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1630 12-Month Outcomes of the Us Patient Cohort in the Sonata Pivotal IDE Trial of Transcervical Ablation of Uterine Fibroids
Abstracts / Journal of Minimally Invasive Gynecology 26 (2019) S98−S231
S161
Design: We used the ISI Web of Science database to identify the most frequently cited articles published in JMIG between the years of 2005, when it was first published, to 2018. The top 100 most frequently cited articles were included in our analysis. The articles were then characterized by publication year, study design, specialty, country of origin, and topic. The topics were subdivided into the following categories: surgical techniques, education, urogynecology, endometriosis, reproductive surgery, abnormal uterine bleeding, leiomyomata, oncology, sterilization, and, surgical complications. Setting: N/a Patients or Participants: N/a Interventions: N/a Measurements and Main Results: A total of 2,727 articles were published by JMIG in this time frame. Of the top 100 articles, 47% were observational studies, 11% were new procedures/assays, and 11% were randomized control trials. 57% were from international authors. The most frequently cited topic was surgical techniques (30%), followed by surgical complications (17%) and endometriosis (11%). The mean citation number was 68.94. The median publication year of the top 100 articles was 2008. After 2008, the number of articles on surgical technique decreased (37% vs 26%) whereas the prevalence of those focusing on surgical complications increased (13% to 22%). Conclusion: The majority of publications were observational studies, with a strong focus on surgical techniques. The number of articles on this topic decreased slightly after 2008, which also saw an increased focus on surgical complications. This data reiterates the leading role and global impact of JMIG in gynecological surgery.
86.8% noted >20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively). Mean maximal fibroid volume reduction per patient was 63.8%. There were no device related adverse events. Mean length of stay was 2.5 hours and 50% of patients returned to normal activity within 1 day. Conclusion: This analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. Treatment with the Sonata system significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of Sonata as a first-line treatment for women affected by symptomatic uterine fibroids.
Virtual Poster Session 2: Basic Science/Research/Education (1:40 PM − 1:50 PM) 1:40 PM: STATION G 1630 12-Month Outcomes of the Us Patient Cohort in the Sonata Pivotal IDE Trial of Transcervical Ablation of Uterine Fibroids Hudgens JL,1,* Johns DA,2 Lukes A,3 Forstein DA,4 Delvadia D5. 1 Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA; 2Gynecology, Baylor Research Institute-Fort Worth, Fort Worth, TX; 3 Carolina Women’s Research and Wellness Center, Durham, NC; 4Touro College of Osteopathic Medicine, New York, NY; 5Drexel University College of Medicine, Philadelphia, PA *Corresponding author. Study Objective: The SONATA trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical radiofrequency ablation in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: 21 clinical sites in the US. Patients or Participants: Premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to fibroids. Interventions: Transcervical, intrauterine radiofrequency ablation was performed on ≤10 uterine fibroids from 1 to 5 cm in diameter with the SonataÒ system. Twelve-month co-primary endpoints were reduction in menstrual bleeding and rate of surgical reintervention. Symptom severity, quality of life, satisfaction, safety, and fibroid volume reduction were also evaluated. Measurements and Main Results: 125 patients were enrolled/treated in the US. Both IDE trial co-primary endpoints were achieved, as 65.3% of patients reported ≥50% reduction in menstrual bleeding and 99.2% of patients were free from surgical reintervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and
Virtual Poster Session 2: Basic Science/Research/Education (1:40 PM − 1:50 PM) 1:40 PM: STATION H 2782 The Impact of a Simulation Curriculum Designed for Instituting Gynecologic Laparoscopy in Low and Middle Income Settings Harvey LFB,1 Mata AJ,2,* Curlin HL,3 Grimm BS,2 Lovett BJ,2 Sizemore CM,2 Ulysse JC4. 1Minimally Invasive Gynecology, Vanderbilt University Medical Center, Nashville, TN; 2Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN; 3Vanderbilt University Medical Center, Nashville, TN; 4Obstetrics and Gynecology, H^ opital Universitaire de Mirebalais, Mirebalais, Haiti *Corresponding author. Study Objective: To measure the effect of a simulation curriculum designed for instituting gynecologic laparoscopy in low and middleincome settings on competent gynecologic surgeons with novice laparoscopic skills Design: Prospective, single center, implementation study Setting: H^opital Universitaire de Mirebalais in Haiti (HUM), a 300-bed hospital operating with the Haitian Ministry of Health and Partners in Health, a Boston-based non-profit organization. Patients or Participants: Four recent OB/GYN residency graduates and three attending OB/GYN physicians at HUM. The physicians had minimal experience with laparoscopy but were skilled abdomino-pelvic surgeons. Interventions: A 5-day gynecologic laparoscopy curriculum was instituted. Trainees participated in increasingly complex simulations interspersed with didactic learning. Simulations included assembling and operating laparoscopic equipment, completing a laparoscopy specific surgical checklist, positioning patients, placing trocars, operating on a box trainer, and troubleshooting surgical complications and equipment malfunctions. Finally, participants completed bilateral salpingectomies on selected patients at HUM with at-the-elbow instructors. The trainees underwent pre- and post-training tests with simulation box training on 3 laparoscopic skills tasks; peg transfer, rubber band manipulation, and circle cut. Measurements and Main Results: There were no operative complications. Two evaluators independently scored de-identified pre- and post-test videos of box trainer tasks using a modified OSATS scale (Objective Structured Assessments of Technical Skills). Both were fellowship trained gynecologic surgeons who regularly teach laparoscopy. The mean increase in OSATS scores after training was 4.3 out of 25 possible points (SD 2.7, R 0-8). A Wilcoxon signed rank test of equality of matched pairs was significant. (Prob > jzj = 0.0001.) Conclusion: An intensive, short-term curriculum designed for instituting gynecologic laparoscopy in low and middle-income settings significantly increased the measurable laparoscopic skill of 7 gynecologic surgeons who were novices to laparoscopy. Further implementation science regarding the development of gynecologic laparoscopy in low and middleincome settings is needed.
S161
Design: We used the ISI Web of Science database to identify the most frequently cited articles published in JMIG between the years of 2005, when it was first published, to 2018. The top 100 most frequently cited articles were included in our analysis. The articles were then characterized by publication year, study design, specialty, country of origin, and topic. The topics were subdivided into the following categories: surgical techniques, education, urogynecology, endometriosis, reproductive surgery, abnormal uterine bleeding, leiomyomata, oncology, sterilization, and, surgical complications. Setting: N/a Patients or Participants: N/a Interventions: N/a Measurements and Main Results: A total of 2,727 articles were published by JMIG in this time frame. Of the top 100 articles, 47% were observational studies, 11% were new procedures/assays, and 11% were randomized control trials. 57% were from international authors. The most frequently cited topic was surgical techniques (30%), followed by surgical complications (17%) and endometriosis (11%). The mean citation number was 68.94. The median publication year of the top 100 articles was 2008. After 2008, the number of articles on surgical technique decreased (37% vs 26%) whereas the prevalence of those focusing on surgical complications increased (13% to 22%). Conclusion: The majority of publications were observational studies, with a strong focus on surgical techniques. The number of articles on this topic decreased slightly after 2008, which also saw an increased focus on surgical complications. This data reiterates the leading role and global impact of JMIG in gynecological surgery.
86.8% noted >20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively). Mean maximal fibroid volume reduction per patient was 63.8%. There were no device related adverse events. Mean length of stay was 2.5 hours and 50% of patients returned to normal activity within 1 day. Conclusion: This analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. Treatment with the Sonata system significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of Sonata as a first-line treatment for women affected by symptomatic uterine fibroids.
Virtual Poster Session 2: Basic Science/Research/Education (1:40 PM − 1:50 PM) 1:40 PM: STATION G 1630 12-Month Outcomes of the Us Patient Cohort in the Sonata Pivotal IDE Trial of Transcervical Ablation of Uterine Fibroids Hudgens JL,1,* Johns DA,2 Lukes A,3 Forstein DA,4 Delvadia D5. 1 Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA; 2Gynecology, Baylor Research Institute-Fort Worth, Fort Worth, TX; 3 Carolina Women’s Research and Wellness Center, Durham, NC; 4Touro College of Osteopathic Medicine, New York, NY; 5Drexel University College of Medicine, Philadelphia, PA *Corresponding author. Study Objective: The SONATA trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical radiofrequency ablation in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort. Design: Prospective, longitudinal, multicenter, single-arm trial. Setting: 21 clinical sites in the US. Patients or Participants: Premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to fibroids. Interventions: Transcervical, intrauterine radiofrequency ablation was performed on ≤10 uterine fibroids from 1 to 5 cm in diameter with the SonataÒ system. Twelve-month co-primary endpoints were reduction in menstrual bleeding and rate of surgical reintervention. Symptom severity, quality of life, satisfaction, safety, and fibroid volume reduction were also evaluated. Measurements and Main Results: 125 patients were enrolled/treated in the US. Both IDE trial co-primary endpoints were achieved, as 65.3% of patients reported ≥50% reduction in menstrual bleeding and 99.2% of patients were free from surgical reintervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and
Virtual Poster Session 2: Basic Science/Research/Education (1:40 PM − 1:50 PM) 1:40 PM: STATION H 2782 The Impact of a Simulation Curriculum Designed for Instituting Gynecologic Laparoscopy in Low and Middle Income Settings Harvey LFB,1 Mata AJ,2,* Curlin HL,3 Grimm BS,2 Lovett BJ,2 Sizemore CM,2 Ulysse JC4. 1Minimally Invasive Gynecology, Vanderbilt University Medical Center, Nashville, TN; 2Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN; 3Vanderbilt University Medical Center, Nashville, TN; 4Obstetrics and Gynecology, H^ opital Universitaire de Mirebalais, Mirebalais, Haiti *Corresponding author. Study Objective: To measure the effect of a simulation curriculum designed for instituting gynecologic laparoscopy in low and middleincome settings on competent gynecologic surgeons with novice laparoscopic skills Design: Prospective, single center, implementation study Setting: H^opital Universitaire de Mirebalais in Haiti (HUM), a 300-bed hospital operating with the Haitian Ministry of Health and Partners in Health, a Boston-based non-profit organization. Patients or Participants: Four recent OB/GYN residency graduates and three attending OB/GYN physicians at HUM. The physicians had minimal experience with laparoscopy but were skilled abdomino-pelvic surgeons. Interventions: A 5-day gynecologic laparoscopy curriculum was instituted. Trainees participated in increasingly complex simulations interspersed with didactic learning. Simulations included assembling and operating laparoscopic equipment, completing a laparoscopy specific surgical checklist, positioning patients, placing trocars, operating on a box trainer, and troubleshooting surgical complications and equipment malfunctions. Finally, participants completed bilateral salpingectomies on selected patients at HUM with at-the-elbow instructors. The trainees underwent pre- and post-training tests with simulation box training on 3 laparoscopic skills tasks; peg transfer, rubber band manipulation, and circle cut. Measurements and Main Results: There were no operative complications. Two evaluators independently scored de-identified pre- and post-test videos of box trainer tasks using a modified OSATS scale (Objective Structured Assessments of Technical Skills). Both were fellowship trained gynecologic surgeons who regularly teach laparoscopy. The mean increase in OSATS scores after training was 4.3 out of 25 possible points (SD 2.7, R 0-8). A Wilcoxon signed rank test of equality of matched pairs was significant. (Prob > jzj = 0.0001.) Conclusion: An intensive, short-term curriculum designed for instituting gynecologic laparoscopy in low and middle-income settings significantly increased the measurable laparoscopic skill of 7 gynecologic surgeons who were novices to laparoscopy. Further implementation science regarding the development of gynecologic laparoscopy in low and middleincome settings is needed.