Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Computed tomography angiography-based evaluation of great saphenous vein conduit for lower extremity bypass.

OBJECTIVE: Lower extremity computed tomography angiography (CTA) is frequently used for anatomic assessment of lower extremity peripheral arterial disease. When lower extremity bypass is planned, duplex ultrasound (DUS) is routinely obtained to evaluate the great saphenous vein (GSV) for use as conduit. Although GSV can be visualized on CTA images, diameter assessment is not routinely included in formal study interpretation. We hypothesized that CTA images could be used to measure GSV diameters and that CTA-based diameters would correlate with measurements obtained using DUS. METHODS: Consecutive patients undergoing lower extremity arterial bypass who were evaluated preoperatively with both CTA and DUS vein mapping were identified at a single hospital. Minimum above- and below-knee GSV diameters were measured from electronically archived CTA images by two independent observers. CTAs were performed using standard arterial phase protocol without additional venous phase imaging. Between-observer reproducibility of CTA-based diameter measurements was evaluated using intraclass correlation coefficients. Correlation between CTA and DUS-based GSV diameters was evaluated with Spearman correlation coefficients. CTA diameter cut-points for identification of adequate GSV bypass conduit, defined as DUS-based minimum GSV diameter≥3 mm, were determined using receiver-operating characteristic curves. RESULTS: Sixty-three lower extremities were evaluated in 36 patients. In the absence of previous surgical removal, GSV was visible on all CTAs reviewed. No instances of GSV thrombosis were identified on DUS. Minimum DUS-based above-knee GSV diameter was 2.9±0.1 mm (range, 1.4-4.6 mm), and mean below-knee diameter was 2.6±0.1 mm (range, 1.3-4.0 mm). When GSV was visible and exceeded the minimum diameter threshold for CTA measurement, correlation between CTA- and DUS-based diameters was both positive and highly significant (ρ=0.595; P<.0001). CTA-based diameters also had excellent reliability between observers (r [95% CI]: 0.88 [0.85-0.91]). For identification of adequate bypass conduit using CTA, above-knee GSV diameter≥3.9 mm was 67% sensitive and 73% specific; below-knee GSV diameter≥3.0 mm was 75% sensitive and 84% specific. CONCLUSIONS: CTA-based GSV diameter measurements have good reproducibility and highly significant correlation with DUS-based diameters. CTA-based GSV diameter is a specific but relatively insensitive indicator of adequate bypass conduit. When CTA-based diameters indicate inadequate GSV bypass conduit, confirmatory DUS vein mapping is warranted. Confirmatory DUS vein mapping may be unnecessary when adequate vein diameter is identified on CTA.

Preoperative inpatient hospitalization and risk of perioperative infection following elective vascular procedures.

BACKGROUND: Health care-associated infections are not uncommon after elective vascular surgery and can negatively impact mortality rates and hospital resource utilization. Identification of modifiable risk factors for perioperative infection is critical for efforts aimed toward reducing their incidence. We evaluated the associations between preoperative inpatient hospitalization and perioperative surgical site infection (SSI), pneumonia, and urinary tract infection (UTI) following elective vascular surgery procedures. METHODS: Vascular procedures were identified from the 2005 to 2008 American College of Surgeons National Safety Quality Improvement Participant User Data File by using primary Current Procedural Terminology (CPT) codes. Perioperative infections were evaluated as outcomes based on three categories: SSI, pneumonia, and UTI. Patients admitted ≥1 day before operation were considered inpatients before surgery. Associations between preoperative inpatient hospitalization and perioperative SSI, pneumonia, and UTI were evaluated using the Cochran-Armitage trend test and multivariable logistic regression. RESULTS: In total 40,669 elective vascular procedures were identified, of which 7,514 (18.5%) were preoperative inpatients. Patients with preoperative inpatient hospitalization had a greater frequency of age >80 years and dependent functional status and also had higher rates of several comorbid conditions, including congestive heart failure, severe chronic obstructive pulmonary disease, >10% weight loss over the past 6 months, history of bleeding disorder, and current smoker within 1 year, than patients admitted on the same day of their procedure. The overall rates of SSI, pneumonia, and UTI were 3.2%, 1.9%, and 1.4%, respectively. Patients with preoperative inpatient hospitalization had higher 30-day incidence of SSI (4.5 vs. 2.9%), pneumonia (3.1 vs. 1.6%), and UTI (2.3 vs. 1.2%). In multivariable models including preoperative risk factors, preoperative inpatient hospitalization was associated with increased 30-day risk of SSI (odds ratio [OR], 1.21; 95% confidence interval [CI]: 1.06-1.39; p = 0.0066), pneumonia (OR, 1.64; 95% CI: 1.39-1.94; p < 0.0001), and UTI (OR, 1.46; 95% CI: 1.20-1.77; p < 0.0001). CONCLUSION: Preoperative inpatient hospitalization is associated with higher rates of perioperative SSI, pneumonia, and UTI in patients undergoing elective vascular surgery procedures. Avoidance of unnecessary preoperative hospitalization has potential to reduce rates of perioperative infection, but additional research is needed to develop evidence-based management strategies when hospitalization before elective procedures is necessary.

Process of care for carotid endarterectomy: perioperative medical management.

Carotid endarterectomy (CEA) has been repeatedly described as a safe and efficacious procedure to provide a stroke-risk reduction benefit in both symptomatic and asymptomatic cases. Contemporary outcomes are acceptable using the large-scale randomized trials as a metric of success. Class I and II data can be applied to improve the care process of patients undergoing CEA. Myocardial infarction remains the most significant nonstroke complication; however, there is no significant benefit to noninvasive stress testing in patients with clinically stable disease. Perioperative beta-blockade may offer up to a 10-fold reduction in the rate of perioperative myocardial infarction, but deleterious effects are attributable to high-dose regimens. Angiotensin blockade has been shown to reduce cardiovascular mortality in patients with atherosclerosis by up to 25%, although few studies have examined these agents directly in carotid surgery patients. Statins are beneficial to patients undergoing CEA with trials demonstrating up to a 3% absolute reduction in the incidence of stroke following CEA. Aspirin therapy is associated with an up to 7% absolute reduction in early stroke following CEA; however, the efficacy of combination or high-dose antiplatelet therapy remains ill-defined. A treatment strategy that involves perioperative medical optimization is likely to improve surgical outcomes and long-term cardiovascular risk for patients undergoing CEA.

Cost per day of patency: understanding the impact of patency and reintervention in a sustainable model of healthcare.

BACKGROUND: Healthcare resource utilization is an understudied aspect of vascular surgery. Initial cost of a given procedure is not an accurate reflection of resource utilization because it does not account for procedural durability and efficacy. Herein we describe an amortized cost model that accounts for procedural costs, durability, and re-intervention costs. METHODS: A cost model was developed using patency data endpoints and total hospital costs (direct and indirect) associated with an inital revascularization and subsequent re-interventions. This model was applied to a retrospective database of femoropopliteal reconstructions. One hundred and eighty-three open cases were compared with 198 endovascular cases; and the endpoints of initial cost, amortized cost at 12 months, and assisted patency were examined. RESULTS: The open and endovascular cases were not statistically different with respect to indication, patient co-morbid profiles, or post-procedural pharmacotherapy. Primary assisted patency was better in the open revascularization group at 12 months (78% versus 66%, P < .01). There was a statistically significant higher initial cost for open reconstruction when compared with endovascular ($12,389 +/- $408 versus $6,739 +/- $206, P < .001). However, at 12 months post-procedure, the initial cost benefit was lost for endovascular patients ($229 +/- $106 versus $185 +/- $124, P = .71). There was, however, a trend for endovascular cost savings in claudicants, though this did not reach significance ($259 +/- $189 versus $86 +/- $52, P = .31). For patients with critical limb ischemia, renal dysfunction, and end stage renal disease, the trend favored open surgery. CONCLUSIONS: An amortized cost model provides insight into the healthcare resource utilization associated with a particular revascularization and assistive procedures. The initial cost savings of endovascular therapies are not sustained over time. Cost-savings trends were noted, however, longer follow-up is required to see if these will reach statistical significance.

Mid-term results with laser atherectomy in the treatment of infrainguinal occlusive disease.

BACKGROUND: Laser atherectomy offers a potential intervention for multivessel infrainguinal disease in patients with poor revascularization options. Despite promising early results reported in the literature, the proper patient population who might benefit from laser atherectomy has yet to be determined. METHODS: From July 2004 to June 2006, patients undergoing laser atherectomy were retrospectively reviewed and assessed for comorbidities, operative and follow-up variables potentially associated with the end points of nondefinitive therapy, and limb salvage. RESULTS: During the study period, 40 patients (21 women, 19 men) underwent laser atherectomy, and the average follow-up was 461 +/- 49 days (range, 17 to 1050 days). Their average age was 68 +/- 2 years (range, 43 to 93 years). The indication for laser atherectomy was critical limb ischemia in 26 (65%) and lower limb claudication in 11 (35%). A total of 47 lesions were treated in the following arterial segments: 34 femoropopliteal and 13 infrapopliteal. Femoropopliteal distribution by the Trans-Atlantic Society Classification (TASC) was A in 3, B in 17, C in 10, D in 4, and infrapopliteal lesions distribution was A in 1, B in 3, C in 4, and D in 5. Adjunctive angioplasty was used in 75% of cases. The overall technical success rate (<50% residual stenosis) was 88%. Laser atherectomy-based treatment was the definitive therapy for 23 patients (58%), and the overall 12-month primary patency was 44%. The limb salvage rate at 12 months in 26 patients with critical limb ischemia was 55%. Renal failure was a risk factor for amputation (P < .001) and failed primary patency (P < .05), type 2 diabetes mellitus was a risk factor for amputation (P < .05), and poor tibial runoff was associated with failed primary patency and amputation (P < .05). Outcome was associated with the number of patent infrapopliteal runoff vessels. CONCLUSION: These data demonstrate that laser atherectomy can be used with high initial technical success rate. Chronic renal failure and diabetes are risk factors for a negative outcome. Poor results in patients with diabetes and renal failure necessitate careful case selection in this subgroup, in which laser atherectomy is less likely to provide a definitive revascularization result or limb salvage.