The German Aortic Valve Registry (GARY): A Nationwide Registry for Patients Undergoing Invasive Therapy for Severe Aortic Valve Stenosis

Background The increasing prevalence of severe aortic valve defects correlates with the increase of life expectancy. For decades, surgical aortic valve replacement (AVR), under the use of extracorporeal circulation, has been the gold standard for treatment of severe aortic valve diseases. In Germany ~12,000 patients receive isolated aortic valve surgery per year. For some time, percutaneous balloon valvuloplasty has been used as a palliative therapeutic option for very few patients. Currently, alternatives for the established surgical procedures such as transcatheter aortic valve implantation (TAVI) have become available, but there are only limited data from randomized studies or low-volume registries concerning long-time outcome. In Germany, the implementation of this new technology into hospital care increased rapidly in the past few years. Therefore, the German Aortic Valve Registry (GARY) was founded in July 2010 including all available therapeutic options and providing data from a large quantity of patients.Methods The GARY is assembled as a complete survey for all invasive therapies in patients with relevant aortic valve diseases. It evaluates the new therapeutic options and compares them to surgical AVR. The model for data acquisition is based on three data sources: source I, the mandatory German database for external performance measurement; source II, a specific registry dataset; and source III, a follow-up data sheet (generated by phone interview). Various procedures will be compared concerning observed complications, mortality, and quality of life up to 5 years after the initial procedure. Furthermore, the registry will enable a compilation of evidence-based indication criteria and, in addition, also a comparison of all approved operative procedures, such as Ross or David procedures, and the use of different mechanical or biological aortic valve prostheses.Results Since the launch of data acquisition in July 2010, almost all institutions performing aortic valve procedures in Germany joined the registry. By now, 91 sites which perform TAVI in Germany participate and more than 15,000 datasets are already in the registry.Conclusion The implementation of new or innovative medical therapies needs supervision under the conditions of a well-structured scientific project. Up to now relevant data for implementation of TAVI and long-term results are missing. In contrast to randomized controlled trials, GARY is a prospective, controlled, 5-year observational multicenter registry, and a real world investigation with only one exclusion criterion, the absence of patients' written consent.

[1]  Andreas Beckmann,et al.  Cardiac Surgery in Germany during 2011: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery , 2012, Thoracic and Cardiovascular Surgeon.

[2]  J. Bavaria,et al.  Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, Part 1: transcatheter aortic valve replacement. , 2012, The Annals of thoracic surgery.

[3]  Susheel Kodali,et al.  Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. , 2012, The New England journal of medicine.

[4]  B. Prendergast,et al.  ESC Working Group on Valvular Heart Disease Position Paper: assessing the risk of interventions in patients with valvular heart disease. , 2012, European heart journal.

[5]  Sanjay Kaul,et al.  2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. , 2012, Journal of the American College of Cardiology.

[6]  M. Mack,et al.  Transcatheter valve therapy: a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. , 2011, The Annals of thoracic surgery.

[7]  Stuart J Pocock,et al.  Transcatheter versus surgical aortic-valve replacement in high-risk patients. , 2011, The New England journal of medicine.

[8]  T. Walther,et al.  Aortenklappenregister: Hintergründe, Akteure und Ziele , 2011 .

[9]  Pascal Vranckx,et al.  Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. , 2011, Journal of the American College of Cardiology.

[10]  T. Walther,et al.  Aortenklappenregister : Hintergründe, Akteure und Ziele (Evidenzbasierte Medizin) , 2011 .

[11]  W. Keeling,et al.  Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery , 2011 .

[12]  R. Erbel,et al.  Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic review of current literature , 2011, Clinical Research in Cardiology.

[13]  Enrico Ferrari,et al.  Transcatheter aortic valve implantation (TAVI): state of the art techniques and future perspectives. , 2010, Swiss medical weekly.

[14]  A. Vahanian,et al.  Transcatheter valve implantation for patients with aortic stenosis , 2010, Heart.

[15]  S. Pocock,et al.  Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. , 2010, The New England journal of medicine.

[16]  T. Walther,et al.  Positionspapier zur kathetergeführten Aortenklappenintervention , 2009 .

[17]  N. Al-Attar,et al.  Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). , 2008, European heart journal.

[18]  Helmut Baumgartner,et al.  Guidelines on the management of valvular heart disease The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology , 2007 .

[19]  Mark Oppe,et al.  EQ-5D value sets : inventory, comparative review, and user guide , 2007 .

[20]  T. Vassiliades,et al.  The clinical development of percutaneous heart valve technology: a position statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI). , 2005, The Annals of thoracic surgery.

[21]  Philippe Ravaud,et al.  A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. , 2003, European heart journal.

[22]  Assaf Bash,et al.  Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis: First Human Case Description , 2002, Circulation.