Use of novel oxygenated right ventricular assist device hybrid ECLS for adolescents with refractory hypoxemic respiratory dailure due to Covid-19 pneumonia

Objectives: To describe institutional experience using Oxygenated Right Ventricular Assist Device (OxyRVAD) Hybrid ECLS for adolescents with respiratory failure due to SARS-CoV-2 pneumonia. Method(s): Between September and December 2021, 44 Covid-19+ patients were admitted to our regional Pediatric Intensive Care Unit (PICU), including 4 adolescents who required Extracorporeal life support (ECLS) due to refractory hypoxemia. Two patients were initially cannulated onto Veno-Venous (VV) ECLS and converted to Oxy-RVAD ECLS due to refractory hypoxemia;the others were cannulated directly onto Oxy-RVAD ECLS. Two patients had observed right ventricular (RV) dysfunction or failure on echocardiography. Cannulations were performed in the cardiac catheterization suite by an interventional cardiologist using percutaneous technique under fluoroscopy. Circuit construction was varied and included the use of a dedicated RVAD cannula or standard cannula used for VA/VV ECLS. All patients were connected to Cardiohelp systems with built in centrifugal pumps and oxygenators. Result(s): Two patients were initially placed on VV-ECLS and converted to Oxy-RVAD ECLS days into their course due to severe, refractory hypoxemia with one having improvement in hypoxemia after the conversion. Two patients received renal replacement therapy (RRT) without complications, the others did not have indications for renal support. Two patients underwent tracheostomy on ECMO though none were able to separate from mechanical ventilation. Three patients survived to discharge. No incidents of circuit air or clotting were noted. The patient with the longest ECLS run required one circuit change and was the only patient to develop a superinfection: a successfully-treated fungal infection. All patients were mobilized on ECLS to sitting in a chair;one was able to ambulate. Conclusion(s): Oxy-RVAD hybrid ECLS can be used to effectively support adolescents with severe respiratory disease from conditions associated with RV dysfunction. Pediatric providers can collaborate with adult critical care colleagues to use novel methods to support these patients. RRT can also be used with this circuit. While more experience and data on this modality is needed, Oxy-RVAD ECLS should be considered in patients with severe RV dysfunction and associated refractory hypoxemia. (Figure Presented).

Use of Novel Oxygenated Right Ventricular Assist Device Hybrid ECLS for Adolescents with Refractory Hypoxemic Respiratory Failure due to Covid-19 Pneumonia

Objective: To describe institutional experience using Oxygenated Right Ventricular Assist Device Oxy-RVAD) Hybrid ECLS for adolescents with respiratory failure due to SARS-CoV-2 pneumonia. Method(s): Between September and December 2021, 44 Covid-19+ patients were admitted to our regional Pediatric Intensive Care Unit (PICU) including 4 adolescents who required Extracorporeal life support (ECLS) due to refractory hypoxemia. Two patients were initially cannulated onto Veno-Venous (VV) ECLS and converted to Oxy-RVAD ECLS due to refractory hypoxemia;the others were cannulated directly onto Oxy-RVAD ECLS. Two patients had observed right ventricular dysfunction (RV) or failure on echocardiography. Cannulations were performed in the cardiac catheterization suite by an interventional cardiologist using percutaneous technique under fluoroscopy. Circuit construction was varied and included the use of a dedicated RVAD cannula or standard cannula used for VA/VV ECLS. All patients were connected to CardiohelpTM systems with built-in centrifugal pumps and oxygenators. Result(s): Two patients were initially placed on VV-ECLS and converted to Oxy-RVAD ECLS days into their course due to severe, refractory hypoxemia with one having improvement in hypoxemia after the conversion. Two patients were cannulated directly to Oxy-RVAD ECLS support. Two patients received renal replacement therapy (RRT) without complications, the others did not have indications for renal support. Two patients underwent tracheostomy on ECMO though none were able to separate from mechanical ventilation. Three patients survived to discharge. No incidents of circuit air or clotting were noted. The patient with the longest ECLS run required one circuit change and was the only patient to develop a superinfection: a successfully-treated fungal infection. All patients were mobilized on ECLS to sitting in a chair;one was able to ambulate. Conclusion(s): Oxy-RVAD hybrid ECLS can be used to effectively support adolescents with severe respiratory disease from conditions associated with RV dysfunction. Pediatric providers can collaborate with adult-focused colleagues to use novel methods to support these patients. RRT can also be used with this circuit. While more experience and data on this modality is needed, Oxy-RVAD ECLS should be considered in patients with severe RV dysfunction and associated refractory hypoxemia.

Oxygenated right ventricular assist device as part of veno-venopulmonary extracorporeal membrane oxygenation to support the right ventricle and pulmonary vasculature.

COVID-19 infection can lead to severe acute respiratory distress syndrome (ARDS), right ventricular (RV) failure and pulmonary hypertension. Venovenous extracorporeal membrane oxygenation (V-V ECMO) has been used for patients with refractory hypoxemia. More recently dual-lumen right atrium to pulmonary artery oxygenated right ventricular assist devices (Oxy-RVAD) have been utilized in the severe medical refractory COVID ARDS setting. Historically, animal data has demonstrated that high continuous non-pulsatile RVAD flows, leading to unregulated and unprotected circulation through the pulmonary vessels is associated with an increased risk of pulmonary hemorrhage and increased amount of extravascular lung water. These risks are heightened in the setting of ARDS with fragile capillaries, left ventricular (LV) diastolic failure, COVID cardiomyopathy, and anticoagulation. Concurrently, due to infection, tachycardia, and refractory hypoxemia, high V-V ECMO flows to match high cardiac output are often necessary to maintain systemic oxygenation. Increase in cardiac output without a concurrent increase in VV ECMO flow will result in a higher fraction of deoxygenated blood returning to the right heart and therefore resulting in hypoxemia. Several groups have suggested using a RVAD only strategy in COVID ARDS; however, this exposes the patients to the risk of pulmonary hemorrhage. We present one of the first known cases using an RV mechanical support, partial flow pulmonary circulation, oxygenated Veno-venopulmonary (V-VP) strategy resulting in RV recovery, total renal recovery, awake rehabilitation, and recovery.

Successful Use of Biventricular Assist Devices in Fulminant Myocarditis

Background Fulminant myocarditis can cause biventricular dysfunction with a mortality rate over 40%. We report a case with severe biventricular failure due to fulminant myocarditis that was successfully supported by left and right ventricular assist devices. Case A 65-year-old woman presented with chest pain, abdominal pain and diarrhea. She was hypotensive and labs revealed elevated troponin-T of 13.5 ng/mL and lactate of 4.3 mmol/L. She was positive for COVID by antigen testing. She was started on multiple vasopressor infusions and admitted to the intensive care unit. Echocardiogram revealed a severely reduced left ventricular ejection fraction of 15% and severe global hypokinesis. The following day, she developed a wide complex tachycardia that was refractory to amiodarone, lidocaine and multiple defibrillation attempts. She was transferred emergently to the cardiac cath lab where coronary angiography revealed an isolated 70% stenosis of the distal left circumflex artery. A Swan-Ganz catheter was placed that yielded a cardiac index by Fick of 1.2 L/min/m2, systemic vascular resistance of 1270 dynesseccm-5 and mixed venous oxygen saturation of 35%. Decision was made to emergently insert an Impella CP device. That evening, she developed complete heart block and transvenous pacing wire was inserted. Due to frequent suction alarms, decision was made to insert ProtekDuo device, which resulted in hemodynamic stabilization. A temporary coronary sinus pacing lead for atrial capture was inserted to improve atrioventricular synchrony. After several days of monitoring, repeat echocardiogram showed complete recovery of biventricular function and Impella CP and ProtekDuo devices were removed. Decision-making The decision of early implantation of ProtekDuo device was made to provide adequate blood flow to the left ventricular assist device for hemodynamic support. In addition, increased atrioventricular synchrony via insertion of temporary coronary sinus pacing wire improved cardiac output. Conclusion Fulminant myocarditis involving biventricular dysfunction can be supported by the use of simultaneous left and right ventricular assist devices.Copyright © 2023 American College of Cardiology Foundation

Evaluating Outcomes of Extracorporeal Life Support Use in Peripartum Patients: A Single Institution Experience

Background Indications and practice of extracorporeal membrane oxygenation (ECMO) use in pregnant patients are known;however, there is minimal evidence outside of meta-analysis and case series that comprehensively documents the outcomes. This study systematically evaluates the outcomes of ECMO utilization for peripartum patients in the setting of respiratory and/or cardiovascular failure. Methods All peripartum patients from 2018 to 2021 from a single center were screened to see if ECMO was initiated in the setting of cardiac, pulmonary, or combined failure. 15 patients met inclusion criteria of requiring ECMO while pregnant or up until 6 weeks postpartum. The patient demographics;operative details;ECMO registry data;critical care characteristics;adverse events per the codes for extracorporeal life support complications;and adverse outcome for maternal, fetus, and neonates were all collected. Results The cohort studied had a mean age of 30.3 years old, was racially diverse, and had few preexisting medical conditions before pregnancy. ECMO was indicated in 10/15 patients due to COVID-19 and 4/15 patients due to cardiac disease. ECMO was intended to be a bridge to recovery for 14/15 patients of which 11/14 patients recovered to discharge. The temporary ventricular decompression therapies used in VA ECMO patients were limited to the Protek Duo Right Ventricular Assist Device and TandemHeart device. No patients required transplantation or a durable mechanical device. Notable complications: 1 intrauterine fetal demise from placental malperfusion before ECMO was started;4 maternal deaths, of which 3 were related to ECMO;4 cardiac arrest events;1 limb ischemia event after ECMO cannulation;4 cannulation site hematomas;0 cannulation site hemorrhage;1 cardiac arrhythmia event;2 patients comprised all the intracranial hemorrhage events;and 2 patients comprised all the Gastrointestinal hemorrhage events. Conclusion To our knowledge;this is the first comprehensive documentation of adverse events in peripartum patients describing maternal, fetal, neonatal, and ECMO related outcomes. This data provides a standard format to evaluate risks of ECMO use in peripartum patients.Copyright © 2023 American College of Cardiology Foundation

Percutaneous debulking of tricuspid valve endocarditis in severe COVID-19 pneumonia after prolonged venovenous extracorporeal membrane oxygenation with right-ventricular support: a case series.

Background: Over the past 2 years, the utilization of venovenous extracorporeal membrane oxygenation (VV-ECMO) for the treatment of coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) has increased. While supporting respiratory function, VV-ECMO requires large-bore indwelling venous cannulas, which risk bleeding and infections, including endocarditis. Case summary: We describe two adults hospitalized for COVID-19 pneumonia who developed ARDS and right-ventricular failure, requiring VV-ECMO and ProtekDuo cannulation. After over 100 days with these devices, both patients developed tricuspid valve vegetations. Our first patient was decannulated from ECMO and discharged, but re-presented with a segmental pulmonary embolism and tricuspid mass. The Inari FlowTriver system was chosen to percutaneously remove both the tricuspid mass and pulmonary thromboembolism. Pathological examination of the mass demonstrated Candida albicans endocarditis in the setting of Candida fungemia. Our second patient developed a tricuspid valve vegetation which was also removed with the FlowTriever system. Pathological examination demonstrated endocarditis consistent with Pseudomonas aeruginosa in the setting of Pseudomonas bacteremia. Both patients experienced resolution of fungemia and bacteremia after percutaneous vegetation removal. After ECMO decannulation and percutaneous debulking, both patients experienced prolonged hospital stays for ventilator weaning and were eventually discharged with supplemental oxygen. Discussion: VV-ECMO and right-ventricular support devices are invasive and create various risks, including bloodstream infection and infective endocarditis. Percutaneous debulking of valvular vegetations associated with these right-sided indwelling devices may be an effective means of infection source control. It is unclear whether prolonged use of VV-ECMO provides a mortality benefit in COVID-19 ARDS.

The Society of Thoracic Surgeons Intermacs 2022 Annual Report: Focus on 2018 Heart Transplant Allocation System.

The thirteenth annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous flow durable left ventricular assist devices (LVAD) over the last decade (2012-2021). In 2021, 2,464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared to peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the COVID-19 pandemic and the change in the US heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported pre-implant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing outcomes analysis, the proportion of transplant eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, while the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology.

The ProtekDuo in ECMO configuration for ARDS secondary to COVID-19: A systematic review.

OBJECTIVE: Assessment of the results of the ProtekDuo cannula applied for dedicated right ventricular support with oxygenator in ARDS secondary to COVID-19. METHODS: Systematic literature search in NHS library, Medline (Pubmed) and EMBASE using appropriate keywords as well as PICOS and PRISMA approach. RESULTS: Out of 285 publications found, 5 publications met the search criteria and were included in this review. A total of 194 patients with ARDS secondary to COVID-19 underwent ProtekDuo placement to establish a combination of respiratory [veno-venous extracorporeal membrane oxygenation (V-V ECMO)] and right ventricular support. Patients treated using the ProtekDuo cannula had survival rates between 59% and 89% throughout the five studies, and a significant survival benefit when compared to an invasive ventilation group or compared to dual site V-V ECMO or other double lumen ECMO cannulas. One study focused on extubation and discontinuation of ventilator support, which could be achieved in 100% of ProtekDuo patients. An association for reduced incidence of acute kidney injury (AKI) and use of continuous renal replacement therapy (CRRT) could be shown when the ProtekDuo was used. CONCLUSION: Only limited literature is available for the ProtekDuo in V-P ECMO configuration in the setting of COVID-19 ARDS and should be interpreted with caution. Data on the ProtekDuo is suggestive for lower rates of mortality, AKI and CRRT as compared to other respiratory support modalities.

The ProtekDuo for percutaneous V-P and V-VP ECMO in patients with COVID-19 ARDS.

OBJECTIVE: The ProtekDuo with oxygenator mimics veno-venous (V-V) extracorporeal membrane oxygenation (ECMO) in veno-pulmonary (V-P) configuration. We have recently developed a new configuration by utilizing a 25 Fr multistage femoral venous drainage cannula and by returning oxygenated blood through both lumina of the double lumen ProtekDuo cannula (V-VP configuration), thereby creating partial right ventricular bypass and oxygenated blood flow of up to seven LPM. We investigated our experience with V-P and V-VP ECMO in patients suffering from COVID-19 acute respiratory distress syndrome (ARDS). METHODS: Single center, retrospective observational study. RESULTS: Of nine patients, one was initiated on V-A, two on V-P, and six on V-V ECMO. All patients were reconfigured to V-P and five patients in addition had V-VP ECMO configuration. All patients had at least one and up to three circuit exchanges. Patients were on ECMO support between 20 and 122 (55 ± 29) days, were in ICU between 46 and 161 (78 ± 40) days with a total hospital length of stay between 35 and 171 (82 ± 42) days. Six of nine (67%) patients could successfully be weaned off ECMO, survived, and were discharged. CONCLUSION: The ProtekDuo cannula in V-P configuration provides ECMO blood flow while reducing RV flow, wall-stress and dilatation, as well as oxygen consumption. The V-VP configuration is useful to provide high blood flows of up to seven LPM of oxygenated blood, and partial RV support without over-circulating the pulmonary vascular bed. Our results show that V-P and V-VP ECMO configurations are feasible, have good outcome and are without complications.

First-in-man successful use of the SPECTRUM percutaneous dual-stage right ventricle and right atrium to pulmonary artery ventricular assist device.

BACKGROUND: Over the past decade, several minimally invasive mechanical support devices have been introduced into clinical practice to support the right ventricle (RV). Percutaneous cannulas are easy to insert, minimally invasive, and treat acute RV failure rapidly. In December 2021, the Food and Drug Administration approved a new 31 French dual lumen single cannula for use as a right ventricular assist device. AIMS: Descirbe the use of the new dual lumen percutaneous right ventricular assist device (RVAD) cannula. MATERIAL AND METHODS: Deployment of the RVAD can be done surgically or percutaneously. This cannula, manufactured by Spectrum, is dual staged. It has inflow ports positioned both in the right atrium (RA) as well as the RV for maximal drainage of the right heart. The distal end of the cannula which includes the outflow port is positioned in the pulmonary artery (PA). RESULTS: Deployment of the Spectrum RVAD can be done percutaneously with transesophageal and flouroscopy guidence. Cannulation requires requisite wire skills in order to navigate into the main pulmonary artery. Utilization of this cannula can be done in acute RV failure secondary to ischemia, post cardiotomy shock, acute respiratory failure or other causes of isolated RV failure. DISCUSSION: The dual stage drainage design optimizes venous drainage as well as limits suck-down events. Theoretically, direct RV decompression also decreases RV dilation and wall tension, and facilitates improved transmural pressure gradient to reduce RV strain. CONCLUSION: Here we describe the first-in-man successful use of the dual-stage RA and RV to PA Spectrum cannula in a patient with severe COVID acute respiratory distress syndrome and acute right ventricular failure, bridged to recovery.

Protek Duo Cannula Strategy for Adolescent Mechanical Circulatory Support: A Stepwise Approach in a Pediatric COVID-19 Pneumonia Patient

The SARS-CoV-2 (COVID-19) pandemic has been an ongoing healthcare battle for nearly 2 years. According to CDC data, as of January 2022, there have been over 60 million cases of COVID-19 with over 800,000 lives lost, in the United States alone. Patients less than 18 years of age account for approximately 15% of these cases and only 0.14% of all deaths. The Extracorporeal Life Support Organization (ELSO) COVID-19 data registry has been tracking the use of Extracorporeal Membrane Oxygenation (ECMO) since the start of the pandemic. Internationally, there have been 12,133 confirmed positive cases of COVID-19 requiring ECMO, of these, 330 (2.8%) have been patients under the age of 18. In North America, there have been 7,780 confirmed positive COVID-19 patients requiring ECMO support, of which, 272 (3.5%) have been pediatric patients. Of these 272 pediatric patients, the median age is 12 with a median BMI of 29 (IQR of 18 to 40) and an in-hospital mortality of 32%. We present the case of a 14-year-old, morbidly obese (BMI 48), adolescent male who presented in the early fall of 2021 with COVID-19. The patient developed a cough and dyspnea and was positive for COVID-19 two days prior to presentation. On the day of presentation, was initially taken to the emergency department at an outside institution where he was found to be profoundly hypoxic requiring up 60L of high-flow nasal cannula. After resuscitation and stabilization, he was transferred to our institution for a higher level of care. He continued to be tachypneic, lightheaded and febrile. Over the next 24 hours he required increasing respiratory support pressures and despite escalating support, he remained hypoxic and required intubation. After intubation the patient transiently improved, however, over the next 48 hours he developed worsening hypoxia with elevated airway pressures leading to a right-side pneumothorax and significant pneumomediastinum. Given the risk of ongoing barotrauma with worsening pneumomediastinum and isolated severe hypoxia with maintained cardiac function, the decision was made to initiate V-V ECMO. Due to the severity of hypoxia and predicted flow requirements, he was initially cannulated using a dual site, ultrasound guided percutaneous technique at the bedside. The right femoral vein was accessed for drainage and the left internal jugular vein was accessed for infusion to preserve the right internal jugular vein for future dual lumen cannula placement. Cannula placement was confirmed with x-ray and echocardiography. Over the next two weeks the patient stabilized on V-V ECMO, and flow requirements were weaned to less than 5 L/min. With the stabilization on V-V ECMO the decision was made to transition to an ambulatory configuration. Due to the patient's size and experience of our adult colleagues with the earlier phase of the COVID-19 pandemic, the Protek Duo (TandemLife, Pittsburgh PA) dual lumen cannula was used. The patient was taken to the cardiac catheterization suite where he underwent fluoroscopy guided placement of the Protek Duo cannula with drainage from the right atrium and infusion into the main pulmonary artery. This stepwise application of the Protek Duo oxygenated right ventricular assist device (OxyRVAD) in a morbidly obese adolescent with COVID-19 pneumonia, allowed increased participation in therapy. The increased mobility and right heart support aided his recovery to decannulation and eventual hospital discharge. As the COVID-19 pandemic shows no signs of slowing down and has proven to be adept at mutating to increase transmissibility, it is more important than ever to continue to evolve our practices to battle this disease.

The ProtekDuo as double lumen return cannula in V-VP ECMO configuration: A first-in-man method description.

We present a case of acute respiratory distress syndrome (ARDS) secondary to COVID-19 who required venovenous extracorporeal membrane oxygenation (V-V ECMO). Initially, a right ventricular assist device (RVAD), the ProtekDuo with an oxygenator, was placed in an outside heart center and the patient was transferred to us for ECMO management. Due to severe hypoxia, the configuration was later modified, and a 25 Fr femoral drainage cannula was inserted for venous drainage only. The arterial return tubing was spliced and using a Y-connector, arterialized blood was returned through both limbs of the ProtekDuo resulting in a significantly increased oxygenation and flow.

Extracorporeal Membrane Oxygenation with Right Ventricular Assist Device for COVID-19 ARDS.

BACKGROUND: Right ventricular failure is an underrecognized consequence of COVID-19 pneumonia. Those with severe disease are treated with extracorporeal membrane oxygenation (ECMO) but with poor outcomes. Concomitant right ventricular assist device (RVAD) may be beneficial. METHODS: A retrospective analysis of intensive care unit patients admitted with COVID-19 ARDS (Acute Respiratory Distress Syndrome) was performed. Nonintubated patients, those with acute kidney injury, and age > 75 were excluded. Patients who underwent RVAD/ECMO support were compared with those managed via invasive mechanical ventilation (IMV) alone. The primary outcome was in-hospital mortality. Secondary outcomes included 30-d mortality, acute kidney injury, length of ICU stay, and duration of mechanical ventilation. RESULTS: A total of 145 patients were admitted to the ICU with COVID-19. Thirty-nine patients met inclusion criteria. Of these, 21 received IMV, and 18 received RVAD/ECMO. In-hospital (52.4 versus 11.1%, P = 0.008) and 30-d mortality (42.9 versus 5.6%, P= 0.011) were significantly lower in patients treated with RVAD/ECMO. Acute kidney injury occurred in 15 (71.4%) patients in the IMV group and zero RVAD/ECMO patients (P< 0.001). ICU (11.5 versus 21 d, P= 0.067) and hospital (14 versus 25.5 d, P = 0.054) length of stay were not significantly different. There were no RVAD/ECMO device complications. The duration of mechanical ventilation was not significantly different (10 versus 5 d, P = 0.44). CONCLUSIONS: RVAD support at the time of ECMO initiation resulted in the no secondary end-organ damage and higher in-hospital and 30-d survival versus IMV in specially selected patients with severe COVID-19 ARDS. Management of severe COVID-19 ARDS should prioritize right ventricular support.