Medtronic today shared long-term results from a global pivotal trial of its extravascular implantable cardioverter defibrillator (EV-ICD).

美敦力今天分享了其血管外植入式心脏复律除颤器（EV-ICD）全球关键试验的长期结果。

Dr. Francis Murgatroyd of Kings College Hospital, London, presented the results at the 2024 ESC (European Society of Cardiology) Congress.

伦敦国王学院医院的FrancisMurgatroyd博士在2024年欧洲心脏病学会（ESC）大会上介绍了这一结果。

The medtech giant said the study evaluated its Aurora EV-ICD system. Aurora delivers defibrillation, anti-tachycardia pacing (ATP) and backup (pause-prevention) pacing therapies. It features a similar size, shape and longevity to traditional transvenous ICDs. However, the implant goes below the left armpit with the Epsila defibrillation lead placed under the breastbone.

这家医疗科技巨头表示，该研究评估了其极光EV-ICD系统。Aurora提供除颤、抗心动过速起搏（ATP）和备用（暂停预防）起搏疗法。它的大小，形状和寿命与传统的经静脉ICD相似。然而，植入物位于左腋下，Epsila除颤导线位于胸骨下方。

This helps avoid certain risks associated with transvenous ICDs..

这有助于避免与经静脉ICD相关的某些风险。。

Aurora also features anti-tachycardia pacing (ATP), a safe and effective feature for terminating ventricular tachycardia (VT). ATP restores the heart’s normal rhythm, briefly delivering pacing pulses to the heart at a faster rate than the tachycardia.

Aurora还具有抗心动过速起搏（ATP），这是终止室性心动过速（VT）的安全有效功能。ATP恢复心脏的正常节律，短暂地以比心动过速更快的速度向心脏传递起搏脉冲。

Medtronic received FDA approval for the Aurora EV-ICD MRI SureScan extravascular defibrillator in October 2023.

美敦力于2023年10月获得FDA批准用于Aurora EV-ICD MRI SureScan血管外除颤器。

The EV ICD pivotal trial, a prospective, multicenter, single-arm, non-randomized, pre-market clinical study, assessed the safety and effectiveness of the Aurora system for patients at risk of sudden cardiac death. Investigators enrolled 356 patients across 46 sites in 17 countries across North America, Europe, the Middle East, Asia, Australia and New Zealand..

EV ICD pivotal试验是一项前瞻性，多中心，单臂，非随机，上市前临床研究，评估了Aurora系统对心源性猝死风险患者的安全性和有效性。调查人员在北美、欧洲、中东、亚洲、澳大利亚和新西兰的17个国家的46个地点招募了356名患者。。

Investigators published primary results in The New England Journal of Medicine. Medtronic says it saw previously reported safety and effectiveness results sustained out to 18 months.

研究人员在《新英格兰医学杂志》上发表了初步结果。美敦力表示，之前报道的安全性和有效性结果持续了18个月。

“The final results from the EV ICD pivotal trial confirm the ongoing safety of the procedure and system and consolidate the benefits of the extravascular implantable cardioverter defibrillator,” said Murgatroyd. “We also now have increased evidence for the effectiveness and tolerability of anti-tachycardia pacing, rather than just shocks..

Murgatroyd说：“EV ICD pivotal试验的最终结果证实了手术和系统的持续安全性，并巩固了血管外植入式心脏复律除颤器的益处。”。“我们现在也有越来越多的证据表明抗心动过速起搏的有效性和耐受性，而不仅仅是电击。。

“This is a fundamental feature built into the extravascular ICD, which offers my patients a less painful solution, improved quality of life, and peace of mind, knowing they are protected against sudden cardiac death.”

“这是血管外ICD的一个基本功能，它为我的患者提供了一个不那么痛苦的解决方案，提高了生活质量，让他们心平气和，因为他们知道自己可以防止心源性猝死。”

A look at the data shared by Medtronic

查看美敦力共享的数据

The final results showed that ATP proved successful in 37 out of 48 episodes (77%). That fell in line with transvenous ATP success. The EV-ICD effectively terminated ventricular tachycardia/ventricular fibrillation (VT/VF), delivering 100% shock success for discrete spontaneous episodes.

最终结果显示，ATP在48集中有37集（77%）成功。这与经静脉ATP的成功相符。EV-ICD有效地终止了室性心动过速/心室颤动（VT/VF），为离散的自发性发作提供了100%的休克成功率。

Medtronic also said ATP utilization increased significantly through the duration of the study follow-up (an average of 30.6 months). ATP, which is nominally programmed off, was reported as programmed on in a majority of patients (81.2%) at 24 months. No patient with successful ATP had the therapy programmed off subsequently..

美敦力还表示，在研究随访期间（平均30.6个月），ATP利用率显着增加。据报道，在24个月时，大多数患者（81.2%）的ATP名义上被编程为关闭。没有成功ATP的患者随后停止了治疗。。

In 299 patients with a successful implant, 24 patients experienced 82 spontaneous arrhythmic episodes appropriately treated with either ATP only (38), shock only (34) or both (10). The EV-ICD demonstrated a low major complication rate, Medtronic said, and a high success rate for appropriate therapy.

在299例成功植入的患者中，24例患者经历了82次自发性心律失常发作，分别接受了仅ATP（38），仅休克（34）或两者（10）的适当治疗。美敦力表示，EV-ICD的主要并发症发生率较低，适当治疗的成功率较高。

Investigators reported avoided shocks in nearly half the episodes due to the availability of ATP..

调查人员报告说，由于ATP的可用性，近一半的事件避免了电击。。

Medtronic also reported positive patient-reported quality of life (QOL) metrics and patient acceptance of the device. Investigators evaluated this through a standardized, device-specific quality of life survey, the Florida Patient Acceptance Survey.

美敦力还报告了患者报告的生活质量（QOL）指标和患者对该设备的接受程度。调查人员通过一项标准化的、特定于设备的生活质量调查（佛罗里达州患者接受度调查）对此进行了评估。

EV-ICD patients reported fewer body image concerns and less device-related distress from baseline to six-month follow-up. They also reported greater overall acceptance of their ICD than subcutaneous ICD patients.

从基线到六个月的随访，EV-ICD患者报告的身体图像问题较少，与设备相关的痛苦较少。他们还报告说，与皮下ICD患者相比，他们对ICD的总体接受程度更高。

“The final results of the EV ICD Pivotal Trial presented at ESC 2024 underscore the longer-term benefits for patients at risk of sudden cardiac death who receive a Medtronic extravascular defibrillator,” said Dr. Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic.

美敦力心律管理业务首席医疗官Alan Cheng博士说：“在ESC 2024年会议上提出的EV ICD Pivotal试验的最终结果强调了接受美敦力血管外除颤器治疗的心源性猝死风险患者的长期益处。”。

“These findings highlight our commitment to continuing to create innovative products that allow physicians to provide device therapy with the advantages of transvenous defibrillators, while remaining outside the heart and vascular space.”.

“这些发现突显了我们致力于继续创造创新产品，使医生能够利用经静脉除颤器的优势提供设备治疗，同时保持在心脏和血管空间之外。”。

Medtronic also has a global post-approval, prospective, non-randomized, observational, multicenter registry across more than 125 sites for the Aurora EV-ICD system. It expects to enroll a minimum of 500 patients, with follow-up data collected through the lifetime of the device.

美敦力还在Aurora EV-ICD系统的125多个站点上拥有一个全球批准后，前瞻性，非随机，观察性，多中心注册中心。它预计将招募至少500名患者，并在设备的整个生命周期内收集随访数据。