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. 2021 Feb 1;4(2):e2037748.
doi: 10.1001/jamanetworkopen.2020.37748.

Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

Sanket S Dhruva  1   2 , Joseph S Ross  3   4   5 , Bobak J Mortazavi  3   6   7   8 , Nathan C Hurley  6 , Harlan M Krumholz  3   5   8 , Jeptha P Curtis  3   8 , Alyssa P Berkowitz  3 , Frederick A Masoudi  9 , John C Messenger  9 , Craig S Parzynski  3 , Che G Ngufor  10   11 , Saket Girotra  12   13 , Amit P Amin  14 , Nilay D Shah  10   15 , Nihar R Desai  3   8
Affiliations

Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock

Sanket S Dhruva et al. JAMA Netw Open. .

Abstract

Importance: Mechanical circulatory support (MCS) devices, including intravascular microaxial left ventricular assist devices (LVADs) and intra-aortic balloon pumps (IABPs), are used in patients who undergo percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) complicated by cardiogenic shock despite limited evidence of their clinical benefit.

Objective: To examine trends in the use of MCS devices among patients who underwent PCI for AMI with cardiogenic shock, hospital-level use variation, and factors associated with use.

Design, setting, and participants: This cross-sectional study used the CathPCI and Chest Pain-MI Registries of the American College of Cardiology National Cardiovascular Data Registry. Patients who underwent PCI for AMI complicated by cardiogenic shock between October 1, 2015, and December 31, 2017, were identified from both registries. Data were analyzed from October 2018 to August 2020.

Exposures: Therapies to provide hemodynamic support were categorized as intravascular microaxial LVAD, IABP, TandemHeart, extracorporeal membrane oxygenation, LVAD, other devices, combined IABP and intravascular microaxial LVAD, combined IABP and other device (defined as TandemHeart, extracorporeal membrane oxygenation, LVAD, or another MCS device), or medical therapy only.

Main outcomes and measures: Use of MCS devices overall and specific MCS devices, including intravascular microaxial LVAD, at both patient and hospital levels and variables associated with use.

Results: Among the 28 304 patients included in the study, the mean (SD) age was 65.4 (12.6) years and 18 968 were men (67.0%). The overall MCS device use was constant from the fourth quarter of 2015 to the fourth quarter of 2017, although use of intravascular microaxial LVADs significantly increased (from 4.1% to 9.8%; P < .001), whereas use of IABPs significantly decreased (from 34.8% to 30.0%; P < .001). A significant hospital-level variation in MCS device use was found. The median (interquartile range [IQR]) proportion of patients who received MCS devices was 42% (30%-54%), and the median proportion of patients who received intravascular microaxial LVADs was 1% (0%-10%). In multivariable analyses, cardiac arrest at first medical contact or during hospitalization (odds ratio [OR], 1.82; 95% CI, 1.58-2.09) and severe left main and/or proximal left anterior descending coronary artery stenosis (OR, 1.36; 95% CI, 1.20-1.54) were patient characteristics that were associated with higher odds of receiving intravascular microaxial LVADs only compared with IABPs only.

Conclusions and relevance: This study found that, among patients who underwent PCI for AMI complicated by cardiogenic shock, overall use of MCS devices was constant, and a 2.5-fold increase in intravascular microaxial LVAD use was found along with a corresponding decrease in IABP use and a significant hospital-level variation in MCS device use. These trends were observed despite limited clinical trial evidence of improved outcomes associated with device use.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Dhruva reported receiving funding from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH), National Evaluation System for Health Technology Coordinating Center, Greenwall Foundation, and Arnold Ventures. Dr Ross reported receiving grants from the US Food and Drug Administration (FDA) during the conduct of the study and grants from the FDA, Johnson and Johnson, Medical Devices Innovation Consortium, Agency for Healthcare Research and Quality (AHRQ), NHLBI/NIH, Laura and John Arnold Foundation, Centers for Medicare and Medicaid Services (CMS), and Medtronic Inc outside the submitted work. Dr Mortazavi reported receiving support from the NIH. Dr Krumholz reported receiving personal fees from UnitedHealth, IBM Watson Health, Element Science, Aetna, Facebook, Siegfried & Jensen Law Firm, Arnold & Porter Law Firm, Martin/Baughman Law Firm, F-Prime, and the National Center for Cardiovascular Diseases in Beijing, China; is a co-founder of HugoHealth, a personal health information platform, and a co-founder of Refactor Health, an enterprise healthcare AI-augmented data management company; receiving contracts from the CMS through Yale-New Haven Hospital; and receiving grants from Medtronic and the FDA, Medtronic and Johnson and Johnson, and Shenzhen Center for Health Information outside the submitted work. Dr Curtis reported receiving salary support from the American College of Cardiology and CMS during the conduct of the study and equity ownership from Medtronic outside the submitted work. Mr Berkowitz reported receiving grants from the FDA during the conduct of the study. Dr Masoudi reported receiving a contract for being a chief scientific advisor for the National Cardiovascular Data Registry from the American College of Cardiology outside the submitted work. Dr Ngufor reported receiving grants from the FDA during the conduct of the study. Dr Amin reported receiving grants from Terumo outside the submitted work. Dr Shah reported receiving grants from the FDA during the conduct of the study; research support through Mayo Clinic from the FDA to establish the Yale–Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI) program; and grants from the CMS Innovation (under the Transforming Clinical Practice Initiative), the AHRQ, the NHLBI/NIH, the National Science Foundation, and the Patient Centered Outcomes Research Institute. Dr Desai reported receiving a CERSI award from the FDA during the conduct of the study and grants from Amgen, AstraZeneca, Boehringer Ingelheim, Cytokinetics, Relypsa, Novartis, and SC Pharmaceuticals outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Quarterly Use of Mechanical Circulatory Support (MCS) Devices for Patients Who Underwent Percutaneous Coronary Intervention (PCI) for Acute Myocardial Infarction (AMI) Complicated by Cardiogenic Shock From October 2015 to December 2017 at Hospitals Participating in the National Cardiovascular Data Registry CathPCI and Chest Pain-MI Registries
Patients were categorized according to those receiving an intra-aortic balloon pump (IABP) only, intravascular microaxial left ventricular assist device (LVAD) only, IABP and intravascular microaxial LVAD, LVAD, extracorporeal membrane oxygenation (ECMO), IABP and other MCS devices, and other MCS devices or combination of MCS devices.
Figure 2.
Figure 2.. Proportion of Hospitals That Used Mechanical Circulatory Support (MCS) Devices for Patients Who Underwent Percutaneous Coronary Intervention for Acute Myocardial Infarction Complicated by Cardiogenic Shock From October 2015 to December 2017
The horizontal lines in the center of each box indicate the median; the lower and upper bounds of each box, the 25th and 75th percentiles; and error bars, 1.5 times the interquartile range. Each hospital is represented as a point. Only hospitals with at least 10 cases of cardiogenic shock during the study period were included. IABP indicates intra-aortic balloon pump; LVAD, left ventricular assist device.
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