Twelve-month results of percutaneous endovascular reconstruction for chronically occluded superficial femoral arteries: a quality-of-life assessment.

BACKGROUND: We report our experience on the technical feasibility and impact on quality of life (QOL) for angioplasty and primary stenting of chronic total occlusion (CTO) of the superficial femoral artery (SFA). METHODS: Forty-four patients (51 legs) underwent attempted percutaneous revascularization for SFA CTO utilizing the self-expanding nitinol SMART stent (Cordis Corp., Miami, Florida). The Walking Impairment Questionnaire (WIQ score range: 0 to 14,080) was used to assess quality of life and ankle-brachial indices (ABI) were obtained pre- and post-procedure. RESULTS: Successful revascularization was achieved in 90.2% of the cases; Mean follow up was 374 +/- 321 days. The mean occlusion length was 15.5 +/- 9.9 cm; the mean stented segment length was 23.2 +/- 12.2 cm. The minimum stent diameter averaged 7.0 +/- 0.6 mm, and the maximum final balloon diameter averaged 5.9 +/- 0.6 mm. The mean pre- and post-intervention WIQ scores were 722 +/- 1503, and 8,421 +/- 5,741 (p < 0.0005), respectively. The mean delta-WIQ was 7,405 (95% CI: 6,555 to 9,245). The mean pre- and post-intervention ABI were 0.61 +/- 0.18, and 0.91 +/- 0.19 (p < 0.0005), respectively. The mean delta-ABI was 0.27 (95% CI: 0.21 to 0.33). The clinically-driven target lesion revascularization rate at 12 months was 11.8%. CONCLUSIONS: Chronically occluded SFAs can be treated by percutaneous nitinol stenting techniques with a high degree of success that is durable at 12-month follow up. Patients have a significant improvement in QOL and ABI. Repeat revascularization rates are reasonably low, and parallel the historical surgical data.

Eptifibatide in peripheral vascular interventions: results of the Integrilin Reduces Inflammation in Peripheral Vascular Interventions (INFLAME) trial.

An acute inflammatory response occurs following percutaneous coronary and peripheral vascular interventions (PVI), partly mediated by platelet activation. Glycoprotein (GP) IIb-IIIa inhibitors might partially attenuate this inflammation rise in the coronary patient, but data in patients undergoing PVI are lacking. In the Integrilin Reduces Inflammation in Peripheral Vascular Interventions trial (INFLAME), we hypothesized that eptifibatide reduces the acute inflammatory responses following PVI. This is a single-center, randomized, open-label study of intravenous eptifibatide (180 micro/kg bolus x 2, 10 minutes apart, then 2 micro/kg/min infusion over 18 hours) and low-dose unfractionated heparin (60 Units per kg, target activated clotting time (ACT) 200-250 sec) [LDH+I group; n = 21] versus high-dose unfractionated heparin alone (100 Units per kg, target ACT 300-400 sec) [HDH group; n = 21] in patients undergoing iliac and infrainguinal interventions. The primary endpoints of the study were markers of inflammation (soluble CD-40L [sCD-40L], high-sensitivity C-reactive protein [hs-CRP] and interleukin-6 [IL-6]), thrombin generation (Fragment 1.2 [F1.2]), and fibrinogen measured at baseline and postrandomization. Markers were assayed at baseline, postdilatation at 30 minutes, 2 hours, 18 hours, 48 hours and 7 days. Mean platelet inhibition with eptifibatide was 98% (range 92-100%) using the Accumetrics Rapid Platelet Function Assay at 10 minutes after final bolus. After adjusting for baseline values, the mean +/- SE difference in sCD-40L (loge scale), hs-CRP and F1.2 between the LDH+I group and the HDH was not significant. Fibrinogen had significantly higher mean levels at 7 days for the LDH+I group (541.19 mg/dL versus 472.26 mg/dL; p-value = 0.024). IL-6 was more detectable in the LDH+I group compared to the HDH following intervention. We conclude that LDH+I combination did not reduce acute inflammatory responses as compared to HDH in patients undergoing peripheral vascular interventions.

Bivalirudin in peripheral vascular interventions: a single center experience.

Unfractionated heparin is a widely utilized anticoagulant during peripheral angioplasty procedures (PTA). In contrast to heparin, bivalirudin is a direct thrombin inhibitor with predictable anticoagulation, does not activate platelets, and inhibits both soluble and bound thrombin. The experience with bivalirudin during PTA remains limited. In this single-center prospective study, 48 consecutive patients (60.4% males, mean age 70.0 12.1) received bivalirudin as the primary anticoagulant during PTA (0.75 mg/kg bolus, 1.75 mg/kg/h during the procedure). Thirty-four (70.8%) had claudication and 6 (12.5%) had ulceration. Thrombus was angiographically seen in 3 (6.3%) patients. In-hospital serious procedural complications were limited to 2 (4.2%) (exact 95% confidence interval: (0.5%,14.3%]) patients with major bleeding; none (0.0%) of the other following endpoints occurred: death, limb loss, emergent need for revascularization of the same vessel, embolic strokes, and vascular complications (exact 95% confidence intervals: [0.0%,6.1%]). This compared favorably to previously reported data using unfractionated heparin and the same serious procedural complications endpoints from our group at the same institution (9.2%). We conclude that the use of bivalirudin during PTA appears feasible and safe. Large prospective registries are needed to confirm these findings.

In-hospital complications of peripheral vascular interventions using unfractionated heparin as the primary anticoagulant.

Unfractionated heparin is the current antithrombotic of choice in peripheral vascular interventions. The rate of in-hospital major complications during peripheral angioplasty procedures (PTA) using heparin as the primary anticoagulant has not been well defined. In this single-center study, the charts of 213 consecutive PTA procedures in a 1-year period were reviewed. Of unstaged procedures, a total of 131 patients (57.3% males; mean age, 66.4 12.1 years) met inclusion criteria. Forty-five patients (34.4%) had recent onset of claudication and 15 (11.5%) had ulceration. Thrombus was angiographically visualized in 16.7% of patients. Unfractionated heparin was administered at a mean of 4,672 1,238 U (59.1 20.0 U/kg) during the procedure. The highest activated clotting time (ACT) during the procedure was recorded in 114 patients. ACTs were < 300, 300 400 and > 400 seconds in 29.0%, 29.0% and 42.1%, respectively. In-hospital clinical events occurred in 12 patients (9.2%) who met any one of the following endpoints: death (0.8%), limb loss (1.5%), major bleeding (4.6%), emergent need for repeat revascularization of the same vessel (7.6%), embolic stroke (0.0%) and vascular complications (1.5%). The best model associated with salvage revascularization included cigarette smoking within the past year, recent onset of claudication and PTA treatment below the knee. Increased dosages of heparin (U/kg) were associated with a trend toward higher rates of complications. A significant number of patients have in-hospital major complications following PTA procedures using unfractionated heparin as the primary anticoagulant. Current ongoing registries are evaluating the feasibility of direct thrombin inhibitors bivalirudin instead of heparin as a primary anticoagulant during PTA.