الفهرس 
AcknowledgementOnly 14 pages are availabe for public view
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Abstract
We compared endovenous mechanochemical ablation (EVMCA) (ClariVein, vascular insights) with endovenous thermoablation (EVTA) (endovenous laser ablation with 1470 nm diode laser, Biolitec) or radiofrequency ablation (VNUS Closure FAST) in the treatment of primary insufficiency in great saphenous vein with varicose veins. Methods : 125 patients underwent great saphenous vein (GSV) ablation and simultaneous local phlebectomies in tumescent anaesthesia. Inclusion criteria were clinical classification C2-C4, duplex-verified reflux in GSV, mean diameter of the GSV in the thigh 5-12 mm. One month and one-year follow-up included clinical and duplex US examination. Duration of postoperative sick leave was determined. Furthermore, patients were asked to determine what would have been the optimal sick leave after the procedure. Visual Analogue Scale was used to assess pain during the procedure, before discharge and at 1 week postoperatively. Results : Sixty-six patients were randomized to EVTA, and 59 patients to EVMCA. There were no significant differences (ns) in the mean age (49.8 years (SD 12.7), and 50.9 years (SD 11.9) (P= 0.58) in the groups respectively, nor the mean GSV diameter at the saphenofemoral junction, (8.9 mm (SD 2.0), and 9.4 mm (SD 2.4) (P= 0.19) respectively. Preoperative baseline C-classification (C2/C3/C4) did not differ between the groups (38/14/14), and (31/14/13). The mean time of stay in the operating room was 65.4 (SD14.8) min in the EVTA group, and 69.9 (SD 13.8) min in EVMCA group (P=0.08). The mean postoperative stay in the recovery room was 101.1 (SD 35.7) min in the EVTA group and 87.4 (SD 44.0) min in the EVMCA group (p=0.063). The perioperative need of sedative agent (propofol) was significantly less in the EVMCA group (78.4 mg (SD39.1) vs (34.6 mg (SD22.2) (P<0.001). The median VAS during the procedure was 3 (IQR 2-5) during EVTA, and 4 (IQR2.3-7) during EVMCA (P=0.3). At the time of discharge, VAS was 1 (IQR 0-2), and 2 (R 0.3 -4) (P=0.4), and after one week 1 (IQR 0-3), and 1 (IQR 0-3) in EVTA and EVMCA groups respectively (P=0.9). The mean number of pain killer pills used during the first month was 9.6 (SD12.1) in EVTA group, and 6.9 (SD11.2) in the EVMCA (p=0.2). The mean sick leave was 5.0 (SD 3.8) days after EVTA group, 4.3 days (SD3.2) after EVMCA (p=0.3). When patients were asked how many days they would recommend sick leave after the procedure, the answer was mean 7.5 (SD4.8) and 7.8 (SD4.6) days respectively (p=0.7). At one month all patients had an occluded GSV. One patient (EVMCA) had reflux at the saphenofemoral junction but not in the distal GSV. 4(6.3%) EVTA patients had sensory nerve injury, compared to none in the EVMCA group (p=0.053). Totally pain free were 72.7% of the EVTA, and 69.0% of the EVMCA patients (ns). One patient (1.7%) had a mild superficial infection after EVMCA, which was healed between follow-up visits. At one year all patients had occluded GSV (100%) occlusion rate in EVTA group and 90.9% occlusion rate in EVMCA group (P-value =0.21). All patients who attended the one-year follow-up showed significant improvement in all assessment parameters from the baseline values, moreover, those patients with both partial recanalization or fully opened VCSS, QVVA, VDS, and CEAP all were significantly improved at all time interval during follow-up from the baseline data (P-value>0.000). 62 patients in EVTA and 55 patients in EVMCA group joined the one-year follow-up, with 4 patients were lost in each group. One of the limitations of this study is that the maximum diameter of treated GSVs was 12 mm. There is no sufficient data on technical and clinical success of EVMCA in larger-diameter varicose veins. In addition, patients on oral anticoagulants were excluded in this study; because we have no published data on the anticoagulation effects during EVMCA. In contrast to endothermal therapy, anticoagulants might influence clot formation and lead to increased recanalization. Moreover, the need for simultaneous phlebectomies with the main trunk ablation affected the intraoperative pain assessment. Veins with previous thrombophlebitis which have recanalized and are incompetent were excluded because those veins may not be candidates for mechanochemical ablation because the rotating wire may be tangled on the synechiae and trabeculae of the recanalized vein and limits mechanical treatment (Elias and Raines 2012). Finally, further studies are required to compare EVMCA with other techniques in the treatment of SSV and other refluxing veins.