IABP vs Impella

IABP vs Impella®: Incidence of Bleeding and Vascular Complications

April 21, 2017

Key Takeaways

  • Patients undergoing high-risk PCI often require additional hemodynamic support, particularly with the help of ventricular assist devices.
  • There is no significant difference between Impella 2.5® and IABP in terms of bleeding risk and vascular complications.

High-risk patients with acute coronary syndrome (ACS) often require additional cardiac support during a protected percutaneous coronary intervention (PCI). Two of the most commonly used devices to improve hemodynamics during high-risk PCI are the intra-aortic balloon pump (IABP) and the Impella 2.5 left ventricular assist device. Despite previously demonstrated efficacy,1 bleeding risk and vascular complications are not uncommon with these devices. A study from Acute Cardiac Care compared these risks among IABP and Impella 2.5 to determine device-related outcomes in patients with ACS.2

This retrospective study analyzed patients receiving IABP (n=62) or Impella 2.5 (n=13) during high-risk PCI. Physician decision dictated which patient received which device; this study was not randomized. The formation of arteriovenous (AV) fistula, mesenteric ischemia, aortic rupture, and leg ischemia defined the vascular complications related to the procedure. Also, the incidence of bleeding was defined as a patient requiring ≥1 unit of packed red blood cell (PRBC) transfusion.

There was no statistically significant difference between the two groups in terms of left ventricular systolic function, coronary artery anatomy, or degree of stenoses. PCI was was performed on either the left main artery (18.6%) or the left anterior descending artery (64.0%).

Additionally, there was no difference between each group in regard to vascular complications. Overall, only 2 patients in the Impella group and 4 patients in the IABP group experienced vascular complications.

A significant decrease in hematocrit levels post-procedure was observed in both groups for Impella at 48 h and 72 h, and IABP at 24 h, 48 h, and 72 h. Differences in postprocedural hematocrit was also insignificant among each group. PRBC transfusion was basically equivalent to the Impella (38.4%) and IABP (38.5%) groups. Medical records failed to demonstrate the source of bleeding in some of patients; however, gastrointestinal bleeding was shown to be the source in around 30.7% of patients.

While there was no in-hospital deaths for the Impella group and 13 deaths in the IABP group, the small number of patients did not achieve statistical significance. Mortality was mainly related to myocardial infarction (n=10). Although a higher percentage of patients with STEMI were in the IABP group (59.6% vs 15.3%), the authors believe that the mortality findings may be due to enhanced hemodynamic support with the Impella heart pump.

References:

  1. Iliodromitis KE, Kahlert P, Plicht B, et al. High-risk PCI in acute coronary syndromes with Impella LP 2.5 device support. Int J Cardiol. 2011;153(1):59-63.
  2. Boudoulas KD, Pederzolli A, Saini U, et al. Comparison of Impella and intra-aortic balloon pump in high-risk percutaneous coronary intervention: vascular complications and incidence of bleeding. Acute Card Care. 2012;14(4):120-124.

IM2-018-17

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/