University of South Florida

Fadi is a seasoned Cath Lab Medical Director with a proven track record in the higher education sector. He possesses 25 years of robust experience in interventional cardiology, interventional structural heart disease, clinical research, medicine, and public speaking, with a commitment to providing strong healthcare services.

Please tell us about the journey that you've had so far and your roles and responsibilities at University of South Florida.

I am an interventional cardiologist at USF Tampa General, with a 30-year history at the institution. Initially focused on coronary artery disease, our field expanded to address valvular diseases like aortic and mitral valve issues. Over the years, we've advanced in treating structural heart diseases, broadening our capabilities in the Cath lab without resorting to open-heart surgeries. Our journey involved rigorous clinical trials for various devices, some of which are now widely used. Currently, we're exploring new devices for mitral and tricuspid valve issues, aiming to apply them in patient care.

What are some of the major challenges in the cardiovascular device market today?

The current hurdles in the field of valve replacements primarily lie at the level of the mitral and tricuspid valves. While percutaneous treatments have been more feasible for the aortic valve, addressing issues with the mitral and tricuspid valves has proven to be a more intricate challenge. It is anticipated that a comprehensive solution for these complexities may not be achieved in the near future. It is due to the fact that these valves are closely tied to the left and right ventricles and atria. Diseases affecting the left atrium, left ventricle, right atrium, and right ventricle can impact the mitral and tricuspid valves, adding to the intricacies of finding suitable solutions.

“It is vital to vigilantly identify tricuspid regurgitation in patients and refer them to specialized centers with advanced technologies for timely enrollment in trials and access to therapeutic interventions.”

Also determining the optimal time for valve replacement becomes challenging, as there is a delicate balance between when a valve is affected and when it starts affecting the surrounding structures. The wide variation in sizes and the dilation patterns of the ventricles and atria further complicate the decision-making process. The need for larger devices to accommodate these variations raises concerns about their successful deployment through percutaneous methods. This adds an additional layer of difficulty in deciding when to replace a valve and emphasizes the need for careful consideration to avoid delays that may lead to complications.

What are recent trends that have evolved to help tackle these pain points?

The treatment landscape for heart valves is diverse, with various approaches being explored in the industry to find the most effective solutions. Currently, there's a focus on developing multiple types of devices that can cater to different patient anatomies. This approach aims to offer tailored solutions based on individual needs.

In the tricuspid and mitral realms, therapies targeting the leaflets are gaining prominence. Notable examples include edge-to-edge repairs such as the Mitral clip and Pascal devices. These interventions aim to bring the leaflets of the valves together, reducing leakage.

However not everyone is eligible for certain therapies due to factors like fake or calcified leaflets, or if the valve is small that can lead to obstruction. To address this, the industry is developing mitral valve replacement therapies where a new valve is percutaneously implanted, eliminating the diseased valve entirely.

An alternative approach to mitral valve replacement involves the use of the Alta valve. Unlike traditional methods that may lead to complications such as left ventricular outflow tract obstruction, the Alta valve is designed to be implanted inside the left atrium. This valve features a cage or stent that sits at the bottom of the left atrium, allowing the mitral valve to function without interference. The Alta valve prevents leakage from reaching the left atrium by intercepting it on the left atrial side of the mitral valve. This eliminates the need to pin the old leaflets and mitigates the risk of obstruction, providing a different and effective solution for mitral valve replacements.

In addition, tricuspid valve replacement therapies, like the upcoming Evoke trial by Edwards, present a promising avenue. It involves pinning the old tricuspid leaflets in place, creating a foundation for the new valve.  The promising data for this therapy anticipates imminent approval for addressing severe tricuspid regurgitation.

Is there a project initiative that you've been part of recently and have implemented one or couple of these trends to make that successful?

In our exploration of tricuspid valve replacement, a crucial aspect involves anticipating the point at which the right ventricle becomes irreversibly damaged due to tricuspid regurgitation. It is important because if the right ventricle has undergone extensive damage over an extended period, then it's too late for intervention. We now possess advanced technology, known as pressure-volume loop catheters, that aids in determining the suitability of patients for tricuspid valve replacement. These catheters are inserted into the right ventricle, allowing precise measurement of the interaction between volume and pressure throughout the cardiac cycle. This valuable information provides insights into the genuine functionality of the right valve.

We are currently engaged in a project aimed at determining whether it is possible to predict which patients would be suitable candidates for tricuspid valve replacement before irreversible damage occurs. In addition, we are investigating indicators to identify patients who may be beyond the optimal window for tricuspid valve replacement.

In another project we analyzed data from Tampa General's database over a year that focused on tricuspid regurgitation patients. The findings, currently under publication review, reveal that only 10 percent of those with progressive valve regurgitation are suitable candidates for tricuspid valve replacement. A significant 75 percent are identified as late presenters, prompting the need to raise awareness in the community about the importance of early referral for interventional management in tricuspid regurgitation cases.

Any specific piece of advice that you'd like to share with your fellow peers or other industry leaders?

My guidance is primarily centered on patients with tricuspid regurgitation, a valve condition often overlooked. It is important to be of vigilant in identifying tricuspid regurgitation, even in its moderate stages. It is crucial not to delay action but rather promptly refer these patients to specialized centers equipped with advanced technologies, enabling their enrollment in trials and ensuring they can access therapeutic interventions sooner rather than later.