Drs. Martin Leon and Dan Burkhoff Discuss Hemodynamics of Protected PCI with Impella

December 3, 2015

In the video below, the Cardiovascular Research Foundation presents a discussion between Drs. Martin Leon and Dan Burkhoff from Columbia University, New York, NY entitled “Understanding the Hemodynamics of Protected PCI with Impella.”

Dr. Leon begins the discussion with a brief history of interventional cardiology from the 1980’s to the present day and the latest development—the Impella heart pump, which allows Protected PCI in complex higher-risk and indicated patients (CHIP). CHIP patients are those with severe coronary artery disease who are hemodynamically stable, have a depressed left ventricular ejection fraction of ≤35%, and comorbid conditions such as heart failure, peripheral vascular disease, complex lesions, diabetes, advanced age, and unstable angina.

The highlight of the discussion is Dr. Burkhoff’s presentation of the Harvi simulator, which shows pressure volume loops, aortic pressures, and coronary blood flow heartbeat-by-heartbeat. Dr. Burkhoff provides detailed explanations of the heart function of simulated patients under three conditions: no hemodynamic support, support with the intra-aortic ballon pump (IABP), and the use of the Impella, a left ventricular assist device. The Harvi simulator enables physicians to visualize what is happening in the heart and understand the hemodynamics under each of these conditions. The Harvi simulator was showcased using the data derived from real life clinical cases, which were presented by Dr. Burkhoff and discussed with Dr. Leon.

The Harvi simulator allows clinicians to understand that the primary difference between the IABP and the Impella is the type of support provided: IABP supplements the heart’s actions while the Impella heart pump maintains hemodynamic support independent of contractility, which uncouples ventricular and systemic perfusion. Clinical trials from the Impella Registry are presented, which indicate that the Impella heart pump maintains hemodynamic support, and may allow for a more complete revascularization.

Complete revascularization is the therapeutic goal of Protected PCI. The benefits of complete revascularization include increased left ventricular function, decreased major adverse cardiovascular and cerebrovascular events (MACCE), and fewer repeat revascularizations, among other outcomes.

View this demonstration of the Harvi tool now by watching the video above or by clicking here.


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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