Category Archives: Clinical Issues

Does the Blood Flow Up?

I can’t tell you how many times I have been asked that question when I present our aortic valve bypass concept to non-surgeons. I no longer need to answer by referring the doubting Thomas’ only to the substantial body of clinical evidence published over the past 40 years demonstrating that apex to aorta valve bypass [...]

PARTNER Exclusion #23 – Bulky calcified aortic valve leaflets in close proximity to coronary ostia

In prior posts I have argued in support of the clinical need for the AVBG procedure because transcatheter heart valves, even if proven safe and effective, will have significant limitations with regard to broad clinical use.  The recently published Partner Study evaluating the Sapien transcatheter valve in non-operable patients seems to support my argument.  The [...]

How Invasive?

Less invasive is a term that is hard to define.  One simple way is by size of scar.

Transcatheter Heart Valve Procedures Generate Embolic Brain Lesions in Most Patients

Recently, clinical investigators using both the Edwards and Medtronic transcatheter heart valves reported that in the majority of patients undergoing a transcatheter valve implantation, one or more embolic induced lesions are created in the brain, presumably from calcific embolic material breaking loose during the procedure. Emboli could be created while traversing the arch, performing the [...]

All Surgeons / All Operating Rooms / Most Patients

We believe a logical aortic valve surgery business should revolve around highly skilled surgeons safely implanting proven, state of the art heart valves even if the procedure is done “off pump”. We believe all cardiac surgeons in all operating rooms around the world should be able to confidently provide most patients an “off pump” procedure. [...]

Data and Common Sense – Powerful Predictors of the Future of AVBG

Dr. Gammie and his colleagues at the University of Maryland continue to present impressive data with regard to the clinical effectiveness of the AVBG procedure in high risk patients.  In a recent publication in the Annals of Thoracic Surgery (Ann Thor Surg 2010;90:136-43), lead author Dr. Crystal Vliek reviews hemodynamic data from 47 very high [...]

Death is not a New York Heart Class

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 [...]

The State of the Art

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 [...]

Will Transcatheter Implants Send Coronaries to Stent Jail?

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%?

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 [...]

Are We Complementary or Competitive to Transcatheter?

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.  [...]

I’ll be happy to give you innovative thinking. What are the guidelines?

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 would [...]

Risky Business

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)

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 [...]

AVBG in the News

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.   [...]