Protected PCI Offers New Option for Patients Turned Down for CABG or Traditional PCI

September 17, 2015

Improving the health of patients and offering the best possible treatments is the primary ethos and goal of any medical professional. A new procedure called Protected PCI, with the Impella 2.5 pump, offers cardiologists the chance to reduce complications and improve outcomes for a wide range of high risk patients. These patients are severe heart disease patients who are characterized as being hemodynamically stable, but who have a depressed left ventricular ejection fraction (< 35%), complex coronary anatomy such as triple vessel disease or left main disease, and various comorbidities (such as heart failure, diabetes, advanced age, peripheral vascular disease, complex lesions, history of angina, prior surgeries).

These “high risk” patients often present to the cath lab as either a scheduled PCI case – they have been turned down for CABG or traditional PCI but have little to no options left to improve their heart failure symptoms, or, they present urgently with unstable angina and are in need of revascularization with hemodynamic support.

The Impella 2.5 is the only percutaneous hemodynamic support device proven safe and effective for treating these high risk patients with severe coronary artery disease and diminished (but stable) heart function. The Impella 2.5 is a miniature blood pump that reduces the strain on the heart during complex PCI procedures by maintaining mean arterial pressure and directly unloading the left ventricle -- allowing for a more complete revascularization.

After the recent FDA approval of the Impella 2.5 device in March 2015, the agency issued a press release, stating that the "use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence."

Clinical evidence has demonstrated that Impella 2.5 can reduce major adverse cardiac and cerebral events (MACCE) by 29% over the former standard of care, the intra-aortic balloon pump, in PCI procedures. Additionally, the data has shown that the Impella 2.5 can reduce hospital stays and repeat procedures, and improve the quality of life of patients with severe coronary artery disease.

The benefits of a Protected PCI with the Impella 2.5 could potentially improve patients outcomes when compared to traditional methods. On top of those benefits, a Protected PCI program with the Impella 2.5 also opens up the potential to treat more patients, whom in the past would not have been candidates for PCI.

To find out more about the Impella 2.5 FDA approval for high risk PCI, you can read the FDA article here.

To learn more about the Impella 2.5 approved indications for use, as well as important warning, safety, and contraindication information, visit abiomed.com/impella.

 


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/

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