Analysis of PARTNER Focuses on Timing, Risk Factors, and Outcomes of TIA and Stroke After TAVR

September 13, 2016—Samir Kapadia, MD, et al published findings from a comprehensive analysis of time-related incidence, risk factors, and outcomes of stroke and transient ischemic attack (TIA) after transcatheter aortic valve replacement (TAVR) in the PARTNER trial, the pivotal study of the Sapien device (Edwards Lifesciences). The study is available online ahead of print in Circulation: Cardiovascular Interventions.

According to the investigators' previous studies of stroke and TIA after TAVR are limited by reporting and follow-up variability.

As summarized in Circulation: Cardiovascular Interventions, the study was composed of 2,621 patients who were 84 ± 7.2 years of age and underwent transfemoral (TF; 1,521) or transapical (TA; 1,100) TAVR in the PARTNER trial, including the continued access registry, from April 2007 to February 2012. Stroke and TIA were identified by protocol and adjudicated by a clinical events committee.

The investigators reported that within 30 days of TAVR, 87 (3.3%) patients experienced a stroke (TF, 58 [3.8%]; TA, 29 [2.7%]; P = .09); 85% of those events occurred within 1 week. Instantaneous stroke risk peaked on day 2, then fell to a low prolonged risk of 0.8% by 1 to 2 weeks. Within 30 days, 13 (0.5%) patients experienced a TIA (TF, 10 [0.67%]; TA, 3 [0.27%]; P > .17).

Stroke and TIA were associated with lower 1-year survival than expected (TA, 47% after stroke vs 82% and 64% after TIA vs 83%; TA, 53% after stroke vs 80% and 64% after TIA vs 83%).

Risk factors for early stroke after TA-TAVR included more postdilatations, pure aortic stenosis without regurgitation, and possibly more pacing runs, earlier date of procedure, and no dual-antiplatelet therapy. High pre-TAVR aortic peak gradient was a risk factor for stroke early after TF-TAVR.

The investigators concluded that the risk of stroke or TIA is highest early after TAVR and is associated with increased 1-year mortality. Modifications of TAVR, emboli prevention devices, and better intraprocedural pharmacological protection may mitigate this risk, advised the investigators in Circulation: Cardiovascular Interventions.