From Intervention to Prevention: The Latest Innovations and Expertise from TCT 2024

The Transcatheter Cardiovascular Therapeutics (TCT) conference has long been one of the top educational forums in interventional cardiovascular medicine. Founded nearly forty years ago by Martin Leon, MD, an interventional cardiologist, chief innovation officer, and the director of the Cardiovascular Data Science Center for the Division of Cardiology at NewYork-Presbyterian and Columbia, the Cardiovascular Research Foundation's (CRF) annual scientific symposium brings together experts from around the world to learn about cutting-edge trials and pressing issues in interventional cardiology.

This year, more than 10,000 attendees attended TCT 2024 in Washington, DC, which focused on comprehensively treating the cardiovascular disease process as a whole with a new theme of "from intervention to prevention." NewYork-Presbyterian doctors from Columbia and Weill Cornell Medicine have always maintained a strong presence at the event and this year was no different. Physicians served as speakers, participants, and program directors, including Dr. Leon; Ajay Kirtane, MD, director of the interventional cardiovascular care program at Columbia; and Sahil Parikh, MD, director of interventional cardiology endovascular services at Columbia.

In addition to the program directors, other NewYork-Presbyterian clinicians from both Columbia and Weill Cornell Medicine served on the TCT program development committee, including:

• Russell A. Brandwein, MS, PA-C
• Brian G. DeRubertis, MD, FACS
• Mahesh V. Madhavan, MD
• Margaret B. McEntegart, MD, PhD
• Tamim M. Nazif, MD
• Vivian G. Ng, MD
• Megha Prasad, MD
• Sanjum S. Sethi, MD
• Torsten P. Vahl, MD

Various other NewYork-Presbyterian interventional cardiologists and surgeons presented ground-breaking research updates about early intervention and new treatment options in the areas of coronary artery disease, structural heart disease, and endovascular intervention. Additionally, three live cases were presented by NewYork-Presbyterian and Columbia physicians highlighting a redo transcatheter aortic valve replacement (TAVR) case, a challenging TAVR case, and the final case in the EMPOWER CAD trial using intravascular lithotripsy to treat calcified lesions in women.

Additionally, Jeffrey W. Moses, MD, was honored as the recipient of the TCT 2024 Master Operator Award, which is presented annually to a physician in recognition of their contributions to the field of interventional cardiology. Dr. Moses, who is director of interventional cardiovascular therapeutics at NewYork-Presbyterian and Columbia, received the award for his technical excellence and leadership.

With a plethora of research presented over the four-day event, some of the most notable presentations from NewYork-Presbyterian physicians were related to TAVR, coronary artery calcification, and the management of severe tricuspid regurgitation.

Intervening with TAVR before patients with severe aortic stenosis become symptomatic

Findings for the EARLY TAVR trial, which were published in the New England Journal of Medicine and also shared at TCT 2024, provide hope that considering earlier intervention in severe AS will improve patient outcomes. Allan Schwartz, MD, chief of cardiology at NewYork-Presbyterian and Columbia, was a co-principal investigator for EARLY TAVR; Dr. Leon served as the study chairman.

Results from the pivotal trial could result in a paradigm shift in severe aortic stenosis (AS). While it used to be typical for patients with severe AS to not have either surgical valve replacement or TAVR until they showed symptoms, results from this newly published study show that there are benefits to considering intervening before patients become symptomatic.

Within the trial, which enrolled patients with asymptomatic AS, an early TAVR strategy reduced the incidence of mortality, strokes, and unplanned hospitalizations and worsening of symptoms. This difference in outcomes was observed despite the fact that during a mean follow-up of 3.8 years, 87% of patients in the clinical surveillance arm underwent TAVR.

	EARLY TAVR	AS Surveillance
Mortality	8.4% (-9%)	9.2%
Stroke	4.2% (-37%)	6.7%
Unplanned hospitalization	20.9% (-50%)	41.7%

The trial found differences in outcomes between those who underwent an early TAVR strategy versus aortic stenosis surveillance.

Comparing strategies for combating calcified lesions

Severe coronary artery calcification is a significant issue in patients undergoing percutaneous coronary intervention (PCI), particularly in the elderly population. Despite its association with procedural complexity and higher morbidity and mortality, there have been very limited comparisons between treatment strategies for severe calcification.

The ECLIPSE trial was a large-scale, prospective randomized trial comparing two strategies for treating severe coronary calcification. At TCT 2024, Dr. Kirtane, principal investigator for the ECLIPSE trial, presented the comparison between conventional balloon angioplasty and a more advanced lesion preparation strategy, orbital atherectomy.

Dr. Kirtane presented the results of the ECLIPSE trial, which found that the best outcomes were achieved when using intravascular imaging to further inform treatment.

Dr. Kirtane and his colleagues found that the outcomes were similar with both strategies, and the best outcomes were achieved using intravascular imaging to see within the vessel itself to further inform treatment. Notably, these findings were observed in the context of a 62% use rate of intravascular imaging to guide the PCI procedures. Most hospitals use intravascular imaging in <30% of procedures; physicians at NewYork-Presbyterian and Columbia use intravascular imaging in more than 90% of PCI cases.

Especially in older patients with more complex cases of calcium buildup, the ECLIPSE trial demonstrates that conventional balloons can work just as well as more advanced calcium modification strategies, especially when using intravascular imaging to guide these procedures.

A new treatment for severe tricuspid regurgitation offers promise in a field with limited options

Because surgery has traditionally been considered too risky for managing moderate to severe tricuspid regurgitation, these patients have limited options especially for symptom relief. The latest findings from the TRISCEND II trial, examining the use of a minimally invasive valve replacement system in these patients, were published in the New England Journal of Medicine and shared at TCT 2024. The study's principal investigator was Dr. Kodali and Rebecca T. Hahn, MD, director of interventional echocardiography at NewYork-Presbyterian and Columbia; Dr. Leon was also an investigator on the trial.

The TRISCEND II trial showed that a minimally invasive valve replacement system, EVOQUE, can dramatically reduce the severity of tricuspid regurgitation as compared with medical therapy alone, and this was associated with a significant improvement in symptoms for patients. Results also showed a cardiovascular mortality of just 3% at 30-days with all patients undergoing successful implantation of the device to treat TR.

The ability to manage severe tricuspid regurgitation percutaneously means that a broader range of patients will be able to receive treatment, and sicker patients will no longer have to go untreated because they are not able to have surgery. NewYork-Presbyterian and Columbia is one of few hospitals in the area that studied and offers EVOQUE and other minimally invasive therapies to patients with severe tricuspid regurgitation.

Live case concludes all-women trial on intravascular lithotripsy

As principal investigator of the EMPOWER CAD trial, Dr. McEntegart, director of cardiac catheterization laboratories and director of the complex PCI and CTO programs at NewYork-Presbyterian and Columbia, is testing the efficacy of intravascular lithotripsy, or shockwave, to treat calcified arteries in women. Alongside Dr. Prasad, an interventional cardiologist and director of the cardiorenal program at NewYork-Presbyterian and Columbia, and Akiko Maehara, MD, MBA, an interventional cardiologist at NewYork-Presbyterian and Columbia, Dr. McEntegart presented the final case in the trial via an educational live transmission from NewYork-Presbyterian and Columbia to TCT 2024.

As women are traditionally understudied in cardiology, it was significant to have the final case of an all-women study done by three expert female operators. Drs. McEntegart, Prasad, and Maehara were able to successfully treat the patient's calcified arteries and improve her blood flow during the live case, while at the same time demonstrating how to safely perform a complex procedure guided by intravascular imaging.

Late-breaking clinical trial presentations highlight progress toward improved outcomes

More research on innovations in interventional cardiology presented at TCT 2024 in addition to the clinical trials discussed above included:

• ALIGN-AR Trial - Dr. Vahl, an interventional cardiologist at NewYork-Presbyterian and Columbia, served as the principal investigator of a trial that focused on using TAVR and a device to manage severe aortic regurgitation instead of surgery to replace the aortic valve. Dr. Vahl presented the two-year outcomes of the trial, which assesses the efficacy of the JenaValve Pericardial TAVR System, a US FDA-designated "breakthrough" device.
• ACURATE IDE Trial - Dr. Nazif, an interventional cardiologist NewYork-Presbyterian and Columbia, served as the site principal investigator of a trial that examined the safety and efficacy of the ACURATE Valve device for TAVR in patients with severe aortic stenosis.
• TAVR UNLOAD Trial - Dr. Kodali served as the site principal investigator of a trial that aimed to determine whether using TAVR to replace a narrowed heart valve can reduce strain on the heart in patients with moderate aortic stenosis and heart failure.

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