Medical Care Center Prof Mathey, Prof Schofer and Hamburg University Cardiovascular Center, University Heart Center Hamburg, Hamburg, Germany.
Circ Cardiovasc Interv. 2008 Oct;1(2):126-33. doi: 10.1161/CIRCINTERVENTIONS.108.800607. Epub 2008 Sep 3.
To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic valve prosthesis (Direct Flow Medical Inc, Santa Rosa, Calif), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery.
Fifteen patients (intention-to-treat cohort) with an aortic valve area < or = 0.8 cm(2), a > or = 35-mm Hg mean transvalvular pressure gradient, and a logistic EuroSCORE > or = 20% were enrolled. Percutaneous aortic valve replacement was performed with the patient under general anesthesia. Hemodynamic parameters were assessed before and after implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient; 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely in a significant increase in aortic valve area (median, 1.64 [interquartile range, 1.27 to 1.74] versus 0.60 [0.46 to 0.69] cm(2); P = 0.0033) and a concomitant reduction in the mean pressure gradient (14.0 [13.2 to 16.5] versus 54.0 [43.2 to 59.8] mm Hg; P = 0.0033). At 30 days, 1 cardiac death (6.7%; 95% CI, 0.2% to 32.0%) and 1 major stroke were observed. The 10 surviving patients with a permanent implant showed marked hemodynamic and clinical improvement at this time point.
In this small series of patients, percutaneous implantation of the Direct Flow Medical aortic valve prosthesis in high-surgical-risk patients was feasible and associated with a reasonably low safety profile.
为评估新型非金属主动脉瓣假体（Direct Flow Medical Inc，加利福尼亚州圣罗莎）逆行经动脉植入的可行性和安全性，对高风险开胸手术的严重主动脉瓣狭窄患者进行了一项前瞻性单中心研究。
共纳入 15 例主动脉瓣瓣口面积<或=0.8cm2、平均跨瓣压差>或=35mmHg 且 logistic EuroSCORE>或=20%的患者（意向治疗队列）。在全身麻醉下进行经皮主动脉瓣置换术。通过经食管超声心动图评估植入前后的血液动力学参数。在 30 天时进行临床随访和经胸超声心动图评估。12 例患者（80%）获得了手术成功。1 例患者在第 2 天需要转为外科手术；11 例患者（73%）出院时植入了永久性假体。在这些患者中，植入后主动脉瓣瓣口面积显著增加（中位数，1.64[四分位距，1.27 至 1.74]比 0.60[0.46 至 0.69]cm2；P=0.0033），平均压差也相应降低（14.0[13.2 至 16.5]比 54.0[43.2 至 59.8]mmHg；P=0.0033）。在 30 天时，观察到 1 例心脏性死亡（6.7%；95%CI，0.2%至 32.0%）和 1 例主要脑卒中。此时，10 例存活并植入永久性假体的患者显示出明显的血液动力学和临床改善。
在本小系列高危手术患者中，经皮植入 Direct Flow Medical 主动脉瓣假体是可行的，且安全性相对较低。
