Dr. John Rogers outlines disparities in cardiovascular health outcomes among different genders, races, and ethnicities and examines indications for ICD and CRT therapy from the ACC/AHA/HRS.
Mhm. Mhm. Hi, thank you, welcome back everyone. Hopefully you had a chance to take a quick break. I'm glad you're still spending your saturday morning with us. I know that this time is valuable so we appreciate you tuning into this conference. Very excited for our next set of talks. We're going to be starting with Dr john Rogers who is one of my favorite people on the planet. But in addition to that he's a very well known cardiologist and implant er in our area here in SAn Diego scripts Clinic is the associate chief of cardiology and the director of cardiac pacing and tacky arrhythmia and device therapy at Scripps Clinic Medical Group in La Hoya. He received his medical degree from Chicago Medical school in Illinois and he completed his residency in internal medicine and fellowship in cardiovascular disease at Scripps Clinic. So he's been with us in SAn Diego for some time. Um He has participated in numerous clinical trials research studies. I'm sure he'll talk about some of those during his talk. Um he's been involved in the reveal study a lot of work with Medtronic as well. We are very lucky I was able to pull him away. He's actually surrounding this weekend and I was able to pull him away because he is one of our experts, particularly in devices and implant. And so I really wanted everybody to have a chance to hear from him. Thank you. Dr Rogers thank you. Doctor routine and please um everybody excuse excuse my work clothes because like Dr Dean said I'm rounding today so I appreciate the opportunity to be here and to talk with all of you regarding disparities when it comes to implantable cardiac devices. And I think it's important that we talk about this number one because there is disparity. I'm going to show you the evidence of that. And then we're going to talk about the gender disparity in cardiac devices. By that. I mean, implantable cardiac monitors, pacemakers, defibrillators, and CRT devices. Um talk about the data that exists proving that there is disparity. And this can be a very uncomfortable topic because there's not only gender disparity, there is racial disparity and it's a multifactorial problem and it's uncomfortable to talk about. But it must be talked about, it must be discussed. So, I think that that's the only way that we're going to be able to address this this issue. Um, I want to talk about the definition of disparity in case that's in anybody's mind. Not quite clear. We'll talk about gender disparity. Show some of the evidence and studies that talk about this and show us that it exists. And then my thoughts on fixing this problem. It is a problem and it needs to be fixed. So, we'll talk about my thoughts are and I'm sure that will open up for questions later too. Disparity is really the lack of similarity or equality inequality or a difference that exists. That disparity is a word that doesn't just refer to race or gender. It can relate to any any topic where there is inequality or differences. You only have to look at these maps and it can be a little busy. But I wanted to show you if you look at the bottom of here, if you look at the bottom of this image, you can see this scale that goes from blue to red. And this is a scale of proportion percentage of males, Right? So it's only looking at males. And if we look at pacemakers, this map of the United States, we can see that the yellow percentage here is predominantly what's present in the country. So that the predominantly the country is probably close to 50 50 may be a little more disparate with pacemakers. And if you look up at the graphs up above, you can see that males and blue females in this um pinkish color show that they're pretty close 55% to 45%. But look at I. C. D. S, males 74%, females 25%. And you can see on the map here, it's mostly orange and darker orange, which, as you can see, is becoming more male. So there is a gender disparity between pacemakers, not as much, but there is and ICDs especially, but where that disparity seems to be uh less is in C. R. T. Pacemakers or by the pacemakers. So just an interesting look across the nation, as far as this gender disparity, what's the blame for this? Well, there isn't one bad person here or boogie person, there is blame to go around everywhere, blame within our health care systems, blame amongst us as health care professionals and blame even amongst patients. At the end of my discussion, I want to talk about, I think how we can fix this and what we should do to fix it, it's not going to be a switch that changes overnight, but it's important that we address this issue and continue to address this issue because it is multifactorial. But we have to keep in mind that heart disease is the number one killer of both american men and women. It's not just men. Cardiovascular disease causes more deaths in the americans of both genders and all racial and ethnic groups than any other diseases. It is a leading cause of disability in the United States, more women than men die of heart disease. One in three americans has some form of cardiovascular disease and minority patients bear a disproportionate burden of cardiovascular death and disability. If we look at other profiles of heart disease. So let's look, you can see here on the right men and women death within one year of M. I. Women tend to die more within one year of my than men sudden deaths with no previous symptoms. Again, the same, same statistic. It occurs more in women than in men within five years of a recognized my, what's the percentage of people who will have another heart attack? You can see the trends here. Men and women, women have more of an issue or more of a problem or statistically don't do as well as men. And we've we've heard this for a long time. We know that there's differences between men and women as far as symptoms, as far as how well they do, from a cardiovascular standpoint for a multitude of reasons. But if we break it down into men and women, white versus black versus latino, you can see that cardiovascular disease prevalence is higher in black females and black males than it is in white males and white females. Yet you'll see as we go through this discussion, that white males do better than white females, white males do better than black males and females and better than hispanic or latino patients as well. And that also holds true for asian good females. As it turns out, asian females probably have the most disparity from white females and white males. We know that one American woman dies nearly each minute of cardiovascular disease and women of color at greater risk of heart disease. Only 31 of black women and 29 of Latino women knew that heart disease was their greatest risk when compared to white women. So it's interesting that that disparity exists but it also exists in the education or the knowledge of knowing that heart disease is a risk for these people. If we look at the guidelines that are put together in this country for pacemakers, defibrillators, implantable monitors by the device is basically anything we do in the world of medicine. We all have guidelines which are groups that get together to decide based on the data and studies that exist what should be the standard of care for our patients, What should every physician ascribed to to be doing for their patients? These are what leads to these guidelines. And the guidelines are uh in the matter of cardiac devices are pulled together from the A. C. C. The American College of Cardiology American Heart Association and the european Society of Cardiology. And the guidelines basically tell us who should get a pacemaker, who should get a defibrillator. But the important point here is not for you to memorize these guidelines and that there will be a test on this because going over guidelines can be very boring but it's very important to understand that there are guidelines that exist to help physicians know what to do for their patients. But nowhere on there does it say anything about if you're a male or if you're a black female or if you're a hispanic male, there is no gender, there's no race. There's no any discussion amongst the indications, indications or indications. There's no qualifiers and the indications for any of these devices based on gender or race. In fact some studies on CRT. The by V. Therapy suggests this therapy may be more effective in black and other non white patients and in women. Yet there's a disparity. So the current disparities in the United States tell us that there is a problem. We know that men and women are different. We know that this is kind of a funny slide. There's just an often an on switch for men for women, it's much more complex. That's not true. But this is the perception that exists out there in our communities. Notice I said, this is not true. So there's no hate chat coming in for me on that because I do not believe that we are that much different and in many ways we are the same. But in many ways we're not. When it comes to what we're talking about, we should be the same. Um, let's look at the patients who are indicated for IC therapy. Right? So what these statistics, I don't want you to get bogged down in the statistics but I want you to understand there's there's a lot of people who are indicated for devices based on our guidelines and things. Yet in general not all those people are getting devices and that maybe physician choice that may be a patient choice. No thank you. I don't want it but there's a lack of penetration into the market of who's getting these devices that are indicated for it. And then even amongst that smaller group that are actually getting the devices these disparities exist. So looking at Medicare patients with an ischemic cardiomyopathy who received a defibrillator by race and gender. There was 132,500 patients. 10.2 of the males versus 3.5 of the females received an i. c. d. They have the same indication but a dramatic difference. Women were 65 less likely than men to receive a defibrillator and black women. Black patients were 31 less likely to receive a defibrillator when compared to other races. You can see the bar graphs here. Males fared better than females. White males fared better than blacks and black females. So definite disparity there. There's there's the lack of devices going into people which may be multifactorial. But then even within those that are getting them, these disparities exist. This isn't new, this has been going on for a long time. Guys. There's there's an advance that study was a study that looked to investigate the impact of gender and race on rates of implantation of pacemakers and defibrillators. In those with a lower ejection fraction. Data was obtained from a multi center registry enrolling patients. And then basically this is again, previously showing there's been disparity for some time. There were 26,000 patients that were enrolled. 10,000 of those had devices implanted. Remember these are all patients who were indicated. So it turns out less than half of the people got a device who it was indicated for. And in that group of people, those half of people who was indicated for, you can see the mean age was 66. 71 were male. That's another problem that we see that I think has already been addressed about in these randomized controlled trials. They're mostly men and in addition, there mostly white men. So there's less representation of females and of people of non white heritage. But 10,394 subjects had a device implanted. Of those people that have a device implanted ethnic minorities had a 12 reduction in the odds of receiving any when compared with white subjects. Gender disparity was also present with 30 reduction in the odds of receiving any device and a 40 reduction in the odds of receiving an icd in men compared to women multi. Very analysis showed that clinical and socioeconomic factors did not account for the differing rates of device utilization because race and gender remains strong. Independent negative predictors of device and I see to use. So it wasn't just a matter of, well, they're socioeconomically challenged. Well, heart disease doesn't care. These people were indicated and it turns out it wasn't due to socioeconomic differences. It wasn't due to other separate clinical differences. There was a big, we're not sure why this disparity exists. Well, there's lots of reasons and we'll talk about that. This is just a graph that shows that when you take gender and race as combined burials and their effect on device utilization. So if you look far over here, white men you can see that clearly there indicate they're implanted more with stds and pacemakers than white women and non white men. Even less so than white men and non white men more so than non white women. So in this large cohort with reduced EF minorities and women were significantly less likely to receive device implants. These were most pronounced and non white women and could not be explained by disparities and demographic and clinical characteristics. More recently, we've used the word rigged registry. So what this means for those of you not aware of this. This is a registry where for many many years we had to fill out a form on this a registry form on every patient that was having an I. C. D. Or by the I. CDI implanted. So a lot of demographic data was collected on these registry forms. These studies suggest that or some studies suggest that maybe physician perceptions of minority patients may influence fluency clinical decision making. Well does that mean that there's prejudice? Possibly the folks who were heading up the GDR registry hypothesized that disparities for the OECD and by the would be prevalent because the technology is relatively new and requires clinicians with more experience in training than necessary for placement alone. Well as it turns out this is an older slide 2000 and nine and yes less people were trained in the ability to put in defibrillators or by V. Or CRT devices but that disparity continues to exist even with more people being trained and more people capable of doing this. So it's not just an education and training issue. So is it a prejudice issue? Is it an education and training issue? The answer is probably a lot of both. Some investigators have hypothesized that racial and ethnic disparities are more likely for the equivocal indications than when indications are clear. So maybe it's not so clear if they need. The device turns out more white males are probably getting it. In that circumstance, minority patients with established indications for CRT devices were less likely to receive it, but yet certain groups have been shown to maybe be even as twice as likely to respond better to this therapy. So the people who could benefit from it, most aren't necessarily getting it. Um, maybe they are, maybe the question that came up in another hypothesis. Well, maybe there's groups of people that won't do as well. So do we should we really be implanting these devices, as it turns out? Non ischemic cardiomyopathy is more prevalent in black and hispanic patients. And yet those are the people who again would likely do better with CRT therapy. So the argument that maybe some people won't benefit maybe there's not enough doctors to do it. Maybe maybe maybe all these things are possible as contributing to the disparity we're seeing in both race and gender between getting a device or not. As it turns out CRT. D. Or by v. Eligible hispanic and black patients in the N. C. D. R. Registry were less likely to receive CRT. D. Therapy than were eligible white patients That disparity exists. White patients were more likely to receive CRT defibrillators outside of the published guidelines. So when the indications were a little gray for that patient um And both effects reflect unexplained racial and ethnic differences in treatment for patients with advanced heart failure. But this also this also is pertinent to women. Another real world study among 78,000 male patients who are newly indicated for an I. D. Or by the I. CDI. 12,000 were implanted. Right? So only about less than 20 actually received a device when they needed it. Likewise, in women of 5800 patients, excuse me 5800 patients out of 46,000 were indicated for a device that's only 12% little over 12% actually got implanted. So again the saturation into who needs these devices isn't that they're not getting them. But it's even worse for women Devices were implanted in 15.6 of white patients, 14.3 of Hispanic patients, 13.3 of black patients and 11.2 of Asian patients. Again white men received a device more often than men. Of any other color device used in Asian women was lower at 9.5 than other female race groups. If you look at this graph, it can be a bit busy, but you can see each of the ethnic, um, labels asian, black, white hispanic and the gender female male showing who is indicated and who was treated and the percent that were treated. So you can see the numbers for white males and females are better than, well about the same for black females, but better than white males are better than black males. And you can see the significant disparity between white females and asian females. So this disparity exists across races and and within the genders. So in this real world analysis of device indicated patients there were disparities, both an ICD and see RTD across both race and gender device use was highest. Again, amongst white men, you can see the pattern that I'm describing with all these different registries and studies again highlighting the need for why is this happening? If we look at CRT therapy and men versus women, basically what I'd like you to look at is these Kaplan Meier curves, graphs and women are here this solid red line and you can see that this is a graph showing survival over years that see RTD and women, there's better survival than in men or just versus I alone. And in the non left bundle branch block. This is in the setting of a left bundle branch block, but in the setting of non left bundle branch blog women still favored a little better, but it was closer together. So again, the people who would benefit the most of CRT therapy, women aren't getting the devices as much. But yet we see their survival could be greater if they were. So again, it just doesn't seem to make sense that there is disparity, but it's there. And here we can see that there really was if you look at men and women that don't have a bundle branch block, there wasn't much benefit in either gender. But maybe in the group of women that have a Q. R. S. That's significantly widened. Even if it's not a left bundle branch block, they may do better. So again, we have evidence women may do better than men in certain groups yet they're not getting the device as often. What's known from that type of the study is that both genders will benefit in a left bundle branch block with a CRT or by the device. But that benefit is more pronounced in women. And so the bottom line again from that from that discussion was that a study population of 75,000 people, 32 were women. Unfortunately not 50 but 32 were women. Which is better than a lot of other studies comparing I. C. D. To C. R. T. There was a much greater benefit with a left bundle branch block even above 1 30. Now keep in mind the prior guidelines said left bundle branch block and Q. R. S. Greater than 1 50. But the studies like made it CRT and other studies show that Bennett women with the left bundle benefit much more dramatically than men with a Q. R. S. Of over 130. So our guidelines tell us that we can implant and we can expect benefit especially in women with non ischemic cardiomyopathy with love bundle branch block and the QRS greater than 1 30. So that guideline actually decreased the duration of that QRS. Because women benefit so much more. So is there any other body or physical characteristics that can make a difference? Is the disparity? All racial or socioeconomic? It turns out when that's been looked at the it's not there's nothing racial or socioeconomic really there to describe it. Do any other biometrics have a role? What if we take gender? Race and genetics out of the question? Do women really respond differently the CRT than men or is it more structural? So These questions are still debated, but women do respond differently. They do respond better than men given those circumstances of the cure restoration above 1:30 uh and non ischemic cardiomyopathy. So if we look at survival and I've broken this down into three categories pacemaker, icD and CRT and they can get busy but you don't have to be an expert in reading these types of grass to realize here's a pacemaker in general. The red and blue lines, they're pretty much superimposed. So the survival for men and women. So women being the red lines. Men being the blue lines or purplish pinkish reddish lines for women. You can see in pacemakers their survival is about the same and that's in single chamber and in dual chamber pacemakers I. C. D. S. The same thing. Survival is about the same. But look here in the CRT CRT defibrillator, women's survival is much better than men's and CRT pacemaker. Even without a defibrillator the same thing, Survival is much better in CRT. So why shouldn't this population of patients women be getting the devices as equal to men? Or even more so than men? Great question. And again it's something that's multifactorial. Um Is it more difficult to implant cardiac devices in women? Is that's the problem. Is that is that a perceived problem? Well, we know from looking at the data, women have a higher incidence of complications. They have a higher incidence of pneumothorax, hemothorax, cardiac perforation from leeds, perforating very thin walled, right ventricular apex or atria and resulting in Tampa not and requiring a pair of cardio synthesis. There are cosmetic concerns that may exist more in women than doing men. And there may be challenging anatomy, breast implants and things like that. But again, it's not the sole cause for disparity. Even when we look at the micro leaderless pacemaker, a new technology new. It's been around for like seven years or so, 6 to 7 years and it's a very popular single chamber pacemaker. Well, that's the entire pacemaker right there. And that entire pacemaker is delivered through a catheter from the femoral vein, Like a heart catheterization. But it goes, Catheter goes and it's a rather large catheter, 27 French. So that's a big catheter and it goes into the femoral vein, passes up to the heart, delivers this pacemaker. This is the entire pacemaker. If you're not aware of these, this entire device is about the size of two Tylenol capsules, and that's the entire pacemaker. It's delivered with the catheter. And these little Knighton, all metal feet come out of the device or come out of the catheter on when the device is pushed out against the heart muscle and those little feet grab onto the heart muscle and hold on and the electrode making contact is right here in the center, there is no leads, there's no surgical incision, the catheter is removed and the pacemaker is in the right ventricle only. But if we look at that procedure, and again, this was earlier on when doctors were learning how to implant these devices, it turns out even in this group of folks, the complications were much higher in women. So in male subjects, 426 female and in of almost 300 so less females. But end of 300 total major complications. About 11 in males with a 2.1 incidents and females there were 17, so 5.35 incidents. Well, why is there more complications? Well, if you look at these complications, it's about the same with DVT and pulmonary embolism between men and women. Growing puncture site complications, it's about the same between men and women. Again, it's a big catheter, but where there's a dramatic difference is in the traumatic cardiac injury or cardiac perforation, causing pericardial fusion. So what happens here is that those little knight in all feet may go through the thin wall apex of the right ventricle. Now we try to deliver these pacemakers to the a pickle septum and more on the septum than the apex, the apex of the right ventricle. The very tip is very thin wall, so those little feet can go through the muscle pretty easily. So perhaps a woman who's not hypertensive and has never had heart surgery doesn't have pulmonary hypertension. Perhaps that right ventricular apex, maybe thinner walled when compared to two males. So that could be a reason why there's more traumatic injury. Um but it's a definite difference between the two male and females here, um pacing issues about the same device, dislocation and such. Um Other complications where the it's just a little bit more than men occur down here in acute M. I. Cardiac failure, uh metabolic acidosis, things like that. What's interesting is in the a lot of the single chamber leaderless pacemakers that I put in, you know, we're pacing the ventricle majority of the time and I've seen a lot of those people that they've developed some right ventricular a pickle pacing LV dysfunction. And we've had to upgrade those folks to CRT therapy. So when we look at cardiac failure, you know, two of the patients compared to one in males, I would say that more. I put more of these leaders, pacemakers in women, especially older women who are very thin and don't have much subcutaneous fat and worry about healing here, who only needed a single chamber pacemaker. But maybe it's only because I put them in more in women than men that I saw the need to upgrade them to CRT from pacing all the time in the ventricle. So it's hard to really dig through these complications without knowing a little bit more about the patients. But the most important thing is here is that dramatic difference is between 0.7 and 2.7 in the trauma to the heart itself from the procedure. Well, if we look at gender hike, your restoration on CRT therapy as it turns out, CRT becomes most beneficial and shorter people and those that have a longer Q. R. S. So on average women tend to be shorter than men. They may have a longer left bundle QRS. Is that why they respond better? They have less ischemic cardiomyopathy, more dilated cardiomyopathy. All those potentially could be causes. So for taller patients they may still have a benefit if their QRS is longer. But the greatest benefit is even in short men, If the QRS is even less than 1:30. So there's a height difference. Bmi differences that exist amongst all these things as well. So A meta analysis of five randomized controlled trials including about 5000 patients, 23 women. You can see the list of all the studies here show that CRT benefit most profound prevented benefited. Those most profoundly that have the wider QRS or were shorter height. Most incurious operation that benefited had 162 190 milliseconds. That's a very long Q. R. S. Um Again there was a significant CRT benefit in short men even at a. Q. R. S. Less than 1 30. And it turns out the benefit was really independent of sex if there was a left bundle branch block. Um But women who are shorter on average have less ischemic cardiomyopathy may be the reason why they actually respond better. So this disparity exists. It's a lot of times people are uncomfortable talking about it because you think to yourself I'm not racist, I'm not sexist. I do. I implant devices and everybody the same. But as it turns out, everybody is probably saying that, but this disparity exists. Where does it come from? Does it come from the physicians who don't want to offer therapy? Maybe to some degree, maybe it's a lack of understanding on their part. Does it come from patients themselves? Well, I don't think I would benefit from that. That's not for me. Well, it turns out this problem is multifactorial. There's not one bad player here that is keeping women from getting these devices. Again, I believe it's multifactorial and I think we have to focus on both ends of the health care. Continuum prevention and delivery of evidence based treatment to teaching this to physicians, teaching this to medical societies to make sure they're disseminating this information. I think that people more often than not are influenced by those with whom they have a relationship. So their doctor, their their religious leaders, their friends, their social circles. So I think engaging all these people anybody with a stake in improving cardiovascular outcomes is important. And the only metric that should matter is the positive shift in cardiovascular health outcomes. I think we have to focus on community education, patient education and advocating for more quality measures and actually calling out the fact that these disparities exist and calling out the fact that unless these disparities improve certain things could happen that would be less beneficial to health care systems penalties. Uh Doctors having a scoring system to say how are you doing in your disparity between gender and race is with the therapies that you deliver. And we're talking about I. C. D. And pacemaker and CRT. But that may be something that's necessary to force this issue. I think we have to increase awareness of cardiovascular risk factors and evidence based therapeutic solutions for the currently indicated. I showed you that less than half of the people who are indicated for a device are getting a device now as a device and planter. That sounds may be self serving. But the reality is for some reason people are not getting devices and it may be the patient's choice. It may be a religious belief, a cultural belief, a doctor, lack of education, all the multifactorial. So we have to work in all these areas to help decrease this disparity. I think we have to partner with community institutions, faith based organizations in my world, collegiate and professional sports teams to get the word out to those athletes and to their families. Um non healthcare businesses. Why not go into a large corporation and have an educational program about knowing your risk for heart disease, another patient advocacy groups as well. And I want to finish by talking about, you know, to promote community awareness. I think we are, you know, hospitals try to do a good job of having health fairs and everything. Covid changed all that because everybody can't get together right. But that's going to end one day and we'll be able to get back together. And I think we need to press this issue even further health screening events, risk assessments like we do with the P Save a Life for those of you who know what that is. A foundation here in town that I'm very active in. A lot of us are that work here that volunteer there. But basically to do risk assessments and screenings and we try to extend that to the families as well. And I think doing a better job at even doing that, especially events focused on women and minority health, whether it's radio tv, podcast, print media, digital media. Getting that word out there as much as we can. Church groups, parent teacher organizations, women and cultural organizations, health clubs, weight loss clinics, anywhere where people gather, especially if they're concerned about their health. We have to get this information out there. So if you take home something from this, know that gender, gender disparity exists. Racial disparity exists when it comes to device in plantations and many other areas of medicine. But it's multifactorial and I think we all have to do a better job myself included about helping people understand this exists and how to remedy it. Thank you Dr Rogers. You know, I really, really I think that's such an important topic and I really appreciate that you actually offer some suggestions to. I mean we're obviously bringing up the purpose. One of the purposes of this whole symposium is to kind of create awareness and put it in everybody's face, but also it's really nice that you actually have some suggestions, rather than just saying, okay, you know, what do we do about this? I really, really appreciate that. Um I know Dr Rogers has to run back to the hospital. He does have a great case presentation specifically talking about the challenging anatomy of women breast implant, that sort of thing when it comes to implant. So we're going to save that for 12 15 when we come back for the case presentation, so hopefully you'll be able to do that then, and otherwise, thank you again. Any questions for Dr Rogers will will also take at that time as well.