When and why did you decide to study the psychosocial data from this group of patients? It actually came up shortly after the trial was completed. I was on the Quality-of-Life (QoL) committee, which was responsible for planning and analyzing studies revolving around QoL instruments that were collected throughout the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial. Our original intent of using QoL instruments was to assess the quality of life in the participants of the trial; in particular, compare QoL issues between the two randomized arms (i.e., medical therapy and device therapy). When the results were analyzed, we did not see substantial differences between treatment arms, but it dawned on me as I delved into this that we really knew very little about the ramifications of collecting that kind of psychological and psychosocial information, and how it correlated with a patient s ultimate outcome. Subsequently, we explored those analyses post hoc, after the trial had been completed. Has the issue of psychological wellness of ICD patients possibly been overlooked by the medical community? Not exactly. Most importantly, we have seen in past research that a defibrillator patient s psychological life is most dramatically affected when they receive a shock from their device. In fact, many years ago my group at the hospital did formal psychological profiling of defibrillator patients, and found a very strong negative impact when patients received a shock; if the patients received multiple shocks, there was an even stronger negative effect as well as a decline in their sense of wellbeing. This is of interest the psychological relationship to defibrillator patients is one that we have further explored here. In the AVID trial, we found that although there were no differences in QoL between the randomized arms, we confirmed that a painful ICD shock was what led defibrillator patients to a decline in their sense of well-being (an adverse effect to medication was the same in the other arm). However, what had never been explored was the long-term prognosis of patients relative to psychosocial profiles. What we do know from other clinical contexts is that patients psychological characteristics can strongly correlate with how they do over time; for example, depression or a sense of satisfaction and well-being are all in many ways predictive of how patients do in various cardiac conditions. But what we did not know is how those characteristics reflect patients long-term outcomes when they ve already had a life-threatening arrhythmia requiring a defibrillator. I thought the term vital exhaustion was very interesting. Can you tell us a little about it and why it is important that this be recognized in patients? Vital exhaustion was a term coined by other researchers, specifically when they put together a set of psychosocial characteristics and then studied them long term. It was not specifically studied in a QoL or separate instrument, but we went back and looked at it by pulling out questions in our questionnaires that could mimic the sense of vitality that other people had studied previously. The vital exhaustion characteristics were defined as a sense of demoralization or loss of energy in other words, patients who were giving up or were so beaten down by their medical conditions that they didn t feel the same positive outlook towards the future, and that tends not to correlate well with outcome. How many patients participated in the QoL tests? In addition, what QoL instruments were used? In the study that we presented in HeartRhythm, there were 740 patients who completed the QoL forms at baseline; that was about three-quarters of all the participants in AVID. Some patients, because of timing or severity of illness or unwillingness to provide consent, did not complete the QoL questionnaires. However, the group overall was representative of the AVID study population as a whole. The QoL instruments were variable; there were three main ones: 1) SF-36, which is a very common medical questionnaire; 2) the Patient Concerns Checklist, which gives patients a chance to describe their perception of how their body is functioning; and 3) the Quality of Life Index, which gives the patient a chance to express their sense of satisfaction with regards to their psychosocial health, family life, and socio-economical status. Were QoL measurements predictive of the fatal events/ outcomes? Yes, and very powerfully statistically significant, they imparted an increased risk to patients likelihood of dying. So roundly speaking, patients who had a self-perceived lesser quality of life did much worse than patients who were in either the moderate or better categories. In addition, over time, the difference tended to become accentuated. For example, at the end of three years, the worst third of the patients had a 40 percent death rate, whereas the best third of the patients had about a 15 percent death rate. This is quite a remarkable difference. Will you be doing further research on this topic? Yes, we have done some more. Some of our most interesting research was done after 9/11. We hypothesized that 9/11 had been such a powerful emotional event, particularly since our patients draw from the NY metropolitan area, that we were concerned that there was going to be an increase in potentially life-threatening arrhythmias that may occur in the aftermath of 9/11. We studied our defibrillator patients who came to our various clinics and we re located all over the NY metropolitan area, both very close to the World Trade Center site and also in the more suburban locations. We compared patients event rates in the months after 9/11 to the months before 9/11. Since defibrillators record whenever life-threatening arrhythmias happen and specifically can record the time and date when it happens, it becomes a very accurate way to chronologically assemble timelines of arrhythmic events and compare them to various periods. To make a long story short, we found that for a whole month after 9/11, there was a marked increase in the number of life-threatening arrhythmias that occurred in our defibrillator patients, regardless of how close they were to the World Trade Center on 9/11 and how close they lived in the community. Not only that, but it stayed up for a whole month, and then went back down to baseline levels. Now baseline levels are remarkably constant from month to month, so this really stood out. If you look at the month-to-month event rate, that one month sticks out like a sore thumb it s completely different than all other subsequent months, completely different from all other preceding months, and completely different from the same month a year before. We published this a few years ago, but again, it strikingly demonstrates the strong relationship between psychological distress and cardiovascular function, and shows that dangerous cardiovascular events can result from psychological stress. Do you think there needs to be more therapeutic strategies for ICD patients? What is the current protocol, if any, for measuring psychological or psychosocial stress in ICD patients? Unfortunately, there is probably no standard of care currently in place. I think it varies a lot, and patients do have to rely a great deal on what their individual doctor decides to do. I think in general, and in particular for defibrillator patients, we need to be mindful that emotional and psychological problems can lead to both a deterioration in cardiovascular stability and in long-term outcomes, so we need to be looking out for it and react appropriately if it s detected. I think that there are some patients who do benefit from counseling, although others may require more intensive psychological care. In general it s a good idea to support the emotional needs of defibrillator patients, and one of the things that is done by our group is hosting patient support groups. This way, patients with defibrillators can get together and we can speak with them as a group. We also need to just keep doing more research to understand how to best to treat patients in a standard way, and for that, we ll need larger clinical trials. For more information, please see: HeartRhythm 2008;5:361-365.