Curr Cardiol Rep (2014) 16:544 DOI 10.1007/s11886-014-0544-x
MANAGEMENT OF ACUTE CORONARY SYNDROMES (R GULATI, SECTION EDITOR)
Use of Left Ventricular Support Devices During Acute Coronary Syndrome and Percutaneous Coronary Intervention Jon Spiro & Sagar N. Doshi
Published online: 19 October 2014 # Springer Science+Business Media New York 2014
Abstract In an effort to improve outcomes in percutaneous coronary intervention (PCI), percutaneous ventricular assist devices (PVADs) have been investigated in (1) high-risk PCI, (2) acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) and (3) in AMI without CS. PCI has become an increasing complex due to an ageing population with complex disease and the frequent presence of impaired LV function. Patients undergoing high-risk PCI in these circumstances are prone to acute cardiovascular collapse. Additionally, mortality in AMI complicated by CS remains high. Lastly, LV support during AMI may reduce infarct size and therefore preserve LV function. At present, four commercially available devices exist: intra-aortic balloon pump counterpulsation (IABP), Impella, TandemHeart and extracorporeal membrane oxygenation (ECMO). These devices are employed in an effort to increase cardiac output, mean arterial pressure (MAP) and coronary perfusion and to reduce pulmonary capillary wedge pressure (PCWP). The mechanism of action differs with each device, and there are advantages and disadvantages. In this update, we discuss recent data describing the use of PVADs to support patients with AMI with or without cardiogenic shock and during high-risk PCI. We focus on the unique features of each device, highlighting strengths, weaknesses and frequently encountered complications, which may be important when tailoring the most appropriate PVAD therapy to an individual patient’s need.
This article is part of the Topical Collection on Management of Acute Coronary Syndromes J. Spiro : S. N. Doshi (*) Department of Cardiology, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham B15 2WB, UK e-mail: [email protected]
Keywords Intra-aortic balloon counterpulsation . TandemHeart . Impella . Extracorporeal membrane oxygenation . Percutaneous coronary intervention . Cardiogenic shock . Acute coronary syndrome
Introduction Percutaneous coronary intervention (PCI) among patients with severe LV systolic dysfunction, acute myocardial infarction (AMI) with hemodynamic instability, single remaining conduit or unprotected left main coronary artery (LMCA) may precipitate profound cardiovascular collapse. Once established, circulatory collapse will encourage multi-organ dysfunction and systemic inflammatory response syndrome [1], both of which predict mortality [2]. Once multi-organ dysfunction occurs, simply increasing cardiac output alone may be insufficient to prevent further decline. Consequently, there exists a desire to provide hemodynamic support among these patients, either to correct or prevent circulatory collapse. At present, four commercially available percutaneous ventricular assist devices (PVADs) exist: (1) intra-aortic balloon pump counterpulsation (IABP), (2) Impella (Abiomed, Danvers, MA), (3) extracorporeal membrane oxygenation (ECMO) and (4) TandemHeart (CardiacAssist, Inc., Pittsburgh, PA). Traditionally, mechanical hemodynamic support has been provided with IABP. However, the use of IABP has failed to demonstrate consistent benefit. Indeed, mortality among patients with AMI complicated by cardiogenic shock (CS) remains disappointingly high [3, 4]. Devices that afford greater hemodynamic support, such as Impella, TandemHeart and ECMO, are therefore appealing. Whether increased cardiac support translates to improved clinical outcome remains unclear. In addition, ease of use, cost and safety must also be taken into consideration when
544, Page 2 of 9
choosing a PVAD in a given situation. This update will discuss the recent data concerning PVADs in high-risk PCI and AMI and comment on the strengths and weaknesses of each device.
Curr Cardiol Rep (2014) 16:544
patients with acute anterior STEMI to primary PCI with or without IABP. No significant difference was observed in either mean infarct size, the primary end point, or in mortality, the secondary end point, at 6 months. AMI with CS
A. Intra-Aortic Balloon Pump Counterpulsation (IABP)
In early studies, IABP in AMI following thrombolytic therapy [6] or coronary angioplasty [7], was associated with lower rates of infarct-related vessel occlusion and fewer adverse clinical events compared to those who were managed without IABP. However, in a recent meta-analysis [8•], involving 7 randomised trials and a total of 1,009 ST-segment elevation MI (STEMI) patients, the use of IABP was not associated with improved 30-day survival nor any improvement in LV function. Indeed, IABP was associated with a 2 % greater absolute risk of stroke (p=0.03) and 6 % greater risk of bleeding (p= 0.02). The more recent CRISP AMI trial [9] randomised 337
Until recently, IABP insertion had received a class I recommendation in AHA/ACC guidelines for CS complicating AMI [10]. Recently, four meta-analyses have reviewed the use of IABP in this setting and have challenged this recommendation. The Cochrane Database systematic review [11], that included 8 randomised control trials (105 patients with IABP) demonstrated no survival benefit for IABP when used in patients with CS and AMI. In contrast, Bahekar et al. [12] analysed 6 cohorts containing 24,541 patients with IABP and reported a 28 % (p4.5
+ +++ +++++ + ++ ++++ 7–9F femoral artery 12–13F femoral artery 21F subclavian
+++++ +++++ 18–31F inflow right atrium
Cannula implantation technique Ease of implantation Pump mechanism Time taken to implant (min) Anticoagulation Hemolysis Contraindications
Seldinger
Seldinger
Surgical or Seldinger
++++ Pneumatic 10 No 0 Significant AR/AS, severe sepsis, coagulopathy + +
Risk of limb ischemia Bleeding risk
+++ Axial 11–25 Yes ++++ PVD, LV thrombus, VSD, severe AS
++++ ++++ 21F inflow left atrium (TS) 15/17F outflow femoral artery Surgical Surgical, trans-septal puncture ++ + Axial Centrifugal 10–15 25–65 Yes Yes ++++ ++ LV thrombus, VSD, PVD, RV failure severe AS
+ Centrifugal 10–15 Yes +++ PVD, contraindication to anticoagulation
++ +
0 ++
++++ ++++
+++ +++
TS trans-septal puncture, CO cardiac output, CPO cardiac power output, AR aortic regurgitation, AS aortic stenosis, PVD peripheral vascular disease
The divergent observations from these large meta-analyses require some explanation. In the meta-analysis by Bahekar et al. [12], there was no separation of those receiving thrombolysis and those treated by PCI. The apparent reduction in mortality in patients receiving thrombolysis may be explained by confounding influences and selection bias; patients receiving thrombolysis were younger, more often male and sicker patients deemed ‘too ill’ may have been excluded. Thus, heterogeneity within the study populations, non-stratification with regard to reperfusion strategy and publication bias may have confounded these data. The recently reported IABP-SHOCK II trial [14•] attempted to address some of these potential confounders. In this large, prospective, randomised, multicentre trial, 600 patients with CS were randomised to IABP (301 patients) or no IABP (299 patients) with the majority (95.8 %) of patients receiving early revascularization with PCI. IABP failed to
Table 2 Hemodynamic effects of the PVADs, based on Werdan et al. [52] IABP Impella TandemHeart ECMO Afterload Cardiac output Coronary perfusion LV pre-load PCWP Peripheral tissue perfusion
⬇ ⬆ ⬆ ⬇ ⬇ −
− ⬆⬆ ⬆ ⬇ ⬇⬇ ⬆
⬆ ⬆⬆ Unknown ⬇⬇ ⬇⬇ ⬆
⬆ ⬆⬆ Unknown ⬇⬇ ⬇⬇ ⬆
improve all-cause mortality, the primary endpoint, either at 30 days (39.7 % IABP vs 41.3 % control; p=0.69) or at 12 months (52 % IABP vs 51 % control, p=0.91) [15]. However, with
MANAGEMENT OF ACUTE CORONARY SYNDROMES (R GULATI, SECTION EDITOR)
Use of Left Ventricular Support Devices During Acute Coronary Syndrome and Percutaneous Coronary Intervention Jon Spiro & Sagar N. Doshi
Published online: 19 October 2014 # Springer Science+Business Media New York 2014
Abstract In an effort to improve outcomes in percutaneous coronary intervention (PCI), percutaneous ventricular assist devices (PVADs) have been investigated in (1) high-risk PCI, (2) acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) and (3) in AMI without CS. PCI has become an increasing complex due to an ageing population with complex disease and the frequent presence of impaired LV function. Patients undergoing high-risk PCI in these circumstances are prone to acute cardiovascular collapse. Additionally, mortality in AMI complicated by CS remains high. Lastly, LV support during AMI may reduce infarct size and therefore preserve LV function. At present, four commercially available devices exist: intra-aortic balloon pump counterpulsation (IABP), Impella, TandemHeart and extracorporeal membrane oxygenation (ECMO). These devices are employed in an effort to increase cardiac output, mean arterial pressure (MAP) and coronary perfusion and to reduce pulmonary capillary wedge pressure (PCWP). The mechanism of action differs with each device, and there are advantages and disadvantages. In this update, we discuss recent data describing the use of PVADs to support patients with AMI with or without cardiogenic shock and during high-risk PCI. We focus on the unique features of each device, highlighting strengths, weaknesses and frequently encountered complications, which may be important when tailoring the most appropriate PVAD therapy to an individual patient’s need.
This article is part of the Topical Collection on Management of Acute Coronary Syndromes J. Spiro : S. N. Doshi (*) Department of Cardiology, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham B15 2WB, UK e-mail: [email protected]
Keywords Intra-aortic balloon counterpulsation . TandemHeart . Impella . Extracorporeal membrane oxygenation . Percutaneous coronary intervention . Cardiogenic shock . Acute coronary syndrome
Introduction Percutaneous coronary intervention (PCI) among patients with severe LV systolic dysfunction, acute myocardial infarction (AMI) with hemodynamic instability, single remaining conduit or unprotected left main coronary artery (LMCA) may precipitate profound cardiovascular collapse. Once established, circulatory collapse will encourage multi-organ dysfunction and systemic inflammatory response syndrome [1], both of which predict mortality [2]. Once multi-organ dysfunction occurs, simply increasing cardiac output alone may be insufficient to prevent further decline. Consequently, there exists a desire to provide hemodynamic support among these patients, either to correct or prevent circulatory collapse. At present, four commercially available percutaneous ventricular assist devices (PVADs) exist: (1) intra-aortic balloon pump counterpulsation (IABP), (2) Impella (Abiomed, Danvers, MA), (3) extracorporeal membrane oxygenation (ECMO) and (4) TandemHeart (CardiacAssist, Inc., Pittsburgh, PA). Traditionally, mechanical hemodynamic support has been provided with IABP. However, the use of IABP has failed to demonstrate consistent benefit. Indeed, mortality among patients with AMI complicated by cardiogenic shock (CS) remains disappointingly high [3, 4]. Devices that afford greater hemodynamic support, such as Impella, TandemHeart and ECMO, are therefore appealing. Whether increased cardiac support translates to improved clinical outcome remains unclear. In addition, ease of use, cost and safety must also be taken into consideration when
544, Page 2 of 9
choosing a PVAD in a given situation. This update will discuss the recent data concerning PVADs in high-risk PCI and AMI and comment on the strengths and weaknesses of each device.
Curr Cardiol Rep (2014) 16:544
patients with acute anterior STEMI to primary PCI with or without IABP. No significant difference was observed in either mean infarct size, the primary end point, or in mortality, the secondary end point, at 6 months. AMI with CS
A. Intra-Aortic Balloon Pump Counterpulsation (IABP)
In early studies, IABP in AMI following thrombolytic therapy [6] or coronary angioplasty [7], was associated with lower rates of infarct-related vessel occlusion and fewer adverse clinical events compared to those who were managed without IABP. However, in a recent meta-analysis [8•], involving 7 randomised trials and a total of 1,009 ST-segment elevation MI (STEMI) patients, the use of IABP was not associated with improved 30-day survival nor any improvement in LV function. Indeed, IABP was associated with a 2 % greater absolute risk of stroke (p=0.03) and 6 % greater risk of bleeding (p= 0.02). The more recent CRISP AMI trial [9] randomised 337
Until recently, IABP insertion had received a class I recommendation in AHA/ACC guidelines for CS complicating AMI [10]. Recently, four meta-analyses have reviewed the use of IABP in this setting and have challenged this recommendation. The Cochrane Database systematic review [11], that included 8 randomised control trials (105 patients with IABP) demonstrated no survival benefit for IABP when used in patients with CS and AMI. In contrast, Bahekar et al. [12] analysed 6 cohorts containing 24,541 patients with IABP and reported a 28 % (p4.5
+ +++ +++++ + ++ ++++ 7–9F femoral artery 12–13F femoral artery 21F subclavian
+++++ +++++ 18–31F inflow right atrium
Cannula implantation technique Ease of implantation Pump mechanism Time taken to implant (min) Anticoagulation Hemolysis Contraindications
Seldinger
Seldinger
Surgical or Seldinger
++++ Pneumatic 10 No 0 Significant AR/AS, severe sepsis, coagulopathy + +
Risk of limb ischemia Bleeding risk
+++ Axial 11–25 Yes ++++ PVD, LV thrombus, VSD, severe AS
++++ ++++ 21F inflow left atrium (TS) 15/17F outflow femoral artery Surgical Surgical, trans-septal puncture ++ + Axial Centrifugal 10–15 25–65 Yes Yes ++++ ++ LV thrombus, VSD, PVD, RV failure severe AS
+ Centrifugal 10–15 Yes +++ PVD, contraindication to anticoagulation
++ +
0 ++
++++ ++++
+++ +++
TS trans-septal puncture, CO cardiac output, CPO cardiac power output, AR aortic regurgitation, AS aortic stenosis, PVD peripheral vascular disease
The divergent observations from these large meta-analyses require some explanation. In the meta-analysis by Bahekar et al. [12], there was no separation of those receiving thrombolysis and those treated by PCI. The apparent reduction in mortality in patients receiving thrombolysis may be explained by confounding influences and selection bias; patients receiving thrombolysis were younger, more often male and sicker patients deemed ‘too ill’ may have been excluded. Thus, heterogeneity within the study populations, non-stratification with regard to reperfusion strategy and publication bias may have confounded these data. The recently reported IABP-SHOCK II trial [14•] attempted to address some of these potential confounders. In this large, prospective, randomised, multicentre trial, 600 patients with CS were randomised to IABP (301 patients) or no IABP (299 patients) with the majority (95.8 %) of patients receiving early revascularization with PCI. IABP failed to
Table 2 Hemodynamic effects of the PVADs, based on Werdan et al. [52] IABP Impella TandemHeart ECMO Afterload Cardiac output Coronary perfusion LV pre-load PCWP Peripheral tissue perfusion
⬇ ⬆ ⬆ ⬇ ⬇ −
− ⬆⬆ ⬆ ⬇ ⬇⬇ ⬆
⬆ ⬆⬆ Unknown ⬇⬇ ⬇⬇ ⬆
⬆ ⬆⬆ Unknown ⬇⬇ ⬇⬇ ⬆
improve all-cause mortality, the primary endpoint, either at 30 days (39.7 % IABP vs 41.3 % control; p=0.69) or at 12 months (52 % IABP vs 51 % control, p=0.91) [15]. However, with
