CIT 2020 -- Prof.Eberhard Grube with Prof. Yongjian Wu's Team: How TAVR technology is amazingly transformed, breaking cocoons into butterflies?

     Editor：Jiamo Ren Data：01-07-2020

On June 17-19, 2020, the 18th China Interventional Cardiology Congress (CIT 2020) Phase 1 was successfully held online. Among them, the surgical broadcast special showed the hybrid catheter room of Fuwai Hospital, Chinese Academy of Medical Sciences The first valvular surgery fully demonstrated the whole picture of the latest hybrid catheterization room. At the same time, Professor Yong jian Wu and his team of the surgeon who participated in this operation and Professor Eberhard Grube, a pioneer of valve interventional therapy at the University of Bonn, Germany, were invited to conduct a discussion on Transcatheter Aortic Valve Replacement (TAVR) .

 

Prof. Yong jian Wu: When did you start doing Transcatheter Aortic Valve Replacement implants in Germany?

Prof. Eberhard Grube: We started our journey in 2003-2004. We had our first cases here in our hospital in Germany in 2004-2005. Those were the first 25 patients that we treated together with our surgical colleagues. It was not easy in the beginning. Many of our colleagues did not believe that this treatment would be possible. I think when you are convinced that some treatment is possible and you believe in it, you just have to work on it regardless of what the community tells you, and regardless of whether they are upset with you. If you think it is the right thing to do, then proceed. Today, as we all know, it is a convenience.Times have changed, and I am very happy. I remember my very first days in China when I was there working in Beijing and Shanghai. At that time, I was very happy. I was also very proud because I believed this less-invasive treatment option would be very valuable for the large population of Chinese patients. Your country is so big and so rich in resources, that we thought this would be a very good thing for the Chinese people. I have to also say that many of my surgical colleagues in China greeted me very fondly. They were very polite. When I presented the first data at the German Society Meeting in 2004 or 2005, I relied on some backup from the United States so I would not be trashed and, at least, treat me politely. So, we have had some times, but things are very good now that we have reached the high level of standard of care we are at today.

 

Prof. Yong jian Wu: Thank you for telling us the early story of TAVR. In the early stages, fifteen years ago, it was a tough time for you and other pioneers in the field. Initially, the device was so big, and the morphology of the leaflets was largely unknown. Now, everything has changed. TAVR techniques are now widely used around the world. In China, nearly 200 hospitals are using the TAVR technique for their patients. Our younger doctors owe you a great deal. In recent years, the indications for TAVR have been for medium- and low-risk patients, and the guidelines have also changed. We have many questions. In China, the procedure is still in its early stages, even though we have been performing TAVR since 2012. Nearly 5000 cases have been performed, and most of those have used domestic devices such as Venus-A, VitaFlow, and TaurusOne. Tomorrow, I am presenting the data for TaurusOne, the third locally produced device used in China. More and more Chinese physicians and cardiac surgeons are showing interest in TAVR. I think this is similar in Germany, that about 30% of operators are cardiac surgeons, and 17% are cardiologists. I know that in Germany, cardiac surgeons are also using the TAVR procedure.

 

Dr. Guangyuan Song: With last year’s low-risk TAVR trials, how will practice change in Germany?

 

Prof. Eberhard Grube: Thank you for having me. It is always great to see friends in good spirits and in good health in these difficult times. So thank you for discussing with me some of the points Professor Wu was mentioning. Most importantly, recently, we had the low-risk approval for the S3 and CoreValve Evolut platforms. The low-risk situation is a logical consequence of going down the surgical risk spectrum from inoperable down to low-risk. So we have reached an important goal in the treatment options for patients with low surgical risk based on the randomized trial with the two devices. In addition, in Europe, including Germany, we have a CE mark now for the bicuspid application of the Evolut platform, which I think is very important. You have a lot of bicuspid heavily calcified patients in China. The most severe cases I have seen in my professional career were in China- heavily calcified, small annulus, bicuspid morphology. You have taught the rest of the world a lot about bicuspid anatomies, and based on your expertise and experience, we built our knowledge up to where we are now. Yesterday, I had a call from Brasil, asking about an 81-year old individual with heavily calcified bicuspid morphology, and what would I do? Let us not forget that surgeons are not our enemies. Surgeons are our colleagues and friends. If there is a good patient for surgery with biscuspid anatomy, I am still inclined to send this patient to surgery, if the risk is low and if the result will be good. This is a very important step – the low-risk situation, and the biscuspid approval, based on what we have learnt from our Chinese colleagues.

However, let me point out something that is very important. Many people are confusing, and even confounding, low-risk with young age. You always hear people talking about lower risk patients, when what they really mean are younger age patients. These are two entirely different patient groups. I think we have to be aware that with younger age (patients in their 50s and 60s), we have to look at TAVR differently than for patients who are 75, for obvious reasons. Also, don’t forget the low-risk TAVR trials, both for Evolut and S3, were including patients in favor of TAVR morphology and anatomy. Patients with severe coronary disease, patients with bad access, and the whole bicuspid morphology were all excluded. So when we talk about low-risk, the patients who were included in these trials were favorable for TAVR. This is a different story if you have patients with coronary heart disease, or with bicuspid morphology, or with bad access, and we have to be a little careful in saying that TAVR is available for everyone. I don’t think we are there yet. 

 

Dr. Guang yuan Song: Yes, I agree with you. The message is that low-risk characteristics for surgery are not low-risk for TAVR, because of morphology.You mentioned age, and that low-risk does not equate to younger age. What is your limit for age for a recommendation for TAVR? Is it 60 years old, or even younger?

Prof. Eberhard Grube: Obviously, younger age in our world with heart disease is very arbitrary. You cannot say >70 or <70, because there are very old 70s and very young 70s. There is also the biological age. In Germany, we are making the cutoff between 70 and 75. Between 70 and 75, we are discussing cases regularly with surgeons, so that the patients have the options to proceed either way. Above 75, the majority of patients go into the TAVR program, unless they have some prohibitive risk for TAVR, and then surgery is an option. Between 70 and 75, we discuss with the surgeons. Below 70, we have to be very careful, and this also involves discussion with the surgeons. When a 65-year old gets a TAVR valve, they will probably require a second TAVR valve during their lifetime. If we go even younger, they may need two TAVR valves depending on age. We have to be careful what we recommend at the very first step for those patients. Should it be a bioprosthetic surgical valve, and then a TAVR valve, followed by another TAVR valve? Or, should there be a TAVR valve followed by a TAVR valve, and then surgery? Then we are shifting the risk for surgery to the older age. Then question needs to be answered very carefully. My personal opinion is that it is not a bad idea if you are 60-65 years old with a bicuspid valve, to take the surgical option first, have the valve removed and a biological valve put in, and then follow the patient. If the valve degenerates by perhaps 75 or older, then a TAVR valve can be implanted. Coronary access also has to be considered seriously. We have to have access to the coronary artery. When younger, the chances of developing coronary heart disease is high, and we cannot risk blocking the ostia of the coronaries with the TAVR device. This is an important consideration that has never had to be raised when treating older patients. Also, the questions of durability have not been answered yet. We have good reason to believe we are doing well with TAVR valves compared to surgical valves, but we don’t know yet whether when we look at the bicuspid anatomies and calcification when the valves are not really expanded well, that the durabilities are the same as for surgery. These questions have to be answered on top of the conduction disturbances of left-bundle branch block and right-bundle branch block. There are many considerations in play. Experienced operators like yourselves, as well as responsible operators, need to weigh up what is best for an individual patient if <70-75 years old. What are their best options? Remember that the low-risk data included patients with low surgical risk, but still in their 80s. We need to consider all of these things when we open the door for our patients, in the belief that with low-risk being approved, we can do TAVR on every patient. 

 

Prof. Yongjian Wu: Now with this low-risk approval, if a surgeon has a patient with low-risk, what should the criteria be for deciding whether to transfer the patient for a TAVR procedure?

Prof. Eberhard Grube: It’s a good question, because it affects the young generation of cardiovascular surgeons. How can they gain experience with these severe aortic stenosis patients? If they do not operate on these patients anymore, they will never gain experience. When talking about severe and high-risk patients, the situation for surgeons is a little easier. When talking about low-risk patients, it depends on your heart team situation locally. There are experienced operators and experienced surgeons. And there are mediocre operators and mediocre surgeons. We are not all equally skilled. It is important to be aligned with your surgical colleagues when talking about low-risk patients. Obviously, these are good patients for TAVR, but also good patients for surgery. If we assume the results of both treatment arms are the same, the patient will always prefer the less invasive approach. I think that is a fair statement. Nobody likes major open surgery, but many surgeons do minimally invasive approaches now with smaller incisions, making surgery a more viable option. In the US and Europe, they do not cut the complete sternum. They do a mid-sternal cut or minimally invasive from the side. So there are various options. Then it depends on the morphology as to whether procedures are successful or not successful. Everything really depends on individual cases. At our institutions, in general, lower-risk patients even of higher age (>75) go for TAVR. If <75, then there will be a discussion on an individual basis together with the surgeons. Then, depending on the morphology, decisions are made for surgery or TAVR. Patients are included in this decision-making process. The patient has to know the advantages of a good surgical procedure, and the advantages of a TAVR procedure. That is an important issue when talking with patients. 

 

Prof. Yongjian Wu: We are doing more and more TAVR procedures. Not all patients with high-risk or low-risk for surgery are suitable for TAVR. We need to select patients according to morphology.

Prof. Eberhard Grube: Absolutely. Individually, it depends how extensive any coronary heart disease is. It is reasonable to say that if you can resolve it with a percutaneous procedure fairly quickly without additional risk. But you are right that when it is a more complex situation, bypass surgery together with an implant is a good option. At the end of the day, we want to treat the patient and do what is best for the patient. Where there is complex coronary morphology, that can be the most important decision-maker for going percutaneously or surgically.

 

Prof. Yongjian Wu: Where there is coronary disease, there is an increased risk of occlusion following TAVR. Should we persist with coronary protection techniques or transfer patients for surgery where occlusion risk appears high?

Prof. Eberhard Grube: It is an important issue you are raising. The low takeoff of the coronaries always carries a risk of occlusion. If you have an occlusion, then it is a disaster, and your patient may die. Using the protection of a wire followed by a stent is something you might consider. Personally though, I don’t think it is a very good option, because if a patient is at risk of coronary occlusion given all of our criteria (small sinus, small root, depending on the prosthesis), I would seriously consider a surgical approach instead of TAVR. Even though you can protect with a wire and a stent, the literature indicates that a wire is not enough and a stent is required. If the coronary is closed, the stent can be placed and a  “snorkel” technique performed. But this is a bailout situation. This is something you do when occlusion is occurring. This is not good as an elective procedure. Rather than doing a snorkel technique, I would consider surgery in high-risk patients, knowing that when the patient has to come back for coronary disease or restenosis, it is very difficult to access through the snorkel. I would consider these wire and snorkel procedures as bailout procedures, and would only use it if there were no other option for that particular patient. The long-term outcomes with a snorkel are not very good, even with BASILICA and other options that are available down the track. When there is the chance to decide which way to go, we should favor the patient and go for a surgical procedure instead of risking an obstruction with potential follow-up problems in the medium to long term. 

Dr. Mo yang Wang: From the PARTNER 3 first year follow-up, we can see that the TAVR group had better results. The 2-year outcomes show that the CABG group is catching up. TAVR showed an increased rate of valve thrombosis at this 2-year stage. Should anticoagulation therapy be considered in these cases?

Prof. Eberhard Grube: You are raising an important point obviously. It is a good example of where we cannot only look at intermediate- and short-term outcomes, but also the long-term. This is why trials are so important. Looking at the S3 trial and valve deterioration signals, we can only apply those findings to the S3, and not in general to the situation for Evolut and LOTUS and other valves. We have to be careful, but overall, the situation is still favorable. We have to see what the long-term results show and whether the curves are going parallel from now on, or whether the curves cross. Time will tell. We have to follow these patients for five, or even better, ten years. In the meantime though, we have to make decisions. We cannot wait until we have a result in five years. The future will reveal the best way to go, but I think this is a flag, and that we can’t take things for granted. We need a long follow-up before we make definitive decisions, and also, that we look at certain individual valves and not apply blanket statements for all of them. So it is important to differentiate S3 from other low-risk trials. It was very good to see you. It is excellent to see you in good spirits and good health. Hopefully, we will see each other again soon person-to-person so we can talk and exchange our opinions face-to-face.