Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement (QUALITY-AVR)

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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases
• Intervention / Treatment: Procedure: ministernotomy; Procedure: Full sternotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ministernotomy; 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; Partial upper "J" hemisternotomy trough 4th right intercostal space)
Active Comparator: full sternotomy; Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice.	Procedure: Full sternotomy; Conventional full median sternotomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Investigators: Principal Investigator: Emiliano A Rodriguez-Caulo, MD,PhD,FECTS, Hospital Universitario Virgen de la Victoria, Málaga, spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 20, 2016
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: March 13, 2016
• First Submitted That Met QC Criteria: March 27, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: cardiac surgery; quality of life; satisfaction; aortic valve stenosis; Ministernotomy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: CALIDAD-SVAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No