Intravascular Microaxial Left Ventricular Assist Device for Acute Myocardial Infarction With Cardiogenic Shock—A Call for Evidence of Benefit

Hu, Gene; Habib, Anand R.; Redberg, Rita F.

doi:10.1001/jamainternmed.2022.2734

JAMA Intern Med

2022

DOI: 10.1001/jamainternmed.2022.2734

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Intravascular Microaxial Left Ventricular Assist Device for Acute Myocardial Infarction With Cardiogenic Shock—A Call for Evidence of Benefit

Gene Hu

Anand R. Habib

Rita F. Redberg

Abstract: 2. US Preventive Services Task Force. Behavioral counseling interventions to promote a healthy diet and physical activity for cardiovascular disease prevention in adults without cardiovascular disease risk factors: US Preventive Services Task Force recommendation statement. JAMA.

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2023

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Cited by 2 publications

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References 23 publications

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“…The critical questions around pathways of device approval and evidentiary standards aside, the clinical community deserves the kind of evidence base that the authors advocate for as they continue to make difficult decisions for patients every day. Until we have the requisite data to have a systematic, evidence-based approach, our study with its stated limitations and other studies are highlighting the need for large, appropriately powered randomized clinical trials of MCS for the treatment of cardiogenic shock …”

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confidence: 99%

Caution With Conclusions and Context of Mechanical Circulatory Devices—Reply

Miller

Desai

2023

JAMA Intern Med

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To the Editor In a recent article, Dr Miller and colleagues 1 reported an increased risk of 1-year mortality and bleeding among patients supported by an intravascular microaxial left ventricular assist device (LVAD) vs an intra-aortic balloon pump (IABP) who had all experienced an acute myocardial infarction complicated by cardiogenic shock (CS) and were undergoing percutaneous coronary intervention. This retrospective, propensity-matched analysis was performed in more than 800 patients. Similar conclusions (ie, increased mortality and major bleeding in the LVAD vs the IABP group) were previously reported by 2 large retrospective studies across the US involving 3360 propensity-matched patients with CS and mechanical circulatory support (MCS) 2 and more than 48 300 patients undergoing percutaneous coronary intervention supported by MCS. 3 Although these findings 1 are important, we must strongly emphasize that the focus on outcome among this critically ill population should be shifted from device-stratified outcome to outcome according to patient selection and case management. Because this study population was highly heterogeneous-including stratification of severity, phenotypes and related pathophysiology, complication rates, and intensive care unit management-throughout different institutions, we agree with the authors that all of the findings should be cautiously contextualized by the retrospective nature of the analyses. Indeed, no information was provided on the shock stage classification 4 of patients with CS for the LVAD vs IABP groups nor on the device selection. 1 Because LVAD allows a higher level of support, it may likely have been used in patients with more severe CS and worse organ function, or more severe CS levels may have been associated with intrinsic or congestionrelated coagulation dysfunction.The importance of a standardized heparin anticoagulation strategy-based on parallel activated partial thromboplastin time and anti-Xa assay measurements-in microaxial flow pumpsupported patients to avoid (major) bleeding complications and hemolysis has recently been emphasized. 5 In none of 3 the above-mentioned retrospective analyses was information provided on the anticoagulant drug used, the tests for monitoring the anticoagulant, nor the anticoagulation target. Moreover, major bleeding was not defined. Therefore, we believe that a detailed pathophysiological assessment-including organ function, CS severity, and a more standardized approach toward managing these devices in patients in the intensive care unitis mandatory before any firm conclusions can be drawn regarding complications associated with the device itself.

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Caution With Conclusions and Context of Mechanical Circulatory Devices—Reply

Miller

Desai

2023

JAMA Intern Med

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“…Examples include inferior vena cava filters, 9 percutaneous left atrial appendage occlusion devices, 10 and intravascular microaxial left ventricular assist devices. 11 Rita has been a leader in the revolution that stimulated clinicians to think about the potential harms of technologies, such as electron beam computed tomographic scans for coronary calcium. 12, 13 Similarly, she has supported studies showing that overuse of computed tomographic scans and other imaging tests expose patients to needless radiation, which in aggregate results in substantial increased cancer risk.…”

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“…Rita’s work and other articles in this journal have highlighted concerns about many devices in cardiology and other fields. Examples include inferior vena cava filters, percutaneous left atrial appendage occlusion devices, and intravascular microaxial left ventricular assist devices …”

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The Rita Redberg Era at JAMA Internal Medicine

2023

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We, the senior editors, write to recognize her achievements over the past 14 years. On behalf of the entire editorial team, we thank Rita for her creative and tireless leadership and valued friendship.When Rita took over as Editor in 2009, this journal was known as the Archives of Internal Medicine and had an impact factor in the single digits. At present, JAMA Internal Medicine is a highly respected general internal medicine journal with an impact factor for 2021 of 44.46, about 13.8 million article views and downloads a year, extensive coverage in the news media, and thousands of social media followers. Beyond these statistics, however, Rita spoke her mind and added a note of robust independence to our pages. She developed a clear identity for JAMA Internal Medicine as a home for high-quality research that can improve clinical care and "right size medicine," balancing the benefits of health care with risks and costs. Her voice traveled internationally because it was so clearly focused on the key issues of individual choices and public health. By publishing articles that are thought provoking and interesting, Rita transformed JAMA Internal Medicine into a "must-read" journal.JAMA Internal Medicine is the home of Less is More, a longrunning series of articles on the harms of overusing medical care, a philosophy that Rita instilled in all of us. 1 The less-ismore approach may help to reduce the bloated cost of medical care, particularly in the US, but more importantly reduce the harms associated with overuse of low-value testing, treatment, and procedures. Advocating for this path forward has not been easy, however. It requires bucking the mainstream view in medicine, where more is always better, new technology is better than old technology (or no technology at all), and doing something is better than doing nothing.

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Intravascular Microaxial Left Ventricular Assist Device for Acute Myocardial Infarction With Cardiogenic Shock—A Call for Evidence of Benefit

Abstract: 2. US Preventive Services Task Force. Behavioral counseling interventions to promote a healthy diet and physical activity for cardiovascular disease prevention in adults without cardiovascular disease risk factors: US Preventive Services Task Force recommendation statement. JAMA.

Cited by 2 publications

References 23 publications

Caution With Conclusions and Context of Mechanical Circulatory Devices—Reply

Caution With Conclusions and Context of Mechanical Circulatory Devices—Reply

The Rita Redberg Era at JAMA Internal Medicine

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