Primary results from the DEFINE AFib clinical study show the Medtronic LINQ family of insertable cardiac monitors (ICM), paired with a novel algorithm, were able to detect atrial fibrillation episodes and properly risk stratify patients as high risk prior to an AF-related healthcare utilization 80% of the time.

DEFINE AFib临床研究的主要结果显示，美敦力LINQ系列可插入心脏监护仪（ICM）与一种新算法相结合，能够检测心房颤动发作，并在与房颤相关的医疗保健利用率之前将患者正确分为高风险80%的时间。

Using artificial intelligence (AI)-based algorithms, the Reveal LINQ™ and LINQ II™ ICMs quantified AF burden (a measure of time a person spends in atrial fibrillation during a monitored period) to inform treatment decisions and help anticipate future healthcare needs. The results were presented at the AF Symposium 2025..

使用基于人工智能（AI）的算法，Reveal LINQ™和LINQ II™ICMs量化了房颤负担（衡量一个人在监测期间在房颤中花费的时间），以告知治疗决策并帮助预测未来的医疗保健需求。研究结果发表在2025年AF研讨会上。。

By 2030, approximately 12.2 million people in the U.S. will have AF, an irregular and potentially dangerous heart rhythm.

到2030年，美国将有大约1220万人患有房颤，这是一种不规则且潜在危险的心律。

Despite AF being a serious, chronic and progressive disease, there remains a lack of clinical consensus on AF burden thresholds and how much AF is clinically relevant.

尽管房颤是一种严重的慢性进行性疾病，但对于房颤负担阈值以及房颤的临床相关性仍然缺乏临床共识。

The DEFINE AFib clinical study enrolled 973 patients using an app-based enrollment feature and characterized the impact of AF burden on patient outcomes and quality of life. Using the data, researchers built an algorithm capable of predicting patients’ risk of needing AF-related healthcare in the next 30-day period, in addition to predicting clinically meaningful reductions in patient-reported quality of life..

DEFINE AFib临床研究使用基于应用程序的注册功能招募了973名患者，并表征了房颤负担对患者结局和生活质量的影响。利用这些数据，研究人员建立了一种算法，能够预测患者在未来30天内需要房颤相关医疗保健的风险，此外还可以预测患者报告的生活质量在临床上有意义的降低。。

Results from the study showed that 22% of study participants who crossed into the high-risk threshold for the first time experienced an AF-related healthcare utilization (AFHCU) at a mean time of 164±145 days compared to 9% of patients in the low-risk group. The data supports the conclusion that the AI-based analytics from the ICMs provide valuable information, particularly for those at a higher risk of an AF-related hospitalization, clinic visit, or therapeutic intervention..

研究结果显示，22%首次进入高风险阈值的研究参与者平均在164±145天内经历了房颤相关的医疗保健利用（AFHCU），而9%的患者在低风险组。这些数据支持这样的结论，即来自ICMs的基于AI的分析提供了有价值的信息，特别是对于那些与房颤相关的住院，诊所就诊或治疗干预风险较高的人。。

“The first-of-its-kind DEFINE AFib study leveraged a unique design that engaged patients from the very beginning. We know that how much AF a patient experiences matters, but we don’t know how different durations or patterns impact the risk of future health events. Combining continuous rhythm monitoring with traditional risk factors has helped clarify how AF burden and patterns can inform risk, prioritization, and treatment decisions,” said Jonathan P.

JonathanP说：“这是第一项定义AFib的研究，它利用了一种独特的设计，从一开始就吸引了患者。我们知道患者经历的房颤程度很重要，但我们不知道不同的持续时间或模式如何影响未来健康事件的风险。将连续节律监测与传统风险因素相结合，有助于阐明房颤负担和模式如何告知风险，优先顺序和治疗决策。”。

Piccini, M.D., clinical cardiac electrophysiologist and professor of medicine and population health at Duke University Hospital and the Duke Clinical Research Institute, and chair of the DEFINE AFib clinical study steering committee. “Using upgraded AI-based algorithms and ICM data, physicians are better equipped to understand variance in patients’ AF patterns, offering the opportunity to provide the right patient with the right therapy at the right time.”.

医学博士Piccini是杜克大学医院和杜克临床研究所的临床心脏电生理学家、医学和人口健康教授，也是DEFINE AFib临床研究指导委员会主席。“使用升级的基于人工智能的算法和ICM数据，医生可以更好地了解患者房颤模式的差异，从而有机会在正确的时间为正确的患者提供正确的治疗。”。

Performance of consumer wearables in AF detection

消费者可穿戴设备在AF检测中的性能

A sub-analysis from the DEFINE AFib clinical study, recently presented at the European Society of Cardiology (ESC) Congress in 2024, showed important differences in performance between the LINQ family of ICMs and the Apple Watch™* for AF episode detection. Notably, 40% of AF episodes (191 episodes) occurred while the Apple Watch was not being worn; AF episodes can often occur at night while wearables are often taken off to recharge.

最近在2024年欧洲心脏病学会（ESC）大会上发表的DEFINE AFib临床研究的一项子分析显示，LINQ系列iCM和Apple Watch™之间在AF发作检测方面的性能存在重要差异。值得注意的是，40%的房颤发作（191次）发生在苹果手表未佩戴时；AF发作通常发生在晚上，而可穿戴设备通常会被取下充电。

In addition, when worn, the Apple Watch was only able to detect 26% of AF episodes (lasting 75 minutes or more) that the LINQ ICM detected..

此外，当佩戴时，Apple Watch只能检测到LINQ ICM检测到的26%的房颤发作（持续75分钟或更长时间）。。

“Wearables allow patients to capture more real-time heart health data than ever before, but medical grade technology, like the LINQ family of ICMs, is necessary to provide clinicians with an accurate and reliable way to detect and manage cardiac conditions like AF,” said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic.

“可穿戴设备使患者比以往任何时候都能捕获更多的实时心脏健康数据，但医疗级技术，如ICMs的LINQ家族，对于为临床医生提供准确可靠的方法来检测和管理房颤等心脏疾病是必要的，”美敦力心血管投资组合的一部分心律管理业务首席医疗官Alan Cheng医学博士说。

“These findings also indicate that, while consumer-grade devices such as smartwatches and monitors can provide some insights into overall heart health, they are limited in their ability to screen for and help manage chronic conditions like AF. Medical grade devices with continuous monitoring capabilities like ICMs are more appropriate.”.

“这些发现还表明，虽然智能手表和监护仪等消费级设备可以提供对整体心脏健康的一些见解，但它们在筛查和帮助管理房颤等慢性病方面的能力有限。具有ICM等连续监测功能的医疗级设备更合适。”。

The DEFINE AFib clinical study used AI and machine-learning techniques to analyze changes in AF burden over time; the ICM-based model separated individuals into high- vs low-risk of AFHCU groups. AFHCUs included clinical actions such as ablation, cardioversion, initiation/intensification of rate or rhythm control medication, or progression to a pacemaker or implantable cardioverter-defibrillator..

DEFINE AFib临床研究使用AI和机器学习技术来分析房颤负担随时间的变化；基于ICM的模型将个体分为AFHCU高风险组和低风险组。AFHCUs包括临床行动，例如消融，复律，开始/强化心率或节律控制药物，或进展为起搏器或植入式心脏复律除颤器。。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

大胆思考。更大胆的行动。我们是美敦力。总部位于爱尔兰戈尔韦的美敦力公司是全球领先的医疗保健技术公司，通过寻找和寻找解决方案，大胆应对人类面临的最具挑战性的健康问题。我们的使命是减轻痛苦，恢复健康，延长寿命，我们团结了150多个国家的95000多名充满激情的全球团队。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .

随着我们增强洞察力驱动的护理、以人为本的体验以及为我们的世界带来更好的结果，对我们的期望会更高。在我们所做的每件事中，我们都在创造非凡。有关美敦力的更多信息，请访问。