Seeking Direction: How to Manage Device Patients at the End of Life
Nearly 20 percent of patients with implantable cardioverter-defibrillators (ICDs) receive painful shocks near the end of life, leaving physicians to question how to care for patients in these trying times (Pacing Clin Electrophysiol 2000;23[6]:934-938). When to initiate end-of-life discussions, as well as the legal and ethical ramifications of withdrawing a device in a terminally ill device patient, are challenging considerations for physicians and administrators. 
 

Reaching a consensus

More than 100,000 patients in the U.S. undergo cardiovascular implantable electronic device (CIED) procedures each year. Because pacemakers, ICDs and cardiac resynchronization therapy (CRT) are deemed life-sustaining therapies and often are depicted as a form of life support, some physicians feel uncomfortable withdrawing device therapy, even when they painfully shock patients at the end of their lives. Others have questioned the legality of deactivating CIEDs at the end of life.

At HRS.10, Rachel J. Lampert, MD, associate professor of medicine at the Yale School of Medicine in New Haven, Conn., and other key players created a consensus statement to help address such questions for the electrophysiology community. The document has become a go-to resource guide for providers looking for recommendations on how to manage device patients properly, particularly those near the end of life. For instance, the Heart Rhythm Society (HRS) concluded that withdrawing unwanted therapies, like CIEDs, is not hastening death, but instead is alleviating the burden of the device. Therefore, ethically, the patient should have the right to such deactivation.

“Informed consent is the most important legal doctrine in the clinician-patient relationship,” Lampert et al wrote. “Clinicians are ethically and legally obligated to ensure that patients are informed and allowed to participate in decision making regarding their diagnoses and treatment options.” Patients have the right to refuse treatment that was previously consented if it no longer meets their treatment goals and wishes, the statement outlined. “Honoring these decisions is an integral part of patient-centered care.”

The Supreme Court has affirmed the rights of patients or their surrogates to discontinue life-sustaining interventions, Lampert notes, including device therapy. “It is not specific procedures that have rights,” Lampert says. “It is patients.”

Have the conversation

CIEDs can help tack on years to a patient’s life, says William R. Lewis, MD, chief of clinical cardiology at MetroHealth Medical Center Heart and Vascular Center in Cleveland. Therefore, as device patients age, they may be more apt to acquire other life-threatening diseases such as cancer that are independent of the CIED. These considerations could make the issue of device deactivation a real concern at some point.  

Often, due to failing health, device patients are shocked near the end of their lives and want their devices turned off immediately. “This becomes a very difficult situation for caregivers, because at that point, the end is near and a device patient may be in too much pain to hear conversations about device deactivation,” says Lewis.

Nathan E. Goldstein, MD, associate professor of geriatrics and palliative medicine at the Mount Sinai School of Medicine in New York City, says there are three key elements emerging from literature:
  • Device patients are being shocked near the end of life;
  • Physicians and patients rarely talk about this issue; and
  • Patients who are on hospice are being shocked by devices.
When Goldstein and colleagues assessed how 414 hospice care centers handled ICD patients at the end of life, they found that only 10 percent of respondents said that they had a policy in place to discuss device deactivation with these patients (Ann Intern Med 2010;152[5]:296-299). However, 58 percent of survey respondents said that an ICD patient had received a shock within the past year.

“We in the field in medicine should be doing a better job of letting device patients know that device deactivation is really something to think about,” says Goldstein.

The first piece of the puzzle is getting the patient on board and allowing him or her to understand the functions of the CIED, especially the fact that they may result in shock or pain, says Lewis. That begins with a patient-physician tête-à-tête about risks and benefits. But the literature shows that these conversations are few and far between in practice.

In 2004, Lampert, Goldstein and others evaluated how often end-of-life consultations took place in a retrospective cohort study that included the next of kin of 100 ICD patients who died of any cause (Ann Intern Med 2004;141[11]:835-838). When the researchers telephoned the next of kin, they found that device deactivation discussions occurred in only 27 of the 100 cases, and most conversations took place within the last few days of life.

“These are not conversations that should happen within the last hours or minutes of a patient’s life,” says Goldstein, who believes the best time for these conversations is during device implantation.

However, Lampert suggests that patients usually are overwhelmed with the drastic changes that will occur with their new device during the implantation stage. “These patients are not thinking about the end of their lives, they are thinking about moving forward,” she says.

The period when a patient’s health status changes, advanced directives are called into question or do not resuscitate papers are signed may instead be the best time for these conversations, she says. “It is not the role of the doctor to decide whether a patient should have the device turned off. Instead, it is the role of the doctor to educate his or her patients, so that they understand the implications of leaving a device on or off and knowing their options.”

When patients are faced with a terminal illness, they will want to be comfortable, Lewis says. “At that point, deactivating the device may be very appropriate.”

Pacemakers vs. ICD deactivation

While device deactivation at the end of life remains a touchy subject, another controversy within patient management is whether pacemaker deactivation should occur. In a 2010 analysis, McGeary et al listed the following situations where ICDs differ from the pacemaker (Med Sci Law 2010;50[1]:40-44):
  • ICD discharges are both physically painful and emotionally distressing to most patients, and may impose an additional symptom burden;
  • There is a theoretical risk of the patient’s caregivers receiving an accidental shock if they are in direct close physical contact with the patient;
Terminally ill patients may be at increased risk of ICD shocks due to electrolyte disturbances, hypoxia and heart failure.

Many still feel that “once a device becomes incorporated into the body, like a pacemaker, it shouldn’t be turned off,” says Lewis. A 2008 study by Mueller et al found 56.7 percent of clinicians surveyed said they did not feel comfortable deactivating an ICD, while only 34.4 percent said they felt comfortable deactivating a pacemaker (Pacing and Clinical Electrophysiology 2008;31[5]:560-568).

“If a patient told me he or she wanted to have the pacemaker turned off, and understood the risks and benefits, I feel I should  respect the autonomy of that patient and deactivate his or her pacemaker,” Lewis says. “Our position is that a pacemaker can be a comfort care measure and we must preach that to the patient.” Because pacemakers are used as a comfort of care measure, Lewis says he may advise against turning them off.

The patient and physician must discuss whether device deactivation is appropriate, and when the two parties disagree, how conflicts will be resolved. While the physician has a right to decline performing a procedure to a patient if he or she doesn’t feel comfortable with it, a patient also has the right to decline recommended treatment. These issues may be resolved with earlier discussions about device deactivations, advocates say. Making these conversations a more widespread and ongoing practice is imperative to busting down the myths of device deactivation at the end of life.

“Discussions on comfort care should be continuous, not ones that occur in the throes of multiple ICD shocks,” Lewis says. “You don’t implant ICDs or pacemakers and forget it. … You must remain their doctor for life.”

MRI Management in CIED Patients
J. Rod Gimbel, MD - 156.18 Kb
J. Rod Gimbel, MD
A drawback of cardiovascular implantable electronic devices (CIEDs) is that patients with these devices are restricted from undergoing MRI testing to assess lesions, masses, tissues or neurological conditions. However, with the recent approval of the first MRI-compatible pacemaker and leads, imaging these device patients has become more feasible.

Approximately 50 to 70 percent of device patients will require an MRI in their lives. However, scans performed with non-MRI conditional devices are not reimbursed, sticking some patients with an expensive bill if they undergo the scan. J. Rod Gimbel, MD, a cardiologist at East Tennessee Heart Consultants in Knoxville, Tenn., says patients are often left with a difficult choice:
  • Receive the MRI, agree to be responsible for payment and sign the Advanced Beneficiary Notice (ABN); or
  • Not receive the test or procedure and sign the ABN.
While, in some cases, Gimbel says the cardiologist may be willing to perform an off-label scan, hospital administrators may not want the compliance headache.

Saman Nazarian, MD, director of cardiac electrophysiology at Johns Hopkins Hospital in Baltimore, and colleagues evaluated protocols that could allow device patients to undergo MRI with little adjustment. In the non-randomized trial, the researchers evaluated 438 device patients (54 percent with pacemakers and 46 percent with ICDs) who underwent 555 MRI studies (Ann Intern Med 2011;155[7]:415-424).

Nazarian et al found that a device had reverted to a transient backup programming mode with long-term effects in only three patients. The test safely can be done in patients with devices manufactured after 2000 and equipped with electromagnetic interference protection features. However, one must take into consideration how many leads a patient has implanted.

“If the wires and leads that connect the battery and computer to the heart are old, they have the potential to heat up and induce a current during the scan,” Nazarian says. Therefore, patients with disconnected wires and epicardial wires are not scanned.  

“Devices need to be reprogrammed for the scan so they ignore noise from the MRI scanner,” Nazarian says. While the protocol will be effective in some patients, there are some risks. “Sometimes during these scans, the device can reset,” he says. “However, this occurred in less than 1 percent of patients.”  

In some cases, the parameters in the device can see some subtle changes; Nazarian notes that it is difficult to tell whether these changes are normal variation or from the MRI. However, often there is no need to reprogram the device.

Gimbel, who has evaluated the use of the FDA-approved MRI-compatible pacemaker (Revo MRI SureScan, Medtronic-pictured), says these compatible devices should be the default choice. With the device, electrophysiologists do not need to monitor the scan, which cuts down on workflow and time. If an operator does 30 of these scans per year and each one takes between 45 minutes to an hour, “that is an entire week’s worth of time,” he says. The protocol streamlines this process and allows device patients to be scanned at high volume with simple programming and rudimentary monitoring, Gimbel notes.

In terms of the protocols for patients with non-conditional devices to undergo MRI, Gimbel says, “It really comes down to program and pray.” Ultimately, the medical community, government and payors must decide whether they want patients to continue paying out of pocket for off-label scans or to be implanted with MRI-compatible devices.

While Gimbel says patients with non-MRI-conditional devices can undergo the exam safely, there are some risks. “Simply put, properly labeled devices lead to safe, smooth care for the patient with reliable and deserved reimbursement for the hospital and physician for the service (MRI) that was provided,” Gimbel sums. “Everybody wins when the right device is chosen out of the box for the patient at the initial implant.”

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