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How MitraClips were used to fix two separate leaking valves

The procedure was a first in India and also in southeast Asia

Innovative solution: MitraClip; (left) the clip in the tricuspid valve.

Till October last year, Deewan Singh Dardi, 87, was managing a call centre with 5,000 employees. And then, he was not up to it anymore.

Dardi had a chequered medical history: bypass surgeries and operations on the gall bladder and prostrate, and one for hernia plus morbid obesity. His latest health concern was massive water retention that had started from his legs. In a decade, it had moved through his body and even affected his face and eyes. Everyday activities were a challenge and even his speech was slurred.

The same MitraClip was used to treat both the mitral and the tricuspid valve leaks, simply because the dedicated tricuspid valve clip was not available in India.
Even younger patients can be considered, especially when traditional surgery is not a viable option due to various reasons. It primarily depends on the presence of comorbidities and previous surgeries. - Dr Praveen Chandra, chairman, interventional and structural heart cardiology, Heart Institute, Medanta, Gurugram.

After consulting two doctors, Dardi’s daughter Priya Monga took him to Dr Praveen Chandra, chairman, interventional and structural heart cardiology, Heart Institute, Medanta Gurugram. Chandra and his team (including Dr Manish Bansal and Dr Nagendra Chauhan) suspected that the swelling was a result of congestive heart failure. An echocardiogram (an ultrasound test that checks the structure and function of the heart) revealed that two of his valves were leaking.

But first, some understanding of the heart’s valves.

There are four types of heart valves―tricuspid valve (located between the right atrium and the right ventricle), pulmonary valve (located between the right ventricle and the pulmonary artery), mitral valve (located between the left atrium and the left ventricle) and aortic valve (the final one encountered by the oxygenated blood as it leaves the heart).

In Dardi’s case, the mitral and tricuspid valves were leaking, which means that blood was not flowing in one direction as it should. Blood flow in our system goes from the heart to the lungs, gets oxygenated, then goes back to the heart from where it is distributed throughout the body via the arteries. In this case, the blood was moving in two ways―forward, towards the lungs, and backwards, towards the body from where it had just come. This was a very dangerous situation. When blood bombards the heart from different directions, the heart grows larger to accommodate this and its efficiency plummets. The patient begins to exhibit the first signs of heart failure. This pressure on the heart causes breathing problems, discomfort, weakness, fatigue, lethargy and swelling in the body.

The medical term for the condition is ‘massive tricuspid regurgitation’.

MitraClip treatments, wherein MitraClips (that look like large staples) are used to clip defective valves, are standard procedures for high-risk patients of mitral regurgitation with suitable anatomy. US-based Abbott Laboratories holds the patent for MitraClip.

But Dardi’s was a different case―the same MitraClip was to be used to treat both the mitral and the tricuspid valve leaks, simply because the dedicated tricuspid valve clip was not available in India. The procedure was a first not just in India, but also in southeast Asia.

Tricuspid regurgitation along with mitral regurgitation can cause congestive cardiac failure with symptoms of both left- and right-sided heart failure. If not treated in time, it can be life threatening.

“The primary reason this happens is because of age,” said Chandra. “As people get older, their heart valves wear out naturally. Additionally, this patient had undergone two bypass surgeries, in 1987 and 2001. That also contributed to the valves getting damaged.”

The doctor’s first suggestion was medication to manage heart failure. However, drugs are effective in only 25 to 30 per cent of patients. They experience improvement in terms of decrease in the leakage and require no additional treatment. “But in this case, that did not happen. The patient was put on medicines for six months but did not get better,” said Chandra.

Now, three months later, the improvements are gradual but marked. Deewan Singh Dardi's (in pic) dosage of diuretics is down, the swelling on his face and eyes has significantly decreased, and his speech is clearer.

The team then initiated an extensive consultation with a wider network of colleagues and a New York-based specialist. Across conference calls and video information sharing, a plan was devised. A seemingly simple solution that required clipping the abnormal part of the valves with the same kind of clip; closing them tightly enough so that the rest of the valves would function as intended.

Clipping itself is relatively risk free as it eliminates the need for open-heart surgery. It is minimally invasive and a non-surgical treatment option for symptomatic patients who are at high risk for surgery and do not respond to just medicines. It involves no traditional surgery, chest incisions, stitches or cuts.

“We use a small device inserted through the legs,” said Chandra. “This device is introduced via an injection, and it contains a catheter. We perform the entire procedure remotely using this catheter, which is controlled from a distance. We don't go deep into the heart; we work through the leg, guided by ultrasound and X-rays, so we need to be really precise.”

Chandra could try the approach because he had, for years, attended specialist meetings and live case demonstrations. “These are vital aspects of advanced medical conferences,” he said. “These events allow us to discuss various treatment options for complex diseases. I had seen such a live surgery in New York.”

Dr Praveen Chandra

While the doctor makes it sound simple, there were complexities. “One major concern was the possibility that the valve might not fit properly, in which case we would need the surgeons to open the chest,” Chandra said. “To address this, we had a surgical team on standby in the second operating theatre. We were fortunate to have a hybrid cath (where there is equipment for both catheterisation and surgery) lab in our hospital, a rare facility in India, which was essential for this procedure. The success of such complex operations relies heavily on teamwork. During this procedure, we had a team of approximately 25 individuals ready to address any further steps that might have been required.”

The challenge of the unavailable clip had to be tackled with extreme precision.

“By itself, the clip is a simple tool we place there to make sure both leaflets are fixed in the right position,” said Chandra. “Once we do this, there is no gap left, and there is no more leaking. We used a similar clip for the tricuspid valve, which is a bit different. It is like using a special tool because the tricuspid valve is in a different spot. The important thing is to put the clip exactly where the problem is.”

The tricuspid valve is a larger valve and requires use of specifically designed clips to address the problem effectively. The number of clips used varies from patient to patient. In Dardi’s case, four MitraClips were used―three in the tricuspid valve.

Tricuspid clips are still not manufactured in India; the bulk are imported from the US. “It wasn't a standard practice for this equipment to be developed or introduced in the country at that time,” said Chandra. “This is why we felt the need to initiate this programme. The necessary skills and expertise had not been developed locally. I conducted the necessary research and preparation so that in case a patient with such specific needs came in, we would be equipped to provide the appropriate treatment.”

Monga said the family’s faith in Chandra came from the “comprehensive and unique understanding of the procedure he and his team” provided. “He explained the process in a way that no other doctor had suggested before,” she said. “While other doctors suggested opting for longer and more complicated processes, Dr Chandra recommended the clipping method because the valve was quite damaged. I had not received a recommendation for the clipping process from anyone else, but he was confident and assured us that it was the right approach.... I had initially thought it would be a one-hour surgery, but it took him around four hours to complete.”

Dardi was in hospital for three days.

Now, three months later, the improvements are gradual but marked. His dosage of diuretics (medicines to reduce water retention) is down, the swelling on his face and eyes has significantly decreased, and his speech is clearer. The only medication he is on is to maintain sugar levels. “The recovery process was quite normal, but it definitely didn't happen overnight due to his age,” said Monga. “It has been three months, and I can confidently say that he has made remarkable progress. He is now going out, meeting friends, taking walks and attending his club meetings.”

In addition to reading and consulting with relatives and friends, the Dardi family’s choice was helped by the fact that they were never pressurised into making an immediate decision. “The MitraClip procedure is not widely known, and awareness needs to be raised about it,” said Monga. “It is not typically covered by insurance in India. We believe the government should recognise such procedures and work to reduce costs, making high-quality operations more accessible to people. MitraClip, despite its high cost, offers better recovery and lower risks, making it a valuable option for patients.”

Chandra said he could see this becoming standard procedure soon. “Even younger patients can be considered, especially when traditional surgery is not a viable option due to various reasons,” he said. “It primarily depends on the presence of comorbidities and previous surgeries.”

As for Dardi, his optimism is rising. “He will regain more energy and feel even better,” said Monga.

What more could one ask for from a simple clip?

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