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Objective: Our study examines the long-term outcomes of patients discharged from the hospital without heart replacement therapy (HRT) after recovery from cardiogenic shock using venoarterial extracorporeal life support (VA-ECLS)., Methods: We retrospectively reviewed 615 cardiogenic shock patients who recovered from VA-ECLS at our institution between January 2015 and July 2021. Of those, 166 patients (27.0%) who recovered from VA-ECLS without HRT were included in this study. Baseline characteristics, discharge labs, vitals, electrocardiograms and echocardiograms were assessed. Patients were contacted to determine vital status. The primary outcome was post-discharge mortality., Results: Of 166 patients, 158 patients (95.2%) had post-discharge follow-up, with a median time of follow-up of 2 years (IQR: [1 year, 4 years]). At discharge, the median ejection fraction (EF) was 52.5% (IQR: [32.5, 57.5]). At discharge, 92 patients (56%) were prescribed β-blockers, 28 (17%) were prescribed an ACE inhibitor, ARB or ARNI, and 50 (30%) were prescribed loop diuretics. Kaplan-Meier analysis showed a 1-year survival rate of 85.6% (95% CI: [80.1%, 91.2%]) and a 5-year survival rate of 60.6% (95% CI: [49.9%, 71.3%]). A Cox regression model demonstrated that a history of congestive heart failure (CHF) was strongly predictive of increased mortality hazard (HR = 1.929; p = 0.036), while neither discharge EF nor etiology of VA-ECLS were associated with increased post-discharge mortality., Conclusions: Patients discharged from the hospital after full myocardial recovery from VA-ECLS support without HRT should have close outpatient follow-up due to the risk of recurrent heart failure and increased mortality in these patients., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) following acute myocardial infarction with cardiogenic shock (AMI-CS) is increasing, but the ability to predict favorable outcomes with support remains limited. We retrospectively reviewed all patients with AMI-CS supported with VA-ECMO between December 2008 and June 2018. One hundred twenty-six patients received VA-ECMO for AMI-CS during the study period; of these, 39 (31.0%) experienced ventricular recovery and were discharged while 87 (69.0%) did not recover, with 71 (56.3%) dying in the hospital and 16 (12.7%) surviving to discharge with either left ventricular assist device or heart transplant. TIMI 3 flow in culprit artery (OR, 4.01; 95% CI, 1.25-12.77; p = 0.02), serum lactate (OR, 0.89; 95% CI, 0.80-0.99; p = 0.04), and prompt revascularization (OR, 3.39; 95% CI, 1.18-9.81; p = 0.02) were independent predictors of ventricular recovery. Four variables emerged as independent predictors of in-hospital mortality and were used to create the AMI-ECMO Risk Score: age >70 years, creatinine >1.5 mg/dL, serum lactate > 4.0 mmol/L, and lack of TIMI 3 flow in culprit artery. In patients supported with VA-ECMO for AMI-CS, prompt, successful revascularization, and lower serum lactate were associated with ventricular recovery while younger age, lower serum lactate, and creatinine, and successful revascularization were associated with survival to discharge. The AMI-ECMO risk score is a simple tool that can help risk stratify patients with AMI-CS being considered for VA-ECMO support., (Copyright © ASAIO 2021.)

Background: The 2018 U.S. heart allocation system offers an accelerated pathway for heart transplantation to the most urgent patients., Objectives: This study sought to determine whether the new allocation system resulted in lower likelihood of candidate recovery., Methods: Adult patients waitlisted for heart transplantation with temporary mechanical circulatory support at the time of initial listing between 2010 and 2020 in the United Network for Organ Sharing registry were included. Competing events of heart transplantation, waitlist death or delisting for deteriorating condition, and delisting for improved condition (candidate recovery) were analyzed in the new vs old heart allocation system., Results: A total of 688 patients were waitlisted with venoarterial extracorporeal membrane oxygenation or a surgical nondischargeable biventricular assist device (status 1 or old 1A). Overall, 2,237 patients were waitlisted with an intra-aortic balloon pump, a percutaneous left ventricular assist device (LVAD), or a surgical nondischargeable LVAD (status 2 or old 1A). Patients waitlisted with venoarterial extracorporeal membrane oxygenation or a nondischargeable biventricular assist device had significantly shorter median waitlist times (5 vs 31 days), higher incidence for cardiac transplantation (81.5% vs 43.0%), and lower incidence of candidate recovery (1.5% vs 7.9%) in the new vs old heart allocation system (all P < 0.05). Patients waitlisted with an intra-aortic balloon pump or percutaneous or a nondischargeable LVAD also had significantly shorter median waitlist times (8 vs 35 days), higher incidence of transplantation (88.9% vs 64.9%), and lower incidence of candidate recovery (0.2% vs 1.6%) in the new vs old heart allocation system (all P < 0.05)., Conclusions: Current practice of the new allocation system may not offer select temporary mechanical circulatory support patients the opportunity and adequate time to recover to the point of waitlist removal. Further research will determine which patients would benefit from urgent transplantation vs recovery strategy., Competing Interests: Funding Support and Author Disclosures Dr Topkara has been supported by NIH K08 HL146964. Dr Sayer has received consulting fees from Abbott Laboratories. Dr Clerkin has been supported by NIH K23 HL148528. Dr Wever-Pinzon has been supported by NIH K23 HL150322. Dr Burkhoff has received institutional educational grant support from Abiomed; and has received consulting fees from CardioDyme Inc and from Abbott Laboratories unrelated to mechanical circulatory assist. Dr Uriel has received consulting fees from Leviticus and LiveMetric. Dr Drakos is supported by the American Heart Association Heart Failure Strategically Focused Research Network (16SFRN29020000), NIH R01 HL135121, NIH R01 HL132067, Merit Review Award I01 CX0002291 (U.S. Department of Veterans Affairs), and Nora Eccles Treadwell Foundation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This analysis sought to investigate the waitlist and post-transplant outcomes of individuals bridged to transplantation by using temporary percutaneous endovascular mechanical circulatory support (tMCS) through a status 2 designation (cardiogenic shock and exception)., Background: The 2018 donor heart allocation policy change granted a status 2 designation to patients supported with tMCS., Methods: Adult patients in the United Network for Organ Sharing registry after October 18, 2018 who received a status 2 designation for tMCS were included and grouped by their status 2 criteria: cardiogenic shock with hemodynamic criteria (CS-HD), cardiogenic shock without hemodynamic criteria before tMCS (CS-woHD), and exception. Baseline characteristics, waitlist events (death and delisting), and post-transplant outcomes were compared., Results: A total of 2,279 patients met inclusion criteria: 68.6% (n = 1,564) with CS-HD, 3.2% (n = 73) with CS-woHD, and 28.2% (n = 642) with exceptions. A total of 64.2% of patients underwent heart transplantation within 14 days of status 2 listing or upgrade, and 1.9% died or were delisted for worsening clinical condition. Among the 35.8% who did not undergo transplantation following 14 days, only 2.8% went on to receive a left ventricular assist device (LVAD). The 30-day transplantation likelihood was similar among groups: 80.1% for the CS-HD group vs 79.7% for the exception group vs 73.3% for the CS-woHD group; P = 0.31. However, patients who met criteria for CS-woHD had 2.3-fold greater risk of death or delisting (95% CI: 1.10-4.75; P = 0.03) compared with CS-HD patients after multivariable adjustment. Pre-tMCS hemodynamics were not associated with adverse waitlist events., Conclusions: The use of tMCS is an efficient, safe, and effective strategy as a bridge to transplantation; however, patients with CS-woHD may represent a high-risk cohort. Transition to a durable LVAD was a rare event in this group., Competing Interests: Funding Support and Author Disclosures Dr Clerkin is supported by National Heart, Lung and Blood Institute grant K23 HL148528. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The purpose of this study was to compare outcomes between patients on extracorporeal membrane oxygenation (ECMO) bridged to left ventricular assist device (LVAD) versus heart transplantation (HT) using registry data., Background: Patients with heart failure supported with ECMO represent the highest priority in the new HT allocation system. For patients on ECMO, bridging to LVAD may be non-inferior compared with bridging to HT., Methods: Adult patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) from 2006 to 2017 and United Network for Organ Sharing (UNOS) database from 2006 to June 2019 requiring ECMO were included. Cause-specific hazard models were created and cumulative incidence functions were calculated with mortality, transplantation, and re-transplantation as competing events., Results: A total of 906 patients received ECMO as bridge to VAD (n = 587, 64.8%) or as bridge to HT (n = 319, 35.2%). Patients bridged directly to HT were younger (age 46.3 ± 15.4 years vs. 52.1 ± 13.2 years; p < 0.001) and more likely to be female (93 [29.2%] vs. 139 [23.7%]; p = 0.022). Patients bridged directly to HT were more likely to have a nonischemic cardiomyopathy, restrictive physiologies, and allograft failure; (p < 0.05 for all). ECMO use increased over time in both UNOS and INTERMACS. There was no significant difference in mortality between groups (Gray's p = 0.581). This remained true even when the analysis was restricted to transplant-listed or eligible patients as well as patients with dilated phenotypes (excluding patients with congenital heart disease, restrictive phenotypes, and allograft failure)., Conclusions: There was no difference in mortality on pump support compared with posttransplant mortality among those bridged from ECMO to LVAD or HT., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Chronic systolic heart failure (HF) with acute decompensation can result in cardiogenic shock (CS) requiring short-term mechanical circulatory support. We sought to identify predictors of survival for acute decompensated HF (ADHF) patients requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Patients >18 years old treated at our institution with VA-ECMO from 2009 to 2018 for ADHF with CS were studied. Demographic, hemodynamic, and echocardiographic data were collected. The primary outcome was survival to discharge. Fifty-two patients received VA-ECMO for ADHF with CS; 24 (46.2%) survived. Seventeen (32.7%) had suffered cardiac arrest, and 37 (71.2%) were mechanically ventilated. Mean lactate was 4.33 ± 3.45 mmol/L, and patients were receiving 2.7 ± 1.2 vasopressor/inotropic infusions at ECMO initiation; these did not differ significantly between survivors and nonsurvivors. Pre-ECMO cardiac index was 1.84 ± 0.56L/min/m and 1.94 ± 0.63L/min/m in survivors and nonsurvivors, respectively (p = 0.57). In multivariable analysis, only diabetes mellitus (DM; OR, 13.25; CI, 1.42-123.40; p = 0.02) and mineralocorticoid receptor antagonist use (OR, 0.12; CI, 0.02-0.78; p = 0.03) were independent predictors of mortality. Nineteen (79.2%) survivors required durable ventricular assist device. Among ADHF patients receiving VA-ECMO, DM is a powerful predictor of outcomes while markers of clinical acuity including hemodynamics, vasopressor/inotrope use, and lactate are not. The vast majority of survivors required durable left-ventricular assist devices.

Combination of venoarterial extracorporeal membrane oxygenation (VA-ECMO) and a percutaneous microaxial left ventricular assist device (pLVAD), or "EC-VAD," has been reported in cases of left ventricular decompression with mixed results. We conducted a retrospective review of patients who received EC-VAD (n = 29) or isolated VA-ECMO therapy (ECMO-only; n = 196) for refractory cardiogenic shock between February 2011 and October 2014. Fourteen patients received VA-ECMO and then Impella pLVAD (E→EC-VAD), and 15 received the Impella pump then VA-ECMO (I→EC-VAD). E→EC-VAD patients demonstrated decreased pulmonary artery systolic (36.00 ± 16.84 mm Hg versus 30.63 ± 12.13 mm Hg; p = 0.049) and diastolic (24.25 ± 13.45 mm Hg versus 17.25 ± 7.96 mm Hg, p = 0.049) pressures by 24 hours post-EC-VAD implant. In the same period, I→EC-VAD patients demonstrated improved SvO2 (43.14 ± 16.75% versus 75.18 ± 13.88%, p = 0.043) and PaO2/FiO2 ratio (148.55 ± 67.69 mm Hg versus 374.51 ± 170.97 mm Hg, p = 0.043). Thirty-day survival rates were 42.9% in E→EC-VAD, 46.7% in I→EC-VAD, and 49.0% in ECMO-only (p = 0.913). Hemolysis occurred more in EC-VAD patients (44.83% versus 17.35% in ECMO-only, p = 0.002); however, there was no increased frequency of other adverse events including bleeding and lower limb ischemia. Despite increased hemolysis, combined use of VA-ECMO and pLVAD may improve or circumvent left ventricular distension in refractory cardiogenic shock while promoting adequate blood flow.

Background: Early right ventricular (RV) failure after left ventricular assist device (LVAD) implantation increases morbidity and mortality. Percutaneous right ventricular assist device (pRVAD) support is an alternative to more invasive surgical RVAD (sRVAD)., Methods and Results: We retrospectively reviewed patients receiving isolated pRVAD or sRVAD after durable LVAD at our center in the years 2007-2018. Hemodynamic parameters before and after implantation and survival outcomes were compared among groups. Nineteen patients received pRVAD and 21 sRVAD. Hemodynamic parameters improved immediately with the use of pRVAD; central venous pressure decreased (from 15.9 ± 2.4 to 12.3 ± 3.2 mm Hg; P<.001) and cardiac index increased (from 2.4 ± 0.5 to 3.5 ± 0.8 L·min -1 ·m - 2 ; P<.001). These were sustained after device removal and were similar to those with the use of sRVAD. Patients with pRVAD required fewer blood transfusions and mechanically ventilated days than those with sRVAD. Among survivors, intensive care unit and hospital days were fewer with the use of pRVAD: 21 (16-27) versus 34 (27-46) ICU days (P = .01); 43.5 (30-66) versus 91 (62-111) hospital days (P = .03). There was no significant difference in 30-day mortality with the use of pRVAD compared with sRVAD (21.1% vs 42.9%; P = .14), but there was a trend toward a higher rate of discharge free from hemodialysis (73.7% vs 47.6%; P = .09)., Conclusions: Novel pRVAD systems for RV failure provide hemodynamic benefits similar to sRVAD, are associated with less morbidity, and should be considered as an alternative to sRVAD., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background:: Cardiogenic shock following acute myocardial infarction (AMI-CS) portends a poor prognosis. Short-term mechanical circulatory support devices (MCSDs) provide hemodynamic support for patients with cardiogenic shock but predictors of survival and the ability to wean from short-term MCSDs remain largely unknown., Methods:: All patients > 18 years old treated at our institution with extra-corporeal membrane oxygenation or short-term surgical ventricular assist device for AMI-CS were studied. We collected acute myocardial infarction details with demographic and hemodynamic variables. Primary outcomes were survival to discharge and recovery from MCSD (i.e. survival without heart replacement therapy including durable ventricular assist device or heart transplant)., Results:: One hundred and twenty-four patients received extra-corporeal membrane oxygenation or short-term surgical ventricular assist device following acute myocardial infarction from 2007 to 2016; 89 received extra-corporeal membrane oxygenation and 35 short-term ventricular assist device. Fifty-five (44.4%) died in the hospital and 69 (55.6%) survived to discharge. Twenty-six (37.7%) required heart replacement therapy (four transplant, 22 durable ventricular assist device) and 43 (62.3%) were discharged without heart replacement therapy. Age and cardiac index at MCSD implantation were predictors of survival to discharge; patients over 60 years with cardiac index <1.5 l/min per m 2 had a low likelihood of survival. The angiographic result after revascularization predicted recovery from MCSD (odds ratio 9.00, 95% confidence interval 2.45-32.99, p=0.001), but 50% of those optimally revascularized still required heart replacement therapy. Cardiac index predicted recovery from MCSD among this group (odds ratio 4.06, 95% confidence interval 1.45-11.55, p=0.009)., Conclusion:: Among AMI-CS patients requiring short-term MCSDs, age and cardiac index predict survival to discharge. Angiographic result and cardiac index predict ventricular recovery but 50% of those optimally revascularized still required heart replacement therapy.

With the impending United Network for Organ Sharing (UNOS) heart allocation policy giving VA-ECMO supported heart transplant (HT) candidates highest priority status (Tier 1), identifying patients in cardiogenic shock (CS) with severe and irreversible heart failure (HF) appropriate for urgent HT is critically important. In a center where wait times currently preclude this approach, we retrospectively reviewed 119 patients (ages 18-72) with CS from 1/2014 to 12/2016 who required VA-ECMO for >24 hours. Underlying aetiologies included postcardiotomy shock (45), acute coronary syndromes (33), and acute-on-chronic HF (16). Eighty-four percent of patients (100) had ≥1 contraindication to HT with 61.3% (73) having preexisting contraindications (eg, multiorgan dysfunction and substance abuse), and 68.1% (81) experienced preclusive complications (eg, renal failure, coagulopathy, and infection). Potential HT candidates were significantly more likely to survive to discharge (potential HT candidates 84.2% vs preexisting contraindications 43.8% vs contraindications developing on VA-ECMO 33.3%, P = 0.001). Among potential HT candidates, 11 (68.8%) were discharged without advanced therapies and 4 received durable left ventricular assist device (25.0%). Importantly, 1-year survival was 100% for the 11 patients with follow-up. Thus, further work is critical to define appropriate candidates for HT from VA-ECMO while avoiding preemptive transplantation in those with otherwise favorable outcomes., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objectives: We recently developed a novel minimally invasive surgical approach that combines extracorporeal membrane oxygenation and CentriMag ventricular assist device (Ec-VAD) for the treatment of cardiogenic shock as a short-term circulatory support. We compared the outcomes of this new approach to conventional CentriMag biventricular assist device (BiVAD) support through a median sternotomy., Methods: Between July 2015 and August 2016, 22 patients were implanted with CentriMag Ec-VAD and 90 patients were implanted with conventional CentriMag BiVAD. The Ec-VAD circuit was configured with left ventricular apical cannulation via a mini-thoracotomy and femoral venous cannulation as inflows and right axillary artery cannulation as an outflow., Results: Patients with Ec-VAD were older (58 ± 9.9 vs 53 ± 13 years, P = 0.06), had more preoperative percutaneous mechanical circulatory support use (82% vs 44%, P < 0.01) and less cardiopulmonary bypass use intraoperatively (0% vs 66%, P < 0.01). Patients who received Ec-VAD required less transfusions. The Ec-VAD group had a significantly lower incidence of major bleeding events during support (32% vs 72%, P < 0.01). Average systemic flow was similar (Ec-VAD: 5.5 ± 0.94 vs BiVAD: 5.7 ± 1.1 l/min, P = 0.4). Seventeen patients (77%) with Ec-VAD survived to the next destination compared with 66 patients (73%) with BiVAD (P = 0.45). Thirty-day survival was similar between groups (Ec-VAD 86% vs BiVAD 76%, P = 0.39), and overall 1-year survival was 61% in Ec-VAD and 55% in BiVAD (P = 0.7)., Conclusions: Ec-VAD is a unique approach for the treatment of patients in cardiogenic shock. It eliminates the need for cardiopulmonary bypass and reduces blood product utilization and bleeding events., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Left ventricular distention (LVD) during venoarterial extracorporeal membrane oxygenation (VA-ECMO) support is increasingly recognized but seldom reported in the literature. The current study defined LVD as not present (LVD-); subclinical (LVD+, evidence of pulmonary edema on chest radiograph AND pulmonary artery diastolic blood pressure greater than 25 mm Hg within the first 2 hours of intensive care unit admission); or clinical (LVD++, need for decompression of the left ventricle immediately following VA-ECMO initiation). Among 226 VA-ECMO device runs, 121 had sufficient data to define LVD retrospectively. Nine patients (7%) developed LVD++ requiring immediate decompression, and 27 patients (22%) met the definition of LVD+. Survival to discharge was similar among groups (LVD++: 44%, LVD+: 41%, LVD-: 44%). However, myocardial recovery appeared inversely related to the degree of LVD (LVD++: 11%, LVD+: 26%, LVD-: 40%). When death or transition to device was considered as a composite outcome, event-free survival was diminished in LVD++ and LVD+ patients compared with LVD-. Multivariable analysis identified cannulation of VA-ECMO during extracorporeal cardiopulmonary resuscitation (ECPR) as a risk factor for decompression (odds ratio [OR]: 3.64, confidence interval [CI]: 1.21-10.98; p = 0.022). Using a novel definition of LVD, the severity LVD was inversely related to the likelihood of myocardial recovery. Survival did not differ between groups. Extracorporeal cardiopulmonary resuscitation was associated with need for mechanical intervention.

Objectives: The use of short-term mechanical circulatory support (MCS) has increased in the treatment of refractory cardiogenic shock (RCS). Percutaneous short-term MCS technology has emerged rapidly; however, limitations in flow and durability remain. We therefore investigated a minimally invasive surgical approach using an external ventricular assist device (VAD) and extracorporeal membrane oxygenation (ECMO) in patients with RCS., Methods: Twenty-five patients underwent minimally invasive external VAD insertion with a magnetically levitated centrifugal pump for various causes of cardiogenic shock between April 2010 and May 2016. An external VAD was established with left ventricular apical cannulation through a minithoracotomy and right or left axillary artery cannulation. In patients with biventricular failure or pulmonary complications, femoral venous cannulation was added as an additional inflow source, and ECMO was spliced into the external VAD circuit., Results: Mean patient age was 58 ± 9.1 and 80% were men. All patients were in Interagency Registry for Mechanically Assisted Circulatory Support profile I RCS. The aetiology of RCS was decompensated chronic heart failure in 13 (52%), and acute myocardial infarction in 12 (48%). Twenty-three (92%) received percutaneous short-term MCS prior to surgery. The procedure was performed without cardiopulmonary bypass in all patients. ECMO was added in 17 patients (68%) and explanted after a median of 4 days of support. The average flow obtained was 5.3 ± 1.1 l/min. The median duration of external VAD support was 22 days. Major complications during support included bleeding events in seven (28%) and cerebrovascular events in four (16%). The in-hospital mortality rate was 32%. Seventeen patients (68%) survived to the next destination including myocardial recovery in three (12%), device exchange to a durable VAD in 12 (48%) and heart transplantation in two (8%). The Kaplan-Meier survival rates at 6 months and 1 year were 92% and 77%, respectively., Conclusions: Our minimally invasive surgical approach using an external VAD is a feasible strategy for patients with cardiogenic shock who are refractory to percutaneous short-term MCS support., (© The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)