Revolutionizing Cardiovascular Care: Expanding the Reach of Interventional Cardiology
Interventional cardiology’s breakthrough devices and minimally invasive strategies for treating heart and vascular disease continue to push the envelope of what can be treated without surgery. As more and more data demonstrates the safety and viability of transcatheter treatments as alternatives to traditional surgery, the focus is expanding to offer these proven treatment options to more patient populations in need.
Every year, thousands of members of the interventional cardiology community gather to highlight this growing body of research at the Transcatheter Cardiovascular Therapeutics (TCT) conference. Founded in 1988 by Martin B. Leon, MD, Chief Innovation Officer and the Director of the Cardiovascular Data Science Center at Columbia, this annual gathering sheds light on today's most promising innovations and takes stock of the latest research findings in the world of transcatheter cardiovascular care.
Expanding How We Use Current Devices
The use of innovative devices has been the hallmark of interventional cardiology for the past few decades. Transcatheter Aortic Valve Replacement (TAVR) redefined how we treat valve disease by offering a viable option for patients with aortic stenosis (AS) who were not candidates for surgery. The established success of TAVR has led to new areas and approaches that build on this innovative trancatheter strategy.
Using TAVR Earlier - Treating Asymptomatic AS with TAVR
During TCT, highly anticipated results were presented from the EARLY TAVR trial, which examined whether early intervention with transcatheter aortic valve replacement (TAVR) can improve outcomes for patients with asymptomatic but severe AS.
Current guidelines recommend routine clinical surveillance every 6 to 12 months to monitor for disease progression, with intervention reserved for when symptoms appear. Recently, researchers have been exploring whether early intervention might help slow or halt disease progression. This prospective, randomized, controlled, multicenter study compared early TAVR against clinical surveillance.
Presented in collaboration with the New England Journal of Medicine, the results of the EARLY TAVR trial indicated that for patients with asymptomatic severe aortic stenosis, early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes.
These findings have the potential to greatly influence current guidelines for treating asymptomatic severe AS and is one of many trials exploring early transcatheter intervention for AS.
TAVR UNLOAD Trial - TAVR in Patients with Moderate AS and AF
The TAVR UNLOAD trial examined whether using TAVR in patients with moderate aortic stenosis and heart failure improved outcomes by reducing the strain on the heart before symptoms worsened.
The presented results indicate that while the procedure was safe, performing early TAVR did not provide a significant benefit over clinical surveillance and waiting to perform TAVR only when severe AS develops.
Triscend II Trial - Evoque Valve Replacement for Tricuspid Regurgitation
After many years with limited treatment options, tricuspid valve disease has become a center of attention in clinical and research settings. Transcatheter tricuspid valve replacement (TTVR) is now becoming available to treat tricuspid regurgitation (TR), offering quality-of-life improvements beyond those available with medications like diuretics.
Susheel Kodali, MD, Director of the Structural Heart and Valve Center at Columbia, presented follow-up results for the TRISCEND II trial. This international, multicenter trial compared TTVR using the Evoque device and medical therapy with medical therapy alone. The trial included over 400 patients with severe symptomatic tricuspid regurgitation.
Published in the New England Journal of Medicine, the follow-up results presented at this year's TCT showed improvements in symptoms, function, and quality of life at one year when compared with medical therapy, as well as fewer deaths from all causes and hospitalizations for heart failure (HF).
Previously published early results were used by the U.S. Food and Drug Administration to approve the Evoque TTVR system in early 2024. These new results supported the conclusion that transcatheter tricuspid-valve replacement was superior to medical therapy alone for patients with severe tricuspid regurgitation.
New Devices
As the saying goes, it’s important to have the right tool for the right job. When an existing device falls short of what is needed to treat a specific form of valve disease, new devices can step in and fill that gap and make sure that need is met.
ALIGN-AR Trial - TAVR for Aortic Regurgitation
TAVR was originally developed to treat AS but is sometimes used as an off-label treatment for aortic regurgitation (AR) due to a lack of other options for patients with a high surgical risk. TAVR valves are designed to take advantage of the calcium deposits found in AS to anchor the device. Because patients with AR do not have that same calcium buildup, a revised approach is needed to safely apply TAVR.
Results presented from the ALIGN-AR trial continue to demonstrate the safety and efficacy of the JenaValve Trilogy Heart Valve System for treating severe aortic regurgitation. The Trilogy System uses locator attachments that clip and grasp onto the valve's leaflets to form a secure implantation.
The ALIGN-AR 1-and-2-year results were encouraging enough to have the U.S. Food and Drug Administration considering regulatory approval for the device, according to Torsten P. Vahl, MD, who presented the findings at this year's TCT. Already approved for use in Europe, the Trilogy System may soon offer a much-needed treatment option here in the US for patients with AR.
Research That Help Improve Treatment
Advances in treatment wouldn’t be possible without first assessing the effectiveness of current strategies. Research can help identify the best ways to treat specific conditions and populations, and it can also help us understand how factors like gender bias can leave patients underrepresented and in need of better care.
Right-Sided Infective Endocarditis
Right-sided infective endocarditis (RSIE) is a condition affecting the tricuspid valve and lining of the heart. In RSIE, pathogens form lesions (vegetations) that can erode the tissue in the valve and cause TR. These lesions can also break off and enter the bloodstream, causing vascular inflammation and pulmonary embolisms. If left untreated, RSIE can also lead to other life-threatening conditions like sepsis and heart failure.
While the condition is rare, the patient population is growing and becoming more complex. RSIE is most common in people who abuse injectable drugs like heroin but is also seen in patients with implantable devices like pacemakers.
RSIE can be treated with surgery and medications, but these patients are often not candidates for surgery, and medication therapy is not always effective. Percutaneous mechanical aspiration (PMA) uses a vacuum device to remove the vegetations without surgery. The use of PMA to remove these lesions is becoming more common, but more data is needed to assess how well this treatment is working.
The CLEAR IE Multicenter Registry was created to examine outcomes of percutaneous mechanical aspiration in right-sided infective endocarditis. This multicenter registry examined the outcomes for over 250 patients who underwent PMA for RSIE.
The retrospective data collected in the registry indicates that PMA was an effective treatment option for these patients. While randomized trials are still needed to confirm these findings, the registry gives encouraging support for the use of PMA as an effective RSIE treatment option.
Coronary Artery Disease
Coronary artery disease (CAD) has traditionally been treated as a "men's" disease, despite being the leading cause of death for women. This misperception has led to women being underrepresented in cardiovascular clinical trials, making up only around a quarter of enrolled patients in many leading studies.
Women make up only a tenth of trial leadership committees, which may help explain the continued imbalance in study design.
CAD symptoms present differently in female patients, and studies show that women have a higher risk of procedural complications than men when undergoing percutaneous coronary intervention (PCI) for CAD. Closing this research gap and gathering gender-specific data is crucial to improving outcomes.
The EMPOWER CAD study is the first prospective all-female study of percutaneous coronary intervention (PCI) in complex calcific disease. The study examined the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions. The study enrolled 400 participants across multiple sites and countries. Significantly, the study was led by a female majority of principal investigators.
The study enrollment was completed during a live case at this year's TCT, with a team of all-female operators that included Drs. Margaret McEntegart, Megha Prasad, and Akiko Maehara from Columbia.
The EMPOWER CAD study drives home the importance of gender equity in how we research and treat heart disease, but also highlights the need for greater diversity and representation for providers.
Applying Transcatheter Innovations in New Ways
As transcatheter procedures become more popular for treating cardiac conditions without surgery, we are witnessing innovation not just in the further development of new devices but in the expansion of how and when we apply these strategies.
TCT is instrumental in sharing the latest research and encouraging providers to adopt these evidence-based treatments in a thoughtful and effective manner. As more data becomes available, we can look forward to seeing transcatheter treatments offer new hope and improved lives for millions of patients worldwide.
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