Saturday, December 14, 2019
Breaking Medical Device Industry News

New Evidence Points to Less Invasive Management for Women Suffering from Uterine Fibroids

Hysterectomies represent the second most common women’s surgical procedure performed annually, despite results favoring minimally invasive, outpatient, uterus-preserving treatment options

Saturday, December 14, 2019

The Journal of the Society of Laparoendoscopic Surgeons has released a publication led by Dr. Yelena Havryliuk and her colleagues from the Weill Cornell Medical College, “Symptomatic Fibroid Management: Systematic Review of the Literature.” The authors set out to define the standard of care in treating symptomatic uterine fibroids.

The authors conducted a 10-year systematic review with a meta-analysis1 that compared results across multiple studies and evaluated therapeutic approaches offering the most patient benefit. The authors assessed 143 articles between January 2006 and January 2016 which resulted in 45 papers qualifying a robust quantitative analysis. The results from hysterectomy trials were compared with those from uterine-preserving fibroid studies that included myomectomy, uterine artery embolization (UAE), laparoscopic radiofrequency ablation (Lap-RFA) and magnetic resonance-guided focused ultrasound (MRg-FUS). The authors concluded that procedures with short or no hospital stay, low complication and reintervention rates, and high levels of patient satisfaction in controlling symptoms may become the first line approaches for treating uterine fibroids.

Women’s health issues have recently taken center stage and underpin major issues facing the U.S. healthcare system. Hysterectomies are the second most common women’s surgical procedure in the U.S., with more than 400,000 inpatient surgeries performed annually. The overwhelming indication is symptomatic fibroids.2 Despite these numbers, many women put off treatment because of the invasiveness and observed risks. Studies have shown women desire a treatment that does not involve invasive surgery, preserves the uterus and preserves fertility3.

The Lap-RFA procedure, also known as the Acessa® System, stood out in the publication. The Acessa procedure is a minimally invasive, uterine sparing option for women. Unlike many alternative interventions, Acessa can treat almost all sizes and locations of fibroids, including those outside the uterine cavity and within uterine walls. The procedure requires no cutting or suturing of uterine tissue, and patients typically go home the same day, experiencing minimal discomfort and a rapid return to normal activities. FDA approved in 2012, the Acessa System has been used to successfully treat more than 2,000 women.

Dr. Havryliuk and her colleagues concluded that the Lap-RFA procedure was associated with low complication rates, minimal blood loss and low re-intervention rates. In addition, patients reported major improvement in their quality of life and symptom severity scores compared to reports of more traditional interventions, such as hysterectomy, myomectomy and UAE.

Ryan Graver, vice president market access and reimbursement highlights, “Barriers such as negative coverage policies from commercial insurers that limit women’s access to less invasive, appropriate and effective care continues to be a major issue in the U.S.” “At Acessa Health, we are working with physicians and commercial insurers to expand women’s treatment options. We believe this study continues to build on the body of evidence that the Acessa procedure should be a first-line therapy for women suffering from symptomatic uterine fibroids,” concluded Graver.

References

1 Havryliuk Y, Setton R, Carlow JJ, Shaktman BD. Symptomatic fibroid management: systematic review of the literature. J Soc Laparoenosc Surg. 2017;21(3): e2017.00041
2 Wright JD, Herzog TJ, Tsui J, Ananth CV, Lewin SN, Lu YS, Neugut AI, Hershman DL. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2):233–41.
3 The Impact of Uterine Leiomyomas: A National Survey of Affected Women, Bijan J. Borah, PhD,1 Wanda K. Nicholson, MD, MPH, MBA,2 Linda Bradley, MD,3 and Elizabeth A. Stewart, MD4, Am J Obstet Gynecol. 2013 Oct; 209(4): 319.e1–319.e20. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4167669/)

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