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Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery.

Publication ,  Journal Article
Ghadimi, K; Cappiello, JL; Wright, MC; Levy, JH; Bryner, BS; DeVore, AD; Schroder, JN; Patel, CB; Rajagopal, S; Shah, SH; Milano, CA ...
Published in: Circulation
October 24, 2023

BACKGROUND: Right ventricular failure (RVF) is a leading driver of morbidity and death after major cardiac surgery for advanced heart failure, including orthotopic heart transplantation and left ventricular assist device implantation. Inhaled pulmonary-selective vasodilators, such as inhaled epoprostenol (iEPO) and nitric oxide (iNO), are essential therapeutics for the prevention and medical management of postoperative RVF. However, there is limited evidence from clinical trials to guide agent selection despite the significant cost considerations of iNO therapy. METHODS: In this double-blind trial, participants were stratified by assigned surgery and key preoperative prognostic features, then randomized to continuously receive either iEPO or iNO beginning at the time of separation from cardiopulmonary bypass with the continuation of treatment into the intensive care unit stay. The primary outcome was the composite RVF rate after both operations, defined after transplantation by the initiation of mechanical circulatory support for isolated RVF, and defined after left ventricular assist device implantation by moderate or severe right heart failure according to criteria from the Interagency Registry for Mechanically Assisted Circulatory Support. An equivalence margin of 15 percentage points was prespecified for between-group RVF risk difference. Secondary postoperative outcomes were assessed for treatment differences and included: mechanical ventilation duration; hospital and intensive care unit length of stay during the index hospitalization; acute kidney injury development including renal replacement therapy initiation; and death at 30 days, 90 days, and 1 year after surgery. RESULTS: Of 231 randomized participants who met eligibility at the time of surgery, 120 received iEPO, and 111 received iNO. Primary outcome occurred in 30 participants (25.0%) in the iEPO group and 25 participants (22.5%) in the iNO group, for a risk difference of 2.5 percentage points (two one-sided test 90% CI, -6.6% to 11.6%) in support of equivalence. There were no significant between-group differences for any of the measured postoperative secondary outcomes. CONCLUSIONS: Among patients undergoing major cardiac surgery for advanced heart failure, inhaled pulmonary-selective vasodilator treatment using iEPO was associated with similar risks for RVF development and development of other postoperative secondary outcomes compared with treatment using iNO. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03081052.

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Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

October 24, 2023

Volume

148

Issue

17

Start / End Page

1316 / 1329

Location

United States

Related Subject Headings

  • Vasodilator Agents
  • Nitric Oxide
  • Humans
  • Heart Failure
  • Epoprostenol
  • Cardiovascular System & Hematology
  • Cardiac Surgical Procedures
  • Administration, Inhalation
  • 4207 Sports science and exercise
  • 3202 Clinical sciences
 

Citation

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Ghadimi, K., Cappiello, J. L., Wright, M. C., Levy, J. H., Bryner, B. S., DeVore, A. D., … INSPIRE-FLO Investigators, . (2023). Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery. Circulation, 148(17), 1316–1329. https://doi.org/10.1161/CIRCULATIONAHA.122.062464
Ghadimi, Kamrouz, Jhaymie L. Cappiello, Mary Cooter Wright, Jerrold H. Levy, Benjamin S. Bryner, Adam D. DeVore, Jacob N. Schroder, et al. “Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery.Circulation 148, no. 17 (October 24, 2023): 1316–29. https://doi.org/10.1161/CIRCULATIONAHA.122.062464.
Ghadimi K, Cappiello JL, Wright MC, Levy JH, Bryner BS, DeVore AD, et al. Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery. Circulation. 2023 Oct 24;148(17):1316–29.
Ghadimi, Kamrouz, et al. “Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery.Circulation, vol. 148, no. 17, Oct. 2023, pp. 1316–29. Pubmed, doi:10.1161/CIRCULATIONAHA.122.062464.
Ghadimi K, Cappiello JL, Wright MC, Levy JH, Bryner BS, DeVore AD, Schroder JN, Patel CB, Rajagopal S, Shah SH, Milano CA, INSPIRE-FLO Investigators. Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery. Circulation. 2023 Oct 24;148(17):1316–1329.

Published In

Circulation

DOI

EISSN

1524-4539

Publication Date

October 24, 2023

Volume

148

Issue

17

Start / End Page

1316 / 1329

Location

United States

Related Subject Headings

  • Vasodilator Agents
  • Nitric Oxide
  • Humans
  • Heart Failure
  • Epoprostenol
  • Cardiovascular System & Hematology
  • Cardiac Surgical Procedures
  • Administration, Inhalation
  • 4207 Sports science and exercise
  • 3202 Clinical sciences