Medtronic, Edwards, Abbott tout TAVR data at CRT 2024

A trio of cardiovascular companies put forward data this week bolstering their transcatheter aortic valve replacement programs. Medtronic, Edwards Lifesciences and Abbott presented studies at the annual Cardiovascular Research Technologies conference being held in Washington, D.C.

Medtronic spotlighted two late-breaking datasets from a randomized trial of its Evolut valve offered as a less-invasive alternative for patients with low risk factors for undergoing open heart surgery.

One four-year analysis of nearly 1,300 implants showed that the rate of all-cause mortality or disabling stroke in the Evolut TAVR arm reached 10.7%, compared to 14.2% in a cohort that underwent a surgical valve procedure (p=0.06). The company also said the Evolut showed better blood flow control through the valve, indicating stronger hemodynamic durability.

Medtronic also delivered a cost-effectiveness comparison that compared TAVR to surgery using the trial’s four-year data. In low-risk patients, the company said Evolut provided an incremental cost-effectiveness ratio of $2,119 per quality-adjusted life year gained. Additionally, the total cost of the minimally invasive procedure, hospitalization and rehabilitation was estimated to be $45,887 after 30 days, versus $51,075 with open-heart surgery.

Edwards, meanwhile, touted safety and performance results from two real-world analyses of registry data tracking its Sapien TAVR platform.

The company’s latest valve—the Sapien 3 Ultra Resilia, which received FDA approval in late 2022—recorded lower rates of leaks around the outside edges of the valve in the month following implantation among more than 10,000 U.S. patients, as well as lower pressure gradients across the valve and larger effective orifice areas compared to its Sapien 3 predecessor models.

A separate study of 8,100 patients found that patients receiving a smaller Sapien valve fared just as well compared to those who received larger ones—with a 20mm implant showing equivalent all-cause mortality and stroke rates after three years compared to 23, 26 and 29 mm sizes.

Finally, Abbott reported a pooled analysis from three clinical studies of its first-generation Portico TAVR implant, studying patients at high and extreme risk levels for open surgery over five years. 

The data showed that major adverse cardiac event rates remained similar to the level expected in a high-risk population, as well as sustained blood flow and only 2% of paravalvular leaks being classified at the moderate level.

The Portico’s successor, the Navitor valve, features the same leaflet design and insertion procedure but adds a sealing skirt to help prevent paravalvular leaks. A one-year, single-arm study presented at the CRT conference showed that the cuff around the outside edge of the Navitor system was able to hold the proportion of moderate paravalvular leaks to 0.5%, with 99.5% of cases being described as mild, trace or undetectable.