From ACOG - Philadelphia, Pennsylvania - May, 1999
Dr. Jeff Levy: "I'm Jeff Levy, and I'm the Director of Medical Education for IMET which is Innovations in Medical Education and Training. We run several conferences and educational programs. Tim McKinny, who is sitting on my right, has been involved in many of those programs and is at the University of Medicine and Dentistry in New Jersey, and he has an expertise in urogynecology. He's had tremendous experience with multiple types of procedures in one of the world's largest experiences in laparoscopic Burch procedures - and especially using mesh, but is now started working with a new procedure called the "TVT." I'd like Tim to talk about that procedure a little bit, and tell us why he uses it."
Dr. Tim McKinny: "Thanks a lot, Jeff. It's kind of an exciting, innovative procedure that has not been new to the world but it's new to this country. It's been used since about 1984 in Europe, and particularly over the last three to four years heavily. There's been over 14,000 of these procedures done over in Europe, which has been followed very carefully and studied very carefully by Dr. Ulmstun. The results is three-year data which has been very scrutinized as 86% total cure, with another 11% tremendously improved - for about a 97% success rate which rivals most procedures. The beauty of this is that it is a procedure that can be done under a local anesthesia in a rather rapid sequence with these kind of results. It is done so that the patients themselves can participate in the surgery and actually give us the input for when we have completed the procedure and gotten them dry. So during the procedure, once we get the tape in the right position, we're able to have the patient cough, sneeze, and do their normal provocative maneuvers. When they end up losing the urine, we tighten up the tape until we stop seeing them leak from the urine - at that point, we end the procedure. In that way we can actually customize the procedure to the patient, not customize the patient to what we're doing, which is a tremendous improvement. The other design difference is most of the procedures for incontinence have all been designed around supportive measures with the urethra-vesico junction. This is a supportive procedure for the mid-urethra, which physiologically is where most of the urethral closure pressure occurs in a normal patient. In fact, post-operatively, if we look at this, we're not changing the physiology at all of the urethra at rest, we actually augment the urethra and the maximal urethral closure pressure during stress situations, so pressure transmission tests will show a tremendous uplifting of the pressure, and therefore, causes us to have the incontinence procedure done."
Dr. Jeff Levy: "Tim, you have the device here. Can you explain to us what it is and how you use it?"
Dr. Tim McKinny: "The device involves a disposable portion which involves two trocars that are connected by way of the actual tension free tape, which consists of Prolene mesh, as well as a covering over it of a plastic sheathing that is perforated or separated in the middle, and it kind of overlies itself. The reason why you need to have this plastic sheathing is so that it can slide through the tissue easily. Once you've exposed the mesh, it's almost like Velcro, it sticks to everything. That's why when you end up finishing the procedure - after you get the sling in the right place and the right tension - you release the cellophane off the outside of it. Now you've got the sling underneath it, and you don't have to sew it in place because it sticks that well. The other device to introduce it - attaches onto the tail end and gives you a handle to be able to give you some fulcrum and elevation ability, and allows you some distance away from your trocars to slide it right underneath the pubic bone and out."
Dr. Jeff Levy: "The sling procedures are generally done by urogynecologists, do you feel that general gynecologists can do this procedure?"
Dr. Tim McKinny: "I think that people with proper training and proper abilities to understand the complexities of incontinence, and who have an interest in incontinent patients and not just trying to do the procedure, can absolutely do this. It doesn't take a tremendous training aspect to be able to do this. You need to be able to assure that you don't do any harm to the patient so you have to have cystoscopy privileges to be able to make sure that this has not done any harm. You also need to do appropriate work-ups for the patient so you don't miss any underlying disease states because incontinence is a symptom for underlying reasons that include things such as cancer, neurological reasons - multiple sclerosis, so we don't want to miss those little early key off to other diseases. As long as we don't miss those, I think anybody can take care of this."
Dr. Jeff Levy: "Now do you have any pearls or suggestions of how you would select patients for this procedure?"
Dr. Tim McKinny: "Originally, I started off with utilizing this procedure on the worst of my worst population, by that I mean the worst candidates for surgery. I had a 350-pound lady with a two pack per day smoke history, couldn't even lay flat, that I ended up doing a procedure on times eight, eight other surgical procedures ! She had been wet since 1985, and I performed this procedure on her. My selection process at first was intrinsic sphincter deficiency, the classic sling usage. Over in Europe, they use this as a primary procedure for incontinence. Indeed, it's probably because of the low mobility to it; it is probably a good choice for a primary procedure especially with the data that's coming in. Although not long, long term data, it's getting to be rather compulsive as far as the actual findings and with the minimum invasion to it, with the shortness of time involved in the O.R. which everybody is concerned over - cost containment and O.R. time equals money. The average time for our study in the United States, which is a virgin study over the last six months, we looked into the first ninety-five patients, and we found that even our time in the initial findings were less than thirty minutes - anything from sixteen to about forty some odd minutes for the procedure. So it's very exciting, and I wish I'd have come up with the design."
Dr. Jeff Levy: "We're going to have several courses at IMET that are going to be featuring some of the issues around TVT. Tim will be involved in those courses so we look forward to some of the developments, and we look forward to some of the long term data in the United States."
Dr. Tim McKinny: "Thank you."