Key Takeaways
- The pandemic resulted in positive changes to ECMO accessibility and technological upgrades.
- Continued advancements of the treatment device will likely lead to more flexibility in patient care and improved patient outcomes.
- Limitations to ECMO usage and expansion are primarily related to staffing capabilities and ICU overhead.
With the COVID-19 pandemic in our communal rearview mirror, we can now appreciate the healthcare advances that have resulted, including vaccine technology, virtual care options and reimbursement, supply chain efficiency, and staffing optimization. One specific technology that gained mainstream attention was Extracorporeal Membrane Oxygenation or ECMO.
The History of the Heart-Lung Machine
If you’ve heard of cardiopulmonary bypass (the “heart/lung machine”) that is used daily in cardiothoracic surgery, then you can imagine ECMO, which is based on that technology. Optimal pump mechanics took several decades in the mid-20th century to perfect, but the concept has not changed:
- Plastic tubes, or cannulas, are inserted into the heart or peripheral blood vessels –> blood is removed from the patient and enters the bypass machine –> oxygen is diffused into the blood via an oxygenator –> oxygenated blood is returned to the patient through another cannula.
In the operating room, this technique is used to temporarily offload blood from the heart and lungs so that open heart procedures can be safely performed. The “open” circuit allows a technician, called a perfusionist, to add and remove blood products, medications, and even anesthetics in gas form to the patient’s bloodstream.
However, there is a time limit to using a bypass circuit. Since it is “open,” exposure to air results in adverse side effects the longer the circuit is used.
The Advent of ECMO
ECMO is a closed circuit with no blood-air interface and, therefore, can be continued for extended periods of time. Although first successfully reported in 1972, the use of ECMO in critically ill adult patients in the ICU did not gain significant momentum until the 21st century. For the first 40 years of its existence, prohibitive bleeding and clotting complications led to very poor outcomes, limiting significant application to the pediatric population.
Improvements in pump and cannula technology in the 2000s led to increased utilization in adults awaiting or recovering from open heart surgery and heart and lung transplantation. International experience during the 2009 H1N1 influenza pandemic led to an expansion of the use of this technology in the following years for various critical illnesses, including severe allergic reactions, lung and heart infections, and trauma.
Interestingly, until the COVID-19 pandemic, the Food and Drug Administration (FDA) approved ECMO for only up to 6 hours, despite extensive clinical experience utilizing the technology in the intensive care unit (ICU) for days and even weeks.
Overall, ECMO utilization has been primarily limited to high-volume academic centers due to the extensive resources necessary, including hardware, specialized personnel, and prolonged length of stay.
Although ECMO treatment device technology has been saving lives for decades, only in the past few years has demonstrable market growth occurred and exploded, mainly due to the COVID pandemic.
How Covid Has Impacted ECMO Utilization
Severe COVID-19 infections in some patients caused lung failure. As a result, during the pandemic, demand for ECMO increased. The initiation of ECMO saved many lives, but the existing treatment model required adaptation for a rapidly changing treatment environment.
Many additional centers developed ECMO programs to accommodate the changes, and existing treatment algorithms were modified. In addition, the FDA dramatically extended the permissible length of ECMO support from 6 hours to 30 days.
To meet demand, the industry rushed to increase its portfolio and production of ECMO pumps, cannulas, and oxygenators.
As a result of the pandemic, the current landscape of ECMO technology is dramatically different from just a few short years ago, resulting in more positive change than has occurred over the last five decades.
The ECMO Market Today
These are the major players in the ECMO treatment device market and their impact on the industry:
- Maquet (Maquet Getinge Group, Rastatt, Germany): a dominant industry presence with their Rotaflow ECMO console considered the historic workhorse. The newer Cardiohelp console developed in 2010 is a compact, extra-light version for transporting ECMO patients and has dominated the mobile ECMO scene for the past decade. In 2022 the updated Rotaflow II hit the European market, although it has yet to be approved in the US. They also have a stronghold on ECMO cannulas and were the first movers for dual-lumen cannulas (Avalon Elite). Shortcomings: supply chain issues with disposable kits
- Medtronic: a late entrant into the ECMO but makers of some of the highest quality cannulas and oxygenators available. Their peripheral cannulas are highly utilized for their ease of use, price, and reliability. Since 2018, their dual-lumen cannula (Crescent) has competed with Maquet’s Avalon Elite; however, with a similar price point and improved flow dynamics, it has taken a significant market share in this space.
- Abbott Technologies: historically, it has focused on long-term cardiac support devices (e.g., left-ventricular assist devices) but has advanced its short-term ECMO support portfolio in the past several years. The recent shift has increased their market share. Shortcomings: recent corporate struggles have diminished customer support and frustrated clinicians. The lack of a reliable oxygenator continues to be a problem.
- Livanova: their Lifesparc pump is light, simple, and gaining significant traction despite a recent software complication resulting in an FDA-mandated upgrade. They were first to market with the ProtekDuo cannula to support the right heart, which was the only such cannula until early 2022. They acquired Hemolung in 2022 and added the only FDA-approved device for extracorporeal carbon dioxide removal (ECCO2R), another aspect of extracorporeal support, to their portfolio.
- Abiomed: has dominated the percutaneous left ventricular assist device market with its Impella system. The recent release of Impella RP Flex is touted as a significant improvement over the first-generation Impella RP utilized to support the right heart chambers and competes with Livanova’s ProtekDuo. Shortcomings: they struggle with a dedicated ECMO device.
- Spectrum: Their Quantum cannula challenges the ProtekDuo with some theoretical benefits and cost savings, although experience is still limited. Their Quantum Perfusion System ECMO unit is marketed as the highest-technology device with several interface benefits and communication with electronic health records. Shortcomings: their price point and early clinical struggles may offset these benefits.
- Fresenius: Their Novalung ECMO system has been very popular in Europe, with less adoption in the US. They reportedly lead the pack with a pulsatile flow mode which has the potential benefit over a continuous flow model; however, this, too, is limited to the European market.
Financial Implications of Using ECMO
Although ECMO is a costly treatment device, the bulk of the cost of utilizing the device for patient care is related to ICU overhead costs. For instance, paying the physicians to care for patients on ECMO, the perfusionists to manage the device, and nursing care.
Additionally, patients on ECMO generally have a prolonged ICU admission and hospital treatment course, which alone increases the cost of care. However, since survival is potentially improved, the cost differential is secondary to the potential survival advantage.
Patient Care, Outcomes & Efficacy
Unfortunately, no current data exist on survival and length of stay for patients receiving ECMO versus those that do not, as ECMO is only deployed in life-saving situations. This has been the most significant barrier to demonstrating efficacy: no randomized trial has been successful as clinicians that endorse ECMO will not hold it back from near-death patients, leading to significant cross-over when randomized trials have been attempted.
Despite the lack of definitive data, ECMO has become the standard of care in critically ill patients. It Is universally accepted as the ultimate life-saving intervention for various potentially fatal conditions and will likely see increasing indications in the near future.
The Future of ECMO
The COVID pandemic has driven ECMO outside major academic medical centers into smaller healthcare systems. Although unavailable at most community hospitals, many healthcare systems now have an ECMO referral center within their network or collaborate with other systems, expanding accessibility significantly. This change was necessary and beneficial and is here to stay.
Hardware and disposable costs have decreased slightly due to a more competitive marketplace; however, staffing remains the bulk of the overhead and the most significant limitation to expansion.
How Usage Of This Treatment Device Can Be Improved
A strategy for decreasing overhead is moving from a perfusionist-led model to a nursing-driven model. Perfusionists, whose primary focus is cardiopulmonary bypass in the operating room, have graduate-level training and are reimbursed significantly more than nurses. Managing an ECMO pump is second nature for them, whereas even experienced nurses require additional training to manage these patients.
The transition toward a nursing model significantly decreases costs; however, pandemic-related nursing staffing shortages do not appear to be receding any time soon, making this cost-saving strategy challenging to implement.
Additional room for improvement around ECMO treatment devices revolves around safety, portability, and cost:
- The major risks of ECMO are bleeding and thrombosis; thus, continuous improvement in pump, tubing, and oxygenator technology will further decrease these risks.
- Applying real-time data monitoring and potential artificial intelligence integration into pump software is a distant but real possibility.
- Lighter and more compact hardware will improve mobility for the deployment of ECMO teams to remote locations, potentially increasing the growth of “pre-hospital” ECMO, specifically for out-of-hospital cardiac arrest.
- Compact units and less invasive cannulation strategies will allow the patients to be more mobile, allowing for rehabilitation while on ECMO, which reduces the length of stay, and cost and allows for more direct discharges home instead of nursing facilities for ongoing recovery.
Final Thoughts
With such rapid growth in demand in such a short period, many new companies are attempting to enter the ECMO market. The CARL ECLS System was recently launched in Germany with an extremely portable device focusing on full-body resuscitation. The Inspira ART System, designed and manufactured in Israel, recently entered a distribution agreement with Terumo Cardiovascular for North American implementation. Several new cannulas will soon enter the market, with eager clinicians awaiting.
Although ECMO treatment device technology has been saving lives for decades, only in the past few years has demonstrable market growth occurred and exploded, mainly due to the COVID pandemic.
As international experience grows, so will clinical applications and the need for further technological advances. Ultimately, this will drive industry growth but, more importantly, save many more lives.
Gary Schwartz, MD
Gary Schwartz, MD, is the Chief of the Department of Thoracic Surgery at Baylor University Medical Center in Dallas, TX, where he runs the Extracorporeal Membrane Oxygenation and the Lung Transplantation programs. He is also a Clinical Associate Professor of Surgery at Texas A&M School of Medicine. A native New Yorker, he received his medical degree at the Albert Einstein College of Medicine before training in General Surgery at St. Luke’s-Roosevelt Hospital Center. He completed his training in Baltimore in Cardiothoracic Surgery at the Johns Hopkins Hospital.
