PMID- 33616664 OWN - NLM STAT- MEDLINE DCOM- 20210412 LR - 20210920 IS - 2574-3805 (Electronic) IS - 2574-3805 (Linking) VI - 4 IP - 2 DP - 2021 Feb 1 TI - Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. PG - e2037748 LID - 10.1001/jamanetworkopen.2020.37748 [doi] LID - e2037748 AB - 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. FAU - Dhruva, Sanket S AU - Dhruva SS AD - University of California, San Francisco School of Medicine, San Francisco. AD - Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California. FAU - Ross, Joseph S AU - Ross JS AD - Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. AD - Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut. AD - Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut. FAU - Mortazavi, Bobak J AU - Mortazavi BJ AD - Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. AD - Department of Computer Science and Engineering, Texas A&M University, College Station. AD - Center for Remote Health Technologies and Systems, Texas A&M University, College Station. AD - Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut. FAU - Hurley, Nathan C AU - Hurley NC AD - Department of Computer Science and Engineering, Texas A&M University, College Station. FAU - Krumholz, Harlan M AU - Krumholz HM AD - Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. AD - Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut. AD - Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut. FAU - Curtis, Jeptha P AU - Curtis JP AD - Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. AD - Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut. FAU - Berkowitz, Alyssa P AU - Berkowitz AP AD - Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. FAU - Masoudi, Frederick A AU - Masoudi FA AD - Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora. FAU - Messenger, John C AU - Messenger JC AD - Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora. FAU - Parzynski, Craig S AU - Parzynski CS AD - Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. FAU - Ngufor, Che G AU - Ngufor CG AD - Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota. AD - Division of Digital Health Sciences, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. FAU - Girotra, Saket AU - Girotra S AD - Division of Cardiovascular Diseases, Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City. AD - Center for Access & Delivery Research & Evaluation (CADRE), Iowa City Veterans Affairs Medical Center, Iowa City, Iowa. FAU - Amin, Amit P AU - Amin AP AD - Cardiovascular Division, Washington University School of Medicine, St Louis, Missouri. FAU - Shah, Nilay D AU - Shah ND AD - Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota. AD - Division of Health Care Policy Research, Mayo Clinic, Rochester, Minnesota. FAU - Desai, Nihar R AU - Desai NR AD - Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut. AD - Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut. LA - eng GR - U01 FD005938/FD/FDA HHS/United States GR - UL1 TR001863/TR/NCATS NIH HHS/United States PT - Journal Article PT - Research Support, U.S. Gov't, P.H.S. DEP - 20210201 PL - United States TA - JAMA Netw Open JT - JAMA network open JID - 101729235 SB - IM MH - Aged MH - Assisted Circulation/trends MH - Cross-Sectional Studies MH - Extracorporeal Membrane Oxygenation/*trends MH - Female MH - Heart Arrest/epidemiology MH - Heart-Assist Devices/*trends MH - Hospitals, High-Volume MH - Hospitals, Low-Volume MH - Hospitals, Teaching MH - Humans MH - Intra-Aortic Balloon Pumping/*trends MH - Male MH - Middle Aged MH - Myocardial Infarction/complications/*therapy MH - Percutaneous Coronary Intervention/*methods MH - Risk Factors MH - Shock, Cardiogenic/etiology/*therapy PMC - PMC7900859 COIS- 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. EDAT- 2021/02/23 06:00 MHDA- 2021/04/13 06:00 PMCR- 2021/02/22 CRDT- 2021/02/22 12:14 PHST- 2021/02/22 12:14 [entrez] PHST- 2021/02/23 06:00 [pubmed] PHST- 2021/04/13 06:00 [medline] PHST- 2021/02/22 00:00 [pmc-release] AID - 2776709 [pii] AID - zoi201135 [pii] AID - 10.1001/jamanetworkopen.2020.37748 [doi] PST - epublish SO - JAMA Netw Open. 2021 Feb 1;4(2):e2037748. doi: 10.1001/jamanetworkopen.2020.37748.