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Jude Medical now also offer their own systems. These function in a similar manner, although they do have technical differences. Older implantable devices require a telemetry wand for manual interrogation by the patient, which is an obvious setback. Recent implantable devices have an incorporated antenna that allows wireless automatic data transmission with a unit installed in the patient's home, and that does not require any action by the patient other than correctly setting up the system. A message is then sent to the physician by email, short message service SMS or by fax depending on the system and its configuration , who may then consult the data via a secure internet access see Figure 1.

None of the existing systems currently allow remote programming of the implanted device, mainly for security reasons although this would be technically feasible. Is Remote Follow-up Safe? Remote monitoring has been shown to dramatically reduce the time to detection of events such as arrhythmias and technical issues. Data analysed as secondary endpoints from several trials are encouraging. Incidence of inappropriate shock was also reduced by remote monitoring from These data are encouraging, but need to be confirmed by adequately powered randomised trials, several of which are currently underway.

There are currently no guidelines on which patient should be followed by remote device management. Some centres include all patients implanted with a device equipped with wireless technology, but current practice is to choose patients on a case-by-case basis. Travel distance and patient mobility should be considered for remote follow-up.

Elderly, debilitated patients benefit from remote device management, with participation of the patient's family or caregivers if manual transmissions are necessary. As it concerns remote monitoring, the sickest patients e. Likewise, devices that are most prone to technical issues e. Implications for Workflow Whereas remote follow-up is a convenience for both patients 8,16 and caregivers, 17 remote monitoring adds work burden to the device clinic. Phone contact with the patients in response to the alerts can be time-consuming and may increase patient anxiety.

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Technical troubleshooting, reviewing of alert messages and patient contact in response to these alerts may require considerable time and effort. Most centres have a device nurse who periodically logs on to the secure servers to perform remote follow-up and to deal with the alert messages.

The nurse may perform triage of the alerts local protocols on how to deal with the different alerts are useful in this respect , and thus filter the data that require attention by the physician. Patients often express a desire to know about the results of their device check, whether in-person or remote. Results of an automatic remote follow-up may be communicated by sending a letter, but some systems allow automatic feedback to the patient e.

Jude Medical Merlin.


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As current and future generations of patients are likely to increase their use of SMS and email, these may be increasingly employed in the future to provide a rapid, efficient and cheap means to communicate results. It is accepted that remote monitoring is usually only provided during office hours, and patients should be made aware that it does not replace emergency healthcare.

2013 ESC Guidelines on Cardiac Pacing and CRT: Practical approach makes them accessible to all

Economic Aspects A review on the economic implications of remote device management for patients, manufacturers, caregivers and payers has recently been published. Remote follow-up of PMs and ICDs has been reimbursed in the US since , in Germany since and also in a few other countries, but still needs to be addressed across most of Europe. Energy consumption by the system should be minimised to avoid premature battery drain.

The Medtronic system consumes approximately days of device longevity for each transmission, 23 which are therefore usually performed at intervals ofseveral weeks or months. Your points will be added to your account once your order is shipped.

Click on the cover image above to read some pages of this book! Since the publication of the first edition of Cardiac Pacing for the Clinician, the use of implantable cardiac devices has expanded rapidly. Certain classes of devices such as implantable loop recorders and cardiac resynchronization pacing systems were not commonly used when the first edition was published, and recent studies have shown that implantable cardioverter defibrillators are beneficial in large, previously unrecognized patient populations at risk for sudden death.

In order to meet this demand, cardiologists without special training in electrophysiology or pacing are implanting an increasing number of cardiac devices. It is in this rapidly evolving setting that Cardiac Pacing for the Clinician, Second Edition is being undertaken. The main focus of this volume will be to provide a practical discussion of the a oenuts and boltsa of implantable cardiac devices.

The target audience will be cardiologists in practice and in training as well as nurses, technologists and industry. In addition, it will benefit physicians preparing for certification. This new edition of Cardiac Pacing for the Clinician, Second Edition will become a valuable resource to the general cardiologist and cardiology fellow by providing practical information for managing patients with complex cardiac devices.


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Country of Publication: US Dimensions cm : Help Centre. My Wishlist Sign In Join. The APC Medical E, E, E and E external pacemaker models incorporate a design feature whereby the pacing rate will increase by approximately 20ppm, when either the battery voltage becomes low, or when electromagnetic interference is sensed. In both instances the mode of pacing changes from demand to asynchronous pacing.

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Some patients however may not tolerate such a sudden increase in pacing rate, which may be detrimental to their condition eg open-heart surgery, valve replacement, congestive heart failure, myocardial infarction, arrhythmia etc. MDA became aware of an incident involving one of the above devices, where the design feature initiated an unexpected change in pacing therapy, which could be inappropriate for certain patients. In the device concerned, failure analysis determined an internal component failure in the battery monitoring circuit.

This resulted in inaccurate detection of the battery voltage, which was incorrectly sensed as low. This initiated asynchronous pacing and an increase in pacing rate by an additional 20ppm. The clinician concerned was unaware of the device feature. The APC Medical E, E, E and E pacemakers were designed and manufactured over 20 years ago and therefore clinicians may not be familiar with all the instructions for use, which may not be readily accessible. The design feature common to the above models is not widely used in modern external pacemakers, which incorporate different warning systems to alert users to low battery voltage or the presence of electromagnetic interference.

MDA has previously advised that some external pacemakers including APC model E are susceptible to interference from mobile communications systems 1,2,3 and care should be taken to ensure that patients supported via external pacemakers are not exposed to electromagnetic fields from mobile phones, walkie-talkies etc. MDA has also previously advised that older external pacemaker models should be withdrawn and replaced. Consideration should therefore be given to replacing the above models as soon as practicable.

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Risk managers are reminded of the Controls Assurance Standard - Medical Devices Management Criterion 18 6, which addresses the replacement of medical devices in detail, extract as follows:. For both hospital and community devices, a stage is reached at which replacement must be considered. If any of the following seven criteria apply, the device is no longer serviceable:. Please bring this notice to the attention of all who need to know or be aware of it.