Sildenafil for the Treatment of Pulmonary Hypertension in the Early Postoperative Period after Mitral Valve Surgery
Eilon Ram, Leonid Sternik, Eyal Nachum, Robert Klempfner, Dina Kogan, Michael Eldar, Ilan Goldenberg, Ehud Raanani, Alexander Kogan.
Sheba Medical Center, Israel, Jerusalem, Israel.
OBJECTIVE: Phosphodiesterase-5 inhibitor sildenafil was developed for the treatment of pulmonary arterial hypertension. We investigated the efficacy and safety of the sildenafil in the early postoperative period after mitral valve surgery in the patients with pulmonary hypertension.
METHODS: We perform double-blinded, placebo-controlled randomized trial. Fifty consecutive patients, who underwent mitral valve surgery, suffered from pulmonary hypertension were randomly assigned into two groups, 25 patients in each: group A received 10-25 ppm of inhaled NO after disconnection from cardiopulmonary bypass and followed sildenafil 50 mg every 8 hours during 72 postoperative hours, and group B received also 10-25 ppm of inhaled NO and followed placebo. Inhaled NO was discontinued after extubation. Hemodynamic parameters were studied by using pulmonary artery catheter at baseline, and every 8 hours up to 72 hours.
RESULTS: Patients in group A (inhaled NO and sildenafil) had decreasing of mean pulmonary artery pressure (mPAP), from 38.2±11.6 mm Hg at baseline to 17.7±5.6 mm Hg and pulmonary vascular resistance (PVR) from 497±202 dyn x sec x cm(-5) to 123±54 dyn x sec x cm(-5) after 72 hours. Patients in group B (inhaled NO and placebo) also had decreasing of mPAP from 36.2±10.7 mmHg to 24.7±8.2 mmHg and PVR from 45±169 dyn x sec x cm(-5) to 193±67 dyn x sec x cm(-5). Mean PAP after 72 hours in the group A (17.7±5.6 mmHg) was significantly lower than in the group B (24.7±8.2 mmHg) (p <0.05). No significant changes in systemic hemodynamic and oxygenation were observed.
CONCLUSIONS: The combination of sildenafil and inhaled NO versus inhaled NO alone, in the early postoperative period in patients suffered from pulmonary hypertension undergoing mitral valve surgery, is safe and results in an additive favorable effect on pulmonary arterial pressure and pulmonary vascular resistance, without systemic hypotension and ventilation/perfusion mismatch.
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