Hand-held digital hysteroscopy system a game-changer

September 13, 2016

If you suffer from technophobia, ergonophobia, or econophobia, this device is for you.

 

 

Dr Anderson is the Betty and Lonnie S. Burnett Professor and Vice Chair for Gynecology, Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee.

The ability to look inside the uterus to diagnosis anatomic abnormalities that affect reproductive health and underlying gynecologic disorders is an invaluable tool for the modern gynecologist. Doing that in the office not only offers the benefit of convenience for the patient and the surgeon, but also has the potential to contribute significantly to overall reduction in healthcare costs. Any new technological advancement that facilitates efficient and accurate diagnosis and management of intrauterine pathology in the office offers the potential to significantly improve gynecologic healthcare delivery. The EndoSee hysteroscope with disposable diagnostic cannula (Cooper Surgical, Trumbull, CT) does exactly that.

Hysteroscopy’s beginnings

Hysteroscopy dates back to the late 1800s when Pantaleoni visualized and treated an endometrial polyp. Then, instrumentation was primitive and uterine cavity distention was grossly insufficient.1 It wasn’t until almost half a decade later that carbon dioxide was first used for uterine distention, but instrumentation was still rather crude. Developments in the 1950s brought improvements in instrumentation and introduction of various fluids to achieve uterine expansion, but it wasn’t until the 1970s that hysteroscopy had become an integral component of the gynecologist’s armamentarium.2 In 1989, Loffer demonstrated that hysteroscopy with directed biopsy was superior to blind dilatation and curettage for diagnosis of abnormal uterine bleeding,3 further securing the beneficial role of hysteroscopy in the treatment of uterine disorders.

Related: Pain management during office hysteroscopy

In the 1990s, diagnostic hysteroscopy transitioned from the operating theater to the office environment, emerging as a more common practice.4 This was made possible by availability of small-caliper rigid and flexible hysteroscopes with high resolution, a better understanding of pain management in the office setting, gynecologists’ greater experience with hysteroscopy, and greater comfort in performing office procedures in general.

 

 

Hysteroscopy indications and utilization

Hysteroscopic evaluation of the uterine cavity has multiple indications and relatively few contraindications, some of which are listed in the Table. The most common potential use includes evaluation of abnormal uterine bleeding, which may represent up to one-third of the typical gynecologist’s practice. The utility of diagnostic hysteroscopy prior to operative hysteroscopy, especially in predicting this excess of hysteroscopic myomectomy, has been well established.5,6

In addition, the cost-effectiveness of office hysteroscopy in identifying patients who do not need to go to the operating room for operative hysteroscopy interventions has been well established. Moawad et al reported that almost 60% of women undergoing diagnostic office hysteroscopy for abnormal uterine bleeding were able to avoid intervention in the operative suite, saving almost $1500 per patient.7 Given the incidence of abnormal uterine bleeding in as much as 20% of reproductive-age women, the cost savings of this strategy to overall healthcare expenditures is staggering.

Still, with all these advancements in instrumentation and technique, relative ease of use, excellent convenience with concomitant patient acceptance, and demonstration of cost effectiveness, hysteroscopy in general (and office hysteroscopy in particular) remains grossly underutilized in the diagnosis of uterine pathology. In fact, it is estimated that only about 15% to 20% of gynecologists routinely use hysteroscopy as a diagnostic, much less operative, tool.5

I maintain that there are 3 elements of concern that impede the full integration of office hysteroscopy. First, many physicians are uncomfortable with all the “gear” required to implement office hysteroscopy (technophobia). The plethora of choices includes hysteroscopes with or without sheathes and available accessories, cameras and controllers to which they must be attached, light sources and the cords required to deliver that illumination to the conduction system in the hysteroscope, monitors for image viewing, and either printers or image transfer systems to incorporate findings into the medical record.

Second, the processes involved in assembly, effective and optimal utilization, cleaning and sterilizing, and proper maintenance of all this equipment can be intimidating (ergonophobia). In addition, it can be challenging to integrate office procedures into a daily schedule and provide and plan for appropriate recovery when necessary, not to mention all the training of staff and protocols required for dealing with emergencies. Third, acquisition and maintenance of all the equipment and assignment of dedicated office space to support office procedures represents considerable expense and subsequent concerns about return on investment (econophobia).

 

 

Enter the EndoSee

The EndoSee hysteroscope, approved by the US Food and Drug Administration in 2015, is a reposable device that addresses all 3 elements of concern. It consists of a reusable hand-held unit, complete with video monitor, which attaches to a single-use disposable cannula containing both camera and light source at the tip (Figure 1). The hand-held unit measures only 4.6 x 1.2 in and contains a video processor for image or video viewing and digital capture. This is attached to a touch-sensitive adjustable 3.7 x 3.5-in LCD screen. The entire device weighs only 0.2 lb. It can rest on a base unit to which it attaches via a connector identical to that of the cannula (Figure 2). This permits battery recharging and allows for USB transfer of images or videos to a laptop. A fully charged battery provides about 2 hours of continuous use, which can be monitored by an on-screen battery life indicator.

Photo courtesy of Cooper SurgicalEach sterile single-use cannula is approximately 11 in long and 4 mm in diameter. The slightly curved tip (25 degrees) mimics an angled hysteroscopic lens, which contains a miniature complementary metal-oxide semiconductor (CMOS) camera and an LED light source (Figures 1-3). The cannula aligns with and snaps securely onto a receptacle at the end of the hand-held monitor and contains a channel for fluid distension medium (Figure 4).

The EndoSee hysteroscope eliminates the need to acquire a traditional “endoscopic tower” with separate cameras, light sources, and monitors. Further, it eliminates the need for equipment needed for sterile processing of equipment between uses. It does not even require a dedicated procedure room. The handheld unit can be carried comfortably in the typical white coat pocket and cannulas can be stocked in exam rooms much like pipelle biopsy cannulas. Indeed, its use draws many parallels to office endometrial biopsy. Minimal patient preparation is necessary. If planned, you might consider misoprostol preparation of the cervix, but extemporary use is possible with or without a paracervical block and usually does not require cervical dilation.

A video found at https://youtu.be/QLGpGeCZCI4 demonstrates its routine use in the exam room. After entering a patient identifier using the touch-sensitive screen and connecting the sterile cannula, the fluid distension medium is connected via intravenous extension tubing. In this video, a bag of saline was used, but you could just as easily use a 30-cc syringe with saline delivered by your office assistant. The cannula is inserted into the uterine cavity much like a pipelle. Although the vaginoscopic approach can be used, the flexibility of the catheter makes this approach much more challenging. Use of even a small speculum to visualize the cervix allows for placement of the catheter tip into the os and use of distension fluid to aid in cervical dilation and passage of the catheter into the uterine cavity. It is rare that minimal cervical dilation is required for insertion.

 

 

The contours of the uterine cavity can be explored by gently turning the unit to take advantage of the curved tip for optimal visualization. There is one button on the handheld unit that adjusts the light intensity and another that captures an image or activates video capture, depending on how long you depress it. Multiple reports have described EndoSee to be easy to use and well tolerated by patients while providing for excellent evaluation of the uterine cavity and producing high-quality images and videos.8-10 While currently only a diagnostic cannula is available, it is anticipated that a cannula with an operative channel will be available soon.

Photo courtesy of Cooper Surgical

Summary

Rarely does a device come along that radically changes the way we practice. The EndoSee handheld digital hysteroscopy system addresses the 3 main impediments to full integration of office hysteroscopy: technophobia, ergonophobia, and econophobia. It is a simple, handheld, battery-operated device that requires no endoscopy tower and no cords to connect light source or camera. It requires only the snap of the cannula and the push of a button to be fully operational. In addition to its simplicity, it has been demonstrated to be as well tolerated as office endometrial biopsy while producing a high-resolution view on the monitor and in digitally captured images or videos. Finally, it is a fraction of the cost of a traditional hysteroscopy system and requires no additional expense for sterile processing between uses, providing for rapid and excellent return on investment. With these characteristics, the EndoSee handheld digital hysteroscopy system is a game-changer for office hysteroscopy.

Dr Anderson has no conflicts of interest to report in respect to the content of this article.

 

REFERENCES

Bradley L. Indications and contraindications for office hysteroscopy. In: LD Bradley and T Falcone, eds. Hysteroscopy. Office evaluation and management of the uterine cavity. Philadelphia: Mosby Elsevier; 2009:19-38.

Marlow JL. Media and delivery systems. Obstet Gynecol Clin N Am. 2000;27 (2):367–374.

Loffer FD. Hysteroscopy with selective endometrial sampling compared with D&C for abnormal uterine bleeding: The value of a negative hysteroscopic view. Obstet Gynecol. 1989;73(1):16–20.

Bradley L, Widrich T. State-of-the-art flexible hysteroscopy for office gynecologic evaluation. J Am Assoc Gynecol Laparosc. 1995;2(3):263–267.

Isaacson K. Office hysteroscopy: A valuable but under-utilized technique. Curr Opin Obstet Gynecol. 2002;14:381–385.

Shinar S, Bibi G, Barzilay L, et al. The value of diagnostic hysteroscopy before operative hysteroscopy for suspected abnormal intrauterine findings. JMIG. 2014;21:228–232.

Moawad NS, Santamaria E, Johnson E, et al. Cost-effectiveness of office hysteroscopy for abnormal uterine bleeding. JSLS. 2014;18:1–5.

Harris MS. Experience with EndoSee: A novel hand-held digital hysteroscope for use in diagnostic office hysteroscopy. JMIG. 2015;20:S67.

Wortman M. The EndoSee hysteroscope: initial experience with a self-contained hand-held hysteroscopy system. JMIG. 2015;20:S68.

Munro M. Pilot evaluation of the EndoSee hand-held hysteroscopic system for diagnostic hysteroscopy. JMIG. 2015;20:S68–69.