Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

— QUALITY-AVR  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726087
• Other study ID #: CALIDAD-SVAO
• Status: Completed
• Phase: N/A
• Start date: March 20, 2016
• Est. completion date: October 20, 2019

Study information

• Verified date: February 2020
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis
• Heart Valve Diseases

Intervention

Procedure:
• ministernotomy
Partial upper "J" hemisternotomy trough 4th right intercostal space)
• Full sternotomy
Conventional full median sternotomy

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de La Victoria	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Satiscore Questionnaire	Satisfaction in cardiac surgery	1-6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cardiopulmonary bypass time in minutes and cross-clamp ischemic heart time in minutes needed in the surgery		day 1 after surgery
Secondary	Mechanical Ventilatory Support time needed after surgery (in hours)		7 days
Secondary	Transfusional requirements (number of red packed cells, fresh frozen plasma and platelets)		First 72 hours after surgery
Secondary	New York Heart Association functional class scale for heart failure	To assess heart failure status between participants	baseline-1-6-12 months
Secondary	Number of participants alive (Survival)	To assess first year mortality	6-12 months
Secondary	Number of participants alive (Survival)	To assess 5 year mortality	5 years
Secondary	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
Secondary	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