Effectiveness of Percutaneous VADs for High-Risk PCI
This study investigated the clinical and cost effectiveness of pVADs compared with the use of IABP therapy in cardiogenic shock and high-risk PCI patients. A review of published data demonstrates no conclusive clinical benefit in trial patients treated with pVADs compared with IABP.
Different algorithms have been suggested to assist physicians in deciding when to place a TH or Impella. Most physicians agree that an escalating approach is reasonable. In this approach, patients should initially receive vasopressor agents and an IABP. If a patient fails to stabilize, a TH or Impella can be considered. Use of pVADs has a theoretical benefit for improved left ventricular unloading and improved cardiac output. However, their larger cannulae sizes are associated with a higher rate of vascular complications, bleeding, and hemolysis. It is important that hospitals use this information to establish treatment protocols and payers adjust their coverage policies to reinforce clinician behavior to practice evidence-based medicine. Given clinical evidence and the cost-effectiveness data, use of pVADs as a first-line therapy may not be justified.
The Food and Drug Association (FDA) panel recently decided to reclassify IABP as a class II device because of its proven safety and efficacy profile, while maintaining the TH and Impella 2.5 as class III devices, considering them investigational and requiring a pre-market approval (PMA) study. Furthermore, the American College of Cardiology/American Heart Association guidelines recommend keeping these alternative left ventricular assist devices available for patients in refractory cardiogenic shock.
Gregory et al recently reported that initial inpatient charges are lower with IABP, and provide a sensitivity analysis that quantifies a 10% migration costing the payer an additional $603,415 based on a health plan that consists of approximately 25 million members and an additional $3,017,075 based on a 50% migration. These amounts reflect actual payer-allowed charges.
The same authors published a value-based analysis of hemodynamic support strategies that utilized the PROTECT II study to establish an incremental cost-effectiveness ratio (ICER) for Impella. This model used the composite MAE to make projections; however, given the lack of difference in the individual MAE rates between the two groups, it is difficult to draw conclusions from this analysis. Despite these limitations, the study did confirm a significant reduction in the procedure cost and charge associated with cases that used IABP therapy instead of Impella. While no prospective randomized trial currently exists specifically addressing cost effectiveness, the PROTECT II study is the largest randomized trial to date that studied pVAD versus IABP and the secondary cost analysis of this trial suggest increased cost for the use of a pVAD in a relatively controlled patient population.
Use of pVADs in the high-risk PCI and cardiogenic shock setting does not confer additional clinical benefit over the use of IABP despite the additional costs of the device. Furthermore, use of pVADs does not appear to reduce hospital readmission in this high-risk patient cohort. The use of IABP for cardiogenic shock and high-risk PCI patients should be implemented as a first-line strategy with an escalating approach toward TH or Impella for refractory patients. This methodology can avoid up to $2.5 billion annually of incremental cost to the health-care system.
This study focused only on the TH and Impella 2.5, and not the Impella CP, the Impella 5.0, or the Impella LD. Given that the Impella 5.0 and LD are primarily utilized in the operating room and not in the cardiac catheterization laboratory for the treatment of high-risk PCI patients, inclusion of these devices in this study is unlikely to change the results. The Impella CP is a relatively new device that has not been extensively studied, so therefore it was not included in this study.
This study relied on data from Medicare and did not analyze data from private payers. It is unknown whether the analysis of data from private payers would impact the findings of this study since the majority of the patients who receive this therapy are covered under Medicare.
Furthermore, a univariate analysis was performed between the two groups with regard to the differences in the pVAD and IABP groups. Further details on the clinical characteristics of the two groups were not performed given that patients were identified based on their diagnosis. Physicians may choose a pVAD over an IABP because of a certain clinical situation that may not be necessarily reported in the data reported to Medicare. However, given the diagnosis, and associated modifiers, clinical differences between the two groups may not be that different, but a randomized, controlled trial would be the only way to fully control for this possible confounder.
Discussion
This study investigated the clinical and cost effectiveness of pVADs compared with the use of IABP therapy in cardiogenic shock and high-risk PCI patients. A review of published data demonstrates no conclusive clinical benefit in trial patients treated with pVADs compared with IABP.
Different algorithms have been suggested to assist physicians in deciding when to place a TH or Impella. Most physicians agree that an escalating approach is reasonable. In this approach, patients should initially receive vasopressor agents and an IABP. If a patient fails to stabilize, a TH or Impella can be considered. Use of pVADs has a theoretical benefit for improved left ventricular unloading and improved cardiac output. However, their larger cannulae sizes are associated with a higher rate of vascular complications, bleeding, and hemolysis. It is important that hospitals use this information to establish treatment protocols and payers adjust their coverage policies to reinforce clinician behavior to practice evidence-based medicine. Given clinical evidence and the cost-effectiveness data, use of pVADs as a first-line therapy may not be justified.
The Food and Drug Association (FDA) panel recently decided to reclassify IABP as a class II device because of its proven safety and efficacy profile, while maintaining the TH and Impella 2.5 as class III devices, considering them investigational and requiring a pre-market approval (PMA) study. Furthermore, the American College of Cardiology/American Heart Association guidelines recommend keeping these alternative left ventricular assist devices available for patients in refractory cardiogenic shock.
Gregory et al recently reported that initial inpatient charges are lower with IABP, and provide a sensitivity analysis that quantifies a 10% migration costing the payer an additional $603,415 based on a health plan that consists of approximately 25 million members and an additional $3,017,075 based on a 50% migration. These amounts reflect actual payer-allowed charges.
The same authors published a value-based analysis of hemodynamic support strategies that utilized the PROTECT II study to establish an incremental cost-effectiveness ratio (ICER) for Impella. This model used the composite MAE to make projections; however, given the lack of difference in the individual MAE rates between the two groups, it is difficult to draw conclusions from this analysis. Despite these limitations, the study did confirm a significant reduction in the procedure cost and charge associated with cases that used IABP therapy instead of Impella. While no prospective randomized trial currently exists specifically addressing cost effectiveness, the PROTECT II study is the largest randomized trial to date that studied pVAD versus IABP and the secondary cost analysis of this trial suggest increased cost for the use of a pVAD in a relatively controlled patient population.
Use of pVADs in the high-risk PCI and cardiogenic shock setting does not confer additional clinical benefit over the use of IABP despite the additional costs of the device. Furthermore, use of pVADs does not appear to reduce hospital readmission in this high-risk patient cohort. The use of IABP for cardiogenic shock and high-risk PCI patients should be implemented as a first-line strategy with an escalating approach toward TH or Impella for refractory patients. This methodology can avoid up to $2.5 billion annually of incremental cost to the health-care system.
Study Limitations
This study focused only on the TH and Impella 2.5, and not the Impella CP, the Impella 5.0, or the Impella LD. Given that the Impella 5.0 and LD are primarily utilized in the operating room and not in the cardiac catheterization laboratory for the treatment of high-risk PCI patients, inclusion of these devices in this study is unlikely to change the results. The Impella CP is a relatively new device that has not been extensively studied, so therefore it was not included in this study.
This study relied on data from Medicare and did not analyze data from private payers. It is unknown whether the analysis of data from private payers would impact the findings of this study since the majority of the patients who receive this therapy are covered under Medicare.
Furthermore, a univariate analysis was performed between the two groups with regard to the differences in the pVAD and IABP groups. Further details on the clinical characteristics of the two groups were not performed given that patients were identified based on their diagnosis. Physicians may choose a pVAD over an IABP because of a certain clinical situation that may not be necessarily reported in the data reported to Medicare. However, given the diagnosis, and associated modifiers, clinical differences between the two groups may not be that different, but a randomized, controlled trial would be the only way to fully control for this possible confounder.