Lee Heemoon, Sung Kiick, Kim Wook Sung, Jeong Dong Seop, Ahn Joong Hyun, Carriere Keumhee Chough, Park Pyo Won
Department of Thoracic and Cardiovascular Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Biostatistics and Clinical Epidemiology Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
J Thorac Dis. 2018 Jun;10(6):3361-3371. doi: 10.21037/jtd.2018.06.03.
The study aimed to evaluate the late clinical outcomes of new-generation mechanical valves for severe aortic stenosis (AS) compared with old mechanical valves.
We retrospectively reviewed data from 254 patients with severe AS, who underwent primary mechanical aortic valve replacement from 1995 to 2013. Patients were classified into two groups: old-valve group (n=65: 33 ATS standard, 32 Medtronic-Hall) and new-valve group (n=189: 113 St. Jude Regent, 46 On-X, 30 Sorin Overline). Median patient age was 58 years (Q1-Q3: 52-61). With propensity score matching based on demographic information, 56 patients in the old-valve group were matched with 177 patients in the new-valve group. The median follow-up duration was 91 months (Q1-Q3: 48-138).
Cardiac-related mortality and hemorrhagic events were significantly lower in the new-valve group (P=0.047 and P=0.032, respectively). The median international normalized ratio (INR) at follow-up was significantly higher in the old-valve group [2.23, Q1-Q3: 2.14-2.35 (old-valve group); 2.08, Q1-Q3: 1.92-2.23 (new-valve group), P<0.001]. The incidence of prosthesis-patient mismatch (PPM) was significantly higher in the old-valve group (P<0.001). Multivariate analysis of the total population revealed that PPM was a significant risk factor for cardiac-related events [hazard ratio (HR) =5.279, 95% CI, 1.886-14.561, P=0.002] and showed higher trend of increasing mortality (HR =3.082, P=0.076).
New mechanical prostheses showed a better hemodynamic performance and lower incidence of PPM. Anticoagulation strategy to lower the target INR in patients with new mechanical valves may improve late outcomes by reducing hemorrhagic events.
本研究旨在评估新一代机械瓣膜用于严重主动脉瓣狭窄（AS）的晚期临床结局，并与旧款机械瓣膜进行比较。
我们回顾性分析了1995年至2013年间254例接受初次机械主动脉瓣置换术的严重AS患者的数据。患者分为两组：旧瓣膜组（n = 65：33例ATS标准瓣膜，32例美敦力-霍尔瓣膜）和新瓣膜组（n = 189：113例圣犹达Regent瓣膜，46例On-X瓣膜，30例索林Overline瓣膜）。患者年龄中位数为58岁（第一四分位数-第三四分位数：52-61岁）。根据人口统计学信息进行倾向评分匹配后，旧瓣膜组的56例患者与新瓣膜组的177例患者进行了匹配。中位随访时间为91个月（第一四分位数-第三四分位数：48-138个月）。
新瓣膜组的心脏相关死亡率和出血事件显著更低（分别为P = 0.047和P = 0.032）。随访时旧瓣膜组的国际标准化比值（INR）中位数显著更高[2.23，第一四分位数-第三四分位数：2.14-2.35（旧瓣膜组）；2.08，第一四分位数-第三四分位数：1.92-2.23（新瓣膜组），P<0.001]。旧瓣膜组人工瓣膜-患者不匹配（PPM）的发生率显著更高（P<0.001）。对总体人群的多因素分析显示，PPM是心脏相关事件的显著危险因素[风险比（HR）=5.279，95%置信区间，1.886-14.561，P = 0.002]，且显示出死亡率增加的更高趋势（HR = 3.082，P = 0.076）。
新型机械瓣膜显示出更好的血流动力学性能和更低的PPM发生率。降低新型机械瓣膜患者目标INR的抗凝策略可能通过减少出血事件改善晚期结局。
