Minimally invasive transcervical radiofrequency ablation shows promising results for uterine fibroids

Ultrasound-guided transcervical radiofrequency ablation provides an effective, safe and minimally invasive alternative for the treatment of symptomatic uterine fibroids suggests the results of pivotal IDE trial published in the January issue of Obstetrics & Gynecology.

The prospective, longitudinal, multicenter Sonography-Guided Transcervical Fibroid Ablation (SONATA) trial evaluated Gynesonics's investigational Sonata system in the treatment of heavy menstrual bleeding (HMB) because of uterine leiomyomata.

The Sonata System combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure to treat symptomatic uterine fibroids.

The trial enrolled 147 premenopausal women between age 25-50 years with HMB for at least three months, across 22 centers in the United States and Mexico. The size and number of fibroids varied between 1 to 5 cm diameters and 1-10 fibroids per woman respectively.

All women were followed for 12 months and results assessed in terms of relief from heavy menstrual blood loss, device-related complications, and surgical intervention rate.

Scott Chudnoff, Chief of OB/GYN at Stamford Hospital, Stamford CT a principal investigator in the SONATA trial, said in a press release, “The actual results achieved in the SONATA trial far exceed the required thresholds established by the FDA for the co-primary endpoints of reduction in menstrual bleeding and freedom from surgical reintervention for bleeding. These results, along with the impressive levels of patient satisfaction and rapid return to normal activity achieved, clearly demonstrate the potential for Sonata as a first line treatment for symptomatic fibroids.”

At the end of follow-up period of 12 months, 99% of patients did not require any additional surgical intervention for controlling HMB, 94% of patients reported relief from substantial blood loss with 60% reporting a 50% reduction in the amount of blood loss.

There was minimal surgical downtime with half of them returning to regular activity the next day of surgery, and 97% were satisfied with the procedure. No device-related complications were reported.

Procedure-related adverse events reported include fibroid sloughing (30.6%), cramping or pain (7.5%), leukorrhea (6.1%), and uncomplicated genitourinary infections (4.8%).

The results of the study earned FDA clearance for the SONATA system in August 2018. The results were also consistent with the previously published FAST-EU trial. Chris Owens, President and CEO stated.

 “Considering these two prospective, multicenter trials were comprised of several disparate patient populations across two continents and performed by a broad range of physician operators across various healthcare delivery systems, and clinical settings, the consistency of these results is remarkable. The reproducible results highlight the robustness of the Sonata platform design and its potential to become a new standard of care for fibroid treatment.”

Gynesonics funded the study, and lead author have received travel and lodging expenses and honoraria for speaking for Gynesonics. 

Here is a video showing SONATA system overview

Abstract

Gynesonics Press Release

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Media courtesy: Gynesonics

New café in Tokyo houses all robot staff operated remotely by people with disabilities

A new café recently opened in Tokyo is entirely staffed by robots controlled by disabled people remotely. Contrary to the negative side of automation, the café creates jobs for people with severe debilitating conditions like amyotrophic lateral sclerosis (ALS) and spinal cord injuries.

Named Diverse Avatar Working Network) ver.β (DAWN), the café was launched as a joint project between Ory Lab, which develops the robots, Nippon Foundation, and ANA Holdings. The robots serving in the café is OriHime-D–a 4-foot-tall, altogether robot that moves, look around, handles objects, and speak with patrons at Tokyo’s Café. It has a built-in camera, a microphone and a speaker and can remotely control from a smartphone or a PC using the Internet.

Joysticks, blow tubes, or just the movements of the eye easily control the robots to serve coffee and intermingle with the customers. The disabled person or other people who cannot get out of home can earn money comfortably working from home or nursing home.

Currently, there is a staff of 10 people all working remotely from home and get paid 1,000 yen (US$8.80) an hour (a standard wage for part-time work in Japan).

The café was a pilot project for a temporary period and was funded by crowdfunding drive which doubled its funding goal. If the funds are made available on a regular basis, it is hoped that a full-fledged Dawn will open in 2020.

Here is a promo video to give a glimpse of how the concept works

A more realistic demonstration of how a operator controls the robot

A video of the opening ceremony

Product page

Via SoraNews

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What is the most effective uterotonic agent to prevent PPH?

Postpartum hemorrhage (PPH) is responsible for more than 25% of all maternal death around the world and is the leading cause of maternal mortality in low resource settings. It affects 5% of all women during labor and leads to substantial morbidity because of compromised maternal blood volume. 

Use of uterotonics during the third stage of labor could avoid a majority of complications due to PPH. WHO recently published updated guidance on uterotonics for the prevention of PPH, after which the Cochrane Review published the results of a network meta‐analysis to identify the most effective uterotonic agent.

The network meta‐analysis included 196 trials involving 135,559 women, with the majority of women having vaginal births (71.5%, 140/196) in a hospital setting (95.4%, 187/196). 

The WHO recommendations and results of the Cochrane analysis suggest:

To effectively prevent PPH, only one of the following uterotonics should be used: Oxytocin, Carbetocin, Misoprostol, Ergometrine/methylergometrine, Oxytocin, and ergometrine fixed-dose combination.

Oxytocin (10 IU, IM/IV) is the standard recommended drug of choice for prevention of PPH in all cases. The drug has minimum side effects and is cost effective too. The main problem with Oxytocin is it requires refrigeration and rapidly loses its potency if stored at room temperature.

The use of carbetocin (100 µg, IM/IV) is also recommended for the prevention of PPH for all births if cost is not the limiting factor. It is also not readily available everywhere.

Misoprostol, injectable prostaglandins, and ergometrine have no additional benefits compared with oxytocin. Misoprostol causes more undesirable effects than oxytocin (including nausea, vomiting, shivering, fever, and diarrhea).

Combination therapy involving ergometrine plus oxytocin combination (Syntometrine ®), misoprostol plus oxytocin combination and carbetocin have the additional desirable effects compared with oxytocin and can be used if oxytocin is unavailable. However, there is always a risk of undesirable side effects as compared to oxytocin. Injectable prostaglandins (carboprost or sulprostone) are not recommended for the prevention of PPH.

Misoprostol and oxytocin are not available in fixed-dose combination and require different routes of administration so its use in routine clinical settings may not be very feasible as compared to using them alone.

If using ergometrine (alone or in combination), it is important to rule out hypertensive disorders and cardiovascular diseases.

In low resource settings and non-availability of skilled healthcare personnel, misoprostol (400 µg or 600 µg) can be administered orally by the community or lay health workers.

WHO recommendations Uterotonics for the prevention of postpartum haemorrhage

Uterotonic agents for preventing postpartum haemorrhage: a network meta‐analysis

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