Outcomes of patients with COVID-19 supported by venovenous extracorporeal membrane oxygenation for greater than 90 days.

Objective: To determine the characteristics and outcomes of patients requiring prolonged (>90 days) venovenous extracorporeal membrane oxygenation (VV ECMO) support for refractory Coronavirus disease 2019 (COVID-19)-associated respiratory failure. Methods: A retrospective, observational analysis of consecutive patients requiring VV ECMO for COVID-19-associated respiratory failure was performed at a single institution between March 2020 and January 2022. Data were collected from the medical records. Patients were predominantly cannulated and supported long-term with a single, dual-lumen cannula in the internal jugular vein with the tip positioned in the pulmonary artery. All patients were managed with an awake VV ECMO approach, emphasizing avoidance of sedatives, extubation, ambulation, physical therapy, and nutrition. Patients requiring >90 days of ECMO were identified, analyzed, and compared to those needing a shorter duration of support. Results: A total of 44 patients were supported on VV ECMO during the study period, of whom 36 (82%) survived to discharge. Thirty-one patients were supported for <90 days, of whom 28 (90%) were discharged alive. Thirteen patients required >90 days of ECMO. All patients were extubated. Eight patients (62%) survived to discharge, with 1 patient requiring lung transplantation prior to decannulation. All survivors were free from mechanical ventilation and alive at a 6-month follow-up. Of the 4 patients who died on prolonged ECMO, 2 developed hemothorax necessitating surgery and 2 succumbed to fatal intracranial hemorrhage. Conclusions: Patients treated with VV ECMO for COVID-19-associated respiratory failure may require prolonged support to recover. Extubation, ambulation, aggressive rehabilitation, and nutritional support while on ECMO can yield favorable outcomes.

Outcomes of Extubated COVID and Non-COVID Patients Receiving Awake Venovenous Extracorporeal Membrane Oxygenation.

Cessation of continuous analgesia and sedation in patients with acute respiratory distress syndrome (ARDS) receiving venovenous (VV) extracorporeal membrane oxygenation (ECMO) facilitates early extubation, family, patient and provider engagement, and mobility. Outcomes associated with an awake ECMO strategy have not been well described in the literature. The purpose of this study was to evaluate outcomes in patients receiving this strategy. This was a retrospective review of ARDS patients receiving awake VV ECMO. The primary outcome was survival to hospital discharge. Secondary outcomes included days requiring ECMO, time from cannulation to extubation, complications, patients requiring tracheostomy, hospital and intensive care unit (ICU) length of stay (LOS), and discharge disposition. In a subgroup analysis, outcomes were compared between non-COVID and COVID ECMO patients. Sixty-two patients were included with a survival to hospital discharge of 85.5%. Days requiring ECMO was 33.0 (0.0-75.0) and cannulation to extubation was 6.0 (4.0-11.0). Three patients received a tracheostomy (4.8%). Bleeding and infection were reported in 80.6% and 82.3% of patients, respectively. Intensive care unit length of stay was 46.0 days (29.0-90.0) and hospital LOS was 51.0 days (32.0-91.0). Over half of the patients (51.6%) were discharged to an acute rehabilitation facility and 27.4% were discharged home. There was similar survival to hospital discharge between the COVID and non-COVID awake ECMO patients (85% in both groups, p = 1.000). This study highlights the impact of an awake ECMO approach on survival to hospital discharge. Future studies are needed to evaluate this approach as compared to current practice to determine if this should become the standard.

Outcomes by cannulation methods for venovenous extracorporeal membrane oxygenation during COVID-19: A multicenter retrospective study.

In a multicenter, retrospective analysis of 435 patients with refractory COVID-19 placed on V-V ECMO, cannulation by a single, dual-lumen catheter with directed outflow to the pulmonary artery was associated with lower inpatient mortality.

Characteristics and outcomes of patients with COVID-19 supported by extracorporeal membrane oxygenation: A retrospective multicenter study.

OBJECTIVE: To determine characteristics, outcomes, and clinical factors associated with death in patients with COVID-19 requiring extracorporeal membrane oxygenation (ECMO) support. METHODS: A multicenter, retrospective cohort study was conducted. The cohort consisted of adult patients (18 years of age and older) requiring ECMO in the period from March 1, 2020, to September 30, 2020. The primary outcome was in-hospital mortality after ECMO initiation assessed with a time to event analysis at 90 days. Multivariable Cox proportional regression was used to determine factors associated with in-hospital mortality. RESULTS: Overall, 292 patients from 17 centers comprised the study cohort. Patients were 49 (interquartile range, 39-57) years old and 81 (28%) were female. At the end of the follow-up period, 19 (6%) patients were still receiving ECMO, 25 (9%) were discontinued from ECMO but remained hospitalized, 135 (46%) were discharged or transferred alive, and 113 (39%) died during the hospitalization. The cumulative in-hospital mortality at 90 days was 42% (95% confidence interval [CI], 36%-47%). Factors associated with in-hospital mortality were age (adjusted hazard ratio [aHR], 1.31; 95% CI, 1.06-1.61 per 10 years), renal dysfunction measured according to serum creatinine level (aHR, 1.21; 95% CI, 1.01-1.45), and cardiopulmonary resuscitation before ECMO placement (aHR, 1.87; 95% CI, 1.01-3.46). CONCLUSIONS: In patients with severe COVID-19 necessitating ECMO support, in-hospital mortality occurred in fewer than half of the cases. ECMO might serve as a viable modality for terminally ill patients with refractory COVID-19.

Time in Therapeutic Range Significantly Impacts Survival and Adverse Events in Destination Therapy Patients.

The study aim was to examine the impact time in therapeutic range (TTR, International Normalized Ratio [INR] 2.0-3.0) has on survival and adverse events in patients receiving the HeartWare HVAD System in the ENDURANCE and ENDURANCE Supplemental Trials. Evaluable subjects (n = 495) had >1 INR value recorded 1-24 months postimplant and were categorized as: low TTR (10-39%), moderate TTR (40-69%), and high TTR (≥70%). Baseline characteristics, adverse events, and survival were analyzed. Low TTR patients experienced higher rates of major bleeding (1.69 vs. 0.54 events per patient year [EPPY]; p < 0.001), GI bleeding (1.22 vs. 0.38 EPPY; p < 0.001), stroke (0.47 vs. 0.17 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.02), infection (1.44 vs. 0.69 EPPY; p < 0.001), and renal dysfunction (0.23 vs. 0.05 EPPY; p < 0.001) compared with high TTR. Moderate TTR had higher rates of major bleeding (0.75 vs. 0.54 EPPY; p < 0.001), thrombus requiring exchange (0.05 vs. 0.01 EPPY; p = 0.007), cardiac arrhythmia (0.32 vs. 0.24 EPPY; p = 0.04), and infection (0.90 vs. 0.69 EPPY; p = 0.001) compared with high TTR. Two year survival was greater among moderate and high versus low cohorts (Log-rank p = 0.001). The significant reduction in morbidity and mortality in destination therapy (DT) HVAD patients with well-controlled TTR (≥70%) emphasizes the importance of vigilant anticoagulation management.

Management of Pulmonary Mucormycosis After Orthotopic Heart Transplant: A Case Series.

Invasive pulmonary mucormycosis is a potentially fatal infection that can occur in immunosuppressed patients such as those who have undergone orthotopic heart transplant (OHT). High-dose intravenous antifungal agents, including amphotericin B, are generally accepted as the first-line medical treatment, with prompt surgical resection of lesions if feasible. The body of evidence guiding treatment decisions, however, is sparse, particularly regarding adjustment of immunosuppression during acute infection and long-term recovery. We present 2 cases of patients with pulmonary mucormycosis occurring within the first 6 months after OHT, both of whom successfully recovered after appropriate medical and surgical treatment, and we highlight differences in immunosuppression management strategies for this life-threatening condition.

Comparative Propensity Matched Outcomes in Severe COVID-19 Respiratory Failure-Extracorporeal Membrane Oxygenation or Maximum Ventilation Alone.

OBJECTIVE: Does extracorporeal membrane oxygenation (ECMO) improve outcomes in ECMO-eligible patients with COVID-19 respiratory failure compared to maximum ventilation alone (MVA)? SUMMARY BACKGROUND DATA: ECMO is beneficial in severe cases of respiratory failure when mechanical ventilation is inadequate. Outcomes for ECMO-eligible COVID-19 patients on MVA have not been reported. Consequently, a direct comparison between COVID-19 patients on ECMO and those on MVA has not been established. METHODS: A total of 3406 COVID-19 patients treated at two major medical centers in Chicago were studied. One hundred ninety-five required maximum ventilatory support, and met ECMO eligibility criteria. Eighty ECMO patients were propensity matched to an equal number of MVA patients using detailed demographic, physiological, and comorbidity data. Primary outcome was survival and disposition at discharge. RESULTS: Seventy-one percent of patients were decannulated from ECMO. Mechanical ventilation was discontinued in 75% ECMO and 16% MVA patients. Twenty-five percent of patients in the ECMO arm expired, 21% while on ECMO, compared with 74% in the MVA cohort. Mortality was significantly lower across all age and BMI groups in the ECMO arm. Sixty-eight percent ECMO and 26% MVA patients were discharged from the hospital. Fewer ECMO patients required long-term rehabilitation. Major complications such as septic shock, ventilator associated pneumonia, inotropic requirements, acute liver and kidney injuries are less frequent among ECMO patients. CONCLUSIONS: ECMO-eligible patients with severe COVID-19 respiratory failure demonstrate a 3-fold improvement in survival with ECMO. They are also in a better physical state at discharge and have lower overall complication rates. As such, strong consideration should be given for ECMO when mechanical ventilatory support alone becomes insufficient in treating COVID-19 respiratory failure.

Impact of COVID-19 on Patients Supported with a Left Ventricular Assist Device.

Patients on left ventricular assist device (LVAD) support may be susceptible to severe disease and complications from coronavirus disease-19 (COVID-19). The purpose of this study was to describe the clinical course of COVID-19 in LVAD patients. A retrospective review was performed at our center; 28 LVAD patients who developed COVID-19 between March 2020 and March 2021, and six patients with a prior COVID-19 infection who underwent LVAD implantation, were identified and examined. Of the 28 patients, nine (32%) died during the study period, five (18%) during their index hospitalization for COVID-19. Two patients (7%) presented with suspected pump thrombosis. In a nonadjusted binary regression logistic analysis, admission to the intensive care unit (unadjusted odds ratio, 7.6 [CI, 1.2-48], P = 0.03), and the need for mechanical ventilation (unadjusted odds ratio 14 [CI, 1.3-159], P = 0.03) were associated with mortality. The six patients who previously had COVID-19 and subsequently received a LVAD were on intra-aortic balloon pump and inotropic support at time of surgery. All six experienced a complicated and prolonged postoperative course. Three patients (50%) suffered from ischemic stroke, and there was one (17%) 30 day mortality. We observed an increased risk of morbidity and mortality in LVAD patients with COVID-19.

Outcomes of pre- heart transplantation desensitization in a series of highly sensitized patients bridged with left ventricular assist devices.

Desensitization therapy for heart transplantation (HT) candidates can shorten transplant wait times and broaden the donor pool. Specific evidence-based recommendations on both protocols and indications are lacking. We retrospectively assessed left ventricular assist devices-bridged candidates who received pre-HT desensitization therapy. The therapeutic protocol consisted of intravenous immunoglobulin and rituximab followed by bortezomib and plasmapheresis if an insufficient response was achieved. Desensitization was attempted in 10 patients; only 7 tolerated therapy and underwent transplant. For those patients, median decrease in unacceptable calculated panel reactive antibody was 11%; there was no significant decrease for 3 patients. Post-desensitization adverse events were observed in all patients which included coagulopathy, bone marrow suppression, and infection. Median time to first infection was 16 days. One patient had clinically significant rejection and 3 patients had uptrending donor-specific antibodies. Decisions to proceed with desensitization should be individualized understanding potential risks and benefits.

Outcomes Following Left Ventricular Assist Device Exchange: Focus on the Impacts of Device Infection.

Hemodynamic support with continuous-flow left ventricular assist device (CF-LVAD) therapy has proven a reliable treatment for advanced heart failure. Although modern LVADs are highly durable, device failure and infection can be resolved with surgical exchange of pump components. In this study, we investigated the incidence and outcomes of LVAD exchange with the HeartMate II and HeartWare HVAD. Data were obtained from 677 patients who underwent CF-LVAD implantation between 2005 and 2016. Patients who underwent a device exchanged were included. The primary outcomes were length of hospital stay and mortality. Of the 677 patients included in this study, 72 (10.6%) required LVAD exchange. Thirty-day and 1-year mortality rates were comparable to primary LVAD implantation: 4.3% vs. 3.49%, p = 0.727 and 20.3% vs. 20.7%, p = 0.989, respectively. Thirty-one patients (4.5%) underwent exchange with ongoing infection. Kaplan-Meier analysis indicated significant differences in survival between groups based on indication for exchange. Patients who underwent exchange after more than 150 days of active infection suffered worse postexchange survival than those who underwent exchanged earlier (P = 0.007). While exchange was required only in 10.6% of patients undergoing LVAD implantation, our results show device exchange may be executed safely and effectively, with long-term outcomes similar to primary LVAD implantation. The indication for device exchange impacts postexchange outcomes, and those exchanged with LVAD infection tend to fare worse than those exchanged for device malfunction or thrombus. Patients who are exchanged with active infection have better postoperative survival if the exchange is performed expeditiously after medical management has failed.

Endocarditis Complicated by Severe Aortic Insufficiency in a Patient with COVID-19: Diagnostic and Management Implications.

A 38-year-old man presented with cough, shortness of breath, and fatigue. He was diagnosed with Coronavirus Disease-2019 (COVID-19) as well as Enterococcus faecalis bacteremia. Imaging revealed a subaortic membrane with aortic valve endocarditis and severe aortic insufficiency. He had successful aortic valve replacement with a mechanical prosthesis and subaortic membrane resection. This case highlights some of the diagnostic and therapeutic challenges presented by COVID-19 pandemic.

A case series of patients with left ventricular assist devices and concomitant mechanical heart valves.

Mechanical heart valves left in situ at the time of left ventricular assist device (LVAD) implantation are thought to potentially increase the risk of thromboembolism. Recommendations exist to replace dysfunctional mechanical mitral valves and any mechanical aortic valves at the time of LVAD implantation. Due to potential increases in cardiopulmonary bypass time and associated comorbidities with valve replacement, leaving a functional mechanical valve in place at LVAD implantation has been suggested to be a safe option. We retrospectively reviewed all patients with prior mechanical mitral or aortic valves undergoing LVAD implantation at our center between 2012 and 2017. Echocardiograms were read by a single cardiologist to assess for mechanical valve dysfunction. We identified 15 patients. Five patients had major bleeding requiring transfusion. On follow-up, 2 patients had hemorrhagic stroke and 2 had transient ischemic attach/ischemic stroke. In addition, 2 patients had LVAD thrombosis and 2 patients had LVAD driveline malfunction. Mild mechanical valve regurgitation was identified on follow-up echocardiograms of 2 patients. Rate of complications in patients with mechanical valves undergoing LVAD implantation was comparable to that reported for the general LVAD population. Leaving a functional mechanical valve in place at the time of LVAD implantation could be a reasonable alternative to valve replacement. More data are required to further guide patient care in these individuals.

Venoarterial extracorporeal membrane oxygenation use in staged combined heart-kidney transplant.

Outside of heart and lung transplantation, only few cases have been reported describing venoarterial extracorporeal membrane oxygenation (VA-ECMO) use in solid organ transplantation. We present a case of a staged combined heart-kidney transplant in which VA-ECMO was utilized after a complicated orthotopic heart transplantation to successfully complete the subsequent renal transplantation.

Treatment of HeartMate II Short-to-Shield Patients With an Ungrounded Cable: Indications and Long-Term Outcomes.

Despite modifications and a procedure to externally replace the distal portion of the percutaneous lead, damage to the wiring insulation causing an electrical short to ground, referred to as a short to shield (STS), has become an important factor in the longevity of the HeartMate II left ventricular assist device (LVAD). Device exchange has been the suggested treatment option. The aim of this study was to evaluate the long-term clinical outcomes of patients with an STS supported on an ungrounded cable. A retrospective review of all patients (n = 479) implanted with a HeartMate II at our center between January 2008 and December 2017 was performed. Patients with a documented STS maintained on an ungrounded cable were examined. Patient characteristics, time from device implantation to STS, treatment strategies, and duration of support on an ungrounded cable were summarized. The association between support with an ungrounded cable and clinical outcomes was evaluated. A total of 53 (11% of 479) patients (83% males and 81% destination therapy) with an STS were supported on an ungrounded cable for a median duration of 195 days (range 2 days to 3.3 years). Patients were more active (New York Heart Association [NYHA] p < 0.001, 6 minute walk test [6MWT] p = 0.003) and had a trend toward increased weight gain (p = 0.055) from time of implant to STS. Duration of support before the STS was 1.9 years (range 165 days to 8.6 years). Twenty-two patients were treated directly with an ungrounded cable and 31 patients underwent an external driveline repair and still required an ungrounded cable within 2 days (range 0 days to 1.3 years). During the study period, 38 patients were maintained on an ungrounded cable: 21 patients were ongoing for 299 days (range 114 days to 2.8 years), 11 patients transplanted after 79 days (range 7-295 days), four patients died because of comorbid conditions after 1.6 years (range 141 days to 3.2 years), one patient exchanged for thrombosis after 229 days, and one patient explanted after 279 days. The other 15 patients developed a phase-to-phase electrical short after 51 days (range 2 days to 3.3 years): 14 patients underwent a successful pump exchange and one patient transplanted within 2 days. No patients died because of support with an ungrounded cable or worsening lead damage necessitating device exchange. With extended durations of support, some patients with a HeartMate II LVAD will experience device failure in the form of an STS. Select patients with an STS can be safely supported on an ungrounded cable for several years with close monitoring. This treatment approach should be considered before a device exchange.

A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.

BACKGROUND: In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device. METHODS: We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years. RESULTS: This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group. CONCLUSIONS: Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

Improved Nutrition Status in Patients With Advanced Heart Failure Implanted With a Left Ventricular Assist Device.

BACKGROUND: Left ventricular assist device (LVAD) implantation for advanced heart failure is known to improve survival, functional capacity, and quality of life. Most patients implanted with LVADs suffer from moderate to severe malnutrition and deconditioning due to their advanced disease. The Mini Nutritional Assessment (MNA) and the short form of the survey (MNA-SF) are 2 well-validated clinical tools, previously used to assess patient nutrition status in numerous conditions. Earlier work has demonstrated that low nutrition scores can independently predict mortality in the LVAD population. This study explored changes in MNA scores and other clinical markers following LVAD. METHODS: This retrospective study included 74 patients implanted with LVADs between 2012 and 2017. MNA or MNA-SF along with other clinical data and nutrition indices were assessed during the preoperative workup and reassessed on average 423.9 days post LVAD. Paired-samples t-tests were used to evaluate any changes. RESULTS: Despite an average body mass index of 30.8, 28.3% of patients were classified by MNA as malnourished, and 58.5% were considered at risk prior to LVAD implantation. Post LVAD implantation, MNA scores improved from an average of 19.2-23.0 (P < 0.001), with now only 3.8% classified as malnourished and 45.3% classified as at risk. MNA-SF and prognostic nutritional index also improved significantly. CONCLUSIONS: This study indicates that LVAD implantation is associated with a long-term improvement in nutrition status when compared with the preoperative heart failure state.