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Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement

2020; Elsevier BV; Volume: 33; Issue: 2 Linguagem: Inglês

10.1053/j.semtcvs.2020.07.013

1532-9488

Emiliano A. Rodríguez-Caulo, Ana Guijarro-Contreras, Arantza Guzón, Juan Otero-Forero, María J. Mataró, Gemma Sánchez-Espín, Carlos Porras, José Manuel Villaescusa, José María Melero-Tejedor, Manuel F. Jiménez‐Navarro,

Aortic Disease and Treatment Approaches

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. 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. Commentary: Randomized Trials Must Provide New and Important InformationSeminars in Thoracic and Cardiovascular SurgeryVol. 33Issue 2PreviewRodríguez-Caulo et al1 report the results of the QUALITY-AVR trial, a small single-center prospective randomized clinical trial (RCT) evaluating differences in quality of life (QOL) between patients who received conventional aortic valve replacement (AVR), full median sternotomy, vs minimally invasive ministernotomy AVR. Full-Text PDF