Impella device

Impella® Device Support During High-Risk Unprotected Left Main Percutaneous Coronary Intervention Demonstrates Favorable Safety and Efficacy Outcomes

November 21, 2017

Reference: Schreiber T et al. Catheter Cardiovasc Interv. 2017;90(4):576-581.

The use of prophylactic Impella® device support during unprotected left main (ULM) percutaneous coronary intervention (PCI) is safe and effective for improving hemodynamic variables in high-risk, non-cardiogenic shock (CS) patients, according to findings from a large, single-center, retrospective review of the USpella registry from Schreiber et al.1

Coronary artery bypass grafting (CABG) surgery has been considered the “gold standard” approach to anatomically challenging left main lesions; however, PCI in conjunction with additional mechanical and medical support is becoming increasingly adopted for high-risk and surgically ineligible patients.2,3,4 The rationale for utilizing prophylactic mechanical hemodynamic support during revascularization in these patients is primarily derived from its effect on reducing myocardial ischemia and minimizing hemodynamic collapse.

In this analysis, investigators evaluated consecutive patients with ULM who received Impella device support during ULM PCI (N = 127). Following surgical consultation, approximately 50% refused CABG surgery. The majority of the 24 patients with acute coronary syndrome had non-ST-elevation myocardial infarction (79.17%) compared with 20.83% with ST-elevation myocardial infarction.

To obtain predicted risks for surgical morbidity and mortality, the investigators used the Society for Thoracic Surgery (STS) scores. According to the STS scores, risk for mortality and morbidity were 4% and 23%, respectively.

Approximately 76% of patients received Impella 2.5 (n = 97) vs 24% of those received Impella CP (n = 30). Average support duration was 1.65 ± 4.69/hour. Pre- vs post-PCI SYNTAX scores significantly decreased from 31.4 to 7.86 (P < 0.001) following support.

The endpoint of in-hospital mortality was 1.57%, and 30-day mortality was 2.36%. No device-related mortalities were observed. Five (3.94%) Impella recipients experienced major bleeding which required transfusion, only 1 (0.79%) patient experienced a vascular event requiring surgical intervention, and 1 (0.79%) patient developed an acute kidney injury.

Although this study did not compare ULM PCI with CABG, the investigators state that their findings demonstrate the utility of “prophylactic placement of percutaneous left ventricular hemodynamic support...in high-risk patients with ULM and [an] adverse clinical risk profile.” In addition, the researchers showed that the risk for PCI-related mortality was approximately 50% less than that would have been predicted with CABG (STS score: 2.36% vs 4%, respectively), demonstrating a potential survival benefit associated with ULM PCI in this patient population.

Reference:

  1. Schreiber T, Htun WW, Blank N, et al. Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry. Catheter Cardiovasc Interv. 2017;90(4):576-581.
  2. Chaitman BR, Fisher LD, Bourassa MG, et al. Effect of coronary bypass surgery on survival patterns in subsets of patients with left main coronary artery disease. Report of the Collaborative Study in Coronary Artery Surgery (CASS). Am J Cardiol. 1981;48(4):765–777.
  3. Holmes AA, Bangalore S. PCI or CABG for severe unprotected left main coronary artery disease: making sense of the NOBLE and EXCEL trials. J Thorac Dis. 2017;9(5):E451-E456.
  4. Kandzari DE, Ormiston JA. Revascularization for unprotected left main coronary artery disease: an evolution in clinical decision making. Curr Cardiol Rep. 2011;13(5):424-431.

IMP-422-17

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.

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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