Clinical trial NCT04632095: Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement
Official title: Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
minimally invasive surgery
parasternal approach
quality of life
aortic valve replacement
inflammatory markers
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: The German Heart Foundation
First posted: 2020-11-17
Enrollment: 50
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: Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.

Detailed description: The classic surgical treatment of aortic stenosis is valve replacement through complete midline opening of the breastbone (median sternotomy) and use of cardiopulmonary bypass (CPB). Risks of this procedure are related to both the surgical approach and the use of CPB. Using minimally invasive approaches in non-cardiac patients (e.g laparoscopy) resulted in reduced postoperative inflammatory response when compared to patients undergoing the same procedures carried out with a conventional "open" technique. Minimally invasive surgical approaches in which the sternum is partially opened (partial sternotomy) or not opened at all (parasternal access) have thus far shown similar procedure related mortality and lower incidence of perioperative complications, despite longer CPB times. Our single center experience thus far suggests superiority of parasternal aortic valve replacement (O/E ratio of 0.19 over the last 2 years), as well as a reduced postoperative inflammatory response (as measured by lower CRP (C reactive protein ) levels taken 6 hours post-surgery). However, these data have several confounders and there is currently no prospective randomized trial addressing this topic. We therefore conduct a randomized comparison of parasternal versus classic sternotomy aortic valve replacement. Based on our previous experience, we expect very low mortality risk in both groups (expected ≤ 1%). The primary endpoint is therefore quality of life assessed using the SF-36 (Short Form) health survey questionnaire. This approach is similar to other current large multicenter trials. In order to address the impact of reduced surgical trauma on inflammatory response; we will quantify an established panel of inflammatory markers (PCT, CRP, interleukin 6) and use bio-banking to allow for further in depth analysis later on. Standardized clinical endpoints will be analyzed as additional secondary parameters. Power analysis determined a number of 50 patients allocated to 2 equal groups to achieve a power of 80%. The parasternal approach is expected to be superior when compared to sternotomy in both the primary and some, if not most, secondary endpoints. We expect our study to become an important milestone for decision-making in the treatment of aortic stenosis. Patients currently fear sternotomy, but the less invasive transcatheter valve implantation appears to be limited by inferior long-term outcome. The parasternal, sternotomy-sparing, classic aortic valve replacement is therefore an attractive therapeutic alternative. Our investigation in relation to systemic inflammatory response will further shed light on the underlying mechanisms explaining differences in clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Indication for elective isolated aortic valve replacement
* Anatomical suitability for both sternotomy and parasternal access
* Age ≥ 18
* Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Planned simultaneous cardiac surgery interventions (Mitral valve surgery, tricuspid valve surgery, CABG, Pacemaker or defibrillator implantation, Pulmonalvenenisolation, Maze, closure of left atrial appendage , patent foramen ovale or atrial septal defect closure)
* Acute myocardial infarction within 4 weeks, coronary heart disease
* Acute endocarditis
* TIA or stroke within 6 months prior to the procedure
* Pregnant or breast-feeding women
* Renal failure requiring dialysis
* Ejection fraction ≤ 30%
* Re-operation
* Disease with a life expectancy \< 2 years
* Therapy with glucocorticoids or immunosuppressants

Primary outcomes:
measure: Quality of life - physical function
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Inflammatory markers: Procalcitonin, C-reactive protein, Interleukin-6
timeFrame: During the first 48 hours after surgery
measure: Quality of Life - mental function
timeFrame: 30 days after surgery
measure: Duration of the Operation
timeFrame: During the aortic valve replacement surgery
measure: Duration of cardiopulmonary bypass
timeFrame: During the aortic valve replacement surgery
measure: Duration of aortic clamping
timeFrame: During the aortic valve replacement surgery
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Blood transfusion
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Rethoracotomy for bleeding
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Post-operative pain
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Duration of mechanical ventilation
timeFrame: Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours
measure: Length of ICU stay
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 30 days
measure: Length of hospital stay
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 30 days
measure: Atrial fibrillation
timeFrame: From the time of surgery until the patient is discharged from hospital, an average of 7 days
measure: Wound infection
timeFrame: During the first 30 days after surgery
measure: Mortality
timeFrame: During the first 30 days after surgery
Other outcomes:
Locations:
city: Jena
country: Germany
facility: UKJ
state: Thueringen
Study officials:
affiliation: University Hospital Jena
name: Sophie Tkebuchava, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Jena
name: Torsten Doenst, MD
role: PRINCIPAL_INVESTIGATOR
References: