Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Health-related Quality of Life, Satisfaction and Outcomes After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement. A Randomized Controlled Trial (QUALITY-AVR TRIAL)

Conditions
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Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease

Intervention / Treatment
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* Procedure: ministernotomy
* Procedure: Full sternotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ministernotomy<br>Minimally invasive aortic valve replacement with Partial J upper hemisternotomy through right 4th intercostal space, performed according to current standard of care practice. | Procedure: ministernotomy<br>* Partial upper J hemisternotomy trough 4th right intercostal space)<br>|
| Active Comparator: full sternotomy<br>Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice. | Procedure: Full sternotomy<br>* Conventional full median sternotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Index at 1, 6 or 12 months | Questionnaire EQ-5D-5L® for quality of life | baseline-1-6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Visual Analogic Scale for pain at 1, 6 or 12 months | Questionnaire EQ-5D-5L® for quality of life | baseline-1-6-12 months | 
| Early postoperative combined endpoint of 6 complications | All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, nosocomial infections (Pneumonia, early endocarditis, mediastinitis, sepsis) and need of any reintervention | 1 month | 
| Satiscore Questionnaire | Satisfaction in cardiac surgery | 1-6 months | 
| Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® severity index at 1, 6 and 12 months | Questionnaire EQ-5D-5L® for quality of life | baseline-1-6-12 months | 
| Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® health index (severity index inverse) at 1, 6 and 12 months | Questionnaire EQ-5D-5L® for quality of life | baseline-1-6-12 months | 
| Late postoperative combined endpoint of 6 complications | All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, nosocomial infections (Pneumonia, early endocarditis, mediastinitis, sepsis) and need of any reintervention | 1-5 years | 
| Total in-Hospital and Intensive Care Unit stay (in days) |  | From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year | 
| Cardiopulmonary bypass time in minutes and cross-clamp ischemic heart time in minutes needed in the surgery |  | day 1 after surgery | 
| Mechanical Ventilatory Support time needed after surgery (in hours) |  | 7 days | 
| Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets) |  | First 72 hours after surgery | 
| New York Heart Association functional class scale for heart failure | To assess heart failure status between participants | baseline-1-6-12 months | 
| Number of participants alive (Survival) | To assess first year mortality | 6-12 months | 
| Number of participants alive (Survival) | To assess 5 year mortality | 5 years | 
| Early postoperative combined endpoint of 4 complications | All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, and acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, | 1 month | 
| Late postoperative combined endpoint of 4 complications | All cause Mortality, acute myocardial infarction, cerebrovascular or transient ischemic accident, and acute renal failure AKIN (acute kidney injury classification) greater or equal than 2, | 1-5 years year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ministernotomy, aortic valve stenosis, quality of life, satisfaction, cardiac surgery