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Transcatheter Aortic Valve Implantation Now Approved by Indian Regulatory Authorities

New technology to replace Surgical Aortic Valve replacement, which is highly risky for the elderly

Dr. Vivek Gupta

Interventional Cardiologist

Indraprastha Apollo Hospital, Delhi


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Dr. Vivek Gupta

</b> I am working in Apollo Hospital for the last almost 15 years and I would like to highlight little features about the new technique which is transcatheter aortic valve implantation and for the layman what we told is (TAVI) transcatheter aortic valve implantation, it is actually nonsurgical deployment of the aortic valve that means without opening the chest, without doing the open heart surgery, the aortic valve can be deployed another one without removing the first one and this is a new technique which has come up. Though it is not still available in India because of some regulations, the whole worldwide more than 1, 40, 000 patients have been operated worldwide. To give the historical part of this, this is transcatheter aortic valve implantation also known TAVI was actually in the animal experimentation since 1999. I had the privilege of working with Professor Alain Cribier in 1996, 1997, 1998 where this point was being discussed and under hypothetically being used with a lot of animal experimentation. The first case of balloon aortic valvular plasty which is also known as BAV that means doing the ballooning of the aortic valve. Aortic valve disease, before I tell you about the procedure, I would like to tell you about the disease, what is this disease. This disease is different from coronary artery disease which is normally angina and heart attack. This disease of the valve as we know that there are four valves in the heart, one is aortic valve, mitral valve and then tricuspid valve and pulmonary valve. Of this the most two important are mitral valve and aortic valve. Aortic valve is a valve which starts when the left ventricle which is the pumping part of the heart when it pumps into the rest of the body, it crosses through a valve known as aortic valve. It is a very important valve because this really determines how much the blood is being transferred from the pumping organ which is heart to the rest of the body. The aortic valve can be having a stenosis or it can have a leakage. Leakage means regurgitation or ?. It has been seen that this valve is affected in young people because of rheumatic heart disease, but in the elderly population which we are going to consider today, I am going to tell you about the aortic valve stenosis that is narrowing of the aortic valve which happens because of the elderly age and more of a degenerative aging processes. We are seeing that whole over the world, the life span is going up and more and more aging population is present in our country as well as in the European, as well as American continent. So, we see that more elderly population is present and these patients have the stenosis of the aortic valve. The stenosis of the aortic valve after certain narrowing becomes a life threatening problem. Aortic stenosis which is known as aortic valve stenosis is a life threatening problem and this starts with initially less narrowing but when the narrowing becomes very critical, the heart is unable to pump the blood into rest of the body and the patient suffers from angina, the patient suffers from loss of consciousness and the patient also suffers from weakness and overall fatigue on exertion. It has been that once the symptoms of angina or syncope means loss of consciousness happens. Because of aortic valve stenosis, the life span of the patient is not more than two to three years unless you treat the patient. You see overall this disease of aortic valve stenosis has been conventionally being treated by the surgical open heart surgery where you replace the valve and you put artificial valve. This is known as surgical aortic valve replacement which has been there for long time and it has been seen that these patients do very well after surgery, but that these patients who are ageing populations which are more than 70 years or 75 years who are also having other disease. Other disease means like nephropathy, kidney functions are bad, or the patient has a poor lung function, because when you have ageing population, you are likely to have associated other disease. When the patient has associated other disease like bad lung or bad kidneys or a bypass surgery being done, these patients became a high risk for the surgical open heart surgery. When these patients become high risk, lot of times the patient’s surgeons do not want to take up these cases. Why they do not want to take up because of the high motility. Motility means risk of death during or postoperative period which range from 10 to 20 or 30%. This is a very high surgical risk and the surgeons normally in such cases decline that they do not want to operate. Even the patient does not want to get operated if he is told that the patient had a 20% surgical race or 30% surgical race. So, what is the solution? The solution came earlier in 1985. These patients were being treated by balloon aortic valvuloplasty. Balloon aortic valvuloplasty means putting a balloon across the aortic valve and then the patient of course the balloon is inflated and the valve gets open. This technique was introduced by Professor Alain Cribier in 1985, but it was initially a big achievement, but later on in 1990s, it was found that when you put the balloon it becomes restenosed sooner and therefore, the motility benefit was not there and therefore there was a search in his mind and of course other doctors also that can we do something without opening the chest, without opening the heart putting a valve through the groin and that this year after lot of experimentation 2002 April, the first artificial valve was implanted without opening the chest through a vein in the groin and this was done with a complicated technique of doing a transspetal technique. This was April 16, a landmark day for this fourth important revolution in the interventional cardiology April 2002, the first case was done and from 2002 to 2004, there were lot of cases which happened in France and lot of patients were treated about 40 to 50 patients. From 2004 onwards, there were further important landmarks because new companies came up to take up this project and they found that this is a very feasible project and the valve technology changed form different valve technique with equine pericardium to bovine pericardium and so many technical things happened and from that onwards, the more and more cases have been done and now in 2015 what we say that it is recognized by FDA. FDA means Federal Drug Administrator in USA. It is recognized by European Centers Guidelines and more than 1,40,000 patients have been treated. These patients are normally earlier being treated for only for the high risk patients, but now there it has been seen that more and more less risky patients. Even those who patients who can be treated by surgery can also be done without surgery. Because of course it is a patient friendly. For the patient if he does not want to be operated for the patient who does not want general anesthesia, for the patient who wants to be discharged early, it is a very important boon and this is just like a coronary stenting which you know for the heart attack and angina. We find that these patients are actually treated and discharged on third or fourth day of the patients, long-term benefit, motility benefit, long-term utility of this valve has been very well established. For this percutaneous technique, percutaneous means nonsurgical going through the groin has been now fully established. I think in India, we are going to have soon. So, I repeat that for the calcific aortic stenosis in elderly patients, earlier it was surgical open heart surgery, but now it is a percutaneous nonsurgical treatment without opening the chest, without opening the heart, through the groin vein and now the groin artery because we go to the retrograde approach and we put the valve, it takes not more than one hour. The patient is discharged the third day and without any major surgical complication or risk involved. This is known as TAVI transcatheter aortic valve implantation first done by Professor Alain Cribier where I was also involved in the initial part because I was working with him and this Indian patients are still deprived of this technique because sooner I think the drug controller government of India will soon get it approved and once it is approved, I think Indian patient will also get the benefit of this treatment which is a boon for this. This is known as fourth revolution. The first revolution was the coronary angioplasty, second was the coronary stenting, the third was of course a biovascular scaffold for the of course over the heart attack and angina. Fourth revolution is known as the aortic valve implantation without doing a surgery. I hope that you understand that this is for specifics group of calcific aortic stenosis which is our major problem in the elderly population. Not only in US and Europe, but also India and soon we will have it. We have a possibility of treating this patient outside France. Indian patient can travel to France and get that treated, but in India it will come soon this is what we hope. Thank you very much. This was my particular talk about the transcatheter valve implantation which is a specific subgroup. I will also tell the people of India (09

  • Acute Myocardial Infarction
  • Primary PCI
  • Angioplasty
  • Heart Failure
  • ECHO

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