Impella Mechanical Circulatory Support

Top Cardiogenic Shock Treatment Objectives and Device Options

October 3, 2016

In patients with acute myocardial infarction (AMI), cardiogenic shock (CS) is a primary cause of mortality. According to ACC.org’s “Latest in Cardiology”, AMI with CS presents three main treatment objectives, all of which can be achieved with acute mechanical circulatory support devices:

  1.  Achieve a mean arterial pressure and vital organ perfusion,
  2.  Reduce myocardial oxygen demand via ventricular unloading, and
  3.  Recanalize an occluded coronary vessel to augment myocardial perfusion and minimize burden of myocardial injury.

Hemodynamic support is recommended for patients with CS who fail to improve with medication therapy. Further guidelines suggest the elective insertion of a hemodynamic support device in CS patients as a complementary approach to PCI. While these guidelines may be helpful for some patients, the lack of controlled, randomized trials demonstrating hemodynamic support is worth noting. Intra-aortic balloon pumps (IABPs) are devices that have been rigorously studied for cardiogenic shock, yet their utility in CS is somewhat limited. The Impella CP® from Abiomed has shown some hemodynamic superiority over IABP therapy, with one large study demonstrating a 60% rate of 30-day survival in 117 CS patients.

Read the full article or subscribe to stay informed on the latest high-risk cardiology news and insight.

Protected PCI™ – Indication & Safety Info.

Indication for Use

The Impella 2.5™ System is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 System 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.

Contraindications

In connection with the above indication, the Impella 2.5™ is 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 2.5™ System

Potential Adverse Events

Additionally, potential for the following risks has been found to exist with use of the Impella 2.5 in the above indication: Acute renal dysfunction; Aortic insufficiency; Aortic valve injury; Atrial fibrillation; Bleeding; Cardiogenic shock; Cardiac tamponade; Cardiopulmonary resuscitation; Cerebral vascular accident/Stroke; Death; Device malfunction; Failure to achieve angiographic success; Hemolysis; Hepatic failure; Insertion site infection; Limb ischemia; Myocardial infarction; Need for cardiac, thoracic or abdominal operation; Perforation; Renal failure; Repeat revascularization; Respiratory dysfunction; Sepsis; Severe hypotension; Thrombocytopenia; Thrombotic vascular (non-CNS) complication; Transient ischemic attack; Vascular injury; Ventricular arrhythmia, fibrillation or tachycardia.

Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

IMPELLA® LEFT-SIDE DEVICES INDICATION & SAFETY INFORMATION

High-Risk PCI

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.

Cardiogenic Shock

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

CONTRAINDICATIONS

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.

 

Impella Connect®

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.

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/

Subscribe to the Digital Community

Receive weekly updates including case review videos, tips and tricks, specialists opinions, and resources and downloads regarding Protected PCI and Cardiogenic Shock.

Subscribe to the Digital Community

Receive weekly updates including case review videos, tips and tricks, specialists opinions, and resources and downloads regarding Protected PCI and Cardiogenic Shock.