COVID-19, Protected PCI
Treating Protected PCI & Impella® Therapies as Essential During COVID-19
Shami Mahmud, MD, FSCAI, discusses high-risk PCI (HRPCI) in the era of COVID-19. Dr. Mahmud is the Chief of Cardiology at UC San Diego and lead author of the consensus statement from the Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC), and the American College of Emergency Physicians (ACEP) titled “Management of Acute Myocardial Infarction During the COVID-19 Pandemic.”
Dr. Mahmud tells interviewer Chuck Simonton, MD, that some of the issues addressed in this consensus guidance for North America have become even more applicable now (at the end of the summer of 2020) as COVID-19 burden continues to expand. “And now we have to figure out how to execute that platform. And it will vary a little bit. I think it’s going to vary which part of the country you’re in, what kind of practice you’re in, and what the local disease burden is.”
Dr. Mahmud addresses the questions: “What do we do with patients who have complex disease, multi-vessel disease, maybe advanced heart failure with anginal symptoms?... Do they go to bypass surgery? Do they undergo a high-risk intervention?” And in answer to the question “Is it safe to do so?” Dr. Mahmud responds, “Absolutely.”
Dr. Mahmud describes some of the strategies adopted at his institution, which include knowing the COVID status of every patient undergoing therapy, having a designated COVID cath lab, and doing much of the workup virtually prior to patients coming in. “And when they come in, if they need a high-risk intervention, and they need hemodynamic support, or they need complete revascularization, our intent is really, try and do it in one setting in the fastest way possible and get them out of the hospital.” He also emphasizes, “If we’re going to stage, we’ll do what we can and send them home and bring them back a few weeks later.”
Dr. Mahmud discusses the current STEMI volume at his institution and the importance of being able to “titrate up or down our elective or urgent cases if the COVID burden becomes excessive locally.” He describes local and national public campaigns that inform and encourage patients to seek healthcare when they have cardiovascular symptoms.
Dr. Mahmud notes the continuing relevance of the consensus guidance but emphasizes: “Work with your local health authorities. Work with your own health system and figure out what the local disease burden is because what might work in San Diego, will look very different in Las Vegas, and very different in Boston. Because it all depends on how well COVID has been managed locally and also what resources are available to support those patients.”
EMERGENCY USE AUTHORIZATION
Impella Left Ventricular (LV) Support Systems (Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist) are authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients (i.e. patients in the intensive care unit) with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. The Impella LV Support Systems have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.