Sazzad Faizus, Kim Ki Han, Moideen Irwan Shah Bin Mohd, El Gohary Abdulrahman, Stevens John C, Kofidis Theo
Department of Surgery, National University of Singapore, Singapore, Singapore.
Department of Cardiac, Thoracic and Vascular Surgery, NUHCS, Singapore, Singapore.
Interdiscip Cardiovasc Thorac Surg. 2025 Feb 5;40(2). doi: 10.1093/icvts/ivaf017.
Minimally invasive cardiac surgery (MICS) struggles with effective caval isolation and cannulation for cardiopulmonary bypass (CPB). We aimed to develop a novel MICS venous cannula, eliminating external manipulations. The goal of this study is to thoroughly evaluate both the safety and the efficacy of a newly developed venous cannula.
The study presents the Aulus venous cannula for MICS, designed with internal balloons to block caval blood flow. Preclinical bench tests with a cardiac biosimulator and large animal studies per ISO10993-2016, evaluated performance and safety.
The heparin-coated Aulus cannula had a post-sterilization comparable density of ∼0.200 μg/cm2. In ex vivo tests, using porcine heart models, the cannula enabled full caval occlusion, with endoscopic views confirming precise positioning. The pressure drop remained below the haemolytic threshold of 100 mmHg, indicated lower values compared to BioMedicus. A non-Good Laboratory Practice (GLP) large animal study included eight ovine models, divided into short- and long-term follow-up groups. Clinical pathology values were consistent CPB procedures, and histopathology indicated favourable tolerance despite short-term vessel injuries and long-term stenosis with fibrosis.
The Aulus cannula showed effective anticoagulant activity, strong integrity, and good tolerance in vitro and in vivo, highlighting its clinical potential.
微创心脏手术（MICS）在体外循环（CPB）时的有效腔静脉隔离和插管方面存在困难。我们旨在开发一种新型的MICS静脉插管，消除外部操作。本研究的目的是全面评估一种新开发的静脉插管的安全性和有效性。
本研究展示了用于MICS的奥卢斯静脉插管，其设计有内部球囊以阻断腔静脉血流。根据ISO10993 - 2016进行了心脏生物模拟器的临床前台架试验和大型动物研究，评估其性能和安全性。
肝素涂层的奥卢斯插管在灭菌后的密度约为0.200μg/cm²。在体外试验中，使用猪心脏模型，该插管能够实现完全腔静脉闭塞，内镜观察证实了其精确定位。压降保持在100mmHg的溶血阈值以下，与百多力相比数值更低。一项非良好实验室规范（GLP）的大型动物研究纳入了8只绵羊模型，分为短期和长期随访组。临床病理学值与CPB手术一致，组织病理学表明尽管存在短期血管损伤和长期纤维化狭窄，但耐受性良好。
奥卢斯插管在体外和体内均显示出有效的抗凝活性、强大的完整性和良好的耐受性，突出了其临床潜力。
