I hadn't seen it before, so thanks for supplying the link. I'm only four hours from Vanderbilt, so their doing the first TAVR is of special interest to me.
The article is a little confusing, Since Vanderbilt has been taking part in Medtronics Corevalve trials (
http://clinicaltrials.gov/ct2/show/study/NCT01240902?term=corevalve&rank=4&show_locs=Y#locn ) since July but these are their first patients using the Sapien now that is has been approved for higher risk patients.
So Now their patients who dont qualify, (or dont want to take Part in trials I guess) for the trial can get the Sapien IF they qualify for that, which is pretty exciting.
There were some interesting things in this article
"Nearly 200,000 people each year are diagnosed with aortic stenosis, a narrowing of the main valve allowing blood to leave the heart. Seventy-five percent of those diagnosed are deemed high risk or ineligible for open-heart surgery — the standard therapy"
seemed pretty high to me, but then I remeberred what is considerred "high risk" even for the trials is "Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days"
15% still seems like pretty good to me compared to some other heart surgeries risks we've heard, so I would imagine alot of people could qualify as "high risk"
I also thought these quotes were interesting
"Zhao anticipates performing several hundred replacement procedures a year using the newest technology from Edwards SAPIEN." and
"Byrne, William S. Stoney Professor and Chairman of the Department of Cardiac Surgery, said the non-surgical valve replacement technique will become a standard therapy in the next three to five years"
Its all pretty exciting. One thing that I personally thinK is great is quite a few centers all over the Country (world) are taking part in the various trials and building the hybrid type of suites that you should have to do them, so when the different valves are approved, people wont have to travel far to be able to get them and there wont be huge waiting list, like I remember when Justin was a baby and only a handful of hospitals in the world could do some of the more complex heart surgeries, so not only would most people have to travel far for weeks at a time, but often they didnt even know surgery or transplant was an option. Of course until they are actually approved for more people and more brands are approved, its just the thoughts from another centers doctors about when it will be common, but it is good to read what another group of doctors working with percutaneous valves think will happen in the near future