Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement (PASTA)

Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Aortic valve replacement due to sternotomy; Procedure: Aortic valve replacement due to parasternal right anterior mini-thoracotomy

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
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thueringen
    • Jena, Thueringen, Germany, 07747
      • Recruiting
      • UKJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sternotomy AVR; Aortic valve replacement due to sternotomy	Procedure: Aortic valve replacement due to sternotomy; conventional surgery of aortic stenosis
ACTIVE_COMPARATOR: Mini AVR; Aortic valve replacement due to parasternal right anterior mini-thoracotomy	Procedure: Aortic valve replacement due to parasternal right anterior mini-thoracotomy; surgery of aortic stenosis in minimally invasive technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life - physical function	Comparison of the physical quality of life between the two groups 30 days after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generaly health perceptions.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	Incidence of new-onset atrial fibrillation after cardiac surgery	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Inflammatory markers: Procalcitonin, C-reactive protein, Interleukin-6	Plasma profiles of inflammatory biomarkers at defined time points in the course of the surgical intervention (baseline, before introduction of CPB, 1 hour after introduction of CPB, disconnection of CPB, 6, 24 and 48 hours post-surgery)	During the first 48 hours after surgery
Quality of Life - mental function	Comparison of the mental quality of life between the two Groups 30 days after surgery using the mental component score of the 36-Item Short Form Health Survey (SF-36). The mental function score is a scale from 0 (poor mental quality of life) to 100 (excellent mental quality of life), with an average score of 50. It includes items that assess vitality, general health perceptions, emotional role functioning, social role functioning, and mental health.	30 days after surgery
Duration of the Operation	Comparison of the average duration of operation between the groups	During the aortic valve replacement surgery
Duration of cardiopulmonary bypass	Comparison of the average duration of cardiopulmonary bypass between the groups	During the aortic valve replacement surgery
Duration of aortic clamping	Comparison of the average duration of aortic clamping between the two groups	During the aortic valve replacement surgery
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	A composite endpoint of mortality, myocardial infarction, urgent revascularization, stroke and major bleeding	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Blood transfusion	A comparison of the number of transfusions between the groups	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Rethoracotomy for bleeding	The incidence of rethoracotomy for bleeding after surgery	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Post-operative pain	Measurement of patient's subjective assessment of their pain after surgery using a visual scale	From the time of surgery until the patient is discharged from hospital, an average of 7 days
Duration of mechanical ventilation	Comparison of the average duration of mechanical ventilation between the groups	Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours
Length of ICU stay	Comparison of the average number of days spent in Intensive Care Unit between the two groups	From the time of surgery until the patient is discharged from hospital, an average of 30 days
Length of hospital stay	Comparison of the average number of days spent in hospital between the groups	From the time of surgery until the patient is discharged from hospital, an average of 30 days
Wound infection	Incidence of wound infections	During the first 30 days after surgery
Mortality	intra- and postoperative mortality	During the first 30 days after surgery

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: The German Heart Foundation
• Investigators: Principal Investigator: Sophie Tkebuchava, MD, University Hospital Jena; Principal Investigator: Torsten Doenst, MD, University Hospital Jena

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2021
• Primary Completion (ANTICIPATED): March 16, 2022
• Study Completion (ANTICIPATED): November 15, 2022

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (ACTUAL): November 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; aortic valve replacement; Aortic Valve Stenosis; inflammatory markers; minimally invasive surgery; parasternal approach
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: PASTA-UKJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No