Masters R G, Helou J, Pipe A L, Keon W J
Division of Cardiothoracic Surgery, University of Ottawa Heart Institute, Ontario, Canada.
J Heart Valve Dis. 2001 May;10(3):403-9.
Whether the St. Jude Medical (SJM), Medtronic Hall (MH) or CarboMedics (CM) heart valves confer any relative benefits to patient outcome remains controversial. While numerous studies have analyzed clinical results with a single brand, and a few studies have compared two brands, there are no single-center trials comparing all three valves.
Our experience with patients who had either a SJM, MH or CM mechanical valve in isolated aortic valve (AVR) or mitral valve (MVR) replacement was reviewed. AVR was performed in 953 patients (SJM = 394, MH = 314, CM = 245) and MVR in 591 patients (SJM = 193, MH = 264, CM = 134). Survivors were assessed annually; follow up consisted of 3336 patient-years (pt-yr) after AVR and 1693 pt-yr after MVR.
Preoperatively, in the AVR group, more MH patients had previous valve surgery (p = 0.001) or were in NYHA class III/IV (p = 0.03), and more CM patients had a concomitant surgical procedure (p = 0.005). The hospital mortality after AVR with SJM, MH and CM valves was 3.8, 4.7 and 5.3%, respectively (p = 0.65). In the MVR group, there were more males in the CM group (p = 0.011), more CM patients had concomitant surgery (p = 0.001), and more MH patients had previous surgery (p = 0.006). The hospital mortality after MVR with SJM, MH and CM valves was 8.3, 10.2 and 6.0%, respectively (p = 0.35). There was no late survival advantage in either the AVR or MVR group according to the valve used (p = 0.24 and p = 0.90, respectively). For the AVR group the five-year actuarial freedom from thromboembolism was: SJM 85.8 +/- 2.5%, MH 80.1 +/- 2.7% and CM 85.9 +/- 3.5% (p = 0.04), and for MVR it was: SJM 84.2 +/- 4.0%, MH 77.5 +/- 3.4% and CM 86.9 +/- 5.2% (p = 0.27). Bleeding occurred with a similar frequency in the AVR (p = 0.36) and MVR (p = 0.70) groups. No cases of structural failure were identified in this study. At follow up, among AVR patients NYHA class III/IV was present in: SJM 5%, MH 6% and CM 3% (p = 0.50), while among MVR patients this was identified in: SJM 7%, MH 10% and CM 4% (p = 0.22).
It is concluded that the SJM, MH and CM mechanical valves offer similar clinical results when used for isolated AVR or MVR. While there is a suggestion of an advantage with bileaflet valves, any differences detected may simply reflect differences in the preoperative patient variables.
圣犹达医疗（SJM）、美敦力霍尔（MH）或卡波医药（CM）心脏瓣膜是否对患者预后具有任何相对优势仍存在争议。虽然众多研究分析了单一品牌的临床结果，少数研究比较了两个品牌，但尚无比较所有三种瓣膜的单中心试验。
回顾了我们对接受孤立主动脉瓣置换术（AVR）或二尖瓣置换术（MVR）且植入SJM、MH或CM机械瓣膜患者的经验。953例患者接受了AVR（SJM = 394例，MH = 314例，CM = 245例），591例患者接受了MVR（SJM = 193例，MH = 264例，CM = 134例）。每年对存活患者进行评估；随访包括AVR术后3336患者年（pt-yr）和MVR术后1693 pt-yr。
术前，在AVR组中，更多MH患者曾接受过瓣膜手术（p = 0.001）或处于纽约心脏协会（NYHA）III/IV级（p = 0.03），更多CM患者接受了同期手术（p = 0.005）。使用SJM、MH和CM瓣膜进行AVR后的医院死亡率分别为3.8%、4.7%和5.3%（p = 0.65）。在MVR组中，CM组男性更多（p = 0.011），更多CM患者接受了同期手术（p = 0.001），更多MH患者曾接受过手术（p = 0.006）。使用SJM、MH和CM瓣膜进行MVR后的医院死亡率分别为8.3%、10.2%和6.0%（p = 0.35）。根据所使用的瓣膜，AVR组和MVR组均无晚期生存优势（分别为p = 0.24和p = 0.90）。对于AVR组，五年血栓栓塞无事件生存率为：SJM 85.8 +/- 2.5%，MH 80.1 +/- 2.7%，CM 85.9 +/- 3.5%（p = 0.04），对于MVR组为：SJM 84.2 +/- 4.0%，MH 77.5 +/- 3.4%，CM 86.9 +/- 5.2%（p = 0.27）。AVR组（p = 0.36）和MVR组（p = 0.70）出血发生率相似。本研究未发现结构故障病例。随访时，AVR患者中NYHA III/IV级的比例为：SJM 5%，MH 6%，CM 3%（p = 0.50），而MVR患者中该比例为：SJM 7%，MH 10%，CM 4%（p = 0.22）。
得出结论，SJM、MH和CM机械瓣膜用于孤立AVR或MVR时临床结果相似。虽然双叶瓣膜有优势的迹象，但检测到的任何差异可能仅反映术前患者变量的差异。
