Janelle De Souza
Doctors of patients with severe tricuspid regurgitation now have an option other than open heart surgery for their critical patients in TT.
The Advanced Cardiovascular Institute (ACI) has assembled a multi-disciplinary team who have successfully done minimally invasive, non-surgical heart procedures to treat valve disease and to review candidates.
Managing director at ACI and MRI of TT Christopher Camacho was happy to know patents no longer had to travel abroad to have caval valve implantation (CAVI), a minimally invasive procedure to treat severe tricuspid regurgitation, as a successful procedure was recently done in TT.
“This is personal to me because my mom passed from valve disease. I saw a patient who was very close to me while I am in the cardiac arena – I know surgeons nationally and internationally – and yet there was no option for her because no surgical option was available. She could not have her valve replaced.
“So seeing how we are maturing to where more and more patients like my mom now have an option here in Trinidad is important. It’s gratifying to me to see us make that step forward as a society.”
The breakthrough procedure was successfully performed for the first time in TT and the Caribbean region on November 30, 2021 at West Shore Private Hospital. The medical team was led by interventional cardiologist, and founder and executive chairman of Cardiovascular Associates Ltd, Dr Ronald Henry; and included professor Dr Prashant Vaijyanath, a renowned cardiothoracic surgeon from India who was trained by the manufacturers of the CAVI device; anaesthesiologist Dr Sheldon Olton and cardiothoracic surgeon Dr Wazir Mohammed.
It was done on a patient suffering from severe tricuspid regurgitation – a leaking heart valve condition associated with severe heart failure – and the patient was showing a promising outcome after six months of medical follow-ups.
The CAVI procedure involves the implantation of two valves through a small cut in the patient’s upper thigh. They are deployed using catheters and guidewires under X-ray guidance, all conducted in a special procedural room called a catheterization laboratory.
Camacho explained with age or because of different diseases, some people suffered from valvular disease. Valves in the heart make sure blood flows on one direction and at the right time. These valves can either start to leak so that blood goes in the wrong direction, or do not open well so there is less blood flow.
Tricuspid regurgitation is a condition which causes the blood to flow backwards in the upper chamber of the heart (right atrium) when the lower chamber (right ventricle) contracts. This leads to recurrent right heart failure, excessive abdominal swelling, liver congestion, swollen feet, digestive problems and chronic fatigue.
Traditionally, treating valvular disease meant open heart surgery where a surgeon would have to crack open the chest bone, stop the heart from beating, put the patient on a bypass machine, cut open the heart to access the valve, either repair or insert a prosthetic valve, and close the heart and the chest, leaving the patient with a lengthy recovery ahead.
“That process is a very invasive one and may patients, when their valve condition progresses to a certain extent and they have other comorbidities, they are not able to do surgery. The risk is rated too high for the potential benefits of the surgery, the chances of surviving is too low, and there’s nothing available for them. At that point you just try to give them the best care for the rest of the time they have.”
Camacho said CAVI is a similar procedure to transcatheter aortic valve implantation (TAVI) which is done on the aortic valve in the left ventricle of the heart. With TAVI, a new, synthetic valve is placed inside the old valve through a catheter. Once the new valve is expanded, it pushes the old valve leaflets out of the way and the tissue in the replacement valve takes over the job of regulating blood flow. Now, in many instances, it is the standard of care for someone with a bad aortic valve.
“With the successes of TAVI, researchers have been looking at the other valves but they all have complications that make them particularly challenging so that they haven’t yet been done this way.
“The tricuspid valve is not particularly amenable to the same approach as TAVI and that took them a while to figure out. Since that valve is difficult to replace where it is, they leave that dysfunctional valve inside the heart alone and put two check valves on the two main inlet valves, the inferior and superior vena cava, to prevent blood going the wrong way.”
The TricValve system procedure performed with CAVI was developed by a German company. It gained European approval in May 2021 and US approval in January 2022 but is still under trial.
He said the ACI programme worked with Vaijyanath who noted that the patient was not a good candidate for conventional valve replacement surgery because of multiple comorbidities and suggested the use of CAVI. After review, the ACI medical team medical team decided the patient would be ideal for the revolutionary new procedure.
Vaijyanath called the manufacturers who released the valve to him in India based on “compassionate use” (the patient had a fatal condition and had no other option) to bring it to TT for the patient.
The patient was discharged a few days after the procedure followed by six months of check ups and recovery before results were confirmed. Now six months post-discharge, the patient continues to demonstrate significant improvement in symptoms and requires much less medications.
“This is one of the few times little TT was able to do a procedure before the US. But more importantly it highlights our programmes at ACI at West Shore. We have embarked, with Dr Prashant Vaijyanath, into this arena of structural heart treatment. We have done several TAVI cases which highlights the partnership and success of an international expert working with local experts to successfully transfer technology.”
Henry, who is considered the pioneer of interventional cardiology in the Caribbean, explained the left side of the heart was a high pressure area which received oxygenated blood from the lungs and pumped it to the body. Meanwhile, the right side of the heart received deoxygenated blood from the body and sent it to the lungs to be oxygenated. The right side was a low pressure circuit with less wear and tear so any issues there were not natural.
“What happens when the valve goes down, usually these people are very sick. There are other problems that have caused undue stress which caused the valve the leak. It’s not natural wear and tear so even after you fix the valve problem, theses people continue to have other comorbidities.”
He said addressing the tricuspid valve surgically was always a challenge as surgeons either pinned the valve back together or placed a substitute valve in the location. Neither produced satisfactory results.
He said the CAVI procedure was more applicable to this part of the world when comparing the cost of other treatments with their expensive specialised tools, equipment and overhead costs. Those treatments, he said, were out of the reach of the average patient in the Caribbean.
However, CAVI, TAVI and stent placement generally used the same catheterization laboratory, equipment, and skill set except there were nuances to every procedure.
“The biggest change is the approach to structural heart disease where is it now collaborative. You have to get the surgeons, interventional cardiologists, anaesthesiologists, radiologists, everybody, all working within the same environment of the cath lab.”
He said even before the patient went into the procedure room, the team needed high speed and high-fidelity CAT scans to analyse veins and arteries and to use 3D reconstruction technology. They also had to take measurements so they could collaborate with manufacturers regarding the sizes of the valves. And since the valves were custom made in Germany from cow heart sacs from Brazil, there was a lag time before delivery.
He added that the valves were already constantly evolving which was not surprising because, generally, when there were “revolutionary” aspects of medical care, there was a period of rapid evolution in the early stages that eventually levelled off as they matured.
“This structural heart disease is in an explosive growth period where there is exponential knowledge. New things are coming out every year. It’s a very exciting time and a very consoling time for people who previously did not have options.”
Henry said CAVI was not standard because there were no long-term randomised trials or 20 years of data to compare. So, for now, it was only to be used on people who had severe, life-threatening leaks, on whom medical therapy had failed, and there were no other options.
He said small leaks responded well to medication so only a small number of people with valvular disease had severe leaks in the tricuspid valve. Nevertheless, the ACI team was in the process if screening patients but none had yet to be selected.
“Ten, 15 years from now when there are long-term follow up studies, then one might be able to offer it at an earlier stage. But, for now, the appropriate time to offer it is only after traditional treatments fail and the patient is in a life-threatening situation with no alternative.”
Camacho too stressed that the CAVI procedure was still relatively young and so still relatively expensive. However, he anticipated the price would reduce in time as the technology matured and there were more competitors on the market.
“I am proud to say Trinidad has led the English-speaking Caribbean in interventional cardiology, electrophysiology and now, I’m happy to see that also taking place in the structural heart arena with this team.”
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