Is data emanating from human transcatheter aortic valve trials showing clinical strength or weakness? Here is an example – you be the judge.
At the recent TCT conference in San Francisco, the midterm results of the PARTNER EU transcatheter valve study were presented. This study followed 120 patients implanted with the Edwards Sapien Valve.
Heartwire [...]
Category Archives: Clinical Issues
Death is not a New York Heart Class
October 6, 2009 – 2:08 pm
The State of the Art
October 6, 2009 – 1:50 pm
At Cardious, our goal is to move the aortic valve bypass graft procedure from a procedure performed only by
surgeons willing and able to source needed components (off label) and build the implant on the back table, to a predictable, easy to perform procedure using an approved device and tool. We will be successful when all [...]
Will Transcatheter Implants Send Coronaries to Stent Jail?
September 2, 2009 – 3:42 pm
In my last post, I argued that 40% of patients over age 70 presenting for AVR surgery with a stenotic aortic valve will have a bicuspid shaped valve and therefore will not be eligible for a transcatheter device. What about the 60% that have a tricuspid valve? Are all of these candidates for a transcatheter [...]
When does 2% equal 55%?
September 2, 2009 – 11:06 am
In my last post, I said that 40% of patients over age 70 presenting for stenotic
AVR (Aortic Valve Replacement) have a bicuspid shaped valve and that a bicuspid shaped aortic valve is a major contraindication to transcatheter valve implantation (reference PARTNER Trial and European Guidelines). Rationale for this contraindication can be found in a paper [...]
Are We Complementary or Competitive to Transcatheter?
August 25, 2009 – 4:30 pm
The answer is yes.
Our device can be viewed as both complementary and directly competitive to the new class of transcatheter valves being developed by Edwards, Medtronic, and others.
It is complementary because it can be implanted in patients that present with a bicuspid shaped valve – a condition strictly contraindicated for transcatheter valve devices. Even [...]
I’ll be happy to give you innovative thinking. What are the guidelines?
April 16, 2009 – 6:44 pm
In an earlier post, I mentioned that a few years back my design consulting firm was involved in the development of a transcatheter valve device. Like my cartoon friend to the left, when I started the project I asked my client what were the design guidelines. Basically, the answer I received, which I think [...]
Risky Business
January 30, 2009 – 1:33 pm
I am always asked – Why do you think the AvA Bypass Graft is a superior off-pump aortic valve procedure compared to stent valve procedures being developed by Edwards LifeScience , CoreValve, and probably a dozen smaller companies?
My short answer:
Superior risk management profile
Now for the longer answer.
Video of Human AVBG Procedure (on Pump)
October 21, 2008 – 3:52 pm
As I have mentioned, aortic valve bypass procedures are currently being performed by cardiac surgeons around the world. Using generally “on pump” techniques, surgeons employ components off label to create an integrated implant at the time of surgery.
A good example of the procedure basics is shown in a video recently posted on the CTSNet web [...]
AVBG in the News
October 12, 2008 – 4:33 pm
Dr. James Gammie, a cardiac surgeon at the University of Maryland, has performed many AVBG (Aortic Valve Bypass Graft) procedures over the past few years.
Recently, Shelly Wood, a reporter for heartwire, did a story on his work in this area. The article is titled Aortic-valve bypass: A time-tested, minimally invasive alternative to valve-replacement surgery. I [...]