Clinical Outcomes Among Cardiogenic Shock Patients Supported with High-Capacity Impella Axial Flow Pumps: A Report from the Cardiogenic Shock Working Group.

BACKGROUND: The 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. OBJECTIVES: To 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. METHODS: The 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). RESULTS: Among 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). CONCLUSIONS: In 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 ABSTRACT: High 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.

Outcomes of Patients Transferred to Tertiary Care Centers for Treatment of Cardiogenic Shock: A Cardiogenic Shock Working Group Analysis.

BACKGROUND: Consensus recommendations for cardiogenic shock (CS) advise transfer of patients in need of advanced options beyond the capability of "spoke" centers to tertiary/"hub" centers with higher capabilities. However, outcomes associated with such transfers are largely unknown beyond those reported in individual health networks. OBJECTIVES: To analyze a contemporary, multicenter CS cohort with the aim of comparing characteristics and outcomes of patients between transfer (between spoke and hub centers) and nontransfer cohorts (those primarily admitted to a hub center) for both acute myocardial infarction (AMI-CS) and heart failure-related HF-CS. We also aim to identify clinical characteristics of the transfer cohort that are associated with in-hospital mortality. METHODS: The Cardiogenic Shock Working Group (CSWG) registry is a national, multicenter, prospective registry including high-volume (mostly hub) CS centers. Fifteen U.S. sites contributed data for this analysis from 2016-2020. RESULTS: Of 1890 consecutive CS patients enrolled into the CSWG registry, 1028 (54.4%) patients were transferred. Of these patients, 528 (58.1%) had heart failure-related CS (HF-CS), and 381 (41.9%) had CS related to acute myocardial infarction (AMI-CS). Upon arrival to the CSWG site, transfer patients were more likely to be in SCAI stages C and D, when compared to nontransfer patients. Transfer patients had higher mortality rates (37% vs 29%, < 0.001) than nontransfer patients; the differences were driven primarily by the HF-CS cohort. Logistic regression identified increasing age, mechanical ventilation, renal replacement therapy, and higher number of vasoactive drugs prior to or within 24 hours after CSWG site transfer as independent predictors of mortality among HF-CS patients. Conversely, pulmonary artery catheter use prior to transfer or within 24 hours of arrival was associated with decreased mortality rates. Among transfer AMI-CS patients, BMI > 28 kg/m2, worsening renal failure, lactate > 3 mg/dL, and increasing numbers of vasoactive drugs were associated with increased mortality rates. CONCLUSION: More than half of patients with CS managed at high-volume CS centers were transferred from another hospital. Although transfer patients had higher mortality rates than those who were admitted primarily to hub centers, the outcomes and their predictors varied significantly when classified by HF-CS vs AMI-CS.

Impact of Female Sex on Cardiogenic Shock Outcomes: A Cardiogenic Shock Working Group Report.

BACKGROUND: Studies reporting cardiogenic shock (CS) outcomes in women are scarce. OBJECTIVES: The authors compared survival at discharge among women vs men with CS complicating acute myocardial infarction (AMI-CS) and heart failure (HF-CS). METHODS: The authors analyzed 5,083 CS patients in the Cardiogenic Shock Working Group. Propensity score matching (PSM) was performed with the use of baseline characteristics. Logistic regression was performed for log odds of survival. RESULTS: Among 5,083 patients, 1,522 were women (30%), whose mean age was 61.8 ± 15.8 years. There were 30% women and 29.1% men with AMI-CS (P = 0.03). More women presented with de novo HF-CS compared with men (26.2% vs 19.3%; P < 0.001). Before PSM, differences in baseline characteristics and sex-specific outcomes were seen in the HF-CS cohort, with worse survival at discharge (69.9% vs 74.4%; P = 0.009) and a higher rate of maximum Society for Cardiac Angiography and Interventions stage E (26% vs 21%; P = 0.04) in women than in men. Women were less likely to receive pulmonary artery catheterization (52.9% vs 54.6%; P < 0.001), heart transplantation (6.5% vs 10.3%; P < 0.001), or left ventricular assist device implantation (7.8% vs 10%; P = 0.01). Regardless of CS etiology, women had more vascular complications (8.8% vs 5.7%; P < 0.001), bleeding (7.1% vs 5.2%; P = 0.01), and limb ischemia (6.8% vs 4.5%; P = 0.001). More vascular complications persisted in women after PSM (10.4% women vs 7.4% men; P = 0.06). CONCLUSIONS: Women with HF-CS had worse outcomes and more vascular complications than men with HF-CS. More studies are needed to identify barriers to advanced therapies, decrease complications, and improve outcomes of women with CS.

Pulmonary Artery Catheter Use and Risk of In-hospital Death in Heart Failure Cardiogenic Shock.

BACKGROUND: Pulmonary artery catheters (PACs) are increasingly used to guide management decisions in cardiogenic shock (CS). The goal of this study was to determine if PAC use was associated with a lower risk of in-hospital mortality in CS owing to acute heart failure (HF-CS). METHODS AND RESULTS: This multicenter, retrospective, observational study included patients with CS hospitalized between 2019 and 2021 at 15 US hospitals participating in the Cardiogenic Shock Working Group registry. The primary end point was in-hospital mortality. Inverse probability of treatment-weighted logistic regression models were used to estimate odds ratios (ORs) and corresponding 95% confidence intervals (CI), accounting for multiple variables at admission. The association between the timing of PAC placement and in-hospital death was also analyzed. A total of 1055 patients with HF-CS were included, of whom 834 (79%) received a PAC during their hospitalization. In-hospital mortality risk for the cohort was 24.7% (n = 261). PAC use was associated with lower adjusted in-hospital mortality risk (22.2% vs 29.8%, OR 0.68, 95% CI 0.50-0.94). Similar associations were found across SCAI stages of shock, both at admission and at maximum SCAI stage during hospitalization. Early PAC use (≤6 hours of admission) was observed in 220 PAC recipients (26%) and associated with a lower adjusted risk of in-hospital mortality compared with delayed (≥48 hours) or no PAC use (17.3% vs 27.7%, OR 0.54, 95% CI 0.37-0.81). CONCLUSIONS: This observational study supports PAC use, because it was associated with decreased in-hospital mortality in HF-CS, especially if performed within 6 hours of hospital admission. CONDENSED ABSTRACT: An observational study from the Cardiogenic Shock Working Group registry of 1055 patients with HF-CS showed that pulmonary artery catheter (PAC) use was associated with a lower adjusted in-hospital mortality risk (22.2% vs 29.8%, odds ratio 0.68, 95% confidence interval 0.50-0.94) compared with outcomes in patients managed without PAC. Early PAC use (≤6 hours of admission) was associated with a lower adjusted risk of in-hospital mortality compared with delayed (≥48 hours) or no PAC use (17.3% vs 27.7%, odds ratio 0.54, 95% confidence interval 0.37-0.81).

Hemodynamic and Clinical Performance of Hearts Donated After Circulatory Death.

BACKGROUND: Donor organ demand continues to outpace supply in heart transplantation. Utilization of donation after circulatory death (DCD) hearts could significantly increase heart donor availability for patients with advanced heart failure. OBJECTIVES: The purpose of this study was to describe hemodynamic and clinical profiles of DCD hearts in comparison to standard of care (SOC) hearts donated after brain death (DBD). METHODS: This single-center retrospective cohort study of consecutive heart transplant recipients analyzed right heart catheterization measurements, inotrope scores, echocardiograms, and clinical outcomes between DCD and DBD heart recipients. RESULTS: Between April 2016 and February 2022, 47 DCD and 166 SOC hearts were transplanted. Median time from DCD consent to transplant was significantly shorter compared with SOC waiting list time (17 days [6-28 days] vs 70 days [23-240 days]; P < 0.001). Right heart function was significantly impaired in DCD recipients compared with SOC recipients 1 week post-transplant (higher median right atrial pressure (10 mm Hg [8-13 mm Hg] vs 7 mm Hg [5-11 mm Hg]; P < 0.001), higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 [0.54-0.82] vs 0.57 [0.43-0.73]; P = 0.016), and lower pulmonary arterial pulsatility index (1.66 [1.27-2.50] vs 2.52 [1.63-3.82]; P < 0.001), but was similar between groups by 3 weeks post-transplant. DCD and SOC recipient mortality was similar at 30 days (DCD 0 vs SOC 2%; P = 0.29) and 1 year post-transplant (DCD 3% vs SOC 8%; P = 0.16). CONCLUSIONS: DCD heart utilization is associated with transient post-transplant right heart dysfunction and short-term clinical outcomes otherwise similar to transplantation using DBD hearts.

Clinical myocardial recovery in advanced heart failure with long term left ventricular assist device support.

Left ventricular assist-device (LVAD) implantation is a life-saving therapy for patients with advanced heart failure (HF). With chronic unloading and circulatory support, LVAD-supported hearts often show significant reverse remodeling at the structural, cellular and molecular level. However, translation of these changes into meaningful cardiac recovery allowing LVAD explant is lagging. Part of the reason for this discrepancy is lack of anticipation and hence promotion and evaluation for recovery post LVAD implant. There is additional uncertainty about the long-term course of HF following LVAD explant. In selected patients, however, guided by the etiology of HF, duration of disease and other clinical factors, significant functional improvement and LVAD explantation with long-term freedom from recurrent HF events has been demonstrated to be feasible in a reproducible manner. The identified predictors of myocardial recovery suggest that the elective therapeutic use of potentially less invasive VADs for reversal of HF earlier in the disease process is a future goal that warrants further investigation. Hence, it is prudent to develop and implement tools to predict HF reversibility prior to LVAD implant, optimize unloading-promoted recovery with guideline directed medical therapy and monitor for myocardial improvement. This review article summarizes the clinical aspects of myocardial recovery and together with its companion review article focused on the biological aspects of recovery, they aim to provide a useful framework for clinicians and investigators.

Twelfth Interagency Registry for Mechanically Assisted Circulatory Support Report: Readmissions After Left Ventricular Assist Device.

The twelfth annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 26 688 continuous-flow left ventricular assist device (LVAD) patients over the past decade (2011-2020). In 2020, we observed the largest drop in yearly LVAD implant volumes since the registry's inception, which reflects the effects of the COVID-19 pandemic on cardiac surgical volumes in the United States. The 2018 heart transplant allocation policy change in the United States continues to affect LVAD implantation volumes and device strategy, with 78.1% of patients now receiving LVAD implants as destination therapy. Despite an older and sicker patient cohort, survival in the recent era (2016-2020) at 1 and 2 years continues to improve at 82.8% and 74.1%. Patient adverse event profile has also improved in the recent era, with significant reductions in stroke, gastrointestinal bleeding, infection, and device malfunction/pump thrombosis. Finally, we review the burden of readmissions after LVAD implant and highlight an opportunity to improve patient outcomes by reducing this frequent and vexing problem.

Effect of Impella 5.5 on Preexisting Functional Mitral Regurgitation in Patients with Heart Failure-Related Cardiogenic Shock.

Background: Heart failure-related cardiogenic shock (HF-CS) is increasingly common. Moderate/severe functional mitral regurgitation (FMR) is commonly seen in patients presenting with decompensated heart failure and is associated with worse outcomes. Percutaneous mechanical circulatory support devices are increasingly used to provide hemodynamic support for ongoing CS. There is no description of the impact of Impella device on hemodynamic response when used in combination with preexisting FMR. Methods: Retrospective review of patients aged ≥18 years, who underwent Impella 5.5 implant for HF-CS, and who had a transthoracic echocardiogram performed pre- and post-Impella. Results: Of 24 patients, 33% had moderate-to-severe/severe FMR, 38% had mild-moderate/moderate FMR, and 29% had trace/mild FMR on pre-Impella transthoracic echocardiogram. Additional right ventricular assist device was simultaneously inserted in 3 patients, of whom 1 had severe, 1 had moderate, and another had mild FMR pre-Impella. Despite maximally tolerated Impella unloading, 6 patients (25%) had persistent moderate-severe/severe FMR, and 9 (37.5%) patients had persistent moderate FMR. Overall, however, there was a decrease in central venous pressure, pulmonary artery diastolic pressure, serum lactate, and vasoactive-inotrope score at 24 â€‹hours post-Impella, and survival was high at 83%. Conclusions: In a retrospective cohort of patients admitted with HF-CS who underwent Impella 5.5 implant for hemodynamic support, Impella did not seem to acutely ameliorate FMR severity. Despite this, there was a significant improvement in hemodynamic response at 24 â€‹hours post-Impella. In carefully selected patients, especially those with isolated left ventricular failure, Impella 5.5 may provide adequate hemodynamic support even in the presence of higher severity FMR.

How to Turn It Down: The Evidence and Opinions Behind Adult Venoarterial Extracorporeal Membrane Oxygenation Weaning.

Adequate and durable recovery in patients supported with venoarterial (VA) extracorporeal membrane oxygenation (ECMO) can be challenging to predict. Extracorporeal membrane oxygenation weaning is the process by which the ECMO flows are decreased to assess if a patient is ready for decannulation. The optimal strategies for deciding who to wean and how to wean VA ECMO remain undefined. A retrospective literature review was performed to understand the evidence supporting current practices in ECMO weaning and in particular patient selection and methods. Most published work and expert opinions agree that once the underlying process has resolved, the minimum required physiologic parameters for weaning from ECMO include: hemodynamic stability and cardiac pulsatility, adequate lung function to support oxygenation and ventilation, and evidence of recovered end organ function. Echocardiography is universally used to assess cardiac function during the weaning process. Currently, there is no consensus regarding who is eligible to wean or how to wean ECMO in adults. We have reviewed the literature to summarize the evidence and expert opinions behind VA ECMO weaning, and give an example of the protocol used at our center. We believe this protocol optimizes patient selection for weaning and helps to predict successful decannulation.

Inflow Cannula Position Influences Improvement in Mitral Regurgitation After Ventricular Assist Device Implantation.

Significant residual mitral regurgitation (MR) after left ventricular assist device (LVAD) implantation has been associated with increased morbidity and mortality. The effect of cannula position on improvement of preexisting MR has yet to be evaluated. Consecutive patients who underwent centrifugal LVAD implantation with >mild preoperative MR and without concomitant mitral repair were reviewed. Left ventricular assist device position was determined by the angle between actual and ideal inflow cannula on computed tomography. The magnitudes of angles (anterior and lateral angle) were added to form an LVAD position assessment (LVADpa). Mitral regurgitation was numerically classified, and improvement in MR was determined by difference in MR preoperatively to MR >1 month postoperatively with a median of 162 (interquartile range: 78-218) days. The primary analysis examined the relationship between LVADpa and postoperative MR. Forty-one patients were identified with >mild preoperative functional MR. Mean age was 51 ± 13 years with an ejection fraction of 16 ± 4%. Overall, MR improved from moderate-severe preoperatively to mild postoperatively (p < 0.001). On multivariable analysis, higher LVADpa deviation was associated with greater postoperative MR (odds ratio [OR] = 2.29, p = 0.005) and higher 1-month pulsatility index was associated with lower postoperative MR (OR = 0.47, p = 0.011). Inflow cannula position during centrifugal LVAD implantation is an important determinant of postoperative MR.

Clinical Outcomes of Perioperative Desensitization in Heart Transplant Recipients.

BACKGROUND: Sensitization remains a barrier to heart transplantation (HT). Perioperative desensitization strategies have been described; however, a paucity of evidence exists to demonstrate efficacy and safety in HT. METHODS: This single-center, retrospective study consisted of adults who received an HT. Perioperative desensitization was initiated if virtual crossmatch or flow-cytometry crossmatch was positive. Therapy consisted of plasmapheresis, intravenous immunoglobulin, and rabbit antithymocyte globulin. Historical controls received standard immunosuppression or induction. The primary endpoint was survival at 12 mo. Secondary endpoints included freedom from acute rejection, cardiac allograft vasculopathy (CAV), and infectious complications. RESULTS: Of the 104 patients included, 48 received no induction, 46 received induction, and 10 underwent perioperative desensitization. No differences were observed in the primary endpoint at 12 mo (90.0% versus 97.9%, P = 0.25 for desensitization versus no-induction; 90.0% versus 100%, P = 0.72 for desensitization versus induction). Rates of acute rejection were lower with induction and desensitization compared with no-induction. There were no significant differences in CAV between the groups. Infectious complications were also similar among the groups (10.0% versus 16.7%, P = 0.62 for desensitization versus no-induction; 10.0% versus 30.4%, P = 0.34 for desensitization versus induction). CONCLUSIONS: This study suggests that a perioperative desensitization strategy triggered by positive virtual crossmatch or flow-cytometry crossmatch allows for successful transplantation of sensitized HT recipients and results in acceptable rates of survival, rejection, CAV, and infection at 12 mo.

High Right Ventricular Afterload Is Associated with Impaired Exercise Tolerance in Patients with Left Ventricular Assist Devices.

Patients with left ventricular assist device (LVAD) have poor exercise tolerance. We aimed to characterize relationship between right ventricular (RV) afterload and exercise capacity, RV reserve, and adaptation to load. Twelve well-compensated LVAD subjects underwent right heart catheterization at rest and during symptom-limited exercise. Cardiopulmonary exercise tests were also performed. Hemodynamics were compared with age- and sex-matched subjects with pulmonary arterial hypertension (PAH) and normal non-athletes. Hemodynamic changes were expressed as Δ(exercise - rest). At rest, LVAD subjects had normal biventricular pressures and cardiac output (CO). On exercise, despite similar increases in pulmonary artery wedge pressure (PAWP) between three groups, RV afterload increased only in LVAD cohort (pulmonary elastance [ΔEa] LVAD: 0.4, PAH: 0.1, normal: 0.1 mmHg/ml, p = 0.0024). This afterload increase coincided with the largest rise in right atrial pressure (RAP), lowest change in RV stroke work index, and smallest CO augmentation (ΔCO LVAD: 1.5, PAH: 4.3, normal: 5.7 L/min, p = 0.0014). Peak VO2 negatively correlated with RV afterload (Ea) (r = -0.8, p = 0.0101), while VE/VCO2 slope had the inverse correlation. During exercise, pulmonary artery pulsatility index worsened while RAP:PAWP ratio was unchanged in LVAD subjects. Well-compensated LVAD patients had poor RV reserve and adaptation to load on exercise compared with PAH and normal subjects.

Novel Use of Tamoxifen to Reduce Recurrent Gastrointestinal Bleeding in Patients with Left Ventricular Assist Devices.

Gastrointestinal bleeding (GIB) is a frequent complication in patients with continuous-flow left ventricular assist devices (LVAD). We retrospectively evaluated eight patients implanted with a HeartWare LVAD between July 2017 and June 2020 who experienced at least one episode of GIB and were started on tamoxifen 20 mg once daily for secondary prevention. Tamoxifen was associated with a significant decrease in major GIB from a median of 3 (IQR 1.4-7) events/patient-year pre-tamoxifen initiation to 0 (IQR 0-0.9) events/patient-year post-tamoxifen initiation (p = 0.02). Transfusion of packed red blood cells also decreased from 16.8 (IQR 9.9-30.6) units/patient-year pre-tamoxifen initiation to 1.5 (IQR 0-7.5) units/patient-year post-tamoxifen (p = 0.04). Tamoxifen was well tolerated and no thromboembolic complications were observed. This small cohort study suggests that tamoxifen is associated with reduced GIB and transfusion requirements, with no apparent increase in thrombotic risk. A larger, randomized study is warranted to confirm the results of this exploratory analysis. Graphical abstract.

Should we overcome the resistance to bioelectrical impedance in heart failure?

INTRODUCTION: Heart failure is associated with increased neurohormonal activation that results in changes in body composition including volume overload and the loss of skeletal muscle, body fat, and bone density. Bioelectrical impedance measures body composition based on the conduction of electrical current through body fluids. AREAS COVERED: The PubMed and Scopus databases were reviewed up to the third week of June 2020. Cross-sectional studies, retrospective observational studies, prospective observational studies, and randomized controlled trials have examined numerous bioelectrical impedance monitoring strategies to guide the diagnosis, prognosis, and treatment of heart failure. These monitoring strategies include intrathoracic impedance, lung impedance, bioelectrical impedance vector analysis, leg bioelectrical impedance, and thoracic bioreactance. EXPERT COMMENTARY: Based on the current evidence, more studies are needed to validate bioelectrical impedance in heart failure. Lung impedance appears to be useful for guiding heart failure treatment in patients with ST-elevation myocardial infarction and improving outcomes in outpatients with heart failure. Furthermore, bioelectrical impedance has potential as a noninvasive, quantitative heart failure variable for population-based research.

Less Invasive Approach to Left Ventricular Assist Device Implantation May Improve Survival in High-Risk Patients.

OBJECTIVE: Despite improvement in outcomes after left ventricular assist device (LVAD) implantation over the past 2 decades, high-risk recipients continue to have a prohibitive rate of morbidity and mortality. We hypothesized that a less invasive approach to LVAD implantation would be associated with improved survival compared to a conventional approach in this high-risk cohort. METHODS: All consecutive LVAD recipients (2013 to 2017) that underwent centrifugal LVAD implantation were retrospectively reviewed. Patients were classified as high-risk if INTERMACS 1 or required temporary VAD/venoarterial extracorporeal membrane oxygenation prior to durable VAD implantation. Patients were stratified into 3 groups: left thoracotomy with hemi-sternotomy (LTHS) high-risk, conventional sternotomy (CS) high-risk, and non-high-risk. The primary outcome was 1-year survival. RESULTS: A total of 57 patients (LTHS high-risk: 11, CS high-risk: 12, non-high-risk: 34) were identified. Preoperative right ventricular failure scores, HeartMate-II mortality scores, and end-organ dysfunction were similar between the 2 high-risk groups. While operative time was similar between the 3 groups, cardiopulmonary bypass time was significantly shorter in the LTHS high-risk group compared to other groups. There was a trend toward decreased intensive care unit length of stay and ventilator time in LTHS high-risk compared to CS high-risk patients. Moreover, between these 2 groups, there was a significant decrease in temporary right VAD support (50% vs 0%, P = 0.014), and 1-year survival was significantly higher in the LTHS group (42% vs 91%, P = 0.025). CONCLUSIONS: Less invasive LVAD implantation appears to be associated with improved survival compared to conventional LVAD implantation in high-risk patients.

Short- and long-term adverse events in patients on temporary circulatory support before durable ventricular assist device: An IMACS registry analysis.

BACKGROUND: Patients with cardiogenic shock (CS) needing temporary circulatory support (TCS) have poor survival rates after implantation of durable ventricular assist device (dVAD). We aimed to characterize post-dVAD adverse event burden and survival rates in patients requiring pre-operative TCS. METHOD: We analyzed 13,511 adults (Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS] Profiles 1-3) with continuous-flow dVADs in International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support (2013-2017) according to the need for pre-operative TCS (n = 5,632) vs no TCS (n = 7,879). Of these, 726 (5.4%) had biventricular assist devices (BiVAD). Furthermore, we compared prevalent rates (events/100 patient-months) of bleeding, device-related infection, hemorrhagic and ischemic cerebrovascular accidents (hemorrhagic cerebral vascular accident [hCVA], and ischemic cerebral vascular accident [iCVA]) in early (<3 months) and late (≥3 months) post-operative periods. RESULTS: TCS included extracorporeal membrane oxygenation (ECMO) (n = 1,138), intra-aortic balloon pump (IABP) (n = 3,901), and other TCS (n = 593). Within 3 post-operative months, there were more major bleeding and cerebrovascular accidents (CVAs) in patients with pre-operative ECMO (events/100 patient-months rates: bleeding = 19, hCVA = 1.6, iCVA = 2.8) or IABP (bleeding = 17.3, hCVA = 1.5, iCVA = 1.5) vs no TCS (bleeding = 13.2, hCVA = 1.1, iCVA = 1.2, all p < 0.05). After 3 months, adverse events were lower and similar in all groups. Patients with ECMO had the worst short- and long-term survival rates. Patients with BiVAD had the worst survival rate regardless of need for pre-operative TCS. CVA and multiorgan failures were the common causes of death for patients with TCS and patients without TCS. CONCLUSIONS: Patients requiring TCS before dVAD had a sicker phenotype and higher rates of early post-operative adverse events than patients without TCS. ECMO was associated with very high early ischemic stroke, bleeding, and mortality. The extreme CS phenotype needing ECMO warrants a higher-level profile status, such as INTERMACS "0."