Janelle De Souza
Physicians of patients with severe tricuspid regurgitation now have an alternative to open heart surgery for their critical TT patients.
The Advanced Cardiovascular Institute (ACI) has assembled a multidisciplinary team that has successfully performed minimally invasive, non-surgical cardiac procedures to treat valvular disease and to assess candidates.
ACI and TT MRI Managing Director Christopher Camacho was pleased to know that patents no longer needed to travel overseas to have a cava valve implantation (CAVI), a procedure that is not widely available. invasive procedure to treat severe tricuspid regurgitation, as a successful procedure has recently been performed in TT.
“It’s personal to me because my mother passed away from valve disease. I saw a patient who was very close to me when I was in the cardiac field – I know surgeons nationally and internationally – and yet there was no option for her because no surgical option was available She was unable to have her valve replaced.
“So it’s important to see how we mature so that more and more patients like my mother now have an option here in Trinidad. It is gratifying for me to see us take this step forward as a company.
The groundbreaking 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 Prof. Dr. Prashant Vaijyanath, a renowned cardiothoracic surgeon from India who was trained by the makers of the CAVI device; anesthesiologist Dr. Sheldon Olton and cardiothoracic surgeon Dr. Wazir Mohammed.
This was done on a patient with severe tricuspid regurgitation – a heart valve leak associated with severe heart failure – and the patient was showing a promising result after six months of medical follow-up.
The CAVI procedure involves the implantation of two valves through a small incision in the patient’s upper thigh. They are deployed using catheters and guidewires under X-ray guidance, all in a special procedure room called a catheterization lab.
Camacho explained that with age or due to different illnesses, some people suffer from valve disease. The valves of the heart ensure that blood flows in one direction and at the right time. These valves can either start to leak, causing blood to go in the wrong direction, or fail to open properly, reducing blood flow.
Tricuspid regurgitation is a condition that causes blood to flow back into 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, treatment for valve disease meant open-heart surgery where a surgeon had to cut open the chest bone, stop the heart from beating, place the patient on a bypass machine, open the heart to access the valve, repair or insert a prosthesis. valve, and close the heart and chest, leaving the patient with a long recovery ahead of him.
“This process is very invasive and patients, when their valve status progresses to some degree and they have other comorbidities, may not be able to perform surgery. The risk is considered too high for the potential benefits of surgery, the chances of survival are too low and there is nothing available for them, at this point you are just trying to give them the best care for the rest of the time they have.
Camacho said CAVI is a procedure similar 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 dilated, it pushes out the old valve leaflets and the replacement valve tissue takes over the regulation of blood flow. Now, in many cases, this is the standard of care for someone with a bad aortic valve.
“With the successes of TAVI, researchers have looked at the other valves, but they all have complications that make them particularly difficult, so they haven’t been done that way yet.
“The tricuspid valve doesn’t particularly lend itself to the same approach as TAVI and it took them a while to figure out. Since this valve is difficult to replace where it is, they leave this dysfunctional valve inside of the heart and place two check valves on the two main inlet valves, the inferior and superior vena cava, to prevent blood from 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 being tested.
He said the ACI program worked with Vaijyanath who noted that the patient was not a good candidate for conventional valve replacement surgery due to multiple comorbidities and suggested the use of CAVI. After review, the medical team at ACI Medical Team decided that the patient would be ideal for the revolutionary new procedure.
Vaijyanath called on the manufacturers who supplied him with the valve in India on the basis of “compassionate use” (the patient had a life-threatening condition and had no other choice) to bring it to the TT for the patient.
The patient was discharged a few days after the procedure followed by six months of monitoring and recovery before the results were confirmed. Now, six months after discharge, the patient continues to demonstrate significant improvement in symptoms and requires significantly less medication.
“This is one of the few times that little TT was able to do a procedure before the US. But more importantly, it highlights our programs at ACI in West Shore. We got started, with Dr. Prashant Vaijyanath, in this area of Structural Cardiac Treatment, we have done several TAVI cases that highlight the partnership and success of an international expert working with local experts to achieve successful technology transfer.
Henry, who is considered the pioneer of interventional cardiology in the Caribbean, explained that the left side of the heart is a high pressure area that receives oxygenated blood from the lungs and pumps it to the body. During this time, 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, so any issues were unnatural.
“What happens when the valve falls off, usually these people are very sick. There are other issues that caused undue stress that caused the valve to leak. This is not natural wear and tear, so even after resolving the valve issue, these people continue to have other comorbidities.
He said surgical treatment for the tricuspid valve was always a challenge, as surgeons either pinned the valve or placed a replacement 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 specialist tools, equipment and overhead. These treatments, he said, were beyond the reach of the average Caribbean patient.
However, CAVI, TAVI, and stenting generally used the same cath lab, equipment, and skill set, except there were nuances with each procedure.
“The biggest change is the approach to structural heart disease where it’s now collaborative. You have to have surgeons, interventional cardiologists, anesthesiologists, radiologists, everyone, all working in the same lab environment of catheterization.
He said that even before the patient enters the operating room, the team needed high-speed, high-fidelity CT scans to analyze veins and arteries and to use 3D reconstruction technology. They also had to take steps so they could work with manufacturers on valve sizes. And since the valves were custom-made in Germany from bags of cow’s heart from Brazil, there was a delay before delivery.
He added that the valves were already constantly evolving, which was not surprising because usually when there were “revolutionary” aspects of medical care, there was a period of rapid evolution in the early stages that ended by stabilizing as they matured.
“This structural heart disease is in a period of explosive growth where knowledge is exponential. New things come out every year. It’s a very exciting time and a very consoling time for people who had no options before.
Henry said CAVI was non-standard because there were no long-term randomized 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, where medical treatment had failed, and there were no other options.
He said small leaks respond well to medication, so only a small number of people with valve disease have severe leaks in the tricuspid valve. Nevertheless, the ACI team was in the process of screening the patients but none had yet been selected.
“Ten, 15 years from now, when there are long-term follow-up studies, then maybe they can be offered at an earlier stage. But, for now, the appropriate time for the to offer is only after traditional treatments have failed and the patient is in a life-threatening situation with no alternative.
Camacho also pointed out that the CAVI procedure was still relatively young and therefore still relatively expensive. However, he expected the price to come down over time as the technology matured and there were more competitors in the market.
“I’m proud to say that Trinidad is leading the English-speaking Caribbean in interventional cardiology, electrophysiology and now I’m happy to see it happening in structural heart as well with this team.”