Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry (SATURNO)

Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques

The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Surgery
• Intervention / Treatment: Procedure: aortic valve replacement; Device: biological prosthetic valve; Device: Mechanical valve

Detailed Description

The study will focus on data recorded and collected from daily clinical treatment of patients undergoing isolated aortic valve replacement due to symptomatic aortic stenosis who consented to the use of their personal data. After surgery patients will be followed up to a minimum of 12 months. In-hospital and follow-up outcomes of the different surgical approaches will be analysed.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

• Study Contact: Name: Elisa Mikus, MD; Email: elisamikus@yahoo.it
• Study Contact Backup: Name: Luca Dozza, PhD; Phone Number: 390545217175; Email: ldozza@esrefo.org

Study Locations

• Italy
  • Ravenna
    • Cotignola, Ravenna, Italy, 48010
      • Maria Cecilia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing isolated aortic valve surgery

Description

Inclusion Criteria:

• All patients undergoing isolated aortic valve surgery
• Written Informed consent to the use of personal data

Exclusion Criteria:

• other associated cardiac surgery
• emergency surgery

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
upper mini-sternotomy; aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)	Procedure: aortic valve replacement; aortic valve replacement with either biological prosthetic valve or mechanical valve; Other Names: AVR; Device: biological prosthetic valve; aortic valve replacement with either biological prosthetic valve or mechanical valve; Device: Mechanical valve; aortic valve replacement with either biological prosthetic valve or mechanical valve
right mini thoracotomy; aortic valve replacement/repair surgery via right mini thoracotomy	Procedure: aortic valve replacement; aortic valve replacement with either biological prosthetic valve or mechanical valve; Other Names: AVR; Device: biological prosthetic valve; aortic valve replacement with either biological prosthetic valve or mechanical valve; Device: Mechanical valve; aortic valve replacement with either biological prosthetic valve or mechanical valve
conventional sternotomy; aortic valve replacement surgery via conventional full sternotomy	Procedure: aortic valve replacement; aortic valve replacement with either biological prosthetic valve or mechanical valve; Other Names: AVR; Device: biological prosthetic valve; aortic valve replacement with either biological prosthetic valve or mechanical valve; Device: Mechanical valve; aortic valve replacement with either biological prosthetic valve or mechanical valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiopulmonary bypass time	during surgery
Total duration of Intensive Care Unit stay	during hospital stay, usually lasting one to two weeks
Blood transfusions	during hospital stay, usually lasting one to two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30 days after surgery
renal insufficiency	need for haemofiltration	during hospital stay, usually lasting one to two weeks
Prolonged ventilation	longer than 24 hours	during hospital stay
Re-exploration for bleeding	need of surgical revision for bleeding	during hospital stay, usually lasting one to two weeks
sepsis		during hospital stay, usually lasting one to two weeks
Neurological complications	stroke and/or transient ischemic attacks	during hospital stay, usually lasting one to two weeks
in-hospital mortality		during hospital stay, usually lasting one to two weeks

Collaborators and Investigators

• Sponsor: Maria Cecilia Hospital
• Collaborators: Ettore Sansavini Health Science Foundation
• Investigators: Principal Investigator: Elisa Mikus, MD, Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimated): October 30, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ESREFO21