TY - JOUR
T1 - Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump with In-Hospital Mortality and Major Bleeding among Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock
AU - Dhruva, Sanket S.
AU - Ross, Joseph S.
AU - Mortazavi, Bobak J.
AU - Hurley, Nathan C.
AU - Krumholz, Harlan M.
AU - Curtis, Jeptha P.
AU - Berkowitz, Alyssa
AU - Masoudi, Frederick A.
AU - Messenger, John C.
AU - Parzynski, Craig S.
AU - Ngufor, Che
AU - Girotra, Saket
AU - Amin, Amit P.
AU - Shah, Nilay D.
AU - Desai, Nihar R.
N1 - Funding Information:
reported receipt of travel reimbursement from the US Food and Drug Administration (FDA) Center for Drug Research and Evaluation/Office of Medical Policy and the National Evaluation System for Health Technology (NEST); and research support from the National Heart, Lung, and Blood Institute
Funding Information:
(NHLBI) of the National Institutes of Health (NIH) (K12HL138046). Dr Ross reported current receipt of grants from Johnson & Johnson (research support through Yale University to develop methods of clinical trial data sharing), the Medical Device Innovation Consortium (as part of NEST), the Agency for Healthcare Research and Quality (AHRQ; R01HS022882), NHLBI/NIH (R01HS025164), and the Laura and John Arnold Foundation (to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency at Yale) outside the submitted work; and past receipt of grants from the Centers for Medicare & Medicaid Services (CMS; to develop and maintain performance measures used for public reporting [HHSM-500-2013-13018I]), Medtronic and the FDA (research support through Yale University to develop methods for postmarket surveillance of medical devices [U01FD004585]), and the Blue Cross Blue Shield Association (to better understand medical technology evaluation) outside the submitted work. Dr Mortazavi reported receipt of grants and nonfinancial support from the American College of Cardiology (ACC) during the conduct of the study. Dr Krumholz reports receipt of grants from Medtronic and Johnson & Johnson (Janssen) (through Yale University to develop methods of clinical trial data sharing [research agreements]), Medtronic and the FDA (through Yale University to develop methods for postmarket surveillance of medical devices), and the Shenzhen Center for Health Information; other from CMS (working under contract to develop and maintain performance measures that are publicly reported), Refractor Health, and Hugo (founder; the company is a personal health information platform); and personal fees from United Health (chair of a cardiac scientific advisory board), IBM Watson Health life sciences board (participant/participant representative), Element Science (advisory board member), Aetna (physician advisory board), the National Center for Cardiovascular Diseases (Beijing), Arnold & Porter law firm, Siegfried & Jensen law firm, Ben C. Martin law firm, and Facebook (advisory board member) outside the submitted work. Dr Curtis reported receipt of other from CMS (salary support to develop and maintain performance measures used for public reporting), the ACC National Cardiovascular Data Registry (NCDR; salary support), and Medtronic (equity interest) outside the submitted work. Dr Masoudi reports having a contract with the ACC for his role as chief scientific advisor of the NCDR outside the submitted work. Dr Amin reports receipt of grants from the Clinical and Translational Science Award program of the National Center for Advancing Translational Sciences of NIH (support from a comparative effectiveness research KM1 career development award [UL1TR000448, KL2TR000450, TL1TR000449]), the National Cancer Institute of NIH (1KM1CA156708-01), AHRQ (an R18 grant [R18HS0224181-01A1]), and Volcano Corporation and MedAxiom Synergistic Healthcare Solutions (unrestricted); receipt of personal fees from Terumo (consulting), AstraZeneca (consulting), and GE Healthcare during the conduct of the study. Dr Parzynski reported receipt of other from the ACC (salary support [Yale/Yale New Haven Hospital is contracted with the ACC as a data analytic center]) outside the submitted work. Dr Shah reported receipt of a grant from AHRQ during the conduct of the study; and grants in the past 36 months from the FDA (research support through Mayo Clinic to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program [U01FD005938]), CMS Innovation under the Transforming Clinical Practice Initiative, AHRQ (R01HS025164; R01HS025402; R03HS025517; K12HS026379), NHLBI/NIH (R56HL130496; R01HL131535), the National Science Foundation, and the Patient-Centered Outcomes Research Institute (to develop a clinical data research network). Dr Desai reported receipt of grants and personal fees outside the submitted work from Amgen, Boehringer Ingelheim, and Cytokinetics; and personal fees from Novartis, Relypsa, and ScPharmaceuticals outside the submitted work. No other disclosures were reported.
Funding Information:
Funding/Support: Funding for this research was provided by a Center of Excellence in Regulatory Science and Innovation (CERSI) grant to Yale University and Mayo Clinic from the FDA (U01FD005938).
PY - 2020/2/25
Y1 - 2020/2/25
N2 - Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding. Results: Among 28304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P <.001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P <.001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.
AB - Importance: Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. Objective: To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. Design, Setting, and Participants: A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Exposures: Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. Main Outcomes and Measures: The primary outcomes were in-hospital mortality and in-hospital major bleeding. Results: Among 28304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P <.001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P <.001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Conclusions and Relevance: Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.
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U2 - 10.1001/jama.2020.0254
DO - 10.1001/jama.2020.0254
M3 - Article
C2 - 32040163
AN - SCOPUS:85079220168
VL - 323
SP - 734
EP - 745
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
SN - 0002-9955
IS - 8
ER -