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Erschienen in: Heart and Vessels 10/2019

16.04.2019 | Original Article

Clinical safety and efficacy of tolvaptan for acute phase therapy in patients with low-flow and normal-flow severe aortic stenosis

verfasst von: Miho Mitsui, Akihisa Kataoka, Yugo Nara, Fukuko Nagura, Hideyuki Kawashima, Hirofumi Hioki, Makoto Nakashima, Yusuke Watanabe, Naoyuki Yokoyama, Ken Kozuma

Erschienen in: Heart and Vessels | Ausgabe 10/2019

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Abstract

Conventional diuretic therapy for low-flow (LF) severe aortic stenosis (SAS) often has an inadequate effect or causes hemodynamic instability. Tolvaptan is used for acute heart failure in addition to conventional diuretics, and it does not cause intravascular dehydration. This study aimed to retrospectively investigate the safety and efficacy of tolvaptan in the acute phase in 56 consecutive patients with SAS and compared LF-SAS with normal-flow (NF) SAS. The primary endpoints were adverse clinical events (death, worsening heart failure, worsening renal failure, fatal arrhythmia, cardiogenic or hypovolemic shock, and use of inotropic agents) and the volume of urine within 48 h of tolvaptan administration. Among 56 patients, 16 had LF-SAS (29%), and 40 had NF-SAS (71%). Severe adverse clinical events were not observed 48 h after tolvaptan administration. In both groups, the urine volume significantly increased after tolvaptan administration in comparison to 24 h before tolvaptan administration (both, p < 0.01). There were no changes in the urine volume during the initial 24 and 48 h. In the LF-SAS group, tolvaptan resulted in a significant decrease in fluid balance during the initial 24 and 48 h compared to 24 h before tolvaptan administration (p < 0.05). Adding tolvaptan to conventional treatment is safe and effective without renal dysfunction and hypotension in patients with SAS, including those with LF.
Literatur
1.
Zurück zum Zitat Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M (2006) Burden of valvular heart diseases: a population-based study. Lancet 368:1005–1011CrossRef Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M (2006) Burden of valvular heart diseases: a population-based study. Lancet 368:1005–1011CrossRef
2.
Zurück zum Zitat Takasu K, Miyazaki T, Negoro K, Yatsu S, Shimizu M, Murata A, Kato T, Suda S, Hiki M, Kasai T, Miyauchi K, Daida H (2017) Successful treatment of congestive heart failure due to severe aortic valve stenosis with low dose tolvaptan in elderly patients. Int Heart J 58:378–384CrossRefPubMed Takasu K, Miyazaki T, Negoro K, Yatsu S, Shimizu M, Murata A, Kato T, Suda S, Hiki M, Kasai T, Miyauchi K, Daida H (2017) Successful treatment of congestive heart failure due to severe aortic valve stenosis with low dose tolvaptan in elderly patients. Int Heart J 58:378–384CrossRefPubMed
3.
Zurück zum Zitat Herrmann HC, Pibarot P, Hueter I, Gertz ZM, Stewart WJ, Kapadia S, Tuzcu EM, Babaliaros V, Thourani V, Szeto WY, Bavaria JE, Kodali S, Hahn RT, Williams M, Miller DC, Douglas PS, Leon MB (2013) Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis. Circulation 127:2316–2326CrossRefPubMed Herrmann HC, Pibarot P, Hueter I, Gertz ZM, Stewart WJ, Kapadia S, Tuzcu EM, Babaliaros V, Thourani V, Szeto WY, Bavaria JE, Kodali S, Hahn RT, Williams M, Miller DC, Douglas PS, Leon MB (2013) Predictors of mortality and outcomes of therapy in low-flow severe aortic stenosis: a Placement of Aortic Transcatheter Valves (PARTNER) trial analysis. Circulation 127:2316–2326CrossRefPubMed
4.
Zurück zum Zitat Kataoka A, Watanabe Y, Kozuma K, Nara Y, Nagura F, Kawashima H, Hioki H, Nakashima M, Yamamoto M, Takagi K, Araki M, Tada N, Shirai S, Yamanaka F, Hayashida K (2018) Prognostic impact of low-flow severe aortic stenosis in small-body patients undergoing TAVR: the OCEAN-TAVI Registry. JACC Cardiovasc Imaging 11:659–669CrossRefPubMed Kataoka A, Watanabe Y, Kozuma K, Nara Y, Nagura F, Kawashima H, Hioki H, Nakashima M, Yamamoto M, Takagi K, Araki M, Tada N, Shirai S, Yamanaka F, Hayashida K (2018) Prognostic impact of low-flow severe aortic stenosis in small-body patients undergoing TAVR: the OCEAN-TAVI Registry. JACC Cardiovasc Imaging 11:659–669CrossRefPubMed
5.
Zurück zum Zitat Le Ven F, Freeman M, Webb J, Clavel MA, Wheeler M, Dumont É, Thompson C, De Larochellière R, Moss R, Doyle D, Ribeiro HB, Urena M, Nombela-Franco L, Rodés-Cabau J, Pibarot P (2013) Impact of low flow on the outcome of high-risk patients undergoing transcatheter aortic valve replacement. J Am Coll Cardiol 62:782–788CrossRefPubMed Le Ven F, Freeman M, Webb J, Clavel MA, Wheeler M, Dumont É, Thompson C, De Larochellière R, Moss R, Doyle D, Ribeiro HB, Urena M, Nombela-Franco L, Rodés-Cabau J, Pibarot P (2013) Impact of low flow on the outcome of high-risk patients undergoing transcatheter aortic valve replacement. J Am Coll Cardiol 62:782–788CrossRefPubMed
6.
Zurück zum Zitat Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C (2007) 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 297:1332–1343CrossRefPubMed Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C (2007) 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 297:1332–1343CrossRefPubMed
7.
Zurück zum Zitat Matsuzaki M, Hori M, Izumi T, Fukunami M (2011) 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:S33–45CrossRefPubMed Matsuzaki M, Hori M, Izumi T, Fukunami M (2011) 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:S33–45CrossRefPubMed
8.
Zurück zum Zitat Goldsmith SR, Bart BA, Burnett J (2014) Decongestive therapy and renal function in acute heart failure: time for a new approach? Circ Heart Fail 7:531–535CrossRefPubMed Goldsmith SR, Bart BA, Burnett J (2014) Decongestive therapy and renal function in acute heart failure: time for a new approach? Circ Heart Fail 7:531–535CrossRefPubMed
9.
Zurück zum Zitat Nomoto H, Satoh Y, Kamiyama M, Yabe K, Masumura M, Sakakibara A, Yamashita S, Suzuki M, Sugiyama T, Oumi T, Ohno M, Takahashi Y, Isobe M (2017) Mechanisms of diuresis for acute decompensated heart failure by tolvaptan. Int Heart 58:593–600CrossRef Nomoto H, Satoh Y, Kamiyama M, Yabe K, Masumura M, Sakakibara A, Yamashita S, Suzuki M, Sugiyama T, Oumi T, Ohno M, Takahashi Y, Isobe M (2017) Mechanisms of diuresis for acute decompensated heart failure by tolvaptan. Int Heart 58:593–600CrossRef
10.
Zurück zum Zitat Inomata T, Ikeda Y, Kida K, Shibagaki Y, Sato N, Kumagai Y, Shinagawa H, Ako J, Izumi T (2017) Effects of additive tolvaptan vs. increased furosemide on heart failure with diuretic resistance and renal impairment -results from the K-STAR study. Circ J 82:159–167CrossRefPubMed Inomata T, Ikeda Y, Kida K, Shibagaki Y, Sato N, Kumagai Y, Shinagawa H, Ako J, Izumi T (2017) Effects of additive tolvaptan vs. increased furosemide on heart failure with diuretic resistance and renal impairment -results from the K-STAR study. Circ J 82:159–167CrossRefPubMed
11.
Zurück zum Zitat Masuda T, Murakami T, Igarashi Y, Okabe K, Kobayashi T, Takeda SI, Saito T, Sekiguchi C, Miyazawa Y, Akimoto T, Saito O, Muto S, Nagata D (2016) Dual impact of tolvaptan on intracellular and extracellular water in chronic kidney disease patients with fluid retention. Intern Med 55:2759–2764CrossRefPubMedPubMedCentral Masuda T, Murakami T, Igarashi Y, Okabe K, Kobayashi T, Takeda SI, Saito T, Sekiguchi C, Miyazawa Y, Akimoto T, Saito O, Muto S, Nagata D (2016) Dual impact of tolvaptan on intracellular and extracellular water in chronic kidney disease patients with fluid retention. Intern Med 55:2759–2764CrossRefPubMedPubMedCentral
12.
Zurück zum Zitat Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD (2014) 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 63:e57–185CrossRefPubMed Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD (2014) 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 63:e57–185CrossRefPubMed
13.
Zurück zum Zitat Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL (2013) 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 128:1810–1852CrossRefPubMed Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL (2013) 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 128:1810–1852CrossRefPubMed
14.
Zurück zum Zitat Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU (2015) Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr 28:1–39CrossRef Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU (2015) Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr 28:1–39CrossRef
15.
Zurück zum Zitat Baumgartner H, Hung J, Bermejo J, Chambers JB, Evangelista A, Griffin BP, Iung B, Otto CM, Pellikka PA, Quiñones M (2009) Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr 22:1–23 (quiz 101–102) CrossRef Baumgartner H, Hung J, Bermejo J, Chambers JB, Evangelista A, Griffin BP, Iung B, Otto CM, Pellikka PA, Quiñones M (2009) Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr 22:1–23 (quiz 101–102) CrossRef
16.
Zurück zum Zitat Hachicha Z, Dumesnil JG, Pibarot P (2009) Usefulness of the valvuloarterial impedance to predict adverse outcome in asymptomatic aortic stenosis. J Am Coll Cardiol 54:1003–1011CrossRef Hachicha Z, Dumesnil JG, Pibarot P (2009) Usefulness of the valvuloarterial impedance to predict adverse outcome in asymptomatic aortic stenosis. J Am Coll Cardiol 54:1003–1011CrossRef
17.
Zurück zum Zitat Cramariuc D, Cioffi G, Rieck AE, Devereux RB, Staal EM, Ray S, Wachtell K, Gerdts E (2009) Low-flow aortic stenosis in asymptomatic patients. JACC Cardiovasc Imaging 2:390–399CrossRefPubMed Cramariuc D, Cioffi G, Rieck AE, Devereux RB, Staal EM, Ray S, Wachtell K, Gerdts E (2009) Low-flow aortic stenosis in asymptomatic patients. JACC Cardiovasc Imaging 2:390–399CrossRefPubMed
18.
Zurück zum Zitat Herrmann S, Störk S, Niemann M, Lange V, Strotmann JM, Frantz S, Beer M, Gattenlöhner S, Voelker W, Ertl G, Weidemann F (2011) Low-gradient aortic valve stenosis myocardial fibrosis and its influence on function and outcome. J Am Coll Cardiol 58:402–412CrossRef Herrmann S, Störk S, Niemann M, Lange V, Strotmann JM, Frantz S, Beer M, Gattenlöhner S, Voelker W, Ertl G, Weidemann F (2011) Low-gradient aortic valve stenosis myocardial fibrosis and its influence on function and outcome. J Am Coll Cardiol 58:402–412CrossRef
19.
Zurück zum Zitat Ambrosy A, Goldsmith SR, Gheorghiade M (2011) Tolvaptan for the treatment of heart failure: a review of the literature. Expert Opin Pharmacother 12:961–976CrossRefPubMed Ambrosy A, Goldsmith SR, Gheorghiade M (2011) Tolvaptan for the treatment of heart failure: a review of the literature. Expert Opin Pharmacother 12:961–976CrossRefPubMed
20.
Zurück zum Zitat Dohi K, Ito M (2014) Novel diuretic strategies for the treatment of heart failure in Japan. Circ J 78:1816–1823CrossRefPubMed Dohi K, Ito M (2014) Novel diuretic strategies for the treatment of heart failure in Japan. Circ J 78:1816–1823CrossRefPubMed
21.
Zurück zum Zitat Rajamannan NM, Evans FJ, Aikawa E, Grande-Allen KJ, Demer LL, Heistad DD, Simmons CA, Masters KS, Mathieu P, O'Brien KD, Schoen FJ, Towler DA, Yoganathan AP, Otto CM (2011) Calcific aortic valve disease: not simply a degenerative process: a review and agenda for research from the National Heart and Lung and Blood Institute Aortic Stenosis Working Group. Executive summary: calcific aortic valve disease-2011 update. Circulation 124:1783–1791CrossRefPubMedPubMedCentral Rajamannan NM, Evans FJ, Aikawa E, Grande-Allen KJ, Demer LL, Heistad DD, Simmons CA, Masters KS, Mathieu P, O'Brien KD, Schoen FJ, Towler DA, Yoganathan AP, Otto CM (2011) Calcific aortic valve disease: not simply a degenerative process: a review and agenda for research from the National Heart and Lung and Blood Institute Aortic Stenosis Working Group. Executive summary: calcific aortic valve disease-2011 update. Circulation 124:1783–1791CrossRefPubMedPubMedCentral
22.
Zurück zum Zitat Kinugawa K, Inomata T, Sato N, Yasuda M, Shimakawa T, Bando K, Mizuguchi K (2015) Effectiveness and adverse events of tolvaptan in octogenarians with heart failure. Interim analyses of Samsca Post-Marketing Surveillance In Heart faiLurE (SMILE study). Int Heart J 56:137–143CrossRefPubMed Kinugawa K, Inomata T, Sato N, Yasuda M, Shimakawa T, Bando K, Mizuguchi K (2015) Effectiveness and adverse events of tolvaptan in octogenarians with heart failure. Interim analyses of Samsca Post-Marketing Surveillance In Heart faiLurE (SMILE study). Int Heart J 56:137–143CrossRefPubMed
23.
Zurück zum Zitat Belziti CA, Bagnati R, Ledesma P, Vulcano N, Fernández S (2010) Worsening renal function in patients admitted with acute decompensated heart failure: incidence, risk factors and prognostic implications. Rev Esp Cardiol 63:294–302CrossRefPubMed Belziti CA, Bagnati R, Ledesma P, Vulcano N, Fernández S (2010) Worsening renal function in patients admitted with acute decompensated heart failure: incidence, risk factors and prognostic implications. Rev Esp Cardiol 63:294–302CrossRefPubMed
24.
Zurück zum Zitat Shirakabe A, Hata N, Yamamoto M, Kobayashi N, Shinada T, Tomita K, Tsurumi M, Matsushita M, Okazaki H, Yamamoto Y, Yokoyama S, Asai K, Shimizu W (2014) 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 78:911–921CrossRefPubMed Shirakabe A, Hata N, Yamamoto M, Kobayashi N, Shinada T, Tomita K, Tsurumi M, Matsushita M, Okazaki H, Yamamoto Y, Yokoyama S, Asai K, Shimizu W (2014) 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 78:911–921CrossRefPubMed
25.
Zurück zum Zitat Matsue Y, Suzuki M, Torii S, Yamaguchi S, Fukamizu S, Ono Y, Fujii H, Kitai T, Nishioka T, Sugi K, Onishi Y, Noda M, Kagiyama N, Satoh Y, Yoshida K, Goldsmith SR (2016) Clinical effectiveness of tolvaptan in patients with acute heart failure and renal dysfunction. J Card Fail 22:423–432CrossRefPubMed Matsue Y, Suzuki M, Torii S, Yamaguchi S, Fukamizu S, Ono Y, Fujii H, Kitai T, Nishioka T, Sugi K, Onishi Y, Noda M, Kagiyama N, Satoh Y, Yoshida K, Goldsmith SR (2016) Clinical effectiveness of tolvaptan in patients with acute heart failure and renal dysfunction. J Card Fail 22:423–432CrossRefPubMed
26.
Zurück zum Zitat Testani JM, Cappola TP, Brensinger CM, Shannon RP, Kimmel SE (2011) Interaction between loop diuretic-associated mortality and blood urea nitrogen concentration in chronic heart failure. J Am Coll Cardiol 58:375–382CrossRefPubMedPubMedCentral Testani JM, Cappola TP, Brensinger CM, Shannon RP, Kimmel SE (2011) Interaction between loop diuretic-associated mortality and blood urea nitrogen concentration in chronic heart failure. J Am Coll Cardiol 58:375–382CrossRefPubMedPubMedCentral
27.
Zurück zum Zitat Kajimoto K, Sato N, Takano T (2016) eGFR and outcomes in patients with acute decompensated heart failure with or without elevated BUN. Clin J Am Soc Nephrol 11:405–412CrossRefPubMedPubMedCentral Kajimoto K, Sato N, Takano T (2016) eGFR and outcomes in patients with acute decompensated heart failure with or without elevated BUN. Clin J Am Soc Nephrol 11:405–412CrossRefPubMedPubMedCentral
Metadaten
Titel
Clinical safety and efficacy of tolvaptan for acute phase therapy in patients with low-flow and normal-flow severe aortic stenosis
verfasst von
Miho Mitsui
Akihisa Kataoka
Yugo Nara
Fukuko Nagura
Hideyuki Kawashima
Hirofumi Hioki
Makoto Nakashima
Yusuke Watanabe
Naoyuki Yokoyama
Ken Kozuma
Publikationsdatum
16.04.2019
Verlag
Springer Japan
Erschienen in
Heart and Vessels / Ausgabe 10/2019
Print ISSN: 0910-8327
Elektronische ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-019-01411-3

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