I thought this was a pretty good article talking about all the TAVI valves beng worked on or available in the US or elsewhere now. there is a good chart describing all the valve, sizes how to implant toward the bottom and good news how this will most likely help with the cost going down,
MY Opinion ...it looks like alot of companies believe there will be alot of money to be made from TAVI valves so are spending lots of money now. It also talks about how in some peoples opinion the FDA is keeping US patients from being able to have the best available even newer models now even tho it would probably be best for some patients, like the newer valves have smaller sheiths ...
hopefully in a couple years things will shake out and things will be more like how dfferent brands and models of surgery valves are introduced now. I know they (FDA) do good things and things in the percutaneous valve are just happening so quickly, in just 10 years, that they have to make sure things are safe for patients but not make them wait for things that could help them and available elsewhere with good results.
It must be so frustrating. I remember when Justin was 10 he needed surgery to replace a section of his conduit and at the time his docotrs who just came back to the US from europe were saying IF we lived in europe at that time chances are he could have avoided surgery and have it stented open but what he needed wasnt approved yet so he had OHS and the recovery that goes along with that. Luckily 2 years later, when his conduit was stenosed again the stents were available so he was able to have them placed instead of another surgery and was back to doing everything he loved a week or so later instead of months.
off my soap box now back to the article
http://www.theheart.org/article/145...20121008_EN_Heartwire&utm_campaign=newsletter
Docs debate valve choice as number of TAVI devices set to mushroom
- As many as a dozen new transcatheter valves are poised to enter the market soon—at least outside of the US—so there was much discussion at the PCR London Valves 2012 meeting this week as to how practitioners would choose which new devices to adopt for transcatheter aortic-valve implantation (TAVI).
"At this point, we are only beginning this era, and choice will largely be based on additional advantageous features of the second-generation devices as compared with the first-generation valves," Dr Nicolo Piazza (German Heart Center, Munich) told a session on how to decide valve size and type
SO far it was pretty easy, we had a balloon expandable valve (Sapien, Edwards Lifesciences) and a self-expanding one (CoreValve, Medtronic)," Dr Stephan Windecker (University of Bern, Switzerland), chair of the session, commented. But new criteria will need to be developed for choosing additional valves, he explained.
Currently, some centers have adopted only one of the two established valves, while others choose according to the anatomy of the patient, the optimal access route for that person, and the annulus size of valve required. Piazza said he believes small-volume centers (performing 30 to 50 TAVIs per year) likely need to employ only a couple of valves, as this will cover 90% of the patients encountered. But a higher-volume center could perhaps have a bigger pool to choose from, he noted.
One of the upsides of the growth in the market, say doctors, is that the availability of more devices will ultimately drive down the cost; a transcatheter valve alone, without the associated costs of the procedure, can typically cost up to $30 000. "
more at link above
also another good article from same conference about the history of TAVI so far and how things have happend in the last 10 years. and thoughts on the near future http://www.theheart.org/article/1455725.do
From ugly duckling to swan: 10 years of TAVI
London, UK- The PCR London Valves meeting this week celebrated 10 years of transcatheter aortic-valve implantation (TAVI), with Dr Henning Rud Andersen (Aarhus University Hospital, Denmark)—the interventional cardiologist whose pioneering animal work laid the foundations for the technology—stating that Dr Alain Cribier (University of Rouen, France) had turned it "from an ugly ducking into a beautiful swan." Touchingly, Rud Anderson's elderly father received a TAVI device just last year
In his keynote lecture, Dr Martin Leon (Columbia University, New York, NY) showed film footage of the first TAVI performed by Cribier and colleagues in April 2002 on a 57-year old man who Cribier acknowledged "would probably have been turned down for TAVI today." The patient presented in cardiogenic shock, with major left ventricular dysfunction (ejection fraction of 12%) and multiple comorbidities, which meant surgical aortic-valve replacement (SAVR) was contraindicated.
Their eyes wide with anticipation but at the same time full of anxiety, Cribier and his team waited to see what would happen following deployment of the valve. The procedure was a success, to their visible relief, and confirmed the feasibility of TAVI in humans. The patient unfortunately died four months later, but the foundation was laid for what is now recognized "as a breakthrough technology," said Leon...."
MY Opinion ...it looks like alot of companies believe there will be alot of money to be made from TAVI valves so are spending lots of money now. It also talks about how in some peoples opinion the FDA is keeping US patients from being able to have the best available even newer models now even tho it would probably be best for some patients, like the newer valves have smaller sheiths ...
hopefully in a couple years things will shake out and things will be more like how dfferent brands and models of surgery valves are introduced now. I know they (FDA) do good things and things in the percutaneous valve are just happening so quickly, in just 10 years, that they have to make sure things are safe for patients but not make them wait for things that could help them and available elsewhere with good results.
It must be so frustrating. I remember when Justin was 10 he needed surgery to replace a section of his conduit and at the time his docotrs who just came back to the US from europe were saying IF we lived in europe at that time chances are he could have avoided surgery and have it stented open but what he needed wasnt approved yet so he had OHS and the recovery that goes along with that. Luckily 2 years later, when his conduit was stenosed again the stents were available so he was able to have them placed instead of another surgery and was back to doing everything he loved a week or so later instead of months.
off my soap box now back to the article
http://www.theheart.org/article/145...20121008_EN_Heartwire&utm_campaign=newsletter
Docs debate valve choice as number of TAVI devices set to mushroom
- As many as a dozen new transcatheter valves are poised to enter the market soon—at least outside of the US—so there was much discussion at the PCR London Valves 2012 meeting this week as to how practitioners would choose which new devices to adopt for transcatheter aortic-valve implantation (TAVI).
"At this point, we are only beginning this era, and choice will largely be based on additional advantageous features of the second-generation devices as compared with the first-generation valves," Dr Nicolo Piazza (German Heart Center, Munich) told a session on how to decide valve size and type
SO far it was pretty easy, we had a balloon expandable valve (Sapien, Edwards Lifesciences) and a self-expanding one (CoreValve, Medtronic)," Dr Stephan Windecker (University of Bern, Switzerland), chair of the session, commented. But new criteria will need to be developed for choosing additional valves, he explained.
Currently, some centers have adopted only one of the two established valves, while others choose according to the anatomy of the patient, the optimal access route for that person, and the annulus size of valve required. Piazza said he believes small-volume centers (performing 30 to 50 TAVIs per year) likely need to employ only a couple of valves, as this will cover 90% of the patients encountered. But a higher-volume center could perhaps have a bigger pool to choose from, he noted.
One of the upsides of the growth in the market, say doctors, is that the availability of more devices will ultimately drive down the cost; a transcatheter valve alone, without the associated costs of the procedure, can typically cost up to $30 000. "
more at link above
also another good article from same conference about the history of TAVI so far and how things have happend in the last 10 years. and thoughts on the near future http://www.theheart.org/article/1455725.do
From ugly duckling to swan: 10 years of TAVI
London, UK- The PCR London Valves meeting this week celebrated 10 years of transcatheter aortic-valve implantation (TAVI), with Dr Henning Rud Andersen (Aarhus University Hospital, Denmark)—the interventional cardiologist whose pioneering animal work laid the foundations for the technology—stating that Dr Alain Cribier (University of Rouen, France) had turned it "from an ugly ducking into a beautiful swan." Touchingly, Rud Anderson's elderly father received a TAVI device just last year
In his keynote lecture, Dr Martin Leon (Columbia University, New York, NY) showed film footage of the first TAVI performed by Cribier and colleagues in April 2002 on a 57-year old man who Cribier acknowledged "would probably have been turned down for TAVI today." The patient presented in cardiogenic shock, with major left ventricular dysfunction (ejection fraction of 12%) and multiple comorbidities, which meant surgical aortic-valve replacement (SAVR) was contraindicated.
Their eyes wide with anticipation but at the same time full of anxiety, Cribier and his team waited to see what would happen following deployment of the valve. The procedure was a success, to their visible relief, and confirmed the feasibility of TAVI in humans. The patient unfortunately died four months later, but the foundation was laid for what is now recognized "as a breakthrough technology," said Leon...."
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