Effect of geography on the use of ultrafiltration during cardiac surgery with cardiopulmonary bypass.

BACKGROUND: Ultrafiltration (UF) is a common practice during cardiopulmonary bypass (CPB) where it is used as a blood management strategy to reduce red blood cell (RBC) transfusion, minimize adverse effects of hemodilution, and reduce proinflammatory mediators. However, its clinical utilization has been shown to vary throughout the continents. PURPOSE: The purpose of this investigation was to assess the distribution of UF use across the United States. DATA COLLECTION: Data on UF use during cardiac surgery was obtained from a national (United States) perfusion database for adult cardiac procedures performed from January 2016 through December 2018. STUDY SAMPLE: Four geographical regions were established: Northeast (NE), South (SO), Midwest (MW) and West (WE). The primary endpoint was the use of UF with secondary endpoints UF volume, CPB and anesthesia asanguineous volumes, intraoperative allogeneic RBC transfusion, nadir hematocrit and urine output (UO). 92,859 adult cardiac cases from 191 hospitals were reviewed. RESULTS: The NE and the WE had similar usages of UF (59.9% and 59.7% respectively), which were higher than the MW and the SO (38.6% and 34.9%, p < .001). When UF was utilized, the median [IQR] volume removed was highest in the NE (1900 [1200-2800]mL), and similar in all other regions (WE 1500 [850-2400 mL, MW 1500 [900-2300]mL and SO 1500 [950-2200]mL, p < .001. Median total UO was lowest in the NE 400 [210,650]mL vs all other regions (p < .001), and remained so when indexed by patient weight and operative time (NE-0.8 [0.5, 1.3]mL/kg/hour, MW-1.1 [0.7, 1.8] mL/kg/hour, SO-1.3 [0.8, 2.0]mL/kg/hour, WE-1.1 [0.7, 1.3]mL/kg/hour, p < .001. Intraoperative RBC transfusion rate was highest in the SO (21.3%) and WE (20.5%), while similar rates seen in the NE (16.2%) and MW (17.6%), p < .001. CONCLUSIONS: Across the United States there is geographic variation on the use of UF. Further research is warranted to investigate why these practice variations exist and to better understand and determine their reasons for use.

Establishment of a national quality improvement process on oxygen delivery index during cardiopulmonary bypass.

Targeted oxygen delivery during cardiopulmonary bypass (CPB) has received significant attention due to its influence on patient outcomes, especially in mitigating acute kidney injury. While it has gained popularity in select institutions, there remains a gap in establishing it globally across multiple centers. The purpose of this investigation was to describe the development of a quality improvement process of targeted oxygen delivery during CPB across hospitals throughout the United States. A systematic approach to utilize oxygen delivery index (DO2i) as a key performance indicator within hospitals serviced by a national provider of perfusion services. The process included a review of the current literature on DO2i, which yielded a target nadir value (272 mL/min/m2) and an area under the curve (DO2i272AUC) cut off of 632. All data is displayed on a dashboard with results categorized across multiple levels from system-wide to individual clinician performance. From January 2020 through December 2022, DO2i data from 91 hospitals and 11,165 coronary artery bypass graft procedures were collected. During this period the monthly proportion of DO2i measurements above the target nadir DO2i272 ranged from 60.5% to 78.4% with a mean+/-SD of 70.8 +/- 4.2%. Binary logistic regression for the first 7 months following monthly DO2i performance reporting has shown a statistically significant positive linear trend in the probability of achieving the target DO2i272 (p < .001), with a crude increase of approximately 7.8% for DO2i272AUC, and a 73.8% success rate (p < .001). A survey was sent to all individuals measuring oxygen delivery during CPB to assess why a target DO2i272 could not be reached. The two most common responses were an 'inability to improve CPB flow rates' and 'restrictive allogeneic red blood cell transfusion policies'. This study demonstrates that targeting a minimum level of oxygen delivery can serve as a key performance indicator during CPB using a structured quality improvement process.

Exeporfinium chloride (XF-73) nasal gel dosed over 24 hours prior to surgery significantly reduced Staphylococcus aureus nasal carriage in cardiac surgery patients: Safety and efficacy results from a randomized placebo-controlled phase 2 study.

We studied 83 cardiac-surgery patients with nasal S. aureus carriage who received 4 intranasal administrations of XF-73 nasal gel or placebo <24 hours before surgery. One hour before surgery, patients exhibited a S. aureus nasal carriage reduction of 2.5 log10 with XF-73 compared to 0.4 log10 CFU/mL for those who received placebo (95% CI, -2.7 to -1.5; P < .0001).

Variation in outcomes with extracorporeal membrane oxygenation in the era of coronavirus: A multicenter cohort evaluation.

Extracorporeal membrane oxygenation (ECMO) is used in critically ill patients with coronavirus disease 2019 (COVID-19) with acute respiratory distress syndrome unresponsive to other interventions. However, a COVID-19 infection may result in a differential tolerance to both medical treatment and ECMO management. The aim of this study was to compare outcomes (mortality, organ failure, circuit complications) in patients on ECMO with and without COVID-19 infection, either by venovenous (VV) or venoarterial (VA) cannulation. This is a multicenter, retrospective analysis of a national database of patients placed on ECMO between May 2020 and January 2022 within the United States. Nine-hundred thirty patients were classified as either Pulmonary (PULM, n = 206), Cardiac (CARD, n = 279) or COVID-19 (COVID, n = 445). Patients were younger in COVID groups: PULM = 48.4 ± 15.8 years versus COVID = 44.9 ± 12.3 years, p = 0.006, and CARD = 57.9 ± 15.4 versus COVID = 46.5 ± 11.8 years, p < 0.001. Total hours on ECMO were greatest for COVID patients with a median support time two-times higher for VV support (365 [101, 657] hours vs 183 [63, 361], p < 0.001), and three times longer for VA support (212 [99, 566] hours vs 70 [17, 159], p < 0.001). Mortality was highest for COVID patients for both cannulation types (VA-70% vs 51% in CARD, p = 0.041, and VV-59% vs PULM-42%, p < 0.001). For VA supported patients hepatic failure was more often seen with COVID patients, while for VV support renal failure was higher. Circuit complications were more frequent in the COVID group as compared to both CARD and PULM with significantly higher circuit change-outs, circuit thromboses and oxygenator failures. Anticoagulation with direct thrombin inhibitors was used more often in COVID compared to both CARD (31% vs 10%, p = 0.002) and PULM (43% vs 15%, p < 0.001) groups. This multicenter observational study has shown that COVID patients on ECMO had higher support times, greater hospital mortality and higher circuit complications, when compared to patients managed for either cardiac or pulmonary lesions.

A Practical Approach to Left Main Coronary Artery Disease: JACC State-of-the-Art Review.

The treatment of left main (LM) coronary artery disease (CAD) requires complex decision-making. Recent clinical practice guidelines provide clinicians with guidance; however, decisions regarding treatment for individual patients can still be difficult. The American College of Cardiology's Cardiac Surgery Team and Interventional Council joined together to develop a practical approach to the treatment of LM CAD, taking into account randomized clinical trial, meta-analyses, and clinical practice guidelines. The various presentations of LM CAD based on anatomy and physiology are presented. Recognizing the complexity of LM CAD, which rarely presents isolated and is often in combination with multivessel disease, a treatment algorithm with medical therapy alone or in conjunction with percutaneous coronary intervention or coronary artery bypass grafting is proposed. A heart team approach is recommended that accounts for clinical, procedural, operator, and institutional factors, and features shared decision-making that meets the needs and preferences of each patient and their specific clinical situation.

Surgical Triage and Timing for Patients With Coronavirus Disease: A Guidance Statement from The Society of Thoracic Surgeons.

The coronavirus disease 2019 (COVID-19) pandemic continues to disrupt the provision of cardiac procedural services due to overwhelming interval surges in COVID-19 cases and the associated crisis of cardiac intervention deferment. Despite the availability of widespread testing, highly efficacious vaccines, and intensive public health efforts, the pandemic is entering its third year, where new severe acute respiratory syndrome-coronavirus-2 variants have increased the likelihood that patients scheduled for a cardiac intervention will contract COVID-19 in the perioperative period. The Society of Thoracic Surgeons (STS) Workforce on Critical Care, the STS Workforce on Adult Cardiac and Vascular Surgery, and the Canadian Society of Cardiac Surgeons have developed this document, endorsed by the STS and affirmed by the Society of Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology, to provide guidance for cardiac procedure deferment and intervention timing for preoperative patients diagnosed with COVID-19. This document is intended for the perioperative cardiac surgical team and outlines the present state of the pandemic, the impact of COVID-19 on intervention outcome, and offers a recommended algorithm for individualized cardiac procedure triage and timing.

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%.

The assessment of patients undergoing cardiac surgery for Covid-19: Complications occurring during cardiopulmonary bypass.

The outbreak of the novel coronavirus pandemic (COVID-19) has resulted in dramatic changes to the conduct of surgery both from a patient management perspective and in protecting healthcare providers. The current study reports on the status of COVID-19 infections in patients presenting for cardiac surgery with cardiopulmonary bypass (CPB) on circuit complications. A tracking process for monitoring the presence of COVID-19 in adult cardiac surgery patients was integrated into a case documentation system across United States hospitals where out-sourced perfusion services were provided. Assessment included infection status, testing technique employed, surgery status and CPB complications. Records from 5612 adult patients who underwent cardiac surgery between November 1, 2020 and January 18, 2021 from 176 hospitals were reviewed. A sub-cohort of coronary artery bypass graft patients (3283) was compared using a mixed effect binary logistic regression analysis. 4297 patients had negative test results (76.6%) while 49 (0.9%) tested positive for COVID-19, and unknown or no results were reported in 693 (12.4%) and 573 (10.2%) respectively. Coagulation complications were reported at 0.2% in the negative test results group versus 4.1% in the positive test result group (p < 0.001). Oxygenator gas exchange complications were 0.2% in the negative test results group versus 2.0% in the positive test results group (p = 0.088). Coronary artery bypass graft patients with a positive test had significantly higher risk for any CPB complication (p = 0.003) [OR 10.38, CI 2.18-49.53] then negative test patients [OR 0.01, CI 0.00-0.20]. The present study has shown that patients undergoing cardiac surgery with CPB who test positive for COVID-19 have higher CPB complication rate than those who test negative.

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.

Anticoagulant Use During Extracorporeal Membrane Oxygenation Using Heparin and Direct Thrombin Inhibitors in COVID-19 and ARDS Patients.

Coagulopathies develop in patients supported with the use of extracorporeal membrane oxygenation (ECMO) and can be hemorrhagic and/or thrombophilic in spite of the use of systemic anticoagulation. The purpose this study was to examine the use of heparin and direct thrombin inhibitors (DTI) in COVID-19 patients with acute respiratory distress syndrome (ARDS) on ECMO, with a subset analysis by disease state. Following IRB approval, 570 consecutive records were reviewed of adult patients on venovenous ECMO between May 2020 and December 2021. Patients were grouped by anticoagulant use: Heparin Only (n = 373), DTI Only (bivalirudin or argatroban, n = 90), or DTI after Heparin (n = 107). The effect of anticoagulant grouping was assessed using Bayesian mixed-effects logistic regression adjusting for age, body mass index (BMI), gender, days of mechanical ventilation prior to ECMO, indication for ECMO support, hepatic and renal failure, hours on ECMO, hours off anticoagulation, coagulation monitoring target, and hospital. The primary endpoint was circuit failure requiring change-out with secondary endpoints of organ failure and mortality. Regression-adjusted probability of circuit change-outs were as follows: DTI after Heparin patients-32.7%, 95% Credible Interval [16.1-51.9%]; DTI Only patients-23.3% [7.5-40.8%]; and Heparin Only patients-19.8% [8.1-31.3%]. The posterior probability of difference between groups was strongest for DTI after Heparin vs. Heparin Only (97.0%), moderate for DTI after Heparin vs. DTI Only (88.2%), and weak for DTI Only vs. Heparin only (66.6%). The occurrence of both hepatic and renal failure for DTI Only and DTI after Heparin patients was higher than that of Heparin Only patients. Unadjusted mortality was highest for DTI after Heparin (64.5%) followed by DTI Only (56.7%), and Heparin Only (50.1%, p = 0.027). DTI after Heparin was associated with an increased likelihood of circuit change-out. Unadjusted hepatic failure, renal failure, and mortality were more frequent among DTI patients than Heparin Only patients.

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.

Surgeons' re-operative valve replacement practices in patients with endocarditis due to drug use.

BACKGROUND: This study discerns surgeons' attitudes and practices in the determination of heart valve replacement for patients with infectious endocarditis (IE) due to intravenous drug use (IVDU). We aimed to identify the factors contributing to surgeons' decision-making process for initial and recurrent surgical heart valves and the availability of institutional guidance. METHODS: An IRB-approved, anonymous mixed-methods, open survey instrument was designed and validated with 24 questions. A convenience sample of cardiothoracic surgeons in the United States and globally resulted in a total of 220 study participants with 176 completing every question on the survey. RESULTS: A cluster analysis revealed that although surgeons can be divided into subgroups based on their previous experience with valve replacements, these groups are not perfectly homogenous, and the number of identified clusters is dependent on technique used. Analysis of variance revealed the variables that most clearly divided the surgeons into subgroups were, in order of importance, years of practice, number of valve replacements, and geography. CONCLUSIONS: Our analysis showed heterogeneity among cardiothoracic surgeons regarding how they make clinical decisions regarding re-operative valve replacement related to IE-IVDU. Therefore, an opportunity exists for interprofessional teams to develop comprehensive guidelines to decrease variability in surgical decision-making regarding valve replacement associated with IE-IVDU.

The 2019-2020 Novel Coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2) Pandemic: A Joint American College of Academic International Medicine-World Academic Council of Emergency Medicine Multidisciplinary COVID-19 Working Group Consensus Paper.

What started as a cluster of patients with a mysterious respiratory illness in Wuhan, China, in December 2019, was later determined to be coronavirus disease 2019 (COVID-19). The pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel Betacoronavirus, was subsequently isolated as the causative agent. SARS-CoV-2 is transmitted by respiratory droplets and fomites and presents clinically with fever, fatigue, myalgias, conjunctivitis, anosmia, dysgeusia, sore throat, nasal congestion, cough, dyspnea, nausea, vomiting, and/or diarrhea. In most critical cases, symptoms can escalate into acute respiratory distress syndrome accompanied by a runaway inflammatory cytokine response and multiorgan failure. As of this article's publication date, COVID-19 has spread to approximately 200 countries and territories, with over 4.3 million infections and more than 290,000 deaths as it has escalated into a global pandemic. Public health concerns mount as the situation evolves with an increasing number of infection hotspots around the globe. New information about the virus is emerging just as rapidly. This has led to the prompt development of clinical patient risk stratification tools to aid in determining the need for testing, isolation, monitoring, ventilator support, and disposition. COVID-19 spread is rapid, including imported cases in travelers, cases among close contacts of known infected individuals, and community-acquired cases without a readily identifiable source of infection. Critical shortages of personal protective equipment and ventilators are compounding the stress on overburdened healthcare systems. The continued challenges of social distancing, containment, isolation, and surge capacity in already stressed hospitals, clinics, and emergency departments have led to a swell in technologically-assisted care delivery strategies, such as telemedicine and web-based triage. As the race to develop an effective vaccine intensifies, several clinical trials of antivirals and immune modulators are underway, though no reliable COVID-19-specific therapeutics (inclusive of some potentially effective single and multi-drug regimens) have been identified as of yet. With many nations and regions declaring a state of emergency, unprecedented quarantine, social distancing, and border closing efforts are underway. Implementation of social and physical isolation measures has caused sudden and profound economic hardship, with marked decreases in global trade and local small business activity alike, and full ramifications likely yet to be felt. Current state-of-science, mitigation strategies, possible therapies, ethical considerations for healthcare workers and policymakers, as well as lessons learned for this evolving global threat and the eventual return to a "new normal" are discussed in this article.

A Case of Postoperative Covid-19 Infection After Cardiac Surgery: Lessons Learned.

While the focus of the medical community is on the management of COVID-19 and its associated complex presentations, it is critical to recognize that patients will continue to present with other medical problems that require urgent therapeutic interventions. There is growing concern that such interventions might have an impact on the natural history of COVID-19. We present a case of a patient who presented with unstable angina and multivessel coronary artery disease for which coronary artery bypass surgery was indicated and performed. Unfortunately, he succumbed to respiratory complications attributed to COVID-19. Our experience suggests concern about adverse outcomes in patients undergoing cardiac surgery who might be infected with COVID-19. Clearly, additional investigations and experience are needed.

Successful COVID-19 rescue therapy by extra-corporeal membrane oxygenation (ECMO) for respiratory failure: a case report.

BACKGROUND: The value of extracorporeal membrane oxygenation (ECMO) for patients suffering from novel coronavirus disease 2019 (COVID-19) as a rescue therapy for respiratory failure remains controversial and associated with high mortality rates of 50 to 82% in early reports from Wuhan, China. We hypothesized that patient outcomes would be improved at our tertiary cardiothoracic surgery referral center with a protocolized team-approach for ECMO treatment of patients with severe COVID-19 disease. CASE PRESENTATION: A 51-year-old healthy female developed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) bilateral pneumonia while vacationing in Colorado with her family. She was transferred to our facility for a higher level of care. Her respiratory status continued to deteriorate despite maximized critical care, including prone positioning ventilation and nitric oxide inhalation therapy. Veno-venous ECMO was initiated on hospital day 7 in conjunction with a 10-day course of compassionate use antiviral treatment with remdesivir. The patient's condition improved significantly and she was decannulated from ECMO on hospital day 17 (ECMO day 11). She was successfully extubated and eventually discharged to rehabilitation on hospital day 28. CONCLUSION: This case report demonstrates a positive outcome in a young patient with COVID-19 treated by the judicious application of ECMO in conjunction with compassionate use antiviral treatment (remdesivir). Future prospective multi-center studies are needed to validate these findings in a larger cohort of patients.

Isolation protocol for a COVID-2019 patient requiring emergent surgical intervention: case presentation.

BACKGROUND: The concerns of the highly contagious and morbid nature of Coronavirus Disease-2019 (COVID-2019) have prompted healthcare workers to implement strict droplet and contact isolation precautions. Unfortunately, some patients who may be or presumptively or confirmed as infected with COVID-2019 may also require emergent surgical procedures. As such, given the high-risk for exposure of many healthcare workers involved the complex requirements for appropriate isolation must be adhered to. CASE PRESENTATION: We present our experience with a 77-year-old who required emergency cardiac surgery for a presumed acute aortic syndrome in the setting of a presumed, and eventually confirmed, COVID-2019 infection. We outline the necessary steps to maintain strict isolation precautions to limit potential exposure to the surgical Team. CONCLUSIONS: We hereby provide our algorithm for emergent surgical procedures in critically-ill patients with presumptive or confirmed infection with COVID-2019. The insights from this case report can potentially be templated to other facilities in order to uphold high standards of infection prevention and patient safety in surgery during the current COVID-19 pandemic.

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.

Epicardial left atrial appendage occlusion with a new medical device: assessment of procedural feasibility, safety and efficacy in a large animal model.

BACKGROUND: Left atrial appendage occlusion (LAAO) represents a treatment alternative to anticoagulation in patients with atrial fibrillation. We evaluate a novel device for epicardial LAAO in a translational canine model. METHODS: Nine hounds (n = 9) were used to assess usability, safety, and efficacy of the TigerPaw Pro (TPP) device for epicardial LAAO. Following baseline imaging (intra-cardiac echocardiography (ICE) and angiography) and intraoperative visual inspection, usability was tested via a ``closure/re-opening`` maneuver followed by deployment of a total of twenty TPP devices (n = 20) on the left and right atrial appendages respectively. Procedural safety was evaluated by assessing for adverse-events via direct Epicardial inspection and endocardial imaging. Efficacy evaluation included assessment of device positioning, presence of residual stumps and completeness of closure. Post-mortem evaluation was performed to confirm safety and efficacy. RESULTS: Usability testing of all TPP devices was successful (n = 20;100%, delivery-time range 22-120 s) without any procedural adverse-events (tissue damage or tears, bleeding, vessel-impingement, structural impact). All devices fully traversed the ostium (n = 18) or appendage body (n = 2), and conformed smoothly to adjacent cardiac anatomy. In nineteen deployments (n = 19;95%), all device connector pairs were fully engaged, while in one TPP device the most distal pair remained unengaged. ICE and post-mortem inspections revealed complete closure of all appendage ostia (n = 18;100%) and only in one case a small residual stump was detected. Intraoperative safety findings were further confirmed post-mortem. Devices created a nearly smooth line of closure via symmetric endocardial tissue-coaptation. CONCLUSIONS: In this preclinical model, the TPP demonstrated good ease of use for ostial access, ability to re-position (after engagement) and rapid deployment, while achieving safe and effective LAAO.