Abstract
Objectives
Our objective was to explore the effects of tolvaptan as a new therapeutic approach in patients with right heart failure with tricuspid insufficiency (TI).
Methods
This prospective, multicenter, non-randomized controlled pilot study enrolled patients (N = 40) with TI from the Shanghai Chest Hospital and Shanghai Tongren Hospital who fulfilled inclusion criteria between March 2015 and June 2016. Participants were assigned to receive either tolvaptan combined with torasemide (n = 20) or torasemide monotherapy (n = 20; control group). The primary endpoints were changes in patient weight and in tricuspid annular plane systolic excursion (TAPSE) after 10 days of treatment. The secondary endpoints included net fluid balance and cardiac functions before and after medication from the first to the tenth day of treatment. Safety was evaluated by monitoring adverse and serious adverse events.
Results
TAPSE significantly increased in the tolvaptan group compared with the control group after 10 days of medication (P = 0.029). Daily weight losses in the tolvaptan group significantly increased as the time of treatment increased (time × group, P = 0.022). Recovery to New York Heart Association (NYHA) grade I occurred 4 days earlier in the tolvaptan group. In addition, the net fluid balance and median net fluid balance were significantly higher in the tolvaptan group. Eight adverse events and one serious adverse event were recorded in the tolvaptan group and 15 adverse events were recorded in the control group.
Conclusions
Our results indicate that tolvaptan might be a useful and safe drug to improve heart function in patients with right heart failure with TI after left heart valve replacement.
Clinical Trial Registration
ClinicalTrials.gov identifier no. NCT02644616.
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References
Izumi C. Tricuspid regurgitation following left-sided valve surgery: echocardiographic evaluation and optimal timing of surgical treatment. J Echocardiogr. 2015;13(1):15–9. https://doi.org/10.1007/s12574-014-0236-y.
Vargas Abello LM, Klein AL, Marwick TH, Nowicki ER, Rajeswaran J, Puwanant S, et al. Understanding right ventricular dysfunction and functional tricuspid regurgitation accompanying mitral valve disease. J Thorac Cardiovasc Surg. 2013;145(5):1234.e5–1241.e5. https://doi.org/10.1016/j.jtcvs.2012.01.088.
Chan KM, Zakkar M, Amirak E, Punjabi PP. Tricuspid valve disease: pathophysiology and optimal management. Prog Cardiovasc Dis. 2009;51(6):482–6. https://doi.org/10.1016/j.pcad.2008.08.009.
Wong RC, Abrahams Z, Hanna M, Pangrace J, Gonzalez-Stawinski G, Starling R, et al. Tricuspid regurgitation after cardiac transplantation: an old problem revisited. J Heart Lung Transplant. 2008;27(3):247–52. https://doi.org/10.1016/j.healun.2007.12.011.
Gargani L, Schmidt PH, Gheorghiade M. Tolvaptan for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion. Expert Rev Cardiovasc Ther. 2011;9(12):1505–13. https://doi.org/10.1586/erc.11.163.
Udelson JE, Bilsker M, Hauptman PJ, Sequeira R, Thomas I, O’Brien T, et al. A multicenter, randomized, double-blind, placebo-controlled study of tolvaptan monotherapy compared to furosemide and the combination of tolvaptan and furosemide in patients with heart failure and systolic dysfunction. J Card Fail. 2011;17(12):973–81. https://doi.org/10.1016/j.cardfail.2011.08.005.
Miyazaki T, Fujiki H, Yamamura Y, Nakamura S, Mori T. Tolvaptan, an orally active vasopressin V(2)-receptor antagonist—pharmacology and clinical trials. Cardiovasc Drug Rev. 2007;25(1):1–13. https://doi.org/10.1111/j.1527-3466.2007.00001.x.
Payvar S, Orlandi C, Stough WG, Elkayam U, Ouyang J, Casscells SW, et al. Comparison of 60-day mortality in hospitalized heart failure patients with versus without hypothermia. Am J Cardiol. 2006;98(11):1485–8. https://doi.org/10.1016/j.amjcard.2006.06.051.
Konstam MA, Gheorghiade M, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, et al. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007;297(12):1319–31. https://doi.org/10.1001/jama.297.12.1319.
Suzuki S, Yoshihisa A, Yamaki T, Sugimoto K, Kunii H, Nakazato K, et al. Acute heart failure volume control multicenter randomized (AVCMA) trial: comparison of tolvaptan and carperitide. J Clin Pharmacol. 2013;53(12):1277–85. https://doi.org/10.1002/jcph.197.
Zulkifli Amin H, Suridanda Danny S. Tolvaptan: a novel diuretic in heart failure management. J Tehran Heart Center. 2016;11(1):1–5.
Ikeda Y, Inomata T, Iida Y, Nabeta T, Iwamoto M, Ishii S, et al. The vasopressin V2-receptor antagonist, tolvaptan, can not only induce aquaresis but also enhance natriuresis in heart failure patients refractory to loop diuretics. Eur Heart J. 2013;34(suppl_1):P3338-P. https://doi.org/10.1093/eurheartj/eht309.p3338.
Rodriguez Y, Mesa J, Arguelles E, Carrillo RG. Tricuspid insufficiency after laser lead extraction. Pacing Clin Electrophysiol PACE. 2013;36(8):939–44. https://doi.org/10.1111/pace.12160.
Matsunaga A, Duran CM. Progression of tricuspid regurgitation after repaired functional ischemic mitral regurgitation. Circulation. 2005;112(9 Suppl):I453–7. https://doi.org/10.1161/CIRCULATIONAHA.104.524421.
Takano H, Hiramatsu M, Kida H, Uenoyama M, Horiguchi K, Yamauchi T, et al. Severe tricuspid regurgitation after mitral valve surgery: the risk factors and results of the aggressive application of prophylactic tricuspid valve repair. Surg Today. 2017;47(4):445–56. https://doi.org/10.1007/s00595-016-1395-4.
Song H, Kim MJ, Chung CH, Choo SJ, Song MG, Song JM, et al. Factors associated with development of late significant tricuspid regurgitation after successful left-sided valve surgery. Heart. 2009;95(11):931–6. https://doi.org/10.1136/hrt.2008.152793.
Gheorghiade M, Niazi I, Ouyang J, Czerwiec F, Kambayashi J, Zampino M, et al. Vasopressin V2-receptor blockade with tolvaptan in patients with chronic heart failure: results from a double-blind, randomized trial. Circulation. 2003;107(21):2690–6. https://doi.org/10.1161/01.cir.0000070422.41439.04.
Forfia PR, Fisher MR, Mathai SC, Housten-Harris T, Hemnes AR, Borlaug BA, et al. Tricuspid annular displacement predicts survival in pulmonary hypertension. Am J Respir Crit Care Med. 2006;174(9):1034–41. https://doi.org/10.1164/rccm.200604-547OC.
Niwa T, Waseda K, Mizuno T, Nakano Y, Mukai K, Wakabayashi H, et al. Predictability of tricuspid annular plane systolic excursion for the effectiveness of tolvaptan in patients with heart failure. J Echocardiogr. 2017;15(3):118–26. https://doi.org/10.1007/s12574-017-0330-z.
Kinugawa K, Sato N, Inomata T, Shimakawa T, Iwatake N, Mizuguchi K. Efficacy and safety of tolvaptan in heart failure patients with volume overload. Circ J. 2014;78(4):844–52.
Gheorghiade M, Gattis WA, O’Connor CM, Adams KF Jr, Elkayam U, Barbagelata A, et al. Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure: a randomized controlled trial. JAMA. 2004;291(16):1963–71. https://doi.org/10.1001/jama.291.16.1963.
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Fang Yuan, Zhangmin Wu, Li Jiang, Jun Zhou, Lei Xu, Hua Liu, Lan Ma, Zhenzhou Zhai, and Junjie Zhang have no conflicts of interest that might be relevant to the contents of this manuscript.
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All data generated or analyzed during this study are included in this article.
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This study was funded by the Acute Heart Failure Specialist (Grant number: 20162002).
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Yuan, F., Wu, Z., Jiang, L. et al. Short-Term Effects of Tolvaptan in Tricuspid Insufficiency Combined with Left Heart Valve Replacement-Caused Volume-Overload Patients: Results of a Prospective Pilot Study. Am J Cardiovasc Drugs 19, 211–218 (2019). https://doi.org/10.1007/s40256-018-0304-1
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DOI: https://doi.org/10.1007/s40256-018-0304-1