Howard Herrmann, MD, director of interventional cardiology at Penn Medicine, reviews the evolution of TAVR at Penn Medicine and at a national level, including data trends, clinical trials and procedural innovations, and current state.
Related Links: See Dr. Herrmann's physician profile Good morning and thank you for joining this first pen cmi valve symposium and allowing me the opportunity to share with you the current state of Tavern at nationally and also at the University of pennsylvania. So Tavern at Penn Medicine. These are my disclosures. So I want to emphasis as I start that Tavern is just one portion of our trans catheter therapy program for structural and valvular heart disease. We perform a number of structural interventions closing holes in the heart such as patent foramen of alley and stds as well as Peyton duck, Tous V. S. Ds, fistulas and also para valvular leaks either after surgical valves or Taber procedures. We also have a robust valvular program for static lesions, mitral and aortic stenosis as well as adults with harmonic stenosis with balloon angioplasty and a commercial as well as investigational program for the trans catheter repair and replacement of mitral and regurgitation. We also do other structural interventions septal ablation with alcohol for hokum left atrial appendage occlusion and investigational therapies such as renal generation for resistant hypertension and atrial septal hasta. Me for patients with But Traver is by far the number one volume procedure that we perform in this arena and that's true both nationally and independent here You see some new data just hot off the presses from the TVT registry that's still unpublished. Looking at the number of procedures performed in the US by year. And you can see that it's estimated that in calendar year, 2021 more than 90,000 Taber procedures will be performed in the US almost doubling the number of surgical forms of aortic valve replacement. And you can see how that has grown over the years from the initial procedures and commercial approval back in late 2012, early 2013. Part of that growth has been fueled by the large number of sites that are now performing tavern over almost 800 of them in the US and also by the indication expansion. When we began with very high risk patients. Um That has that was based on data showing that Tavern was better than not doing anything and better than surgery in high risk patients. But we've gradually expanded the indications through the randomized trials to intermediate risk patients and even low risk patients. And although the number of high risk patients has remained relatively constant at about 30,000 per year. The percentage of high risk patients has fallen as intermediate risk patients and low risk patients start to make up more of the pie Mortality has gradually fallen over time. As we've learned to select patients better have gotten more experience with the procedure. And the devices have improved and you can see that now the risk of dying with a tavern procedure in hospital approaches 1%. And part of that is due to the fact that the great majority, 96% of the procedures are now done via trans femoral cutaneous access approach. Um through the groin. Our first patient was treated back in 2007 at Huh. This was the first patient enrolled in the partner one B. Trial for inoperable patients joe bavaria. And I started the program at that point and this was one of the first patient we treated 89 year old woman who had an sts score based on frailty age. Redo diabetes of over 15%. And as most of you know when we do balloon expandable tavern we do that by pacing patients into a form of shock for a very short period of time so that the balloon is not ejected by the ventricle. And this is what that procedure looked like back then. Were pacing the patient you can see the blood pressure falling the rapid heart rate. We wait until the patient's blood pressure is below 50 of mercury systolic and then we can inflate the balloon, deploy the valve inside the old valve here you see it on T. E. Deflate the balloon and remove it and successfully treat aortic stenosis. Today, the state of the art procedure at pan involves a number of evolutionary changes. We've been a partner in all of the key trials of tab are from the early balloon expandable Taber. Um trials with the balloon expandable prosthesis as well as with the self expanding prosthesis that you see here is in the intermediate risk trial. We were part of investigational devices such as the mechanically expandable device And we also participated in the symbolic protection trials here you see the sentinel device which is a filter that we place to try to prevent stroke and this is now commercially available and we utilize this in the majority of our procedures at penn had the privilege of being part of more than 50 publications in major journals and also to expand the procedure with a number of procedural innovations. We were among the first to do trans septal mitral valve and valve procedures. We also do leaflet laceration for surgical patients who need to get valve valve procedures in order to splay open the valve leaflet of the old surgical valve before placing the tavern thesis in there in order to reduce the risk for coronary occlusion. And we've expanded alternative access from trans a pickle where we started with large devices to transact celery, both cut down and park you titanius and most recently to trans cable procedures where we cross from the inferior vena cava into the order to do the procedure and then close the hole that we make with an am Platzer closure device. Were most recently part of the smart trial. This is a small analyst trial in which patients are randomized to either of the two commercial devices available in the U. S. This is the largest randomized trial of the two devices. I have the privilege of leading this trial and we've been rolling Are enrolling well in it. It's more than 50% enrolled When it's finished. It will include over 700 patients at more than 90 sites internationally. And we hope to compare these two very important devices for both clinical endpoints such as death stroke and rehospitalization as well as for human dynamic differences, bio prosthetic valve dysfunction. To determine whether some of the improved human dynamics that one might achieve with one of the devices results in better outcomes and or longer durability. We enrolled the first patient in this trial just over a year ago and the trial hopes to complete enrollment in this calendar year. So today it is a state of the art program at Penn. We perform the procedures in a hybrid operating room. We have four of those at hup and two of them at presbyterian. We include an entire heart team which is a big group of people includes um anesthesiologists, the cardiovascular surgeons, interventional cardiologists, imagers, nurses and our advanced practice providers who care for these patients both in the office and after their procedures. Almost all of the procedures are done under monitored anesthesia care um And a per cutaneous approach. We rarely go to the C. C. U. R. I. C. U. Now and most patients go home in 1 to 2 days. As I mentioned earlier joe and I started the program but now we have more than a dozen practitioners who performed have our procedures that hub domesticity and I run the program with four other interventional ists and for surgeons who participate in these procedures rob lee and Wilson's ito. Head the program at Presbyterian Hospital and Mohammed raza and um Stephen Weiss at Chester County Together we are one of the fifth largest programs in the US. Um and we had the privilege Wilson and I have been on the cover of the new york times some years ago when they did a story on one of our patients and we continue to have a very high rating program in U. S. News and World Report. This is what our volume looks like. We've performed almost 5000 Taber procedures now and close to 600 procedures annually. Of large increase occurred in the program after it became commercially available in January of 2013. You can see the uptick. We hit a peak of about 600 procedures just before COVID. And we are on the way back toward that number. Um at the current day David jones is our trans catheter valve program manager and has done a great job of helping all of this growth. And I want to acknowledge the great number of people um at all three hospitals who have contributed to the growth of this very successful program that is now the main way that we treat critical aortic stenosis. Thank you for your attention