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\begin{document}

\title{Performance of Electrophysiology Procedures at an Academic Medical
Center Amidst the 2020 Coronavirus (COVID-19) Pandemic}



\author[1]{Geoffrey Rubin}%
\author[2]{Angelo Biviano}%
\author[1]{Jose Dizon}%
\author[1]{Hirad Yarmohammadi}%
\author[1]{Frederick Ehlert }%
\author[2]{Deepak Saluja}%
\author[1]{David Rubin}%
\author[1]{John Morrow}%
\author[1]{Marc Waase}%
\author[1]{Jeremy Berman }%
\author[2]{Alexander Kushnir}%
\author[1]{Mark Abrams}%
\author[2]{Hasan Garan}%
\author[2]{Elaine Wan}%
\affil[1]{Columbia University}%
\affil[2]{Columbia University Medical Center}%


\vspace{-1em}



  
  \date{May 15, 2024}


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\selectlanguage{english}
\begin{abstract}
A global coronavirus (COVID-19) pandemic occurred at the start of 2020
and is already responsible for more than 74,000 deaths worldwide, just
over 100 years after the influenza pandemic of 1918. At the center of
the crisis is the highly infectious and deadly SARS-CoV-2, which has
altered everything from individual daily lives to the global economy and
our collective consciousness. Aside from the pulmonary manifestations of
disease, there are likely to be several electrophysiologic (EP) sequelae
of COVID-19 infection and its treatment, due to consequences of
myocarditis and the use of QT-prolonging drugs. Most crucially, the
surge in COVID-19 positive patients that have already overwhelmed the
New York City hospital system requires conservation of hospital
resources including personal protective equipment (PPE), reassignment of
personnel, and reorganization of institutions, including the EP
laboratory. In this proposal, we detail the specific protocol changes
that our EP department has adopted during the COVID-19 pandemic,
including performance of only urgent/emergent procedures,
afterhours/7-day per week laboratory operation, single attending-only
cases to preserve PPE, appropriate use of PPE, telemedicine and video
chat follow-up appointments, and daily conferences to collectively
manage the clinical and ethical dilemmas to come. We discuss also
discuss how we perform EP procedures on presumed COVID positive and
COVID tested positive patients in order to highlight issues that others
in the EP community may soon face in their own institution as the virus
continues to spread nationally and internationally.%
\end{abstract}%



\sloppy


\textbf{Introduction}

In December 2019, a highly infectious novel coronavirus (COVID-19)
outbreak was reported in Wuhan, China\textsuperscript{1}. Less than 3
months later, we are now amidst a global COVID-19 pandemic which has
disrupted the international economic order and significantly altered
activities of daily living and personal interactions for nearly everyone
on earth, due to requisite social distancing, ``shelter-at-home'' and
lockdown orders instituted in many locations.

In New York state, as of April 6, 2020 there are over 130,000 confirmed
COVID-19 cases, the most in the United States. The vast majority of
COVID-19 diagnoses have been made within the densely populated New York
City, which itself has 72,000 confirmed cases and is now considered a
COVID-19 epicenter. At NewYork-Presbyterian Hospital (NYPH), the case
rate is nearly doubling every day, which mirrors the overall state
trend. Personal protective equipment (PPE), as has been reportedly
nationally, is at a critical shortage.

The coronavirus principally causes pulmonary manifestations of fever,
cough and dyspnea with occasional rapid progression to severe
respiratory failure and acute respiratory distress syndrome (ARDS) in
both high-risk and healthy patient populations. Yet between 7.2-12\% of
total COVID-19 patients manifest cardiac injury and progression to
fulminant myocarditis was recently described\textsuperscript{2-4}.

Importantly, there are likely to be several electrophysiologic (EP)
sequelae of COVID-19 infection. Wang et al. describe arrhythmia burden
of 16.7\% in 138 total COVID-19 patients and 44.4\% of COVID-19 ICU
patients\textsuperscript{2}. As yet, it is unknown whether the virus
directly seeds the cardiac conduction system. Electrophysiologists will
play an important role in the upcoming months, especially since COVID-19
treatments such as hydroxychloroquine carry known deleterious
electrophysiological effects\textsuperscript{5}. EPs may see more cases
of drug-induced torsades in the near future. There have also been recent
reported cases of ventricular arrhythmias due to COVID
myocarditis.\textsuperscript{6}

It was therefore important to institute specific EP laboratory protocols
not only to treat the inevitable COVID-19-infected patient requiring any
urgent or emergent procedures, but also so that we may continue to treat
sick, non-COVID infected patients with a high quality standard of care.
Management operations are in flux during this crisis and may even change
from day-to-day. We present our overarching workflow model to optimize
laboratory function with the aim of both adequately protecting
providers, successfully treating patients and conserving PPE during this
unprecedented period. This has been an urgent collaborative formulation
by the Columbia University Electrophysiology subdivision at Columbia
University Medical Center, and is not a reflection of official NYPH
policy. We present this as a model for other EP labs in the nation who
are facing or soon may be faced with this healthcare challenge.

\textbf{Indications for Procedures from the Outpatient Setting}

As per the recent consensus statement from the Heart Rhythm Society,
American Heart Association and American College of Cardiology, only
urgent and emergent procedures were performed during the current upswing
of the COVID-19 infection curve in order to minimize virus transmission
between patients and providers.\textsuperscript{7} Emergent procedures
according to clinical discretion may include cardioversion, implantation
of temporary or permanent pacemaker (PPM), or ablation for arrhythmias
refractory to medical management. The goal is to reduce non-urgent
person-to-person interactions. ``Elective'' cases that ultimately may be
life-prolonging or symptom-relieving have been delayed, since incidental
and unpredictable infection with COVID-19 in a stable out-patient would
be regrettable and harmful. As of March 16, NYPH suspended elective
cases in order to concentrate equipment, supplies, and providers on
responding to the COVID-19 public health crisis.

Elective cases have consisted of routine ablations for paroxysmal
supraventricular tachycardia (SVT), atrial fibrillation (AF), premature
ventricular contractions (PVCs) or ventricular tachycardia (VT) and
device implant procedures such as primary-prevention internal
cardioverter defibrillator (ICD), PPM for sinus node dysfunction with
stable rhythm or asymptomatic 2:1 atrioventricular block (AVB), cardiac
resynchronization therapy (CRT) or upgrade, as well as cardioversion for
symptomatic AF and loop recorder implantation. Patients with cancelled
elective procedures have been followed with weekly check-ins and use of
telehealth services as needed to reevaluate their clinical status.
Deferment of elective cases have been rationalized to patients either by
phone or telemedicine visit, and during these communications health care
providers ensure patients have sufficient medication to manage their
arrhythmias for at least 3 months or longer.

\textbf{Indications for Procedures from the In-patient or Unstable
Out-patient Setting}

Prior to performing a procedure on patients from both the in- or
out-patient setting, COVID testing is performed on all patients with the
understanding that there may be false negative results. It is important
to ensure sufficient standard PPE for procedures is identified ahead of
time, as hospital resources diminish quickly. We have prioritized and
performed due to their urgent/emergent nature: PPM for symptomatic,
high-grade or wide-complex complete heart block (CHB), generator change
for PPM-dependent patient with device nearing end of life (EOL), cardiac
resynchronization therapy devices nearing EOL to prevent detrimental
hemodynamic consequences, VT ablation in unstable/hospitalized patients
with VT storm refractory to medication, accessory pathway ablation in
pre-excited AF, and device/lead extraction in an unstable patient with
active sepsis. We have also performed pacemakers immediately after
urgent/emergent transcatheter aortic valve replacement with resultant
heart block to facilitate discharge on the same day.

The expedition of urgent procedures for patients waiting in intensive
care units (ICUs) is paramount. We have structured a multidisciplinary
approach with intensive care unit (ICU) and nursing staff to facilitate
performing procedures on extended weekday and weekend hours to minimize
use of institutional resources and free up much-needed ICU beds for the
growing COVID-19 patient population.

The more challenging decision involves semi-urgent indications for EP
procedures such as secondary prevention ICD, primary prevention ICD in a
very high-risk patient (i.e. ischemic heart disease with nonsustained
VT, muscular dystrophy or sarcoid), or lead revision/replacement in the
setting of malfunction/dislodgment in patients who are currently or
imminently will be hospitalized. It may be necessary to rely on a
wearable defibrillator (LifeVest, Zoll, Chelmsford, MA) for the
secondary prevention patient population until the inflection point of
COVID-19 cases is reached and transmission risk is lower. Furthermore,
maximal medication management has been implemented for patients with
symptomatic, recurrent SVT at the current time. Alternatively, these
procedures must be evaluated and performed on an individual case-by-case
basis to weigh risk versus benefit from the procedure. If it is decided
that cardiovascular benefit outweighs the risk, then scheduling the
patient for the earliest daytime slot possible to facilitate same-day
discharge is advisable. Coordination with infectious disease (ID)
prevention and control colleagues is also essential.

\textbf{Urgent/emergent Procedures in COVID-19 Infected Patients}

Unless urgent/emergent, we have avoided performing procedures on
COVID-19 infected patients in the EP laboratory to prevent transmission
not only during transport to the laboratory, but also to prevent seeding
the lab itself in the case of a prolonged operation. The coronavirus may
maintain aerosolization for an unspecified time period and was recently
shown to stay viable for up to 72 hours on stainless steel
surfaces,\textsuperscript{8} which are readily found in EP laboratories.

In light of myocarditis and elevated inflammatory markers in active
COVID infection, there are likely to be patients that develop
clinically-significant bradyarrhythmias during their course. Since these
will presumably be more severely-ill patients amidst a prolonged
hospitalization, we have used medical management with dopamine and
avoiding any medications that may be overtly catecholaminergic due to
concern of myocarditis. If clinically significant bradycardia persists,
then temporary ventricular pacemaker (TVP) placement is the best option.
TVP placement is quick (typically \textless{}10 minutes), may be
performed at bedside, involves less hospital transport with the
potential for aerosolization and health care provider exposure, and
allows temporization until the patient either recovers from their
systemic illness or deteriorates further.

If it is decided that a COVID-19 infected patient must have a procedure
performed in the EP laboratory, we have a protocol illustrated by Figure
1. If the patient is not intubated, a mask is placed on the patient
prior to transport and there is a specific room designated for infected
patients. That room is thoroughly disinfected after the procedure.

\textbf{Pre-procedure Workflow}

In order to prevent virus transmission, preserve PPE and protect
patients, the typical and familiar pre-procedure workflow patterns
should be significantly altered.

First, with regard to EP attending allocation, each day there is only
one designated procedure attending in-house. A back-up attending is
on-call within range of the hospital in case of a second emergent case.
This shift-based arrangement is meant to prevent the potential for
widespread and unintentional doctor-to-doctor transmission, and thus
minimize the risk of ``wiping out'' an entire EP department, which would
be devastating. Additionally, elderly (\textgreater{}60 years-old)
attendings at high-risk for severe COVID-19 infection are encouraged to
avoid hospital-based patient care and instead focus their attentions on
telehealth visits or urgent out-patient clinic consultations.

Patient time in the pre-procedure ``holding area'' is minimized as
possible and in-patients are brought down directly to the procedure room
to prevent lingering in multiple different hospital areas. Although it
is not current NYPH policy, with the medical-legal team and laboratory
directors, we have considered transition of patient consent to a
strictly verbal process in order to minimize patient-provider contact
through touchscreen, pen or clipboard exchange.

\textbf{Performing the EP procedure}

Since the majority of cases performed during the present era of
exponentially rising COVID-19 infections are implantable devices, the
rule for us has been single-operator cases only. Our academic attending
role as educator currently plays a secondary role to efficiency and
safety at this time. Performing single-operator cases has been adopted
to preserve the critically low PPE supply. For more complex procedures
such as unstable VT or system extraction, the EP fellow assists either
by running the console stimulator or lending an extra set of operative
hands. Our EP fellows have served as scrub nurses and circulating nurses
since there has been redeployment of our highly trained nurses to the
emergency room or ICU. If available, a negative pressure procedure room
is ideal for treating COVID-19 infected patients. In emergent cases,
where there is no COVID testing and little patient medical history
available, it may be prudent to treat the patient as COVID-19 positive,
since coughing or vomiting during emergent circumstances may pose an
exposure threat to the health care providers.

If anesthesia deems a patient to be at high-risk of respiratory failure,
it is prudent to perform endotracheal intubation prior to the procedure
(i.e. in the patient's room) to prevent aerosolization of viral
particles in the case of emergent intra-procedure intubation and
suctioning. The closed-system mechanical ventilator is preferred to the
higher-risk bi level positive airway pressure or nonrebreather systems.
Additionally, during ablations or extractions, it is advisable for the
proceduralist to use intracardiac echocardiography instead of
anesthesia-operated transesophageal echocardiography in order to prevent
aerolization

Prior to the case, the procedure attending, scrub nurse or technician
should don the appropriate PPE after proper hand hygiene is performed as
recommended by ID prevention and control. We have adopted using N95 for
both intubated and non-intubated COVID+ patients for two main reasons:
(1) dislodgement of the endotracheal tube may occur during movement of
the patient onto or off the operating table, or during emergency
resuscitation and (2) previous studies on human papilloma virus suggest
that laser or electrosurgery plume may cause infectious aerosol hazards
resulting in viral transmission.\textsuperscript{9} We don a surgical
mask on top of the N95 mask as per NYPH recommendation to preserve the
length of use of the N95. Our surgical PPE includes goggles that form a
seal around the eyes for splash protection, a surgical cap, shoe
coverings, at least two layers of sterile gloves and a sterile surgical
gown. We have all been trained in proper doffing of PPE which is
deliberate and meticulous to adhere to the strict protocol of doffing
with proper hand hygiene between steps.

\textbf{Nurses and device representatives}

Scrub nurses and device representatives are an integral part of EP
procedures and will remain as such. It is critical to avoid the loss of
highly specialized EP nurses in the event of illness or home quarantine,
therefore nurses ought to similarly stagger their hospital attendance to
prevent multiple concurrent staff losses.

In our laboratory, device representatives provide necessary functions
such as lead selection counsel, intraprocedural interrogations and
device programming. To limit risk, device companies have recommended
that their representatives no longer present to the hospital daily
unless requested for cases. We have assigned a different device company
technician to each day of the week and sharing this schedule with the
representatives (if a specific company's proprietary algorithm function
is required). During cases, both device technicians and nurses should
maintain \textgreater{}6 feet distance from the patient and don
appropriate PPE.

\textbf{Post-procedure follow-up}

The follow-up of patients after recent ablation or device placement have
been significantly virtualized. After device implantation, each patient
is discharged with remote monitoring device. To minimize vulnerable
patient exposure to the high-risk hospital setting, telemedicine
services have been enabled for video-visits between provider and
patient. Furthermore, due to the ongoing COVID-19 national emergency,
the Centers for Medicare and Medicaid services have relaxed HIPAA
requirements for telehealth visits. To improve accessibility for
patients, video chat applications such as Apple FaceTime, Facebook
Messenger, Google or Skype may be used, as long as patients are aware of
the third-party privacy risks\textsuperscript{10}. These visits have
been used to evaluate for post-procedure pain or palpitations.

Similarly, after an ablation, patients may use the digital
electrocardiogram recording devices such as Apple Watch or Kardia
application (AliveCor, Mountain View, CA) in lieu of a follow-up
post-procedure electrocardiogram. If there is concern for recurrent
arrhythmia, at home Holter monitoring may be arranged by mailing the
apparatus to the patient with instructions. Lastly, if antiarrhythmic
drug initiation is required, frequent transmissions may be used to
estimate QTc interval change after dosages.

\textbf{Future Questions and Directions}

Daily life around the world has changed significantly due to COVID-19.
In addition to adapting to new home life and social distancing, work
life and work flow must also adapt. The EP laboratory is no exception.
We are living in unprecedented and precarious times where resource
shortages may demand previously unimaginable ethical choices of us, such
as whether a patient should or should not undergo a lifesaving
procedure. We find that close collaboration and frequent communications
by phone or teleconference at least once a day allows us to share the
burden together and support one another. It is also crucial to support
and salute the selfless nursing, hospital staff during this challenging
time of collective action. We also appreciate the executive leadership
of NewYork-Presbyterian for their transparency and daily communications
with clinical staff and faculty.

Much remains to be discovered about COVID-19, especially with regard to
the acute and chronic EP consequences. In light of viral-induced
myocardial injury, it is likely that patients who recover from severe
illness may develop cardiomyopathies or scar-related substrate for VT.
The elucidation of viral shedding duration even after symptom resolution
will be critical for future procedure timing in patients with history of
COVID-19 infection. Lastly, it has been critical to establish COVID-19
dedicated hospitals, such as converting college dormitories or unused
sports stadiums into care centers, to not only to expand patient care
and relieve the front-line health care workers, but also to allow safer
treatment of non-infected patients in the EP laboratory.

\textbf{Acknowledgements}

We thank Lynsey Lipowicz, RN, BSN, MBA, Director of Nursing, Nancy
Kelley, Director of Cardiovascular Service Line, and Alessandra Capizzi,
chief PA for their contributions to this manuscript.

\textbf{References}

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\end{enumerate}\selectlanguage{english}
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