Fédération de Cardiologie, Hôpital de la Croix Rousse et Hôpital Lyon Sud, Hospices Civils de Lyon, 103 Grande Rue de la Croix-Rousse, 69004 Lyon, France.
Université de Lyon, CREATIS UMR5220, INSERM U1044, INSA Lyon, 7 avenue Jean Capelle, 69621 Villeurbanne Cedex, Lyon, France.
Eur Heart J. 2023 Dec 7;44(46):4847-4858. doi: 10.1093/eurheartj/ehad629.
Intra-pocket ultrasound-guided axillary vein puncture (IPUS-AVP) for venous access in implantation of transvenous cardiac implantable electronic devices (CIED) is uncommon due to the lack of clinical evidence supporting this technique. This study investigated the efficacy and early complications of IPUS-AVP compared to the standard method using cephalic vein cutdown (CVC) for CIED implantation.
ACCESS was an investigator-led, interventional, randomized (1:1 ratio), monocentric, controlled superiority trial. A total of 200 patients undergoing CIED implantation were randomized to IPUS-AVP (n = 101) or CVC (n = 99) as a first assigned route. The primary endpoint was the success rate of insertion of all leads using the first assigned venous access technique. The secondary endpoints were time to venous access, total procedure duration, fluoroscopy time, X-ray exposure, and complications. Complications were monitored during a follow-up period of three months after procedure.
IPUS-AVP was significantly superior to CVC for the primary endpoint with 100 (99.0%) vs. 86 (86.9%) procedural successes (P = .001). Cephalic vein cutdown followed by subclavian vein puncture was successful in a total of 95 (96.0%) patients, P = .21 vs. IPUS-AVP. All secondary endpoints were also significantly improved in the IPUS-AVP group with reduction in time to venous access [3.4 vs. 10.6 min, geometric mean ratio (GMR) 0.32 (95% confidence interval, CI, 0.28-0.36), P < .001], total procedure duration [33.8 vs. 46.9 min, GMR 0.72 (95% CI 0.67-0.78), P < .001], fluoroscopy time [2.4 vs. 3.3 min, GMR 0.74 (95% CI 0.63-0.86), P < .001], and X-ray exposure [1083 vs. 1423 mGy.cm², GMR 0.76 (95% CI 0.62-0.93), P = .009]. There was no significant difference in complication rates between groups (P = .68).
IPUS-AVP is superior to CVC in terms of success rate, time to venous access, procedure duration, and radiation exposure. Complication rates were similar between the two groups. Intra-pocket ultrasound-guided axillary vein puncture should be a recommended venous access technique for CIED implantation.
由于缺乏支持该技术的临床证据，经皮腔内超声引导腋窝静脉穿刺（IPUS-AVP）用于植入经静脉心脏植入式电子设备（CIED）的静脉通路并不常见。本研究旨在比较 IPUS-AVP 与传统头静脉切开术（CVC）用于 CIED 植入的有效性和早期并发症。
ACCESS 是一项由研究者主导的、介入性、随机（1:1 比例）、单中心、对照优势试验。共纳入 200 例接受 CIED 植入的患者，随机分为 IPUS-AVP（n=101）或 CVC（n=99）作为首选静脉通路。主要终点是使用首选静脉通路技术插入所有导线的成功率。次要终点是静脉通路建立时间、总手术时间、透视时间、X 射线暴露量和并发症。在术后 3 个月的随访期间监测并发症。
IPUS-AVP 在主要终点方面明显优于 CVC，成功率为 100（99.0%）vs. 86（86.9%）（P=0.001）。头静脉切开术联合锁骨下静脉穿刺共成功 95 例（96.0%），P=0.21 vs. IPUS-AVP。IPUS-AVP 组的所有次要终点也均显著改善，静脉通路建立时间缩短[3.4 分钟 vs. 10.6 分钟，几何均数比（GMR）0.32（95%置信区间，CI，0.28-0.36），P<0.001]，总手术时间缩短[33.8 分钟 vs. 46.9 分钟，GMR 0.72（95%CI 0.67-0.78），P<0.001]，透视时间缩短[2.4 分钟 vs. 3.3 分钟，GMR 0.74（95%CI 0.63-0.86），P<0.001]，X 射线暴露量减少[1083 mGy.cm² vs. 1423 mGy.cm²，GMR 0.76（95%CI 0.62-0.93），P=0.009]。两组并发症发生率无显著差异（P=0.68）。
IPUS-AVP 在成功率、静脉通路建立时间、手术时间和辐射暴露方面优于 CVC。两组并发症发生率相似。经皮腔内超声引导腋窝静脉穿刺应为 CIED 植入的推荐静脉通路技术。
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