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William W Oneill - One of the best experts on this subject based on the ideXlab platform.
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tct 27 left ventricular function following higher risk percutaneous coronary intervention performed with Hemodynamic Support
Journal of the American College of Cardiology, 2018Co-Authors: Juan J Russo, Magnus E Ohman, William W Oneill, Darshan Doshi, Dimitrios Karmpaliotis, Manish Parikh, Ziad A Ali, Martin B Leon, Jeffrey W MosesAbstract:In contrast to coronary artery bypass grafting, there is a paucity of published data on the effect of percutaneous coronary intervention (PCI) among patients with ischemic cardiomyopathy and severe left ventricular systolic dysfunction (LVSD). We assessed the change in left ventricular ejection
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the role of impella for Hemodynamic Support in patients with aortic stenosis
Current Treatment Options in Cardiovascular Medicine, 2018Co-Authors: Vikas Singh, Igor F Palacios, Rodrigo Mendirichaga, Ignacio Inglessisazuaje, William W OneillAbstract:The goal of this review is to discuss the effects of Impella (Abiomed, Danvers, MA), to Support in the Hemodynamics of patients with severe aortic stenosis, and to explore the clinical scenarios in which the use of Impella may be beneficial in this setting. The management of patients with severe aortic stenosis who go on to develop left ventricular failure and cardiogenic shock remains an important clinical challenge associated with increased morbidity and mortality. Once considered a relative contraindication, the use of Impella in severe aortic stenosis has now been proven feasible and demonstrated promising results in selected high-risk patients. The use of Impella to provide Hemodynamic Support maybe considered in patients with aortic stenosis in cardiogenic shock or those with severe left ventricular dysfunction and CAD who require high-risk PCI and or balloon aortic valvuloplasty. Impella is also an attractive option in selected cases of Hemodynamic collapse during TAVR.
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patients with 3 vessel coronary artery disease and impaired ventricular function undergoing pci with impella 2 5 Hemodynamic Support have improved 90 day outcomes compared to intra aortic balloon pump a sub study of the protect ii trial
Journal of Interventional Cardiology, 2015Co-Authors: Jason C Kovacic, Joseph M Massaro, William W Oneill, M Annapoorna D Kini, M Subhash D Banerjee, M George D Dangas, M Roxana D Mehran, M Jeffrey D Popma, K Samin M D SharmaAbstract:Objectives To evaluate the efficacy of Hemodynamic Support using Impella 2.5 (IR2.5) vs intra-aortic balloon pump (IABP) in patients with 3-vessel coronary artery disease (3VD). Background PROTECT II demonstrated favorable 90-day outcomes in patients with impaired LVEF and left main or 3VD undergoing PCI with Hemodynamic Support with IR2.5 compared to IABP. It is unclear if this was due to a specific benefit in a patient sub-population and if certain patients may derive particular benefit from PCI with IR2.5 Support. Methods Patients in PROTECT II were stratified upon enrollment into the left main/last patent vessel or 3VD subgroups and randomized to IR2.5 or IABP within those groups. Patients in the 3VD substratum were required to have LVEF ≤30%. Results Among the 3VD subgroup (n = 325 patients; IR2.5 167, IABP 158) patients were well matched, except for prior heart failure or CABG, which were more common in the IR2.5 group (both P ≤ 0.01). Mean number of lesions treated was 3.0 ± 1.5 vs. 2.9 ± 1.4 (P = 0.61). At 30 days after PCI, patients that received IR2.5 compared to IABP Support trended toward a reduction in incidence of major adverse events (MAE): 32.9% vs. 42.4% (P = 0.078). At 90 days after PCI, there was a significant difference favoring IR2.5 for incidence of MAE: 39.5% vs. 51.0% (P = 0.039), with this effect being consistent across multiple clinical subgroups. Use of IR2.5 was an independent predictor of improved 90-day outcomes. Conclusions Patients with 3VD and reduced LVEF show improved outcomes when PCI is performed with IR2.5 Hemodynamic Support. (J Interven Cardiol 2015;28:32–40)
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tct 445 patients with 3 vessel coronary artery disease and impaired lvef undergoing pci with impella 2 5 Hemodynamic Support have improved 90 day outcomes compared to intra aortic balloon pump a substudy of the protect ii trial
Journal of the American College of Cardiology, 2013Co-Authors: Jason C Kovacic, George Dangas, Annapoorna Kini, Jeffrey J Popma, William W Oneill, Subhash Banerjee, Roxana Mehran, Samin K SharmaAbstract:PROTECT II demonstrated a trend of improved outcomes in patients with impaired LVEF and left main or 3-vessel disease (3VD) undergoing PCI with Hemodynamic Support using Impella 2.5 (IR2.5) or intra-aortic balloon pump (IABP). However, it is unclear if this trend was due to a specific benefit in a
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a value based analysis of Hemodynamic Support strategies for high risk heart failure patients undergoing a percutaneous coronary intervention
American health & drug benefits, 2013Co-Authors: David Gregory, Simon R Dixon, Igor F Palacios, Brijeshwar Maini, Dennis J Scotti, Gregory De Lissovoy, William W OneillAbstract:BACKGROUND The economic burden of heart disease is heavy and growing. As advanced technologies for treating heart disease become available, decision makers need to be able to assess the relative value of such options against existing standards of care. OBJECTIVES To compare the clinical and economic benefits of a percutaneous ventricular assist device (pVAD) versus an intra-aortic balloon pump (IABP) observed during the 90-day duration of the PROTECT II clinical trial, and to supplement these findings with a simulation of the longer-term value of this technology through the use of a Markov model to estimate the incremental cost-effectiveness of a pVAD relative to an IABP, in terms of quality-adjusted life-years (QALYs). METHODS Hospital bills were collected for patients enrolled in the PROTECT II trial who received Hemodynamic Support for high-risk percutaneous coronary intervention (PCI) provided by a pVAD (Impella 2.5) versus a conventional IABP during a 90-day episode of care (EOC). Length of stay, charges, and costs were analyzed for the index admissions, intensive care unit confinements, readmissions, and overall EOC. In addition, a probabilistic Markov model was used to project these parameters and their impact on a patient's quality of life for up to 10 years in relation to a pVAD versus an IABP. RESULTS Hospital costs for the index admission were lower for the IABP compared with the pVAD ($33,684 vs $47,667; P <.001), whereas readmission length of stay and costs were lower for the pVAD versus the IABP (5 days vs 7 days; and $11,007 vs $21,834, respectively; P <.001). The total 90-day hospital charges were similar for the pVAD and the IABP ($172,564 vs $172,758, respectively; P = .785); however, the total 90-day EOC cost was lower for the IABP than for the pVAD ($44,032 vs $53,171, respectively; P <.001). The median hospital days for the entire EOC were 7 days for the pVAD versus 9 days for the IABP (P = .008). Critical care stays were considerably shorter for a pVAD than for an IABP on readmissions (3.88 days vs 7.00 days; P = .145). Reduction in major adverse cardiovascular and cerebrovascular events resulted in a projected gain of 0.26 QALYs over 10 years, yielding an incremental cost-effectiveness ratio of $39,389/QALY. CONCLUSIONS For high-risk patients with advanced heart failure undergoing PCI, the new pVAD reduced major adverse events, critical care and readmission length of stay, and readmission cost over the 90-day EOC, and was determined to be cost-effective over the long-term. These findings can assist decision makers in forming value-based judgments with regard to new Hemodynamic Support strategies.
Simon R Dixon - One of the best experts on this subject based on the ideXlab platform.
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the cvad registry for percutaneous temporary Hemodynamic Support a prospective registry of impella mechanical circulatory Support use in high risk pci cardiogenic shock and decompensated heart failure
American Heart Journal, 2017Co-Authors: George W Vetrovec, Simon R Dixon, Jeffrey J Popma, Brijeshwar Maini, M H Anderson, Theodore Schreiber, William Lombardi, Jacob E Moller, Andreas Schafer, Shelley A HallAbstract:Management of patients requiring temporary, mechanical Hemodynamic Support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the availability of the Impella 2.5, CP, 5.0, LD, and RP percutaneous mechanical circulatory Support devices, there is a need for continued surveillance of outcomes. Three factors underline the importance of a registry for these populations. First, large randomized trials of Hemodynamic Support, involving cardiogenic shock, are challenging to conduct. Second, there is increasing interest in the use of registries to provide “real-world” experience and to allow the flexibility to evaluate individual patient uses and outcomes. Third, current, large databases have not captured the specific impact of mechanical Support treatment of cardiogenic shock. The predecessor to the catheter-based ventricular assist devices registry, known as USpella, began in 2009 with paper data acquisition but beginning in 2011 transferred to electronic data capture, enrolling 3,339 patients through 2016. Throughout, registry data have been used to assess the outcomes of Impella therapy, leading to 8 publications and 4 Food and Drug Administration premarket approvals covering multiple indications and Impella devices. Going forward, the registry will continue to assess not only in-hospital outcomes but long-term follow-up to 1 year. In addition, data management will be enhanced to assess quality and clinical experiences. The registry will also provide a mechanism for postmarketing surveillance. This manuscript reviews the ongoing catheter-based ventricular assist devices registry design, management, and contributions of the registry data. The upgraded registry will provide a more robust opportunity to assess acute and late outcomes of current and future device use worldwide. Condensed abstract The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella Hemodynamic Support. The registry has Supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure.
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comparison of the use of Hemodynamic Support in patients 80 years versus patients 80 years during high risk percutaneous coronary interventions from the multicenter protect ii randomized study
American Journal of Cardiology, 2014Co-Authors: Ashish Pershad, Simon R Dixon, Joseph M Massaro, Magnus E Ohman, Neal S Kleiman, Ghassan Fraij, Shukri David, Ali E Denktas, Hadley B Wilson, Pamela S DouglasAbstract:The outcomes of Hemodynamic Support during high-risk percutaneous coronary intervention in the very elderly are unknown. We sought to compare outcomes between the patients ≥80 years versus patients
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impact of Hemodynamic Support with impella 2 5 versus intra aortic balloon pump on prognostically important clinical outcomes in patients undergoing high risk percutaneous coronary intervention from the protect ii randomized trial
American Journal of Cardiology, 2014Co-Authors: George Dangas, Jose P S Henriques, Annapoorna Kini, Samin K Sharma, Bimmer E Claessen, Simon R Dixon, Joseph M Massaro, Igor F Palacios, Jeffrey J Popma, Magnus E OhmanAbstract:A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >8× normal has been previously validated as predictive of subsequent mortality. We examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II [A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI] trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intra-aortic balloon pump (IABP, n = 211) or a left ventricular assist device (Impella, n = 216). All eligible patients per study protocol were included in the analysis. Patient outcomes were compared up to 90 days, the longest available follow-up, on the composite end points of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE = death, stroke, myocardial infarction, and repeat revascularization). At 90 days, the rates of both composite end points were lower in the Impella group compared with the IABP group (MAE, 37% vs 49%, p = 0.014 respectively; MACCE, 22% vs 31%, p = 0.034 respectively). There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio = 0.75 [95% confidence interval 0.61 to 0.92], p = 0.007) and MACCE (odds ratio = 0.76 [95% confidence interval 0.61 to 0.96], p = 0.020) at 90 days postprocedure. In conclusion, Hemodynamic Support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further Supported by multivariate analyses.
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a value based analysis of Hemodynamic Support strategies for high risk heart failure patients undergoing a percutaneous coronary intervention
American health & drug benefits, 2013Co-Authors: David Gregory, Simon R Dixon, Igor F Palacios, Brijeshwar Maini, Dennis J Scotti, Gregory De Lissovoy, William W OneillAbstract:BACKGROUND The economic burden of heart disease is heavy and growing. As advanced technologies for treating heart disease become available, decision makers need to be able to assess the relative value of such options against existing standards of care. OBJECTIVES To compare the clinical and economic benefits of a percutaneous ventricular assist device (pVAD) versus an intra-aortic balloon pump (IABP) observed during the 90-day duration of the PROTECT II clinical trial, and to supplement these findings with a simulation of the longer-term value of this technology through the use of a Markov model to estimate the incremental cost-effectiveness of a pVAD relative to an IABP, in terms of quality-adjusted life-years (QALYs). METHODS Hospital bills were collected for patients enrolled in the PROTECT II trial who received Hemodynamic Support for high-risk percutaneous coronary intervention (PCI) provided by a pVAD (Impella 2.5) versus a conventional IABP during a 90-day episode of care (EOC). Length of stay, charges, and costs were analyzed for the index admissions, intensive care unit confinements, readmissions, and overall EOC. In addition, a probabilistic Markov model was used to project these parameters and their impact on a patient's quality of life for up to 10 years in relation to a pVAD versus an IABP. RESULTS Hospital costs for the index admission were lower for the IABP compared with the pVAD ($33,684 vs $47,667; P <.001), whereas readmission length of stay and costs were lower for the pVAD versus the IABP (5 days vs 7 days; and $11,007 vs $21,834, respectively; P <.001). The total 90-day hospital charges were similar for the pVAD and the IABP ($172,564 vs $172,758, respectively; P = .785); however, the total 90-day EOC cost was lower for the IABP than for the pVAD ($44,032 vs $53,171, respectively; P <.001). The median hospital days for the entire EOC were 7 days for the pVAD versus 9 days for the IABP (P = .008). Critical care stays were considerably shorter for a pVAD than for an IABP on readmissions (3.88 days vs 7.00 days; P = .145). Reduction in major adverse cardiovascular and cerebrovascular events resulted in a projected gain of 0.26 QALYs over 10 years, yielding an incremental cost-effectiveness ratio of $39,389/QALY. CONCLUSIONS For high-risk patients with advanced heart failure undergoing PCI, the new pVAD reduced major adverse events, critical care and readmission length of stay, and readmission cost over the 90-day EOC, and was determined to be cost-effective over the long-term. These findings can assist decision makers in forming value-based judgments with regard to new Hemodynamic Support strategies.
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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, 2012Co-Authors: William W Oneill, Jose P S Henriques, Simon R Dixon, Joseph M Massaro, Igor F Palacios, Brijeshwar Maini, Neal S Kleiman, Jeffrey W Moses, Suresh R Mulukutla, Vladimir DžavikAbstract:Background—Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with Hemodynamic Support may be feasible for these patients. Currently, there is no systematic comparative evaluation of Hemodynamic Support devices for this indication. Methods and Results—We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) Support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior Hemodynamic Support in comparison with IABP, with maximal...
Jose P S Henriques - One of the best experts on this subject based on the ideXlab platform.
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percutaneous mechanical circulatory Support versus intra aortic balloon pump for treating cardiogenic shock meta analysis
Journal of the American College of Cardiology, 2017Co-Authors: Dagmar M Ouweneel, Erlend Eriksen, Melchior Seyfarth, Jose P S HenriquesAbstract:In patients with cardiogenic shock after acute myocardial infarction (AMI), mortality remains high despite advances in treatment. Short-term percutaneous circulatory Support devices provide superior Hemodynamic Support compared with the intra-aortic balloon pump (IABP). American guidelines have
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impact of Hemodynamic Support with impella 2 5 versus intra aortic balloon pump on prognostically important clinical outcomes in patients undergoing high risk percutaneous coronary intervention from the protect ii randomized trial
American Journal of Cardiology, 2014Co-Authors: George Dangas, Jose P S Henriques, Annapoorna Kini, Samin K Sharma, Bimmer E Claessen, Simon R Dixon, Joseph M Massaro, Igor F Palacios, Jeffrey J Popma, Magnus E OhmanAbstract:A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >8× normal has been previously validated as predictive of subsequent mortality. We examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II [A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI] trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intra-aortic balloon pump (IABP, n = 211) or a left ventricular assist device (Impella, n = 216). All eligible patients per study protocol were included in the analysis. Patient outcomes were compared up to 90 days, the longest available follow-up, on the composite end points of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE = death, stroke, myocardial infarction, and repeat revascularization). At 90 days, the rates of both composite end points were lower in the Impella group compared with the IABP group (MAE, 37% vs 49%, p = 0.014 respectively; MACCE, 22% vs 31%, p = 0.034 respectively). There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio = 0.75 [95% confidence interval 0.61 to 0.92], p = 0.007) and MACCE (odds ratio = 0.76 [95% confidence interval 0.61 to 0.96], p = 0.020) at 90 days postprocedure. In conclusion, Hemodynamic Support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further Supported by multivariate analyses.
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tct 67 impact of Hemodynamic Support with impella vs intraaortic balloon counterpulsation on prognostically important ischemic endpoints results from the protect ii trial
Journal of the American College of Cardiology, 2012Co-Authors: George Dangas, Jose P S Henriques, Annapoorna Kini, Samin K Sharma, Kleanthis Theodoropoulos, Gregg W Stone, William O NeillAbstract:Improved Hemodynamic Support may facilitate high risk PCI. The appropriate definition of peri-procedural cardiac enzyme elevation to define a clinically relevant myocardial infarction (MI) is controversial, although the advent of new Q-waves or a CK-MB elevation >8x normal have been previously
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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, 2012Co-Authors: William W Oneill, Jose P S Henriques, Simon R Dixon, Joseph M Massaro, Igor F Palacios, Brijeshwar Maini, Neal S Kleiman, Jeffrey W Moses, Suresh R Mulukutla, Vladimir DžavikAbstract:Background—Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with Hemodynamic Support may be feasible for these patients. Currently, there is no systematic comparative evaluation of Hemodynamic Support devices for this indication. Methods and Results—We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) Support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior Hemodynamic Support in comparison with IABP, with maximal...
Magnus E Ohman - One of the best experts on this subject based on the ideXlab platform.
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tct 27 left ventricular function following higher risk percutaneous coronary intervention performed with Hemodynamic Support
Journal of the American College of Cardiology, 2018Co-Authors: Juan J Russo, Magnus E Ohman, William W Oneill, Darshan Doshi, Dimitrios Karmpaliotis, Manish Parikh, Ziad A Ali, Martin B Leon, Jeffrey W MosesAbstract:In contrast to coronary artery bypass grafting, there is a paucity of published data on the effect of percutaneous coronary intervention (PCI) among patients with ischemic cardiomyopathy and severe left ventricular systolic dysfunction (LVSD). We assessed the change in left ventricular ejection
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comparison of the use of Hemodynamic Support in patients 80 years versus patients 80 years during high risk percutaneous coronary interventions from the multicenter protect ii randomized study
American Journal of Cardiology, 2014Co-Authors: Ashish Pershad, Simon R Dixon, Joseph M Massaro, Magnus E Ohman, Neal S Kleiman, Ghassan Fraij, Shukri David, Ali E Denktas, Hadley B Wilson, Pamela S DouglasAbstract:The outcomes of Hemodynamic Support during high-risk percutaneous coronary intervention in the very elderly are unknown. We sought to compare outcomes between the patients ≥80 years versus patients
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impact of Hemodynamic Support with impella 2 5 versus intra aortic balloon pump on prognostically important clinical outcomes in patients undergoing high risk percutaneous coronary intervention from the protect ii randomized trial
American Journal of Cardiology, 2014Co-Authors: George Dangas, Jose P S Henriques, Annapoorna Kini, Samin K Sharma, Bimmer E Claessen, Simon R Dixon, Joseph M Massaro, Igor F Palacios, Jeffrey J Popma, Magnus E OhmanAbstract:A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >8× normal has been previously validated as predictive of subsequent mortality. We examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II [A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI] trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intra-aortic balloon pump (IABP, n = 211) or a left ventricular assist device (Impella, n = 216). All eligible patients per study protocol were included in the analysis. Patient outcomes were compared up to 90 days, the longest available follow-up, on the composite end points of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE = death, stroke, myocardial infarction, and repeat revascularization). At 90 days, the rates of both composite end points were lower in the Impella group compared with the IABP group (MAE, 37% vs 49%, p = 0.014 respectively; MACCE, 22% vs 31%, p = 0.034 respectively). There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio = 0.75 [95% confidence interval 0.61 to 0.92], p = 0.007) and MACCE (odds ratio = 0.76 [95% confidence interval 0.61 to 0.96], p = 0.020) at 90 days postprocedure. In conclusion, Hemodynamic Support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further Supported by multivariate analyses.
Igor F Palacios - One of the best experts on this subject based on the ideXlab platform.
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the role of impella for Hemodynamic Support in patients with aortic stenosis
Current Treatment Options in Cardiovascular Medicine, 2018Co-Authors: Vikas Singh, Igor F Palacios, Rodrigo Mendirichaga, Ignacio Inglessisazuaje, William W OneillAbstract:The goal of this review is to discuss the effects of Impella (Abiomed, Danvers, MA), to Support in the Hemodynamics of patients with severe aortic stenosis, and to explore the clinical scenarios in which the use of Impella may be beneficial in this setting. The management of patients with severe aortic stenosis who go on to develop left ventricular failure and cardiogenic shock remains an important clinical challenge associated with increased morbidity and mortality. Once considered a relative contraindication, the use of Impella in severe aortic stenosis has now been proven feasible and demonstrated promising results in selected high-risk patients. The use of Impella to provide Hemodynamic Support maybe considered in patients with aortic stenosis in cardiogenic shock or those with severe left ventricular dysfunction and CAD who require high-risk PCI and or balloon aortic valvuloplasty. Impella is also an attractive option in selected cases of Hemodynamic collapse during TAVR.
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impact of Hemodynamic Support with impella 2 5 versus intra aortic balloon pump on prognostically important clinical outcomes in patients undergoing high risk percutaneous coronary intervention from the protect ii randomized trial
American Journal of Cardiology, 2014Co-Authors: George Dangas, Jose P S Henriques, Annapoorna Kini, Samin K Sharma, Bimmer E Claessen, Simon R Dixon, Joseph M Massaro, Igor F Palacios, Jeffrey J Popma, Magnus E OhmanAbstract:A periprocedural myocardial infarction, defined as the advent of new Q-waves or a creatine kinase-MB elevation >8× normal has been previously validated as predictive of subsequent mortality. We examined the effects of using this clinically relevant definition of periprocedural myocardial infarction instead of the original protocol definition on outcomes in the recent PROTECT II [A Prospective, Multi-center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump (IABP) in Patients Undergoing Non Emergent High Risk PCI] trial. In this trial, patients who were undergoing high-risk percutaneous coronary intervention (PCI) were randomized to either an intra-aortic balloon pump (IABP, n = 211) or a left ventricular assist device (Impella, n = 216). All eligible patients per study protocol were included in the analysis. Patient outcomes were compared up to 90 days, the longest available follow-up, on the composite end points of major adverse events (MAE) and major adverse cardiac and cerebral events (MACCE = death, stroke, myocardial infarction, and repeat revascularization). At 90 days, the rates of both composite end points were lower in the Impella group compared with the IABP group (MAE, 37% vs 49%, p = 0.014 respectively; MACCE, 22% vs 31%, p = 0.034 respectively). There were no differences in death or large myocardial infarction between the 2 arms. By multivariable analysis, treatment with Impella as opposed to IABP was an independent predictor for freedom from MAE (odds ratio = 0.75 [95% confidence interval 0.61 to 0.92], p = 0.007) and MACCE (odds ratio = 0.76 [95% confidence interval 0.61 to 0.96], p = 0.020) at 90 days postprocedure. In conclusion, Hemodynamic Support with Impella compared with IABP during high-risk PCI in the PROTECT-II trial resulted in improved event-free survival at 3-month follow-up; this finding was further Supported by multivariate analyses.
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a value based analysis of Hemodynamic Support strategies for high risk heart failure patients undergoing a percutaneous coronary intervention
American health & drug benefits, 2013Co-Authors: David Gregory, Simon R Dixon, Igor F Palacios, Brijeshwar Maini, Dennis J Scotti, Gregory De Lissovoy, William W OneillAbstract:BACKGROUND The economic burden of heart disease is heavy and growing. As advanced technologies for treating heart disease become available, decision makers need to be able to assess the relative value of such options against existing standards of care. OBJECTIVES To compare the clinical and economic benefits of a percutaneous ventricular assist device (pVAD) versus an intra-aortic balloon pump (IABP) observed during the 90-day duration of the PROTECT II clinical trial, and to supplement these findings with a simulation of the longer-term value of this technology through the use of a Markov model to estimate the incremental cost-effectiveness of a pVAD relative to an IABP, in terms of quality-adjusted life-years (QALYs). METHODS Hospital bills were collected for patients enrolled in the PROTECT II trial who received Hemodynamic Support for high-risk percutaneous coronary intervention (PCI) provided by a pVAD (Impella 2.5) versus a conventional IABP during a 90-day episode of care (EOC). Length of stay, charges, and costs were analyzed for the index admissions, intensive care unit confinements, readmissions, and overall EOC. In addition, a probabilistic Markov model was used to project these parameters and their impact on a patient's quality of life for up to 10 years in relation to a pVAD versus an IABP. RESULTS Hospital costs for the index admission were lower for the IABP compared with the pVAD ($33,684 vs $47,667; P <.001), whereas readmission length of stay and costs were lower for the pVAD versus the IABP (5 days vs 7 days; and $11,007 vs $21,834, respectively; P <.001). The total 90-day hospital charges were similar for the pVAD and the IABP ($172,564 vs $172,758, respectively; P = .785); however, the total 90-day EOC cost was lower for the IABP than for the pVAD ($44,032 vs $53,171, respectively; P <.001). The median hospital days for the entire EOC were 7 days for the pVAD versus 9 days for the IABP (P = .008). Critical care stays were considerably shorter for a pVAD than for an IABP on readmissions (3.88 days vs 7.00 days; P = .145). Reduction in major adverse cardiovascular and cerebrovascular events resulted in a projected gain of 0.26 QALYs over 10 years, yielding an incremental cost-effectiveness ratio of $39,389/QALY. CONCLUSIONS For high-risk patients with advanced heart failure undergoing PCI, the new pVAD reduced major adverse events, critical care and readmission length of stay, and readmission cost over the 90-day EOC, and was determined to be cost-effective over the long-term. These findings can assist decision makers in forming value-based judgments with regard to new Hemodynamic Support strategies.
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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, 2012Co-Authors: William W Oneill, Jose P S Henriques, Simon R Dixon, Joseph M Massaro, Igor F Palacios, Brijeshwar Maini, Neal S Kleiman, Jeffrey W Moses, Suresh R Mulukutla, Vladimir DžavikAbstract:Background—Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with Hemodynamic Support may be feasible for these patients. Currently, there is no systematic comparative evaluation of Hemodynamic Support devices for this indication. Methods and Results—We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) Support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior Hemodynamic Support in comparison with IABP, with maximal...