Efficacy of tolvaptan for fluid management after cardiovascular surgery: A systematic review and meta‑analysis of randomized control trials

Chen,Huiling; Jiang,Weihong; Li,Xiaogang; Meng,Zhaohui; Chen,Huamei; Li,Jiaying; Wang,Junwen; Zhao,Xiexiong

doi:10.3892/etm.2020.9007

Efficacy of tolvaptan for fluid management after cardiovascular surgery: A systematic review and meta‑analysis of randomized control trials

Authors:
- Huiling Chen
- Weihong Jiang
- Xiaogang Li
- Zhaohui Meng
- Huamei Chen
- Jiaying Li
- Junwen Wang
- Xiexiong Zhao
View Affiliations

Affiliations: Department of Cardiology, the Third Xiangya Hospital of Central South University, Changsha, Hunan 410013, P.R. China, Department of Cardiology, the First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 660034, P.R. China
Published online on: July 13, 2020 https://doi.org/10.3892/etm.2020.9007
Pages: 2585-2592
Copyright: © Chen et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

Metrics: Total Views: 0 (Spandidos Publications: | PMC Statistics: )

Metrics: Total PDF Downloads: 0 (Spandidos Publications: | PMC Statistics: )

Cited By (CrossRef): 0 citations Loading Articles...

Abstract

The purpose of this study was to systematically search the literature and analyze evidence from randomized controlled trials (RCTs) comparing tolvaptan with conventional diuretics for postoperative fluid management in cardiac surgery patients. An electronic search of PubMed, Scopus, BioMed Central, CENTRAL (Cochrane Central Register of Controlled Trials) and Google scholar databases was carried out up to 1st December 2019. Four RCTs were included. Tolvaptan was co‑administered with conventional diuretics in all the studies. The mean postoperative urine output was significantly greater in patients receiving tolvaptan as compared to controls (MD=0.39; 95% CI: 0.17 to 0.61; P=0.006, I2=48%). Body weight of patients on tolvaptan returned to pre‑operative levels significantly earlier (MD=‑1.57; 95% CI: ‑2.48 to ‑0.66; P=0.007, I2=50%). There was statistical significant difference in the highest postoperative serum sodium levels (MD=2.34; 95% CI: ‑1.65 to 3.03; p<0.00001, I2=0%), lowest serum sodium levels (MD=2.05; 95% CI: 1.41 to 2.68; p<0.00001, I2=0%) and mean serum sodium levels (MD=1.69; 95% CI: 0.98 to 2.40; p<0.00001, I2=0%) between the tolvaptan and control groups. Lowest serum potassium was significantly higher with tolvaptan as compared to the control group (MD=0.10; 95% CI: 0.01 to 0.18; P=0.03, I2=19%). There was no significant difference in the length of ICU stay or incidence of arrhythmias between the two groups. The quality of the included studies was not high. Within the limitations of our study, our results indicate that co‑administration of tolvaptan with low dose of conventional diuretics significantly increases urine output while maintaining electrolyte balance in postoperative cardiac surgery patients. Faster return of body weight to pre‑operative levels is evident with tolvaptan. Further high‑quality RCTs are required to confirm this evidence.

View Figures

View References

1	Nishi H, Toda K, Miyagawa S, Yoshikawa Y, Fukushima S, Kawamura M, Yoshioka D, Saito T, Ueno T, Kuratani T, et al: Effects of tolvaptan in the early postoperative stage after heart valve surgery: Results of the STAR (Study of Tolvaptan for fluid retention AfteR valve surgery) trial. Surg Today. 45:1542–1551. 2015.PubMed/NCBI View Article : Google Scholar
2	Kishimoto Y, Nakamura Y, Harada S, Onohara T, Kishimoto S, Kurashiki T, Fujiwara Y and Nishimura M: Can Tolvaptan Protect Renal Function in the Early Postoperative Period of Cardiac Surgery? - Results of a Single-Center Randomized Controlled Study. Circ J. 82:999–1007. 2018.PubMed/NCBI View Article : Google Scholar
3	Felker GM: Loop diuretics in heart failure. Heart Fail Rev. 17:305–311. 2012.PubMed/NCBI View Article : Google Scholar
4	Haller C, Salbach P, Katus H and Kübler W: Refractory oedema in congestive heart failure: A contributory role of loop diuretics? J Intern Med. 237:211–214. 1995.PubMed/NCBI View Article : Google Scholar
5	Costello-Boerrigter LC, Smith WB, Boerrigter G, Ouyang J, Zimmer CA, Orlandi C and Burnett JC Jr: Vasopressin-2-receptor antagonism augments water excretion without changes in renal hemodynamics or sodium and potassium excretion in human heart failure. Am J Physiol Renal Physiol. 290:F273–F278. 2006.PubMed/NCBI View Article : Google Scholar
6	Sen J, Chung E and McGill D: Tolvaptan for Heart Failure in Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis. Heart Lung Circ. 27:928–939. 2018.PubMed/NCBI View Article : Google Scholar
7	Ito H, Mizumoto T, Tempaku H, Fujinaga K, Sawada Y and Shimpo H: Efficacy of Tolvaptan on Fluid Management After Cardiovascular Surgery Using Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 30:1471–1478. 2016.PubMed/NCBI View Article : Google Scholar
8	Yamada M, Nishi H, Sekiya N, Horikawa K, Takahashi T and Sawa Y: The efficacy of tolvaptan in the perioperative management of chronic kidney disease patients undergoing open-heart surgery. Surg Today. 47:498–505. 2017.PubMed/NCBI View Article : Google Scholar
9	Kido T, Nishi H, Toda K, Ueno T, Kuratani T, Sakaki M, Takahashi T and Sawa Y: Predictive factors for responders to tolvaptan in fluid management after cardiovascular surgery. Gen Thorac Cardiovasc Surg. 65:110–116. 2017.PubMed/NCBI View Article : Google Scholar
10	Moher D, Liberati A, Tetzlaff J and Altman DG: PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. PLoS Med. 6(e1000097)2009.PubMed/NCBI View Article : Google Scholar
11	Higgins J and Green S (eds): Cochrane Handbook for Systemic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration, 2011. http://www.handbook.cochrane.orgsimplewww.handbook.cochrane.org. Updated March, 2011.
12	Higgins J, Altman D and Sterne J: Cochrane Statistical Methods Group and the Cochrane Bias Methods Group. Chapter 8: Assessing risk of bias in included studies. In: Cochrane Handbook for Systemic Reviews of Interventions, Version 5.1.0. The Cochrane Collaboration, 2011. http://www.handbook.cochrane.orgsimplewww.handbook.cochrane.org. Accessed May 8, 2014.
13	Noguchi K, Tanaka M, Katayama I, Yamabe T, Yuji D, Oosiro N and Sirouzu M: Efficacy of Tolvaptan in Patients with Volume Overload after Cardiac Surgery. Heart Surg Forum. 18:E232–E236. 2015.PubMed/NCBI View Article : Google Scholar
14	Kato TS, Ono S, Kajimoto K, Kuwaki K, Yamamoto T and Amano A: Early introduction of tolvaptan after cardiac surgery: A renal sparing strategy in the light of the renal resistive index measured by ultrasound. J Cardiothorac Surg. 10(143)2015.PubMed/NCBI View Article : Google Scholar
15	Katayama Y, Ozawa T, Shiono N, Masuhara H, Fujii T and Watanabe Y: Safety and effectiveness of tolvaptan for fluid management after pediatric cardiovascular surgery. Gen Thorac Cardiovasc Surg. 65:622–626. 2017.PubMed/NCBI View Article : Google Scholar
16	Matsuyama K, Koizumi N, Nishibe T, Iwasaki T, Iwahasi T, Toguchi K, Takahashi S, Iwahori A, Maruno K and Ogino H: Effects of short-term administration of tolvaptan after open heart surgery. Int J Cardiol. 220:192–195. 2016.PubMed/NCBI View Article : Google Scholar
17	Kato TS, Nakamura H, Murata M, Kuroda K, Suzuki H, Yokoyama Y, Shimada A, Matsushita S, Yamamoto T and Amano A: The effect of tolvaptan on renal excretion of electrolytes and urea nitrogen in patients undergoing coronary artery bypass surgery. BMC Cardiovasc Disord. 16(181)2016.PubMed/NCBI View Article : Google Scholar
18	Suehiro Y, Hosono M, Shibata T, Sasaki Y, Hirai H, Nakahira A, Kubota Y, Kaku D and Suehiro S: Efficacy and Safety Evaluation of Tolvaptan on Management of Fluid Balance after Cardiovascular Surgery Using Cardiopulmonary Bypass. Osaka City Med J. 62:111–119. 2016.PubMed/NCBI
19	Woods WG, Forsling ML and Le Quesne LP: Plasma arginine vasopressin levels and arterial pressure during open heart surgery. Br J Surg. 76:29–32. 1989.PubMed/NCBI View Article : Google Scholar
20	Jochberger S, Mayr VD, Luckner G, Wenzel V, Ulmer H, Schmid S, Knotzer H, Pajk W, Hasibeder W, Friesenecker B, et al: Serum vasopressin concentrations in critically ill patients. Crit Care Med. 34:293–299. 2006.PubMed/NCBI View Article : Google Scholar
21	Miyazaki T, Fujiki H, Yamamura Y, Nakamura S and Mori T: Tolvaptan, an orally active vasopressin V(2)-receptor antagonist - pharmacology and clinical trials. Cardiovasc Drug Rev. 25:1–13. 2007.PubMed/NCBI View Article : Google Scholar
22	Gheorghiade M, Gattis WA, O'Connor CM, Adams KF Jr, Elkayam U, Barbagelata A, Ghali JK, Benza RL, McGrew FA, Klapholz M, et al: Acute and Chronic Therapeutic Impact of a Vasopressin Antagonist in Congestive Heart Failure (ACTIV in CHF) Investigators: Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure: A randomized controlled trial. JAMA. 291:1963–1971. 2004.PubMed/NCBI View Article : Google Scholar
23	Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, et al: Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators: Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: The EVEREST Clinical Status Trials. JAMA. 297:1332–1343. 2007.PubMed/NCBI View Article : Google Scholar
24	Slight RD, Demosthenous N, Nzewi OC, Soliman AR, McClelland DBL and Mankad PS: The effect of gain in total body water on haemoglobin concentration and body weight following cardiac surgery. Heart Lung Circ. 15:256–260. 2006.PubMed/NCBI View Article : Google Scholar
25	Bellos I, Iliopoulos DC and Perrea DN: The Role of Tolvaptan Administration After Cardiac Surgery: A Meta-Analysis. J Cardiothorac Vasc Anesth. 33:2170–2179. 2019.PubMed/NCBI View Article : Google Scholar
26	Crestanello JA, Phillips G, Firstenberg MS, Sai-Sudhakar C, Sirak J, Higgins R and Abraham WT: Postoperative hyponatremia predicts an increase in mortality and in-hospital complications after cardiac surgery. J Am Coll Surg. 216:1135–43, 1143.e1. 2013.PubMed/NCBI View Article : Google Scholar
27	Matsuzaki M, Hori M, Izumi T and Fukunami M: Tolvaptan Investigators. Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: A phase III, randomized, double-blind, placebo-controlled study (QUEST study). Cardiovasc Drugs Ther. 25 (Suppl 1):S33–S45. 2011.PubMed/NCBI View Article : Google Scholar
28	Peretto G, Durante A, Limite LR and Cianflone D: Postoperative arrhythmias after cardiac surgery: Incidence, risk factors, and therapeutic management. Cardiol Res Pract. 2014(615987)2014.PubMed/NCBI View Article : Google Scholar
29	Lazzarini V, Bettari L, Bugatti S, Carubelli V, Lombardi C, Metra M and Dei Cas L: Can we prevent or treat renal dysfunction in acute heart failure? Heart Fail Rev. 17:291–303. 2012.
30	Tominaga N, Kida K, Matsumoto N, Akashi YJ, Miyake F, Kimura K and Shibagaki Y: Safety of add-on tolvaptan in patients with furosemide-resistant congestive heart failure complicated by advanced chronic kidney disease: A sub-analysis of a pharmacokinetics/ pharmacodynamics study. Clin Nephrol. 84:29–38. 2015.PubMed/NCBI View Article : Google Scholar
31	Shirakabe A, Hata N, Yamamoto M, Kobayashi N, Shinada T, Tomita K, Tsurumi M, Matsushita M, Okazaki H, Yamamoto Y, et al: Immediate administration of tolvaptan prevents the exacerbation of acute kidney injury and improves the mid-term prognosis of patients with severely decompensated acute heart failure. Circ J. 78:911–921. 2014.PubMed/NCBI View Article : Google Scholar