Women and ICDs: The FEMALE-ICD Study

In this interview, we speak with Lauren D. Vazquez, PhD, lead investigator of the Female-Specific Education, Management, and Lifestyle Enhancement for Implantable Cardioverter Defibrillator Patients Study (FEMALE-ICD Study).[1] What are some of the most common concerns faced by ICD patients in general? How many ICD patients, on average, experience anxiety and depression? ICD patients may experience a unique set of concerns very specific to living with their cardiac device. These may include fears about ICD shock, changes they have experienced as a result of their cardiovascular disease or device implantation, or even fears of death or dying. Research suggests that approximately 13-38% of ICD patients experience difficulties with anxiety, while approximately 24-48% of patients experience significant depression. Certain risk factors have been established that can help identify ICD patients who are thought to be particularly susceptible to developing adjustment difficulties. These include being young (under the age of 50), having a history of ICD shock, poor knowledge of one’s condition and/or device, a history of psychological difficulties, poor social support, and being female. Why are women with cardiovascular disease thought to be more susceptible to psychosocial distress? Women with cardiovascular disease are thought to be more susceptible to psychosocial distress due to a variety of biopsychosocial factors, including concerns about body image, shifts in role responsibilities, and changes in physical functioning. In the general cardiovascular literature, women have been found to have a higher incidence of depression and anxiety after myocardial infarction, stent implantation, or congestive heart failure, in comparison with males. Our recent research with a multi-site, international sample of ICD patients showed that young women (under the age of 50) reported significantly higher rates of shock anxiety, death anxiety, and body image concerns than their older-aged cohorts. Additional studies have consistently demonstrated that female ICD patients experience higher levels of anxiety and depressive symptoms, worse functional outcomes, and more ICD-related concerns. Tell us about the purpose of the FEMALE-ICD Study. Also, when did the study take place? The Female-Specific Education, Management, and Lifestyle Enhancement for Implantable Cardioverter Defibrillator Patients Study (FEMALE-ICD Study) was funded by the National Institutes of Health and was conducted in 2008 at Shands Hospital at the University of Florida. The purposes of the study were to develop, implement, and test the effectiveness of a female-specific psychosocial group intervention on ICD-specific quality of life outcomes in outpatient female ICD recipients vs. a wait list control group. Why is it important to recognize shock anxiety in ICD patients? Research indicates that ICD patients who receive shocks have poorer adjustment to the device than patients who receive no shocks. Shock anxiety is defined as the fear of ICD shock that may result in increased anxiety and avoidance behaviors, and has emerged as a construct of interest, both in research and in clinical settings, particularly with regards to quality of life of ICD patients. In general, patients who receive shocks after implantation generally report decreased quality of life. Even in those ICD patients who do not experience shock, shock anxiety may result in increased avoidance behaviors and a perceived limitation in performing everyday activities. Tell us about the patient demographics in the FEMALE-ICD Study. In addition, explain the differences between the intervention and wait-list control group. Most women identified themselves as being Caucasian (93.1%) and married (75.9%). Average length of time since ICD implantation was about 4 years. Approximately 34% of women had received ICD shock therapies prior to enrollment in the study. One woman experienced a shock during study participation. Regarding diagnoses, 72.4% had congestive heart failure, 37.9% had coronary artery disease, and 10.3% had long QT syndrome. Twenty-four percent of women had a history of sudden cardiac arrest, and 24% had suffered a myocardial infarction. With regards to psychological history, 44.8% of women reported past psychopharmacologic treatment and 37.9% reported prior psychological treatment. No significant differences in variables existed between the intervention and control groups (using p What were some of the responses during the intervention to questions such as “How has implantation posed unique challenges to you as a woman” and “How does ICD implantation affect your role as a wife, mother, daughter, etc.”? Interventions that utilize a group format that offer women essential social support that provide an opportunity to discuss the meaning of having a potentially life-threatening condition, and that instruct women in coping strategies for dealing with emotional stress after a cardiac event, have resulted in significant benefits among females with cardiovascular disease. I kept these concepts in mind as I was developing this intervention. At several points during the intervention, I facilitated patient discussion of a variety of female-specific topics, and utilized key questions such as those mentioned. Women shared their unique experiences with each other, normalized their concerns, provided insightful stories about how their lives had been challenged, and offered each other considerable social support. This was a component of the study that I could not personally provide them – they provided this for one another. Their stories were truly remarkable and I felt privileged to be able to facilitate these conversations. I then used their personal examples as jumping off points for discussing how to develop more effective coping strategies for dealing with typical device-related concerns. Explain the concept of developing a shock plan. How does it help patients and their families? The experience of shock is an event outside of a patient’s control. Having a shock plan, or in other words, a plan of what to do in the event of a shock, helps a patient and their family be more in control of a seemingly out of control situation. By being prepared in the steps one might need to take in the event of a shock, a patient can feel confident that they can handle a shock successfully. All patients and their families should develop a shock plan with their physician. Helping patients identify what to do in the event of a shock is a key step towards providing patients with ICD-specific education in an effort to decrease shock anxiety and increase device acceptance. For more information regarding developing a shock plan, please refer to Dr. Sam Sears’ 2005 Circulation patient page, available to all patients, at https://circ.ahajournals.org/cgi/reprint/111/23/e380. You noted that one woman experienced a shock during study participation. What else can you tell us about this patient? How did intervention help this particular patient? This particular woman actually had many risk factors for adjustment difficulties subsequent to having an ICD: she was young, had a history of shock, and had poor knowledge of her condition and what the device did for her. On the morning that she was scheduled to attend the intervention, she actually received a shock while getting dressed. She came to the intervention anyway (although she did appropriately contact her electrophysiologist’s office to alert them to the event before coming in). During the intervention, we used her experience as an example of how a patient can successfully handle an ICD shock. She shared her experience with the group, provided valuable insight into what a shock felt like, and we discussed what was appropriate to do afterwards. I used this event as a means of facilitating discussion about how an ICD provides patients with safety and confidence in an otherwise dangerous situation. This patient also had the opportunity to ask questions, explore her own fears and concerns, and assert her newfound confidence in being able to live life despite having an ICD. This patient is a perfect example of how tailored psychosocial interventions can be effective in decreasing shock anxiety and improving device acceptance, particularly in those already at risk for adjustment difficulties. Tell us about the study findings. Why do you think younger women had a greater reduction in shock anxiety than others? Women in the intervention group reported significantly greater reduction in shock anxiety at 1-month follow-up than women in the wait-list control group (p = .026). Given the magnitude of change on the measure, this also represented a clinically significant change in reported shock anxiety. Women in the intervention group also reported a significant increase in device acceptance compared to controls (p = .023). Similarly, this magnitude of change also likely represents clinical significance in self-reported device acceptance. Additionally, women under the age of 50 experienced greater reduction in shock anxiety compared to their middle-aged cohorts (p = .046). Notably, young women had higher rates of shock anxiety than middle- and older-aged women at baseline. However, all age groups showed reduction in shock anxiety from baseline to one-month follow-up, on average. As in other studies of female ICD recipients, women under the age of 50 reported higher rates of shock anxiety than their older cohorts. Younger age has been identified as a predictor of future psychological difficulties in ICD patients and is associated with greater quality of life deficits. As noted previously, our recent investigation of female ICD patients revealed that women under the age of 50 appear to be at greatest risk for the development of psychosocial distress. Results from the current study further strengthen this body of literature, and emphasize the utility of tailored psychosocial treatment for this group of females. What are the essential components of a successful psychosocial treatment plan for female ICD patients? Female ICD patients may experience improved health outcomes through a combination of optimal medical treatment and tailored psychosocial care. The provision of treatment that addresses ICD-specific education, cognitive-behavioral strategies for dealing with stress and anxiety, and female-specific concerns, such as body image, sexual functioning, and relationship issues, is likely the most appropriate step toward establishing a routine, comprehensive, treatment plan for female ICD patients. As therapies continue to advance, female ICD patients, particularly those under the age of 50, may benefit from these well-established treatment guidelines. Is psychosocial intervention best before ICD implantation, or can it be beneficial at any time? Ideally, ICD-specific psychoeducation such as how the device functions, what to do in the event of a shock, and strategies for coping with the stress and anxiety often associated with device implantation, would be best provided prior to device placement. However, given the constraints of the typical electrophysiology clinic, the provision of extensive psychosocial treatment is not easily accomplished. Providing patient education handouts, screening for those patients most at risk for adjustment difficulties, and making early and appropriate psychological referrals are likely the most effective physician strategies for facilitating timely psychosocial care for ICD patients. Will further research be done? The FEMALE-ICD Study establishes the utility of a female-specific psychosocial intervention involving ICD-specific education, cognitive-behavioral therapy strategies, and group social support in producing improvements in shock anxiety and device acceptance. The continued investigation of the unique issues women face in living with an ICD, as well as effective treatment strategies, are noteworthy, as they could largely improve adjustment and psychological fitness of female ICD recipients. I have utilized this intervention in my own clinical practice, in both individual and group formats, with great success. The beauty of this intervention is that it is portable and could be easily delivered in a variety of settings or geographical locations. I routinely speak at patient support groups and am certainly interested in investigating the effectiveness of this intervention in support group settings.