Catheterization and Cardiovascular Interventions 83:E183–E192 (2014)
CORONARY ARTERY DISEASE Original Studies Percutaneous Cardiac Assist Devices Compared with Surgical Hemodynamic Support Alternatives: Cost-Effectiveness in the Emergent Setting Brijeshwar Maini,1 MD, David Gregory,2* MPA, Dennis J. Scotti,3 PhD, MBA, and Larisa Buyantseva,1 MD, MS Objectives: This study evaluates the cost-effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives. Background: Previous research has demonstrated the costeffectiveness of pVAD hemodynamic support for patients undergoing high-risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS). Methods: National utilization and outcome data from the 2010–2011 MedPAR and state-sponsored all-payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (n 5 883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (n 5 305). Results: Discharge survival was greater with pVADs than with surgical alternatives (56% vs. 42%, P < 0.001) and was achieved with a strong trend toward reduced LOS (13.2 and 17.9 days, respectively, P 5 0.055) and a significantly lower cost of the index admission ($90,929 and $144,257, respectively, P < 0.001). Cost-effectiveness analysis based on the national data demonstrated that pVAD achieved improved outcomes at lower cost. Data were also collected for similar patients who underwent protocol-guided pVAD therapy (using Impella 2.5) at PinnacleHealth, between 2009 and 2011 (n 5 30). At this site, the survival rate increased to 60%, length of hospitalization was shortened to 6 days, and admission costs were lowered to $53,850 relative to the surgical alternatives strategy. Conclusions: For patients in CS requiring emergent hemodynamic support, pVAD therapy offers a less invasive alternative that can be deployed sooner, resulting in better outcomes, shorter LOS, lower costs and with no incremental cost, and a survival benefit when compared with traditional surgical hemodynamic support alternatives. PVAD therapy (and Impella 2.5 in particular) is emerging as a dominant strategy for this challenging patient population. VC 2013 Wiley Periodicals, Inc. Key words: angioplasty; cost-effectiveness analysis; pVAD; myocardial infarction; cardiogenic shock; length of stay
1
PinnacleHealth, Harrisburg, Pennsylvania Presscott Associates—A Division of ParenteBeard LLC, Avon, Connecticut 3 Fairleigh Dickinson University, Teaneck, New Jersey 2
Conflict of interest: Dr. Brijeshwar Maini, MD, reported that he or his institution has received research support/speaker honoraria from Abbott Laboratories, InfraReDx, Abiomed and Medtronic. Mr. David Gregory, MPA, reported that he has received consulting fees as an advisor to Abiomed. Dr. Dennis Scotti, PhD, MBA, reported that he has received consulting fees as an advisor to Abiomed. Dr. Larisa Buyantseva, MD, has no disclosures to report. C 2013 Wiley Periodicals, Inc. V
*Correspondence to: David Gregory, Presscott Associates—A Division of ParenteBeard LLC, 21A Arts Center Court, Avon, CT. E-mail: [email protected] Received 2 January 2013; Revision accepted 10 October 2013 DOI: 10.1002/ccd.25247 Published online 15 October 2013 in Wiley Online Library (wileyonlinelibrary.com)
E184
Maini et al.
INTRODUCTION
Cardiogenic shock (CS) is a state of end-organ hypoperfusion. It is the leading cause of death in patients with acute myocardial infarction (AMI) and, despite advances in medical therapy, it is still associated with an in-hospital mortality of approximately 60% [1–5]. Considering that 8–10% of AMI cases are complicated by CS and there are approximately 1,260,000 new and/ or recurrent AMIs in the United States annually, this translates to a potential $1.7 billion in annual expenditures [6]. Because CS is a life-threatening condition, circulatory support is often necessary to stabilize hemodynamics and/or prevent peri-procedural hemodynamic collapse. Numerous circulatory support devices are currently available but each has limitations. The intraaortic balloon pump (IABP) has been the most commonly used device during cardiac revascularization procedures, but its use has been challenged recently as numerous large-scale studies failed to show any clear benefits for high-risk PCI [7,8], AMI without complications of CS [9,10], and AMI complicated by CS [11]. Extracorporeal membrane oxygenation (ECMO) provides more extensive circulatory support but it is associated with high rates of peri-procedural adverse events [12–16]. Left ventricular assist devices (LVADs) also have their place in the treatment of cardiac disease; however, they require invasive surgical procedures for their implantation, take longer to deploy, are associated with high complication rates, and often damage the heart muscle [17–19]. No study has yet demonstrated that LVAD therapy is cost-effective based on conventional definitions of willingness-to-pay criteria [20–24]. In an effort to reduce the invasiveness and periprocedural complications of contemporary circulatory support systems, temporary percutaneous cardiac assist devices (pVADs) such as the Impella family of devices (Abiomed, Danvers, MA) and the TandemHeartTM (CardiacAssist, Pittsburgh, PA) have been developed. In patients with or without CS undergoing a high-risk PCI, the effectiveness of prophylactic circulatory support with Impella 2.5 has been clearly demonstrated with high procedural success, low complication rates, and clinically significant improvements in hemodynamics [25–31]. For example, results from the randomized PROTECT II trial revealed a 22% relative risk reduction of major adverse events in favor of Impella and a 52% reduction in the number of repeat revascularization procedures [31]. These improvements translated into cost efficiencies through shorter length of hospital stay (LOS) and fewer re-hospitalizations for revascularizations and, compared with the IABP, Impella was
shown to be cost-effective for high-risk PCI with an incremental cost-effectiveness ratio (ICER) of $39,389/ QALY, well below the cost threshold for innovative technologies [32,33]. An ICER is a standard economic metric that represents the additional cost of one unit of outcome gained (in this case, a quality-adjusted lifeyear or QALY) by a healthcare intervention or strategy when compared with the next best alternative or standard of care. The ICER threshold is society’s or a payer’s willingness to pay for an intervention. Contemporary studies show the accepted ICER in the U.S. at
CORONARY ARTERY DISEASE Original Studies Percutaneous Cardiac Assist Devices Compared with Surgical Hemodynamic Support Alternatives: Cost-Effectiveness in the Emergent Setting Brijeshwar Maini,1 MD, David Gregory,2* MPA, Dennis J. Scotti,3 PhD, MBA, and Larisa Buyantseva,1 MD, MS Objectives: This study evaluates the cost-effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives. Background: Previous research has demonstrated the costeffectiveness of pVAD hemodynamic support for patients undergoing high-risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS). Methods: National utilization and outcome data from the 2010–2011 MedPAR and state-sponsored all-payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (n 5 883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (n 5 305). Results: Discharge survival was greater with pVADs than with surgical alternatives (56% vs. 42%, P < 0.001) and was achieved with a strong trend toward reduced LOS (13.2 and 17.9 days, respectively, P 5 0.055) and a significantly lower cost of the index admission ($90,929 and $144,257, respectively, P < 0.001). Cost-effectiveness analysis based on the national data demonstrated that pVAD achieved improved outcomes at lower cost. Data were also collected for similar patients who underwent protocol-guided pVAD therapy (using Impella 2.5) at PinnacleHealth, between 2009 and 2011 (n 5 30). At this site, the survival rate increased to 60%, length of hospitalization was shortened to 6 days, and admission costs were lowered to $53,850 relative to the surgical alternatives strategy. Conclusions: For patients in CS requiring emergent hemodynamic support, pVAD therapy offers a less invasive alternative that can be deployed sooner, resulting in better outcomes, shorter LOS, lower costs and with no incremental cost, and a survival benefit when compared with traditional surgical hemodynamic support alternatives. PVAD therapy (and Impella 2.5 in particular) is emerging as a dominant strategy for this challenging patient population. VC 2013 Wiley Periodicals, Inc. Key words: angioplasty; cost-effectiveness analysis; pVAD; myocardial infarction; cardiogenic shock; length of stay
1
PinnacleHealth, Harrisburg, Pennsylvania Presscott Associates—A Division of ParenteBeard LLC, Avon, Connecticut 3 Fairleigh Dickinson University, Teaneck, New Jersey 2
Conflict of interest: Dr. Brijeshwar Maini, MD, reported that he or his institution has received research support/speaker honoraria from Abbott Laboratories, InfraReDx, Abiomed and Medtronic. Mr. David Gregory, MPA, reported that he has received consulting fees as an advisor to Abiomed. Dr. Dennis Scotti, PhD, MBA, reported that he has received consulting fees as an advisor to Abiomed. Dr. Larisa Buyantseva, MD, has no disclosures to report. C 2013 Wiley Periodicals, Inc. V
*Correspondence to: David Gregory, Presscott Associates—A Division of ParenteBeard LLC, 21A Arts Center Court, Avon, CT. E-mail: [email protected] Received 2 January 2013; Revision accepted 10 October 2013 DOI: 10.1002/ccd.25247 Published online 15 October 2013 in Wiley Online Library (wileyonlinelibrary.com)
E184
Maini et al.
INTRODUCTION
Cardiogenic shock (CS) is a state of end-organ hypoperfusion. It is the leading cause of death in patients with acute myocardial infarction (AMI) and, despite advances in medical therapy, it is still associated with an in-hospital mortality of approximately 60% [1–5]. Considering that 8–10% of AMI cases are complicated by CS and there are approximately 1,260,000 new and/ or recurrent AMIs in the United States annually, this translates to a potential $1.7 billion in annual expenditures [6]. Because CS is a life-threatening condition, circulatory support is often necessary to stabilize hemodynamics and/or prevent peri-procedural hemodynamic collapse. Numerous circulatory support devices are currently available but each has limitations. The intraaortic balloon pump (IABP) has been the most commonly used device during cardiac revascularization procedures, but its use has been challenged recently as numerous large-scale studies failed to show any clear benefits for high-risk PCI [7,8], AMI without complications of CS [9,10], and AMI complicated by CS [11]. Extracorporeal membrane oxygenation (ECMO) provides more extensive circulatory support but it is associated with high rates of peri-procedural adverse events [12–16]. Left ventricular assist devices (LVADs) also have their place in the treatment of cardiac disease; however, they require invasive surgical procedures for their implantation, take longer to deploy, are associated with high complication rates, and often damage the heart muscle [17–19]. No study has yet demonstrated that LVAD therapy is cost-effective based on conventional definitions of willingness-to-pay criteria [20–24]. In an effort to reduce the invasiveness and periprocedural complications of contemporary circulatory support systems, temporary percutaneous cardiac assist devices (pVADs) such as the Impella family of devices (Abiomed, Danvers, MA) and the TandemHeartTM (CardiacAssist, Pittsburgh, PA) have been developed. In patients with or without CS undergoing a high-risk PCI, the effectiveness of prophylactic circulatory support with Impella 2.5 has been clearly demonstrated with high procedural success, low complication rates, and clinically significant improvements in hemodynamics [25–31]. For example, results from the randomized PROTECT II trial revealed a 22% relative risk reduction of major adverse events in favor of Impella and a 52% reduction in the number of repeat revascularization procedures [31]. These improvements translated into cost efficiencies through shorter length of hospital stay (LOS) and fewer re-hospitalizations for revascularizations and, compared with the IABP, Impella was
shown to be cost-effective for high-risk PCI with an incremental cost-effectiveness ratio (ICER) of $39,389/ QALY, well below the cost threshold for innovative technologies [32,33]. An ICER is a standard economic metric that represents the additional cost of one unit of outcome gained (in this case, a quality-adjusted lifeyear or QALY) by a healthcare intervention or strategy when compared with the next best alternative or standard of care. The ICER threshold is society’s or a payer’s willingness to pay for an intervention. Contemporary studies show the accepted ICER in the U.S. at
