Insertable cardiac monitors for syncope and cryptogenic stroke
UK case study Stoke Hospital
Insertable cardiac monitors (ICMs), also known as insertable or implantable loop recorders, are subcutaneous devices for long-term monitoring of cardiac arrhythmias.1 ICMs are indicated for detecting atrial fibrillation (AF) or other irregular heart rhythms in patients who have experienced either an unexplained syncope or a cryptogenic stroke/transient ischaemic attack (TIA).2 Timely arrhythmia detection can initiate interventions to minimise the risk of a serious recurrent cardiac event or secondary ischaemic stroke.3,4
Evidence
Many patients with unexplained syncope or cryptogenic stroke are still followed up with external cardiac monitoring (ECM) using a 24–48-hour ambulatory electrocardiogram Holter monitor. However, conventional symptom-driven or short-term monitoring is inadequate for detecting intermittent arrhythmia episodes, which are typically asymptomatic5 and often occur after the traditional 30-day monitoring period.6 Therefore, in both these indications, national and international guidelines recommend early use of continuous monitoring with an ICM.7,8 These recommendations are well supported by research demonstrating the clinical and cost benefits of ICMs compared with conventional follow-up in syncope or stroke, including improved diagnostic guidance, treatment initiation and secondary disease prevention.7-11
Implantation in practice
The three case studies highlight how hospitals across Europe have successfully transitioned to using Medtronic’s Reveal LINQ™ ICM and its next-generation LINQ II™ system. Each implementation was supported by the development and refinement of tailored care pathways for unexplained syncope and cryptogenic stroke, demonstrating how targeted approaches can improve arrhythmia detection and overcome diagnostic challenges.
Features of the LINQ II system
References
Note See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions and potential adverse events. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat Reader with the browser. This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies are not intended for users in markets that do not have authorisation for use. Declarations of interest These case studies have been commissioned and funded by Medtronic. Compensation These faculties involved are being paid for consultancy and the services being provided in accordance with applicable laws and regulations. Caution statement: The content and opinions in these case studies are provided by physician faculty and not all comments are the opinion of Medtronic. This page is provided for general educational purposes only and should not be considered the exclusive source for this type of information. The content does not replace or supersede approved labelling. The content will be shared with physicians and allied health professionals who seek a deeper understanding of the operation and use of Medtronic products and therapies with the intent of enhancing their knowledge of features and operations described in the clinician manuals. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features and results may vary. The device functionality and programming described in this video are based on Medtronic products and can be referenced in the published device manuals. 2025-linq-case-studies-en-gb-emea-18293079
CRYSTAL-AF (cryptogenic stroke and underlying atrial fibrillation)* AF detection at 6 months in cryptogenic stroke
ICM
ECM
Hazard ratio 6.4 (95% CI 1.9–21.7); P<0.001
8.9% (n=19/221)
1.4% (n=3/220)
Anticoagulant initiation at 6 months in cryptogenic stroke
10.1%
4.6%
SCROLL
Diagnostic yield in unexplained syncope
Clinical impact of ICMs
AF detection in cryptogenic stroke
Diagnosis yield in patients with unexplained syncope Brignole et al (2018 ESC Guidelines for the diagnosis and management of syncope)8
SoC†
45.6% (n=152/333)
12.3% (n=40/324)
Relative probability=3.6; p=0.001
†Standard of care
Rates of therapeutic interventions with ICM (Reveal LINQ) De Melis et al (Rates of therapeutic interventions in a large real-world cohort with insertable cardiac monitors)12
Any therapeutic procedure
Arrhythmia-related medication
25.0% (n=4257/17 037)
44.0% (n=7492/17 037)
*De Melis M, Margetta J, Rosemas SC et al. Rates of therapeutic interventions in a large real-world cohort with insertable cardiac monitors. Eur Heart J. 2024;45(Sup1): ehae666–346. https://doi.org/10.1093/eurheartj/ehae666.346
Total therapeutic intervention
54.5% (n=9284/17 037)
Monitoring and triaging service In addition, staffed with certified ECG device specialists and cardiologists, Medtronic provides monitoring & triaging service, which filters out non-actionable transmissions and alerts you to only the 20% of data that requires clinical action.17-18
ICM & insertion tool
Remote programming
Personalised monitoring
Enhanced patient engagement and onboarding service
Monitoring and triaging service
AI enhanced detection
Enhanced patient engagement and onboarding service Medtronic now provides an experienced patient support team, who help patients onboard with their optimal monitoring solution and answer any device & monitoring questions.17-18
Personalised monitoring A user-friendly patient monitor sends data from the ICM to the patient’s clinic. And for LINQ II™, depending on level of comfort with technology and how much time is spent away from home, patients have a choice of app (MyCareLink Heart™) or bedside monitor (MyCareLinkRelay™ home communicator).
AI enhanced detection The AccuRhythm AI platform is an artificial intelligence (AI) system that applies deep learning algorithms to LINQ II insertable cardiac monitor (ICM) data flowing into the CareLink™ network. AccuRhythm™ AI algorithms significantly reduce AF and Pause false positives, without compromising sensitivity.14-16
ICM & insertion tool The LINQ II™ ICM is the most advanced ICM system, featuring AccuRhythm enhanced artificial intelligence (AI) algorithms, remote programming, and 4.5-year† longevity.13 LINQ II™ ICM is ideal for patients experiencing infrequent symptoms that require long-term monitoring or ongoing management. The device comes with a pre-loaded insertion tool. †Nominal settings.
Remote programming LINQ II™ was the first ICM with remote programming capability.*13 Remote programming enables programming directly from clinic for all device parameters post-insertion, enables on-going programming optimisation which reduces non-actionable transmissions and may reduce patient office visits and scheduling challenges.13 *First CE-marked ICM with remote programming capabilities, approved for LINQ ICM on 5 November 2019.
Italy case study GB Grassi Hospital
Germany case study St Vinzenz-Hospital
*Sanna T, Diener H-C, Passman RS et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014;370(26):2478–2486. https://doi.org/10.1056/NEJMoa1313600
AF detection at 6 months in cryptogenic stroke CRYSTAL-AF (cryptogenic stroke and underlying atrial fibrillation)5
*Brignole M, Moya A, de Lange FJ et al. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018;39(21):2002. https://doi.org/10.1093/eurheartj/ehy306 †Standard of care
Visit the LINQ II system website
Sanghvi MM, Jones DM, Kalindjian J et al. The utility of implantable loop recorders in patient management: an age- and indication-stratified study in the outpatient-implant era. Eur Heart J – Qual Care Clin Outcomes. 2022;8(7):770–777. https://doi.org/10.1093/ehjqcco/qcab071 Medtronic. LINQ II™ insertable cardiac monitor. 2025. https://www.medtronic.com/en-…ors/linq-ii-icm.html (accessed August 2025) Freedman B, Potpara TS, Lip GYH. Stroke prevention in atrial fibrillation. The Lancet. 2016;388(10046):806–817. https://doi.org/10.1016/S0140-6736(16)31257-0 Giancaterino S, Lupercio F, Nishimura M et al. Current and future use of insertable cardiac monitors. JACC Clin Electrophysiol. 2018;4(11):1383–1396. https://doi.org/10.1016/j.jacep.2018.06.001 Sanna T, Diener H-C, Passman RS et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014;370(26):2478–2486. https://doi.org/10.1056/NEJMoa1313600 Buck BH, Hill MD, Quinn FR et al. Effect of implantable vs prolonged external electrocardiographic monitoring on atrial fibrillation detection in patients with ischemic stroke: the PER DIEM randomized clinical trial. JAMA. 2021;325(21):2160–2168. https://doi.org/10.1001/jama.2021.6128 Edwards SJ, Wakefield V, Jhita T et al. Implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke: a systematic review and economic evaluation. Health Technol Assess Winch Engl. 2020;24(5):1–184. https://doi.org/10.3310/hta24050 Brignole M, Moya A, de Lange FJ et al. 2018 ESC guidelines for the diagnosis and management of syncope Eur Heart J. 2018 Jun 1;39(21):1883-1948. https://dx.doi.org/10.1093/eurheartj/ehy037 (accessed March 2025) Edvardsson N, Frykman V, van Mechelen R et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Eur Eur Pacing Arrhythm Card Electrophysiol J Work Groups Card Pacing Arrhythm Card Cell Electrophysiol Eur Soc Cardiol. 2011;13(2):262–269. https://doi.org/10.1093/europace/euq418 Tsivgoulis G, Katsanos AH, Grory BM et al. Prolonged cardiac rhythm monitoring and secondary stroke prevention in patients with cryptogenic cerebral ischemia. Stroke. 2019;50(8):2175–2180. https://doi.org/10.1161/STROKEAHA.119.025169 Krahn AD, Klein GJ, Yee R et al. Randomized assessment of syncope trial: conventional diagnostic testing versus a prolong monitoring strategy. Circulation. 2001;104(1):46–51. https://doi.org/10.1161/01.CIR.104.1.46 De Melis M, Margetta J, Rosemas SC et al. Rates of therapeutic interventions in a large real-world cohort with insertable cardiac monitors. Eur Heart J. 2024; 45(Supplement_1):ehae666.346. https://doi.org/10.1093/eurheartj/ehae666.346 LINQ II™ LNQ22 ICM clinician manual. M974764A001D Radtke, A, et al. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. Presented at Heart Rhythm Society Conference, 2021. AccuRhythm™ Clinician Manual Supplements M015316C001 and M015314C001 Cheng YJ Ousdigian, KT, Koehler J, Cho YK, Kloosterman M. Innovative Artificial Intelligence Application Reduces False Pause Alerts while Maintaining. Perfect True Pause Sensitivity for Insertable Cardiac Monitors. Presented at Heart Rhythm Society Conference 2021. Published online August 1, 2021. Cronin, Edmond M., et al. “Remote monitoring of cardiovascular devices: a time and activity analysis.” Heart Rhythm 9.12 (2012): 1947-1951. Giannola, Gabriele, et al. “Outsourcing the remote management of cardiac implantable electronic devices: medical care quality improvement project.” JMIR cardio 3.2 (2019): e9815. Medtronic. Cardiac diagnostics and monitoring: patient education 2025. https://www.medtronic.com/uk-en/healthcare-professionals/therapies-procedures/cardiac-rhythm/cardiac-diagnostics-monitoring/resources/patient-education-materials.html (accessed April 2025) Medtronic. What is the BeConnected service? 2025. https://europe.medtronic.com/xd-en/healthcare-professionals/products/cardiac-rhythm/managing-your-patients/patient-clinic-services/be-connected.html (accessed July 2025) Rosemas SC, Archer N, O’connor E et al. Impact of novel insertable cardiac monitoring system on real-world cardiac device clinic workflow. EP Eur. 2023;25(S1):euad122.553. https://doi.org/10.1093/europace/euad122.553 Singh J, Radtke A, Rosemas S, Ousdigian KT. Impact of enhanced artificial intelligence on clinic burden from false alerts of insertable cardiac monitors. 2023;148(Sup 1). Circulation. https://doi.org/10.1161/circ.148.suppl_1.18672 Radtke A, Ousdigian K, Koehler J, Margetta J, Han J K. AI Enables Significant Reduction of Clinic Review Burden for Legacy ICMs. Heart Rhythm. 2024 May: 21 (5) Supplement: S261. https://doi.org/10.1016/j.hrthm.2024.03.850 Medtronic. AccuRhythm AI report for Royal Stoke University Hospital. Data on file March 2025 Siddiqi TJ, Usman MS, Shahid I et al. Utility of the CHA2DS2-VASc score for predicting ischaemic stroke in patients with or without atrial fibrillation: a systematic review and meta-analysis. Eur J Prev Cardiol. 2022;29(4):625–631. https://doi.org/10.1093/eurjpc/zwab018 Italian Association of Arrhythmology and Cardiac Pacing. AIAC for patients 2025. https://aiac.it/aiac-per-i-pazienti/ (accessed March 2025) Medtronic. AccuRhythm AI report for GB Grassi Hospital. Data on file March 2025 British Heart Rhythm Society. Standards for insertion, follow up and explant of implantable loop recorders [ILRs] by non‐medical staff 2020. https://bhrs.com/wp-content/uploads/2020/10/BHRS-ILR-Standards-for-Insertion-revised.pdf (accessed October 2024) Monkhouse C, Labiase P, Ahsan S. Maximising clinic efficiencies using an implantable loop recorder with remote programming and monitoring: a case study. https://doi.org/10.12968/bjhc.2025.0022 Medtronic. AccuRhythm AI report for St Vinzenz-Hospital. Data on file 2025
P=0.04
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Case 1 Royal Stoke University Hospital, Stoke-on-Trent
Syncope pathway for implantation of insertable cardiac monitors at the Royal Stoke University Hospital, Stoke-on-Trent
Indira Natarajan Clinical Director, Stroke West Midlands Integrated Stroke Delivery Network, UK
Credit to author
Service pathway for implantation of insertable cardiac monitors at the Royal Stoke University Hospital, Stoke-on-Trent
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Ashish Patwala Consultant Cardiologist, Royal Stoke University Hospital, Stoke-on-Trent, UK
Vince Walker Head of Electrophysiology, Royal Stoke University Hospital, Stoke-on-Trent, UK
Despite the evidence, the standard of care for syncope and high-risk AF post-TIA/stroke patient populations across much of the UK remains 24–48 hour ECG monitoring, with only select cases being referred for an ICM. This case study discusses the initiation and evolution of two bespoke pathways that have moved away from the conventional standard of care and instead favour ICM insertion. The pathways In 2020, the Royal Stoke University Hospital had well-established cardiology and neurology departments, with the cardiology team already providing a small ICM service of 380 implants. Both departments regularly and independently submitted requests to the electrophysiology department for 24-hour ECG monitoring of syncope and high-risk AF post-TIA/stroke patients. However, the lead of cardiac rhythm management noted that, despite the large number of 24-hour tapes, the subsequent detection of AF or irregular cardiac arrhythmia was minimal. A small internal trial conducted at the Royal Stoke University Hospital comparing ICMs and Holter monitors further highlighted that the diagnostic yield of Holter monitors at detecting AF was less than 1%, compared with the 15% diagnostic yield of ICMs in the stroke population. Holter monitor results could take up to 4 weeks, which could delay diagnosis. Given the evidence in support of ICM use, the consultant electrophysiologist, neurologists and cardiologist expanded on the existing ICM service and established two standard referral pathways for TIA/stroke and syncope that bypassed traditional holter monitoring and referred patients directly for an ICM: Reveal LINQ or LINQ II. In the Royal Stoke University Hospital post-TIA/stroke pathway, patients who have had a TIA or stroke and are at high-risk of AF, if the standard stroke work-up fails to detect AF, are referred to the cardiology department for ICM insertion. In the syncope pathway, there are multiple portals of entry, including A&E, GP and cardiology referrals, and patients presenting with an unexplained case of syncope are directly referred for ICM. A local ICM audit between February 2014 and March 2025 recorded 5104 ICM implants, of which 4861 were conducted by a trained specialist nurse and 89% were performed out of the cardiology catheterisation labratory in a outpatient procedure. The hospital currently has two outpatient ICM lists per week. Moving the procedure out of the catheterisation laboratory has not only reduced the total cost of ICM insertion but has also increased the availability of the catheterisation laboratory and personnel for more complex procedures. Following insertion, surveillance of ICM data is performed by the electrophysiology department. If AF is detected, the electrophysiology team notify the neurology team, and the patient is initiated on anticoagulant therapy. In the Royal Stoke University Hospital’s post-TIA/stroke pathway, ICM-detected AF is found in 16.7% of patients, all of receive anticoagulant therapy. The average time from implant to AF detection is 191 days. The time from AF detection to anticoagulant therapy initiation is under 72 hours. If irregular cardiac arrhythmia is detected in those patients with unexplained syncope, the cardiology team are notified and a pacemaker may be considered. In the Royal Stoke post-stroke patient cohort, following the diagnosis of AF, the pathway model shifts towards a management of AF condition from that of arrhythmia diagnosis. AF rate control using medical therapy is required in around 29% of patients, with a further 4% requiring pacemaker therapy and 1% requiring cardiac electrophysiology study with ablation. In a recent large cohort study, 50.1% of patients with cryptogenic stroke (n=4852) and 58.9% of those with suspected AF (n=1346) underwent a relevant therapeutic intervention during follow-up after ICM insertion, with a mean time from insertion to intervention of 13 months for procedures and 7 months for medication.12
Interdepartmental communication There are multiple reasons why the ICM pathways at the Royal Stoke University Hospital have succeeded, with effective communication and collaboration between the cardiology, neurology and electrophysiology departments being pivotal. For many hospitals, the biggest obstacle to establishing a similar ICM service is the lack of communication between departments, with most neurology and cardiology teams being separate entities. However, collaborative working comes with its own challenges, and, once these services and links are established, it is vital that a mutual level of respect between departments and individuals is agreed upon. For example, at the Royal Stoke University Hospital, the consultant neurologist and cardiologist disagreed on the duration of AF needed to initiate anticoagulant therapy in post-TIA/stroke patients. However, the consultant cardiologist recognised that patients on the post-TIA/stroke pathway sat within the neurology department and, therefore, are the responsibility of the consultant neurologist, who recommended a 6-minute minimum. Mutual respect between consultants and between their departments has facilitated the collaboration necessary for these pathways to co-exist. The consultant cardiologist and neurologist behind the Royal Stoke University Hospital’s ICM service acknowledged that planning and discussing each pathway step before implementation was largely responsible for the service’s success. However, for the pathways to become established entities in the departments, there had to be some element of trial and error to ensure the theoretical plans worked in practice.
“There are multiple reasons why the ICM pathways at the Royal Stoke University Hospital have succeeded, with effective collaboration between the cardiology, neurology and electrophysiology departments being pivotal”
Multidisciplinary approach The day-to-day management and running of the ICM pathways falls to a multidisciplinary team (MDT), consisting of consultants, therapists and nurses, who meet remotely around once a month. Ultimately, this MDT approach aims to ensure that patient selection for ICM referral is warranted. Therefore, both the cardiology and neurology teams know and trust that each patient being referred for an ICM device is healthy and able enough, as well as that they will truly benefit from the therapy. For example, physiotherapists in the post-TIA/stroke ICM pathway are vital for the assessment of the functional ability of patients following their TIA or primary stroke. Also important to the success of the ICM service has been having sufficient staff to ensure the pathway can operate. This is especially applicable when considering the electrophysiology department and the number of people needed to analyse ICM data immediately after it is transmitted, which is essential for the device to be diagnostically useful. Therefore, it is vital that growth of the ICM service is accompanied by growth of the electrophysiology department and the workforce analysing the data.
Patient education Pre-procedure patient education is a key element of any ICM pathway. As the point of referral is the most common time that patients refuse the procedure and device; substantial patient education at this point has helped the Royal Stoke University Hospital maintain low refusal rate of less than 3%. Common pre-procedure patient concerns include worries about the invasiveness of the procedure and future implications of the device being made of metal, such as x-rays and airport metal detectors. Therefore, on referral for an ICM device, cardiology nurses with specialist training in Reveal LINQ or LINQ II take the time to speak with and educate the patient, helping to relieve any anxiety. Patients may also be directed to educational resources from the ICM manufacturer.7-11, 19 After the procedure, patients require further education on how the ICM works. For example, improved post-procedure education has helped overcome a major intial obstacle facing the ICM MDT. Initially, post-procedure education was provided by cardiac physiolgists, but they could not dedicate sufficient time to this. Consequently, newly implanted patients often did not fully understand how the ICM functioned and would thus inundate the electrophysiology department with concerns about whether the device and automatic data transmission were working. Therefore, as the pathway evolved, the post-procedure patient education was taken on by device educators, who had more time to dedicate to educating the patient on the use of Reveal LINQ or LINQ II ICMs and the associated Carelink remote monitor or MyCareLink Heart mobile app, including data transmission. Consequently, the MDT have seen better patient adherence and a more manageable amount of transmitted data. The amount of data that requires overview averages at 1.9 patients per day in the active stroke cohort of 176 patients. Patient non-adherence with remote monitoring is low, with only 1.75% of those patients temporarily disconnected from continuous follow-up and 1% of patients discharged due to non-adherence to follow up. Patient education also has also been seen to help promote self-care and disease ownership among patients, empowering them to take more responsibility for their health. Patients can also receive support regarding Reveal LINQ or LINQ II via Medtronic’s BeConnected™ service.20
Technological opportunities Pathway evolution is not solely dependent on service or organisational improvements, and technological improvements to the ICM device and associated systems can also assist pathway refinement. Different ICMs vary in diagnostic performance, and Reveal LINQ and LINQ II have demonstrated notable sensitivity, alongside other advantages.7,21 For example, the introduction of the AccuRhythm AI algorithm has helped to reduce the number of false positives, reducing the amount of overall data and background noise transmitted to the electrophysiology team. Ultimately, this increases the diagnostic accuracy of the ICM without compromising on the sensitivity, improving both the running of the ICM service and patient outcomes.22-23 As of March 2025, use of AccuRhythm at the Royal Stoke University Hospital had reduced pause alerts by 56% and AF alerts by 52%, saving an estimated 979 hours a year.24
Future directions The consultant neurologist, cardiologist and electrophysiologist were pivotal for the establishment of the two ICM pathways. However, to evolve, the pathways must become service-led rather than consultant-led. This has already occurred within the post-TIA/stroke ICM pathway, with ICM referals being made by multiple people from the stroke MDT, rather than just the consultant. However, neurology is still referring to the individual consultant cardiologist and electrophysiologist. Therefore, the next step for the ICM pathways at the Royal Stoke University Hospital is to promote service-to-service referrals. In both ICM pathways, the primary use of the ICM device is to detect AF or irregular arrhythmia. In those patients where AF and irregular arrhythmias are detected, the consultant cardiologist and neurologist at the Royal Stoke University Hospital plan to maximise on the 3-year lifespan of Reveal LINQ device or the 4.5-year span of LINQ II, as well as expand the service to provide long-term disease progression and modification within the patient population. Additionally, the consultant cardiologist recognised the potential role of the ICM device in patients with dilated cardiomyopathy and hypertrophic cardiomyopathy who are not fitted for a defibrillator, and there is a plan to expand the syncope ICM pathway to include these patient populations.
Note See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions and potential adverse events. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat Reader with the browser. This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies are not intended for users in markets that do not have authorisation for use. Declarations of interest These case studies have been commissioned and funded by Medtronic. Compensation These faculties involved are being paid for consultancy and the services being provided in accordance with applicable laws and regulations. Caution statement: The content and opinions in these case studies are provided by physician faculty and not all comments are the opinion of Medtronic. This page is provided for general educational purposes only and should not be considered the exclusive source for this type of information. The content does not replace or supersede approved labelling. The content will be shared with physicians and allied health professionals who seek a deeper understanding of the operation and use of Medtronic products and therapies with the intent of enhancing their knowledge of features and operations described in the clinician manuals. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation. Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features and results may vary. The device functionality and programming described in this video are based on Medtronic products and can be referenced in the published device manuals.
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Case 2 GB Grassi Hospital, Rome
At the GB Grassi Hospital in Rome, insertable cardiac monitors (ICMs) are used for the diagnosis of undetermined syncope, cryptogenic stroke and patients with acute coronary syndrome with high arrhythmic risk. The cases observed in this hospital demonstrate how syncope and stroke pathways can be optimised in practice through communication, education, data management and technological innovation. Syncope and cryptogenic stroke pathways The accident and emergency department is the main path of entry into the syncope service, with approximately 30% of patients presenting with unexplained syncope receiving ICM implantation, according to unpublished internal data. However, an outpatient syncope pathway also exists, where ICM implantation is regarded as the final step following diagnostic tests to eliminate all other possible causes of syncope. In Italy, ICM implantation is always an inpatient procedure, meaning patients on the outpatient pathway are admitted to the hospital as a day case to undergo ICM implantation. There has been an increase in the number of ICM implantations at the GB Grassi Hospital following an update to the European Society of Cardiology syncope guidelines, stating that an ICM can be considered earlier in the diagnostic pathway for low-risk patients presenting with arrhythmia-like symptoms.8 After many years of using ICMs for the detection of syncope, the service naturally expanded to include cryptogenic stroke. Unlike the syncope pathway, the cryptogenic stroke pathway only has one point of entry, with all patients referred to the cardiology department for ICM implantation by the two neurologists working at the GB Grassi Hospital. However, this referral only happens once diagnostic testing and monitoring in the acute phase of the attack has been unable to identify the cause of the stroke. For both pathways, once an ICM is implanted, the patient is discharged and undergoes remote monitoring for future atrial fibrillation (AF) or other arrhythmic episodes. For patients on the cryptogenic stroke pathway, AF detection initiates anticoagulant therapy. However, due to the lack of clear recommendations, there is no set duration of AF that would make the initiation of anticoagulation therapy mandatory for patients in the cryptogenic stroke pathway, but rather an individual assessment is made for each patient. For patients with stroke and previously documented AF, any detection of AF during remote monitoring should initiate anticoagulant therapy. However, for patients presenting with AF for a few seconds, the decision to anticoagulate is based on a thrombo-embolic risk assessment, such as the CHA2DS2-VASc score.25
Syncope pathway for implantation of insertable cardiac monitors at the GB Grassi Hospital, Rome, Italy
Prodromes Recurrent syncopes No structural heart disease Normal electrocardiogram Normal physical examination
Luca Santini Consultant Cardiologist, GB Grassi Hospital, Rome, Italy
Conclusions The ICM pathways established at the GB Grassi Hospital in Rome demonstrate a comprehensive, multidisciplinary approach to the diagnosis and management of patients with syncope and cryptogenic stroke. Through years of clinical experience and cross-specialty collaboration, the hospital has refined its processes to ensure timely diagnosis, appropriate patient selection, and effective follow-up care. Bluetooth-enabled remote monitoring and programming and AI-assisted data filtering have enhanced follow-up care and reduced patient burden. Despite these advances, challenges such as disconnected monitors and fragmented data systems persist, highlighting the need for continued manufacturer support in education, connectivity and data integration. This case study reinforces the role of ICMs within a broader ecosystem of technology, collaboration and patient-focused care.
“After many years of using ICMs for the detection of syncope, the service naturally expanded to include cryptogenic stroke”
High-risk features
Risk stratification
Low-risk features
Low risk if all criteria met
Cryptogenic stroke pathway for implantation of insertable cardiac monitors at the GB Grassi Hospital, Rome, Italy
“Through years of clinical experience and cross-specialty collaboration, the GB Grassi Hospital has refined its processes to ensure timely diagnosis, appropriate patient selection, and effective follow-up care”
No prodromes New chest/abdominal pain, breathlessness or headache Pre-syncope sudden-onset palpitations Syncope during exertion Syncope when supine or sitting Structural heart idease Family history of SCD Systolic blood pressure >90mmHg Undiagnosed systolic murmur Abnormal electrocardiogram
High risk if one criterion met
Interprofessional communication Clear and effective communication within and between the cardiology and neurology departments have been critical for the success of these ICM pathways. Strong communication when establishing the cryptogenic stroke pathway its long-term success, as the multidisciplinary approach introduced specific challenges and barriers in the early stages. For example, the cardiology team observed that the neurologists were referring patients for ICM implantation who were not considered appropriate candidates for the procedure. Establishing an educational element to the pathway, whereby the cardiology and neurology teams regularly met for the cardiologists to share their experiences from the syncope pathway and inform the neurologists on patient selection, helped to overcome these challenges. As a result, clear patient selection criteria were developed and enforced, and this assisted the neurologists in becoming completely autonomous with patient selection and the overall pathway. However, it is highly important to maintain this communication throughout the pathway. For example, when AF is detected in a patient with cryptogenic stroke, it is important to share this information with the neurology team to maintain collaboration and to ensure the decision to anticoagulate a patient is a joint one.
Patient education Patients receiving an ICM are educated on the implantation procedure, the function of the ICM device and the role of remote monitoring during the follow-up period. A key objective of this education is to overcome and minimise patient hesitation about ICM implantation, and it should be emphasised that an ICM can diagnose syncope or detect AF without negatively impacting quality of life. At GB Grassi Hospital, patient education is the responsibility of all personnel involved in the pathways. Moreover, educational tools are not standardised, so each clinician must determine the appropriate approach for the situation. Individual clinicians will have their own preferred methods of communication. For example, I often use the ‘If’ method to inform patients that, if they have an ICM during an event (such as syncope), they will have already received confirmation or exclusion of a diagnostic suspicion and would therefore be further along the treatment pathway. However, it is important that clinicians’ preferred methods are adapted to the specific needs of individual patients and their pathway. For example, patients on the syncope and cryptogenic stroke pathways at the GB Grassi Hospital refuse ICMs at very similar rates but with different reasons. On the cryptogenic stroke pathway, refusal is often associated with a lack of understanding about the heart’s connection with the brain and how it can contribute to stroke occurrence, and therefore education should emphasise the link between the heart, AF detection and stroke onset. On the syncope pathway, refusal may owe to a lack of acceptance about being ill, as the syncope episode that initiates ICM implantation is usually the first manifestation of the disease, and education should be adapted accordingly. The absence of specific designated educators or standardised educational tools does present risks. Although very rare, it is possible that a clinician’s lack of empathy, unsupportive attitude or apathetic communication style may cause a patient to refuse the procedure. To improve education and minimise risk of refusal, clinicians can supplement patient conversations with relevant educational tools, such as brochures, videos and websites. This can help direct patients to reliable sources, rather than leaving them too carry out their own research. At the GB Grassi Hospital, patients are directed to useful online educational tools from the Italian Association of Arrhythmology and Cardiac Pacing,26 as well as from Medtronic, the manufacturer of the LINQ II System.19
Remote monitoring and programming Recent advances in Bluetooth technology allow patients to connect their ICM to a smartphone application, such as Medtronic’s MyCareLink Heart™ App. Bluetooth connectivity also enables patients to be remotely monitored by clinicians, who can adjust device settings and inform them of any changes without disrupting their daily routines with a hospital visit. This alert-based strategy can be tailored to each patient and their capabilities and needs. However, not all patients have been able to make adequate use of this feature, and around 15% of patients with an ICM at the GB Grassi Hospital are not properly connected. Contacting the disconnected patients to provide updates or attempt to connect them is highly time consuming, and this is an area where manufacturers could provide support. Users of the LINQ II System can seek support for disconnected monitors from Medtronic’s Directo™ service (equivalent to BeConnected ™ in the UK), usually based on twice-monthly hospital input.
Data management A considerable amount of data is transmitted through the remote monitoring of ICMs. Reviewing this data requires adequate resources and an efficient organisational model. At the GB Grassi Hospital, all ICM transmissions are reviewed by a dedicated team of nurses and technicians. The team is assisted in completing these checks by the AccuRhythm™ artificial intelligence (AI)-based filtering algorithm, now incorporated in the Reveal LINQ and LINQ II Systems. AccuRhythm™ AI helps reduce the volume of non-actionable alerts, increasing the efficiency of the service. Importantly, it does this without compromising on sensitivity, helping ensure that no episode of AF is overlooked and all arrhythmic events are detected.22,23 At GB Grassi Hospital, AccuRhythm™ AI had eliminated 145 AF and pause false alerts as of March 2025.27 However, at the GB Grassi Hospital, intrahospital collaboration is fragmented, and there are separate data platforms for each department. Remote-monitoring data for the cryptogenic stroke and syncope pathways are stored on separate platforms within the neurology and cardiology departments, respectively. This makes it difficult to share important patient information, and it creates a barrier to effective multidisciplinary working and communication. However, this barrier could be overcome by creating a shared interdepartmental data platform. A shared platform for ICM data would be challenging for hospitals to establish alone but could be set up with assistance from the ICM manufacturer.
“Recent advances in Bluetooth technology allow patients to connect their ICM to a smartphone application”
Case 3 St Vinzenz-Hospital, Cologne
In Germany, health insurance companies reimburse inpatient insertable cardiac monitor (ICM)implantation but not outpatient procedures or follow-up care. Additionally, some inpatient ICM implantation reimbursements have been retrospectively denied due to claims of insufficient proof of benefit. Despite this challenging setting, St Vinzenz-Hospital in Cologne includes ICMs as part of the established clinical pathways for cryptogenic stroke and unexplained syncope. This is based on an understanding that the risk of refusal of payment for implantation is outweighed by the potential for ICMs to detect atrial fibrillation (AF) or syncope, resulting in further interventions, such as pacemaker implantation and anticoagulation, that are reimbursed and ultimately improve patient outcomes. These pathways make economical use of the limited resources dedicated to the ICM service owing to the reimbursement challenges. The pathways The syncope ICM pathway was initially created to standardise decision making and establish a coherent treatment approach for all cardiology referrals. The service later evolved to include a cryptogenic stroke ICM pathway. Both ICM pathways have been developed into pocket-sized booklets for clinicians to carry around, providing a quick and easy assessment of the correct next steps.
Syncope pathway for implantation of insertable cardiac monitors at St Vinzenz-Hospital, Cologne, Germany
Ergometric test: in case of syncope during or immediately after physical exertion Tilt table test: if there is a reasonable suspicion of reflex syncope; stage IIaB; as a confirmatory test; in cases of orthostatic hypotension; as a screening tool; in cases of postural orthostatic tachycardia syndrome Neurological examination: duplex ultrasound and cranial computed-tomography scan; stage III; only in case of neurological abnormalities Electrophysiological study: only after consultation with the electrophysiology department, after negative, non‑invasive clarification, especially in cases of syncope, scarring in the myocardium and palpitations Carotid sinus massage: aged >40 years; a confirmation test in cases of clinical suspicion of classic trigger mechanisms
Stefan Winter Cardiologist, St Vinzenz-Hospital, Cologne, Germany
“ICMs offer significant value by enabling earlier and more accurate diagnosis, leading to timely treatment decisions that improve patient outcomes and reduce long-term healthcare costs”
Standard diagnostics (on the ward )
Stroke pathway for implantation of insertable cardiac monitors at St Vinzenz-Hospital, Cologne, Germany
Targeted diagnostics
Echocardiogram Monitoring (telemetry with findings at high recurrence rate and long-time Holter electrocardiogram)
Collaborative partnerships The ICM service at St Vinzenz-Hospital collaborates with approximately eight partner hospitals, some lacking dedicated cardiology or neurology departments, and others that have discontinued the procedure due to reimbursement challenges. This network facilitates comprehensive patient care through shared expertise and resources. Moreover, as there is no neurology department at the St Vinzenz-Hospital, the cryptogenic stroke ICM pathway is led by a neurologist based at a partner hospital. The neurologist visits the St Vinzenz-Hospital around twice a week, which is critical to ensure accurate patient selection. This partnership structure is unusual, and several initial bureaucratic and referral barriers had to be overcome before the ICM service could flourish. It was initially challenging for the cardiologists and neurologists from partner hospitals to work collaboratively and agree to the pathways. Moreover, the internal medicine teams at partner hospitals were originally hesitant to refer cardiology patients to St Vinzenz-Hospital. However, these barriers were overcome with clear pathways and an open dialogue between all clinicians from all partner hospitals. Now that the service is well established, clinicians at the St Vinzenz-Hospital can identify cryptogenic stroke patients suitable for ICM implantation, and partner hospitals can refer patients with syncope for ICM implantation or cardiology patients for pacemaker implantation.
Remote patient monitoring and follow-up care At St Vinzenz-Hospital, once the ICM is implanted, patients are followed up by a dedicated ICM and pacemaker team. Efficient management of these patients is reliant on remote monitoring. All data is reviewed regularly, and if atrial fibrillation or another significant cardiac event is detected, the patient is typically brought in for assessment within 24 hours. That allows for timely intervention, whether starting anticoagulation post-stroke or implanting a pacemaker in syncope cases. This is supported with the CareLink Network, which provides secure, remote access to ICM transmissions from the device and thus streamlines the workflow. The team is no longer reliant on face-to-face appointments just to check data. Instead, time can be focussed on patients who need to be seen. It has made a meaningful difference in how follow-ups are managed and, ultimately, helps provide faster, more responsive care. Until recently, a dedicated nurse manually reviewed all incoming data each morning, which meant the number of patients on ICM monitoring had to be limited to stay within the team’s capacity. However, the introduction of the AccuRhythmTM AI algorithm has made it possible to expand that capacity. The algorithm helps by filtering out non-actionable AF and pause alerts, reducing the number of transmissions to review, without compromising the device’s sensitivity or specificity.22-23 At St Vinzenz-Hospital, for example, the use of AccuRhythmTM with both Reveal LINQ and LINQ II resulted in a 17% reduction in AF alerts and a 22% reduction in pause alerts as of March 2025,30 saving an estimated 43 hours of clinician time per year. These benefits have been seen in practice, allowing more patients to be managed without adding to staff workload. It is important to note that hospitals can only really benefit from the AI algorithms and future AI updates if they are using CareLink™ for remote monitoring, as the AI is integrated into that system. At St Vinzenz-Hospital, CareLink™ has been key to delivering efficient and responsive follow-up care. All hospitals should seriously consider adopting remote monitoring, as it is not just about convenience. It truly helps to optimise clinical resources, while improving standards of care for patients with cardiac devices.
Conclusions The experience of St Vinzenz-Hospital shows the potential of a collaborative ICM service in partnership with other hospitals, despite a challenging reimbursement situation. The hospital’s resource-limited experience has also highlighted the value of AI algorithms to reduce the burden of data review without losing sensitivity, as well as the potential economic advantages of non-physician implantation. Importantly, ICMs offer significant value by enabling earlier and more accurate diagnosis, leading to timely treatment decisions that improve patient outcomes and reduce long-term healthcare costs.
Patient education Before implantation, patients are educated to help them understand the need for and nature of the procedure. As a result, very few patients at St Vinzenz-Hospital refuse an ICM. After implantation, patients receive further education on the functionality of the device and the role of Bluetooth connectivity, supplemented by educational materials from the ICM manufacturer. A dedicated nurse is responsible for patient education and support, playing a pivotal role in the pathway’s success by ensuring continuity of care before and after implantation. Consequently, many patients regard the nurse as the head of the ICM service. Implantation At St Vinzenz-Hospital, around 60 ICM implantations are caried out annually. ICM implantation for both syncope and cryptogenic stroke is completed as an inpatient procedure (day case) by the pacemaker team in the catheter laboratory. In Germany, implantation is only carried out by physicians (consultants and doctors). However, adopting implantation by non-physicians (nurses), as is common in other European countries, would have clear economic advantages. Non-physician implantations could be moved out of the catheter laboratory, freeing the space and personnel for other procedures, such as pacemaker implantations, that are more consistently reimbursed. The same would also apply to explantations, of which around 60 are carried out annually.28,29 The primary ICM implanted at St Vinzenz-Hospital is Reveal LINQ. Given the ongoing reimbursement challenges, careful justification and patient selection would be required to upgrade to the more advanced LINQ II system.
