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GARY: German Aortic Valve RegistrY - in hospital outcome

See the press release:
Munich, Germany – August 27 2012: The German Aortic Valve Registry (GARY) was started in July 2010 and is the only registry so far to include both transcatheter aortic valve implantation (TAVI) and conventional aortic valve replacements and repair.(1) The intention is to deliver a complete picture of current and future practice of treating aortic valve disease and to deliver reliable data on the short and long-term outcome of different treatment strategies. This specifically includes data about quality of life before and after treatment besides numerous medical variables...
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Valvular Heart Diseases


 

Presenter: Christian Hamm | see Discussant report

List of Authors: Prof. Christian Hamm / Germany
Co-authors: Friedrich Mohr, Germany
for the ASTRID Investigators

Abstract:

 

Background
Standard treatment for aortic stenosis is surgical valve replacement. In recent years catheter based procedures have gained attention and is used in Germany already in 30% of the cases. Randomized studies are still insufficient or ongoing. In order to assess the impact and role of these new technics in comparison to conventional surgery a nationwide registry was started in Germany in 2010 to capture all interventional and surgical procedures. Accordingly, this is the largest registry of its kind.

Methods
Prospective registry with follow-up for 5 years.

Results
The data base of ~ 17.145 patients entered in 2010 and 2011 with an high rate of follow-up (95%) will be locked for presentation of inhospital outcome data. This includes approx. 69% surgical cases, 21%transfermoral, 9% transapical procedures and 1% valvuloplasties.

Conclusion
available in July 2012. The results will allow a better understanding of the role of catheter-based aortic procedures.


Discussant: Olaf Wendler | see Presenter abstract 

Report:

Results from PARTNER US have demonstrated that transcatheter aortic valve implantation (TAVI) is superior in patients unsuitable for surgical aortic valve replacement (sAVR) and are an alternative in patients high-risk for sAVR. As always in prospective randomised trials, the patient cohort in PARTNER is highly selected and surgical risks estimated based on the personal opinion of a cardiologist and cardiac surgeon. Therefore the results may not represent European “real world” experience.

The German Aortic Valve Registry (GARY) is the first registry of its kind, and not only patients undergoing TAVI are included, but also patients who receive sAVR with and without coronary artery bypass grafting. German cardiologists, cardiac surgeons and cooperating health authorities have to be congratulated to their success of creating the worlds largest (n=13,860) and most comprehensive registry on patients who underwent invasive therapy for acquired aortic valve disease. This offers not only the opportunity to analyse outcome after TAVI using various devices, but also to get an idea about how TAVI and sAVR are used in the “real world” and how outcomes of these two treatment options compare in similar patient cohorts.

Nevertheless, from the number of participating surgical and cardiological centers, it is clear that not all German centers participate in this registry and it would be helpful to know more about the reasons for this. It is also surprising to see that the number of TAVI’s using CoreValve(TM) is lower compared to Edwards Sapien(TM) valves, although to my knowledge market share in Germany is the other way round. It is surprising to see that nearly 50% of patients ≥75 years currently receive a TAVI in Germany, which seems to be much higher compared to other countries. Although EuroSCORE’s are significantly higher in the TAVI cohorts, around 50% of TAVI patients have a EuroSCORE of less than, which may explain these figures.

Regarding baseline characteristics TAVI patients are in general older and present with more co-morbidities. Nevertheless, given previously reported risk factors from other surgical and TAVI registries, I miss information on renal disease and peripheral vascular disease. In addition, definitions of baseline characteristics such as pulmonary hypertension, chronic obstructive pulmonary disease and coronary artery disease need to be provided as they are of particular importance for future detailed data analysis to avoid misleading results.

In contrast to most TAVI registries the authors report on in-hospital mortality and German TAVI mortalities are lower compared to thirty-day mortality reported in other TAVI registries. Like in other TAVI series, vascular complications and new onset AV-blockage are highest in the transvascular group and renal failure is more often seen in transapical patients. Cerebrovascular events are comparable to other European registries but not as high as in PARTNER. Definitions for vascular complications and cerebrovascular events are missing and I wonder if adverse events are VARC adjudicated which would make comparison to other registries easier?

The authors also compare outcomes using the two most commonly used devices and find that CoreValve(TM) patients more often suffer from AV-blockage and residual aortic regurgitation which may be of particular importance for long-term patient survival.

This is the first international presentation of this registry and with respect to the time constraints of the presentation I am not surprised that there is a limitation on which data is presented. Given the high number of patients with low EuroSCORE’s in the TAVI cohorts, I would be particularly interested in a comparison of their outcomes with the low risk cohort from the sAVR arms. Nevertheless, I am certain that we will see lot more detailed analyses from GARY in the future.

References


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SessionTitle:

Hot Line II: Late Breaking Trials on Interventions

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.