Medical Care Center Prof Mathey, Prof Schofer, Hamburg University Cardiovascular Center, Hamburg University Heart Center, and Radiologische Allianz, Hamburg, Germany.
Circ Cardiovasc Interv. 2011 Dec 1;4(6):595-601. doi: 10.1161/CIRCINTERVENTIONS.111.964072. Epub 2011 Nov 29.
Misplacement during percutaneous aortic valve implantation can be associated with severe complications. The direct flow medical (DFM) valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the valve results in less radial force, which may have an impact on stability and valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM percutaneous aortic valve.
Sixteen symptomatic high-risk for surgery patients with aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM valve over time. Echocardiography revealed a significant decrease of the mean gradient from baseline (50.1±11.3 mm Hg) to 30 days (19.6±5.7 mm Hg, P<0.001), which remained stable over 2 years. The aortic valve area increased from 0.57±0.15 cm(2) at baseline to 1.47±0.35 cm(2) at 30 days (P<0.001) and did not significantly change during 2-year follow-up. Of the patients, 73% had no aortic regurgitation (AR) and 27% had minimal AR.
In this preliminary series, the 2-year follow-up data of patients, in whom the nonmetallic, repositionable, and retrievable DFM valve was successfully implanted, show stability of the position, shape, and hemodynamic performance, with no AR in most patients.
经皮主动脉瓣植入过程中的错位可能会导致严重并发症。直接血流医疗（DFM）瓣膜可重新定位和取回；然而，瓣膜的非金属充气和顺应性设计导致径向力较小，这可能会对瓣膜的稳定性和功能产生影响。因此，我们分析了 DFM 经皮主动脉瓣的中期位置、形状和血流动力学性能的稳定性。
16 名患有主动脉瓣狭窄且手术风险高的有症状高危患者和逻辑 EuroSCORE>20 接受了植入手术，并进行了此分析。在 2 年的随访中获得了临床、超声心动图和双源多层 CT 数据。1 年和 2 年的生存率分别为 81%和 69%。双源多层 CT 随访表明，DFM 瓣膜的位置、直径和瓣口面积随时间没有变化。超声心动图显示，平均梯度从基线（50.1±11.3 mm Hg）显著下降至 30 天（19.6±5.7 mm Hg，P<0.001），2 年内保持稳定。主动脉瓣面积从基线时的 0.57±0.15 cm2 增加到 30 天时的 1.47±0.35 cm2（P<0.001），在 2 年的随访中没有明显变化。在这些患者中，73%的患者没有主动脉瓣反流（AR），27%的患者仅有轻微的 AR。
在本初步系列中，成功植入非金属、可重新定位和可取回的 DFM 瓣膜的患者 2 年随访数据显示，位置、形状和血流动力学性能稳定，大多数患者没有 AR。
