IABP vs Impella®: Incidence of Bleeding and Vascular Complications
- 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.
- 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.
- 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.
Impella® Device — Indication & Safety Information
INDICATIONS FOR USE
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.
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.
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.
Important Risk Information for Impella devices
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/