Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.
This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.
Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.
Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.
Abbott’s TriClip, MitraClip shine along with drug-eluting stent
Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.
TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomatic, severe tricuspid regurgitation (TR). MitraClip again proved that it offers benefits across a broad group of patients with mitral regurgitation (MR).
Key findings for TriClip included significant improvements in quality of life along with an excellent safety profile. Meanwhile, MitraClip demonstrated the highest reported MR reduction in a mitral TEER study to date, Abbott said. Patients sustained results through one year with MR reduction to mild or less achieved in 93% of patients.
Following the positive TriClip and MitraClip results, Abbott also had more good news on another cardiovascular offering. The LIFE-BTK trial of the Esprit drug-eluting stent met both of its primary safety and effectiveness endpoints. It demonstrated the reduction of disease progression and improved medical outcomes compared to balloon angioplasty, the current standard of care.
The company designed Esprit BTK to treat people with chronic limb-threatening ischemia (CLTI), a severe stage of peripheral artery disease (PAD).
Avertix brings heart attack detection data to TCT 2023
Avertix designed its Guardian system to improve the long-term management and outcomes of recurrent vents in high-risk patients who have survived one or more heart attacks. It alerts patients to rapidly progressive ST-segment deviation associated with coronary occlusion.
Guardian alerts patients in real-time of abnormal heart rates and rhythms. It also provides a recent history of intracardiac recordings. Avertix shared data from the first 12 months of each subject.
At TCT, the company shared that its FDA-cleared device led to an increase of more than 150% in new administration or titration of medications related to rate and rhythm normalities. These occurred in patients with activated Guardian alarms, compared to those with the alarms turned off.
Conformal Medical has LAAO technology updates
Nashua, New Hampshire-based Conformal Medical’s TCT data highlighted the success of its left atrial appendage occlusion (LAAO) device, the CLAAS device.
Conformal Medical designed CLAAS to seal the LAA in patients with non-valvular AFib. It aims to reduce the risk of stroke without the need for anticoagulants. The CLAAS device features a proprietary foam-based architecture, addressing a wide spectrum of LAA anatomies with two sizes.
The early feasibility study of the CLAAS device demonstrated high sealing rates at implantation. Those rates persisted at one year, with follow-up data demonstrating 97.7% seal without significant (>3mm) leaks.
Edwards keeps paving the way in TAVR
At TCT, Edwards shared new data demonstrating continued positive outcomes with its Sapien 3 transcatheter aortic valve replacement (TAVR).
Results from the PARTNER 3 trial showed continued low rates of all-cause mortality, disabling stroke and rehospitalization at five years. The analysis of five-year data found that mortality, stroke and rehospitalization rates remained low with stable secondary endpoints. Results remained statistically consistent with the surgical control arm, in which more than 70% of patients received an Edwards surgical heart valve.
“The Sapien 3 valve has demonstrated 99% freedom from death and disabling stroke at one year, 90% survival at five years, and is the only valve with a THV-in-THV indication,” said Larry Wood, Edwards VP and group president, TAVR and surgical structural heart. “These data add to the robust body of clinical evidence that shows the versatility and durability of the Sapien 3 valve, highlighted by 10 approved indications and the real-world experience in the treatment of over one million patients worldwide, who have benefited from the design of a valve intended for true lifetime management.”
GE HealthCare, Boston Scientific strike up partnership
Among many new developments and partnerships at GE HealthCare is a new collaboration with Boston Scientific. At TCT, the company shared some details on this image-guided therapy-centered deal.
GE HealthCare unveiled Interact Touch, the latest feature in its Allia imaging platform, at the symposium. The company received a new FDA clearance for its next-generation Allia IGS Pulse system last week.
Interact Touch allows clinicians the freedom to access third-party devices and control up to three of those devices through a single touch panel. Clinicians can use the platform without breaking the sterile environment.
To build an ecosystem around Allia, GE HealthCare made available the first third-party application with Interact Touch. The Avvigo+ multi-modality guidance system from Boston Scientific integrates with Allia to provide multimodality control in one click.
“Our collaboration with Boston Scientific helps to bring this new ecosystem, rooted on the Allia platform, to life and will provide clinicians with access to innovative technology, multi-modality control and a seamless workflow experience – all with the touch of a button,” said Philip D. Rackliffe, president & CEO for image-guided therapy at GE HealthCare.
In addition to the partnership with GE HealthCare, Boston Scientific had positive news of its own at TCT. The company announced data supporting the use of its Agent drug-coated balloon in treating coronary in-stent restenosis (ISR).
JenaValve makes headway in the TAVR race
In a late-breaking clinical trial session at TCT, JenaValve shared that 180 high-risk patients with symptomatic, moderate to severe aortic regurgitation with severe symptomatic aortic regurgitation underwent the Trilogy Transcatheter Heart Valve (THV) implementation in a study of its own TAVR implant.
The study met its primary safety endpoint, evaluating the safety of the Trilogy THV system at 30 days post-implantation. Regarding efficacy, investigators noted significant improvements in left ventricular systolic diameters, systolic volumes, and mass regression.
Patients exhibited sustained improvements in both quality of life (QOL) and heart failure functional status over the course of a year.
“You see really significant improvements in the ventricle after having the aortic regurgitation obliterated,” Dr. Vinod Thourani, co-principal investigator of the ALIGN-AR study, said.
More good news from Medtronic
On top of positive TAVR data, Medtronic had results supporting another transcatheter technology — transcatheter mitral valve replacement (TMVR). The investigative Medtronic Intrepid TMVR system uses transfemoral access as an alternative to surgical mitral valve replacement. It treats MR in patients unsuitable for surgery or transcatheter edge-to-edge repair (TEER).
Medtronic presented one-year results from the Intrepid early feasibility study at TCT 2023. The study demonstrated the early benefits of the Intrepid TMVR-transfemoral system, maintained up to one year. The system demonstrated near complete and durable elimination of mitral regurgitation (MR) with a 93.3% survival rate.
Key outcomes included low mortality rates at 6.7% and zero strokes, Medtronic said. The company also reported a low re-intervention rate (3%) along with the near complete elimination of MR.
Adding to the pile of positive TAVR studies, Medtronic had data supporting its Evolut system as well. Four-year results from a trial of Evolut implants demonstrated “exceptional outcomes and sustained valve performance,” Medtronic said. It showed significantly better hemodynamics than surgical aortic valve replacement (SAVR).
“These results are not only encouraging, but pivotal in shaping treatment decisions for low-risk patients with symptomatic severe aortic stenosis,” Dr. Michael Reardon, principal investigator. “We are seeing sustained, excellent valve performance in patients treated with Evolut TAVR, which ultimately translates into improved outcomes, including mortality and disabling stroke.”
Philips provides data backing its interventional guidance tech
Dr. Matthias Götberg presented results from a longitudinal analysis looking at Philips iFR technology at TCT 2023.
Philips offers instant wave-free ratio (iFR) in guiding percutaneous coronary intervention (PCI) as a pressure-derived index to assess coronary blockages during interventional procedures. iFR avoids the use of hyperemic agents — drugs that maximize blood flow but can impact the patient experience.
The study looked at the National Swedeheart Quality Registry of more than 42,000 patients undergoing coronary procedures. Results demonstrated no difference between iFR and fractional flow reserve (FFR) in major adverse cardiac events (MACE).
“These new findings once again confirm the safety of iFR. We continue to see that iFR-guided treatment offers consistent outcomes, reduces costs, and provides a better patient experience,” said Götberg. “The data from this new analysis provides additional confidence in the safety of iFR for physicians.”
More good renal denervation news for Recor Medical
As the company closes in on potentially becoming the first to have a renal denervation authorized by the FDA as a hypertension treatment, Recor Medical had more data to back up its Paradise treatment at TCT.
A combined analysis of six-month follow-up data from three RADIANCE global studies evaluated Paradise ultrasound renal denervation (uRDN) as a hypertension treatment. The analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN compared to sham. It also saw fewer antihypertensive treatments added in the treatment group.
The data provides further support for the renal denervation system, which looks the most likely to garner the first FDA nod for treating hypertension. An FDA panel in August voted in favor of the Paradise uRDN system and the company continues to work toward premarket approval. The same panel voted against recommending Recor’s closest competition, Medtronic’s Symplicity Spyral, a day later.