Posted by Gary Schwitzer in Medical devices
Yesterday we posted a guest column that raised questions about whether reseachers overstate the benefits of implantable heart devices known as implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.
Ultimately, that issue could influence the messages that patients receive.
A paper in the journal Health Expectations, “Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death,” raises more questions about the messages patients receive concerning these devices.
In a small study, the researchers explored the decision-making process that took place among 44 patients. They report:
“Participants who experienced heart failure symptoms or non-life-threatening arrhythmic events (uncontrolled atrial arrhythmias) tended to (incorrectly) view the ICD as a possible treatment. Several were hopeful that the device would improve overall energy and ⁄ or breathing difficulties. It was challenging for many participants who were experiencing symptoms to avoid associating the ICD with symptom relief, when the single- or dual-chamber ICDs were not intended for that purpose.
One could argue that the life-prolonging aspect of ICD therapy acts as a powerful influence towards acceptance of the device. However, patients may make sense of their personal risk depending on the manner in which the information is presented during medical consultations. Communication that includes statements about prolongation of life and statistical probabilities favouring survival is powerful and, as we discovered, influential when presented in isolation (without a balance of what to expect without the ICD). However, those seeking symptom relief from heart failure, acquiring information that delineates what a single- or dual-chamber ICD can and cannot deliver (i.e. symptom relief in the absence of cardiac resynchronization) could inform the decision-making process regardless of active or passive approach.
A preference for physicians to make final treatment choices was apparent among the majority of our participants. The alternative to not receiving an ICD did not surface as a focal point in conversations shared between our participants and physicians. These findings bring the question of informed consent to light. Do patients who adopt a passive approach truly comprehend what they are consenting or declining to? The alternative to not receiving an ICD may not be as appealing, in fact likely quite the opposite; however, treatment alternatives, especially in the context of existing comorbid health conditions, require discussion. What is more, the complexity of ICD technology demands a level of health literacy (that some patients may not have) also shown to influence health-related patient decision making, but that given the time or technique could be explained to patients’ satisfaction.”