DEFLECT III: Cerebral protection device safe at 30 days after TAVR

Cerebral protection with an investigational device designed to deflect debris away from the brain during transcatheter aortic valve replacement was safe at 30 days, according to new data presented at EuroPCR 2015.

Patients who underwent protected TAVR also had a higher rate of freedom from ischemic brain lesions, less neurologic deficit, and improved cognitive function at discharge and 30 days compared with patients who underwent TAVR without neuroprotection.

Andreas Baumbach

Andreas Baumbach, MD, of the Bristol Heart Institute, United Kingdom, reported 30-day outcomes after use of the TriGuard HDH cerebral protection device (Keystone Heart) during TAVR. The device has a single-wire nitinol frame and mesh filter with a pore size of 130 µm.

The randomized controlled trial was conducted at 13 centers in Europe and Israel. Eighty-five patients were randomly assigned to undergo TAVR with the device (n = 46) or without the device (n = 39).

The rate of technical success was 88.9%. The researchers reported that the device did not interfere with the valve, and there were no cases of device failure.

The primary in-hospital procedural safety endpoint was MACCE (death, stroke, life-threatening/disabling bleeding, acute kidney injury and major vascular complications). In-hospital MACCE occurred in 21.7% of patients who underwent protected TAVR vs. 30.8% who underwent unprotected TAVR (RR = 0.71; 95% CI, 0.34-1.46). Examined alone, patients assigned protected TAVR also had lower rates of stroke, life-threatening bleeding and major vascular complications. Acute kidney injury occurred in 2.2% of patients who underwent protected TAVR vs. 0% of patients who underwent unprotected TAVR (RR = 2.55; 95% CI, 0.11-60.9).

At 30 days, the rate of MACCE was 26.1% for patients who underwent protected TAVR vs. 31.2% for patients who underwent unprotected TAVR (RR = 0.83; 95% CI, 0.37-1.84). The 30-day mortality rate was 2.3% in the protected group vs. 5.1% in the unprotected group (RR = 0.4; 95% CI, 0.04-4.44), stroke rate was 4.4% vs. 5.6% (RR = 0.81; 95% CI, 0.11-5.76), life-threatening bleeding rate was 4.5% vs. 7.8% (RR = 0.54; 95% CI, 0.09-3.24) and major vascular complications rate was 17.4% vs. 20.7% (RR = 0.83; 95% CI, 0.31-2.21). Acute kidney injury at 30 days was reported in 2.2% of patients who underwent protected TAVR vs. 0% who underwent unprotected TAVR (RR = 2.55; 95% CI, 11-60.9).

Baumbach also reported a 40% reduction in brain lesion volume and a 45% increase in freedom from cerebral ischemic lesions. He noted that 3.1% of patients who underwent protected TAVR experienced new neurologic deficits after the procedure compared with 15.4% of patients who underwent unprotected TAVR. The device also was associated with a twofold increase in recovery of normal cognitive function at 30 days.

“Neuroprotection is important to reduce the embolic burden in a population with ongoing embolic risk,” Baumbach said during a presentation. – by Rob Volansky

Reference:

Baumbach A, et al. Hot Line: Late-Breaking Trials and Innovations. Presented at: EuroPCR; May 19-22, 2015; Paris.

Lansky AJ, et al. Eur Heart J. 2015;doi:10.1093/eurheartj/ehv191.

Disclosure: Baumbach reports advising for and receiving research grants from Keystone Heart.