TAVI in-Hospital Death, Stroke Rates Stay Low Even as Use Climbs: GARY

August 27, 2012

August 27, 2012 (Munich, Germany) — Data collected in 2011 for the German Aortic Valve Registry (GARY) suggest that several forms of transcatheter aortic-valve implantation (TAVI) were being used primarily in high-risk patients, just as the guidelines recommend, researchers concluded here at the European Society of Cardiology (ESC) 2012 Congress.

Dr Christian W Hamm

In that high-risk group, in-hospital mortality was "just as good, if not better" with TAVI as with conventional aortic-valve surgery, said Dr Christian W Hamm (Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany) when formally presenting the registry's in-hospital outcomes. And, he said, it was well in line with in-hospital mortality reported for the procedures in clinical trials.

Although the in-hospital rate of cerebrovascular events was lowest for conventional surgery in absolute terms, it wasn't significantly higher in the TAVI groups and stayed fairly low for those patients, "in the 3.5% range," said Hamm. Nor was the risk significant between the two main categories of TAVI based on the catheter approach, transfemoral and transapical.

Hamm was enthusiastic about the performance of TAVI in the registry, but it's not just him--Germany itself seems to love the procedure. And the GARY data potentially show that as the proportion of eligible patients who actually undergo TAVI climbs, generally the right patients are still getting it and outcomes aren't suffering.

Speaking with heartwire , Dr Olaf Wendler (King's College Hospital, London, UK), who critiqued the GARY data following Hamm's presentation as the assigned discussant, observed--as have many--that the threshold for favoring TAVI procedures over traditional surgery seems to be lower in Germany than in other countries where they are available.

As discussant he said, "It is quite impressive to see that, nowadays, around 50% of patients more than 75 years of age receive transcatheter aortic-valve implantation in Germany. This is by far a higher number than any other country worldwide."

He also observed that the TAVI rate of cerebrovascular complications was lower than observed in one of the technique's most important clinical trials, PARTNER. That, he said, suggests it "may be less of a problem than we thought about transcatheter-valve treatment in the past."

But Wendler raised a caution based on some of the presented data. The observed in-hospital mortality for the registry's lower-risk TAVI patients was higher than what was predicted, at least by one risk-stratification system used in the study, "questioning if this is the right treatment for this group of patients."

The GARY registry, which is supported by the German Heart Foundation as well as the valve-implant industry, is voluntary for the current 92 participating centers out of 99 in the country that do the procedures, the ESC noted in a statement. It includes patients undergoing either conventional surgical aortic replacement or TAVI. The current analysis encompasses 13 860 patients treated during the last complete calendar year at 53 centers, but the registry had grown to >26 000 patients by July 2012, of whom 23% had TAVI.

In-Hospital Mortality and Complication Rates, Conventional Aortic Valve Surgery and TAVI

In-hospital events Isolated conventional aortic valve surgery (n=6523) % Conventional aortic surgery with CABG (n=3462) % Transfemoral TAVI (n=2694), % Transapical TAVI (n=1181), %
Mortality 2.1 4.5 5.1 7.7
Cerebrovascular events 2 4 3.7 3.5
Pacemaker implantation 5 4 23.7 9.9
Vascular complications 1 2 11.9 2.5

Hamm also flaunted the TAVI population's low prevalence and severity of a nagging concern unique to the procedure--residual postimplant aortic regurgitation. "The results seem to be excellent, because more than 90% of the patients had no or [only] grade 1 aortic regurgitation. Only a few patients had grade 2, and only a few had grade 3 or 4."

Prevalence and Severity of Residual Aortic Regurgitation in GARY, by TAVI Technique

Aortic regurgitation grade Transfemoral (%) Transapical (%)
0 37 57
1 55 39
2 7 3
3–4 0 1

Dr Harald Darius (Vivantes Klinikum Neukölln, Berlin, Germany), who officiated at an ESC-sponsored press conference about the GARY registry, observed for heartwire that the guidelines cite fairly strict criteria for TAVI patient selection: only those at high operative risk using a validated risk-assessment tool.

"However, since success of these TAVI procedures [has been] very high and [the cardiology community] is excited, it means that now the risk of patients is going down," he said. "More and more, intermediate-risk patients are recommended for the TAVI procedure instead of open-heart surgery."

The trend is to broaden the procedure to more than just high-risk patients, "which I think is okay, because of the very good experience we have had with high-risk patients."

But for now, TAVI shouldn't be performed in intermediate- to low-risk patients, Darius said, until there are supporting survival data. "And that's more or less one of the purposes of this German registry."

According to the ESC, GARY was launched by the German Society of Cardiology and German Society for Thoracic and Cardiovascular Surgery, is supported by the German Heart Foundation, "and receives unrestricted grants from the heart-valve manufacturing industry." According to Hamm, the investigator-initiated study was supported by unrestricted grants from Edwards Lifesciences, Medtronic, Symetis, JenaValve, St Jude Medical, and Sorin. Hamm discloses receiving honoraria for lectures from Medtronic and Edwards Lifesciences and for advisory board activities from Medtronic; and participating in clinical trials for Medtronic, Edwards Lifesciences, JenaValve, and Symetis. Wendler discloses having research contracts with Edwards Lifesciences and consulting for Medtronic, JenaValve, Edwards Lifesciences, and St Jude Medical.

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