Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock.
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SUBMITTER: Samsky M
PROVIDER: S-EPMC7604661 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock.
Samsky Marc M Krucoff Mitchell M Althouse Andrew D AD Abraham William T WT Adamson Philip P Aguel Fernando F Bilazarian Seth S Dangas George D GD Gilchrist Ian C IC Henry Timothy D TD Hochman Judith S JS Kapur Navin K NK Laschinger John J Masters Roy G RG Michelson Eric E Morrow David A DA Morrow Valarie V Ohman E Magnus EM Pina Ileana I Proudfoot Alastair G AG Rogers Joseph J Sapirstein John J Senatore Fred F Stockbridge Norman N Thiele Holger H Truesdell Alexander G AG Waksman Ron R Rao Sunil S
American heart journal 20191107
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Project description: Not available
| S-EPMC7704747 | biostudies-literature
Project description:AimsThe Shock Academic Research Consortium (SHARC) recently proposed pragmatic consensus definitions to standardize classification of cardiogenic shock (CS) in registries and clinical trials. We aimed to describe contemporary CS epidemiology using the SHARC definitions in a cardiac intensive care unit (CICU) population.Methods and resultsThe Critical Care Cardiology Trials Network (CCCTN) is a multinational research network of advanced CICUs coordinated by the TIMI Study Group (Boston, MA). Cardiogenic shock was defined as a cardiac disorder resulting in SBP < 90 mmHg for ≥30 min [or the need for vasopressors, inotropes, or mechanical circulatory support (MCS) to maintain SBP ≥ 90 mmHg] with evidence of hypoperfusion. Primary aetiologic categories included acute myocardial infarction-related CS (AMI-CS), heart failure-related CS (HF-CS), and non-myocardial (secondary) CS. Post-cardiotomy CS was not included. Heart failure-related CS was further subcategorized as de novo vs. acute-on-chronic HF-CS. Patients with both cardiogenic and non-cardiogenic components of shock were classified separately as mixed CS. Of 8974 patients meeting shock criteria (2017-23), 65% had isolated CS and 17% had mixed shock. Among patients with CS (n = 5869), 27% had AMI-CS (65% STEMI), 59% HF-CS (72% acute-on-chronic, 28% de novo), and 14% secondary CS. Patients with AMI-CS and de novo HF-CS were most likely to have had concomitant cardiac arrest (P < 0.001). Patients with AMI-CS and mixed CS were most likely to present in more severe shock stages (SCAI D or E; P < 0.001). Temporary MCS use was highest in AMI-CS (59%). In-hospital mortality was highest in mixed CS (48%), followed by AMI-CS (41%), similar in de novo HF-CS (31%) and secondary CS (31%), and lowest in acute-on-chronic HF-CS (25%; P < 0.001).ConclusionSHARC consensus definitions for CS classification can be pragmatically applied in contemporary registries and reveal discrete subpopulations of CS with distinct phenotypes and outcomes that may be relevant to clinical practice and future research.
| S-EPMC11518926 | biostudies-literature
Project description:The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.
| S-EPMC11025346 | biostudies-literature
Project description:BackgroundCardiac sarcoidosis is found to occur in approximately 5% of patients with sarcoidosis. Its presentation can typically range from complete heart block to ventricular arrhythmias. This condition can rarely present with severe heart failure and cardiogenic shock requiring aggressive and timely management strategies. Advanced imaging techniques are usually required to assist with its diagnosis.Case presentationA 70-year-old woman with a history of pulmonary sarcoidosis presented with non-ST elevation myocardial infarction, congestive hepatopathy, and acute renal failure. Left heart catheterization showed evidence of non-obstructive coronary artery disease, and right heart catheterization revealed severely elevated filling pressures and depressed cardiac index. She underwent aggressive diuresis and placement of an intra-aortic balloon pump in addition to initiation of inotropic and vasopressor support. While in the cardiac intensive care unit, she experienced frequent episodes of ventricular tachycardia and went into cardiac arrest requiring cardiopulmonary resuscitation. High clinical suspicion for cardiac sarcoidosis was confirmed by cardiac magnetic resonance imaging findings. After starting immunosuppressive therapy for cardiac sarcoidosis, she demonstrated clinical improvement.ConclusionPatients with cardiac sarcoidosis may remain asymptomatic or present with conduction abnormalities and arrhythmias. They rarely present with severe biventricular heart failure and cardiogenic shock, and in such cases, they require timely initiation of pharmacologic and device therapies, along with implementation of mechanical circulatory support.
| S-EPMC10150484 | biostudies-literature
Project description:BackgroundTakotsubo cardiomyopathy (TTS) is an extremely rare complication of fluorouracil containing chemotherapy regimes such as FOLFOX used for colorectal cancer, occurring in only five previous case reports. Due to its potentially fatal outcomes, yet infrequent presence in the literature, it is worthwhile reviewing the clinical features and outcomes of this phenomenon.Case summaryA 54-year-old lady was admitted with cardiogenic shock. A cardiac magnetic resonance imaging (CMR) showed mid-ventricle to apical hypokinesis and confirmed TTS. She was managed with inotropes and non-invasive ventilation after which she recovered fully both clinically and in her CMR features 6 weeks following discharge.DiscussionThis is the first case showing the acute CMR features of this complication and highlights the need for awareness of this rarely occurring cardiotoxicity. It also shows the potentially fatal phenomenon can be fully reversible when diagnosed and managed promptly even in patients with metastatic cancer and critical illness.
| S-EPMC6939794 | biostudies-literature
Project description:BackgroundAmyloidosis is a systemic infiltrative disease that can affect nearly every organ in the human body. It is characterized by the deposition of misfolded protein within various tissues and organs. Once there is cardiac involvement this portends a worse prognosis.Case summaryWe describe a case series of two patients with cardiac amyloidosis presenting as a cardiogenic shock. There were several missed opportunities in diagnosing cardiac amyloid prior to their fatal presentations. In the first case, a 65-year-old African-American male patient presented with worsening shortness of breath and signs of heart failure. Echocardiography revealed preserved ejection fraction. He was diagnosed with light chain subtype of cardiac amyloidosis, and rapidly deteriorated during his admission. Patient in the second case is a 75-year-old African-American female who presented with worsening heart failure and hypotension. Echocardiography revealed reduced ejection fraction. She was diagnosed with transthyretin cardiac amyloid. Her clinical status worsened during admission and she went into cardiogenic shock requiring multiple vasopressors.DiscussionThis case series discusses two incidences of cardiac amyloidosis presenting as cardiogenic shock in African-American patients. This article postulates that cardiac amyloidosis may be misdiagnosed for more common causes of heart failure especially among this demographic group. Once patients with cardiac amyloid present with cardiogenic shock their clinical course is typically rapidly fatal despite aggressive measures. Earlier detection is imperative to prevent poor outcomes.
| S-EPMC8343451 | biostudies-literature
Project description:BackgroundPhaeochromocytoma multisystem crisis (PMC) is characterized by labile blood pressures (extremes of hypo- and/or hypertension) and multiorgan failure as a result of catecholamine excess. Initial stabilization requires pharmacological and/or mechanical circulatory support, followed by the institution of antihypertensives to correct the underlying pathophysiology.Case summaryA previously well 40-year-old male developed a sudden onset of breathlessness. On presentation, he was in shock with multiorgan failure. He required intubation, mechanical ventilation, dual inotropic support, and renal replacement therapy. Bedside echocardiogram showed a severely impaired left ventricular ejection fraction (LVEF) of 25%. Coronary angiography revealed normal coronary arteries. In view of raised inflammatory markers and transaminitis, a computed tomography abdomen/pelvis was performed. An incidental left adrenal mass was found. Further work-ups revealed raised plasma metanephrine and normetanephrine, 24-h urine epinephrine, and norepinephrine. A cardiac magnetic resonance (CMR) showed myocardial inflammation and reverse Takotsubo pattern of regional wall motion abnormality (RWMA). The diagnosis of cardiogenic shock and stress cardiomyopathy secondary to PMC was made. He was subsequently initiated on α- and β-blockers and goal-directed medical therapy for heart failure. A 68Ga-DOTATATE scan showed avid tracer uptake of the left phaeochromocytoma. An interval CMR 3 weeks from presentation showed near normalization of the LVEF and RWMA. He underwent a successful laparoscopic left adrenalectomy and was antihypertensive-free since.DiscussionThe clinical suspicion for PMC as the cause of cardiogenic shock requires astute clinical judgement, while the management requires an understanding of the underlying pathophysiology that calls for multidisciplinary inputs.
| S-EPMC11420679 | biostudies-literature
Project description:BackgroundCardiac sarcoidosis (CS) occasionally disrupts circulatory haemodynamics due to arrhythmia or cardiac dysfunction.Case summaryA 70-year-old woman was diagnosed with CS, then was admitted for syncope because of complete atrioventricular block and frequently non-sustained ventricular tachycardia. Although a temporary pacemaker and intravenous amiodarone were introduced, she subsequently went into cardiopulmonary arrest by ventricular fibrillation. After the return of spontaneous circulation, Impella cardiac power (CP) was introduced because of sustained hypotension and severely impaired left ventricular contraction. High-dose intravenous corticosteroid therapy was simultaneously introduced. Her atrioventricular conduction and left ventricular contraction drastically improved. Impella CP was successfully removed after 4 days of support. She was eventually administered steroid maintenance therapy and discharged.DiscussionWe report a case of CS with fulminant haemodynamic collapse treated with high-dose intravenous corticosteroid therapy under Impella assistance for acute haemodynamic support. Although CS has been known as an inflammatory disease with progressive cardiac dysfunction and rapid deterioration due to fatal arrhythmias, it can be improved with steroid therapy. It was suggested that strong haemodynamic support by Impella could be a bridge to manifest the effects after introducing steroid therapy to patients with CS.
| S-EPMC9924496 | biostudies-literature
Project description:Although great strides have been made in the pathophysiological understanding, diagnosis and management of cardiogenic shock (CS), morbidity and mortality in patients presenting with the condition remain high. Acute MI is the commonest cause of CS; consequently, most existing literature concerns MI-associated CS. However, there are many more phenotypes of patients with acute heart failure. Medical treatment and mechanical circulatory support are well-established therapeutic options, but evidence for many current treatment regimens is limited. The issue is further complicated by the fact that implementing adequately powered, randomized controlled trials are challenging for many reasons. In this review, the authors discuss the history, landmark trials, current topics of medical therapy and mechanical circulatory support regimens, and future perspectives of CS management.
| S-EPMC11588188 | biostudies-literature
Project description:BackgroundCardiogenic shock is the main cause of death in hospitalized patients with acute coronary syndromes, with a high mortality rate. The management of graft thrombosis after coronary artery bypass graft (CABG) surgery is challenging and the best revascularization strategy is not well defined. In patients who develop cardiac arrest due to graft thrombosis, the benefits of mechanical support during advanced cardiac life support are uncertain. Rescue extracorporeal cardiac bypass resuscitation has been used in the context of cardiopulmonary arrest, with survival rates of around 34.7% of which 28.5% with good neurological outcome.Case summaryWe present here the case of a patient who developed cardiogenic shock after CABG graft occlusion. The patient suffered refractory cardiac arrest during percutaneous revascularization and received rescue cardiopulmonary support. Revascularization was achieved and there was a successful resuscitation with the placement of venous-arterial extracorporeal membrane oxygenation (VA-ECMO) and an Impella CP device. After a 29-day hospitalization the patient was discharged with no neurological sequelae.DiscussionAlthough there is limited evidence of the benefit of a combined use of mechanical support (VA-ECMO with other mechanical devices) in the management of cardiogenic shock and cardiac arrest following CABG surgery, there seems to be a lower mortality with this approach, and possibly more favourable neurological outcomes. Further research is needed to elucidate the advantages of Impella vs. intra-aortic balloon pump combined with VA-ECMO in such patients.
| S-EPMC7793049 | biostudies-literature