Peter Stalmans
Department Ophthalmology UZLeuven, Herestraat 49, Leuven, 3000, Belgium.
Int J Retina Vitreous. 2024 Jun 24;10(1):45. doi: 10.1186/s40942-024-00563-3.
The EVA Nexus system offers several technical improvements over its predecessor. The newly designed Aveta cannula system for vitrectomy surgery avoids the need for removal of the valve from the infusion cannula. The chamfered leading edge of the cannula also reduces the insertion force needed. The new EquiPhaco needles in combination with SmartIOP provide excellent anterior chamber stability during phaco-emulsification surgery, enabling to work at lower infusion pressures, and the multiburst phaco mode allows easier removal of hard cataracts. The system offers a secondary active infusion line for independent control of pressure to the anterior and posterior chambers, monitoring of flow rate/reflux and warning of infusion bottle emptying. This study evaluated whether these technical improvements result in improved surgical safety.
In total, 250 eyes that underwent vitrectomy (53%) or phaco-vitrectomy (47%) using the EVA Nexus system were prospectively included. The occurrence of intraoperative adverse events was compared to that of historically operated eyes using the EVA system.
The average age of the patients was 63 years. A total of 33% of the patients were operated on for retinal detachment, 17% for macular pucker, 11% for treating floaters, 9% for removing silicone oil, 8% for macular hole repair and 22% for other diseases. In 75% of surgeries, 23 G instruments were used, and 27 G instruments were used in 25% of cases. Device issues that occurred included priming cycle issues (n = 4), eye pressure stability problems (n = 6) and vitrectome performance issues (n = 1), all of which in the first 100 patients who were included and were fixed with software updates. The frequency of surgical complications in the anterior segment was lower than that in the historically recorded surgical reports. Intraoperative events in the posterior segment included hemorrhage from retinal vessels, choroidal hematoma, iatrogenic retinal damage/tear, and subchoroidal infusion. Again, these events occurred rarely and less frequently than in the historical surgical reports.
The EVA Nexus provides a surgical platform that reduces the incidence of intraoperative adverse events and iatrogenic complications in both anterior and posterior segment surgery. This could increase surgical safety during cataract and vitrectomy surgery. TRIAL REGISTRATION NUMBER CLINICALTRIALS.GOV: : NCT05229094 Data 22/5/2021.
EVA Nexus系统相比其前身有多项技术改进。新设计的用于玻璃体切割手术的Aveta套管系统无需从输液套管上取下阀门。套管的倒角前缘也降低了所需的插入力。新型EquiPhaco针头与SmartIOP相结合，在超声乳化手术期间可提供出色的前房稳定性，能够在较低的输液压力下操作，并且多脉冲超声乳化模式使硬白内障的摘除更加容易。该系统提供一条二级主动输液管线，用于独立控制前房和后房的压力、监测流速/回流以及提示输液瓶排空。本研究评估了这些技术改进是否能提高手术安全性。
前瞻性纳入了总共250只使用EVA Nexus系统进行玻璃体切割术（53%）或超声乳化玻璃体切割术（47%）的眼睛。将术中不良事件的发生率与使用EVA系统的既往手术眼睛进行比较。
患者的平均年龄为63岁。共有33%的患者因视网膜脱离接受手术，17%因黄斑皱襞，11%因治疗飞蚊症，9%因取出硅油，8%因黄斑裂孔修复，22%因其他疾病。在75%的手术中使用了23G器械，25%的病例使用了27G器械。出现的设备问题包括灌注周期问题（n = 4）、眼压稳定性问题（n = 6）和玻璃体切割器性能问题（n = 1），所有这些问题都出现在最初纳入的100名患者中，并通过软件更新得到解决。前段手术并发症的发生率低于既往手术报告中的记录。后段术中事件包括视网膜血管出血、脉络膜血肿、医源性视网膜损伤/撕裂和脉络膜下灌注。同样，这些事件很少发生，且比既往手术报告中的发生率更低。
EVA Nexus提供了一个手术平台，可降低前段和后段手术中术中不良事件和医源性并发症的发生率。这可能会提高白内障和玻璃体切割手术期间的手术安全性。试验注册号：CLINICALTRIALS.GOV：NCT05229094 数据2021年5月22日。
