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CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

April 3rd, 2011

TAVI: PARTNER or Blind Date?

Almost 700 patients with severe aortic stenosis who were considered “high risk” for conventional valve replacement (AVR) were randomized to transcatheter aortic valve implantation (TAVI) or AVR.

In comparison to AVR, TAVI was associated with a higher incidence of stroke (5.1% vs 2.4% at one year), vascular complications (11.0% vs 3.2% at 30 days), and moderate-severe perivalvular leak (6.8% vs 1.9% at one year), with no mortality (24.2% vs. 26.8% at one year) or clinical benefit. 

Yet the lead investigator touts TAVI as an “excellent alternative” to AVR because it was associated with less atrial fibrillation (8.6% vs 16%) and bleeding (9.3% vs 19.5%).

This is an interesting conclusion, since most physicians and patients are more concerned about periprocedural stroke and vascular complications than atrial fibrillation or transfusions.

In “high-risk” patients eligible for AVR, is TAVI really a PARTNER or a blind date (“Thanks, but no thanks”)? 

Will you offer TAVI to your “high-risk” aortic stenosis patients as an “excellent alternative” to AVR?

View our news coverage of the PARTNER A trial here, and for more of our ACC.11 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Roundup.

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11 Responses to “TAVI: PARTNER or Blind Date?”

  1. David Powell , MD, FACC says:
    April 3, 2011 at 2:03 pm

    No, not yet. Stroke is the problem, as is absence of longer term follow-up. Does the apical approach decrease stroke? Does an apical approch increase periop mortality compared with thefemoral approach? Were all patients screened for aortic and arch atheroma?

    Competing interests pertaining specifically to this post, comment, or both:
    None

  2. Steven Greer, MD says:
    April 3, 2011 at 8:07 pm

    We asked some cardiologists that same question: is the cardiac surgeon apical trocar approach associated with less debris embolic to the brain. The aortic arch likely is the source of the stroke causing debris.

  3. Steven Greer, MD says:
    April 3, 2011 at 8:12 pm

    The true “stroke rate” is higher in the TAVI cohort because the cleverly did not include “TIA” in the stroke data. With TIA included, there is a statistically significant increase in stroke from TAVI compared to open-heart surgery valve replacement. Carotid stent trials do not make such a distinction.

  4. Mohamed Wafiq Shoukry, Master degree in Cardiology says:
    April 4, 2011 at 2:29 am

    It is not an encouraging outcome particularly Stroke rate,, i do not know if there will be future trials enrolling non eligible severe AV stenosis surgically to be managed by TAVI through an apical approach will improve the Stroke outcome ?? assuming that most of atherosclerotic debris emboly arise from atherocalcific Aorta during the procedure,,, also if the future will shows us more advanced delivery system of TAVI through transfemoral approach ??

  5. Robin Motz, M.D., Ph.D. says:
    April 5, 2011 at 12:36 am

    Again, if the evidence does not clearly point to one of two procedures, we should outline the % of negative outcomes with each, and let the patient decide.

  6. Adelmo Gomes Machado, Master says:
    April 5, 2011 at 11:02 am

    Now , more than ever, we need wait for tree or four years wathing several combinations in outcomes. I agree whith Robin Motz,but not in all. A metanalysis is necessary now. when we let the patients dedide,they wants our opinion too,and this ishoud be very important in
    this choice.

    Competing interests pertaining specifically to this post, comment, or both:
    NO coinflicts of intest.

  7. Richard A. Lange, MD, MBA says:
    April 6, 2011 at 7:18 am

    More information concerning stroke in the PARTNER study (i.e., timing, cause, procedure-related, etc) will be presented next month at the American Assn for Thoracic Surgery (AATS) meeting. With TAVI, it will be interesting to see if the stroke rate is different for apical vs femoral route. Also, it will be interesting to see if patients who had valve replacement were more likely placed on coumadin (because of atrial fibrillation), which may have resulted in fewer late strokes.

  8. Richard A. Lange, MD, MBA says:
    April 6, 2011 at 7:22 am

    Any adverse neurologic event (CVA or TIA) is undesirable. But a reversible neurologic event (TIA) isn’t nearly as devastating as permanent one (CVA). I appreciate the investigator’s transparency in presenting the incidence of both for TAVI and valve replacement.

  9. Richard A. Lange, MD, MBA says:
    April 6, 2011 at 7:27 am

    The issue of valve durability is an important one. The patients enrolled in PARTNER had a mean age of 84 yrs. TAVI valve longevity is less of an issue in these patients than in patients who are in their 60’s or 70’s.

  10. Mani Prasad Gautam, MD says:
    April 30, 2011 at 2:59 am

    Personally I feel that TAVI may not be right alternative for AVR at this stage of development. More improvement in technique and measures to lower down the incidence of stroke and vascular complications is required. Moreover, we should see the longterm benefit of TAVI over AVR if any after one year.

    Competing interests pertaining specifically to this post, comment, or both:
    No

  11. Mani Prasad Gautam, MD says:
    June 1, 2011 at 1:17 pm

    But the TAVI seems quite promising as I expect the development of novel techniques to prevent from embolic stroke such as putting distal protecting devices and more advanced form of this kind of approach.

    Competing interests pertaining specifically to this post, comment, or both:
    no