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.

Application of Cardiogenic Shock Working Group-defined Society for Cardiovascular Angiography and Interventions (CSWG-SCAI) Staging of Cardiogenic Shock to the Medical Information Mart for Intensive Care IV (MIMIC-IV) database.

BACKGROUND: The optimal parameters for defining stages of cardiogenic shock (CS) are not yet known. The Cardiogenic Shock Working Group-defined Society for Cardiovascular Angiography and Interventions (CSWG-SCAI) staging of CS was developed to provide simple and specific parameters for risk-stratifying patients. OBJECTIVES: The purpose of this study was to test whether the Cardiogenic Shock Working Group-defined Society for Cardiovascular Angiography and Interventions (CSWG-SCAI) staging is associated with in-hospital mortality, using the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. METHODS: We utilized the open-access MIMIC-IV database, which includes >300,000 patients admitted between 2008 and 2019. We extracted the clinical profile of patients admitted with CS and stratified them into different SCAI stages at admission based on the CSWG criteria. We then tested the association between in-hospital mortality and parameters of hypotension, hypoperfusion, and overall CSWG-SCAI stage. RESULTS: Of the 2463 patients, CS was predominantly caused by heart failure (HF; 54.7 %) or myocardial infarction (MI; 26.3 %). Mortality was 37.5 % for the total cohort, 32.7 % for patients with HF, and 40 % for patients with MI (p < 0.001). Mortality was higher among patients with mean arterial pressure < 65 mmHg, lactate >2 mmol/L, ALT >200 IU/L, pH ≤ 7.2, and more than one drug/device support at baseline. Increasing CSWG-SCAI stages at baseline and maximum CSWG-SCAI stage achieved were significantly associated with in-hospital mortality (p < 0.05). CONCLUSIONS: The CSWG-SCAI stages are significantly associated with in-hospital mortality and may be used to identify hospitalized patients at risk of worsening cardiogenic shock severity. CONDENSED ABSTRACT: We analyzed data from 2463 patients with cardiogenic shock using the MIMIC-IV database to investigate the relationship between the Cardiogenic Shock Working Group-defined Society for Cardiovascular Angiography and Interventions (CSWG-SCAI) staging and in-hospital mortality. The main causes of cardiogenic shock were heart failure (54.7 %) and myocardial infarction (26.3 %). The overall mortality rate was 37.5 %, with a higher rate among patients with myocardial infarction (40 %) compared to those with heart failure (32.7 %). Mean arterial pressure < 65 mmHg, lactate >2 mmol/L, ALT >200 IU/L, and pH ≤ 7.2 were significantly associated with mortality. Increasing CSWG-SCAI stages at baseline and maximum achieved stages were strongly associated with higher mortality (p < 0.05). Therefore, the CSWG-SCAI staging system can be used to risk-stratify patients with cardiogenic shock.

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).

Preparing for the End of Life: Medical Students Completing Their Own Advance Directives Described Increased Empathy for Patients.

BACKGROUND AND OBJECTIVES: Family medicine offers the opportunity to integrate advance care planning into routine primary care, connecting relationship-centered orientation with thoughtful action before a terminal diagnosis. However, physicians are undertrained in end-of-life counseling and care. To address this educational gap, we had clerkship students complete their own advance directives and submit a written reflection about the experience. The aim of this study was to learn about how students report on the value of completing their own advance directives, according to their written reflections. We hypothesized that self-described empathy, previously defined as understanding patients' emotions and communicating that understanding back to patients, would increase, as reported by students in their reflections. METHODS: We analyzed 548 written reflections over 3 academic years using a qualitative content analysis approach. An iterative process included open coding, building of themes, and verification with the text by four professionally diverse researchers. RESULTS: After completing their own advance directives, students reported increased empathy for patients facing end-of-life decisions and discussed the intention to change their future clinical practice regarding helping patients plan for the end of life. CONCLUSIONS: Using experiential empathy, an approach to teaching and cultivating empathy in which the participants experience the topic first-hand, we directed medical students to consider their own end-of-life wishes. Upon reflection, many noted this process changed their attitudes and clinical approaches to patients' death. This learning experience could be one meaningful component of a longitudinal and comprehensive curriculum to prepare medical school graduates to help patients plan for and face the end of life.