乌鸦传媒

WASHINGTON -- A dual-filter embolic protection device failed to diminish new lesion volume or stroke rates after transcatheter aortic valve replacement (TAVR), according to results of the 363-patient SENTINEL study.

Retrieved devices revealed filtered histopathologic debris in 99% of TAVR patients. Besides acute thrombus, operators commonly found arterial wall, valve tissue, and calcification material in the captured debris.

Thirty days following intervention, however, use of the Sentinel embolic protection device , including stroke (5.6% versus 9.1% for control, P=0.25) and death (1.3% versus 1.8%, P=0.65).

In protected territories, new lesions formed after TAVR were no smaller compared than control, either (102.8 mm³ versus 178 mm³, P=0.33), according to , of New York-Presbyterian Hospital/Columbia University Medical Center, who presented the SENTINEL study at the annual Transcatheter Cardiovascular Therapeutics meeting. The investigation was simultaneously published online in the Journal of the American College of Cardiology.

Valve type, however, was important: a prespecified analysis determined that Sapien XT recipients subsequently developed lesions with lower volumes than their peers undergoing TAVR without the Sentinel, (P=0.046), indicating an interaction between valve type and treatment arm (P=0.02).

Given that, to save money, only half the test arm got MRIs, "the small imaging sample size is probably the main reason the SENTINEL study is negative," suggested , and , both of San Raffaele Scientific Institute in Italy, in an .

"From a logical standpoint, a device that captures cerebral embolic material in 99% of cases should prevent ischemic injury of the brain, yet the data from this randomized trial does not appear to support routine cerebral protection with the Sentinel device. However, in our opinion, it would be inappropriate and unfair to close the book on cerebral protection after this chapter."

The editorialists cited other reasons why the SENTINEL trial painted an incomplete picture of embolic protection, ranging from Sentinel's incomplete coverage of all 28 brain regions to the study's lack of stratification based on different implantation techniques (use of pre- and post-dilation, for example).

Originally slated for presentation at this year's European Society of Cardiology congress in Rome, the SENTINEL trial randomized patients with severe aortic stenosis 1:1:1 to TAVR with the Sentinel plus imaging, TAVR with Sentinel but no imaging, or to TAVR alone.

Patients got Evolut R, Sapien 3, or Sapien XT devices with a transfemoral approach in most cases (94.7%); the Sentinel embolic protection device was usually delivered through a radial artery (93.2%).

Adding the dual-filter device increased total procedure time (P=0.01) and fluoroscopy time (P=0.007).

Neurocognitive test results were similar between groups up to 90 days. Improvement in the score over time was inversely correlated with the size of new lesions formed, according to Kodali and colleagues.