Repeat left ventricular-assisted device exchange and upgrade from second- to third-generation devices in a high-volume single center.

BACKGROUND: Pump exchange is an established strategy to treat LVAD-related complications such as thrombosis, infection, and driveline failure. Pump upgrades with an exchange to newer generation devices are being performed to the advantage of the patient on long-term support. The safety and efficacy of a repeat LVAD exchange with a concomitant upgrade to a third-generation pump have not been reported. METHODS: We performed a retrospective analysis of all consecutive patients who underwent a repeat LVAD device exchange and upgrade to HeartMate III (HMIII) at Houston Methodist Hospital between December 2018 and December 2020. RESULTS: Five patients underwent exchange and upgrade to HMIII within the specified timeframe. Four patients had already had two prior exchanges (all HMII to HMII), and one patient had one prior exchange (HVAD to HVAD). In all cases, implantation was performed as destination therapy. The surgical exchange was performed via redo median sternotomy on full cardiopulmonary bypass. No unplanned redo surgery of the device component was required. In-hospital mortality was 20% in this very high-risk population. At 1-, 3-, and 6-month follow-up, all discharged patients were on HMIII support, with no major LVAD-related adverse events reported. CONCLUSION: We report the feasibility and safety of a repeat pump exchange with an upgrade to HMIII in a high-volume center. The decision for medical therapy versus surgical exchange has to be tailored to individual cases based on risk factors and clinical stability but in expert hands, even a re-redo surgical approach grants options for good medium-term outcomes.

Cloning a profibrotic stem cell variant in idiopathic pulmonary fibrosis.

Idiopathic pulmonary fibrosis (IPF) is a progressive, irreversible, and rapidly fatal interstitial lung disease marked by the replacement of lung alveoli with dense fibrotic matrices. Although the mechanisms initiating IPF remain unclear, rare and common alleles of genes expressed in lung epithelia, combined with aging, contribute to the risk for this condition. Consistently, single-cell RNA sequencing (scRNA-seq) studies have identified lung basal cell heterogeneity in IPF that might be pathogenic. We used single-cell cloning technologies to generate "libraries" of basal stem cells from the distal lungs of 16 patients with IPF and 10 controls. We identified a major stem cell variant that was distinguished from normal stem cells by its ability to transform normal lung fibroblasts into pathogenic myofibroblasts in vitro and to activate and recruit myofibroblasts in clonal xenografts. This profibrotic stem cell variant, which was shown to preexist in low quantities in normal and even fetal lungs, expressed a broad network of genes implicated in organ fibrosis and showed overlap in gene expression with abnormal epithelial signatures identified in previously published scRNA-seq studies of IPF. Drug screens highlighted specific vulnerabilities of this profibrotic variant to inhibitors of epidermal growth factor and mammalian target of rapamycin signaling as prospective therapeutic targets. This profibrotic stem cell variant in IPF was distinct from recently identified profibrotic stem cell variants in chronic obstructive pulmonary disease and may extend the notion that inappropriate accrual of minor and preexisting stem cell variants contributes to chronic lung conditions.

Progress in Combined Liver-lung Transplantation at a Single Center.

Combined liver-lung transplantation is an uncommon, although vital, procedure for patients with simultaneous end-stage lung and liver disease. The utility of lung-liver transplant has been questioned because of initial poor survival outcomes, particularly when compared with liver-alone transplant recipients. Methods: A single-center, retrospective review of the medical records of 19 adult lung-liver transplant recipients was conducted, comparing early recipients (2009-2014) with a recent cohort (2015-2021). Patients were also compared with the center's single lung or liver transplant recipients. Results: Recent lung-liver recipients were older (P = 0.004), had a higher body mass index (P = 0.03), and were less likely to have ascites (P = 0.02), reflecting changes in the etiologies of lung and liver disease. Liver cold ischemia time was longer in the modern cohort (P = 0.004), and patients had a longer posttransplant length of hospitalization (P = 0.048). Overall survival was not statistically different between the 2 eras studied (P = 0.61), although 1-y survival was higher in the more recent group (90.9% versus 62.5%). Overall survival after lung-liver transplant was equivalent to lung-alone recipients and was significantly lower than liver-alone recipients (5-y survival: 52%, 51%, and 75%, respectively). Lung-liver recipient mortality was primarily driven by deaths within 6 mo of transplant due to infection and sepsis. Graft failure was not significantly different (liver: P = 0.06; lung: P = 0.74). Conclusions: The severity of illness in lung-liver recipients combined with the infrequency of the procedure supports its continued use. However, particular attention should be paid to patient selection, immunosuppression, and prophylaxis against infection to ensure proper utilization of scarce donor organs.

Outflow cannula alignment in continuous flow left ventricular devices is associated with stroke.

We sought to evaluate whether differences in left ventricular assist device (LVAD) canula alignment are associated with stroke. There is a paucity of clinical data on contribution of LVAD canulae alignment to strokes. We conducted a retrospective analysis of patients who underwent LVAD implantation at Houston Methodist hospital from 2011 to 2016 and included those who had undergone cardiac computed tomography (CT) with contrast. LVAD graft alignment using X-ray, echocardiography, and cardiac CT was evaluated. The primary outcome was stroke within 1 year of LVAD implantation. Of the 101 patients that underwent LVAD Implantation and cardiac CT scan during the study period, 78 met inclusion criteria. The primary outcome occurred in 12 (15.4%) patients with a median time to stroke of 77 days (interquartile range: 42-132 days). Of these, 10 patients had an ischemic and two had hemorrhagic strokes. The predominant device type was Heart Mate II (94.8%). Patients with LVAD outflow cannula to aortic angle lesser than 37.5° and those with outflow graft diameter of anastomosis less than 1.5 cm (assessed by cardiac CT) had significantly higher stroke risk (p < 0.001 and p = 0.01 respectively). In HMII patients, a lower LVAD speed at the time of CT scan was associated with stroke. Further studies are needed to identify optimal outflow graft configuration to mitigate stroke risk.

Extracorporeal Membrane Oxygenation for COVID-19: Collaborative Experience From the Texas Medical Center in Houston With 2 Years Follow-Up.

Patients with severe refractory hypoxemic respiratory failure may benefit from extracorporeal membrane oxygenation (ECMO) for salvage therapy. The Coronavirus disease 2019 (COVID-19) pandemic offered three high-volume independent ECMO programs at a large medical center the chance to collaborate to optimize ECMO care at the beginning of the pandemic in Spring 2020. Between March 15, 2020, and May 30, 2020, 3,615 inpatients with COVID-19 were treated at the Texas Medical Center. During this time, 35 COVID-19 patients were cannulated for ECMO, all but one in a veno-venous configuration. At hospital discharge, 23 (66%) of the 35 patients were alive. Twelve patients died of vasodilatory shock (n = 9), intracranial hemorrhage (n = 2), and cannulation-related bleeding and multiorgan dysfunction (n = 1). The average duration of ECMO was 13.6 days in survivors and 25.0 days in nonsurvivors ( p < 0.04). At 1 year follow-up, all 23 discharged patients were still alive, making the 1 year survival rate 66% (23/35). At 2 years follow-up, the overall rate of survival was 63% (22/35). Of those patients who survived 2 years, all were at home and alive and well at follow-up.

Pre-operative sarcopenia is predictive of recurrent gastrointestinal bleeding on left ventricular assist device support: A multicenter analysis.

INTRODUCTION: Whether pre left ventricular assist device (LVAD) sarcopenia is associated with higher incidence of gastrointestinal bleeding (GIB) on LVAD support remains unknown. METHODS: To study the association between preoperative sarcopenia and post LVAD GIB events, we performed a retrospective, multi-centered study including patients with chest CTs performed ≤ 3 months prior to LVAD implantation at the University of Minnesota (n = 143) and Houston Methodist Hospital (n = 133). To quantify sarcopenia, unilateral pectoralis muscle mass indexed to body surface area (PMI) and attenuation (approximated by mean Hounsfield units; PHUm) were measured on pre-operative chest CT scans. Negative binomial regression analyses were performed to determine the association between pectoralis muscle measures and number of GIB events to 2 years of LVAD support. RESULTS: The study cohort included 276 LVAD recipients with 43 % designated as bridge to transplant at the time of LVAD implantation. High pectoralis muscle mass and tissue attenuation were both protective against GIB events. Each 5 unit increase in PHUm was associated with an adjusted 19 % reduction in the incidence rate of GIB (95 % CI 7-29 %, p = 0.002). Each unit increase in PMI was associated with an adjusted 17 % reduction in the incidence of GIB (95 % CI 1- 29 %, p = 0.04). The models were adjusted for age, sex, INTERMACS profile, bridge to transplant status, creatinine, albumin and implanting center. CONCLUSION: Preoperative sarcopenia, as quantified by pectoralis muscle size and attenuation, was associated with the development of recurrent GI bleeding after LVAD implantation. These CT quantitative measures appear to predict not only early mortality but morbidity on LVAD as well.

Degree of change in right ventricular adaptation measures during axillary Impella support informs risk stratification for early, severe right heart failure following durable LVAD implantation.

Risk assessment for early, severe right heart failure (RHF) after LVAD implantation remains imperfect. We sought to define the differences in RV adaptation and load after axillary Impella support between patients who experienced RHF and those who did not. Seventeen of 18 patients included were deemed intermediate or high risk for RHF by EUROMACS-RHF score. Before Impella insertion, RV adaptation parameters (RAP, RAP:PCWP, PAPi) were worse in the non-RHF group compared to the RHF group. In both groups, RV load parameters (effective pulmonary arterial elastance, pulmonary vascular resistance, and pulmonary vascular compliance) improved after Impella insertion. Lesser improvements in RV adaptation were seen in the RHF group. Moreover, load-to-adaptation relationships (EA/RAP and EA/RAP:PCWP) worsened to a greater degree. In patients at intermediate or high risk for RHF after LVAD, assessment of RV adaptation and load during axillary Impella support may improve risk stratification.

Defining Vasoplegia Following Durable, Continuous Flow Left Ventricular Assist Device Implantation.

This study aimed to develop a definition of vasoplegia that reliably predicts clinical outcomes. Vasoplegia was evaluated using data from the electronic health record for each 15-minute interval for 72 hours following cardiopulmonary bypass. Standardized definitions considered clinical features (systemic vascular resistance [SVR], mean arterial pressure [MAP], cardiac index [CI], norepinephrine equivalents [NEE]), threshold strategy (criteria occurring in any versus all measurements in an interval), and duration (criteria occurring over multiple consecutive versus separated intervals). Minor vasoplegia was MAP < 60 mm Hg or SVR < 800 dynes⋅sec⋅cm-5 with CI > 2.2 L/min/m2 and NEE ≥ 0.1 µg/kg/min. Major vasoplegia was MAP < 60 mm Hg or SVR < 700 dynes⋅sec⋅cm-5 with CI > 2.5 L/min/m2 and NEE ≥ 0.2 µg/kg/min. The primary outcome was incidence of vasoplegia for eight definitions developed utilizing combinations of these criteria. Secondary outcomes were associations between vasoplegia definitions and three clinical outcomes: time to extubation, time to intensive care unit discharge, and nonfavorable discharge. Minor vasoplegia detected anytime within a 15-minute period (MINOR_ANY_15) predicted the highest incidence of vasoplegia (61%) and was associated with two of three clinical outcomes: 1 day delay to first extubation (95% CI: 0.2 to 2) and 7 day delay to first intensive care unit discharge (95% CI: 1 to 13). The MINOR_ANY_15 definition should be externally validated as an optimal definition of vasoplegia.

A multi-institutional retrospective analysis on impact of RV acute mechanical support timing after LVAD implantation on 1-year mortality and predictors of RV acute mechanical support weaning.

BACKGROUND: There is little insight into which patients can be weaned off right ventricular (RV) acute mechanical circulatory support (AMCS) after left ventricular assist device (LVAD) implantation. We hypothesize that concomitant RV AMCS insertion instead of postoperative implantation will improve 1-year survival and increase the likelihood of RV AMCS weaning. METHODS: A multicenter retrospective database of 826 consecutive patients who received a HeartMate II or HVAD between January 2007 and December 2016 was analyzed. We identified 91 patients who had early RV AMCS on index admission. Cox proportional-hazards model was constructed to identify predictors of 1-year mortality post-RV AMCS implantation and competing risk modeling identified RV AMCS weaning predictors. RESULTS: There were 91 of 826 patients (11%) who required RV AMCS after CF-LVAD implantation with 51 (56%) receiving a concomitant RV AMCS and 40 (44%) implanted with a postoperative RV AMCS during their ICU stay; 48 (53%) patients were weaned from RV AMCS support. Concomitant RV AMCS with CF-LVAD insertion was associated with lower mortality (HR 0.45 [95% CI 0.26-0.80], p = 0.01) in multivariable model (which included age, BMI, angiotensin-converting enzyme inhibitor use, and heart transplantation as a time-varying covariate). In the multivariate competing risk analysis, a TPG < 12 (SHR 2.19 [95% CI 1.02-4.70], p = 0.04) and concomitant RV AMCS insertion (SHR 3.35 [95% CI 1.73-6.48], p < 0.001) were associated with a successful wean. CONCLUSIONS: In patients with RVF after LVAD implantation, concomitant RV AMCS insertion at the time of LVAD was associated with improved 1-year survival and increased chances of RV support weaning compared to postoperative insertion.

Outcomes of Heart Transplant Recipients with Class II Obesity: A United Network for Organ Sharing Database Analysis.

BACKGROUND: In the 2016 ISHLT listing criteria guidelines for heart transplantation, recipients were recommended to have a body mass index (BMI) <35 kg/m². However, outcomes data for subgroups of transplant recipients with a BMI >35 kg/m² are limited. We examined the outcomes of heart transplant recipients who had a BMI of 35 to 39.9 kg/m² or ≥40 kg/m² and compared their outcomes with recipients who had a BMI <35 kg/m2. METHODS: Using data from the United Network for Organ Sharing database, we performed a retrospective cohort analysis of 23,009 adults who underwent cardiac transplantation between 2009 and 2018. Transplant recipients were stratified by BMI categories (<35 kg/m², 35-39.9 kg/m², and ≥40 kg/m²). Patient survival was depicted by Kaplan-Meier curves. Cox proportional-hazards modeling was used to determine the prognostic factors associated with mortality within 90 days, 1 year, and 5 years after transplantation. RESULTS: Survival at 90 days, 1 year, and 5 years after transplantation was better in recipients who had a BMI <35 kg/m² than in those who had a BMI of 35 to 39.9 kg/m² (P values ranged from 0.01 to < 0.001) or ≥40 kg/m² (P < 0.001). Additionally, survival at 90 days (P < 0.001) and 1 year (P = 0.002) was significantly better in recipients who had a BMI of 35 to 39.9 kg/m² than in those who had a BMI ≥40 kg/m². In multivariate analysis, a BMI of 35 to 39.9 was significantly associated with increased 90-day mortality (HR = 1.53; 95% CI 1.12, 2.08; P = 0.01) but not increased 1-year (HR = 1.28; 95% CI 0.99, 1.66; P = 0.06) or 5-year mortality (HR = 1.11; 95% CI 0.91, 1.36; P = 0.29). CONCLUSIONS: Although heart transplant recipients with class II obesity (BMI 35-39.9 kg/m²) may have suboptimal survival compared with those who have a BMI <35 kg/m², these patients have better outcomes than do those with class III obesity (BMI ≥40 kg/m²). Thus, contrary to current guidelines, selected patients with class II obesity should be considered for transplantation.

Predicting post-operative right ventricular failure using video-based deep learning.

Despite progressive improvements over the decades, the rich temporally resolved data in an echocardiogram remain underutilized. Human assessments reduce the complex patterns of cardiac wall motion, to a small list of measurements of heart function. All modern echocardiography artificial intelligence (AI) systems are similarly limited by design - automating measurements of the same reductionist metrics rather than utilizing the embedded wealth of data. This underutilization is most evident where clinical decision making is guided by subjective assessments of disease acuity. Predicting the likelihood of developing post-operative right ventricular failure (RV failure) in the setting of mechanical circulatory support is one such example. Here we describe a video AI system trained to predict post-operative RV failure using the full spatiotemporal density of information in pre-operative echocardiography. We achieve an AUC of 0.729, and show that this ML system significantly outperforms a team of human experts at the same task on independent evaluation.

Ventricular Fibrillation Arrest and Pulmonary Homograft Rupture During Transcatheter Pulmonary Valve: Successful Rescue by Heart Team.

We describe a 31-year-old woman with pulmonary homograft rupture and ventricular fibrillation arrest complicating a transcatheter pulmonary valve (TPV) procedure. She underwent extracorporeal membrane oxygenation (ECMO) with immediate surgical repair including bioprosthetic pulmonary valve replacement. She had difficulty weaning off ECMO due to hyperacute failure of the valve and ultimately underwent successful hybrid TPV with complete recovery. This case illustrates the importance of the heart team approach during catheter and surgical interventions in adult congenital heart disease.

Long-term survival in patients with post-LVAD right ventricular failure: multi-state modelling with competing outcomes of heart transplant.

BACKGROUND: Multicenter data on long term survival following LVAD implantation that make use of contemporary definitions of RV failure are limited. Furthermore, traditional survival analyses censor patients who receive a bridge to heart transplant. Here we compare the outcomes of LVAD patients who develop post-operative RV failure accounting for the transitional probability of receiving an interim heart transplantation. METHODS: We use a retrospective cohort of LVAD patients sourced from multiple high-volume centers based in the United States. Five- and ten-year survival accounting for transition probabilities of receiving a heart transplant were calculated using a multi-state Aalen Johansen survival model. RESULTS: Of the 897 patients included in the study, 238 (26.5%) developed post-operative RV failure at index hospitalization. At 10 years the probability of death with post-op RV failure was 79.28% vs 61.70% in patients without (HR 2.10; 95% CI 1.72 - 2.57; p = < .001). Though not significant, patients with RV failure were less likely to be bridged to a heart transplant (HR 0.87, p = .4). Once transplanted the risk of death between both patient groups remained equivalent; the probability of death after a heart transplant was 3.97% in those with post-operative RV failure shortly after index LVAD implant, as compared to 14.71% in those without. CONCLUSIONS AND RELEVANCE: Long-term durable mechanical circulatory support is associated with significantly higher mortality in patients who develop post-operative RV failure. Improving outcomes may necessitate expeditious bridge to heart transplant wherever appropriate, along with critical reassessment of organ allocation policies.

Remote versus early corticosteroid wean outcomes in heart transplant recipients in the contemporary era.

PURPOSE: The risks and benefits of remote corticosteroid weaning in heart transplant recipients more than 2 years post-transplant are unknown. We compared outcomes in patients undergoing early and remote steroid weaning after heart transplantation. METHODS: We performed a retrospective study (range 09, 1991-04, 2017). Primary outcomes included short-term and long-term mortality, allograft dysfunction, and burden of rejection. Secondary outcomes included impact on hemoglobin A1c, lipid panel, bone scan T-score, and body mass index. RESULTS: 63 patients underwent corticosteroid weaning between 2012 and 2017. Outcomes of patients weaned early (n = 34; median time from transplant = 1.1 years) were compared with those weaned late (n = 29; median time from transplant = 4.4 years). 52 (82.5%) patients were successfully weaned off corticosteroids. No statistically significant difference in outcomes was found between the early and late weaning groups (p = .20). There were no differences in allograft function (p-value = .16), incidence of rejection (p = .46), or mortality (p = .15). Improvement in metabolic profile was seen in both groups but was not statistically significant. CONCLUSIONS: In heart transplant recipients, remote vs early weaning of corticosteroids is not associated with significant differences in graft function or the incidence of rejection after 1-year follow-up. Moreover, there were no significant differences in survival up to 3 years between the two groups.

Prediction of right heart failure after left ventricular assist implantation: external validation of the EUROMACS right-sided heart failure risk score.

AIMS: Prediction of right heart failure (RHF) after left ventricular assist device (LVAD) implant remains a challenge. The EUROMACS right-sided heart failure (EUROMACS-RHF) risk score was proposed as a prediction tool for post-LVAD RHF but lacks from large external validation. The aim of our study was to externally validate the score. METHODS AND RESULTS: From January 2007 to December 2017, 878 continuous-flow LVADs were implanted at three tertiary centres. We calculated the EUROMACS-RHF score in 662 patients with complete data. We evaluated its predictive performance for early RHF defined as either (i) need for short- or long-term right-sided circulatory support, (ii) continuous inotropic support for ≥14 days, or (iii) nitric oxide for ≥48 h post-operatively. Right heart failure occurred in 211 patients (32%). When compared with non-RHF patients, pre-operatively they had higher creatinine, bilirubin, right atrial pressure, and lower INTERMACS class (P < 0.05); length of stay and in-hospital mortality were higher. Area under the ROC curve for RHF prediction of the EUROMACS-RHF score was 0.64 [95% confidence interval (CI) 0.60-0.68]. Reclassification of patients with RHF was significantly better when applying the EUROMACS-RHF risk score on top of previous published scores. Patients in the high-risk category had significantly higher in-hospital and 2-year mortality [hazard ratio: 1.64 (95% CI 1.16-2.32) P = 0.005]. CONCLUSION: In an external cohort, the EUROMACS-RHF had limited discrimination predicting RHF. The clinical utility of this score remains to be determined.

Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control.

This clinical study compares 2 hemostatic agents, a novel combination powder (CP) (HEMOBLAST™ Bellows) and an established polysaccharide starch powder (PP) (Arista™ AH) to assess the usefulness of CP. Retrospective comparative analysis of CP (July 2018 to July 2019, 68 patients) to PP (January 2011 to January 2013, 94 patients) in cardiothoracic patients was performed using linear regression models adjusting for age, sex, and procedure type for the endpoints: blood loss; protamine to skin closure time (hemostasis time); chest tube output and blood products required 48 hours postoperatively; ICU stay; postoperative comorbidities; and 30 day mortality. 162 patients (108 M: 54 F) underwent 162 cardiothoracic surgical procedures including: transplantation (n = 44), placement of ventricular assist device (n = 87), and others (n = 31). Use of CP compared to PP (Estimated Mean Difference [95% CI], P-value) produced significant reductions: blood loss (mL) (-886.51 [-1457.76, -312.26], P = 0.003); protamine to skin closure time (min) (-16.81 [-28.03, -5.59], P = 0.004); chest tube output (48 hrs, mL) (-445.76 [-669.38, -222.14], P < 0.001); packed red blood cell transfusions (units) (-0.98 [-1.56, -0.4], P = 0.001); and postoperative comorbidities (-0.31 [-0.55, -0.07], P = 0.012). There were no differences in the ICU stay (4.07 [-2.01, 10.15], P = 0.188) or 30-day mortality (0.57 [0.20, 1.63], P = 0.291). The use of CP in complex cardiothoracic operations resulted in improved hemostasis and significant clinical benefits in blood loss, transfusion requirements, morbidity, and time in operating room.

Pulse assessment is important with blood pressure measurement in individuals with continuous flow left ventricular assist devices.

While Doppler and cuff blood pressure techniques are prevalent methods of assessing blood pressure in patients with continuous flow left ventricular assist devices, the impact of pulsatility on measurement is not well established. Retrospective chart analysis of clinical variables including pulse perception, blood pressure (Doppler and standard cuff), and aortic valve opening on echo at clinic visit were abstracted. Stable outpatients on continuous flow left ventricular assist devices support with concomitant portable echo assessment were included. Mean average difference was calculated and Pearson's correlation performed for all those patients who had both Doppler and cuff pressure obtained. In all, 74 Heartmate-II patients with a median time from implant of 380 days were analyzed. A pulse was perceived in 82% of patients with persistent aortic valve opening on portable echo and also in 30% of those who had a persistently closed aortic valve. The mean average difference between the Doppler and systolic cuff pressure was ~13 mmHg (r = 0.5, p = 0.004) when a pulse was present and ~11 mmHg when aortic valve was open (r = 0.68, p < 0.0001). Pulse presence seems to reflect aortic valve opening a majority of the time but not always. In the presence of a prominent pulse or persistent aortic valve opening, the Doppler pressure seems to be more reflective of a systolic pressure than mean perfusion pressure. Hence, assessment of pulsatility needs to be incorporated into blood pressure measurement methods for patients with continuous flow left ventricular assist devices.

Successful Treatment of Pregnant and Postpartum Women With Severe COVID-19 Associated Acute Respiratory Distress Syndrome With Extracorporeal Membrane Oxygenation.

There are limited data on the use of extracorporeal membrane oxygenation (ECMO) for pregnant and peripartum women with COVID-19 associated acute respiratory distress syndrome (ARDS). Pregnant women may exhibit more severe infections with COVID-19, requiring intensive care. We supported nine pregnant or peripartum women with COVID-19 ARDS with ECMO, all surviving and suffering no major complications from ECMO. Our case series demonstrates high-maternal survival rates with ECMO support in the management of COVID-19 associated severe ARDS, highlighting that these pregnant and postpartum patients should be supported with ECMO during this pandemic.

Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial.

BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery. METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial. RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support. CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.