Frank Praetorius

Diminishing resources seem to be forcing rationing of medical services. Rationing the public health care system means that there needs to be ethical discussion on justice. Several years before resource allocation could impact on the levels of morbidity and mortality, economic problems created numerous methods of regulating medical and nursing services. In clinical practice, regularisation means a reduction of the possibility to decide autonomously and therefore requires specific ethical discussion. The different methods of regularisation from standards and quality control to managed care are discussed with respect to their influence on medical thinking and decision making. Formalised decisions in severe disease can also be a field for regularisation, for example guidelines on the termination of life sustaining treatment (vs. Do-Not-Attempt-Resuscitation Orders). The debate on futility is discussed as a part of the economic discussion, with special regard to the impact of the macroeconomic situation on ”peripheral” medical decisions, which very often are made unconsciously, as shown by a new German study. It is impossible to discuss the influence of macroeconomy, different attempts at regularisation and the individual decision of the doctor without reflecting on their principle interdependency. Ethical reflection in this field cannot be sectioned into an economic, medical decision-making and futility sections.

Definition of the problem: In 1997, Percutaneous Transluminal Coronary Angioplasty (PTCA) was performed in 138.001 cases in Germany. The standard indications, single vessel disease and badly controlled angina, are more and more extended to multivessel disease with and without severe angina, unstable or preinfarction angina, and acute myocardial infarction (AMI) itself. Dilating asymptomatic stenoses of more than 70–80% is a widely used indication, intending prophylaxis of complete occlusion and AMI. Actually there is no generally accepted guideline for the different new indications, conservative versus invasive treatment schedule. It is difficult for the patient to get appropriate information before his decision between mechanical procedures and conservative methods; authentic informed consent actually seems to be in a very bad position. In 1992 the working group called ”Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte (ALKK)” decided to start a registry of all PTCA procedures, in order to gain knowledge about the present status of PTCA in Germany. Up to March 1999, 198.608 PTCA are logged.Arguments: Each PTCA was included on an intention-to-treat basis. The registry succeeded in a nearly complete recording with 98,6% of all PTCA procedures complete on March 17th, 1999. 93,5% of stenosed and 72,2% of the total occluded vessels were successfully dilated. In 4.729 cases (2,63%) the PTCA caused severe complications. The overall in-hospital mortality was only 0,5%, if the procedures done for AMI were excluded (including AMI it was 1,1%). The calculation of complications should be an essential part of the patients informed consent.Conclusion: Complete recording of all PTCA procedures is feasible even on a nationwide basis. Some results of the registry, as the indication control and the complication rate may help to realize a better doctor-patient-conversation on risks and benefits of either concept. The trend of many CHD patients is ”modern”: It should be done what can be done (mechanically), with results at once. Although said somehow paternalistic, this point of view cannot be tolerated: Proper informed consent today includes the realistic alternative of modern medicaments, especially those with an aggressive cholesterol lowering potency

Zusammenfassung. Die Ballonangioplastie (PTCA) expandiert quantitativ und qualitativ, Eingriffe werden in wesentlich erweiterten Indikationen durchgeführt, immer häufiger auch in prophylaktischer Indikation. In einer Situation ohne allgemein akzeptierte Richtlinien für Indikation und Durchführung begann die „Arbeitsgemeinschaft leitender kardiologischer Krankenhausärzte” (ALKK) 1992 mit einem PTCA-Register, um eine Übersicht über die eigenen Handlungsgewohnheiten und zugleich den Anfang einer internen Qualitätskontrolle zu erhalten. Von zentraler Bedeutung für die Wirksamkeit der Qualitätsbeurteilung ist die konsequente Einhaltung des „intention-to-treat-Prinzips”. Die aktuell (3/1999) ausgewerteten vollständigen Datensätze entsprechen 98,6% der insgesamt erfaßten 198.608 Fälle. Von unabhängigen Kommissionen wurden nur 3,7% der Indikationen als „nicht gegeben” angesehen. Weitere 15% fallen unter „unsicher” bzw. „umstritten”, ein Ausdruck der zunehmenden Unsicherheit über den Vorrang entweder modernster medikamentöser Therapie oder invasiver Kardiologie wie der PTCA. Für viele Fälle gibt es Hinweise auf statistisch nachweisbare Vorteile der neuen konservativen Behandlungsformen. Diese Änderung des wissenschaftlichen Leitbildes hat Konsequenzen für die Aufklärung des „modernen” Koronar-Patienten.