[Risk factor management of coronary heart disease : what is evidence-based?]. / Risikofaktorenmanagement bei koronarer Herzerkrankung : Was ist evidenzbasiert?

In patients with coronary heart disease the further course of the disease can be substantially influenced by means of a targeted treatment of risk factors. A reduction of hospital referrals, an improvement in quality of life and an extension in life expectation by secondary prophylactic measures have been well documented. In addition to an optimized medicinal therapy, an often drastic change in lifestyle with a focus on a consistent abstinence from nicotine, a healthy diet and regular physical exercise is necessary. Data from healthcare research show that these targets are only insufficiently achieved. The implementation of current guidelines should therefore be rigorously applied. There is a need for research particularly with respect to the prognostic significance of beta blocker therapy for patients with stable coronary heart disease and preserved left ventricular function, the prognostic significance of targeted weight loss for overweight or obese coronary heart disease patients, the effectiveness of psychosocial interventions in the various patient groups and their implementation into routine care. Research is also necessary with respect to optimization of structured rehabilitation programs and improvement in patient compliance.

The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis.

Background The increasing prevalence of severe aortic valve defects correlates with the increase of life expectancy. For decades, surgical aortic valve replacement (AVR), under the use of extracorporeal circulation, has been the gold standard for treatment of severe aortic valve diseases. In Germany ~12,000 patients receive isolated aortic valve surgery per year. For some time, percutaneous balloon valvuloplasty has been used as a palliative therapeutic option for very few patients. Currently, alternatives for the established surgical procedures such as transcatheter aortic valve implantation (TAVI) have become available, but there are only limited data from randomized studies or low-volume registries concerning long-time outcome. In Germany, the implementation of this new technology into hospital care increased rapidly in the past few years. Therefore, the German Aortic Valve Registry (GARY) was founded in July 2010 including all available therapeutic options and providing data from a large quantity of patients.Methods The GARY is assembled as a complete survey for all invasive therapies in patients with relevant aortic valve diseases. It evaluates the new therapeutic options and compares them to surgical AVR. The model for data acquisition is based on three data sources: source I, the mandatory German database for external performance measurement; source II, a specific registry dataset; and source III, a follow-up data sheet (generated by phone interview). Various procedures will be compared concerning observed complications, mortality, and quality of life up to 5 years after the initial procedure. Furthermore, the registry will enable a compilation of evidence-based indication criteria and, in addition, also a comparison of all approved operative procedures, such as Ross or David procedures, and the use of different mechanical or biological aortic valve prostheses.Results Since the launch of data acquisition in July 2010, almost all institutions performing aortic valve procedures in Germany joined the registry. By now, 91 sites which perform TAVI in Germany participate and more than 15,000 datasets are already in the registry.Conclusion The implementation of new or innovative medical therapies needs supervision under the conditions of a well-structured scientific project. Up to now relevant data for implementation of TAVI and long-term results are missing. In contrast to randomized controlled trials, GARY is a prospective, controlled, 5-year observational multicenter registry, and a real world investigation with only one exclusion criterion, the absence of patients' written consent.

First clinical experiences with an endovascular clamping system for neuroprotection during carotid stenting.

OBJECTIVES: This report evaluates the feasibility and efficacy of an endovascular blood flow blockage technique to prevent intracerebral embolization of plaque debris during carotid artery stenting. METHODS: Forty-two patients were enrolled in five clinical sites in Germany and Italy with either an asymptomatic internal carotid artery stenosis > or =75% (mean 87%) or a symptomatic stenosis > or =60% (mean 85%). Cerebral protection during the stenting procedure was achieved using an endovascular clamping technique, obtained by occlusion of the external and common carotid artery via two independently inflatable balloons integrated in the Mo.Ma system. Blood with particulate plaque debris was aspirated before flow was restored. The patient's clinical and the neurological status were assessed during intervention, at discharge, and at 3 months follow-up. RESULTS: Stenting was performed in all but one patient. The mean flow occlusion time was 10.6+/-6.5 min. Transient clamping intolerance was observed in five patients (12%). In two patients, neurological deficits persisted for 2 and 12 h, respectively. Two minor strokes (4,7%) occurred at 5 and 72 h after the procedure. No major strokes or deaths were observed at 3 months follow-up. CONCLUSIONS: This first clinical experience with the Mo.Ma device substantiates the feasibility of endovascular clamping in preventing cerebral embolization during carotid artery stenting.

Initial results of laser-based percutaneous myocardial revascularization for angina pectoris.

Results of a 30-patient pilot study of a recently developed percutaneous myocardial revascularization approach are described. The feasibility and positive safety profile of percutaneous myocardial revascularization are clearly demonstrated, with no mortality associated with the treatment or in the immediate post-treatment period and an incidence of only 1 major complication.

Improved clinical effectiveness with a collagen vascular hemostasis device for shortened immobilization time following diagnostic angiography and percutaneous transluminal coronary angioplasty.

This study prospectively compared immobilization time followed by use of a vascular hemostasis device (VasoSeal) versus manual compression to achieve hemostasis at the arterial puncture after angiography and percutaneous transluminal coronary angioplasty (PTCA). The trial shows that use of a vascular hemostasis device results in earlier mobilization, even in highly anticoagulated PTCA patients compared with manual compression, with no statistically significant complications.

Effect of an acute beta-adrenergic blockade on the relationship between ventilatory and plasma lactate threshold.

The present study assesses interobserver variability and day-to-day reproducibility of ventilatory threshold T(ven) and lactate threshold T(lac) in healthy young men. The data were obtained before and after acute beta-adrenergic blockade with metoprolol (100 mg/d p.o.). Fifteen healthy young men underwent progressively increased treadmill ergometry tests on two separate days (day 1, 2). Ten out of fifteen subjects participated in a third exercise test under an acute beta-adrenergic blockade (day 3). Interobserver variability of oxygen uptake at T(ven) (8%; +/- 0.136 l/min) and T(lac) (5%; +/- 0.984 l/min) was small and day-to-day reproducibility of T(ven) (7%; +/- 0.131 l/min) and T(lac) (7%; +/- 0.133 l/min) high. Under acute beta-adrenergic blockade T(ven) occurred at a significantly lower work load (360 +/- 117 s) as compared with T(ven) of days 1 and 2 (477 +/- 153 s; p < 0.05), and T(lac) of day 3 after beta-adrenergic blockade (456 +/- 76 s; p < 0.05). Therefore, a significantly lower oxygen uptake (1.409 +/- 0.29 l/min) could be observed at T(ven) of day 3 as compared with T(ven) of days 1 and 2 (1.852 +/- 0.30; p < 0.001), and T(lac) of days 1 and 2 (1.724 +/- 0.22; p < 0.001). There was a significant linear correlation between oxygen uptake at T(ven) and T(lac) before beta-adrenergic blockade (r = 0.86; p < 0.001). This correlation, however, was lost following an acute beta-adrenergic blockade (r = 0.56; n.s.).(ABSTRACT TRUNCATED AT 250 WORDS)

Greater diagnostic sensitivity of treadmill versus cycle exercise testing of asymptomatic men with coronary artery disease.

Maximal hemodynamic and ventilatory responses using cycle and treadmill ergometer were compared in 52 asymptomatic patients with angiographically proved coronary artery disease. Moreover, test sensitivity with respect to ST-segment depression and typical angina pectoris were compared between exercise modes used. Exercise tests were performed on different days in randomized order. In 42 patients, exercise-induced myocardial ischemia, expressed as a fraction of left ventricular circumference, was assessed by thallium-201 scintigraphy. The main finding of this study was a significantly higher maximal oxygen uptake (1.87 +/- 0.4 vs 2.2 +/- 0.5 liters/min; p less than 0.001), heart rate (148 +/- 19 vs 158 +/- 18 beats/min; p less than 0.001) and rate-pressure product (28.3 +/- 5 x 10(3) vs 30.7 +/- 5 x 10(3); p less than 0.001) during treadmill walking than during cycling. Therefore, stress-induced myocardial ischemia was significantly more extensive after treadmill walking (31 +/- 37 degrees vs 45 +/- 40 degrees; p less than 0.001). Moreover, there were significantly more patients with signs of myocardial ischemia (ST-segment depression or typical angina pectoris, or both) during treadmill than during cycle ergometry (35 vs 25 patients; p less than 0.05). However, lactate levels measured at peak exercise (4.07 +/- 2.0 vs 4.38 +/- 1.9 mmol/liter) and 3 minutes into the recovery period (5.60 +/- 2.2 vs 5.80 +/- 2.2 mmol/liter) were comparable between both methods, indicating no significant difference in anaerobic energy production. These findings suggest that walking on a treadmill represents an exercise method with a greater ability than cycling to detect coronary artery disease.