Congratulations to March 2017 Impella Heart Team Certification Program Graduates

March 13, 2017
The Protected PCI Blogging Team wants to take a moment to recognize the physicians who recently completed the “Impella Heart Team Certification Program.” This program is completed by those customers who are part of the Limited Market Release of the Impella RP Device.
The Impella Heart Team Certification Program consists of two parallel sessions: one for cardiologists, focusing on the New Era of Protected PCI, and one for surgeons concentrating on the Impella 5.0 device platform, with a focus on insertion procedures and simulation training. A portion of the training features an introduction to Impella RP device and case presentations from participating centers in which Impella RP would have been used had it been available. The discussion was facilitated by Navin Kapur, MD on improving outcomes in cardiogenic shock with the Impella platform. Another portion of the program is focused entirely on the Impella RP device certification, including insertion techniques from established implanters, patient identification, and a presentation concentrating on “Tips and Tricks.”

Below are the physicians who completed the March certification program.

Left to Right:

Seth Bilazarian, MD, Abiomed; Dan Raess, MD, Abiomed; Cathy Jeon, MD, Abiomed; Norberto Schecthmann, MD, Holmes Regional Medical Center; Matthew Campbell, MD, Holmes Regional Medical Center; Jason Richard, Abiomed; Theodore Bass, MD, UF Health Jacksonville; Joseph S. Rossi, MD, University of North Carolina – Chapel Hill; Michael Yeung, MD, University of North Carolina – Chapel Hill

Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

Protected PCI

The Impella 2.5® and Impella CP® Systems are a 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 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 and Impella CP 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 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 and Impella CP, and ≤ 6 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 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
www.protectedpci.com/hcp/information/isi and www.cardiogenicshock.com/hcp/information/isi to learn more.

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.