Using Novalung to Treat Respiratory and Cardiac Failure with Dr. David Thompson

A year ago, the FDA cleared a product for use in the U.S. called Novalung®, an extracorporeal membrane oxygenation system (ECMO). Listen as Dr. David Thompson, Vice President and Medical Director of Critical Care for the Renal Therapies Group, a division of Fresenius Medical Care North America, joins Field Notes to discuss successful experiences with the first ECMO system-FDA cleared for long-term use over six hours in patients with acute respiratory or acute cardiopulmonary failure.

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Brad Puffer: Welcome everyone to this episode of Field Notes. I’m Brad Puffer on the Medical Office Communications team at Fresenius Medical Care North America and your host for this discussion today. Here we interview the experts, researchers, physicians, and caregivers who bring experience, compassion, and insight into the work we do every day.

Well, Fresenius Medical Care is most known for a company focused on kidney disease. New innovations that build on the company's expertise means we're now offering new therapies such as heart and lung support. Just a year ago, the FDA cleared a product for us in the US called Novalung. It's an Extracorporeal Membrane Oxygenation System or ECMO that will hopefully transform how we support respiratory and cardiac failure. Novalung is the first ECMO system FDA cleared for long term use over 6 hours.

And because we're talking about our product today, a quick disclaimer before we begin: all extracorporeal life support procedures involve risks, including bleeding from biotic events, hemolysis, cardiopulmonary complications, infection, neurological injuries and death. Carefully review full instructions for use and indications for use prior to incorporation in patient care.

We're excited to be joined today by Dr. David Thompson, Vice President and Medical Director of critical care for the Renal Therapies Group, a division of Fresenius Medical Care North America. Dr. Thompson has been very involved in the rollout of this new technology over the past year. Dr. Thompson, welcome to Field Notes.

Dr. David Thompson: Thank you for having me, Brad.

Brad Puffer: But, I wanted to start, Dr. Thompson, with a little more about just what ECMO is, I gave a little bit of a definition in my intro. But how would you define it?

Dr. David Thompson: ECMO is extracorporeal membrane oxygenation, which is a form of extracorporeal life support or ECLS. Briefly, ECMO is a modified heart-lung machine that is used to provide temporary support for severe respiratory or cardiac failure.

Dr. David Thompson: Think of it as a way of removing blood via a pump and processing, adding oxygen and removing carbon dioxide and returning it back to the body during times where the heart or the lungs are not functioning properly. Just recognize that it's actually not a treatment, nor does it correct the pathologic insult, but rather is a support.

Brad Puffer: Pretty fascinating to think about that and just how that works. Novalung, our device, first received FDA clearance in February of 2020. How has the reception been in the marketplace so far and what are you hearing from some of the early adopters?

Dr. David Thompson: We've seen great excitement in demand given the pandemic, the feedback has been very positive and most common responses describing ease of use---the flexibility of the device, its first utility, simple alarm settings, and our superior customer service.

Brad Puffer: Well, Dr. Thompson, as someone who's been with the company for a while and Fresenius Medical Care, certainly known as a leader in kidney disease therapies, but not so much in ECMO, how has it been for you to be involved in this new direction, which in many ways signals the future strategy for the company too, correct?

Dr. David Thompson: You're correct, Brad. This is an exciting time for Fresenius Medical Care as our DNA has been in extracorporeal therapy supporting kidney disease. We have the opportunity now to take that experience and evolve and develop into the heart-lung space, and Novalung will lead this charge into the critical care arena.

Brad Puffer: Well, ECMO is certainly not a new technology or concept, so can you provide us some of the history behind this technology? How did we get to today?

Dr. David Thompson: ECMO can really be traced back to an extension of cardiopulmonary bypass that was actually developed in the early 1950s. More recently, I would say through the late 70s and into the early 80s we saw expansion where it had previously been used successfully in children and transitioned to the adult population for heart and lung support. Through the turn of the century, we saw with the Cesar trial, outcomes were better with ECMO compared to conventional mechanical ventilation in ARDS. This was then confirmed with the success in support of the H1N1 epidemic with the continued success in both cardiopulmonary support, we've seen the development of over 650 ECMO programs within the United States, and as industry continues to develop modified pumps, oxygenerators, encodings, this is resulted in safer, simpler and more reliable devices specific to ECMO.

Brad Puffer: And so Dr. Thompson, well ECMOs have been around for a while. Why is having a device that is cleared for over 6 hours of use so important?

Dr. David Thompson: To put that into context, historically as an extension of a modified cardiopulmonary device, ECMO has historically been limited to less than 6 hours. However, we are the first ECMO system approved by the FDA for greater than 6 hours. And it makes sense that the majority of these disease states require support longer than 6 hours, and in fact, days to even months of support in some cases.

Brad Puffer: Well, it's pretty extraordinary to think that a patient in acute respiratory or cardiopulmonary failure that their life could be supported for longer than 6 hours with a device like this. I assume that gives doctors time to treat those underlying conditions, correct?

Dr. David Thompson: That is indeed correct. It gives them time to continue support. As I mentioned earlier, this is not necessarily a treatment, but rather support until they can make decisions for improvement or to make decisions about end of life in some cases.

Brad Puffer: Well, Dr. Thompson, when we think about a hospital setting in your clinical experience, what are the types of conditions that might lead to acute respiratory or cardiopulmonary failure and necessitate the use of an ECMO device like Novalung?

Dr. David Thompson: This is a very topical question with the COVID pandemic. This has left us with refractory hypoxic respiratory failure or acute respiratory distress syndrome, which is probably one of the most common indications at this time. Others would include acute myocardial infarction with cardiogenic shock, perhaps septic shock with acute respiratory distress syndrome, or cardiac dysfunction, chronic lung disease as a bridge to transplantation. Others would include decompensated congestive heart failure with cardiogenic shock bridging to transplantation or possible destination therapy.

Brad Puffer: So it sounds like there's a lot of different conditions or situations in which this urgent life support system would be needed. 

Dr. David Thompson: You're absolutely correct, and in fact, some of our successes outside the setting of COVID have been related to acute lung injury related to multi-organ failure.

Brad Puffer: Have you seen specific cases where patients had acute cardiopulmonary failure and Novalung was used to treat those patients during the pandemic?

Dr. David Thompson: I am told that approximately 3 out of 4 have survived with limited data shared by our customers.

Brad Puffer: And we started talking about some of the successes related to the pandemic. Are there other success stories that you're hearing from the field this year?

Dr. David Thompson: Yes, beyond successes in treating COVID-19, like treating a COVID care-giver back from acute respiratory failure, Novalung has been used as the bridge to successful cardiac transplantation as well as successful support in lung injury related to multi-organ failure.

Brad Puffer: Dr. Thompson, what do you see as the future of this technology? Do you see, for example, Novalung and ECMO becoming an even more widely used critical care tool?

Dr. David Thompson: I do Brad. My hope is that the course will be one similar to one seen in continuous renal replacement therapy for support of acute kidney injury in the intensive care unit. Perhaps we'll see more expanded use, expanded education, and user experience.

Brad Puffer: Well, it's great. Dr. Thompson, it is really exciting to think about what that future might hold for ECMO devices, and specifically Novalung.  This has been a really fascinating conversation and interesting to learn about a subject that goes beyond kidney disease, but is still making such a life sustaining impact for people with critical conditions. You help make a really complicated, yet important subject easy to understand. Thanks, Dr. Thompson.

Dr. David Thompson: My pleasure, Brad.

Brad Puffer: To our audience, thank you for joining us. Please know that your feedback is always welcome. If you have comments on today's episode topics of interest to you or speakers you want to hear from, let us know by clicking the feedback link featured on the Field Notes website on fmcna.com.

Don't forget you can find Field Notes in the Apple Store or Google Play or right here at fmcna.com. Or you can also find our annual medical report and other featured articles. We hope you'll come back and join us as we have many more topics to discuss in the weeks ahead. Until next time I’m Brad Puffer and you've been listening to Field Notes by Fresenius Medical Care. Take care, everyone.

 

INDICATIONS FOR USE

The Novalung System is indicated for long-term (>6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

  • Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
  • ECMO-assisted cardiopulmonary resuscitation in adults
     

Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.

Note: Read the Instructions for Use for safe and proper use of these devices. The Indications for Use for this device can be found at https://fmcna.com/products/indications-safety-and-warnings.

© 2021 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo and Novalung are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies.

All other trademarks are the property of their respective owners. P/N 104605-01 Rev A 06/2021