Five-year quality of life outcome from a randomized controlled trial comparing aortic valve replacement through upper hemisternotomy and full median sternotomy
Abstract
Objectives: The impact of minimally invasive surgical aortic valve replacement (SAVR) on long-term quality of life (QoL) is uncertain. This randomized controlled trial compared QoL 5 years after SAVR through upper hemisternotomy (UHS) or full median sternotomy.Methods Patients undergoing SAVR were randomized to UHS or full median sternotomy. The primary outcome was postoperative cardiac-specific QoL during 5 years, assessed by the Kansas City Cardiomyopathy Questionnaire physical limitations domain. Secondary outcomes include survival, other QoL domains, and factors associated with declined QoL between 1 and 5 years.
Results: Surgical aortic valve replacement via UHS resulted in better QoL as indicated by more favourable physical limitation and total symptoms scores (estimated mean difference [95% confidence interval] -1.89 [-2.93 to -0.85; P-value <=.001] and 2.96 [-4.71 to -1.22; P-value = .016], respectively). Quality of life improvement persisted for 5 years, despite a decline after 1 year postoperative. Age and valve size smaller than or equal to 21 were independent predictors of decline in physical functioning, while full median sternotomy independently predicted declined total symptoms score. Five-year survival was 91.9% and similar between approaches (P-value = .417).
Conclusions: Minimally invasive SAVR was associated with a modest but statistically significant improvement in cardiac-specific QoL over 5 years compared to median sternotomy, driven by earlier recovery, with comparable outcomes at 5 years. Full median sternotomy independently predicted decline in QoL demonstrated by decreased total symptom scores. Clinical registration number: The Limited access Aortic valve Replacement trial is registered at ClinicalTrials.gov, number NCT04012060. Available via https://clinicaltrials.gov/study/NCT04012060.Severe aortic valve stenosis (AS) is a serious disease and is strongly associated with mortality if untreated.
