Prospective analysis after coronary-artery bypass grafting: platelet GP IIIa polymorphism (HPA-1b/PIA2) is a risk factor for bypass occlusion, myocardial infarction, and death.

Recently, we have demonstrated that human platelet antigen 1b (HPA-1b or P1A2) is a hereditary risk factor for platelet thrombogenicity leading to premature myocardial infarction in preexisting coronary artery disease. However, HPA-lb does not represent a risk factor for coronary artery disease itself. The aim of our present study was to evaluate the role of HPA-lb on the outcome in patients after coronary-artery bypass surgery. We prospectively determined the HPA-1 genotype in 261 consecutive patients prior to saphenous-vein coronary-artery bypass grafting. The patients were followed for one year. Among patients with bypass occlusion, myocardial infarction, or death more than 30 days after surgery, the prevalence of HPA-lb was significantly higher than among patients without postoperative complications (60 percent, 6/10, vs. 24 percent, 58/241, p <0.05, odds ratio 4.7). Using a stepwise logistic regression analysis with the variables HPA-1b, age, sex, body mass index, smoking (pack-years), hypertension, diabetes, cholesterol and triglyceride concentration, only HPA-lb had a significant association with bypass occlusion, myocardial infarction, or death after bypass surgery (p = 0.019, odds ratio 4.7). This study shows that HPA-1b is a hereditary risk factor for bypass occlusion, myocardial infarction, or death in patients after coronary-artery bypass surgery.

Aprotinin counterbalances an increased risk of peri-operative hemorrhage in CABG patients pre-treated with Aspirin.

OBJECTIVE: As Aspirin (ASA) has proven efficacy in preventing patients with CAD from complications related to cardiovascular diseases, most patients scheduled for CABG are treated with ASA therapy. Consequently, impaired hemostasis is a problem in the management of CABG patients. Clinical studies have shown that Aprotinin can reduce bleeding and the use of blood products by 50% in patients both with and without pre-operative ASA therapy. Concerning the combined effect of peri-operative low-dose ASA therapy and intra-operative high-dose Aprotinin therapy, the gathering of additional and prospective data seemed to be necessary. METHODS: We conducted a double-blind two-centre randomised three-arm study in patients with elective primary CABG surgery. Three groups have been tested, comprising 119 patients in total (group A: ASA + Aprotinin, group B: placebo + Aprotinin, group C: placebo + placebo) to investigate a possible reduction of bleeding in Aprotinin treated patients. For all patients, thromboxane levels were used to identify ASA or placebo treatment. RESULTS: The post-operative blood loss is significantly reduced by 21% after Trasylol administration (B vs. C; P = 0.009). The unexpected result of this study has been that the pre-treatment with ASA led to a further reduction of 18% (A vs. C; P < 0.0001). The difference between the two Aprotinin groups (A and B) is significant (P = 0. 01) in favour of ASA pre-treatment. Myocardial infarction (MI) had been diagnosed at levels of 1.8% in total (2/113), 2.6% (1/38) in group B and 3.2% (1/31 ) in group C. An additional blinded evaluation of ECG, enzyme levels and clinical status revealed 'definite, probable and possible' MIs of 5% in group A, compared to 16% in group B and 13% in group C, thus providing no evidence for a higher risk of infarction by Aprotinin treatment. When comparing the ASA group to non-ASA pre-treatment, a strong trend towards a reduction in MI rate becomes obvious, from 15% to 5% in favour of the ASA pre-treatment (P = 0.08). Concerning other peri-operative complications, no statistical difference between the groups could be detected. CONCLUSIONS: A reduction in post-operative blood loss in primary elective CABG surgery with intra-operative Aprotinin treatment could be confirmed. A low-dose ASA treatment combined with a high-dose aprotinin administration during surgery not only neutralized a potentially higher risk of bleeding, but did in fact reduce the post-operative blood loss. The protective effect of ASA on peri-operative MI has been evident through a reduction of MI rate in ASA treated patients.

[Not Available]. / HTA-Berichte auf dem Prüfstand Standardverfahren zur Erstellung und Beurteilung von HTA-Berichten : Standardverfahren zur Erstellung und Beurteilung von HTA-Berichten.

Quality-oriented medicine, which has the goal of healing or improving the patients quality of life as highest imperative, also has the obligation to fulfil the required standards itself. Standards, defined for the implementation of this goal, are supported thereby by standard operating procedures (SOPs), the structured and systematic descriptions of the necessary working processes. Both (Standards and SOPs) are part of the integrated quality management of the Total Quality Management (TQM).The quality demands of the German agency for Health Technology Assessment (DAHTA@DIMDI) apply to the processes of product creation as well as to the product itself. The quality management used by DAHTA@DIMDI orients itself on internationally recognized quality assurance standards (e.g. DIN EN ISO 9000:2000FF). The DAHTA@DIMDI pursues the goal, that the development processes and the contents of the evaluation of medical procedures (Health Technology Assessment - HTA) attains the highest acceptance possible in all target groups.

[Not Available]. / Die deutsche Agentur für Health Technology Assessment (HTA) beim DIMDI (DAHTA@DIMDI).

With the Health Reform Act 2000 the assessment of medical procedures (Health Technology Assessment, HTA) was first applied to quality assurance in German public health. Since taking this step Germany belongs to the group of countries (Great Britain, Sweden, Australia, etc.) that employ HTA as an objective instrument to determine scientific grounds for political health decisions, for instance for decisions concerning absorption of costs or the development of a benefit catalogue. The German Agency for Health Technology Assessment was founded in September 2000 at the German Institute for Medical Documentation and Information (DAHTA@DIMDI) to fulfil the legal requirements. DAHTA set up and operates a databank-supported information system to supply HTA- relevant information. Additionally research assignments are commissioned for this area and quality standards determined. The goal is to create an up to date and objective information base for health politics and also for medical qualified personnel and consumers that considers the social, ethical, economical and legal results besides the efficacy and effectiveness of medical procedures.

Centrifugal pumping during routine open heart surgery improves clinical outcome.

Carrying out a 1,000 patient prospective, randomized study comparing a roller pump and the BioMedicus centrifugal pump (CP), hematological parameters, blood loss, renal function, postoperative complications, and lethality data were evaluated. Using a validated preoperative risk stratification method (Cardiac RiskMaster), patients were divided into different risk categories for statistical analysis. This study verified an improved outcome with the use of a CP in routine cardiac surgery, demonstrated by blood handling, blood loss, renal function, and nephrological complication data. There was also a significant reduction in neurological complications. There was no significant difference in postoperative lethality, but high risk patients demonstrated outcomes comparable to those being defined for medium risk patients. Routine cardiac surgical patients as well as multimorbid patients benefit from the use of a CP. Preoperative risk stratification is a valid tool to demonstrate how the employment of new technologies can provide for an improved outcome without increasing overall costs at the same time.

Early and late results after thymectomy in myasthenia gravis: a retrospective study [correction of analysis].

BACKGROUND: This study aims to evaluate the early and late outcome of patients treated by surgery for myasthenia gravis and the diagnostic value of the Besinger Score, which is based on a correlation of severity of symptoms with specific antibodies to acetylcholine receptors, in the follow-up investigation after surgical therapy. METHODS: Between June 1984 and April 1992 thoracotomy was performed in 51 myasthenia gravis cases at our department. The retrospective analysis considered patients with (n = 13) or without thymoma (n = 38). The Besinger score was used to describe the severity of disease preoperatively and up to 5 years postoperatively. RESULTS: The Besinger score fell continually post surgery. Changes in relative serum concentrations of antibodies were similar to the Besinger score. Five years after thymectomy complete remission was diagnosed in 40% of the patients. The required dosage of pyridostigmine had fallen by two thirds after 5 years. Patients with follicular hyperplasia had significantly higher remission rates than those with thymoma. CONCLUSIONS: Surgery for myasthenia gravis is successful. The Besinger score well quantifies the severity of the disease.