Guest guest Posted June 2, 2004 Report Share Posted June 2, 2004 Well, Carla, quickly - as I eat my lunch - here are a few of my reactions (given a day or two to think about it, I'm sure I could come up with a more intelligent reaction -- l). The Discussions Questions seem sort of cryptic to me – but from what I read into them & based on my understanding – and thinking quickly here rather than pondering: Frm what I know patients for the study were very carefully selected – so even if they had excellent results it would only demonstrate that patients with a few fibroids of a certain size and location might benefit. – These questions don't seem to addess the vast difference between the general population of fibroidians and the speicific patients carefully selected for the study. However, even with strict selection criteria they seem to have an astonishing drop off in the ITT success rate between 6 and 12 months!! Given that sort of fall-off I’d think data over a much longer time would be beneficial to see where they stood after a longer time. Fibroids seem to be getting larger between 6 and 12 months after treatment – is that the old fibroids growing again – fibroids not included in the treatment continuing to grow or new fibroids? Has anyone tried to even figure this out? (What portion of all fibroids present were actually treated?) With such a high rate of alternative treatment within 12 months – isn’t it likely to be extremely higher over a longer period of time?? What is the value of a treatment in which so many participants seek alternative treatment so quickly – how does this rate compare to rates following other alternative treatments? Comparison only to TAH is ridiculous. There are already a lot of us who aren’t going for TAH and aren’t comparing treatment options to TAH – we’re comparing them to each other. How does this compare to myomectomy, ufe, etc.? And – it seems even their TAH group was not a carefully selected control group – not matched to the patients in the study – so it’s like comparing apples and oranges. Alternatives to TAH ought to also be compared to other alternatives to TAH. Were the women in the TAH group informed about the study – about the ExAblate alternative – about other alternatives – such as myo and ufe - or were they railroaded into hysterectomy? How many fibroids does the “average” patient have? - and what are the locations of fibroids and sizes of fibroids in all patients – compared to the numbers, sizes and locations of fibroids in patients selected for these studies. – What percentage of all symptomatic fibroid patients would meet the criteria for the study group? – Will approval be only for those who meet the same criteria (ha!)?? How many patients are within the limits of the mitigation criteria used in the studies - total fibriod volume, per fibroid volume - placement so as not to require treatment w/i 4 cm of any bone surface, etc., etc.?? Specifically WHAT adverse events occurred? How many, how frequently? Are they more likely to occur even more often in the general population than in the specifically selected study group? That is patients with more, larger fibroids and with fibroids located closer to other organs? How do they compare to the adverse effects of other treatments -- both in severity and frequency??? Are they reversible - how often not? Pat _________________________________________________________________ FREE pop-up blocking with the new MSN Toolbar – get it now! http://toolbar.msn.click-url.com/go/onm00200415ave/direct/01/ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 2, 2004 Report Share Posted June 2, 2004 > > However, even with strict selection criteria they seem to have an > astonishing drop off in the ITT success rate between 6 and 12 months!! This was surprising to me, too. Out of 109 patients...only 44 remained in the " success " category by the 12 month mark? The loss to follow-up rate by 6 months was phenomenal all by itself. Especially considering the lengths to which women went to in order to undergo HIFUS. Under the circumstances, and in consideration of the desperate attempts women make to avoid surgical intervention, I have a very hard time imagining why so many women would be lost to follow-up so soon after treatment. > > With such a high rate of alternative treatment within 12 months – isn't it > likely to be extremely higher over a longer period of time?? What is the > value of a treatment in which so many participants seek alternative > treatment so quickly – how does this rate compare to rates following other > alternative treatments? Hate to say it...but I think naturopathic remedies may have a better success rate at the 6 month/12 mark than this study shows for HIFUS!!! > Comparison only to TAH is ridiculous. Totally agreed. > Were the women in the TAH group informed about the study – about the > ExAblate alternative – about other alternatives – such as myo and ufe - or > were they railroaded into hysterectomy? Who knows? Can't even begin to second guess the researchers on this query. > What percentage of all symptomatic fibroid patients would meet > the criteria for the study group? – Will approval be only for those who meet > the same criteria (ha!)?? This is truly a very serious question, indeed. Particularly since none of the news accounts or reports from Insightec or clinical investigators have been truly forthcoming on exclusionary criteria for the future use of this equipment/treatment. A few exclusionary items I was able to muster up via research: - pedunculated submucosal or subserosal fibroids - fibroids smaller than 4 cm or larger than 10 cm - presence of more than 3-4 fibroids - presence of abdominal/pelvic scars or keloids from prior treatment - fibroid(s) located too close (w/in 4 cm?) to bladder, bowel, or bone - desired fertility Exclusionary items related to ultrasound, contrast, and MRI: - contrast allergies - impaired renal function - claustrophia (~15% of the population has claustrophobia severe enough to NOT tolerate the enclosure of MRI) - presence of any metallic substances or implanted materials (such as: heart pacemaker, surgical clips from prior surgery--sometimes applied during c-section or myo to the uterine artery OR via tubal ligation, insulin pumps, cochlear implants, etc.) Also, those belly rings would have to be clipped off! - presence of abdominal/pelvic tattoos -- depending on location they may contain enough trace elements of metal as to interfere with clarity of MRI - weight/girth of less than 350 pounds (table limit) but abdominal GIRTH limit might place this at less than 250-300 pounds -- depending on the individual > Specifically WHAT adverse events occurred? How many, how frequently? Are > they more likely to occur even more often in the general population than in > the specifically selected study group? That is patients with more, larger > fibroids and with fibroids located closer to other organs? How do they > compare to the adverse effects of other treatments -- both in severity and > frequency??? Are they reversible - how often not? Without a radiology/gynecology training and certification plan in place for this equipment/treatment, I fear the worse for the 'general population.' Furthermore, I have an even more serious question: in the initial phases of study where women underwent hysterectomy after HIFUS, there was a seemingly inordinate number of those patients who developed post-operative hematomas. My concern? If HIFUS is non-durable for a great many women, what is their subsequent surgical risks? Has surgical risk increased due to treatment with HIFUS? If so, at what ratio and what would the severity of that potential risk truly be? From AHRQ: " Based on the 1997 Healthcare Cost and Utilization Project (HCUP) State Inpatient Database for 19 States, the Postoperative Hemorrhage or Hematoma rate was 1.61 per 1,000 population at risk. " http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=619 It would seem that the hysterectomy-after-HIFUS group had an incidence ratio significantly higher than the 'norm', per the above study. If HIFUS is NOT durable long-term for many women, has undergoing the treatment compromised the potential for undergoing a more durable treatment safely, such as hysterectomy or myomectomy or even embolization? I have many, many more questions. But, given the lack of information provided on the FDA website prior to this meeting tomorrow, it's honestly a crapshoot whether or not my questions are even valid. Needless to say, I am concerned. And, my public commentary will most likely lean towards additional study of 1-2 years and further review of data collected prior to potential approval. Even so, given all the public and political machinations which have gone on regarding this treatment in the last two years, it wouldn't surprise me in the least if it was FDA approved on the basis of these few patients and this limited data. Given the level of durability, safety, and exclusionary criteria concerns, it would NOT make me happy -- but it simply would not surprise me. Carla Quote Link to comment Share on other sites More sharing options...
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