Using Vascular Closure Devices Following Out-Of-Hospital Cardiac Arrest?

Objectives and Background: Despite a generally broad use of vascular closure devices (VCDs), it remains unclear whether they can also be used in victims from out-of-hospital cardiac arrest (OHCA) treated with mild therapeutic hypothermia (MTH).Methods: All victims from OHCA who received immediate coronary angiography after OHCA between January 1^st 2008 and December 31^st 2013 were included in this study. The operator decided to either use a VCD (Angio-Seal™) or manual compression for femoral artery puncture. The decision to induce MTH was based on the clinical circumstances.Results: 76 patients were included in this study, 46 (60.5%) men and 30 (39.5%) women with a mean age of 64.2 ± 12.8 years. VCDs were used in 26 patients (34.2%), and 48 patients (63.2%) were treated with MTH. While there were significantly more overall vascular complications in the group of patients treated with MTH (12.5% versus 0.0%; p=0.05), vascular complications were similar between patients with VCD or manual compression, regardless of whether or not they were treated with MTH.Conclusion: In our study, the overall rate of vascular complications related to coronary angiography was higher in patients treated with mild therapeutic hypothermia, but was not affected by the application of a vascular closure device. Therefore, our data suggest that the use of VCDs in victims from OHCA might be feasible and safe in patients treated with MTH as well, at least if the decision to use them is individually carefully determined.     

美国医疗器械上市前监管概述与启示

美国食品和药物管理局(Food and Drug Administration,FDA)经过多年发展和改革,已形成了成熟的上市前监管体系。本文通过对FDA上市批准路径(上市前批准、上市前通告、人道主义用器械豁免)和申报流程进行系统介绍,总结了加强事前沟通、降低产品风险等级和设立实质审查程序三个方面的启示,希望我国监管机构能充分吸收美国FDA对于医疗器械监管的经验和教训,建立适合中国国情的医疗器械监管体系,确保公众用器械安全。     

Ausbildung eines koronaren Pseudoaneurysmas nach komplexer Koronarintervention mit Drug-eluting-Stentimplantation

We report on a 68-year-old woman with typical symptoms of angina pectoris and unspecific findings in the 12-lead surface electrocardiogram. Invasive diagnostics with coronary angiography revealed a severely calcified ostial filiform stenosis of the right coronary artery (RCA). Therefore, a complex coronary intervention was performed and a drug-eluting stent was implanted (Taxus? stent, Boston Scientific). After 6 weeks a control coronary angiography with intracoronary optical coherence tomography was performed and a new pseudoaneurysm before the RCA stent (proximal RCA) was visible. In a conference with cardiologists and cardiac surgeons (heart team) indications for cardiac surgery were confirmed. The pseudoaneurysm was removed by clipping and an aortocoronary RCA bypass was performed. The postoperative follow-up was without any complications.     

Dreißig Jahre Defibrillatortherapie in Deutschland (1984–2014)

An automatic cardioverter defibrillator (ICD) was implanted for the first time in a human in Baltimore USA in 1980. The first ICD implants were performed in Germany in January 1984 in Düsseldorf and Hannover. Sudden cardiac death (SCD) is one of the major problems in the western world with approximately 70,000–100,000 SCD patients in Germany and 450,000 in the USA. Currently, 34 years after the first implant in USA and 30 years after the first implants in Germany, the ICD is the method of choice for primary or secondary prevention of SCD and is superior to all other therapeutic approaches. Cardiac resynchronization therapy (CRT) is an important additional therapeutic tool and leads to improvements in congestive heart failure and overall survival.     

骨质疏松症中医体质与辨证分型的相关性研究——附300例临床分析

目的 探讨骨质疏松症中医体质与辨证分型之间的相关性。方法 按照中西医诊断标准,将确诊的骨质疏松症患者进行中医体质分类与中医辨证分型的临床研究,找出其相关性与规律性,并进行总结。 结果 对300例患者进行中医辨证分型发现脾胃气虚证最多,占总病例数的23.00%,其次为肝肾不足证,占22.00%,以后依次为肾阳虚证、肾阴虚证、气血不足证、血瘀证、骨痿证、肝气郁结证、痰湿证、湿热证;在9种体质分类中阴虚质发病率排在第一位,其次为气虚质,以后依次为阳虚质、血瘀质、特禀质、平和质、痰湿质、湿热质与气郁质。结论 提示9种中医体质中阴虚质与气虚质发病率较高, 辨证分型中发病率较高的2个证型是脾胃气虚型与肝肾阴虚型。说明了体质类型与OP发病率有密切的相关性。     

Abnorme Verkürzung der linksventrikul?ren Diastolendauer unter k?rperlicher Belastung bei Patienten mit dilatativer Kardiomyopathie

BACKGROUND AND PURPOSE: Cardiac performance can be characterized in terms of the relative duration of systole and diastole. In pediatric patients with dilated cardiomyopathy (DCM), a disproportionate shortening of left ventricular diastole was observed. The present study was intended to reproduce these findings in an adult patient group and to evaluate exercise-related changes of both time intervals. PATIENTS AND METHODS: Exercise radionuclide angiography was used in 61 patients with DCM NYHA (New York Heart Association) stage II-III. The phases of the cardiac cycle were derived from a radionuclide time-activity curve with high temporal resolution. The control group consisted of 26 patients referred for ventricular function assessment with radionuclide angiography before cardiotoxic cancer treatment. RESULTS: When the duration of systole was expressed as the product of systolic time and heart rate, DCM patients exhibited a significant increase in left ventricular systolic time at rest (23.9 vs. 21.5 s/min; p = 0.006) and during peak exercise (29.2 vs. 26.7 s/min; p = 0.01). The prolongation of left ventricular systole at peak exercise was evident, although the peak heart rate was significantly lower in the patient group than in the control group (118 vs. 127/min; p = 0.04). In DCM patients the diastolic time loss per beat was further quantified using a regression equation obtained from the healthy control group. A significant shortening of left ventricular diastolic time was confirmed during peak exercise. Furthermore, a progressive loss in diastolic time per beat from rest to peak exercise was noted. CONCLUSION: Cardiac cycle abnormalities of patients with DCM are characterized by a prolongation of left ventricular systole and an abnormal shortening of left ventricular diastole. The systolic-diastolic mismatch is accentuated during exercise and has the potential to impair the cardiac reserve in these patients by restricting ventricular filling and perfusion.     

Nonhuman primates express human leukemia-associated antigens

Serologic studies using four murine monoclonal antibodies specific for the common acute lymphoblastic leukemia antigen (CALLA) and five monoclonal antibodies specific for the gp24 surface antigen indicate that these leukemia-associated antigens are present on cells of comparable tissues in man and in four nonhuman primates. As in man, adherent cell populations obtained from skin, lung, and bone marrow of Macaca fascicularis, M mulatta, M nemestrina, and Papio cynocephalus react with these antibodies. Similarly, granulocytes from both man and these nonhuman primates bind CALLA- and gp24-specific antibodies. Radioimmune precipitation experiments confirm the identity of these antigens. Our studies suggest that nonhuman primates can be used to screen serologic reagents to leukemia-associated antigens for potential toxic effects on normal tissues prior to their use in man. Similarly, nonhuman primates could be employed to assess the possible role of antigen-positive stromal cells in the reconstitution of bone marrow following transplantation.