MIGS surgeons discuss novel vNOTES technology

Einarsson,Jon;

vNOTES is a minimally invasive alternative for performing procedures—such as hysterectomies, cystectomies, and oophorectomies—in which the vagina is used as the surgical access route, providing access to the uterus, fallopian tubes, and ovaries.

Brandi Hardin, MD, is affiliated with Spartanburg Medical Center in Spartanburg, South Carolina, and is on the medical executive committee of the Ambulatory Surgery Center of Spartanburg.

Grover May, MD, managing partner of a large obstetrician-gynecologist (ob-gyn) private practice in Johnson City, Tennessee, was an early adopter of single-incision laparoscopic surgery and has provided contemporary mixed techniques to his patients for over 20 years.

Thomas Pitman, MD, is board certified in obstetrics, gynecology, female pelvic medicine, and reconstructive surgery, and practices in Southaven, Mississippi.

The panel discussion was moderated by Jon I. Einarsson, MD, PhD, MPH, deputy medical editor of Contemporary OB/GYN®; director of the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women’s Hospital; and professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School, both in Boston, Massachusetts.

This transcript has been edited for clarity and meaning.

EINARSSON: I think a lot of ob-gyns are interested in knowing more about vNOTES. Which patients are good candidates for this approach?

MAY: When I first started, I looked for candidates who were very similar to a vaginal hysterectomy patient because I felt like I had relatively abandoned the technique of vaginal hysterectomy in favor of my laparoscopic instruments, and like Dr Pitman, I do a lot of single-site cases. I felt like I was already offering a very minimally invasive technique. But that said, I found that doing vaginal surgery is even more minimally invasive than my single-incision cases were. When I looked for candidates, I looked for ones who had prolapse, who had small uteri, who were multiparous, who had had no prior cesarean deliveries, things of that nature. But what I found as time went on is that a lot of that was unnecessary. And the real rate-limiting step for me is [that I] cannot perform a safe colpotomy and obtain access. And beyond that point, it becomes quite a bit easier to perform the procedure, and it is not at all like a vaginal hysterectomy once you place the laparoscopic port and begin to operate laparoscopically.

PITMAN: I agree. The idea of waiting until you have the ideal patient, when you adopt this procedure, is a mistake. You just need to evaluate each patient individually. If they’ve got an accessible vaginal apex, where you can do that colpotomy, proceed. This technique is adaptable and very exciting.

HARDIN: I would say that from my standpoint, everybody wants to pick the easiest and best cases first. But if you don’t start doing them, the volume of doing them is more important than the type of case you’re doing. So very quickly, I was at the point where I was like, “I’m going to consider everybody for vNOTES, and then I’m going to exclude people based on certain criteria.” But I think that vaginal surgery begets vaginal surgery. The more vaginal surgery you do, the more comfortable you get with it.

Dr Hardin, maybe you can answer this first. What are your contraindications? You wouldn’t do this on every case, would you?

HARDIN: I basically switched from complete laparoscopic assisted vaginal hysterectomy to vNOTES. Several of my partners are robotic surgeons, but since I adopted this, I have sent

1 patient to them for robotic surgery. And it had to do with a possible borderline cancer that I did not want to rupture through the vagina that was a large mass. Otherwise, I have attempted every other hysterectomy since March, when I began this, through vNOTES.

PITMAN: We need to counsel our patients that we want to proceed in the least invasive way possible. You don’t lock yourself into “This is where we’re going to do it.” I explained to them, “I’m going to evaluate you under anesthesia, and plan A is the vNOTES. I think that’s the best way to proceed.” I did my training in April. And I’ve done 90% of my hysterectomies now [with] vNOTES since then.

MAY: I agree with that in general. But when I counsel patients, if I know that I need the manual dexterity and 3D visualization of the robot for deep endometriosis in the anterior compartment or in the pelvic neuroanatomy, and if I’m going to be working in those spaces doing neuro resections, I probably wouldn’t start with the vNOTES approach. I would either do those robotically or refer them to someone who has a high volume of that type of procedure. But those are infrequent for my practice. My real thing is, I guess if I can make the colpotomy again, I’d like to keep it as simple as I can. I’ve also noticed that sometimes prolapse can make it difficult because it’s already out of the body, and so you have to kind of work around that. But surgeons who do that a lot have found that it simplifies prolapse. But for me, it’s: Is the anterior and/or posterior cul-de-sac completely fused or obliterated? If I can get in on either one, I can proceed with better visualization.

EINARSSON: What about other surgeries? Are you doing myomectomies, ovarian cystectomies, or other procedures through this approach?

PITMAN: I’ve done adnexal surgeries, [fallopian] tubes, and ovaries. I have not done the myomectomies yet. Again, just an early adopter. I’ve done 30 vaginal hysterectomies, and of course, also uterosacral [ligament] suspensions. That’s big for me because you can see the ureter so well and you know that your stitch placement is well away from the ureter and you can pull on the suture to make sure that the ureter doesn’t kink. To have that kind of reassurance is moving me away from the sacrospinous [ligament] suspension. So, I’m really pleased with the uterosacral suspension.

EINARSSON: Do you have any tips on how to get the colpotomy initial entry done?

HARDIN: The first thing is patient position. These patients don’t have to be as far down off the exam table or the operating table as in a traditional TVH [total vaginal hysterectomy] just because of the retractors you’re using. I think that helps them postoperatively as well. But make sure that they’re centered on the table, that their bottom is kind of at the very end of the table. I always start with a little bit of Trendelenburg [position]. I’m injecting more circumferentially around the cervix than I used to for my standard LAVHs [laparoscopically assisted vaginal hysterectomies]. I also went from a straight direct entry technique colpotomy to circumscribing and really taking kind of a wet, slightly moist, open Raytec gauze and advancing all the way around, and that helps you find posteriorly with an allis clamp where you really can kind of tug on it and see that it tents off the cervix. That makes it a little easier to make the posterior colpotomy. Making a big colpotomy is a really important step because the narrower your colpotomy is, the harder it is to get your ring placement in there, and then you’ll have the ring pop out.

MAY: In the past few years, since we came back and started teaching this, I found that there’s a kind of a bifurcation of what that rate-limiting step is. The most challenging step that you mentioned for many surgeons I think is the anterior colpotomy. I think our residency training programs are struggling to get vaginal hysterectomy numbers up, and the residents who are trained in the more recent years have had difficulty with getting adequate volume to feel very confident with colpotomy. Likewise, throughout the nation, there are numbers of surgeons who have relatively abandoned the vaginal route as their primary route. Despite the evidence that ACOG [American College of Obstetricians and Gynecologists] continues to champion that, vaginal surgery should be our first route and laparoscopy would be an acceptable alternative if it’s not feasible. I think the first step is if you’re comfortable with anterior colpotomy, the next most challenging thing is placing the access devices. These rings that we typically use, these V-path type rings that go in and roll down to allow us to develop a pneumoperitoneum, can be difficult to place if you haven’t been trained. To overcome that, I would say attend a training course like those that are sponsored by the iNOTESs through Jan Baekelandt, MD, and Applied Medical. They teach these techniques of how to place a ring, as well as introducer courses that have made it a lot easier for surgeons to overcome this challenging step.

EINARSSON: How do you bill for this? What’s the right billing rate code for this type of surgery?

MAY: We’re currently billing under the LAVH codes. And of course, there’s the less than and greater than 250 g. Same thing for the 58661 for salpingectomy. It’s still a laparoscopic case. If I move my ports to the left upper quadrant, that doesn’t alter whether I’m doing a laparoscopic hysterectomy or not. And likewise, it’s been our position that a LAVH is the same as VALH, a vaginally assisted laparoscopic hysterectomy. The only other option within the coding manual that I can find would be using a specials code.

HARDIN: I was approached by one of the reps from Applied Medical who said, “Would you be interested in learning this new technique?” Then I went to a class this January and was really impressed with it. I thought my LAVH patients would do really well. But what if I could do it without any incisions and without all the rigamarole in the operating room [OR] where you start vaginally, go abdominally, come back vaginally, go back abdominally. It feels more efficient in the OR to start vaginally, stay vaginally. The number of instruments you need is probably one-third or less of the number of instruments that they would pull for an LAVH. From my standpoint, I want a new pack developed just for my vNOTES. I liked that it was just exactly what we needed—minimizing the waste. We use less suture, and after you do a few of them, you see how well the patients do and that makes you an adopter quickly.

PITMAN: Most definitely. They [Applied Medical] reached out to me because I had such a high volume of the single-site TLHs [total laparoscopic hysterectomies]. We get our training, and you think, “I’m doing the least invasive thing that I can do, either vaginal, or LAVH, or TLH.” This is the first time I’ve been excited since I finished my residency about something. Because the patients just do so well. They come in and they’re so happy, so thankful for the ability to get back to work in a week and resume normal activity so quickly. The transition from the single-site laparoscopy to this vNOTES has been pretty smooth. I’m excited.

MAY: I’ve always been interested in offering my patients the least invasive route. And interestingly, I’ve had a passion for teaching doctors in private practice. I like the interactions with other colleagues who have excellent ideas and can share those back with me. Somebody, I think it was Lee Cohen at Applied Medical, had said, “Do you know Dr Baekelandt? I think he’s friends with you as fellow MIGS director. But he’s over in Belgium.” So I come to hear about him through my teaching experiences. And shortly after that, I had the opportunity to speak to the Southern OB/GYN Society about [approaching] hysterectomy and morbidly obese [patients].” I took the unpopular but realistic perspective that you should do it in the manner that you’re best trained to handle. So for some, it’s laparoscopic; for some, it’s open; and for some, it’s vaginal. People who supported the data reminded me that vaginal is the answer if you look at studies. I got convinced of the need to reengage vaginal surgery and started visiting with Dr Baekelandt in Belgium and learned the technique, and the aha moment for me was when he placed the ring in and showed me that you don’t have to do an anterior colpotomy. You can develop a pneumoperitoneum and do that laparoscopically even. I realized then that I could overcome the colpotomy fear that I had. Those first few patients came back, and the testimonials they gave kept me going after I tried this new technique. But it was the 33rd patient whom I’ll never forget, who changed my life. She was 685 lb, and 5 ft 2 in. And she had a large abdominal mesh, a prior colostomy, and an operative report on her chart that said, “Do not go back in this pelvis, essentially, or you will be in her bowels again.” And I remembered I had said, “The evidence says you should try this vaginally.” I didn’t believe I could do her case vaginally from her other challenges. But we were able to do that with the vNOTES approach vaginally. This patient convinced me that we need to really explore this.

EINARSSON: What do the data look like in terms of comparing vNOTES with vaginal hysterectomy, like pure vaginal hysterectomy, and/or robotic or laparoscopic hysterectomy?

MAY: While currently there’s good evidence for hysterectomy, there’s level 1b and adnexectomy with the classic HALON trial and the NOTABLE trial, which was looking at adnexectomy.1,2 Evidence exists to tell us that [vNotes] is at least as efficacious as, if not better than in some ways, standard laparoscopic hysterectomy. To my knowledge, there’s not a direct head-to-head vs vaginal hysterectomy. And I think those are data that those of us who are engaged in this field want to see developed. That is a need for those of us who are performing it to continue to do that. But the data are coming out more and more, especially in some other countries where they’ve engaged it quicker, in Europe and in China, places like that.

PITMAN: I agree. I’m excited to see a head-to-head. Anecdotally, when you think about the techniques with vaginal hysterectomy, traction is downward constantly. With vNOTES, the movement is out of the pelvis—you’re actually pushing the specimen up and medially constantly during the procedure, so you’re not really pulling down on those ligaments. I hypothesize that the pain is going to be much less than a typical vaginal hysterectomy for a large uterus.

HARDIN: I think there is a lot to be said about how much tissue manipulation there is involved in traditional vaginal surgery, just clamp-cut-tie surgery vs this. The traction you put on it is minimal. And then you’re not strangulating vascular pedicles like you do when you tie things off with a suture. I think it’s probably going to be less scarring to people because it’s probably less inflammatory just like traditional laparoscopy taking out ectopics vs leaving vicryl or chromic in there and how inflammatory that can be. But as a woman who has had 2 babies, and I’ve had a cesarean delivery and I’ve had a vaginal delivery, the ligaments are an issue for sure.

MAY: Also, I will say there are some meta-analyses that have been published. There was one in December 2020 in the Journal of Clinical Medicine.³ But that was a systematic review and meta-analysis comparing hysterectomy by vNOTES vs laparoscopic hysterectomy for benign indications. It showed that there was equal efficacy for operation, operating time, hospitalization, and estimated blood loss with no differences in complication rates, readmission rates, or pain scores at 24 hours. Those types of data exist to say that at least it’s as good as TLH. And I don’t think that we’re at the point where we have the head-to-head comparison to vaginal, but what I would say is we’re not doing just vaginal nowadays.

EINARSSON: I think Dr. Hardin alluded to this, but you can see everything. And not just you but everybody in the OR can see what you’re doing. Which I think is one of the reasons vaginal surgery or vaginal hysterectomy hasn’t taken off as much. Because when we’re doing laparoscopic cases, everybody [in the] OR can see, you can teach hundreds of people what you’re doing there.

HARDIN: That’s correct. And I can do it with 1 less assistant as well. So that’s another level of efficiency when [there is] 1 less person in the OR.

PITMAN: The camera doesn’t have to be trained as much either because with laparoscopic surgery you’re the person who’s running that camera. It can be a really great limiting factor. When you’re working in such a small space with a 10-degree, 30-degree scope, it’s pretty much minimal manipulation of the camera for the whole case.

MAY: And cost is one of those things that I think we’re starting to look at nationwide about what’s the ethical nature of how much we spend on a patient. When I started treating these patients, OR staff members told me, “We don’t need that many instruments.” And so, they quickly made a new tray and their turnover time reduced. Anybody could set this case up. It didn’t require a special knowledge of equipment. It really didn’t require a lot of time for sterilization. Where I could previously perform 3 major cases in a day, 3 to 4, I can easily do 5 to 6 now. And the actual cost of instrumentation was lower because 90% of it, or more, is reusable, and that’s huge.

EINARSSON: Is there any advice for the reader to make the transition to vNOTES easier?

HARDIN: One thing I would say is that most people who are learning these procedures, at the courses that I’ve gone to help teach, are people who have not just gotten out of residency in the last year or 2. So remembering why you’re doing it: It’s always uncomfortable to learn something new. You’re going to have frustrations—anytime you use a new instrument in the OR, anytime you have a new scrub tech in the OR, there are frustrations. You may say, “That was too frustrating. I had to put the ring in 4 different times.” But every time it gets a little bit better, a little bit better. And I think that’s my thing, kind of where your mind-set is when you start.

MAY: I would say to understand the surgical geometry. When Harry Reich[,MD,] first showed us that we could use a laparoscope and some instruments that we were doing tubals with to take out a uterus, it was a watershed moment in our careers that generated many other techniques and tricks. We’ve always been vaginal surgeons. It’s what makes us different from general surgeons. Attend a course where you can network with other surgeons; develop relationships and proctorships until you feel confident. Lean on those people who’ve walked down that path before to work with you and hold your hand getting started. Understand that you’re going from the least invasive route to a more invasive route. There’s no harm in starting vaginally converting to laparoscopy any more than there was starting a laparoscopic case and converting it to an LAVH. It’s just reversing the order of events. I believe that those tips would help anyone who’s starting out become more successful.