Anene Ukaigwe, MD, details the impact of mitral and tricuspid valve regurgitation, while providing an overview of percutaneous therapies and devices in clinical trials.
good day everyone thank you for coming to this talk. I'll be going over per cutaneous options for the treatment of trackers. Bit of nitro regurgitation have no disclosures but I'll be talking about investigational devices. Goals have to go over the impact of nitrogen trikus patrick agitation and an overview of available packaging of therapies and a dose are currently underway. Untreated symptomatic matter, vegetation irregardless with theology is associated with increased mortality, estimated about 5% per year and up to the third of these patients do not undergo any surgery because of high risk. This led to the development of Peca tina's strategies to address this disease. The mitral regurgitation can be primary due to a disease of the mitral defects themselves. Of secondary due to the rest of the mitral valve apparatus that includes the analyst sub valvular parameters in the left ventricle, the park catania therapy options and they make those of surgery and are either repair or replacement. There's several repair strategies which includes as handsomely for corrupt ation with trans catheter extra at repair um augmenting deficient deflects. Director indirect annual classes depending on whether the coronary sinus is utilized and Kordell replacement therapies. There are several different devices that are currently either approved in europe or as part of the investigational trials worldwide. However, there's only one that is available for commercial use in the United States and that's the Nitro club. The micro clips essentially a method that is wrapped in polyester fabric and forms a clip that is delivered by a transept access to to approximate the edges of the mitral valve, especially in every budget into area, thereby reducing mitral regurgitation. This is an example of the patient where this therapy was used who had to be a natural vegetation following a myocardial infection. That led to reduction in natural vegetation and improvement in human dynamics. As evidenced by this echo images on top before the clip and below after the clip and we can see at the left of the right side corner there is normalization of the pulmonary vein field. The efficacy of this clip has been tested for degenerative disease and the Everest trial and that was what led to its approval of a commercial use and it was found that it was associated with reduction in nitrogen vegetation. However the micro clip arm there was increased need for repeat repeat interventions which which based off of which this therapist to reserved only for high risk patients who have degenerative mitral regurgitation. It was then tested in patients with secondary mitral regurgitation in two different trials and will focus on the coop tra, which informed the changes in the A. C. C. H. A. Bad disease guidelines. Randomizing patients to microbial therapy and mitral clip therapy rather and guideline directed medical therapy and found that there was a significant improvement in heart failure. Hospitalizations and survival with clip therapy that was found to be safe the other lives that co optation devices the paschal and this essentially consists of a placer attached to two paddles and the paddles then approximately leaflets, edges to the space are releasing mitral regurgitation. This was tested in the single arm and class pivotal study. And following those patients out of one year, they still had sustained material, vegetation reduction down to moderate or less. Their symptoms were improved to N. Y. J. Class two or less and mortality overall was only about 8%. This device is approved for use in europe since 2000 and 19 however, is still currently and tested against the Metro Club. Um for primary and secondary mental regurgitation co optation augmentation happens with this investigational device and um uhh is part of the trial is looking at this basically there is another a baffle against which the interior defense is supposed to co ops and therefore reduce mitral regurgitation. This is the first in man implantation of this device and the left of severe mitral regurgitation and if we look on the right is reduction in that metro re vegetation. The advantages of this device is that is also supposed to reduce is also supposed to allow for further trans catheter therapies such as replacement if needed. The bottom image is essentially are supposed to show what it looks at 30 days follow up as we can see there the caravan metro construction devices and annual plastic device and it consists of anchors that are laid across the posterior mitral deflect connected by a wire that is then tension to reduce the Metro annuals and therefore the mitral regurgitation was tested in about 60% 60% of 60 patients have survived out too One year in 88% of them, but my short vegetation reduction was only about 70%. It's again being investigated for using functional military vegetation and as with any intervention that involves the mitral valve. And unless there's a risk of less complex injury, which happened 6% of these patients, the military iris system, consistent ankles that are directly implanted to the micro bob annuals from the left atrial side and then again tension to result in reduction. Annual plastic was associated with military vegetation reduction. And again, there's a trial under way looking at this. This is essentially what it looks like when it's implanted um position and left atrial side and at the bottom images of what it's supposed to look like after it's done. Again, it's part of the clinical trial. The carried on device inserts um Two anchors into the coronary sinus and then tensions them to reduce my drove up mucus because of the close relationship between the annuals and the coronary sinus. This was tested in studies with only about an 85% procedural success rate that was limited by difficulties in integration of the coronary sinus as well as the complex injury. There's another try looking at this for functional mitral regurgitation. The acrid stench was designed to result in LV remodeling in patients with dilated left ventricles and by doing that, it's purported to also reduce my trophy vegetation. This is being tested in the cost singe trial and I'm the result of this is still pending. The new court system is basically an artificial microbial court implantation that helps to reduce posterior defect prolapse and is implanted through a transit vehicle access the FDA people. Self study is still enrolling patients is still being still ongoing to evaluate the safety and efficacy. The hard point is a similar device. Trans Catherine mitral valve replacement is indicator because not all repair strategies are durable, just like surgical repairs. Unlike the erotic valve mitral valve replacement is complex and designing interventions for this valve is complex because of the complex anatomy. The valve is D shaped, it is also enough flat, is about saddle shaped and it doesn't have significant and it doesn't always have significant classification that allows to allows wealth anchoring and so there are different strategies that have been employed to ensure that this prosthesis get anchored to the tracker spit valve which are outlined um on that cracks. There's there whenever there's a trans catheter mitral valve replacement, we have to be careful not to limit our interaction with the sub fabulous up artists. And also there's a concept of new L. Beauty which um hold significantly results in obstruction obstructing flow out of the left ventricle after the track hospital wealth is replaced. This is predicted from baseline T. E. T. Baseline ct scans and can result in screen failures for these patients, there are several devices that have been tried in trance Catherine mitral valve replacement space. But there's only one. There's a proof of commercial use anywhere in the world and that's a tendon device improved for using europe. It's currently undergoing an expanded trial in the United States that we're hoping will be to FDA approval for commercial use. It consists of per cardio Parson deflects that are attached to a 19 all stand. There's also an outer coating of another national stance and this is this this house is the valve frame. The valve frame is then attached to an atypical pad through a tether. And this is what helps make sure that the valve is anchored. When this 1st 100 patients were evaluated successful device implantation, according 96% of patients with very low complications, mortality at 30 days was only 6% and 26% of one year bearing in mind that Israel predominantly functional mitral regurgitation patients. There are several other devices that are being tested for the mitral valve. Um Some of the ones I will note here will be the Apollo device no set on the M and N, which is being trialed also here at university hospitals, there are several other devices that are still at different stages of investigation. The track hospital vegetation is very common and when present is significantly reduced survival despite even when you correct with atrial fibrillation, vibrant, regular pressures, right ventricular size of pulmonary pressures and even after we've done a great job, we're treating left sided valve disease. If the procedural track prosperity vegetation, that's definitely attenuate that benefit and reduces survival. It is the most on undertreated about disease. According to the CMS database in the anatomy of the track hospital bob is peculiar. The leaflets are then the vibe is only track hospital about a third of the time. The popular muscles are variable and their multiple different structures close with the right coronary, the coronary sinus and the A. V. E mailed the bob is also very interior and it's difficult to see on the conventional trans visual um T. E imaging. One of the things that we assess is when we're trying to enhance cooperation in this valve, we have to be sure because the patients tend to present me is that there is a partition gap to is within the physical limits of the clip. Additionally, significant tethering the needs the ability to restore co optation again increases the risk of procedure or failure. Trans gather therapies in the track hospital space again mimic surgical therapies but also a lot of them are borrowed from the mitral valve space. So co optation enhancements is one of the first ones that we're going to look at again. Bird for the trackers bidwell space or mitral valve space. The micro clip was initially designed was initially designed for the micro bob and by modified steering techniques can be used in the track hospital. Now that was studied or evaluated in the tribal registering was found that when the procedure was successful was associated with improve them survival and heart failure reduction in heart failure. Hospitalizations. The manufacturers then designed is terrible get catheter that was designed for steering the right atrium towards the track hospital file. And it is this delivery system with the traditional known cliff that is being studied in the tri eliminate trial. This is an example of the patient who was treated with this and therapy and begins in the top left corner. There is torrential track hospital gravitation but after the placement of four clips is reduced to trivial. This is trying to eliminate single arm early feasibility study that showed that the procedure was safe implant to safe. There's no procedural mortality After six months cardiovascular mortality was very low. But what was noted is that there was significant reduction in my trophy vegetation and symptom relief and in fact it was also shown that even a one great reduction in societies are with significance and gun improvement. These benefits extended out to one year. And in addition to the sustained benefits of this was demonstrated that there is a desirable reverse R. V. RA modeling after successful track has been well prepared and reduce heart video hospitalization and mortality. When the procedure was successful. The paschal device is exactly the same as used for the mitral valve. Also adapted to the track of spent foul and in the compassionate use protocol. It was demonstrated that it's associated with very high procedural success. It was also safe and resulted in significant track hospital vegetation reduction and symptom improvement that will sustain out to a year, the cardio band and military exactly as described for the mitral valve. So I will not go over these in details. But additional annual classic techniques for the track of spit well include bike hospitalization. This is achieved with the mitral lying device which consists of two pledge. It's that then pull the enter posterior edge and the push yourself to the edge of the mitral valve, changing the state by hospital up and reducing track hospital agitation. The early feasibility study led to a about a reduced track hospital agitation, reason about 60%. And there was no procedure of mortality and there's an ongoing extend their trial. The triceps essentially tries to reduce this until receptacle dimensions of the track hospital while by putting a knob or a little project about the interior at the edge where the anterior annual, the annual towards the anterior leaflet site would be. And then there's a a threat that is then used to maintain tension and then approximately anterior septal until septal dimensions of the tractor spit valve and this tension is transferred to a extent that is placing the inferior vena cava. So this test isn't to prevent trial that demonstrated symptom improvement and tear reduction. However, there were complications that lead to a divine reiteration. The cardioversion is mentioned is exactly the same as the tripod spit as using the mitral valve space. And was tested in the tri repair trial. That this enrolled about 30 patients and demonstrated that there was significant track hospital vegetation reduction when the cardio band was used And this translated to one years ago, about 83%. An improvement in symptoms That to sustain about 88% of patients valve implantation can also happen is tricastin space and is borrowed again from the mitral valve space. The first was a compassionate use protocol for the navigate and which one is a self expanding night. In our standard it was implanted either to the trans jugular right HR approach. And this is kind of what the deployment um looks like and this is what the final result looks like. There is practically complete elimination of track hospital agitation, with only a mild parabolic ascent at the bottom right T image. There was the procedure was efficacious in eliminating track hospital vegetation and improving symptoms. However, 30 day mortality was up to 30% which may be acceptable for compassionate use protocol but again, is approaching the outcomes that we see in surgical track hospital vegetation, surgical track hospital of interventions and that world was less than desirable. Most recently this year, the evoque, which again was for the mitral valve was then implanted by a transfer Meral access. in 25 patients who had severe track hospital vegetation. But they also were more selective and exclusive patients with severe RV. Dysfunction and pulmonary hypertension. This the procedural success rate was about 92% with no need for surgical interventions and like to navigate one patient needed an additional valve implantation with the CPN and there was marked improvement in functional status as well as reduction in track prospective agitation. The other bars are being tested in other countries. The locks were built specifically for the track hospital are being looked at in china. The cardio. Volvo's borrow for the from the mitral valve and is being evaluated for the track hospital space. There have been thoughts about using cable bob implantation. Although this doesn't change the severity of track hospital vegetation. Excuse me. It starts to limit the passive congestion. And the inter abdominal organs was first child with the second vows. But due to the dynamic nature of the inferior being a cover. There were problems with anchoring and led to migration and so this was aborted in the initial trial. Mhm. Is self expanding nightingale stent was then specifically constructed for each patient I. D. C. Based out of the city scam and has been used with improved results. Mm hmm. Above all, what's most important despite all these technologies is making sure that we value these patients as part of a heart team approach which has been demonstrated to be beneficial. The management of about disease and several other cardiovascular pathologies. In conclusion for high risk patients. Yeah, pakistanis, valve replacement or repair procedures are promising alternative to surgery when you can be avoided. We need more information on the efficacy and safety of these procedures, and lots of it are in development as we have increasing experiences with this, It would allow us to heal all these procedures to each patient's anatomy, possibly allowing combination procedures and earlier interventions to achieve the goal of significant mitral attract hospital vegetation, which is and it is in this cohort that the benefits are derived. Thank you.
