Impella Versus Intra-Aortic Balloon Pump for High-Risk PCI: A Propensity-Adjusted Large-Scale Claims Dataset Analysis

Abstract

Impella was approved by the Food and Drug Administration in 2015 for use during high-risk percutaneous coronary interventions (PCIs); however, its safety and efficacy compared with intra-aortic balloon pump (IABP) has not been evaluated in contemporary practice and remains debated. We aimed to compare postapproval outcomes and costs of Impella versus IABP support for high-risk PCI in real-world practice across hospitals in the United States. We identified patients from the Premier Healthcare Database undergoing nonemergent Impella- or IABP-supported high-risk PCI. We used propensity adjustment to control baseline, procedure, and post-PCI medical treatment differences between treatment groups. We included patients undergoing nonemergent single-PCI procedures with either Impella or IABP support and excluded patients presenting with acute ST-elevation myocardial infarction or cardiogenic shock or requiring >1 mechanical support devices during index hospitalization. Outcomes included in-hospital survival, myocardial infarction (MI), cardiogenic shock, stroke, bleeding requiring transfusion, acute kidney injury, index hospitalization length of stay, and costs. From April 2016 to June 2019, a total of 48,179 patients were treated with Impella or IABP mechanical circulatory support at 304 hospitals in the United States. Among these, we identified 2,156 patients undergoing nonemergent high-risk PCI treated with Impella (n = 1,447) or IABP (n = 709). After propensity adjustment, Impella use was associated with improved survival (odds ratio [OR] 1.55, 95% confidence interval [CI] 1.02 to 2.36) and less MI (OR 0.29, 95% CI 0.18 to 0.46) and cardiogenic shock (OR 0.54, 95% CI 0.39 to 0.74). Stroke, bleeding requiring transfusion, and acute kidney injury were similar between groups. In conclusion, this Premier Healthcare Database propensity-adjusted analysis, Impella use during nonemergent high-risk PCI was associated with improved survival and reduced in-hospital MI and cardiogenic shock compared with IABP. Impella was approved by the Food and Drug Administration in 2015 for use during high-risk percutaneous coronary interventions (PCIs); however, its safety and efficacy compared with intra-aortic balloon pump (IABP) has not been evaluated in contemporary practice and remains debated. We aimed to compare postapproval outcomes and costs of Impella versus IABP support for high-risk PCI in real-world practice across hospitals in the United States. We identified patients from the Premier Healthcare Database undergoing nonemergent Impella- or IABP-supported high-risk PCI. We used propensity adjustment to control baseline, procedure, and post-PCI medical treatment differences between treatment groups. We included patients undergoing nonemergent single-PCI procedures with either Impella or IABP support and excluded patients presenting with acute ST-elevation myocardial infarction or cardiogenic shock or requiring >1 mechanical support devices during index hospitalization. Outcomes included in-hospital survival, myocardial infarction (MI), cardiogenic shock, stroke, bleeding requiring transfusion, acute kidney injury, index hospitalization length of stay, and costs. From April 2016 to June 2019, a total of 48,179 patients were treated with Impella or IABP mechanical circulatory support at 304 hospitals in the United States. Among these, we identified 2,156 patients undergoing nonemergent high-risk PCI treated with Impella (n = 1,447) or IABP (n = 709). After propensity adjustment, Impella use was associated with improved survival (odds ratio [OR] 1.55, 95% confidence interval [CI] 1.02 to 2.36) and less MI (OR 0.29, 95% CI 0.18 to 0.46) and cardiogenic shock (OR 0.54, 95% CI 0.39 to 0.74). Stroke, bleeding requiring transfusion, and acute kidney injury were similar between groups. In conclusion, this Premier Healthcare Database propensity-adjusted analysis, Impella use during nonemergent high-risk PCI was associated with improved survival and reduced in-hospital MI and cardiogenic shock compared with IABP. Mechanical circulatory support (MCS) with the intra-aortic balloon pump (IABP) or the microaxial Impella blood pump is frequently used during high-risk percutaneous coronary interventions (PCIs) to maintain hemodynamic stability and enable complete revascularization.1Levine GN Bates ER Blankenship JC Bailey SR Bittl JA Cercek B Chambers CE Ellis SG Guyton RA Hollenberg SM Khot UN Lange RA Mauri L Mehran R Moussa ID Mukherjee D Nallamothu BK Ting HH American College of Cardiology FoundationAmerican Heart Association Task Force on Practice GuidelinesSociety for Cardiovascular Angiography and Interventions2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions.J Am Coll Cardiol. 2011; 58: e44-e122Crossref PubMed Scopus (1934) Google Scholar,2Rihal CS Naidu SS Givertz MM Szeto WY Burke JA Kapur NK Kern M Garratt KN Goldstein JA Dimas V Tu T Society for Cardiovascular Angiography and Interventions (SCAI)Heart Failure Society of America (HFSA); Society of Thoracic Surgeons (STS)American Heart Association (AHA), and American College of Cardiology (ACC)2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care: endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention.J Am Coll Cardiol. 2015; 65: e7-e26Crossref PubMed Scopus (311) Google Scholar The Impella ventricular devices can provide up to 3.5 l/min of cardiac output and reduce left ventricular preload and afterload, maintain cardiac power output, and prevent myocardial ischemia.3Dixon SR Henriques JP Mauri L Sjauw K Civitello A Kar B Loyalka P Resnic FS Teirstein P Makkar R Palacios IF Collins M Moses J Benali K O'Neill WW A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience.JACC Cardiovasc Interv. 2009; 2: 91-96Crossref PubMed Scopus (264) Google Scholar, 4O'Neill WW Kleiman NS Moses J Henriques JP Dixon S Massaro J Palacios I Maini B Mulukutla S Dzavík V Popma J Douglas PS Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study.Circulation. 2012; 126: 1717-1727Crossref PubMed Scopus (516) Google Scholar, 5Popma J. PROTECT III first look: high-risk PCI outcomes in 800 Impella-supported patients. Presented at: TCT 2019; September 27, 2019; San Francisco, CA. Accessed September 29, 2022. https://www.tctmd.com/slide/protect-iii-first-look-high-risk-pci-outcomes-800-impella-supported-patientsGoogle Scholar, 6Azzalini L Johal GS Baber U Bander J Moreno PR Bazi L Kapur V Barman N Kini AS Sharma SK. Outcomes of Impella-supported high-risk nonemergent percutaneous coronary intervention in a large single-center registry.Catheter Cardiovasc Interv. 2021; 97: E26-E33Crossref PubMed Scopus (8) Google Scholar, 7Baumann S Werner N Al-Rashid F Schäfer A Bauer T Sotoudeh R Bojara W Shamekhi J Sinning JM Becher T Eder F Akin I. Six months follow-up of protected high-risk percutaneous coronary intervention with the microaxial Impella pump: results from the German Impella registry.Coron Artery Dis. 2020; 31: 237-242Crossref PubMed Scopus (6) Google Scholar, 8Burzotta F Russo G Ribichini F Piccoli A D'Amario D Paraggio L Previ L Pesarini G Porto I Leone AM Niccoli G Aurigemma C Verdirosi D Crea F Trani C Long-term outcomes of extent of revascularization in complex high risk and indicated patients undergoing Impella-protected percutaneous coronary intervention: report from the Roma-Verona registry.J Interv Cardiol. 2019; 20195243913Crossref PubMed Scopus (18) Google Scholar, 9Chieffo A Ancona MB Burzotta F Pazzanese V Briguori C Trani C Piva T De Marco F Di Biasi M Pagnotta P Casu G Giustino G Montorfano M Pappalardo F Tarantini G CollaboratorsObservational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry.EuroIntervention. 2020; 15: e1343-e1350Crossref PubMed Scopus (30) Google Scholar, 10Maini B Naidu SS Mulukutla S Kleiman N Schreiber T Wohns D Dixon S Rihal C Dave R O'Neill W Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: the USpella Registry.Catheter Cardiovasc Interv. 2012; 80: 717-725Crossref PubMed Scopus (117) Google Scholar The PROTECT II randomized trial demonstrated that Impella 2.5 provided superior hemodynamic support compared with IABP and improved major adverse events at 90 days in the per-protocol population (40% with Impella vs 51% with IABP, p = 0.023).4O'Neill WW Kleiman NS Moses J Henriques JP Dixon S Massaro J Palacios I Maini B Mulukutla S Dzavík V Popma J Douglas PS Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study.Circulation. 2012; 126: 1717-1727Crossref PubMed Scopus (516) Google Scholar Based on these results, the Food and Drug Administration approved Impella 2.5 in 2015 and Impella CP in 2016 for patients undergoing high-risk PCI. We aimed to evaluate outcomes of nonemergent, mechanical supported, high-risk PCI with IABP compared with Impella since its approval in 2016 in a real-world setting, using a large-scale claims database. Although previous registry-based studies have compared population-wide outcomes11Amin AP Spertus JA Curtis JP Desai N Masoudi FA Bach RG McNeely C Al-Badarin F House JA Kulkarni H Rao SV. The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support.Circulation. 2020; 141: 273-284Crossref PubMed Scopus (174) Google Scholar and acute myocardial infarction (MI) outcomes,12Dhruva SS Ross JS Mortazavi BJ Hurley NC Krumholz HM Curtis JP Berkowitz A Masoudi FA Messenger JC Parzynski CS Ngufor C Girotra S Amin AP Shah ND Desai NR. 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.JAMA. 2020; 323: 734-745Crossref PubMed Scopus (162) Google Scholar this is the first such study to compare outcomes between Impella and IABP in patients with high-risk PCI. We identified patients undergoing MCS with Impella or IABP from the Premier Healthcare Database (PHD), a large, real-world, hospital-based, service-level, all-payer database, with more than 700 contributing hospitals from all regions of the United States.13Premier. Newsroom. https://learn.premierinc.com/white-papers/premier-healthcaredatabase-whitepaper. Accessed on February 12, 2021.Google Scholar Inpatient admissions include over 121 million visits, with more than 10 million annual visits since 2012, representing approximately 25% of annual United States inpatient admissions.13Premier. Newsroom. https://learn.premierinc.com/white-papers/premier-healthcaredatabase-whitepaper. Accessed on February 12, 2021.Google Scholar PHD contains discharge-level information on International Classification of Diseases (ICD) diagnostic codes, hospital-submitted Current Procedural Terminology, and Healthcare Common Procedure Coding System codes for diagnostic and therapeutic procedures recorded during each admission, in addition to demographic characteristics, co-morbidities, and medications. Hospitalization costs of all billed items, including hospital services, medical procedures, equipment fees, medications, diagnostics, and laboratory tests can be determined from the PHD charge master by the cost-accounting department, administrative records on length of stay (LOS), and discharge status. We identified patients from the PHD undergoing MCS with Impella or IABP at 304 hospitals in the United States after Impella approval from April 2016 to June 2019 (Supplementary Figure 1). Among those, we included only patients undergoing nonemergent high-risk PCI, identified by ICD Tenth Revision (ICD-10) procedure codes (Supplementary Appendix 1) and compared outcomes based on the type of MCS device (Impella or IABP) used during PCI, identified based on ICD-10 procedures codes (i.e., 5A0221D, 5A0211D, 5A02210, and 5A02110) (Supplementary Appendix 1). We included patients with nonemergent admissions undergoing a single-PCI procedure with either Impella or IABP support on the day of admission and excluded all admissions coded as emergent. We excluded patients with cardiogenic shock or ST-elevation MI (STEMI) on hospital admission, patients undergoing more than 1 PCI procedure during the admission, requiring multiple MCS devices during index hospitalization, or undergoing PCI and MCS on different days. Although single-PCI procedures were selected to exclude patients returning for PCI complications during the same admission, this may have excluded some high-risk procedures for left main or multivessel disease treatment that were staged during the same hospitalization. This likely excluded some but not most of the left main interventions, which are customarily treated first with MCS, and when staging is required, often it is done during a readmission, and therefore, these patients would be included in the population studied. The patient flowchart with is in Figure patient for this were and from approval The clinical outcomes of the study were in-hospital survival, cardiogenic shock, all and or bleeding requiring transfusion, and acute kidney injury included in Appendix during the index hospitalization at the PCI clinical outcomes were identified during the hospitalization or discharge but were not coded on The use of ICD Revision and ICD-10 codes to and in administrative have been N D V of myocardial infarction in administrative a PubMed Scopus Google H B CI A of and ICD-10 administrative in clinical in a coded PubMed Scopus Google Scholar outcomes included the index hospital and costs. A was a and the was by the We compared the clinical outcomes of patients treated with Impella versus IABP. or tests and tests were used to differences in demographic and clinical characteristics, and differences were propensity were to control for differences in characteristics, procedure characteristics, and in-hospital between the Impella and IABP treatment The propensity to be treated with Impella or IABP was using based on the admission hospital of hospital and on admission, including acute multivessel PCI, and In the propensity included the procedure intravascular total and in-hospital K and the of the propensity differences were and after propensity adjustment, of the propensity were (Supplementary Figure and the of the was We and propensity-adjusted outcomes during index hospitalization. The were using or tests and using and 95% confidence tests were used to differences in and costs. outcomes were using and costs were using were for the propensity as as selected on admission multivessel PCI, and acute and as or with 95% The for propensity adjustment using propensity was a The was at an adjustment for were using major from the of and cardiogenic shock as on when it have been on admission, we to the of the results by first patients with and the and cardiogenic The of these was to evaluate outcomes by treatment by cardiogenic shock as major as complications than on admission for high-risk PCI of in-hospital we a that included patient characteristics, and treatment in the propensity-adjusted The of the study in analysis, the or the to the The to all the in the study and all the and provided for the of the and to the for From April 2016 to June 2019, a total of 48,179 patients were treated with Impella or IABP MCS at 304 hospitals in the United among these, we identified 2,156 patients undergoing nonemergent high-risk PCI, including patients treated with Impella and patients treated with IABP (Supplementary Figure 1). and clinical included in Appendix are in adjustment, Impella patients were more likely to be with more multivessel PCI, and coronary total than patients with IABP. with IABP were more more acute at PCI, and and use 1). differences and after propensity adjustment, with of the propensity are in Figure between were after propensity The for the propensity was and = = type of hospital or with or in in Appendix and in Appendix procedures exclude left main coronary total Mechanical = IABP = intra-aortic balloon = myocardial PCI = percutaneous coronary are or differences were and after propensity with with kidney and or with or in in Appendix and in Appendix exclude left main in a = IABP = intra-aortic balloon = myocardial PCI = percutaneous coronary intervention. are or differences were and after propensity with with kidney and The in-hospital survival was with Impella than the IABP vs 95% CI to of MI and cardiogenic shock were with Impella than the IABP were differences between in the of stroke, or After adjustment, patients with Impella improved survival (OR 1.55, 95% CI 1.02 to 2.36) and of MI (OR 0.29, 95% CI 0.18 to 0.46) and cardiogenic shock (OR 0.54, 95% CI 0.39 to than IABP were differences in the of stroke, bleeding requiring transfusion, or between the treatment however, the of in the Impella was after risk adjustment than the vs and in-hospital clinical Impella versus = = requiring kidney = intra-aortic balloon MI = myocardial = myocardial = myocardial outcomes were using or tests and using and 95% outcomes were using for the propensity as as selected on The with 95% CI are The was at an adjustment for in a IABP = intra-aortic balloon MI = myocardial = myocardial = myocardial outcomes were using or tests and using and 95% outcomes were using for the propensity as as selected on The with 95% CI are The was at an adjustment for The first patients with for as on admission (Supplementary Figure with survival with Impella than with IABP vs p = as as improved of and cardiogenic shock were differences in stroke, or between groups. After adjustment, the survival was with Impella (OR 95% CI to p = the in and cardiogenic shock of in-hospital clinical = = requiring kidney or = = requiring kidney were as in as in in a were as in as in We a that patients with or cardiogenic shock as as a than on admission (Supplementary Figure survival vs 95% CI to and less vs 95% CI to in the Impella were differences in the of stroke, or between groups. was by approximately days with Impella in the population days with Impella vs days with a that was to approximately days but after adjustment days with Impella vs days with the index hospitalization costs with Impella were than with IABP and in the population Impella costs were with Impella vs IABP, p in the and index hospital costs were in (Supplementary and Impella versus = = = = = length of stay outcomes were using outcomes were using in a = length of stay outcomes were using outcomes were using are in of the propensity-adjusted population identified the in-hospital complications as of in-hospital cardiogenic shock, stroke, and bleeding requiring cardiogenic shock after PCI was the of in-hospital mortality (OR 95% CI to 1). This of patients undergoing nonemergent MCS high-risk PCI that Impella support is associated with a in survival, a in and a in cardiogenic shock, with in the of stroke, bleeding requiring transfusion, or to evaluate the of the and major from the in the treated with Impella-supported high-risk PCI in-hospital survival and outcomes and at the of index hospital costs compared with IABP. cardiogenic shock after PCI was the of in-hospital The of with MCS devices during PCI are to prevent hemodynamic enable and clinical The PROTECT II trial demonstrated a in the of stroke, or the of at 90 days with Impella 2.5 compared with IABP among patients the MCS device WW Kleiman NS Moses J Henriques JP Dixon S Massaro J Palacios I Maini B Mulukutla S Dzavík V Popma J Douglas PS Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study.Circulation. 2012; 126: 1717-1727Crossref PubMed Scopus (516) Google Scholar In a analysis, Impella use was an of from major adverse events (OR 95% CI to and major adverse cardiac and events (OR 95% CI to at 90 days after the Kini AS Sharma Henriques JP Dixon SR Massaro JM Palacios I Popma Ohman M O'Neill WW of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump on clinical outcomes in patients undergoing high-risk percutaneous coronary intervention the PROTECT II randomized J Cardiol. PubMed Scopus Google Scholar to patients complete H A O'Neill W Moses J Kleiman N Dixon S Palacios I Ohman Popma The of left ventricular support in patients with reduced left ventricular undergoing an From the randomized Cardiovasc Interv. 2019; PubMed Scopus Google Scholar in a contemporary population are with and the PROTECT II trial results, however, large-scale studies of Impella use for including cardiogenic shock, and high-risk PCI, and in acute MI that in-hospital outcomes with Impella than AP Spertus JA Curtis JP Desai N Masoudi FA Bach RG McNeely C Al-Badarin F House JA Kulkarni H Rao SV. The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support.Circulation. 2020; 141: 273-284Crossref PubMed Scopus (174) Google SS Ross JS Mortazavi BJ Hurley NC Krumholz HM Curtis JP Berkowitz A Masoudi FA Messenger JC Parzynski CS Ngufor C Girotra S Amin AP Shah ND Desai NR. 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.JAMA. 2020; 323: 734-745Crossref PubMed Scopus (162) Google Scholar differences in outcomes of the previous study using the same PHD to the population of patients from a that Impella approval to patient and from the of clinical included in the study AP Spertus JA Curtis JP Desai N Masoudi FA Bach RG McNeely C Al-Badarin F House JA Kulkarni H Rao SV. The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support.Circulation. 2020; 141: 273-284Crossref PubMed Scopus (174) Google Scholar In was to use the PHD to real-world practice on a clinical in a to Food and Drug of using propensity-adjusted and to and of claims In this more results the of Impella use compared with IABP for high-risk PCI of the of Impella are the of in-hospital cardiogenic shock with Impella compared with IABP, which was the identified of mortality in In not an risk of or bleeding requiring with Impella compared with IABP. with a bleeding risk with percutaneous ventricular assist devices compared with M W P H S P C and trial percutaneous ventricular assist devices versus intra-aortic balloon pump during high-risk percutaneous coronary intervention or cardiogenic J Cardiol. PubMed Scopus Google Scholar in bleeding in study are with of have the in contemporary practice in are to the of and bleeding to in-hospital with an approximately mortality risk and bleeding an approximately mortality risk based on of contemporary including use of MCS, is with the of clinical practice and Although Impella use reduced index index hospitalization costs with as was using AP Spertus JA Curtis JP Desai N Masoudi FA Bach RG McNeely C Al-Badarin F House JA Kulkarni H Rao SV. The evolving landscape of Impella use in the United States among patients undergoing percutaneous coronary intervention with mechanical circulatory support.Circulation. 2020; 141: 273-284Crossref PubMed Scopus (174) Google Scholar and in the PROTECT II study with Impella vs with IABP, p D de G Palacios I Dixon S Maini B O'Neill W A of hemodynamic support for high-risk patients undergoing a percutaneous coronary Drug Google Scholar and costs were for after 90 the total hospital were similar for Impella and IABP vs p = that the initial may be at 90 based on improved and less use of D de G Palacios I Dixon S Maini B O'Neill W A of hemodynamic support for high-risk patients undergoing a percutaneous coronary Drug Google Scholar study be in the of the of large claims for the of than for of treatment and the for the The for and the to use MCS and the type were determined by the to the for high-risk PCI. include across of and for use or or coronary or disease hemodynamic or and and of which can to in the of IABP versus Impella and We population to undergoing single-PCI procedures to exclude PCI complications during the same this excluded some not high-risk patients with left main or multivessel disease treatment that were staged during the same hospitalization. The a of high-risk patients treated with Impella in a and of patients treated with IABP. Although the study and to the of these these not the for therefore, this study be in the of these on the of from and and for and from and on the of and and and of to with

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