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- W2018834165 abstract "I would like to thank Dr. Reekers and the EMMY study investigators for their response to my commentary on the results of that study published recently in the Journal (1Spies JB The EMMY trial of uterine artery embolization for the treatment of symptomatic uterine fibroid tumors: randomized, yes, but a flawed trial nonetheless.J Vasc Interv Radiol. 2006; 17: 413-415Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 2Volkers NA Hehenkamp WJ Birnie E et al.Uterine artery embolization in the treatment of symptomatic uterine fibroid tumors (EMMY trial): periprocedural results and complications.J Vasc Interv Radiol. 2006; 17: 471-480Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar). I understand their concern of my criticism of certain aspects of the study and I apologize if my comments caused offense.I recognize that any study can be dissected and analyzed and much of my own work would certainly not stand up to the level of scrutiny that the EMMY study has undergone. However, the authors have again stated that the primary strength of their study is that it is a randomized trial, and that in comparison to the FIBROID Registry and other published studies, they believe that it provides a truer estimate of expected outcomes. The authors also suggest that the EMMY study is the definitive study comparing outcomes of uterine embolization versus hysterectomy.They may be right and that is why my comments were so pointed. The core of my criticism was that for such an important study, the patient management used should have been a reflection of the standard of care for both procedures. Such standards for UAE have been written (3Andrews RT Spies JB Sacks D et al.Patient care and uterine artery embolization for leiomyomata.J Vasc Interv Radiol. 2004; 15: 115-120Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar), but do not appear to have been applied in this study. The authors believe that their practice management better represents the current standard of care for the procedure and their results are therefore a truer reflection of expected outcomes.If that is so, then I think it is time to reconsider what we are doing. If we cannot perform a minimally invasive procedure with fewer complications than a major operative procedure such as hysterectomy, we should either question the role that UAE can play in fibroid management or question the postprocedure management that we provide. If the EMMY investigators have found that UAE cannot be performed as safely as hysterectomy, then perhaps they should ask whether the procedure should be performed at all.I don't believe this study or any other single study is definitive and I would not advocate abandoning UFE until we better understand these results. As the authors requested, I am keeping an open mind on the EMMY Trial results. Perhaps we will all be surprised to find that UAE is more effective than hysterectomy at controlling symptoms from fibroids at the 2-year follow-up. In the meantime, a critical examination of short-term recovery is in order. If most centers' results parallel those of the EMMY investigators, then developing and refining better UAE recovery management protocols at these centers should be a priority. I would like to thank Dr. Reekers and the EMMY study investigators for their response to my commentary on the results of that study published recently in the Journal (1Spies JB The EMMY trial of uterine artery embolization for the treatment of symptomatic uterine fibroid tumors: randomized, yes, but a flawed trial nonetheless.J Vasc Interv Radiol. 2006; 17: 413-415Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 2Volkers NA Hehenkamp WJ Birnie E et al.Uterine artery embolization in the treatment of symptomatic uterine fibroid tumors (EMMY trial): periprocedural results and complications.J Vasc Interv Radiol. 2006; 17: 471-480Abstract Full Text Full Text PDF PubMed Scopus (76) Google Scholar). I understand their concern of my criticism of certain aspects of the study and I apologize if my comments caused offense. I recognize that any study can be dissected and analyzed and much of my own work would certainly not stand up to the level of scrutiny that the EMMY study has undergone. However, the authors have again stated that the primary strength of their study is that it is a randomized trial, and that in comparison to the FIBROID Registry and other published studies, they believe that it provides a truer estimate of expected outcomes. The authors also suggest that the EMMY study is the definitive study comparing outcomes of uterine embolization versus hysterectomy. They may be right and that is why my comments were so pointed. The core of my criticism was that for such an important study, the patient management used should have been a reflection of the standard of care for both procedures. Such standards for UAE have been written (3Andrews RT Spies JB Sacks D et al.Patient care and uterine artery embolization for leiomyomata.J Vasc Interv Radiol. 2004; 15: 115-120Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar), but do not appear to have been applied in this study. The authors believe that their practice management better represents the current standard of care for the procedure and their results are therefore a truer reflection of expected outcomes. If that is so, then I think it is time to reconsider what we are doing. If we cannot perform a minimally invasive procedure with fewer complications than a major operative procedure such as hysterectomy, we should either question the role that UAE can play in fibroid management or question the postprocedure management that we provide. If the EMMY investigators have found that UAE cannot be performed as safely as hysterectomy, then perhaps they should ask whether the procedure should be performed at all. I don't believe this study or any other single study is definitive and I would not advocate abandoning UFE until we better understand these results. As the authors requested, I am keeping an open mind on the EMMY Trial results. Perhaps we will all be surprised to find that UAE is more effective than hysterectomy at controlling symptoms from fibroids at the 2-year follow-up. In the meantime, a critical examination of short-term recovery is in order. If most centers' results parallel those of the EMMY investigators, then developing and refining better UAE recovery management protocols at these centers should be a priority." @default.
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- W2018834165 date "2006-09-01" @default.
- W2018834165 modified "2023-10-16" @default.
- W2018834165 title "Re: Dr. Spies' Commentary on the EMMY Study" @default.
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