Clinical trial NCT02726087: Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
Official title: Health-related Quality of Life, Satisfaction and Outcomes After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement. A Randomized Controlled Trial (QUALITY-AVR TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Valve Diseases
Aortic Valve Disease
Keywords: Ministernotomy
aortic valve stenosis
quality of life
satisfaction
cardiac surgery
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Index at 1, 6 or 12 months
timeFrame: baseline-1-6-12 months
Secondary outcomes:
measure: Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Visual Analogic Scale for pain at 1, 6 or 12 months
timeFrame: baseline-1-6-12 months
measure: Early postoperative combined endpoint of 6 complications
timeFrame: 1 month
measure: Satiscore Questionnaire
timeFrame: 1-6 months
measure: Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® severity index at 1, 6 and 12 months
timeFrame: baseline-1-6-12 months
measure: Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® health index (severity index inverse) at 1, 6 and 12 months
timeFrame: baseline-1-6-12 months
measure: Late postoperative combined endpoint of 6 complications
timeFrame: 1-5 years
measure: Total in-Hospital and Intensive Care Unit stay (in days)
timeFrame: From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year
measure: Cardiopulmonary bypass time in minutes and cross-clamp ischemic heart time in minutes needed in the surgery
timeFrame: day 1 after surgery
measure: Mechanical Ventilatory Support time needed after surgery (in hours)
timeFrame: 7 days
measure: Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)
timeFrame: First 72 hours after surgery
measure: New York Heart Association functional class scale for heart failure
timeFrame: baseline-1-6-12 months
measure: Number of participants alive (Survival)
timeFrame: 6-12 months
measure: Number of participants alive (Survival)
timeFrame: 5 years
measure: Early postoperative combined endpoint of 4 complications
timeFrame: 1 month
measure: Late postoperative combined endpoint of 4 complications
timeFrame: 1-5 years year
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
Study officials:
affiliation: Hospital Universitario Virgen de la Victoria, Málaga, spain
name: Emiliano A Rodriguez-Caulo, MD,PhD,FECTS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Caulo EA, Guijarro-Contreras A, Otero-Forero J, Mataro MJ, Sanchez-Espin G, Guzon A, Porras C, Such M, Ordonez A, Melero-Tejedor JM, Jimenez-Navarro M. Quality of life, satisfaction and outcomes after ministernotomy versus full sternotomy isolated aortic valve replacement (QUALITY-AVR): study protocol for a randomised controlled trial. Trials. 2018 Feb 17;19(1):114. doi: 10.1186/s13063-018-2486-x.