Effect of a Decision Aid on Agreement Between Patient Preferences and Repair Type for Abdominal Aortic Aneurysm: A Randomized Clinical Trial.

Importance: Patients with abdominal aortic aneurysm (AAA) can choose open repair or endovascular repair (EVAR). While EVAR is less invasive, it requires lifelong surveillance and more frequent aneurysm-related reinterventions than open repair. A decision aid may help patients receive their preferred type of AAA repair. Objective: To determine the effect of a decision aid on agreement between patient preference for AAA repair type and the repair type they receive. Design, Setting, and Participants: In this cluster randomized trial, 235 patients were randomized at 22 VA vascular surgery clinics. All patients had AAAs greater than 5.0 cm in diameter and were candidates for both open repair and EVAR. Data were collected from August 2017 to December 2020, and data were analyzed from December 2020 to June 2021. Interventions: Presurgical consultation using a decision aid vs usual care. Main Outcomes and Measures: The primary outcome was the proportion of patients who had agreement between their preference and their repair type, measured using χ2 analyses, κ statistics, and adjusted odds ratios. Results: Of 235 included patients, 234 (99.6%) were male, and the mean (SD) age was 73 (5.9) years. A total of 126 patients were enrolled in the decision aid group, and 109 were enrolled in the control group. Within 2 years after enrollment, 192 (81.7%) underwent repair. Patients were similar between the decision aid and control groups by age, sex, aneurysm size, iliac artery involvement, and Charlson Comorbidity Index score. Patients preferred EVAR over open repair in both groups (96 of 122 [79%] in the decision aid group; 81 of 106 [76%] in the control group; P = .60). Patients in the decision aid group were more likely to receive their preferred repair type than patients in the control group (95% agreement [93 of 98] vs 86% agreement [81 of 94]; P = .03), and κ statistics were higher in the decision aid group (κ = 0.78; 95% CI, 0.60-0.95) compared with the control group (κ = 0.53; 95% CI, 0.32-0.74). Adjusted models confirmed this association (odds ratio of agreement in the decision aid group relative to control group, 2.93; 95% CI, 1.10-7.70). Conclusions and Relevance: Patients exposed to a decision aid were more likely to receive their preferred AAA repair type, suggesting that decision aids can help better align patient preferences and treatments in major cardiovascular procedures. Trial Registration: ClinicalTrials.gov Identifier: NCT03115346.

The natural history of duplex-detected stenosis after femoropopliteal endovascular therapy suggests questionable clinical utility of routine duplex surveillance.

OBJECTIVE: Duplex ultrasound (DU) surveillance (DUS) criteria for vein graft stenosis and thresholds for reintervention are well established. The natural history of DU-detected stenosis and the threshold criteria for reintervention in patients undergoing endovascular therapy (EVT) of the femoropopliteal system have yet to be determined. We report an analysis of routine DUS after infrainguinal EVT. METHODS: Consecutive patients undergoing EVT of the superficial femoral artery (SFA) or popliteal artery were prospectively enrolled in a DUS protocol (≤1 week after intervention, then at 3, 6, and 12 months thereafter). Peak systolic velocity (PSV) and velocity ratio (Vr) were used to categorize the treated artery: normal was PSV <200 cm/s and Vr <2, moderate stenosis was PSV = 200-300 cm/s or Vr = 2-3, and severe stenosis was PSV >300 cm/s or Vr >3. Reinterventions were generally performed for persistent or recurrent symptoms, allowing us to analyze the natural history of DU-detected lesions and to perform sensitivity and specificity analysis for DUS criteria predictive of failure. RESULTS: Ninety-four limbs (85 patients) underwent EVT for SFA-popliteal disease and were prospectively enrolled in a DUS protocol. The initial scans were normal in 61 limbs (65%), and serial DU results remained normal in 38 (62%). In 17 limbs (28%), progressive stenoses were detected during surveillance. The rate of thrombosis in this subgroup was 10%. Moderate stenoses were detected in 28 (30%) limbs at initial scans; of these, 39% resolved or stabilized, 47% progressed to severe, and occlusions developed in 14%. Five (5%) limbs harbored severe stenoses on initial scans, and 80% of lesions resolved or stabilized. Progression to occlusion occurred in one limb (20%). The last DUS showed 25 limbs harbored severe stenoses; of these, 13 (52%) were in symptomatic patients and thus required reintervention regardless of DU findings. Eleven limbs (11%) eventually occluded. Sensitivity and specificity of DUS to predict occlusion were 88% and 60%, respectively. CONCLUSIONS: DUS does not reliably predict arterial occlusion after EVT. Stenosis after EVT appears to have a different natural history than restenosis after vein graft bypass. EVT patients are more likely to have severe stenosis when they present with recurrent symptoms, in contrast to vein graft patients, who commonly have occluded grafts when they present with recurrent symptoms. The potential impact of routine DU-directed reintervention in patients after EVT is questionable. The natural history of DU-detected stenosis after femoropopliteal endovascular therapy suggests questionable clinical utility of routine DUS.

Current assessment of endovascular therapy for infrainguinal arterial occlusive disease in patients with diabetes.

Endovascular therapy (EVT) has increasingly become the initial clinical option for treatment of lower extremity peripheral arterial disease (PAD), not only for patients with claudication, but also for those with critical limb ischemia. Despite this major clinical practice paradigm shift, the outcomes of EVT for PAD are difficult to evaluate and compare with established surgical benchmarks because of the lack of prospective, randomized trials, incomplete characterization of indications for intervention, mixing of arterial segments and extent of disease treated, the multiplicity of EVT techniques used, the exclusion of early treatment failures, crossover to open bypass during follow-up, and the frequent lack of intermediate and long-term patency and limb salvage rates in life-table format. These data limitations are especially problematic when one tries to assess the outcome of EVT in patients with diabetes. The purpose of the present report is to succinctly review and objectively analyze available data regarding the results of EVT in patients with diabetes.

Current assessment of endovascular therapy for infrainguinal arterial occlusive disease in patients with diabetes.

Endovascular therapy has increasingly become the initial clinical option for the treatment of lower-extremity peripheral arterial occlusive disease not only for patients with claudication but also for those with critical limb ischemia. Despite this major clinical practice paradigm shift, the outcomes of endovascular therapy for peripheral arterial disease are difficult to evaluate and compare with established surgical benchmarks because of the lack of prospective randomized trials, incomplete characterization of indications for intervention, mixing of arterial segments and extent of disease treated, the multiplicity of endovascular therapy techniques used, the exclusion of early treatment failures, crossover to open bypass during follow-up, and the frequent lack of intermediate and long-term patency and limb salvage rates in life-table format. These data limitations are especially problematic when one tries to assess the outcomes of endovascular therapy in patients with diabetes. The purpose of the present article is to succinctly review and objectively analyze available data regarding the results of endovascular therapy in patients with diabetes.

Vein diameter is the major predictor of fistula maturation.

OBJECTIVES: Preoperative duplex ultrasound mapping of veins and arteries has been widely advocated to maximize the creation of native arteriovenous fistula (AVF) for hemodialysis access, but reliable diameter criteria have not been established. We sought to determine patient and anatomic variables predictive of fistula maturation in patients receiving their initial permanent hemodialysis access. METHODS: All patients undergoing dialysis access creation from January 2003 to June 2007 were retrospectively reviewed. We analyzed fistula type and functional maturation rates (Society for Vascular Surgery [SVS] reporting standards) based on patient characteristics and findings on physical examination, preoperative vein mapping studies, or venography. Maturation and patency rates were determined by Kaplan Meier analysis. The following factors were analyzed: age, race, gender, body-mass index (BMI), fistula site, preoperative duplex vein diameter, diabetes, hyperlipidemia, HTN, prior central catheter placement, HIV, and history of IV drug abuse. RESULTS: From January 2003 to June 2007, 298 vascular access procedures were performed. One hundred ninety-five (65%) were initial hemodialysis access procedures, among which a native AVF was created in 185 (95%); 158 patients with posterior radiocephalic AVF (PRCAVF, n = 24), wrist radiocephalic AVF (WRCAVF, n = 72), or brachiocephalic AVF (BCAVF, n = 62) had adequate follow-up and were included in the analysis. PRCAVF, WRCAVF, and BCAVF had 54%, 66%, and 81% maturation rates, respectively. Both the type of fistula type (P = .032) and vein size (P = .002) significantly affected maturation by univariate analysis. In contrast, by multivariate logistic regression analysis, vein diameter was the sole independent predictor of fistula functional maturation (P = .002). CONCLUSION: In this series of 158 patients undergoing initial hemodialysis access creation, native AVF creation was performed in 95%. In contrast to previous reports, age, gender, diabetes, and BMI had no significant effect on functional maturation. By multivariate logistic regression analysis, vein diameter was the sole independent predictor of functional fistula maturation.

Infrainguinal atherectomy: a retrospective review of a single-center experience.

By decreasing plaque burden, atherectomy provides an alternative to angioplasty and stenting as a means of revascularizing patients with peripheral arterial disease. A new atherectomy device (SilverHawk) has recently been approved by the Food and Drug Administration, but the results with its use are unclear. We analyzed a series of consecutive patients undergoing atherectomy. We retrospectively reviewed the charts of 35 patients undergoing infrainguinal (IF) atherectomy in 38 limbs. The Trans-Atlantic Inter-Society Consensus (TASC) classification and Society of Vascular Surgery runoff scores were calculated. Time to event analysis was performed using Kaplan-Meier estimates. Risk factors affecting patency were analyzed with a multivariate Cox model. Mean patient age was 70 +/- 9.6 years. Indications for intervention were claudication (26%), rest pain (21%), and tissue loss (53%). Femoropopliteal (FP) atherectomy was performed in 68% and tibial atherectomy in 32%. For FP lesions, the TASC distribution was A, 42%; B, 23%; C, 4%; and D, 15%. The average lesion treatment length was 9.4 +/- 10.6 cm (range 1-40), and the runoff score was 5.1 +/- 3.5. For tibial lesions, the TASC distribution was A, 0%; B, 17%; C, 8%; and D, 75%. The average lesion treatment length was 9.2 +/- 6.0 cm (range 2-20), with a runoff score of 5.4 +/- 2.4. A total of 39% of patients had prior IF interventions. Adjunctive angioplasty of the atherectomized lesion was performed in 55% of cases, stenting in 0%, and adjunctive therapy for tandem lesions in 39%. The postoperative ankle-brachial index increased by 0.30 +/- 0.14 and toe pressures increased by 40 +/- 32.4 mm Hg. Mean follow-up was 10 +/- 8 months (range 0.3-23). During the studied period, seven patients required major limb amputation and five open surgical revascularization. Total primary and secondary patency rates were 66% and 70% at 1 year, respectively. Primary and secondary patency rates for FP atherectomy were 68% and 73% at 1 year, respectively. The limb salvage rate was 74% at 6 months. Patients with prior interventions in the atherectomized segment had an almost 10-fold decrease in primary patency. Atherectomy produces acceptable results, similar to those in reported series of conventional balloon angioplasty/stenting. Patients with prior IF interventions had a nearly 10-fold decrease in primary patency. A greater than sixfold decrease in patency rates was noted in patients who underwent simultaneous inflow or outflow procedures, but this finding did not reach statistical significance (p = 0.082). Future studies should focus on cost comparisons with other treatments such as angioplasty and stenting, and prospective randomized trials should be performed to compare these treatment alternatives.

Comparison of the effects of open and endovascular aortic aneurysm repair on long-term renal function using chronic kidney disease staging based on glomerular filtration rate.

OBJECTIVE: It has been suggested that endovascular aneurysm repair (EVAR) in concert with serial contrast-enhanced computed tomography (CT) surveillance adversely impacts renal function. Our primary objectives were to assess serial renal function in patients undergoing EVAR and open repair (OR) and to evaluate the relative effects of method of repair on renal function. METHODS: A thorough retrospective chart review was performed on 223 consecutive patients (103 EVAR, 120 OR) who underwent abdominal aortic aneurysm (AAA) repair. Demographics, pertinent risk factors, CT scan number, morbidity, and mortality were recorded in a database. Baseline, 30- and 90-day, and most recent glomerular filtration rate (GFR) were calculated. Mean GFR changes and renal function decline (using Chronic Kidney Disease [CKD] staging and Kaplan-Meier plot) were determined. EVAR and OR patients were compared. CKD prevalence (>or=stage 3, National Kidney Foundation) was determined before repair and in longitudinal follow-up. Observed-expected (OE) ratios for CKD were calculated for EVAR and OR patients by comparing observed CKD prevalence with the expected, age-adjusted prevalence. RESULTS: The only baseline difference between EVAR and OR cohorts was female gender (4% vs 12%, P = .029). Thirty-day GFR was significantly reduced in OR patients (P = .047), but it recovered and there were no differences in mean GFR at a mean follow-up of 23.2 months. However, 18% to 39% of patients in the EVAR and OR groups developed significant renal function decline over time depending on its definition. OE ratios for CKD prevalence were greater in AAA patients at baseline (OE 1.28-3.23, depending upon age group). During follow-up, the prevalence and severity of CKD increased regardless of method of repair (OE 1.8-9.0). Deterioration of renal function was independently associated with age >70 years in all patients (RR 2.92) and performance of EVAR compared with OR (RR 3.5) during long-term follow-up. CONCLUSIONS: Compared with EVAR, OR was associated with a significant but transient fall in GFR at 30 days. Renal function decline after AAA repair was common, regardless of method, especially in patients >70 years of age. However, the renal function decline was significantly greater by Kaplan-Meier analysis in EVAR than OR patients during long-term follow-up. More aggressive strategies to monitor and preserve renal function after AAA repair are warranted.

Endovascular common iliac aneurysm exclusion with antegrade hypogastric artery flow preservation: a novel approach.

Open surgical repair of iliac aneurysms has been usually associated with significant morbidity and mortality. The introduction of novel endovascular techniques has expanded the currently available options to treat these aneurysms. However, the use of endoluminal stent grafts to treat common iliac artery aneurysms by landing their distal end into the hypogastric artery in patients where flow into the latter artery is crucial to avoid end-organ ischemia has only been rarely reported in the past. A case report of a common iliac aneurysm case treated with a novel therapeutic approach, not previously reported is herein presented. Three telescopically-overlapping Hemobahn/Viabahn polytetrafluoroethylene (PTFE)-covered endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) were used with success.

Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score.

OBJECTIVE: A recent randomized trial suggested nitinol self-expanding stents (SES) were associated with reduced restenosis rates compared with simple percutaneous transluminal angioplasty (PTA). We evaluated our results with superficial femoral artery (SFA) SES to determine whether TransAtlantic InterSociety Consensus (TASC) classification, indication for intervention, patient risk factors, or Society of Vascular Surgery (SVS) runoff score correlated with patency and clinical outcome, and to evaluate if bare nitinol stents or expanded polytetrafluoroethylene (ePTFE) covered stent placement adversely impacts the tibial artery runoff. METHODS: A total of 109 consecutive SFA stenting procedures (95 patients) at two university-affiliated hospitals from 2003 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome. RESULTS: Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency. CONCLUSIONS: Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed.

The application of split-thickness skin graft as an autogenous arterial conduit in a goat (Capra hircus) model.

Adequate autogenous vein is often the limiting factor in achieving a successful infrainguinal bypass. Attempts have been made to find alternative conduits; however, these alternatives have demonstrated inferior patency rates. We attempt to show that a split-thickness skin graft conduit provides a feasible autogenous arterial conduit. Neoconduits were prepared with an autogenous split-thickness skin graft (STSG) tubularized for a length of 5-6 centimeters with an appropriate caliber match to native artery. The deep dermal side of the graft was randomized to form either the external surface or the luminal surface. The neoconduit was placed as an interposition graft in the left common carotid artery. Grafts were studied in vivo with duplex ultrasonography and ex vivo by histopathology and immunohistochemistry. Feasibility study involved 4 animals with grafts harvested for study at 24 hours (n = 2) and 7 days (n = 2). Two subsequent groups were studied to evaluate 3-month (n = 8) and 6-month (n = 5) patency. All grafts (n = 4) in the feasibility phase of the study were patent at the time of harvest without evidence of aneurysmal degeneration. In the subsequent 8 goats, grafts with the deep dermal side forming the extraluminal surface (n = 4) had a propensity to ulcerate and rupture or to become aneurysmal (75%). The patency rate of these grafts at 6 weeks was 25%. In contrast, grafts with the deep dermal side forming the intraluminal surface (n = 4) demonstrated 75% patency at 6 weeks. Because of these results the remaining goats underwent placement of neoconduits with the deep dermal side forming the luminal surface. These grafts maintained a patency rate of 80% at 6 months. Neoconduits implanted with a diameter greater than 1.5 times the native arterial diameter became aneurysmal. Histopathology demonstrated neointimal formation in all grafts patent for longer than 7 days. Immunohistochemical staining for Factor VIII/von Willebrand's factor (vWF) was reactive in the endoluminal cells of these grafts. Immunohistochemical staining for a-smooth muscle actin demonstrated reactivity in conduits patent for greater than 1 month. Split-thickness skin may provide a feasible source for autogenous conduit in arterial reconstructions and warrants further study. Technical factors affecting patency include orientation of the deep dermal surface of the STSG and the diameter of the neoconduit at the time of implantation.