Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement

Study Overview
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Brief Summary
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The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery.

Detailed Description
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The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). To reduce potential confounding by differences in implanted valve prostheses, in both arms of the trail, the diseased native aortic valve is planned to be replaced with a rapid deployment stented aortic bioprosthesis (Edwards Intuity Elite Valve System®, Edwards Lifesciences Corporation), the preferred type of valve prosthesis for a limited access approach. Patients will be randomized 1:1 to both arms with 80 patients per arm. Patients who are unwilling or unable to participate in the randomized study will be treated via conventional median sternotomy with a sutured aortic valve prosthesis and participate in a prospective registry. Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36 (SF-36), postoperative pain, perioperative outcome (i.e. technical success rate, operating time) and postoperative outcome (i.e. 30 day and one-year mortality, complication rate, hospital length of stay, reoperation rate and readmission rate). Questionnaires are administered face to face or by telephone prior to surgery and at one, three, six and twelve months after surgery. In the prospective registry the quality of life questionnaires and all clinical data from the patients will be collected and analyzed the exact same way as the data from patients included and randomized in the trial.

Official Title
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Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement: Design and Rationale of the LIAR-Trial.

Conditions
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Aortic Valve Stenosis, Limited Access Aortic Valve Replacement, Quality of Life

Intervention / Treatment
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* Procedure: Limited access aortic valve replacement.
* Procedure: Conventional aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an isolated biological aortic valve replacement for a severe and/or symptomatic aortic valve stenosis, defined as: An aortic valve area of ≤1.0cm2, and; Mean valve gradient ≥40mmHg, and/or; A peak velocity of at least 4.0m/s. Able to understand the nature of the study and what will be required of them; All adult men and non-pregnant women; BMI between 18-35. Exclusion Criteria: Inability to give written informed consent; Inability to adequately answer the questionnaires; Patients requiring additional cardiac surgery during the same procedure; Patients requiring a reoperation; (relative) contraindications for a limited access approach; Undergoing an emergency operation; Recent myocardial infarction (<90 days); Recent stroke or transient ischemic attack (<6 months);
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
Interventional Model Description: Patients will be randomized 1:1 to both arms with 80 patients per arm. Patients who are unwilling or unable to participate in the randomized study will be treated via conventional median sternotomy with a sutured aortic valve prosthesis and participate in a prospective registry.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional group<br>All patients undergoing aortic valve replacement through full sternotomy. | Procedure: Conventional aortic valve replacement<br>* Aortic valve replacement through full median sternotomy<br>|
| Experimental: Limited access group<br>All patients undergoing aortic valve replacement through partial upper hemisternotomy. | Procedure: Limited access aortic valve replacement.<br>* Limited access aortic valve replacement through partial upper hemisternotomy<br>|
| Other: Registry group<br>All patients unwilling or unable to participate in the randomized part of the trial. All patients will undergo aortic valve replacement through median full sternotomy. | Procedure: Conventional aortic valve replacement<br>* Aortic valve replacement through full median sternotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac-specific quality of life after aortic valve replacement. | Change in cardiac specific quality of life after aortic valve replacement measured by the physical limitations and symptoms domains from the Kansas City Cardiomyopathy Questionnaire (KCCQ). | One, three, six and twelve months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the self-efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Changes in the self-efficacy domain of the KCCQ, after aortic valve replacement. | One, three, six and twelve months after surgery | 
| Changes in social interference domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Changes in social interference domain of the KCCQ, after aortic valve replacement. | One, three, six and twelve months after surgery | 
| Changes in quality of life domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Changes in quality of life domain of the KCCQ, after aortic valve replacement. | One, three, six and twelve months after surgery | 
| Change is generic quality of life, assessed with the Physical Component Summary (PCS) of the Short Form-36 (SF-36). | The SF-36 consists of eight domains: physical functioning, role physical functioning, role emotional functioning, bodily pain, vitality, mental health, role social functioning and general health. These domains can be combined into the PCS and MCS. | One, three, six and twelve months after surgery | 
| Change is generic quality of life, assessed with the Mental Component Summary (MCS) of the Short Form-36 (SF-36). | The SF-36 consists of eight domains: physical functioning, role physical functioning, role emotional functioning, bodily pain, vitality, mental health, role social functioning and general health. These domains can be combined into the PCS and MCS. | One, three, six and twelve months after surgery | 
| Postoperative sternal pain | Assessed with a visual analogue score. The VAS is depicted as a straight line from left to right and ranges from 0 (no pain) to 100 (worst imaginable pain) | First seven days after surgery and one, three, six and twelve months after surgery | 
| Perioperative outcomes | aortic cross clamp time (minutes), cardio-pulmonary bypass time (minutes), operating time (minutes) are the main focus. All three outcomes will be measured in minutes. | During surgery | 
| Clinical outcomes | 30-day mortality and one year mortality rate, complication rate, reoperation rate and readmission rate | Up to one year postoperatively. | 
| Technicall success rate of the aortic valve replacement. | Technical success rate is defined as a limited access approach without conversion and placement of the rapid deployment bioprosthesis | During surgery (peri-operatively) | 
| Hospital length of stay | The number of days a patient is admitted in the hospital after surgery (aortic valve replacement) | Up to one year postoperatively | 
| Intensive Care length of stay | The hours a patient has to stay in the Intensive Care Unit postoperatively | Up to one year postoperatively | 
| Effective orifice area of the aortic valve prosthesis | Postoperatively hemodynamic outcomes of the aortic valve prosthesis that is placed during surgery will be measured. A transthoracic echocardiography will be made during follow-up. The effective orifice area, in square centimeters (cm^2), will be measured. | Up to one year postoperatively | 
| Need of analgetic drugs | The intake of analgesic drugs (paracetamol and morfine) will be measured. | Up to one year postoperatively | 
| Mean pressure gradient of the aortic valve prosthesis. | Postoperatively hemodynamic outcomes of the aortic valve prosthesis that is placed during surgery will be measured. A transthoracic echocardiography will be made during follow-up. The mean pressure gradients in milimeters of mercury (mmHg) will be measured. | Up to one year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limited access, Aortic valve replacement, upper hemisternotomy, patient reported outcomes, randomized clinical trial