1. Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
- Author
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Emiliano A. Rodríguez-Caulo, M.J. Mataró, Gemma Sánchez-Espín, José M. Melero-Tejedor, Ana Guijarro-Contreras, Arantza Guzón, Jose M. Villaescusa, Juan Otero-Forero, Manuel Jiménez-Navarro, and Carlos Porras
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Randomization ,business.industry ,medicine.medical_treatment ,General Medicine ,030204 cardiovascular system & hematology ,medicine.disease ,Surgery ,law.invention ,03 medical and health sciences ,Stenosis ,0302 clinical medicine ,Patient satisfaction ,030228 respiratory system ,Aortic valve replacement ,Randomized controlled trial ,law ,medicine ,Clinical endpoint ,Intubation ,Myocardial infarction ,Cardiology and Cardiovascular Medicine ,business - Abstract
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
- Published
- 2021
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