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58-Ashok-Seth All smiles: Dr Ashok Seth, chairman and cardiologist, Fortis Escorts Heart Institute, with a patient | Arvind Jain

A cutting-edge technique to replace valves in elderly patients and another to determine rational use of stents are changing the face of cardiac care

  • A Transcatheter Aortic Valve Replacement procedure underway at Fortis Escorts Heart Institute in New Delhi. The first TAVR procedure was done in France in 2002, and after several trials, it was approved by the US Food and Drug Administration in 2011, but just for extremely high-risk patients. The Drug Controller General of India approved the procedure in August 2016.

The end seemed near. There were just too many issues plaguing N. Ramanathan—a chronic obstructive pulmonary disease, a debilitating cough and a valve disease.

Four years ago, Ramanathan, 69, suffered a bad bout of pneumonia. During the treatment, doctors found that his aortic valve (one of the three valves in the heart) was calcified, and had been obstructing the blood flow from his left ventricle to the aorta. This thickening, inflexibility and narrowing of the aortic valve is called aortic stenosis, caused due to ageing. It could also be the result of a congenital defect called bicuspid valve, where the valve has two leaflets instead of the normal three.

The aortic stenosis was making Ramanathan's heart pump harder to push the blood through the narrow opening of the valve. The strain on the heart made him breathless and tired, making it difficult for him to walk or do his daily chores.

By December 2016, things had worsened, recalls Ramanathan. The valve disease had also caused a fluid buildup in his lungs. “I had incessant cough, and could barely sleep at night. For days on end, I would lie in an inclined position to avoid the cough. I also had chest pain, and had to be put on oxygen,” says the Chennai resident. “It just felt like I was waiting for my last day.”

Open heart surgery was not an option for Ramanathan, owing to his age and weak condition. Fortunately for people like him, who are sick, infirm, old and unfit for an open heart surgery, a new procedure called Transcatheter Aortic Valve Replacement (TAVR) has shown great results. Most cardiologists that THE WEEK spoke to define TAVR as “revolutionary” and say the procedure has changed the face of cardiac care globally.

In TAVR, a catheter is inserted through the patient's groin, up to the aorta, where it is blown up into a balloon to fix the tissue valve. The new valve that is inserted is made from the pericardium (membrane enclosing the heart) of cows and pigs and is encased in a metal stent. This valve that opens up like an umbrella, works to widen the opening of the old valve, thereby, increasing blood flow.

“It is the biggest innovation in cardiac surgery in recent times. It is minimally invasive, safe and the patient can walk home in a couple of days,” says Dr Ashok Seth, chairman and cardiologist, Fortis Escorts Heart Institute. Another big draw is that it can be done even while a patient is awake. The procedure, he says, is a boon for those who are inoperable because of age and related conditions such as kidney and lung problems.

Or, for even someone like Delhi-based Krishan Ohri, 82, who had chikungunya last year that made him so weak that only TAVR was the possible solution for his aortic stenosis. “We had a cousin in the US, so we also took his suggestion before going for the procedure,” says Ohri's son, Vikram, 46.

61-A-Transcatheter-Aortic-Valve-Replacement Arvind Jain

The first TAVR procedure was done in France in 2002, and after several trials, it was approved by the US Food and Drug Administration in 2011, but just for extremely high-risk patients. The Drug Controller General of India approved the procedure in August 2016. But, Apollo Hospitals in Chennai, where Ramanathan was admitted, had been doing TAVR prior to 2016, with special permissions, says Dr Sengottuvelu G., interventional cardiologist at the hospital.

With the approvals last year, however, the procedure seems to have got a new lease of life. Today, most cardiologists are optimistic about it. “The most common surgery for the heart still remains the bypass surgery. But, for those with aortic stenosis, which would be about 20 per cent of those affected with valve disease, this is a boon,” says Sengottuvelu.

But for a procedure that is being termed “revolutionary”, what is holding patients back? Both doctors and patients say it is the cost. The procedure could cost Rs 25 lakh. “It is a great procedure and has given me a new life; this is my second term. But the costs can be prohibitive for others,” says Ramanathan, who had to borrow money from relatives for the procedure. Says Vikram, “Just like for stents, the government should introduce a price cap for these valves, too.”

Another technique that is making waves is the fractional flow reserve, which helps cardiologists decide whether a patient needs stents or not. “This technique is cost effective because it helps diagnose whether the flow across the blockage is functionally significant or not,” says Dr Viveka Kumar, cardiologist, Max hospital, Delhi. While patients with 40-70 per cent blockages are advised the stent, he says, it is important to understand how much blood flows across the blockage, and this technology helps one do that. “If it is functionally significant, then we need a stent, otherwise not,” says Kumar.

Kumar explains how certain blockages may or may not affect a patient—for those within the range of 40-70 per cent or borderline cases, this test is effective in measuring the blood pressure and flow across the artery with blockages. The wire-guided test is done during an angiogram, and the readings of the pressure and flow determine the usage of stent. Kumar advises caution when it comes to stents, because once a patient gets it, the arteries are never as good as before, and each year the risk of complications increase by 0.1 per cent. The cost of the procedure is around Rs 25,000, and Kumar insists that third-party insurance must recognise the technique and reimburse the costs for the patient.

Despite financial constraints, Ramanathan is happy he went ahead with the TAVR procedure. Today, he is able to walk again and the incessant cough is just a nightmare from the past. But the first year post TAVR is crucial, and Ramanathan takes care not to stress himself. “It will be a year in February,” he says, “and I am really looking forward to be able to climb stairs to hang my laundry.” Till then, his family is happy to help.

59-Bhubaneswar
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