Temporary Mechanical Circulatory Support Devices Research Articles

Abstract 4129945: Risk of stroke for AMI treated with temporary mechanical circulatory support: ten-year data from National Inpatient Sample

Objectives: The aim of this study was to assess the risk of stroke for temporary mechanical circulatory support (tMCS) device treated acute myocardial infarction (AMI). Background: Data are limited regarding risk of stroke for temporary mechanical circulatory support (tMCS) device treated acute myocardial infarction (AMI). Methods: The national inpatient sample database was analyzed to identify adults who were hospitalized for AMI between 2012 and 2021, hospitalizations were grouped based on the temporary mechanical circulatory support device. Study design: In the final cohort, there are 8,272,163 (96.0%) weighted hospitalizations treated without tMCS, 265,870 (3.1%) with Intra-Aortic Balloon Pump (IABP) alone, 59,240 (0.7%) with Impella alone, and 16,225 (0.2%) with Extracorporeal Membrane Oxygenation (ECMO) used during the hospitalization. Results: The overall stroke rates for patients who treated without tMCS, IABP alone, Impella alone, and ECMO group were 3.41%, 3.46%, 4.51%, and 13.34% respectively. Specifically, the rates of ischemic stroke for these groups were 2.95%, 3.12%, 3.96% and 10.11% respectively. The rates for hemorrhagic stroke were 0.68%, 0.55%, 0.81%, and 4.90% for the same groups. In the stepwise forward Cox regression analysis, the adjusted OR (aOR) of ECMO use for overall stroke was 3.04 (95%CI [2.66-3.48]), followed by Impella only use with an aOR of 1.79 (95%CI [1.61-2.00]), and atrial fibrillation (aOR 1.34, 95%CI [1.31-1.38]). The subgroup analysis revealed that hospitalization with age younger than 50 years old, those without hypertension, and those presented with ST-elevation myocardial infarction are at particularly high risk of stroke for ECMO treated AMI. Conclusion: This ten years AMI hospitalizations analysis revealed that ECMO and Impella treatment associated with increased risk of both ischemic and hemorrhagic stroke. Particularly for those younger than 50, those without hypertension, and those presented with ST-elevation myocardial infarction. However, treatment with IABP alone does not increase the risk of stroke.

Research Progress on Acute Kidney Injury in Patients with Cardiogenic Shock Undergoing Venoarterial Extracorporeal Membrane Oxygenation

Cardiogenic shock (CS) is a life-threatening syndrome characterized by peripheral hypoperfusion and organ dysfunction caused by primary heart disease. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary mechanical circulatory support device for CS, used in cases of profound shock, biventricular failure, respiratory failure, and cardiac arrest that require urgent maximal support. While VA-ECMO provides effective tissue perfusion and ensures oxygen supply to organs, it is also associated with severe complications, among which acute kidney injury (AKI) is one of the most common and serious. To date, no comprehensive review has been conducted on the pathophysiology, influencing factors, and treatment of AKI associated with VA-ECMO. This paper aims to elaborate on the pathophysiological mechanisms, influencing factors, and treatment options for AKI in patients with CS undergoing VA-ECMO, providing clinical and nursing references.

Echocardiographic evaluation of ventricular performance in VA-ECMO weaning: results from a observational monocentric prospective study

Abstract Background Although temporary mechanical circulatory support (MCS) devices are increasingly used in the management of cardiogenic shock (CS), several open question regarding the kind of support and timing of institution/weaning remains open. Echocardiography is widely applied to drive the weaning process and decision although there are no standardized protocols for the trial nor accordance on the parameters to apply. Purpose We sought to evaluate the overall accuracy of echocardiographic indices in predicting successful weaning from VA ECMO in patients with CS. Specifically, we tested total isovolumic time (tIVT), an index of ventricular performance, and longitudinal function (MAPSE) on top of the commonly used parameters (left ventricular ejection fraction, LVEF; left ventricular velocity time integral, LV VTI; TAPSE; right ventricular S’ at tissue Doppler imaging, RV S’). Methods Monocentric prospective study on adults receiving VA-ECMO due to refractory CS and/or cardiac arrest (CA) from 2012 to 2020. Echocardiography was performed at VA-ECMO placement and during the weaning trials. Weaning trials were performed daily, starting 48 hours after VA-ECMO institution, when patients were hemodynamically stable: mean arterial pressure >65 mmHg, no or minimum adrenergic support (vasoactive inotropic score <10), heart rate <110 bpm, lactate <2 mmol/L, and no signs of respiratory distress. Weaning trials were performed with a stepwise decrease of VA-ECMO blood flow until reaching 1 or 1.5 L/min under adequate anticoagulation. Successful weaning was defined as removal of VA-ECMO with no requirement for further MCS in the following 30 days. Results 76 patients were enrolled (23.8% female, 54.2±10.6 years-old), 52.6% due to CA. Median duration of VA-ECMO was 58 hours; 47 (61.8%) had intra-aortic balloon pump (IABP) inserted upfront. In-hospital mortality was 62.4% overall, 40% for CS without CA. 6 of the 32 weaned patients died for multiorgan failure due to septic shock. The baseline echocardiographic parameters associated with successful weaning were (table): stroke volume >13.9 mL (p 0.002), tIVT >23.6 min/sec (p 0.053), LV VTI >6.6 cm (p<0.001), MAPSE >6.15 mm (p 0.001), TAPSE >11 mm (p 0.023), RV S’ >10 cm/s (p 0.012). LVEF did not reach the statistical significance. Figure shows Kaplan-Meier analysis on echocardiographic indices collected at time of cannulation (panel A) and during the last weaning trial (panel B). Conclusions Echocardiography is pivotal in defining cardiac recovery and monitoring the weaning trial. Indices reflecting ventricular performance and delivered flow from LV were associated with weaning success both at VA-ECMO institution and throughout the weaning trials. Considering the known limitations of LVEF (heart rate, loading and left ventricular dyssynchrony dependence), tIVT and MAPSE should be introduced in the standard evaluation of patients in the acute setting.TableFigure

Extending the window in clinical decision making: the role for Impella 5.5 in cardiogenic shock

Abstract Background Acute decompensated heart failure (HF) refractory to medical management deteriorates quickly to cardiogenic shock, ultimately requiring mechanical circulatory support (MCS). These devices aim to provide circulatory support as a bridge to advanced therapies. We report patient outcomes with the latest minimally invasive temporary MCS device: Impella 5.5 with SmartAssist. Methods All patients who underwent Impella 5.5 implantation between January 2020 and December 2023 were analyzed. Duration of Impella support and peri-implant parameters were collected from electronic medical records. ANOVA was performed and utilized a p-value of <0.05 as significant for statistical analysis. Results During our review period, a total of 99 patients were supported with Impella 5.5 in the setting of cardiogenic shock. 92 were bridged to heart transplant (BTT), of which 17 also received combined kidney transplantation. Two underwent durable VAD implantation (BTVAD), and 3 had native heart recovery (BTR) and explant. Two patients died, yielding a survival rate of 98%. For BTT group, the median age was 60 years (52-65) at implant and a median BMI of 27 kg/m² (24-31) with a mean support duration of 29 days (SD ±24). Baseline GFR was 49 mL/min/1.73m² (35-65). In the BTVAD group, the median BMI was 43 kg/m² (39-46) with an average duration of support of 22 days (SD ±8) with a GFR of 55 mL/min/1.73m² (38-73). The BTR group had a median BMI of 29 kg/m² (27-30) with an average duration of support of 15 days (SD ±7) and a lower baseline GFR of 36 mL/min/1.73m² (26 – 37) compared to BTT or BTVAD. The two patients that died were supported for an average of 42 days (SD ±9.2) and expired due to non-candidacy in the setting of newly detected prostate cancer in one patient and multi-organ failure in another. All BTVAD and BTT patients did not have a stroke or major vascular complications before terminal therapy. Conclusion Our center highlights the role of early Impella 5.5 placement in the stabilization of patients in cardiogenic shock, thereby providing both patients and providers time for decision-making while optimizing end-organ perfusion beyond the accepted duration of 14 days.Impella Data - Entire CohortImpella Data - Stratified by Outcome

Impella 5.5: A Systematic Review of the Current Literature.

Impella 5.5 (Abiomed, Danvers, MA, USA) is a temporary mechanical circulatory support device used for patients in cardiogenic shock. This review provides a comprehensive overview of the device's clinical effectiveness, safety profile, patient outcomes, and relevant procedural considerations. We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the PubMed/MEDLINE database. The search query included articles available from October 6, 2022, through January 13, 2023. Our initial search identified 75 studies. All records were screened by 2 independent reviewers using the Covidence software for adherence to our inclusion criteria, and 8 retrospective cohort studies were identified as appropriate for inclusion. Across the included studies, the sample size ranged from 4 to 275, with predominantly male cohorts. Indications for Impella support varied, and the duration of support ranged from 9.8 to 70 days. Overall, Impella support appeared to be associated with favorable survival rates and manageable complications in various patient populations. Complications associated with Impella use included bleeding, stroke, and device malfunctions. Two studies compared prolonged and Food and Drug Administration-approved Impella support, showing similar outcomes and adverse events. Impella 5.5 continues to be an attractive option for bridging patients to definitive therapy. Survival during and after Impella 5.5 was favorable for patients regardless of initial indication. However, device use was associated with several important complications, which calls for judicious use and a precontemplated exit strategy. Limitations of this literature review include biases inherent to the retrospective studies included, such as selection and publication bias.

Review of Advancements in Managing Cardiogenic Shock: From Emergency Care Protocols to Long-Term Therapeutic Strategies.

Cardiogenic shock (CS) is a complex multifactorial clinical syndrome of end-organ hypoperfusion that could be associated with multisystem organ failure, presenting a diverse range of causes and symptoms. Despite improving survival in recent years due to new advancements, CS still carries a high risk of severe morbidity and mortality. Recent research has focused on improving early detection and understanding of CS through standardized team approaches, detailed hemodynamic assessment, and selective use of temporary mechanical circulatory support devices, leading to better patient outcomes. This review examines CS pathophysiology, emerging classifications, current drug and device therapies, standardized team management strategies, and regionalized care systems aimed at optimizing shock outcomes. Furthermore, we identify gaps in knowledge and outline future research needs.

Three-Year Left Ventricular Assist Device Outcomes and Strategy After Heart Transplant Allocation Score Change

BackgroundThe United Network for Organ Sharing (UNOS) adopted new criteria for the heart allocation score on 10/18/2018 to reflect changing trends of candidates’ mortality while awaiting transplant. We examined the impact of these policy changes on rates of left ventricular assist device (LVAD) implantation and outcomes posttransplant from a relatively newer UNOS database. MethodsThe UNOS registry was used to identify first-time adult heart recipients with LVAD at listing or transplant who underwent transplantation between 1/1/2016 and 3/10/2020. Survival data was collected through 3/30/2023. Those listed prior to 10/18/2018 but transplanted after were excluded. Patients were divided into before or after change groups. Demographics and clinical parameters were compared. Survival was analyzed with Kaplan-Meier curves and log-rank tests. A p<0.05 was considered significant. ResultsWe identified 4387 heart recipients with LVAD in the before (n=3606) and after (n=781) score change eras. The after group had a lower rate of LVAD implantation while listed compared to the before group (20.4% vs 34.9%, p<0.0001), and were more likely to be female (25.1% vs 20.2%, p=0.002); in both groups, most recipients (62.8%) were white. There was significantly farther distance from the donor hospital to transplant center in the after group (264.4 NM vs 144.2NM, p<0.0001) and decreased waitlist days (84.9 ± 105.1 vs 369.2 ± 459.5, p<0.0001). Recipients in the after group were more likely to utilize ECMO (3.7% vs 0.5%, p<0.0001) and IV inotropes (19.1% vs 7.5%, p<0.0001), and receive a CDC increased-risk donor organ (37.9% vs 30.5%, p<0.0001). Survival at 3-years was comparable between the two groups. ConclusionsThe allocation score change in 2018 yielded considerable changes in mechanical circulatory support device implantation strategy and outcomes. The rate of LVAD implantation decreased with increased utilization of temporary mechanical circulatory support devices.

Pragmatic approach to temporary mechanical circulatory support in acute right ventricular failure

Acute right ventricular failure (RVF) is prevalent in multiple disease states and is associated with poor clinical outcomes. Right-sided temporary mechanical circulatory support (tMCS) devices are used to unload RV congestion and increase cardiac output in cardiogenic shock (CS) with hemodynamically significant RVF. Several RV-tMCS device platforms are available; however consensus is lacking on patient selection, timing of escalation to RV-tMCS, device management, and device weaning. The purposes of this review are to 1) describe the current state of tMCS device therapies for acute RVF with CS, 2) discuss principles of escalation to RV-tMCS device therapy, 3) examine important aspects of clinical management for patients supported by RV-tMCS devices including volume management, anticoagulation, and positive pressure ventilation, and 4) provide a framework for RV-tMCS weaning.

Clinical outcomes among cardiogenic shock patients supported with high-capacity Impella axial flow pumps: A report from the Cardiogenic Shock Working Group

BackgroundThe Impella 5.0 and 5.5 pumps (Abiomed, Danvers, MA) are large-bore transvalvular micro-axial assist devices used in cardiogenic shock (CS) for patients requiring high-capacity flow. Despite their increasing use, real-world data regarding indications, rates of utilization and clinical outcomes with this therapy are limited. ObjectivesTo examine clinical profiles and outcomes of patients in a contemporary, real-world CS registry of patients who received an Impella 5.0/5.5 alone or in combination with other temporary mechanical circulatory support (tMCS) devices. MethodsThe CS Working Group (CSWG) Registry includes patients from 34 US hospitals. For this analysis, data from patients who received an Impella 5.0/5.5 between 2020-2023 were analyzed. Use of Impella 5.0/5.5 with or without additional tMCS therapies, duration of support, adverse events and outcomes at hospital discharge were studied. Adverse events including stroke, limb ischemia, bleeding and hemolysis were not standardized by the registry but reported per individual CSWG Primary Investigator discretion. For those who survived, rates of native heart recovery (NHR) or heart replacement therapy (HRT) including heart transplant (HT), or durable ventricular assist device (VAD) were recorded. We also assessed outcomes based on based on shock etiology (acute myocardial infarction or MI-CS vs. heart failure-related CS or HF-CS). ResultsAmong 6,205 patients, 754 received an Impella 5.0/5.5 (12.1%), including 210 MI-CS (27.8%) and 484 HF-CS (64.1%) patients. Impella 5.0/5.5 was used as the sole tMCS device in 32% of patients, while 68% of pts received a combination of tMCS devices. Impella cannulation sites were available for 524/754 (69.4%) of patients, with 93.5% axillary configuration. Survival to hospital discharge for those supported with an Impella 5.0/5.5 was 67%, with 20.4% NHR and 45.5% HRT. Compared to HF-CS, patients with MI-CS supported on Impella 5.0/5.5 had higher in-hospital mortality (45.2% vs 26.2%, p<0.001) and were less likely to receive HRT (22.4% vs 56.6%, p<0.001. For patients receiving a combination of tMCS during hospitalization, this was associated with higher rates of limb ischemia (9% vs. 3%, p<0.01), bleeding (52% vs. 33%, p<0.01), and mortality (38% vs 25%; p<0.001) compared to Impella 5.0/5.5 alone. Among Impella 5.5 recipients, the median duration of pump support was 12.9 days (IQR: 6.8-22.9) and longer in patients bridged to HRT (14 days; IQR: 7.7-28.4). ConclusionsIn this multi-center cohort of patients with CS, use of Impella 5.0/5.5 was associated with an overall survival of 67.1% and high rates of HRT. Lower adverse event rates were observed when Impella 5.0/5.5 was the sole support device used. Further study is required to determine whether a strategy of early Impella 5.0/5.5 use for CS improves survival. Condensed abstractHigh capacity Impella heart pumps provide up to 5.5 L/min of flow, while axillary surgical cannulation allows for ambulation. Patients with advanced cardiogenic shock from acute myocardial infarction or heart failure requiring temporary mechanical circulatory support may benefit from upfront use of Impella 5.5 to improve overall survival, including native heart recovery or successful bridge to durable left ventricular assist device surgery or heart transplantation, and to reduce adverse event rates.

Understanding the complexity of cardiogenic shock management: the added value of advanced computational modeling.

The purpose of this review is to explain the value of computational physiological modeling for in-depth understanding of the complex derangements of cardiopulmonary pathophysiology during cardiogenic shock, particularly when treated with temporary mechanical circulatory support (tMCS) devices. Computational physiological models have evolved in recent years and can provide a high degree of clinical realism in the simulation of cardiogenic shock and related conservative and interventional therapies. These models feature a large spectrum of practically relevant hemodynamic and respiratory parameters tunable to patient-specific disease states as well as adjustable to medical therapies and support device settings. Current applications work in real-time and can operate on an ordinary computer, laptop or mobile device. The use of computational physiological models is increasingly appreciated for educational purposes as they help to understand the complexity of cardiogenic shock, especially when sophisticated management of tMCS is involved in addition to multimodal critical care support. Practical implementation of computational models as clinical decision support tools at the bedside is at the horizon but awaits rigorous clinical validation.

Discordance between aPTT and anti-Xa in monitoring heparin anticoagulation in mechanical circulatory support.

It is unclear whether activated partial thromboplastin time (aPTT) or anti-Xa is more accurate for monitoring heparin anticoagulation in mechanical circulatory support (MCS) patients. This study investigates the relationship between aPTT and anti-Xa in MCS patients and identifies predictors of discordance. aPTT and anti-Xa were simultaneously measured in a prospective cohort of MCS patients receiving unfractionated heparin at a tertiary academic medical centre. Therapeutic aPTT and anti-Xa levels were 60-100s and 0.3-0.7IU/mL, respectively, and concordance was defined as both levels being subtherapeutic, therapeutic, or supratherapeutic. To identify predictors of discordance, both a machine learning random forest model and a multivariate regression model were applied to patient demographics, device type, and 14 laboratory variables; 23001 pairs of simultaneously measured aPTT/anti-Xa were collected from 699 MCS patients. aPTT and anti-Xa were concordant in 35.5% of paired observations and discordant in 64.5% (aPTT>antiXa 61.5%; aPTT<antiXa 3.0%). Discordance with a high aPTT relative to anti-Xa (aPTT>antiXa) was associated with high INR, eGFR, and total bilirubin, as well as low platelets, haemoglobin, pre-albumin, white blood cell count, and haptoglobin. Total artificial heart and durable ventricular assist devices were more likely to be associated with aPTT>anti-Xa than temporary MCS devices. aPTT and anti-Xa were frequently discordant in MCS patients receiving heparin anticoagulation. Clinical conditions common in MCS patients such as concurrent warfarin use, malnutrition, haemolysis, and thrombocytopenia, as well as durable type of MCS devices were associated with a high aPTT relative to anti-Xa.

Echocardiographic evaluation of ventricular performance in VA-ECMO weaning: results from a observational multicentric prospective study

Abstract Funding Acknowledgements None. Background Although temporary mechanical circulatory support devices are increasingly used in the management of cardiogenic shock (CS), several open question regarding the kind of support and timing of institution/weaning remains open. Echocardiography is widely applied to drive the weaning process from VA-ECMO although there are no standardized protocols. Purpose We sought to evaluate the accuracy of echocardiographic indices in predicting successful weaning from VA-ECMO in CS patients. We tested total isovolumic time (tIVT), an index of ventricular performance(1,2), and longitudinal function (MAPSE) on top of the commonly used parameters (left ventricular ejection fraction, LVEF; E/e’ at mitral valve; left ventricular velocity time integral, LV VTI; TAPSE; right ventricular S’ at tissue Doppler imaging, RV S’). Methods Multicentric prospective study on adults receiving VA-ECMO due to refractory CS and/or cardiac arrest (CA) from 2012 to 2020. Echocardiography was performed at VA-ECMO placement and during the weaning trials. Waning trials were performed daily starting from 48 hours after VA-ECMO institution. A stepwise decrease of VA-ECMO blood flow was applied, until reaching 1 or 1.5 L/min. Successful weaning was defined as removal of VA-ECMO with no requirement for further MCS in the following 30 days. Results 76 patients were enrolled (23.8% female, 54.2±10.6 years-old), 52.6% due to CA. Median duration of VA-ECMO was 58 hours; 47 (61.8%) had intra-aortic balloon pump (IABP) inserted upfront. In-hospital mortality was 62.4% overall, 40% for CS without CA. 6 of the 32 weaned patients died in hospital for multiorgan failure due to septic shock. The baseline echocardiographic parameters associated with successful weaning were (Figure 1-A): stroke volume (SV) &amp;gt;13.2 ml (HR 4.12 [1.71-9.95], p 0.002), tIVT &amp;gt;23.6 min/sec (HR 0.14 [0.02-1.03], p 0.053), LV VTI &amp;gt;6.6 cm (HR 4.99 [1.94-12.87], p&amp;lt;0.001), MAPSE &amp;gt;6.15 mm (HR 4.42 [1.90-10.24], p 0.001), TAPSE &amp;gt;11 mm (HR 10.13 [1.37-7.02], p 0.023), RV S’ &amp;gt;7 cm (HR 5.40 [1.45-20.12], p 0.012). LVEF, E/e’ and S’ at mitral valve did not reach the statistical significance. Figure 1-B shows Kaplan-Meier analysis on echocardiographic indices collected during the last weaning trial; figure 2 details HR of all these parameters. Conclusions Echocardiography is pivotal in defining cardiac recovery and monitoring the weaning trial. Indices reflecting ventricular performance and delivered flow from LV were associated with weaning success both at VA-ECMO institution and throughout the weaning trials. Parameters reflecting ventricular activation and systo-diastolic interaction already demonstrated superiority in defining ventricular performance. Considering the known limitations of LVEF (HR, loading and LV dyssynchrony dependence), tIVT and MAPSE should be introduced in the standard evaluation in the acute setting.

Contemporary approach to cardiogenic shock care: a state-of-the-art review.

Cardiogenic shock (CS) is a time-sensitive and hemodynamically complex syndrome with a broad spectrum of etiologies and clinical presentations. Despite contemporary therapies, CS continues to maintain high morbidity and mortality ranging from 35 to 50%. More recently, burgeoning observational research in this field aimed at enhancing the early recognition and characterization of the shock state through standardized team-based protocols, comprehensive hemodynamic profiling, and tailored and selective utilization of temporary mechanical circulatory support devices has been associated with improved outcomes. In this narrative review, we discuss the pathophysiology of CS, novel phenotypes, evolving definitions and staging systems, currently available pharmacologic and device-based therapies, standardized, team-based management protocols, and regionalized systems-of-care aimed at improving shock outcomes. We also explore opportunities for fertile investigation through randomized and non-randomized studies to address the prevailing knowledge gaps that will be critical to improving long-term outcomes.

Complications and Outcomes in 39,864 Patients Receiving Standard Care Plus Mechanical Circulatory Support or Standard Care Alone for Infarct-Associated Cardiogenic Shock.

Temporary mechanical circulatory support devices (tMCS) are increasingly being used in patients with infarct-associated cardiogenic shock (AMICS). Evidence on patient selection, complications and long-term outcomes is lacking. We aim to investigate differences in clinical characteristics, complications and outcomes between patients receiving no tMCS or either intra-aortic balloon pump (IABP), veno-arterial extracorporeal membrane oxygenation (V-A ECMO) or Impella® for AMICS, with a particular focus on long-term outcomes. Using health claim data from AOK-Die Gesundheitskasse (local health care funds), we retrospectively analysed complications and outcomes of all insured patients with AMICS between 1 January 2010 and 31 December 2017. A total of 39,864 patients were included (IABP 5451; Impella 776; V-A ECMO 833; no tMCS 32,804). In-hospital complications, including renal failure requiring dialysis (50.3% V-A ECMO vs. 30.5% Impella vs. 29.2 IABP vs. 12.1% no tMCS), major bleeding (38.1% vs. 20.9% vs. 18.0% vs. 9.3%) and sepsis (22.5% vs. 15.9% vs. 13.9% vs. 9.3%) were more common in V-A ECMO patients. In a multivariate analysis, the use of both V-A ECMO (HR 1.57, p < 0.001) and Impella (HR 1.25, p < 0.001) were independently associated with long-term mortality, whereas use of IABP was not (HR 0.89, p < 0.001). Kaplan-Meier estimates showed better survival for patients on IABP compared with Impella, V-A ECMO and no-tMCS. Short- and long-term mortality was high across all groups. Our data show noticeably more in-hospital complications in patients on tMCS and higher mortality with V-A ECMO and Impella. The use of both devices is an independent risk factor for mortality, whereas the use of IABP is associated with a survival benefit.

Impact of high-profile transvalvular pumps in heasrt failure related cardiogenic shock

Abstract Background Heart failure-related cardiogenic shock (HF-CS) not related to acute MI is a leading cause of CS.(1) Congestion is a major predictor of mortality among patients with HF-CS, for whom in-hospital mortality remains between 25-40%.(2,3) Both low-profile (Impella CP) and high-profile (Impella 5.0/5.5) transvalvular pumps are used to manage these patients. In the last few years, use of Impella 5.0/5.5 pumps in these patients is increasing, although it is often used as an escalation strategy from other temporary mechanical circulatory support (tMCS) devices. Purpose To assess the impact of LV unloading using high profile transvalvular pump (Impella 5.0/5.5) compared to a low-profile pump (Impella CP) on outcomes in HF-CS. Methods The Cardiogenic Shock Working Group (CSWG) is a large, multi-center international prospective registry of CS patients.(1) For this analysis, we retrospectively reviewed patients with HF-CS who underwent Impella 5.0/5.5 therapy for HF-CS and compared them to patients who underwent an Impella CP. Patients who received an Impella device as part of their escalation strategy from another device (IABP) or concomitant or de-escalation strategy with ECMO were excluded. Results Of the 2,755 patients with HF-CS, 125 patients received an Impella 5.0/5.5 while 152 patients received an Impella CP alone; 13 patients were escalated from an Impella CP to 5.0/5.5 pump. Of these 292 patients who either received an Impella CP or 5.0/5.5 or a combination of the two, 228(78%) were male, 208(71%) were white with a mean LVEF at presentation of 19%. About a third (n=78, 27%) presented with de-novo HF-CS while 214(73%) were acute on chronic HF-CS. In-hospital mortality in the entire HF-CS cohort was 717(26%). Unadjusted mortality was higher in those who underwent Impella CP alone (n= 57; 38%) compared to patients with Impella 5.0/5.5 (n=27, 23%; p=0.01). This improvement in mortality was seen in acute on chronic HF-CS with Impella 5.5/5.0 vs CP (41% vs 26%, p=0.02), and as a trend in de-novo HF-CS (30% vs 14%, p=0.13). More patients on Impella 5.0/5.5 went on to receive heart replacement therapies (durable LVAD or heart transplantation) compared to Impella CP (56% vs 9%, p&amp;lt;0.001). Conclusion(s) Use of a high-profile transvalvular pump (Impella 5.0/5.5) was associated with improved mortality compared to a low-profile transvalvular pump (Impella CP) in HF-CS.

Abstract 14879: Stroll in Style: Rocking the MCS Catwalk!

Introduction: Patients who present with cardiogenic shock may require temporary mechanical circulatory support (tMCS) devices in the ICU. Hypothesis: Physical therapy (PT) and rehabilitation is associated with improved outcomes. But literature investigating the feasibility and safety of mobilization in patients on tMCS is limited. Methods: In this survey-based study, we examined various practice patterns in ambulating patients supported on tMCS globally. We received 93 responses of which 73 (80.22%) were from United States. Results: 82 programs believed that mobilization improved outcomes in these patients. Of these 81 programs (87.1%) ambulate patients supported on tMCS, but only 61 programs (65.59%) have an MCS trained physical therapist ambulating patients on tMCS. 72 programs (77.42%) reported staffing issues as a limiting factor in mobilizing these patients. (Figure 1) 82 programs (88.17%) would change the cannulation site for more convenient patient mobilization. 59 (63.44%) programs reported complications associated with mobilization which included device/cannula dislodgement, pump malfunction, bleeding, hemolysis, etc. (Figure 2) Only 41 programs (44.1%) have a guideline or protocol to ambulate these patients. Conclusions: We conclude that current state of PT in patients on tMCS is suboptimal and needs a uniform standardized protocol. Most programs need an experienced physical therapist to facilitate mobilization of these patients. We also outlined various patient and device related factors which can improve mobilization and outcomes in these patients. More studies are needed to assess impact of mobilization on outcomes and length of stay.

Abstract 16305: Closing the Disparities Gap for Heart Transplant Patients Bridged to Transplant With Temporary Mechanical Circulatory Support

Background: There are known disparities in waitlist outcomes by race and sex among patients bridged to heart transplant (BTT) with durable mechanical circulatory support (MCS). With the increasing use of temporary MCS devices (tMCS), we examined waitlist and post-transplant outcomes of patients who had BTT with tMCS. Methods: Data from the United Network for Organ Sharing (UNOS) database was used to identify patients BTT with tMCS between 2008 and 2018. Patients were stratified by race and sex. Primary outcomes were waitlist mortality within 1 year of listing and 1 year post-transplant mortality among those who successfully reached transplant. Survival was examined with the Kaplan Meier method and Cox proportional hazard modeling. Results: A total of 997 patients received tMCS as BTT, including 606 white, 203 Black, 119 Hispanic, 56 Asian, 13 other race, and 302 (30%) female patients. Baseline hemodynamics were comparable among groups. Waitlist mortality within 1 year of listing was 35.8% overall and similar for all races (p=0.418) and both sexes (p=0.617). Among those who successfully reached transplant, there were no differences in 1 year post-transplant survival by race (p=0.722) or sex (p= 0.475). On multivariable Cox proportional hazard modeling, neither race nor sex was associated with waitlist or post-transplant mortality (p=NS). Level of education (&lt;high school) was independently associated with 1 year waitlist mortality (HR 1.49, 95% CI 1.06 - 2.06). History of diabetes (HR 1.38, 95% CI 1.07-1.74) and post-transplant dialysis (HR 1.66, 95% CI 1.18-2.29) were associated with 1 year post transplant mortality. Conclusions: Unlike in BTT with durable MCS, we did not find differences in outcomes associated with race and sex among patients BTT with tMCS. Given the sharp increase in tMCS use after the 2018 U.S. allocation change, it will be important to closely monitor that access to transplantation and outcomes of BTT with tMCS patients continue to be equitable.

Network meta-analysis of temporary mechanical circulatory support in acute myocardial infarction cardiogenic shock

We performed a network meta-analysis of 11 published randomized clinical trials examining the use of temporary mechanical circulatory support (MCS) devices in adults with acute myocardial infarction cardiogenic shock (AMICS), including 1053 total patients with an observed in-hospital or 30-day mortality of 40.4%. None of the temporary MCS devices was associated with lower in-hospital or 30-day mortality compared with initial medical therapy or any other MCS device, either individually or in combination. These data do not support the routine use of temporary MCS devices for the purpose of reducing short-term mortality in unselected patients with AMICS.

Anticoagulation Management in Temporary Mechanical Circulatory Support Devices.

Anticoagulation Management in Temporary Mechanical Circulatory Support Devices.

Temporary Mechanical Circulatory Support Use and Clinical Outcomes of Simultaneous Heart/Kidney Transplant Recipients in the Pre- and Post-heart Allocation Policy Change Eras.

The use of temporary mechanical circulatory support (tMCS) devices (intra-aortic balloon pump; Impella 2.5, CP, 5.0; venoarterial extracorporeal membrane oxygenation) increased significantly across the United States for heart transplant candidates after the allocation policy change. Whether this practice change also affected simultaneous heart-kidney (SHK) candidates and recipient survival is understudied. We used the Scientific Registry of Transplant Recipients database to identify adult SHK recipients between January 2010 and March 2022. The population was stratified into pre- and post-heart allocation change cohorts. Kaplan-Meier curves were generated to compare 1-y survival rates. A Cox proportional hazards model was used to investigate the effect of allocation period on patient survival. Recipient outcomes bridged with eligible tMCS devices were compared in the post-heart allocation era. In a separate analysis, SHK waitlist mortality was evaluated between the allocation eras. A total of 1548 SHK recipients were identified, and 1102 were included in the final cohort (534 pre-allocation and 568 post-allocation change). tMCS utilization increased from 17.9% to 51.6% after the allocation change, with venoarterial extracorporeal membrane oxygenation use rising most significantly. However, 1-y post-SHK survival remained unchanged in the full cohort (log-rank P = 0.154) and those supported with any of the eligible tMCS devices. In a separate analysis (using a larger cohort of all SHK listings), SHK waitlist mortality at 1 y was significantly lower in the current allocation era ( P = 0.002). Despite the remarkable increase in tMCS use in SHK candidates after the heart allocation change, 1 y posttransplant survival remained unchanged. Further studies with larger cohorts and longer follow-ups are needed to confirm these findings.