Faculty Bibliography

The occurrence of venous thromboembolisms in patients with COVID-19 has been established. We sought to evaluate the clinical impact of thrombosis in patients with COVID-19 over the span of the pandemic to date. We analyzed patients with COVID-19 with a diagnosis of thrombosis who presented to the MedStar Health system (11 hospitals in Washington, District of Columbia, and Maryland) during the pandemic (March 1, 2020, to March 31, 2021). We compared the clinical course and outcomes based on the presence or absence of thrombosis and then, specifically, the presence of cardiac thrombosis. The cohort included 11,537 patients who were admitted for COVID-19. Of these patients, 1,248 had noncardiac thrombotic events and 1,009 had cardiac thrombosis (myocardial infarction) during their hospital admission. Of the noncardiac thrombotic events, 562 (45.0%) were pulmonary embolisms, 480 (38.5%) were deep venous thromboembolisms, and 347 (27.8%) were strokes. In the thrombosis arm, the mean age of the cohort was 64.5 ± 15.3 years, 53.3% were men, and the majority were African-American (64.9%). Patients with thrombosis tended to be older with more co-morbidities. The in-hospital mortality rate was significantly higher (16.0%) in patients with COVID-19 with concomitant non-cardiac thrombosis than in those without thrombosis (7.9%, p <0.001) but lower than in patients with COVID-19 with cardiac thrombosis (24.7%, p <0.001). In conclusion, patients with COVID-19 with thrombosis, especially cardiac thrombosis, are at higher risk for in-hospital mortality. However, this prognosis is not as grim as for patients with COVID-19 and cardiac thrombosis. Efforts should be focused on early recognition, evaluation, and intensifying antithrombotic management for these patients.

BACKGROUND:Cardiac involvement in coronavirus disease 2019 (COVID-19) is known, manifested by troponin elevation, and these patients have a worse prognosis than patients without myocardial injury. METHODS:We analyzed COVID-19-positive patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the pandemic (March 1-September 30, 2020). We compared renal function and subsequent in-hospital clinical outcomes based on the presence or absence of troponin elevation. The primary outcome was the incidence of acute kidney injury in COVID-19 patients with troponin elevation. We also evaluated in-hospital mortality, overall and based on the presence and absence of both troponin elevation and renal dysfunction. RESULTS:The cohort included 3386 COVID-19-positive admitted patients for whom troponin was drawn. Of these patients, 195 had troponin elevation (defined as ≥1.0 ng/mL), mean age was 61 ± 16 years, and 51% were men. In-hospital mortality was significantly higher (53.8%) in COVID-19-positive patients with concomitant troponin elevation than in those without troponin elevation (14.5%; p < 0.001). COVID-19-positive patients with troponin elevation had a higher prevalence of renal dysfunction (58.5%) than those without troponin elevation (23.4%; p < 0.001). Further analysis demonstrated that having both troponin elevation and renal dysfunction carried the worst in-hospital prognosis (in-hospital mortality 57.9%; intensive-care-unit admission 76.8%; ventilation requirement 63.2%), as compared to the absence or presence of either. CONCLUSION:COVID-19 patients with troponin elevation are at higher risk for worsening renal function, and these patients subsequently have worse in-hospital clinical outcomes. Efforts should focus on early recognition, evaluation, and intensifying care of these patients.

BACKGROUND:Cardiac involvement in coronavirus disease 2019 (COVID-19) is known, manifested by troponin elevation. Studies in the initial phase of the pandemic demonstrated that these patients tended to have a worse prognosis than patients without myocardial injury. We sought to evaluate the clinical impact of significant troponin elevation in COVID-19-positive patients, along with predictors of poor outcomes, over the span of the pandemic to date. METHODS:We analyzed COVID-19-positive patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the pandemic (March 1-June 30, 2020). We compared clinical course and outcomes based on the presence of troponin elevation and identified predictors of mortality. RESULTS:The cohort included 2716 COVID-19-positive admitted patients for whom troponin was drawn. Of these patients, 250 had troponin elevation (≥1.0 ng/mL). In the troponin-elevation arm, the minimum troponin level was 1.9 ± 8.82 ng/mL; maximum elevation was 10.23 ± 31.07 ng/mL. The cohort's mean age was 68.0 ± 15.0 years; 52.8% were men. Most (68.5%) COVID-19-positive patients with troponin elevation were African American. Patients with troponin elevation tended to be older, with more co-morbidities, and most required mechanical ventilation. In-hospital mortality was significantly higher (48.4%) in COVID-19-positive patients with concomitant troponin elevation than without troponin elevation (12.2%; p < 0.001). CONCLUSION:COVID-19 patients with troponin elevation are at higher risk for mechanical ventilation and mortality. Efforts should focus on early recognition, evaluation, and intensifying care of these patients.

BACKGROUND:Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS). METHODS:The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS. RESULTS:A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year. CONCLUSION:Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies. TRIAL REGISTRY:NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899.

BACKGROUND:Most pivotal transcatheter aortic valve replacement (TAVR) trials have excluded patients with bicuspid aortic stenosis (AS). This study compared TAVR in low-risk patients with bicuspid AS to those with tricuspid AS, incorporating data from prospective trials. METHODS:We selected prospective US low-risk TAVR trials containing a bicuspid arm for this meta-analysis, examining outcomes at 30 days. Study results were pooled using a hierarchical Bayesian random-effects model. RESULTS:, NA) and coronary obstruction (OR, 0.21; 95% CrI: 0.05, 0.91) that disappeared after sensitivity analysis by adding a single event to the tricuspid arm. Hemodynamics were similar at 30 days. CONCLUSIONS:Preliminary data from the FDA-approved IDE trials of low-risk patients with bicuspid AS undergoing TAVR demonstrated 30-day outcomes comparable to low-risk tricuspid patients, except for a trend toward higher stroke in bicuspid patients. Randomized trials are warranted to reassure the safety and long-term outcome of TAVR in patients with severe bicuspid AS.

Refractory angina is considered a devastating condition with limited medical and therapeutic options. The Neovasc Reducer device, when implanted in the coronary sinus, is designed to alleviate anginal symptoms. However, the available clinical data are sparse. The US Food and Drug Administration (FDA) assembled the Circulatory Systems Devices Panel to discuss the Reducer's safety and effectiveness. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we detail the deliberation and discussion among the circulatory panel members, including their final vote.

BACKGROUND/PURPOSE:Several studies have reported that mitral regurgitation (MR) can improve following transcatheter aortic valve replacement (TAVR) alone using earlier-generation valves. The purpose of this study was to determine the predictors and short-term outcome impact of MR in patients undergoing TAVR using all generation valves across all risk groups. METHODS/MATERIALS:In this retrospective, study from 2012 to 2020, we reviewed data on 1822 low-, intermediate-, and high-risk patients who underwent TAVR. Included were 1266 patients with baseline MR who underwent transfemoral TAVR. Our primary outcome was persistence or worsening of baseline MR post-TAVR. Additional endpoints included an inpatient composite (intensive care unit length of stay >24 h, post-TAVR length of stay >2 days, and inpatient death), 30-day composite (30-day death or readmission), and 1-year composite (1-year death or readmission). RESULTS:Of the 1266 patients included, 665 had significant baseline MR (≥moderate), which improved in 79.4% of patients (n=528). Female patients, those with lower body mass indices, and those with higher right ventricular systolic pressures were more likely to have persistence or worsening of baseline MR. Patients whose baseline MR persisted or worsened, had higher rates (80.3% vs. 77.3%, p=0.0019) of our inpatient composite, higher rates (15.3% vs. 10.0%, p=0.0389) of our 30-day composite, and higher rates (36.7% vs. 26.8%, p=0.0107) of our 1-year composite when compared to patients whose baseline MR improved post-TAVR. CONCLUSIONS:Our study identifies clinical characteristics, which help identify patients who may require closer post-procedural follow-up and warrant possible staged mitral valve intervention post-TAVR across all risk groups.

Cardiac involvement in coronavirus disease 2019 (COVID-19) has been established. This is manifested by troponin elevation and associated with worse patient prognosis. We evaluated whether patient outcomes improved as experience accumulated during the pandemic. We analyzed COVID-19-positive patients with myocardial injury (defined as troponin elevation) who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the "Early Phase" of the pandemic (March 1 - June 30, 2020) and compared their characteristics and outcomes to the COVID-19-positive patients with the presence of troponin elevation in the "Later Phase" of the pandemic (October 1, 2020 - January 31, 2021). The cohort included 788 COVID-19-positive admitted patients for whom troponin was elevated, 167 during the "Early Phase" and 621 during the "Later Phase." Maximum troponin-I in the "Early Phase" was 13.46±34.72 ng/mL versus 11.21±20.57 ng/mL in the "Later Phase" (p = 0.553). In-hospital mortality was significantly higher in the "Later Phase" (50.3% vs. 24.6%; p<0.001), as were incidence of intensive-care-unit admission (77.8% vs. 46.1%; p<0.001) and need for mechanical ventilation (61.7% versus 28%; p<0.001). In addition, more "Early Phase" patients underwent coronary angiography (6% vs. 2.3%; p=0.013). Finally, 3% of "Early Phase" and 0.8% of "Later Phase" patients underwent percutaneous coronary intervention (p=0.025). In conclusion, treatment outcomes have significantly improved since the beginning of the pandemic in COVID-19-positive patients with troponin elevation. This may be attributed to awareness, severity of the disease, improvements in therapies, and provider experience.

Acute coronary artery occlusion is a rare but devastating complication of transcatheter aortic valve replacement. Coronary obstruction is angiographic evidence of a new-partial or complete-obstruction of a coronary artery. Key factors identifying patients at risk are aortic root anatomy, type of aortic valve, and type of transcatheter heart valve. Techniques to prevent coronary obstruction include intentional leaflet laceration. If acute coronary obstruction does occur, bailout stenting can be challenging and conversion to emergent open heart surgery may be required, both of which are associated with high morbidity and mortality.