Published Articles about the Acessa™ Procedure, the Clinical Studies, and the Technology

Three Years’ Outcome from the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

Jay M. Berman, MD, Richard S. Guido, MD, José Gerardo Garza Leal, MD, Rodolfo Robles Pemueller, MD, Fredrick S. Whaley, PhD, Scott G. Chudnoff, MD, MS

The authors analyzed the clinical success of radiofrequency volumetric thermal ablation (RFVTA) after three years of follow up in terms of subject responses to validated questionnaires and surgical re-intervention for fibroids. This was a prospective, multicenter, international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine fibroids. One hundred thirty-five premenopausal women (mean age, 42.5 ± 4.6 years; mean BMI, 30.5 ± 6.1) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL) underwent RFVTA with 104 evaluable participants followed through 36 months. This article will be published in The Journal of Minimally Invasive Gynecology 2014; the abstract is available at http://dx.doi.org/10.1016/j.jmig.2014.02.015.

Initial Results from a Randomized Controlled Study of Laparoscopic Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy

Sara Y. Brucker, Markus Hahn, Dorit Kraemer, Florin Andrei Taran, Keith B. Isaacson, Bernhard Krämer.

This article describes a post-market, randomized, prospective, single-center study that compares mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation (RFVTA) of fibroids and laparoscopic myomectomy (LM). All surgeries were performed at the University of Tübingen, Germany. Surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound. Compared to LM, RFVTA resulted in the treatment of more fibroids, a significantly shorter hospital stay, and less intraoperative blood loss compared to laparoscopic myomectomy. The article was published in the International Journal of Gynaecology and Obstetrics and is available online at http://authors.elsevier.com/sd/article/S0020729214001040.

Radiofrequency volumetric thermal ablation of symptomatic fibroids: two years’ outcome from the Halt Trial

Richard S. Guido, James Macer, Karen Abbott, Janice L. Falls, Ian B. Tilley, Scott G. Chudnoff

The authors of this manuscript report on the analysis of the 24-month outcomes from the large prospective, multicenter, international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine fibroids. Authors concluded that RFVTA of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up. The manuscript was published in Health and Quality of Life Outcomes2013, 11:139 and is available online at http://www.hqlo.com/content/11/1/139

Outpatient Procedure for the Treatment and Relief of Symptomatic Uterine Myomas

SG Chudnoff, MD, MS, JM Berman, MD, DJ Levine, MD, M. Harris, MD, RS Guido, MD, E. Banks, MD

The 12-month results of this multicenter, prospective, international clinical study of a large cohort of premenopausal women with confirmed moderate-to-severe heavy menstrual bleeding and symptomatic uterine fibroids are presented and discussed. Outpatient, laparoscopic, ultrasound-guided radiofrequency volumetric thermal ablation of myomas was shown to be safe and effective in reducing uterine and myoma volumes, reducing severity of symptoms, and improving quality of life through 12 months follow up. The posttreatment menstrual blood loss changes showed clinically and statistically significant menstrual blood loss reduction in women with heavy menstrual bleeding. This article was published in Obstet Gynecol 2013;121(5):1075–82. An abstract is available at http://www.ncbi.nlm.nih.gov/pubmed/23635746.

Sensitivity of Myoma Imaging with Laparoscopic Ultrasound Compared to Magnetic Resonance Imaging and Transvaginal Ultrasound

DJ Levine, MD, JM Berman, MD, M. Harris, MD, SG Chudnoff, MD, MS, FS Whaley, PhD, SL Palmer, MD

This retrospective study examined the efficacy of laparoscopic ultrasound (LUS) when compared to contrast-enhanced magnetic resonance imaging (CE-MRI) and transvaginal ultrasound (TVUS) in the detection of uterine fibroids. Compared to CE-MRI and TVUS, LUS demonstrated the most fibroids, regardless their size or type. The analysis of the preoperative and operative imaging data in 135 treated women demonstrated that laparoscopic ultrasound used during the Acessa treatments was twice as effective in detecting myomas compared to transvaginal ultrasound and also superior to contrast-enhanced magnetic resonance imaging. This article was published in J Minim Invasive Gynecol 2013; 20(6):770-774. An abstract of the article is available at http://www.jmig.org/article/S1553-4650(13)00205-7/abstract.

Does menstrual bleeding decrease after ablation of intramural fibroids? A Retrospective Study

DI Galen, MD, KB Isaacson, MD, BB Lee, MD

This retrospective study evaluates the effect intramural fibroids have upon menstrual bleeding. Of the 122 in whom menstrual blood loss was quantified at baseline and 12 months postprocedure, more than half of the subject (n = 63) had intramural fibroids with no submucosal fibroids; after RFVTA, these subjects achieved a decrease in MBL of -31.8% (p < .001). Of those 63 subjects was a subset with intramural fibroids (n = 27) without fibroids abutting the endometrium nor submucous fibroids. This group also achieved clinically and statistically significant reduction in menstrual blood loss (-25.0%; p = .001). This is the first study to demonstrate that radiofrequency ablative therapy for intramural fibroids without a submucosal component will result in a significant reduction in MBL This article was published in J Minim Invasive Gynecol 2013; 20(6):830-835. An abstract of the article is available at http://www.jmig.org/article/S1553-4650(13)00282-3/abstract.

Laparoscopic radiofrequency fibroid ablation: Phase II / Phase III Results

Donald I. Galen, Rodolfo Robles Pemueller, José Gerardo Garza Leal, Karen Abbott, Janice Falls, James Macer

This retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic RFVTA evaluates both the Phase II (n = 69) and Phase III (137) 12-month results in terms of quality of life, symptom severity, uterine volume, device-related adverse events, and return to normal activities. RFVTA in both phases provided a uterine-sparing procedure with rapid recovery, significant reduction in uterine volume, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life. This manuscript has been accepted for JSLS Volume 18, Number 2 (Apr/May/Jun 2014 Issue).

Laparoscopic Ultrasound-Guided Radiofrequency Ablation: A Viable Option for Your Patients with Fibroids

James Macer

Dr. Macer starts this article with a case history, summarizes the background of RFVTA, presents the Acessa procedure, and discusses the data to date. He makes that point that patients as well as doctors are becoming increasingly aware of uterine-sparing and minimally invasive treatment options for the management of symptomatic fibroids. Dr. Macer goes on to say that Acessa is a significant recent advancement in minimally invasive gynecologic treatment. The full article is available in OBG Management November 2013 | Vol. 25 No. 11: 50-55 and available for viewing online at http://www.obgmanagement.com/the-latest/past-issues-single-view/for-uterine-sparing-fibroid-treatment-consider-laparoscopic-ultrasound-guided-radiofrequency-ablation/7558329afb80a989b3b3181162253132.html.

Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic leiomyomas: feasibility study using the Halt 2000 Ablation System

JG Garza Leal, M.D., I Hernandez Leon, M.D., L Castillo Saenz, M.D., BB Lee, M.D.

The authors describe the procedure and system in detail as well as their use in a single-center study in Latin America. Results include significant improvement in symptom severity and quality of life at 6 months and 12 months. Treatment provided an outpatient, minimally invasive option that allowed rapid recovery and the avoidance of the risks, cost, and discomfort of major surgery. This article was published in J Minim Invasive Gynecol 2011;18(3):364–71. An abstract of the article can be found at http://www.jmig.org/article/S1553-4650(11)00112-9/abstract.

Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up

R Robles, V Aguirre, AI Argueta, MR Guerrero

This 12-month study conducted in Latin America underscored the continued and significant improvement in symptom severity and quality of life after laparoscopic radiofrequency fibroid ablation. Patients returned to work or resumed normal activities in an average of 5 days. The authors’ conclusions supported the findings by Garza et al that the radiofrequency ablation system is a viable, outpatient alternative to other uterine-sparing procedures for the treatment of fibroids. This article was published in the Int J Gynecol Obstet 2013;120:65–9. The open access article is available at http://www.ijgo.org/article/S0020-7292(12)00503-6/fulltext.

The electrical conductivity of in vivo human uterine fibroids.

R DeLonzor, R Spero, J Williams

The authors describe the radiofrequency energy mechanism of action and conductivity of the energy in uterine fibroids. Results of this in vitro study showed that electrical conductivity modeling can be used for RFVTA of human uterine fibroids at temperatures from 37°C to 100°C. This article was published in the International Journal of Hyperthermia, 2011;27(3):255-65. The abstract can be accessed online at http://www.ncbi.nlm.nih.gov/pubmed/?term=International+Journal+of+Hyperthermia%2C+Delonzor+R.

 

 

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