Success of the TAVR technology has been tremendous because of its simplicity: Prof Alain Cribier – ETHealthworld.com

Shahid Akhter, editor, ETHealthworld spoke to Prof Alain Cribier, a pioneer of TAVR therapy and Founder, Director, Rouen Medical Training Center, France to know more about the growing acceptance of TAVI technology.

CVD Burden Coronary artery disease (CAD) is the leading cause of mortality amongst cardiovascular diseases in India and world-wide just after cancer. There is another disease which is extremely frequent, which is the disease of the valve of the heart i.e, Valvular Heart Disease, which is also very important. The reason for my visit in India is mainly because I have been working a lot on the treatment of valvular disease, especially because this treatment is now commercially available from more than 15 years across the globe but still a lot of awareness is required for this treatment option in India and lifesaving benefits of this therapy for old age population.

About Aortic Stenosis Aortic stenosis is a disease consisting of a dysfunction of the aortic valve. The AV is one of the four valves inside the heart and this valve in some patients gets fibrotic in such a way that it thickens and gets calcified, preventing the valve from opening and closing normally. This valve is located at the exit of the heart, just between the left ventricle and the aorta. If the valve is blocked, then the blood flow is disrupted. Adequate blood does not reach to all vital organs, resulting in health complications for the patients. This disease of the valve is extremely frequent in western countries.

For decades the only possible treatment, was invasive surgery which consists of removing the diseased valve and replacing it with an artificial aortic valve. The surgery for aortic stenosis was initiated in the 60s by Dr. Starr, a very well-known surgeon in the United States and this has been the only possible treatment until a very recent period. Today due to age and associated heart conditions, many patients have been declined by the surgeons for having invasive surgery. Without any treatment it was noticed that these patients succumbed to the disease within 1 to 2 years in my department of cardiology. This motivated me to try to find a way to treat the disease without surgery. An interventional cardiologist by profession, I have been closely working on doing CI, angioplasty performing non -invasive cardiovascular procedures on series of patients. With the same thought in the background, we decided to do something using the interventional cardiology procedures to give a hope to those patients who were declined by surgeons.

In September 85, I proposed to treat the calcified aortic stenosis by dilating the valve with a balloon catheter. This is what we call balloon aortic valvuloplasty (BAV). I performed the first human case in my Centre and after that because of the success of procedure, I performed it for a series of patients, which was published in The Lancet, a reference journal. The series was like a major development in the medical community and everybody wanted to do that and 10,000s of patients were treated by balloon aortic valvuloplasty (BAV). It is true that we were improving the patients, removing the symptoms of the patients who were clearly doing well. But unfortunately there was restenosis, i.e., the disease appeared again after 1 to 3 years and this was unacceptable.

In the 90s, I started thinking about the possibility of replanting an artificial valve without surgery using the interventional cardiology techniques and this took 15 years of research, to make a valve which was possible to insert in the body through the vessels reaching the diseased calcified aortic valve and implanted by the inflation of the balloon, so the valve was crimped on the balloon and the balloon was inflated inside the diseased valve and replaced the function of the valve. This was done very successfully and we performed the first human case in my center in April 2002. This treatment has been very successfully spread across the world. Today, this is a true alternative to surgery. Many patients can now have this procedure done without having the chest opened and the valve replaced surgically.

TAVR Technology Advantage TAVR technology consists of introducing the valve, which is crimped over the balloon catheter pushed inside the peripheral vessel, which further goes in the heart where diseased Aortic valve is present. This procedure is done under x-ray guidance. The balloon is inflated and the valve is delivered and staged in place of native diseased valve. This technique is relatively simple and can be performed by most of the interventional cardiologists today and this is why success of the procedure has been tremendous. We started in 2002 and today we have almost 400,000 patients benefitted in the world in 65 countries including India.

The advantage is huge because the patients feel that it is an acceptable procedure which is done in 90% of cases under local anesthesia. The valve is introduced with a small cut on the groin taken through the femoral artery and the device implanting technique lasts between 30 and 40 minutes. The patient is able to go back home after 2 days. In majority of cases, 75% of patients within 3 days return to their normal occupation without any rehabilitation. In comparison, surgery is a very heavy procedure with general anesthesia, opening of the chest with extracorporeal circulation and replacement of the valve which takes 2 hours. At the end of that, the patient has to stay at the hospital for one week and has two months of rehabilitation. So, this is nothing to compare with TAVI. The procedure can be applied to all the patients at high risk of surgery and it has been demonstrated by numerous trials that if the patient has contraindications to surgery or is considered high risk for surgery then he can have TAVR done. Recently, the procedure has also been approved by numerous trials in intermediate risk patients, which means patients who are not at high risk for surgery. Today, all the patients above the age of 75 years have this procedure done on regular basis. From this year, the technique has also been approved by FDA in the United States for low risk patients. All the patients above the age of 75 years in western countries can have the procedure done as an alternative to surgery.

TAVR Technology Adoption in India This procedure is expensive; the treatment cost is more than heavy surgery because the valve itself is very expensive to buy. Taking example of developed countries like France, the payment is reimbursed by the Social Security so patients have nothing to pay on their own. But in many other countries the procedure has to be reimbursed by insurance companies, for example, this is the case in India. The insurances can reimburse the cost of the procedure, when people are working for example, in railways or in some industries, but unfortunately, the majority of patients and especially in developing countries are not covered under insurance and they have to pay for it on their own. So, the only possibility for increasing the availability of this procedure to anyone would be to have this procedure reimbursed largely by the insurance companies.

TAVR - Technology Future Innovations This technique has pushed companies and physicians to try and develop other techniques as an alternative to surgery. Today, we have many structural heart diseases which can be treated with surgery but can be performed using interventional cardiology techniques. This is the case for example of disease of the mitral valve; we can do many other procedures without performing surgery. The future is to expand this kind of interventional cardiology techniques to most of the cardiovascular diseases.

More here:
Success of the TAVR technology has been tremendous because of its simplicity: Prof Alain Cribier - ETHealthworld.com