The efficacy of a treatment is primarily based on objective criteria, such as mortality and morbidity. Besides these criteria, the interest in measuring quality of life (QOL) in relation to health care has increased in recent years. Although the concept of patients' QOL is inherently subjective, and definitions vary, it can be assessed on a basis of 3 major components: physical condition, psychological well-being, and social activities. The basic requirements of QOL assessments are: multidimensional construct, reliability, validity, sensitivity, responsiveness, appropriateness to question or use, and practical utility. The instruments to assess QOL can be disease specific or generic, depending on the context. In 1991 a prospective and systematic evaluation of QOL in implantable cardioverter-defibrillator (ICD) recipients was started at the University of Bonn: psychological profile and patient acceptance were assessed in 57 consecutive patients using a specifically designed questionnaire. The results of this pilot study demonstrated that the acceptance of the ICD was remarkably high. Restrictions on driving a vehicle may have a substantial impact on QOL in patients with ICDs. A specifically designed questionnaire was addressed to 47 European national delegates in order to determine their present practices and criteria utilized when advising driving restrictions to patients after ICD implantation. Of the 39 (83%) respondents, 22 (56%) cardiologists advised all patients to abstain from driving—13 (33%) advising permanent abstinence, while 26 (67%) recommended temporary driving abstinence for periods of 3–18 months (mean 9 ± 4 months). Despite medical advice not to drive, one third of the patients resume driving; half of the patients resumed driving after 6 months, with the vast majority driving within 12 months after ICD surgery. Two patients experienced ICD discharges while driving, but no motor vehicle accident occurred. Another patient had a motor vehicle collision with a fatal outcome, which was not caused by loss of consciousness or ICD discharge. Conclusions: (1) Fatal accidents or ICD discharges while driving are a rare finding in ICD patients. (2) About half of the physicians always advise their patients to cease driving for a period of 9 ± 4 months. Despite this medical advice, the majority of the patients resume driving within 6 months of ICD implantation. (3) Criteria used in advising driving abstinence are not uniform among physicians. (Am J Cardiol 1996;78(suppl 5A):51–56)