TAVI Registry

Aims of the TAVI Registry

Patients: 11,753                Sites: 45

The Transcatheter Aortic Valve Implantation (TAVI) Registry is a clinical quality registry whose development is supported by the Australasian Cardiac Outcomes Registry (ACOR) Ltd as part of quality control and monitoring of procedural and clinical outcomes of patients undergoing aortic valve replacement via a transcatheter approach.

TAVI is an interventional procedure used for the treatment of aortic stenosis for patients that are deemed as high risk or inoperable. Guidelines produced by the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS ) and the Cardiac Society of Australia and New Zealand (CSANZ), titled ‘Position Statement for the Operator and Institutional Requirements for a Transcatheter Aortic Valve Implantation (TAVI) Program’, are the basis for institution and operator credentialing within Australia. Key points specified in these guidelines include the need for a multi-disciplinary team of professionals to oversee the governance, decision making and outcomes of institutional TAVI programs as well as institution participation in outcome monitoring in the form of a national TAVI Registry (TAVIR).

Specifically, the Registry aims to:

• Improve patient care and outcomes.
• Educate clinicians and healthcare providers.
• Identify areas of excellence and opportunities for improvement.
• Ensure sites and clinicians meet the accreditation requirements to undertake TAVI procedures.
• Provide an accurate and transparent assessment of the safety of the TAVI procedure and devices.

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Governance

ACOR is an initiative of CSANZ which recognises the critical value of a national clinical cardiovascular quality registry incorporating quality, safety and appropriateness outcomes. The CSANZ formed ACOR with the purpose to supervise the development of national clinical quality cardiovascular registries. Although ACOR runs as a separate entity from the Society, ACOR acts in collaboration with CSANZ to draw on expert advice from the CSANZ to optimise clinician support and engagement.

ACOR has a Board of Directors responsible for legal compliance, financial responsibilities and the strategic direction of the registries. Each Registry has a Steering Committee comprised of senior clinicians in a leadership role with the relevant specialty group. The TAVI Steering Committee Chair is elected by the Steering Committee and endorsed by the ACOR Board.

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TAVI Steering Committee

A/Prof Ajay Sinhal (Chair)
A/Prof Jayme Bennetts
Professor Ravinay Bhindi
Dr Anthony Camuglia
Dr Robert Gooley
A/Prof David Muller
Prof Martin Ng
Prof Darren Walters
A/Prof Antony Walton
Prof Robert Whitbourn
Dr William Wilson
Dr Gerald Yong

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Frequently Asked Questions

How was the database developed?
The database developed by the ACOR TAVI Registry Steering Committee is based on the US registry, TVT, and adapted for local conditions. Feedback on the data being collected is welcome but at this stage there has been an initial finalisation to allow data collection and entry to proceed.

Who owns the data and how will the generated data be used?
The Client Services Agreement (CSA) details that, subject to clause 6.2(a), the Client (the hospital) retains all Intellectual Property Rights in the data submitted to the Registry. It further states that the Client grants to ACOR an irrevocable, nonexclusive, worldwide, perpetual, royalty free licence to use, reproduce, publish, communicate and adapt the data submitted to the Registry in accordance with the CSA for its purposes including to incorporate the data in ACOR’s reports and to aggregate that data with other data.

Individual clinicians may access aggregated de-identified data and data relating to themselves.

Hospitals (the Client) may only access their own data and aggregated de-identified data.

Patients have the right to request their data be removed from the Registry, corrected if there is an error or be provided with access to their data.

Publication of data
ACOR’s Research and Publications Committee oversees requests for publication and ensures fairness and equity.

What is the mechanism for data entry?
The ACOR TAVI database is hosted on REDCaps and SAHMRI is working with each accredited hospital to facilitate the transfer of data. A excel spreadsheet is being developed to enable bulk data transfer.

How is the Registry funded and is there support available to hospitals to defray the cost of participating?
The TAVI registry does not have government funding. The TAVI Registry is a “user pays” registry and all funds are expended on the development, running and maintenance of the Registry.

The commencement phase of the build was achieved via a donation from industry. The final development, ongoing running and maintenance together with the costs of running the Steering Committee, Project Manager’s time and associated expenses are covered via a hospital registration fee which is paid annually. ACOR appreciates that a number of practitioners already contribute to their own internal databases. Our Registry provider, SAHMRI, is working with each accredited practitioner and their accredited hospital to ensure the smooth transfer of data to the ACOR Registry.

How was the TAVI Steering Committee formed?

2015:

• ACOR identified the need for a National TAVI Registry
• The CSANZ Interventional Council recommended experienced operators from all jurisdictions across Australia and New Zealand
• The ANZSCTS were involved in the early planning and represented on the Steering Committee by their President at that time, Prof Paul Bannon
• Acting Chair – Prof David Brieger;

2017:

• Nominations and election of Chair (Prof Darren Walters) and Deputy Chair (A/Prof Ajay Sinhal)

2018:

• Expressions of Interest called for two positions on the Committee. One for an senior accredited TAVI practitioner and one for a practitioner who is within 5 years of having commenced TAVI practice

What is the term of office of the TAVI Steering Committee?
The term of office is 3 years with the option of a second three year term. No member may serve for more than 6 consecutive years, however a member may serve in different positions on the Committee for a period exceeding 6 consecutive years.

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Accreditation Requirements

Cardiac Accreditation Services Ltd (CAS) is responsible for the Accreditation, Reaccreditation, Review and “De-accreditation” of TAVI Practitioners (Cardiothoracic Surgeon and/or Interventional Cardiologist) to perform transcatheter aortic valve implantation (TAVI) as an item on the Medicare Benefits Schedule (MBS).

The Commonwealth Department of Health has authorised the ANZSCTS and the CSANZ to develop the processes and criteria for the accreditation of TAVI Practitioners, and to carry out the accreditation of those Practitioners, including an assessment of clinical suitability of the institution for which the accreditation is being provided. The CSANZ has nominated ACOR as the National TAVI Registry responsible for the collection of TAVI data.

Practitioners must contribute data to the National TAVI Registry which in turn provides data to CAS for the purpose of practitioner accreditation, review and de-accreditation. Hospitals must be registered with ACOR to allow the submission of data. Information on how hospitals can register can be found in the section below: Information for Practitioners.

Information relating to CAS accreditation requirements can be found at tavi.org.au

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Information for Practitioners

Practitioners who have been accredited for TAVI through Cardiovascular Accreditation Services Ltd or who are seeking accreditation are required to contribute to the National TAVI Registry.

To contribute:

• Contact SAHMRI directly to find out if your hospital is already approved for ethics and local governance. Please email acor-registry@sahmri.com or phone 1800 290 571
• Should ethics and/or local governance still be required for your site, scope any specific requirements that are in place and provide support for associated site submissions
• A Client Services Agreement (CSA) will require signature by the appropriate representation for your site. The CSA is a contract between the participating site and ACOR and discusses further the obligations of both parties in contributing to the national database
• Complete the Hospital Registration Form and email to info@acor.net.au
• Note that Hospital Registration Fees apply
• Once all ethics, local governance and hospital registration requirements have been established practitioners will be provided with login credentials and application training

Then you are ready to go for data submission.

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Hospital Registration Fees

The ANZSCTS and the CSANZ have jointly developed processes and criteria for the accreditation of TAVI Practitioners. They have formed Cardiac Accreditation Services Ltd which is responsible for the “Accreditation”, “Reaccreditation”, “Review” and “Deaccreditation” of TAVI Practitioners to perform transcatheter aortic valve implantation (TAVI) as an item on the Medicare Benefits Schedule (MBS).

ACOR is an initiative of the CSANZ which recognises the critical value of a national clinical cardiovascular quality registry incorporating quality, safety and appropriateness outcomes. The CSANZ formed ACOR with the purpose to supervise the development of national clinical quality cardiovascular registries.

The accreditation criteria requires the submission of data to the National TAVI Registry. ACOR has developed a National TAVI Registry for that purpose.

Hospitals must register with ACOR in order to submit data which will be used by Cardiac Accreditation Services (CAS) to review credentialed practitioners.

A fee of $5000 per hospital applies at the time of registration and thereafter, an annual fee applies.

The registration fee covers the development of the Registry and the ongoing maintenance costs. The ACOR Board and Steering Committee members are all voluntary and are not paid for their participation or contribution to the work of the Registry.

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