Résumé
Objective To compare the hemostatic safety and efficacy of a new butterfly femoral artery compression device (FACD) with those of manual compression (MC) in patients undergoing percutaneous peripheral endovascular interventions via femoral artery. Methods A total of 283 patients, who received percutaneous endovascular interventions via femoral artery during the period from September 2016 to December 2017, were enrolled in this study. After endovascular intervention, 167 patients received FACD to make hemostasis (FACD group), and 116 patients received MC hemostasis (MC group) . The patient's comfortableness, time used for hemostasis (min), limb immobilization time (h), and the incidence of vascular complications in both groups were analyzed. Results All 283 patients were included in analysis, the results indicated that the hemostatic success rates in FACD group and MC group were 96.4％ (161/167) and 94.0％ (109/116) respectively, the difference between the two groups was not statistically significant (P>0.05) . The postoperative Kolcaba Comfort Scale score of FACD group was (85.0 ±11.2) points, which was remarkably higher than (58.4±11.7) points of MC group (P<0.05), the time used for hemostasis in FACD group was (9.2 ±2.2) min, which was strikingly shorter than (18.5 ±2.9) min in MC group (P <0.05) . The limb immobilization time in FACD group was (10.4±2.4) hours, which was obviously shorter than (23.1±4.1) hours in MC group (P <0.05) . The incidence of vascular complications in FACD group was 3.6％, which was dramatically lower than 9.5％ in MC group (χ2=4.206, P=0.04) . Conclusion The use of the new butterfly FACD can promptly, safely and effectively stop bleeding of femoral artery puncture site. The new butterfly FACD is superior to MC in shortening hemostatic time and limb immobilization time, in reducing incidence of vascular complications, as well as in improving patient's comfortableness degree.
Résumé
Objective To evaluate the safety and efficacy of SilverHawk directional atherectomy device in the treatment of femoropopliteal occlusive disease. Methods From August 2012 to June 2014,46 patients(58 limbs)with femoropopliteal occlusive diseases in the treatment by SilverHawk directional atherectomy device were analyzed retrospectively . The mean lesion length and degree of diameter stenosisin the femoropopliteal stenoses(52 limbs) were (4.6 ± 2.3) cm and (85.6 ± 11.3)％.The mean lesion length in the femoropopliteal occlusions(6 limbs)was(6.3 ± 3.2)cm. Rutherford score was 3 ～ 5. Mean ABI was 0.45 ± 0.36. Patency was evaluated with color duplex sonography,CTA and DSA postoperatively. Results 46 patients(58 limbs)were recanalizated suc-cessfully via intraluminal approach. The overall technical success rate was 100％. The procedural success rate was 93.10％. Postoperative residual stenosis and ABI were(10.3 ± 6.2)％and 1.05 ± 0.32,which had statistical diff erence compared with preoperative(t=5.83,P=0.02). The average period of follow-up was 22 months. Mean ABI during the follow-up was 0.96 ± 0.15,which had statistical difference compared with preoperative(t = 5.09,P =0.03). The 6-month and 1-and 2-year primary patency rate was 94.83％、91.38％、84.48％,and secondary patency rate was 98.28％、96.55％、93.10％,respectively. Conclusion SilverHawk directional atherectomy device is safe and effective in treament offemoropopliteal occlusive disease ,with satisfactory early-middle results.
Résumé
Objective To evaluate the safety and efficacy of SilverHawk directional atherectomy device in the treatment of femoropopliteal occlusive disease. Methods From August 2012 to June 2014,46 patients(58 limbs)with femoropopliteal occlusive diseases in the treatment by SilverHawk directional atherectomy device were analyzed retrospectively . The mean lesion length and degree of diameter stenosisin the femoropopliteal stenoses(52 limbs) were (4.6 ± 2.3) cm and (85.6 ± 11.3)％.The mean lesion length in the femoropopliteal occlusions(6 limbs)was(6.3 ± 3.2)cm. Rutherford score was 3 ～ 5. Mean ABI was 0.45 ± 0.36. Patency was evaluated with color duplex sonography,CTA and DSA postoperatively. Results 46 patients(58 limbs)were recanalizated suc-cessfully via intraluminal approach. The overall technical success rate was 100％. The procedural success rate was 93.10％. Postoperative residual stenosis and ABI were(10.3 ± 6.2)％and 1.05 ± 0.32,which had statistical diff erence compared with preoperative(t=5.83,P=0.02). The average period of follow-up was 22 months. Mean ABI during the follow-up was 0.96 ± 0.15,which had statistical difference compared with preoperative(t = 5.09,P =0.03). The 6-month and 1-and 2-year primary patency rate was 94.83％、91.38％、84.48％,and secondary patency rate was 98.28％、96.55％、93.10％,respectively. Conclusion SilverHawk directional atherectomy device is safe and effective in treament offemoropopliteal occlusive disease ,with satisfactory early-middle results.