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Next Generation Implantable Cardiac Devices and Cardiac Resynchronisation Therapy Devices in Europe

Authors: Klaus Witte and Rob Kowal

An expert interview with Klaus Witte1 and Rob Kowal2

1. Senior Lecturer and Consultant Cardiologist, Division of Cardiovascular and Diabetes Research, School of Medicine, University of Leeds, Leeds, UK;

2. Chief Medical Officer and Vice President, Medtronic Cardiac Rhythm and Heart Failure, Minneapolis, MN, USA


Heart failure impacts more than 26 million people worldwide.1 It is a growing epidemic that is expected to increase in prevalence by 46% by 2030 in the US alone.2

The growing prevalence of heart failure has led to advancements in treatment options including implantable cardiac devices. Implantable cardiac defibrillators (ICD) monitor heart rhythms and deliver therapy to correct heart rates that are too fast, and cardiac resynchronisation therapy-defibrillators (CRT-Ds) resynchronise the contractions of the ventricles by sending tiny electrical impulses to the lower chambers. Both devices are designed to stop dangerously fast heart rhythms that can lead to sudden cardiac arrest.

To continue to improve outcomes and increase patient engagement for those with heart failure, Medtronic recently launched the next generation portfolio of ICDs and CRT-Ds. This includes the Cobalt XT™, Cobalt™ and Crome™ ICDs and CRT-Ds. The device portfolio recently received the CE Mark. With this improved technology, the devices include connected health via app-based monitoring that will help physicians respond to patients’ individual needs through informed clinical decision making.

In this expert interview, we speak with Dr Klaus Witte of the University of Leeds and Dr Rob Kowal of Medtronic on the future of implantable cardiac devices.

Q. What is the background for the creation of these new integrated technologies and their introduction into Europe?

Robert Kowal: We believe this device portfolio offers several key advantages: they round out our BlueSync-enabled, connected-health platform, offering patients with ICDs and CRT-Ds (in addition to pacemakers) access to our mobile app and physicians greater device programming flexibility with the SmartSync tablet programmer. Beyond that, the Intrinsic ATP and Triage HF features are unique to our portfolio, the latter of which stratifies heart failure patients into three risk categories (high, medium or low) by evaluating factors such as heart rate variability, atrial fibrillation and fluid status.

Medtronic has been a leader in anti-tachycardia pacing therapy, which can help reduce shocks by delivering painless pacing therapy to reset an unusually fast heart rhythm, and our exclusive SmartShock technology reduces the incidence of inappropriate shocks.

Intrinsic ATP is the next advancement in ventricular antitachycardia pacing (ATP) therapy. It’s an automatic algorithm that learns and adapts ATP therapy in real time. If Intrinsic ATP is unsuccessful in the first sequence, it will assess why it was unsuccessful, and adapt the next sequence to try to terminate the fast rhythm.

Q. What is the importance of the new CE mark for the Cobalt and Crome implantable cardioverter-defibrillators and cardiac resynchronization therapy-defibrillators?

Klaus Witte: A CE Mark is a recognition that the devices are appropriate and safe to use in patients across the European sphere. The CE mark sets a high standard of quality and makes it clear to physicians and patients that the devices do what they claim to do.

Q. How do these devices work to offer connected health for physicians and patients, and how does this aim to benefit disease management?

Klaus Witte: One of the major difficulties for patients with heart failure (HF) is that they see a number of different physicians not just for their HF but also for the average two co-morbidities. Poor communication between specialists (and also between specialists and patients) is a driver of less than optimal outcomes for patients both in terms of the usual hospitalisations and mortality, but also in terms of patient quality of life and acceptance and self-management of their condition(s). The patient-facing interface (a mobile phone) is so easy to use that it allows the patients to ‘check’ their device themselves, whilst also giving non-specialists the information they need to plan their aspect of the patients holistic care without concerning themselves about the device. In an ideal world, the HF physician would also take the lead on the device management. This goes a long way towards facilitating that, but things move slowly in the real world and most patents still have a HF physician and an electrophysiologist looking after their device. Now, both have easy access to updated information about the device functionality. Eventually, the data should be used by the HF physician to guide medical therapy and other decisions.

Q. What studies or trials have taken place or been planned to measure the impact of these new devices in clinical practice?

Robert Kowal: Medtronic submitted bench testing as part of its application for these devices. Further, for Intrinsic ATP, Medtronic collected data through an US Food and Drug Administration (FDA)-approved investigational device exemption clinical feasibility study.

Q. What are the future implications of the integration of smart technology for implanted cardiac devices?

Klaus Witte: The ultimate aim is a truly connected service where the HF physician can guide the device therapy in addition to the other aspects of care. However, patients will of course be admitted or receive care elsewhere, but the smart technology gives access to all medical team members, wherever in the world they (or the patient) may be to facilitate optimal care at all times.

 References

  1. Ponikowski P, Anker SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25.
  2. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics-2016 Update: A report from the American Heart Association. Circulation. 2016;133:e38–360.

Support: No funding was received in the publication of this insight article.

Published: 27 March 2020

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