Tom's Guestbook

Hi. I was asked 4 days before my scheduled AVR in Aug. whether or not I wanted to be part of the Transform trial. From the info I gathered, the main benefit of this approach (relative to standard open-heart AVR with no complications) is the possible smaller amount of time on the bypass machine. I think the avg. reduction in time was expected to be 15-20 min or so. A main difference is how the valve is deployed and seated--using a wand-like implement and only 3-4 main sutures to attach the replacement valve compared to many more (>10, I don't remember) for standard replacements. Whoever contacted you about the study should have or should be able to send detailed info sheets on the study, describing the protocol, risks and hypothesized benefits. This approach has been used for some years in Europe already. Read through the info on clinicaltrials.gov and the Edwards Lifesciences site (search on Intuity valve or Transform trial). Lots of info out there, and call the researchers (and surgeon) back with your list of questions--review risks, expected benefits, # of surgeries your surgeon has done as part of trial (mine had done >100), patient age-ranges, outcomes, etc. I tracked down one person from another site who had asked about the trial. She agreed to participate but it was determined during her surgery the Intuity valve wasn't appropriate, so got a standard valve. I crammed a lot of reading and research into a day after being contacted, but ultimately decided I would have wanted more time to consider the pros and cons, and also wasn't willing to commit to the regular followup testing.