Cardiac Care and COVID-19 - Important Questions Answered

Maddalena Lettino of San Gerardo Hospital, Monza (Italy) answers some important questions regarding cardiology patients, cardiac care and COVID-19 in the new series of podcasts by the European Society of Cardiology (ESC).

What have we learned from this experience? And what is the situation of the acute cardiology patient in this pandemic situation?

Dr. Lettino says that cardiology patients are not so many in these times because most of the patients arriving at the hospital are patients with infectious disease and probably cardiology patients are staying at home, waiting until they have much more severe symptoms to go to the hospital. The number of beds dedicated to COVID-19 infected patients are definitely much more than the number of beds dedicated to cardiology patients. She explained that in Italy, they had to change the organisation of the cardiovascular emergency network because they couldn’t have so many people from the cardiology department available for the current patients as most of the intensivists and doctors were dedicated to COVID-19 patients.

She also explained that keeping in mind the model of hub-and-spoke, they have several hubs in northern Italy in particular. These hubs receive patients from many more spokes than before and are still trying to maintain intensive care beds for them. Hence, the total number of intensive care beds available for cardiology patients are much less, but in this way, it’s much easier to organise the transportation of patients.

What is the incidence of ST elevation or ACS in ventilated COVID19 patients and how should they be managed?

According to Dr. Lettino, when the patients are in the general ward, they are mainly non-invasively ventilated and the EKG monitoring is very low and these patients usually are much more affected by respiratory symptoms then by any other kind of symptoms. Therefore, these patients have no far not required the attention of cardiologists. However, when these patients are in the intensive care units and mechanically ventilated, and if their condition gets worse and the severe respiratory failure becomes more evident, the development of multi-organ failure is a natural consequence. They could have also some changes in the EKG, or some alterations of troponin, But according to Dr. Lettino, so far they haven’t had acute coronary syndromes in these patients or at least, this has not been brought to their attention. Hence, it’s difficult to see what is the mortality of infected cardiovascular disease patients, but for sure, cardiovascular disease patients have a worse outcome. Mortality is much higher in cardiovascular disease patients than in patients without any cardiovascular disease. Mortality is even higher in cardiovascular disease patients compared with hypertensive patients who have higher mortality compared with patients who without any risk factors. Dr. Lettino explained that if they had to grade patients, it would be: patients with no risk factors= lower mortality, patients with some risk factors=higher mortality and patients with cardiovascular disease=the highest mortality.

COVID-19 (Coronavirus) Response Fund

We are coordinating with colleagues across the Bay Area and Northern California to care for patients while also protecting the health of our faculty, staff, students, patients, and visitors. As the COVID-19 outbreak expands, teams throughout UCSF’s hospitals, clinics, and research labs are actively monitoring and responding to the evolving situation.

If you would like to support this effort, given the pressure it is placing on UCSF’s constrained resources, please consider a gift to the UCSF COVID-19 Response Fund.

Your gift will be used to address the needs of patients and caregivers impacted by COVID-19, and to support emerging areas of greatest need, such as:

expanding diagnostic and testing capacity. securing our ability to cover extended staff time and benefits for health care providers working directly on the crisis. addressing expenses of exposed patients who are not covered by insurance. ensuring necessary housing for patients and equipment for health care workers. Your gift may also be used to combat COVID-19 through a number of research and educational efforts, including:

utilizing next-generation sequencing and gene-editing technologies to develop novel methods for diagnosing the disease. using cell mapping and computational tools to uncover new or existing therapeutics for treating COVID-19. training frontline health workers in the US and abroad to respond effectively to the pandemic. You can learn more about UCSF’s response to COVID-19 by visiting our comprehensive resource site.

We also encourage you to consider supporting regional and national efforts to address COVID-19 by contacting the San Francisco Department of Public Health, the Alameda County Public Health Department, and the US Centers for Disease Control and Prevention.

PREP Act Immunity from Liability for COVID-19 Related Medical Equipment

Everyone wants to help by providing necessary equipment to the COVID-19 frontline: hospitals, doctors, nurses, and other healthcare providers battling COVID-19 need ventilators, masks, gowns and other supplies.

Here are answers to commonly asked questions on how companies position themselves to obtain the immunity from liability provided by The Public Readiness and Emergency Preparedness Act (“PREP Act”). Read more about the PREP Act in our earlier alert.

  1. I plan to make component parts to be used in ventilators. Do component parts fall within the liability protections of the PREP Act?

ANSWER: Yes. Under the PREP Act, suppliers and licensers of any “component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure” are considered Covered Persons, and the HHS Secretary’s Declaration under the PREP Act extends immunity protections to any device used in a Covered Countermeasure, as well as all components and constituent materials of Covered Countermeasures.

  1. My component parts are not cleared by FDA for use in medical devices such as ventilators or masks. Will they be covered under the PREP Act?

ANSWER: The HHS Secretary’s PREP Act declaration does not override the requirements of the Federal Food, Drug, and Cosmetic Act (FDCA). Drugs, devices and other articles regulated by FDA would still need to comply with regulatory obligations and fall within criteria for a “qualified pandemic or epidemic product” or “security countermeasure,” or be subject to an Emergency Use Authorization (EUA) issued by FDA. The HHS Secretary or the FDA Commissioner may issue an EUA for products otherwise not approved, licensed, or cleared for commercial distribution under certain provisions of the FDCA (for drugs and devices) and the Public Health Service Act (PHSA) (for biological products). FDA is taking action to help lessen these barriers, and has issued several EUAs for Covered Countermeasures that would be subject to the PREP Act’s immunities.

On March 25, 2020, FDA issued its most recent EUA for certain “ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators …, ventilator tubing connectors, and ventilator accessories that FDA determines meet the criteria for safety, performance and labeling.” Earlier this month FDA released an EUA concerning Personal Protective Equipment. For products that don’t fit squarely within the definition of “qualified pandemic or epidemic products” or “emergency countermeasures,” ensuring coverage by an EUA is important to maximize protection under the PREP Act.

  1. What could go wrong?

ANSWER: Three things primarily.

Making sure the product falls in the definition of Covered Countermeasures and has been distributed in accordance with the HHS Secretary’s Order is critical. Having this acknowledged in writing by the federal government or state authorities could also prove useful, but may not be practicable given the extreme need for these items in some jurisdictions.

Also, the PREP Act does not apply to willful misconduct. Willful misconduct requires more than reckless or negligent behavior. To prove willful misconduct, the PREP Act requires clear and convincing evidence of an act or failure to act that is taken 1) intentionally to achieve a wrongful purpose; 2) knowingly without legal or factual justification; and 3) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.

Timing can also go wrong, since the immunity expires in October 2024. The PREP Act has a provision for ensuring the return of unused items at the end of this period. Uniquely identifying them now by date code, to ensure they can be identified for retrieval later, will help mitigate any residual risk. If you are supplying a component, make sure to alert your customers of the need for traceability.

  1. What if I use a 3D printer to make Covered Countermeasures or their component parts? Will I get coverage?

ANSWER: You can. 3D printing enables manufacturers to expeditiously bring their products to market, and is therefore attractive to companies seeking to quickly manufacture Covered Countermeasures for the first time. In doing so, a manufacturer need only ensure that the products comply with existing regulatory requirements for that type of product. FDA, like most federal agencies, does not regulate products based upon the method of manufacturing. It focuses on the result. FDA did issue guidance in December 2017 to manufacturers of 3D-printed medical devices and that guidance remains operative today. 5. Do I need to have contracted with HHS to supply the goods to the federal government in order to get PREP Act immunity?

ANSWER: No. You can contract with any federal agency to get immunity under the PREP Act. The immunities of the PREP Act cover items procured under “present or future federal contracts” or any “other federal agreements,” regardless of the procuring agency. HHS Order VII (limiting scope only by contract term (present or future) but not procuring agency), citing 42 U.S.C. §§ 247d-6d(a)(5) and (b)(2)(E). As long as your company falls within the definition of a “Covered Person” and the products are “Covered Countermeasures,” both highly likely here, the immunities flow as long as the products are being provided pursuant to a present or future contract.

  1. Will the PREP Act immunities apply to supplying Covered Countermeasures to states rather than under a federal contract?

ANSWER: PREP Act benefits will likely flow to State level procurement activity. Procurement at the state level, however, must fall into the second prong of distribution methods allowed under the HHS Secretary’s order. That allows for immunity if the supply of Covered Countermeasures falls within “activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following Declaration of an emergency.” “Authority Having Jurisdiction” means “the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.” That would include the Public Health department and presumably the Governor and Mayor of a state with the right emergency declaration in place. There must be a state “Declaration of Emergency” which means “any Declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures.” Every state order is different, and getting updated often, but supply to state officials can be covered if done right.

COVID-19: Quarantine Measures, Laws and Limits

COVID-19 continues to spread, and governments across the globe have imposed quarantines and travel bans. China locked down its cities, Italy imposed restrictions throughout the country, and the US and Canada have enforced self-quarantine. The US has banned the entry of travellers from China, Iran, and most of Europe, while many other countries have implemented heavy screening protocols. However, despite these quarantine measures and laws, the number of COVID-19 cases continues to increase.

Quarantines and travel bans are usually the first response when a new infectious disease outbreak occurs. But the question is: with a virus-like COVID-19, is this sufficient? If a disease is highly transmissible, can these measures help? Especially if they are imposed or implemented in a haphazard manner?

Typically, when we say quarantine, it refers to the separation of people or communities who have been explored to an infectious disease while isolation refers to the separation of people who are known to be infected. But in some countries, such as the US, quarantine refers to both types of interventions and also includes travel bans.

Quarantine measures are definitely needed to contain COVID-19, but what else can be done to flatten the curve? Are there any other, more constructive tools that can be used? As far as COVID-19 is concerned, slowing its spread is the priority. ICUs and emergency departments cannot sustain the continuous influx of patients. That is why it is being advised that patients who have mild symptoms should stay home. Workers should telecommute wherever possible. But will social distancing and self-isolation be sufficient to slow down the spread?

What more could be done? This is an important question. This recent outbreak has highlighted the need for better measures, improved laws and new tools that could help us better handle a pandemic like COVID-19.