Shahverdyan Robert, Tabbi Paola, Mestres Gaspar
Vascular Access Center, Asklepios Clinic Barmbek, Hamburg, Germany.
Department of Vascular Surgery, San Giovanni Hospital, Rome, Italy.
J Vasc Surg. 2022 Jan;75(1):248-254. doi: 10.1016/j.jvs.2021.07.120. Epub 2021 Jul 24.
To evaluate the outcomes of arteriovenous fistulae (AVF), created with VasQ external support device under standard clinical practice across three vascular access clinics.
This multinational, retrospective study evaluated prospectively collected clinical outcomes of both forearm and upper arm brachiocephalic AVF (BCAVF) created using the VasQ device. Fifty-one AVF patients were pooled from three different vascular access centers in Germany, Italy, and Spain. Postprocedure outcomes were assessed by flow measurement with ultrasound examination in all centers. Primary failure, usability, patency, and intervention rates during the study period were evaluated.
Fifty-one VasQ devices were implanted during 37 forearm (36 radiocephalic and 1 ulnar-basilic AVF) and 14 BCAVF procedures. The study population comprised mostly males (73%) and Caucasians (82%), with a mean age of 62.5 years (range, 38-84 years) and mean body mass index of 29.2. One patient died owing to access-unrelated reasons, and one patient was lost to follow-up without AVF assessment after its creation. From the remaining 49, 3 patients had a follow-up of less than 4 weeks and were excluded from maturation, primary failure, and dialysis initiation analysis (because those factors could not be evaluated yet), leaving 46 patients in this evaluation. Maturation was achieved in 91% of patients. The primary failure rate was 9%. A primary patency rate of 77% was observed at 6, 12, and 18 months. The secondary patency rate was 91% at 6 months, and 85% at 12 months and 18 months. Both primary patency and secondary patency did not differ statistically when comparing forearm AVF with BCAVF (P > .25). Successful cannulation was achieved in 86% of patients (32/37) requiring dialysis with a median time from creation to cannulation of 46 days. Of those patients, the functional patency rate was 94%. Five patients underwent seven interventions to maintain or restore patency or functionality, with an overall rate of 0.248 interventions per patient-year.
AVFs created with VasQ external support device demonstrated promising patency and functionality outcomes in multicentric real-world setting across the two most commonly used anatomic locations.
评估在三个血管通路诊所的标准临床实践中，使用VasQ外部支撑装置创建的动静脉内瘘（AVF）的效果。
这项多国回顾性研究评估了前瞻性收集的使用VasQ装置创建的前臂和上臂头臂动静脉内瘘（BCAVF）的临床结果。从德国、意大利和西班牙的三个不同血管通路中心汇总了51例AVF患者。所有中心均通过超声检查测量血流量来评估术后结果。评估了研究期间的原发性失败、可用性、通畅率和干预率。
在37例前臂手术（36例桡动脉-头静脉内瘘和1例尺动脉-贵要静脉内瘘）和14例BCAVF手术中植入了51个VasQ装置。研究人群主要为男性（73%）和白种人（82%），平均年龄62.5岁（范围38 - 84岁），平均体重指数29.2。1例患者因与血管通路无关的原因死亡，1例患者在创建AVF后失访，未进行AVF评估。在其余49例中，3例患者随访时间少于4周，被排除在成熟度、原发性失败和透析开始分析之外（因为这些因素尚无法评估），本评估中剩余46例患者。91%的患者实现了成熟。原发性失败率为9%。在6个月、12个月和18个月时观察到原发性通畅率为77%。6个月时继发性通畅率为91%，12个月和18个月时为85%。比较前臂AVF和BCAVF时，原发性通畅率和继发性通畅率在统计学上无差异（P > 0.25）。86%（32/37）需要透析的患者成功进行了穿刺，从创建到穿刺的中位时间为46天。在这些患者中，功能性通畅率为94%。5例患者接受了7次干预以维持或恢复通畅或功能，每位患者每年的总体干预率为0.248次。
在两个最常用解剖部位的多中心实际应用中，使用VasQ外部支撑装置创建的AVF显示出有前景的通畅率和功能结果。
