Cardiogenic Shock - ICYMI Articles - News

Striving to Improve Patient Care and Survival with Impella® Best Practices: Data from the IQ Database and cVAD Registry

March 21, 2017

Improving care for cardiogenic shock patients treated with percutaneous coronary intervention (Protected PCI) relies on examining real-world case data from cardiac care registries, databases, and randomized clinical trials.  Abiomed’s Impella® Quality (IQ) Assurance Program, which includes the IQ Database and cVAD registry, offers insight into the treatment of approximately 50,000 patients, with a subset of patients (n=15,259) with acute myocardial cardiogenic shock (AMICS). Provided by the data is the confirmation of best practices for Impella device use in AMICS patients.

Best practices for Impella device support include:

  • Early support (pre-PCI)
  • Calling upon experienced operators
  • Reducing inotropic agents
  • Providing hemodynamic monitoring during therapy

When used in line with best practices, Impella devices may assist in improving outcomes for AMICS patients.

Best Practices for Impella® Support

Data from the Detroit Cardiogenic Shock Initiative (DCSI), which includes case information from 5 Detroit cardiac care centers, provides insight into the application of best practices for Impella® device use.  According to data reported by Dr. William O’Neill at the American College of Cardiology’s 66th Annual Scientific Session in Washington, D.C., an improvement in AMICS survival from 51% at baseline to 84% at discharge was observed among 37 AMICS patients following the highlighted best practices for Impella® device support.1 Additionally, 100% of survivors were able to return home with their native heart following therapy.

In 2016, there were 89,923 patients presenting with acute myocardial infarction complicating cardiogenic shock (AMICS) in the U.S.2   According to data from the IQ Database, only 6% of patients with AMICS were managed with Impella® devices in 2016, up from just 1% in 2010.3 Contrary to using Impella® devices, 42% of AMICS patients were managed with the intra-aortic balloon pump (IABP) in 2016, despite no randomized clinical trials demonstrating IABP’s benefit for hemodynamic improvement. From these data, it appears the Impella® device is used conservatively in patients with AMICS.

Observational Data suggests Early Impella® Support is Associated with Improved Survival

Data from the IQ Database and cVAD registry demonstrates correlation between  early Impella® device support – specifically prior to PCI —  and improved outcomes.  The IQ Database also compared early inotropic agents to early Impella® device support in AMICS patients. The observational data showed that patients receiving inotropes prior to PCI had a 52% survival, whereas patients receiving Impella® device support prior to PCI had a 59% survival rate.4  The cVAD Registry reported similar findings; survival for patients with inotropes pre-PCI was 62%, and Impella® device support pre-PCI was 67%.5

Hemodynamic Monitoring

Hemodynamic monitoring has been considered an integral approach for improving overall survival in patients with AMICS, and this has been supported by the IQ Database and cVAD registry.  In the IQ Database, hemodynamic monitoring was associated with better survival in AMICS vs no hemodynamic monitoring (63% vs 49%, respectively).4  cVAD showed similar findings for survival with hemodynamic monitoring vs no hemodynamic monitoring (76% vs 68%, respectively).6

Inotropes

Inotropic agents are often provided to patients with AMICS, yet their risks can sometimes outweigh potential benefits.  Data from the cVAD registry show that with increasing inotrope use, there is a stepwise increase in mortality.5  According to the registry, AMICS patients treated with no inotropes correlate with a 32% mortality rate vs 74% mortality with patients treated with 4 or more.

The Importance of Impella Devices

While significant technological advancements in cardiac care have been made in the past 2 decades, survival for AMICS has remained virtually unchanged. Only 6% of patients with cardiogenic shock are currently receiving Impella device support, despite the fact that Impella devices remain the only percutaneous hemodynamic support devices proven safe and effective by the FDA for use in that clinical indication.. According to observational data from the IQ database and the cVAD registry, four best practice protocols can be associated with improved outcomes, including reducing inotropic agents, initiating Impella device support prior to PCI, using experienced operators, and designing a protocol with hemodynamic monitoring to guide both escalation and weaning.

Abiomed’s IQ Database is a collection of real-world, observational quality assurance data on over 95% of Impella patients since the Impella 2.5™ heart pump’s introduction to the United States in 2008. The IQ database, combined with additional clinical data collected in the cVAD Registry™ and FDA pre- and post-market studies, is helping to identify best practices and protocols that are linked to the highest survival and native heart recovery rates at hospitals utilizing Impella heart pumps. The data contained in the IQ Assurance Database is useful in establishing certain trends associated with the use of Impella. The data contained therein is not pre-specified or statistically-powered and no statistical conclusions can be drawn from the hypothesis-generating information.

References:

  1. O’Neill, M. Basir, S. Dixon, K Patel, T Schreiber, S. Almany. Abiomed Impella Quality (IQ) Database, Jan 2015 to July 2016, for Aggregate DTW Metro Hospitals AMI/CGS Survival to Explant; Feasibility of Early Mechanical Support During Mechanical Reperfusion of Acute Myocardial Infarct Cardiogenic Shock. JACC Interventions.
  2. Sandhu A, McCoy l, Negi S, et al. Use of Mechanical Circulatory Support in Patients Undergoing Percutaneous Coronary Intervention; Insights from the National Cardiovascular Data Registry. Circulation. 2015;132:1243-1251.
  3. Data on file. Abiomed Impella Quality (IQ) Database, US AMI/CGS Jan 2009 – Dec 2016. Danvers, MA: Abiomed.
  4. Abiomed Impella Quality (IQ) Database, US AMI/CGS Apr 2009– Jan 2017. Survival to Explant. Danvers, MA: Abiomed.
  5. Basir M, Schreiber T, Grines C, et al. Effect of Early Initiation of Mechanical Circulatory Support on Survival in Cardiogenic Shock. Am J Cardiol. 2017;119(6):845-851.
  6. cVAD survival to explant 2009-2016.

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® is indicated for providing circulatory assistance for up to 14 days in pediatric or adult 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 is contraindicated for use with patients experiencing any of the following conditions: Pulmonary artery wall disorders precluding placement or correct positioning of the Impella RP device; Anatomic conditions precluding insertion of the pump; Tricuspid or pulmonic valve abnormalities including: mechanical valves, severe stenosis or regurgitation; Mural thrombus of the right atrium or vena cava; Other illnesses or therapy requirements precluding use 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

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 www.abiomed.com/impella/impella-rp to learn more.

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.

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/hcp/information/isi and www.cardiogenicshock.com/information/isi