In-Person and Online: TCT to Showcase Imaging, Valves, DCBs, and More

TCT 2021 kicks off Thursday with its signature mix of new technologies, first-in-man studies, and larger clinical trials and registries at a scaled-down, in-person meeting that will also be streamed live. Members of the program committee, speaking to the media last week, promised this return to in-person programming will have a “futuristic” and “television-like” feel.

{What's Going to Be Hot at TCT 2021? VIDEO WILL APPEAR HERE}

“This will actually be quite a special edition of TCT,” said Juan Granada, president and CEO of the Cardiovascular Research Foundation, noting that the decision by US health authorities to reopen US borders for nonessential travel 1 week after the start of TCT has meant that many would-be attendees and faculty cannot actually be there in person, causing “mixed emotions.”

But there’s also “extreme excitement” that this year’s conference is still able to go ahead with a real-life component, allowing for in-person interaction, Granada said.

In all, more than 600 faculty are participating this year, both virtually and on-site. The conference will offer over 60 hours of educational programming, including 22 late-breaking clinical trials and clinical research presentations, 20 featured clinical research studies, and 24 live cases over the packed, 3-day schedule.

There are three separate theaters for in-person attendees, all of which will be streamed as separate channels. A fourth “World Connect” studio can be glimpsed by passersby who will recognize the open-air studio from years past: this one will not have formal seating, but will be streamed live for virtual attendees, making for a total of four channels.

Whereas in the past the “Main Arena” has been the main stage for late-breaking trials, late-breaking clinical science, and live cases, these last will be broadcast differently this year, with a dedicated “Live Case” theater for this popular content. Late-breakers will be aired in the “Clinical Science” theater, while a third “Innovation” theater will showcase a range of sessions devoted to emerging technology, including the Shark Tank competition and the Town Hall meetings, as well as additional abstract-based featured clinical research.

Describing this year’s live cases, roughly half of which are hosted by sites outside the US, Ajay Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, NY), noted that half were prerecorded, allowing for time differences as well as novel scenarios, including one prerecorded case of a surgically explanted transcatheter valve.

“That's not something that would transmit itself very well in a live case format, but in a prerecorded format, it certainly can be done and will be remarkably educationally important for our colleagues to see what actually happens when you do a TAVR and for reasons of degeneration or otherwise it needs to be explanted,” Kirtane said.

Late-Breaking Trials and Science

Kirtane and Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, NY), walked the press through the late-breaking trial and science sessions on a conference call.

The Thursday, November 4, late-breaking trials, focused on coronary artery disease include FAME 3, comparing fractional flow reserve-guided stenting to CABG; FAVOR III, a sham-controlled comparison of quantitative flow ratio-guided and angiography-guided PCI; and SUGAR comparing a novel amphilimus-eluting stent to a zotarolimus-eluting device in patients with diabetes.

On Friday, November 5, TAVR devices and procedures are the focus. This trio of late-breaking trials includes 5-year results from the SURTAVI intermediate-surgical-risk trial; 2-year economic outcomes from the PARTNER 3 low-risk trial; and CHOICE-CLOSURE, comparing plug-based versus suture-based closure following the use of large-bore devices.

The lineup for Saturday, November 6, is more of a “mix” of trials, said Kirtane, something TCT often serves up on the last day of the meeting. The first, SWISS-APERO, is a head-to-head comparison of the Amulet and Watchman devices for left atrial appendage (LAA) closure. The second, OPT-PEACE, compares different antiplatelet regimens to limit gastrointestinal injury, and the third is a deeper dive into the GUIDE-HF randomized trial of hemodynamic-guided heart failure management, stratified by ejection fraction.

The three late-breaking clinical science sessions, held immediately following the clinical trial late-breakers, feature an even broader mix of studies, many of which are longer follow-up or subset analyses of previously presented trials. Thursday’s features an assortment of renal denervation and advanced imaging studies, and Friday’s is devoted to bleeding, with longer follow-up from two earlier LAA closure studies—AMULET IDE and PRAGUE-17—and new prespecified ACS analyses from MASTER DAPT and the pooled STOPDAPT-2 ACS and STOPDAPT-2 trials.

For Saturday, Kirtane highlighted three studies of drug-coated balloons for coronary artery disease—an indication that the devices do not currently hold in the US—as well as new transcatheter valve technologies for mitral and tricuspid valve replacement.

Additional high-impact abstracts can be found in the Innovation theater grouped in three featured clinical research sessions. For those attending TCT in person there are also moderated “challenging cases” and poster abstracts in dedicated on-site hubs.

Innovation Highlights

The Shark Tank competition takes place Thursday at 10AM, with the award presentation on Saturday at 1PM (both Eastern time). This year’s contenders aren’t necessarily core interventional tech, Granada hinted, but they represent “a very nice combination of digital healthcare and technological innovation.”

The winners of the last five competitions are now companies that are doing “extremely well,” Granada added, so anyone attending this session will be afforded a “glimpse of the future.”

The first day of the US Food and Drug Administration Town Hall will address the impact of COVID-19 on innovation and clinical trials, the “black swan event” that COVID-19 has imposed, and what bearing this may have on the pragmatism of clinical trials going forward. Day two of the town hall will cover interventions for tricuspid valves, heart failure, LAA closure, and finally digital health apps.

In a nod to the fact that this in-person TCT will be different than year’s past, Mehran noted that FDA officials are not yet travelling and these sessions, in particular, will have a larger proportion of speakers attending electronically.