THE COVID PANDEMIC AND INTERVENTIONAL PRACTICE
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The COVID Pandemic and Interventional Practice

Jose David Tafur1, Christopher J White2
1Program Director. Cardiovascular Disease Fellowship. Ochsner Medical Center. New Orleans, LA
2System Chairman of Cardiology. Ochsner Health. New Orleans, LA

SUMMARY

The COVID-19 pandemic has represented a major challenge in the way our society operates. Both the virus itself and the measures taken to mitigate controlling the spread of the disease have impacted our every day lives. Interventional Cardiology practices around the world were impacted by this pandemic. This chapter reviews the cardiovascular manifestations of COVID-19 as well as how the pandemic has affected the way we care for patients both with and without COVID.

INTRODUCTION

Infection by the novel coronavirus SARS-CoV2 was first described in a cluster of pneumonia cases in Wuhan China in December of 2019. [1] Over one year later, after 120 million cases and 2.7 million deaths around the globe, the world is a different place. The pandemic response by governments and individuals across the globe has significantly impacted how we interact with each other, how we are educated and how we work. The clinical practice of Interventional Cardiology has also changed. This chapters seeks to provide some insights on what we experienced, what we have learned and where we go from here as we approach work and life in a post-pandemic era.

Cardiovascular manifestations of COVID-19

The initial reports on the epidemiology of COVID-19 from China warned of the disproportionate risks of severe complications and mortality in patients with underlying comorbidities, particularly cardio-pulmonary disease, and the elderly. These observations have been confirmed subsequently in numerous reports including studies from Europe and the US. The mechanisms responsible for this vulnerability remain to be fully elucidated, but there are several possibilities. Some of these adverse consequences could reflect the underlying fragility of older individuals with chronic conditions subjected to the stress of severe pneumonia similar to influenza infections. In addition, development of type 2 myocardial infarction related to increased myocardial oxygen demand in the setting of hypoxia is a concern, and among patients with chronic coronary artery disease, an episode of acute systemic inflammation might contribute to plaque instability, thus precipitate an acute coronary syndrome, which has also been reported during influenza outbreaks. There are a few considerations unique to COVID-19 with regards to the cardiovascular system worth mentioning.

Acute myocardial injury

There have been several definitions of myocardial injury in the setting of COVID-19. The most accepted definition requires at least one cardiac troponin (cTn) concentration above the 99th percentile of the upper reference limit (URL). Other definitions go beyond troponin elevations and include electrocardiographic (ECG) and transthoracic echocardiographic (TTE) abnormalities regardless of the biomarker levels. The term myocardial injury represents multiple pathophysiologic processes that affect the heart and includes endothelial dysfunction, microvascular thrombosis, inflammation and direct infection of the cardiomyocytes by the virus.

The prevalence of myocardial injury has been reported as high as 36% in hospitalized patients. [2] Patients with myocardial injury had a higher prevalence of ECG and TTE abnormalities than did patients without myocardial injury. Multiple TTE abnormalities were identified and included global left ventricular (LV) dysfunction, regional wall motion abnormalities, diastolic dysfunction, right ventricular (RV) dysfunction, and pericardial effusions. Myocardial injury was independently associated with an increased risk of in-hospital mortality (27 vs. 3%) after adjustment for other major complications of COVID-19 including adult respiratory distress syndrome (ARDS), cardiogenic shock, and acute kidney injury (AKI). [3]

Acute coronary syndromes

Acute coronary syndromes are responsible for many of the cases of myocardial injury. In a study from China with 416 patients, 82 were found to have myocardial injury (defined as elevated troponin) and this was independently associated with mortality. [4] Of the patients with cardiac injury, only 22 (26.8%) underwent an ECG after admission, and 14 of 22 ECGs (63.6%) were performed at the same time as the elevation of cardiac biomarkers. All ECGs were described as abnormal, with findings compatible with myocardial ischemia, such as T-wave depression and inversion, ST-segment depression, and Q waves. The above findings suggest that 14 out of 416 patients in this cohort (3.36%) developed myocardial ischemia, with features consistent with non-ST elevation myocardial infarction (NSTEMI).

Several mechanisms could explain the onset of acute myocardial injury related to myocardial ischemia in SARS-CoV-2 infection. Some resemble those identified for other respiratory infectious agents, such a pro-inflammatory state and a cytokine storm (which could cause plaque instability), or a prothrombotic state and hypoxemia-related damage due to acute respiratory failure. The rise in cTn tracks with other inflammatory biomarkers, such as D-dimer, interleukin-6, and lactate dehydrogenase, raising the possibility that this may reflect cytokine storm more than isolated myocardial injury. On the other hand, some reports of patients presenting with cardiac symptoms, ECG changes, or new wall motion abnormalities may suggest a different pattern, such as viral myocarditis and stress cardiomyopathy. The underutilization of coronary angiography during this outbreak due to the high infectious risk makes it more difficult to establish a definite differential diagnosis.

Acute heart failure, myocarditis and cardiogenic shock

COVID-19 can present with both de novo cardiomyopathy or worsening of an underlying cardiomyopathy. Human cardiomyocytes express the viral entry receptor, ACE2, and can be directly infected by SARS-CoV-2. Viral replication can cause contractile dysfunction and cellular death. There has been evidence of replicating SARS-CoV-2 in cardiomyocytes. [5, 6] Myocarditis or inflammatory cardiac dysfunction should be considered in patients with COVID-19 who have elevated cardiac biomarkers with worsening hemodynamics and/or arrhythmias. Elevated NT-proBNP, elevated cTn and preexisting heart failure are important risk factors for mortality [7] and their presence should trigger a TTE evaluation. During the initial peaks of the pandemic, multiple intensive care units had limited access to formal TTE and point of care ultrasound with hand-held devices became useful to rapidly identify patients with evidence of cardiac dysfunction.

A high index of suspicion is necessary for diagnosis of myocarditis as the time course is variable. Cardiac magnetic resonance (CMR) imaging studies in patients who have recovered from COVID-19 suggest that cardiac involvement may be more frequent than suspected. Of 100 patients recently recovered from COVID-19, 67% recovered at home, while 33% required hospitalization. At the time of CMR, high-sensitivity troponin T (hsTnT) was detectable (greater than 3 pg/mL) in 71 patients recently recovered from COVID-19 (71%) and significantly elevated (greater than 13.9 pg/mL) in 5%. Compared with healthy controls and risk factor–matched controls, patients recently recovered from COVID-19 had lower left ventricular ejection fractions, and higher left ventricular volumes. CMR findings included raised myocardial native T1, raised myocardial native T2, myocardial late gadolinium enhancement, or pericardial enhancement. [8]

Endomyocardial biopsy may have a role in differentiating stress-induced cardiomyopathy from inflammatory myocarditis, thus allowing for appropriate consideration for clinical trials of anti-inflammatory therapy. Current autopsy data suggest that the inflammatory infiltrate associated with COVID-19 is macrophage predominant with a minor T-cell infiltrate. [9]

Stable patients with suspected cardiovascular involvement should continue guideline-directed medical therapy for heart failure. It is important to mention that discontinuation of angiotensin converting enzyme (ACE) inhibitor or aldosterone receptor blocker (ARB) in hospitalized patients was not associated with better outcomes and therefore the current recommendation is to continue these agents unless other contraindications are present. [10]

In hospitalized patients with refractory shock, consider the use of inotropes, vasopressors or mechanical support with objective guidance by a pulmonary artery catheter. Patients with isolated RV dysfunction related to respiratory failure may benefit from pharmacological RV support with inotropic agents, selective pulmonary vasodilators or mechanical circulatory support/extracorporeal membrane oxygenation (ECMO). Data are emerging regarding outcomes, cannulation strategies and duration of support for patients requiring ECMO for COVID-19 (See below).

Venous thromboembolism

Venous thromboembolism (VTE) is one of the major cardiovascular hazards in patients with COVID-19. A meta-analysis of 47 studies including 18,093 patients hospitalized with COVID-19 found the incidence of VTE to be 17.0%. [11] VTE was more common among patients admitted to the intensive care unit (ICU; 27.9%) than the general medical wards (7.1%) and was higher among studies that employed a screening approach (33.1%) rather than relying on a clinical diagnosis (9.8%). Standard VTE prophylaxis was used in ≥70% of the patients. In contrast to the high incidence of VTE among hospitalized patients with COVID-19, the risk of VTE appears much lower in patients who are never hospitalized or after hospital discharge. A high prevalence of in situ microthrombosis due to endothelial injury from direct viral infection has also been described[12, 13, 14]. Whether there is a direct prothrombotic effect of viral infection or the increased incidence of VTE reflects the critically ill nature of the patients remains to be elucidated.

Cardiovascular interventions in patients with COVID 19

Percutaneous coronary intervention (PCI)

Patients with COVID-19 can present with acute coronary syndromes or acute heart failure and therefore require cardiac catheterization and possible intervention. Cardiac catheterization laboratories (CCL) have established protocols to minimize healthcare workers (HCW) exposure to the virus while maintaining appropriate standards of care for cardiac conditions. Such protocols are reviewed in the next session.

With regards to unique characteristics of patients with COVID-19 and PCI, data are still limited. In a single center study from the United Kingdom (UK), 115 consecutive patients who were admitted with STEMI during a 12 week period were analyzed: 29 were subsequently found to have COVID 19. Without significant differences in age, sex, ethnic background, or body mass index, those with COVID-19 were more likely to be diabetic (46% vs. 26%, p = 0.038), hypertensive (72% vs. 42%, p = 0.003), hyperlipidemic (62% vs. 37%, p = 0.038) and were more likely to have a history of previous PCI (23% vs. 7%, p = 0.016). The time from symptoms to reperfusion, ECG presentations, rates of cardiogenic shock, and requirement for pre-hospital intubation were similar in both groups. However, there was a higher incidence of cardiac arrest in patients who were COVID-19 positive compared with the non-COVID-19 group (28% vs. 9%, p = 0.0013). A large thrombus burden (modified thrombus grade 4/5) was twice as likely in patients with COVID-19 and STEMI compared with those without COVID-19 (75.0% vs. 31.4%; p = 0.0006). There was significantly greater use of glycoprotein (GP) IIb/IIIa inhibitors (p < 0.0001) and aspiration thrombectomy (p = 0.0021) in patients with COVID-19 due to the higher thrombus burden ( Figure 1). [15] These findings are comparable to a multicenter registry in Spain that showed higher rates of mechanical thrombectomy, GP IIb/IIIa use, stent thrombosis and cardiogenic shock in patients with STEMI and COVID-19. [16]

Mechanical circulatory support

In the case of cardiogenic shock, temporary mechanical circulatory support (MCS) can be lifesaving. MCS remains the last resort after medical treatment fails to sustain sufficient cardiac output. At the beginning of the pandemic, the scope of MCS was mainly acute respiratory distress syndrome (ARDS). ECMO is used to re‐establish sufficient gas exchange in cases of severe lung failure. Venovenous (VV)‐ECMO represents an efficient method of lung replacement therapy. However, if heart failure coexists and cardiac output is low, venoarterial (VA)-ECMO may become necessary.

The Extracorporeal Life Support Organization recently published their guidance on the application of temporary MCS in COVID‐19 affected patients.[17] They suggest a “case by case” decision. For the use of MCS, patient characteristics and local circumstances such as limited resources, must be taken into account whenever a patient develops cardiopulmonary failure with regard to COVID‐19. It is important to remember that this is a very resource intensive therapy, requiring dedicated personnel and specialized equipment. All of these resources have been scarce at some point during the pandemic. The Impella RP has been reported to provide right ventricular circulatory support for patients who develop right side ventricular failure or decompensation caused by COVID-19 complications, including pulmonary embolus.[18]

Catheter directed interventions for VTE

Pulmonary embolism (PE) is a frequent complication for patients hospitalized with COVID-19. Systemic thrombolytic therapy is indicated for the treatment of massive PE in patients without contraindications. For patients who have a massive PE and high bleeding risk, rapid clinical deterioration, or have failed systemic thrombolytic therapy, catheter directed therapies can be beneficial.

An intermediate-risk or submassive acute PE is one that does not result in sustained hypotension, profound bradycardia, or cardiac arrest but does show signs of right ventricular (RV) dysfunction and/or myocardial necrosis. These signs may include right ventricular (RV) dysfunction [RV dilation (RV/LV > 0.9), RV systolic dysfunction or elevated BNP (>90 pg/mL], ECG changes (new complete or incomplete right bundle branch block (RBBB), anteroseptal ST elevation, depression or T-wave inversion) or myocardial necrosis (elevated troponin). These markers, in the presence of an acute PE and in the absence of shock, warrant consideration for catheter-directed therapy.

There are several devices available for catheter-directed interventions, including infusion-only catheters, ultrasound-assisted catheters and mechanical thrombectomy devices. The choice of the device depends on the local expertise, resources available and the clinical presentation. In the US, the Inari FlowTriever device (Inari Medical, Irvine, California) is currently the only device the FDA has approved for percutaneous mechanical PE thrombectomy. The FlowTriever Pulmonary Embolectomy Clinical Study (FLARE) study found a 25% reduction in RV/LV ratio and only 1% incidence of major bleeding in patients with submassive PE who were hemodynamically stable treated with the FlowTriever device.[19]

The EkoSonic Endovascular System (EKOS) (EKOS Corporation, Bothell, WA) was the first device approved by the FDA for catheter-directed treatment of PE. The device directly delivers thrombolytics via catheter while utilizing ultrasound to assist in the cavitation of the thrombus. The Ultrasound Accelerated Thrombolysis of Pulmonary Embolism (ULTIMA) [20] and Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy (SEATTLE II) [21] trials demonstrated improved RV function without an increased risk of bleeding after treatment with EKOS for submassive PE. The Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism (OPTALYSE PE) trial showed that this device could be effectively used employing low doses of thrombolytics and short infusion durations. [22]

Challenges for catheter directed therapies in COVID-19 patients include: 1) The overlap in the signs and symptoms of COVID-19-associated ARDS and COVID-19 with concurrent PE creates a diagnostic challenge. 2) Safety measures limiting the use of computed tomography. 3) Maintaining COVID-19 safety measures and personal protective equipment in accordance with local guidelines and availability. 4) Patients in the prone position and the possible need to access popliteal or jugular veins for interventions.

Emergency cardiovascular interventions during the pandemic

During the pandemic, the emergency treatment of many medical conditions has been affected. Cardiovascular emergencies are not an exception. Patients presenting with acute myocardial infarction (AMI), acute limb ischemia or acute heart failure exacerbation who require resource intensive treatments have had to receive care adapted to the current conditions of a frequently over-extended healthcare system. COVID-19 has placed hurdles at multiple levels ranging from patient awareness and willingness to seek medical care, to the availability of hospital beds and specialized care.

A Hong Kong group observed a prolongation of symptom onset to first medical contact time intervals compared with a historical control period; none of the patients were COVID-19 positive. [23] During the initial peak of the pandemic in the United States, a 43% reduction in acute cardiovascular hospitalizations in March 2020 compared with March 2019 was described in a Massachusetts health system.[24] As the pandemic has progressed, there has been a marked increase in deaths caused by ischemic heart disease (ratio of the relative change in deaths per 100,000 in 2020 vs. the relative change in 2019: 1.11; 95% CI: 1.04 to 1.18) and hypertensive diseases (1.17; 95% CI: 1.09 to 1.26) based on data from National Center for Health Statistics ( Figure 2). [25] The most widely accepted explanation for this has been the hesitation to seek medical care because of fear of getting infected with COVID in the hospital.

Acute coronary syndromes

Multiple studies in the United States and Europe have shown decreased hospitalization rates for AMI and increased case fatality rates for patients hospitalized with AMI. The COVID-19 pandemic had a substantial impact on the management of patients with STEMI, resulting in a 19% reduction in primary PCI procedures, especially among patients with hypertension, and in longer ischemic and door to balloon times. This could have contributed to increased mortality during the pandemic. [26]

During this pandemic, finding a balance between risks related to timely treatment of ACS patients and SARS-CoV-2 infection control has become a global challenge. Several trials and meta-analyses endorsed by European and American Guidelines have clearly established the superiority of primary PCI compared to thrombolysis over the years. Despite this clinical evidence, to cope with the abrupt COVID-19 outbreak, clinical decisions were individualized at the beginning of the pandemic, taking into account the risk of SARS-CoV-2 exposure versus the risk of delaying diagnosis or therapy. Subsequently, hospitals in China proposed recommendations with regard to STEMI patients with thrombolytic therapy recommended over primary PCI if COVID-19 was confirmed or could not be excluded within a short time, while for NSTEMI–UA, the priority was to exclude SARS-CoV-2 infection first. These recommendations are useful for minimizing and controlling the spread of SARS-CoV-2 infection, but data on the outcomes of ACS patients are needed to confirm that delaying treatment and use of thrombolysis as a first therapy to treat STEMI in confirmed or suspected Covid-19 patients are not associated with worse outcomes.

A first case series from New York City described 18 COVID-19 patients with ST-segment elevation. Among those patients, 9 (50%) underwent coronary angiography, 6 out of 9 (67%) had obstructive disease, and 5 (56%) underwent PCI. [27] 33% of patients did not have obstructive disease and had they received thrombolytic therapy without angiography for their “STEMI” presentation, this would’ve added hemorrhagic risk without any benefit on the ischemic side. Since reperfusion may not be indicated in a great number of patients who present with COVID-19 and ST elevation (possibly due to other mechanisms for myocardial injury), relying on systematic thrombolysis may not to be justified from these initial European and American reports. Based on those findings, the Society for Cardiovascular Angiography and Interventions (SCAI), American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), and American Heart Association (AHA) published guidance on the management of AMI during the COVID-19 pandemic in the US. [28] These guidelines state that after a first evaluation in the ED to assess the infectious risks, STEMI patients should undergo angiography and primary PCI whenever possible if it can be provided within an adequate time frame from the symptom onset and STEMI diagnosis. STEMI patients should be brought to the catheterization laboratory as rapidly as possible, and although door-to-balloon times are expected to be longer during the COVID-19 pandemic, a primary PCI strategy should remain the first choice. Thrombolytic therapy should not be the standard of care strategy and should be limited to particular situations, such as in a non-PCI capable hospital or when PCI cannot be performed within an acceptable time frame. An algorithm summarizing these processes is shown in Figure 3. Those latest recommendations are more consistent with previous European and American Guidelines on STEMI [29] confirming that primary PCI remains the reperfusion therapy of choice if feasible within an acceptable time frame from STEMI diagnosis.

FOCUS BOX 1
  • STEMI patients should be brought to the CCL as rapidly as possible, and although door-to-balloon times are expected to be longer during the COVID-19 pandemic, a primary PCI strategy should remain the first choice.
  • CCL must guarantee appropriate PPE for all personel and establish protocols with infection control to protect their staff and other patients

In summary, protocols should guarantee the feasibility of performing PCI in facilities approved for treatment of COVID-19 patients, avoiding potentially harmful thrombolysis, in compliance with adequate safety measures to protect healthcare workers, since primary PCI should remain the default strategy in patients with clear evidence of a STEMI. One strategy could be to designate separate catheterization labs and subsequently CCUs or cardiology wards for patients with and without SARS-CoV-2 infections, although this may be possible only larger medical centers. SCAI and the Canadian Association of Interventional Cardiology (CAIC) established the North American Covid-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI). Preliminary results reported in October 2020 showed that when compared to propensity matched controls, COVID-19 patients with STEMI were more likely to present with cardiogenic shock, have more atypical symptoms and were less likely to receive coronary angiography.

Peripheral interventions

Limb threatening vascular emergencies are not unexpected with the prothrombotic nature of COVID-19. There are several case reports in the literature of acute limb ischemia that required either surgical or endovascular intervention. The same considerations described in the management of cardiac emergencies apply with limb-threatening emergencies. Early detection of COVID-19 infection and appropriate contact precautions with good use of personal protective equipment are of extreme importance. Based on the patient's overall stability, degree of ischemia, and limb viability, a determination needs to be made whether intervention is appropriate, and if so, whether an endovascular or open approach should be used. It is crucial to consider the severity of systemic illness when considering intervention. Because of the severe pulmonary complications associated with COVID-19, critically ill patients may not be candidates for surgical intervention and endovascular treatments may be preferred. Additionally, with the heavy burden of COVID-19 on renal replacement therapy services, the need for vascular access and dialysis access related complications, endovascular physicians become a very important resource in managing the pandemic.

Non-emergent interventions during the pandemic

With overwhelmed hospitals in the early stages of the pandemic, many government authorities issued a restriction on scheduling “elective” surgical procedures. This was done in order to prevent further spread of the virus and to protect hospital resources conserving personal protective equipment. However, it is difficult to use the word elective in Interventional Cardiology. Symptomatic coronary artery disease patients may become unstable without warning. Stable angina may be lifestyle limiting despite medical treatment and require revascularization, and progressive renal artery stenosis may progress to irreversible renal failure. Because of this, healthcare systems have been forced to categorize procedures based upon their priority. Table 1 shows most of the procedures performed in our catheterization laboratory separated as emergent, urgent, semi-urgent and non-urgent. This classification allowed us to safely defer some procedures when required by the overall situation of the hospital, city and state. It is important to highlight that institutional protocols need to be adapted to the local expertise and usual practice keeping within boundaries of evidence based medicine.

Same day discharge

Same day discharge (SDD) for PCI has been shown to be safe in randomized controlled trials and observational registries, and represents standard practice in many health systems. [30] Complications after 4- to 6-hour periods of observation are rare and usually occur after 24 hours, therefore keeping patients overnight would not capture such events. With COVID-19, the benefit of SDD is twofold: 1) Hospitals are a potential high-risk area for patients, who have cardiovascular disease and are at high risk of adverse outcomes with COVID-19. 2) Hospital beds used for overnight stay can be reassigned to meet with the hospital demands set by the pandemic. SDD is an effective strategy to reduce risk of nosocomial-acquired infection. SDD after elective PCI allows for more efficient healthcare by optimizing patient flow and resource utilization. Pre-procedure considerations include clinical factors, social factors, and staff/system factors. Physician input regarding the patient’s clinical candidacy for SDD, in addition to adequate home support for the patient and the patient being scheduled at an appropriate time for the procedure to allow for SDD later in the day all should be considered prior to PCI. Post-PCI considerations include a thorough assessment of post-procedural complications, PCI success, absence of any mental status changes, and the patient’s willingness to be discharged home. Prior to discharge, confirming availability of P2Y12 inhibitors and adequate follow-up will be needed. Patients should be educated on monitoring the access site and be given clear instructions on an emergency number to call.

Telemedicine

One of the silver linings of the COVID-19 pandemic is the adoption of telemedicine as a means to sustain patient care in the era of social distancing. Once the Centers for Medicare and Medicaid Services (CMS) confirmed reimbursement for remote patient care in March 2020, telemedicine became a major vehicle to provide non-critical patient care to reduce the transmission of COVID-19. Telemedicine can allow patients to receive care from home or work with minimal wait time, no travel time or expense. Using various platforms to create clinical social distancing in hospitals to protect frontline cardiologists and health care workers from the COVID-19 infection and help conserve PPE supplies, telemedicine is also a tool for home visits to decompress emergency rooms and keep people home.

The benefits of telemedicine have gone beyond physician visits. Home-based cardiac rehabilitation programs via telehealth allow patients to receive evidence-based foundational intervention for secondary prevention that is endorsed by multiple guidelines. However, it remains an underutilized resource.

Telemedicine is the new standard; so even after this pandemic has passed, it will remain an integral part of cardiology and health care. Telemedicine is not a disruptor of the practice of health care but rather it augments the traditional delivery of health care, enables a more agile and continuous mechanism of care provision and engages the patient as an equal partner in their care.

Outpatient cardiovascular care now includes: 1) in-person visits, 2) virtual synchronous visits between clinician and patient, 3) asynchronous communication (such as patient reported outcomes), 4) electronic consultation (between clinicians), and 5) remote monitoring, digital tracking, wearables and use of data. A blend of virtual and in-person visits ensures high-quality, safe care. The question is not whether to adopt telemedicine rather how to best use it in your practice.

Stable coronary artery disease

Current evidence supports medical management of stable coronary artery disease. Just a few months before the pandemic started, the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial [31] confirmed that younger patients with stable symptoms, normal ejection fraction and evidence of moderate-to-severe ischemia on stress testing could be risk stratified with computed tomographic coronary angiography (CTCA) to exclude significant unprotected left main disease, and then managed with optimal medical therapy alone. Invasive coronary angiography could be reserved for those who have refractory angina despite medical therapy. The findings of these study have been helpful to ease the anxiety of patients and non-invasive Cardiologists. An initial medical therapy approach to stable CAD is indicated and safe.

Structural heart disease

Patients with structural heart disease are at increased risk of adverse outcomes from COVID-19 due to advanced age and comorbidities. Delaying procedures like left atrial appendage closure, atrial septal defect or perivalvular leak closures may be safe in most patients. However, delaying transcatheter aortic valve replacement (TAVR) or mitral edge-to-edge repair may result in worse patient outcomes including unplanned heart failure hospitalization and death. A case by case evaluation by the heart team is very important when weighing the risks and benefits of the procedure. Decreasing the time of patients in the hospital decreases both the risk of nosocomial infection and the bed availability of the hospital system. The minimalistic approach with shorter lengths of stay and less resource utilization has never been more attractive. SDD after mitral edge-to-edge repair is safe in most patients who are stable post procedure since it is a transvenous procedure and major complications like pericardial effusion can be ruled out before the patient leaves the catheterization table. [32] The same concept applies to left atrial appendage closure, atrial septal defects and most perivalvular leak procedures. For transcatheter valve replacement there are a few extra considerations that need to be considered: The use of large bore arterial access and the potential AV conduction abnormalities post procedure may require longer monitoring. Studies support that next-day discharge (NDD) for carefully selected patients following minimalist TAVR is safe and feasible and has become standard practice. A single center reported their experience with SDD after TAVR in a highly selected group of patients: Minimal pre-morbid conditions, no vascular complications, no new conduction abnormalities, low contrast volumes, no need for vasopressors and the presence of a good support network with the ability to do a telemedicine follow up the next day had similar outcomes when compared to a historic matched NDD group of patients. [33] Another silver lining of the pandemic has been how it has forced us to think outside the box and figure out ways to provide the same high quality of care with more limited resources, one has to hope that in the long term this will benefit more patients.

Cath lab and personnel management

The regular operations in hospitals and CCLs have been affected significantly by the pandemic. CCL leaders have seen challenges in supply chains, staff redeployment, staff isolation due to infection, fatigue, local government limitations and availability of personal protective equipment.

Supply chain challenges

The pandemic has exposed significant gaps in health care supply chains, which are complex and highly fragmented. Health care requires five categories of products: pharmaceuticals, personal protective equipment, medical devices, medical supplies, and blood. Each of these categories has a distinct supply chain, and the failure of any these can cause significant disruption of the system.

Medications have long life cycles, their supply chain is global, and pharmaceutical imports in the US are up to 44% and increasing. [34] An estimated two-thirds of the active ingredients of generic drugs used in the United States come from China. Regulatory restrictions and virus-related manufacturing issues have disrupted the global supply chains for pharmaceuticals. Critical care medications like vasoactive and sedative agents have been in short supply at different points during the pandemic. Judicious use of these medications is mandatory, and central planning to prepare for potential shortages and having alternative options may become necessary in the long run.

Blood products have a unique supply chain, there are billions of supply points and millions of demand points. Voluntary donations work well in normal times, but they have been problematic during the pandemic. Blood supplies have been low. Social distancing measures make collection at hospitals and community centers difficult, and some potential donors are unwilling to visit blood collection centers. Massive blood donation campaigns and de-centralized donations centers may help mitigate this.

Personal protective equipment (PPE)

Ensuring adequate protection of all health care workers is critical. The type and amount of PPE that should be used when treating a patient with COVID-19 varies based on clinical job and setting. [35] Cardiovascular teams have established protocols for rapid testing in the emergency room in order to triage the patients into different infectious risk categories. However, given the long incubation period of the disease, a negative rapid test does not necessarily rule out the infection. Therefore, all patients requiring emergent cardiac catheterization should be treated as COVID-19 possible. Since the start of the COVID-19 outbreak, the World Health Organization maintains the recommendation of using medical masks for regular care of COVID-19 patients in the context of droplet and contact precautions, and respirators for circumstances and settings where aerosol generation can occur like endotracheal intubation, bi-level or continuous positive pressure ventilation, defibrillation with need for cardiopulmonary resuscitation (CPR), and airway suctioning; all of these high-risk situations can be encountered during primary PCI for STEMI. The current ACC/SCAI consensus guidelines recommend PPE with aerosolization protection for the entire cardiac catheterization laboratory staff during PCI for all STEMI patients during this COVID-19 pandemic. [28] These recommendations may change in the near future as most of the healthcare workers worldwide become vaccinated.

In early March 2020, the US emergency stockpile of N95 masks was deemed insufficient which put providers at risk. Although capacity has increased, new guidance from the Centers for Disease Control and Prevention has increased demand from the general public. Providers are sometimes asked to reuse protective masks. States, hospital systems, and the federal government are all competing for the same resources and paying a significant premium over list price. In the long run, a judiciously maintained emergency stockpile, rotated to keep inventory fresh, will prevent this situation from recurring.

Staff redeployment

Interventional Cardiologists have a special skill set that makes them attractive options for critical care help during the pandemic: They can care for critically ill patients and are proficient in CPR, obtaining vascular access and managing vasoactive medications and sedation. During the initial peaks of the pandemic, when hospitals were overwhelmed many interventional cardiologists volunteered in intensive care units to offload the hard work intensive care doctors were performing. This was matched by the decrease of interventional procedures that was noticed during that initial peak. However, as the pandemic has progressed, the need for such help has decreased as hospitals have been able to establish different staffing algorithms adjusted to their local needs.

Cath lab nurses and x-ray technicians have also been moved to different services in the hospitals for the same reasons. All these movements in personnel represent an additional challenge to keeping the practice operations as usual and therefore maintaining the value of the services provided.

Staff burn out and moral injury

Clinicians and hospital staff are facing unprecedented conditions with the pandemic. As a result, clinicians are highly stressed and at risk of adverse mental health conditions. A recent survey [36] demonstrated a high prevalence of experiencing stress (93%), anxiety (86%), frustration (77%), exhaustion and burnout (76%). More than half reported physical symptoms of stress (headaches, stomachache), appetite change, and compassion fatigue. Self-care, both physical and emotional, is essential to caring for patients, family and colleagues, and increasing professional fulfillment. Non-clinical situations like school closures, financial stress and civil unrest also need to be taken into account as they affect the well-being of all the team members. An X-ray technician that cannot come to work because they don’t have child-care and their children’s school is closed affects the normal operations of the practice. Another team member may be struggling because a loved one is sick with COVID-19 and one of the practice partners may have COVID-19 themselves and have to be in isolation. Preparing for such scenarios is critical to keep the functionality of the team and the moral high.

It is critical to manage the pillars of self-care, (nutrition, physical activity, sleep and social connection) to address stress. Participation in exercise and hobbies can be helpful methods to combat stress and anxiety. Workplace fatigue can be reduced with getting adequate sleep and using a buddy system to monitor each other for signs of fatigue or increased work demands. Maintaining social connections with friends and family is important to avoid social isolation and can allow one to mentally separate from work. However, the professional community is equally important. Clinicians participate in meaningful work with each other in teams and share a unique opportunity to support and share with each other, specifically in the care of patients and when they mourn the loss of patients, loved ones and colleagues.

Clinical trials during the pandemic

The pandemic has created an unprecedented challenge in clinical research activities. Whereas other natural or human disasters (for instance, Hurricane Katrina in New Orleans) affected research activities in specific geographical areas, the current pandemic is a challenge of global proportions.

With hospitals and health care centers overcrowded with patients who have COVID-19, access poses a significant health risk to research personnel as well as study participants. For this reason, most academic medical centers have modified or suspended clinical research activities during the pandemic, with the only exception being trials considered of essential importance and/or have prioritized research about COVID-19. The definition of an essential trial is not very clear.

Most clinical trials rely on pre-specified estimates of event rates and on limited time windows for patients’ enrollment and data acquisition, and even a temporary suspension may lead to trial failure. Invested resources in terms of patients and study personnel time will be wasted and important ethical questions with regard to those patients who have already completed the study and have accepted a potential risk in exchange of societal benefits that will no longer be possible will arise.

Even though local agencies such as the National Institutes of Health and U.S. Food and Drug Administration (FDA) have rapidly produced guidelines and recommendations for clinical research during the pandemic, the variability in local guidelines have destabilized multicenter trials, especially those conducted internationally. Some trials have been halted by the funding agencies, but others are left to continue at the discretion to the principal investigators.

In addition, data safety-monitoring boards and research ethics committees are prioritizing review of COVID-19 protocols that need to be initiated expeditiously, while all other trials are on hold until all activities return to normal.

Follow-up of patients currently enrolled in trials has been affected by local regulations, patient’s beliefs and access to care. Events like death and hospitalization may be biased given the concomitant increase of those events related to the pandemic. The consequences of this disruption of trial activity are unprecedented and are likely to affect the evidence generated in the next few to several years.

Challenges to cardiovascular graduate medical education (GME)

The pandemic has also resulted in unprecedented disruption in post-graduate medical training.

In New Orleans, hurricane Katrina also caused a major disruption in medical education, but was a focal event confined to a specific region. Katrina's negative impact was mitigated by the ability of unaffected institutions to relocate trainees from decimated training programs. In contrast, because there are no unaffected regions during this pandemic, we must "shelter in place" and adapt to the exigencies of this new situation.

A national survey of 3500 fellows in training (FIT) at US hospitals showed that their main concerns during the pandemic included contracting or exposing their loved ones to the virus, the perceived lack of appropriate PPE, the ability to meet (Core Cardiovascular Training Statement) COCATS 4 requirements for graduation and the availability of job opportunities for those in their final years of training. [37] The Accreditation Council for Graduate Medical Education (ACGME) has allowed institutions to self-declare pandemic emergency status, which permits suspension of some program requirements for at least 30 days. Through this provision, traditional rotation schedules created to fulfill COCATS 4 and ACGME requirements have been modified. Many FITs have found themselves in atypical roles such as primary providers or attending physicians and believed that they may incur significant personal risk without commensurate compensation or legal protection. FITs reported fewer procedural training opportunities due to reduced staffing levels and the cancellation of elective and nonurgent procedures.

Gaining training and experience in the "allocation of healthcare resources" is a particularly critical skill in making U.S. healthcare affordable as we prioritize value over volume. Moving forward, beyond the burden of this pandemic, trainees will practice medicine in an environment of shrinking healthcare dollars. Reducing waste (unnecessary, inefficient, or inappropriate care) and prioritizing resource utilization (the right patient, the right procedure, the right time) will be rewarded. To the extent it accelerates this educational change, the pandemic may be a catalyst for positive change.

Second, this will not be the last worldwide infectious disease pandemic current trainees will face in their careers. Developing a fundamental understanding of "healthcare worker protection" will serve them well. The COVID-19 pandemic has demanded novel responses, including restrictive hospital and clinic visitor policies, adapting to remote learning, implementing telehealth visits, and learning to prioritize procedures based upon the intensity of community infection. All are valuable lessons.

Last, teaching "end of life decision-making and planning" has been brutally pushed to the forefront by COVID-19. Patients and families benefit when they can make informed decisions regarding what is best for them. Palliative medicine is an underused and underappreciated specialty that brings enormous value to our patients and their families. The harsh experience gained during COVID-19 sheds light on a significant deficit in our graduate education programs. Our trainees (and their patients) would benefit more from a rotation on palliative medicine than an elective month in procedure training.

Virtual learning and virtual meetings have made substantial progress during this crisis and proven to be an efficient way to deliver knowledge to individuals anywhere in the world. Certainly they will not replace in-person learning, but will help to enhance it, and make learning more widely available at a lower cost.

Conclusion

One year after the onset of the pandemic we are in a better position than when we started. Today we have a much better understanding of the disease and how it spreads and we can target our preventive and therapeutic measurements to be more effective. The expedited development of highly efficacious vaccines, together with the implementation of social distancing and wearing masks have helped decrease the burden of this disease in our healthcare system and in our society overall. We must look back at what we have learned both as a medical community and as a society. Highly infectious viral diseases have occurred in the last decade providing small warnings to what we have experienced now. Middle East Respiratory Syndrome (MERS), Swine Flu and Zika epidemics are some examples. One has to wonder how society will respond to the next epidemic. Can we prevent a new infectious agent from taking over the world again? Hopefully, with the lessons learned from the COVID-19 pandemic we will respond a little better next time.

Personal Perspective - Jose David Soto

When the pandemic began spreading in the United States, New Orleans became one of the first epicenters of the crisis. Two weeks prior to the confirmation of the first case, the city celebrated its famous, weeks-long carnival. During Mardi Gras, locals and tourists gather in large masses around the city to watch parades roll by in an atmosphere of music, alcohol and food. Many health officials believe this was the reason the city saw an early peak in cases.

Like most of the cities first hit by the virus, hospital systems were not prepared. And soon, the collapse of the hospitals that we witnessed across the Atlantic was a reality for us. Elective case cancellation, the fear of seeking medical care and the report of increasing COVID-19 admissions became the daily news. Soon, many physicians found themselves with little to do and massive amounts of anxiety piling up. Cardiologists soon volunteered to help the intensive care physicians with critically ill patients. We ran towards the fire when “all hands on deck” were needed, while we made arrangements necessary to protect our families. In the frontlines, we had the opportunity to work with colleagues from different specialties, benefiting from their knowledge, but most importantly creating bonds that didn’t exist before.

As time went by, we learned more about the virus, along with how to treat and prevent it. The hospital became better prepared and installed protocols of action based on the initial experience and the experience of others. This made the second and third “waves” more manageable, in terms of hospital resources and preparedness. We have adapted to our new life, and continue to face challenges every day, but one-by-one we have embraced them and we are always learning how to do better.

Today we are hopeful, with a massive vaccination program ongoing across the country we have hope that this pandemic will be over soon. With new variants of the virus there is some uncertainty and only time will tell. What is most important is to look back to the lessons we have learned, what did we did right and how to prepare for the next time.

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