Dr Amin Yeyha discusses the collaboration between heart failure and device specialists to improve patient outcomes by ensuring appropriate timing and sequencing of therapies.
Well, good morning everyone and uh thank you for those who joined us this morning either in person or in audio. uh we'll be talking today about optimizing heart fair treatment, the synergy between device therapies and contemporary GDMT. These are my disclosures. I will not discuss off-label on investigation use of any drugs or devices. So we'll be talking a little bit about the current GDMT and is it enough for our patients with heart failure. And then we're gonna talk about also the device therapies for managing patients with heart failure and reduced ejection fraction mainly. Um, just a quick reminder for everybody that heart failure is growing in numbers, and every year the total number of adults in the states with heart failure continues to increase. Around 6.8 million adults in the states have had heart failure, and this number, as I mentioned, will continue to increase around more than 8.5 million in 2030 and even. More than 11 million by 2050 and I think it's gonna be much more than that because every year we're diagnosing more and more patients with heart failure and preserved ejection fraction knowing the increase in uh the comorbidities being obesity, hypertension, and more aging population. So it's not just like we have increasing numbers for heart failure, but also we have increasing heart hospitalizations despite Having the GDMT as we can see here from the latest publication, uh, late last year, we have seen the number of hospitalizations continue to increase around 1.3 million hospitalizations are attributed to heart failure and it's the number one associated diagnosis with 30 days readmissions. Not only hospitalizations going up but also uh mortality which continues to go up as we saw, uh, we can see here in this figure, um, 2012 was the lowest mortality rate but then um in 2021 it peaked, um, again, uh, with, um, despite having the resto at that time and as as the altitu inhibitors were approved at 20, um, close to that time as well, 2019, 2020. So, um, again it is contributing cost for around 400,000 deaths every year and 45% of all the cardiovascular deaths are because of heart failure and out of the total deaths in the United States around 13%. Uh, the one year mortality rate for patients who are ambulatory with heart rate around 13.5%, and as we have more hospitalizations, the mortality rate increases. So what are the treatment, um, approved treatments for patients with heart failure and reduced ejection fraction? This is the algorithm that has been utilized and used and according to the latest and uh guidelines and recommendations, patients with heart and reduced EF with EF less than 40%, they need to be uh. On, uh, guideline directed medical therapies which include the four pillars, the beta blockers, bisoprol, metoprolol, succinate or carvedilol, MRAs, as inhibitors, and intresto or Arni ideally, and if they're not able to do that, it could be, uh, ARB or lisinopril. And uh if patients remain symptomatic despite being on these maximum tolerated dosages of medications if they're African Americans with NYHA class 3 and 4, you'd consider hydralazine nitrates and you check their ejection fraction. If their ejection fraction less than 35%, these patients need to have an ICD as a primary prevention. And if these patients continue to progress on GDMT or having worsening of symptoms, increased hospitalization rate. Uh, or inability to tolerate GDMT, these patients should be evaluated for advanced hardware surgical options, or even palliative therapies with ionotropic support. So these are the as we talked a couple of minutes ago about the GDMT and despite having GDMT or guideline directed medical therapy, we continue to see that there is increased mortality rate around 9% of patients on maximum tolerated GDMT continue to have around um 2 year mortality because of cardiovascular diseases, so you know this. If you want to treat 4 patients for over 2 years' time, you can save 1 patient from cardiovascular mortality. So again, even though we have great therapies, the mortality rate, despite being on therapies remain high. And one thing I wanna uh mention as well too is that not every patients or not all of us are able to get these patients on GDMT around less than 10% of all patients with heart failure are on the target dosages of guideline directed medical therapies. So again there's a lot of work to do on our end to try to get our patients on optimal medical management. So again, despite medical therapy, the survivor rate and hospitalization rate continue to be high. So how does, um, device therapy basically work along and come in the picture, try to help support patients with heart failure? Just a little bit about device therapies, they started in 1962 when the first surgical placement of pneumatic pump similar to and LVAD started. And With time it was very hard to identify and find the benefit of these therapies because getting trials uh to get these therapies approved is pretty expensive and it's time um intensive in nature. So the FDA introduced uh in 2015 the ex expedited excuse me, access program which later transformed into the breakthrough device program in 2018. Uh, where the goal is to try to speed up the process of getting these devices approved, um, and treating high impact diseases such as heart failure. There. 510202. So CMS increased hospital reimbursement also as well because you know uh these devices, there's not much good reimbursement for the devices um for the hospital system so they were not very much endorsed so again there was increasing reimbursement and that has showed the rapid growth of device therapies and the trials for these devices so this is the uh you know uh figure from also latest. Um, consensus document by the American College of Cardiology, American Heart Association, and Heart Sci of America where we can see where device therapies can come into play basically for patients with heart failure and reduced CF as we can see here, when patients get diagnosed with heart failure, we start to put them on guideline directed medical therapy, and they might do well, but there's a point in time when these patients start to decompensate again. And um it is kind of the time where we have to think beyond medical management especially if the patients are optimized or optimal dosages of medications and here we can talk about the ICDs, uh, CRTDs, but also. The other therapies are available for patients with uh heart failure and reduced EF which could be benefited, which is the M tier which we're gonna talk about TAY um for the tricuspid valve, also, um, devices and remote monitoring and the bar reflex activation and CCM. We're gonna talk a little bit about, um, each one of them, but this is the time where we have. To think about these patients and again as I mentioned, if the patients decompensate and don't do well um then we have to think about uh advanced heart for surgical options. So ICD therapy is basically is recommended for primary prevention, uh, for sudden cardiac death and secondary prevention for sure, but, uh, this is the latest publication, uh, in Jack Heart failure which um. Published with a group of um leaders in the field, uh where you know we started to rechalenge the idea of the timing for ICD therapies and most of the trials as we can see here made it 1, made it 2. And all these trials were done where medical therapy, the optimum medical therapy included patients on beta blocker or ACE inhibitors, and even the initial trials that were done were not an optimal dosage of the medication, lower dosages of these medicines, and now we're living in time and day where we have a lot of medication which improve improved survival, improved LVF, and reduced risk of sudden cardiac death. So in this, um, our review we started, um. To rediscuss the process when and who are the patient would identify uh would benefit from uh ICD uh therapies compared to the standards because. Probably you've seen it in your practice that we have seen patients with ejection fraction improving with time on uh on GDMT, and I have seen multiple patients of ours. Her EF EF were like less than 35 and after 3 or 6 months' time the ejection fraction improves and their need for ICD therapy um is not there anymore. What about the mitral and tricuspid valve therapies? Doctor Summer's team, um, they do a great job, uh, identifying these patients, and we work closely together in the, uh, multi, uh, disciplinaryval conference. We meet every Monday or either in person or virtually to discuss different patients' therapeutic options. Uh, we have the Mitra clip which, uh, you know, it is approved in 2013. After the trial of co op trial, which was a landmark landmark randomized control trials in around 600 patients with at least a moderate to severe mor regurgitation, uh, who remains symptomatic despite GDMT, uh, so the COA trial, uh, they found that patients who received the mira clip at um. Basically 2 and 5 years they have reduced all cause mortality and reduced heart failure hospitalization, which is pretty impressive. Uh there's another small trial called the MRFR trial, which is more randomized controlled trial, less than 50% of the patients from the COA trial. This trial did not find difference in all cause mortality or heart for hospitalization at 12 months. Um, that's, uh, unlike the CA trial and one proposed reason for it are the differences, um, because the, uh, patients in the Mitra FR, um, are different than the patients, uh, with the co op trial because those had more severe MR and the LV is uh less dilated. So if we're looking at the 5 year follow up with the COA trial, which is also published uh a couple of years ago in June 2023, New England Journal of Medicine where we can see that the outcomes remain significant. It for with 5 years of follow up and this is the control group and this device group hospitalizations for heart failure is significantly lower in the device group and also all cause mortality is lower in the device group which is the Mitra clip patients compared to the control group and when they looked at looking at the outcomes separate in 3 years and 5 years. The main benefit occurs within a 3 year period of time, but also you can see here after 3 years the benefit continues to be evident as well. Uh, the other devices for, uh, basically the mitral valves, the Pascal, which is by the Edward Science approved in 2022, it utilizes a different, um, procedure methodologies, people in the cath lab who work closely with Doctor Summers and his team. Uh, the pascal basically uses broad paddles and it's grasping mechanisms to the apparatus. It has a spacer and 3 catheters, um, opposed to 2 in mitral clip and making it more favorable for complex mitral anatomy. Um, the clasp 2D trial compared the pascal against the mitral clip in patients with primary or degenerative mitral regurgitation. There was this trial was non inferior in major adverse events and mitral regurgitation reduction at 1 year, and they're looking to follow up these patients for 5 years. Secondary outcomes, uh, also showed improvement in your heart associations, heart failure symptoms, 6 minute walk, and quality of life. What about the TMVR or the trans catheter mitral valve replacement, um. By Sapien Edward Science, it's approved in 2021. It's also another viable options for patients with severe asymptomatic AR who are not candidate for surgery. And as you notice here, it is mor valve replacement compared to the mat valve repair which we use it for the mara clip in the pascal, um, uh, so this is a trans catheter matri valve replacement. So in contrast to mitral clip and Sapien M3, as you see, is used for patients who need valve replacement, not just repair, particularly in patients with failing bioprosthetic valves or with severe annual calcifications, and probably, um, the Acute who go and work closely with the structural heart team can be looking out for these, uh, calcifications and the mitral valve anatomy, Doctor Cohen and. And others as well, uh, be, um, looking at these images pretty close. So today there are no randomized control trials exist directly comparing the sapien to the mitral clip, but they did a propensity score matching that showed that TMVR was associated with superior reduction in MR severity and superior symptomatic improvement. However, mortality rate post procedure remained higher than, um. TMVR basically. What about the triclip? uh, triclip is also utilized, uh, for patients with severe tricuspid regurgitation, um, and basically it's, uh, manufactured by Abbott and it also use trans catheter edge to edge repair and it has shown to reduce the severity of tricuspid regurgitation. It was approved in 2024. The main trial was the triuminate trial. And it's basically randomized patients 1 to 1, uh, with patients with severe TR either receiving triclip or received uh medical therapies and. Though at 12 months there was no significant reduction in um heart far hospitalization between the two groups, but if you look closely there is a trend towards uh lower hospitalizations, but there was significant improvement in quality of life and um reduction in TR compared um to others. So again it's uh one of the therapies that we're using here too. Uh, the Evoke is also similar to to MVR. It is, uh, it's used for the trans catheter tricuspid valve replacement as you can see here. It's approved in 2024. Um, the Transcend trial, which, uh, you know, study that evoke, um, valve. Noted improvement in New York Heart Association, KCCQ and 6 minute walk, and the Transcend was, uh, transcend was a randomized trial comparing device group versus optimum medical therapy similar to the tri-clip, uh, the tri-clip again it is, um, it's like matriclip like a repair. Here is a replacement, um, but, um, again we have improvement in. Quality of life and 6 minute walks um again when they compared Evoke and tri-clip evoke system may be more suitable for larger coaptation gaps or more complex valve anatomy that makes edge to edge repair difficult similar to that tri-clip uh and uh clip I'm sorry, and TMVR TMVR usually for more severe cases, um, and have more complex anatomy. So moving on to the pressure sensor monitors and um patients that we see in the hospital or in our clinics when they start developing symptoms of shortness of breath or weight gain um it's most of the time. This has been brewing for days, not even weeks before, and if we're able to catch these patients early on through um pulary pressure sensor monitoring would be really good because as we can see here, the first thing that happens is increasing in uh filling pressures and then there's some uh antigraphic impedance changes and then we have the weight changes and we have symptoms and then eventually end up at the hospital. So cards which you use it uh here at Centera um across the system which are pulmonary pressure monitor pressure sensor monitors which can help detect um increases in intravascular volumes and cardios has been approved to decrease risk of heart fail hospitalization. The main trial that has um got cardioms approved with the champion trial which showed that there are on 28% reduction of heart fare hospitalizations after 6 months. And when they looked at utilizing cardiomes to optimize GDMT in outpatient setting, the Monter HF trial demonstrated that patients who are managed by cardios had, 00, OK, yeah, yeah. Oh, no worries, yeah, perfect. So, uh, the monitor HF demonstrate that patients managed by cardios had significant improvement in quality of life and reduction in heart for hospitalization. This is the cardiomes, as you can see here, um, pretty simple. We go through either the neck or the groin and we implant it in the pulmonary artery. Another for pulmonary pressure sensor monitor is corella, which we, uh, did before and my colleague Doctor Barrier. And Doctor Old um implanted it and our center was one of the early implanters, uh, as we can see here, um, you know, with Cordella we have, uh, it's implanted the right pulmonary artery and, um, it is basically it collects in addition to cardiom's, uh, pressure, uh, intravascular pressure that can also collect data on the blood pressure, 02ATs weight and heart rate. Uh, the main trial was a proactive HF trial which was published in Jack Heart failure as you can see here, it had 4456 patients with NYHA class 3. They were implanted through an open label single arm study, and they looked at these patients, and they found that with remote monitoring of seated, uh, patients, as you can see here, patients don't have to lay on a pillow. They can hold this handheld device while they're seated or they're standing, and they can transmit directly. Um, and it showed that, you know, remote remote management is safe and results in lower heart fare hospitalization and mortality. It was approved in 2024. We're not implanting it uh here now because we had a couple of implanters again, Doctor Barrier who's not here anymore and Doctor O, and we're just doing uh mainly cardioMs in our center here. See? So the other uh pressure sensor called VAP, I don't know if, uh, and if you heard of it, it's a victorious left atrial pressure, it is a little bit more invasive than the cardioams because it's a leadless left atrial pressure sensor. So with the cardioomes we detect, uh, mainly the PAD or uh pulmonary artery diastolic. Pressures which kind of another way we can say correlates with the pumer Capri wedge pressures which we think it can correlate mainly with the left sided feeling pressure so but the victorious um left atrial pressures is go straight into the left atrial um system and we can detect pressures directly there. So vector HF was the trial that studied this device. It deemed it to be safe, but there's no significant reduction in heart for hospitalizations or cardiovascular death, though the sample size is 30, which is pretty small, but as you can see here again, it is safe, but it is pretty invasive. We have to do like transeptal technique and there is a high risk of complications with it. And it did not gain traction as of yet though the trial has been uh published recently as uh you can see here, um, and but it doesn't gained traction in the United States, mainly it's in Europe. So the interim results from the vector HF, um, studies showed a decrease in heart fare hospitalizations and improvement in 6 minute walk and KCCQ scores. But what do the ACCHA guidelines recommends so um. We also have to mention something we have HeartLogic which is used by Boston Scientific as well. Heart logic, uh, for patients who have, um, the Boston Scientific ICDs can give us a score, uh, which is, you know, the higher the score, the higher the chances of the patients to be overloaded and the higher the risk of. ization s but the American College of Cardiology and American Heart Association and HFSA currently give cardIMs only class 2B, which is um low uh level of recommendation but still cardioms is the one who has um has been endorsed by the uh societies. As a result, and other therapies such as heart logic or others are not been recommended yet. It is, you know, they said per guidelines results from previous clinical trials do not support the alternative remote monitoring like non-invasive telemonitoring or remote monitoring, um, such as the heart logic. What about autonomic nervous system modulation, which is also uh gaining a lot of traction recently and we implanted here now in our facility. So on autonomic nervous system, uh, there's in heart failure there's are imbalances between the sympathetic and parasympathetic nervous system. Um, usually the autonomic nervous system modulates heart rate, systemic vascular resistance, arterial blood pressure, and cardiac after load, um, and the stimulation, um, usually results in maladaptive responsive responses and cardiac remodeling. So there are some devices which we're using, as I mentioned, the bear stem, uh, which we're implanting when work closely with our vascular surgeons, um, bear stem are devices to modulate the autonomic nervous system. What do they do? So bear stem includes a pulse generator usually on the right side, similar to the ICD on the left side. But this pulse generator is connected to a wire that stimulate the carotid, um, basically bear receptors, and, uh, it can increase the sympathetic and lower the increase the parasympathetic excuse me, and lower the sympathetic nervous system so it's simply the carotid bear receptors by electrical impulses, uh, from the generator and leading to cent mediated responses as I just mentioned. So this Behr stem uh came after the BTHF trial, which is a multi-center randomized trial around 400 patients, uh, with EF less than 35% and antipro BMP less than 1600, and they had NYHA C class 3, and these patients did not have indication for CRT. What this trial showed is that there's improvement in quality of life and exercise capacity, decrease antipro BMP and trend to decrease heart fare hospitalizations again because we see a lot of patients. Who want to focus on quality of life, and I've seen a lot of patients in our clinic who we implanted their bare stem. These patients were not able to walk. They were on like a wheelchair because they're so fatigued and they don't have good quality of life. And after the device implantation, they were really doing much better. They were walking to clinic. They have good quality of life. So if you have those patients out on. Um, in your practice with low EF and remain symptomatic despite GDMT, consider referring them to us to help, you know, offer them this therapy again with pretty novel, and again it is gaining a lot of traction all over uh the country and the world as well. In 2019, the Brisson was approved for NHA Class 3 or Class 2 with the previous class 3, you have less than 35%, and these patients are not candidates for CRT. As you can see here, that's what does it do. It lowers the sympathetic, increased per sympathetic, and improves the heart failure symptoms. The guidelines from 2022 and the um American guidelines or European guidelines 2021. Uh, do not at this time acknowledge it just says um. There's no benefit in mortality, but they know there's some quality of life benefit and decrease in antiprobiMP. Other devices which we don't use here but it's always good to know about, uh, are the vagal nerve stimulation or cy uh you know, again it's all about increasing the sympathetic nervous system. Uh, the vagus nerve sim uh stimulation aims to reduce the ventricular remodeling and chronic cardiovascular strain via sympathetic nervous system and parasympathetic nervous system, but again increasing the per uh persympathetic nervous system. And it's usually through elective stimulation of the right cervical vagus nerve, so it's vagal uh vagal nerve stimulation. The main trial that led to its approval was innovate heart failure trial, which randomized around 107 patients with class 3 and EF less than 35%, and it showed that there's no significant difference in heart failure or hospitalization or all cause mortality, but there was some improvement in quality of life, and that was also demonstrated in the nectar HF trial. Different names of trials but um pretty um so they there's improvement in quality of life but there is no improvement in heartfare hospitalization or mortality but also that there was high implantation failure which makes it also not very well appealing and not many centers have endorsed it or implanting it now. One other thing is also gaining traction is plastic nerve stimulation and there was uh recent publications on it um and. Which basically showed that you know the thought process that um some of the blood is in the periphery and with the activation or innervation of the viscera this blood can be redistributed into the heart so if we're able to block the plankic nerve, uh, basically we reduce the stress on the heart and keep the blood in the viscera. So prevents this redistribution and as I mentioned, blockade can decrease the sympathetic tone tone and hence prevent the blood shifts. The main trials they've been studying it called the rebalance HF trials 1 and 2 and 3, they're looking at the efficacy of it. The primary endpoints for reduction in pulmonary capillary pressure at 1 month. And secondary endpoint includes quality of life and NYA class and anti-ro BMP. The feasibility trials show that it has favorable safety and efficacy, but again, the trials still out there. They're enrolling patients, but we're gonna hear more about it, so just know that there's another way where we are gonna try to modulate the preload and affect the after load, um, is was through splenic nerve stimulation. Other, uh, modalities also looking at stimulation of phrenic nerves and diaphragmatic stimulations, the remedy system. I don't know if we ever implanted it here, but, um, it is basically used for patients with heart failure and sleep apnea. Um, it's an area of interest for patients of hypoxemia. I mean, I noticed it. Sometimes patients who in the cath lab doing the right heart cath, I see a lot of respiratory variations. Patients have sleep apnea which definitely affect their heart failure symptoms and affect their outcomes. So that's the thought process behind is that there's frenic nerve stimulation for patients who have become hypoxemic, um, with sleep apnea. So the remedy system by Zal, uh, Medical had this pivotal trial with, uh, 96 patients with heart failure and center sleep apnea. Uh, this remedy system improved quality of life and decreased heart fare hospitalization, but this, uh, system is not approved for, uh, heart failure right now as you can see here, um, this is the, um, device, the generator you can see here this is the wire which has stimulation lead there's a sensing lead and this is where it goes to the phrenic nerve, um. So it's pretty um laborious process and getting access and all of that. So also there's some concern for safety and uh for this trial, but again it has not gained traction for the hard in the hardware world and as you can see the main trial was in 2021 and um it's not much endorsed. What about the cardiac contractility modulators, um, CCM and my previous healthcare system we used to implant it, uh, but, uh, they've been approached here multiple times about it also, um, it's been out for a long time, uh, so the thought process with the optimizer, there's an, um, it's called Impulse optimizer where we have also generator which sends, uh, two major, uh. Uh, pulses into the right ventricle septal wall uh during the absolute refractory period. So, um, it's it's biphasic, as I mentioned, high voltage electrical signal to the RV septal basically and that's in the phase where the RV is like the during the cycle where the there's absolute refractory period. It does not cause um mycular contraction. What it does, it affects the calcium release and calcium uh basically um. Concentration inside the cytosol, um, it leads to structural changes in the myocardium. It enhances contractility, uh, through, as I mentioned, through calcium, increased intracellular calcium, uh, without increasing the myocardial oxygen requirement, it has shown to decrease the LV volume, uh, again, the changes are mainly through the intracellular calcium, uh, changes. So, um, it is approved in 2019 around six years ago through and before that has been multiple trials. Fixed HF trial we can see here went from fixed HF 12345, 5C, which uh was finally led to its approval in 2019 for EF less than 45% uh for patients with NYC C class 3 and not candidates for CRT. It's mainly utilized also in Europe. In Europe they love uh CCM devices, uh, again for patients who are not, uh, candidates for CRT but with lower ejection fraction, and they found the most benefit of these patients happen with the lower ejection fraction. um, so ACCHA guidelines mention it that it improves quality of life and exercise, um, tolerance, but there's no benefits in death or heart for hospitalization. Similarly, did not make it to the uh recommendations by European Society of Cardiology. Other devices also too we tried before the inter arterial shunting in atrial shunting excuse me devices which is the Corvia, um, again, as you can see here it is creating this uh. Shunt between the left atrium and the right atrium and the goal is to reduce the pressure from the left side to unload the left atrial um left sided system so reduce the left atrial and pulmonary artery pressures as you can see here this is the corvia um. It's how it looks like and it is, it was approved as a breakthrough, as I mentioned, device and the main trial would reduce uh left atrial pressure or reduce LAP heart failure 1 and 2 trials which demonstrated a relative decreases in the filling pressures, but there are no difference in outcomes again there are a lot of devices for heart failure, especially. Uh, the inter, uh, atrial shunting devices, multiple studies, but all these studies for now have been negative and technically I do not recommend it much because again it's pretty invasive as you can see we're creating a full shunt patients, um, it's pretty invasive, uh. You know, uh, implantation of the device and there's no improvement in uh hard outcomes or uh hard for hospitalizations or quality of life even. The V-wave trial, which is, uh, you know, uh, device as you can see here, there was a recent publication that TCT they talked about it also there is some improvement in quality of life but also high complication rates including device stenosis which again it's similar you can see here, uh, goes from the left atrium to right atrium. Um, and the main trial was the relief HF trial and the Ventura shunt, uh, they had a sham controlled which is pretty also, um, aggressive in the sense that some patients had the procedure but they didn't have the, um, benefit from it so they had to be, uh, patients were randomized to a sham control. Had to undergo this um cause of this shunting but again there was no difference in outcomes death or hard for hospitalization or changing KCCQ. Last, uh, thing gonna talk about is ventriculoplasty, which is pretty interesting model, um, again, before if you all remember years and years and years ago, the stitch, uh, trial where they tried to affect the LV, um, volume and remodeling and but the stitch trial was negative at that time. Now they're trying to use it. No now non-surgical, which is a percutaneous approach called the accuci, and also our center participated and had one patient on this, uh, trial. The acusein system, which is by the Aura Heart, is a catheter delivered ventriculplasty device. That reduces the LV volume uh by deploying anchors under the madu annulus basically to reverse remodeling and when we did it in our center here again we had one patient we had a lot of work between heart failure, interventional cardiology, vascular surgery, CT surgery um and um. It's definitely laborious and very high risk for our patients. The Equiin trial is an ongoing trial, uh, evaluating the safety and uh and efficacy of the system, and preliminary results showed some improvement in LV dimension and functional outcomes, but again it's pretty aggressive. And if these patients with severe LV systolic dysfunction or LV dilatation with MR, these patients might benefit more from either LVAD or transplant rather than putting them through this, um, you know, uh, a lot of, um. Complex procedure. So what happens if patients continue to progress and decompensate despite medical and device therapy and you can see here this is a summary of most device therapies that have been used and utilized, um, so again it's important to refer them to advanced heart failure center to discuss these options for patients because again these patients are. Could be candidates for devices and this is a golden window where they are on GDMT. They're not too far gone where they are need the vet or transplant or need tropic support as palliative therapy, but also they could be optimized and try to give them more um time on their own native heart and try to keep them out of the hospital. So, but if they decompensate and don't tolerate um therapies, heart transplantation is still the ideal treatment modality for patients with heart failure, and the survival rate with heart transplant continues to improve. It's called conditional survival. If the patients made it the first year, the 50% survival rates around 13 to 14 years' time. And this number continues to improve, uh, but again the donor hearts remain scarce as we know here, uh, though we have increased in the number after the, um, latest, um, you know, changes in the, uh, allocation system we have doing more donor hearts but again it's still we have a lot of uh a lot of differences who are patients who need more advanced therapies but can get hearts. So LVAD therapy, uh, you know, uh, has been shown to improve outcomes, survival and quality of life, and recently we celebrated, uh, our LVAD patients. We had around 7 or 8 LVAD patients who are more than 10 years on support with LVADs, and again these patients without therapies such as LVAD, these patients have been not with us, uh, so we've seen a lot of a lot of successes with LVADs, especially with the Heart Made 3. Uh, latest, uh, data on survival of Heart May 3 in 5 years, around 60% plus of patients are alive, um, on Heart May 3, and which is again significant improvement from prior. So LEDs are, um, patients are living longer and feeling better. And this is also from the latest publication from the ACCHA and HFSA consensus documents from 2014 we found that you know the number for transplants heart continued to increase in 2019, 2018 was the allocation system, but also we're seeing more, uh, donation after circuitory death or DCD in which we are, um, reconsidering um. Restarting it here at uh Centera we did it in 2020 at that time um and then we stopped it uh but then now we're thinking of like trying to increase our transplant volume specially for patients who have, um, you know, increase the pool for the patients so but you know to increase the transplants as we can see here the vet numbers have gone down significantly throughout the country in 2022 there was around. Only 2500 vets across the whole country and again we did more heart transplant than we did VATs um before. And if patients are not candidates for transplant or a vet or do not wanna do um any surgical interventions, onotropic support patients on Millanone ordbutamine um have shown to improve their quality of life, but there's no difference in survival. This is data from 20 plus years ago, but it still holds. I mean, patients who are end stage heart failure and otropic support, they have improved the quality of life, but there is no improvement in survival. So to sum it up, basically GDMT know it stands for guideline directed medical therapy, but the M and GDMT should not only include pharmacotherapy, but also we need to incorporate device therapies in appropriately managing patients with heart failure, um, so we have to think of devices as as synergistic. They work together to get our patients to feel better and try to keep them out of the hospital. And this is a figure from a uh latest work which it's been in uh press now that we did uh that can summarize different therapeutic options that are available for patients beyond GDMT. And um on that note um if you have any questions I'll be happy to answer but um it's kind of like it's a little bit uh overview of all device therapies and heart fail that we're using. So thank you.
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