Keystone Heart is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, atrial fibrillation ablation and other structural heart procedures.

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Moving to Lower Risk

A “silent” infarct is still an infarct whether random or iatrogenic. Until someone proves these DWI lesions are somehow beneficial to the patient, we need to take steps to prevent them from occurring.

The fact of the matter is, no matter how “minor” or severe the effects of an embolic lesion are for a patient, it’s senseless to not take the necessary precautions.

Here’s how TAVR lowers the risk:

  • TAVR is currently approved in the US only for patients at prohibitive or high-risk for surgical AVR – a relatively elderly and frail population.
  • Despite this, TVT registry data demonstrates that the average risk of patients undergoing TAVR commercially in the US is that of an intermediate-risk patient (STS 5.0%).1
  • TAVR has been approved for use for intermediate-risk patients in Europe and studies of TAVR in intermediate-risk patients in the US have been favorable indicating that FDA approval for TAVR in this population is imminent.
  • Studies of TAVR in low-risk patients with essentially no major co-morbidities are currently enrolling in the US.

 

1 Holmes DR, Ann Thorac Surg 2016;101:789.

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