Encore Programmer. Image depicts an encore programmer sitting on a desk, open. More information see more Less information see less. The reader allows you to quickly identify issues and respond to significant clinical events without using a device programmer. The CardioSight reader provides heart failure read-only information without changing device parameters.
It shows heart trends that relate specifically to heart failure. The concept of futility, especially in the latter category, could be assigned when the ICD is no longer able to restore a stable cardiac rhythm. Any decision about the deactivation of an ICD must clearly aim primarily at relieving the patient's pain and discomfort.
If these modes are not intrinsically available, the rate can be lowered and output voltage and pulse width adjusted down to a sub-threshold level, so as to make the device non-functional. A more active approach is the surgical removal of the device. Such an approach, however, is likely to cause discomfort and inconvenience to the already suffering patient and is not recommended. In the case of ICDs, the antitachycardia pacing and shock defibrillator function of the device may be noninvasively deactivated with appropriate programming or, for most devices, with continuous application of a magnet over the generator.
It is important to remember that the caregiver, together with the patient or surrogates, should decide whether the antitachycardia pacing algorithms should be deactivated, or just the shock therapy. Whether the pacing function of an ICD should also be inactivated is a decision that should be governed by principles already stated in the case of the pacemaker patient. It should also be noted that a decision not to replace a pacemaker or ICD device that has reached its elective replacement indicator or end of life is a passive approach available for terminating device therapy.
The termination of device therapy, whether a pacemaker or an ICD, must be distinguished from the deactivation of the diagnostic or remote-monitoring capabilities of the device. Under rare circumstances, the patient may not wish to know or for others to know the status of his device or, alternatively, if any arrhythmias have occurred. Alert features may trigger an alarm under a variety of situations, such as lead or device malfunction, declining battery, or arrhythmia detection. As already stated, there is a medical, bioethical, and legal consensus that even a patient who is not terminally ill has the right to refuse any or all treatment provided the patient is cognitively competent and aware of the consequences.
Withholding or withdrawing treatment on the patient's instruction is not equivalent to aided suicide or euthanasia, because the latter will cause death irrespective of disease, whereas non-treatment merely allows the progression of a disease from which the patient already suffers. Apart from ethical and legal considerations, cultural and religious differences may influence a patient's decision.
This factor must be taken into account by caregivers and the patient's beliefs should be given precedence over their own. Any such request will potentially create dilemmas for patients and caregivers, especially if the patient is pacemaker dependent, where the interruption of treatment will have an immediate and dramatic result. Physicians should not impose their moral values on their patients. Some patients with malignant tumors may, for example, be resolute in wanting to keep their ICD activated.
In this discussion, the physician must communicate the details of the patient's medical condition and the predicted consequences of any decisions that involve the patient's implanted device. It is widely accepted that family members may act as surrogate decision makers for a patient who is cognitively incapacitated. Such surrogates should usually advocate for the patient's expressed wishes, if known, or otherwise should use their best judgment in determining the patient's most probable choice. In such cases deactivation of the device should be seriously considered.
The arrhythmias being treated reflect the primary cardiac condition and not an irreversible secondary medical illness;. Prompt ICD therapy confers the likelihood of added survival with meaningful quality of life and without post-arrest disabilities e.
If the patient's decision making capacity is judged to be compromised or doubtful, or when relatives or other surrogates believe the patient to be incompetent, then the correct decision making requires the participation of an experienced arbitrator who is acceptable to all parties. Such a person could be someone with a legal background, or a member of the hospital's ethics committee. From the point of view of both patient psychology and health care practice, the timing of the discussion about device deactivation is of great importance when the patient is capable of decision making.
It has been demonstrated that anticipating earlier deactivation of an ICD device as part of a comfort care strategy may result in fewer shocks during the final days of a patient's illness. The implication of this document describing the purpose, process, personnel, equipment and techniques required for device follow-up is that the human and financial resources are available to accomplish the task.
Unfortunately the implantation of the device has been the focal point of reimbursement and the ongoing application of the therapy has received much less attention. In North America there is a system that provides some reimbursement for the time, equipment and personnel involved in device follow-up, but this is less consistent in other parts of the world including most of the nation states of Europe.
As the technology advances, including the application of remote interrogation and advanced diagnostics, new models for reimbursement are required. It is easier to value face-to-face time than remote interrogations done over a longer period of time, collecting information for 3 or more months.
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This transformation of event based follow-up to life monitored follow-up for intervals of time requires new economic models and safeguards against abuse. The importance of remote monitoring as compared to office visits extends beyond the organizational aspects e.
Contemplating the Need to Advance Cardiac Device Algorithms
A most important aspect of remote monitoring is that it leaves the frequency of system check up to individual situations. Some patients require or may individually request more frequent system checkups for a variety of reasons e. In such instances the availability of a remote system for device follow-up becomes a way of delivering much better care to patients and may prove life saving.
In Europe the implant rate is lower than in North America; however, there is an expected increase in the near future in relationship to the release of evidence based guidelines. The availability of remote monitoring seems to be a fundamental requirement to facilitate patients' access to therapy. However there are many clinical situations including perioperative programming that are not reimbursed.
Specific reimbursement has not been generally available for remote CIED follow-up. Discussions are underway in various geographic locations to seek similar in person reimbursement for remote CIED evaluations. Currently, since in many countries there is no reimbursement for remote CIED follow-up there is a disincentive for adoption of this technology. This negative incentive may delay the benefits, improved quality of care and eventually the efficiency gains for health care providers.
WHAT IS A PACEMAKER?
Without adequate value placed on these activities the promise of device therapy is hollow. Intrinsic to the implantation of a CIED is the care of the patient and device after implantation. The purpose of the device is not implantation but ongoing therapy. However the therapy requires monitoring and adjustments, which implies the availability of resources, including space, equipment and personnel.
Without follow-up the therapy is incomplete and without resources to achieve appropriate follow-up the desired outcome is unlikely. Over the last decades there has been an exponential growth in the number of implantable devices, their electronic and software complexity, and widening of their function and application.
New Pacemaker Technologies
This has led to a distinct and at the same time complex medical service as represented by monitoring of CIEDs. Until now, the complexity and importance of follow-up care and monitoring of CIEDs have been given too little attention by scientists, competent authorities and third-part payers. This is the first attempt to provide an expert consensus document on monitoring of CIEDs. As outlined in this document, a few paradigm shifts have already occurred but many more are likely to come over the ensuing years.
The large number of implanted devices has already put significant pressure on physicians, allied professionals, institutions and competent authorities for maintaining the high quality, quantity, efficiency and reliability that this group of patients deserves. Globalization and new Internet-based technologies for monitoring CIEDs are imposing new rules for patient data management and data-sharing.
Competent authorities, national ministries of health, and patient organizations need to find practical and easy solutions for physicians to have rapid and complete access to device relevant data for delivering the most appropriate therapy. Moreover during CIED follow-up, new approaches to the ethical complexities may arise. Appropriate follow-up monitoring of patients with CIEDs is critical to the achievement of maximal clinical benefit from their implantation and is essential for the prevention and management of potential adverse outcomes related to the device.
The monitoring should be done by professionals who are specially trained and dedicated to this special patient population. With the increasing complexity of devices and the widening array of technologies involved in monitoring, the device industry, health care institutions and physician practices must provide the necessary infrastructure and personnel in order for this care to be effective and safe. Payers and regulators need to improve their recognition of the importance of CIED follow-up and develop adequate reimbursement strategies.
There is no point investing in the device without comparable investment in the long-term follow-up and therapy! Current standards for implanted device traceability for devices used in A clinical trials and B standard commercial transactions in the European Union EU with reference to North America.
Cardiac Electrophysiology and Pacing Section | Cleveland Clinic
For clinical trials, standard ISO 57 deals with traceability, both for the sponsor as well as the investigator. Responsibility of the sponsor chapter 8. The sponsor shall 8.