2017 COURSE OFFERINGS Committed to Improving Outcomes in Cardiogenic Shock and Protected PCI Through Excellence in Education.
ABOUT THIS COURSE BOOKLET Abiomed offers a full curriculum of educational programs that welcome a wide range of users and experience levels to include Interventional Cardiologists, Heart Failure Cardiologists and Cardiac Surgeons, Interventional Fellows, Technicians and Nurses. COURSE CONTENT INCLUDES: Didactic Sessions Patient Identification Protocols and Algorithms Current Clinical Data Case Studies Hands-on Simulation Workshops Live Cases Physician Best Practice Exchange Abiomed s Impella 2.5 received FDA approval for high-risk PCI in March of 2015 and in April 2016 Abiomed s Impella 2.5, Impella CP, Impella 5.0, and Impella LD heart pumps became FDA indicated to provide treatment of ongoing cardiogenic shock. Most recently, in December 2016 the FDA approved the Impella CP for high-risk PCI. These FDA indications now offer patients a new treatment option. Proper identification and management is critical to improve patient outcomes. Abiomed is committed to assisting the Cardiology community to optimize the care of patients in the setting of Cardiogenic Shock and Protected PCI through excellence in education and training, technology, innovation, clinical science, and appropriate and standardized use. We encourage you to register for the program that meets your needs and educational interest. For additional information please contact education@abiomed.com or your local Abiomed rep. Recovering hearts. Saving lives.
ABIOMED TRAINING & EDUCATION Developing an Impella Program for Cardiogenic Shock and Protected PCI: The Core Team Approach This course focuses on the use of Hemodynamic Support and building your Protected PCI program. Like TAVR and Mitral Clip, a Protected PCI program allows hospitals to treat more complex patients not currently being treated. The course begins on day one with dinner presentations and is followed by a full day program on day two. These programs are small, allowing for intimate and interactive sessions and focuses on the steps required to build a program complete with product demonstrations, health economics and workshops addressing special aspects related to Cardiologists/Cath Lab Nurses / ICU Technicians. The program also reviews the heart team approach to using hemodynamic support in patients with cardiogenic shock following an acute myocardial infarction. This program is designed for hospitals that have recently acquired Impella and that want to accelerate the learning curve in order to maximize outcomes. We will accommodate up to 5 team members from each institution s Interventional team to include Ix Cardiology (Mandatory), Primary Tech and/or Nurse, Heart Failure (optional), Surgery (Optional) and Administration. COURSES OFFERED AT: University Hospital Cleveland Cleveland, OH June 8-9, 2017 UCLA Medical Center - Los Angeles, CA July 27-28, 2017 Northwell Health Manhasset, NY September 14-15, 2017 Greenville Health Greenville, SC November 30 - December 1 JOIN THE DIGITAL COMMUNITY Now the largest source of education and reference materials on pvads and the Impella platform. Engage with other interventional cardiologists about the latest data and patient cases, find conference news & updates, watch video interviews with leading experts and read summaries of key studies. DOWNLOAD KEY RESOURCES AND SIGN UP FOR EMAIL UPDATES AT: WWW.PROTECTEDPCI.COM 3 2017 COURSE OFFERING
Symposia: Sponsored Educational Programs These satellite programs offered in conjunction with major conferences and tradeshows, are geared towards physicians seeking to better understand the use of hemodynamic support in complex patients and the timing of support in patients with cardiogenic shock following an acute myocardial infarction. Participants will learn how to manage challenging patient subsets, such as those with advanced heart failure and depressed LVEF, as well as how to provide optimal hemodynamic support in shock. Expert faculty will offer insights on patient selection, benefit of hemodynamic support, treatment strategies for complex cases, optimal support strategy and escalation for AMI CGS and treatment outside the Cath lab. The latest clinical data and guidelines for complex, higher-risk procedures and cardiogenic shock indications will also be reviewed. This course is specifically for physicians familiar with the use of Impella device and would like to enhance their knowledge of the appropriate application of hemodynamic support. This course is most applicable for attendees that have a basic level of Impella experience. UPCOMING SYMPOSIA Hyperlinks to Conference Site TEACH @ ISHLT - Washington, DC April 18, 2017 SCAI Annual Meeting - New Orleans, LA May 10, 2017 CCVVC 2017 - New York, NY June 14, 2017 C3 2017 - Orlando, FL June 27, 2017 Hartzler ICS Shock Symposium - Maui, HI July 16, 2017 CICT 2017- San Francisco, CA July 21, 2017 SDIC 2017- San Diego, CA July 28, 2017 Cardiovascular Innovations 2017- Denver, CO August 3, 2017 CHIP Seattle - Seattle, WA August 10, 2017 4
ABIOMED TRAINING & EDUCATION Advanced Hemodynamics: Impella in Protected PCI & Cardiogenic Shock. HOST CITIES Chicago, IL - July 27-28, 2017 Phoenix, AZ - December 1-2, 2017 This course is intended for the Interventionalist seeking to better understand complex PCI in the modern era and the use and timing of support in patients with AMI CGS. Didactic presentations will address treatment of left main disease, MVD, chronic total occlusions, long lesions, bifurcation lesions, small vessels, and saphenous vein grafts. In addition, participants will learn how to manage challenging patient subsets, such as those with advanced heart failure and depressed LVEF, as well as how to provide optimal hemodynamic support in the shock setting. Some programs also offer hands-on simulation workshops. In addition, expert faculty will offer insights on patient selection, benefit of hemodynamic support, treatment strategies for complex cases, optimal support strategy and escalation for AMI CGS and treatment outside the Cath lab. The latest clinical data and guidelines for complex, higher-risk procedures and cardiogenic shock indications will also be reviewed. This course is invitation-only and geared toward physicians familiar with the use of Impella who would like to enhance their knowledge of the most recent FDA indications allowing them to expand their application of hemodynamic support. This course is most applicable for attendees that have a basic level of Impella experience. 5 2017 COURSE OFFERINGS
Practicum on Complex Skills in Protected PCI This program is primarily for the experienced Interventional Cardiologist seeking to expand his or her skill sets in the treatment of complex, high-risk patients. The course predominantly focuses on live case demonstrations addressing the treatment of left main disease, MVD, chronic total occlusions, long lesions, bifurcation lesions, small vessels, and saphenous vein grafts. In addition, participants will engage in hands-on simulations and learn how to manage challenging patient subsets, such as those with advanced heart failure and depressed LVEF, as well as how to provide optimal hemodynamic support. Expert faculty will offer insights on patient selection, benefit of hemodynamic support, treatment strategies for complex cases, optimizing technique, and overcoming difficult anatomy. The latest clinical data and guidelines for complex, higher-risk procedures also will be reviewed. We recommend this program to experienced physicians with proficient use of Impella. Participants should want to refine their skills and advance their knowledge of treating complex anatomy and procedures such as CTOs, large bore closure, bifurcated lesions and multi-vessel disease. Attendees should have interest in establishing themselves as specialists in the treatment of complex, high-risk patients. PROCTORED BY: Columbia University - New York, NY March 23-24, 2017 October 5-6, 2017 Tennessee Interventional Forum - Nashville, TN April 20-21, 2017 Detroit Medical Center - Detroit, MI April 30 - May 1, 2017 September 24-25, 2017 York Hospital - Philadelphia, PA May 4-5, 2017 August 17-18, 2017 Mid-America Heart Institute - Kansas City, KS May 15-16, 2017 University of Washington - Seattle, WA June 19-20, 2017 September 11-12, 2017 Torrance Memorial - Torrance, CA July 13-14, 2017 Edward Hospital - Napierville, IL August 20-21, 2017 6
FELLOWS CURRICULUM An Introductory Look at the Effects of Hemodynamic Support: Basics to Hands-On Immersion Abiomed Headquarters Boston, MA June 26 - June 28, 2017 Basics of Hemodynamics & Understanding Hemodynamic Support Devices June 26, 2017 The first program in the series is specifically for fellows in PGY3 and PGY4 and will focus on the basics of hemodynamics covering topics such as function of the heart, PV loops, hemodynamic dysfunction, hypertension, urgent & emergent and cardiac arrest. The course will also provide an overview and differences between various mechanical circulatory support devices. Impella Device Use in the ICU: Best Practices June 27, 2017 The second course is designed for fellows in PGY5 and will focus primarily on patient management, patient care and best practices in the ICU. Introduction to Impella: Hands-On June 28, 2017 The final course in the series has been developed for fellows in PGY6 and are about to enter their Interventional fellowship in July. This course is very interactive with product simulation covering techniques and best practices from access management to removal. Courses and Sponsored Symposia for Cardiology Fellows These courses focus on the use of Hemodynamic Support for Complex High-Risk Procedures and the need to treat these patients not currently being treated. Presentations will also focus on the importance of timing of hemodynamic support in the setting of AMI CGS. Fellows will gain knowledge and the technical and cognitive skills required to develop his or her own Protected PCI program and develop an algorithm for CGS. This course is for 4th year Interventional fellows or 5th year subspecialty Interventional Fellows (CHIP, Structural, Peripheral, etc.) about to graduate and looking for education to apply to their future practice. UPCOMING SYMPOSIA CRF Fellows 2017 - Orlando, FL April 5, 2017 Mt. Sinai Fall Fellows - New York, NY November 12, 2017 SCAI Fall Fellows - Las Vegas, NV December 9, 2017 This program is by invitation only. For more information, please conatct education@abiomed.com. 7
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. Impella RP 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 m 2 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. ABIOMED, IMPELLA, PROTECTED PCI, CVAD, and the ABIOMED Logo are registered marks and trademarks of ABIOMED, Inc. 2017 ABIOMED, Inc. COR-001-17.v5 ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923 USA www.abiomed.com