Zingg U, Aeschbacher B, Seiler C, Althaus U, Carrel T
Clinic for Thoracic and Cardiovascular Surgery, University Hospital Berne, Switzerland.
J Heart Valve Dis. 1997 Sep;6(5):535-41.
Aortic valve replacement in the small aortic root results in a heart-prosthesis mismatch in a significant number of patients. The new Masters series of St. Jude Medical (SJM) valves represents the company's most recent innovation, combining the beneficial Hemodynamic Plus (HP) characteristics with rotatability. Thus, this valve allows for a larger valve orifice area with an equivalent tissue annulus diameter and reduces the potential interferences of subannular tissue with leaflet mobility.
We compared prospectively the hemodynamic characteristics and the early clinical results in four groups of 25 patients each who received either the 21 Masters-HP, the 21 Standard, the 21 HP or the 23 Standard SJM valves. Patients were selected from our database and matched rigorously for age, gender, body surface area, NYHA functional class, underlying lesion, native valve opening area and left ventricular function, as well as preoperative peak and mean valve gradients. Postoperative evaluation included clinical examination and echocardiographic studies before hospital discharge and at six months.
Short-term clinical follow up was marked by a complete absence of valve-related complications in all groups. Doppler-derived mean and maximal pressure gradients were significantly lower in the 21 HP (8.7 +/- 3.1 mmHg and 15.1 +/- 4.0 mmHg, respectively) and 21 Masters-HP groups (8.9 +/- 2.6 mm +/- Hg and 14.5 +/- 3.8 mmHg) than those in the 21 Standard group (15.1 +/- 3.2 mmHg and 22.5 +/- 6.1 mmHg; p = 0.002 and p = 0.004, respectively). These results confirm that the superior hemodynamic performance of the HP series is maintained in the Masters-HP valve, despite the introduction of a new cuff design allowing rotatability. Pressure gradients did not differ significantly between the 21 HP, the 21 Masters-HP and the 23 Standard groups.
The hemodynamic performance of the 21 Masters-HP SJM valve corresponds closely with that of the 21 HP and 23 Standard valves and is substantially better than that of the 21 Standard valve. The Masters-HP valve will continue to reduce cardiac-prosthesis mismatch in normal-sized patients with a narrowed aortic root; its performance index is equal to that of the 21 HP valve and significantly higher than that of the 21 Standard valves. The valve will also further reduce the need for aortic annulus enlargement.
在小主动脉根部进行主动脉瓣置换术会导致相当数量的患者出现心脏-人工瓣膜不匹配的情况。圣犹达医疗公司（SJM）的新型Masters系列瓣膜代表了该公司的最新创新成果，它将有益的血流动力学增强型（HP）特性与可旋转性相结合。因此，这种瓣膜在组织瓣环直径相同的情况下可提供更大的瓣口面积，并减少瓣环下组织对瓣叶活动的潜在干扰。
我们前瞻性地比较了四组患者（每组25例）的血流动力学特征和早期临床结果，这四组患者分别接受了21号Masters-HP瓣膜、21号标准瓣膜、21号HP瓣膜或23号标准SJM瓣膜。患者从我们的数据库中选取，并在年龄、性别、体表面积、纽约心脏协会（NYHA）心功能分级、基础病变、自身瓣膜开口面积和左心室功能以及术前峰值和平均瓣膜压差方面进行了严格匹配。术后评估包括出院前及术后6个月的临床检查和超声心动图研究。
所有组在短期临床随访中均未出现与瓣膜相关的并发症。21号HP组（平均压差8.7±3.1 mmHg，最大压差15.1±4.0 mmHg）和21号Masters-HP组（平均压差8.9±2.6 mmHg，最大压差14.5±3.8 mmHg）经多普勒测量得到的平均和最大压力阶差显著低于21号标准组（平均压差15.1±3.2 mmHg，最大压差22.5±6.1 mmHg；p分别为0.002和0.004）。这些结果证实，尽管引入了允许可旋转性的新型套囊设计，但HP系列优越的血流动力学性能在Masters-HP瓣膜中得以保持。21号HP组、21号Masters-HP组和23号标准组之间的压力阶差无显著差异。
21号Masters-HP SJM瓣膜的血流动力学性能与21号HP瓣膜和23号标准瓣膜密切相关，且明显优于21号标准瓣膜。Masters-HP瓣膜将继续减少主动脉根部狭窄的正常体型患者的心脏-人工瓣膜不匹配情况；其性能指标与21号HP瓣膜相当，且显著高于21号标准瓣膜。该瓣膜还将进一步减少主动脉瓣环扩大的需求。
