OBG Management

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

FDA REMOVES ALCOHOL BAN WITH ADDYI

Sprout Pharmaceuticals announced that the US Food and Drug Administration (FDA) has removed their contraindication on alcohol use with Addyi® (flibanserin). Addyi was approved in 2015 and is an oral nonhormonal pill for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Patients are advised to discontinue drinking alcohol at least 2 hours before taking Addyi at bedtime or skip the Addyi dose that evening.

The FDA also removed the requirement, under its Risk Evaluation and Mitigation Strategy (REMS) program, for health care practitioners or pharmacies to be certified to prescribe or dispense Addyi. Sprout says that to make all labeling elements consistent with the FDA’s findings the boxed warning will change and the medication guide will be updated and included under the REMS. 

The most commonly reported adverse events among patients taking Addyi are dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. Addyi is contraindicated in patients taking moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors and in those with hepatic impairment.

FOR MORE INFORMATION AND THE FULL PRESCRIBING INFORMATION AND MEDICATION GUIDE, VISIT: www.addyi.com

FEZOLINETANT FOR VMS

FOR MORE INFORMATION, VISIT: http://www.clinicaltrials.gov, TRIAL IDENTIFIERS NCT04003155, NCT04003142, AND NCT04003389

SOLUTIONS FOR OUTCOME TRACKING

DrChrono and OutcomeMD announce a partnership to track and analyze patient outcome data and confounding factors. DrChrono is an electronic health record (EHR) system, and OutcomeMD is a software solution that uses literature-validated patient-reported outcome instruments to score and track a patient’s symptom severity and inform treatment decisions for users.

Via a HIPAA compliant process, patients answer a list of questions that are accessed through a web link on their mobile or desktop devices. OutcomeMD summarizes the symptoms into a score that displays to both the physician and patient. Patients’ answers and scores are pushed to the clinician’s DrChrono EHR medical note. As care progresses in the OutcomeMD platform, patients remotely track how their symptoms change, and notifications alert clinicians of patients who may need attention. The integration with DrChrono also allows patient data on confounding factors to be automatically pushed from the patient’s device into the clinician’s medical note. The partnership will enable physicians to visualize patients’ status, and all the factors involved in their care, on one screen, says DrChrono and OutcomeMD, strengthening documentation and saving time for both patients and clinicians. An integration demo video is available at https://youtu.be/jnh7YPII080.

FOR MORE INFORMATION, VISIT: www.outcomemd.com

Continue to: NEW MATERNITY GOWN...

ImageFIRST launched a new maternity gown for expecting mothers. The Comfort Care^® Maternity Gown is a lightweight, premium polyester/nylon fabric that front snaps to allow for skin-to-skin access and optional breastfeeding. The gown also includes shoulder snaps and a full cut for extra coverage and to accommodate a variety of body types, says ImageFIRST.

ImageFIRST is a national linen rental provider. It developed the Comfort Care^® Maternity Gown with input from labor and delivery departments to best meet the needs of expecting mothers. It also says that a portion of the proceeds from each gown rental will be donated to the National Pediatric Cancer Foundation. 

FOR MORE INFORMATION, VISIT: www.imagefirst.com

Genital lichen simplex chronicus

Lichen simplex chronicus (LSC) is an inflammatory skin condition that develops secondary to persistent rubbing or scratching of skin. Although LSC can occur anywhere on the body, genital LSC develops in association with genital itch, with the itch often described as intense and unrelenting. The itching sensation leads to scratching and rubbing of the area, which can provide temporary symptomatic relief.^1,2 However, this action of rubbing and scratching stimulates local cutaneous nerves, inducing an even more intense itch sensation. This process, identified as the ‘itch-scratch cycle,’ plays a prominent role in all cases of LSC.¹

On physical examination LSC appears as poorly defined, pink to red plaques with accentuated skin markings on bilateral labia majora. Less commonly, it can present as asymmetrical or unilateral plaques.³ LSC can extend onto labia minora, mons pubis, and medial thighs. However, the vagina is spared.¹ Excoriations, marked by their geometric, angular appearance, often can be appreciated overlying plaques of LSC. Additionally, crusting, scale, broken hairs, hyperpigmentation, and scarring may be seen in LSC.²

In this case, white discharge was noted on vaginal examination, which was suspicious for vaginal candidiasis. Wet mount examination revealed multiple candida hyphae and spores (FIGURE 2), confirming vaginal candidiasis. This vulvovaginal fungal infection caused persistent vulvar pruritus, with subsequent development of LSC due to prolonged scratching. The patient was treated with both oral fluconazole and topical mometasone ointment, for vaginal candidiasis and vulvar LSC, respectively. Mometasone ointment is categorized as a class II (high potency) topical steroid. However, it is worth noting that mometasone cream is categorized as a class IV (medium potency) topical steroid.
 

FIGURE 2 Wet mount of vaginal discharge, revealing candida hyphae and spores

Treatment

Successful treatment of LSC requires addressing 4 elements, including recognizing and treating the underlying etiology, restoring barrier function, reducing inflammation, and interrupting the itch-scratch cycle.³

Identifying the underlying etiology. Knowing the etiology of vulvar pruritus is a key step in resolution of the condition because LSC is driven by repetitive rubbing and scratching behaviors in response to the itch. The differential diagnosis for vulvar pruritus is broad. Evaluation and workup should be tailored to suit each unique patient presentation. A review of past medical history and full-body skin examination can identify a contributing inflammatory skin disease, such as atopic dermatitis, psoriasis, lichen planus, lichen sclerosus, or autoimmune vesiculobullous disease (pemphigus).^1,2 Careful review of products applied in the genital area can reveal an underlying irritant or allergic contact dermatitis. Scented soap or detergent commonly cause vulvar dermatitis.¹ A speculum examination may suggest inflammatory vaginitis or atrophic vaginitis (genitourinary syndrome of menopause); run off of vaginal discharge onto the vulvar skin can result in vulvar pruritus. Vaginal wet mount can diagnose vulvovaginal candidiasis, trichomonas infection, and bacterial vaginitis.¹ A skin scraping with mineral oil or potassium hydroxide can suggest scabies infestation or cutaneous dermatophyte infection, respectively.² Treatment of vulvar pruritus should be initiated based on diagnosis.

Restoring barrier function. The repetitive scratching and rubbing behaviors disrupt the cutaneous barrier layer and lead to stimulation of the local nerves. This creates more itch and further traumatization to the barrier. Barrier function can be restored through soaking the area, with sitz baths or damp towels. Following 20- to 30-minute soaks, a lubricant, such as petroleum jelly, should be applied to the area.³

Reducing inflammation. To reduce inflammation, topical steroids should be applied to areas of LSC.³ In severe cases, high potency topical steroids should be prescribed. Examples of high potency topical steroids include:

• clobetasol propionate 0.05%
• betamethasone dipropionate 0.05%
• halobetasol propionate 0.05%.

Ointment is the choice vehicle because it is both more potent and associated with decreased stinging sensation. High potency steroid ointment should be applied twice daily for at least 2 to 4 weeks. The transition to lower potency topical steroids, such as triamcinolone acetonide 0.1% ointment, can be made as the LSC improves.²

Interrupting the itch-scratch cycle. As noted above, persistent rubbing and scratching generates increased itch sensation. Thus, breaking the itch-scratch cycle is essential. Nighttime scratching can be improved with hydroxyzine. The effective dosage ranges between 25 and 75 mg and should be titrated up slowly every 5 to 7 days. Sedation is a major adverse effect of hydroxyzine, limiting the treatment of daytime itching. Selective serotonin reuptake inhibitors (SSRIs), such as citalopram, also have been found to be effective. Over the counter, nonsedation antihistamines have not been found to be useful in breaking the itch-scratch cycle. The clinical course of LSC is chronic (as the name implies), waxing and waning, and sometimes can be challenging to treat—some patients require years-long continued follow-up and treatment.³
 

Genital lichen simplex chronicus

Lichen simplex chronicus (LSC) is an inflammatory skin condition that develops secondary to persistent rubbing or scratching of skin. Although LSC can occur anywhere on the body, genital LSC develops in association with genital itch, with the itch often described as intense and unrelenting. The itching sensation leads to scratching and rubbing of the area, which can provide temporary symptomatic relief.^1,2 However, this action of rubbing and scratching stimulates local cutaneous nerves, inducing an even more intense itch sensation. This process, identified as the ‘itch-scratch cycle,’ plays a prominent role in all cases of LSC.¹

On physical examination LSC appears as poorly defined, pink to red plaques with accentuated skin markings on bilateral labia majora. Less commonly, it can present as asymmetrical or unilateral plaques.³ LSC can extend onto labia minora, mons pubis, and medial thighs. However, the vagina is spared.¹ Excoriations, marked by their geometric, angular appearance, often can be appreciated overlying plaques of LSC. Additionally, crusting, scale, broken hairs, hyperpigmentation, and scarring may be seen in LSC.²

In this case, white discharge was noted on vaginal examination, which was suspicious for vaginal candidiasis. Wet mount examination revealed multiple candida hyphae and spores (FIGURE 2), confirming vaginal candidiasis. This vulvovaginal fungal infection caused persistent vulvar pruritus, with subsequent development of LSC due to prolonged scratching. The patient was treated with both oral fluconazole and topical mometasone ointment, for vaginal candidiasis and vulvar LSC, respectively. Mometasone ointment is categorized as a class II (high potency) topical steroid. However, it is worth noting that mometasone cream is categorized as a class IV (medium potency) topical steroid.
 

FIGURE 2 Wet mount of vaginal discharge, revealing candida hyphae and spores

Treatment

Successful treatment of LSC requires addressing 4 elements, including recognizing and treating the underlying etiology, restoring barrier function, reducing inflammation, and interrupting the itch-scratch cycle.³

Identifying the underlying etiology. Knowing the etiology of vulvar pruritus is a key step in resolution of the condition because LSC is driven by repetitive rubbing and scratching behaviors in response to the itch. The differential diagnosis for vulvar pruritus is broad. Evaluation and workup should be tailored to suit each unique patient presentation. A review of past medical history and full-body skin examination can identify a contributing inflammatory skin disease, such as atopic dermatitis, psoriasis, lichen planus, lichen sclerosus, or autoimmune vesiculobullous disease (pemphigus).^1,2 Careful review of products applied in the genital area can reveal an underlying irritant or allergic contact dermatitis. Scented soap or detergent commonly cause vulvar dermatitis.¹ A speculum examination may suggest inflammatory vaginitis or atrophic vaginitis (genitourinary syndrome of menopause); run off of vaginal discharge onto the vulvar skin can result in vulvar pruritus. Vaginal wet mount can diagnose vulvovaginal candidiasis, trichomonas infection, and bacterial vaginitis.¹ A skin scraping with mineral oil or potassium hydroxide can suggest scabies infestation or cutaneous dermatophyte infection, respectively.² Treatment of vulvar pruritus should be initiated based on diagnosis.

Restoring barrier function. The repetitive scratching and rubbing behaviors disrupt the cutaneous barrier layer and lead to stimulation of the local nerves. This creates more itch and further traumatization to the barrier. Barrier function can be restored through soaking the area, with sitz baths or damp towels. Following 20- to 30-minute soaks, a lubricant, such as petroleum jelly, should be applied to the area.³

Reducing inflammation. To reduce inflammation, topical steroids should be applied to areas of LSC.³ In severe cases, high potency topical steroids should be prescribed. Examples of high potency topical steroids include:

• clobetasol propionate 0.05%
• betamethasone dipropionate 0.05%
• halobetasol propionate 0.05%.

Ointment is the choice vehicle because it is both more potent and associated with decreased stinging sensation. High potency steroid ointment should be applied twice daily for at least 2 to 4 weeks. The transition to lower potency topical steroids, such as triamcinolone acetonide 0.1% ointment, can be made as the LSC improves.²

Interrupting the itch-scratch cycle. As noted above, persistent rubbing and scratching generates increased itch sensation. Thus, breaking the itch-scratch cycle is essential. Nighttime scratching can be improved with hydroxyzine. The effective dosage ranges between 25 and 75 mg and should be titrated up slowly every 5 to 7 days. Sedation is a major adverse effect of hydroxyzine, limiting the treatment of daytime itching. Selective serotonin reuptake inhibitors (SSRIs), such as citalopram, also have been found to be effective. Over the counter, nonsedation antihistamines have not been found to be useful in breaking the itch-scratch cycle. The clinical course of LSC is chronic (as the name implies), waxing and waning, and sometimes can be challenging to treat—some patients require years-long continued follow-up and treatment.³
 

Genital lichen simplex chronicus

Lichen simplex chronicus (LSC) is an inflammatory skin condition that develops secondary to persistent rubbing or scratching of skin. Although LSC can occur anywhere on the body, genital LSC develops in association with genital itch, with the itch often described as intense and unrelenting. The itching sensation leads to scratching and rubbing of the area, which can provide temporary symptomatic relief.^1,2 However, this action of rubbing and scratching stimulates local cutaneous nerves, inducing an even more intense itch sensation. This process, identified as the ‘itch-scratch cycle,’ plays a prominent role in all cases of LSC.¹

On physical examination LSC appears as poorly defined, pink to red plaques with accentuated skin markings on bilateral labia majora. Less commonly, it can present as asymmetrical or unilateral plaques.³ LSC can extend onto labia minora, mons pubis, and medial thighs. However, the vagina is spared.¹ Excoriations, marked by their geometric, angular appearance, often can be appreciated overlying plaques of LSC. Additionally, crusting, scale, broken hairs, hyperpigmentation, and scarring may be seen in LSC.²

In this case, white discharge was noted on vaginal examination, which was suspicious for vaginal candidiasis. Wet mount examination revealed multiple candida hyphae and spores (FIGURE 2), confirming vaginal candidiasis. This vulvovaginal fungal infection caused persistent vulvar pruritus, with subsequent development of LSC due to prolonged scratching. The patient was treated with both oral fluconazole and topical mometasone ointment, for vaginal candidiasis and vulvar LSC, respectively. Mometasone ointment is categorized as a class II (high potency) topical steroid. However, it is worth noting that mometasone cream is categorized as a class IV (medium potency) topical steroid.
 

FIGURE 2 Wet mount of vaginal discharge, revealing candida hyphae and spores

Treatment

Successful treatment of LSC requires addressing 4 elements, including recognizing and treating the underlying etiology, restoring barrier function, reducing inflammation, and interrupting the itch-scratch cycle.³

Identifying the underlying etiology. Knowing the etiology of vulvar pruritus is a key step in resolution of the condition because LSC is driven by repetitive rubbing and scratching behaviors in response to the itch. The differential diagnosis for vulvar pruritus is broad. Evaluation and workup should be tailored to suit each unique patient presentation. A review of past medical history and full-body skin examination can identify a contributing inflammatory skin disease, such as atopic dermatitis, psoriasis, lichen planus, lichen sclerosus, or autoimmune vesiculobullous disease (pemphigus).^1,2 Careful review of products applied in the genital area can reveal an underlying irritant or allergic contact dermatitis. Scented soap or detergent commonly cause vulvar dermatitis.¹ A speculum examination may suggest inflammatory vaginitis or atrophic vaginitis (genitourinary syndrome of menopause); run off of vaginal discharge onto the vulvar skin can result in vulvar pruritus. Vaginal wet mount can diagnose vulvovaginal candidiasis, trichomonas infection, and bacterial vaginitis.¹ A skin scraping with mineral oil or potassium hydroxide can suggest scabies infestation or cutaneous dermatophyte infection, respectively.² Treatment of vulvar pruritus should be initiated based on diagnosis.

Restoring barrier function. The repetitive scratching and rubbing behaviors disrupt the cutaneous barrier layer and lead to stimulation of the local nerves. This creates more itch and further traumatization to the barrier. Barrier function can be restored through soaking the area, with sitz baths or damp towels. Following 20- to 30-minute soaks, a lubricant, such as petroleum jelly, should be applied to the area.³

Reducing inflammation. To reduce inflammation, topical steroids should be applied to areas of LSC.³ In severe cases, high potency topical steroids should be prescribed. Examples of high potency topical steroids include:

• clobetasol propionate 0.05%
• betamethasone dipropionate 0.05%
• halobetasol propionate 0.05%.

Ointment is the choice vehicle because it is both more potent and associated with decreased stinging sensation. High potency steroid ointment should be applied twice daily for at least 2 to 4 weeks. The transition to lower potency topical steroids, such as triamcinolone acetonide 0.1% ointment, can be made as the LSC improves.²

Interrupting the itch-scratch cycle. As noted above, persistent rubbing and scratching generates increased itch sensation. Thus, breaking the itch-scratch cycle is essential. Nighttime scratching can be improved with hydroxyzine. The effective dosage ranges between 25 and 75 mg and should be titrated up slowly every 5 to 7 days. Sedation is a major adverse effect of hydroxyzine, limiting the treatment of daytime itching. Selective serotonin reuptake inhibitors (SSRIs), such as citalopram, also have been found to be effective. Over the counter, nonsedation antihistamines have not been found to be useful in breaking the itch-scratch cycle. The clinical course of LSC is chronic (as the name implies), waxing and waning, and sometimes can be challenging to treat—some patients require years-long continued follow-up and treatment.³
 

Through the years, the surgical approach to hysterectomy has expanded from its early beginnings of being performed only through an abdominal or transvaginal route with traditional surgical clamps and suture. The late 1980s saw the advent of the laparoscopic-assisted vaginal hysterectomy (LAVH), and from that point forward several additional hysterectomy methods evolved, including today’s robotic approaches.

Although clinical evidence and societal endorsements support vaginal hysterectomy as a superior high-value modality, it remains one of the least performed among all available routes.^1-3 In an analysis of inpatient hysterectomies published by Wright and colleagues in 2013, 16.7% of hysterectomies were performed vaginally, a number that essentially has remained steady throughout the ensuing years.⁴

Attempts to improve the application of vaginal hysterectomy have been made.⁵ These include the development of various curriculum and simulation-based medical education programs on vaginal surgical skills training and acquisition in the hopes of improving utilization.⁶ An interesting recent development is the rethinking of vaginal hysterectomy by several surgeons globally who are applying facets of the various hysterectomy methods to a transvaginal approach known as vaginal natural orifice transluminal endoscopic surgery (vNOTES).^7,8 Unique to this thinking is the incorporation of conventional laparoscopic instrumentation.

Although I have not yet incorporated this approach in my surgical armamentarium at Columbia University Medical Center/New York–Presbyterian Hospital, I am intrigued by the possibility that this technique may serve as a rescue for vaginal hysterectomies that are at risk of conversion or of not being performed at all.⁹

At this time, vNOTES is not a standard of care and should be performed only by highly specialized surgeons. However, in the spirit of this Update on minimally invasive surgery and to keep our readers abreast of burgeoning techniques, I am delighted to bring you this overview by Dr. Xiaoming Guan, one of the pioneers of this surgical approach, and Dr. Tamisa Koythong and Dr. Juan Liu. I hope you find this recent development in hysterectomy of interest.

—Arnold P. Advincula, MD

Continue to: Development and evolution of NOTES...

Development and evolution of NOTES 

Over the past few decades, emphasis has shifted from laparotomy to minimally invasive surgery because of its proven significant advantages in patient care, such as improved cosmesis, shorter hospital stay, shorter postoperative recovery, and decreased postoperative pain and blood loss.¹⁰  Advances in laparoendoscopic surgery and instrumentation, including robot-assisted laparoscopy (RAL), single-incision laparoscopic surgery (SILS), and most recently natural orifice transluminal endoscopic surgery (NOTES), reflect ongoing innovative developments in the field of minimally invasive surgery. 

Here, we provide a brief literature review of the NOTES technique, focus on its application in gynecologic surgery, and describe how we perform NOTES at our institution. 

NOTES application in gynecology 

With NOTES, peritoneal access is gained through a natural orifice (such as the mouth, vagina, urethra, or anus) to perform endoscopic surgery, occasionally without requiring an abdominal incision. First described in 2004, transgastric peritoneoscopy was performed in a porcine model, and shortly thereafter the first transgastric appendectomy was performed in humans.^11,12 The technique has further been adopted in cholecystectomy, appendectomy, gastrectomy, and nephrectomy procedures.¹³ 

Given rapid interest in a possible paradigm shift in the field of minimally invasive surgery, the Natural Orifice Surgery Consortiumfor Assessment and Research (NOSCAR) was formed, and the group published an article on potential barriers to accepted practice and adoption of NOTES as a realistic alternative to traditional laparoscopic surgery.¹⁴ 

While transgastric and transanal access to the peritoneum were initially more popular, the risk of anastomotic leaks associated with incomplete closure and subsequent infection were thought to be prohibitively high.¹⁵ Transvaginal access was considered a safer and simpler alternative, allowing for complete closure without increased risk of infection, and this is now the route through which the majority of NOTES procedures are completed.^16,17 

The eventual application of NOTES in the field of gynecology seemed inevitable. The American College of Obstetricians and Gynecologists stated that transvaginal surgery is the most minimally invasive and preferred surgical route in the management of patients with benign gynecologic diseases.¹⁸ However, performing it can be challenging at times due to limited visualization and lack of the required skills for single-site surgery. NOTES allows a gynecologic surgeon to improve visualization through the use of laparoendoscopic instruments and to complete surgery through a transvaginal route. 

In 2012, Ahn and colleagues demonstrated the feasibility of the NOTES technique in gynecologic surgery after using it to successfully complete benign adnexal surgery in 10 patients.¹⁹ Vaginal NOTES (vNOTES) has since been further developed to include successful hysterectomy, myomectomy, sacrocolpopexy, tubal anastomosis, and even lymphadenectomy in the treatment of early- stage endometrial carcinoma.^20-26 vNOTES also can be considered a rescue approach for traditional vaginal hysterectomy in instances in which it is necessary to evaluate adnexal pathology.⁹ Most recently, vNOTES hysterectomy has been reported with da Vinci Si or Xi robotic platforms.^27,28 

Continue to: Operative time, post-op stay shorter in NAOC-treated patients...

Few studies have compared outcomes with vNOTES to those with traditional laparoscopy. In 2016, Wang and colleagues compared surgical outcomes between NOTES-assisted ovarian cystectomy (NAOC) and laparoscopic ovarian cystectomy (LOC) in a case-matched study that included 277 patients.²⁹ Although mean (SD) blood loss in patients who underwent LOC was significantly less compared with those who underwent NAOC (21.4 [14.7] mL vs 31.6 [24.1] mL; P = .028), absolute blood loss in both groups was deemed minimal. Additionally, mean (SD) operative time and postoperative stay were significantly less in patients undergoing NAOC compared with those having LOC (38.23 [10.19] minutes vs 53.82 [18.61] minutes; P≤.001; and 1.38 [0.55] days vs 1.82 [0.52] days; P≤.001; respectively).²⁹ 

How vNOTES hysterectomy stacked up against TLH 

In 2018, Baekelandt and colleagues compared outcomes between vNOTES hysterectomy and total laparoscopic hysterectomy (TLH) in a noninferiority single-blinded trial of 70 women.⁸ Compared with TLH, vNOTES hysterectomy was associated with shorter operative time (41 vs 75 minutes; P<.001), shorter hospital stay (0.8 vs 1.3 days; P = .004), and lower postoperative analgesic requirement (8 vs 14 U; P = .006). Additionally, there were no differences between the 2 groups in postoperative infection rate, intraoperative complications, or hospital readmissions within 6 weeks.⁸

Approach for performing vNOTES procedures 

At our institution, Baylor College of Medicine, the majority of gynecologic surgeries are performed via either transumbilical robot-assisted single-incision laparoscopy or vNOTES. Preoperative selection of appropriate candidates for vNOTES includes: 

• low suspicion for or prior diagnosis of endometriosis with obliteration of the posterior cul-de-sac 
• no surgical history suggestive of severe adhesive disease, and 
• adequate vaginal sidewall access and sufficient descent for instrumentation for entry into the peritoneal cavity. 

In general, a key concept in vNOTES is "vaginal pull, laparoscopic push," which means that the surgeon must pull the cervix while performing vaginal entry and then push the uterus back in the peritoneal cavity to increase surgical space during laparoscopic surgery. 

Continue to: Overview of vNOTES steps...

Below we break down a description of vNOTES in 6 sections. Our patients are always placed in dorsal lithotomy position with TrenGuard (D.A. Surgical) Trendelenburg restraint. We prep the abdomen in case we need to convert to transabdominal surgery via transumbilical single-incision laparoscopic surgery or traditional laparoscopic surgery. 

1. Vaginal entry 

Accessing the peritoneal cavity through the vagina initially proceeds like a vaginal hysterectomy. We inject dilute vasopressin (20 U in 20 mL of normal saline) circumferentially in the cervix (for hysterectomy) or in the posterior cervix in the cervicovaginal junction (for adnexal surgery without hysterectomy) for vasoconstriction and hydrodissection. 

We then incise the vaginal mucosa circumferentially with electrosurgical cautery and follow with posterior colpotomy. We find that reapproximating the posterior peritoneum to the posterior vagina with either figure-of-8 stitches or a running stitch of polyglactin 910 suture (2-0 Vicryl) assists in port placement, bleeding at the peritoneal edge, and closure of the cuff or colpotomy at the end of the case. We tag this suture with a curved hemostat. 

Depending on whether a hysterectomy is being performed, anterior colpotomy is made. Again, the anterior peritoneum is then tagged to the anterior vaginal cuff in similar fashion, and this suture is tagged with a different instrument; we typically use a straight hemostat or Sarot clamp (FIGURE 1). 

2. Traditional vaginal hysterectomy 

After colpotomy, we prefer to perform progressive clamping of the broad ligament from the uterosacral and cardinal ligaments to the level of uterine artery as in traditional vaginal hysterectomy, if feasible. 

3. Single-site port placement 

The assembled GelPOINT Mini advanced access platform (Applied Medical) (FIGURE 2) is introduced through the vagina after the Alexis wound protector (included with the kit) is first placed through the colpotomy with assistance of Babcock clamps (FIGURE 3). 

After ensuring that the green rigid ring of the Alexis wound protector is contained and completely expanded within the peritoneal cavity, we cross our previously tagged sutures as we find this helps with preventing the GelPOINT Mini access platform from inadvertently shifting out of the peritoneal cavity during surgery. The GelSeal cap is then secured and pneumoperitoneum is established (FIGURE 4). 

Continue to: 4. Laparoendoscopic surgery...

Instruments used in our surgeries include a 10-mm rigid 30° 43-cm working length laparoscope; a 44-cm LigaSure device (Medtronic); a 5-mm, 37-cm laparoscopic cobra grasping forceps and fenestrated grasper (Karl Storz); and a 5-mm, 45-cm laparoscopic suction with hydrodissection tip (Stryker) (FIGURE 5). 

vNOTES allows a gynecologic surgeon the unique ability to survey the upper abdomen. The remainder of the surgery proceeds using basic laparoscopic single-site skills. 

During vNOTES, as with all single-site surgical procedures, understanding the optimal placement of crossed instruments is important for successful completion. For example, when securing the right uterine artery, the surgeon needs to push the cervix toward the patient's left and slightly into the peritoneal cavity using a laparoscopic cobra grasper with his or her left hand while then securing the uterine pedicle using the LigaSure device with his or her right hand. This is then reversed when securing the left uterine artery, where the assistant surgeon pushes the cervix toward the patient's right while the surgeon secures the pedicle ("vaginal pull, laparoscopic push") (FIGURE 6). 

This again is reiterated in securing the ovarian pedicles, which are pushed into the peritoneal cavity while being secured with the LigaSure device. 

5. Specimen removal 

For large uteri or specimens that need morcellation, a 15-mm Endo Catch specimen retrieval bag (Medtronic) is introduced through the GelPOINT Mini system. The specimen is then placed in the bag and delivered to the vagina, where contained bag morcellation is performed in standard fashion (FIGURES 7 AND 8). We utilized the "big C" technique by first grasping the specimen with a penetrating clamp. The clamp is then held in our nondominant hand and a No. 10 blade scalpel is used to create a reverse c-incision, keeping one surface of the specimen intact. This is continued until the specimen can be completely delivered through the vagina. 

Specimens that do not require morcellation can be grasped laparoscopically, brought to the GelPOINT Mini port, which is quickly disassembled, and delivered. The GelSeal cap is then reassembled. 

6. Vaginal cuff closure 

The colpotomy or vaginal cuff is closed with barbed suture continuously, as in traditional vaginal hysterectomy cuff closure. Uterosacral ligament suspension should be performed for vaginal cuff support.  
 

Through the years, the surgical approach to hysterectomy has expanded from its early beginnings of being performed only through an abdominal or transvaginal route with traditional surgical clamps and suture. The late 1980s saw the advent of the laparoscopic-assisted vaginal hysterectomy (LAVH), and from that point forward several additional hysterectomy methods evolved, including today’s robotic approaches.

Although clinical evidence and societal endorsements support vaginal hysterectomy as a superior high-value modality, it remains one of the least performed among all available routes.^1-3 In an analysis of inpatient hysterectomies published by Wright and colleagues in 2013, 16.7% of hysterectomies were performed vaginally, a number that essentially has remained steady throughout the ensuing years.⁴

Attempts to improve the application of vaginal hysterectomy have been made.⁵ These include the development of various curriculum and simulation-based medical education programs on vaginal surgical skills training and acquisition in the hopes of improving utilization.⁶ An interesting recent development is the rethinking of vaginal hysterectomy by several surgeons globally who are applying facets of the various hysterectomy methods to a transvaginal approach known as vaginal natural orifice transluminal endoscopic surgery (vNOTES).^7,8 Unique to this thinking is the incorporation of conventional laparoscopic instrumentation.

Although I have not yet incorporated this approach in my surgical armamentarium at Columbia University Medical Center/New York–Presbyterian Hospital, I am intrigued by the possibility that this technique may serve as a rescue for vaginal hysterectomies that are at risk of conversion or of not being performed at all.⁹

At this time, vNOTES is not a standard of care and should be performed only by highly specialized surgeons. However, in the spirit of this Update on minimally invasive surgery and to keep our readers abreast of burgeoning techniques, I am delighted to bring you this overview by Dr. Xiaoming Guan, one of the pioneers of this surgical approach, and Dr. Tamisa Koythong and Dr. Juan Liu. I hope you find this recent development in hysterectomy of interest.

—Arnold P. Advincula, MD

Continue to: Development and evolution of NOTES...

Development and evolution of NOTES 

Over the past few decades, emphasis has shifted from laparotomy to minimally invasive surgery because of its proven significant advantages in patient care, such as improved cosmesis, shorter hospital stay, shorter postoperative recovery, and decreased postoperative pain and blood loss.¹⁰  Advances in laparoendoscopic surgery and instrumentation, including robot-assisted laparoscopy (RAL), single-incision laparoscopic surgery (SILS), and most recently natural orifice transluminal endoscopic surgery (NOTES), reflect ongoing innovative developments in the field of minimally invasive surgery. 

Here, we provide a brief literature review of the NOTES technique, focus on its application in gynecologic surgery, and describe how we perform NOTES at our institution. 

NOTES application in gynecology 

With NOTES, peritoneal access is gained through a natural orifice (such as the mouth, vagina, urethra, or anus) to perform endoscopic surgery, occasionally without requiring an abdominal incision. First described in 2004, transgastric peritoneoscopy was performed in a porcine model, and shortly thereafter the first transgastric appendectomy was performed in humans.^11,12 The technique has further been adopted in cholecystectomy, appendectomy, gastrectomy, and nephrectomy procedures.¹³ 

Given rapid interest in a possible paradigm shift in the field of minimally invasive surgery, the Natural Orifice Surgery Consortiumfor Assessment and Research (NOSCAR) was formed, and the group published an article on potential barriers to accepted practice and adoption of NOTES as a realistic alternative to traditional laparoscopic surgery.¹⁴ 

While transgastric and transanal access to the peritoneum were initially more popular, the risk of anastomotic leaks associated with incomplete closure and subsequent infection were thought to be prohibitively high.¹⁵ Transvaginal access was considered a safer and simpler alternative, allowing for complete closure without increased risk of infection, and this is now the route through which the majority of NOTES procedures are completed.^16,17 

The eventual application of NOTES in the field of gynecology seemed inevitable. The American College of Obstetricians and Gynecologists stated that transvaginal surgery is the most minimally invasive and preferred surgical route in the management of patients with benign gynecologic diseases.¹⁸ However, performing it can be challenging at times due to limited visualization and lack of the required skills for single-site surgery. NOTES allows a gynecologic surgeon to improve visualization through the use of laparoendoscopic instruments and to complete surgery through a transvaginal route. 

In 2012, Ahn and colleagues demonstrated the feasibility of the NOTES technique in gynecologic surgery after using it to successfully complete benign adnexal surgery in 10 patients.¹⁹ Vaginal NOTES (vNOTES) has since been further developed to include successful hysterectomy, myomectomy, sacrocolpopexy, tubal anastomosis, and even lymphadenectomy in the treatment of early- stage endometrial carcinoma.^20-26 vNOTES also can be considered a rescue approach for traditional vaginal hysterectomy in instances in which it is necessary to evaluate adnexal pathology.⁹ Most recently, vNOTES hysterectomy has been reported with da Vinci Si or Xi robotic platforms.^27,28 

Continue to: Operative time, post-op stay shorter in NAOC-treated patients...

Few studies have compared outcomes with vNOTES to those with traditional laparoscopy. In 2016, Wang and colleagues compared surgical outcomes between NOTES-assisted ovarian cystectomy (NAOC) and laparoscopic ovarian cystectomy (LOC) in a case-matched study that included 277 patients.²⁹ Although mean (SD) blood loss in patients who underwent LOC was significantly less compared with those who underwent NAOC (21.4 [14.7] mL vs 31.6 [24.1] mL; P = .028), absolute blood loss in both groups was deemed minimal. Additionally, mean (SD) operative time and postoperative stay were significantly less in patients undergoing NAOC compared with those having LOC (38.23 [10.19] minutes vs 53.82 [18.61] minutes; P≤.001; and 1.38 [0.55] days vs 1.82 [0.52] days; P≤.001; respectively).²⁹ 

How vNOTES hysterectomy stacked up against TLH 

In 2018, Baekelandt and colleagues compared outcomes between vNOTES hysterectomy and total laparoscopic hysterectomy (TLH) in a noninferiority single-blinded trial of 70 women.⁸ Compared with TLH, vNOTES hysterectomy was associated with shorter operative time (41 vs 75 minutes; P<.001), shorter hospital stay (0.8 vs 1.3 days; P = .004), and lower postoperative analgesic requirement (8 vs 14 U; P = .006). Additionally, there were no differences between the 2 groups in postoperative infection rate, intraoperative complications, or hospital readmissions within 6 weeks.⁸

Approach for performing vNOTES procedures 

At our institution, Baylor College of Medicine, the majority of gynecologic surgeries are performed via either transumbilical robot-assisted single-incision laparoscopy or vNOTES. Preoperative selection of appropriate candidates for vNOTES includes: 

• low suspicion for or prior diagnosis of endometriosis with obliteration of the posterior cul-de-sac 
• no surgical history suggestive of severe adhesive disease, and 
• adequate vaginal sidewall access and sufficient descent for instrumentation for entry into the peritoneal cavity. 

In general, a key concept in vNOTES is "vaginal pull, laparoscopic push," which means that the surgeon must pull the cervix while performing vaginal entry and then push the uterus back in the peritoneal cavity to increase surgical space during laparoscopic surgery. 

Continue to: Overview of vNOTES steps...

Below we break down a description of vNOTES in 6 sections. Our patients are always placed in dorsal lithotomy position with TrenGuard (D.A. Surgical) Trendelenburg restraint. We prep the abdomen in case we need to convert to transabdominal surgery via transumbilical single-incision laparoscopic surgery or traditional laparoscopic surgery. 

1. Vaginal entry 

Accessing the peritoneal cavity through the vagina initially proceeds like a vaginal hysterectomy. We inject dilute vasopressin (20 U in 20 mL of normal saline) circumferentially in the cervix (for hysterectomy) or in the posterior cervix in the cervicovaginal junction (for adnexal surgery without hysterectomy) for vasoconstriction and hydrodissection. 

We then incise the vaginal mucosa circumferentially with electrosurgical cautery and follow with posterior colpotomy. We find that reapproximating the posterior peritoneum to the posterior vagina with either figure-of-8 stitches or a running stitch of polyglactin 910 suture (2-0 Vicryl) assists in port placement, bleeding at the peritoneal edge, and closure of the cuff or colpotomy at the end of the case. We tag this suture with a curved hemostat. 

Depending on whether a hysterectomy is being performed, anterior colpotomy is made. Again, the anterior peritoneum is then tagged to the anterior vaginal cuff in similar fashion, and this suture is tagged with a different instrument; we typically use a straight hemostat or Sarot clamp (FIGURE 1). 

2. Traditional vaginal hysterectomy 

After colpotomy, we prefer to perform progressive clamping of the broad ligament from the uterosacral and cardinal ligaments to the level of uterine artery as in traditional vaginal hysterectomy, if feasible. 

3. Single-site port placement 

The assembled GelPOINT Mini advanced access platform (Applied Medical) (FIGURE 2) is introduced through the vagina after the Alexis wound protector (included with the kit) is first placed through the colpotomy with assistance of Babcock clamps (FIGURE 3). 

After ensuring that the green rigid ring of the Alexis wound protector is contained and completely expanded within the peritoneal cavity, we cross our previously tagged sutures as we find this helps with preventing the GelPOINT Mini access platform from inadvertently shifting out of the peritoneal cavity during surgery. The GelSeal cap is then secured and pneumoperitoneum is established (FIGURE 4). 

Continue to: 4. Laparoendoscopic surgery...

Instruments used in our surgeries include a 10-mm rigid 30° 43-cm working length laparoscope; a 44-cm LigaSure device (Medtronic); a 5-mm, 37-cm laparoscopic cobra grasping forceps and fenestrated grasper (Karl Storz); and a 5-mm, 45-cm laparoscopic suction with hydrodissection tip (Stryker) (FIGURE 5). 

vNOTES allows a gynecologic surgeon the unique ability to survey the upper abdomen. The remainder of the surgery proceeds using basic laparoscopic single-site skills. 

During vNOTES, as with all single-site surgical procedures, understanding the optimal placement of crossed instruments is important for successful completion. For example, when securing the right uterine artery, the surgeon needs to push the cervix toward the patient's left and slightly into the peritoneal cavity using a laparoscopic cobra grasper with his or her left hand while then securing the uterine pedicle using the LigaSure device with his or her right hand. This is then reversed when securing the left uterine artery, where the assistant surgeon pushes the cervix toward the patient's right while the surgeon secures the pedicle ("vaginal pull, laparoscopic push") (FIGURE 6). 

This again is reiterated in securing the ovarian pedicles, which are pushed into the peritoneal cavity while being secured with the LigaSure device. 

5. Specimen removal 

For large uteri or specimens that need morcellation, a 15-mm Endo Catch specimen retrieval bag (Medtronic) is introduced through the GelPOINT Mini system. The specimen is then placed in the bag and delivered to the vagina, where contained bag morcellation is performed in standard fashion (FIGURES 7 AND 8). We utilized the "big C" technique by first grasping the specimen with a penetrating clamp. The clamp is then held in our nondominant hand and a No. 10 blade scalpel is used to create a reverse c-incision, keeping one surface of the specimen intact. This is continued until the specimen can be completely delivered through the vagina. 

Specimens that do not require morcellation can be grasped laparoscopically, brought to the GelPOINT Mini port, which is quickly disassembled, and delivered. The GelSeal cap is then reassembled. 

6. Vaginal cuff closure 

The colpotomy or vaginal cuff is closed with barbed suture continuously, as in traditional vaginal hysterectomy cuff closure. Uterosacral ligament suspension should be performed for vaginal cuff support.  
 

Through the years, the surgical approach to hysterectomy has expanded from its early beginnings of being performed only through an abdominal or transvaginal route with traditional surgical clamps and suture. The late 1980s saw the advent of the laparoscopic-assisted vaginal hysterectomy (LAVH), and from that point forward several additional hysterectomy methods evolved, including today’s robotic approaches.

Although clinical evidence and societal endorsements support vaginal hysterectomy as a superior high-value modality, it remains one of the least performed among all available routes.^1-3 In an analysis of inpatient hysterectomies published by Wright and colleagues in 2013, 16.7% of hysterectomies were performed vaginally, a number that essentially has remained steady throughout the ensuing years.⁴

Attempts to improve the application of vaginal hysterectomy have been made.⁵ These include the development of various curriculum and simulation-based medical education programs on vaginal surgical skills training and acquisition in the hopes of improving utilization.⁶ An interesting recent development is the rethinking of vaginal hysterectomy by several surgeons globally who are applying facets of the various hysterectomy methods to a transvaginal approach known as vaginal natural orifice transluminal endoscopic surgery (vNOTES).^7,8 Unique to this thinking is the incorporation of conventional laparoscopic instrumentation.

Although I have not yet incorporated this approach in my surgical armamentarium at Columbia University Medical Center/New York–Presbyterian Hospital, I am intrigued by the possibility that this technique may serve as a rescue for vaginal hysterectomies that are at risk of conversion or of not being performed at all.⁹

At this time, vNOTES is not a standard of care and should be performed only by highly specialized surgeons. However, in the spirit of this Update on minimally invasive surgery and to keep our readers abreast of burgeoning techniques, I am delighted to bring you this overview by Dr. Xiaoming Guan, one of the pioneers of this surgical approach, and Dr. Tamisa Koythong and Dr. Juan Liu. I hope you find this recent development in hysterectomy of interest.

—Arnold P. Advincula, MD

Continue to: Development and evolution of NOTES...

Development and evolution of NOTES 

Over the past few decades, emphasis has shifted from laparotomy to minimally invasive surgery because of its proven significant advantages in patient care, such as improved cosmesis, shorter hospital stay, shorter postoperative recovery, and decreased postoperative pain and blood loss.¹⁰  Advances in laparoendoscopic surgery and instrumentation, including robot-assisted laparoscopy (RAL), single-incision laparoscopic surgery (SILS), and most recently natural orifice transluminal endoscopic surgery (NOTES), reflect ongoing innovative developments in the field of minimally invasive surgery. 

Here, we provide a brief literature review of the NOTES technique, focus on its application in gynecologic surgery, and describe how we perform NOTES at our institution. 

NOTES application in gynecology 

With NOTES, peritoneal access is gained through a natural orifice (such as the mouth, vagina, urethra, or anus) to perform endoscopic surgery, occasionally without requiring an abdominal incision. First described in 2004, transgastric peritoneoscopy was performed in a porcine model, and shortly thereafter the first transgastric appendectomy was performed in humans.^11,12 The technique has further been adopted in cholecystectomy, appendectomy, gastrectomy, and nephrectomy procedures.¹³ 

Given rapid interest in a possible paradigm shift in the field of minimally invasive surgery, the Natural Orifice Surgery Consortiumfor Assessment and Research (NOSCAR) was formed, and the group published an article on potential barriers to accepted practice and adoption of NOTES as a realistic alternative to traditional laparoscopic surgery.¹⁴ 

While transgastric and transanal access to the peritoneum were initially more popular, the risk of anastomotic leaks associated with incomplete closure and subsequent infection were thought to be prohibitively high.¹⁵ Transvaginal access was considered a safer and simpler alternative, allowing for complete closure without increased risk of infection, and this is now the route through which the majority of NOTES procedures are completed.^16,17 

The eventual application of NOTES in the field of gynecology seemed inevitable. The American College of Obstetricians and Gynecologists stated that transvaginal surgery is the most minimally invasive and preferred surgical route in the management of patients with benign gynecologic diseases.¹⁸ However, performing it can be challenging at times due to limited visualization and lack of the required skills for single-site surgery. NOTES allows a gynecologic surgeon to improve visualization through the use of laparoendoscopic instruments and to complete surgery through a transvaginal route. 

In 2012, Ahn and colleagues demonstrated the feasibility of the NOTES technique in gynecologic surgery after using it to successfully complete benign adnexal surgery in 10 patients.¹⁹ Vaginal NOTES (vNOTES) has since been further developed to include successful hysterectomy, myomectomy, sacrocolpopexy, tubal anastomosis, and even lymphadenectomy in the treatment of early- stage endometrial carcinoma.^20-26 vNOTES also can be considered a rescue approach for traditional vaginal hysterectomy in instances in which it is necessary to evaluate adnexal pathology.⁹ Most recently, vNOTES hysterectomy has been reported with da Vinci Si or Xi robotic platforms.^27,28 

Continue to: Operative time, post-op stay shorter in NAOC-treated patients...

Few studies have compared outcomes with vNOTES to those with traditional laparoscopy. In 2016, Wang and colleagues compared surgical outcomes between NOTES-assisted ovarian cystectomy (NAOC) and laparoscopic ovarian cystectomy (LOC) in a case-matched study that included 277 patients.²⁹ Although mean (SD) blood loss in patients who underwent LOC was significantly less compared with those who underwent NAOC (21.4 [14.7] mL vs 31.6 [24.1] mL; P = .028), absolute blood loss in both groups was deemed minimal. Additionally, mean (SD) operative time and postoperative stay were significantly less in patients undergoing NAOC compared with those having LOC (38.23 [10.19] minutes vs 53.82 [18.61] minutes; P≤.001; and 1.38 [0.55] days vs 1.82 [0.52] days; P≤.001; respectively).²⁹ 

How vNOTES hysterectomy stacked up against TLH 

In 2018, Baekelandt and colleagues compared outcomes between vNOTES hysterectomy and total laparoscopic hysterectomy (TLH) in a noninferiority single-blinded trial of 70 women.⁸ Compared with TLH, vNOTES hysterectomy was associated with shorter operative time (41 vs 75 minutes; P<.001), shorter hospital stay (0.8 vs 1.3 days; P = .004), and lower postoperative analgesic requirement (8 vs 14 U; P = .006). Additionally, there were no differences between the 2 groups in postoperative infection rate, intraoperative complications, or hospital readmissions within 6 weeks.⁸

Approach for performing vNOTES procedures 

At our institution, Baylor College of Medicine, the majority of gynecologic surgeries are performed via either transumbilical robot-assisted single-incision laparoscopy or vNOTES. Preoperative selection of appropriate candidates for vNOTES includes: 

• low suspicion for or prior diagnosis of endometriosis with obliteration of the posterior cul-de-sac 
• no surgical history suggestive of severe adhesive disease, and 
• adequate vaginal sidewall access and sufficient descent for instrumentation for entry into the peritoneal cavity. 

In general, a key concept in vNOTES is "vaginal pull, laparoscopic push," which means that the surgeon must pull the cervix while performing vaginal entry and then push the uterus back in the peritoneal cavity to increase surgical space during laparoscopic surgery. 

Continue to: Overview of vNOTES steps...

Below we break down a description of vNOTES in 6 sections. Our patients are always placed in dorsal lithotomy position with TrenGuard (D.A. Surgical) Trendelenburg restraint. We prep the abdomen in case we need to convert to transabdominal surgery via transumbilical single-incision laparoscopic surgery or traditional laparoscopic surgery. 

1. Vaginal entry 

Accessing the peritoneal cavity through the vagina initially proceeds like a vaginal hysterectomy. We inject dilute vasopressin (20 U in 20 mL of normal saline) circumferentially in the cervix (for hysterectomy) or in the posterior cervix in the cervicovaginal junction (for adnexal surgery without hysterectomy) for vasoconstriction and hydrodissection. 

We then incise the vaginal mucosa circumferentially with electrosurgical cautery and follow with posterior colpotomy. We find that reapproximating the posterior peritoneum to the posterior vagina with either figure-of-8 stitches or a running stitch of polyglactin 910 suture (2-0 Vicryl) assists in port placement, bleeding at the peritoneal edge, and closure of the cuff or colpotomy at the end of the case. We tag this suture with a curved hemostat. 

Depending on whether a hysterectomy is being performed, anterior colpotomy is made. Again, the anterior peritoneum is then tagged to the anterior vaginal cuff in similar fashion, and this suture is tagged with a different instrument; we typically use a straight hemostat or Sarot clamp (FIGURE 1). 

2. Traditional vaginal hysterectomy 

After colpotomy, we prefer to perform progressive clamping of the broad ligament from the uterosacral and cardinal ligaments to the level of uterine artery as in traditional vaginal hysterectomy, if feasible. 

3. Single-site port placement 

The assembled GelPOINT Mini advanced access platform (Applied Medical) (FIGURE 2) is introduced through the vagina after the Alexis wound protector (included with the kit) is first placed through the colpotomy with assistance of Babcock clamps (FIGURE 3). 

After ensuring that the green rigid ring of the Alexis wound protector is contained and completely expanded within the peritoneal cavity, we cross our previously tagged sutures as we find this helps with preventing the GelPOINT Mini access platform from inadvertently shifting out of the peritoneal cavity during surgery. The GelSeal cap is then secured and pneumoperitoneum is established (FIGURE 4). 

Continue to: 4. Laparoendoscopic surgery...

Instruments used in our surgeries include a 10-mm rigid 30° 43-cm working length laparoscope; a 44-cm LigaSure device (Medtronic); a 5-mm, 37-cm laparoscopic cobra grasping forceps and fenestrated grasper (Karl Storz); and a 5-mm, 45-cm laparoscopic suction with hydrodissection tip (Stryker) (FIGURE 5). 

vNOTES allows a gynecologic surgeon the unique ability to survey the upper abdomen. The remainder of the surgery proceeds using basic laparoscopic single-site skills. 

During vNOTES, as with all single-site surgical procedures, understanding the optimal placement of crossed instruments is important for successful completion. For example, when securing the right uterine artery, the surgeon needs to push the cervix toward the patient's left and slightly into the peritoneal cavity using a laparoscopic cobra grasper with his or her left hand while then securing the uterine pedicle using the LigaSure device with his or her right hand. This is then reversed when securing the left uterine artery, where the assistant surgeon pushes the cervix toward the patient's right while the surgeon secures the pedicle ("vaginal pull, laparoscopic push") (FIGURE 6). 

This again is reiterated in securing the ovarian pedicles, which are pushed into the peritoneal cavity while being secured with the LigaSure device. 

5. Specimen removal 

For large uteri or specimens that need morcellation, a 15-mm Endo Catch specimen retrieval bag (Medtronic) is introduced through the GelPOINT Mini system. The specimen is then placed in the bag and delivered to the vagina, where contained bag morcellation is performed in standard fashion (FIGURES 7 AND 8). We utilized the "big C" technique by first grasping the specimen with a penetrating clamp. The clamp is then held in our nondominant hand and a No. 10 blade scalpel is used to create a reverse c-incision, keeping one surface of the specimen intact. This is continued until the specimen can be completely delivered through the vagina. 

Specimens that do not require morcellation can be grasped laparoscopically, brought to the GelPOINT Mini port, which is quickly disassembled, and delivered. The GelSeal cap is then reassembled. 

6. Vaginal cuff closure 

The colpotomy or vaginal cuff is closed with barbed suture continuously, as in traditional vaginal hysterectomy cuff closure. Uterosacral ligament suspension should be performed for vaginal cuff support.  
 

Minimally invasive surgical techniques, which have revolutionized modern-day surgery, are the current standard of care for benign hysterectomies.^1-4 Many surgeons use a video-laparoscopic approach, with or without robotic assistance, to perform a hysterectomy. The development of a bladder flap or vesicovaginal surgical space is a critical step for mobilizing the bladder. When properly performed, it allows for appropriate closure of the vaginal cuff while mitigating the risk of urinary bladder damage.

In patients with no prior pelvic surgeries, this vesicovaginal anatomic space is typically developed with ease. However, in patients who have had prior cesarean deliveries (CDs), the presence of vesicouterine adhesions could make this step significantly more challenging. As a result, the risk of bladder injury is higher.^5-8

With the current tide of cesarean birth rates approaching 33% on a national scale, the presence of vesicouterine adhesions is commonly encountered.⁹ These adhesions can distort the anatomy and thereby create more difficult dissections and increase operative time, conversion to laparotomy, and inadvertent cystotomy. Such a challenge also presents an increased risk of injuring adjacent structures.

In this article, we describe an effective method of dissection that is especially useful in the setting of prior CDs. This method involves developing a "new" surgical space lateral and caudal to the vesicocervical space. 

Steps in operative planning

Preoperative evaluation. A thorough preoperative evaluation should be performed for patients planning to undergo a laparoscopic hysterectomy. This includes obtaining details of their medical and surgical history. Access to prior surgical records may help to facilitate planning of the surgical approach. Previous pelvic surgery, such as CD, anterior myomectomy, cesarean scar defect repair, endometriosis treatment, or exploratory laparotomy, may predispose these patients to develop adhesions in the anterior cul-de-sac. Our method of reverse vesicouterine fold dissection can be particularly efficacious in these settings.

Surgical preparation and laparoscopic port placement. In the operative suite, the patient is placed under general anesthesia and positioned in the dorsal lithotomy position.¹⁰ Sterile prep and drapes are used in the standard fashion. A urinary catheter is inserted to maintain a decompressed bladder. A uterine manipulator is inserted with good placement ensured.

Per our practice, we introduce laparoscopic ports in 4 locations. The first incision is made in the umbilicus for the introduction of a 10-mm laparoscope. Three subsequent 5-mm incisions are made in the left and right lower lateral quadrants and medially at the level of the suprapubic region.¹⁰ Upon laparoscopic entry, we perform a comprehensive survey of the abdominopelvic cavity. Adequate mobility of the uterus is confirmed.¹¹ Any posterior uterine adhesions or endometriosis are treated appropriately.¹²

First step in the surgical technique: Lateral dissection

We proceed by first desiccating and cutting the round ligament laterally near the inguinal canal. This technique is carried forward in a caudal direction as the areolar tissue near the obliterated umbilical artery is expanded by the pneumoperitoneum. With a vessel sealing-cutting device, we address the attachments to the adnexa. If the ovaries are to be retained, the utero-ovarian ligament is dessicated and cut. If an oophorectomy is indicated, the infundibulopelvic ligament is dessicated and cut.

Continue to: Using the tip of the vessel sealing...

Using the tip of the vessel sealing-cutting device, the space between the anterior and posterior leaves of the broad ligament is developed and opened. A grasping forceps is then used to elevate the anterior leaf of the broad ligament and maintain medial traction. A space parallel and lateral to the cervix and bladder is then created with blunt dissection.

The inferior and medial direction of this dissection is paramount to avoid injury to nearby structures in the pelvic sidewall. Gradually, this will lead to the identification of the vesciovaginal ligament and then the vesicocervical ligament. The development of these spaces allows for the lateral and inferior displacement of the ureter. These maneuvers can mitigate ureter injury by pushing it away from the planes of dissection during the hysterectomy.

Continued traction is maintained by keeping the medial aspect of the anterior leaf of the broad ligament intact. However, the posterior leaf is dissected next, which further lateralizes the ureter. Now, with the uterine vessels fully exposed, they are thoroughly dessicated and ligated. The same procedure is then performed on the contralateral side.¹¹ (See the box below for links to videos that demonstrate the techniques described here.)

Creating the “new” space

In the “new” space that was partially developed during the lateral dissection, blunt dissection is continued, using a sweeping motion from an inferior-to-superior direction, to extend this avascular space. This is performed bilaterally until both sides are connected from the inferior aspect of the vesicouterine adhesions, if present. This thorough dissection creates what we refer to as a “new” space¹¹ (FIGURE 1).

Medially, the new space is bordered by the vesicocervical-vaginal ligament, also known as the bladder pillar. Its distal landmark is the bladder. The remaining intact anterior leaf of the broad ligament lies adjacent to the space anteriorly. The inner aspect of the obliterated umbilical artery neighbors it laterally. Lastly, the vesicovaginal plane’s posterior margin is the parametrium, which is the region where the ureter courses into the bladder. The paravesical space lies lateral to the obliterated umbilical ligament.

Visualization of this new space is made possible in the laparoscopic setting. The pneumoperitoneum allows for better demarcation of the space. Additionally, laparoscopic views of the anatomic spaces differ from those of the laparotomy view because of the magnification and the insufflation of carbon dioxide gas in the spaces.^13,14 In our experience, approaching the surgery from the “new” space could significantly decrease the risk of genitourinary injuries in patients with anterior cul-de-sac adhesions (FIGURE 2).

Using the reverse vesicouterine fold dissection technique

Among patients with prior CDs, adhesions often are at the level of or superior to the prior CD scar. By creating the new space, safe dissection from a previously untouched area can be accomplished and injury to the urinary bladder can be avoided.

The reverse vesicouterine fold dissection can be performed from this space. Using the previously described blunt sweeping motion from an inferior-to-superior direction, the vesicovaginal and vesicocervical space is further developed from an unscarred plane. This will separate the lowest portion of the bladder from the vagina, cervix, and uterus in a safe manner. Similar to the technique performed during a vaginal hysterectomy, this reverse motion of developing the bladder flap avoids erroneous and blind dissection through the vesicouterine adhesions (FIGURES 3–5).

Continue to: Completing the surgery...

Completing the surgery

Once the bladder is freely mobilized and all adhesions have been dissected, the cervix is circumferentially amputated using monopolar cautery. The vaginal cuff can then be closed from either a laparoscopic or vaginal approach using polyglactin 910 (0-Vicryl) or barbed (V-Loc) suture in a running or interrupted fashion. Our practice uses a 1.5-cm margin depth with each suture. At the end of the surgery, routine cystoscopy is performed to verify distal ureteral patency.¹⁶ Postoperatively, we manage these patients using a fast-track, or enhanced recovery, model.¹⁷

An effective technique in challenging situations

Genitourinary injury is a common complication of hysterectomy.¹⁸ The proximity of the bladder and ureters to the field of dissection during a hysterectomy can be especially challenging when the anatomy is distorted by adhesion formation from prior surgeries. One study demonstrated a 1.3% incidence of urinary tract injuries during laparoscopic hysterectomy.⁶ This included 0.54% ureteral injuries, 0.71% urinary bladder injuries, and 0.06% combined bladder and ureteral injuries.⁶ Particularly among patients with a prior CD, the risk of bladder injury can be significantly heightened.¹⁸

The reverse vesicouterine fold dissection technique that we described offers multiple benefits. By starting the procedure from an untouched and avascular plane, dissection into the plane of the prior adhesions can be circumvented; thus, bleeding is limited and injury to the bladder and ureters is avoided or minimized. By using blunt and sharp dissection, thermal injury and delayed necrosis can be mitigated. Finally, with bladder mobilization well below the colpotomy site, more adequate vaginal tissue is free to be incorporated into the vaginal cuff closure, thereby limiting the risk of cuff dehiscence.¹⁶

While we have found this technique effective for patients with prior cesarean deliveries, it also may be applied to any patient who has a scarred anterior cul-de-sac. This could include patients with prior myomectomy, cesarean scar defect, or endometriosis. Despite the technique being a safeguard against bladder injury, surgeons must still use care in developing the spaces to avoid ureteral injury, especially in a setting of distorted anatomy.

Minimally invasive surgical techniques, which have revolutionized modern-day surgery, are the current standard of care for benign hysterectomies.^1-4 Many surgeons use a video-laparoscopic approach, with or without robotic assistance, to perform a hysterectomy. The development of a bladder flap or vesicovaginal surgical space is a critical step for mobilizing the bladder. When properly performed, it allows for appropriate closure of the vaginal cuff while mitigating the risk of urinary bladder damage.

In patients with no prior pelvic surgeries, this vesicovaginal anatomic space is typically developed with ease. However, in patients who have had prior cesarean deliveries (CDs), the presence of vesicouterine adhesions could make this step significantly more challenging. As a result, the risk of bladder injury is higher.^5-8

With the current tide of cesarean birth rates approaching 33% on a national scale, the presence of vesicouterine adhesions is commonly encountered.⁹ These adhesions can distort the anatomy and thereby create more difficult dissections and increase operative time, conversion to laparotomy, and inadvertent cystotomy. Such a challenge also presents an increased risk of injuring adjacent structures.

In this article, we describe an effective method of dissection that is especially useful in the setting of prior CDs. This method involves developing a "new" surgical space lateral and caudal to the vesicocervical space. 

Steps in operative planning

Preoperative evaluation. A thorough preoperative evaluation should be performed for patients planning to undergo a laparoscopic hysterectomy. This includes obtaining details of their medical and surgical history. Access to prior surgical records may help to facilitate planning of the surgical approach. Previous pelvic surgery, such as CD, anterior myomectomy, cesarean scar defect repair, endometriosis treatment, or exploratory laparotomy, may predispose these patients to develop adhesions in the anterior cul-de-sac. Our method of reverse vesicouterine fold dissection can be particularly efficacious in these settings.

Surgical preparation and laparoscopic port placement. In the operative suite, the patient is placed under general anesthesia and positioned in the dorsal lithotomy position.¹⁰ Sterile prep and drapes are used in the standard fashion. A urinary catheter is inserted to maintain a decompressed bladder. A uterine manipulator is inserted with good placement ensured.

Per our practice, we introduce laparoscopic ports in 4 locations. The first incision is made in the umbilicus for the introduction of a 10-mm laparoscope. Three subsequent 5-mm incisions are made in the left and right lower lateral quadrants and medially at the level of the suprapubic region.¹⁰ Upon laparoscopic entry, we perform a comprehensive survey of the abdominopelvic cavity. Adequate mobility of the uterus is confirmed.¹¹ Any posterior uterine adhesions or endometriosis are treated appropriately.¹²

First step in the surgical technique: Lateral dissection

We proceed by first desiccating and cutting the round ligament laterally near the inguinal canal. This technique is carried forward in a caudal direction as the areolar tissue near the obliterated umbilical artery is expanded by the pneumoperitoneum. With a vessel sealing-cutting device, we address the attachments to the adnexa. If the ovaries are to be retained, the utero-ovarian ligament is dessicated and cut. If an oophorectomy is indicated, the infundibulopelvic ligament is dessicated and cut.

Continue to: Using the tip of the vessel sealing...

Using the tip of the vessel sealing-cutting device, the space between the anterior and posterior leaves of the broad ligament is developed and opened. A grasping forceps is then used to elevate the anterior leaf of the broad ligament and maintain medial traction. A space parallel and lateral to the cervix and bladder is then created with blunt dissection.

The inferior and medial direction of this dissection is paramount to avoid injury to nearby structures in the pelvic sidewall. Gradually, this will lead to the identification of the vesciovaginal ligament and then the vesicocervical ligament. The development of these spaces allows for the lateral and inferior displacement of the ureter. These maneuvers can mitigate ureter injury by pushing it away from the planes of dissection during the hysterectomy.

Continued traction is maintained by keeping the medial aspect of the anterior leaf of the broad ligament intact. However, the posterior leaf is dissected next, which further lateralizes the ureter. Now, with the uterine vessels fully exposed, they are thoroughly dessicated and ligated. The same procedure is then performed on the contralateral side.¹¹ (See the box below for links to videos that demonstrate the techniques described here.)

Creating the “new” space

In the “new” space that was partially developed during the lateral dissection, blunt dissection is continued, using a sweeping motion from an inferior-to-superior direction, to extend this avascular space. This is performed bilaterally until both sides are connected from the inferior aspect of the vesicouterine adhesions, if present. This thorough dissection creates what we refer to as a “new” space¹¹ (FIGURE 1).

Medially, the new space is bordered by the vesicocervical-vaginal ligament, also known as the bladder pillar. Its distal landmark is the bladder. The remaining intact anterior leaf of the broad ligament lies adjacent to the space anteriorly. The inner aspect of the obliterated umbilical artery neighbors it laterally. Lastly, the vesicovaginal plane’s posterior margin is the parametrium, which is the region where the ureter courses into the bladder. The paravesical space lies lateral to the obliterated umbilical ligament.

Visualization of this new space is made possible in the laparoscopic setting. The pneumoperitoneum allows for better demarcation of the space. Additionally, laparoscopic views of the anatomic spaces differ from those of the laparotomy view because of the magnification and the insufflation of carbon dioxide gas in the spaces.^13,14 In our experience, approaching the surgery from the “new” space could significantly decrease the risk of genitourinary injuries in patients with anterior cul-de-sac adhesions (FIGURE 2).

Using the reverse vesicouterine fold dissection technique

Among patients with prior CDs, adhesions often are at the level of or superior to the prior CD scar. By creating the new space, safe dissection from a previously untouched area can be accomplished and injury to the urinary bladder can be avoided.

The reverse vesicouterine fold dissection can be performed from this space. Using the previously described blunt sweeping motion from an inferior-to-superior direction, the vesicovaginal and vesicocervical space is further developed from an unscarred plane. This will separate the lowest portion of the bladder from the vagina, cervix, and uterus in a safe manner. Similar to the technique performed during a vaginal hysterectomy, this reverse motion of developing the bladder flap avoids erroneous and blind dissection through the vesicouterine adhesions (FIGURES 3–5).

Continue to: Completing the surgery...

Completing the surgery

Once the bladder is freely mobilized and all adhesions have been dissected, the cervix is circumferentially amputated using monopolar cautery. The vaginal cuff can then be closed from either a laparoscopic or vaginal approach using polyglactin 910 (0-Vicryl) or barbed (V-Loc) suture in a running or interrupted fashion. Our practice uses a 1.5-cm margin depth with each suture. At the end of the surgery, routine cystoscopy is performed to verify distal ureteral patency.¹⁶ Postoperatively, we manage these patients using a fast-track, or enhanced recovery, model.¹⁷

An effective technique in challenging situations

Genitourinary injury is a common complication of hysterectomy.¹⁸ The proximity of the bladder and ureters to the field of dissection during a hysterectomy can be especially challenging when the anatomy is distorted by adhesion formation from prior surgeries. One study demonstrated a 1.3% incidence of urinary tract injuries during laparoscopic hysterectomy.⁶ This included 0.54% ureteral injuries, 0.71% urinary bladder injuries, and 0.06% combined bladder and ureteral injuries.⁶ Particularly among patients with a prior CD, the risk of bladder injury can be significantly heightened.¹⁸

The reverse vesicouterine fold dissection technique that we described offers multiple benefits. By starting the procedure from an untouched and avascular plane, dissection into the plane of the prior adhesions can be circumvented; thus, bleeding is limited and injury to the bladder and ureters is avoided or minimized. By using blunt and sharp dissection, thermal injury and delayed necrosis can be mitigated. Finally, with bladder mobilization well below the colpotomy site, more adequate vaginal tissue is free to be incorporated into the vaginal cuff closure, thereby limiting the risk of cuff dehiscence.¹⁶

While we have found this technique effective for patients with prior cesarean deliveries, it also may be applied to any patient who has a scarred anterior cul-de-sac. This could include patients with prior myomectomy, cesarean scar defect, or endometriosis. Despite the technique being a safeguard against bladder injury, surgeons must still use care in developing the spaces to avoid ureteral injury, especially in a setting of distorted anatomy.

Minimally invasive surgical techniques, which have revolutionized modern-day surgery, are the current standard of care for benign hysterectomies.^1-4 Many surgeons use a video-laparoscopic approach, with or without robotic assistance, to perform a hysterectomy. The development of a bladder flap or vesicovaginal surgical space is a critical step for mobilizing the bladder. When properly performed, it allows for appropriate closure of the vaginal cuff while mitigating the risk of urinary bladder damage.

In patients with no prior pelvic surgeries, this vesicovaginal anatomic space is typically developed with ease. However, in patients who have had prior cesarean deliveries (CDs), the presence of vesicouterine adhesions could make this step significantly more challenging. As a result, the risk of bladder injury is higher.^5-8

With the current tide of cesarean birth rates approaching 33% on a national scale, the presence of vesicouterine adhesions is commonly encountered.⁹ These adhesions can distort the anatomy and thereby create more difficult dissections and increase operative time, conversion to laparotomy, and inadvertent cystotomy. Such a challenge also presents an increased risk of injuring adjacent structures.

In this article, we describe an effective method of dissection that is especially useful in the setting of prior CDs. This method involves developing a "new" surgical space lateral and caudal to the vesicocervical space. 

Steps in operative planning

Preoperative evaluation. A thorough preoperative evaluation should be performed for patients planning to undergo a laparoscopic hysterectomy. This includes obtaining details of their medical and surgical history. Access to prior surgical records may help to facilitate planning of the surgical approach. Previous pelvic surgery, such as CD, anterior myomectomy, cesarean scar defect repair, endometriosis treatment, or exploratory laparotomy, may predispose these patients to develop adhesions in the anterior cul-de-sac. Our method of reverse vesicouterine fold dissection can be particularly efficacious in these settings.

Surgical preparation and laparoscopic port placement. In the operative suite, the patient is placed under general anesthesia and positioned in the dorsal lithotomy position.¹⁰ Sterile prep and drapes are used in the standard fashion. A urinary catheter is inserted to maintain a decompressed bladder. A uterine manipulator is inserted with good placement ensured.

Per our practice, we introduce laparoscopic ports in 4 locations. The first incision is made in the umbilicus for the introduction of a 10-mm laparoscope. Three subsequent 5-mm incisions are made in the left and right lower lateral quadrants and medially at the level of the suprapubic region.¹⁰ Upon laparoscopic entry, we perform a comprehensive survey of the abdominopelvic cavity. Adequate mobility of the uterus is confirmed.¹¹ Any posterior uterine adhesions or endometriosis are treated appropriately.¹²

First step in the surgical technique: Lateral dissection

We proceed by first desiccating and cutting the round ligament laterally near the inguinal canal. This technique is carried forward in a caudal direction as the areolar tissue near the obliterated umbilical artery is expanded by the pneumoperitoneum. With a vessel sealing-cutting device, we address the attachments to the adnexa. If the ovaries are to be retained, the utero-ovarian ligament is dessicated and cut. If an oophorectomy is indicated, the infundibulopelvic ligament is dessicated and cut.

Continue to: Using the tip of the vessel sealing...

Using the tip of the vessel sealing-cutting device, the space between the anterior and posterior leaves of the broad ligament is developed and opened. A grasping forceps is then used to elevate the anterior leaf of the broad ligament and maintain medial traction. A space parallel and lateral to the cervix and bladder is then created with blunt dissection.

The inferior and medial direction of this dissection is paramount to avoid injury to nearby structures in the pelvic sidewall. Gradually, this will lead to the identification of the vesciovaginal ligament and then the vesicocervical ligament. The development of these spaces allows for the lateral and inferior displacement of the ureter. These maneuvers can mitigate ureter injury by pushing it away from the planes of dissection during the hysterectomy.

Continued traction is maintained by keeping the medial aspect of the anterior leaf of the broad ligament intact. However, the posterior leaf is dissected next, which further lateralizes the ureter. Now, with the uterine vessels fully exposed, they are thoroughly dessicated and ligated. The same procedure is then performed on the contralateral side.¹¹ (See the box below for links to videos that demonstrate the techniques described here.)

Creating the “new” space

In the “new” space that was partially developed during the lateral dissection, blunt dissection is continued, using a sweeping motion from an inferior-to-superior direction, to extend this avascular space. This is performed bilaterally until both sides are connected from the inferior aspect of the vesicouterine adhesions, if present. This thorough dissection creates what we refer to as a “new” space¹¹ (FIGURE 1).

Medially, the new space is bordered by the vesicocervical-vaginal ligament, also known as the bladder pillar. Its distal landmark is the bladder. The remaining intact anterior leaf of the broad ligament lies adjacent to the space anteriorly. The inner aspect of the obliterated umbilical artery neighbors it laterally. Lastly, the vesicovaginal plane’s posterior margin is the parametrium, which is the region where the ureter courses into the bladder. The paravesical space lies lateral to the obliterated umbilical ligament.

Visualization of this new space is made possible in the laparoscopic setting. The pneumoperitoneum allows for better demarcation of the space. Additionally, laparoscopic views of the anatomic spaces differ from those of the laparotomy view because of the magnification and the insufflation of carbon dioxide gas in the spaces.^13,14 In our experience, approaching the surgery from the “new” space could significantly decrease the risk of genitourinary injuries in patients with anterior cul-de-sac adhesions (FIGURE 2).

Using the reverse vesicouterine fold dissection technique

Among patients with prior CDs, adhesions often are at the level of or superior to the prior CD scar. By creating the new space, safe dissection from a previously untouched area can be accomplished and injury to the urinary bladder can be avoided.

The reverse vesicouterine fold dissection can be performed from this space. Using the previously described blunt sweeping motion from an inferior-to-superior direction, the vesicovaginal and vesicocervical space is further developed from an unscarred plane. This will separate the lowest portion of the bladder from the vagina, cervix, and uterus in a safe manner. Similar to the technique performed during a vaginal hysterectomy, this reverse motion of developing the bladder flap avoids erroneous and blind dissection through the vesicouterine adhesions (FIGURES 3–5).

Continue to: Completing the surgery...

Completing the surgery

Once the bladder is freely mobilized and all adhesions have been dissected, the cervix is circumferentially amputated using monopolar cautery. The vaginal cuff can then be closed from either a laparoscopic or vaginal approach using polyglactin 910 (0-Vicryl) or barbed (V-Loc) suture in a running or interrupted fashion. Our practice uses a 1.5-cm margin depth with each suture. At the end of the surgery, routine cystoscopy is performed to verify distal ureteral patency.¹⁶ Postoperatively, we manage these patients using a fast-track, or enhanced recovery, model.¹⁷

An effective technique in challenging situations

Genitourinary injury is a common complication of hysterectomy.¹⁸ The proximity of the bladder and ureters to the field of dissection during a hysterectomy can be especially challenging when the anatomy is distorted by adhesion formation from prior surgeries. One study demonstrated a 1.3% incidence of urinary tract injuries during laparoscopic hysterectomy.⁶ This included 0.54% ureteral injuries, 0.71% urinary bladder injuries, and 0.06% combined bladder and ureteral injuries.⁶ Particularly among patients with a prior CD, the risk of bladder injury can be significantly heightened.¹⁸

The reverse vesicouterine fold dissection technique that we described offers multiple benefits. By starting the procedure from an untouched and avascular plane, dissection into the plane of the prior adhesions can be circumvented; thus, bleeding is limited and injury to the bladder and ureters is avoided or minimized. By using blunt and sharp dissection, thermal injury and delayed necrosis can be mitigated. Finally, with bladder mobilization well below the colpotomy site, more adequate vaginal tissue is free to be incorporated into the vaginal cuff closure, thereby limiting the risk of cuff dehiscence.¹⁶

While we have found this technique effective for patients with prior cesarean deliveries, it also may be applied to any patient who has a scarred anterior cul-de-sac. This could include patients with prior myomectomy, cesarean scar defect, or endometriosis. Despite the technique being a safeguard against bladder injury, surgeons must still use care in developing the spaces to avoid ureteral injury, especially in a setting of distorted anatomy.

The most recently concluded term of the US Supreme Court, which began on October 1, 2018, yielded a number of decisions of interest to health care professionals and to ObGyns in particular. Although the term was viewed by some observers as less consequential than other recent terms, a review of the cases decided paints a picture of a more important term than some commentators expected.

When the term began, the Court had only 8 justices—1 short of a full bench: Judge Brett Kavanaugh had not yet been confirmed by the Senate. He was confirmed on October 6, by a 50-48 vote, and Justice Kavanaugh immediately joined the Court and began to hear and decide cases.

Increasingly, important decisions affect medical practice

From the nature of practice (abortion), to payment for service (Medicare reimbursement), resolution of disputes (arbitration), and fraud and abuse (the federal False Claims Act), the decisions of the Court will have an impact on many areas of medical practice. Organized medicine increasingly has recognized the significance of the work of the Court; nowhere has this been more clearly demonstrated than with amicus curiae (friend of the court) briefs filed by medical organizations.

Amicus curiae briefs. These briefs are filed by persons or organizations not a party to a case the Court is hearing. Their legitimate purpose is to inform the Court of 1) special information within the expertise of the amicus (or amici, plural) or 2) consequences of the decision that might not be apparent from arguments made by the parties to the case. Sometimes, the Court cites amicus briefs for having provided important information about the case.

Filing amicus briefs is time-consuming and expensive; organizations do not file them for trivial reasons. Organizations frequently join together to file a joint brief, to share expenses and express to the Court a stronger position.

Three categories of health professionals file amicus briefs in ObGyn-related cases:

• Major national organizations, often representing broad interests of health care professions or institutions (the American Medical Association [AMA], the Association of American Medical Colleges, and the American Hospital Association [AHA]), have filed a number of amicus briefs over the years.
• Specialty boards increasingly file amicus briefs. For example, the American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine have filed briefs related to abortion issues.
• In reproductive issues, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations have been active amicus filers—frequently taking positions different than, even inconsistent with, amicus briefs filed by major specialty boards.

Amicus briefs filed by medical associations provide strong clues to what is important to clinicians. We have looked at such briefs to help us identify topics and cases from the just-concluded term that can be of particular interest to you.

Continue to: Surveying the shadow docket...

Surveying the shadow docket. As part of our review of the past term, we also looked at the so-called shadow docket, which includes decisions regarding writs of certiorari (which cases it agrees to hear); stays (usually delaying implementation of a law); or denials of stays. (Persuading the Court to hear a case is not easy: It hears approximately 70 cases per year out of as many as 7,000 applications to be heard.)

Abortion ruling

At stake. A number of states recently enacted a variety of provisions that might make an abortion more difficult to obtain. Some of the cases challenging these restrictions are making their way through lower courts, and one day might be argued before the Supreme Court. However, the Court has not (yet) agreed to hear the substance of many new abortion-related provisions.

Box v Planned Parenthood of Indiana and Kentucky, Inc.

The Court decided only 1 abortion restriction case this term.¹ The Indiana law in question included 2 provisions that the Court considered:

Disposal of remains. The law regulated the manner in which abortion providers can dispose of fetal remains (ie, they cannot be treated as “infectious and pathologic waste”).

Motivation for seeking abortion. The Indiana law makes it illegal for an abortion provider to perform an abortion when the provider knows that the mother is seeking that abortion “solely” because of the fetus’s race, sex, diagnosis of Down syndrome, disability, or related characteristics.

Final rulings. The Court held that the disposal-of-remains provision is constitutional. The provision is “rationally related to the state’s interest in proper disposal of fetal remains.”² Planned Parenthood had not raised the issue of whether the law might impose an undue burden on a woman’s right to obtain an abortion, so the Court did not decide that issue.

The Court did not consider the constitutionality of the part of the law proscribing certain reasons for seeking an otherwise legal abortion; instead, it awaits lower courts’ review of the issue. Justice Clarence Thomas wrote an extensive concurring opinion suggesting that this law is intended to avoid abortion to achieve eugenic goals.³

Key developments from the shadow docket

The Court issued a stay preventing a Louisiana statute that requires physicians who perform abortions to have admitting privileges at a nearby hospital from going into effect, pending the outcome of litigation about that law.⁴ Four dissenters noted that all 4 physicians who perform abortions in Louisiana have such privileges. Chief Justice Roberts was the fifth vote to grant the stay. This case likely will make its way back to the Court, as will a number of other state laws being adopted. The issue may be back as soon as the term just starting.

The Court is also considering whether to take another Indiana case, Box v Planned Parenthood of Indiana and Kentucky, Inc. (Box II). This case involves an Indiana ultrasonography viewing option as part of the abortion consent process.⁵

The Court declined to hear cases from Louisiana and Kansas in which the states had cut off Medicaid funding to Planned Parenthood. Lower courts had stopped the implementation of those laws.⁶ The legal issue was whether private parties, as opposed to the federal government, had standing to bring the case. For now, the decision of the lower courts to stop implementation of the funding cutoff is in effect. There is a split in the Circuit Courts on the issue, however, making it likely that the Supreme Court will have to resolve it sooner or later.

Health care organizations have filed a number of amicus briefs in these and other cases involving new abortion regulations. ACOG and others filed a brief opposing a Louisiana law that requires abortion providers to have admitting privileges at a nearby facility,⁷ and a brief opposing a similar Oklahoma law.⁸ The Association of Pro-Life Obstetricians and Gynecologists and others filed amicus curiae briefs in Box II⁹ and in an Alabama case involving so-called dismemberment abortion.¹⁰

Continue to: Medicare payments...

Medicare payments

Azar, Secretary of Health and Human Services v Allina Health Services, et al¹¹

This case drew interest—and many amicus briefs—from health care providers, including the AMA and the AHA.^12,13 There was good reason for their interest: First, the case involved more than $3 billion in reimbursements; second, it represented a potentially important precedent about the rights of providers and patients to comment on Medicare reimbursement changes. The question involved the technical calculation of additional payments made to institutions that serve a disproportionate number of low-income patients (known as Medicare Fractions).

At stake. The issue was a statutory requirement for a 60-day public notice and comment period for rules that “change a substantive legal standard” governing the scope of benefits, eligibility, or payment for services.¹⁴ In 2014, the Secretary of the Department of Health and Human Services (HHS) in the Obama administration posted a spreadsheet announcing Medicare fractions rates for hospitals (for 2012)—without formal notice or comment regarding the formula used. (The spreadsheet listed what each qualifying institution would receive, but it was based on a formula that, as noted, had not been subject to public notice and comment.) The AMA and AHA briefs emphasized the importance of a notice and comment period, especially when Medicare reimbursement is involved.

Final ruling. The Court held that the HHS process violated the notice and comment provision, thereby invalidating the policy underlying the so-called spreadsheet reimbursement. The decision was significant: This was a careful statutory interpretation of the 60-day notice and comment period, not the reimbursement policy itself. Presumably, had the HHS Secretary provided for sufficient notice and comment, the formula used would have met the requirements for issuing reimbursement formulas.

Key points. Hospitals will collectively receive $3 or $4 billion as a consequence of the ruling. Perhaps more importantly, the decision signals that HHS is going to have to take seriously the requirement that it publish Medicare-related reimbursement policies for the 60-day period.

Liability under the False Claims Act

The False Claims Act (FCA) protects the federal government from fraudulent claims for payment and for shoddy goods and services. It incentivizes (by a percentage of recovery) private parties to bring cases to enforce the law.¹⁵ (Of course, the federal government also enforces the Act.)

At stake. The FCA has been of considerable concern to the AHA, the Association of American Medical Colleges, and other health care organizations—understandably so.¹⁶ As the AHA informed the Court in an amicus brief, “The prevalence of [FCA] cases has ballooned over the past three decades.... These suits disproportionately target healthcare entities.... Of the 767 new FCA cases filed in 2018, for example, 506 involved healthcare defendants.”¹⁷

Final ruling. The Court considered an ambiguity in the statute of limitations for these actions and the Court unanimously ruled to permit an extended time in which qui tam actions (private actions under the law) can be filed.¹⁸

Key points. As long a period as 10 years can pass between the time an FCA violation occurs and an action is brought. This decision is likely to increase the number of FCA actions against health care providers because the case can be filed many years after the conduct that gave rise to the complaint.

Continue to: Registering sex offenders...

Registering sex offenders

The Court upheld the constitutionality of the federal Sex Offender Registration and Notification Act (SORNA).¹⁹ Sex offenders must register and periodically report, in person, to law enforcement in every state in which the offender works, studies, or resides.

At stake. The case involved the applicability of SORNA registration obligations to those convicted of sex offenses before SORNA was adopted (pre-Act offenders).²⁰ The court upheld registration requirements for pre-Act offenders.

Arbitration

The Court continued its practice of deciding at least one case each term that emphasizes that federal law requires that courts rather strictly enforce agreements to arbitrate (instead of to litigate) future disputes.²¹ In another case, the Court ruled that there can be “class” or “joint” arbitration only if the agreement to arbitrate a dispute clearly permits such class arbitration.²²

Pharma’s liability regarding product risk

The Court somewhat limited the liability of pharmaceutical companies for failing to provide adequate warning about the risk that their products pose. The case against Merck involved 500 patients who took denosumab (Fosamax) and suffered atypical femoral fractures.²³

At stake. Because prescribing information (in which warnings are provided) must be approved by the US Food and Drug Administration (FDA), the legal test is: Would the FDA have refused to approve a change in the warning if Merck had “fully informed the FDA of the justifications for the warning” required by state law to avoid liability?^24,25 Lower-court judges (not juries) will be expected to apply this test in the future.

The doctor and the death penalty

The Court has established a rule that, when a prisoner facing capital punishment objects to a form of execution because it is too painful, he has to propose an alternative that is reasonably available. In one case,²⁶ a physician, an expert witness for the prisoner, did not answer some essential relative-pain questions (ie, would one procedure be more painful than another?).

At stake. The AMA filed an amicus brief in this case, indicating that it is unethical for physicians to participate in an execution. The brief noted that “testimony used to determine which method of execution would reduce physical suffering would constitute physician participation in capital punishment and would be unethical.”²⁷

The expert witness’s failure to answer the question on relative pain had the unfortunate result of reducing the likelihood that the prisoner would prevail in his request for an alternative method of execution.

Analysis

Despite obvious disagreements about big issues (notably, abortion and the death penalty) the Court maintained a courteous and civil demeanor—something not always seen nowadays in other branches of government. Here are facts about the Court’s term just concluded:

• The Court issued 72 merits opinions (about average).
• Only 39% of decisions were unanimous (compared with the average of 49% in recent terms).
• On the other hand, 26% of decisions were split 5 to 4 (compared with a 10% recent average).
• In those 5 to 4 decisions, Justices were in the majority as follows²⁸: Justice Gorsuch, 65%; Justice Kavanaugh, 61%; Justice Thomas, 60%; Chief Justice Roberts and Justices Ginsburg and Alito, each 55%; Justice Breyer, 50%; and Justices Sotomayor and Kagan each at 45%.
• There were 57 dissenting opinions—up from 48 in the previous term.
• What is referred to as “the liberal-conservative split” might seem more profound than it really is: “Every conservative member of the court at some point voted to form a majority with the liberal justices. And every liberal at least once left behind all of his or her usual voting partners to join the conservatives.”²⁹

Continue to: Last, it was a year of personal health issues for...

Last, it was a year of personal health issues for the Court: Justice Ginsburg had a diagnosis of lung cancer and was absent, following surgery, in January. Of retired Justices, Sandra Day O’Connor suffers from dementia and former Justice John Paul Stevens died.

In closing

The Court has accepted approximately 50 cases for the current term, which began on October 7. The first 2 days of the term were spent on arguments about, first, whether a state can abolish the insanity defense and, second, whether nondiscrimination laws (“based on sex”) prohibit discrimination based on sexual orientation or transgender status. Cases also will deal with Patient Protection and Affordable Care Act payments to providers; the Deferred Action for Childhood Arrivals, or DACA; the death penalty; and international child custody disputes. The Court will be accepting more cases for several months. It promises to be a very interesting term.

The most recently concluded term of the US Supreme Court, which began on October 1, 2018, yielded a number of decisions of interest to health care professionals and to ObGyns in particular. Although the term was viewed by some observers as less consequential than other recent terms, a review of the cases decided paints a picture of a more important term than some commentators expected.

When the term began, the Court had only 8 justices—1 short of a full bench: Judge Brett Kavanaugh had not yet been confirmed by the Senate. He was confirmed on October 6, by a 50-48 vote, and Justice Kavanaugh immediately joined the Court and began to hear and decide cases.

Increasingly, important decisions affect medical practice

From the nature of practice (abortion), to payment for service (Medicare reimbursement), resolution of disputes (arbitration), and fraud and abuse (the federal False Claims Act), the decisions of the Court will have an impact on many areas of medical practice. Organized medicine increasingly has recognized the significance of the work of the Court; nowhere has this been more clearly demonstrated than with amicus curiae (friend of the court) briefs filed by medical organizations.

Amicus curiae briefs. These briefs are filed by persons or organizations not a party to a case the Court is hearing. Their legitimate purpose is to inform the Court of 1) special information within the expertise of the amicus (or amici, plural) or 2) consequences of the decision that might not be apparent from arguments made by the parties to the case. Sometimes, the Court cites amicus briefs for having provided important information about the case.

Filing amicus briefs is time-consuming and expensive; organizations do not file them for trivial reasons. Organizations frequently join together to file a joint brief, to share expenses and express to the Court a stronger position.

Three categories of health professionals file amicus briefs in ObGyn-related cases:

• Major national organizations, often representing broad interests of health care professions or institutions (the American Medical Association [AMA], the Association of American Medical Colleges, and the American Hospital Association [AHA]), have filed a number of amicus briefs over the years.
• Specialty boards increasingly file amicus briefs. For example, the American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine have filed briefs related to abortion issues.
• In reproductive issues, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations have been active amicus filers—frequently taking positions different than, even inconsistent with, amicus briefs filed by major specialty boards.

Amicus briefs filed by medical associations provide strong clues to what is important to clinicians. We have looked at such briefs to help us identify topics and cases from the just-concluded term that can be of particular interest to you.

Continue to: Surveying the shadow docket...

Surveying the shadow docket. As part of our review of the past term, we also looked at the so-called shadow docket, which includes decisions regarding writs of certiorari (which cases it agrees to hear); stays (usually delaying implementation of a law); or denials of stays. (Persuading the Court to hear a case is not easy: It hears approximately 70 cases per year out of as many as 7,000 applications to be heard.)

Abortion ruling

At stake. A number of states recently enacted a variety of provisions that might make an abortion more difficult to obtain. Some of the cases challenging these restrictions are making their way through lower courts, and one day might be argued before the Supreme Court. However, the Court has not (yet) agreed to hear the substance of many new abortion-related provisions.

Box v Planned Parenthood of Indiana and Kentucky, Inc.

The Court decided only 1 abortion restriction case this term.¹ The Indiana law in question included 2 provisions that the Court considered:

Disposal of remains. The law regulated the manner in which abortion providers can dispose of fetal remains (ie, they cannot be treated as “infectious and pathologic waste”).

Motivation for seeking abortion. The Indiana law makes it illegal for an abortion provider to perform an abortion when the provider knows that the mother is seeking that abortion “solely” because of the fetus’s race, sex, diagnosis of Down syndrome, disability, or related characteristics.

Final rulings. The Court held that the disposal-of-remains provision is constitutional. The provision is “rationally related to the state’s interest in proper disposal of fetal remains.”² Planned Parenthood had not raised the issue of whether the law might impose an undue burden on a woman’s right to obtain an abortion, so the Court did not decide that issue.

The Court did not consider the constitutionality of the part of the law proscribing certain reasons for seeking an otherwise legal abortion; instead, it awaits lower courts’ review of the issue. Justice Clarence Thomas wrote an extensive concurring opinion suggesting that this law is intended to avoid abortion to achieve eugenic goals.³

Key developments from the shadow docket

The Court issued a stay preventing a Louisiana statute that requires physicians who perform abortions to have admitting privileges at a nearby hospital from going into effect, pending the outcome of litigation about that law.⁴ Four dissenters noted that all 4 physicians who perform abortions in Louisiana have such privileges. Chief Justice Roberts was the fifth vote to grant the stay. This case likely will make its way back to the Court, as will a number of other state laws being adopted. The issue may be back as soon as the term just starting.

The Court is also considering whether to take another Indiana case, Box v Planned Parenthood of Indiana and Kentucky, Inc. (Box II). This case involves an Indiana ultrasonography viewing option as part of the abortion consent process.⁵

The Court declined to hear cases from Louisiana and Kansas in which the states had cut off Medicaid funding to Planned Parenthood. Lower courts had stopped the implementation of those laws.⁶ The legal issue was whether private parties, as opposed to the federal government, had standing to bring the case. For now, the decision of the lower courts to stop implementation of the funding cutoff is in effect. There is a split in the Circuit Courts on the issue, however, making it likely that the Supreme Court will have to resolve it sooner or later.

Health care organizations have filed a number of amicus briefs in these and other cases involving new abortion regulations. ACOG and others filed a brief opposing a Louisiana law that requires abortion providers to have admitting privileges at a nearby facility,⁷ and a brief opposing a similar Oklahoma law.⁸ The Association of Pro-Life Obstetricians and Gynecologists and others filed amicus curiae briefs in Box II⁹ and in an Alabama case involving so-called dismemberment abortion.¹⁰

Continue to: Medicare payments...

Medicare payments

Azar, Secretary of Health and Human Services v Allina Health Services, et al¹¹

This case drew interest—and many amicus briefs—from health care providers, including the AMA and the AHA.^12,13 There was good reason for their interest: First, the case involved more than $3 billion in reimbursements; second, it represented a potentially important precedent about the rights of providers and patients to comment on Medicare reimbursement changes. The question involved the technical calculation of additional payments made to institutions that serve a disproportionate number of low-income patients (known as Medicare Fractions).

At stake. The issue was a statutory requirement for a 60-day public notice and comment period for rules that “change a substantive legal standard” governing the scope of benefits, eligibility, or payment for services.¹⁴ In 2014, the Secretary of the Department of Health and Human Services (HHS) in the Obama administration posted a spreadsheet announcing Medicare fractions rates for hospitals (for 2012)—without formal notice or comment regarding the formula used. (The spreadsheet listed what each qualifying institution would receive, but it was based on a formula that, as noted, had not been subject to public notice and comment.) The AMA and AHA briefs emphasized the importance of a notice and comment period, especially when Medicare reimbursement is involved.

Final ruling. The Court held that the HHS process violated the notice and comment provision, thereby invalidating the policy underlying the so-called spreadsheet reimbursement. The decision was significant: This was a careful statutory interpretation of the 60-day notice and comment period, not the reimbursement policy itself. Presumably, had the HHS Secretary provided for sufficient notice and comment, the formula used would have met the requirements for issuing reimbursement formulas.

Key points. Hospitals will collectively receive $3 or $4 billion as a consequence of the ruling. Perhaps more importantly, the decision signals that HHS is going to have to take seriously the requirement that it publish Medicare-related reimbursement policies for the 60-day period.

Liability under the False Claims Act

The False Claims Act (FCA) protects the federal government from fraudulent claims for payment and for shoddy goods and services. It incentivizes (by a percentage of recovery) private parties to bring cases to enforce the law.¹⁵ (Of course, the federal government also enforces the Act.)

At stake. The FCA has been of considerable concern to the AHA, the Association of American Medical Colleges, and other health care organizations—understandably so.¹⁶ As the AHA informed the Court in an amicus brief, “The prevalence of [FCA] cases has ballooned over the past three decades.... These suits disproportionately target healthcare entities.... Of the 767 new FCA cases filed in 2018, for example, 506 involved healthcare defendants.”¹⁷

Final ruling. The Court considered an ambiguity in the statute of limitations for these actions and the Court unanimously ruled to permit an extended time in which qui tam actions (private actions under the law) can be filed.¹⁸

Key points. As long a period as 10 years can pass between the time an FCA violation occurs and an action is brought. This decision is likely to increase the number of FCA actions against health care providers because the case can be filed many years after the conduct that gave rise to the complaint.

Continue to: Registering sex offenders...

Registering sex offenders

The Court upheld the constitutionality of the federal Sex Offender Registration and Notification Act (SORNA).¹⁹ Sex offenders must register and periodically report, in person, to law enforcement in every state in which the offender works, studies, or resides.

At stake. The case involved the applicability of SORNA registration obligations to those convicted of sex offenses before SORNA was adopted (pre-Act offenders).²⁰ The court upheld registration requirements for pre-Act offenders.

Arbitration

The Court continued its practice of deciding at least one case each term that emphasizes that federal law requires that courts rather strictly enforce agreements to arbitrate (instead of to litigate) future disputes.²¹ In another case, the Court ruled that there can be “class” or “joint” arbitration only if the agreement to arbitrate a dispute clearly permits such class arbitration.²²

Pharma’s liability regarding product risk

The Court somewhat limited the liability of pharmaceutical companies for failing to provide adequate warning about the risk that their products pose. The case against Merck involved 500 patients who took denosumab (Fosamax) and suffered atypical femoral fractures.²³

At stake. Because prescribing information (in which warnings are provided) must be approved by the US Food and Drug Administration (FDA), the legal test is: Would the FDA have refused to approve a change in the warning if Merck had “fully informed the FDA of the justifications for the warning” required by state law to avoid liability?^24,25 Lower-court judges (not juries) will be expected to apply this test in the future.

The doctor and the death penalty

The Court has established a rule that, when a prisoner facing capital punishment objects to a form of execution because it is too painful, he has to propose an alternative that is reasonably available. In one case,²⁶ a physician, an expert witness for the prisoner, did not answer some essential relative-pain questions (ie, would one procedure be more painful than another?).

At stake. The AMA filed an amicus brief in this case, indicating that it is unethical for physicians to participate in an execution. The brief noted that “testimony used to determine which method of execution would reduce physical suffering would constitute physician participation in capital punishment and would be unethical.”²⁷

The expert witness’s failure to answer the question on relative pain had the unfortunate result of reducing the likelihood that the prisoner would prevail in his request for an alternative method of execution.

Analysis

Despite obvious disagreements about big issues (notably, abortion and the death penalty) the Court maintained a courteous and civil demeanor—something not always seen nowadays in other branches of government. Here are facts about the Court’s term just concluded:

• The Court issued 72 merits opinions (about average).
• Only 39% of decisions were unanimous (compared with the average of 49% in recent terms).
• On the other hand, 26% of decisions were split 5 to 4 (compared with a 10% recent average).
• In those 5 to 4 decisions, Justices were in the majority as follows²⁸: Justice Gorsuch, 65%; Justice Kavanaugh, 61%; Justice Thomas, 60%; Chief Justice Roberts and Justices Ginsburg and Alito, each 55%; Justice Breyer, 50%; and Justices Sotomayor and Kagan each at 45%.
• There were 57 dissenting opinions—up from 48 in the previous term.
• What is referred to as “the liberal-conservative split” might seem more profound than it really is: “Every conservative member of the court at some point voted to form a majority with the liberal justices. And every liberal at least once left behind all of his or her usual voting partners to join the conservatives.”²⁹

Continue to: Last, it was a year of personal health issues for...

Last, it was a year of personal health issues for the Court: Justice Ginsburg had a diagnosis of lung cancer and was absent, following surgery, in January. Of retired Justices, Sandra Day O’Connor suffers from dementia and former Justice John Paul Stevens died.

In closing

The Court has accepted approximately 50 cases for the current term, which began on October 7. The first 2 days of the term were spent on arguments about, first, whether a state can abolish the insanity defense and, second, whether nondiscrimination laws (“based on sex”) prohibit discrimination based on sexual orientation or transgender status. Cases also will deal with Patient Protection and Affordable Care Act payments to providers; the Deferred Action for Childhood Arrivals, or DACA; the death penalty; and international child custody disputes. The Court will be accepting more cases for several months. It promises to be a very interesting term.

The most recently concluded term of the US Supreme Court, which began on October 1, 2018, yielded a number of decisions of interest to health care professionals and to ObGyns in particular. Although the term was viewed by some observers as less consequential than other recent terms, a review of the cases decided paints a picture of a more important term than some commentators expected.

When the term began, the Court had only 8 justices—1 short of a full bench: Judge Brett Kavanaugh had not yet been confirmed by the Senate. He was confirmed on October 6, by a 50-48 vote, and Justice Kavanaugh immediately joined the Court and began to hear and decide cases.

Increasingly, important decisions affect medical practice

From the nature of practice (abortion), to payment for service (Medicare reimbursement), resolution of disputes (arbitration), and fraud and abuse (the federal False Claims Act), the decisions of the Court will have an impact on many areas of medical practice. Organized medicine increasingly has recognized the significance of the work of the Court; nowhere has this been more clearly demonstrated than with amicus curiae (friend of the court) briefs filed by medical organizations.

Amicus curiae briefs. These briefs are filed by persons or organizations not a party to a case the Court is hearing. Their legitimate purpose is to inform the Court of 1) special information within the expertise of the amicus (or amici, plural) or 2) consequences of the decision that might not be apparent from arguments made by the parties to the case. Sometimes, the Court cites amicus briefs for having provided important information about the case.

Filing amicus briefs is time-consuming and expensive; organizations do not file them for trivial reasons. Organizations frequently join together to file a joint brief, to share expenses and express to the Court a stronger position.

Three categories of health professionals file amicus briefs in ObGyn-related cases:

• Major national organizations, often representing broad interests of health care professions or institutions (the American Medical Association [AMA], the Association of American Medical Colleges, and the American Hospital Association [AHA]), have filed a number of amicus briefs over the years.
• Specialty boards increasingly file amicus briefs. For example, the American College of Obstetricians and Gynecologists (ACOG) and the American Society for Reproductive Medicine have filed briefs related to abortion issues.
• In reproductive issues, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations have been active amicus filers—frequently taking positions different than, even inconsistent with, amicus briefs filed by major specialty boards.

Amicus briefs filed by medical associations provide strong clues to what is important to clinicians. We have looked at such briefs to help us identify topics and cases from the just-concluded term that can be of particular interest to you.

Continue to: Surveying the shadow docket...

Surveying the shadow docket. As part of our review of the past term, we also looked at the so-called shadow docket, which includes decisions regarding writs of certiorari (which cases it agrees to hear); stays (usually delaying implementation of a law); or denials of stays. (Persuading the Court to hear a case is not easy: It hears approximately 70 cases per year out of as many as 7,000 applications to be heard.)

Abortion ruling

At stake. A number of states recently enacted a variety of provisions that might make an abortion more difficult to obtain. Some of the cases challenging these restrictions are making their way through lower courts, and one day might be argued before the Supreme Court. However, the Court has not (yet) agreed to hear the substance of many new abortion-related provisions.

Box v Planned Parenthood of Indiana and Kentucky, Inc.

The Court decided only 1 abortion restriction case this term.¹ The Indiana law in question included 2 provisions that the Court considered:

Disposal of remains. The law regulated the manner in which abortion providers can dispose of fetal remains (ie, they cannot be treated as “infectious and pathologic waste”).

Motivation for seeking abortion. The Indiana law makes it illegal for an abortion provider to perform an abortion when the provider knows that the mother is seeking that abortion “solely” because of the fetus’s race, sex, diagnosis of Down syndrome, disability, or related characteristics.

Final rulings. The Court held that the disposal-of-remains provision is constitutional. The provision is “rationally related to the state’s interest in proper disposal of fetal remains.”² Planned Parenthood had not raised the issue of whether the law might impose an undue burden on a woman’s right to obtain an abortion, so the Court did not decide that issue.

The Court did not consider the constitutionality of the part of the law proscribing certain reasons for seeking an otherwise legal abortion; instead, it awaits lower courts’ review of the issue. Justice Clarence Thomas wrote an extensive concurring opinion suggesting that this law is intended to avoid abortion to achieve eugenic goals.³

Key developments from the shadow docket

The Court issued a stay preventing a Louisiana statute that requires physicians who perform abortions to have admitting privileges at a nearby hospital from going into effect, pending the outcome of litigation about that law.⁴ Four dissenters noted that all 4 physicians who perform abortions in Louisiana have such privileges. Chief Justice Roberts was the fifth vote to grant the stay. This case likely will make its way back to the Court, as will a number of other state laws being adopted. The issue may be back as soon as the term just starting.

The Court is also considering whether to take another Indiana case, Box v Planned Parenthood of Indiana and Kentucky, Inc. (Box II). This case involves an Indiana ultrasonography viewing option as part of the abortion consent process.⁵

The Court declined to hear cases from Louisiana and Kansas in which the states had cut off Medicaid funding to Planned Parenthood. Lower courts had stopped the implementation of those laws.⁶ The legal issue was whether private parties, as opposed to the federal government, had standing to bring the case. For now, the decision of the lower courts to stop implementation of the funding cutoff is in effect. There is a split in the Circuit Courts on the issue, however, making it likely that the Supreme Court will have to resolve it sooner or later.

Health care organizations have filed a number of amicus briefs in these and other cases involving new abortion regulations. ACOG and others filed a brief opposing a Louisiana law that requires abortion providers to have admitting privileges at a nearby facility,⁷ and a brief opposing a similar Oklahoma law.⁸ The Association of Pro-Life Obstetricians and Gynecologists and others filed amicus curiae briefs in Box II⁹ and in an Alabama case involving so-called dismemberment abortion.¹⁰

Continue to: Medicare payments...

Medicare payments

Azar, Secretary of Health and Human Services v Allina Health Services, et al¹¹

This case drew interest—and many amicus briefs—from health care providers, including the AMA and the AHA.^12,13 There was good reason for their interest: First, the case involved more than $3 billion in reimbursements; second, it represented a potentially important precedent about the rights of providers and patients to comment on Medicare reimbursement changes. The question involved the technical calculation of additional payments made to institutions that serve a disproportionate number of low-income patients (known as Medicare Fractions).

At stake. The issue was a statutory requirement for a 60-day public notice and comment period for rules that “change a substantive legal standard” governing the scope of benefits, eligibility, or payment for services.¹⁴ In 2014, the Secretary of the Department of Health and Human Services (HHS) in the Obama administration posted a spreadsheet announcing Medicare fractions rates for hospitals (for 2012)—without formal notice or comment regarding the formula used. (The spreadsheet listed what each qualifying institution would receive, but it was based on a formula that, as noted, had not been subject to public notice and comment.) The AMA and AHA briefs emphasized the importance of a notice and comment period, especially when Medicare reimbursement is involved.

Final ruling. The Court held that the HHS process violated the notice and comment provision, thereby invalidating the policy underlying the so-called spreadsheet reimbursement. The decision was significant: This was a careful statutory interpretation of the 60-day notice and comment period, not the reimbursement policy itself. Presumably, had the HHS Secretary provided for sufficient notice and comment, the formula used would have met the requirements for issuing reimbursement formulas.

Key points. Hospitals will collectively receive $3 or $4 billion as a consequence of the ruling. Perhaps more importantly, the decision signals that HHS is going to have to take seriously the requirement that it publish Medicare-related reimbursement policies for the 60-day period.

Liability under the False Claims Act

The False Claims Act (FCA) protects the federal government from fraudulent claims for payment and for shoddy goods and services. It incentivizes (by a percentage of recovery) private parties to bring cases to enforce the law.¹⁵ (Of course, the federal government also enforces the Act.)

At stake. The FCA has been of considerable concern to the AHA, the Association of American Medical Colleges, and other health care organizations—understandably so.¹⁶ As the AHA informed the Court in an amicus brief, “The prevalence of [FCA] cases has ballooned over the past three decades.... These suits disproportionately target healthcare entities.... Of the 767 new FCA cases filed in 2018, for example, 506 involved healthcare defendants.”¹⁷

Final ruling. The Court considered an ambiguity in the statute of limitations for these actions and the Court unanimously ruled to permit an extended time in which qui tam actions (private actions under the law) can be filed.¹⁸

Key points. As long a period as 10 years can pass between the time an FCA violation occurs and an action is brought. This decision is likely to increase the number of FCA actions against health care providers because the case can be filed many years after the conduct that gave rise to the complaint.

Continue to: Registering sex offenders...

Registering sex offenders

The Court upheld the constitutionality of the federal Sex Offender Registration and Notification Act (SORNA).¹⁹ Sex offenders must register and periodically report, in person, to law enforcement in every state in which the offender works, studies, or resides.

At stake. The case involved the applicability of SORNA registration obligations to those convicted of sex offenses before SORNA was adopted (pre-Act offenders).²⁰ The court upheld registration requirements for pre-Act offenders.

Arbitration

The Court continued its practice of deciding at least one case each term that emphasizes that federal law requires that courts rather strictly enforce agreements to arbitrate (instead of to litigate) future disputes.²¹ In another case, the Court ruled that there can be “class” or “joint” arbitration only if the agreement to arbitrate a dispute clearly permits such class arbitration.²²

Pharma’s liability regarding product risk

The Court somewhat limited the liability of pharmaceutical companies for failing to provide adequate warning about the risk that their products pose. The case against Merck involved 500 patients who took denosumab (Fosamax) and suffered atypical femoral fractures.²³

At stake. Because prescribing information (in which warnings are provided) must be approved by the US Food and Drug Administration (FDA), the legal test is: Would the FDA have refused to approve a change in the warning if Merck had “fully informed the FDA of the justifications for the warning” required by state law to avoid liability?^24,25 Lower-court judges (not juries) will be expected to apply this test in the future.