Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis.

OBJECTIVE: To compare the comparative effects of treatment with contemporary mechanical thrombectomy (MT) or anticoagulation (AC) on Villalta scores and post-thrombotic syndrome (PTS) incidence through 12 months in iliofemoral deep vein thrombosis (DVT). METHODS: Patients with DVT in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) randomized trial and the ClotTriever Outcomes (CLOUT) registry were included in this analysis. Both studies evaluated the effects of thrombus removal on the incidence of PTS. Patients with bilateral DVT, isolated femoral-popliteal DVT, symptom duration of >4 weeks, or incomplete case data for matching covariates were excluded. Propensity scores were used to match patients 1:1 who received AC (from ATTRACT) with those treated with mechanical thrombectomy (from CLOUT) using nearest neighbor matching on nine baseline covariates, including age, body mass index, leg treated, provoked DVT, prior venous thromboembolism, race, sex, Villalta score, and symptom duration. Clinical outcomes, including Villalta score and PTS, were assessed. Logistic regression was used to estimate the likelihood of developing PTS at 12 months. RESULTS: A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching. There were fewer patients with any PTS at 6 months (19% vs 46%; P < .001) and 12 months (17% vs 38%; P < .001) in the MT treatment group. Modeling revealed that, after adjusting for baseline Villalta scores, patients treated with AC had significantly higher odds of developing any PTS (odds ratio, 3.1; 95% confidence interval, 1.5-6.2; P = .002) or moderate to severe PTS (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = .027) at 12 months compared with those treated with MT. Mean Villalta scores were lower through 12 months among those receiving MT vs AC (3.3 vs 6.3 at 30 days, 2.5 vs 5.5 at 6 months, and 2.6 vs 4.9 at 12 months; P < .001 for all). CONCLUSIONS: MT treatment of iliofemoral DVT was associated with significantly lower Villalta scores and a lower incidence of PTS through 12 months compared with treatment using AC. Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS after an acute DVT event.

One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial.

OBJECTIVE: This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the polymer based Endologix Alto Stent Graft System in treating abdominal aortic aneurysms (AAAs), with sealing 7 mm below the top of the fabric in aortic neck diameters from 16 to 30 mm. METHODS: Seventy-five patients were treated with Alto devices between March 2017 and February 2018 in 16 centers in the United States for infrarenal AAAs (max diameter ≥5.0 cm in diameter or size increase by 0.5 cm in 6 months or diameter ≥1.5 times the adjacent normal aorta). Patients were followed for 30 days, 6 months, and 1 year by clinical evaluation and computed tomography and abdominal x-ray imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture or surgical conversion, stent graft stenosis, occlusion, kink, thromboembolic events, and stent fracture attributable to the device requiring secondary intervention through 12 months. Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 1 year were analyzed. RESULTS: The mean patient age was 73 years, with 93% of patients being male. The 30-day major adverse event rate was 5.3%. At 1 year, the primary endpoint was met with a treatment success rate of 96.7%. Through 1-year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%. CONCLUSIONS: This prospective study demonstrates the Endologix Alto is safe and effective in treating AAAs with appropriate anatomy at 1 year. The safety endpoint is met by a 5.3% 30-day major adverse event rate, whereas the effectiveness endpoint is met by a treatment success rate of 96%.

Factors that affect cost and clinical outcome of endovascular aortic repair for abdominal aortic aneurysm.

OBJECTIVE: This study evaluated the effect of indication for use (IFU), additional graft components, and percutaneous closure of endovascular aortic repair (PEVAR) on clinical outcomes and cost of endovascular aortic repair (EVAR). METHODS: Clinical and financial data were obtained for all elective EVARs completed at a university-affiliated medical center between January 2012 and June 2013. Data were analyzed by χ2, Student t-test for independent samples, and Kaplan-Meier survival. RESULTS: There were 67 elective EVARs. Additional cuffs/extensions were used in 37%, increasing the baseline graft cost by 36% (P < .001), total costs by 20% (P < .001), and negatively affecting the contribution margin. Aortic neck IFU (P = .02), failure of the index graft to seal the neck (P = .02), and need for an additional cuff (P = .008) were related to the need for reintervention for type Ia endoleak for graft B (Excluder; W. L. Gore and Associates, Flagstaff, Ariz), whereas limb IFU was related to the need for additional limb extension for graft A (Powerlink; Endologix, Irvine, Calif; P < .001). Limb extension (P = .06) and failure of the index graft to provide an adequate seal (P < .001) were associated with reintervention for type Ib endoleak. Reintervention-free rates at 24 months were 96% for graft A and 94% for graft B (P =.54), but different patterns in reintervention emerged: graft A required reoperation early (<2 months) then stabilized; graft B did not require reintervention until 24 months, but rates increased substantially by 25 months. PEVAR was attempted in 61 (91%): 49 (73%) bilaterally, 7 (10%) unilaterally, and 5 (8%) failed. The mean number of closure devices was four (range, 1-9): $1000 (3.5% of total cost). Bilateral PEVAR was associated with shorter operating time than unilateral PEVAR/failed PEVAR (P < .001) and lower operating room use costs (P = .005) and total hospital costs (P = .003) than failed PEVAR. The contribution margin was higher for bilateral PEVAR than unilateral PEVAR/failed PEVAR (P = .005). Patients with bilateral PEVAR and unilateral PEVAR were more often discharged on postoperative day 1 than those with failed PEVAR (P = .002). Hospital length of stay (P = .49), operating room duration (P = .31), and total costs (P = .72) were similar for unsuccessful PEVAR and EVAR completed with cutdown. CONCLUSIONS: Higher rates of reintervention occurred when EVAR was performed outside of IFU guidelines or when additional components were needed. Additions raised graft costs significantly above baseline. Notable differences in graft performance in complex anatomy and varied patterns of reoperation could be useful in the graft selection process to improve outcome and contain costs. Bilateral PEVAR was associated with lower costs and postoperative day 1 discharge. Attempting PEVAR may be reasonable unless there is serious concern for failure.

Flow cytometry and gene expression profiling of immune cells of the carotid plaque and peripheral blood.

OBJECTIVES: The relative contribution of the local vs. peripheral inflammation to the atherothrombotic processes is unknown. We compared the inflammatory status of the immune cells of the carotid plaque with similar cells in peripheral circulation of patients with advanced carotid disease (PCDs). METHODS: Mononuclear cells (MNCs) were extracted from carotid endarterectomy (CEA) samples by enzymatic digestion and subsequent magnetic cell sorting. The cell surface antigenic expressions, and mRNA expression levels were compared between CEA MNCs and peripheral MNCs, using flow cytometry and RT-PCR techniques. RESULTS: The percentages of resting MNCs were lower, and activated MNCs, particularly monocytes, were higher in the CEAMNCs, as compared to the peripheral MNCs. The percentages of activated T cells and B cells were higher in the peripheral MNCs of PCDs, than in healthy controls (HCs), but the percentages of activated monocytes did not differ between the two groups. The expression levels of both pro-inflammatory/pro-thrombotic (P(38), JNKB-1, Egr-1 PAI-1, MCP-1, TF, MMP-9, HMGB-1, TNF-α, mTOR) and anti-inflammatory (PPAR-γ, TGF-ß) mediators were significantly higher in the CEA MNCs as compared to the peripheral MNCs. Furthermore, MMP-9 and PPAR-γ expression levels were higher in the peripheral MNCs of PCDs than HCs. CONCLUSION: The inflammatory status is higher in the immune cells of the carotid plaque, as compared to those cells in the peripheral blood. The altered expression levels of both pro-inflammatory/pro-thrombotic and anti-inflammatory mediators in the milieu of the plaque suggest that the balance between these various mediators may play a key role in carotid disease progression.

Successful reduction of surgeries secondary to arterial access site complications: a retrospective review at a single center with an extravascular closure device.

BACKGROUND: Access site complications requiring emergent surgery following femoral catheterization expose patients to additional morbidities and mortality. We observed a significant decrease in such surgeries after the Mynx device was introduced. METHODS: A retrospective review of surgeries performed as a complication of 6F & 7F femoral cardiac and peripheral catheterization was done. Rates of surgeries among 3 closure methods were compared during the study period July 2006 to July 2008 (Mynx, AngioSeal, and manual/mechanical compression). RESULTS: Of 11 006 6F &7F transfemoral catheterization procedures, 26 (0.24%) surgeries secondary to access complications resulted. Surgeries were done in 14 (0.61%) AngioSeal patients, 10 (0.19%) manual/mechanical compression, and 2 (0.06%) Mynx patients (P < .0001 vs AngioSeal, P = .14 vs compression). CONCLUSIONS: Significant reduction in surgeries was seen in the Mynx vs Angioseal patients, no difference was noted in compression subset. Further analysis is warranted to prospectively evaluate these findings.

Distal venous arterialization for limb salvage--a case report.

The reperfusion of an ischemic limb in the absence of suitable target artery remains a formidable task. The authors report a case of an ischemic limb in patient whose distal arteries were identified intraoperatively as unsuitable for conventional revascularization. A distal arteriovenous fistula was created between the already arterialized in situ greater saphenous vein conduit and the inframalleolar superficial venous system of the foot. The flow through the superficial venous system salvaged the limb and continues to perfuse the foot 4 years post-operatively with resolution of rest pain.