Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, single-blind, all comer, randomized controlled trial. Patients
 scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la
 Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be
 randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full
 sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta
 error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life
 EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).
This is a single-center, single-blind, all comer, randomized controlled trial. Patients
 scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la
 Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be
 randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full
 sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta
 error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life
 EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale.

 Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic
 valve replacement due to aortic stenosis in patients >18 years.

 Exclusion criteria are left ventricular ejection fraction less than 40%, previous cardiac
 surgery, urgent/emergent surgery, infective endocarditis, need of concomitant procedures
 other than isolated Morrow miectomy and thorax deformity.

 CE-marked and FDA-approved mechanical (Sorin Carbomedics®) and stented bioprosthetic aortic
 valves will be implanted (Carpentier Edwards Perimount® and Sorin Crown®). Perceval S
 Sutureless bioprosthetic valves (LivaNova®) could be used if needed in very small aortic
 annulus or high risk patients Quality of Life postoperative outcomes will be assessed, as QOL
 measurements and health status with the EQ-5D-5L® questionnaire (QOL index, health visual
 analogic scale, severity index and health index), repeatedly assessed preoperatively and
 postoperatively at 1-6-12 months. Clinical postoperative complications and outcomes will be
 registered at 1 month and 1 year as main secondary and safety end-point (combined end-point
 of 4 and 6 major complications) Patient Satisfaction will be assessed with a 20 question
 cardiac-surgery specific satisfaction questionnaire (SATISCORE®).

 Survival will be assessed at 1 year. Clinical pre and postoperative characteristics will be
 registered. Routine blood sampling will be performed pre- and postoperatively. All available
 data will be collected prospectively. Informed consent) will be obtained from patients
 meeting the inclusion criteria before the initiation of any study-specific procedures.

 The Institutional Review Board Ethic Comittee approved this study.
Inclusion Criteria:

 -  ≥ 18 years of age

 -  Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area
 of 0.6 cm2/m2 or mean gradient greater than 40 mmHg by echocardiography or double
 lesion with predominant stenosis.

 -  Referred for medically indicated aortic valve replacement

 -  Provide written informed consent

 Exclusion Criteria:

 -  Left ventricular ejection fraction less than 0.40

 -  Presence of any coexisting severe valvular disorder

 -  Previous cardiac surgery

 -  Urgent or emergent surgery

 -  Infective endocarditis

 -  Need for concomitant procedures other than isolated myectomy

 -  Severe COPD

 -  Severe thorax deformity.