Impella® Quality Assurance Program: Importance of Treatment Protocols to Improve Patient Survival and Heart Recovery
Data from Abiomed’s Impella® Quality (IQ) Assurance Program, which includes the IQ Database and cVAD Registry, was presented today as late-breaking Featured Clinical Research by Dr. William O'Neill of Henry Ford Hospital System at the American College of Cardiology (ACC) 66th Annual Scientific Session in Washington, D.C. These data were derived from the IQ Database documenting the real-world treatment of approximately 50,000 U.S. patients, with a subset of 15,259 Acute Myocardial Infarction Cardiogenic Shock (AMICS) patients. The Impella heart pump results indicate an association between the use of best practice protocols and improved survival and native heart recovery, as compared to inconsistent treatment or inexperienced hospitals.
Learn More:
- Explore information and coverage of the Detroit Cardiogenic Shock Initiative, a real-world application of standardized protocols.
- Download protocols and best practices to identify, stabilize, and asses cardiogenic shock patients.
- Read Abiomed's press release on the Impella Quality Assurance Program.
IMP-107-17
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.
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
CONTRAINDICATIONS
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/
