SNOWMASS, COLO. – Cardiologist-patient discussions at the time of decision making about implantable cardioverter-defibrillator therapy are fraught with a disturbing degree of misrepresentation and omission, according to a recent study involving patient focus groups and formal scrutiny of observed physician-patient interactions.
"Our study demonstrates that patient-physician communication about ICDs is characterized by patient misinformation and a lack of attention to psychosocial and long-term risks by the prescribing physicians. ... Training of cardiologists on information exchange with patients may promote informed decision making and preempt threats to patient quality of life," concluded Dr. Paul J. Hauptman and his coinvestigators at St. Louis University.
Dr. Clyde W. Yancy
At the Annual Cardiovascular Conference at Snowmass, Dr. Clyde W. Yancy highlighted the Hauptman study for shining a spotlight on an area in which the quality of communication with patients apparently leaves much to be desired. The study has drawn interest at the federally funded Patient-Centered Outcomes Research Institute (PCORI), where Dr. Yancy, a former president of the American Heart Association, is part of the leadership. Dr. Joe V. Selby, PCORI executive director, recently announced plans to spend roughly $1 billion on patient-centered comparative effectiveness research projects over the next 2 years.
The Hauptman study involved eight focus groups with a total of 41 ICD recipients in three different metropolitan areas as well as observation of 11 cardiologists as they each conducted two discussions about ICDs with individual device candidates.
Trained observers faulted 18 of the 22 cardiologist-patient interviews because the cardiologists didn’t address, minimized, or outright denied quality of life issues and the long-term consequences of ICD therapy, including increased risks for anxiety and depression as well as for inappropriate shocks.
Among the actual statements by cardiologists extracted from the physician-patient discussions were these: "The ICD will only go off if you are in VT/VF," "Inadvertent shock is not detrimental," "Inappropriate shock ... almost never happens," and "These devices are well tested and rarely have problems, so don’t worry about it." Cardiologists frequently compared the ICD to a seat belt, a safety net, or "an ambulance that follows you around." The first mention of a quality of life issue occurred on average halfway through the preimplantation discussions, which averaged 24 minutes in length. Although an increased prevalence of depression secondary to inappropriate ICD discharge or change in body image has been well documented in multiple studies, this possibility was discussed in only 1 of the 22 physician-patient interactions.
Dr. Paul Hauptman
"No cardiologist discussed the epidemiological or clinical data on the prevalence of actual lifesaving ICD shocks, the prevalence of patients who ever require a shock, or the risk for death, despite ICD shock," the investigators noted (JAMA Intern. Med. 2013;173:571-7).
In the 2-hour-long patient focus groups, which were conducted with a different population than in the observed cardiologist-patient discussions, only 2 of 41 patients with ICDs could recall preimplantation mention of the possibility of depression or other emotional consequences of having an ICD. Only 5 of 41 patients could recall having a preimplantation discussion about inappropriate shocks. Two remembered mention of the possibility of device recalls.
The small sample size is a limitation of this study. Nevertheless, these rather disheartening data constitute some of the little evidence available on the information exchange between patients and cardiologists surrounding decision-making about ICDs, noted Dr. Yancy, professor of medicine and of medical social sciences as well as chief of cardiology at Northwestern University, Chicago.
"It just continues to be very startling that when you sit down with patients and understand what prism they’re using to see the data, you see information like this," he commented.
Another speaker, Dr. Bernard J. Gersh, was less circumspect. He was left shaking his head following Dr. Yancy’s overview of the Hauptman study findings.
"I was absolutely flabbergasted by the ICD patient information data. I was amazed and disappointed," said Dr. Gersh, professor of medicine at the Mayo Clinic in Rochester, Minn.
Dr. Yancy reported having no financial conflicts. Dr. Gersh is on the advisory boards of St. Jude Medical and Boston Scientific.