Wednesday, November 12, 2008

Destination LVADs

Philosophy, Ethics, and Humanities in Medicine has a review/discussion of the ethics & end of life challenges of left ventricular assist devices for heart failure (free full-text here).

(See this Fast Fact if you're interested in a concise summary: LVADs are partially internalized pumps for supporting circulatory function - they pump your heart for you - and were initially designed as temporary interventions for patients awaiting heart transplantation. At least one device is now approved as 'destination therapy' meaning it's implanted with the expectation that the patient will remain on it for life. Average survival is somewhere in the one year range. At least two trials have shown LVADs improve survival - even doubling it at one year [from ~25% to ~50%] - in well-selected patients.)

This is an absolutely essential paper for clinicians who encounter these patients (my assumption is that hospital-based palliative care clinicians who work at institutions with cardiac transplant programs see patients with LVADs at least on occasion) - I'm throwing it into my program's fellowship to-read list. The first section of the paper is a detailed, critical review of the data (survival, symptom, quality of life) from the largest LVAD trials, as well as an overview of LVADs' many complications (both easily measured ones like stroke, sepsis, device failure, etc. - as well as less concrete ones like the device's social impact, pain, inability to travel, anxiety from the device alarming, etc.).

The second section describes the critical importance of communication at the time of LVAD placement, and describes what patients and families really need to understand in order for there to be true informed consent about initiating it. It recommends getting palliative care clinicians involved up front, for a variety of reasons, but particularly to talk about alternatives to LVADs and what that would look like.

It then gets really wonky (a philosopher is first author on this paper), but wonky for a good reason, and that is that assist devices are often placed in emergency circumstances and without the patient's consent (instead using surrogate consent). (Alternatively they are placed with the patient hoping they'll be a 'bridge to transplant,' circumstances change, and the LVAD ends up as destination therapy.) Given that these devices don't represent a cure (although they clearly prolonged life for most who received them in a clinical trial setting), and are associated with major burdens and morbidity - the authors ask is it appropriate to initate them in patients without they themselves agreeing to them?

They cautiously conclude that it's ok to do this, which I can't technically disagree with, because the device can be stopped if the patient wakes up and says No thanks. That analysis, of course, greatly underestimates the emotional/psychic differences between withholding and withdrawing a therapy, not to mention the tremendous pressure that patients and families can feel from health care providers to continue with a course of therapy once started. This pressure is not because cardiothoracic surgeons aren't nice, patient-centered physicians (I'm sure a few aren't, but most I know are): but if you perform a super high-risk, time-consuming surgery, manage a patient through a rocky post-operative course, and then the patient wakes up and says Take this thing out - that puts you in a difficult, frustrating place. In addition, there are likely some patients who if you went through a full informed consent process, talking about alternatives in detail, would choose medical management instead of an LVAD; my guess is that a good number of these patients who receive one in emergency conditions would keep it any, given the difficulty of asking to have this thing which is pumping your heart for you turned off/explanted. This is not to say it was a wrong decision to do the LVAD, but I think we have to be realistic that even though patients have the right to say No it’s never as simple as that.

Wonkish speculation aside, it seems to me that patients considering LVADs therapy are prime candidates for palliative care expertise if there ever was one: facing an incurable, terminal illness, a potentially life-prolinging but also very risky and potentially high morbid therapy, poor prognosis under all circumstances. It's the closest thing we have to taking people dying from a terminal illness and hooking them up to a portable life-support machine (and it works). I’m curious as to if any pall care colleagues out there are in centers in which they routinely see these patients pre-LVAD decision (and not just when they are dying on the LVAD)?

(Image is from the article.)

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