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
N1 - Funding Information:
This study was sponsored by and statistical analysis of the data was conducted by Ikaria Inc, Clinton, New Jersey. General editorial support (eg, format, style) for this article was provided by Peloton Advantage LLC and funded by INO Therapeutics LLC, a subsidiary of Ikaria Inc.
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
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U2 - 10.1016/j.healun.2011.03.005
DO - 10.1016/j.healun.2011.03.005
M3 - Article
C2 - 21530317
AN - SCOPUS:79959984649
SN - 1053-2498
VL - 30
SP - 870
EP - 878
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 8
ER -