Talking Tall Rounds: Contemporary Treatment of End Stage Heart Failure

Podcast Transcript

Announcer:

Welcome to the Talking Tall Rounds Series, brought to you by the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic.

Edward Soltesz, MD:

Good morning everyone and welcome to Tall Rounds. Today we are going to discuss the contemporary treatment of end-stage heart failure. Is it time for a new heart? We'll explore some of the treatment options for end-stage heart failure, talk about multi-organ transplant, and other options if we don't have a heart, such as durable mechanical circulatory support. Dr. Najm will discuss congenital heart transplant, and we'll also feature some interesting new developments in donor heart procurement. And lastly, we will learn about the outcomes of heart transplantation in the modern era. But first, to begin our presentation, I would like to invite our fellow, Dr. Alhossan up to provide a case presentation.

Abdulaziz Alhossan, MD:

Thanks, Dr. Soltesz. Good morning everybody. To start with our case presentation as heart transplant case presentation is 62 years old male with history of non-ischemic cardiomyopathy with EF of 15%, status post-ICD implanted and recurrent VT and VF, and post-ablation maintained on amiodarone. Given his recurrent VT not suitable for LVAD, was listed as status two for heart transplant.

Edward Soltesz, MD:

Thank you. I'd like to introduce Dr. Finet, he is one of our advanced heart failure cardiologists in the section for heart failure, to talk about the roadmap to advanced heart failure therapies. Emanuel.

Emanuel Finet, MD:

Welcome everyone. So the treatment of current heart failure has been cemented by these four pillars of sacubitril-valsartan beta blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors. In addition to that, we then tend to customize based on populations and response, other agents such as diuretics, hydralazine, isosorbide, ivabradine, and vericiguat.

Based on recent data, we know that after patients have been hospitalized with acute heart failure and there is an intense up-titration in follow-up of these patients. Congestion tends to stay down and decrease after. And then as well as there's an improvement in mortality and a decrease in heart failure readmissions. Also in the long term, we have an improved, actually additional improvement, of each of these agents in survival over time. So it is actually quite dramatic change between having no medical therapy to have it all agents combined.

I'm briefly going to just mention those things, but there are other treatments and pre procedures of course that we use such as iron replacement, atrial fibrillation ablation when needed, IV nodal ablation, CRT, CPAP bypass, et cetera, that obviously, I'm not going to go into it. But there's many things that are being done sequentially over time.

And in recent years also there has been an explosion of devices. In addition to ICDs and CRTs that we know, now we have approval for the transcatheter edge-to-edge mitral valve and tricuspid valve repairs, AVRs, CardioMEMS, Barostims and CCMs or cardiac contractility modulation. And now the up-and-coming combination of CCM and ICD that we are also implanting here at Cleveland Clinic.

This is not really a sequential model. It should not be a sequential model in which we lead procedures or devices at the end of the road, but actually has to be integrated along the heart failure care, trying to not only start and maximize medications, but also seeing avenues to add devices when needed throughout this pathway before we get to advanced heart failure.

The advanced heart failure has been historically defined by a new association class and more recently in terms of INTERMACS profiles. But there's a mnemonic that was created back in 2017 that actually has been recently adopted by the heart failure and ICH guidelines. It's called "I Need Help." And I Need Help stands for the use of previous or ongoing inotropes, advanced New York Association class or elevated natriuretic peptides and organ dysfunction, low ejection fraction, frequent defibrillation jogs, hospitalizations for heart failure, persistent edema, hypotension or inability to titrate medications. And all these are markers or surrogates the patient's actually in advanced heart failure state.

When patients are in advanced heart failure, now that should trigger an evaluation for advanced heart failure therapies, in particular heart transplantation after discussion with the patient. And we use CPER as a marker to quantify exercise intolerance as well as prognosis. And then is also recommended to measure hemodynamics because the current allocation system since 2018 actually has a great focus on hemodynamics, particularly in the presence of low output or cardiogenic shock. You can see this is a list of priorities. Status one, highest priority. Status six lowest priority.

And you can see that the patients on a status one are the patients who are, and this is a simplified scheme, but patients that are supported with surgical devices such as VVAs or ECMO CentriMags or ECMO. Status two patients on percutaneous temporary support devices like balloon pumps or Impellas. Status three, those that have a complication with their LVADs or having multiple inotropes. Status four are the special populations like congenital heart disease or they have an LVAD, a durable mechanical device, which by itself would require for patients who are having low output state to begin with. In status five, multi-organs. And then status six is the rest of the INTERMACS profiles four to six, which I just talked about.

So there's a big great interest. This has led to an actual increase of patients being transplanted in less than 90 days since 2018 actually. And the rest of the patients that have been waiting less than three months, it actually continues to go down. And that has been at expense of a very rapid increase in patients listed for status two and a status one. It has led to an increase of transplants in all types of cardiomyopathies, but again, the rates are highest in patients on a status one and a status two, are the ones who are mainly transplanted.

So we know that the V ECMO has not shown to improve survival so far in cardiogenic shock. However, when we decongest the ventricle to decrease the pressure volume area under the curve and myocardial oxygen that demand, this seems to be an improvement in mortality compared to regular ECMO. But that at least in the current data, some patients that have been decongested or at least put on Impella in less than two hours since ECMO. But we do use ECMO increasingly now for the bridging of advanced heart failure therapies. You can see both LVAD and transplants.

However, there's a cost to pay in which even those patients that make it to transplant after being supported on ECMO still have a lower survival even after a year. So something to keep in mind. Survival is about, if you think about it, mortality in ECMO is about 50% after 10 days. So that is something to ponder on.

Balloon pumps are not been shown to be of survival benefit in the management of cardiogenic shock. However, we do use them for bridging advanced heart failure therapies. There's two reports here, one from Houston Methodist, the other one's from Chicago, about 60% in one cohort and about almost 90% on the other cohort have been bridged to advanced heart failure therapies. Survival after being supported with this device about a year after transplantation is very good. It's about 87% of these patients are able to be ambulated, and we do this often in our unit.

Impella has been so far the only device that has shown mortality benefit in the management of cardiogenic shock albeit with a little bit of extra bleeding and complications. But the big daddy of Impella, the Impella 5.5 and 5.0 has been recorded in the last three years in the cardiogenic shock working group here in the United States. And we see the survival, the report is about 67%, but 46% of those patients actually have done heart replacement therapies, either LVAD or transplants, and 80% of those patients that had this actually have heart failure mediated cardiogenic shock. And the survival of patients supported with Impella after a year they were transplanted is actually excellent as well. It's almost 90%.

There's been case reports of BiPellas. So in this case, Impella 5.0 and RP, Cleveland Clinic reported the first one about 20 days of wait time back in 2019, and some of them have reached to LVADs, however, with a 50% mortality.

So what is better, either an Impella or a balloon pump? And actually there is a recent analysis of all the regions in the United States, over 4,000 patients. You can see that there is all these regions in the OPO (organ procurement organization) as transplants, and there's a ratio between balloon pump to Impella. For example, in our OPO here, region 10 is about seven. So we use about seven balloon pumps per Impella supported. Wait times are long. But as you can see, they're actually been decreasing in recent years. And overall in the whole country, there's been a trend or a decrease in balloon pump usage and an increase in Impella usage. However, survival has remained the same so far in all these patients.

And finally, just to wrap up and ponder, this change in allocation status and being more aggressive in managing pre-transplant cardiogenic shock as a bridge to transplant with mechanical devices has led to an increase in heart transplantations compared to the prior allocation system, both in status one or two, and a decrease in wait list mortality, which is obviously important. However, there's actually been a decrease in the recovery of patients as well, right, because we transplant them too fast. And it's in less than 90 days, both in status one and status two. So it's something for us to ponder. So thank you.

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