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CLINICAL TRIAL
COMPARATIVE STUDY
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
Inhaled Nitric Oxide as a Preoperative Test (INOP Test I): the INOP Test Study Group.
Circulation 2002 September 25
BACKGROUND: This study was performed to determine whether a preoperative hemodynamic evaluation with oxygen and inhaled nitric oxide identifies patients with pulmonary hypertension who are appropriate candidates for corrective cardiac surgery or transplantation more accurately than an evaluation with oxygen alone.
METHODS AND RESULTS: At 10 institutions, 124 patients with heart disease and severe pulmonary hypertension underwent cardiac catheterization to determine operability. The ratio of pulmonary and systemic vascular resistance (Rp:Rs) was determined at baseline while breathing approximately 21% to 30% oxygen, and in approximately 100% oxygen and approximately 100% oxygen with 10 to 80 parts per million nitric oxide to evaluate pulmonary vascular reactivity. Surgery was performed in 74 patients. Twelve patients died or developed right heart failure secondary to pulmonary hypertension following surgery. Rp:Rs<0.33 and a 20% decrease in Rp:Rs from baseline were chosen as 2 criteria for operability to determine, in retrospect, the efficacy of preoperative testing in patient selection. In comparison to an evaluation with oxygen alone, sensitivity (64% versus 97%) and accuracy (68% versus 90%) were increased by an evaluation with oxygen and nitric oxide when Rp:Rs<0.33 was used as the criterion for operability. Specificity was only 8% when a 20% decrease in Rp:Rs from baseline was used as the criterion for operability.
CONCLUSION: By using a combination of oxygen and inhaled nitric oxide, a greater number of appropriate candidates for corrective cardiac surgery or transplantation can be identified during preoperative testing when a specific value of Rp:Rs is used as a criterion for operability.
METHODS AND RESULTS: At 10 institutions, 124 patients with heart disease and severe pulmonary hypertension underwent cardiac catheterization to determine operability. The ratio of pulmonary and systemic vascular resistance (Rp:Rs) was determined at baseline while breathing approximately 21% to 30% oxygen, and in approximately 100% oxygen and approximately 100% oxygen with 10 to 80 parts per million nitric oxide to evaluate pulmonary vascular reactivity. Surgery was performed in 74 patients. Twelve patients died or developed right heart failure secondary to pulmonary hypertension following surgery. Rp:Rs<0.33 and a 20% decrease in Rp:Rs from baseline were chosen as 2 criteria for operability to determine, in retrospect, the efficacy of preoperative testing in patient selection. In comparison to an evaluation with oxygen alone, sensitivity (64% versus 97%) and accuracy (68% versus 90%) were increased by an evaluation with oxygen and nitric oxide when Rp:Rs<0.33 was used as the criterion for operability. Specificity was only 8% when a 20% decrease in Rp:Rs from baseline was used as the criterion for operability.
CONCLUSION: By using a combination of oxygen and inhaled nitric oxide, a greater number of appropriate candidates for corrective cardiac surgery or transplantation can be identified during preoperative testing when a specific value of Rp:Rs is used as a criterion for operability.
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