Five-year results of the LEOPARD trial of commercially available endografts.

OBJECTIVE: The LEOPARD (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) trial is a randomized controlled trial comparing the outcomes of endovascular aneurysm repair (EVAR) using commercially available devices in a real-world population. METHODS: A prospective, randomized, multi-center trial was performed to compare the anatomically fixated (AF) AFX/AFX2 endograft system (Endologix) with endografts with proximal fixation (PF) (Cook Medical Zenith Flex; Gore Excluder; and Medtronic Endurant II) in patients with infrarenal abdominal aortic aneurysms. The primary endpoint was freedom from aneurysm-related complications (ARCs), a composite endpoint consisting of perioperative death (≤30 days), aneurysm rupture, conversion to open surgical repair, postoperative endoleaks, endograft migration (≥10 mm), aneurysm enlargement (≥5 mm), endograft limb occlusion, and device- or aneurysm-related reintervention. RESULTS: The study population was 455 patients enrolled at 56 United States centers: 235 patients were treated with AF devices and 220 with PF devices. The primary endpoint supported noninferiority of the AF cohort at 1 year. The 5-year freedom from ARC Kaplan-Meier estimates were 63.8% for AF patients and 55.5% for PF patients (P = .10). Kaplan-Meier estimates for freedom from aneurysm-related mortality were 98.7% and 97.0% in the AF group and 99.5% and 98.5% in the PF group at 1 and 5 years. There was no difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and type I and type III endoleak between the two cohorts. The type III endoleak rate at 5 years for the AFX cohort was 1.5% and 0.0% for the comparator cohort (P = .11). There was a lower type II endoleak rate in the AF group at 5 years (78.8% vs 68.4%; P = .037). There were zero open surgical conversions (0.0%) in the AF group and four (2.0%) in the PF group. CONCLUSIONS: The 5-year results from the LEOPARD study demonstrated that there was no clinically significant difference in overall aneurysm-related outcomes between patients randomized to the AFX endograft system or commercially available endografts with proximal fixation.

PATENCY-2 trial of vonapanitase to promote radiocephalic fistula use for hemodialysis and secondary patency.

OBJECTIVE: Arteriovenous fistulas created for hemodialysis often fail to become usable and are frequently abandoned. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in increasing radiocephalic fistula use for hemodialysis and secondary patency. METHODS: PATENCY-2 was a randomized, double-blind, placebo-controlled trial in patients on or approaching the need for hemodialysis undergoing radiocephalic arteriovenous fistula creation. Of 696 screened, 613 were randomized, and 603 were treated (vonapanitase n = 405, placebo n = 208). The study drug solution was applied topically to the artery and vein for 10 min immediately after fistula creation. The primary endpoints were fistula use for hemodialysis and secondary patency (fistula survival without abandonment). Other efficacy endpoints included unassisted fistula use for hemodialysis, primary unassisted patency, fistula maturation and unassisted maturation by ultrasound criteria, and fistula procedure rates. RESULTS: The proportions of patients with fistula use for hemodialysis was similar between groups, 70% vonapanitase and 65% placebo, (p = 0.33). The Kaplan-Meier estimates of 12-month secondary patency were 78% (95% confidence interval [CI], 73-82) for vonapanitase and 76% (95% CI, 70-82) for placebo (p = 0.93). The proportions with unassisted fistula use for hemodialysis were 46% vonapanitase and 37% placebo (p = 0.054). The Kaplan-Meier estimates of 12-month primary unassisted patency were 50% (95% CI, 44-55) for vonapanitase and 43% (95% CI, 35-50) for placebo (p = 0.18). There were no differences in the proportion of patients with fistula maturation or in fistula procedure rates. Adverse events were similar between groups. Vonapanitase was not immunogenic. CONCLUSIONS: Vonapanitase treatment did not achieve clinical or statistical significance to meaningfully improve radiocephalic fistula surgical outcomes. Outcome in the placebo group were better than in historical controls. Vonapanitase was well-tolerated and safe. TRIAL REGISTRATION: clinicaltrials.gov: NCT02414841 (https://clinicaltrials.gov/ct2/show/NCT02414841).

A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis.

OBJECTIVE: Arteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis. METHODS: PATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation. Of these, 313 were randomized and 311 treated. Patients were assigned to vonapanitase (n = 210) or placebo (n = 103). The study drug solution was applied topically to the artery and vein for 10 minutes immediately after fistula creation. The primary and secondary end points were primary patency (time to first thrombosis or corrective procedure) and secondary patency (time to abandonment). Tertiary end points included use of the fistula for hemodialysis, fistula maturation by ultrasound, and procedure rates. RESULTS: The Kaplan-Meier estimates of 12-month primary patency were 42% (95% confidence interval [CI], 35-49) and 31% (95% CI, 21-42) for vonapanitase and placebo (P = .25). The Kaplan-Meier estimates of 12-month secondary patency were 74% (95% CI, 68-80) and 61% (95% CI, 51-71) for vonapanitase and placebo (P = .048). The proportions of vonapanitase and placebo patients were 39% and 25% (P = .035) with unassisted use for hemodialysis and 64% and 44% (P = .006) with unassisted plus assisted use. CONCLUSIONS: Vonapanitase treatment did not significantly improve primary patency but was associated with increased secondary patency and use for hemodialysis. Further research is needed to evaluate these end points.

Humerus fracture and combined venous injury increases limb loss in axillary or subclavian artery injury.

OBJECTIVE: Axillosubclavian vessel injury is rare, with most cases occurring after penetrating trauma. A prior database (2002-2006) analysis demonstrated an overall limb loss rate of 2.9%, with no difference between isolated arterial axillosubclavian vessel injury and combined artery/vein axillosubclavian vessel injury. Given increases in advanced vascular surgical techniques, as well as improved multidisciplinary care and expeditious diagnosis with computed tomography angiography, we hypothesized the national rate of limb loss in patients with arterial axillosubclavian vessel injury has decreased. In addition, we attempted to identify current predictors for limb loss in arterial axillosubclavian vessel injury. Finally, we hypothesized that combined artery/vein axillosubclavian vessel injury, as well as associated brachial plexus injury will have a higher risk for limb-loss and mortality compared to isolated arterial axillosubclavian vessel injury. METHODS: A retrospective analysis of the National Trauma Data Bank was performed between 2007 and 2015. All patients ≥ 18 years of age with arterial axillosubclavian vessel injury were included. The primary outcome was limb loss. After a univariable logistic regression model identified significant covariates, we performed a multivariable logistic regression for analysis. RESULTS: Of the total 5,494,609 trauma admissions, 3807 patients had arterial axillosubclavian vessel injury (<0.1%). Of these, 3137 (82.4%) had isolated arterial axillosubclavian vessel injury and 670 (17.6%) had combined artery/vein axillosubclavian vessel injury. The overall limb loss rate was 2.4% (from 2.9% in 2006, p = 0.47). After adjusting for covariates, independent risk factors for limb loss included a combined artery/vein axillosubclavian vessel injury (odds ratio = 3.54, confidence interval = 2.06-6.11, p < 0.001), blunt mechanism (odds ratio = 7.81, confidence interval = 4.21-14.48, p < 0.001), open repair (odds ratio = 2.37, confidence interval = 1.47-3.82, p < 0.001), and open proximal humerus fracture (odds ratio = 8.50, confidence interval = 4.97-14.54, p < 0.001). An associated brachial plexus injury was not associated with limb loss ( p = 0.37). Combined artery/vein axillosubclavian vessel injury was associated with higher risk for mortality compared to isolated arterial axillosubclavian vessel injury (odds ratio = 2.17, confidence interval = 1.73-2.71, p < 0.001). CONCLUSIONS: The national rate of limb loss in trauma patients with arterial axillosubclavian vessel injury has not changed in the past decade. A combined artery/vein axillosubclavian vessel injury is an independent risk factor for limb loss, as well as open repair. However, the strongest risk factor is an open proximal humerus fracture. An associated brachial plexus injury is not associated with increased risk of limb loss. Patients with combined artery/vein axillosubclavian vessel injury have a twofold increased risk of death compared to patients with isolated arterial axillosubclavian vessel injury.

Decreased National Rate of below the Knee Amputation in Patients with Popliteal Artery Injury.

BACKGROUND: Popliteal arterial injury (PAI) is the second most common infrainguinal arterial injury after femoral artery injury with an incidence < 0.2%. A 2003 analysis of the National Trauma Data Bank (NTDB) reported a below the knee amputation (BKA) rate of 7.1% in patients with PAI as well as higher risk in those with an associated fracture or nerve injury. Given advances in vascular surgical techniques, improved multidisciplinary care, and expeditious diagnosis with computed tomography angiography, we hypothesized that the national rate of BKA in patients with PAI has decreased and sought to identify risk factors for BKA in patients with PAI. METHODS: A retrospective analysis of the NTDB was performed from 2007 to 2015. Patients ≥15 years of age with PAI were included and grouped by mechanism of injury (blunt versus penetrating). Interfacility transfers were excluded. The primary outcome of interest was BKA. Univariable and multivariable analyses were performed to identify predictors of BKA in patients with PAI. RESULTS: From 4,385,698 patients, 5,143 were identified with PAI (<0.2%) with most involved in a blunt mechanism (56.8%). The overall limb loss rate was 5.1% (decreased from 7.1% in 2003, P = 0.0037). After adjusting for covariates, a blunt mechanism (odds ratio [OR] = 3.53, confidence intervals [CI] = 2.49-5.01, P < 0.001) and open proximal tibia/fibula fracture or dislocation (OR = 2.71, CI = 2.08-3.54, P < 0.001) were independent risk factors for BKA in patients with PAI. A combined popliteal vein injury (PVI) did not increase the risk for BKA (P = 0.64). CONCLUSIONS: The national rate of limb loss in trauma patients with PAI has decreased from 7.1 to 5.1%. A blunt mechanism of injury as well as proximal open tibia/fibula fracture or dislocation continue to be the independent risk factors for BKA. Confirming a previous report, we found a combined PVI not to be associated with higher risk for BKA. Future prospective research to determine other possible contributing factors such as intraoperative hemodynamics and utilization of vascular shunt and fasciotomy appears warranted.

Learning Curve of Robotic Lobectomy for Early-Stage Non-Small Cell Lung Cancer by a Thoracic Surgeon Adept in Open Lobectomy.

OBJECTIVE: The aim of the study was to characterize the clinical outcomes and learning curve during the adoption of a robotic platform for lobectomy for early-stage non-small cell lung cancer by a thoracic surgeon experienced in open thoracotomy. METHODS: Retrospective review of 157 consecutive patients (57 open thoracotomies, 100 robotic lobectomies) treated with lobectomy for clinical stage I or II non-small cell lung cancer between 2007 and 2014. Clinical outcomes were compared between the open thoracotomy group and five consecutive groups of 20 robotic lobectomies. We used the following six metrics to evaluate learning curve: operative time, conversion to open, estimated blood loss, hospitalization duration, overall morbidity, and pathologic nodal upstaging. RESULTS: The robotic and open thoracotomy groups had equivalent preoperative characteristics, except for a higher proportion of clinical stage IA patients in the robotic cohort. The robotic group, as a whole, had lower intraoperative blood loss, less overall morbidity, shorter chest tube duration, and shorter length of hospital stay as compared with the open thoracotomy group. Operative time demonstrated a bimodal learning curve. Conversion rate diminished from 22.5% in the first two robotic groups to 6.7% in the latter three groups. The rate of pathologic nodal upstaging was statistically equivalent to the open thoracotomy group. CONCLUSIONS: Adoption of a robotic platform for lobectomy for early-stage non-small cell lung cancer by an experienced open thoracic surgeon is safe and feasible, with fewer complications, less blood loss, and equivalent nodal sampling rate even during the learning curve. The conversion to open rate significantly dropped after the first 40 robotic lobectomies, and operative time for robotic lobectomy approached open thoracotomy after 60 cases, after a bimodal curve.

Hospital Teaching Status and Readmission after Open Abdominal Aortic Aneurysm Repair.

BACKGROUND: Readmission after abdominal aortic aneurysm (AAA) repair to a different (nonindex) hospital has been shown to be associated with high mortality rates. Factors influencing this association remain unknown. The objective of this study was to determine the impact of hospital teaching status on nonindex hospital readmission and mortality. METHODS: An observational analysis of the longitudinally linked California Office of Statewide Health Planning and Development database was conducted from 1995 to 2009. Patients who were readmitted within 30 days after open AAA repair were included. The primary outcome measured was mortality on readmission. RESULTS: Over the 15-year study period, 3,475 readmissions after AAA were analyzed, of which 1,020 (29.4%) were to a nonindex hospital. After adjusting for age, race, gender, insurance, comorbidities, perioperative factors, and reason for readmission, nonindex readmission for patients undergoing their initial operation at a teaching hospital did not impact mortality (odds ratio [OR] 0.78, 95% confidence interval [CI] 0.28-2.17, P = 0.63). Nonindex readmission for patients undergoing their initial operation at a nonteaching hospital, however, significantly increased mortality (OR 1.63, 95% CI 1.04-2.54, P = 0.03). CONCLUSIONS: Readmission to a different hospital is associated with a higher mortality rate for patients undergoing AAA repair at nonteaching hospitals. This effect is not seen in patients having their initial operation performed at teaching hospitals, possibly due to infrastructure at these hospitals allowing for decreased impact from fragmentation of care. In cases where triage to an index hospital for readmission is not possible, communication at a high level between the index hospital and readmission hospital is paramount.

The natural history of type 2 endoleaks after endovascular aneurysm repair justifies conservative management.

Objective Management of type 2 endoleaks after endovascular aneurysm repair has been controversial. Some advocate for conservative management, while others believe that intervention is indicated. This study investigated the natural history of type 2 endoleaks in order to derive direction in management. Methods Patients who had endovascular aneurysm repair at the Veterans Affairs Long Beach were retrospectively identified and computerized tomographic angiography was independently reviewed by a radiologist and a vascular surgeon. Type 2 endoleaks were analyzed for the following outcomes: rupture, duration of endoleak, spontaneous resolution, changes in the size of the aneurysm sac, and reintervention rates. Results Of the 160 patients who had completed required follow-up to date (mean 3 years) after endovascular aneurysm repair, 39 (24.4%) patients were identified as having a type 2 endoleak on computerized tomographic angiography imaging. 6 (15.4%) of these 39 patients required repair due to aneurysm sac growth >1 cm. 2 (5.13%) were repaired with an open procedure and 4 (10.3%) with an endovascular approach. Of these 6 aneurysm leaks requiring repair, 4 (66.7%) had a simultaneous endoleak (types 1 or 3) in addition to the identified type 2 endoleak. Spontaneous resolution of type 2 endoleaks occurred in 16 (41.0%) patients. 4 patients (10.3%) had delayed type 2 endoleaks that presented 4, 9, 12, and 23 months after their 30 day post op computed tomography was normal. None of the 4 patients with delayed type 2 endoleaks required reintervention and none had aneurysm sac growth greater than 5 mm. Conclusions Overall, we found that 85% of patients who had type 2 endoleaks did not require intervention after a mean follow-up time of 3 years. The association of a type 1 or 3 endoleak with a type 2 endoleak was more likely to require correction due to aneurysm expansion >1 cm, thus type 2 endoleaks associated with another type of endoleak require more aggressive management.

Flow Rates at Thirty Days after Construction of Radiocephalic Arteriovenous Fistula Predict Hemodialysis Function.

BACKGROUND: Construction of radiocephalic arteriovenous fistula (RC-AVF) results in successful hemodialysis (HD) in approximately 40% of end-stage renal disease patients. We investigated whether RC-AVF flow measured by ultrasound 30 days postoperative predicted successful HD. METHODS: In this prospective study, color Doppler ultrasound was used to measure cephalic vein outflow volume at 3 forearm sites at 1 and 3 months postoperatively. RESULTS: Of 45 consecutive patients screened for feasibility of RC-AVF by physical examination and US arterial and vein mapping, 41 were considered suitable for construction of RC-AVF. Mean age was 70 (60-78) years. Of the 41 patients who had a forearm RC-AVF, 25 (61%) proceeded to successful AVF dialysis, 4 (10%) had HD via central venous catheter, and 12 (29%) ceased function within the first 30 days postoperatively. The mean flow at 30 days for patent fistulas was 629 ± 305 ml/min and by the third month had increased to 663 ± 367 mL/min. At 1 month, 8/29 (27.6%) patients had a flow rate <400 mL/min. Two (25%) of these clotted, 2 of 3 with closed revisions went on to HD, and 1 died. Of the 21 patients with a flow rate ≥400 mL/min, 19 (90%) functioned for HD, and 2 (10%) AVF occluded before 1 year, resulting in 17 functioning at 1 year (81% 1-year patency). Sixty-two percent of the low-flow fistulas had successful patency within 1 year. CONCLUSIONS: An RC-AVF flow rate of ≥400 mL/min in the first month predicted more successful HD than low flow (<400 mL/min) (81% vs. 62%). Without intervention, low flow rates do not improve significantly and maturation is unlikely. We recommend imaging for all patients at 30 days to identify and promptly correct stenosis in those with low flow rates.

Telavancin in the Treatment of Concurrent Staphylococcus aureus Bacteremia: A Retrospective Analysis of ATLAS and ATTAIN Studies.

INTRODUCTION: Concurrent Staphylococcus aureus bacteremia (SAB) worsens outcomes and increases mortality in patients with complicated skin and skin structure infections (cSSSI), hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia (HABP/VABP). These challenges highlight the need for alternative treatments. Telavancin (TLV), a bactericidal lipoglycopeptide with high in vitro potency, effectively treats patients with cSSSI and HABP/VABP caused by Gram-positive pathogens, particularly S. aureus. METHODS: This retrospective analysis evaluated patients from the Assessment of Telavancin in Complicated Skin and Skin Structure Infections and Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia studies with baseline, concurrent SAB. Differences in the clinical cure rates at test-of-cure and safety outcomes were compared for TLV vs vancomycin (VAN) treatment groups. RESULTS: A total of 105 patients, 32 cSSSI and 73 HABP/VABP, had baseline, concurrent SAB. The clinical cure rates for all-treated SAB patients in the cSSSI (TLV 57.1% and VAN 54.5%) and HABP/VABP (TLV 54.3% and VAN 47.2%) groups were comparable. For both types of infections, the safety profile of TLV and VAN showed similar incidences of adverse events (AEs), serious AEs, or AEs leading to discontinuation. One VAN-treated patient died in the cSSSI group, and there were 13 deaths in each treatment arm of the HABP/VABP group. CONCLUSION: This retrospective analysis demonstrated that TLV is clinically comparable in both efficacy and safety to VAN, and, therefore, may be an appropriate therapeutic option for the treatment of patients with HABP/VABP or cSSSI and concurrent SAB. Given the limited sample size in this subgroup, the interpretation of these results is limited. FUNDING: Theravance Biopharma Antibiotics, Inc.

Postintervention Patency: A Comparison of Stenting versus Patch Angioplasty for Dysfunctional Hemodialysis Access Sites.

BACKGROUND: Arteriovenous access dysfunction is commonly caused by venous outflow stenosis, leading to thrombosis of the conduit. Given that there are limited lifetime hemodialysis access sites, the preservation of existing sites through novel means is of high priority. This study compares the efficacy of balloon angioplasty and stent placement to surgical patch angioplasty for upper arm (brachium) thrombosed or dysfunctional hemodialysis access sites in a group of patients at a single institution. METHODS: Using the operating room log and electronic medical record system, we retrospectively examined the outcomes of 52 consecutive patients (3 were lost to follow-up), who had either stent placement (34 patients) or patch angioplasty (15 patients) for hemodialysis access salvage to calculate postintervention patency. RESULTS: Initial postinterventional patency (PIP1) for patch angioplasty compared with stent placement was not statistically significant at any time during a mean 6-month follow-up (60% vs. 67.65% at 1 month, 33.33% vs. 41.18% at 3 months, and 13.33% vs. 17.65% at 6 months, respectively; P = 0.75). Patency after secondary reintervention (PIP2) was longer for patients who had stent placement as the initial intervention (n = 15) than patients who had patch angioplasty (n = 5; 100% vs. 80% at 1 month, 66.68% vs. 80% at 3 months, and 46.67% vs. 40% at 6 months, respectively), but again there was no statistically significant difference between the 2 groups (P = 0.84). At last, the initial PIP1 of arteriovenous fistula (AVF) and arteriovenous graft (AVG) salvaged before occlusion was significantly different from that of occluded access sites (40% vs. 10% at 6 months, P = 0.024). CONCLUSIONS: Our data suggest that AVF had a longer postinterventional primary patency than AVG though the difference did not reach statistical significance. Stents extended PIP1 for the thrombosed or failing arteriovenous access longer than patch angioplasty, but the difference was not statistically significant. Patency is longer if intervention is made before graft thrombosis. Our data also indicate better prolongation of patency with a second reintervention (PIP2) if the first intervention was a stent placement. Patch angioplasty appears to be a less attractive alternative for correction of venous outflow stenosis given the more invasive and occasionally technically difficult procedure.

Do past mortality rates predict future hospital mortality?

BACKGROUND: This study aimed to determine whether hospitals with higher historical mortality rates are independently associated with worse patient outcomes. METHODS: Observational study of in-hospital mortality in open abdominal aortic aneurysm repair, aortic valve replacement, and coronary artery bypass graft surgery in a California in-patient database was conducted. Hospitals' annual historical mortality rates between 1998 and 2010 were calculated based on 3 years of data before each year. Results were adjusted for race, sex, age, hospital teaching status, admission year, insurance status, and Charlson comorbidity index. RESULTS: Hospitals were divided into quartiles based on historical mortality rates. For abdominal aortic aneurysm repair, the odds ratio (OR) of in-hospital mortality for hospitals within the highest quartile of prior mortality was 1.30 compared with the lowest quartile (95% confidence interval [CI] 1.03 to 1.63). For aortic valve replacement, the OR was 1.41 for the 3rd quartile (95% CI 1.15 to 1.73) and 1.54 for the highest quartile (95% CI 1.27 to 1.87). For coronary artery bypass graft surgery, the OR was 1.33 for the 3rd (95% CI 1.2 to 1.49) and 1.58 for the highest (95% CI 1.41 to 1.76) quartiles. CONCLUSION: Patients presenting to hospitals with high historical mortality rates have a 30% to 60% increased mortality risk compared with patients presenting to hospitals with low historical mortality rates.

Outcomes Improvement Is Not Continuous Along the Learning Curve for Pancreaticoduodenectomy at the Hospital Level.

BACKGROUND: Most studies on learning curves for pancreaticoduodenectomy have been based on single-surgeon series at tertiary academic centers or are inferred indirectly from volume-outcome relationships. Our aim is to describe mortality rates associated with cumulative surgical experience among non-teaching hospitals. STUDY DESIGN: Observational study of a statewide inpatient database. Analysis included hospitals that began performing pancreaticoduodenectomy between 1996 and 2010, as captured by the California Office of Statewide Health Planning and Development database. Cases were numbered sequentially within each hospital. The same sequential series (e.g., first 10 cases, 11th through 20th cases) were identified across hospitals. The outcome measure was in-hospital mortality. RESULTS: A total of 1210 cases from 143 non-teaching hospitals were analyzed. The average age was 63 years old, and the majority of patients were non-Hispanic white. The median overall mortality rate was 9.75 %. The mortality rate for the first 10 aggregated cases was 11.3 %. This improved for subsequent cases, reaching 7.1 % for the 21st-30th cases. However, the mortality rate then increased, reaching 16.7 % by the 41st-50th cases before falling to 0.0 % by the 61st-70th cases. CONCLUSIONS: Initial improvement in surgical outcomes relative to cumulative surgical experience is not sustained. It is likely that factors other than surgical experience affect outcomes, such as less rigorous assessment of comorbidities or changes in support services. Vigilance regarding outcomes should be maintained even after initial improvements.

Survival After Endovascular vs Open Aortic Aneurysm Repairs.

IMPORTANCE: To our knowledge, long-term outcomes of open and endovascular (EVAR) repairs of abdominal aortic aneurysms (AAAs) have not been studied on a population level outside a controlled trial setting. OBJECTIVE: To determine long-term outcomes of EVAR vs open repair on a population level. DESIGN, SETTING, AND PARTICIPANTS: Analysis of the longitudinally linked California Office of Statewide Health Planning and Development inpatient database from 2001 to 2009. Median follow-up was 3.3 years. EXPOSURES: Endovascular vs open repairs. MAIN OUTCOMES AND MEASURES: Mortality and complications at 30 days, as well as long-term mortality and complications up to 9 years. RESULTS: In this observational study, a total of 23 670 patients were studied, with 52% receiving EVAR. Endovascular repair was associated with improved 30-day outcomes (all-cause mortality, readmission, surgical site infection, pneumonia, and sepsis), as well as significantly improved survival until 3 years postoperatively. After 3 years, mortality was higher for patients who underwent an EVAR repair. No significant difference in long-term mortality was observed for the entire cohort on adjusted analysis (hazard ratio, 0.99; 95% CI, 0.94-1.04; P = .64). Endovascular repair was found to be associated with a significantly higher rate of reinterventions and AAA late ruptures. CONCLUSIONS AND RELEVANCE: The survival advantage for EVAR repair in a statewide population is maintained for 3 years. After 3 years, EVAR repair was associated with higher mortality; however, these mortality differences did not reach statistical significance over the entire study period. Reintervention and late AAA rupture rates are higher after EVAR repair.

Skin and soft-tissue infections: a critical review and the role of telavancin in their treatment.

Skin and soft-tissue infections (SSTIs) are an important cause of morbidity and mortality among hospitalized patients and a major therapeutic challenge for clinicians. Although uncomplicated SSTIs are managed successfully on an outpatient basis, more serious infections extending to the subcutaneous tissue, fascia, or muscle require complex management. Early diagnosis, selection of appropriate antimicrobials, and timely surgical intervention are key to successful treatment. Surgical-site infections, an important category of SSTI, occur in approximately half a million patients in North America annually. SSTIs are also a potential source for life-threatening bacteremia and metastatic abscesses. Gram-positive organisms, such as Staphylococcus aureus and Streptococcus pyogenes, are the dominant organisms isolated early in the infectious process, whereas gram-negative organisms are found in chronic wounds. Methicillin-resistant S. aureus (MRSA) is a potential bloodstream invader that requires aggressive antimicrobial treatment and surgery. Recent concerns regarding vancomycin activity include heteroresistance in MRSA and increase in the minimum inhibitory concentrations (>1 or 2 µg/mL); however, alternative agents, such as telavancin, daptomycin, linezolid, ceftaroline, dalbavancin, oritavancin, and tedizolid, are now available for the treatment of severe MRSA infections. Here, we present a review of the epidemiology, etiology, and available treatment options for the management of SSTIs.

Less Than Total Excision of Infected Prosthetic PTFE Graft Does Not Increase the Risk of Reinfection.

BACKGROUND: Traditional treatment of infected polytetrafluoroethylene (PTFE) grafts consist of removal of the entire prosthesis. Closure of the native vessels may compromise vascular patency. We examined the outcomes for patients in whom a PTFE remnant of an infected graft was retained on the vessel. METHODS: We reviewed the operating room log from 2000 to 2011 and identified all patients who had partial removal of an infected PTFE graft used for hemodialysis or peripheral bypass. These patients were examined for subsequent complications. RESULTS: Twenty-seven patients underwent 30 partial graft excisions with mean follow-up of 27 months. A total of 17% (5 of 30) of the partial graft resection procedures resulted in complications. Of 48 total remnants left behind at the arterial or venous anastomoses, reinfection occurred in 15%. CONCLUSIONS: Leaving a well-incorporated small 1-to 5-mm PTFE remnant at the arterial or venous anastomoses can be performed safely with a low risk of complications.

Factors associated with small abdominal aortic aneurysm expansion rate.

IMPORTANCE: Because of the high mortality rate after rupture of small abdominal aortic aneurysms (AAAs), surveillance is recommended to detect aneurysm expansion; however, the effects of clinical risk factors on long-term patterns of AAA expansion are poorly characterized. OBJECTIVE: To identify significant clinical risk factors associated with the AAA expansion rate for both constant and accelerated expansion trajectories. DESIGN, SETTING, AND PARTICIPANTS: A multivariate mixed-effects model was established to identify clinical risk factors associated with the AAA expansion rate. Separate shape factor analysis was used to characterize steady vs accelerated expansion over time. Five hundred sixty-seven patients hospitalized at Veterans Affairs medical centers were randomized to the surveillance arm of the Aneurysm Detection and Management (ADAM) study conducted by the Veterans Affairs Cooperative Studies Program from 1992 to 2000. The patients had an AAA with a maximum diameter from 3.0 to 5.4 cm, which was monitored until a 5.5-cm maximum diameter was reached or the aneurysm became symptomatic. Thirty-three participants were not included in this analysis owing to missing or extraneous values in key predictor variables. The mean (SD) follow-up time was 3.7 (2.0) years. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the AAA expansion rate, determined by measurement of the maximum diameter by ultrasonography at regular intervals. The objective to assess the association of clinical variables with the expansion of the AAA was formulated after data collection. RESULTS: The mean (SD) linear expansion rate of AAAs was 0.26 (0.01) cm/y. Current smoking was associated with a 0.05 (0.01)-cm/y increase in the linear expansion rate (95% CI, 0.25-0.28; P < .001), diastolic blood pressure with a 0.02 (0.01)-cm/y increase per 10 mm Hg (95% CI, 0.01-0.04; P = .001), and diabetes mellitus with a 0.11 (0.02)-cm/y decrease (95% CI, 0.07-0.16; P < .001). Diastolic blood pressure and baseline AAA diameter were associated with accelerated AAA expansion (P = .001 and P < .001, respectively). CONCLUSIONS AND RELEVANCE: Smoking cessation and control of diastolic blood pressure are direct actions that should be taken to reduce the rate of AAA expansion. Other clinical risk factors, except for diabetes, were not associated with the AAA expansion rate. This study also provides evidence of differing trajectories in AAA expansion over time, a finding that merits further investigation.

Stent salvage of arteriovenous fistulas and grafts.

OBJECTIVES: This study analyzes our experience using stents to salvage dysfunctional hemodialysis access sites at a single institution. METHODS: We examined the outcomes of 42 consecutive patients who had covered (36 patients) or bare-metal (9 patients) stent intervention for hemodialysis access salvage. RESULTS: Of our 42 male patients, 11 had stent salvage of an arteriovenous fistula, which yielded postintervention primary and secondary 6-month patencies of 27% and 55%, respectively. For 31 patients with arteriovenous grafts, the postintervention primary and secondary 6-month patencies were 26% and 29%, respectively. Patency rates were superior for stents placed in patent access sites, in fistulas compared to grafts, and when stents were placed in forearm sites although only the latter achieved statistical significance. CONCLUSIONS: Stents can extend patency for the thrombosed or failing arteriovenous access, but results are poor once thrombosis has occurred. Stent placement appears to be more effective in fistulas compared to grafts.

Surveillance computed tomographic arteriogram does not change management before 3 years in patients who have a normal post-EVAR study.

BACKGROUND: Standard surveillance after endovascular abdominal aortic aneurysm repair (EVAR) consists of periodic computed tomographic arteriographies (CTAs) usually performed at postoperative months 1, 6, and 12, and then annually. This imaging regimen is expensive and exposes patients to the hazards of radiation and intravenous contrast. We hypothesized that a normal 1-month CTA after EVAR with no endoleak or other significant abnormality predicts a low rate of future complications, which would justify a reduction in frequency of subsequent CTAs. METHODS: We identified 106 consecutive patients who underwent EVAR at a single hospital from 2003 to 2010 and reviewed all their CTAs. Fifteen patients for whom we could not review a postoperative CTA were excluded. Of the remaining 91 patients, 70 (76.9%) had no abnormality on their CTA at 1 month after EVAR. The medical records of these 70 patients were analyzed for subsequent complications and interventions related to EVAR. RESULTS: The mean patient follow-up was 3.4 ± 2.1 years. Five of the 70 (7.1%) patients with a normal post-EVAR CTA developed late complications consisting of 1 type I endoleak, 3 type II endoleaks, and 1 case of endotension. Only the type I endoleak and one of the type II endoleaks met criteria for intervention, and in both cases, the endoleaks were discovered >3 years after EVAR. Log-rank test showed a statistically significant increased freedom from aneurysm sac expansion in patients with a normal compared with an abnormal 1-month CTA (P < 0.001). CONCLUSIONS: For patients who have a normal CTA with no endoleak 1 month after EVAR, it is reasonable to consider less-frequent CTA surveillance because no significant complications requiring intervention occurred before 3 years. This would decrease unnecessary CTAs and health care expenditures as well as minimize patient exposure to radiation and intravenous contrast.