Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement

• Published in: Seminars in thoracic and cardiovascular surgery 2021-01, Vol.33 (2), p.328-334
• Main Authors: Rodríguez-Caulo, Emiliano A., Guijarro-Contreras, Ana, Guzón, Arantza, Otero-Forero, Juan, Mataró, María José, Sánchez-Espín, Gemma, Porras, Carlos, Villaescusa, José M., Melero-Tejedor, José María, Jiménez-Navarro, Manuel
• Format: Article
• Language: English
• Subjects: Aortic valve replacement; Ministernotomy; Quality of life
• ISSN: 1043-0679; 1532-9488
• DOI: 10.1053/j.semtcvs.2020.07.013

Quality of life and patient satisfaction after ministernotomy have never been compared to conventional full sternotomy in randomized trials. The QUALITY-AVR trial is a single-blind, single-center, independent, randomized clinical trial comparing ministernotomy to full sternotomy in patients with isolated severe aortic stenosis scheduled for elective aortic valve replacement. One hundred patients were randomized in a 1:1 computational fashion. The primary endpoint was a difference between intervention groups of ≥0.10 points in change from baseline quality of life Questionnaire EuroQOL-index, measured at 1, 6, or 12 months. Secondary endpoints were differences in change from other baseline EuroQOL-index utilities, cardiac surgery-specific satisfaction questionnaire (SATISCORE), a combined safety endpoint of 4 major adverse complications at 1 month (all-cause mortality, acute myocardial infarction, neurologic events, and acute renal failure), bleeding through drains within the first 24 hours, intubation time, and other minor endpoints. Clinical follow-up was scheduled at baseline, 1, 6, and 12 months after randomization. Change from baseline mean difference EQ-5D-index was +0.20 points (95% confidence interval 0.10–0.30, P < 0.001) and median difference +0.14 (95% confidence interval 0.06–0.22, P < 0.001), favoring the ministernotomy group at 1 month. Patient satisfaction was also better at 1 month (Satiscore 83 ± 9 vs 77 ± 13 points; P = 0.010). The ministernotomy group had significantly less bleeding in the first 24 hours (299 ± 140 vs 509 ± 251 mL, P = 0.001). Ministernotomy provides a faster recovery with improved quality of life and satisfaction at 1 month compared to full sternotomy. [Display omitted]