Early Impella Support Associated with Increased Survival in Cardiogenic Shock
- This retrospective study evaluated observational data of patients receiving either early or delayed initiation of Impella for the management of acute myocardial infarction complicated by cardiogenic shock (AMICS).
- Receiving mechanical circulatory support (MCS) prior to percutaneous coronary intervention (PCI) compared with post-PCI initiation was associated with a higher survival rate to discharge among AMICS patients.
- Overall survival to discharge for the cohort was 44%.
- Additionally, early initiation of MCS at the first signs of shock and before inotropes, vasopressors, and PCI correlated with a higher rate of survival.
The use of mechanical circulatory support (MCS) in cardiogenic shock (CS) has been consistently shown to correlate with improved survival and assist interventionalists achieve complete revascularization.1,2,3 The use of MCS devices for the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) may also provide hemodynamic support for some patients.4
A retrospective study funded by an educational grant from Abiomed Inc. and published in the American Journal of Cardiology examined the clinical outcomes associated with using Impella 2.5™ or Impella CP® heart pumps for the treatment of AMICS.5 Patients also underwent percutaneous coronary intervention (PCI).
61% of the patient population had a diagnosis of cardiogenic shock (CS). Upon hospital admission, the average left ejection fraction of patients was 25 ± 12%. Approximately 40% of patients had intra-aortic balloon pump support before receiving MCS. Revascularization for these patients occurred, with a median door-to-balloon time of 1.35 hours for patients with STEMI.
Use of inotropes and delaying the initiation of MCS resulted in reduced survival, whereas early initiation of MCS at the first signs of shock was associated with a higher survival rate. The Kaplan-Meier analysis performed for this study (Figure 1) demonstrates the effectiveness of early hemodynamic support in this patient population.
Less than half of the patients (44%) survived to discharge, and hemodynamic profiles prior to MCS among survivors vs nonsurvivors were similar. Survivors, on average, received MCS initiation 1.3 hours earlier after CS onset vs 2.8 hours for nonsurvivors.
The unloading of the left ventricle prior to reperfusion may be partly associated with the improved outcomes of early MCS initiation, according to the authors, leading to increases in cardioprotective signaling and reduction of myocardial damage in AMI.
Also, survivors experienced less ventricular arrhythmia, acidosis, and cardiopulmonary resuscitation. Vascular problems that required surgery were greater amongst survivors. Even though the angiographic success rates were similar between the pre- and post-PCI groups, differences in survival were still noticeable, further demonstrating the observed efficacy of early MCS support.
Appropriate identification of MCS initiation as well as limiting use and duration of inotropes and vasopressors may also be essential for treating AMICS patients effectively. Additionally, a shorter shock-to-support time might be necessary for increasing survival among treated AMICS patients. Physicians should also be well trained in large bore access techniques when using MCS to reduce vascular access complications, hence operator experience may also play a significant role in patient outcomes.
- O'Neill WW, Schreiber T, Wohns DH, et al. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry. J Interv Cardiol. 2014;27(1):1-11.
- Khan MH, Corbett BJ, and Hollenberg SM. Mechanical circulatory support in acute cardiogenic shock. F1000Prime Rep. 2014;6:91.
- Gaudard P, Mourad M, Eliet J, et al. Management and outcome of patients supported with Impella 5.0 for refractory cardiogenic shock. Crit Care. 2015;19:363.
- Atkinson TM, Ohman EM, O'Neill WW, et al. A Practical Approach to Mechanical Circulatory Support in Patients Undergoing Percutaneous Coronary Intervention: An Interventional Perspective. JACC Cardiovasc Interv. 2016;9(9):871-883.
- Basir MB, Schreiber TL, Grines CL, et al. Effect of Early Initiation of Mechanical Circulatory Support on Survival in Cardiogenic Shock. Am J Cardiol. 2016. pii: S0002-9149(16)31937-3.
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
IMPELLA® LEFT-SIDE DEVICES INDICATION & SAFETY INFORMATION
The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.
The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0® and Impella LD® Catheters, in conjunction with the Automated Impella® Controller (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
Important Risk Information for Impella devices
The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*
* This condition is a contraindication for the cardiogenic shock indication only.
POTENTIAL ADVERSE EVENTS
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.
The Impella Connect® transfers the video image of the screen on the Automated Impella® Controller to an authorized remote user. The transmitted image can be viewed by authorized remote users. The users can include the hospital’s clinicians, Abiomed local support staff, and Customer Support Center (CSC) team members.
Impella Connect Precautions
- Impella Connect is not intended to provide real-time information for monitoring patient status on the Automated Impella® Controller.
- During use of the Impella Connect, there will be a delay between when an image appears on the controller screen and when it is displayed at a remote viewing location.
- The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the controller’s alarms.
- During use of the Impella Connect, receipt of the displayed controller information is not confirmed by the Automated Impella® Controller, nor is the delivery of the displayed controller information to the authorized remote users guaranteed.
- The Impella Connect is not designed for use during transport.
- Radiated and conducted electromagnetic interference can affect the performance of the Impella Connect, causing a temporary loss of connectivity. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Any electromagnetic interference related to the Impella Connect will have no impact on any of the controller functional specifications.
- Portable and mobile RF communications equipment can affect medical electrical equipment.
Right-Side Support – Indication & Safety Info.
INDICATIONS FOR USE
The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Important Risk Information for Impella RP
The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter.
POTENTIAL ADVERSE EVENTS
The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.
General Indication and Safety Information
To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/