Routine Sildenafil Does Not Improve Clinical Outcomes After Fontan Operation
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Updated: Feb 23, 2026

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Published on: March 15, 2024
J Leslie Gaddis Collins1, Mark A Law1, Santiago Borasino2
1Division of Pediatric Cardiology, University of Alabama at Birmingham, Birmingham, AL, 35233, USA.
Insights
Early postoperative intravenous sildenafil did not improve outcomes for Fontan operation patients. This study found no reduction in chest tube output or hospital length of stay, and longer ventilation times.
Area of Science:
- Pediatric Cardiology
- Cardiovascular Surgery
- Pharmacology
Background:
- Fontan operation can lead to persistent chest tube output (CTO), increasing hospital length of stay (LOS).
- Postoperative sildenafil has shown promise in improving outcomes for select Fontan patients.
Purpose of the Study:
- To evaluate the impact of early postoperative intravenous (IV) sildenafil on reducing LOS and CTO in patients undergoing Fontan operation.
- To assess the safety and efficacy of a standardized sildenafil protocol in the early postoperative period.
Main Methods:
- A practice change involved administering IV sildenafil to 19 patients post-Fontan operation (Feb 2014-May 2016).
- The protocol included IV sildenafil followed by enteral administration until discharge.
- Outcomes were compared to 84 pre-protocol control patients.
Main Results:
- The sildenafil group experienced longer median LOS (13 vs. 9 days) and CTO days (8 vs. 6 days).
- Mechanical ventilation (6.9 vs. 4 h) and oxygen therapy (99 vs. 14.5 h) durations were significantly longer in the sildenafil group.
- No significant differences were observed in inotrope score, maximum lactate, fluid balance, or readmission rates. No mortality occurred.
Conclusions:
- Routine early administration of IV sildenafil after Fontan operation did not improve clinical outcomes.
- The practice change was not associated with a decrease in postoperative CTO, LOS, colloid administration, or mechanical ventilation duration.
- Sildenafil was well tolerated with no doses withheld, but did not confer the intended clinical benefits.
Abstract:
Fontan operation can be complicated by persistent chest tube output (CTO) leading to prolonged hospital length of stay (LOS). Postoperative sildenafil administration has been shown to improve clinical outcomes in selected patients after Fontan. We initiated a practice change utilizing intravenous (IV) sildenafil in early postoperative period in all patients undergoing Fontan operation with aim to decrease LOS and CTO. Nineteen patients (February 2014-May 2016) received 0.35 mg/kg sildenafil IV (three doses) followed by enteral, 1 mg/kg every eight hours until hospital discharge. Clinical outcomes were compared to 84 pre-protocol controls. Vital signs were recorded after second sildenafil dose. Demographics were similar between groups. Sildenafil group had longer median LOS [9 (7, 11) vs. 13 (8, 25) days, p = 0.016]. CTO days were longer [6 (5, 8) vs. 8 (6, 13) days, p = 0.011]. Sildenafil group had longer mechanical ventilation [6.9 (3.5, 11.1) vs. 4 (2, 7) h, p = 0.045] and longer oxygen therapy [99 (52, 225) vs. 14.5 (14, 56) h, p = 0.001]. There was a trend towards more albumin 5% resuscitation in first 24 h [17 (1, 30) vs. 21 (10, 40) ml/kg, p = 0.069]. There was no difference in inotrope score at 24 h, maximum lactate, or fluid balance. Readmission rates were similar. There was no mortality. IV sildenafil was well tolerated, and no doses were held. Routine early administration of sildenafil after Fontan operation is not associated with an improvement in any measured clinical outcome, including postoperative CTO, LOS, colloid administration, or duration of mechanical ventilation.
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