PARTNER Finds Higher Rate of Neurological Events with TAVI vs. Surgery

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While earlier data showed a higher stroke rate with transcatheter aortic valve implantation (TAVI) compared with surgical valve repair in high-risk surgical candidates, a more detailed analysis from the PARTNER trial shows that TAVI patients suffer a higher overall rate of neurological events, though the 30-day rates of stroke and mortality are low with both procedures. The analysis was reported May 9, 2011, at the American Association for Thoracic Surgery annual meeting in Philadelphia, PA.

Primary results from cohort A of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial were presented April 3, 2011, at the American College of Cardiology Scientific Sessions/i2 Summit in New Orleans, LA. The trial met its primary endpoint of noninferiority of TAVI to surgical valve replacement for all-cause mortality. However, TAVI patients were at higher risk of stroke and vascular complications, while surgical patients were at higher risk of major bleeding.

More Early, Late Events with TAVI

The new per protocol analysis of neurologic event data was presented by D. Craig Miller, MD, of Stanford University School of Medicine (Stanford, CA). In all, 699 patients were enrolled at 26 sites and randomized to receive TAVI (n = 348) or surgery (n = 351). Among the TAVI group, 244 patients were assigned to transfemoral TAVI and 104 to transapical TAVI.

Overall, the rate of neurological events was significantly higher in the TAVI group compared with the surgery group at both 30 days and 1 year (table 1).

Table 1. All Neurological Events




P Value

30 Days




1 Year




In the TAVI group, more than half of the neurological events were major stroke (58%), while minor stroke accounted for 16% and transient ischemic attack (TIA) for 26%. In contrast, 69% of neurological events in the surgical group were major stroke, while minor stroke accounted for 6%, and TIA for 25%.

Within 30 days, significant risk factors for neurological events included use of TAVI and, within the TAVI group, smaller aortic valve area index. At 1 year, risk factors included higher New York Heart Association functional class, stroke or TIA within 6 to 12 months, and not being a transfemoral TAVI candidate.

TAVI patients who underwent the transapical approach experienced the worst outcomes. Compared with the surgical group, these patients experienced a significantly increased event rate at 30 days (7.9% vs. 5.5%; P = 0.5) and a numerically higher event rate at 1 year (14.1% vs. 9.7%; P = 0.37).

In his presentation, Dr. Miller commented on the “remarkably low” 30-day mortality rates in the overall cohort. In addition, 30-day rates of stroke and TIA were low, though increased in the TAVI group. Major strokes were even lower (table 2).

Table 2. 30-Day Outcomes




P Value





Stroke and TIA




Major Stroke




Dr. Miller added that it may be possible to reduce the stroke rate in TAVI patients by using:

  • Clopidogrel loading dose plus dual antiplatelet therapy
  • Warfarin or dabigatran
  • No protamine reversal in transfemoral patients
  • Bridging with heparin
  • Cerebral embolic protection devices
  • Newer low-profile transcatheter heart valve deployment systems
  • Carotid compression during balloon and transcatheter valve deployment

Study Details

Patients were elderly (mean age, 83.6 years), had a mean Society of Thoracic Surgeons score of 11.8%, a mean logistic EuroScore of 29.3%, and were equivalent with respect to most baseline characteristics.


Miller DC. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: Incidence, hazard, determinants, and consequences of neurological events in the PARTNER trial. Presented at: American Association for Thoracic Surgery 91st Annual Meeting; May 9, 2011; Philadelphia, PA.



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  • The trial was sponsored by a research grant from the National Heart, Lung, and Blood Institute.
  • Dr. Miller reports receiving consulting fees from Abbott Vascular, Medtronic, and St. Jude Medical.