≥ 4.0) group and the remaining 76 patients formed the Low-NLR (NLR < 4.0) group. Baseline characteristics were similar between groups, except that the High-NLR group was older (77.9 vs 74.4; P = .047). At a mean of 36.4 months follow-up, the overall mortality rate was 32.4%. Although there were no differences in the perioperative period, the Kaplan-Meier estimates of mortality were significantly greater in the High-NLR group at 1, 2, and 5 years postoperatively (P < .0001). The mean preoperative NLR of the deceased was higher (5.94 ± 5.20; median, 4.75; interquartile range, 3.17-7.83) than those who survived (2.87 ± 1.61; median, 2.53; interquartile range, 1.97-3.49) (P < .0001). Secondary interventions and sac enlargement rates were similar between groups. On univariable analysis, NLR (hazard ratio [HR], 1.17; 95% confidence interval [CI], 1.10-1.23; P < .0001), age (HR, 1.06; 95% CI, 1.02-1.11; P = .004), and aneurysm diameter (HR, 1.04; 95% CI, 1.01-1.07; P = .003) were associated with mortality. On multivariable analysis, NLR (HR, 1.19; 95% CI, 1.12-1.27; P < .0001), age (HR, 1.06; 95% CI, 1.01-1.11; P = .026), and aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.07; P = .003) were associated with mortality. CONCLUSIONS: Patients with an elevated preoperative NLR, irrespective of other comorbidities, may represent a previously unrecognized subset of patients who are at heightened risk of mortality after elective EVAR. A complete blood count with differential is an inexpensive test that may be used as a prognostic indicator for outcome after EVAR. Further research is warranted to identify clinical, pathological, or anatomical factors associated with an elevated NLR and to determine modifiable factors, which may help improve long-term survival.

Frequency of perigraft hygroma after open aortic reconstruction.

OBJECTIVE: The incidence of perigraft hygroma (PGH) development after aortic reconstruction remains poorly defined and its clinical relevance is questionable. This study was designed to establish the incidence of and determine the risk factors associated with PGH formation and its outcomes. METHODS: Patients who underwent open aortic reconstruction for either aneurysmal or occlusive disease with an expanded polytetrafluoroethylene (ePTFE) or polyester graft from 2004 to 2018 were retrospectively reviewed (n = 262). Only those who had follow-up imaging 3 or more months after repair were included. Patients with mixed graft types were excluded. PGH was defined as a perigraft fluid collection of 30 mm or greater in diameter with a radiodensity of 30 or fewer Hounsfield units on computed tomography at a minimum of 3 postoperative months. Analysis was conducted between patients with and without PGH. RESULTS: One hundred forty patients met the inclusion criteria: 88 were treated with ePTFE and 52 with polyester grafts. Twenty-three patients (16.4%) were found to have radiologic evidence of PGH. PGH developed more frequently in patients with ePTFE (21/88 [23.9%]) compared with those with polyester grafts (2/52 [3.8%]) (P = .002). Mean PGH size was 63.5 ± 36.4 mm (range, 33-153 mm) and the average time to PGH detection 27.7 months (range, 3-112 months). Baseline characteristics were similar between the groups. Patients who developed PGH had larger aneurysms, more often received ePTFE grafts, had larger graft diameters, and had bifurcated grafts. The overall mortality was 32.1% at a mean follow-up of 5.2 years. The 5-year mortality rates were similar between patients with and without PGH (26.1% vs 18.8%; P = .41). Of the 23 patients with PGH, 4 (all with ePTFE) presented with symptoms related to the PGH. The average size of symptomatic and asymptomatic PGH were 11.5 and 4.8 cm, respectively. Mortality rates overall were similar between those with and without symptoms (50.0% vs 36.8%; P = .99). CONCLUSIONS: Nearly one-quarter of aortic reconstructions with ePTFE are associated with PGH formation compared with 4% with polyester. Clinically significant PGH-related symptom development occurs in 20%. Patient education and close surveillance are warranted. Manufacturer's device modification is needed.

Paclitaxel-coated peripheral artery devices are not associated with increased mortality.

OBJECTIVE: Long-term safety concerns have been raised that the use of paclitaxel-coated balloons and stents is linked to excess mortality. Our objective was to compare outcomes in patients treated with paclitaxel vs uncoated devices and to analyze long-term mortality. METHODS: We conducted a retrospective single-institution review of 1170 consecutive patients who underwent femoropopliteal percutaneous revascularization by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. The primary outcome measure was all-cause mortality. Groups were divided into patients who received paclitaxel (n = 652) and those who did not (n = 518). Categorical variables were assessed using χ2 analysis and continuous variables with the Wilcoxon signed rank test. A multivariable analysis was performed using multivariable logistic regression models. Mortality was compared using Kaplan-Meier survival analysis. RESULTS: Demographics, risk factors, and Rutherford class were similar between the groups, except that the paclitaxel group was more likely to have diabetes (60.9% vs 55.0%; P = .04), was less likely to be on dialysis (10.7% vs 14.9%; P = .04), and had lower average creatinine concentration (1.6 ± 1.8 mg/dL vs 2.0 ± 2.3 mg/dL; P = .003). There were no differences in all-cause mortality through 2 years between paclitaxel and no-paclitaxel cohorts (25.5% vs 30.3%; log-rank, P = .098). At 3 years and 3.5 years, mortality was significantly lower in the paclitaxel group: year 3, 32.1% vs 39.4% (log-rank, P = .041); year 3.5, 35.2% vs 43.9% (log-rank, P = .027). Survival rates were not significantly different in examining subgroups by diabetes, chronic kidney disease, presence of chronic limb-threatening ischemia, or paclitaxel-coated balloon manufacturer. Multivariable analysis demonstrated that age, dialysis, chronic limb-threatening ischemia, chronic kidney disease, and congestive heart failure were independent risk factors for mortality, whereas paclitaxel use was associated with lower mortality. CONCLUSIONS: The use of paclitaxel-coated balloons and stents does not increase mortality compared with uncoated devices out to 3.5 years. Paclitaxel-coated devices can be used with continued caution, especially in patients at increased risk of restenosis. Further long-term studies are needed to determine the risk of late mortality.

Evaluation of fibrin sealant for biologic mesh fixation at the hiatus in a porcine model.

BACKGROUND: The ideal method to secure biologic mesh during laparoscopic hiatal hernia repair remains uncertain. Suture or tack fixation can be technically difficult, and serious cardiovascular complications have been reported. Fibrin sealant (FS) offers a potential solution to this problem. We hypothesized that FS provides comparable mesh fixation to suture repair during laparoscopic mesh hiatoplasty. STUDY DESIGN: Using a porcine model, laparoscopic hiatal hernia repair was performed with suture reapproximation of the crura and reinforcement with an acellular porcine dermal matrix. Prior to repair, animals were randomized to mesh fixation with sutures (S) or FS. After 30-day survival, an esophagram was performed, the diaphragm harvested, and mesh position, fixation, and incorporation were evaluated histologically and biomechanically using a T-peel test. RESULTS: Twenty (10 S and 10 FS) laparoscopic hiatal hernia repairs were performed. Total operative time was significantly less in the FS group (74.7 versus 127.0 min, p < 0.01). There were no instances of mesh migration in any animal. Mean peel force did not differ significantly between the S and FS groups (0.21 vs. 0.18 N/mm, respectively; p = 0.49). There was no significant difference in cellular repopularization or inflammatory changes around the mesh. CONCLUSIONS: Fibrin sealant offers a reasonable alternative to suturing biologic mesh during laparoscopic hiatal hernia repair with equivalent mesh fixation. At 30 days it provides adhesive strength similar to suture fixation, while significantly reducing operative time.

Thirty-day readmission after ventral hernia repair: predictable or preventable?

INTRODUCTION: Thirty-day readmission has become an increasingly scrutinized event in the field of surgery, especially in light of projected cuts in reimbursement. Although studies have evaluated large populations, little work has been done on procedure-specific populations. Our objective is to determine if any factors are predictive of 30-day readmission in patients undergoing ventral hernia repair. METHODS: We retrospectively reviewed the charts of all patients who underwent laparoscopic or open ventral hernia repair over a 4-year period. We evaluated patients based on demographic, preoperative, and operative variables. The primary outcome measure was all-cause 30-day readmission. RESULTS: There were 420 patients identified for evaluation. Fifty-one (12%) patients required readmission to the hospital within 30 days. The most common indications for readmission were wound infection (57%; n=29) and gastrointestinal (GI) complication (19%; n=10). On analysis, demographic variables were similar between the two groups. However, patients who were readmitted were more likely to have had more prior abdominal surgeries (4 vs. 2; p<0.0001), more previous hernia repairs (2 vs. 1; p=0.006), open repair (76% vs. 46%; p<0.0001), and active abdominal infection (37% vs. 12%; p<0.0001). In addition, patients also had longer procedures (235 vs. 150 min; p<0.0001) and larger defects (350 vs. 96 cm2; p<0.0001). On multivariate analysis, independent predictors of readmission included presence of fistula [odds ratio (OR)=8.55; 95% confidence interval (CI) 3.21-22.72], defect size>300 cm2 (OR=5.35; 95% CI 2.59-11.05), active abdominal infection (OR=4.37; 95% CI 2.28-8.37), and open repair (OR=4.27; 95% CI 2.17-8.42). CONCLUSIONS: Patients undergoing ventral hernia repair can represent a complex group. In our practice, enterocutaneous fistula, defect size>300 cm2, active abdominal infection, and open repair were all independent risk factors (OR>4) for 30-day readmission after ventral hernia repair. Recognition of these high-risk patients can help focus resources to increase surveillance and possible early intervention to reduce readmissions.

Open versus endoscopic component separation: a cost comparison.

BACKGROUND: The components separation technique (CST) is performed through an open or endoscopic approach. It is unclear whether the costs associated with the endoscopic instruments outweigh any clinical benefit derived from their use and the avoidance of lipocutaneous flaps. This study aimed to compare the direct costs associated with each approach. METHODS: A retrospective review of patients undergoing open or endoscopic CST between 2005 and 2009 was performed. The review compared patient-related variables, length of hospital stay, wound morbidity, and costs associated with the index operation and encounters within a 6-month period. RESULTS: Of the 54 patients identified, 59% underwent endoscopic repair, and 41% had an open CST repair. The patients were similar in age, American Society of Anesthesiology (ASA) score, gender, body mass index (BMI), number of prior surgeries, active abdominal infection, defect size, operating room time, and length of hospital stay. The overall median direct costs were similar between endoscopic and open CST ($9,942 vs. $17,701; p = 0.09). No difference was detected in median operating room costs, but an approximate $7,000 difference was noted between endoscopic and open CST ($1,871 vs. $8,705; p = 0.96). The median mesh costs differed significantly between endoscopic and open CST ($733 vs. $8,415; p = 0.05) as did stapler use costs ($35 vs. $190; p = 0.002). The median cost of endoscopic instruments was $848. Open CST had a 41% major wound morbidity rate compared with 19% in the endoscopic group (p = 0.07). Most of the encounters in the 6-month follow-up period (85%) were related to wound morbidity. The median cumulative direct costs differed between endoscopic and open CST at 3 and 6 months ($12,528 vs. $20,326; p = 0.05). CONCLUSIONS: In a similarly complex group of patients, the total direct costs associated with endoscopic and open CST were similar. Endoscopic instruments made a marginal contribution to the total overall costs, but significant cost contributors were the use of biologic grafts and wound morbidity.

Elevated neutrophil to lymphocyte ratio is associated with decreased amputation-free survival after femoropopliteal percutaneous revascularization.

BACKGROUND: An elevated neutrophil-lymphocyte ratio (NLR) is a biomarker associated with adverse outcomes after cardiovascular surgery. This study evaluates the association of preoperative NLR with clinical outcomes after peripheral vascular intervention (PVI) of the femoropopliteal segments. METHODS: A retrospective review identified 488 patients who underwent percutaneous interventions of femoropopliteal arteries between 2011 and 2018 and had a pre-procedural complete blood count with differential with normal white blood cell count within 30 days prior to intervention. Amputation-free survival (AFS), survival, and freedom from major amputation were assessed using Kaplan-Meier methods. Cohorts of patients with NLR <3 (Low), 3-4 (Mid), and >4 (High) were compared using univariate and multivariable statistical models. In these analyses NLR was analyzed as a continuous variable to correlate with clinical outcomes. RESULTS: Mean age was 71.7±12.8 years and males constituted 55.5%. The majority of patients presented with chronic limb threatening ischemia (CLTI, 78.5%). Increasing NLR was correlated with increasing rates of comorbidities, except for smoking history. The 30-day mortality rates increased with increasing NLR: 1.4%, 4.3%, and 7.0% for low (<3), mid (3-4) and high (>4) NLR groups, respectively (P=0.005). Patients with a lower pre-operative NLR achieved significantly greater amputation-free survival at 4-year follow-up: low NLR, 65.5%; mid NLR, 37.5%; and high NLR, 17.6% (P<0.0001). By multivariable analysis, increasing NLR, advanced age, CLTI, and dialysis-dependent renal failure reduced AFS. CONCLUSIONS: Elevated NLR is an independent predictor of decreased AFS following percutaneous interventions of femoropopliteal segments. Further research on identification and modulation of risk factors for high NLR are warranted.

Antibiotic-releasing mesh coating to reduce prosthetic sepsis: an in vivo study.

BACKGROUND: Mesh related infections are a major challenge with few adequate prevention and treatment options. We evaluate the ability of a slow affinity based drug-releasing polymer to prevent a Staphylococcus aureus mesh infection using an in vivo animal model. METHODS: A surgical wound infection model was used to evaluate a vancomycin (VM) drug loaded polymer. Fifty animals underwent creation of a dorsal subcutaneous pocket, insertion of a standard piece of polyester mesh and an inoculum of a clinical strain of green fluorescent protein (GFP) labeled S. aureus (SA) (10(4) CFU/mL). Animals were then randomly allocated to different treatment groups [saline flush (n = 10), VM flush (n = 20), VM polymer coated mesh (n = 20)]. Local tissue and mesh were evaluated at 2 (n = 25) and 4 wk (n = 25) via standard culture studies. RESULTS: Median GFP SA growth from tissue-mesh homogenates were as follows: 2 wk: saline flush = 2.2 × 10(7) CFU/g; VM flush = 1.6 × 10(6) CFU/g; VM polymer = sterile cultures [P value 0.0001]; 4 wk: saline flush = 1.5 × 10(6) CFU/g; VM flush = 1.6 × 10(3) CFU/g; VM polymer = sterile cultures [P value 0.001]. CONCLUSION: Mesh infections pose a significant challenge in hernia surgery with suboptimal treatment modalities and little innovation. Using an in vivo wound infection model our novel affinity based drug delivering polymer was able to effectively prevent a SA mesh infection with efficacy demonstrated at 2 and 4 wk.

Midterm outcomes in patients with upper extremity deep vein thrombosis.

BACKGROUND: Outcomes and the necessity for anticoagulation in patients with upper extremity deep vein thrombosis (UE DVT) are unclear. The purpose of this study was to determine the incidence of UE DVT, the outcomes of patients stratified by anticoagulation treatment, and which factors were significantly associated with mortality. METHODS: This study was a single-center, retrospective review of all patients undergoing UE venous duplex imaging in 2016. Information on patients' demographics, relevant comorbidities, use of anticoagulation at the time of diagnosis, characteristics of the UE DVT, treatment regimen(s), and outcomes was collected. Data were analyzed using descriptive and univariate statistics; multivariate logistic regression and Cox proportional hazard models were used to identify which of the aforementioned covariates are significantly associated with mortality rates at 30 days and 6 months, respectively, at a 95% confidence level. RESULTS: Of the 911 patients undergoing UE venous duplex imaging, 182 (20.0%) were positive for UE DVT. Within the first 30 days, 30 patients (16.5%) died, 13 (7.1%) had pulmonary emboli, 42 (23.1%) had either pulmonary emboli or died, and 3 (1.6%) had ischemic strokes. Within the first 6 months, 50 patients (27.5%) died. The mortality rate at 30 days was found to be significantly increased in patients who were older (odds ratio [OR], 1.06; P < .01), had high-risk contraindications to anticoagulation (OR, 5.14; P < .01), were on dialysis (OR, 3.03; P = .04), had centrally located UE DVTs (OR, 2.72; P < .05), and had a stroke (OR, 20.34; P = .03). Mortality was significantly decreased in patients who were treated with anticoagulation (OR, 0.16; P < .05). At 6 months, however, age (hazard ratio [HR], 1.05; P < .001), male sex (HR, 2.16; P = .02), dialysis (HR, 2.90; P = .01), high-risk contraindications to anticoagulation (HR, 2.67; P = .02), UE DVTs in both central and peripheral veins (HR, 4.55; P = .03), and ischemic stroke in the first 30 days (HR, 71.63; P < .001) were associated with significant increases in mortality. CONCLUSIONS: These data suggest that mortality rates among patients with UE DVT are relatively high and that treatment with anticoagulation is associated with a decrease in mortality at 30 days. Mortality was also associated with multiple comorbid conditions and demographics and not necessarily venous thromboembolism.

Major complications associated with xenograft biologic mesh implantation in abdominal wall reconstruction.

BACKGROUND: There is limited research for xenograft biologic mesh performance in the setting of infection despite widespread use and significant associated costs. DESIGN: The authors retrospectively reviewed an FDA database for reported xenograft adverse events (AEs). All meshes were used in the setting of abdominal wall reconstruction from 1997 to 2008. RESULTS: The authors identified 150 AEs. Permacol and Collamend comprised 75% (n = 112) of reported cases. Main AEs included acute mechanical failure (42%; n = 63), mesh disintegration (32%; n = 48), and poor mesh integration (13%; n = 20); 80% of cases were described as infected, and nearly 90% of AEs required reoperation. CONCLUSIONS: Major complications are reported to the FDA for xenograft biologic meshes. Cross-linked meshes had the most AE reports to the FDA. The intrinsic properties of meshes and how they relate to infection-related outcomes are poorly understood. The findings from this FDA database review point toward a need to carefully evaluate these products.

Effect of surgical wound classification on biologic graft performance in complex hernia repair: an experimental study.

BACKGROUND: Despite relatively sparse data regarding their outcomes in the setting of infection, biologic grafts have gained rapid acceptance by the surgical community for complex hernia repair. These materials are heterogeneous in their procurement and processing techniques, which may ultimately have an impact in their ability to withstand infection. The objective of this study is to evaluate the impact of varying levels of contamination on biologic graft performance in a chronic ventral hernia animal model. METHODS: Four commonly applied biologic grafts were used in the repair of a chronic ventral hernia rat model (n = 218). Each material was repaired in the setting of 1 of 4 surgical wound classifications (clean, clean contaminated, contaminated, dirty infected) with Staphylococcus aureus as our inoculum agent. After a 30-day survival, repairs underwent quantitative cultures, histological, and biomechanical testing. RESULTS: Marked differences were observed in biologic graft bacterial burden, biomechanical and histological responses at 30 days. Persistent bacterial burden varied among the biologic grafts and increased with increasing wound contamination (P < .05). Delays in wound healing were observed in the contaminated and dirty infected setting (P < .05). Increasing infection weakened the biomechanical strength of repairs (P < .05). CONCLUSION: The degree of bacterial contamination at the time of repair affected the rates of bacterial clearance, wound-healing ability, and subsequent repair strength. Material source and processing techniques might alter graft durability, biocompatibility, and ability to clear bacteria in a contaminated field. Clinical trials are warranted in contaminated settings.

Stitch versus scar--evaluation of laparoscopic pediatric inguinal hernia repair: a pilot study in a rabbit model.

BACKGROUND: Many have questioned whether the laparoscopic, percutaneous hernia repair technique is as durable as an open repair in which the sac is divided and ligated. We set out to assess if the suture alone causes enough injury and scar over time to obliterate the internal ring. MATERIALS AND METHODS: In total, 28 male rabbits with congenital patent processus vaginalis underwent laparoscopic repair with the subcutaneous endoscopically assisted ligation technique. For Group 1 the repairs were evaluated laparoscopically at predetermined time points before and after removal of the ligating suture. Group 2 assessed the effect of sharp peritoneal trauma at the time of repair and was evaluated at 2 and 4 weeks. RESULTS: When durability of repair with suture alone was evaluated, all repairs failed after insufflation to 35 mm Hg after suture removal out to a time point of 12 weeks. In the peritoneal trauma group, at the 2- and 4-week survival time point, 87.5% and 100%, respectively, of repairs remained intact after removal of suture. In contrast, only 25% and 12.5%, respectively, of defects remained closed in the animals repaired with suture ligation alone. CONCLUSIONS: The laparoscopic, percutaneous hernia repair may rely heavily on the suture itself to prevent recurrence. In the event of suture failure, this could lead to an increasingly high recurrence rate. The addition of minor peritoneum trauma may induce sufficient scarring to provide a more durable repair.

Predicting severe postoperative respiratory complications following abdominal wall reconstruction.

BACKGROUND: Patients undergoing abdominal wall reconstruction are at risk of developing major postoperative respiratory complications. The authors attempted to identify factors predictive of respiratory complications following abdominal wall reconstruction. METHODS: All patients who underwent complex abdominal wall reconstruction over a 2-year period were reviewed. The primary endpoint studied was severe respiratory complication, defined as respiratory insufficiency requiring intubation or transfer to a higher level of care. RESULTS: Sixty patients underwent complex abdominal wall reconstruction during the study period. The incidence of respiratory complications was 20 percent. Factors predictive of postoperative respiratory complication included age (p = 0.05), American Society of Anesthesiologists score (p = 0.04), and hernia defect size (p = 0.01). In addition, patients who developed respiratory complications were more likely to have had a greater change in plateau pressure (5.8 versus 2.3 cmH(2)O; p = 0.01). The greater the change in plateau pressure, the greater the risk of developing a respiratory complication: for a change in plateau pressure greater than or equal to 6 cmH(2)O, the odds ratio was 8.67; for a change in plateau pressure greater than or equal to 9 cmH(2)O, the odds ratio was 11.5. CONCLUSIONS: Respiratory complications following abdominal wall reconstruction can be serious and are associated with prolonged hospitalizations. Patients with an increase in their plateau pressure of greater than 6 cmH(2)O are at an increased risk of severe postoperative respiratory complications.

Optimum repair for massive ventral hernias in the morbidly obese patient--is panniculectomy helpful?

BACKGROUND: The appropriate surgical management of morbidly obese patients with symptomatic hernias is not well defined. The authors evaluated the role of simultaneous panniculectomy in complex abdominal wall reconstruction. METHODS: A retrospective study (2007-2010) was conducted of morbidly obese (body mass index > 40 kg/m(2)) patients undergoing open complex abdominal wall reconstruction. RESULTS: Thirty patients were identified. Twenty underwent simultaneous panniculectomy. The median pannus weight was 5.2 kg. Greater all-cause postoperative complications and wound-related morbidity occurred in the panniculectomy group (P < .05). Performing a panniculectomy increased the risk for a wound complication by 5-fold (P = .04). Following 7-month to 9-month follow-up, both groups had a recurrence rate of 10%. CONCLUSION: Simultaneous panniculectomy in the setting of complex abdominal wall reconstruction is feasible but associated with significant postoperative morbidity. Its potential for benefit in reducing long-term hernia recurrence remains unclear.