Background-The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb) has shown promising clinical results; however, only limited preclinical data have been published. We sought to investigate detailed pathological responses to the Absorb versus XIENCE V (XV) in a porcine coronary model with duration of implant extending from 1 to 42 months. Methods and Results-A total of 335 devices (263 Absorb and 72 XV) were implanted in 2 or 3 main coronary arteries of 136 nonatherosclerotic swine and examined by light microscopy, scanning electron microscopy, pharmacokinetics, and gel permeation chromatography analyses at various time points. Vascular responses to Absorb and XV were largely comparable at all time points, with struts being sequestered within the neointima. Inflammation was mild to moderate (with absence of inflammation at 1 month) for both devices, although the scores were greater in Absorb at 6 to 36 months. Percent area stenosis was significantly greater in Absorb than XV at all time points except at 3 months. The extent of fibrin deposition was similar between Absorb and XV, which peaked at 1 month and decreased rapidly thereafter. Histomorphometry showed expansile remodeling of Absorb-implanted arteries starting after 12 months, and lumen area was significantly greater in Absorb than XV at 36 and 42 months. These changes correlated with dismantling of Absorb seen after 12 months. Gel permeation chromatography analysis confirmed that degradation of Absorb was complete by 36 months. Conclusions-Absorb demonstrates comparable long-term safety to XV in porcine coronary arteries with mild to moderate inflammation. Although Absorb was associated with greater percent stenosis relative to XV, expansile remodeling was observed after 12 months in Absorb with significantly greater lumen area at ≥36 months. Resorption is considered complete at 36 months. (Circ Cardiovasc Interv. 2014;7:330-342.)
Starting at 12 months, BVS-implanted porcine coronary arteries underwent progressive lumen gain and showed restored pulsatility. These benefits demonstrated preclinically may translate into improvements in long-term clinical outcomes for patients treated with BVS compared with conventional drug-eluting stents.
All cardiac surgical procedures performed in 78 German cardiac surgical units throughout the year 2011 are presented in this report, based on a voluntary registry which is organized by the German Society for Thoracic and Cardiovascular Surgery. In 2011, a total of 100,291 cardiac surgical procedures (implantable cardioverter defibrillator and pacemakers procedures excluded) have been collected in this registry. More than 13.4% of the patients were older than 80 years compared with 12.4% in 2010. Hospital mortality in 41,976 isolated coronary artery bypass graft procedures (14.7% off-pump) was 2.9%. In 26,972 isolated valve procedures (including 5,210 catheter-based procedures), an in-hospital mortality of 5.2% has been observed. This voluntary registry of the German Society for Thoracic and Cardiovascular Surgery will continue to be an important tool enabling quality control and illustrating current facts and the development of cardiac surgery in Germany.
Based on a long-standing voluntary registry founded by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), well-defined data of all cardiac, thoracic, and vascular surgery procedures performed in 78 German heart surgery departments during the year 2016 are analyzed. In 2016, a total of 103,128 heart surgery procedures (implantable defibrillator, pacemaker, and extracardiac procedures excluded) were submitted to the registry. Approximately 15.7% of the patients were at least 80 years of age, resulting in an increase of 0.9% compared with the data of 2015. For 37,614 isolated coronary artery bypass grafting procedures (relationship on-/off-pump 4.4:1), an unadjusted in-hospital mortality of 2.9% was observed. Concerning the 33,451 isolated heart valve procedures (including 11,701 catheter-based procedures), the unadjusted in-hospital mortality was 4.3%. This annual updated registry of the GSTCVS represents voluntary public reporting by accumulating actual information for nearly all heart surgical procedures in Germany, describes advancements in heart medicine, and is a basis for internal and external quality assurances for all participants. In addition, the registry demonstrates that the provision of cardiac surgery in Germany is appropriate and patients are treated nationwide at all times.
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