Variation in survival in patients with Coronavirus Disease 2019 supported with extracorporeal membrane oxygenation: A multi-institutional analysis of 594 consecutive patients with Coronavirus Disease 2019 supported with extracorporeal membrane oxygenation at 49 hospitals within 21 states.

OBJECTIVES: We reviewed 594 consecutive patients with Coronavirus Disease 2019 supported with extracorporeal membrane oxygenation at 49 hospitals within 21 states and examined patient characteristics, treatments, and variation in outcomes over the course of the pandemic. METHODS: A multi-institutional database was used to assess all patients with Coronavirus Disease 2019 supported with and separated from extracorporeal membrane oxygenation between March 2020 and December 2021, inclusive. Descriptive analysis was stratified by 4 time categories: group A = March 2020 to June 2020, group B = July 2020 to December 2020, group C = January 2021 to June 2021, group D = July 2021 to December 2021. A Bayesian mixed-effects logistic regression was used to assess continuous trends in survival where time was operationalized as the number of days between each patient's cannulation and that of the first patient in March 2020, controlling for multiple variables and risk factors. RESULTS: At hospital discharge, of 594 patients, 221 survived (37.2%) and 373 died. Throughout the study, median age [interquartile range] declined (group A = 51.0 [41.0-60.0] years, group D = 39.0 [32.0-48.0] years, P < .001); median days between Coronavirus Disease 2019 diagnosis and intubation increased (group A = 4.0 [1.0-8.5], group D = 9.0 [5.0-14.5], P < .001); and use of medications (glucocorticoids, interleukin-6 blockers, antivirals, antimalarials) and convalescent plasma fluctuated significantly (all P < .05). Estimated odds of survival varied over the study period with a decline between April 1, 2020, and November 21, 2020 (odds ratio, 0.39, 95% credible interval, 0.18-0.87, probability of reduction in survival = 95.7%), improvement between November 21, 2020, and May 17, 2021 (odds ratio, 1.85, 95% credible interval, 0.86-4.09, probability of improvement = 93.4%), and decline between May 17, 2021, and December 1, 2021 (odds ratio, 0.49, 95% credible interval, 0.19-1.44, probability of decrease = 92.1%). CONCLUSIONS: Survival for patients with Coronavirus Disease 2019 supported with extracorporeal membrane oxygenation has fluctuated during the stages of the pandemic. Minimizing variability by adherence to best practices may refine the optimal use of extracorporeal membrane oxygenation in a pandemic response.

Outcomes of acute type A aortic dissection during the COVID-19 pandemic: An analysis of the Society of Thoracic Surgeons Database.

PURPOSE: There have been reported reductions of hospital presentation for acute cardiovascular conditions such as myocardial infarction and acute type A aortic dissection (ATAAD) in the United States during the COVID-19 pandemic. This study examined presentation patterns and outcomes of ATAAD in North America immediately before, and during, the COVID-19 pandemic. METHODS: The Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD) was queried to identify patients presenting with ATAAD in the 12 months pre-pandemic (March 2019-February 2020), and during the early pandemic (March through June 2020). Demographics and operative characteristics were compared using χ² test and Wilcoxon Rank-sum test. The median annual case volume designated low-volume centers versus high-volume centers (>10 cases per month). Step-wise variable selection was used to create a risk set used for adjustment of all multivariable models. RESULTS: There were 5480 patients identified: 4346 pre-pandemic and 1134 during pandemic. There was significantly lower volume of median cases per month during the COVID-19 pandemic period (286 interquartile range [IQR]: 256-306 vs. 372 IQR: 291-433,p = .0152). In historically low-volume centers (<10 cases per year), there was no difference in volume between the two periods (142 IQR: 133-166 vs. 177 IQR: 139-209, p = NS). In high-volume centers, there was a decline during the pandemic (140 IQR: 123-148 vs. 212 IQR: 148-224, p = .0052). There was no difference in overall hospital-to-hospital transfers during the two time periods (54% of cases pre-pandemic, 55% during). Patient demographics, operative characteristics, malperfusion rates, and cardiac risk factors were similar between the two time periods. There was no difference in unadjusted operative mortality (19.01% pre-pandemic vs. 18.83% during, p = .9) nor major morbidity (52.42% pre-pandemic vs. 51.24% during, p = .5). Risk-adjusted multivariable models showed no difference in either operative mortality nor major morbidity between time periods. CONCLUSIONS: For patients presenting to the hospital with ATAAD during the first surge of the pandemic, operative outcomes were similar to pre-pandemic despite a 30% reduction in volume. Out-of-hospital mortality from ATAAD during the pandemic remains unknown. Further understanding these findings will inform management of ATAAD during future pandemics.

Early trends in ECMO mortality during the first quarters of 2019 and 2020: Could we have predicted the onset of the pandemic?

OBJECTIVE: To compare mortality trends in patients requiring Extracorporeal Membrane Oxygenation (ECMO) support between the first quarters of 2019 and 2020 and determine whether these trends might have predicted the severe acute respiratory syndrome coronavirus-2 (SARS)-Cov-2 pandemic in the United States. METHODS: We analyzed 5% Medicare claims data at aggregate, state, hospital, and encounter levels using MS-DRG (Medicare Severity-Diagnosis Related Group) codes for ECMO, combining state-level data with national census data. Necessity and sufficiency relations associated with change in mortality between the 2 years were modeled using qualitative comparative analysis (QCA). Multilevel, generalized linear modeling was used to evaluate mortality trends. RESULTS: Based on state-level data, there was a 3.36% increase in mortality between 2019 and 2020. Necessity and sufficiency evaluation of aggregate data at state and institutional levels did not identify any association or combinations of risk factors associated with this increase in mortality. However, multilevel and generalized linear models using disaggregated patient-level data to evaluate institution mortality and patient death, identified statistically significant differences between the first (p = .019) and second (p = .02) months of the 2 years, the first and second quarters (p < .001 and p = .042, respectively), and the first 6 months (p < .001) of 2019 and 2020. CONCLUSION: Mortality in ECMO patients increased significantly during the first quarter of 2020 and may have served as an early warning of the SARS-Cov-2 pandemic. Granular data shared in real-time may be used to better predict public health threats.

Early results of geometric ring annuloplasty for bicuspid aortic valve repair during aortic aneurysm surgery.

Objectives: Geometric ring annuloplasty has shown promise during bicuspid aortic valve repair for aortic insufficiency. This study examined early outcomes of bicuspid aortic valve repair associated with proximal aortic aneurysm replacement. Methods: From September 2017 to November, 2021, 127 patients underwent bicuspid aortic valve repair with concomitant proximal aneurysm reconstruction. Patient age was 50.6 ± 12.7 years (mean ± standard deviation), male gender was 83%, New York Heart Association Class was 2 (1-2) (median [interquartile range]), and preoperative aortic insufficiency grade was 3 (2-4). Ascending aortic diameter was 50 (46-54) mm, and all patients had ascending aortic replacement. Forty patients had sinus diameters greater than 45 mm, prompting remodeling root procedures. A total of 105 patients had Sievers type 1 valves, 3 patients had type 0, and 7 patients had type 2. A total of 118 patients had primarily right/left fusion, 8 patients had right/nonfusion, and 1 patient had left/nonfusion. Leaflet reconstruction used central leaflet plication and cleft closure, with limited ultrasonic decalcification in 31 patients. Results: Ring size was 23 (21-23) mm, and 26 of 40 root procedures were selective nonfused sinus replacements. Aortic clamp time was 139 (112-170) minutes, and bypass time was 178 (138-217) minutes. Postrepair aortic insufficiency grade was 0 (0-0) (P < .0001), and mean valve gradient was 10 (7-14) mm Hg. No early and 1 late mortality occurred. Four patients required reoperation for bleeding, and 4 patients required pacemakers. At a mean follow-up of 20 months (maximal 93), there were no valve-related complications, 5 late repair failures prompting valve replacement, and 1 death due to Coronavirus Disease 2019. Conclusions: Geometric ring annuloplasty for bicuspid aortic valve repair with proximal aortic aneurysm reconstruction is safe and associated with good early outcomes. Further experience and follow-up will help inform long-term durability.

Multi-institutional Analysis of 505 Patients With Coronavirus Disease-2019 Supported With Extracorporeal Membrane Oxygenation: Predictors of Survival.

BACKGROUND: We reviewed our experience with 505 patients with confirmed coronavirus disease-2019 (COVID-19) supported with extracorporeal membrane oxygenation (ECMO) at 45 hospitals and estimated risk factors for mortality. METHODS: A multi-institutional database was created and used to assess all patients with COVID-19 who were supported with ECMO. A Bayesian mixed-effects logistic regression model was estimated to assess the effect on survival of multiple potential risk factors for mortality, including age at cannulation for ECMO as well as days between diagnosis of COVID-19 and intubation and days between intubation and cannulation for ECMO. RESULTS: Median time on ECMO was 18 days (interquartile range, 10-29 days). All 505 patients separated from ECMO: 194 patients (38.4%) survived and 311 patients (61.6%) died. Survival with venovenous ECMO was 184 of 466 patients (39.5%), and survival with venoarterial ECMO was 8 of 30 patients (26.7%). Survivors had lower median age (44 vs 51 years, P < .001) and shorter median time interval from diagnosis to intubation (7 vs 11 days, P = .001). Adjusting for several confounding factors, we estimated that an ECMO patient intubated on day 14 after the diagnosis of COVID-19 vs day 4 had a relative odds of survival of 0.65 (95% credible interval, 0.44-0.96; posterior probability of negative effect, 98.5%). Age was also negatively associated with survival: relative to a 38-year-old patient, we estimated that a 57-year-old patient had a relative odds of survival of 0.43 (95% credible interval, 0.30-0.61; posterior probability of negative effect, >99.99%). CONCLUSIONS: ECMO facilitates salvage and survival of select critically ill patients with COVID-19. Survivors tend to be younger and have shorter time from diagnosis to intubation. Survival of patients supported with only venovenous ECMO was 39.5%.

Cannulate, extubate, ambulate approach for extracorporeal membrane oxygenation for COVID-19.

OBJECTIVE: We compared outcomes in patients with severe COVID-19 versus non-COVID-19-related acute respiratory distress syndrome (ARDS) managed using a dynamic, goal-driven approach to venovenous extracorporeal membrane oxygenation (ECMO). METHODS: We performed a retrospective, single-center analysis of our institutional ECMO registry using data from 2017 to 2021. We used Kaplan-Meier plots, Cox proportional hazard models, and propensity score analyses to evaluate the association of COVID-19 status (COVID-19-related ARDS vs non-COVID-19 ARDS) and survival to decannulation, discharge, tracheostomy, and extubation. We also conducted subgroup analyses to compare outcomes with the use of extracorporeal cytoreductive techniques (CytoSorb [CytoSorbents Corp] and plasmapheresis). RESULTS: The sample comprised 128 patients, 50 with COVID-19 and 78 with non-COVID-19 ARDS. Advancing age was associated with decreased probability of survival to decannulation (P = .04). Compared with the non-COVID-19 ARDS group, patients with COVID-19 had a greater probability of survival to extubation (P < .01) and comparable survival to discharge (P = .14). CONCLUSIONS: Patients with COVID-19 managed with ECMO had comparable outcomes as patients with non-COVID ARDS. A strategy of early extubation and ambulation might be a safe and effective strategy to improve outcomes and survival, even for patients with severe COVID-19.

Multi-institutional Analysis of 200 COVID-19 Patients Treated With Extracorporeal Membrane Oxygenation: Outcomes and Trends.

BACKGROUND: The role of extracorporeal membrane oxygenation (ECMO) in the management of patients with COVID-19 continues to evolve. The purpose of this analysis is to review our multi-institutional clinical experience involving 200 consecutive patients at 29 hospitals with confirmed COVID-19 supported with ECMO. METHODS: This analysis includes our first 200 COVID-19 patients with complete data who were supported with and separated from ECMO. These patients were cannulated between March 17 and December 1, 2020. Differences by mortality group were assessed using χ2 tests for categoric variables and Kruskal-Wallis rank sum tests and Welch's analysis of variance for continuous variables. RESULTS: Median ECMO time was 15 days (interquartile range, 9 to 28). All 200 patients have separated from ECMO: 90 patients (45%) survived and 110 patients (55%) died. Survival with venovenous ECMO was 87 of 188 patients (46.3%), whereas survival with venoarterial ECMO was 3 of 12 patients (25%). Of 90 survivors, 77 have been discharged from the hospital and 13 remain hospitalized at the ECMO-providing hospital. Survivors had lower median age (47 versus 56 years, P < .001) and shorter median time from diagnosis to ECMO cannulation (8 versus 12 days, P = .003). For the 90 survivors, adjunctive therapies on ECMO included intravenous steroids (64), remdesivir (49), convalescent plasma (43), anti-interleukin-6 receptor blockers (39), prostaglandin (33), and hydroxychloroquine (22). CONCLUSIONS: Extracorporeal membrane oxygenation facilitates survival of select critically ill patients with COVID-19. Survivors tend to be younger and have a shorter duration from diagnosis to cannulation. Substantial variation exists in drug treatment of COVID-19, but ECMO offers a reasonable rescue strategy.

Retrospective serosurveillance for anti-SARS-CoV-2 immunoglobulin during a time of low prevalence: A cautionary tale.

We performed a retrospective screening of 428 serum samples for anti-SARS-CoV-2  immunoglobulin during a period of low prevalence. Employing two different serological tests yielded discrepant results for 10 samples; highlighting an increased risk of potential  false positive results and the need for further confirmatory testing before publication of data.

The Effect of COVID-19 on Adult Cardiac Surgery in the United States in 717 103 Patients.

BACKGROUND: COVID-19 has changed the world as we know it, and the United States continues to accumulate the largest number of COVID-related deaths worldwide. There exists a paucity of data regarding the effect of COVID-19 on adult cardiac surgery trends and outcomes on regional and national levels. METHODS: The Society of Thoracic Surgeons Adult Cardiac Surgery Database was queried from January 1, 2018, to June 30, 2020. The Johns Hopkins COVID-19 database was queried from February 1, 2020, to January 1, 2021. Surgical and COVID-19 volumes, trends, and outcomes were analyzed on a national and regional level. Observed-to-expected ratios were used to analyze risk-adjustable mortality. RESULTS: The study analyzed 717 103 adult cardiac surgery patients and more than 20 million COVID-19 patients. Nationally, there was a 52.7% reduction in adult cardiac surgery volume and a 65.5% reduction in elective cases. The Mid-Atlantic region was most affected by the first COVID-19 surge, with 69.7% reduction in overall case volume and 80.0% reduction in elective cases. In the Mid-Atlantic and New England regions, the observed-to-expected mortality for isolated coronary bypass increased as much as 1.48 times (148% increase) pre-COVID rates. After the first COVID-19 surge, nationwide cardiac surgical case volumes did not return to baseline, indicating a COVID-19-associated deficit of cardiac surgery patients. CONCLUSIONS: This large analysis of COVID-19-related impact on adult cardiac surgery volume, trends, and outcomes found that during the pandemic, cardiac surgery volume suffered dramatically, particularly in the Mid-Atlantic and New England regions during the first COVID-19 surge, with a concurrent increase in observed-to-expected 30-day mortality.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroconversion in hematology-oncology patients.

Since the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in China at the end of 2019, the virus has spread rapidly across the globe leading to millions of infections and subsequent deaths. Although the virus infects those exposed indiscriminately, there are groups in society at an increased risk of severe infection, leading to increased morbidity. Patients suffering from hematological cancers, particularly leukemia, lymphoma, and myeloma, may be one such group and previous studies have suggested that they may be at a three to four times greater risk of severe COVID-19 after SARS-CoV-2 infection, leading to admissions to ICU, mechanical ventilation, and death compared to those without such malignancies. Serological testing for IgG seroconversion has been extensively studied in the immunocompetent, but fewer publications have characterized this process in large series of immunocompromised patients. This study described 20 patients with hematological cancers who tested positive for SARS-CoV-2 via PCR with 12 of the patients receiving further serological testing. We found that of the 12 patients screened for SARS-CoV-2 IgG antibodies, only 2 (16.6%) were able to generate an immune response to the infection. Yet despite this low seroconversion rate in this cohort, none of these patients died or became particularly unwell with COVID-19 or its related complications.

Outcome and Cost of Nurse-Led vs Perfusionist-led Extracorporeal Membrane Oxygenation.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a resource-intense modality of care whose use has grown exponentially. We examined volume and utilization trends to identify the financial break-even point that might serve to dichotomize between nurse specialist-led and perfusionist-led ECMO programs. METHODS: Data pertaining to patients who required ECMO support between 2018 and 2019 were reviewed. ECMO staffing costs were estimated based on national trends and modeled by annual utilization and case volume. A break-even point was derived from a comparison between nurse specialist-led and perfusionist-led models. For each scenario, direct medical costs were calculated based on utilization, which was in turn defined by "low" (4 days), "average" (10 days), and "high" (30 days) duration of time spent on ECMO. RESULTS: Within the study time frame, there was a total of 107 ECMO cases with a mean ECMO duration of 11 days. Overall, ECMO nursing personnel costs were less than those for perfusionists ($108,000 vs $175,000). Programmatic costs were higher in the perfusionist-led vs nurse specialist-led model when annual utilization was greater than 10 cases and ECMO duration was longer than a mean of 9.7 days. There was no difference in survival between the 2 models. CONCLUSIONS: Use of a perfusionist-led ECMO model may be more cost-conscious in the context of low utilization, smaller case volume and shorter ECMO duration. However, once annual case volume exceeds 10 and mean ECMO duration exceeds 10 days, the nurse specialist-led model may be more cost-conscious.

Multi-institutional Analysis of 100 Consecutive Patients with COVID-19 and Severe Pulmonary Compromise Treated with Extracorporeal Membrane Oxygenation: Outcomes and Trends Over Time.

The role of extracorporeal membrane oxygenation (ECMO) in the management of severely ill patients with coronavirus disease 2019 (COVID-19) continues to evolve. The purpose of this study is to review a multi-institutional clinical experience in 100 consecutive patients, at 20 hospitals, with confirmed COVID-19 supported with ECMO. This analysis includes our first 100 patients with complete data who had confirmed COVID-19 and were supported with ECMO. The first patient in the cohort was placed on ECMO on March 17, 2020. Differences by the mortality group were assessed using χ2 tests for categorical variables and Kruskal-Wallis rank-sum tests and Welch's analysis of variance for continuous variables. The median time on ECMO was 12.0 days (IQR = 8-22 days). All 100 patients have since been separated from ECMO: 50 patients survived and 50 patients died. The rate of survival with veno-venous ECMO was 49 of 96 patients (51%), whereas that with veno-arterial ECMO was 1 of 4 patients (25%). Of 50 survivors, 49 have been discharged from the hospital and 1 remains hospitalized at the ECMO-providing hospital. Survivors were generally younger, with a lower median age (47 versus 56.5 years, p = 0.014). In the 50 surviving patients, adjunctive therapies while on ECMO included intravenous steroids (26), anti-interleukin-6 receptor blockers (26), convalescent plasma (22), remdesivir (21), hydroxychloroquine (20), and prostaglandin (15). Extracorporeal membrane oxygenation may facilitate salvage and survival of selected critically ill patients with COVID-19. Survivors tend to be younger. Substantial variation exists in the drug treatment of COVID-19, but ECMO offers a reasonable rescue strategy.

Utilization of Thromboelastogram and Inflammatory Markers in the Management of Hypercoagulable State in Patients with COVID-19 Requiring ECMO Support.

The role of extracorporeal membrane oxygenation (ECMO) in the management of critically ill patients with COVID-19 is evolving. Extracorporeal support independently confers an increased predilection for thrombosis, which can be exacerbated by COVID-19-associated coagulopathy. We present the successful management of a hypercoagulable state in two patients who required venovenous ECMO for the treatment of COVID-19. This included monitoring inflammatory markers (D-dimer and fibrinogen), performing a series of therapeutic plasma exchange procedures, and administering high-intensity anticoagulation therapy and thromboelastography- (TEG-) guided antiplatelet therapy. TPE was performed to achieve goal D-dimer less than 3000 ng/mL D-dimer units (N ≤ 232 ng/mL D-dimer units) and goal fibrinogen less than 600 mg/dL (N = 200-400 mg/dL). These therapies resulted in improved TEG parameters and normalized inflammatory markers. Patients were decannulated after 37 days and 21 days, respectively. Post-ECMO duplex ultrasound of the upper and lower extremities and cannulation sites revealed a nonsignificant deep venous thrombosis at the site of femoral cannulation in patient 2 and no deep venous thrombosis in patient 1. The results of this case report show successful management of a hypercoagulable state among COVID-19 patients requiring ECMO support by utilization of inflammatory markers and TEG.

Extracorporeal Membrane Oxygenation in the Treatment of Severe Pulmonary and Cardiac Compromise in Coronavirus Disease 2019: Experience with 32 Patients.

As coronavirus disease 2019 (COVID-19) cases surge worldwide, an urgent need exists to enhance our understanding of the role of extracorporeal membrane oxygenation (ECMO) in the management of severely ill patients with COVID-19 who develop acute respiratory and cardiac compromise refractory to conventional therapy. The purpose of this manuscript is to review our initial clinical experience in 32 patients with confirmed COVID-19 treated with ECMO. A multi-institutional registry and database was created and utilized to assess all patients who were supported with ECMO provided by SpecialtyCare. Data captured included patient characteristics, pre-COVID-19 risk factors and comorbidities, confirmation of COVID-19 diagnosis, features of ECMO support, specific medications utilized to treat COVID-19, and short-term outcomes through hospital discharge. This analysis includes all of our patients with COVID-19 supported with ECMO, with an analytic window starting March 17, 2020, when our first COVID-19 patient was placed on ECMO, and ending April 9, 2020. During the 24 days of this study, 32 consecutive patients with COVID-19 were placed on ECMO at nine different hospitals. As of the time of analysis, 17 remain on ECMO, 10 died before or shortly after decannulation, and five are alive and extubated after removal from ECMO, with one of these five discharged from the hospital. Adjunctive medication in the surviving patients while on ECMO was as follows: four of five survivors received intravenous steroids, three of five survivors received antiviral medications (Remdesivir), two of five survivors were treated with anti-interleukin-6-receptor monoclonal antibodies (Tocilizumab or Sarilumab), and one of five survivors received hydroxychloroquine. Analysis of these 32 COVID-19 patients with severe pulmonary compromise supported with ECMO suggests that ECMO may play a useful role in salvaging select critically ill patients with COVID-19. Additional patient experience and associated clinical and laboratory data must be obtained to further define the optimal role of ECMO in patients with COVID-19 and acute respiratory distress syndrome (ARDS). These initial data may provide useful information to help define the best strategies to care for these challenging patients and may also provide a framework for much-needed future research about the use of ECMO to treat patients with COVID-19.