Type 1 diabetes mellitus (T1DM) is an autoimmune condition that causes pancreatic beta-cell destruction and complete absence of native insulin production. Risk factors for development of T1DM include family history, genetic predisposition (specific human leukocyte antigen gene variants), and viral triggers.

While T1DM affects only 5% of patients with pregestational diabetes and less than 1% of overall pregnancies, it is important that obstetricians are aware of the pathophysiology, basic management principles, and rapidly evolving insulin pump and continuous glucose monitoring (CGM) technologies.

Patients with poorly controlled T1DM have higher risks of preeclampsia, fetal growth abnormalities, polyhydramnios, intrauterine fetal demise, diabetic ketoacidosis, cesarean delivery, and wound infections.

In order to optimize glycemic control and pre-conception hemoglobin A1c, referral to both a maternal-fetal medicine physician and an endocrinologist is important for all individuals with reproductive potential. 

Preemptive optimization of comorbidities and hemoglobin A1c levels may decrease the risk of congenital birth defects and miscarriage.

Over the past 20 years, there has been a paradigm shift in management of T1DM from self-monitoring of fingerstick capillary blood glucose to CGM and from multiple daily injections (MDI) of insulin to continuous subcutaneous insulin infusion (CSII, colloquially known as “insulin pumps”). 

This review will discuss the science and rationale behind these technologies.

CGMs were first introduced in 1999, with the clinical intent of improving patient’s self-awareness of real-time glycemic control, and reducing the cumulative burden of disease management.

 These monitors utilize a glucose-oxidase enzyme reaction to measure the glucose concentration in interstitial fluid and converts the value via algorithms to expected glucose concentration in the blood.

These devices calculate the capillary blood sugar every 5 minutes, then report the value in real-time via short-range wireless communication to a receiver, mobile device, or insulin pump. The data is reported as 288 distinct data points per day.

The analytics generated from the data stream allows both the patient and the physician to visualize trends and changes in the blood sugar in either real-time or retrospectively. 

The ability to pinpoint specific time points of glucose perturbations and nutrition deficits may explain periods of poor glucose control, and allow for better management strategies. Drilling down to this level allows the provider to adjust insulin doses based on patient physiology, diurnal cycles, time of day, and specific meals. 

Furthermore, impending hypo- and hyperglycemia can trigger an audible alarm that allows for preemptive self-treatment with oral glucose or insulin as indicated.

While the data is mixed, use of CGM has been shown in multiple trials to improve outcomes in both pregnant and non-pregnant patients being treated with CSII or MDI of insulin.

 Notable clinical improvements with CGM use include decrease in hemoglobin A1c levels, increased times within target glucose goals, and decreased frequency of hypoglycemic events.

Some data also suggest that CGM also may confer benefit for patients with type 2 diabetes. Initiation of CGM is strongly recommended for pregnant individuals with T1DM.

 Some studies have found lower rates of preeclampsia, improved hemoglobin A1c, and decreased rates of fetal macrosomia.

 There have been no adverse events related to the use of CGMs and no side effects or adverse events have ever been associated with using CGMs in or outside of pregnancy.

Technological advances and limitations with CGM

Both hardware and algorithmic improvements are continuously being instated for CGMs.

 Traditionally, CGMs required the user to periodically obtain fingerstick glucose levels via a glucometer to calibrate the sensor signal. 

Modern CGM devices have improved in insertion, calibration, and accuracy. Newer models allow patient self-insertion subcutaneously every 7 to 10 days, have internal calibration systems, which eliminate the need for finger sticks, and have significantly decreased the mean absolute relative difference from the gold standard (25% in older models, down to 9-12%). 

Despite the improvements in calibration, intermittent capillary blood glucose checks still are recommended to make sure the readings are accurate.

Of note, healthcare providers need to be aware that acetaminophen is contraindicated in all patients on CGMs because the drug binds to, and interferes with, the sensor and will significantly alter the values reported. Newer models of the Dexcom CGM have begun to address this particularity in the sensors.

There are currently four major CGM products available in the United States: Medtronic, Dexcom, FreeStyle Libre, and Senseonics Eversense 

. Dexcom is the only model that currently has Food and Drug Administration (FDA) approval to make insulin management decisions independent of a closed-loop system. 

The remaining models require an additional point-of-care glucose check to confirm the glucose level before insulin or sugar can be administered. The Dexcom and Medtronic CGMs can be used in closed-loop insulin systems, which are described below. 

It is important to note that none of the products have FDA approval for use in pregnancy.

Continuous subcutaneous insulin infusion (insulin pumps)

Most CSII have a reservoir of insulin that is connected to an electronic pump. The pump is connected to tubing that delivers the insulin subcutaneously via an external port placed subcutaneously by the patient. The anatomical sites used are typically abdomen, anterior thigh, and posterior upper arm, all regions that remain accessible to the pregnant individual.

The exception to this model is the Omnipod. 

This specific CSII has the infusion site, insulin reservoir, and pump all at the level of the skin, eliminating the need for tubing. It also has a separate device that allows the patient to control the pump via Bluetooth wireless communication.

Most CSII now have built-in insulin bolus calculators, based on the prescribed insulin-to-carbohydrate ratios of the patient. This feature eliminates human math errors that can lead to incorrect dosing of insulin, a potentially dangerous event.

The basal rates and bolus amounts are fine-tuned across all CSII to a meticulous level of accuracy. The basal rates can be fine-tuned to a level of 0.1 units/hour (or 10 microliters/hour) and bolus volumes can be calculated to a level of 0.05 units to 0.1 units, depending on the type of CSII. 

This level of accuracy is superior to traditional insulin injections that have an accuracy of 0.5 units per dose.

But even with all the advancements in device accuracy and technology, are pumps truly better than daily MDI in pregnancy? 

Within the last 10 years, most studies looking at CSII vs MDIs have found superior glycemic control outside of pregnancy,

 and one study in pregnancy showed superior glycemic control but no improvement in neonatal or obstetrical outcomes.

 However, this study was not powered to evaluate pregnancy outcomes. 

Literature remains sparse on the efficacy of CSII in pregnancy.

Patient characteristics to consider in recommendation and initiation of CSII in a patient requires evaluation of several factors, listed in 

. It is also important to note that physicians need to ensure that the patient has achieved adequate glycemic control prior to the transition to a CSII, as premature initiation during a period of poor control can be potentially dangerous for the patient. 

This increased risk is secondary to the exclusive use of short-acting insulins in CSIIs, which require that the user be savvy and experienced in adjustments. 

A potential lapse in dosing or temporary interruption due to inexperienced use can increase risk of diabetic ketoacidosis or other complications, compared to patients on MDI who have coverage with some basal insulin throughout the day.

There are five major manufacturers of CSII today, and all have similar efficacy. The differences are the presence of minor features that come down to patient preference of the interface (

Closed-loop insulin systems represent the pinnacle of T1DM technology. In closed-loop systems, the CGM communicates directly with the CSII to adjust basal rates and provide micro-boluses throughout the day, further reducing the daily burden of disease management and potential for human error. 

The governing algorithms can see trends in glucose readings and decrease basal rates when hypoglycemia may occur and can give micro-boluses when a trend towards hyperglycemia is detected. This leads to less corrective dosing regimens in the future and overall better control.

There have been multiple studies on closed-loop systems outside of pregnancy that have shown decreased rates of hypoglycemic episodes, more time in glycemic target range, and improved hemoglobin A1c.

One study in pregnant women showed more time in target range compared to previous standard of care.

While no study has looked at neonatal and pregnancy outcomes, given the ability to improve blood sugar control, there may be benefit to the closed-loop system in pregnancy.

To date, no randomized control trials have evaluated the use of intravenous insulin versus subcutaneous injections versus CSII therapy for intrapartum management. Patient and fetal/neonatal safety are of the highest priority while patients are in labor, so a standardized protocol determined by a multidisciplinary team of endocrinologists and maternal-fetal medicine specialists is recommended. 

While CSII may lead to better control of blood sugars and patient autonomy, labor floor providers who are unfamiliar with CSII may choose to transition to insulin drips. 

Further studies of intrapartum management of T1DM need to be performed to further assess safety of continuation of CSII in various labor and delivery models and populations.

One of the most significant barriers to obtaining this technology is variable insurance coverage. Most, but not all, insurance plans will cover CSII and CGMs for T1DM patients. If coverage is not provided by the insurance company the cost of the CSII system can be between $4,500-$6,000 with annual costs of about $3,500 for supplies.

As research continues to demonstrate the superior control and improved long-term outcomes, we anticipate that more insurance companies will cover this essential technology.

From a societal perspective, there have been multiple cost-effectiveness studies evaluating CSII. The data remains conflicting on the optimal management protocols, with differing models yielding different cost-effectiveness outcomes when comparing MDI, CSII with CGM, and closed-loop systems.

When evaluating CGM alone, in the absence of an insulin delivery system, most studies have found that there is a cost-benefit of using CGMs compared to multiple point-of-care glucose tests throughout the day.

But, given the heterogeneous data, it is unclear if there is a cost-benefit of using CSII and CGMs in combination. 

However, if these technologies can potentially reduce the risk of chronic sequelae, such as kidney disease, vascular disease, cardiac disease, and neurologic disease, there may be a long-term cost-benefit analysis. These long-term outcomes have not been evaluated yet as these technologies are relatively new.

A recent poll of T1DM patients revealed about one-third currently use an insulin pump.

 This number is expected to increase given the emerging evidence of superior control, increased safety with use, and expansion of insurance coverage. 

There is also a movement toward placing poorly controlled T1DM on closed-loop systems because of the reduction of human error with this type of technology. It is now up to the obstetrics community to ensure that these technologies and their continued advancements are studied adequately in pregnant individuals.

 is a Maternal-Fetal Medicine Specialist in Los Angeles at the Center for Fetal Medicine and Women’s Ultrasound. She is the MFM Fellowship Program Director at the University of California, Los Angeles.

 is an ob/gyn in Los Angeles at the University of California, Los Angeles Medical Center and practices at Ronald Reagan UCLA Medical Center and Santa Monica Medical Center.

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Articles

A review of the science and technology behind current insulin pumps and
CGMs for managing type 1 diabetes mellitus in pregnancy.

Advancing technology in diabetes management

Vaginal dilators are an effective medical treatment for women experiencing pelvic pain and pain during intercourse and have demonstrated clinical success for over 75 years. 

These devices (alternately known as vaginal trainers) are inserts of progressive diameter used to stretch the vagina, decrease pain, and reduce anxiety related to intercourse (Table 1). 

Dilators are prescribed by a diversity of medical health care professionals, including ob/gyns, pain specialists, pelvic floor physical therapists, nurse practitioners, counselors, and psychologists. Vaginal dilation also is standard of care for treatment of postoperative male-to-female transgender patients who wish to maintain the patency of the neovagina. 

Proper usage is thought to recondition and facilitate an adaptive body/brain connection to eliminate anticipatory anxiety and pelvic discomfort or pain that women often experience in anticipation of intercourse.

According to a survey of 239 dilator users, 56.8% of women had suffered for more than 2 years, and 52% had seen more than 3 clinicians before they began dilator therapy

 A major hindrance to timely care is patient apprehension about discussing intimate issues with anyone, including their medical professional. 

Health care professionals are often remiss in discussing sexual pain syndromes, and such problems often go unaddressed at the clinical visit. 

Additional barriers to effective assessment include poor communication skills, time constraints, and reimbursement considerations. Many women being treated with vaginal dilators have self-diagnosed their condition and sought over-the-counter treatments. 

Watch: Vaginal dilators with Michael Krychman, MD

Liu et al published a survey by one manufacturer showing that 70% of women who purchased their dilation device used it without direct guidance from a clinician.

 Some information on self-directed treatment of pelvic pain conditions is available directly to consumers in online blogs, message boards, and video-sharing sites. 

In addition, dilators may play a role in sexual pleasure, and some women report improved sensuality and sexuality after use. Minimal published scientific data are available concerning dilator use. Studies are lacking on evaluation of optimal treatment protocols, but a brief report about current dilator usage is appropriate for ob/gyns.

 summarized recently published dilator research in a review article, “

 and noted that the most frequently published data describe treatment of postmenopausal women who also have a diagnosis of genitourinary syndrome of menopause and or dyspareunia. 

Several studies also show high rates of dyspareunia in breast, gynecological, and colorectal cancer survivors, especially among those who have received brachytherapy in the pelvic region. These studies show that many of these patients can benefit from dilator use in sexual rehabilitation. However,optimal protocols for dilator use frequency and duration of dilator sessions remain to be determined and confirmed inscientific literature.

Vaginal dilators have historically been cylindrical medical devices that sequentially increase in diameter and or length. They are placed within the vagina to help expand vaginal tissues that may be contracted due to vaginal atrophy, increased pelvic muscular spasm, or exogenous fibrotic damage due to chemotherapy or brachytherapy. 

By therapeutically stretching tight fibrotic tissues, these devices facilitate relaxation of the vaginal lining.

Ultimately, consistent use of dilators may help a patient reclaim pelvic floor relaxation and provide a method of behavioral modification.

 Often referred to as vaginal trainers, dilators remain an integral part of the overall medical treatment plan for a wide variety of genito-pelvic medical conditions. 

They may be made from materials including but not limited to medical grade plastic, latex, glass, and silicone. They may also have special additive features (Table 2). Head-to-head clinical studies comparing different types of dilators have not been completed. 

Factors that influence health care professional dilator choice include ease of patient use, affordability, material, and durability.

Incorporating dilators into the treatment paradigm

Compliance with dilator use remains low, and some studies report adherence rates below 25%.3 Poorly defined intervals, limited dilator sizes, and difficulty with progressing from one size to another remain challenging obstacles.

 discussed vaginal dilator therapy in patients with vaginal agenesis and reported a comprehensive treatment paradigm. 

Patient readiness for dilation and high patient motivation for dilation are predictive of compliance and success. In addition, the authors outlined a comprehensive plan for patient education and instruction concerning dilators: Patients should be advised to void before dilating, lay in a semi-recumbent position and use the devices with lubricant and/or topical lidocaine ointment if they experience pain. 

Health care professionals should confirm that patients have an awareness and understanding of their own pelvic and vaginal anatomy. More frequent dilation (2 to 4 times per day) was reported as a variable linked to a higher rate of anatomic success compared to dilation only once daily. Henceforth, the authors encourage patients to dilate as frequently as possible. 

Alternately, in the launch data from the Milli™ dilator survey, patients who dilated between 15 to 20 minutes reported the greatest reductions in anxiety and pain. It appeared that 15 to 20 minutes was the optimal dilation duration for success. 

In addition, activities that seemed to distract the patient, including television watching, deep breathing, or relaxation techniques, were associated with large reductions in pain and anxiety.

Patients who were encouraged to use their dilators before coitus had reduction in pain and anxiety. 

Although there is no current consensus in the field, many sexual medicine experts recommend that their patients dilate at minimum 3 times a week for no longer than 10 to 15 minutes per session to prevent patient/dilator burnout. Best practices include provision of detailed dilator instructions regarding position, interval, and duration of use, followed by close surveillance and frequent follow-up visits with the health care professional. 

A multidisciplinary approach to the management of these complex gynecological problems is often best served with a multimodal treatment paradigm, including cognitive behavioral therapy, mindfulness, biofeedback, rhythmic breathing, vaginal and systemic medications, and training to decrease anticipatory anxiety. Genito-pelvic floor physical therapists are an important and integral component of the treatment schema and should be actively involved in the treatment plan.

Dilators are an important, adjunctive mode of treatment for women with pelvic or sexual pain syndromes. They continue to be underutilized and under-prescribed. 

Future research should focus on optimal frequency and duration of dilation sessions needed to achieve the desired clinical outcome, while minimizing patient noncompliance. Comparative studies with validated outcome measures comparing dilators of varying materials should be conducted. 

Such research will help physicians guide their patients toward effective, evidence-based dilator therapy to help mitigate anticipatory anxiety with painful intercourse and accelerate return to coitus. 

is a gynecologist who specializes in sexual health and survivorship medicine. He is executive director of the Southern California Center for Sexual Health and Survivorship Medicine Inc. in Newport Beach, Calif.

is a gynecologist at the University of California, Irvine.

is a fourth-year medical student at the University of California, Irvine.

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Macey K, Gregory A, Nunns D, et al. Women's experiences of using vaginal trainers (dilators) to treat vaginal penetration difficulties diagnosed as vaginismus: a qualitative interview study. BMC Womens Health. 2015;15:49.

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These therapeutic medical devices can be used by patients to effectively treat pelvic pain and anxiety related to intercourse.

Vaginal Dilators: A guide for health care professionals

 Deputy Editor Jon I. Einarsson, MD, MPH, PhD, moderated a discussion with Robert K. Zurawin, MD, adjunct associate professor at the Baylor College of Medicine, Department of OB/GYN; and Gaby Moawad, MD, clinical associate professor of ob/gyn at the George Washington University School of Medicine and Health Sciences, and founder of the Center for Endometriosis and Advanced Pelvic Surgery. 

In this article, adapted from the video interview, the surgeons discuss the current state of robotic surgery; the current robotic options available; and how new technology can be factored into clinical practice, the focus of which is the Hominis surgical system. 

The Hominis is a transvaginal robotic-assisted system that has combined the visual advantages of laparoscopy with the transvaginal approach. It is said to enhance and enable transvaginal approaches. Its humanoid design includes two flexible, snake-like arms that mimic the movement and mobility of human arms.

Much of what the surgeons discuss is moving the needle on how hysterectomies are performed, since the vaginal approach remains the preferred method in the specialty, but is performed at a lower rate due to myriad factors. Abdominal hysterectomy is the most widely used approach. The Hominis is not yet for sale in the U.S. and pending FDA approval. Experts will present on it at the American Association of Gynecologic Laparoscopists Virtual Conference, being held Nov. 6-14.

“Technologies are coming through that will facilitate the ability of those with general knowledge of surgery to approach surgery safer and more cost-effectively, and make it more accessible to them to do these kinds of procedures,” Dr. Zurawin says.

The surgeons see the landscape for surgical technology constantly evolving, but that doesn’t replace the need for highly skilled surgeons. Patient outcomes remain the most critical goal. Artificial intelligence and machine learning could help modern medicine create algorithms to better understand triaging patients to different modalities of surgery, whether vaginal or laparoscopic.

“At the end of the day, it is the surgeon’s skill that is the most important factor and we often forget that,” Dr. Einarsson says. “That is the most important ingredient. New devices that are coming out are facilitating the existing surgeon’s skills and help surgeons to develop those skills.

“We do not need to glorify another robot,” he says. “We need to improve the innovative aspect of how the robot or how the computer-assisted surgery can help the surgeon standardizing the outcome of the surgery, rather than relying on a human to make decisions.”

The discussion begins with Dr. Zurawin, who provides background.

: You wanted to address the vaginal approach and this really speaks to the greatest unmet need of gyn surgeries because every single gynecological organization recommends vaginal hysterectomy as the preferred method of hysterectomy. But the needle hasn’t moved past 15 or 16%, forever. 

The reason for that is anatomy, surgical training, and discomfort with surgeons who are coming through training - and even existing surgeons - who perform vaginal surgeries. The key to vaginal hysterectomy rests in safe dissection into the anterior/posterior cul-de-sacs, a feeling of security with securing the vessels, as well as avoiding the bladder and the rectum. 

That is not only unchanged, but it has actually gotten worse, because the world of vaginal surgery now is out of the hand of the generalists and has moved to urogynecologists and some of the oncologists, and of course, specifically trained minimally invasive surgeons (MIGS-fellowship trained surgeons). So how can you possibly have vaginal hysterectomy as the preferred method of hysterectomy? Practically nobody knows how to do it. And one of the challenges is anatomy, but if you remember, back when many of us were in training, cesarean section was only a small percentage of deliveries and now it’s anywhere from 30 to 50 to 70 percent, depending on where you are. 

Once you perform a c-section, you have an increased risk of scarring in the anterior cul-de-sac, so in addition to just getting cleanly into the anterior cul-de-sac, now you have got to dig through that scar tissue. A number of publications have shown the feasibility of vaginal hysterectomy after a cesarean but it still is keeping most people away. The vaginal robot creates an opportunity to combine robotic surgery with a laparoscopic view and a vaginal single-incision approach. One of the advantages of that is that the entry is guided by a small umbilical laparoscopic scope. 

Then it monitors the entry of the trocar through the posterior cul-de-sac. You are not going to hit anything. It is direct visualization and then once the trocar is in, the robot arms are inserted and then retroflex. You can perform the hysterectomy and also adnexal surgery, and then remove the specimen through the colpotomy you made for the insertion of the trocar. The transvaginal robotic approach facilitates all those steps. 

Other robotic platforms have attempted vaginal surgery but they run into problems of entry. There are a lot of excellent surgeons doing vNotes (transvaginal natural orifice transluminal endoscopic surgery), which of course is a very nice modality, but again, you have to get into the anterior and posterior cul-de-sac, before you even get to put in the GelPoint. By that point, 90% of the work is done. After that, you might just as well put a couple of clamps on the uterine vessels and you’re done. I just wanted to give a little background on the vaginal approach. Of course Hominis still is awaiting FDA approval but it is at the final stages.

Dr. Moawad has done a lot of tremendous work not only on the cost but training; Dr. Zurawin turns the discussion over to him.

: These are all really great points that you brought in. We can start seeing why the value of robotic surgery would be beneficial in moving the needle towards vNotes or robotic vNotes. 

In addition to what you said, the important thing is that the robotic platform is enabling the surgeon to be in control of the visualization as well as all the operative arms, minimizing the use of multiple assistants. 

That always was a struggle when we did vaginal hysterectomies, where we have the learners, the surgeon and the assistant, all not being able to visualize clearly the important structures, like the ureters in vaginal hysterectomy, or other anatomical landmarks. 

That was, I believe, one of the drawbacks of vaginal surgery, especially when we get into more complex and difficult cases. The type of pelvis, the body mass index of the patient, and then the more complexity of benign gynecological surgeries (including endometriosis) all lead to increasing the challenges in the vaginal approach. 

The problem with endometriosis is that there are numerous surgeons who are not able to diagnose an obliterated cul-de-sac or having the tools to diagnose that before the surgery. 

Therefore, many rectovaginal endometriosis [cases] with the general ob/gyn are diagnosed by accident intraoperatively. Imagine now with trying to push vNotes or vaginal surgery to a wide variety of less experienced surgeons, thinking that this is the primary approach without appropriate training and triaging of patients, this will lead to multiple safety issues that can compromise the outcomes. 

Here I am going to play the devil’s advocate a little bit and open the discussion a little more, which is knowing that now most of the surgeries are done laparoscopically or robotically, or minimally invasive, let’s say, what could vNotes add to this safe laparoscopic surgery, especially now that we’re moving to less ports, more micro-ports, to minimize the injury or the trauma to the abdominal wall cavity?

: From my perspective, and this is obviously my biased perspective, I like to see what I am doing. I remember in residency when I graduated, I did my residency with Dr. Zurawin, actually, and we did a lot of vaginal hysterectomies at that time. I think I graduated probably with 50 or 60 of them and I felt very comfortable. 

When I got out I felt very strongly that I should be able to do all of these things and offer all of these modalities to my patients but then gradually just realized that there wasn’t any point because, if you think about the patient outcomes, whether you do it laparoscopically or vaginally, the patient outcomes are very similar but you can tackle anything laparoscopically, as opposed to vaginally, you kind of have to select patients a little bit more so I gradually moved to 100 percent laparoscopic. 

Especially if you’re dealing with more challenging pathology, I think you need to be able to see. I think that adds so much to what you are dealing with. You can deal with endometriosis, complicated cysts, adhesions, much better than vaginally. vNotes has been interesting technology because it does combine the vaginal surgery and being able to see. I think that is probably the key to allow more people to use that access port.

: Those points come together this way; first of all, full disclosure, Dr. Einarsson doesn’t do robotic surgery because he can do anything laparoscopically. He doesn’t need anything else because he has a brilliant understanding of anatomy and decades of experience with thousands upon thousands of cases. 

But for the purposes of this article, we are talking about the majority of gynecologists who don’t have those skills. Residents who finish now only have to do 15 vaginal hysterectomies to graduate, and they have a hard time scraping together even that number. They graduate without the skill or the confidence to perform vaginal surgery once they enter practice. 

The difficulty there really comes back to knowledge of anatomy. In terms of visualization, Dr. Moawad brings up a great point about obliterated cul-de-sac. Many people recommend a diagnostic laparotomy before a lot of this is done to know what you’re getting into before you get into it. Now here is the controversy: if you’re doing a vaginal surgery, why are you popping a laparoscope in there? But let’s talk about that. In 1991, Stovall and Ling1 published their very excellent paper on 91 patients who were scheduled for vaginal hysterectomy. 

Only a few of them were thought to be candidates, but when they popped in the umbilical scope, fully 90% of them were able to be done vaginally because the surgeons had the confidence of knowing the anatomy. That is really the elephant in the room here. 

Unless people are properly trained, it doesn’t matter what modality you use, you are not going to be unable to do it. Unlike the other unfortunate circumstances we had with vaginal mesh, and all these other procedures where doctors were trained in weekend warrior sessions where they would claim to teach you how to do it, this is not something that you can just grab onto. 

Another thing is the definition of a high-volume surgeon that is in the literature. A high-volume surgeon is what, 10, 12, major cases a year? You know, one a month? I mean I wouldn’t get on an airplane with a pilot that only flew once a month. I think what we are talking about is funneling these modalities into competent hands and yet facilitating the rest of the gynecologists who want to improve their vaginal surgery skills. I think vNotes is great; I think robotics is great; and I think laparoscopic surgery is great, but it needs to go into the right hands and that is the key. 

Now the next thing about that is the expenses, the cost versus the benefit, and again, I am not nearly as conversant in that as Dr. Moawad is, so maybe he can help us out with that.

: I’m going to talk about a very important aspect of robotic surgery, how it could help spread the robotic vNotes. And then when we look and learn from the experience about what robotic surgery did to open surgery, or laparotomy. 

When we talk about hysterectomy, robotic surgery was able to shift most of the laparotomy into minimally invasive where a laparoscopy was steady and this was shown clearly in a lot of the graphs that we have in one of our studies, which was published in 

 about the movement to outpatient hysterectomy in benign indications (in the United States, 2008-2014).

We can see that laparoscopic surgery rates were mostly stable from 2008 to almost 2016 in terms of percentage. Robotic surgery, where we thought before it could take away from the laparoscopic surgery pool, ended up shifting the more complex procedures done [via] laparotomy to a minimally invasive option. If we extrapolate those graphs, that might be the actual benefit [of] what robotic surgery could do to the vNotes, where it could shift a lot of the laparoscopic, transabdominal, or robotic transabdominal, into a vNote modality but eventually, it is going to take a lot of learning. 

Now in terms of cost, again, as most of the costs in the U.S., where we are talking the direct costs, comes from two things: The direct cost comes from the operative time length; and redundancy of using multiple instruments that have the same function. The third factor, which we never talk about, is the cost of complications, re-admissions, conversions, re-operations. This is what drives the major costs in the U.S. for surgery. 

It might not be true for other countries but this is the main cost factor here. The more efficient surgeon using the appropriate tools with the right training is what will help drive the costs down. 

We need to consider as well the opportunity costs, which is whatever the hospital can do with those resources that were not used if the patient was not admitted to the hospital; rather, what if the patient was discharged the same day with a minimally invasive surgery option? This is the total cost that we need to look at mainly.

Next, Dr. Zurawin elaborates on Dr. Moawad’s points about complications.

: This brings us to my concern about anatomy and patient volume. The issue that needs to be addressed, with any new technology, from endometrial ablation to hysteroscopic sterilization, mesh - anything that we were doing -it’s not the device itself, it’s the surgeon. In terms of post-operative complications with robotics, I think all three of us see medical-legal cases that are related to robotic surgery and most of them that I see are thermal injury. 

They mostly involve burning the bladder, a burning of the bowel, or of the ureter. I think that visualization is important, of course, but unless we properly train our surgeons, unless we change our training programs, we’re really going to see an acceleration of this problem. 

That is why, when we adopt these technologies, we need to put them in the hands of the people who can do it. In terms of Dr. Moawad’s point about robotic vNotes, I think that is an excellent future for the specialty. It takes all the advantages of the vaginal approach, all of the technical and engineering aspects of robotics, as well as cost and recovery. 

Again, I just feel strongly, at least in the beginning, these technologies have to be directed or restricted to people who really, really know what they are doing. 

One of my other fellows introduced vNotes and robotic vNotes into China where it has really caught on very big but it is a different market there and it’s a different group of surgeons. Gynecologists in China do thousands of cases, many thousands of cases. We don’t have that here in the USA.

: If you think about what is most important, obviously that is patient outcomes, and what is the most important thing there, I agree with you, that it probably is the surgeon’s volume. It’s not which robot they’re using or whether they are doing laparoscopic or vaginal surgery. Of course, that should be the main focus. 

My view on that is actually a little bit more optimistic because I think that more and more cases, especially in urban areas, are going to high-volume providers. We’ve been graduating now a few hundred fellows in laparoscopic surgery or minimally invasive gynecologic surgery, and they’re gradually building their practices and taking more cases. 

If you’re an ob/gyn specialist and coming out of school, then your surgical volume is so low and it’s very hard for you to get up to speed on that. It is almost untenable in larger urban areas because high-volume surgeons are doing much more cases, and I think that translates to better outcomes for patients, which obviously is what we want. I think that is happening, at least in urban areas. In smaller communities, it is not as clear cut.

The debate still is ongoing in the specialty that robotics surgery is less expensive, and there are those who will say it is more expensive. What is the surgeons’ take? As Dr. Zurawin asks, “What is the real news about costs of robotic surgery, if you consider all factors, with costs and morbidity, costs to the hospital and to the insurance system?”

: This is always going to be a question of which comes first – the chicken or the egg? Because it’s the same debate and let me tell you why. All the published studies in the literature have a major bias, which is that we don’t compare apples to apples and oranges to oranges. 

The whole issue arises because we don’t have a complexity score for hysterectomy. What we use as a proxy for complexity is the weight of the uterus, which we all know is nonsense. 

Three esteemed surgeons discuss technology, weighing the pros and cons of existing and newly developed platforms.

Vol 65 No 11

Advancing technology in diabetes management

Vaginal Dilators: A guide for health care professionals

The state of gynecologic robotic surgery

How much is my idea worth?

Innovating for improved patient outcomes

Cesarean delivery leads to unexpected outcome

Vasomotor symptom severity not linked to any clinical event in menopause

Desquamative inflammatory vaginitis

Abdominal entry in laparoscopic surgery

Why shared decision-making matters more than ever