Effect of phosphodiesterase type 5 inhibitors on surgical outcome of ventricular septal defect and pulmonary hypertension patients; a randomized controlled trial

Abstract

Abstract Childrens with ventricular septal defect (VSD) and large systemic-to-pulmonary shunts eventually develop pulmonary hypertension (PH). The perioperative management of patients with VSD and PH is quite troublesome and still debatable, especially in developing countries where the different management options and standardization of treatment is not available. Oral phosphodiesterase type 5(PDE-5) inhibitors are good treatment option being widely available, cheap, of easy administration and does not require extensive monitoring. The aim of our study was to evaluate the effect of the PDE-5 inhibitors when given orally, early pre-operative and continued for 3 months postoperative on controlling post-operative PH with its effect on right ventricle (RV) functions. Fifty-one patients were randomly assigned to either Sildenafil or Tadalafil, 1 week before and continued for 3 months after corrective surgery. The control group received a placebo. There was no significant difference in the improvement in the RVSP between both groups, early in the post operative period (P = 0.255) and on follow up (P = 0.259). there was also no significant difference in the changes in mPAP, post-operatively and on follow up (P = 0.788 and 0.059 respectively). There was a drop in RV functions in both groups post-operatively which improved on follow up, however it was not significant between both groups. The length of ICU stay was similar between both groups (P = 0.143). Peri-operative administration of PDE-5 inhibitors does not have an impact on the clinical course as regard improvement in PA pressure, ventricular functions and ICU stay.