Objective This prospective non-randomised study was performed to compare the psychosocial function and clinical outcomes following surgical and percutaneous implantation of a pulmonary valve at 3 months and 1 year after treatment.
Methods All patients were consecutively admitted for treatment by either method from June 2011 to October 2014. The data of 20 patients treated with the percutaneous technique and 14 patients treated with open heart surgery were compared. Psychosocial function was measured by the Achenbach System of Empirically Based Assessment (ASEBA). We used linear mixed-effect models to investigate group changes between the psychosocial function and clinical data of 34 patients with congenital pulmonary valve disease.
Results A significant difference in favour of the percutaneous pulmonary valve implantation group was observed regarding the ASEBA scores, specifically in the Thought problems subscale at 1 year (p=0.015), Attention problems subscale at 3 months (p=0.016) and 1 year (p=0.007) after treatment. After adjustment for the right ventricle to pulmonary artery pressure gradient at 3 months, a significant change in the Attention problems subscale (p=0.038) was noted in the percutaneous group. The New York Heart Association functional score significantly improved in both groups. The measured right ventricle to pulmonary artery pressure gradient was reduced significantly in both groups at 1 year.
Conclusions Both methods led to significant clinical improvement. Thought and attention problems such as intrusive behaviour significantly decreased only in patients who underwent the percutaneous procedure. Complications as reintervention, bleeding and arrhythmia were only observed in the open surgery group.
- congenital heart disease
- percutaneous valve therapy
- pulmonary valve disease
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Contributors BA, GD, HL, EF and MHA were responsible for the study design. BA and GD collected the data. BA, LMD and MHA analysed the data. All authors revised the work critically, read and approved the final manuscript, and agree to be accountable for all aspects of the work.
Funding The South Eastern Norway Regional Health Authority funded this study (grant no. 2011020).
Competing interests None declared.
Patient consent Obtained.
Ethics approval Regional ethical committee of South East, Norway.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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