Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space.
Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans.
Ablation, cardiac implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas.
Here are some of the biggest stories that came out of the cardiology conference.
Excitement builds around using pulsed-field ablation to treat AFib
Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released news about their ablation systems.
Boston Scientific completed the first enrollment in its Advantage AF clinical trial evaluating the Farapulse PFA system. Farapulse uses pulsed-field ablation to treat persistent AFib. Boston Scientific expects positive trial outcomes to support FDA approval.
Medtronic then announced that its PulseSelect pulsed-field ablation (PFA) system exceeded its safety performance goal in a clinical trial. The Pulsed AF trial exceeded the threshold for its efficacy performance goal for the treatment of AFib, too.
Finally, Biosense Webster announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib. The system enables doctors to toggle between PFA and radiofrequency ablation. It could compete against another ablation device in Medtronic’s portfolio — the Sphere-9 system. That came as part of Medtronic’s $1 billion acquisition of Affera, completed in August 2022.
Analysts also had their say on the prevalence of ablation technologies.
“We expect PFA technologies to be adopted quickly, as so far they seem to be faster and safer than thermal ablation approaches, and the single-shot approach to pulmonary vein isolation (PVI) is likely to take share from cryoablation,” BTIG analyst Marie Thibault wrote in a report. “Whether efficacy will be improved is still an open question. We remain bullish on PFA as a technology class and note there are several other public and private players developing competing approaches.”
Abbott’s MitraClip, TriClip both perform well
Late-breaking data at ACC supported both Abbott’s MitraClip and TriClip offerings.
Five-year data from the COAPT trial highlighted the safety and efficacy of MitraClip for people with mitral regurgitation (MR).
Abbott observed a significantly reduced risk of annual hospitalizations (33% per year for MitraClip against 57% in the control). MitraClip also reduced the risk of death by almost 30% (57% vs. 67%) and achieved durable MR reduction. Reduced MR occurred in 95% of patients.
Data also demonstrated the superiority of the TriClip transcatheter edge-to-edge repair (TEER) system. The Triluminate pivotal study evaluated TriClip against medical therapy in patients with tricuspid regurgitation (TR).
Abbott said TriClip demonstrated a significant reduction in TR grade in 87% of patients at 30 days. That compares to 4.8% in the control. TR reduction registered as sustained and durable at one year.
TAVR remains a point of intrigue
Edwards Lifesciences, one of the main players in the transcatheter aortic valve replacement (TAVR) space, analyzed 10 years of Medicare data, and its findings backed the replacement heart valve procedure.
The analysis showed a low rate of re-intervention after TAVR out to 10 years. Of 230,644 patients treated with transfemoral and transapical TAVR between 2011 and 2021, only 1,880 underwent valvular re-intervention. This translated to a 1.63% rate of re-intervention overall when considering the competing risk of death.
“Certainly, more data are needed, but this is definitely reassuring,” said Suzanne Baron, a Boston-based interventional and structural cardiologist who led the analysis.
In other TAVR news, three-year data supported the Medtronic Evolut TAVR implant. Findings showed the strength of Evolut against surgical aortic valve replacement (SAVR). Evolut showed significantly better hemodynamic valve performance compared to SAVR. The study evaluated a low-risk aortic stenosis (AS) patient population.
iRhythm’s wearable ECG stacks up against the field
Multiple new studies supported the use of iRhythm’s Zio XT wearable heart monitoring technology.
iRhythm’s Camelot study used Medicare data to compare the effectiveness of ambulatory monitors for arrhythmia diagnosis. It demonstrated that long-term continuous monitoring with iRhythm Zio XT is associated with the highest diagnostic yield and fastest time to clinical diagnosis compared to all other ambulatory cardiac monitors (ACMs) when looking at specified arrhythmias.
“Camelot shows how consequential choosing the right monitoring service can be, from achieving a faster clinical diagnosis leading to reduced repeated testing all the way to lower emergency and inpatient health care utilization and lower costs,” said Dr. Mintu Turakhia, CMO and CSO at iRhythm.
Other data demonstrated improved monitoring and decision-making with iRhythm’s next-generation Zio. The company said it also found in another study that non-sustained ventricular tachycardia was independently associated with increased mortality. iRhythm said it may act as a proxy biomarker for cardiovascular risk.
Philips showcases cardiology tech portfolio
Philips presented an array of clinical results, including trends with intravascular imaging, early cardiac implant removal and intracardiac echocardiography catheters.
One study demonstrated that intravascular imaging (IVI) use during PCI procedures as an adjunct to angiography rose by 62% during a seven-year period. Researchers associated this rise with superior patient outcomes.
Another study highlighted a major gap in care among cardiac implantable electronic device infection patients, which results in higher mortality, more health care utilization, and higher cost of care.
Finally, the company observed both safety and efficacy for its Philips VeriSight Pro 3D ICE intracardiac echocardiography catheter in image-guided, minimally invasive cardiac procedures.
“The positive clinical study results announced are further evidence of how we are continuously working with our clinical partners to co-create new innovations and demonstrate how they improve outcomes for patients,” said Dr. Atul Gupta, CMO for image-guided therapy at Philips.