Transcatheter aortic valve replacement during the COVID‐19 pandemic—A Dutch single‐center analysis

Abstract Background and Aim of the Study The coronavirus disease 2019 (COVID‐19) pandemic has put an enormous strain on healthcare systems and intensive care unit (ICU) capacity, leading to suspension of most elective procedures, including transcatheter aortic valve replacement (TAVR). However, deferment of TAVR is associated with significant wait‐time mortality in patients with severe aortic valve stenosis. Conversely, there is currently no data available regarding the safety and feasibility of a continued TAVR program during this unprecedented crisis. The aim of this study is to evaluate the safety and feasibility of patients undergoing TAVR during the COVID‐19 pandemic in our center, with specific emphasis on COVID‐19 related outcomes. Methods All patients who underwent TAVR in our center between February 27, 2020, and June 30, 2020, were evaluated. Clinical outcomes were described in terms of Valve Academic Research Consortium 2 definitions. Patient follow‐up was done by chart review and telephone survey. Results A total of 71 patients have undergone TAVR during the study period. Median age was 80 years, 63% were men, and 25% were inpatients. Procedural success was 99%. After TAVR, 30% involved admission to the ICU, and 94% were ultimately discharged to the cardiac care unit on the same day. Two patients (3%) had confirmed COVID‐19 a few days after TAVR, and both died of COVID‐19 pneumonia within 2 weeks after hospital discharge. Conclusions A continued TAVR program during the COVID‐19 pandemic is feasible despite limited hospital resources. However, COVID‐19 related mortality after TAVR is of concern.


| INTRODUCTION
The coronavirus disease 2019 (COVID-19) pandemic 1 has put an enormous strain on existing healthcare systems and resources worldwide, leading to the deferment of most elective procedures. 2,3 This especially affects patients with severe aortic valve stenosis (AS) awaiting transcatheter aortic valve replacement (TAVR), a recognized vulnerable population with established cardiovascular disease and important comorbidities. There is general consensus that the deferment of these potentially life-saving procedures is associated with dangers of sudden cardiac death or irreversible cardiac deterioration. For example, it has been reported that there are important wait-time mortality risks of 23.3% and 27.5%, respectively at 6-and 12-month awaiting TAVR. 4 The American College of Cardiology (ACC) and Society of Cardiac Angiography and Interventions (SCAI) have recently published a consensus statement regarding triage considerations for patients referred for structural heart disease intervention during the COVID-19 crisis, including when to perform TAVR for severe symptomatic AS. 5 However, the risks of adverse events caused by postponement of these interventions should be balanced against the additional COVID-19 related dangers of performing (high-risk) cardiovascular interventions during this global crisis. Unfortunately, there is currently a paucity of data to properly estimate the additional hazards of TAVR during the COVID-19 pandemic, especially regarding the risks of COVID-19 transmission just before or after the intervention (either through healthcare workers, visitors, or other patients), but also regarding COVID-19 related morbidity and mortality. Therefore, we performed the current study to evaluate the feasibility and safety of a continued TAVR program during the COVID-19 pandemic in the Netherlands, evaluating early clinical results with specific emphasis on COVID-19 related outcomes.

| MATERIALS AND METHODS
We conducted a single-institutional cohort study evaluating all patients who underwent TAVR in our center for various urgency in-

| Patient triage
With progression of the COVID-19 crisis and the increasing COVID-19 caseload on the ICU, our center started with deferral of all nonurgent procedures on March 16, 2020. From that time, all patients on the TAVR waiting list were triaged on a daily basis by a single TAVR cardiologist (MvW), based on an urgency classification system categorized into three levels ( Table 1): Levels 1, 2, and 3, indicating TAVR to be performed preferably within 1 week, 1 month, or 3 months, respectively. Level of urgency was mainly determined by symptom severity and echocardiographic features (Table 1).
Our classification is largely comparable with the later published ACC/SCAI consensus statement. 5 The consenting process to undergo a TAVR procedure during the COVID-19 pandemic did not differ significantly from the one in the pre-COVID-19 era.

| RESULTS
During the study period, 71 consecutive TAVR procedures were performed ( inpatients, admitted with heart failure or syncope due to severe AS. The majority of patients were outpatients who were highly symptomatic with either severe or critical AS (Table 2).

| Case descriptions of two patients with COVID-19 pneumonia after TAVR (Central Figure)
The first patient was a 76-year-old man referred to our hospital as an

| DISCUSSION
In our single-institutional cohort study with 71 patients undergoing TAVR during the COVID-19 crisis, there were two patients (3%) with proven COVID-19 pneumonia a few days after TAVR, both resulting in death approximately 2 weeks after TAVR (and 11-12 days after last hospital stay).
Although it is clear that TAVR cannot be postponed for a prolonged period in patients with symptomatic severe or critical AS, the risk of deferment of the procedure has to be balanced against the dangers of COVID-19 transmission before and after the procedure and associated morbidity and mortality in this vulnerable population.
For inpatients who cannot be discharged due to medical reasons, we believe it is rational to perform the necessary procedures during the COVID-19 crisis, as recommended by the previously mentioned ACC/SCAI consensus statement. 5  had COPD, all which are known risk factors for increased COVID-19 related morbidity and mortality. 11,12 In addition, TAVR might lead to significant inflammatory modulation, 13,14 as with most surgical and interventional procedures, 15 20 The overall prevalence and transmission risks of COVID-19 in the general population may now be much lower. Consequently, focus has already been shifting towards "post-COVID-19" reactivation of surgical and interventional programs. 21 However, concern has also been raised regarding potential resurgence and possible additional COVID-19 waves. 22 Therefore, depending on the actual regional COVID-19 prevalence and hospitalization rates, COVID-19 related concerns will remain. As such, COVID-19 associated risks of in-hospital treatments with accompanied COVID-19 transmission dangers should be an important focus of future reports, and these risks should be balanced against the hazards of deferred interventions for the cardiovascular patient on an individual basis. We expect this will be of continued concern for the foreseeable future.

| CONCLUSION
In conclusion, we have reported the first case series of TAVR procedures performed during the COVID-19 pandemic. Two cases of COVID-19 pneumonia were diagnosed, with an unknown source of transmission soon after the intervention, both leading to mortality within 2 weeks after hospital discharge. We eagerly await subsequent reports from large registries to more accurately clarify the risks and source of COVID-19 transmission after cardiac interventions, as well as the accompanied additional risks caused by COVID-19 related morbidity and mortality. Until then, the complex balancing act of weighing the risks of health loss due to COVID-19 against the risks of postponing a potentially life-saving procedure remains a challenge for the clinician and the patient, and should be part of shared-decision making.
Furthermore, strict visiting policies should be considered in this vulnerable population after TAVR, both during and after hospital stay, with education of potential visitors of all COVID-19 related symptoms.