Department of Cardiology, Toyama Prefectural Central Hospital, Toyama, Japan; Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan.
JACC Clin Electrophysiol. 2024 Aug;10(8):1828-1836. doi: 10.1016/j.jacep.2024.03.033. Epub 2024 May 22.
Differences in the efficacy and safety between the preclose and postclose suture-mediated vascular closure systems for femoral vein access have not been adequately studied.
This study aimed to evaluate the efficacy and safety of these 2 suturing techniques in femoral vein access.
Patients subjected to elective catheter ablation via the femoral vein using a sheath of 8- to 13-F inner diameter (n = 282) were randomized to the preclose or postclose groups for the single-suture technique using ProGlide/ProStyle (Abbott Vascular). Duplex ultrasound was performed on days 1 and 90 after the procedure to evaluate vascular complications. The primary efficacy endpoint was rebleeding requiring recompression, and the primary safety endpoint was any major complication occurring within 90 days. The secondary efficacy endpoints included time to hemostasis and time to ambulation, and the secondary safety endpoint was any minor complication occurring within 90 days.
The preclose group demonstrated a significantly lower rebleeding rate (5 of 141 [3.5%] vs 15 of 141 [10.6%]; P = 0.03) and shorter time to hemostasis (254.0 ± 120.4 seconds vs 299.8 ± 208.2 seconds; P = 0.02) compared with the postclose group. Five patients in each group were lost to follow-up at 90 days. Incidence of major complications were similar in both groups (1 of 136 [0.7%]; P = 1.00), whereas minor complications were observed in 18 of 136 (13.2%) and 21 of 136 (15.4%) patients in the preclose and postclose groups, respectively, without a significant difference (P = 0.73).
In femoral vein access using the single-suture technique with ProGlide/ProStyle, the preclose technique presented a higher hemostasis rate than the postclose technique, without compromising safety.
经股静脉入路使用预缝合和后缝合血管闭合系统在疗效和安全性方面的差异尚未得到充分研究。
本研究旨在评估这两种缝合技术在股静脉入路中的疗效和安全性。
使用内径为 8 至 13-F 的鞘管对 282 例接受经股静脉选择性导管消融术的患者进行随机分组，采用 ProGlide/ProStyle（雅培血管）进行单缝线技术的预缝合或后缝合。术后第 1 天和第 90 天进行双功能超声检查以评估血管并发症。主要疗效终点为需要重新压迫的再出血，主要安全性终点为 90 天内发生的任何重大并发症。次要疗效终点包括止血时间和开始行走时间，次要安全性终点为 90 天内发生的任何轻微并发症。
预缝合组的再出血率显著低于后缝合组（5/141[3.5%]比 15/141[10.6%]；P=0.03），止血时间也显著短于后缝合组（254.0±120.4 秒比 299.8±208.2 秒；P=0.02）。两组各有 5 例患者在 90 天时失访。两组主要并发症发生率相似（1/136[0.7%]；P=1.00），而预缝合组和后缝合组分别有 18/136（13.2%）和 21/136（15.4%）的患者出现轻微并发症，差异无统计学意义（P=0.73）。
在使用 ProGlide/ProStyle 进行单缝线技术的股静脉入路中，预缝合技术的止血率高于后缝合技术，且不影响安全性。
