Ten-year outcome after aortic valve replacement with the freestyle stentless bioprost

[ken]

http://www.ncbi.nlm.nih.gov/entrez/..._uids=16039189&query_hl=3&itool=pubmed_docsum

1: Ann Thorac Surg. 2005 Aug;80(2):480-6; discussion 486-7. Links
Ten-year outcome after aortic valve replacement with the freestyle stentless bioprosthesis.Bach DS, Kon ND, Dumesnil JG, Sintek CF, Doty DB.
Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor, Michigan, USA. [email protected]

BACKGROUND: Stentless aortic bioprostheses offer excellent hemodynamics and potentially improved durability compared with other bioprostheses. The present report describes the clinical and hemodynamic outcomes for the Freestyle aortic root bioprosthesis in a large, multicenter cohort prospectively followed up for 10 years. METHODS: A total of 725 patients at 8 centers in North America (668 [92%] aged more than 60 years) were followed up prospectively after aortic valve replacement with the Freestyle stentless bioprosthesis. Implant technique was subcoronary in 509, total root in 178, and root inclusion in 38. Follow-up was 4,488 patient-years (mean 6.2 years/patient). RESULTS: For subcoronary, full root, and root inclusion groups, 10-year actuarial freedom from structural valve deterioration was 97.0% +/- 2.2%, 96.0% +/- 4.5%, and 90.9% +/- 11.2%, respectively; and actuarial freedom from reoperation was 91.7% +/- 3.5%, 92.3% +/- 6.0%, and 92.0% +/- 10.7%, respectively. Mean pressure gradient at 10 years was 8.9 +/- 7.9 mm Hg for subcoronary, 7.0 +/- 4.1 mm Hg for full root, and 10.0 +/- 11.1 mm Hg for root inclusion groups; effective orifice area was 1.6 +/- 0.5 cm2, 1.6 +/- 0.6 cm2, and 1.7 +/- 0.5 cm2, respectively. Fredom from moderate or more aortic regurgitation at 10 years was good for all three implant groups, but slightly higher for full root (97.7% +/- 1.6%)compared with subcoronary (87.2% +/- 2.8%) patients (p < 0.005). CONCLUSIONS: The Freestyle stentless aortic root bioprosthesis is a versatile option for aortic valve replacement. Measures of clinical outcomes and prosthesis durability remain excellent through 10 years.

 

[Superbob]

Ken,

Thanks very much for posting this. I am one of those freestyle stentless guys so I will be studying this closely.

 

[KMS]

Ditto

Ditto

Ken,

I agree with Bob...thanks from those of us who went with a Freestyle. Many of us made the choice based on the existing good data on the root/valve. Any study with continued information is appreciated.

Kristine

 

[tobagotwo]

...and remember that the vast bulk of this data comes from Freestyles implanted before they had the anticalcification feature and the "zero G" fixation technique in place. Most of the folks here have the new-'n'-improved version.

Realize also that the average followup was just over six years, so the 10-year number was likely about 400 of the patients studied. Still a decent number, especially when from a variety of centers.

Best wishes,

 

[Der Biermeister]

I'm almost afraid to ask ....

What is a "freestyle stentless bioprost" ? ..... and is mine one of them?

 

[Superbob]

Der,

I was hoping Tobagotwo would answer your question because he's sure more of an expert than I am. I think the Freestyle is exclusively under the Metronic label. In my case, I got it because I needed a total aortic valve/root replacement and this stentless technology, though relatively new, made sense to me.

Your Carpentier-Edwards, though not the same as the Freestyle, evidently is a fine piece of work, too. I refer you to an earlier post by Ken that compared the effects of four bioprostheses (including yours and mine) and found essentially that the effects are about the same (and as I read it, that all are performing well.)

Here's the link. Hope this helps:

http://www.valvereplacement.com/forums/showthread.php?t=17294

 

[Superbob]

In addition, Der, you may be interested in this study focusing, I gather, on your CE Magna and seeming to suggest that it is a stented value offering stentless performance.

http://jtcs.ctsnetjournals.org/cgi/content/abstract/130/6/1668

 

[tobagotwo]

Actually, Bob, I did answer DB's question in a PM. The Freestyle (porcine) and the CEPM (bovine) are not at all related, not even same donor animal or manufacturer.

However, it's the pre-anticalcification CE valves that already have the track record of 18-20 years. We're waiting to see how the Freestyle does in comparison. So far the news appears very good.

Another thing to keep in mind is that the CEPM replaces only the valve. The Freestyle can also be used to replace the aortic root in those who need it. Some of the people in the study did have the "root-inclusive" surgery. As such, there's some apples-and-oranges to any comparison of the two.

Basically, this just means that both of you should be happy. Thanks to Ken for finding and posting the study.

Best wishes,

 

[Superbob]

Thanks, Bob H. I thought maybe some apples and oranges had gotten mixed in there together. But it is nice to have some good news from scientific studies as they currently stand. Appreciate your help in keeping us up to date.