Cardiac safety research consortium “shock II” think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock

Samsky, Marc D.; Krucoff, Mitchell W.; Morrow, David A.; Abraham, William T.; Aguel, Fernando; Althouse, Andrew D.; Chen, Eric X.; Cigarroa, Joaquin E.; DeVore, Adam D.; Farb, Andrew; Gilchrist, Ian C.; Henry, Timothy D.; Hochman, Judith S.; Kapur, Navin K.; Morrow, Valarie; Ohman, E. Magnus; O’Neill, William W.; Piña, Ileana L.; Proudfoot, Alastair; Sapirstein, John S.; Seltzer, Jonathan; Senatore, Fred; Shinnar, Meir; Simonton, Charles A.; Tehrani, Behnam; Thiele, Holger; Truesdell, Alexander G.; Waksman, Ron; Rao, Sunil V.

doi:10.1016/j.ahj.2020.09.015

Cited by 15 publications

(17 citation statements)

References 34 publications

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“…The development of sizeable multicenter quality improvement registries with all institutions following standardized protocol to utilize ECMO will help understand its role. The National Cardiogenic Shock Initiative (NSCI) is an ideal example of participating healthcare centers adopting the NSCI treatment algorithm and providing data from these patients ( 29 , 30 ). Such initiatives help analyze the benefit of therapies such as ECMO and underscore the importance of best practices and define the standard of care.…”

Section: Discussionmentioning

confidence: 99%

Venoarterial Extracorporeal Membrane Oxygenation for Acute Massive Pulmonary Embolism: a Meta-Analysis and Call to Action

Kaso

Pan

Salerno

et al. 2021

J. of Cardiovasc. Trans. Res.

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Venoarterial extracorporeal membrane oxygenation (ECMO) has been used to treat acute massive pulmonary embolism (PE) patients. However, the incremental benefit of ECMO to standard therapy remains unclear. Our meta-analysis objective is to compare in-hospital mortality in patients treated for acute massive PE with and without ECMO. The National Library of Medicine MEDLINE (USA), Web of Science, and PubMed databases from inception through October 2020 were searched. Screening identified 1002 published articles. Eleven eligible studies were identified, and 791 patients with acute massive PE were included, of whom 270 received ECMO and 521 did not. In-hospital mortality was not significantly different between patients treated with vs. without ECMO (OR = 1.24 [95% CI, 0.63-2.44], p = 0.54). However, these findings were limited by significant study heterogeneity. Additional research will be needed to clarify the role of ECMO in massive PE treatment.

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Section: Discussionmentioning

confidence: 99%

Venoarterial Extracorporeal Membrane Oxygenation for Acute Massive Pulmonary Embolism: a Meta-Analysis and Call to Action

Kaso

Pan

Salerno

et al. 2021

J. of Cardiovasc. Trans. Res.

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“…Clinical trials designed to evaluate novel drug and device therapy for AMICS are difficult to design and complete. 34,35 Since the SHOCK trial began in 1993, only 2,500 total patients have been enrolled in prospective randomized trials, representing a small fraction of the roughly 150,000 patients in America and Europe with AMICS annually. The first trial evaluating the IABP for AMICS was published in 1973 yet it took nearly four decades until an adequately powered trial designed to determine if IABP improves patient outcomes in AMICS was published.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…16,17,36,37 Ultimately, to improve outcomes in AMICS we need National Institute Health and industry to develop consistent data reporting and trial design for AMICS trials. 34,35 Our review of contemporary AMICS trials highlights the variability of CS and illustrates how the classic definition fails to account for this heterogeneity. Cardiogenic shock is traditionally defined by a SBP <90 mmHg or mean blood pressure <60 mmHg for ≥30 min or the requirement of vasopressor support with evidence of end-organ hypoperfusion.…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

Variability in reporting of key outcome predictors in acute myocardial infarction cardiogenic shock trials

Tyler

Brown

Jentzer³

et al. 2021

Cathet Cardio Intervent

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Background: Among acute myocardial infarction patients with cardiogenic shock (AMICS), a number of key variables predict mortality, including cardiac arrest (CA) and shock classification as proposed by Society for Cardiovascular Angiography and Intervention (SCAI). Given this prognostic importance, we examined the frequency of reporting of high risk variables in published randomized controlled trials (RCTs) of AMICS patients.Methods: We identified 15 RCTs enrolling 2,500 AMICS patients and then reviewed rates of CA, baseline neurologic status, right heart catheterization data, lactate levels, inotrope and vasopressor requirement, hypothermia, mechanical ventilation, left ventricular ejection fraction (LVEF), mechanical circulatory support, and specific cause of death based on the primary manuscript and Data in S1.Results: A total of 2,500 AMICS patients have been enrolled in 15 clinical trials over 21 years with only four trials enrolling >80 patients. The reporting frequency and range for key prognostic factors was: neurologic status (0% reported), hypothermia (28% reported, prevalence 33-75%), specific cause of death (33% reported), cardiac index and wedge pressure (47% reported, range 1.6-2.3 L min −1 m −2 and 15-24 mmHg), lactate (60% reported, range 4-7.7 mmol/L), LVEF (73% reported, range 25-45%), CA (80% reported, prevalence 0-92%), MCS (80% reported, prevalence 13-100%), and mechanical ventilation (93% reported, prevalence 35-100%). This variability was reflected in the 30-day mortality which ranged from 20-73%.Conclusions: In a comprehensive review of seminal RCTs in AMICS, important predictors of outcome were frequently not reported. Future efforts to standardize CS trial data collection and reporting may allow for better assessment of novel therapies for AMICS.

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“…17,18 The administrative mechanisms and networks required to allow patients to transition to a center capable of providing timely clinical, hemodynamic, and imaging profiling in CS are limited; however, despite heterogeneous practices among healthcare systems, a well-outlined spectral severity of illness has been identified with novel severity-based classifications. 19,20 Furthermore, the effect of delaying access to dedicated cardiac intensive care units with a hemodynamicbased approach in CS remains a frontier that affects our interpretation of transitions, disease trajectory, and severity staging while impacting our connection with frontline caregivers. 21,22 Based on the scalable heterogeneity from a cellular level to healthcare systems in hemodynamicbased management of patients experiencing CS, we present considerations towards systematic hemodynamic-based transitions in which distinct clinical entities (AMI-CS, HF-CS, CA-CS, post-cardiotomy shock [PCS], PE-CS, and VHD-CS; Supplementary Material Table 1) share the common path of early identification and rapid transitions through an adaptive longitudinal situational awareness model of care that influences specific management considerations.…”

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confidence: 99%

Hemodynamic-based Assessment and Management of Cardiogenic Shock

Hernández-Montfort

Miranda

Randhawa

et al. 2022

US Cardiology Review

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Cardiogenic shock (CS) remains a deadly disease entity challenging patients, caregivers, and communities across the globe. CS can rapidly lead to the development of hypoperfusion and end-organ dysfunction, transforming a predictable hemodynamic event into a potential high-resource, intense, hemometabolic clinical catastrophe. Based on the scalable heterogeneity from a cellular level to healthcare systems in the hemodynamic-based management of patients experiencing CS, we present considerations towards systematic hemodynamic-based transitions in which distinct clinical entities share the common path of early identification and rapid transitions through an adaptive longitudinal situational awareness model of care that influences specific management considerations. Future studies are needed to best understand optimal management of drugs and devices along with engagement of health systems of care for patients with CS.

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Cardiac safety research consortium “shock II” think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock

Cited by 15 publications

References 34 publications

Venoarterial Extracorporeal Membrane Oxygenation for Acute Massive Pulmonary Embolism: a Meta-Analysis and Call to Action

Venoarterial Extracorporeal Membrane Oxygenation for Acute Massive Pulmonary Embolism: a Meta-Analysis and Call to Action

Variability in reporting of key outcome predictors in acute myocardial infarction cardiogenic shock trials

Hemodynamic-based Assessment and Management of Cardiogenic Shock

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