Genesis and development of POL-TAVI Registry

JZ Joanna Zembala-John
KW Krzysztof Wilczek
ZT Zdzisław Tobota
PC Piotr Chodór
DC Daniel Cieśla
TJ Tomasz Jaźwiec
WB Waldemar Banasiak
JS Janina Stępińska
ZK Zbigniew Kalarus
MZ Marian Zembala
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The aforementioned POL-TAVI First Report was the first medical-economic analysis of transcatheter aortic valve implantation in Poland. The aim of this report was to monitor and evaluate treatment outcomes, safety, quality and cost-effectiveness of this innovative, costly method of treatment in Poland.

By 2011, almost every Polish center authorized by the Ministry of Health to perform TAVI conducted its own internal TAVI registry, designed according to its own project and its own clinical-scientific and organizational needs. Such a solution had enabled heart teams to monitor and assess their treatment outcomes; lack of unification and standardization, however, made comparison of treatment results with other Polish and foreign centers difficult and often unreliable.

When in 2010 on the initiative of the European Society of Cardiology, within the EurObservational Research Program, the Transcatheter Valve Treatment Registry (TCVT) was created, Poland was one of 12 countries that applied for enrolment. Within 2011–2012, the TCVT Pilot Registry, conducted under the leadership of Carlo di Mario, collected data on 4571 TAVI patients across Europe [10].

The participation of Poland (back then of all 11 Polish TAVI centers) in the TCVT Pilot Registry, converted later into a long-term registry, allowed for the first time for unification of the TAVI dataset, and credible assessment of national TAVI outcomes on the broader scale, including in comparison with other European centers.

Experience gained from the TCVT-Pilot Registry, but also from successful coordination of national, large, long-term registries, such as AMI-PL (National Database of Myocardial Infarction) and KROK (National Registry of Cardiac Surgery), resulted in development of the Polish TAVI registry. In 2013, on the initiative of Marian Zembala, national TAVI coordinator and long-term national consultant in cardiac surgery, as well as Waldemar Banasiak, president of the Polish Cardiac Society at the time, the first nation-wide Cardiac-Cardiac Surgical Registry of Transcatheter Aortic Valve Implantation – POL-TAVI – was launched. The initiative was strongly supported by the European Society of Cardiology, TCVT Registry leaders and the previous and present Board of the Polish Cardiac Society.

To ensure high quality, reliability and proper management of the Registry, the Steering Committee, composed of representatives of the leading Polish TAVI centers, cardiology and cardiac surgery domains, was constituted. It has been governed by Marian Zembala (chairman), Janina Stępińska (vice chairman), Grzegorz Opolski (vice chairman), Adam Witkowski (secretary) and members: Waldemar Banasiak, Dariusz Dudek, Krzysztof Filipiak, Piotr Hoffman, Zbigniew Kalarus, Bogusław Kapelak, Tomasz Kukulski, Bohdan Maruszewski, Andrzej Ochała, Piotr Olszówka, Jan Rogowski, Piotr Szymański and Krzysztof Wilczek. In addition, a POL-TAVI working group – an auditing team, including authors of this paper – was set up to monitor the completeness and quality of data reported.

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