Real-world TAVR Complications in the All-comers GARY Registry
Interview | At ACC.15, CardioSource WorldNews: Interventions had the opportunity to speak with Thomas Walther, MD, PhD, head of cardiac surgery at the Kerckhoff Clinic Heart Center in Bad Nauheim, Germany, about the GARY Registry. A simultaneous submission with this late-breaking clinical trial presentation, “Peri-Operative Results and Complications in 15,964 Transcatheter Aortic Valve Implantations (TAVR) from the German Aortic Valve Registry,” appeared in the May 2015 issue of JACC, and explored the positive outcomes for all-comers after TAVR, as well as a regression in complications.
CSWN: Interventions: Tell us about the registry that you call GARY.
Thomas Walther, MD, PhD: The GARY Registry is an all-comers registry in Germany, and we try to include all patients who receive aortic valve treatments. This includes conventional surgeries and TAVR, and, specifically, we now look at TAVR outcomes here in this study.
There are almost 16,000 patients. This is big; I remember your first ESC GARY presentations were about 2 or 3 years ago. There were very good data then. What are you presenting here that’s going to be published in JACC?
Actually, this is a summary of TAVR patients from 2011, 2012, and 2013. [Of] the 16,000 patients, 70% got a transfemoral and 30% a transapical approach. We looked at the overall outcomes, which are basically very good in relation to a high-risk profile: 81 years; STS Score between 5 and 7; and the EuroScore around 20. On average, we have an overall mortality of 5%. However, in addition, we looked at severe vital complications, at technical complications, at the need for sternotomy of these procedures, and we did some multi-varied assessment of those outcomes and of predictors for those outcomes.
Any surprises in the data?
There are a few things we had expected, especially a significant decrease in complication rates. But [complications are] still substantial, so severe vital complications remain at 4%. [However] if you have such a complication, you have still a 60% chance of survival if you’re treated heart team with cardiac surgery on site. Technical complications go significantly down, but there were, for example, no predictors for sternotomy. We cannot tell which patient will require sternotomy.
That was important. I wouldn’t have necessarily projected that.
It’s difficult to project. We need to look at it and actually, it remains at 1.2% no predictors, and this is a clear kind of result that leads us to the conclusion that a heart team should be there to treat those patients.
In the United States, and I suspect it’s the same way in Germany, a heart team is really required. That’s in the guidelines. It has to be a heart-team-centered approach.
It’s in the guidelines in Germany, but there are some sites who would treat patients by means of TAVR, without a cardiac surgery on site, and therefore, we, in part, looked at this data and really can conclude that a heart team is helpful. Again, those patients who have a severe complication can survive to 60%, which I believe it’s worth it to take the effort.
So any take-home message that you want to get across at this point?
The important message is that we have good outcomes in Germany with GARY data from TAVR procedures in 16,000 patients. We have high survival rates but, of course, some complications are still occurring at about 4%—severe vital complications and technical complications. That’s why we need to treat patients in a good heart team.
GARY is an active registry, correct?
So it continues to gather data, So we will continue to see you and your colleagues for some time I hope.
I hope so. Actually, we include full patient inclusion. We continue until the end of 2015, and then, of course, we need to have longer follow-up, so we’re working on 3-year follow-up right now. Then we’ll have 5-year follow-ups, etc.
- Walther T, Hamm CW, Schuler G, et al. J Am Coll Cardiol. 2015;65(20):2173-80.
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