Inhaled nitric oxide after left ventricular assist device implantation: A prospective, randomized, double-blind, multicenter, placebo-controlled trial

Evgenij Potapov, Dan Meyer, Madhav Swaminathan, Michael Ramsay, Aly El Banayosy, Christoph Diehl, Bryan Veynovich, Igor D. Gregoric, Marian Kukucka, Tom W. Gromann, Nandor Marczin, Kanti Chittuluru, James S. Baldassarre, Mark J. Zucker, Roland Hetzer

Research output: Contribution to journalArticle

59 Citations (Scopus)

Abstract

Background: Used frequently for right ventricular dysfunction (RVD), the clinical benefit of inhaled nitric oxide (iNO) is still unclear. We conducted a randomized, double-blind, controlled trial to determine the effect of iNO on post-operative outcomes in the setting of left ventricular assist device (LVAD) placement. Methods: Included were 150 patients undergoing LVAD placement with pulmonary vascular resistance <200 dyne/sec/cm5. Patients received iNO (40 ppm) or placebo (an equivalent concentration of nitrogen) until 48 hours after separation from cardiopulmonary bypass, extubation, or upon meeting study-defined RVD. For ethical reasons, crossover to open-label iNO was allowed during the 48-hour treatment period if RVD criteria were met. Results: RVD criteria were met by 7 of 73 patients (9.6%; 95% confidence interval, 2.816.3) in the iNO group compared with 12 of 77 (15.6%; 95% confidence interval, 7.523.7) who received placebo (p = 0.330). Time on mechanical ventilation decreased in the iNO group (median days, 2.0 vs 3.0; p = 0.077), and fewer patients in the iNO group required an RVAD (5.6% vs 10%; p = 0.468); however, these trends did not meet statistical boundaries of significance. Hospital stay, intensive care unit stay, and 28-day mortality rates were similar between groups, as were adverse events. Thirty-five patients crossed over to open-label iNO (iNO, n = 15; placebo, n = 20). Eighteen patients (iNO, n = 9; placebo, n = 9) crossed over before RVD criteria were met. Conclusions: Use of iNO at 40 ppm in the perioperative phase of LVAD implantation did not achieve significance for the primary end point of reduction in RVD. Similarly, secondary end points of time on mechanical ventilation, hospital or intensive care unit stay, and the need for RVAD support after LVAD placement were not significantly improved.

Original languageEnglish (US)
Pages (from-to)870-878
Number of pages9
JournalJournal of Heart and Lung Transplantation
Volume30
Issue number8
DOIs
StatePublished - Aug 2011

Fingerprint

Heart-Assist Devices
Nitric Oxide
Right Ventricular Dysfunction
Placebos
Artificial Respiration
Intensive Care Units
Confidence Intervals
Cardiopulmonary Bypass
Vascular Resistance
Length of Stay
Nitrogen

Keywords

  • heart failure
  • heart-assist device
  • nitric oxide
  • ventilation

ASJC Scopus subject areas

  • Transplantation
  • Cardiology and Cardiovascular Medicine
  • Pulmonary and Respiratory Medicine
  • Surgery

Cite this

Inhaled nitric oxide after left ventricular assist device implantation : A prospective, randomized, double-blind, multicenter, placebo-controlled trial. / Potapov, Evgenij; Meyer, Dan; Swaminathan, Madhav; Ramsay, Michael; El Banayosy, Aly; Diehl, Christoph; Veynovich, Bryan; Gregoric, Igor D.; Kukucka, Marian; Gromann, Tom W.; Marczin, Nandor; Chittuluru, Kanti; Baldassarre, James S.; Zucker, Mark J.; Hetzer, Roland.

In: Journal of Heart and Lung Transplantation, Vol. 30, No. 8, 08.2011, p. 870-878.

Research output: Contribution to journalArticle

Potapov, E, Meyer, D, Swaminathan, M, Ramsay, M, El Banayosy, A, Diehl, C, Veynovich, B, Gregoric, ID, Kukucka, M, Gromann, TW, Marczin, N, Chittuluru, K, Baldassarre, JS, Zucker, MJ & Hetzer, R 2011, 'Inhaled nitric oxide after left ventricular assist device implantation: A prospective, randomized, double-blind, multicenter, placebo-controlled trial', Journal of Heart and Lung Transplantation, vol. 30, no. 8, pp. 870-878. https://doi.org/10.1016/j.healun.2011.03.005
Potapov, Evgenij ; Meyer, Dan ; Swaminathan, Madhav ; Ramsay, Michael ; El Banayosy, Aly ; Diehl, Christoph ; Veynovich, Bryan ; Gregoric, Igor D. ; Kukucka, Marian ; Gromann, Tom W. ; Marczin, Nandor ; Chittuluru, Kanti ; Baldassarre, James S. ; Zucker, Mark J. ; Hetzer, Roland. / Inhaled nitric oxide after left ventricular assist device implantation : A prospective, randomized, double-blind, multicenter, placebo-controlled trial. In: Journal of Heart and Lung Transplantation. 2011 ; Vol. 30, No. 8. pp. 870-878.
@article{7e1ed3352f94441fa7c79a77a3503a80,
title = "Inhaled nitric oxide after left ventricular assist device implantation: A prospective, randomized, double-blind, multicenter, placebo-controlled trial",
abstract = "Background: Used frequently for right ventricular dysfunction (RVD), the clinical benefit of inhaled nitric oxide (iNO) is still unclear. We conducted a randomized, double-blind, controlled trial to determine the effect of iNO on post-operative outcomes in the setting of left ventricular assist device (LVAD) placement. Methods: Included were 150 patients undergoing LVAD placement with pulmonary vascular resistance <200 dyne/sec/cm5. Patients received iNO (40 ppm) or placebo (an equivalent concentration of nitrogen) until 48 hours after separation from cardiopulmonary bypass, extubation, or upon meeting study-defined RVD. For ethical reasons, crossover to open-label iNO was allowed during the 48-hour treatment period if RVD criteria were met. Results: RVD criteria were met by 7 of 73 patients (9.6{\%}; 95{\%} confidence interval, 2.816.3) in the iNO group compared with 12 of 77 (15.6{\%}; 95{\%} confidence interval, 7.523.7) who received placebo (p = 0.330). Time on mechanical ventilation decreased in the iNO group (median days, 2.0 vs 3.0; p = 0.077), and fewer patients in the iNO group required an RVAD (5.6{\%} vs 10{\%}; p = 0.468); however, these trends did not meet statistical boundaries of significance. Hospital stay, intensive care unit stay, and 28-day mortality rates were similar between groups, as were adverse events. Thirty-five patients crossed over to open-label iNO (iNO, n = 15; placebo, n = 20). Eighteen patients (iNO, n = 9; placebo, n = 9) crossed over before RVD criteria were met. Conclusions: Use of iNO at 40 ppm in the perioperative phase of LVAD implantation did not achieve significance for the primary end point of reduction in RVD. Similarly, secondary end points of time on mechanical ventilation, hospital or intensive care unit stay, and the need for RVAD support after LVAD placement were not significantly improved.",
keywords = "heart failure, heart-assist device, nitric oxide, ventilation",
author = "Evgenij Potapov and Dan Meyer and Madhav Swaminathan and Michael Ramsay and {El Banayosy}, Aly and Christoph Diehl and Bryan Veynovich and Gregoric, {Igor D.} and Marian Kukucka and Gromann, {Tom W.} and Nandor Marczin and Kanti Chittuluru and Baldassarre, {James S.} and Zucker, {Mark J.} and Roland Hetzer",
year = "2011",
month = "8",
doi = "10.1016/j.healun.2011.03.005",
language = "English (US)",
volume = "30",
pages = "870--878",
journal = "Journal of Heart and Lung Transplantation",
issn = "1053-2498",
publisher = "Elsevier USA",
number = "8",

}

TY - JOUR

T1 - Inhaled nitric oxide after left ventricular assist device implantation

T2 - A prospective, randomized, double-blind, multicenter, placebo-controlled trial

AU - Potapov, Evgenij

AU - Meyer, Dan

AU - Swaminathan, Madhav

AU - Ramsay, Michael

AU - El Banayosy, Aly

AU - Diehl, Christoph

AU - Veynovich, Bryan

AU - Gregoric, Igor D.

AU - Kukucka, Marian

AU - Gromann, Tom W.

AU - Marczin, Nandor

AU - Chittuluru, Kanti

AU - Baldassarre, James S.

AU - Zucker, Mark J.

AU - Hetzer, Roland

PY - 2011/8

Y1 - 2011/8

N2 - Background: Used frequently for right ventricular dysfunction (RVD), the clinical benefit of inhaled nitric oxide (iNO) is still unclear. We conducted a randomized, double-blind, controlled trial to determine the effect of iNO on post-operative outcomes in the setting of left ventricular assist device (LVAD) placement. Methods: Included were 150 patients undergoing LVAD placement with pulmonary vascular resistance <200 dyne/sec/cm5. Patients received iNO (40 ppm) or placebo (an equivalent concentration of nitrogen) until 48 hours after separation from cardiopulmonary bypass, extubation, or upon meeting study-defined RVD. For ethical reasons, crossover to open-label iNO was allowed during the 48-hour treatment period if RVD criteria were met. Results: RVD criteria were met by 7 of 73 patients (9.6%; 95% confidence interval, 2.816.3) in the iNO group compared with 12 of 77 (15.6%; 95% confidence interval, 7.523.7) who received placebo (p = 0.330). Time on mechanical ventilation decreased in the iNO group (median days, 2.0 vs 3.0; p = 0.077), and fewer patients in the iNO group required an RVAD (5.6% vs 10%; p = 0.468); however, these trends did not meet statistical boundaries of significance. Hospital stay, intensive care unit stay, and 28-day mortality rates were similar between groups, as were adverse events. Thirty-five patients crossed over to open-label iNO (iNO, n = 15; placebo, n = 20). Eighteen patients (iNO, n = 9; placebo, n = 9) crossed over before RVD criteria were met. Conclusions: Use of iNO at 40 ppm in the perioperative phase of LVAD implantation did not achieve significance for the primary end point of reduction in RVD. Similarly, secondary end points of time on mechanical ventilation, hospital or intensive care unit stay, and the need for RVAD support after LVAD placement were not significantly improved.

AB - Background: Used frequently for right ventricular dysfunction (RVD), the clinical benefit of inhaled nitric oxide (iNO) is still unclear. We conducted a randomized, double-blind, controlled trial to determine the effect of iNO on post-operative outcomes in the setting of left ventricular assist device (LVAD) placement. Methods: Included were 150 patients undergoing LVAD placement with pulmonary vascular resistance <200 dyne/sec/cm5. Patients received iNO (40 ppm) or placebo (an equivalent concentration of nitrogen) until 48 hours after separation from cardiopulmonary bypass, extubation, or upon meeting study-defined RVD. For ethical reasons, crossover to open-label iNO was allowed during the 48-hour treatment period if RVD criteria were met. Results: RVD criteria were met by 7 of 73 patients (9.6%; 95% confidence interval, 2.816.3) in the iNO group compared with 12 of 77 (15.6%; 95% confidence interval, 7.523.7) who received placebo (p = 0.330). Time on mechanical ventilation decreased in the iNO group (median days, 2.0 vs 3.0; p = 0.077), and fewer patients in the iNO group required an RVAD (5.6% vs 10%; p = 0.468); however, these trends did not meet statistical boundaries of significance. Hospital stay, intensive care unit stay, and 28-day mortality rates were similar between groups, as were adverse events. Thirty-five patients crossed over to open-label iNO (iNO, n = 15; placebo, n = 20). Eighteen patients (iNO, n = 9; placebo, n = 9) crossed over before RVD criteria were met. Conclusions: Use of iNO at 40 ppm in the perioperative phase of LVAD implantation did not achieve significance for the primary end point of reduction in RVD. Similarly, secondary end points of time on mechanical ventilation, hospital or intensive care unit stay, and the need for RVAD support after LVAD placement were not significantly improved.

KW - heart failure

KW - heart-assist device

KW - nitric oxide

KW - ventilation

UR - http://www.scopus.com/inward/record.url?scp=79959984649&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79959984649&partnerID=8YFLogxK

U2 - 10.1016/j.healun.2011.03.005

DO - 10.1016/j.healun.2011.03.005

M3 - Article

C2 - 21530317

AN - SCOPUS:79959984649

VL - 30

SP - 870

EP - 878

JO - Journal of Heart and Lung Transplantation

JF - Journal of Heart and Lung Transplantation

SN - 1053-2498

IS - 8

ER -