Comparing Obtura Vascular Closure Device to Manual Compression for Achieving Hemostasis After Percutaneous Transfemoral Procedures: A Randomized Study.

PURPOSE: This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. MATERIAL AND METHODS: This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). RESULTS: The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. CONCLUSIONS: The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. CLINICAL IMPACT: In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

Accuracy of Common Femoral Artery Doppler Waveform Analysis in Predicting Haemodynamically Significant Aortoiliac Lesions.

INTRODUCTION: Doppler ultrasound is cost-effective and accurate noninvasive method for evaluation of peripheral arterial disease. However, there is difficulty in detection of aortoiliac lesions due to inadequate visualization of aortoiliac arteries in many patients. The Doppler waveform changes occurring distal to significant stenosis or occlusion are well documented. Accordingly, common femoral artery (CFA) Doppler waveform analysis may be used to predict haemodynamically significant proximal aortoiliac lesions. AIM: To evaluate the accuracy of Doppler waveform analysis at the CFA for diagnosing haemodynamically significant aortoiliac stenosis or occlusion in patients of peripheral arterial disease. MATERIALS AND METHODS: A total of 67 patients (114 aortoiliac segments) with suspected peripheral arterial disease were retrospectively evaluated and labeled as normal or abnormal by analysing the Doppler waveform of CFA. The triphasic waveform with normal reversal pattern was categorized as normal, while low velocity biphasic or monophasic waveform were labeled as abnormal and indirect diagnosis of normal or diseased (>50% stenosis or occlusion) aortoiliac segment was made. The results were compared to intra-arterial angiography, considered as the gold standard. RESULTS: The Doppler waveform analysis of CFA was abnormal in 41 out of 114 common femoral arteries, while intra-arterial angiography showed significant stenosis (21 arteries) or occlusion (26 arteries) in 47 (41%) of 114 aortoiliac segments in 67 patients. Out of 67 normal aortoiliac segments seen on angiography, the CFA waveform analysis was interpreted as normal in 62 segments. An abnormal CFA waveform could diagnose significant aortoiliac lesion with 87% sensitivity, 92% specificity, 89% Positive Predictive Value (PPV), 91% Negative Predictive Value (NPV) and 90% accuracy using angiography as the gold standard. The low velocity monophasic waveform which was seen in 38 (33%) of 114 segments was reliable predictor of significant aortoiliac disease with 93% positive predictive value. CONCLUSION: CFA Doppler waveform pattern analysis is a sensitive and accurate technique for the prediction of haemodynamically significant aortoiliac stenosis or occlusion.

Outcomes using a 1470-nm laser for symptomatic varicose veins.

PURPOSE: The aim of this study was to evaluate safety and effectiveness of the laser fiber with wavelength of 1470 nm for ablation of symptomatic varicose veins. MATERIALS AND METHODS: This was a prospective study carried out from November 2007 to October 2009. Seventy-six limbs in 72 consecutive patients were treated by endovenous laser ablation (EVLA). Baseline preprocedural clinical and ultrasonic grading of varicose veins was done. Endovenous laser ablation was done under ultrasonic guidance, and prior superficial venogram was taken if required. After the procedure all the patients were followed up with for 1 year with duplex ultrasound scan, and improvement in grading of venous disease was assessed. RESULTS: One hundred eight treated veins of 76 limbs were followed up on day 2, 1 month, 6 month, and 12 months postprocedurally. At the end of 1-year follow-up, venous occlusion rate and ulcer healing rate were 98.61% and 85%, respectively. The average preoprocedure clinical grade and venous disability score improved significantly at 12 months. Most of the postprocedure complications were transient and self limiting; the most common complication was paresthesia (10.53%). No major complications, such as deep vein thrombosis, occurred. When the authors compared legs treated with linear endovenous energy density below or above 100 J/cm, the paresthesia rate and postoperative pain was significantly higher in the second group, with energy density more than 100 J/cm. CONCLUSIONS: EVLA, using 1470-nm laser, is a minimally invasive, safe, outpatient department (OPD) procedure that causes less postprocedural pain with linear endovenous energy density (LEED) less than 100J/cm.