A study comparing three transcatheter aortic valve replacement (TAVR) devices found them similarly effective at 30 days.
The study, published online Jan. 13 in Catheterization and Cardiovascular Interventions, assessed Direct Flow Medical, Medtronic's CoreValve and Edwards Lifesciences' Sapien XT implants. Patients were retrospectively matched, 40 per implant, to compare 30-day outcomes. All patients received TAVR between 2011 and 2014 and all patients had severe aortic stenosis, a baseline mean transaortic gradient of 46.4 mm Hg and a mean aortic-valve area of 0.7 cm 2.
The type and size of the valve dictated the sheath size; Medtronic CoreValve and Direct Flow Medical both used an 18 F sheath, while Edwards Sapien XT utilized different sheaths for different sized valves (18 F for a 23 mm valve, 19 F for a 26 mm valve and 20 F for a 29 mm valve).
Yuan Zhang, MD, from the Contilia Heart and Vascular Center at the Elisabeth-Krankenhaus in Essen, Germany, and colleagues found that the Direct Flow Medical valve had a 95 percent 30-day safety rate. Edwards Sapien XT and Medtronic CoreValve had 30-day safety rates of 82.5 percent and 67.5 percent, respectively.
The Direct Flow Medical, CoreValve and Sapien XT device effectiveness was 100 percent, 92.5 percent and 92.5 percent, respectively. Mortality rates were 0 percent, 7.5 percent and 7.5 percent, respectively.
Immediately following TAVR, the Direct Flow Medical device reduced transaortic gradient by a mean of 8.3 mm Hg; the Sapien XT by a mean of 5.6 mm Hg and CoreValve by 5.3 mm Hg.
The Direct Flow Medical device is not currently available for use in the U.S.
While the mortality trends were promising, Zhang et al wrote that meaningful conclusions on trends data would need larger patient populations.