Conservative Management of Non-Infected Diabetic Foot Ulcers Achieves Reliable Wound Healing and Limb Salvage in the Setting of Mild-Moderate Ischemia.

BACKGROUND: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing among patients with critical limb threatening ischemia (CLTI). Our goal was to analyze the use of a previously reported conservative wound care approach to non-infected (foot infection score of zero), diabetic foot ulcers with mild-moderate peripheral arterial disease enrolled in a conservative tier of a multidisciplinary limb preservation program. METHODS: Veterans with CLTI and tissue loss were prospectively enrolled into our Prevention of Amputation in Veterans Everywhere (PAVE) program. All patients with wounds were stratified to a conservative approach based on perfusion evaluation and a validated pathway of care. Retrospective analysis of a prospectively maintained database was performed to evaluate all conservatively managed patients presenting without foot infection for the primary outcome of wound healing as well as secondary outcomes of time to wound healing, delayed revascularization, wound recurrence, and limb loss. RESULTS: Between January 2006 and December 2019, 1113 patients were prospectively enrolled into the PAVE program. A total of 241 limbs with 281 wounds (217 patients) were stratified to the conservative approach. Of these, 122 limbs (89 patients) met criteria of having diabetic foot wounds without infection at the time of enrollment and are analyzed in this report. Of the 122 limbs, 97 (79.5%) healed their index wound with a mean time to healing of 4.6 months (0.5-20 months). Wound recurrence ensued in 44 (45.4%) limbs, 93.2% of which healed again after recurrence. There were three (3.1%) limbs requiring major amputation in this group (one due to uncontrolled infection and two due to ischemic tissue loss). Of the 25 (20.5%) limbs that did not heal initially, four (16%) required amputation due to progressive symptoms of CLTI. CONCLUSIONS: In patients with diabetes and lower extremity wounds without infection in the setting of mild to moderate peripheral arterial disease, there appears to be an acceptable rate of index wound healing, and appropriate rate of recurrent wound healing with a low risk of limb loss. While wound recurrence is frequent, this can be successfully treated without the need for revascularization.

A single center's 15-year experience with palliative limb care for chronic limb threatening ischemia in frail patients.

OBJECTIVE: Our institution's multidisciplinary Prevention of Amputation in Veterans Everywhere (PAVE) program allocates veterans with critical limb threatening ischemia (CLTI) to immediate revascularization, conservative care, primary amputation, or palliative limb care according to previously reported criteria. These four groups align with the approaches outlined by the global guidelines for the management of CLTI. In the present study, we have delineated the natural history of the palliative limb care group of patients and quantified the procedural risks and outcomes. METHODS: Veterans prospectively enrolled into the palliative limb cohort of our PAVE program from January 2005 to January 2020 were analyzed. The primary outcome was mortality. The secondary outcomes included overall and limb-related readmissions, limb loss, and wound healing. The clinical frailty scale (CFS) score was calculated, and the 5-year expected mortality was estimated using the Veterans Affairs Quality Enhancement Research Initiative tool. Regression analysis was performed to establish associations among the following variables: mortality, wound, ischemia, and foot infection (WIfI) score, CFS score, overall admissions, and limb-related admissions. RESULTS: The PAVE program enrolled 1158 limbs during 15 years. Of the 1158 limbs, 157 (13.5%) in 145 patients were allocated to the palliative limb care group. The overall mortality of the group was 88.2% (median interval, 3.5 months; range, 0-91 months). Of the 128 patients who had died, 64 (50%) had died within 3 months of enrollment. The predicted 5-year mortality for the group was 66%. The average CFS score for the group was 6.2, denoting persons moderately to severely frail. Using the CFS score, 106 patients were considered frail and 39 were considered not frail. No differences were found in mortality between the frail and nonfrail patients. However, a statistically significant difference was found in early (<3 months) mortality (56.2% vs 37.5%; P = .032). The 30-day limb-related readmission rate was 4.7%. Eventual major amputation was necessary for 18 limbs (11.5%). Wound healing occurred in 30 patients (20.6%). Regression analysis demonstrated no association between the CFS score and mortality (r = 0.55; P = .159) or between the WIfI score and mortality (r = 0.0165; P = .98). However, a significant association was found between the WIfI score and limb-related admissions (r = 0.97; P < .001). CONCLUSIONS: Frail patients with CLTI had high early mortality and a low risk of limb-related complications. They also had a low incidence of deferred primary amputation or limb-related readmissions. In our cohort, the vast majority of patients had died within a few months of enrollment without requiring an amputation. A comprehensive approach to the treatment of CLTI patients should include a palliative limb care option because a significant proportion of these patients will have limited survival and can potentially avoid unnecessary surgery and major amputation.

Arteriovenous fistula maturation: Physical exam versus flow study.

PURPOSE: The purpose of this study was to determine the utility of routine duplex flow study 4 to 6 weeks after primary AVF creation and to compare physical exam against a duplex flow study in predicting fistula maturation. A surveillance algorithm was established to evaluate the naïve fistula after primary creation. METHODS: This was a single institution retrospective review of 155 veterans with primary autogenous AVF creation from 2016 to 2018. All patients received a duplex flow study evaluation after primary creation. A comparison was made between physical exam (PE) and flow study at 4 to 6 weeks post creation. Sensitivities and specificities of physical exam and duplex flow study were compared head-to-head in predicting unassisted fistula maturation. A mature AVF was defined as a fistula that could be repetitively cannulated and provided adequate flow for dialysis. Failure of maturation was defined as an AVF that was never usable for dialysis. An abnormal duplex included thrombosis, stenosis (> 50% on gray scale imaging), inadequate vein diameter (< 4 mm), inadequate vein length or superficialization, or poor flow (< 500 ml/min). Bivariate comparisons were conducted using Pearson's χ², Fishers exact test, and Wilcoxon test depending on distribution. Significance was defined as P < 0.05. RESULTS: There were 53 patients with radiocephalic (RC) fistulas, 41 patients with brachiocephalic (BC) fistulas, and 6 patients with brachiobasilic (BB) fistulas. Of patients with a confirmed abnormal duplex ultrasound, 53% had an abnormal PE (sensitivity 53%; PPV 96.3%, P < 0.001). Of the patients with a confirmed normal duplex, 98% had a normal PE (specificity 98%; NPV 68.5%, P < 0.001). An abnormal duplex flow study had a 67% sensitivity for predicting AVF failure or need for reintervention while an abnormal physical examination had a 42% sensitivity in predicting AVF failure or need for reintervention (P < 0.001). In total, 48 fistulas needed reintervention, however only 20 (42%) were associated with an abnormal physical examination. Of those 48 reinterventions, 20 (42%) fistulas exhibited primary assisted maturation (P < 0.001). On duplex flow study alone, 32 patients had hemodynamically significant lesions necessitating reintervention, which went on to afford 9 (28%) primary assisted mature fistulas (P = 0.69). CONCLUSION: Abnormal duplex flow studies have a better sensitivity for detecting AVF failure or the need for reintervention compared to physical exam alone. An abnormal duplex correlates more with needing a reintervention to achieve maturation than physical exam. Therefore, we advocate routine use of a postoperative duplex flow study to identify potentially correctable issues and optimize fistula maturation.

First Reported Case of Neointimal Hyperplasia in the Midportion of a Polytetrafluoroethylene Dialysis Graft.

We report a case of stenosis involving the midportion of a polytetrafluoroethylene graft caused by the infiltration of fibroblasts into the lumen of the graft with the development of fibrovascular tissue.

5-Item Modified Frailty Index Predicts Outcomes After Below-Knee Amputation in the Vascular Quality Initiative Amputation Registry.

Patient frailty indices are increasingly being utilized to anticipate post-operative complications. This study explores whether a 5-factor modified frailty index (mFI-5) is associated with outcomes following below-knee amputation (BKA). All BKAs in the vascular quality initiative (VQI) amputation registry from 2012-2017 were reviewed. Preoperative frailty status was determined with the mFI-5 which assigns one point each for history of diabetes, chronic obstructive pulmonary disease or active pneumonia, congestive heart failure, hypertension, and nonindependent functional status. Outcomes included 30-day mortality, unplanned return to odds ratio (OR), post-op myocardial infarction (MI), post-op SSI, all-cause complication, revision to higher level amputation, disposition status, and prosthetic use. 2040 BKAs were performed. Logistic regression showed an increasing mFI-5 score that was associated with higher risk of combined complications (OR 1.22, confidence interval [CI] 1.07-1.38, P < .05), 30-day mortality (OR 1.60, CI 1.19-2.16, P < .05), post-op MI (OR 1.79, CI 1.30-2.45, P < .05), and failure of long-term prosthetic use (OR 1.17, CI 1.03-1.32, P < .05). In the VQI, every one-point increase in mFI-5 is associated with an increased risk of 22% for combined complications, 60% for 30-day mortality, nearly 80% for post-op MI, and 17% for failure of prosthetic use in BKA patients. The mFI-5 frailty index should be incorporated into preoperative planning and risk stratification.

True Superficial Temporal Artery Aneurysm Presenting as a Delayed Traumatic Pseudoaneurysm: A Case Report and Review of Literature.

A rare case of a true temporal artery aneurysm is presented with review of the literature.

A conservative approach to select patients with ischemic wounds is safe and effective in the setting of deferred revascularization.

OBJECTIVE: The Wound, Ischemia, and foot Infection classification system has been validated to predict benefit from inmediate revascularization and major amputation risk among patients with peripheral arterial disease. Our primary goal was to evaluate wound healing, limb salvage, and survival among patients with ischemic wounds undergoing revascularization when intervention was deferred by a trial of conservative wound therapy. METHODS: All patients with peripheral arterial disease and tissue loss are prospectively enrolled into our Prevention of Amputation in Veterans Everywhere limb preservation program. Limbs are stratified into a validated pathway of care based on predetermined criteria (immediate revascularization, conservative treatment, primary amputation, and palliative care). Limbs allocated to the conservative strategy that failed to demonstrate adequate wound healing and were candidates, underwent deferred revascularization. Rates of wound healing, freedom from major amputation, and survival were compared between patients who underwent deferred revascularization with those who received immediate revascularization by univariate and multivariate analysis. RESULTS: Between January 2008 and December 2017, 855 limbs were prospectively enrolled into the Prevention of Amputation in Veterans Everywhere program. A total of 203 limbs underwent immediate revascularization. Of 236 limbs stratified to a conservative approach, 185 (78.4%) healed and 33 (14.0%) underwent deferred revascularization (mean, 2.7 ± 2.6 months). The mean long-term follow-up was 51.7 ± 37.0 months. Deferred compared with immediate revascularization demonstrated similar rates of wound healing (66.7% vs 57.6%; P = .33), freedom from major amputation (81.8% vs 74.9%; P = .39), and survival (54.5% vs 50.7%; P = .69). After adjustment for overall Wound, Ischemia, and foot Infection stratification stages, deferred revascularization remained similar to immediate revascularization for wound healing (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.7-3.2), freedom from major amputation (HR, 0.7; 95% CI, 0.3-1.7) and survival (HR, 1.2; 95% CI, 0.6-2.4). CONCLUSIONS: Limbs with mild to moderate ischemia that fail a trial of conservative wound therapy and undergo deferred revascularization achieve similar rates of wound healing, limb salvage, and survival compared with limbs undergoing immediate revascularization. A stratified approach to critical limb ischemia is safe and can avoid unnecessary procedures in selected patients.

Immediate Carotid Endarterectomy Is Associated with Higher Risk in Symptomatic Patients.

BACKGROUND: Guidelines recommend that patients with carotid artery stenosis ≥50% (Sx-CAS) undergo carotid endarterectomy (CEA) within 14 days of symptoms. However, perioperative risks, especially stroke, may be increased when CEA is performed within 48 hours. This study seeks to more fully evaluate the effect of timing of surgery on outcomes for Sx-CAS. METHODS: All CEAs in the Southern California Vascular Outcomes Improvement Collaborative (SoCal VOICe) from 2012 to 18 were reviewed. Ipsilateral cortical or visual symptoms within 6 months defined Sx-CAS. Timing from symptom occurrence to CEA was classified as immediate (0-2 days), early (3-14 days), or delayed (>14 days). Perioperative stroke, myocardial infarction (MI), and 30-day mortality rates were compared by time to surgery. RESULTS: Of 2203 CEAs, 436 (20%) were for Sx-CAS (52% stroke, 48% transient ischemic attack). Mean time from symptoms to CEA was 28.3 days (range, 0-172; median, 14 days). Sixty-one cases (14%) were immediate, 166 (38%) early, and 209 (48%) delayed. Perioperative stroke occurred in 2.8% and stroke/MI/30-day mortality in 5.7%. Stroke rate was significantly higher in the immediate group (vs. early and delayed): 8.2%, versus 3.0%, and 0.96%, respectively (P = 0.009). Stroke/MI/30-day mortality was also higher in the immediate group: 13.1%, versus 6.0%, and 3.3%, respectively (P = 0.001). Immediate surgery was associated with greater postoperative events (P = 0.009), and logistic regression confirmed decreased risk of postoperative stroke and stroke/MI/30-day mortality in delayed surgery using immediate surgery as a reference. Wide variability existed among centers in the timing of CEA (immediate-range, 0-50%; delayed-range, 41-83%; P = 0.01). CONCLUSIONS: In the SoCal VOICe, 52% of patients undergo CEA within 2 weeks of symptoms. Increased stroke rates occur when CEA is performed within 2 days, whereas stroke and death rates are decreased at 3-14 days and beyond. These data support avoidance of immediate CEA. Opportunity exists to standardize timing of CEA for Sx-CAS among SoCal VOICe participants. Further study is required to define the role of immediate CEA.

Multidisciplinary approach achieves limb salvage without revascularization in patients with mild to moderate ischemia and tissue loss.

OBJECTIVE: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing and limb salvage of patients with peripheral artery disease (PAD). Our goal was to evaluate the association between WIfI stage and wound healing, limb salvage, and survival in a select cohort of patients with PAD and tissue loss undergoing an attempt of wound healing without immediate revascularization (conservative approach) in a multidisciplinary wound program. METHODS: Veterans with PAD and tissue loss were prospectively enrolled in our Prevention of Amputation in Veterans Everywhere (PAVE) program. Limbs were stratified to a conservative, revascularization, primary amputation, and palliative limb care approach based on the patient's fitness, ambulatory status, perfusion evaluation, and validated pathway of care. Rates of wound healing, wound recurrence, limb salvage, and survival were retrospectively analyzed by WIfI clinical stages (stage 1-4) in the conservative group. Cox regression modeling was used to estimate clinical outcomes by WIfI stage. RESULTS: Between January 2006 and October 2017, there were 961 limbs prospectively enrolled in our PAVE program. A total of 233 limbs with 277 wounds were stratified to the conservative approach. WIfI staging distribution included 19.7% stage 1, 20.2% stage 2, 38.6% stage 3, and 21.5% stage 4. All ischemia scores were classified as 1 or 2. Advanced wound interventions and minor amputations were performed on 40 limbs (16.6%) and 57 limbs (23.7%), respectively. Average long-term follow-up was 41.4 ± 29.0 months. Complete wound healing without revascularization was achieved in 179 limbs (76.8%) during 4.4 ± 4.1 months. Thirty-four limbs (14%) underwent deferred revascularization because of a lack of complete wound healing. At long-term follow-up, wound recurrence per limb was 39%. Overall limb salvage at long-term follow-up was 89.3%. Stratified by WIfI stage, there was no statistically significant difference between groups for wound healing (P = .64), wound recurrence (P = .55), or limb salvage (P = .66) after adjustment for significant patient, limb, and wound characteristics. CONCLUSIONS: In select patients with mild to moderate ischemia and tissue loss, a stratified approach can achieve acceptable rates of wound healing and limb salvage, with limited need for deferred revascularization. WIfI clinical staging did not predict wound healing, limb salvage, or survival in this cohort.

Association between Preoperative Indications and Outcomes after Major Lower Extremity Amputation.

Despite aggressive limb salvage techniques, lower extremity amputation (LEA) is frequently performed. Major indications for LEA include ischemia and uncontrolled infection (UI). A review of the national Vascular Quality Initiative amputation registry was performed to analyze the influence of indication on outcomes after LEA. Retrospective review of the Vascular Quality Initiative LEA registry (2012-2017) identified all above- and below-knee amputations. Outcome measures included 30-day mortality, return to operating room (OR), postoperative myocardial infarctions, and postoperative SSI. Indications for surgery included ischemic rest pain, ischemic tissue loss (TL), acute limb ischemia (ALI), UI, and neuropathic TL. A total of 6701 patients met the inclusion criteria. The indications for surgery included TL (49.0%), UI (31.7%), ALI (8.0%), rest pain (6.6%), and neuropathic TL (2.3%). Patients with ALI had the highest 30-day mortality (12.0%) compared with TL (6.6%) and UI (6.4%) [P < 0.001]. The highest rate of return to OR occurred in the UI group (12.6%) [P < 0.001]. Multivariate analysis demonstrated that patients with UI have significantly higher rates of return to OR, whereas those with ALI have a 30-day mortality twice as high as other indications (both P < 0.001). These data can inform expectations after LEA based on the indications for surgery.

Who is treating venous disease in America today?

OBJECTIVE: This study examined the specialty, board certification, and training of physicians who are treating venous disease in the United States. METHODS: Internet searches were performed to identify the websites of physicians who treat venous disease in large metropolitan areas. The websites of large multistate venous corporations were also searched. The American Board of Venous and Lymphatic Medicine (ABVLM) website was also used to identify venous providers. These providers were then searched for in the American Board of Medical Specialties website. The data were then analyzed statistically. RESULTS: Physicians treating venous disease were certified in a large variety of medical, surgical, and radiologic specialties; 17.6% of providers did not have an active certification. For the South, Northeast, and Mid-West regions, physicians without an active board certification were more common than any other specialty. Vascular surgery was the most common specialty in the Western region. Providers employed by large multistate venous corporations compared with the remainder of the study sample were less likely to have an active primary certification (72.0% vs 87.4%; P = .001), to have received formal endovascular training (22.4% vs 36.0%; P = .013), or to maintain an active certificate in vascular surgery (6.5% vs 22.1%; P < .001). Corporate-employed relative to non-corporate-employed providers were more likely to hold an ABVLM certification (38.3% vs 17.6%; P < .001). CONCLUSIONS: There are a large number of physicians treating venous disease who do not have an active board certification. This was more common for physicians employed by a large multistate venous corporation. Physicians employed by a corporation were more likely to advertise a board certification from the ABVLM.

Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft.

Statistical interpretation of data collected in a randomised controlled trial (RCT) is conducted on the intention-to-treat (ITT) and/or the per-protocol (PP) study populations. ITT analysis is a comparison of treatment groups including all patients as originally allocated after randomisation regardless if treatment was initiated or completed. PP analysis is a comparison of treatment groups including only those patients who completed the treatment as originally allocated, although it is often criticised because of its potential to instil bias. A previous report from an RCT conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane allograft (EpiFix) as an adjunct to standard comprehensive wound therapy consisting of moist dressings and multi-layer compression in the healing of venous leg ulcers (VLUs) only reported PP study results (n = 109, 52 EpiFix and 57 standard care patients), although there were 128 patients randomised: 64 to the EpiFix group and 64 to the standard care group. Primary study outcome was the incidence of healing at 12 weeks. The purpose of the present study is to report ITT results on all 128 randomised subjects and assess if both ITT and PP data analyses arrive at the same conclusion of the efficacy of EpiFix as a treatment for VLU. Rates of healing for the ITT and PP populations were, respectively, 50% and 60% for those receiving EpiFix and 31% and 35% for those in the standard care cohort. Within both ITT and PP analyses, these differences were statistically significant; P = 0.0473, ITT and P = 0.0128, PP. The Kaplan-Meier plot of time to heal within 12 weeks for the ITT and PP populations demonstrated a superior wound-healing trajectory for EpiFix compared with VLUs treated with standard care alone. These data provide clinicians and health policymakers an additional level of assurance regarding the effectiveness of EpiFix.

Early Surgical Referral for Penetrating Aortic Ulcer Leads to Improved Outcome and Overall Survival.

BACKGROUND: The natural history of penetrating aortic ulcer (PAU) has been variably described and clear guidelines are lacking. We reviewed our experience with PAUs in a tertiary referral center. METHODS: Imaging reports from January 2010 to December 2017 were retrospectively searched for the diagnosis of "penetrating aortic ulcer." Diagnosis was confirmed by review of imaging studies. Patient demographics, presenting symptoms, and anatomic characteristics were collected and analyzed for associations with need for surgical intervention, aortic complication, and overall survival. RESULTS: One hundred six patients with PAU were identified. Locations included 57 (53.8%) aortic arch, 24 (22.6%) descending thoracic, and 25 (23.5%) abdominal aorta. Dissection was present in 12 (11.4%) and acute rupture in 4 (3.8%) cases. At presentation, 57 (53.8%) patients were symptomatic. Forty-six (43.8%) patients were evaluated by cardiothoracic or vascular surgeons. Thirteen (12.3%) underwent surgical or endovascular repair and 10 (10.4%) had a change in medical management. Long-term follow-up (LTFU) was available in 30 patients for a mean of 36.5 ± 29.2 months. Twenty-one (70%, 21/30) demonstrated disease stability or resolution and 9 (30%, 9/30) worsened with 3 undergoing surgery. No PAU ruptured during follow-up. Patient demographics, presenting symptoms, and PAU morphology did not predict disease progression. Referral to a cardiovascular surgeon at initial presentation was associated with a 40% decreased likelihood of disease progression (P = 0.046) and a 60% survival advantage at LTFU (P = 0.037). CONCLUSIONS: PAU disease progression occurs in 30% of patients at LTFU of 36.5 ± 29.2 months. All patients identified with PAU on diagnostic imaging should be referred for a surgical evaluation and follow-up, as referral to cardiovascular surgeon is associated with improved disease course.

Analysis of Patients Undergoing Major Lower Extremity Amputation in the Vascular Quality Initiative.

BACKGROUND: Despite an aggressive climate of limb salvage and revascularization, 7% of patients with peripheral artery disease undergo major lower extremity amputation (LEA). The purpose of this study was to describe the current demographics and early outcomes of patients undergoing major LEA in the Vascular Quality Initiative (VQI). METHODS: The VQI amputation registry was reviewed to identify patients who underwent major LEAs. Patient factors, limb characteristics, procedure type, and intraoperative variables were analyzed by the level of amputation. Factors associated with amputation level, 30-day complications, and mortality were analyzed using chi-squared analysis for significance with associated P values. Propensity score adjustment was used to balance statistically significant differences observed in subject characteristics by amputation level for the associated relative risk of a given outcome. RESULTS: Between 2013 and 2015, 2,939 major LEAs were recorded in the VQI amputation registry. The ratio of below-knee to above-knee amputation (BKA:AKA) was 1.29:1. The mean age was 66 years, 64% were male, 84% lived at home before admission, and 68% were ambulatory. Comorbidities included diabetes (67%), coronary artery disease (32%), end-stage renal disease (22%), and chronic obstructive pulmonary disease (23%). The mean preoperative ankle-brachial index (ABI) was 0.78. Overall, 43% had a history of prior ipsilateral revascularization. Indications for amputation were ischemic rest pain or tissue loss (58%), uncontrolled infection (31%), acute ischemia (9%), and neuropathic tissue loss (2%). The overall perioperative complication rate was 15%, 25% were discharged home, and the 30-day mortality was 5%. Patients who received an AKA versus BKA were more likely to be female (40.61% vs. 31.70%), more than age 70 (48.79% vs. 32.55%), underweight (18.63% vs. 9.18%), nonambulatory (40.22% vs. 25.18%), have an ABI <0.6 (58.00% vs. 45.26%), and carry nonprivate insurance (77.40% vs. 69.08%) (all P < 0.001). Patients undergoing AKA were less likely to have 30-day postoperative complications (12.24% vs. 17.87%) but had higher 30-day mortality (6.70% vs. 3.09%) than BKA patients (all P < 0.001). CONCLUSIONS: In the VQI registry, major LEA was performed predominantly for ischemic rest pain and tissue loss with a BKA:AKA ratio of 1.29:1. Patients undergoing AKA versus BKA were older, had lower ABI, lower rates of 30-day postoperative complications but higher rates of 30-day mortality. This registry offers an important real-world resource for studies pertaining to vascular surgery patients undergoing major lower extremity amputation.

A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix® ) allograft for the treatment of venous leg ulcers.

A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non-healing full-thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan-Meier analysis was performed to compare the time-to-healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log-rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25-4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non-healing, full-thickness venous leg ulcers.

Retrospective Review of Billowing Phenomenon-A Mimic of Endoleak Following Placement of Endologix Covered Stent for the Treatment of Abdominal Aortic Aneurysm.

BACKGROUND: Billowing is a unique computed tomography (CT) finding of the Endologix stent graft where a rim of contrast is observed outside the stent's endoskeleton but still contained within the graft cover. The purpose of this study is to evaluate the incidence and clinical outcome of billowing following an Endologix stent-graft placement. METHODS: All patients who underwent abdominal aortic aneurysm (AAA) repair with endovascular placement of an Endologix stent graft from January 2002 to September 2013 and who were followed with imaging were included in the study. The images were evaluated for the incidence of billowing. Demographics and clinical outcomes were also analyzed. RESULTS: One hundred twenty-two patients received an Endologix stent graft for AAA repair at our institution. One hundred patients qualified for this study. Eighty-four patients had billowing with the majority (70 patients) having crescentic billowing, and the remaining 14 patients having focal outpouching. Average billowing thickness measured 4.2 mm (range 1-13). Sixty-three patients with billowing had multiple follow-up CT angiograms to allow serial monitoring. Twelve patients had resolution of billowing, 11 patients had reduction in billowing size, 14 patients had no change in billowing size, and 26 patients had increase in billowing size. Patients with billowing had a statistically significant reduction in aneurysm sac size in anteroposterior and transverse dimensions (P = 0.014 and 0.009, respectively). Five cases of billowing were misdiagnosed as endoleak. Nineteen true endoleaks were identified, of which 13 cases were associated with billowing. CONCLUSIONS: Billowing does not seem to be associated with increased morbidity, mortality, increase in aneurysm size, or presence of endoleak. Billowing should be recognized as a common and benign finding of the Endologix stent.

Smoking Habits of Patients Undergoing Treatment for Intermittent Claudication in the Vascular Quality Initiative.

BACKGROUND: Society for Vascular Surgery practice guidelines for the medical treatment of intermittent claudication give a GRADE 1A recommendation for smoking cessation. Active smoking is therefore expected to be low in patients suffering from intermittent claudication selected for vascular surgical intervention. The aim of this study is to evaluate the prevalence of smoking in patients undergoing intervention for intermittent claudication at the national level and to determine the relationship between smoking status and intervention. METHODS: The Vascular Quality Initiative (VQI) registries for infra-inguinal bypass, supra-inguinal bypass, and peripheral vascular intervention (PVI) were queried to identify patients who underwent invasive treatment for intermittent claudication. Patient factors, procedure type (bypass versus PVI), and level of disease (supra-inguinal versus infra-inguinal) were evaluated for associations with smoking status (active smoking or nonsmoking) by univariate and covariate analysis. RESULTS: Between 2010 and 2015, 101,055 procedures were entered in the 3 registries, with 40,269 (40%) performed for intermittent claudication. Complete data for analysis were present in 37,632 cases. At the time of intervention, 44% of patients were active smokers, with wide variation by regional quality group (16-53%). In covariate analysis, active smoking at treatment was associated with age <70 years (prevalence ratio [PR] 2.42), male gender (PR 1.03), chronic obstructive pulmonary disease (PR 1.35), absence of prior cardiovascular procedures (PR 1.15), poor medication usage (PR 1.10), preoperative ankle-brachial index (ABI) <0.9 (PR 1.19), and supra-inguinal disease (PR 1.14). Invasiveness of treatment (PVI versus bypass procedures) was not significantly associated with smoking status. During follow-up, 36% of patients had quit smoking. Predictors of smoking cessation included age ≥70 years (RR 1.45), ABI ≥0.9 (RR 1.12), and bypass procedures (RR 1.22). CONCLUSIONS: At the time of treatment, 44% of patients undergoing intervention for intermittent claudication in the VQI were active smokers and there was a wide regional variation. Prevalence of active smoking was greater in the presence of younger age, fewer comorbidities, lower ABI, and supra-inguinal disease. Type of procedure performed, and in turn level of invasiveness required, did not appear to be influenced by smoking status. Elderly patients and those undergoing open procedures were more likely to quit smoking during follow up. These findings suggest opportunities for greater smoking cessation efforts before invasive therapies for intermittent claudication.

Arteriovenous Hybrid Graft with Outflow in the Proximal Axillary Vein.

BACKGROUND: The patency of long-term hemodialysis access in end-stage renal disease patients remains a significant challenge. Often these patients are affected with limited venous outflow options, requiring limb abandonment, and creation of new access in the contralateral arm. Vascular surgeons are familiar with the exposure of the proximal axillary artery via an infraclavicular incision. The axillary vein is easily exposed through this technique. The use of the hybrid Gore graft can make the venous anastomosis easier. A hybrid graft with its venous outflow placed in the proximal axillary vein can extend the options of upper extremity access procedures. We reviewed our early experience with this technique. METHODS: A review of dialysis procedures at the Loma Linda VA was performed. All patients undergoing placement of arteriovenous grafts utilizing the Gore hybrid placed into the proximal axillary vein for outflow were identified. Outcomes in terms of primary and secondary patency rates were determined. RESULTS: Eight patients had placement of an arteriovenous hybrid graft in the proximal axillary vein via an infraclavicular incision. All patients had exhausted other options for hemodialysis access in the ipsilateral upper extremity. All grafts were used successfully for dialysis. The mean primary and secondary patency rates at 6 months were 37.5% and 62.5%, respectively. One patient developed steal syndrome, requiring proximalization of the graft. Seven out of the 8 patients required secondary procedures including thrombectomy (n = 16) and angioplasty (n = 17). CONCLUSIONS: Placement of a hybrid graft in the proximal axillary vein is an effective and suitable option for patients who have exhausted arteriovenous access sites in the arm. This procedure can easily be performed in an outpatient setting with a low complication rate and allowing for preservation of the contralateral upper extremity for future use.

Placement of Upper Extremity Arteriovenous Access in Patients with Central Venous Occlusions: A Novel Technique.

BACKGROUND: Central venous occlusion is a common occurrence in patients with end-stage renal disease. Placement of upper extremity arteriovenous access in patients with occlusion of the brachiocephalic veins is often not an option. Avoidance of lower extremity vascular access can decrease morbidity and infection. METHODS: The central venous lesions were crossed centrally via femoral access. The wire was retrieved in the neck extravascularly. A Hemodialysis Reliable Outflow catheter was then placed in the right atrium and completed with an arterial anastomosis. RESULTS: We describe a novel technique for placing upper extremity arteriovenous access in patients with occlusion of the brachiocephalic veins. This technique was utilized in 3 patients. The technical success was 100%. CONCLUSIONS: The placement of upper extremity arteriovenous access in patients with central venous occlusions is technically feasible.