Usefulness of the Quick-Sepsis Organ Failure Assessment Score in Cardiovascular Intensive Care Unit to Predict Prognosis in Acute Coronary Syndrome.

Triage of patients with acute coronary syndrome (ACS) at high risk of in-hospital complications is essential. In this study, we evaluated the quick sepsis organ failure assessment (qSOFA) score as a tool for predicting the prognosis of 964 patients admitted to the cardiovascular intensive care unit (CICU) with ACS over a 4-year period. In total, out of 964 patients included, with a percentage of 4.6% for 30-day mortality. The risk of 30-day mortality was independently associated with qSOFA ≥ 2 at admission (hazard ratio = 2.76, 95% CI 1.32-5.74, p = 0.007). For MACEs, qSOFA ≥ 2 at admission was a predictive factor with (odds ratio = 2.42, 95% CI 1.37-4.36, p = .002). A qSOFA ≥ 2 on admission had an AUC of 0.729 (95% CI [0.694, 0.762]), with a good specificity of 91.6%. For 30-day mortality, an AUC of 0.759 (95%CI [0.726, 0.792]) for cardiogenic shock with specificity of 92.5%. For MACEs, an AUC of 0.702 (95% CI [0.64, 0.700] with a specificity of 95%. Concerning the different scores tested, we found no significant difference between the Zwolle score and the qSOFA score for predicting prognosis, whereas the CADILLAC score was better than qSOFA for predicting 30-day mortality (AUC = 0.829 and De long test = 0.03). However, there was no difference between qSOFA and CADILLAC scores for predicting cardiogenic shock (De Long test at 0.08). This is the first study to evaluate qSOFA as a predictive score for 30-day mortality and MACEs, and the results are very encouraging, particularly for cardiogenic shock.

Serial Assessment of Shock Severity in Cardiac Intensive Care Unit Patients.

BACKGROUND: One-time assessment of the Society for Cardiovascular Angiography and Interventions (SCAI) shock classification robustly predicts mortality in the cardiac intensive care unit (CICU). We sought to determine whether serial SCAI shock classification could improve risk stratification. METHODS AND RESULTS: Unique admissions to a single academic level 1 CICU from 2015 to 2018 were included in this retrospective cohort study. Electronic health record data were used to assign the SCAI shock stage during 4-hour blocks of the first 24 hours of CICU admission. Shock was defined as hypoperfusion (SCAI shock stage C, D, or E). In-hospital death was evaluated using logistic regression. Among 2918 unique CICU patients, 1537 (52.7%) met criteria for shock during ≥1 block, and 266 (9.1%) died in the hospital. The SCAI shock stage on admission was: A, 37.6%; B, 31.5%; C, 25.9%; D, 1.8%; and E, 3.3%. Patients who met SCAI criteria for shock on admission (first 4 hours) and those with worsening SCAI shock stage after admission were at higher risk for in-hospital death. Each higher admission (adjusted odds ratio, 1.36 [95% CI, 1.18-1.56]; area under the receiver operating characteristic curve, 0.70), maximum (adjusted odds ratio, 1.59 [95% CI, 1.37-1.85]; area under the receiver operating characteristic curve, 0.73) and mean (adjusted odds ratio, 2.42 [95% CI, 1.99-2.95]; area under the receiver operating characteristic curve, 0.78) SCAI shock stage was incrementally associated with a higher in-hospital mortality rate. Discrimination was highest for the mean SCAI shock stage (P<0.05). Each additional 4-hour block meeting SCAI criteria for shock predicted a higher mortality rate (adjusted odds ratio, 1.15 [95% CI, 1.07-1.24]). CONCLUSIONS: Dynamic assessment of shock using serial SCAI shock classification assignment can improve mortality risk stratification in CICU patients by quantifying the magnitude and duration of shock.

The changing face of cardiogenic shock: definitions, epidemiology, and severity assessment.

PURPOSE OF REVIEW: Cardiogenic shock (CS) has been recognized for >50 years, most commonly in the setting of myocardial infarction. This review covers recent advances in the definitions, epidemiology and severity assessment of cardiogenic shock. RECENT FINDINGS: In this review, the authors discuss the evolving definitions of cardiogenic shock, detailing the early approaches as well as more contemporary ideas. The epidemiology of CS is reviewed and then granular detail on the assessment of shock severity is provided including the role of lactate measurement and invasive hemodynamic assessment. The development of the Society for Cardiac Angiography and Intervention (SCAI) consensus statement on Classification of Cardiogenic Shock is reviewed by the principal authors. The revised SCAI Shock document is reviewed as well and the future directions for assessment of shock along with clinical applications are reviewed. SUMMARY: Cardiogenic shock mortality has not changed in a significant way in many years. Recent advances such as more granular assessment of shock severity have the potential to improve outcomes by allowing research to separate the patient groups which may respond differently to various therapies.

Shifting surgical archetypes of ICG fluorescent-angiography for bowel perfusion assessment in cardiogenic shock under ECMO support.

Extracorporeal membrane oxygenation (ECMO) has been adopted to support patients with acute severe cardiac or pulmonary failure that is potentially reversible and unresponsive to conventional management. Mesenteric ischemia (MI) can present as a life-threatening complication in patients receiving veno-arterial echocardiogram (ECHO) support. Due to the nature and acuity of these conditions, determining adequate perfusion upon surgical intervention is challenging for the operating surgeon, especially in cardiogenic shock (CS) patients on ECMO support persenting low arterial pulsatility. Indocyanine green fluorescent angiography (ICG-FA) has proven to be useful for real-time assessment of vascular perfusion, which may help determine the extent of bowel ischemia in patients receiving ECMO support. The case report here-in presented, breaks the paradigm of performing non-cardiac surgical procedures on ECMO support via a pioneering visual aid technique. LEARNING OBJECTIVE: ICG-FA is a promising visual intraoperatory technique providing real-time feedback for the adequate identification and assessment of target tissue/organs. The high morbidity and mortality rates associated to MI and CS-particularly when concomitantly present-hinders salvage surgical therapy. The use of ECMO provides hemodynamic stability This case report highlights the importance of adequate surgical intervention under extracorporeal life support in the presence of both CS and MI. To the authors' knowledge, this is the first report of application of ICG-FA to evaluate mesenteric perfusion in a patient receiving ECMO support.

Age stratified sex-related differences in incidence, management, and outcomes of cardiogenic shock.

BACKGROUND: There is a lack of data on age-stratified sex differences in the incidence, treatment, and outcomes of cardiogenic shock (CS). We sought to study these differences from a contemporary database. METHODS: Patients admitted with CS (2004-2018) were identified from the United States National Inpatient Sample. We compared CS (acute myocardial infarction-related cardiogenic shock [AMI-CS] and non-acute myocardial infarction-related cardiogenic shock [Non-AMI-CS]) incidence, management, and outcomes in males and females, stratified into four age groups (20-44, 45-64, 65-84, and ≥85 years of age). Propensity score matching (PSM) was used for adjustment. RESULTS: A total of 1,506,281 weighted hospitalizations for CS were included (AMI-CS, 39%; Non-AMI-CS, 61%). Across all age groups, females had a lower incidence of CS compared with males. After PSM and among the AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 45-64 (28.5% vs. 26.3%) and 65-84 years (39.3% vs. 37.9%) (p < 0.01, for all). Among the Non-AMI-CS cohort, higher mortality among females compared with males was observed in the age groups 20-44 (33.5% vs. 30.5%), 45-64 (35.1% vs. 31.9%), and 65-84 years (41.7% vs. 40.3%) (p < 0.01, for all). Similar age-dependent differences in the management of CS were also observed between females and males. CONCLUSIONS: Females have a lower incidence of CS regardless of age. Significant disparities in the management and outcomes of CS were observed based on sex. However, these disparities varied by age and etiology of CS (AMI-CS vs. Non-AMI-CS) with pronounced disparity among females in the age range of 45-84 years.

Sex Differences in Management and Outcomes of Acute Myocardial Infarction Patients Presenting With Cardiogenic Shock.

OBJECTIVES: The aim of this study was to examine the sex differences in the risk profile, management, and outcomes among patients presenting with acute myocardial infarction cardiogenic shock (AMI-CS). BACKGROUND: Contemporary clinical data regarding sex differences in the management and outcomes of AMI patients presenting with CS are scarce. METHODS: Patients admitted with AMI-CS from the National Cardiovascular Data Registry Chest Pain-MI registry between October 2008 to December 2017 were included. Sex differences in baseline characteristics, in-hospital management, and outcomes were compared. Patients ≥65 years of age with available linkage data to Medicare claims were included in the analysis of 1-year outcomes. Multivariable logistic regression and Cox proportional hazards models adjusting for patient and hospital-related covariates were used to estimate sex-specific differences in in-hospital and 1-year outcomes, respectively. RESULTS: Among 17,195 patients presenting with AMI-CS, 37.3% were women. Women were older, had a higher prevalence of comorbidities, and had worse renal function at presentation. Women were less likely to receive guideline-directed medical therapies within 24 hours and at discharge, undergo diagnostic angiography (85.0% vs 91.1%), or receive mechanical circulatory support (25.4% vs 33.8%). Women had higher risks of in-hospital mortality (adjusted OR: 1.10; 95% CI: 1.02-1.19) and major bleeding (adjusted OR: 1.23; 95% CI: 1.12-1.34). For patients ≥65 years of age, women did not have a higher risk of all-cause mortality (adjusted HR: 0.98; 95% CI: 0.88-1.09) and mortality or heart failure hospitalization (adjusted HR: 1.01; 95% CI: 0.91-1.12) at 1 year compared with men. CONCLUSIONS: In this large nationwide analysis of patients with AMI-CS, women were less likely to receive guideline recommended care, including revascularization, and had worse in-hospital outcomes than men. At 1 year, there were no sex differences in the risk of mortality. Efforts are needed to address sex disparities in the initial care of AMI-CS patients.

Cardiogenic Shock Complicating ST-Segment Elevation Myocardial Infarction: An 18-Year Analysis of Temporal Trends, Epidemiology, Management, and Outcomes.

BACKGROUND: There are limited data on the temporal trends, incidence, and outcomes of ST-segment-elevation myocardial infarction-cardiogenic shock (STEMI-CS). METHODS: Adult (>18 years) STEMI-CS admissions were identified using the National Inpatient Sample (2000-2017) and classified by tertiles of admission year (2000-2005, 2006-2011, 2012-2017). Outcomes of interest included temporal trends, acute organ failure, cardiac procedures, in-hospital mortality, hospitalization costs, and length of stay. RESULTS: In ∼4.3 million STEMI admissions, CS was noted in 368,820 (8.5%). STEMI-CS incidence increased from 5.8% in 2000 to 13.0% in 2017 (patient and hospital characteristics adjusted odds ratio [aOR] 2.45 [95% confidence interval {CI} 2.40-2.49]; P < 0.001). Multiorgan failure increased from 55.5% (2000-2005) to 74.3% (2012-2017). Between 2000 and 2017, coronary angiography and percutaneous coronary intervention use increased from 58.8% to 80.1% and 38.6% to 70.6%, whereas coronary artery bypass grafting decreased from 14.9% to 10.4% (all P < 0.001). Over the study period, the use of intra-aortic balloon pump (40.6%-37.6%) decreased, and both percutaneous left ventricular assist devices (0%-12.9%) and extra-corporeal membrane oxygenation (0%-2.8%) increased (all P < 0.001). In hospital mortality decreased from 49.6% in 2000 to 32.7% in 2017 (aOR 0.29 [95% CI 0.28-0.31]; P < 0.001). During the 18-year period, hospital lengths of stay decreased, hospitalization costs increased and use of durable left ventricular assist device /cardiac transplantation remained stable (P > 0.05). CONCLUSIONS: In the United States, incidence of CS in STEMI has increased 2.5-fold between 2000 and 2017, while in-hospital mortality has decreased during the study period. Use of coronary angiography and PCI increased during the study period.

Multivessel Versus Culprit-Vessel Percutaneous Coronary Intervention in Patients With Non-ST-Segment Elevation Myocardial Infarction and Cardiogenic Shock.

OBJECTIVES: The aim of this study was to compare in-hospital outcomes and long-term mortality of multivessel versus culprit vessel-only percutaneous coronary intervention (PCI) in patients with non-ST-segment elevation myocardial infarction (NSTEMI), multivessel disease (MVD) and cardiogenic shock. BACKGROUND: The clinical benefits of complete revascularization in patients with NSTEMI, MVD, and cardiogenic shock remain uncertain. METHODS: Among 25,324 patients included in the National Cardiovascular Data Registry CathPCI Registry from July 2009 to March 2018, the rates of in-hospital procedural outcomes were compared between those undergoing multivessel PCI and those undergoing culprit vessel-only PCI after 1:1 propensity score matching. Among patients aged ≥65 years matched to the Centers for Medicare and Medicaid Services database, long-term mortality was compared using proportional hazards analysis. RESULTS: Multivessel PCI was performed in 9,791 patients (38.7%), which increased from 32.2% in 2010 to 44.2% in 2017 (p for trend <0.001). After 1:1 propensity matching (n = 7,864 in each group), those undergoing multivessel PCI had a 3.5% (95% confidence interval [CI]: 2.0% to 5.0%) lower absolute rate of in-hospital mortality (30.9% vs. 34.4%; p < 0.001; odds ratio [OR]: 0.85; 95% CI: 0.80 to 0.91), but a higher risk for bleeding (13.2% vs. 10.8%; p < 0.001; OR: 1.26; 95% CI: 1.15 to 1.40) and new requirement for dialysis (5.7% vs. 4.6%; p = 0.001; OR: 1.26; 95% CI: 1.10 to 1.46). Among those surviving to discharge, all-cause mortality was similar through 7 years (conditional hazard ratio: 0.95; 95% CI: 0.87 to 1.03; p = 0.20). CONCLUSIONS: Nearly 40% of patients with NSTEMI with MVD and cardiogenic shock underwent multivessel PCI, which was associated with lower in-hospital mortality but greater peri-procedural complications. Among those surviving to discharge, multivessel PCI did not confer additional long-term mortality benefit.

Cost savings for pVAD compared to ECMO in the management of acute myocardial infarction complicated by cardiogenic shock: An episode-of-care analysis.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMICS) occurs in up to 10% of acute myocardial infarction admissions and is associated with high mortality, frequent adverse outcomes, prolonged hospitalizations, extensive medical resource utilization, and major cost. Using hospital cost data for Medicare Fee-for-Service (FFS) patients with AMICS, we sought to evaluate in hospital and 45-day outcomes and cost, comparing patients treated with percutaneous ventricular assist device (pVAD) versus extracorporeal membrane oxygenation (ECMO). The goal of this study was to better understand clinical and economic outcomes of AMICS to help clinicians and hospitals optimize outcomes most economically for AMICS patients. METHODS: A retrospective claims analysis identified patients from the full census Medicare Standard Analytic Files compiled by the Center for Medicare and Medicaid (CMS) including: Inpatient, Outpatient, Skilled Nursing Facility and Home Health files for Medicare FFS beneficiaries. Study costs were defined as the total costs incurred by providers for treating a population with AMICS. Medicare FFS beneficiaries who experienced an inpatient admission during the index period (January 1, 2015 to March 31, 2017) with a diagnosis of AMICS were eligible for study inclusion and were identified by the presence of appropriate International Classification of Diseases, Ninth and Tenth Versions (ICD-9 and ICD-10) diagnosis and procedure codes. To create a matched sample and control for any baseline differences, a 1:1 Propensity Score Matching (PSM) was performed based on criteria such as age, gender, race, geographic distribution, and 11 high-cost comorbidities (e.g., congestive HF, coronary artery disease, diabetes, etc.). Index length of stay (LOS), index costs, discharge disposition (including mortality), post-index utilization, and episode-of-care (EOC) costs were reviewed. EOC was defined as index admission for all patients plus a 45-day post index period for patients who survived the index admission. RESULTS: Each cohort included 338 patients. Index in-hospital mortality rates were 53% for pVAD versus 64% for ECMO (178 vs. 217; p = .0023), and total EOC in-hospital mortality rates were 66% for pVAD versus 74% for ECMO (222 vs. 250; p = .0160). Index LOS for pVAD was 27% lower versus ECMO (12.12 vs. 16.59; p = .0006). The index LOS for patients discharged alive was 25% lower for pVAD versus ECMO (17.73 vs. 23.62; p = .0016). For patients that experienced in-hospital mortality during their index stay, pVAD had a 44% lower LOS compared to ECMO (7.08 vs. 12.66; p < .0001). Following index hospitalization, the average cost savings with additional inpatient care was 31% lower for pVAD patients ($62,188 vs. $90,087; p = NS). During the EOC, pVAD patients incurred 32% lower costs compared to ECMO patients ($117,849 vs. $172,420; <.0001). CONCLUSIONS: This study of Medicare FFS patients demonstrates that hospitals utilizing pVAD for appropriately selected AMICS patients have reduced mortality rates and reduced index LOS with lower index facility costs and lower post index 45-day costs. The study results offer hospitals and clinicians an opportunity to improve clinical outcomes and reduce total EOC costs in treating patients with AMI complicated by CS.

Quantitative Assessment of Blood Lactate in Shock: Measure of Hypoxia or Beneficial Energy Source.

Blood lactate concentration predicts mortality in critically ill patients and is clinically used in the diagnosis, grading of severity, and monitoring response to therapy of septic shock. This paper summarizes available quantitative data to provide the first comprehensive description and critique of the accepted concepts of the physiology of lactate in health and shock, with particular emphasis on the controversy of whether lactate release is simply a manifestation of tissue hypoxia versus a purposeful transfer ("shuttle") of lactate between tissues. Basic issues discussed include (1) effect of nonproductive lactate-pyruvate exchange that artifactually enhances flux measurements obtained with labeled lactate, (2) heterogeneous tissue oxygen partial pressure (Krogh model) and potential for unrecognized hypoxia that exists in all tissues, and (3) pathophysiology that distinguishes septic from other forms of shock. Our analysis suggests that due to exchange artifacts, the turnover rate of lactate and the lactate clearance are only about 60% of the values of 1.05 mmol/min/70 kg and 1.5 L/min/70 kg, respectively, determined from the standard tracer kinetics. Lactate turnover reflects lactate release primarily from muscle, gut, adipose, and erythrocytes and uptake by the liver and kidney, primarily for the purpose of energy production (TCA cycle) while the remainder is used for gluconeogenesis (Cori cycle). The well-studied physiology of exercise-induced hyperlactatemia demonstrates massive release from the contracting muscle accompanied by an increased lactate clearance that may occur in recovering nonexercising muscle as well as the liver. The very limited data on lactate kinetics in shock patients suggests that hyperlactatemia reflects both decreased clearance and increased production, possibly primarily in the gut. Our analysis of available data in health and shock suggests that the conventional concept of tissue hypoxia can account for most blood lactate findings and there is no need to implicate a purposeful production of lactate for export to other organs.

Clinical picture, management and risk stratification in patients with cardiogenic shock: does gender matter?

BACKGROUND: Early recognition and risk stratification are crucial in cardiogenic shock (CS). A lower adherence to recommendations has been described in women with cardiovascular diseases. Little information exists about disparities in clinical picture, management and performance of risk stratification tools according to gender in patients with CS. METHODS: Data from the multicenter Red-Shock registry were used. All consecutive patients with CS were included. Both CardShock and IABP-SHOCK II risk scores were calculated. The primary end-point was in-hospital mortality. The discriminative ability of both scores according to gender was assessed by binary logistic regression, calculating Receiver operating characteristic (ROC) curves and the corresponding area under the curve (AUC). RESULTS: A total of 793 patients were included, of whom 222 (28%) were female. Women were significantly older and had a lower proportion of chronic obstructive pulmonary disease and prior myocardial infarction. CS was less often related to acute coronary syndromes (ACS) in women. The use of vasoactive drugs, renal replacement therapy, invasive ventilation, therapeutic hypothermia and mechanical circulatory support was similar between both groups. In-hospital mortality was 346/793 (43.6%). Mortality was not significantly different according to gender (p = 0.194). Cardshock risk score showed a good ability for predicting in-hospital mortality both in man (AUC 0.69) and women (AUC 0.735). Likewise, the IABP-II successfully predicted in-hospital mortality in both groups (man: AUC 0.693; women: AUC 0.722). CONCLUSIONS: No significant differences were observed regarding management and in-hospital mortality according to gender. Both the CardShock and IABP-II risk scores depicted a good ability for predicting mortality also in women with CS.

Pathophysiology and Advanced Hemodynamic Assessment of Cardiogenic Shock.

Cardiogenic shock (CGS) is common and highly morbid. According to the National Inpatient Sample, there are more than 100,000 cases per year, and 30-day mortality approaches 50% despite improvements in critical care practices and novel mechanical therapies targeted at restoring normal hemodynamics. This issue aims to enhance clinicians' understanding of CGS, and this review specifically focuses on the underlying pathophysiology. We examine the definition and etiologies of CGS, approaches to risk assessment, and the pressure-volume loop framework that is the foundation for conceptualizing ventricular mechanics, ventricular-vascular interactions, and the derangements observed in CGS. This overview will also contextualize subsequent chapters that discuss nuances of CGS encountered in particular scenarios (ie, post-myocardial infraction, acutely decompensated chronic heart failure, post-cardiac surgery), address pharmacological and mechanical treatments for CGS, and review CGS in a case-based format.

Acute Adrenal Insufficiency Precipitated by the Discontinuation of a Betamethasone and Dextrochlorpheniramine Combination: The Diagnostic Utility of an Echocardiographic Assessment of Systemic Vascular Resistance.

A 72-year-old woman with primary biliary cholangitis was admitted to our hospital with heart failure with a preserved ejection fraction. An accidental right ventricular perforation that occurred during an endomyocardial biopsy precipitated cardiogenic shock. Despite successful surgical treatment, she demonstrated progressive hemodynamic deterioration, which was resistant to the administration of high-dose catecholamines. She was diagnosed with acute adrenal insufficiency, which was attributed to the discontinuation of Celestamine® (betamethasone/dextrochlorpheniramine combination) just after the perforation. Prompt intravenous administration of hydrocortisone (150 mg/day) led to hemodynamic stabilization. The serial noninvasive assessment of systemic vascular resistance using transthoracic echocardiography was instrumental in detecting acute adrenal insufficiency in this case.

Frequency of 30-day readmission and its causes after percutaneous coronary intervention in acute myocardial infarction complicated by cardiogenic shock.

BACKGROUND: Survival after percutaneous coronary intervention (PCI) in acute myocardial infarction complicated by cardiogenic shock (AMI-CS) has increased over the years. Short-term readmission rates in this high-risk population remain unknown. METHODS: We queried the United States (U.S.) Nationwide Readmission Database (NRD) from January 2010 to November 2014 using the International Classification of Diseases-Ninth edition, Clinical Modification (ICD-9 CM) codes to identify all patients ≥18 years readmitted within 30 days after surviving an index hospitalization for PCI in AMI-CS. Incidence, etiologies, and predictors of 30-day readmission were analyzed. RESULTS: Among 46,435 patients who survived to discharge after PCI in AMI-CS, 9,020 (19.4%) were readmitted within 30 days. Median time to 30-day readmission was 11 days. Cardiac conditions were the most common causes of readmission (57.8%). Heart failure was the leading readmission diagnosis (24.8%). Private insurance including HMO and self-pay were predictive of lower 30-day readmission. Among other covariates, female sex, comorbidities such as heart failure, atrial fibrillation, in-hospital complications such as major bleeding, sepsis, respiratory complications, AKI requiring dialysis, utilization of mechanical circulatory support (IABP and ECMO) were independently predictive of 30-day readmission. Trend analysis showed decline in 30-day readmission rates from 21.9% in 2010 to 17.9% in 2014 (ptrend < 0.001). CONCLUSION: In this large real-world database, one in five patients receiving PCI in AMI-CS was readmitted within 30 days after discharge. Cardiac conditions were the most common causes of readmission. Insurance type had significant influence on 30-day readmission.

Interhospital ECMO Transport: Regional Focus.

Utilization of extracorporeal membrane oxygenation (ECMO) has increased dramatically over the last decade. Despite this trend, many medical centers have limited, if any, access to this technology or the resources necessary to manage these complex patients. In an effort to improve the current infrastructure of regional ECMO care, ECMO centers of excellence have an obligation to partner with facilities within their communities and regions to increase access to this potentially life-saving technology. While the need for this infrastructure is widely acknowledged in the ECMO community, few reports describe the actual mechanisms by which a successful interfacility transport program can operate. As such, the purpose of this document is to describe the elements of and methods for providing safe and efficient mobile ECMO services from the perspective of an experienced, high-volume tertiary ECMO center of excellence in the Southeastern United States.

Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

BACKGROUND: The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. METHOD/DESIGN: NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device and the day of withdrawal of a trial device), and changes in left ventricular diastolic dimension (7 days after implantation of a trial device and the day of withdrawal of a trial device). ETHICS AND DISSEMINATION: We will disseminate the findings through regional, national, and international conferences and through peer-reviewed journals. TRIAL REGISTRATION: UMIN Clinical Trials Registry (UMIN-CTR; R000033243) registered on 8 September 2017.