Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement

Brief Title

Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement

Official Title

Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement

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.

Study Type

Interventional

Primary Outcome

Quality of life - physical function

Secondary Outcome

 Inflammatory markers: Procalcitonin, C-reactive protein, Interleukin-6

Condition

Aortic Valve Stenosis

Intervention

Aortic valve replacement due to sternotomy

Study Arms / Comparison Groups

 Sternotomy AVR

Description:  Aortic valve replacement due to sternotomy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

November 15, 2020

Completion Date

November 15, 2022

Primary Completion Date

November 15, 2021

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sophie Tkebuchava, MD, +4936419322928, [email protected]

Administrative Informations

NCT ID

NCT04632095

Organization ID

PASTA-UKJ

Responsible Party

Sponsor

Study Sponsor

Jena University Hospital

Collaborators

 The German Heart Foundation

Study Sponsor

Sophie Tkebuchava, MD, Principal Investigator, University Hospital Jena

Verification Date

November 2020