Revolutionizing Cardiovascular Care: The Next Generation of Innovations in Interventional Cardiology
In the ever-evolving landscape of medicine, the field of interventional cardiology (IC) is driving forward with ground-breaking advances, offering new hope for patients with cardiac conditions. Novel devices and innovative techniques are redefining what is possible for treating heart disease.
One annual event serves to highlight the cutting-edge of IC research: 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 provides a platform to showcase and discuss the most promising developments in IC treatments. TCT presents today's best innovations and research and provides a glimpse into the future of transcatheter procedures for cardiovascular care.
Perhaps the single most impactful development to shape the field of cardiology in the past 20 years has been Transcatheter Aortic Valve Replacement (TAVR). This device represents a seismic shift in treatment strategies, offering a minimally invasive alternative to traditional surgery for treating aortic valve stenosis. TAVR has quickly become established as a safe, effective treatment for a patient population that otherwise had no other options, and the ground-breaking device paved the way for several new transcatheter devices.
TAVR continues to evolve as new evidence supports its durability, new devices and approaches to improve TAVR safety, and new applications for conditions like aortic regurgitation help extend its reach.
During TCT, Dr. Leon unveiled the results of the five-year follow-up from the PARTNER 3 Trial, a randomized, multicenter study designed to assess the safety and efficacy of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) for the treatment of aortic stenosis. The lengthiest clinical follow-up of TAVR patients to date, the PARTNER 3 Trial revealed that TAVR remains a significant and viable alternative to surgical therapy for low-risk, severe, symptomatic aortic stenosis (AS) patients.
Published in the New England Journal of Medicine, these findings underscore the durability and sustained efficacy of TAVR as a long-term solution for low-risk, severe, symptomatic aortic stenosis patients. Dr. Leon, co-principal investigator for PARTNER 3, collaborated with Drs. Susheel Kodali and Rebecca Hahn, who held senior investigator roles in the trial.
As TAVR becomes increasingly established, efforts are underway to further improve the procedure's safety. A number of new and existing devices may help to address risks like stroke and coronary artery obstruction during TAVR.
TAVR, Stroke, and AFib
Some innovations come from finding new ways to utilize existing devices in combination with TAVR to address complex conditions. The WATCH TAVR Trial is examining if the WATCHMAN device, a small parachute-shaped device designed to prevent blood clots from forming in the left atrial appendage, can help prevent strokes and bleeding in people with atrial fibrillation (AF) who are also undergoing TAVR.
Preventing Coronary Artery Obstruction During TAVR
New research is also underway exploring new devices to make TAVR safer. Coronary artery obstruction is a rare but life-threatening complication of TAVR where blood flow to the heart's blood vessels becomes blocked. The ShortCut device splits and positions the valve leaflets of a TAVR device to allow for normal coronary flow. This approach can help reduce the risk of coronary artery obstruction for both TAVR in native valves and degenerated mechanical valves that require reintervention (valve-in-valve.)
Aortic stenosis is caused by plaque buildup on the aortic valve, and pieces of this calcified material can break free during TAVR or traditional surgery. This embolic debris can travel to the brain, increasing the risk of stroke and other ischemic events. Trials like the Protect the Head to Head (ProtectH2H) study are looking at devices like the Emboliner Embolic Protection Catheter to find ways to capture this debris and reduce the risk of stroke. These new filter devices cover the entire aorta during TAVR, offering an even greater level of protection than current devices while allowing seamless integration during the procedure.
New Clinical Uses for TAVR
While TAVR has been proven to be an effective treatment for aortic stenosis, this may just be the beginning. The ALIGN-AR Trial is examining TAVR as a treatment for patients with aortic regurgitation. TAVR typically relies on calcification in and around the valve for anchoring and stability. Patients with regurgitation often have no calcification, leaving patients with no treatment options other than surgery. The Jenavalve device's unique design allows it to securely attach to the valve's leaflets without the need for calcium as an anchor.
The tricuspid valve is often referred to as the "forgotten valve" compared to the aortic and mitral valves. Tricuspid valve disease can be challenging to diagnose, medical therapies have been relatively ineffective, and surgery is associated with higher risks and increased complications. While significant effort has been put into developing new technologies to address left-side valve disease, the tricuspid valve has received less attention in clinical and research settings. Fortunately, as awareness grows regarding tricuspid valve disease and its impact on patient outcomes, there is an increasing focus on conducting dedicated research to address this unmet clinical need.
New Device for Tricuspid Valve Replacement
Patients with tricuspid regurgitation (TR) often experience diminished quality of life and poor long-term survival and often are not candidates for traditional surgery. Traditionally, transcatheter valve replacement for TR has not been an option. That's now changed thanks to the TRISCEND II Trial, which evaluated a tricuspid valve replacement system called the EVOQUE valve for patients with severe TR. This randomized trial has shown positive results based on patient-reported outcomes, including questionnaires about their experience with six-minute walk tests to rate a patient's exercise tolerance.
As a result of the TRISCEND II trial, on February 2, 2024, the EVOQUE tricuspid valve replacement system achieved the distinction of being the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of TR.
Transcatheter Clip Repair for Tricuspid Regurgitation
The TRILUMINATE Study is examining a different transcatheter approach for treating TR using a strategy and design similar to the Mitraclip, a device used to successfully treat mitral valve regurgitation. Using a procedure called transcatheter edge-to-edge repair (TEER), a clip-like device called the TriClip is implanted to hold the leaflets together and reduce tricuspid regurgitation without cardiac surgery.
Stent and Balloon Innovation
Stents and Balloons have played a crucial role in interventional cardiology, offering effective solutions for coronary artery disease (CAD) and other vascular issues for decades. However, new approaches and designs are helping to expand how stents and balloons are used.
Using Balloons to Deliver Drugs
Stents are a common strategy for expanding narrowed coronary arteries, but stent-related complications can be challenging to treat. In-stent restenosis is a gradual re-narrowing of the artery after a procedure like a percutaneous coronary intervention (PCI). The AGENT IDE Trialis looking at the safety and efficacy of a paclitaxel-coated balloon catheter for treating in-stent restenosis. While drugs have previously been delivered using stents, this novel balloon-centered approach may prove to be an effective method of treating the restenosis of the stented segment from a previous PCI.
Peripheral artery disease (PAD) is a serious condition where plaque builds up in the arteries in the extremities, often in the legs, limiting healthy circulation and increasing the risk of dangerous blood clots. PAD can limit mobility and decrease quality of life. For patients with chronic limb-threatening ischemia, the most severe form of PAD, it can lead to tissue death, requiring amputation of the affected limb. Expanding these narrowed arteries while safely treating the underlying cause can be difficult.
The use of a new resorbable scaffold has shown to have a positive impact in patients with chronic limb-threatening ischemia, offering a possible glimpse of how we'll treat this common condition in the future. Dr. Sahil Parikh led a multicenter, randomized, controlled trial demonstrating that an everolimus-eluting resorbable scaffold was superior to angioplasty for treating below-the-knee obstructive vascular disease. The striking results were published in the New England Journal of Medicine.
Denervation for Hypertension
Hypertension (high blood pressure) is a common condition where the force of blood pushing against the walls of the arteries is elevated. This increased pressure makes it harder for the heart to pump blood and can lead to serious health problems. While hypertension can typically be managed with medications and lifestyle changes, not all patients respond to these strategies. Hyperactive nerves in the kidneys can strongly influence hypertension, and medical therapy alone is not enough to regulate blood pressure in these patients.
A new interventional treatment focuses on this connection between kidney nerves and hypertension. This minimally invasive catheter-based procedure uses an ultrasound device to disrupt the nerve signals in the kidney that are associated with hypertension, helping to better regulate blood pressure as early as one month following the procedure.
Ajay Kirtane, MD, SM, an interventional cardiologist and Director of Interventional Cardiovascular Care at Columbia, recently treated the first patient using this cutting-edge technique, opening the door to a new avenue for treating hypertension for millions of people worldwide.
Reinventing How We Treat Cardiovascular Disease
Few areas of medicine have evolved as quickly over the past two decades as IC, and these innovations have set the foundation for this growth to continue. New advances from technologies like advanced imaging techniques, artificial intelligence, and new device designs seem poised to push this development forward at an even faster pace.
As platforms like TCT help educate and encourage the safe and informed adoption of the latest evidence-based advances, we can look forward to seeing tomorrow's new transcatheter treatments coming to clinical practices worldwide.