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AUGS Webinar (Industry Edition): Medtronic InterSt ...
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МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА МУЗЫКАЛЬНАЯ ЗАСТАВКА Dr. Fishburne is a board-certified urogynecologist specializing in female pelvic medicine and reconstructive surgery. Dr. Fishburne currently practices in Charleston, South Carolina area. Dr. Fishburne, thank you so much for joining us today. I will hand it over to you to introduce yourself a little bit more, and let's get started. Thank you so much, Jacqueline. Thank you for the kind introduction. And I really appreciate all of you all who are joining this meeting, and I hope that we can present a good overview of sacral neuromodulation in a way that's engaging and informative and helps you understand where we are with this technology now and where the innovations have been and where we're headed. I want to also thank AUGS, which has had such a profound role in my career development and pathway during my journey, and I'm sure it means all of the same to all of you all here. I'd also like to thank Medtronic, our corporate sponsor for tonight's meeting. They have been an important sponsor, an important partner of us clinicians over the last 25 years in sacral neuromodulations. Just in a general disclosure, I am a consultant on the faculty for Medtronic. I do understand that many of you all tonight may be fellows in FBMRS, and I just want to convey my excitement to you all on the journey that you all are upon. This is a tremendously rewarding and exciting field where we really improve day-to-day the quality of life of our patients, and that has given me great joy, and I'm excited for those of you all who are in the fellowship role. Those of you all who are practicing clinicians, I'm sure you understand what I'm saying when we talk about the joy of improving patient lives. My own journey in sacral neuromodulation started about seven years ago, and I have found this to be a large part of my practice in improving patient lives across a variety of clinical conditions, and I really could not imagine managing for the wide variety of patient clinical conditions that I do without having sacral neuromodulation in my toolbox, and so we'll touch upon that tonight. I started my practice here in the Charleston area about four years ago, and truthfully, being able to offer this clinical option for our patients here in the community has done a lot to help me grow and expand the practice and meet the needs of our community and our patients. So next slide. So I first want to talk about just some of the history and the legacy of sacral neuromodulation, and as I stated, Medtronic has been a partner of us as clinicians over the last 25 years during the many innovations over the last 25 years to improve upon this clinical offering. They've been doing this for 25 years, 350,000 patients treated across 60 countries with 72 FDA approvals and over 90 sacral neuromodulation clinical studies. Next slide. This slide here, I made it kind of an impact in my educational journey. I'm frequently asked by patients if this is something new, if sacral neuromodulation is a new treatment available, and it's helpful for me to go over the timeline here, both for me to understand but also to explain to patients that this is a treatment option that has been in evolution for many, many years. And you can see some of the highlights here. In 1997, InterStim received its first FDA approval for urgency urinary incontinence. That was followed soon after in 1999 with FDA approval for indications of non-obstructive urinary retention and urinary urgency and frequency. And then more recently in 2011 with FDA approval. Excuse me. That would be the telemarketer offering us a great car warranty. Sorry about that. FDA approval in 2011 for chronic fecal incontinence. And then you can see these landmarks of innovation along the way since, including more recently the expanded InterStim MRI labeling that we'll talk about a little bit in 2021. Our agenda tonight, we're going to talk about the prevalence of overactive bladder and fecal incontinence. We're going to talk about the treatment options and society guidelines. We're going to give a good overview of the InterStim system, talking about indications and contraindications and touch on the mechanism of action. We'll review five year clinical data across all of the various indications. We'll take time to go over the basic and advanced evaluations, the testing prior to implant and the differences between. And we will talk about the rechargeable and recharge free device choices. We will also talk about the updated MRI labeling. And we will also talk about a very important concept to consider in caring for our patients, which is the post implant management. And we'll touch upon that later in the talk. At the end, we'll have time for questions and answers. And I certainly invite any questions that you all may have. This slide talks about a three part framework for success, and I think it just helps keep in mind the concepts that we have to think about as we're engaging with our patients. The first the first concept is patient selection, choosing appropriate patient clinical indications, assessing whether our patient may be appropriate for this therapy. Clearly, when we're in the operating room, we all spend a lot of time thinking about technique and trying to perfect our technique. Lead placement is critical to achieve good optimal outcomes here. We'll talk about tips and tricks with that and the importance of trying to get the best lead placement you can get on the front end for the benefit of your patients. And then also we'll talk about the patient management, as I touched upon after the implant. A friend of mine has pointed out very well that once the implant is in, we don't stop being our patient's clinician. So understanding if things are falling off in outcomes, understanding the other patient variables that can be playing a role in helping to be a clinician to guide your patients through that is very important. So maximizing all three of these areas is the best way to achieve clinical success for your patients. And issues with any one of these areas may decrease the long term efficacy and success and ultimately your patient satisfaction. So we'll talk briefly about the prevalence of these conditions. I think this slide is fairly powerful. In my mind, it shows really, truly how prevalent this these disease states are relative to other disease states in our country. You can see at the top bar, overactive bladder is present and has a prevalence of 37.5 million in the U.S. Fecal incontinence or accidental bowel leakage, a prevalence of 20 million in the U.S. And it compares with other common clinical conditions in the U.S., such as diabetes, asthma, Alzheimer's. You can really see how prevalent these conditions are. I think that that just highlights that there are a lot of patients to care for out there. And one thing to be aware of is the physician quality reporting system parameters or guidelines of it. It is a quality measure now for primary care doctors to ask about urinary incontinence in patients 65 and older and to actually establish a plan for this. And this certainly will increase the catchment of patients who are needing care and give us a role to care for these patients in our in our communities. So I think understanding how prevalent it is understands what a great need, good treatment options for these patients will play. This slide highlights something that I think is important for us all to remember as clinicians in FPMRS, we are somewhat unique in that we are really focusing both on urologic conditions and bowel conditions. And so oftentimes we may be the one seeing the overlap between these two conditions the most. Again, 37.5 million prevalence of overactive bladder in the U.S., one out of six Americans. Accidental bowel leakage, fecal incontinence, one out of 12 Americans. This slide says 20 million prevalence. That circle in the middle is important to pay attention to because a significant number of our patients will have both. And oftentimes my patients are very interested in a common treatment option that covers covers across both of these needs at the same time when they're affected by both conditions. So 11.5 million patients estimated prevalence with both fecal incontinence and overactive bladder in the U.S. We're going to focus a little bit on treatment guidelines and society guidelines. This kind of demonstrates an initial thought process with a care pathway, and you'll see an example of care pathways in the next slide as well. But understanding certainly that our care of our patients begins with thorough evaluation. And obviously those on the call understand that probably the greatest tool we can have when we're evaluating a patient's conditions is to listen deeply and empathetically so that we can really understand where our patients are coming from, understand their goals, understand their condition, really listen to the nuances so we can sort out really what their underlying issues are, marry that with an exam so that we can be able to understand, do various other testing options, but really it begins with the evaluation. Behavioral therapy options obviously include bladder and bowel control strategies. We're very familiar with trying to help our patients understand how to functionally improve their quality of life. Dietary management is always something that we want to dive into and understand what inciting factors may be underlying. Using our physical therapy colleagues can be very helpful in managing these conditions and utilizing biofeedback. And once we've exhausted that behavioral therapy approach, consideration of appropriate medications, and we all are familiar on the call with the data that about 70% of our patients will no longer be on overactive bladder medications within six months of that initial prescription, and 80% will not be on it at the end of the year. And we've all been familiar with the story of the patient who keeps trying medications over and over and over again, and eventually gives up and lives with her problem. Understanding the overactive bladder advanced therapies is very key, I think, to managing such a great number of our patients to achieve their overall outcomes. And these advanced therapy options, as we're all familiar with, include sacral neuromodulation, percutaneous tibial neuromodulation, or nerve stimulation, and Botox. When we look at the guidelines from the American Society of Colorectal Surgeons, it matches the guidelines from the American College of Gastroenterologists, where there is a strong recommendation based on moderate evidence for utilization of sacral neuromodulation. Those societies are consistent in that recommendation. They also focus, of course, on these preliminary steps with basic treatment options, and really wait before people have failed standard medical therapy before proceeding to these advanced options. But these are all in their guidelines as well. These are the two examples of care pathway examples that I hinted about at our last slide. These are actually made by Medtronic. I happen to use the bladder care pathway because I find it very helpful. But these are just guidelines to consider and perhaps make your own care pathway in your own practice. But I think it's very helpful to consider these treatment steps as a care pathway, both for yourself, but also for your patient. I have found actually handing out care pathways to my patients in the office to be extremely helpful, helpful to remind the patient of the journey that they're upon, to give them hope that there will be another step if the initial standard medical therapy approach does not meet her needs. We are familiar with the data that about 80% of what we communicate to a patient during the office visit is likely forgotten by the time she gets home. And so I think having a tangible care pathway in our patient's hands can be very helpful to give that patient an overview of where their journey is, and to help them know that there is hope and not to give up if they're not initially satisfied with our initial standard medical therapy options. So we'll touch upon the indications and contraindications for sacro-neuromodulation. On the left is a review of the interstem systems indications, urgency urinary incontinence, urinary urgency and frequency. I'm sure most of us on the call are very familiar with those indications. The last two, I'll talk about the chronic fecal incontinence next. Very important indication and something that you will see in your office on a near daily basis. If I have somebody sent to me by referring provider or refractory overactive bladder or even early non-refractory basic overactive bladder, I always ask about accidental bowel leakage. And as we are all familiar with, patients may or may not bring that to your attention unless you directly ask them about that. So I ask every one of my patients about accidental bowel leakage. It has impacted me over the course of my career how much that condition can be disruptive to a patient's life. I think sometimes people can mask urgency urinary incontinence, but when people have accidental bowel leakage it disrupts their ability to go to restaurants, to engage with their family, to go to church, to live their daily life in a very profound way and people sometimes start becoming reclusive over that condition. I can think of countless patients who have felt the freedom to live their lives again after a successful sacro-neuromodulation intervention. Non-obstructive urinary retention, we should not forget about that indication. I've had the great joy in my probably last two years of watching about six patients truly freed from a chronic indwelling suprapubic catheter with successful neuromodulation and it is profoundly impactful on their lives as you can imagine. I just this week did a stage two implant for somebody who no longer has to self cath and so I think it's important not to forget that indication. When we look at contraindications for this treatment modality, we certainly want to be able to prove efficacy before we put the full implant in and that is where the various testing modality options come into play, but if a patient has not demonstrated an appropriate test stimulation response that would certainly be a contraindication to a full implant. A patient who's unable to operate the neurostimulator would be a contraindication. Diathermy, which is the high frequency energy used by physical therapy to heat deep body tissues, that would also not be appropriate to utilize in the body area in which there is an interest in. We'll touch briefly on mechanism of action. The implanted interstim system electrically stimulates afferent nerves and a sacral spinal root and therefore modulates the nervous interaction between the brain and the bladder and bowel function and it may restore the normal bladder and bowel function in so doing so. A lot of these conditions are a hypersensitivity response from the bowel and the bladder and if we can modulate that afferent signal pathway, we can better modulate the response in many of our patients. So we'll review a little bit of the clinical data. So we'll review a little bit of the clinical data for all three conditions, all three indications. We have long-term results for all indications with the interstim sacral neuromodulation system. The INSIGHT study provided five-year outcomes data for overactive bladder indications and you can see here on this slide that over five years, 82% of patients achieve clinical success, which is defined as greater than or equal to 50% improvement in their underlying condition and at the end of five years, 45% of patients completely continent. When we look at the data on non-obstructive urinary retention over again, five-year outcomes, a full 78% of our patients experienced greater than or equal to 50% reduction in volume per catheterization per day and 65% of patients experienced a greater than or equal to 50% reduction in need for catheterization per day. So we have a full 78% of our patients experience a greater than or equal to 50% reduction in need for catheterization per day. Similar excellent long-term five-year outcome data for the indication of chronic fecal incontinence, 89% of patients achieved over five years or at five years achieved clinical success, and 36% of patients achieved complete continence. I do want to touch base at this time about these slides because I think this is a nice time to talk about the importance of patient expectations going into sacral neuromodulation and I'm sure my patients are like your patients that everybody wants 100% all the time, perfect. And I think sometimes it's very helpful to remember that we're in this to improve quality of life and patient conditions, but we need to have patients understand that it is not a failure if they go from two bowel accidents a day to one a month. It is certainly an improvement. We want to get as close to perfect outcomes as we can. We'll talk about other things we can do to build upon the success of the foundation of sacral neuromodulation, but setting those patient expectations ahead of time, I have found to be very helpful in helping patients to see their gains, see their improvement, and to be satisfied. I have, I'll share one, one vignette where I had a patient come back to me and I asked her how she was doing with her interstem implant. And this was about six weeks at her postoperative visit. And she told me it wasn't working at all. She was very unhappy with it. And I asked her, I find it very helpful at those times to go back to the preexisting data that she provided me in her history of her initial visit. And we covered urinary urgency, urinary incontinence episodes. She went from three or four a day to no incontinence. She went from five to six episodes of nocturia night to one time per night voiding. She took her urgency from five out of five down to two to three out of five. And urinary frequency went from 12 or more times a day down to down to three times a day. And I reviewed all that with her. And then I was puzzled. I asked her what part of it was not successful because she told me it was a real failure. And she said, well, that that's just it, doc. I'm still, I'm still going to the bathroom three times a day. And I realized at that point that I had failed her in expectations because her expectations, frankly, were probably not very healthy for her. But understanding that your patient's expectations may not match your own expectations and helping to have some participation in that journey with that patient along the way, very helpful. And again, also very helpful to go back and compare where the patient currently is with where her symptoms were at baseline. So we'll begin to talk a little bit about the evaluation choices. And again, before we would proceed to implant, we want to prove efficacy. And there are two different evaluation options that you have available. I'll talk briefly about both. And then I'll talk to you a little bit about my own journey in this and my own evolution in my own clinical practice. So basic evaluation or peripheral nerve evaluation has the benefit in that it can be done either in the office under local anesthetic or in an ASC. The test phase lasts up to seven days. You can utilize fluoroscopy if you have it available to you, or you can use simple landmark techniques if you want to perform this simply in the office. There are advanced practice practitioners who are providing this in some practices. I, myself in Charleston, we have kind of a unique model in our region where there are about six gastroenterologists who do their own basic evaluations and refer a patient on to me, either with a successful basic evaluation, in which case it's a very easy decision to move to implant or an unsuccessful evaluation, at which point I will engage deeply in further evaluation and decide upon an appropriate course. But it's nice to have the other physicians in the community engaged in this process as well. When the patient has had a successful basic evaluation, at that point is the appropriate time for her to make a decision between the recharge-free system and the rechargeable system, and that's a distinction from the advanced evaluation we'll talk about next. With advanced evaluation, you are actually putting in, in the operating room or in the ambulatory surgical center, the actual lead that will be utilized if a success has been demonstrated. So you're actually putting in the permanent lead and connecting it to a temporary connection externally paced, but you're actually putting in the permanent lead at day one. It can be done under local with sedation or general. This test is designed to be up to 14 days in length, so you may choose to do this testing if you're looking to treat perhaps a less common condition, somebody who's having accidental bowel leakage maybe twice a week, who may not demonstrate solid efficacy with a basic evaluation, which is only seven days in length. Or sometimes I use this for my non-obstructive urinary retention indications so they can really have time to track the need for catheterization over a longer time. With this evaluation, the true fluoroscopy is used to place the permanent lead. With this evaluation, you need to decide on the front end whether a patient is interested in the recharge-free or the interest in micro-rechargeable system, and that is because the permanent leads are actually different. So once you put in the permanent lead, you're kind of committed down the road of whether it's the interest to recharge-free or the micro-rechargeable system, and that's the distinction between these two as well to keep in mind. A little bit about my own journey, I certainly on the early stages of my journey, I felt much more comfortable being in the operating room, having the benefit of fluoroscopy to help guide my lead placement. What I came to realize though is how much more accessible sacral neuromodulation is to your patients if you offer a basic evaluation either in the office or a simple experience with ASC. Certainly you can use fluoroscopy if you have that available, but you should not feel like you have to have fluoroscopy in order to get good outcomes and good conversion rate. I do basic evaluations and I stack those days in the office. I'll do ideally four at a time. I actually have four tomorrow afternoon, once or twice a month depending on the needs, and we do this in the office with the patient awake, under local, and have a success rate with our basic evaluations that is quite satisfying both for myself and for patients. It's efficient for my practice. It takes away the two-step OR need of the advanced evaluation and then the ultimate implant. It's efficient for your patient. It's a high satisfier for your patient. It's a lot more accessible to come into the office for a simple office test than to commit to two separate anesthesia days in the operating room. So for those of you all who are not using basic evaluation, I would encourage you to reconsider that or to grow in that space. After doing this for six, seven years, I find basic evaluation to be very satisfying in the office and using landmark techniques, very doable in the office with good patient comfort. So when we're thinking about landmark identification, we're going to be doing basic evaluation in the office. Certainly the first thing I do is identify the midline down the spine. I then will literally take a tape measure and I will, with apologies to the patient, I'll explain what I'm doing because she will be prone. I will measure from the tip of the coccyx nine centimeters up the midline of the sacrum. And ideally that is about a bird's eye view level of the S3 sacroforamen. I do palpate for the sciatic notches because that gives a general overview if I'm in the neighborhood because the S3 sacroforamen ought to be about the same plane as the sciatic notches. I then do measure two centimeters lateral for midline and I, and I do actually make marks on the patient's skin with a non-permanent marker while I'm doing this so I can track. The recommendation is to measure two centimeters cephalad in the middle above each, each point two centimeters off midline. I would suggest that you take a look at your patient's habitus. Different BMIs will indicate a different entry point. Remember that you're going to bring the needle in at a 60 degree angle. So somebody with a BMI of 18 is a very different patient than somebody with a BMI of 40. And so actually, can you go back a slide? I hadn't, I was still going to cover that. So I would just, one tip I would say is to try to try to visualize the bird's eye view of where those S3 foramen would be, and then make adjustments based on your patient's habitus because you may be significantly higher than two centimeters or with the patient with very low subcutaneous tissue, you may be right at nine centimeters. So I try to make a judgment with that based on the patient's habitus. When you, so again, when you're considering this, you're deciding where you're going to put your needle point. Local anesthetic, I do a little differently. I, I do do local anesthetic right there, but I do it in a fan pattern, starting about where I think my entry point will be. And I go right up under the skin up a couple of centimeters. And then I fan down to the level of the sacrum itself, because certainly the needle, when it hits the sacrum is an uncomfortable sensation. So I do make sure I get good local anesthetic coverage across the sacrum. So we're going to insert the needle about 60 degrees, uh, aiming for that S3, uh, foramen. Remember that you're going to be aiming to enter the superior medial aspect of that S3 foramen. I actually like to hit bone before I entry, enter into the foramen because that helps me know where I am. It helps me palpate where I am. So I like to hit bone first and you'll feel a step off when you're starting to tap down that bone into the S3 foramen. It almost feels almost like a toilet bowl and you'll feel a step off as you're dropping that needle, uh, to give you good tactile response. As I keep that needle straight up and down, walking down the area, two centimeters lateral midline, where I think my foramen is, I'm looking for that step off and that drop. And if I don't get that, then I'm going to reposition my needle and try again. Once the needle, once you have experienced that step off and you feel like you've entered the S3 foramen, um, doesn't, it doesn't take a deep drop, but then I will start to, um, test stimulate, uh, at that level, looking for the appropriate, uh, sensory threshold, sensory response or motor responses. Now you may, you oftentimes will have sensory responses achieved at a lower threshold before you'll actually see the typical toe and bellows response we look for, but you'll be, you'll be listening for the patient. You'd be actively asking the patient to tell you whether she feels it in the rectum, the perineum, uh, the vagina, the labia off to the side or forward into the bladder. Only being in this, uh, arena for seven years, I've actually seen some, some pretty remarkable changes during the seven years I've been in this arena. Uh, I, uh, certainly got to know very well the predicate legacy lead and, um, I'm, I'm somebody who doesn't always appreciate change. So I was skeptical when the new lead came out and I have learned to really appreciate the new lead and the improvements upon this. The biggest thing that you'll notice those of you all who have used the, the legacy lead in the past is that this is designed to minimize electrode movement during daily activities. And what that really means is you have consistency of stimulation across that week of testing. So when I thought of my not making her up patient who I put the predicate lead, I put the prior leads in and she was doing great. And a day and a half later, she went to her NASCAR racing event. By the end of that weekend, it had dislodged. These will stay in place. This slide is a pretty powerful visual of that. These are both being pulled at the same rates on the right is the predicate legacy lead on the left is the current updated basic evaluation lead. They're both being pulled at the same rates. You can see on the right, this one's being dislodged fairly quickly, and that can happen with normal skin movement during that week with the predicate lead. The one on the left is still preserving the tip, the tip, the electrode tip, despite actively pulling the lead. You can see it slinkies out and sacrifices itself to preserve the electrode tip at the appropriate position. That translates into a more consistent, reliable stimulation during that week of your basic evaluation trial. And I love this video because you can see we're still going. This is a little unsettling when you take out the basic evaluation leads your first time in the office if you're used to the old leads because it does feel like you're slinking these leads out for forever and you'll never get them out. Stay with it, they will come out, but it is different than the old leads and in a better way. Okay, so procedure flow as far as our evaluation, if we're going to be doing the basic evaluation and have a successful implant, we decide in the office that follow-up week, great, you had a success, equal to or greater than 50% response across your parameters, and have the patient decide whether she would like to have the interstem micro rechargeable or the interstem two recharge-free system. And I do give all of my patients the choice, we go through it. Sometimes I help guide patients based on what I think is right for them. And we'll get into that more later, but you do need to decide that at that point before going to the operating room. If you have an inconclusive basic evaluation, so if the patient's not convinced, if she didn't meet the 50% threshold, or maybe she didn't just, she just didn't see enough value, then I do offer all of those patients progression to the advanced evaluation stage one implant. I think it's impressive or important to remember that about that 88% of our patients who have an inconclusive basic evaluation, 88% will have a successful stage one trial if they go on to that advanced evaluation. Remember here that when you go on to stage one, you have to know before stage one, whether your patient's going to want the interstem micro rechargeable or the interstem two recharge-free system, because the leads are different. We're going to talk now about optimal timed lead placement. This is the permanent lead placement. And I want you to, I would encourage all of you all to, to, to focus on optimal placement to achieve optimal outcomes. This is an area where truly a millimeter or two difference can make a big difference in your patient life, both on experience and efficacy and also on battery life for the recharge-free system. You see there a model of the, I'm sorry, let me go back. You see there a model of the sacrum with the nerve roots coming out of the sacral foramen. It's helpful to visualize those nerve roots because it helps me to understand why are we guiding the lead in a lateral inferior direction when we're passing these leads. Think about the nerve roots. We're trying to guide those leads directly over those nerve roots to, to surf the nerve, as we say. We want to enter in the superior medial aspect of the foramen because that's where the nerve lives. And that lower image there, you can see that that's an ideal lead placement. It's nice and medial. You're seeing it have a lateral kick, which would follow the expected natural pathway of the nerve you're looking to stimulate. I love this fluoroscopy view. I can't guarantee that you, that every one of your views in the operating room will look exactly like this, but this is what we would love to achieve. I would like to comment on, it's important to work with your fluoroscopy techs in the operating room to try to get the best images so that you can see these images. We first want to identify the midline. We look for the sacroiliac joints on either side. We identify those sciatic notches. If you look, if you draw a line across the sciatic notches, you can start to see the foramen arcs and that sciatic notch will lead you to that third foramen there that you're looking for in a line across that sciatic notch. We also want to identify the edges of the sacrum there, the medial edges for optimal placement of your needle. I will actually mark on the skin there where those medial edges are so I know where my starting point is, but you can see the foramen arcs there. I was always taught to think about it as fingerprints coming from the side. If you use your imagination, you can think of those little fingerprints and the third one down is S3. This is a lateral view. Once I get my AP view, then when I start passing needles, I go for the lateral view. You're going to look for the hillocks, which are the seams, the bone seams between the vertebral bodies. You can see on the upper right, the sacral promontory, first hillock, which is the end of S1, second hillock S2, and then S3. Those are the sacral bone seams. Again, I find it helpful to look at this iliac shadow and you can see there, that's outlined there. It tends to wrap around and points towards the S3 hillock. It tends to either point towards the S3 hillock or point to the midpoint of the S3 sacral vertebral body, but that helps guide you to the optimal S3 placement. When you're placing this again, when you're placing these leads again, you want to enter into the superior medial aspect of that foramen. You want to exit the foramen on the anterior surface of the sacrum and you want to track it just cephalad of the hillock. I like to be parallel with the bone seam and a little bit cephalad of the bone seam, because that'll put you right in that superior medial aspect. When you're passing the lead under continuous fluoroscopic guidance, you're looking to see that lead follow a medial to lateral path. Ideally, you can see this lead passing here. You can see it taking an inferior uh direction and that that's how it looks when you're following that expected nerve pathway that we saw in the previous diagram. You'd like that lead to literally surf along that nerve root and to track along it. I think it's also helpful, this is a little bit more advanced, but if you look at the separations between the four electrodes, you can see they're a little closer together on the distal electrodes and that lets you know that it's coming towards or away from the x-ray. You don't know which it is from this view, but if you're placing it well, you'd like to see that kick out towards the fluoroscopy so you know you're following that lateral trajectory. Your goal is always to get four out of four electrodes having a stimulation at less than less than two, less than or equal to two, and that's your goal. We don't always get that goal, but that's your goal. That's where you'll have the best options for future programming. We're looking for appropriate motor and sensory responses, so you're looking for the patient if you're having them under sedation and can communicate, you're looking for that, again, that saddle region sensation, and then you're looking for the appropriate toe and bellows response and not looking for an S2 response. Helping patients choose the best system for their lifestyle. This is kind of a segue into talking about some of the advances. All of the systems now, InterStim 2 and InterStim Micro are all fully MRI compatible, both 1-5 and 3T. The updated MRI labeling recently actually shortened down the wait period between 30-minute scans. Now only 7% of your patients will need more than a 30-minute MRI, but the wait time used to be an hour. Now it's down to five minutes, so that's a very helpful thing. It's very easy for the patient to utilize their, if we can go back real quick, it's very easy for the patient to utilize their controller to go into MRI safe mode and to show the technician in the radiology suite that they're in MRI safe mode. Certainly designed for safety, there's been over 19 years of full-body MRI experience in Medtronic in studying this with 10 million patient-simulated scans to give you your background for safety. I did not used to think this was as big a deal because I didn't think many patients would really care that much about MRI. They really do care about MRI, even if they're not having it. Just the knowledge that they can't have an MRI in the past held a lot of patients back, so this was big to get full-body MRI compatibility. Talking about the choices, InterStim 2 is the only recharge-free sacral neuromodulation system currently available. Patients looking for this are looking for simple and convenient and are looking for low maintenance without the need for consistent regular charging, so no recharging routine, no recharging components. I have had a recent patient who did complain about she wished she'd done this because she did didn't like all the recharging components, so somebody looking for simple, out of sight, out of mind may be appropriate for this battery. The newer InterStim micro battery, which you see there on the right, is the recharge battery. It is smaller, as you can see, about the size of half of my pinky. It's smaller. It's longer lasting, FDA-approved for up to 15 years. It does require regular recharging sessions, but recharging in 20 minutes once a week, if they recharge down to zero, it takes less than an hour to recharge, and very easy for them to do so. The belt to wear is very easy and comfortable. They can do other things while wearing the belt. I think it's helpful to realize that they actually redesigned, Medtronic redesigned battery technology with lithium titanate battery, which is very resistant to damage with abuse states of battery, so much more resistant to this than our cell phones are. So, zero battery fade at 15 years. That means at 15 years, that battery works nearly the same as it did on day one. So, if patients take a break from therapy, they leave it off for an extended period of time, they will not damage their battery with this new battery engineering science that has been designed with overdrive with lithium titanate. So, helping you decide how to choose between these two batteries. If you have a patient that may have a history of non-compliance with therapy, it may be very helpful to know that when you put a recharge-free system, it will keep doing what it's told to do until it's told otherwise, until the battery runs out. So, you know you're going to have compliance with that therapy. So, if a patient may have maybe some health issues, reduced compliance expected over the long haul, this may be a better choice for them. A patient who is not as engaged with her therapy, maybe not as motivated, maybe forgetful, this would be a good choice for this. Some patients may have a difficult time with physical dexterity in terms of managing the recharge system. And maybe if they're having a tough time understanding lack of technical knowledge, the recharge device may not be the best choice for them and a recharge-free may be more suitable. Rechargeable, that tends to be my very motivated, compliant, tech-savvy patient. She may like the idea of the smaller implant due to physical activity levels. Maybe she's a high endurance athlete and likes the idea of a smaller battery. If somebody has a high energy stimulation, so if they have, you know, maybe had to have it run very high during the basic evaluation or they burned a prior battery out in a short amount of time, knowing the longer battery life is an option may be a point that patient towards the rechargeable battery. So, patient management and programming basics, we'll cover that briefly. I think this is a very important concept to realize. When we have the device in place and we pick the right patient, we took our time and we got the lead in appropriately, we're getting good stimulation and good implant success technically in the operating room. Once it's working, it tends to stay working. And so, when I have a patient come back who feels like her management control has dropped off, I want to put on my clinician hat and I want to think through other factors that may be contributing to this. Did the device inadvertently get turned off, right? I had a patient who just plain forgot to recharge and it just, the battery went low, we had to recharge the battery. The recharge free, maybe it got turned off inadvertently. Maybe that patient has a urinary tract infection or a flare of underlying colitis. Maybe they've had dietary indiscretions. My diabetic patient who rediscovered the joy of sugar, plenty of sugar jello, had a degradation in her results. And I'm not making that patient up. We had to remind her that bolusing jello eight times a day was not good for her diabetes. Looking for other factors. That's when it's time to put our clinician hats on and understanding and understand in the office why somebody may have had a drop off in symptoms. Again, understanding expectations that if somebody went from 12 bowel accidents a month down to one or two a month, building upon that with reminding her to use the other standard medical therapy approaches, use the bulking agents, do the other things to help her, help her interest in, help her is very helpful. If somebody has had significant trauma where we just can't figure out why there's been drop off in benefit, then I do also use repeat x-ray to understand the leads and to look for lead migration. When it comes to programming basics, the programmer, I find very helpful and user-friendly. My patients are able to certainly turn their therapy on or off with this, adjust the stimulation, change a program, activate the MRI safe mode, check their battery life, on the clinician app, which you'll have access to if you're using this, you'll have access to the clinician app, which helps you to check the impedance levels, to help you to custom design different programs if you need to, to look at usage logs. I have great capability with the clinician app on managing my patients' interest in implant. So in summary, we wanted to help identify the fact that there are undertreated overactive bladder and fecal incontinence patients, and many of them, and looking for a way to expand that, those options for our patients to enhance their care. We sought to demonstrate the overactive bladder and fecal incontinence treatment guidelines and care pathways. I wanted to give you an overview of interstem systems indications and contraindications, give you an idea of what the long-term five-year clinical data look like across each of the three interstem indications. Hopefully we gave you an idea on evaluating the best evaluation choice for your patient, whether basic or advanced evaluation, to give you an overview over the interstem recharge free and interstem micro rechargeable systems, and also to touch upon some of the post-implant management that is important in the care of our patients once the implant has gone in. I would encourage you that, again, once you put the implant in, that's not when we stop being clinicians. These are chronic disease states, and being tuned in with our patients and their expectations and goals will help us to better care for them. So with that, I thank you for your attention. I will show you this slide here that if you're interested in learning more, you can scan this QR code. There's the Medtronic Academy Online Learning for FBMRS Fellows, and you can scan that code to get access to additional content. But I thank you for your attention, and we welcome any and all questions at this time. Great. Thank you so much, Dr. Fishburne. We really appreciate your time today and coming on. Do we have any questions? We are just out of time here, so if anyone has questions Melissa did say, just put them in the chat, and we can follow up with those since we're right at the top of the hour here right now. So thank you so much for everyone for joining us today, and thank you so much, Dr. Fishburne, for taking the time and sharing your wisdom with us this evening. We truly appreciate it. Thank you all so much. Thank you.
Video Summary
In this video, Dr. Fishburne, a urogynecologist, discusses sacral neuromodulation as a treatment option for overactive bladder and fecal incontinence. He thanks AUGS and Medtronic for their support in his career and the sponsorship of the meeting. Dr. Fishburne highlights the prevalence of these conditions and the impact they have on patients' lives. He discusses the treatment guidelines and society recommendations for sacral neuromodulation, emphasizing the importance of thorough evaluation and non-invasive treatment options before considering advanced therapies. He explains the two evaluation options available, basic evaluation and advanced evaluation, and shares his experience with basic evaluation being done in the office. He discusses the indications, contraindications, and mechanism of action of sacral neuromodulation. Dr. Fishburne reviews the long-term clinical data for overactive bladder, non-obstructive urinary retention, and fecal incontinence, showing high success rates. He explains the choices between the Interstim 2 recharge-free system and the Interstim Micro rechargeable system, discussing their features and benefits. Finally, he talks about patient management and programming basics, emphasizing the importance of ongoing care and addressing other factors that may impact treatment outcomes. The video concludes with a QR code for additional online learning resources.
Keywords
sacral neuromodulation
overactive bladder
fecal incontinence
treatment option
urogynecologist
prevalence
evaluation options
mechanism of action
Interstim system
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