April 21st, 2014

The CoreValve Trial: What Do You Say to Your Patients?

This post from CardioExchange Editor Harlan Krumholz asks: How do you communicate with your patients about cutting-edge research findings that are very complex or controversial? Your patients may have questions about the latest guideline or study that they hear about on the news. How do you interpret the nuances of the findings and explain how they may — or may not — apply to their care? If this blog generates valuable discussion, it may be the start of a new series on communicating with your patients about the latest research.

The CoreValve High Risk Study reported that, of 795 patients with severe aortic stenosis who were at increased surgical risk, those who were randomized to have transcatheter aortic-valve replacement (TAVR) with a self-expanding transcatheter aortic-valve bioprosthesis had a significantly higher survival at one year than did those randomized to have surgery. However, the finding was marginally significant and Sanjay Kaul suggested that a couple of extra deaths would have eliminated the finding. Also, the mortality difference did not appear until after two months of follow-up, which also raises a question of what might have accounted for the difference.

A patient comes to see you for a consultation. She is scheduled for surgical AVR with an experienced surgeon — and her clinical profile is identical to that of the patients involved in the CoreValve trial. She asks you if she can expect to live longer if she has TAVR instead of surgery.

The patient is bright but not a medical person.

What do you say to your patient?

2 Responses to “The CoreValve Trial: What Do You Say to Your Patients?”

  1. So, Harlan this is a complex multifaceted discourse.

    I would add to living longer, LIVING BETTER than preoperative status. This entails a calculus of return of function dependent on patient specific deficits(?frailty).

    The decision which would include for a “bright but not a medical person”(see SAVR vs TAVR, A Consumer’s Perspective… JAMA Intern Med. 2014;174(4):495-496. doi:10.1001/jamainternmed.2013.12829) the following considerations(and others):

    1.) Center or Centers at which the competing procedures would be performed with an understanding of volume, experience, number of operators(redundancy), length of program existence, ability to rescue(see “Understanding the Volume-Outcome Effect in Cardiovascular Surgery- The Role of Failure to Rescue”- JAMA Surg. 2014; 149(2):119-123. doi: 10.1001/jamasurg.2013.3649)

    2.) Trade-off of debility induced by each procedure and time to recovery to best attainable performance status(Functional Status and Quality of Life After Transcatheter Aortic Valve Replacement- Ann Intern Med. 2014;160(4):243-254. doi:10.7326/M13-1316). In primary prevention, this has been referred to as “Time Lag to Treatment Benefit”

    3.) Social context of care encounter- ie travel, proximity of family/social support

    4.) Need for patient index of confidence in institution and “heart team”- I would frame this as a “gut” impression of the patient after interaction.

    I will also admit to zero training in ability to broker the complexity of this dynamic.

  2. As to original question posed – “What do you say to your patient?”, and the final statement above re: competency to advise, I would strongly recommend viewing the just completed AHA Emerging Science Series 1 hour session at scientificsessions.org/emergingscience.

    Great emphasis was placed on 1.) Heart Team mediated decision making 2.) endpoint of quality of life – as to patient expectations.