Transcervical Fibroid Ablation (TFA) in an Ambulatory Surgical Center Setting: Utility during the COVID-19 Pandemic

STUDY OBJECTIVE: To describe the experience of TFA with the Sonata® system in the ambulatory surgicenter (ASC) setting, relative to current recommendations by medical societies for elective procedures during the COVID-19 pandemic. DESIGN: Prospective, longitudinal, multicenter controlled trial. SETTING: 22 clinical sites in the US and Mexico. PATIENTS OR PARTICIPANTS: 147 premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to nonpedunculated fibroids. INTERVENTIONS: Transcervical, intrauterine ultrasound-guided radiofrequency ablation with the Sonata system. Pain scores were recorded after each procedure using a scale from 0-10. Length of stay (LOS) was measured from procedure start through discharge. MEASUREMENTS AND MAIN RESULTS: Of 147 treated patients, 49 were treated in an ASC setting and 98 were treated in other outpatient settings. Fifty-five percent of patients treated in an ASC had general anesthesia and 45% had conscious sedation vs 48% and 52%, respectively for non-ASC population. Average number of fibroids treated per patient was 3.2±2.0 and 2.9±2.1 in ASC and non-ASC, respectively. Mean LOS was 2.1±0.9 hours vs. 2.8±1.3 hours for ASC and non-ASC patients, respectively. Mean procedure pain scores were 0±0% for the ASC patients (0.4±1.1 for non-ASC patients). Mean return to normal activity for patients treated in ASC was 1.7±1.4 days (2.4±2.5 for non-ASC patients). Mean 12-month improvements in SSS and HRQL scores were -34.8±23.9 and 48.6±26.2 points, respectively, in ASC patients (-30.4±19.3 and 41.0±23.0, respectively, in non-ASC patients). CONCLUSION: Current surgical guidance during the COVID-19 pandemic encourages avoidance of endotracheal intubation when appropriate and minimizing exposure time for patients and staff. Transcervical Fibroid Ablation with the Sonata system is performed without pneumoperitoneum or a requirement for intubation, providing short LOS, minimal pain scores and improved outcomes while potentially reducing risk to healthcare personnel and patients alike.