Impella 2_5

Impella 2.5™ and VA-ECMO Provide Hemodynamic Improvement in Patients with Cardiogenic Shock

November 8, 2016

Standard treatment of cardiogenic shock often includes the initiation of revascularization and the use of vasoconstrictors, inotropes, and the intra-aortic balloon pump. When cardiogenic shock resists traditional therapy, it can present a clinical challenge in addition to a substantially high mortality rate. Despite the advances in medicine and technology, cardiogenic shock maintains a mortality rate of a little less than 50%.1

Current options for refractory cardiogenic shock have grown to include not only the armamentarium of standard cardiogenic shock therapies, but also percutaneous mechanical circulatory support (MCS) devices like the Impella 2.5™. Additionally, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is often considered for patients with refractory cardiogenic shock, sometimes in combination with MCS devices, to help improve hemodynamic support.

A study from the November issue of the International Journal of Cardiology retrospectively examined in-hospital mortality for refractory cardiogenic shock patients receiving biventricular support from Impella 2.5™ and VA-ECMO. In about 71% of patients, the Impella 2.5™ was initiated before VA-ECMO.2

The center reporting biventricular support in this study notes that Impella 2.5™ is implanted first for cardiogenic shock caused by isolated left ventricular failure, whereas VA-ECMO is generally the first choice in the event of left ventricular failure and persistent cardiac arrest or pulmonary failure.

For the purpose of this study, refractory cardiogenic shock was defined by the following:

  • Continual impaired end-organ perfusion despite aggressive medical therapy
  • Persistent hypotension (systolic blood pressure less than 90 mmHg)

The use of inotropes and vasoconstrictors was significantly reduced 72 hours after biventricular support. Serum lactate, a prominent marker associated with cardiogenic shock, also decreased within the same time period for patients receiving concomitant therapy (Figure 1).

Figure 1 - Serum lactate levels of patients on biventricular supporta

serum lactate levels
aData from Karatolios K, Chatzis G, Markus B2

Roughly half (44%) of treated patients with refractory cardiogenic shock received the dual treatment that allowed for ICU discharge to bridging to a long-term ventricular assist device or cardiac rehabilitation. The 28-day survival was 41%, however, possibly contributable to the critically ill patient selection for this study.

Reference:
  1. Babaev A, Frederick PD, Pasta DJ, et al. Trends in management and outcomes of patients with acute myocardial infarction complicated by cardiogenic shock. JAMA. 2005;294(4):448-454.
  2. Karatolios K, Chatzis G, Markus B, et al. Biventricular unloading in patients with refractory cardiogenic shock. Int J Cardiol. 2016;222:247-252.

Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

Protected PCI

The Impella 2.5® and Impella CP® 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 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 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.

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/