Doty J R, Flores J H, Millar R C, Doty D B
The Department of Surgery, LDS Hospital, Salt Lake City, Utah 84103, USA.
J Card Surg. 1998 May;13(3):208-17. doi: 10.1111/j.1540-8191.1998.tb01264.x.
This study evaluates the initial results for safety and efficacy of aortic valve replacement (AVR) using the Medtronic Freestyle Bioprosthesis.
One hundred three patients underwent AVR with the Medtronic Freestyle Bioprosthesis over a 40-month period. There were 59 male and 44 female patients with a mean age of 74 years (range 36 to 88 years). Valve size ranged from 19 to 27 mm, and all valves were implanted using a freehand subcoronary technique. Anticoagulation with coumadin was only used for atrial fibrillation. Aspirin was given to patients with associated coronary artery disease. Echocardiography to assess transvalvular pressure gradient and effective valve orifice area was performed at discharge, 3 to 6 months, 1 year, and then annually.
There were 4 (3.9%) deaths within 30 days of operation and 5 (4.9%) late deaths. Two (1.9%) deaths were valve-related, one from commissural dehiscence and one from bacterial endocarditis. Three (2.9%) deaths, two early and one late, were from other cardiac causes. The remaining deaths were from noncardiac causes. Five (4.9%) patients suffered a thromboembolic event, two had permanent neurological deficits, two had transient neurological events, and one had coronary artery occlusion. Mean transvalvular gradient assessed by echocardiography was low at all time intervals: discharge (12.8 mmHg), 3 to 6 months (11.3 mmHg), 1 year (12.0 mmHg), and 2 years (11.6 mmHg). Mean effective valve orifice area was good at all time intervals: discharge (1.4 cm2), 3 to 6 months (1.5 cm2), 1 year (1.6 cm2), and 2 years (1.6 cm2). Of the 38 patients assessed by echocardiography at 1 year, 33 (87%) had no or trivial valve incompetence and the remainder had mild valve incompetence.
Aortic valve replacement with the Medtronic Freestyle Bioprosthesis has a low incidence of early valve-related mortality and thromboembolism. The bioprosthesis demonstrates good hemodynamic performance even in small diameters and is particularly well suited for older patients and the small aortic root.
本研究评估使用美敦力Freestyle生物瓣膜进行主动脉瓣置换术（AVR）的安全性和有效性的初步结果。
在40个月的时间里，103例患者接受了美敦力Freestyle生物瓣膜的AVR手术。有59例男性和44例女性患者，平均年龄74岁（范围36至88岁）。瓣膜尺寸范围为19至27毫米，所有瓣膜均采用徒手冠状动脉下技术植入。仅对房颤患者使用香豆素进行抗凝。对伴有冠状动脉疾病的患者给予阿司匹林。在出院时、3至6个月、1年，然后每年进行超声心动图检查，以评估跨瓣膜压力梯度和有效瓣膜口面积。
术后30天内有4例（3.9%）死亡，晚期死亡5例（4.9%）。2例（1.9%）死亡与瓣膜相关，1例因瓣叶开裂，1例因细菌性心内膜炎。3例（2.9%）死亡，2例早期死亡和1例晚期死亡，原因是其他心脏问题。其余死亡原因是非心脏性的。5例（4.9%）患者发生血栓栓塞事件，2例有永久性神经功能缺损，2例有短暂性神经事件，1例有冠状动脉闭塞。超声心动图评估的平均跨瓣膜梯度在所有时间间隔均较低：出院时（12.8 mmHg）、3至6个月（11.3 mmHg）、1年（12.0 mmHg）和2年（11.6 mmHg）。平均有效瓣膜口面积在所有时间间隔均良好：出院时（1.4 cm²）、3至6个月（1.5 cm²）、1年（1.6 cm²）和2年（1.6 cm²）。在1年时接受超声心动图评估的38例患者中，33例（87%）无或仅有轻微瓣膜关闭不全，其余患者有轻度瓣膜关闭不全。
使用美敦力Freestyle生物瓣膜进行主动脉瓣置换术，早期瓣膜相关死亡率和血栓栓塞发生率较低。即使在小直径情况下，该生物瓣膜也具有良好的血液动力学性能，特别适合老年患者和小主动脉根部患者。
