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AVIATOR International Registry of Aortic valve repair Emmanuel Lansac MD PhD Cardiac Surgery Institut Mutualiste Montsouris, Paris, France

Disclosure information Consultant for Coroneo, Inc

Bentall Versus Aortic Valve sparing? Bentall 7165 patients

Aortic Valve Repair 4777 patients

6%

2.2%

Late mortality

2.4%/y

1.5%/y

Reoperation

0.7%/y

1.3%/y

TE Complications

1.1%/y

0.4%/y

Hemorragic complications

1.0%/y

0.2%/y

Endocarditis

0.4%/y

0.2%/y

MAVRE

3.3%/y

1.7%/y

Operative Mortality

TE complications Late mortality Valve Noise

Quality of life Reoperation ?

From JJM Takkenberg, with permission

Is Valve Sparing more risk than Bentall CAVIAAR Trial 130 valve repair versus 131 CVG 30 days mortality 3.8% in each group Despite longer crossclamp times and a learning curve in the REPAIR group, there is no increase in post operative morbi-mortality compared to CVG group

At 30 days, REPAIR group showed a trend towards reduce Major Adverse Valve Related Events compared to CVG group (3.8% versus 9.2%, p<0.08) Lansac et al, JTCVS 2014

Quality of life: Bentall vs repair Quality of live (SF 36) compromise in relation to all criteria outlined in the 36 items Bentall vs Plastie p<0.007 Patients severely disturbed by valve noise Bentall 40% vs repair 4.9%

Patients afraid of valve failure Bentall 50% vs repair 22.4% Self evaluation of patient overall conditions Bentall 5.8/10 vs repair 7.8/10

Franke. ATS 2010

Aicher. JTCVS 2011

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Rationale

• Aortic valve repair seems feasible and safe • Results vary widely and comparison is hampered By differences in: − Patient selection − Repair indications and techniques − Study design, study size and non-uniform reporting

• Mostly single center results • Retrospective design • Need for uniform reporting and collaboration to increase numbers

Open Prospective International Multicenter Registry Isolated AI and/or ascending aorta aneurysm Candidates for Aortic valve repair / sparing

Surgical indication No

Yes

Medical Registry

Surgical Registry

(In process)

Aortic valve Repair / sparing and Replacement

Evaluation of the Guidelines

Evaluation of the results

A clinically oriented data base A clinical Tool

Clinical patient summary and echo results on one screen User friendly data collection

Online statistics Raw data extraction Friendly surgical report of your center compared to all Aside the main data set collection, each team can add a “side branch” of their own study for their own research (for free)

Online CRF

Paper CRF

Data security Cleanweb is FDA 21 CFR Part 11 compliant for both electronic records and signatures • • • •

Data saved on a remote site Secure protocol HTTPS to encrypt communications (SSL) User passwords crypted in the database Authentication provided by a username and password (at least 8 characters including at least 1 upper case, 1 lower case, 1 digit and 1 special character) • Password automatically renewed every 3 months • User is disconnected after 15 minutes of inactivity • Once connected, all user actions are logged to the audit trail of the application.

Our ServerWeb hosting OVH is certified ISO/IEC 27001:2005

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Why participate

● Overview of your results ● Tell you time to follow-up ● Help you to be complete ● In contact with your peers ● Help with science ● “Setting an international multi centre registry of aortic valve repair will play a key role to clarify and standardize the place of repair in aortic valve surgery”

…………………………………………………………………………………… ……………………

Project update 20 centers

11countries

……………………………………………………………………………

How to participate ❶

Contact the AVIATOR secretariat [email protected]



Complete a Participant Contact Form



Complete the Participation Agreement Form

Join us! [email protected]

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AVIATOR

AVIATOR International Registry of Aortic valve repair Emmanuel Lansac MD PhD Cardiac Surgery Institut Mutualiste Montsouris, Paris, France Disclosur...

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