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/cm(-5). 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, 2.8-16.3) in the iNO group compared with 12 of 77 (15.6%; 95% confidence interval, 7.5-23.7) 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.
authors.affiliation: Deutsches Herzzentrum Berlin, Berlin, Germany.
authors.forename: Evgenij
authors.initials: E
authors.lastname: Potapov
authors.forename: Dan
authors.initials: D
authors.lastname: Meyer
authors.forename: Madhav
authors.initials: M
authors.lastname: Swaminathan
authors.forename: Michael
authors.initials: M
authors.lastname: Ramsay
authors.forename: Aly
authors.initials: A
authors.lastname: El Banayosy
authors.forename: Christoph
authors.initials: C
authors.lastname: Diehl
authors.forename: Bryan
authors.initials: B
authors.lastname: Veynovich
authors.forename: Igor D
authors.initials: ID
authors.lastname: Gregoric
authors.forename: Marian
authors.initials: M
authors.lastname: Kukucka
authors.forename: Tom W
authors.initials: TW
authors.lastname: Gromann
authors.forename: Nandor
authors.initials: N
authors.lastname: Marczin
authors.forename: Kanti
authors.initials: K
authors.lastname: Chittuluru
authors.forename: James S
authors.initials: JS
authors.lastname: Baldassarre
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Zucker
authors.forename: Roland
authors.initials: R
authors.lastname: Hetzer
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D059035:Perioperative Period; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D014655:Vascular Resistance / Q000187:drug effects; D018497:Ventricular Dysfunction, Right / Q000503:physiopathology / Q000517:prevention & control*
chemical_list: D009569:Nitric Oxide