Is It Too Late? When to Consider LVAD as an Option

Left ventricular assist devices (LVADs) have dramatically shifted the outcomes for patients with advanced heart failure. The question remains, when is the best time for a patient to begin LVAD therapy? Michael Zhen-Yu Tong, MD, Surgical Director of Heart Transplantation and Mechanical Circulatory Support, reviews a case study with the question, is it too late?

Discover the Left Ventricular Assist Device Center at Cleveland Clinic
https://my.clevelandclinic.org/departments/heart/depts/left-ventricular-assist-device-center

Learn about the Center for Shock and Circulatory Support
https://my.clevelandclinic.org/departments/heart/depts/center-for-shock-and-circulatory-support

View Cleveland Clinic outcomes for LVAD
https://my.clevelandclinic.org/departments/heart/outcomes/445-ventricular-assist-device-implantation

Transcript

Welcome to Cleveland Clinic Cardiac Consult, brought to you by the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at Cleveland Clinic.

Michael Zhen-Yu Tong, MD:

Good morning. My name is Michael Tong. I am the Surgical Director of Heart Transplantation and MCS at Cleveland Clinic. Let's look at an example of a patient that we used to see. It's a 74-year-old with a history of ischemic cardiomyopathy with a longstanding EF of 20%. The patient had a previous CABG and now presents with new onset VTs. EF is only 8% with biventricular failure, renal failure. Baseline creatinine is 1.9 now, they're anuric and they require emergency intubation because of the VTs. Because the patient is so unstable, we institute an emergency ECMO.

Now what do we do for this patient? Is it too late and we just consider palliative care, or do we proceed to an LVAD? If we do proceed to an LVAD, what is the best way to do it? Do we proceed immediately to an LVAD from ECMO or do we bridge them to an ambulatory strategy first where we put an Impella in, maybe get them extubated, get them ambulating before we go onto an LVAD.

If we go back and peel back the layers for this patient over the last couple of years, we see that the creatinine has increased gradually from 1.3 to 1.9 over the last two years. Patient's had three hospital admissions in the last year for heart failure. Patient's becoming increasingly intolerant to GDMT. GDMT is essentially is a regimen of medications that we have these patients on. And on the last admission, the LVAD was discussed with the patient, but the patient felt better after we treated them medically and the patient and their family was not all that interested and says, "I will consider if I get worse." Now the patient is worse and have they missed the boat?

This really comes back to how we understand the clinical course of heart failure and when is the right time to intervene. Obviously, nobody wants to have an LVAD. If you had the choice of living your life with no mechanical device or living with an LVAD, of course we would all choose not to have an LVAD. However, but we also recognize that we don't want to put it too late. The course of heart failure is you can be stable for many, many years and then you will have a series of decompensation where you get fluid overloaded, maybe get short of breath. We bring you to hospital, we put you on Lasix, we give you afterload reduction, and we get you back. You may not be quite as good as you were before, but you feel pretty good overall. And then over time, you have these series of valleys and peaks. And over time, the peaks will become less tall, the valleys will become deeper, the frequencies will increase, and eventually you'll get into the end stage route, end stage heart failure where we can no longer rescue you.

Ideally, we want to intervene before you get there, before when you were still in this phase. However, it is important to recognize that the way patients decline is going to be very heterogeneous. When we put in LVADs, we think about where this patient is in the journey of heart failure, and this is what we call the INTERMACS scale. INTERMACS one is your crash and burn patient. Patient is on ECMO. Two is a patient that's sliding fast, you're escalating inotropic support very, very quickly, you're putting in a mechanical support. Stage three are patients who are on inotropes, but they're stable. Stage four are your patients that are bouncing in and out of hospital for heart failure. Stage five, six and seven are patients who are at home without inotropic treatment. The perception is that patients will have the steady decrease over time for INTERMAC seven to six to five to four, and if we can just intervene as they start initiating on inotropes, then at that point we can avoid patients getting their LVADs too soon, but also not when it's too late.

However, the reality is patients can follow all kinds of different trends and therefore in order for us to avoid missing the patients at the end stage, we have to look a little bit higher, more upstream. And this is where the main focus, so we're using algorithms to try to identify these patients who may be a candidate for heart failure. And for most part, we are intervening on patients slightly earlier than most other centers. Our practice has evolved from doing only patients who are INTERMACS one to three, to patients that are INTERMACS two to five. Now about a third of our patients are INTERMACS four, a third of our patients are INTERMACS three, and a third of our patients are INTERMACS two. And compared to the United States as a whole, only about 15% are INTERMACS four.

If we look at the data, many years ago there was a study comparing patients who were medically treated and with LVADs and those patients that were INTERMACS four, if you look at what happened to them in two years, 40% of these patients were dead at two years and about a quarter of these patients received an LVAD anyway.

In two years you had two thirds of a chance at INTERMACS four to either be dead or need an LVAD anyways. This is our main justification of why we feel INTERMACS four patients, before they need inotropes, will require LVADs. What we think about what is an appropriate LVAD patient, we think about patients who are NYHA Class IV, so they're having resting shortness of breath, they have poor quality of life. If they have more than two hospital admissions for heart failure in the last 12 months, if they have worsened renal failure and hepatic failure, if they're having VTs or they're intolerant to GDMT or intolerant to medications, these are our triggers for getting a patient an LVAD earlier.

And with that, I want to thank you.

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