Mostafa Ezzeldin A, El Midany Ashraf A, Taha Ahmed S, El-Aasy Saeed R, Doghish Ayman A, Helmy Ahmed, Mansour Sherif A, Khorshid Ramy, Ashor Hosam E, Elnahas Yaser, Saffan Mohammed
Department of Cardiovascular and Thoracic Surgery, Faculty of Medicine, Ain-Shams University Hospital, Cairo, Egypt.
Department of Cardiovascular and Thoracic Surgery, Faculty of Medicine, Ain-Shams University Hospital, Cairo, Egypt -
J Cardiovasc Surg (Torino). 2018 Apr;59(2):252-258. doi: 10.23736/S0021-9509.17.10044-3. Epub 2017 Jul 28.
Continuous effort is still provided in designing optimal artificial heart valves with better hemodynamic function and reduced thromboembolic potential. The question is do we have moved forward toward this goal or not.
A prospective, randomized comparative study was done on 360 patients scheduled for elective mitral valve replacement. Patients were grouped into an On-X group (N.=180), who received On-X mechanical valve, and a SJM group (N.=180), who received St Jude mechanical valve. Echocardiographic and clinical assessments were performed for all patients at 6 and 12 months follow-up period.
Rheumatic heart disease was the most common cause of valve affection (94.2%). Early mortality was 6.4%. The mean follow-up time was 3.11±2.44 years. No structural or non-structural valvular dysfunction and no thromboembolism cases were encountered. Late valve thrombosis was1.9%/patient-year in On-X group and 2.1%/patient-year in SJM group. The mean EOA was higher in On-X group (2.0±0.3 cm2) than in SJM group (1.9±0.2 cm2), (P≥0.05). The mean EOAI was higher in On-X group (1.1±0.1 cm2/m2) than in SJM group (1.0±0.1 cm2/m2), (P=0.034), especially significant in small valve size (25 mm) where it was 1.09±021 cm2/m2 in On-X group and 0.93±0.12 cm2/m2 in SJM group (P=0.02).
On-X and St Jude prosthetic valves have a comparable hemodynamic performance in mitral position. However, On-X prosthesis might have a forward step on the way of design technology that may allow better function in terms of EOA and EOAI especially in smaller valve size.
在设计具有更好血流动力学功能和降低血栓栓塞风险的最佳人工心脏瓣膜方面，仍在持续努力。问题是我们是否朝着这个目标前进了。
对360例计划进行择期二尖瓣置换术的患者进行了一项前瞻性、随机对照研究。患者被分为On-X组（n = 180），接受On-X机械瓣膜，和SJM组（n = 180），接受圣犹达机械瓣膜。在随访6个月和12个月时对所有患者进行超声心动图和临床评估。
风湿性心脏病是瓣膜病变最常见的原因（94.2%）。早期死亡率为6.4%。平均随访时间为3.11±2.44年。未发现结构性或非结构性瓣膜功能障碍及血栓栓塞病例。On-X组晚期瓣膜血栓形成率为1.9%/患者年，SJM组为2.1%/患者年。On-X组的平均有效瓣口面积（EOA）（2.0±0.3 cm²）高于SJM组（1.9±0.2 cm²），（P≥0.05）。On-X组的平均有效瓣口面积指数（EOAI）（1.1±0.1 cm²/m²）高于SJM组（1.0±0.1 cm²/m²），（P = 0.034），在小瓣膜尺寸（25 mm）时尤为显著，On-X组为1.09±0.21 cm²/m²，SJM组为0.93±0.12 cm²/m²（P = 0.02）。
On-X和圣犹达人工瓣膜在二尖瓣位置具有可比的血流动力学性能。然而，On-X人工瓣膜在设计技术方面可能向前迈进了一步，在EOA和EOAI方面可能具有更好的功能，尤其是在较小瓣膜尺寸时。
