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Research evaluating technologies to treat heart valve disease was a highlight of the American College of Cardiology’s annual conference, which wrapped up Monday in Chicago.
Here are updates from three studies that focused on devices used in valve treatment from some of medtech’s biggest companies:
1. Medtronic’s Evolut outcomes similar to surgery
Patients who received Medtronic’s Evolut transcatheter aortic valve replacement had rates of death or disabling stroke at five years that were comparable to those treated with a surgically implanted valve, data presented Sunday showed.
Minimally invasive TAVR has surpassed open-heart surgery as the preferred procedure for aortic valve replacement. More than 100,000 TAVR procedures were performed in the U.S. in 2023, topping the less than 60,000 surgical aortic valve replacements, according to an editorial accompanying publication of the Medtronic study in JACC.
The study, which followed people with severe aortic stenosis considered at low risk for surgery, found all-cause mortality or disabling stroke occurred in 15.5% of TAVR patients and 16.4% in the surgical group. Valve durability and performance were excellent in both arms, the study authors wrote.
Kendra Grubb, chief medical officer of Medtronic’s structural heart business, said in a statement the data “will help clinicians make personalized treatment decisions for younger, lower-risk patients” by reinforcing Evolut as a safe and durable alternative to surgery.
Although the study found Evolut had a slight edge over surgery, the difference was not statistically significant, an outcome similar to Edwards Lifesciences’ five-year TAVR data in 2023 that demonstrated the Sapien valve was non-inferior to surgery in low-risk patients, said J.P. Morgan analyst Robbie Marcus.
“Comparable results that still numerically favor TAVR should still allow physicians to confidently sell TAVR as an equivalent alternative to SAVR but with much less upfront morbidity,” Marcus wrote to clients Monday.
Stifel analyst Rick Wise said the performance curve between the two groups in the Medtronic study narrowed from the four-year data readout. Edwards’ five-year performance curve had also narrowed, he said. “This data certainly keeps the TAVR durability debate alive and intensifies the focus on seven-year Edwards low-risk data,” Wise wrote Sunday in a report.
2. Abbott’s TriClip reduces hospitalizations
Patients with severe tricuspid regurgitation who received Abbott’s TriClip device to repair the valve along with medical therapy were 28% less likely to be hospitalized for recurrent heart failure at two years than those treated with drugs alone, according to data presented at ACC.
At two years, 77.6% of patients who got TriClip were alive and did not require tricuspid valve surgery or another valve-repair procedure, compared with 29.3% of patients in the control group.
The transcatheter repair system significantly reduced symptom severity, decreased heart failure hospitalizations and appears to be safe, study author Saibal Kar of Los Robles Health System in California said in a statement.
Tricuspid regurgitation occurs when the valve allows blood to flow back into the right atrium, forcing the heart to work harder to pump effectively. TriClip clips on the tricuspid valve’s leaflets to prevent blood from leaking back.
Abbott gained FDA approval last year for TriClip to treat patients unable to withstand open-heart surgery. The repair device competes against Edwards Lifesciences’ Evoque tricuspid valve replacement system.
3. Boston Scientific’s Sentinel fails to lower stroke risk
Boston Scientific’s Sentinel cerebral embolic protection device failed to reduce the risk of stroke within 72 hours of transcatheter aortic valve implantation, a large U.K. study found.
The British Heart Foundation study of 7,635 participants with aortic stenosis showed no difference between patient groups that underwent the valve procedure with or without the embolic protection device, missing its primary endpoint. In the results, 81 (2.1%) of patients in the CEP group and 82 (2.2%) patients in the control group had a stroke within 72 hours of TAVI or discharge from the hospital.
"Our study provides convincing evidence that there is no value in the routine use of this device during TAVI," study author Rajesh Kharbanda said in a statement. The data, presented Sunday at ACC, was also published in the New England Journal of Medicine.
The BHF PROTECT-TAVI study comes three years after the PROTECTED TAVR trial, published in the NEJM in 2022, also failed to demonstrate a benefit from using the device, which is designed to capture debris during a valve procedure.
Boston Scientific acquired the Sentinel system in 2018 when it bought Claret Medical for $270 million. The device received the CE mark in 2014 and Food and Drug Administration clearance in 2017.
A Boston Scientific spokesperson said both studies confirm a “reassuring safety profile” for the device in a broad TAVI patient population, with no statistical differences in all-cause mortality or access site-related complications.
A meta-analysis combining data from the PROTECTED TAVR and BHF PROTECT-TAVI trials is scheduled to be presented at EuroPCR in May. “By aggregating the data, we may gain a better understanding of the effect of CEP use in TAVI related to stroke reduction and identify patient sub-groups that might benefit from the use of CEP,” the spokesperson wrote in an email.
