Featured mechanical circulatory support articleInhaled nitric oxide after left ventricular assist device implantation: A prospective, randomized, double-blind, multicenter, placebo-controlled trial
Section snippets
Methods
This study was conducted at 8 centers in the United States and Germany between September 2003 and March 2008. Each country's national health authority and local Investigational Review Board/Ethics Committees approved the study. Consent of participating patients was obtained according to local requirements. The study was designed and monitored by a Steering Committee (Appendix 1). An independent Data and Safety Monitoring Committee reviewed unblinded safety data. Investigators are listed in
Results
The study included 150 patients, with 73 randomized to the iNO group and 77 to the placebo groups. The study therapy was not administered to 13 patients (4 iNO, 9 placebo), resulting in 137 patients for the safety and per-protocol populations, comprising 69 in the iNO group and 68 in the placebo group (Figure 1).
In the ITT population, the iNO group had a higher mean age compared with placebo; both groups were otherwise well matched in demographics and baseline characteristics (Table 2),
Discussion
Right heart dysfunction is still a major complication of LVAD placement.5, 7 Elevated PVR is a pre-operative risk factor for morbidities,12, 14 and the absence of pulmonary vasoreactivity confers a worse prognosis.23 Inhaled NO selectively reduces PVR in patients undergoing cardiac surgical procedures.12 Reduction in PVR decreases RV afterload, which in turn may prevent RVD. Numerous strategies have been used to avoid RVD after LVAD placement, including optimizing device placement timing by
Disclosure statement
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.
All authors were responsible for data analysis and interpretation, as well as the development and final approval of the paper. Conception and design of the study were conducted by the Steering Committee members listed in
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2023, Nitric Oxide in Health and Disease: Therapeutic Applications in Cancer and Inflammatory DisordersInhaled nitric oxide for ECPELLA management in fulminant myocarditis complicated with severe right ventricular dysfunction: A case report
2022, Journal of Cardiology CasesCitation Excerpt :Our case suggested a novel strategy of additive iNO for patients with biventricular dysfunction supported by ECPELLA. However, some previous studies showed that the routine perioperative use of iNO in patients with LVAD implantation did not lead to favorable outcomes [4,10]. Because prolonged MCS treatment leads to various complications including bleeding, thrombotic events, and infection, precise weaning timing of MCS should constantly be considered.
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2020, Cardiology ClinicsCitation Excerpt :If high PVR is present in the setting of RHF, RV afterload can be reduced with pulmonary vasodilators as the primary therapy. In the acute setting, inhaled nitric oxide or inhaled or systemic administration of prostacyclins are effective in reducing PVR and decreasing RV afterload.3,28–30 In the chronic setting of RHF, oral therapy with the endothelin receptor antagonist, bosentan, and the phosphodiesterase-5 inhibitor, sildenafil, have been shown to have important benefits in decreasing RV afterload.31
Right ventricle failure in patients treated with left ventricular assist device
2020, Annales de Cardiologie et d'Angeiologie
CLINICAL TRIALS IDENTIFIER: NCT00060840; www.clinicaltrials.gov/ct2/results?term=NCT00060840