Medicine and Health Sciences Commons^™

12-Month Outcomes Of The Us Patient Cohort In The Sonata Pivotal Ide Trial Of Transcervical Ablation Of Uterine Fibroids., Joseph Hudgens, D. Alan Johns, Andrea S. Lukes, David A. Forstein, Dipak Delvadia

Touro College of Osteopathic Medicine (New York) Publications and Research

Objective: The prospective SONATA pivotal Investigational Device Exemption (IDE) trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical fibroid ablation (TFA) in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort.

Methods: TFA with the Sonata System was performed on women with symptomatic uterine fibroids. The 12-month co-primary endpoints were reduction in menstrual blood loss and freedom from surgical reintervention. Symptom severity, quality of life, patient satisfaction, safety, and reductions in uterine and fibroid volumes were also evaluated.

Results: One hundred twenty-five …

Pregnancy-Associated Spontaneous Pneumomediastinum: A Contemporary Review, Sonu Sahni, Narcisse Amine

Touro College of Osteopathic Medicine (New York) Publications and Research

Spontaneous pneumomediastinum (SPM), also referred to as mediastinal emphysema, is defined as the presence of free air in the mediastinal cavity without a clear and identifiable cause. Spontaneous pneumomediastinum, in general, is a relatively rare condition, more so in the setting of pregnancy or labor. Clinically, SPM may present as dyspnea, chest pain, and subcutaneous swelling, which may be of serious concern in the setting of pregnancy. A comprehensive literature review revealed that the majority of patients are primiparas, of a younger age, and have term or longer durations of pregnancy. The second stage of labor was found to be …