Adaptive servo-ventilation therapy for patients with chronic heart failure in a confirmatory, multicenter, randomized, controlled study

SAVIOR-C Investigators

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

Background: Adaptive servo-ventilation (ASV) therapy is expected to be novel nonpharmacotherapy with hemodynamic effects on patients with chronic heart failure (CHF), but sufficient evidence has not been obtained. Methods and Results: A 24-week, open-label, randomized, controlled study was performed to confirm the cardiac function-improving effect of ASV therapy on CHF patients. At 39 institutions, 213 outpatients with CHF, whose left ventricular ejection fraction (LVEF) was <40% and who had mild to severe symptoms [New York Heart Association (NYHA) class: ≥II], were enrolled. After excluding 8 patients, 102 and 103 underwent ASV plus guideline-directed medical therapy (GDMT) [ASV group] and GDMT only [control group], respectively. The primary endpoint was LVEF, and the secondary endpoints were HF deterioration, B-type natriuretic peptide (BNP), and clinical composite response (CCR: NYHA class+HF deterioration). LVEF and BNP improved significantly at completion against the baseline values in the 2 groups. However, no significant difference was found between these groups. HF deterioration tended to be suppressed. The ASV group showed a significant improvement in CCR corroborated by significant improvements in NYHA class and ADL against the control group. Conclusions: Under the present study’s conditions, ASV therapy was not superior to GDMT in the cardiac functionimproving effect but showed a clinical status-improving effect, thus indicating a given level of clinical benefit.

Original languageEnglish
Pages (from-to)982-990
Number of pages9
JournalCirculation Journal
Volume79
Issue number5
DOIs
Publication statusPublished - 2015

Fingerprint

Ventilation
Heart Failure
Stroke Volume
Brain Natriuretic Peptide
Guidelines
Therapeutics
Control Groups
Activities of Daily Living
Outpatients
Hemodynamics

Keywords

  • Adaptive servo-ventilation
  • Cardiac function
  • Chronic heart failure
  • Noninvasive positive pressure ventilation
  • Nonpharmacotherapy

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Adaptive servo-ventilation therapy for patients with chronic heart failure in a confirmatory, multicenter, randomized, controlled study. / SAVIOR-C Investigators.

In: Circulation Journal, Vol. 79, No. 5, 2015, p. 982-990.

Research output: Contribution to journalArticle

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abstract = "Background: Adaptive servo-ventilation (ASV) therapy is expected to be novel nonpharmacotherapy with hemodynamic effects on patients with chronic heart failure (CHF), but sufficient evidence has not been obtained. Methods and Results: A 24-week, open-label, randomized, controlled study was performed to confirm the cardiac function-improving effect of ASV therapy on CHF patients. At 39 institutions, 213 outpatients with CHF, whose left ventricular ejection fraction (LVEF) was <40{\%} and who had mild to severe symptoms [New York Heart Association (NYHA) class: ≥II], were enrolled. After excluding 8 patients, 102 and 103 underwent ASV plus guideline-directed medical therapy (GDMT) [ASV group] and GDMT only [control group], respectively. The primary endpoint was LVEF, and the secondary endpoints were HF deterioration, B-type natriuretic peptide (BNP), and clinical composite response (CCR: NYHA class+HF deterioration). LVEF and BNP improved significantly at completion against the baseline values in the 2 groups. However, no significant difference was found between these groups. HF deterioration tended to be suppressed. The ASV group showed a significant improvement in CCR corroborated by significant improvements in NYHA class and ADL against the control group. Conclusions: Under the present study’s conditions, ASV therapy was not superior to GDMT in the cardiac functionimproving effect but showed a clinical status-improving effect, thus indicating a given level of clinical benefit.",
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AU - Kihara, Yasuki

AU - Adachi, Hitoshi

AU - Yasumura, Yoshio

AU - Yokoyama, Hiroyuki

AU - Wada, Hiroshi

AU - Ise, Takayuki

AU - Tanaka, Koichi

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AU - Sata, M.

AU - Ise, T.

AU - Yagi, S.

AU - Tanaka, K.

AU - Kobayashi, K.

AU - Orita, Y.

AU - Taniguchi, Y.

AU - Oishi, S.

AU - Yokoi, K.

AU - Kihara, Y.

AU - Oda, N.

AU - Hidaka, T.

AU - Kajikawa, M.

AU - Watanabe, Y.

AU - Yokoyama, H.

AU - Anzai, T.

AU - Nakamura, K.

AU - Sugano, Y.

AU - Yasuda, M.

AU - Fukumitsu, M.

AU - Nakayama, T.

AU - Kasai, T.

AU - Ito, M.

AU - Kumagai, N.

AU - Sato, Y.

AU - Dohi, K.

AU - Tanimura, M.

AU - Watanabe, K.

AU - Haruki, N.

AU - Seino, Y.

AU - Inami, T.

AU - Kato, T.

AU - Hiraiwa, H.

AU - Kondo, T.

AU - Ishihara, T.

AU - Fukuda, Keiichi

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N2 - Background: Adaptive servo-ventilation (ASV) therapy is expected to be novel nonpharmacotherapy with hemodynamic effects on patients with chronic heart failure (CHF), but sufficient evidence has not been obtained. Methods and Results: A 24-week, open-label, randomized, controlled study was performed to confirm the cardiac function-improving effect of ASV therapy on CHF patients. At 39 institutions, 213 outpatients with CHF, whose left ventricular ejection fraction (LVEF) was <40% and who had mild to severe symptoms [New York Heart Association (NYHA) class: ≥II], were enrolled. After excluding 8 patients, 102 and 103 underwent ASV plus guideline-directed medical therapy (GDMT) [ASV group] and GDMT only [control group], respectively. The primary endpoint was LVEF, and the secondary endpoints were HF deterioration, B-type natriuretic peptide (BNP), and clinical composite response (CCR: NYHA class+HF deterioration). LVEF and BNP improved significantly at completion against the baseline values in the 2 groups. However, no significant difference was found between these groups. HF deterioration tended to be suppressed. The ASV group showed a significant improvement in CCR corroborated by significant improvements in NYHA class and ADL against the control group. Conclusions: Under the present study’s conditions, ASV therapy was not superior to GDMT in the cardiac functionimproving effect but showed a clinical status-improving effect, thus indicating a given level of clinical benefit.

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KW - Cardiac function

KW - Chronic heart failure

KW - Noninvasive positive pressure ventilation

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