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Launched in May 2019 by Abbott, the next-generation Confirm Rx™ insertable cardiac monitor (ICM) has both the CE Mark in Europe and Food and Drug Administration clearance in the United States. The Confirm Rx ICM is a small, implantable device that combines smartphone connectivity via Bluetooth® wireless technology with continuous, remote monitoring for fast and accurate diagnosis of unpredictable arrhythmias.
Dhanunjaya Lakkireddy (Executive Medical Director, Kansas City Heart Rhythm Institute and Professor of Medicine, University of Missouri, USA) and Simon Beggs (Cardiology Registrar at NHS Scotland and Honorary Lecturer at the University of Glasgow, Glasgow, UK) outlined to Cardiac Rhythm News how recent upgrades to the device have further improved its performance.
A major advance has been the introduction of SharpSense™ technology, a feature that physicians welcome and that has led to a 97% reduction in the detection of false events of atrial fibrillation (AF), bradycardia and pause episodes.1 SharpSense technology harnesses the power of extra discriminators to improve accuracy. Users can now also print scatterplots for better visualisation of trends in heart rates.
In AF, SharpSense technology enables an active review of the previous 30 seconds for P-wave detection to pick up an episode, giving a relative sensitivity of 97.2%.2 True bradycardia episodes are discerned through customized thresholds created by dynamic evaluation of multiple R-waves and P-waves, leading to a relative sensitivity of 98.6%.2 And true pause episodes are detected by customized secondary thresholds based on analysis of P-wave and R-wave characteristics during the previous six seconds, with a relative sensitivity of 98.1%.2
Dr Beggs says: “SharpSense technology is an improved sensing algorithm that filters the data and cleans it up. If there are lots of false events detected, then it is more difficult to analyse the data. The SharpSense technology increases physicians’ confidence that alerts from the device are genuine, and in doing so it reduces the workload of running a healthcare clinic or a remote consultation clinic for healthcare providers and physicians.”
Dr Lakkireddy agrees: “The sensitivity is definitely better, with less detection of false positives, and the crispness of the electrograms that are seen is also significantly better. Improvements in picking up changes in the beat-to-beat amplitude variability mean that the detection algorithms are much more reliable.” A further bonus, he points out, is an improved patient experience for his patients, by avoiding unnecessary follow-up and its attendant anxieties.
Bluetooth® connectivity also enhances patient and physician experiences. The Confirm Rx™ ICM is the only ICM on the market that syncs to a smartphone via Bluetooth® wireless technology. There is no need for a home-based transmitter or patient activator, and the myMerlin™ mobile app for Confirm Rx ICM is user friendly, is compatible with both Android‡ and Apple‡ devices and has been translated into nearly 40 languages. It helps engage patients in their treatment, and they receive automatic notifications when they miss device checks or scheduled transmissions.
Dr Lakkireddy considers the Bluetooth® wireless technology a major advantage: “Patients do not need a separate system to transmit the information, and the ability to do everything through your smartphone is one of the strongest features. I am even able to log on via my smartphone and access patient data; I like that aspect very much.”
Bluetooth® connectivity also benefits patient privacy, says Dr Beggs: “It is more discreet for the patient to record episodes because they are just using their own mobile phone; they are not drawing attention to themselves, and that can be important to patients.”
The implantable nature of the device also aids compliance — Dr Beggs notes that, unlike wearable technology, it cannot be removed at the patient’s whim. And he believes that patients get a psychological boost from the knowledge that their heart rhythm is being continuously monitored. Feedback from his patients indicates that they are grateful for this and that it allays fears, adding to their quality of life.
The Confirm Rx ICM is inserted under the skin in the chest above the heart during a quick, minimally invasive outpatient procedure. Dr Beggs is a “high volume implanter” and says he can insert the device “in a matter of minutes”.
“Previously, it was a more significant undertaking, with a bigger device being implanted under the skin. It required stitching and, in some cases, was performed in surgical operating theatres. The implant itself, and the patient coming and going, is a quick and easy thing to do, and is increasingly being undertaken not only by physicians, but also by cardiac physiologists and trained nurses because it is a much more minor procedural undertaking.”
From procedure to follow-up, Confirm Rx ICM is easy to manage. Enrolment and transfer to a follow-up clinic is simple for procedure staff. Clinicians can then customise alerts with the easy-to-use interface.
Dr Lakkireddy describes the use of Confirm Rx ICM as “multifaceted” and an “integral part of electrophysiology practice and arrhythmia management”.
“We treat the whole breadth of electrophysiology — conduction system abnormalities, sinus node dysfunction, atrioventricular block, left ventricular dysfunction, cardiac arrest, and patients with pacemakers, implantable cardioverter defibrillators and cardiac resynchronization therapy devices. We also have a large population of patients who have syncope, and the Confirm Rx ICM is a very important management tool. It is excellent for patients with polymorphic ventricular tachycardias and non-conductive myocarditis; it uses much better long-term data. And we use it in AF patients to understand the arrhythmia burden while patients are on anti-arrhythmic drugs, and after AF ablation.”
He provides an example of where the Confirm Rx ICM helped pinpoint a diagnosis in a 27-year-old male with episodes of self-resolving torsade de pointes while sleeping; the findings led to the identification of Brugada syndrome uncovered by fever.
And more accurate data capture also means that unnecessary treatments can be avoided; Dr Lakkireddy details the case of a 17-year-old female patient for whom Confirm Rx ICM demonstrated that there was no longer a need for pacemaker implantation: “The second-generation Confirm Rx ICM is definitely a superior device,” he concludes.
- Evaluation of Clinical Impact of Confirm Rx 1.2 Algorithm Enhancements. Document 60098828. April 2019.
- Design Validation Report and Trace Matrix, Insertable Cardiac Monitor (ICM) System DOC 60076435 Rev. E March 2019.
Refer to important safety information below:
One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx ICM has not been specifically tested for pediatric use.
Contraindications: There are no known contraindications for the insertion of the Confirm Rx ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.
Adverse Events: Possible adverse events (in alphabetical order) associated with the device include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Additional Information: Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx ICM. On Merlin.net PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ for Confirm Rx ICM mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.
Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx ICM using the myMerlin for Confirm Rx mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin for Confirm Rx mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.
An Abbott mobile transmitter is available for patients without their own compatible mobile device.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
© 2019 Abbott. All Rights Reserved.
32956-SJM-CFM-0719-0160 | Item approved for global use.