On-X and others

[PapaHappyStar]

For those making a valve choice -- here are links to the FDA approval documents for the On-X and a page listing all the "recently" ( last 10 years or so ) approved heart valves.

http://www.fda.gov/cdrh/pdf/p000037.html - The On-X approval. See especially "Part 2 - Summary of Safety and Effectiveness" -- it has studies including a large sample clinical study and an animal study.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/mda/mda-cardio.cfm?topic=421 -- recently approved heart valves

To get a nice overview of Mechanical Heart Valves and an explanation of their hemodynamics look at:
Wikipedia -- Mechanical Heart Valves (http://en.wikipedia.org/wiki/Mechanical_heart_valves)

Recent paper on research on catheter based approaches to pulmonary valve replacement ( and hopefully in due course aortic ):
http://jtcs.ctsnetjournals.org/cgi/content/abstract/130/2/477 -- I have the full text if you want.

and a paper on new bio-adhesives to give bio-prostheses structure upon implantation:
http://jba.sagepub.com/cgi/content/abstract/19/3/215

[Phyllis]

Thanks, Burair! You should post this again in the reference thread.

[PapaHappyStar]

From Bob (windsurfer) via carpentier-edwards some info on the Magna bioprosthesis:


EOAI or orifice area normalized to the body mass index for various valve sizes of the Perimount Magna from Carpentier Edwards ( with some nice references at the bottom ):
Effective Orifice Area Index (EOAI) Calculator (www.columbia.edu/~bkk5/Magna_PPM_Pocket_Calc.pdf)

a comparison study of a few brands of bioprostheses from Germany, a manufacturer supoorted study from independent researchers published in the JACC:
Hemodynamic Comparison of Bioprostheses for Complete Supra-Annular Position in Patients With Small Aortic Annulus (http://www.columbia.edu/~bkk5/Botzenhardt_bioprosthesis_comparison.pdf)
Botzenhardt et. al, JACC, Vol. 45, No. 12, 2005

[PapaHappyStar]

A table of favorable and unfavorable patient factors:

http://www.ctsnet.org/doc/2382

from here:

http://www.ctsnet.org/doc/2380

by Ron Elkins one of the pioneers of the RP in the US ( and Dr. Stelzer's teacher ).