Dr. Ulrika Birgersdotter-Green outlines gender disparities in cardiac treatment and device selection for primary and secondary prevention in men and women.
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Dr lorca burger's daughter Green. She is a board certified cardiologist who specializes in diagnosing and treating heart rhythm disorders. She directs the pacemaker and I. C. D. Services at U. C. San Diego health and leads one of the largest lead extraction programs in the Western United States. Dr burger's daughter greens. Research interests include the mechanisms of arrhythmias, cardiac re synchronization therapy and developing new methods and indications for cardiac device implantation as well as lead extractions. She is actively involved in large clinical trials evaluating by ventricular pacing therapy for heart failure management, new cardiac device technology and publishes regularly in electrophysiology journals. She's also co authored several major consensus documents including cardiac device regulations and served tutorial review board for several prominent medical journals including Heart rhythm and the Journal of the American College of Cardiology and the american Journal of Cardiology. Dr burger's daughter Green completed her fellowship in cardiology and cardiac electrophysiology at U. C. San Diego. She completed a fellowship in clinical pharmacology as well as her internal medicine residency at Vanderbilt University in Nashville. She earned her medical degree from the Karolinska Institute in Stockholm Sweden and his board certified in cardiovascular disease and electrophysiology. So please join me in welcoming um one of our local friends dr burger's daughter Green, speaking to us about gender disparity in cardiac device selection. Well thank you john and thank you the scripts for having me. I'm really happy to be here in person not in person but in spirit to to talk about something that I think is really important. So we are going to discuss gender disparity and cardiac device selection. These are my disclosures. So when it comes to defibrillators then it's the recommended treatment for primary prevention and secondary prevention. Those who survived the life spread when you read may require sort southern cardiac arrest importantly in men and women. I'm just gonna check my my mic for a second. We just said that the I. C. D. Therapy clearly recommended for primary and secondary prevention. And the recommendations are for men and women equally. So but this is a brings up the first question which I hear a lot about when when you go to meetings is that you know maybe we just put too many defibrillators in. So rather than not putting enough devices in women maybe we put too many I. C. D. S. In men. And I think that's a reasonable question. I think we should try and see what the answer to that is. And there's actually plenty of data here. Um This is from a large data from the uh registry. Pretty recent data where they demonstrate that they looked at I. C. D. Use among Medicare patients with low ejection fraction after an acute. Um I mean this is really your perfect I. C. D. Patient. Right. They posted my patient with a low ejection fraction. And in this large registry in the US Fewer than one in 10 eligible patients received a nice city within a year after an Emmy. So that would certainly suggest that we are far from over using it in our most if you so well. Traditional indication there is other data as well. So on on the left here you see get with the guidelines studied. This is a large large conglomerate of data in how we manage our Philly patients in the U. S. It is specifically looked at hospital use of the federal laters. When they were sent home from the hospital they had an I. C. D. Was indicated How many hospitals send patients home with the defibrillator. Well there were a few hospitals that close to 100 of patients got the indicated icd. But there were also plenty of patients with hardly any plenty of hospitals were hardly any patients who made the indications were nice to be ended up getting the on the right here is data from outside the US the global survey looking that at the heart failure patients this church from the hospital. What kind of therapy were they getting? And you can see across the board reasonably well here with the medical management. But I'm trying to do a little bit surprising if you start looking at by the I said this and I said this that actually more plenty more patients were sent home on everything else but not the defibrillators. And that's that's global data. This is data from a glide HF. Data provided and given to me by dr m. Curtis who is part of this large study. And what is interesting here in the glide HF is that they're looking at And aggregate data across the country using electronic medical records. So now you can of course tap into a large patient populations. So in this conglomerate data set they have over 100,000 patients and they asked the question and in patients with heart failure, reduced ejection fraction who had an indication for primary and secondary prevention. I. City Overall look at this this is 75,000 patients 11 received. In I city. They looked in secondary versus and primary prevention. Primary prevention of Cities. eight of patients. Secondary prevention there shouldn't even really be a question, right? Secondary prevention again, are patients who have survived the cardiac arrest. We have a much higher risk of having another episode of southern cardiac to Those patients we should be looking at the same time kindly say 70%. But they have only 41 of those patients in the US. receiving a secondary prevention indicated I. C. D. I think it really points to the fact that we can solidly answer the question. We are not over using I. C. D. S. And men. It's across the board under use of high cities for both men and women look a little bit more than its secondary prevention i cities. And the comparison between men and women and here what we know is that women have overall a lower incidence of sudden cardiac death than men. And this is even after accounting for predisposing factors. You know, my corneal infections, heart failure overall women have a lower incident women who do suffer and out of hospital cardiac arrest or an average older. They are more likely to present with a. P. E. A. Arrest and they're more likely to have their arrest at home as compared to men. On the other hand, um women, especially those younger women had a higher rate of successful resuscitation and also higher survival from shock people rhythms. And I think the last bullet is something that is incredibly important to keep in mind, which is the majority of women who die from Southern Kardec that we had no higher diagnosis of heart disease. So this was the first symptom that that woman had a heart disease. So there are a lot of interesting differences between men and women in the presentation of secondary prevention indications. So knowing that, you know, maybe maybe women don't respond as well to secondary prevention I city. So maybe that's why women get less secondary prevention I cities. Because they do, if you compare secondary prevention implants, Men are 2.4 times more likely than a woman to receive a nice city again under the same circumstances. And the issue is not that women don't respond as well because the fact is that men and women have the same clinical benefit for nicety and secondary prevention. And this is true, especially at an older age about primary prevention defibrillators. Then If you look at how many are men and women, 40 of patients having heart failure with reduced ejection fraction or women. So it's a sizable component of our patients are women. They tend to be older to diagnosis. They have a higher prevalence of hypertension, vascular heart disease and non scheme according to offer the patients than men and are less likely to have preexisting coronary disease, atrial fibrillation, M. I. Or stroke. So certainly it's slightly different patient population overall now do men and women get primary prevention? I. Cities at the same rate they do not. So men are this time even more likely to receive the defibrillator than a woman. So three point times more likely to receive I. Cd therapy than a woman. So here's another question that comes up and in the primary prevention spectrum maybe women don't want a nice city. Um And I think that's something we should take a look at you then And people have so going back to get with the guidelines again which again has a lot of patients in this ongoing data collection. So here the looked at over 21,000 patients and um if then were already asked if they should if they would like an I. C. D. Or not presume that they met the indications. So women were less likely than a man to receive I city counseling and that was 19 versus 24%. So I will first of all say neither men nor women really got counseled nearly enough on whether you know they should have a defibrillator or not but women even less than men. However if men and women were council there was no difference between women and men in utilization suggesting in this large patient population then then if this is offered to a woman she is just as likely to say yes to the therapy as a man will be. Um This is from a recent meta analysis of several of the most recent I. C. D. Trials. And what is meta analysis set out to do then was to compare and you can see a patient who got a defibrillator versus patients who got optimum medical therapy only without the defibrillator. And then they compared men and women to see who benefited more and overall. You can see here that men across the board in all these studies fell on the side of favoring I. C. D. Therapy. So they did better with I. C. D. Therapy than than with medical therapy alone. Whereas with women it was not as clear cut and women kind of fell here more or less in in the middle arguing then that perhaps women don't do as well with primary prevention niceties. So why would that be then why would women benefit less from a primary prevention defibrillator? And we don't have a clear cut answer to that. But certainly women have a higher prevalence of long scheme occurred in my office who tend to benefit a little bit less. They have less particular arrhythmias overall. And women also appear to have a less aggressive arrhythmic profiles are less susceptible to ventricular arrhythmias and less vulnerable to sudden death. But something you absolutely, we all need to keep in mind here that there is a clear underrepresentation of women in clinical trials And in the registries were 8- 32 and two dates. Their studies have not been powered to detect sex specific differences and any reported interactions. It's all through subgroup analysis. And I actually just listened to a talk very recently for the european heart rhythm society. I thought it was very interesting. Uh They had they presented the data from europe. It was a large registering several countries provided data on ICD use in those countries. They had about 2500 patients and they were talking about the fact that women may not benefit as much. That may be true, but the % women here was 18 18 of patients representing data coming in from multiple countries in europe. I mean at some point we're going to have to say, you know, we we can't just guess right, we're guessing right now. I didn't want to say anything. I would have loved to say something during that study and said really that was the best you can do and you're presenting that. It's this is this is what we look at here and I made it to it started. It was so frequently quote, right, this is the number of women was 18% here, scalp has a little bit better companion. A little bit better carry Jeff. I mean across the board you can see these studies that are quoted all the time in I. C. D. Trials. But how can we say anything about the the whether women benefit or not because they were barely enrolled in these studies. So if you look at women and primary prevention, I. CD therapy kind of summarize stamp men are overall more likely to receive I CD therapy for both primary and secondary prevention. But women and men experience more benefits from the icy for secondary prevention. It is a little less clear in primary prevention. I. City therapy and women are underrepresented in I. C. D. Clinical trials. What about car decrease synchronization therapy? Them? Um We have lots of good data here too. Um This is data from improved HF. Which is another large registry studying looked at evidence based heart failure therapy. In the outpatient studying their study did show that Syracuse underutilized again in patients who met indications but they did not appear to be a sex difference in utilization, suggesting that perhaps we do a little bit better with CRT then we defibrillator when it comes to men and women. Uh sadly though if you go back now here and look at the data from glide HF. Which is again the use of aggregate electronic health records. We're probably not doing as well as we should. So this is here is looking that at patients with a new indications for a bi. V. I. City and Overall so they had a 22,000 patients Overall 32 received an indicated device. Now what about class one indications then? You know those are the ones we love to put. I see Ortiz in left bundle branch blocks wide, curious really should benefit from CRT. 50% here received a class one indicated CRT D device. So I say here too just like I did with I. C. S. I don't think it's the biggest problem is not that we're not putting in any women. The biggest problem is that all our patients who should at least be assessed for a device is clearly not getting that done. We know a lot about women and Kordic re synchronization therapy at this point. Again they are underrepresented in clinical trials and an important right. The prevalence of heart failure is similar in men and women but under represented in the clinical trials. We also know the C. R. T. Making for greater benefit than women than in men, particularly the setting of long schema, cardiomyopathy and left bundle branch block. Women also have a shorter based on pure restoration. So relatively more dissing Quran E for any prolonged your restoration. Which may also then contribute to a better CRT outcome. And that has definitely been demonstrated now in several big studies made it CRT that they had pre specified subgroups in in that large categories synchronization study including were part class to patients. And you can see that women as a pre specified subgroup really did well and benefited from the C. R T. D and and a lot. So more than the man. Another study looked at also the information CRT looked at risk of death or heart failure specifically by gender. They broke it down. So they said, OK, let's look at the total population. That's your heart failure. Heart failure. Only death at any time compared women and men. And and here you can see women overall benefited more than the men from CRT. D. They broke it down to look at your restoration to see what's the difference in cure restoration. And yes, as I alluded to earlier women and more benefit even at the more narrow cure S as demonstrated here once the curious for over 150 milliseconds than both men and women benefited similarly. And then they looked at breaking it down and left under branch for to see if there was a difference and the trend here was both men and women did benefited women even a little bit more uh huh. In the setting of the left bundle branch block. So pretty much across the board, breaking it down in different groups within mated CRT, women did very well and benefited more than the man did from C. R. T. V. This was also demonstrated in another study that we frequently vote when it comes to benefit a product reason. Contestation therapy. That was the raft study. Also looked at the benefit of category synchronization therapy and in new york has to patients specifically. And again, demonstrated an overall benefit from women for women. And more so than then. So if you're going to look at women and CRT to summarize that women benefit from CRT more than men in the setting or non ischemic cardiomyopathy and left underground spot. But again underrepresented in clinical trials. And I thought since we're talking devices, we should put in something about pacemaker students as we do put a lot of pacemakers in. And there are some differences between men and women here as well. If you look at indications sick sinus syndrome in atrial fibrillation is that typically the main indications for pacemakers and women in men. The most common indication is a B block complications are a little bit more common. Certain complications, I should say, are more common in women. Mm A stork's pocket team are thomas are more common in women may be related to a smaller body size vessel diameter and they have a little higher rate of perforation, a thinner RV wall and hospitalization for device related infections are more common in men. I think this similar findings are seen for stds and Crts as well. Um data from 1993 to 2006 during that time period. Um 2.4 million pacemaker patients received a pacemaker in the us and almost 50 of those were women. Um and this is one of the few therapies then that we we offer that looks like we're actually doing well. Men and women are both getting this s indicated And women do well with pacemakers. 30 year follow up study found that women survived longer than men despite being older at the time of getting the pacemaker implanted. And it's probably going to look at more recent data. So this is data from the micro leaderless pacemaker registry Um or women getting that and and here in this smaller patient population, 41 of the patients who are women. So indicating that we are doing well overall, I think in the balance between men and women for peace makers. Coming back though to what I think is so important, which is, we really need to make sure that we involve women in clinical trials. So we can really understand um, differences and indications. This is an example of women enrolled in clinical trials versus women with the disease. And you can see across this coronary artery disease, heart failure, diabetes all across the board, there are plenty of women with the disease, but not enrolled in proportion to the number of women in clinical trials. This is a little bit of older data. Um, but from for a very long time, there was absolutely no improvement in the enrollment of women in cardiovascular clinical trials in the US. If we Didn't budge from 1990 70 2009, it is getting better though now. So we're definitely seeing a trend in the right direction. And and this is no because this is really also mandated FDA start. The mandates NIH studies will not provide funding unless they we look at diversity in the inclusion in clinical trials the way it really should be. So, what can we do then to improve gender disparity? Well, first of all, I think we need to make sure that both men and women can get guideline directed C. A. D. Treatment. Right? That's that's absolutely number one. We do need to look at improve the enrollment of women in clinical trials. I think that we continue to work on increasing awareness of gender disparity. Us. We do that through education and I love that this talk is on on this meeting to do exactly that. And I think there's something to be said for encouraging mentoring and supporting women to go into cardiology to have women treat women. And with that I'm going to say that on behalf of myself and the UCS, the women in the older faculty, thank you scripts for putting this really important talk on the agenda. Thank you. Thank you Ricky. That was wonderful. Really appreciated um everything you said and very helpful for me as well. And um we have time if there's any questions uh that anybody has raised, I haven't seen any come through yet, but I'll go ahead and ask you on Ricky. So being in the role that I play very similar to the role that you play at U. C. S. D. Um you know, I I believe that myself when I'm seeing a woman in consultation or in the preoperative area, I believe I don't see the difference as far as I would withhold treatment or a whole devices because of the gender but how much? But I think a lot of that must exist because like if you pointed out there is this disparity between genders and how what I guess my question would be is what's your thoughts on, is there bias? Um I will say against women maybe unintentionally, maybe subconsciously if you will that maybe a woman won't want this cosmetically, maybe they won't want this for some other preconceived notion that may come from male or female in planters or people who are advising them about the device. Do you think some of that disparity in addition to the education and fostering exactly everything you said? I agree with completely um and mentoring more women to go into this field. But do you think that those biases exist truly subconsciously or even maybe consciously, I think that they must because I would like to think the same way is that we look at all patients equally. But I think subconsciously there must be something uh that that shifts our line of thinking a little bit. And and this this one particular thing about the women may not wanted that, that I've heard a lot and I was, I hear it, but I've never heard a woman say to me, I don't want it in in a higher rate than men do. Um So there was a good study to document that once they're asked and have a good discussion about it. They women are yes, likely is meant to get it. No and Ricky thank you. And I just kind of an interesting story. I had two young women that I was implanting the implantable loop recorders and both in their one late teens, one early twenties with recurrent sync api with injury. And I happened to mention to them, oh, I think we should put this down below the breast. And I was thinking cosmetically they're they're so young and and in discussing and they both said no, no, no, I wanted up where it's supposed to go and I said, well that's interesting. Can I ask why? And they were both volleyball players and they, you know, there's the there's gender difference. But then there's the lifestyle that they when they dive to hit a volleyball, they land below the breast, not adopt the breast. So that was that was a very eye opening. Come come to truth moment for me not to preconceived where I think I should put something, you know, is to to bring them into that discussion. That's that's that's great. And and that may be where we're having a woman cardiologist maybe a little bit more likely just thinking about certain things like that. Yeah. No I think that's I think that's a great point Ricky. There is a question that looks like it's a three part question and I'll just ask them one at a time. Um Or perhaps the first. Yeah let's go one at a time. Is is it male doctors who less often refer women for I. C. D. S. Or is it known that the sex difference between the doctors who recommend it? Do we know is there less referrals from male doctors than from female doctors? So I have I have not seen the data but I would the problem here is that there's such so few women cardiologists that if you look overall um you know there is a 15 of our cardiologist are women so it's gonna be hard to get even that data kind of bias all the way around. It's a biased all the way. Another question. Um is there any insurance based prejudice and approval of device therapy for men greater than women? Yeah. Yeah. Yeah. I don't know. Guideline. And no insurance policy ever says only in males are not in females that I'm aware of. Two. Yeah. And then the last question is kind of a very open question because I think there's so many aspects to this. But why do you think women are underrepresented in trials? Oh yes, that's a big question. And it is a very good question because we why how can we do better? Um So it comes back to to several things. Um it comes back to being asked and perhaps a woman cardiologist is a little bit more likely to enroll more women because she wants to see that happen. Um It may be that men are a little more likely to come to to the doctor's office and when women come in with their disease they're a little old, her little sicker. And you start thinking you know maybe I shouldn't enroll her. Maybe she is you know a little frail. Which may not be the right thing at all. But you start going down that line of thinking. Um I mean it's a it's a very multifaceted and and challenging question. Can I make a comment? Um My friend at mid America Heart Institute, they did a very interesting study when the EMR came out. You know they said you know we want to try to because they saw both a racial and gender disparity and I. C. D. S. And they say what can we do this? So they put an automatic reminder. So when When you were seeing a patient and there was less than 35 you just got a reminder on your computer. This patient might be a candidate for device. And you can do three things. You could say this patient has metastatic cancer. They will never be a candidate done. You could say I'm tight trading medical therapy remind me in six months or refer the patient to the device clinic in which case they would talk to a nurse practitioner of the device. And the gender and racial diversity immediately went away. So there must be an unconscious bias and if we're reminded but it doesn't you know we have to act and these I think we all have to be aware that we have unconscious prejudices that we have to fight against. And you know if there's one thing if the market help us become more diverse and more fair than I'm all for that. Yeah, That was very interesting. Data. Tom do you have been published? Yes. Yes. I'll get you the reference. It's about 10 years ago or so.
