Ray Rassai, MD, discusses venous diseases and treatment options. Venous reflux can lead to varicose veins, leg swelling and various other issues which can lead to venous ulcers.
SPEAKER 1: Dr. Rassai, everybody. RAY RASSAI: Hi. Ray Rassai. I'm with Bay Area Surgical. I do general and vascular surgery. So thanks for coming today. We're gonna talk about venous disease and treatment options. If you have questions, just go ahead-- excuse me? SPEAKER 3: Speak up. RAY RASSAI: Speak up? OK, certainly. SPEAKER 1: There's not a mic [INAUDIBLE]. Sorry. RAY RASSAI: So I'll just speak up. All right, is that better? OK, so venous disease. Unfortunately-- these pictures look better here-- for some reason they look very red on the screen. This is just a picture of different types of venous manifestations and disease that we see, typically, from the underlying problem of venous reflux. The main focus of what we talked about today is a lot of various things coming about from underlying venous reflux. It's a very common problem affecting about 25 million people suffering from venous reflux, which can lead to varicose veins. Again, I apologize, these pictures came out red. Varicose veins, leg swelling, disproportionate swelling, or even bilateral lower extremity swelling. Hyperpigmentation, so venous stasis, which we commonly see, that's a brownish, leathery skin, typically on the medial aspect of the lower leg. And you certainly can't see it on this picture-- and then ultimately leading up to venous stasis ulcers, which can be pretty morbid and painful and difficult to treat. The self-explanatory slide here. Is there a way to get rid of the other stuff, the surrounding stuff, or no? SPEAKER 1: No. RAY RASSAI: That's part of the slide, OK. So the problem is when you compare it to other disease processes, again it's affecting 25 million people. It's a very common problem. And it's not just about spider veins or varicose veins. It can be a pretty morbid condition requiring many days off of work, chronic treatments and plans, and we'll talk about that down the line. Kind of an age breakdown, and a male, female breakdown. Again, 25 million people. A symptomatic-- varying degrees-- it could be symptomatic varicose veins, leg swelling, leg fatigue, any number of things. Unfortunately, it's not well understood that the main problem is underlying venous reflux, so not too many people actually seek treatment. Only a fraction-- maybe 10% at best of the 25 million-- get to seek treatment and potentially get treatment options. It is more common with age, and females are much more affected, typically. And obviously, the difference being underlying cause-- one of the risk factors being pregnancy, whether it's single or multiple pregnancies. Can we move the small video caption? Just a little bit up. Thank you. So the variety of risk factors for venous insufficiency, which again, venous insufficiency-- we hear venous pooling, venous reflux-- it's all saying the same thing. And there will be diagrams that actually will show what that is as we saw on the previous slide, so females, more common. With age, it's more common. There is a hereditary component. Certainly pressure, intra-abdominal pressure-- as a cause, specifically pregnancy. Standing occupations, specifically on hard surfaces, is a common risk factor. Obesity, we know, predisposes to venous reflux. So the common factor that pretty much a lot of these have, except for heredity-- you're just going to be predisposed to it-- it effects long term effects of gravity, whether it's from intra-abdominal pressure from pregnancy, obesity, or just the standing position-- even if prolonged sitting positions, because the effects of gravity will lead to venous dilation, which leads to reflux. Symptoms can be in any variety, which we've already went over-- varicose veins, even spider veins. One of my common complaints is restless leg. And they've gone through a whole gamut of neuromascular workout, and it turns out they have venous reflux as their underlying cause of restless leg, which is a common symptom that I see. And they could have one or all of these symptoms. Certainly, the latest manifestation would be venous stasis ulcer. Even those patients are gonna be candidates where we obviously want to work them up, not only to promote their current ulcer to heal, but to prevent future ones from happening. So the venous system anatomy, if everyone can make out these words here. So the purple is the deep, or the deep system, which is femoral vein. The greater saphenous-- and this comes into play, because there are certain things that we can treat, and there is ones that we can't. And simply put, the deep systems-- currently, there is no technology to fix venous reflux in the deep system, which is the femoral vein. So essentially, this is the main highway out of the leg, whether it's the perforators-- or the lower leg veins-- will all communicate to the deep system. So you can't close or remove the deep system. What we refer to the superficial system, which includes the greater saphenous and the smaller-- we call lesser saphenous, which is the calf vein. And even the perforators-- once they become diseased, those are all treatable. So again, the greater saphenous, which is the inner thigh vein-- running from the ankle all the way to the groin-- and the lesser saphenous, which runs from, basically, the area-- the Achilles-- inserting into the deep system behind the knee. And the perforators, once they've failed, these are all that we can treat, especially with our minimally invasive techniques nowadays. The way venous blood flow works-- there's muscular compression. So aerobic-type exercise does help in prevention, because the muscles are contracting. And that action will have the blood circulate upstream and out of the leg, which is the goal. We don't want blood pooling below the knee, because that will cause symptoms over time. A negative intrathoracic pressure draws the venous blood back up towards the abdomen and, eventually, to the heart. And again, it's all effects of gravity. We don't see this disease process in our arms, we see it in our legs, because of the brunt of gravity repetitively over the years. We talked about muscle acting as a pump. The venous pressure-- the entire thing-- whether it's deep or superficial, it's a low pressure system-- very different than the arterial, which is under significant pressure. Again, if I'm going too fast, let me know if there's any questions. So a diagram. So the pathophysiology of this venous reflux, or venous insufficiency, or venous pooling that we're talking about is-- the diagram to the left here is a normal-- what we refer to as a competent vein-- normal caliber veins throughout, not dilated. The valves, which are numerous in the lower extremity, are competent, meaning blood will-- whether negative intrathoracic pressure or while walking, blood's gonna tend to go up the legs. This valve will close intermittently so that blood cannot pool down. The disease process of venous insufficiency, or this venous reflux, happens from venous dilatation. It can be in the deep venous or superficial system. Either one, or both, can be affected, including the perforators, which you saw in that diagram-- communicate their deep and the superficial system. But once this develops, unfortunately it's not reversible in that particular vein. There's surgical options, and then there's medical options to prevent it from getting worse. But this vein dilates, these valves break, they become incompetent. So if someone is laying flight or supine, or has the leg elevated, we really don't rely on these valves, because gravity does the work and blood's leaving the leg anyway. But most of us are, during the day-- we're either sitting or standing. Once we've lost this valvular function, there's nothing preventing-- at least in that vein-- from now this becoming the culprit blood pooling. And that's the main problem over years when you have repeated pooling of blood. That's what leads to the itching. The back pressure leads to more superficial veins from being dilated, and that's called the varicose vein, or spider vein. That heavy feeling, or muscle aching, is because blood's pooled in the legs all day. And that's where we really advocate wearing compression stockings, or at least intermittently elevating the leg to get that pool blood out of the leg. This is that first picture we saw but just putting numbers to it. The venous reflux is progressive, and it get worse if not treated. Again, we saw these before-- the varicose veins all the way to venous stasis ulcer-- which of that 25 million, at least 500,000 will eventually lead to this venous stasis, which is very morbid for the patient, and also costly. So conservative, or what we call traditional or medical treatments, have been to optimize the venous circulation. So exercise, leg elevation, compressing, Unna Boot-- I'm not using Unna Boot-- I pretty much just prescribe compression stockings, leg elevation, and an aerobic exercise program. You want to avoid heavy weights with the legs, or lunges, and things like that. They put more strain on the venous circulation. But aerobic exercise, whether it's swimming, cycling, or walking, jogging-- are good forms of muscle contractions. And of course, wearing, whether it's knee high, or thigh high-- I think knee high compression stockings are more realistic. Thigh high ones-- no one, or it's hard to use because they roll down. They are hot. They get itchy, so you get less compliance. So you might as well prescribe the knee high compressions. And really that's the area of the foot, ankle, and calf, if you can keep that pooled blood out of there. That's where the symptomatology usually develops. It's rare to see disease-- you can see varicose veins on the thigh, but you're not gonna see venous stasis dermatitis, or venous stasis ulcers, on the thigh. So the foot and the calf is what we really want to protect. Traditionally, as of 15 years ago, all that was available was vein stripping, and/or ligation, which would pretty much have to be done under general anesthesia. It's a morbid procedure. A lot of time off of work, requiring pain medication afterwards. And the later slides, we'll see the modern technique, which is replaced. I haven't performed a vein stripping for 14, 15 years-- because this technology that's been out. And on that note, so what we refer to nonsurgical-- it's a procedure. It's not nearly as invasive as vein stripping, or ligation, used to be under general anesthesia. There's actually an office-based procedure that can be done under local, with really good-- if not, actually, better-- results. The initial studies show the results of venous ablation-- short-term and long-term-- are better than vein stripping. Certainly the short-term, because of the much faster return to work or lifestyle, and the expense associated with it, and significantly less pain and morbidity with this procedure versus vein stripping. The diagnostic study of tests. And so, again, everything's gone noninvasive. I think I was a resident when we last ordered a venogram of the lower extremity. So ultrasounds are really refined and good for this nowadays. So you have to order an ultrasound. Most ultrasounds nowadays, if you order it through the hospitals or big centers, they're used to ruling out acute processes. Like they'll put out a report, rule out DVT. It'll say no DVT, but it doesn't talk about the venous reflux, which is what we're interested in. It's important to know they don't have an acute process. You'll pick up some chronic or old DVTs. That will play a factor in here, but the ultrasound you want to get is really looking for this incompetent valve or the sort of previous pictures that we saw, looking for dilated veins, areas of incompetence where it leads to venous reflux. Any questions so far before-- the next few sides are gonna talk about the actual minimally invasive procedure to treat this. SPEAKER 3: So the diagnostics studied [INAUDIBLE] as just the venous doctor or-- RAY RASSAI; Yes. SPEAKER 3: [INAUDIBLE]. RAY RASSAI: Exactly. It's preferred if you want to put out-- you can put out, rule out DDT and reflux, if that's what you're looking for. If you're not worried about DVT, it's a rule out, a venous reflux study. It does have to be done at a center that has vascular techs that do that study, as opposed to just an acute rule out DVT study, OK. Again, it's completely noninvasive. There's no contrast, just a pure ultrasound study. So it's, again, a technique to treat that underlying problem-- the venous reflux. And I already touched on the deep system versus the superficial system. So the superficial, which encompasses, again, the greater saphenous, which I call the thigh vein for patients. Lesser saphenous, which is the same as the small saphenous, which is the calf-- your calf vein, or any incompetent large perforating veins. Those can be treated with this technique. Those we can get rid of. They're not essential like the deep vein. This technique nor any other surgical technique is indicated on the deep system. Unfortunately, there is no surgical treatment. We go back to the previous slide. If all they have, where after we're done treating all their superficial venous diseases, weight loss, exercise program, compression stocking-- that's how we treat the deep system to prevent it from getting worse. So it's referred to as-- it's a VNUS Closure Procedure. This technology uses RF to create the heat. There's mainly two companies. There's the RF, which is used in this community through the venous company that uses RF technology. Essentially, you need a generator to produce heat at the tip of this catheter. The other company, the heat source is laser, so that the heat generator at the tip of the catheter is laser, whereas this catheter, it's a copper coil. The end of it is connected, and there will be an animation coming up. Sorry, this slide is dark. The end of this catheter, one end goes in the patient, the other end is connected to the generator that produces the heat that's transmitted to this copper coil at the tip of the catheter, where the ablation occurs. Again, it's a minimally invasive procedure. We're talking about a 3 millimeter incision that we close with Steri-Strips in the office. It's performed in the office under local. And again, the key part of this is whatever their presenting symptom may be, you want to treat the underlying problem. So get the ultrasound ruled in or out for this venous reflux, and treat that first, as opposed to jumping to excising their varicose veins, or just treating their venous stasis dermatitis. Or also, you really want to diagnose this and get this underlying problem treated, because no matter what their condition-- presenting symptoms-- was, it will recur if this is not treated. So like I was just talking, it uses RF technology to ablate the specific vein being treated. And there will be an animation that shows this better. But essentially, the catheter is introduced in the vein that you're treating for the day. There's tumescent, or numbing solution, injected around the vein. And that's really the only part the patient feels-- is just the numbing solution. The tip of the catheter heats up, and we're ablating just the one vein that we're treating. We'll see if this animation works here. Is there any questions of any of the other centers? OK, well I guess our animation started, so sorry. So the procedure is done entirely under ultrasound guidance. So in case you're wondering, how do we know where the catheter is? So you can easily see it with ultrasound. Same as when you're doing your tumescent, or numbing injection. So the catheter-- we'll see it back below the knee-- that's where it's inserted. So actually floating. This is treating the greater saphenous, or the thigh vein. So it's floated under ultrasound guidance to a designated location. We want to be a few centimeters away from the deep, or the femoral vein, so that we don't cause a DVT. It didn't show it, but this black area, it takes the numbing solution that was already injected. This is a Cordis sheath. This is how you insert into a tiny little incision. It's like a typical wire technique. You get a needle into the vein, get a guide wire. This is the ultrasound depiction. You can see the catheter, , actually as you're withdrawing. Each six to seven centimeter segment, we're ablating. And it's a 20-second countdown that the machine or the generator does, and we know that part has been adequately treated, then we pull the catheter back until it's completely-- and it is not a stent or any device that's left behind it. It's a one-time use catheter that ablates the particular vein. There is a shorter tipped one to use, as you can imagine, for a shorter vein, like a perforator. They tend to be very short. So there's a very small probe. It used that same generator, same catheter. The tip is differtent. It's not centimeters. But obviously, to make it efficient, we used the bigger copper coil for the longer segment. This is that 20 second count time. Heats to 120 degrees Celsius. So you know 100 degrees Celsius is boiling of water, so we're, in effect, much more than that. And the number to the right was the power. So this catheter is constantly sending a signal back to the generator, so that it knows it's in a good position-- that it's producing how much heat-- all of that is transmitted back, so you're not overly heating a specific segment or causing undue damage. Any questions? The procedural, the fun part. We'll go to the next one. OK. And we already covered this. This is gonna lead to a study. But since we spoke about the details of the actual procedure, one of the main studies that came out early on was multi-center perspective study, specifically comparing this technique-- the VNUS Closure-- with radio frequency technology. So they followed the patients out in this particular study for at least three years. Showed that the vein that was treated was still occluded, or gone. Most of these veins, once they are treated-- even if you do an ultrasound-- typically six months later, you may not even see any remnant of the greater saphenous, or whatever vein you treated. It's ablated and it just all of a sudden goes away. Sometimes there will be a band of scar, which is not painful or known to the patient. You only pick it up on a future ultrasound. But that's how they knew that 93% occlusion, which is better than other techniques that it was compared to. The patient-- they're treated for large varicose veins. A lot of these varicose veins, if not all, were coming off of the greater saphenous. So I can tell you that this treatment was a greater saphenous vein ablation that was feeding this cluster in large varicosities. These lose their flow, and over a few week process, they start the decompressing. And then you're left with this, OK. In fact, I can tell you it's not perfect, because if someone has had many years of large varicose veins, we may-- if they continue to be bothered, they'll get really good results. And most people do not need any follow-up procedures. But once in a while, they'll need a phlebectomy, which means we go in just after a specific varicosity that for whatever reason persists. And that's a minimally invasive outpatient procedure that's not morbid at all. But again, most people get this result without any other procedures, just simply the VNUS Closure. The two techniques that I've mainly talked about, which compares end of radio frequency versus laser. This is this recovery trial that was done. Comparing the two laser versus the radio frequency that we do in this community. There are six centers involved-- blind, randomized. A certain number of patients-- 69. A total of 87 limbs treated. The number of days that were followed. So this one's not so much the long-term results, but the short-term difference between laser technology-- basically your heat source, and what it meant for the patient. So pain was one thing that they looked at. Unfortunately, this slide doesn't show it. The blue is the radio frequency, red is the laser. And it was all statistically significantly less pain if someone had an RF ablation versus a laser ablation. All the pain and tenderness will go hand in hand, same thing. But once you followed them out several days about two weeks later, they were pretty close together. But early on, it was much better and more tolerated in the VNUS Closure procedure versus the laser technique. And again, all of them being statistically significant. So we're talking about tenderness, pain, and ecchymosis. Now, both of these techniques are far, far better than vein stripping used to be, because those numbers used to be off the chart in terms of pain. It would be several weeks' time off of work, bruising, and all of that. But this is also pretty significant, and how little bruising we see with the radio frequency versus the laser. The conclusion, like we just mentioned, is specifically significant less pain, bruising, tenderness. And this was when these technologies first came out. That's why the majority of us-- I know everyone in the local area uses the RF catheter versus the laser. But when these were first published at our college meetings, most people gravitated, obviously, to the VNUS Closure, or that animation that I showed you-- that technology. And these are references for the slides. I'm happy to take any questions.