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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Limited access aortic valve replacement through partial upper hemisternotomy
Aortic valve replacement through full median sternotomy
St Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
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).
Time frame: One, three, six and twelve months after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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DOUBLE
Enrollment
161
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.
Time frame: 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)
Time frame: 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.
Time frame: During surgery
Clinical outcomes
30-day mortality and one year mortality rate, complication rate, reoperation rate and readmission rate
Time frame: 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
Time frame: During surgery (peri-operatively)
Hospital length of stay
The number of days a patient is admitted in the hospital after surgery (aortic valve replacement)
Time frame: Up to one year postoperatively
Intensive Care length of stay
The hours a patient has to stay in the Intensive Care Unit postoperatively
Time frame: 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.
Time frame: Up to one year postoperatively
Need of analgetic drugs
The intake of analgesic drugs (paracetamol and morfine) will be measured.
Time frame: 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.
Time frame: Up to one year postoperatively