January 12th, 2011
Maybe TAVI Is Not All It’s Cracked Up To Be
Richard A. Lange, MD, MBA and L. David Hillis, MD
The PARTNER trial of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis was among the hottest cardiology stories of 2010. Now that the hype is receding, some are questioning whether TAVI is ready for prime time.
In three letters to the Editor of the New England Journal of Medicine, our colleagues point out that the “conventional treatment” group received a rather unconventional treatment (aortic balloon valvuloplasty) and had a higher average EuroSCORE (i.e., estimated mortality) than those treated with TAVI, which may have exaggerated the benefit of TAVI.
In considering the demonstrated increase in periprocedural strokes and bleeding complications with TAVI and the patient population most likely to undergo the procedure (i.e., the elderly with multiple coexisting conditions, limited life expectancy, and disproportionate health care expenditures), some are calling for an analysis of the cost-effectiveness and quality-of-life benefits of TAVI.
On the basis of the available information, are you ready to recommend TAVI to your patients?
If not, what additional information would you convince you to do so?
6 Responses to “Maybe TAVI Is Not All It’s Cracked Up To Be”
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Quality of Life data was already presented at the AHA conference in November. In fact, the study showed positive results for both Sapien and TAVI technology, as expected and inline with expectations. Sapien-treated patients showed a 25 point improvement in QOL (vs. medical management) at one year for KCCQ. Note that KCCQ is based on a scale from 0 to 100, where a 20 point improvement is considered substantial.
Not ready for “prime time.” As usual, the devil is in the details and adequate clinical studies, not the hype.
Competing interests pertaining specifically to this post, comment, or both:
None
Just as an example, my wife’s uncle, a delightful 89 year old athlete was just offered TAVI. In Vancouver, he is completely asymptomatic 20 years post CABG, he developed severe leg caludication and in the work up before vascular surgery was found to have severe AS, so 1- asymptomatic, 2-severe peripheral vascular disease and 3-actually fit for surgery if indicated , such a patient being offered TAVI shows how industry driven is the procedure becoming and the pressure on doctors to “recruit” patients.this severely technically challenging procedure may never be ready for prime time.
I agree with Dr Hany ,the TAVI is not ready for prime time right now ,as if there is a considerable rate of bleeding and stroke?? outcome still present up to date , so the benefit /risk ration in those elderly patient seems to be still significant comparing to the conventional way of AVS therapy.
TAVI is not ready for prime time…and the PARTNERS trialists would be the first to tell you so. PARTNERS was a proof of concept trial to determine if you could (relatively) safely implant the device in very sick people with severe AS. The high rate of ABV in the control arm was to a great extent to “do something” for those randomized to “no treatment” who were, as you can imagine, terribly depressed with the result of randomization. TAVI must now pass the real test of comparison to true “standard therapy” for aortic stenosis, namely AVR in the hands of a qualified surgeon. This must be done in randomized clinical trial fashion powered to demonstrate that the technical and procedural complications are equal to or less than standard AVR and, in todays world, a cost analysis must be included in the investigation.
While the absolute risk reduction was impressive, the mortality rate in the TAVI arm was still >30% at one year, and in addition there was a higher 30-day rate of stroke (attributed to the intervention itself). As TAVI becomes more widely implemented (as seems inevitable) it will be important to provide patients with reasonable expectations for the procedure; in the setting of advanced age and multiple competing comorbidities it is hardly a panacea.