 Welcome to Texas Heart Institute educational programs on innovative technologies and techniques. The purpose of these presentations is to inform and educate the physicians, allied medical personnel, and the general public on the latest advances in cardiovascular medicine. I'm your host. My name is Van Merkrazier. I'm an international cardiologist at Texas Heart Institute and Baylor CHI Medical Center. Our special guest today is Dr. Stephanie Coulter. Dr. Coulter is a director for Women's Heart and Vascular Health and Program Director, Cardiovascular Disease Fellowship and Director of Cardiology Education and also Texas Heart Institute Educational Board Member and Special Section Editor here in Houston, Texas at Texas Heart Institute. Wow that's a mouthful. Welcome to this program. Thank you so happy to be here. You've done a great job providing all of us with all this educational content which is good for our audience. It's my pleasure. Well the topic today of our presentation and discussion is an update on the diagnosis and treatment of abdominal aortic aneurysm in women. That's not a big subject matter right? I mean traditionally we haven't looked for aneurysms in women too much. Absolutely. So Dr. Coulter the question is what is or what did Lucille Ball have in common with Albert Einstein, George C. Scott and Conway Twitty and many others? Well I'm assuming I know one of those people died of an aneurysm so I'm assuming we're talking about ruptured aneurysms. That is absolutely correct. So it affects all races all ages and it doesn't discriminate anything. So what is the epidemiology of an abdominal aortic aneurysm because they're different than from ascending aortic aneurysm? So abdominal aortic aneurysms are common over the age of 50 years of age and with a prevalence of 1.4%. Abdominal aortic aneurysms are more often detected incidentally on some routine evaluation for other conditions typically for gastrointestinal complaints or musculoskeletal complaints and very frequently they go under diagnosed or undiagnosed for a long period of time. The majority of abdominal aortic aneurysms are asymptomatic until they rupture so we call them a silent killer. Risk factors for abdominal aortic aneurysm include older age particularly in males, Caucasian race, history of smoking, history of arterial hypertension and particularly history of abdominal aortic aneurysm and particularly history of ruptured abdominal aortic aneurysm. Are there gender differences for abdominal aortic aneurysm? They are and that is a very important factor to take into consideration. Male gender is well established risk factor for abdominal aortic aneurysm and the ratio is somewhere between four to one and in some reports even seven to one. I think that's why we underestimate women having these because we don't expect it to occur in women because it's such a male dominated condition. Right this is absolutely correct. There is understanding that women because of the hormonal differences are protected against atherosclerosis to menopause and actually it's very rare to diagnose abdominal aortic aneurysms in women before the menopause but after that there are they catch up. They catch up as in anything else as far as atherosclerosis is concerned. So if it's a silent killer screening must be really important in those people that we think are at risk? Well this has been debatable issue for a very long period of time particularly as far as women are concerned. Now as you can see from this information on the U.S. Preventive Services Task Force as far as screening for abdominal aortic aneurysm in women is concerned it's not rated as a very high probability of success in doing evaluation in women and while in men it's more meaningful and more important in women it has been established to be less beneficial. However some other data is available particularly from the SPS screening guidelines that emphasize that screening for abdominal aortic aneurysm in women should be done and the question is when. So we nowadays agree that probably women that are above the age of 65 with family history abdominal aortic aneurysm should definitely be screened and evaluated for abdominal aortic aneurysm and that evidence is between moderate to strong. Is there a difference in the expansion rate and rupture in women compared to men? Yeah that's another very important issue that has been more recently analyzed and what we can see here from this particular information as far as initial abdominal aortic aneurysm size and then increase in size over a period of years or follow-up we can see that aneurysms grow much faster in women than in men. That's a scary looking curve. It's absolutely scary from the point of view that if the aneurysm goes under or undiagnosed in women then we certainly can miss the opportunity to prevent rupture. And another important factor is as we can see here from some other publications the females experience rupture at smaller aneurysm sizes than men. Now this is understandable because female aortic is a smaller in diameter so we cannot use the same criteria as far as the risk of rupture is concerned as in men and this has been documented in several studies. In this particular study as far as aneurysm rupture is concerned we can see again that aneurysm rupture in women at a smaller sizes and the risk of rupture at the same size might be for men 5% and in women 24% which is statistically significant. So women have smaller abdominal aortic aneurysm diameters and higher rate of rupture even at smaller aneurysm sizes. So what are the challenges for the correction by endovascular techniques of aneurysms in women because the arteries are smaller? So obviously we have several challenges and we will mention some of them. One of them could be the exercise vessels because the vessels are significantly smaller particularly with earlier generation stem grafts they were significantly larger in profile and that was a serious challenge. Then the second thing is women as we will see have significantly higher incidence of tortuosity, higher incidence of calcification, higher incidence of thrombus and higher incidence of challenges with the infrared aortic neck as far as diameter is concerned, as far as irregularities presence of thrombus and presence of calcification is concerned. In this particular graph as we can see from this particular publication related to whether the patients are candidates or not candidates for EVAR that significantly larger proportion of men are candidates for EVAR and this is a little bit outdated but at this point of time when this study was published 65 percent of males were candidates for EVAR while only 35 percent of women were candidates for EVAR with current technologies and as we mentioned before and we can see here clearly as far as some of the challenges with EVAR in women is concerned they have more frequently narrowed vessels, occluded vessels, tortuosities, calcifications and aneurysmal dilatations. There are several studies that looked into this particular issue and on an average from M2S database on over 43,000 CTs roughly 40 percent of patients have less than six millimeter access vessel diameters. Now in women this number is significantly greater and 55 percent of female population that have been evaluated for EVAR have access vessels of less than six millimeters. As far as infrarinial neck is concerned again we have certain issues as we mentioned that makes it difficult to perform EVAR such as short necks which are less than 15 millimeters in length, reverse tapered necks, calcium presence of thrombus, severe angulation and large diameter and again from M2S database 48 percent of patients that have been looked into have necks of less than 15 millimeters in diameter and therefore in length and therefore they're not candidates for EVAR. Now for women this number again is significantly larger and 63 percent of women have neck lengths less than 15 millimeters so a significantly larger number of patients have challenging infrarinial neck anatomy in women than in men. This means that women have to go for open procedures because they are not as many candidates for a stint graft. Or the surgery or endovascular treatment was not recommended for that particular reason. So they just were treated with medical therapy. Medical therapy and this is where the rupture rates are higher. So in another publication as we can see here from Lancet we can see that 34 percent of patients were in this particular study eligible for EVAR while 54 percent of males were candidates for EVAR. So as we can see here which is another interesting point is that more women declined intervention than men. So these were women that were offered the procedure but then they decided against it? They decided against it. Again it is not clearly known why but it's a fact that we have to take into consideration. That's a fact in all trials of intervention which is more likely to not pursue the recommended therapy. They're older. They just choose not to do it and to take the conservative route. Yeah this is true because in general women that develop abdominal aortic aneurysm are what we call typical vascular paths. They will have peripheral arterial disease. They will have renovascular disease. They will have coronary disease and frequently they have diabetes and they're smokers. So when we present the information to them I think it's appropriate and we do that. We mentioned that they are at higher risk for any kind of procedure and I think this was one of the factors that some of them declined those procedures. Now also as we can see here from this particular publication a significantly larger number of women have a higher 30-day mortality and again this is due to comorbid conditions. Almost double. Right. So what are the new developments for treatment of triple A in women? Well we have exciting things happening as far as EVAR is concerned or endovascular repair of abdominal aortic aneurysm in women is concerned. I looked at this several decades ago and what we found is that because of the challenges of access and challenges in anatomy we truly didn't have appropriate stem grafts for use in women and we needed devices that would be more suitable to a female anatomy and pathology and within the last decade or so the devices are becoming smaller, they're becoming more flexible and more what I would call user-friendly for deploying the stem graft and also offering good long-term outcomes. One of them is this ovation stem graft that has very innovative aspects from the point of view that it's a very low in profile, significantly lower than the other devices. This device is a 12 French in profile as far as ID and a maximum 14 French OD. While the great majority almost all of the other competitor devices are 16 or 18 French in profile which is a big big issue in challenging anatomy and small access vessels. So this device is well suited for narrowing of the arteries, severe calcification, and tortuosities as well as challenges of the infrowindal neck and one of the studies that we were involved in as a co-principal investigator was so-called life registry and life registry was the first study that looked into percutaneous approach, local anesthesia, no ICU admission and next day discharge using this low profile ovation stem graft and as far as percutaneous approach and successful femoral artery access repair it was achieved in 97 percent of patients which is higher than in any other previous publication. In addition to that this particular study showed the lowest incidence of major adverse events which was 0.4 percent at 30 days. In addition to that we had a very short procedure, significantly shorter than in other published studies as well as shorter hospitals stay 1.1 days and no ICU stay and we were able to achieve that because we had innovative technology with low profile device. So you've made the hospital happy because you got the patients out quicker and you made the patients happy because you were able to provide a service to people that ordinarily wouldn't be offered that service with low side effects. So this was an important step this particular study to look into the benefits of using this type of technologies in women that undergo EVAR and you can use it in men as well. Amen as well right so this study was published in general endovascular therapy a year ago. So what about the lucy trial? So the lucy trial was very exciting trial from the point of view that this was the first ever trial in women that underwent EVAR with a low profile device and the study actually was named on the basis of evaluation of females who are underrepresented candidates for abdominal aortic aneurysm repair and the lucy study was initiated to explore the clinical benefits associated with EVAR using the low profile ovation prime system in female population. The ratio between men and women were two to one two men to one female ratio and again we wanted to make sure that in this particular study we had a control group to determine if there are any unexpected risks that were would be encountered in the female population. There were 75 females in the treated arm and 150 males in control arm and this study was carried on in 45 sites in United States so it means across the board representing most of the centers leading centers that are performing EVAR. So what were the results of this lucy study? The results were impressive I would have to say and here we can see as far as procedural outcomes concern the deployment success or ability to deploy the device in the desired location was 100% in women and 99% in in a male population and again this was not statistically significant but pretty much everybody got the everybody got a device right and there was also very high use of so-called percutaneous approach bilateral percutaneous approach as high in women as in men which again gives a tribute to the low profile device that's designed and dedicated for percutaneous use. Now also we can see there was no difference in procedure time even though women had a more challenging anatomy but it means that this device offered us the opportunity to do this procedure in a very efficient way and the vice time was evenly distributed the blood loss was similar in both groups and the use of adjunctive procedures was similar in both groups. Now what's also very important is when we look at the freedom from device related secondary interventions there was no difference between males and females. That's really impressive so Indoleaks were the same 97% success rate not only type 1 and the leak but also type 3 and the leak or instance of inclusion of the iliac arteries there were basically no significant difference between males and females which is the first time that we have ever seen this type of finding. So can you summarize what we've learned and what are the latest results of the evaluation and treatment of triple A's in women since that's what we're talking about today. Right well we have to realize that women are underrepresented as far as EVA is concerned in clinical trials until present time despite a distinct need to identify appropriate gender specific treatment algorithms which is of great interest and concern at the present time. Current screening procedures for abdominal aneurysm should be expanded to include and be more focused in an effort to identify affected females. So in the past the guidelines for screening aneurysms were for a male with a history of hypertension or smoking or family history to undergo routine screening but I'm not sure that the recommendations before now have included the screening of women for silent aneurysm so in our practice who should we should we be screening women with a family history those with hypertension and those who smoke after age 65 routinely by ultrasound is that what we're recommending now? I think that we should be screening males and females above the age of 65 on routine basis and you know you're expert in the ultrasound and it's a very inexpensive and very reliable tool easy to do easy to do it's being done but maybe not enough I think churches and many other it's not part of life screen I mean it well it may be part of some maybe should be yeah yeah so I think from that point definitely patients whether they're men or women that have hypertension history of smoking above the age of 65 and definitely those individuals that have family history of dominant aneurysm or other risk factors such as diabetes and so on right so females experience rupture at smaller aneurysm sizes than men and fewer women were in the past eligible for EVAR but that is no longer the case on the basis of the lucid trial so I think we have gained very valuable information that we can use for a future treatment of a female population with abdominal aortic aneurysm most excellent we have plenty of room to move on this move the needle on this I actually have patients that come in and with family histories that are worried and ask for screening and I think that getting the message out that we should be more eagerly screening women that are at increased risk but certainly I put the plug in for prevention works too so all the work that we're doing as doctors now for controlling blood pressure and counseling patients not to smoke or hopefully improving our later consequences for the development of aneurysms because certainly they are partially preventable in those patients that have the risk factors that that lead to it I absolutely agree I would like to congratulate you on your efforts through your woman's program that you have here at Texas Heart Institute in public awareness on not just related to the aneurysms but atherosclerotic disease and many other conditions that are of great concern to all of us as far as the future is concerned I see that the screening will be a routine thing I also see that there will be newer technologies available we will be probably more involved in preventive type of a care there is enough of information now available that there are a certain trials ongoing at least first in men that has been done where we can see that we can shrink aneurysms by using chemicals of different kind injecting into the aortic wall not only for atherosclerotic aneurysms but also for connective tissue disease so this was stabilized elastin and stabilize the collagen so makes it stronger right right so preliminary data is very very encouraging the information is already available from cadaver testing and also from the animal studies and first in men study has been already done in this particular that's really exciting so maybe the sten grafts are not going to be the future but medical treatment in the stabilizing the aortic wall and preventing the aneurysm increase over a period of time most excellent thank you very much for participating in this program and i'm looking forward to work with you on many other programs in the future thank you for your attention to these important discussions that we're having here at texas heart institute we're trying to get the message out