June 10th, 2011

TAVR: A Stroke of Genius or Bad Luck?


After presentations at the ACC and American Association for Thoracic Surgery 2011 meetings, the PARTNER A results are finally published. PARTNER A compared  transaortic valve replacement (TAVR, also known as TAVI) with surgical aortic valve replacement (AVR) in patients with aortic stenosis who were eligible for AVR but considered to be at high surgical risk .

At 1-year follow-up, survival and symptom improvement were similar with the two procedures, but the stroke rate was higher with TAVR  (6.0% vs. 3.1%). What do we know about TAVR-associated strokes?

  1. The smaller the valve area, the higher the stroke risk.
  2. Patients with “generalized heavy arteriosclerotic burden” (i.e., those whose severe PAD renders them ineligible for the transfemoral approach) have a higher stroke risk than those with lighter atherosclerotic burdens; however,
  3. Stroke risk was unrelated to atrial fibrillation or TAVR approach (transapical vs. transfemoral).
  4. With TAVR, the hazard for stroke was seen early (within 48 hrs of the procedure) and remained elevated throughout the 24 months of follow-up, but AVR-associated strokes occurred early.

Based on these data, how would you choose which procedure — AVR or TAVR — to recommend for your patients? 

3 Responses to “TAVR: A Stroke of Genius or Bad Luck?”

  1. Steven Greer, MD says:

    Drug and device companies use relative risk to hype a positive statistic, like “A 40% reduction in cancer..”, but no one in this case is saying that TAVI increases the chance of stroke by 100%. These first generation devices are not ready for approval, because in the United States, off-label use is unpreventable and, like Cypher drug eluting stents, TAVI will be used in too many people causing unnecessary strokes.

    Surgical valve replacement can be performed in any patient of any age, contrary to the developers of TAVI who want to us to buy into this “inoperable” definition. Stroke is devastating to an elderly person and many patients, given the facts, would rather die of heart disease than risk stroke.

    Competing interests pertaining specifically to this post, comment, or both:

  2. Muhammad Ansari, M.B.B.S,; MRCP (UK) says:

    1. For some patients, risk of stroke is more devastating than mortality risk as they dont want to spend the rest of their remaining life debilitated. We have to take into account the higher risk of stroke with TAVR. One MRI study done earlier in Jan 2011 from Canada showed that the asymptomatic new lesions were present in substantial number of patients undergoing TAVR.

    2. We still have to account for the relative risk reduction with TAVR when we compare with the medically treated arm (which also included balloon valvuloplasty). TAVR has its advantages, but the control group was actually made worse with aortic valve balloon valvuloplasty. Thus the numbers look too good!

    3. Even mild AI (paravalvular leak) carries bad prognostic significance with the recent observations. When we don’t accept 2+ or 3+ AI after surgical AVR, same should apply to TAVR procedures.

  3. Leon Hyman, Ms M.D. says:

    Stroking a pet is comforting to both the pet and the stroker, but being a stroke victim is to say the least devastating. I agree with Dr. Ansari, TAVR is not ready for prime time.

    Competing interests pertaining specifically to this post, comment, or both: