| Objective:To compare the early clinical results of two bileaflet mechanical mitral valve of different price during the same period,and to preliminarily explore the feasibility of the low-priced domestic mechanical mitral valve could widespread application in conomically underdeveloped areas of our country.Methods:(1)Collecting patients who underwent mitral valve replacement surgery at the department of cardiothoracic surgery of the Chengdu second people's hospital from July2015 to December 2017,according to different wishes of patients who choose their own mechanical mitral valve before surgery,they are divided into the low-priced homemade mitral valve group(group A)and the high-priced imported mitral valve group(group B).(2)Firstly,this study evaluated the safety of clinical application by comparing the difficulty of surgical operation(cardiopulmonary bypass time,aortic cross-clamping time)and the incidence of postoperative adverse events(early postoperative(?30 days)deaths and common complications)between the two group;(3)Secondly,the early clinical efficacy was evaluated by comparing the changes of cardiac function(left ventricular ejection fraction(LVEF)during preoperative and postoperative 7-days),hemodynamic performance(Effective orifice area(EOA)and effective orifice area index(iEOA))and postoperative recovery time(ICU treatment time,mechanical ventilation time and hospitalization days)of the two groups;(4)Finally,the health economics status of the homemade mechanical valve was evaluated by comparing the average hospitalization costs of the two groups.Results:(1)There was no statistically significant difference between the two groups in terms of gender,age,body surface area,body mass index,NYHA functional class,valve type,and various preoperative complications(P>0.05).(2)In terms of clinical safety evaluation,the cardiopulmonary bypass time(group A:165.50±45.96 min vs.group B:155.88±33.98 min)and aortic cross-clamping time(group A:102.65±36.06 min vs.group B:112.27±35.01 min)and the incidence of postoperative adverse events(group A:14.89%vs.group B:15.63%)were not statistically difference(P>0.05).(3)In terms of early clinical efficacy evaluation,the LVEF were compared between the two groups during preoperative and postoperative 7 days(group A:56.21±9.44%and 60.77±8.74%vs.group B:53.97±8.41%and 57.97±7.46%),the difference was statistically significant(P<0.05);in addition,EOA(group A:2.49±0.37 cm~2 vs.group B:2.42±0.29 cm~2)and iEOA(group A:2.49±0.37 cm~2/m~2 vs.group B:2.42±0.29 cm~2/m~2)were compared between the two groups during postoperative 7 days,and ICU treatment time(group A:102.65±36.06 min vs.group B:112.27±35.01 min),mechanical ventilation time(group A:17.68±1.19 h vs.group B:17.31±1.22 h),the days of hospitalization(group A:23.83±5.29 d vs.group B:24.97±6.32 d)were compared between the two groups,there were not significant difference(P>0.05).(4)In terms of health economics evaluation,the average hospitalization costs(group A:93085.05±17439.22 yuan vs.group B:101445.79±16902.51 yuan)were compared between the two groups,the difference was statistically significant(P<0.05).Conclusion:(1)The comparison between homemade mechanical valves and imported mechanical valves,it did not increase the difficulty of operation,and also did not increase the incidence of postoperative adverse events significantly.Showing good safety of clinical application;(2)Homemade mechanical valves can significantly improved the cardiac function of the patient after surgical operation,it has good hemodynamic performance,and it has not obviously prolong the postoperative recovery time,that showing the similar early clinical efficacy as the imported mechanical valve;(3)In terms of health economics status,compared with the imported mechanical valves,the homemade mechanical valves can obviously reduce the average hospitalization cost.It has a certain degree of clinical economic benefits and has the value of popularization and application. |
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