Edward Lifesciences and TAVI wins again..but do patients?


A frightening decision by the FDA just as a savvy reader forwarded an episode of last season’s Grey’s Anatomy – which highlights the issues involved in the use of TAVI.   In this article, “FDA extends Sapien use to high-risk surgical patients“, Shelly Wood at the heart.org explains the FDA’s recent decision to expand eligibility criteria for TAVI use to patients eligible for surgery, (but deemed high risk).  No mention is made of the recent controversy over TAVI due to higher than expected complications.

At the same time, a reader encouraged me to watch last season’s Grey’s Anatomy episode where a low-risk patient demands (and RECEIVES) TAVI instead of traditional surgery because he doesn’t want a scar to mar his physique.  Of course, there is no mention on the show of post-procedural complications (because it’s a fictional program on television) but the very manner in which the episode was handled is frightening.

There was no discussion of unnecessary risk for the patient using experimental technology, or of the Major vascular complications that occur in more than one in seven TAVR patients: according the PARTNER trial.  There is also no mention of the drastic increase in mortality if these complications occur.  In the episode, the resident researches the procedure – and decides (appropriately) that the procedure is not suitable for the patient.  He is then scooped by the cardiac surgeon, who decides, “hey – what the heck – seize the day!”

Link to clip of Grey’s Anatomy

But as I said – it’s only television, right?  Except that it isn’t.  It’s a powerful medium used to disseminate information to the millions of people who watch that program.  (9.5 million people, according to recent ratings information.)  They also make a pretty huge leap on the program – changing TAVI from a procedure supposedly for patients with no other option (surgery ineligible) to a low-risk patient who wants to avoid a scar..

and now – the FDA expands criteria – despite a turbulent summer which included  previous criticism (by the FDA) based on irregularities in the PARTNER trial itself – and a violent controversy over the safety of this procedure.  The British Medical Journal also published an article over the summer decrying the overuse of the procedure.

Additional References – more in archives

1.  Amabile N, Azmoun A, Ghostine S, Ramadan R, Haddouche Y, Raoux F, To NT, Troussier X, Nottin R, Caussin C. (2012).  Incidence, predictors and prognostic value of serious hemorrhagic complications following transcatheter aortic valve implantation. Int J Cardiol. (2012 Oct 15). pii: S0167-5273(12)01131-X. doi: 10.1016/j.ijcard.2012.09.025. [Epub ahead of print]

Since the article is not available – I have included the abstract.

Abstract

BACKGROUND:

TAVI is an alternative solution for patients with aortic valve stenosis (AS) who are refused for conventional surgery. We sought to evaluate the incidence, characteristics, predictors and prognosis impact of serious hemorrhagic complications following transcatheter aortic valve implantation (TAVI).

METHODS:

One hundred and seventy-one consecutive patients with symptomatic severe AS (83.5±6.1y; 53% women; mean EuroSCORE=22.1±12.3) underwent transapical (TA) or transfemoral (TF) TAVI in our institution using Edwards SAPIEN© and Medtronic CoreValve© devices. The primary evaluated criterion was the incidence of any bleeding complication, according to the Valve Academic Research Consortium (VARC) criteria.

RESULTS:

VARC serious hemorrhagic complications occurred in 34.5% of patients (n=23 life-threatening/disabling (LT/D) and n=36 major bleedings). Most of these complications were related to access site complications (69%). Multivariable analysis revealed that TA access, low weight and underlying coronary artery diseases were independent predictors for development of serious bleeding. The mortality was significantly higher in patients with serious events compared to patients without bleeding (p=0.008, log-rank analysis). Although the survival didn’t significantly differ in patients with major hemorrhagic events, subjects with LT/D bleeding events had a higher mortality than the subjects with no hemorrhagic complications (p<0.001, log-rank analysis). Occurrence of VARC LT/D event independently predicted all-cause mortality (HR=5.35 [2.51-11.43], p<0.001) during the first year following TAVI in multivariate Cox regression analysis.

CONCLUSION:

Severe bleeding is frequent following TAVI procedure and is mainly related to local hemorrhage. VARC LT/D events are associated with decreased survival after AS correction.

2.  Gul M, Erkanli K, Erol MK, Bakir I. (2012).  Ventricular Embolization of Edwards SAPIEN Prosthesis Following Transcatheter Aortic Valve Implantation.  J Invasive Cardiol. 2012 Oct;24(10):537-8.  While this is a single case, this illustrates much of the data presented in a previous post.

3.  Latsios G, Toutouzas K, Tousoulis D, Stathogiannis K, Tentolouris C, Synetos A, Filis K, Stefanadis C.  (2012).   Prosthetic aortic valve removal from the abdominal aorta after successful “valve-through” TAVI.  Int J Cardiol. 2012 Oct 12. pii: S0167-5273(12)01285-5. doi: 10.1016/j.ijcard.2012.09.164. [Epub ahead of print]
Given that the patient almost lost his leg (and was taken to the operating room for emergency limb salvage surgery with a vascular surgeon), I think ‘success’ is a bit presumptuous for the title.  Reminds me of an old medical joke around the hospital when I was in training (which I have made some adjustments to.)
Dr. [exhultant as he leaves the cath lab] “I successfully implanted the new TAVI valve.”
Nurse:  But doctor, the patient died twenty minutes ago, [as she covers wheels corpse out of cath lab.]
Want more information on TAVI and aortic stenosis?  Just look in our archives.
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