BACKGROUND:Prostaglandin E1 (PGE1) is a potent vasodilating drug, which has been used in treatment of primary pulmonary hypertension. However intravenous PGE1 infusion may be of benefit and also has been proposed as a therapeutic tool in patients with end-stage heart failure. The aim of this prospective not randomized study was to assess the clinical and instrumental effects of this agent in patients with severe heart failure and pulmonary hypertension. METHODS: To investigate the effects of PGE1 in congestive heart failure we selected 22 consecutive patients (16 males, 6 females, mean age 63±2 years) in the mean NYHA class III, because they had pulmonary hypertension (PAPs>3 m/s and left ventricular ejection fraction (LVEF) ≤35% by echocardiography. A control group of 23 patients (19M, 4F mean age 62±5 years; 9 patients were in the NYHA class IV and 14 in the NYHA class III), with the same instrumental and clinical data, received anoptimized oral treatment with beta-blockers, ACE-inhibitors, furosemide and digitalis. Right heart catheterization was performed to confirm and determine the type of pulmonary hypertension, before starting the PGE1 infusion. Clinical and echocardiography evaluation was performed during follow-up. PGE1 was infused at a mean dose of 10 ng/kg/min for a total of 24 h over three consecutive days every three months. RESULTS: Right heart catheterization confirmed a high systolic pulmonary pressure in all patients; pre-capillary pulmonary hypertension (mean PAP>25 mm/Hg) was 25%. During a mean follow-up of 36±6 months, 16 patients died (10 in the control group and 6 in the PGE1 group). The Kaplan-Meier 3-years survival analysis was not statistically significant (Log-rank test), but at 2 months survival rates began to diverge; 36 months survival: 72.7% in the PGE1 group and 56% in the control group. The mean LVEF increased from 25.78% to 32.1% in the PGE1 group and from 23.38% to 26.15 in the control group (p<0.001); the NYHA mean class improved from 3.18 to 2.24 in the PGE1 group and from 3.46 to 3.38 in the control group (p<0.05). The PAP decreased from 57.65 to 40.82 mm/Hg (p<0.001). An AICD was implanted in 3 patients in the first group and in 5 patients in the control group. Two patients were added to the heart transplantation list. CONCLUSION: These preliminary data suggest that intermittent PGE1 infusion in patients with advanced congestive heart failure and high pulmonary pressure is able to improve NYHA mean class (p<0.05), ventricular contractility (LVEF p<0.001), pulmonary pressure and clinical data. It hasn't been associated to morbid events or increased risk of death.
RCT Entities:
BACKGROUND:Prostaglandin E1 (PGE1) is a potent vasodilating drug, which has been used in treatment of primary pulmonary hypertension. However intravenous PGE1 infusion may be of benefit and also has been proposed as a therapeutic tool in patients with end-stage heart failure. The aim of this prospective not randomized study was to assess the clinical and instrumental effects of this agent in patients with severe heart failure and pulmonary hypertension. METHODS: To investigate the effects of PGE1 in congestive heart failure we selected 22 consecutive patients (16 males, 6 females, mean age 63±2 years) in the mean NYHA class III, because they had pulmonary hypertension (PAPs>3 m/s and left ventricular ejection fraction (LVEF) ≤35% by echocardiography. A control group of 23 patients (19M, 4F mean age 62±5 years; 9 patients were in the NYHA class IV and 14 in the NYHA class III), with the same instrumental and clinical data, received an optimized oral treatment with beta-blockers, ACE-inhibitors, furosemide and digitalis. Right heart catheterization was performed to confirm and determine the type of pulmonary hypertension, before starting the PGE1 infusion. Clinical and echocardiography evaluation was performed during follow-up. PGE1 was infused at a mean dose of 10 ng/kg/min for a total of 24 h over three consecutive days every three months. RESULTS: Right heart catheterization confirmed a high systolic pulmonary pressure in all patients; pre-capillary pulmonary hypertension (mean PAP>25 mm/Hg) was 25%. During a mean follow-up of 36±6 months, 16 patients died (10 in the control group and 6 in the PGE1 group). The Kaplan-Meier 3-years survival analysis was not statistically significant (Log-rank test), but at 2 months survival rates began to diverge; 36 months survival: 72.7% in the PGE1 group and 56% in the control group. The mean LVEF increased from 25.78% to 32.1% in the PGE1 group and from 23.38% to 26.15 in the control group (p<0.001); the NYHA mean class improved from 3.18 to 2.24 in the PGE1 group and from 3.46 to 3.38 in the control group (p<0.05). The PAP decreased from 57.65 to 40.82 mm/Hg (p<0.001). An AICD was implanted in 3 patients in the first group and in 5 patients in the control group. Two patients were added to the heart transplantation list. CONCLUSION: These preliminary data suggest that intermittent PGE1 infusion in patients with advanced congestive heart failure and high pulmonary pressure is able to improve NYHA mean class (p<0.05), ventricular contractility (LVEF p<0.001), pulmonary pressure and clinical data. It hasn't been associated to morbid events or increased risk of death.
Authors: Nehal Hussain; Athanasios Charalampopoulos; Sheila Ramjug; Robin Condliffe; Charlie A Elliot; Laurence O'Toole; Andrew Swift; David G Kiely Journal: Pulm Circ Date: 2016-03 Impact factor: 3.017