In This Article
- Massachusetts General Hospital critical care physicians are utilizing ECMO therapy for severely ill COVID-19 patients
- Physicians have decannulated four patients; four remain on ECMO support
- Selecting the right patients for ECMO therapy as a bridge to recovery is critical to success
- ECMO devices are invasive and labor-intensive, so patient and configuration selection, along with ethical considerations, are key to their indications and use
Massachusetts General Hospital is utilizing extracorporeal membrane oxygenation (ECMO) as a rescue therapy for severely ill COVID-19 (SARS-CoV-2) patients.
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"We're able to provide the support that patients need when the ventilator is not enough," says Kenneth Shelton, MD, a critical care physician, anesthesiologist and medical director of the Corrigan Minehan Heart Center's Intensive Care Unit (ICU). "By using ECMO as a bridge to recovery, we've been able to successfully rescue some of our sickest patients."
Treating Critically Ill COVID-19 Patients with ECMO Therapy
COVID-19 infection can lead to significant lung damage, affecting the lungs' ability to sufficiently oxygenate the blood. Some patients develop acute respiratory and cardiopulmonary failure as a result. Advanced age and comorbidities only compound the potential for injury and death.
The use of ECMO as an effective support device is not unprecedented. It was successfully utilized during 2009's H1N1 influenza pandemic. Over a three-month period, Australian and New Zealand investigators reported a 78% survival rate for patients with H1N1-related acute respiratory distress syndrome (ARDS) treated with ECMO in Chest Physician. Early studies out of Wuhan, China, where the COVID-19 virus originated, reported that 15% to 30% of patients develop ARDS.
To expand ECMO's availability to COVID-19 patients, the U.S. Food and Drug Administration (FDA) recently issued a new policy for ECMO as a rescue therapy when ventilator management is insufficient.
"For patients where even ventilators fail to provide adequate oxygen to the body, ECMO is now an option. It's the equivalent of providing a period of ultimate rest where the heart and the lungs have time to heal," says Dr. Shelton. "It buys time for other therapies to work, including antibiotics for superimposed bacterial pneumonia, investigational therapies and fluid removal for patients that have wet, volume-overloaded lungs."
The FDA's policy is a temporary measure drafted specifically to address ECMO use during the COVID-19 pandemic. The FDA has given clinicians the autonomy to modify indications and configurations on a patient-by-patient basis.
"Different variations provide heart support, lung support or a combination of both," says Dr. Shelton. "You need to be very precise in terms of what you're using it for. If you put someone on a cardiac device that has a pulmonary problem, you can create a scenario where you have cerebral hypoxia, so there needs to be a careful assessment to select the right circuit for each patient."
Survival Rates for COVID-19 Patients on ECMO Highlight the Need for Caution
While early Chinese epidemiological studies on ECMO for COVID-19 patients with ARDS have reported high mortality rates, a recent Journal of Critical Care study concluded that ECMO produced neither harm nor benefit in this patient population. An article published in The Lancet also raised concerns about the "potential harms" of ECMO. But Dr. Shelton says outcomes are largely dictated by each patient's ability to heal when given more time.
"I think that's why you'll see very mixed results depending on which patients are selected to go on the device," he says. "At Mass General, we have a review panel of critical care physicians and cardiac surgeons discuss every case or consult where the primary team feels the patient is not receiving the support needed from the ventilator alone. As of April 17, we've had over 35 consultations."
Ultimately, Dr. Shelton's cross-specialty Heart Center ECMO team has placed eight patients on the device—seven for pulmonary support and one for cardiac support. They have decannulated four patients, and four patients are still on ECMO.
"One of our sickest patients in terms of cardiac involvement secondary to COVID went home, so that was an incredible win. She had viral myocarditis, so in her case, it was the appropriate therapy," says Dr. Shelton. "And one of our very first COVID-positive patients that went on venovenous (VV) ECMO recently left the intensive care unit, free of the ventilator."
The Role of Ethics in ECMO Utilization
Dr. Shelton emphasizes that the ethics of ECMO utilization should play an important role in the care decisions physicians make for COVID-19 patients. It is most appropriate for patients who would benefit from the support ECMO provides as a bridge to recovery over a period of weeks. While physicians may be inclined to use every device available, they must exercise caution for the sake of both patient and care team.
"We don't want to put patients on ECMO without an exit strategy," Dr. Shelton says. "You run the risk of putting a patient on a device that they can never come off of. Because of that, we've worked with our colleagues in ethics exceedingly early. But sometimes, this can be a real strain in those scenarios where our frontline physicians and nurses see a device that is working, but a patient that is failing."
Preparing for and Implementing ECMO in a Critical Care Environment
In anticipation of the COVID-19 pandemic, Mass General clinicians examined the experiences their Chinese and Italian counterparts. As a result, they increased their stockpile of circuits and devices and now can put together more than 20 ECMO devices.
Because these support devices are both invasive and labor-intensive, incorporating them may prove challenging for smaller programs. Hospitals need a large group of experienced ECMO experts to run multiple circuits. But Mass General's long history with ECMO therapy, which began when then-chief of anesthesiology Warren Zapol, MD, conducted the first randomized controlled ECMO trial in 1979, has translated into a multidisciplinary team of specialists who expertly manage these devices.
"From some of the original trials with ECMO for respiratory failure and ARDS, we learned that it ends up being more than the device. It's often a limitation of the staff and their resources—how familiar they are with using and managing the device and its interaction with these critically ill patients," says Dr. Shelton. "As a quaternary center, we often accept patients who have recently been placed on ECMO from programs that can't manage everything that comes with an ECMO patient. As we've seen so far with our results, the patients we've selected for this therapy have had reasonable outcomes, and we have been able to incorporate ECMO patients into the normal critical care environment rather than filling an entire ICU with ECMO patients."
The Mass General Corrigan Minehan Heart Center team has compiled protocols and strategies:
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Refer a patient to the Corrigan Minehan Heart Center