ICDs: Shared decision-making still elusive

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Implantable cardioverter-defibrillators (ICDs) help to prevent sudden cardiac death but they cannot cure underlying heart problems and are associated with a diminished quality of life. Yet, physicians tend to downplay these aspects when discussing ICD recommendations with patients.

A study that analyzed physician communication about ICDs was published online Feb. 18 in JAMA: Internal Medicine, with an accompanying commentary that bemoaned physicians’ failure to provide complete information to patients who are candidates for ICD implantation and questioned whether the decision to implant is driven more by guidelines than patient-centered considerations.  

Paul J. Hauptman, MD, assistant dean of clinical and translational research at the St. Louis University School of Medicine in Missouri, and colleagues examined physician communication about ICDs in two ways: they conducted focus groups of ICD patients to assess their conversations with physicians prior to the implantation of the device, and they assigned standardized patients to have conversations with physicians about the devices. These conversations were observed and videotaped.

The researchers conducted eight focus groups at several U.S. locations, screening participants to ensure that each came from a different cardiology practice and that none had experienced a cardiac death event prior to device implantation. A total of 41 ICD recipients participated; the median age was 61.4 years old and 21 were female.

A large majority (80 percent) of the patients did not recall discussing procedural or long-term complications with their doctors prior to device implantation.  The researchers reported that some patients seemed unaware that the devices may malfunction, while half (49 percent) had undergone two or more device procedures (upgrades, revisions and generator replacement). Twenty percent had undergone procedures due to recalls or advisories.

The patients reported very little discussion of quality of life issues related to the ICD, even though many of the recipients reported that the device had a strong adverse impact on their quality of life, specifically related to their willingness to travel, perceived social stigma and body image concerns.

When asked to rate the quantity and quality of the information they received about their ICD prior to implantation on a scale of 1-10, with 1 being “not at all informed” and 10 being “all the information I needed and wanted,” the mean rating was 5.7. “There was near unanimity that they learned more about ICD risks and benefits after implantation than before implantation,” Hauptman et al wrote.

The standardized patients were portrayed by trained individuals representing a 61-year-old white man with ischemic heart disease and a 31-year-old black woman with post-partum cardiomyopathy, persistent ventricular dysfunction and recent hospitalization for heart failure. Eleven cardiologists who were primary decision-makers for ICD placement in at least 10 patients per year interviewed each of the standardized patients to discuss ICD implantation. There was no researcher in the room during the interviews but the sessions were observed and videotaped.

The interviews lasted for an average of 23.5 minutes. In general, the focus was on procedure-related issues rather than post-procedure expectations. The most common quality of life issue discussed was the need for special security procedures at airports and limitations on magnetic resonance imaging. The researchers reported that quality of life concerns were minimized in 14 of 22 interviews.

Deactivation of the device at end of life was discussed in only one interview, the possible need for generator replacement was mentioned in 10 interviews, and the possibility of device defect or recall was discussed in six interviews. The possibility of inappropriate shock was discussed in 15 interviews.

In an accompanying commentary, Grace A. Lin, MD, MAS, assistant professor of medicine at the Phillip R. Lee Institute for Health Studies in San Francisco, and Daniel D. Matlock, MD, MPH, of the division of general internal medicine at the University of Colorado School of Medicine in Denver, described the findings of Hauptman et al as “important and sobering.”   

They pointed out that ICD implantation can lead to inappropriate shocks, depression, anxiety and post-traumatic stress disorder. Given those risks, “clinical practice guidelines suggest a decision-making process that not only considers the clinical evidence base, life expectancy, co-morbid conditions and procedural risks but also a patient’s preferences.”

However, patients cannot determine their preferences without accurate and complete information about the device. Lin and Matlock asserted that physician/patient “[c]onversations seemed to be geared more toward satisfying informed consent requirements and convincing the patient to undergo the surgical procedure,” than allowing the patient to fully consider options and preferences.

Noting that many physicians believe they are acting in the best interests of patients by recommending an ICD to those who are guidelines-eligible, Lin and Matlock called that approach “paternalistic.” They recommended that future guidelines not only call for shared decision-making, but also “provide ways of measuring physician success at engaging patients in high-quality decision-making processes and reward physicians for doing so.” In addition, they suggested greater use of decision aids, payment reform to reward shared decision-making and legislation that creates and supports a culture of shared decision-making.