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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Aortic Valve Surgery

Intervention / Treatment
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* Procedure: aortic valve replacement
* Device: biological prosthetic valve
* Device: Mechanical valve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| upper mini-sternotomy<br>aortic valve replacement surgery via upper J or T sternotomy (ministernotomy) | Procedure: aortic valve replacement<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>* Other names: AVR;Device: biological prosthetic valve<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>Device: Mechanical valve<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>|
| right mini thoracotomy<br>aortic valve replacement/repair surgery via right mini thoracotomy | Procedure: aortic valve replacement<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>* Other names: AVR;Device: biological prosthetic valve<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>Device: Mechanical valve<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>|
| conventional sternotomy<br>aortic valve replacement surgery via conventional full sternotomy | Procedure: aortic valve replacement<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>* Other names: AVR;Device: biological prosthetic valve<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>Device: Mechanical valve<br>* aortic valve replacement with either biological prosthetic valve or mechanical valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |
| --- | --- | --- |
| 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 | 
| 30-day mortality |  | 30 days after surgery |