Efficacy And Safety Of Tolvaptan In The Treatment Of Right Heart Failure With Tricuspid Insufficiency After Left Heart Valve Replacement

Background:Tricuspid valve(TV)is often known as a "forgotten" valve,as tricuspid insufficiency(TI)is usually not a primary,but rather a secondary disease [1].TI caused right heart failure(HF)commonly occurs in patients who have undergone left heart valve replacement surgery and heart deformity.Prognosis of these patients is often unoptimistic as TI have been reported highly associated mortality after surgery [2].The rate of 1-year survival in patients with absent,mild,moderate,and severe TI was found to be 91,90,70,and 60%,respectively [3].Patients with left heart valve replacement often without performed tricuspid valvuloplasty or replacement in the early time,and patients with right heart failure with tricuspid insufficiency after left heart valve replacement had a high risk of death and a poor prognosis to have second operation.Some patients are reluctant to undergo surgery again,and the long-term use of diuretics are prone to happen diuretic resistance.Therefore,an effective and safe treatment of tricuspid insufficiency with right heart failure after left heart valve replacement is urgently needed.Tolvaptan can increase the amount of urine,reduce weight and improve the heart function of patients quickly.Objective:This study examined the efficacy and safety of vasopressin V2 receptor antagonist tolvaptan for the treatment of right heart failure with tricuspid insufficiency after left heart valve replacement.Methods:This prospective,multicenter,randomized study included 40 patients who visited the Shanghai Tongren Hospital and Shanghai Chest Hospital from March 2016 to December 2016.The patients were randomly assigned in a 1:1 ratio into tolvaptan group(receiving tolvaptan 15 mg combined with torasemide 20mg)and control group(torasemide 20 mg monotherapy),both groups were continuously administrated for 10 days.Patients were on standard background therapy throughout the study.Observing the changes of body weight,24 hours,urine volume,tricuspid annular plane systolic excursion(TAPSE),brain natriureticpeptide(BNP)and New York Heart Association(NYHA)class of both groups.Meanwhile,the pulse,blood pressure,liver function,renal function and blood sodium concentration of both cohorts were recorded as evaluation indexes,and adverse reactions were also observed during hospitalization.Results: Forty patients of two groups all completed the treatment.There were significant differences between two groups in the change of body weight [-(2.58±1.87)kg vs-(0.95±2.42)kg],24 hours urine volume,TAPSE[(16.54±2.63)mm vs(14.69±1.54)mm] and BNP [(221.45±211.15)pg/ml vs(621.65±777.52)pg/ml] after 10 days,treatment(all P <0.05).Compared with before treatment,the NYHA class were significantly improved(P <0.05)in tolvaptan group.There were no significant differences between two groups in the change of pulse,blood pressure,liver function and renal function(P >0.05).After treatment,although the difference of blood sodium concentration were statistically significant between the two groups(P <0.05),the blood sodium concentration was in safe range all the way(Na+<148mmol/L).Throughout the study,there were no serious adverse events in both groups.Conclusion: Tolvaptan for the treatment of right heart failure with tricuspid insufficiency after left heart valve replacement is effective and safe.