COVID-19 Coverage

Pacemaker Generator Replacement in a Patient with COVID-19

David Kenigsberg, MD, FHRS

David Kenigsberg, MD, FHRS

Dr. Kenigsberg describes a recent case of a patient with COVID-19 who underwent pacemaker generator replacement. Dr. Kenigsberg is a founding member of Florida Heart Rhythm Specialists and the medical director of the electrophysiology laboratory at Westside Regional Medical Center in Plantation, Florida. In April 2020, EP Lab Digest spoke with Dr. Kenigsberg about this case; the edited transcripts are included here. 

Introduction 

We were established over 10 years ago and have a very busy practice. Our group manages all forms of clinical cardiac electrophysiology, including the management of all devices, loop recorders, pacemakers, and biventricular devices, as well as doing all the available ablations for atrial fibrillation, ventricular tachyarrhythmias, supraventricular arrhythmias, and other arrhythmias.

However, we have never encountered something in our healthcare system, in my career, or prior to that, as challenging as COVID-19, and it took me and my practice, and I believe the entire healthcare system, by surprise. We’ve had to make many adjustments in order to properly treat our patients in this environment.

COVID-19 is a difficult problem to deal with on many levels, and is definitely a huge burden to the healthcare system. By no means should anyone belittle its significance or importance, or that we have to deal with it and make prudent decisions in this challenging time. However, heart disease still remains the number one killer of patients, and we still have to be cognizant that these patients need care and have to be taken care of appropriately. It was a decision of the practice (myself and my partner) on how to best deal with this crisis. We decided we were going to follow CMS tier criteria for surgical procedures, both in the hospital and in our surgical center, as to how we would address patients, but we would continue to take care of patients.

I do know a number of my colleagues in the area and nationwide have really taken a step back and have not entered the hospital, or have tried to limit their entry into the hospital and entry into the surgical suite to do procedures. We did not take that approach. We have been actively taking care of patients since day one; however, we are taking necessary precautions, and those precautions include trying to do remote device checks on all patients and enrolling patients into remote device clinics. A large percentage — I would say upwards of 85% of our patients — are involved in remote follow-up. That number will increase over time, and we’re working hard to overcome the barriers in that regard to increase that number.

As far as seeing patients, at this point, almost all patients are seen virtually in the office or outpatient setting. In the hospital, we see patients that we feel are safe for us to see. If there is any concern, either we don appropriate personal protective equipment (PPE) or we do a phone visit with hospitalized patients. If a patient is in the hospital for pneumonia and we get consulted for an arrhythmia issue, we have access to the rhythm strips, telemetry, EKG, and echocardiogram. We could take a history on the phone and look in the computer for other practitioners who have done a visit, and use that as information for the physical exam.

So we feel that we’re doing a thorough job in taking care of our patients, but we have taken precautions so that we can stay healthy, and continue to see and operate on patients.

The CMS tier criteria basically states that certain patient populations should still be treated in the hospital, especially if they’re of the sickest type of patients. In the criteria, there are some less sick patients that can be dealt with in an outpatient setting and get procedures done there.

In our outpatient facility, we’re very strict as well. There is only one patient in the facility at a time. We do not allow family members in the facility. Everyone who currently comes into the facility is being checked by temperature, and in the future, will likely be checked with rapid testing.

So in a very short period of time, our practice has made a lot of adjustments. That includes myself, my partner, my associate, our three nurse practitioners, and 30-some odd staff members that cover three offices with our administrative team. Pretty much overnight, the physical offices were closed down and everything turned as virtual as possible.

There are still patients that come to the office, for example, if there is a problem with a wound or if I have to remove a stitch from the groin because of a large sheath that I may have had to put in. But by and large, every visit that is possible is done via some kind of virtual means, including FaceTime, WhatsApp, Zoom, and other available technology.

The other types of procedures that I’m currently doing, aside from emergency pacemakers, are some ablations in patients who have extreme symptoms or are going into heart failure because of arrhythmia. I recently ablated a patient who had an episode of atrial fibrillation that led to ventricular fibrillation with Wolff-Parkinson-White syndrome, and who was not responsive to medical therapy. We are being extremely judicious in our ablation approach. We are a very high-volume practice, and are probably operating at about 20% of our normal volume as far as procedures and patients.

Our virtual clinics are gaining in popularity. My typical Thursday clinic, which usually runs from 8:00 AM to 2:00 PM, sees between 40 and 50 patients. I also recently ran a clinic from 2:00 PM to 5:00 PM, and saw 17 virtual patients.

So things are picking up. I have a huge backlog of elective procedures that will have to be done. Hopefully, everyone will be healthy and I’ll be able to get to them after we’re allowed to after restrictions have lifted. 

Case Description 

Included is a case that really brings to light the gravity of the situation as well as the lengths to which we will go to properly take care of a patient.

This was a patient who presented to the hospital at the end of March, which is towards the beginning of the COVID-19 healthcare crisis in this country. The patient is a 45-year-old female who works in the healthcare industry. She was exposed to a COVID-19 patient approximately a week prior, and developed fever and cough. She was scheduled to have a pacemaker generator replacement done on March 26th. The patient had reached elective replacement interval approximately three months prior. She has had congenital complete heart block with a pacemaker since the age of nine. She was 100% dependent on the pacemaker, and paced in the ventricle 100% of the time and in the atrium 70% of the time.

She came to the hospital for her procedure, and upon screening, was found to have symptoms that were concerning for COVID-19. She was rapidly tested; however, no rapid test was available at that time, meaning that she was tested immediately but the test results were taking days to come back. My major concern was that this was a dependent patient with the type of device where I’m a bit more concerned about the exact longevity once we’re at about three months, since it flips to elective replacement interval. I felt that in any day, she could stop pacing, which could be catastrophic.

The ways to manage this in the hospital, in my opinion, were either to wait for that to happen and then try to manage her with IV drugs (such as dopamine, dobutamine, or isoproterenol) to see if we could get a return rate — but this option was less than ideal. In addition, we could have transcutaneously paced her if the device failed, but I also considered this to be less than ideal. This was an awake patient, she was not currently intubated, and she wasn’t very sick other than having a fever and cough.

The other options were to figure out how to replace this device. I spoke to the administrative team at the hospital, the anesthesia department and the cardiac anesthesiologist, my team, and the infection control officer at the hospital as well. We devised a plan to address this patient as appropriately as possible by doing a rapid generator replacement procedure with only necessary personnel in the room and trying to limit exposure of the patient as much as possible. Again, this patient did not require intubation and we did not want to intubate her just for this procedure, even though that potentially could save the staff from being exposed to droplets from her airway.

The procedure was discussed and scheduled for the next day, and we had a lesson on PPE. With the personal protective equipment available to us at the time, we tried to protect ourselves as much as possible. Each of us went through a process of donning and doffing the proper PPE for the surgical procedure.

The people in the room were the anesthesiologist, who actually volunteered to do this case (the very brave and excellent anesthesiologist, Dr. Ed Parker), the patient, myself, a circulating nurse, and a scrub tech. That was what we felt would be the bare minimum to have this procedure done safely. In addition, my thought was to try to do this procedure without electrocautery. We had both a standard Bovie and some other Bovies, but we did not use them for the case.

We also had two other nurses outside the room that would be able to pass us anything if we needed it for the procedure. I did not allow the rep to come in the room — I told them I would manage the device, leads, and programming.

The procedure was very rapid and took about 15-minutes, skin to skin. The donning and doffing process did take a long time, and it was definitely an eye-opening experience considering how many procedures I jump in and out of every day. On a routine basis, I change all my PPE in-between cases. I also change my scrubs in-between cases, so I’m familiar with what needs to be done from a sterile technique and from the OSHA criteria, but this is a different level. I was wearing a surgical gown covered by a plastic gown, and I had boots on to my knees. 

Fluoroscopy was not in the room for this case. We felt that we would limit any equipment that was in the room, therefore not requiring the need for cleaning of extra equipment if it wasn’t necessary, although it was available if needed.

I then double gloved and put on a full sterile gown in the room, and my scrub tech scrubbed the same way. I also had a shield. I wore an N95 mask covered by a surgical mask, as well as my leaded glasses, a hat, a shield, and three layers of gown. I did not wear lead, because I wasn’t using fluoroscopy.

After the case, the doffing process went one by one as it normally would. I took off the outer glove first and went from there. After each removal, there was handwashing involved. Showers and new scrubs were also available to staff if preferred. 

In all, the procedure went smoothly, and the patient is doing very well. At the time of this interview, she is still testing positive for COVID-19, although she has no symptoms. Her first test was performed on March 24th, so we’re now almost a month out. She cannot return to work until she tests negative.

She was treated with hydroxychloroquine and azithromycin in the hospital. Aside from her routine medication, which was hydrochlorothiazide, there were no other medications used. She did get oxygen for a short period of time in the hospital, but went home the day after the generator replacement without issue.

Final Thoughts 

In summary, this is a 45-year-old woman with diet-controlled diabetes and hypertension controlled with medications, who came to the hospital for a routine generator replacement, found to be positive for COVID-19, underwent generator replacement with the entire staff in full PPE, and went home without issue. About a month later, she was still testing positive for COVID-19, despite being asymptomatic.

As of May 2020, the patient continues to do well in follow-up. She was recently seen in clinic, and had normal device function and wound healing. She was appreciative of the care she had received, and has since returned to work. All of the staff involved in the case, including myself, remain healthy. 

For more information, and to see our video of this interview, please visit: https://bit.ly/3ejXrDm

Disclosures: Dr. Kenigsberg has no conflicts of interest to report regarding the content herein.

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