Quality of Life in Clinical Arrhythmic Trials May 14, 1999 - Dr. Dorian discussed the concept of health-related quality of life. Quality of life is the physical, psychological, emotional and social consequences of an illness, as well as symptom burden and general well being of the individual. Quality of life is defined as the patient's own subjective perception of his health and well being. Health related quality of life involves factors such as how severe disease is and how bad symptoms are, as well as things like side effects from therapy. These physical factors can be altered by mental and social factors like personality, level of education and gender. This results in levels of symptom burden, perceived well being, and functional impairment. This varies from patient to patient and over time. There is increasing recognition of the importance of quality of life, and this has resulted in a lot of scientific publications related to life quality. Quality of life is important: patients are often willing to trade length of life for quality of life. Quality of life measurements may aid in clinical decision making, especially when the goal is to ease symptoms rather than cure the underlying disease. For diseases where treatments cannot cure, quality of life endpoints may be better than traditional measures like mortality. Perceived quality of life can also predict health outcomes and health care use. For example, depression is clearly associated with increased mortality following heart attack. In a large study on the effects of anger, as measured on a questionnaire, within 10 years there is a higher risk of heart disease deaths in the group with highest anger; The angriest patients having the highest risk of heart related death. In patients with heart disease symptoms in the cardiac rehab program, patients who perceived themselves to be distressed have almost twice the rate of re-hospitalization as patients not perceiving themselves to be distressed. Measuring of the Quality of Life Measuring quality of life is complex. Most researchers measure it by giving questionnaires to patients. These are filled in at home by the patient rather than being given by an interviewer. This lowers the chance of the interviewer influencing the answers. Of the many questionnaires that can be used, one kind assesses "outcome" measures - in other words, measures of the actual state of quality of life. Examples are: 1) the Minnesota Living with Heart Failure questionnaire 2) the Duke Activity Survey, an index of exercise capacity 3) the Symptom Checklist, an index of the severity of symptoms from arrhythmias. Other questionnaires have predictive scales: 1) the Life Orientation Test, a measure of optimism 2) the Barsky Scale, which measures somatization (a tendency to amplify harmless bodily sensations) People who score higher on somatization scales tend to have worse quality of life later. Tests to measure quality of life may be generic, and measure aspects of life quality not specific to the illness being studied. The most commonly used such scale is: 1) the SF-36 Survey, which measures physical, emotional, social and psychological components of life quality. 2) The Health Utilities Index is another scale that can be used to calculate QUALYs. Disease-specific questionnaires focus on symptoms of the illness being studied, like measuring shortness of breath in CHF patients. In order for questionnaires to be useful, they must be valid and reliable. Validity is the extent to which a questionnaire measures what it is meant to measure. Reliability is the repeatability of results between and within individuals. Quality of life studies need to be designed with care, generally using both generic and disease-specific questionnaires. Since most questionnairre have many individual questions, hypotheses need to be specified at the start, not made later after some results are in. Lastly, studies that are linear in time rather than cross-sectional allow patients to be compared to themselves, and allow analysis by repeated questioning at intervals, which is more powerful. Quality of life is a "moving target" and may change over time. Quality of Life in MADIT Dr. Mushlin discussed the quality of life outcomes in the MADIT study. This is a study that randomized patients with an EF less than 35%, nonsustained VT and Class 1-2 CHF. The MADIT quality of life substudy included 89 patients randomized to defibrillator and 92 patients randomized to a various anti-arrhythmic drugs. The quality of life questionnaire was the "Sickness Impact Profile" (SIP). Patients who died during the study had worse quality of life at the start in many areas, including sleep, work function and recreation, than those who survived. Looking at the survivors only, the quality of life improved significantly in both groups. Quality of life improved in patients who received either no ICD shocks or less than 4 shocks during follow-up. Quality of life got worse in patients who received more than 4 shocks. Patients with ICDs usually have moderate impairment of life quality but patients with frequent shocks from their ICD have both poorer, and worsening over time, quality of life. Quality of Life in Atrial Fibrillation Dr. Lüderitz reminded us that patients with atrial fibrillation may have poor quality of life, almost as bad as patients with chronic heart failure. He reviewed a large multi-center study about quality of life in a-fib patients. Most of these patients were Class 1 with normal ventricular function; 45% of them perceived themselves to have daily a-fib episodes and 30% perceived themselves to be in continuous a-fib. In about 20%, the episodes lasted either days or hours. Up to 30% had had 1-2 hospitalizations in the previous year for their a-fib. When patients thought they were in sinus rhythm, 86% had Class 1 function and 12% had Class 2 function. When they thought they were in a-fib, the number in Class 2 increased to 39% and the number in Class 3 increased from 2% to 15%. Patients with paroxysmal a-fib had substantially more frequency and severity of symptoms than those with persistent a-fib, who in turn had more symptoms than those in permanent a-fib. Women had more symptoms than men, even when corrected for heart function and age. Patients who were "high somatizers" scored worse on all the quality of life questionnaires than patients less inclined to exaggerate benign bodily sensations. He summarized by saying that quality of life is a mix of physical, psychological and social functioning, and that it can be seriously impaired in the average a-fib patient. It can be assumed that restoring and maintaining sinus rhythm is likely to improve quality of life. Quality of Life in Ablate and Pace Trial Dr. Kay discussed quality of life in the Ablate and Pace trial. This was a registry of 156 patients indicated for ablation and pacemaker implant for a-fib. He noted that this procedure trades one disease, a-fib, for another disease, namely surgically induced AV block and pacemaker implant. Nevertheless, the investigators thought the procedure would improve life quality, exercise capacity, and heart function. 90 patients were male and 66 were female, averaging age 66. 70 had permanent a-fib, 31 persistent a-fib, and 55 paroxysmal a-fib. Reasons for ablation were inability to control the heart rate in 67%, recurrences despite therapy in 55%, or drug side effects in 31% (or a combination of the above). Quality of life and exercise tests were done at start, at 3 months, and at 12 months. 99% of patients had successful ablation and pacemaker implant. In most patients, both rate-controlling therapy and anti-arrhythmic drugs were stopped, with less than 5% on any of these treatments during follow-up. They analyzed the survival rates for patients receiving dual chamber versus single chamber pacemakers, but found no difference. Ablation and pacemaker implant had about 5% early complications, mostly related to the pacemaker and leads, and a 3% rate of sudden death and a 3% rate of stroke. He pointed out that the sudden death rate was not unexpected for these elderly patients with heart disease, but it could not be ruled out that the procedure somehow increased the risk of sudden death. Everyone's ejection fraction improved, but mostly in the group with a starting EF less than 45%. Patients were more likely to have EF improvement if they were in permanent or persistent a-fib to begin with. On treadmill testing, there was no increase in either exercise time or in maximum oxygen consuming capacity (VO2max). Heart Class improved in all patients, indicating better ability to perform everyday activities. At baseline, there was a marked degree of quality of life impairment, as bad as patients with cancer. Following ablation and pacing, all parts of life quality improved. Dr. Kay concluded that in these patients requiring ablation and pacing, there was quite an impairment of quality of life at start and a lot of improvement after treatment, including improvement in CHF symptoms, symptoms due to arrhythmia, and general well being. However, there was no change in maximum exercise capacity and a possible, unresolved concern that the procedure may slightly increase the risk of sudden death. He suggested that future studies of atrial fibrillation should include quality of life as one of their important endpoints.