| Objectives:To observe and compare the clinical efficacy between using Viatorr stents,Fluency stents combining with bare metal stents(BMS)and Viabahn stents combining with BMS in transjugular intrahepatic portal body shunt(TIPS)in patients with portal hypertension due to liver cirrhosis.Methods:466 patients who underwent TIPS at Shandong Provincial Hospital from December 2009 to December 2019 was collected.299 patients met the inclusion criteria finally,including 248 patients who underwent TIPS for esophagogastric variceal bleeding(EVB),42 patients who underwent TIPS for refractory ascites(RA),and 9 patients underwent TIPS for other complications.The patients were divided into three groups according to the type of stent used:Viatorr group(n=81),Viabahn group(n=68)and Fluency group(n=150).Baseline data such as age,etiology,laboratory indices,Child-Pugh score and grading,MELD score,MELD-Na score and portal venous pressure(PVP)were collected and compared among the three groups.The changes of PVP and clinical efficacy such as shunt patency,re-bleeding,recurrence of ascites,occurrence of hepatic encephalopathy(HE)and survival were compared between the three groups,and the influencing factors were analysed.A subgroup analysis was also conducted to compare whether there was any difference in clinical efficacy between different stents based on factors such as Child-Pugh classification(grade A,B or C),age less than 60 years or 60 years and above,presence of thrombosis in the portal vein,and whether there was a combination of hepatocellular carcinoma(defined as hepatocellular carcinoma meeting the Milan criteria).The clinical efficacy of the three groups were compared again in each subgroup for any differences.The statistical software SPSS 23.0 was applied for statistical analysis.T-test,ANOVA or rank sum test were used for quantitative data;chi-square test or rank sum test were used for qualitative data.The Kaplan-Meier method and log-rank test were used to compare the clinical efficacy of the three groups of patients.Results:1.The median follow-up time in the study was 36.3(18.4 to 51.0)months,21.3(14.4 to 26.3)months in the Viatorr group,43.8(37.8 to 51.9)months in the Viabahn group and 43.0(19.5 to 63.9)months in the Fluency group.2.Changes in PVP:Viatorr group decreased from 29.219(±5.77)mmHg to 19.37(±4.54)mmHg(P<0.001);Viabahn group decreased from 27.17(±5.91)mmHg to 18.25(±5.14)mmHg(P<0.001);Fluency group decreased from 26.76(±6.12)mmHg to 17.48(±5.50)mmHg(P<0.001).There was no statistically significant difference in the PVP decrease value and PVP decrease percentage between the three groups(P=0.545,P=0.453).3.Stent patency rate:(1)The cumulative shunt patency rate in the Viatorr group was 86.4%(70/81),with cumulative stent patency rates of 98.8%,93.7%,88.4%,and 83.2%at 1,6,12,and 36 months;the cumulative stent patency rate in the Viabahn group was 64.7%(44/68),with the cumulative stent patency rates at 1,6,12,and 36 months were 96.2%,85.3%,82.8%and 67.7%;the cumulative stent patency rate in the Fluency group was 71.3%(103/150),with the cumulative stent patency rates at 1,6,12,and 36 months were 95.9%,89.5%,84.3%and 68.7%.In terms of curve trends,the cumulative stent patency rate was slightly higher in the Viatorr group than in the Viabahn(P=0.077)and Fluency groups(P=0.155),but the difference was not significant.Further analysis showed a trend towards a higher stent patency rate in the Viatorr group than in the Viabahn and Fluency groups in patients without portal vein thrombosis(P=0.066,P=0.080).(2)Factors influencing stent occlusion:younger age(P=0.002),portal vein thrombosis(P=0.037),and elevated PLT count(P=0.008)were independent risk factors for stent occlusion.4.Re-bleeding rate:A total of248 patients in this study were treated with TIPS for EVB,including 208 patients underwent TIPS for secondary prevention,23 for rescue TIPS and early TIPS in 17 patients.And there were 71 patients in the Viatorr group,59 in the Viabahn group and 118 in the Fluency group.(1)The cumulative non-rebleeding rate in the Viatorr group was 87.3%(62/71),with cumulative non-rebleeding rates of 100.0%,98.6%,91.0%and 81.3%at 1,6,12 and 36 months;the cumulative non-rebleeding rate in the Viabahn group was 72.9%(43/59),with cumulative non-rebleeding rates of 94.9%,91.5%,86.4%and 74.0%at at 1,6,12 and 36 months;the cumulative non-rebleeding rate in the Fluency group was 76.3%(90/118),with cumulative non-rebleeding rates of 98.3%,90.3%,86.8%and 74.7%at 1,6,12 and 36 months.In terms of curve trends,the cumulative non-rebleeding rate was slightly higher in the Viatorr group than in the Viabahn(P=0.312)and Fluency groups(P=0.290),but the difference was not significant.Further analysis showed that the cumulative non-rebleeding rate was significantly higher in the Viatorr group than in the Fluency group(P=0.031)and tended to be better than in the Viabahn group(P=0.146)in patients aged less than 60 years.(2)Factors influencing rebleeding:Child-Pugh classification grade B increased the risk of postoperative rebleeding by 2.134 times compared to grade A(P=0.024).5.Control rate of RA:A total of 42 patients were treated with TIPS for RA in this study,including 10 in the Viatorr group,7 in the Viabahn group and 25 in the Fluency group.At follow-up,a total of 26 patients(61.9%)had remission of RA.(1)The cumulative ascites control rate in the Viatorr group was 70.0%(7/10),and the cumulative ascites control rates were 90.0%,70.0%,70.0%and 70.0%at 1,6,12 and 24 months;the cumulative ascites control rate in the Viabahn group was 71.4%(5/7),and cumulative ascites control rates were 74.1%,70.4%,70.4%and 70.4%at 1,6,12 and 24 months;the cumulative ascites control rate in the Fluency group was 56.0%(14/25),and cumulative ascites control rates were 76.0%,72.0%,67.8%and 58.6%at 1,6,12 and 24 months;there was no statistical difference in the cumulative ascites control rates among the three groups.(2)Factors influencing failure of RA control:elevated ALT(P=0.006)and elevated creatinine(P=0.006)were independent risk factors for failure of ascites control events.6.Hepatic encephalopathy:(1)The cumulative non-occurrence of HE in the Viatorr group was 66.7%(54/81),and the cumulative rates of no HE at 1,6,12 and 36 months were 90.1%,76.5%,72.5%and 60.3%;the cumulative non-occurrence of HE in the Viabahn group was 67.6%(46/68),and the cumulative rates of no HE at 1,6,12 and 36 months were 87.3%,77.6%,73.1%and 68.4%;the cumulative non-occurrence of HE in the Fluency group was 63.3%(95/150),and the cumulative rates of no HE at 1,6,12 and 36 months were 85.0%,70.0%,65.7%and 60.8%;there was no statistical difference in the cumulative rates of no HE among the three groups.Further subgroup analysis also did not show significant differences.(2)Factors influencing the occurrence of HE:older age(P<0.001),etiology due to hepatitis B or C(P=0.011),and elevated ALT(P=0.038)were independent risk factors for occurrence of HE after TIPS.7.Survival:(1)The cumulative survival rate in the Viatorr group was 96.3%(78/81),with cumulative survival rates of 98.8%,97.5%,97.5%and 95.9%at 1,6,12 and 36 months;the cumulative survival rate in the Viabahn group was 92.6%(63/68),with cumulative survival rates of 100.0%,98.5%,97.0%and 92.5%at 1,6,12 and 36 months;the cumulative survival rate in the Fluency group was 86.0%(129/150),and the cumulative survival rates were 97.4%,94.0%,92.6%and 85.6%at 1,6,12 and 36 months;there was no statistical difference between the three cumulative survival rates,but in terms of curve trend,the Fluency group The trend of cumulative survival rate was slightly lower than that of the Viatorr group(P=0.083).Further analysis showed that,in patients aged less than 60 years,the cumulative survival rate was significantly higher in the Viatorr group than in the Fluency group(P=0.025);in patients without liver cancer,the cumulative survival rate was significantly higher in the Viatorr group than in the applied Fluency group(P=0.048),while there was a trend for the Viabahn group to be higher than the Fluency group(P=0.057).(2)Factors influencing death:older age(P=0.009),combined liver cancer(P=0.005),and elevated ALT(P=0.004)were independent risk factors for postoperative mortality events after TIPS.Conclusion:1.The use of Viatorr stents,Viabahn combination stents or Fluency combination stents during TIPS significantly reduces portal pressure in patients with cirrhosis without difference.2.In terms of stent patency,the Viatorr stent appears to be superior to the Viabahn combination stent and the Fluency combination stent,and does not increase the incidence of HE,but further confirmation is needed;especially in patients without portal vein thrombosis,the Viatorr stent has a better stent patency rate.3.There was no significant difference between the three groups in terms of re-bleeding in patients with EVB and control of ascites in patients with RA;however,in terms of control of re-bleeding,the Viatorr stent had an advantage over the Viabahn combination stent and the Fluency combination stent in patients aged less than 60 years.4.In terms of survival,the Viatorr stent was more clinically advantageous in patients younger than 60 years of age or patients without hepatocellular carcinoma. |
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