Abstract：
BACKGROUND: Endovascular embolization procedures are typically the primary treatment modality for arteriovenous fistula (AVF). The objective of this subset analysis was to evaluate the prospective long-term clinical outcomes of AVF patients treated with the SMART COIL System.
METHODS: Patients who had arteriovenous fistulas (AVF) and underwent endovascular coiling using the Penumbra SMART COIL system were part of a subset analysis within the SMART registry. The SMART registry is a post-market registry that is prospective, multicenter, and single-arm in design. After the treatment, these patients were monitored for a period of 12 ± 6 months.
RESULTS: A total of 41 patients were included. No patients (0/41) had a procedural device-related serious adverse event (SAE). Re-access involving a guidewire due to catheter kickout was unnecessary for 85.4% (35/41) of the patients. Complete occlusion after the procedure was achieved in 87.8% (36/41) of patients. The periprocedural SAE rate was 2.4% (1/41), and no periprocedural deaths occurred (0/41). During the follow-up period, there were instances of re-treatment in 3.4% (1/29) of patients. At one year, the lesion occlusion was better or stable in 93.3% (28/30) of patients. The rate of serious adverse events (SAE) from 24 hours to 1 year (±6 months) following the procedure was 26.8% (11/41). The one-year all-cause mortality rate stood at 2.4% (1/ 41), and at the one-year follow-up, 90.9% (20/22) of patients had a modified Rankin Scale score within the range of 0 to 2.
CONCLUSIONS: The coiling procedure for arteriovenous fistulas using the SMART COIL System proved to be safe and effective at the one-year follow-up.
METHODS: Patients who had arteriovenous fistulas (AVF) and underwent endovascular coiling using the Penumbra SMART COIL system were part of a subset analysis within the SMART registry. The SMART registry is a post-market registry that is prospective, multicenter, and single-arm in design. After the treatment, these patients were monitored for a period of 12 ± 6 months.
RESULTS: A total of 41 patients were included. No patients (0/41) had a procedural device-related serious adverse event (SAE). Re-access involving a guidewire due to catheter kickout was unnecessary for 85.4% (35/41) of the patients. Complete occlusion after the procedure was achieved in 87.8% (36/41) of patients. The periprocedural SAE rate was 2.4% (1/41), and no periprocedural deaths occurred (0/41). During the follow-up period, there were instances of re-treatment in 3.4% (1/29) of patients. At one year, the lesion occlusion was better or stable in 93.3% (28/30) of patients. The rate of serious adverse events (SAE) from 24 hours to 1 year (±6 months) following the procedure was 26.8% (11/41). The one-year all-cause mortality rate stood at 2.4% (1/ 41), and at the one-year follow-up, 90.9% (20/22) of patients had a modified Rankin Scale score within the range of 0 to 2.
CONCLUSIONS: The coiling procedure for arteriovenous fistulas using the SMART COIL System proved to be safe and effective at the one-year follow-up.
摘要：
背景：血管内栓塞术通常是动静脉瘘（AVF）的主要治疗方式。此亚组分析的目的是评估使用SMARTCOIL系统治疗的AVF患者的前瞻性长期临床结果。
方法：患有动静脉瘘（AVF）并使用PenumbraSMARTCOIL系统进行血管内盘绕的患者是SMART注册表中子集分析的一部分。SMART注册处是一个预期的上市后注册处，多中心，和单臂设计。治疗后,这些患者的监测时间为12±6个月.
结果：共纳入41例患者。无患者(0/41)出现手术装置相关严重不良事件(SAE)。对于85.4％（35/41）的患者，由于导管伸出而无需重新进入导丝。87.8%(36/41)的患者术后完全闭塞。围手术期SAE率为2.4%(1/41),无围手术期死亡(0/41).在后续期间,3.4%(1/29)的患者有再次治疗的情况.一年，93.3%(28/30)的患者病灶闭塞较好或稳定。术后24小时至1年（±6个月）的严重不良事件（SAE）发生率为26.8%（11/41）。一年全因死亡率为2.4%(1/41),在为期一年的随访中，90.9％（20/22）的患者在0至2的范围内进行了改良的Rankin量表评分。
结论：在一年的随访中，使用SMARTCOIL系统对动静脉瘘进行盘绕手术被证明是安全有效的。
方法：患有动静脉瘘（AVF）并使用PenumbraSMARTCOIL系统进行血管内盘绕的患者是SMART注册表中子集分析的一部分。SMART注册处是一个预期的上市后注册处，多中心，和单臂设计。治疗后,这些患者的监测时间为12±6个月.
结果：共纳入41例患者。无患者(0/41)出现手术装置相关严重不良事件(SAE)。对于85.4％（35/41）的患者，由于导管伸出而无需重新进入导丝。87.8%(36/41)的患者术后完全闭塞。围手术期SAE率为2.4%(1/41),无围手术期死亡(0/41).在后续期间,3.4%(1/29)的患者有再次治疗的情况.一年，93.3%(28/30)的患者病灶闭塞较好或稳定。术后24小时至1年（±6个月）的严重不良事件（SAE）发生率为26.8%（11/41）。一年全因死亡率为2.4%(1/41),在为期一年的随访中，90.9％（20/22）的患者在0至2的范围内进行了改良的Rankin量表评分。
结论：在一年的随访中，使用SMARTCOIL系统对动静脉瘘进行盘绕手术被证明是安全有效的。
