Key result
Treatment with bosentan significantly improved New York Heart Association Functional Class in patients with Fontan circulation (SMD -0.59), but did not significantly improve maximum oxygen consumption.
Why the study?
Complications observed with prolonged follow-up seriously affect the quality of life of Fontan patients, prompting evaluation of pharmacologic therapies to improve exercise capacity.
Do pharmacologic agents improve exercise capacity in patients with Fontan circulation?
Meta-Analysis (n=408)
Do pharmacologic agents improve exercise capacity in patients with Fontan circulation?
Standardized Mean Difference: -0.59 (95% CI -0.94–-0.25)
p-value: p=0.0008
In patients with Fontan circulation, bosentan improves NYHA functional class and 6-minute walk test results, though it does not significantly improve VO2 max.
Bosentan may improve NYHA class and submaximal measures in Fontan patients; supports targeted vasodilator use but leaves peak VO2 effects open for larger RCTs.
Background: The Fontan procedure is currently the mainstay therapy for single functional ventricles. However, with prolonged follow-up duration, various complications have been observed that seriously influence the quality of life of patients. Objectives: The aim of this meta-analysis is to compare the effectiveness of pharmacologic agents in improving exercise capacity in patients with Fontan circulation. Methods: This meta-analysis was conducted according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and has been registered in the International Prospective Register for Systematic Reviews database with registration no. 282352. Quality assessments of the included studies were assessed using the Strengthening Reporting of Observational Studies in Epidemiology (STROBE) statement. Results: Twelve studies met the predetermined inclusion criteria and were included in this metaanalysis. This meta-analysis found that treatment with bosentan significantly improved New York Heart Association Functional Class (NYHA FC) in Fontan patients (standard mean difference - 0.59, 95% CI -0.94 – -0.25; P=0.0008; I2 = 1%). However, the use of bosentan (P=0.66) and sildenafil (P=0.13) did not show a significant improvement in the maximum rate of oxygen consumption (VO2 max). Conclusion: This meta-analysis shows that people with Fontan circulation may benefit from using bosentan as it decreases postexercise heart rate and improves NYHA FC and 6-minute walking test results. Therefore, indirectly improving exercise capacity. Nonetheless, considerable work is required to strengthen our knowledge in improving the exercise capacity of Fontan patients.
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A 2022 study conducted a meta-analysis in Fontan circulation (n=408). Bosentan vs. Placebo or untreated control was evaluated on New York Heart Association Functional Class (NYHA FC) (SMD -0.59, 95% CI -0.94 to -0.25, p=0.0008). Treatment with bosentan significantly improved New York Heart Association Functional Class in patients with Fontan circulation (SMD -0.59), but did not significantly improve maximum oxygen consumption.
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