Hemodynamic And Clinical Studies Of The Edwards Pericardial Bioprosthesis Up To Five Years

Objective:The aim of this study was to investigate the 5-year clinical and hemodynamic outcomes after aortic and mitral valve replacement with the Carpentier-Edwards Perimount bovine bioprosthesis(Edwards Lifesciences,shanghai).Methods:From January to October 2015,Among patients implanted with Edward Perimount bovine pericardial bioprosthesis at tianjin chest hospital,we finally enrolled in 33 patients for mitral valve(type 6900PTFX)replacement with a mean age of 61.9 years(range 47-74 years)and 21 patients for aortic valve(type2800TFX)replacement with a mean age of 60.9 years(range 41-81 years)to our study.Patients were followed-up,including serial echocardiographic assessment,within 7 days,at 6 months,and annually thereafter.The mitral indexed valve effective orifice area(IEOA)was used to define PPM as not clinically significant if1.2 cm~2/m~2,as moderate if 0.9 and 1.2 cm~2/m~2,and as severe if 0.9 cm~2/m~2.The arotic indexed valve effective orifice area(EOAI)was used to define PPM as not clinically significant if 1.0 cm~2/m~2,as moderate if 0.65 and 0.85cm~2/m~2,and as severe if 0.65 cm~2/m~2.Mean follow-ups were 4.6±0.9 years for the groups with aortic valve replacement(AVR)and 4.9±0.5 years for the groups with mitral valve replacement(MVR).The cumulative follow-up was 95 patient-years for AVR and160 patient-years for MVR.Results:Early mortalities(≤30 days post-implantation)were 0.0%for the group of AVR and MVR.Late mortalities(>30 days post-implantation)were1.1%/patient-year for AVR and 1.3%/patient-year for MVR.Overall 5-year survivals were 95.2%±4.6%for AVR and 93.8%±4.2%for MVR.Five-year freedoms from valve-related mortality were 95.2%±4.6%for AVR and 96.9%±3.1%for MVR.At 5years,freedom from structural valve deterioration(SVD)rate is 100.0%for AVR and MVR.Freedoms from valve thrombosis,endocarditis and reoperation at 5 years were 100%for AVR and MVR.At 5 years,freedom from adverse events in the AVR group and MVR group was,respectively,thromboembolism,94.1%±5.7%and87.4%±5.9%;bleeding event,100%and 93.8%±4.2%;Aortic and mitral regurgitation was found by Doppler echocardiography to be none or trivial in all of the patients.The aortic and mitral valve values of peak gradient(PG),mean gradient(MG),left ventricular mass index and pulmonary artery pressure(PAP)were significantly decreased at postoperative than those before operation(P<0.05)and remained stable during the follow-up period(P>0.05).Whereas values of and left ventricular mass index(LVMI)regression was significantly increased(P<0.05)and remained stable during the follow-up period(P>0.05).The moderate patient prosthesis mismatch was 20%for aortic valve replacement and 50%for mitral valve replacement at 5 years.The severe patient prosthesis mismatch was 5.0%for aortic valve replacement and 18.8%for mitral valve replacement at 5 years.At 1 and 5 year in patients with PPM,the aortic peak gradient and mean gradient were significantly higher than those without PPM(P<0.05).The mitral EOAI for all valve sizes ranged from 0.96±0.19cm~2/m~2 at 1 year to 1.0±0.2 cm~2/m~2 at 5 years.The arotic EOAI for all valve sizes ranged from 1.08±0.15cm~2/m~2 at 1 year to 1.3±0.3 cm~2/m~2 at 5 years.The mitral and aortic EOAI in patients with PPM was significantly smaller than those without at 5 years(P<0.05),whereas the mitral and aortic mean left ventricular mass index and mean left ventricular mass index regression in patients with PPM were not significantly differ than those without(P>0.05).By means of simple linear regression analysis,for the MVR group,relationships between IEOA were correlated to the 5-year peak transprosthetic gradient with r=-0.578(p=0.004);to the mean transprosthetic gradient at 5 years with r=-0.682(p<0.001);and to the presence of patient prosthesis mismatch with r=-0.543(p=0.006).For the AVR group,relationships between IEOA were correlated to the 5-year absolute LVM index regression with r=-0.631(p=0.037)and to the the presence of patient prosthesis mismatch at 5 years with r=-0.741(p=0.002);relationships between pulmonary artery pressure were correlated to the 5-year peak transprosthetic gradient with r=0.934(p<0.001)and to the the 5-year mean transprosthetic gradient with r=0.884(p<0.001).The evidence of left ventricular hypertrophy were 41.7%and 21.7%at 5 years for the groups with AVR and MVR.However,our analyses indicate that the residual left ventricular hypertrophy was not caused by valve mismatch but was probably multifactorial.Conclusion:The Carpentier-Edwards Perimount bioprosthesis has provided satisfactory clinical safety and hemodynamic outcome.The present data suggest that PPM and LVH were not related to reduction in the LV mass index for patients with MVR and AVR.However,at long-term follow-up the patients being investigated still had left ventricular hypertrophy examined by echocardiography.PPM is a risk for high mean PG and MG in AVR group.For MVR,the postoperative EOAI of each valve prosthesis has a significant negtive correlation with the rate of PPM and pressure gradient.For AVR,the postoperative EOAI of each valve prosthesis has a significant negtive correlation with the rate of PPM and LVMI regression,the postoperative PAP of each valve prosthesis has a significant positive correlation with PG and MG.For AVR the reduction in mean and peak pressure gradient were better in patients without prosthesis-patient mismatch.