Presentation is loading. Please wait.

Presentation is loading. Please wait.

INTERMACS Annual Meeting

Published byAlisha Ryan Modified over 8 years ago

Similar presentations

Presentation on theme: "INTERMACS Annual Meeting"— Presentation transcript:

1 INTERMACS Annual Meeting
Update on MVAD Trial HeartWare INTERMACS Annual Meeting Atlanta GA March 11,12, 2016 Randall C Starling MD MPH FACC FESC Professor of Medicine Kaufman Center for Heart Failure Department of Cardiovascular Medicine Heart & Vascular Institute

2 INTERMACS Annual Meeting
Update on MVAD Trial HeartWare INTERMACS Annual Meeting Atlanta GA March 11,12, 2016 Randall C Starling MD MPH FACC FESC Disclosure: HeartWare MVAD Advisory Panel Thoratec ROADMAP Study Steering Committee No honoraria received 2015

3 LVAD Therapy: Future LVADs will evolve and improve
Totally implanted with power supply Smaller and lighter MUST reduce adverse events Improved technology will expand the use of LVAD LVAD use in less ill patients….. Cost reduction ESSENTIAL

4 Coagulopathy in Mechanical Circulatory Support:
A Fine Balance Rosenthal J, Starling RC Curr Cardiol Rep 2015 Dec;17(12):114.

5 ROADMAP Trial AEs were more frequent in LVAD patients than in OMM patients. Bleeding was the primary driver of LVAD AE Estep J et al J Am Coll Cardiol Oct 20;66(16):

6 The MVAD System: New Technology
Small size enables less invasive implant and improved anatomical fit Advanced impeller technology Lighter and thoughtfully designed peripherals to enhance patient quality of life MVAD® Pump PAL Patient Peripherals Exclusively for Clinical Investigation. Investigational device to be used by Qualified Investigators Only. CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.

7 MVAD® pump compared to HVAD®
MVAD is less than 1/2 the size of HVAD 22 cc displacement volume 5 cc priming volume Small 85 g pericardial device that provides up to 7 L/min of cardiac support 70 cm driveline with reduced velour length (20 cm). Extraction line to ensure device is properly inserted into sewing ring CAUTION – Investigational Device. Limited by United States law to investigational use. Exclusively for Clinical Investigations.

8 Advanced Impeller Technology
Proven wearless impeller technology engineered for breakthrough hemocompatibility >50% reduction in shear stress* Smooth impeller edges to decrease forces applied on blood Small priming volume & high-throughput design to limit blood time in the pump Reduced surface contact to decrease blood & pump interaction Optimized flow paths to guide 99% of blood through ultra-low stress, high-flow blood channels Wearless Impeller Technology Proven hydrodynamic & magnetic bearing *Compared to the HVAD pump, HeartWare data on file

9 MVAD

10 MVAD® Pump Designed for surgical ease and versatility to support the spectrum of advanced heart failure patients Supports a broad range of patients with varied anatomy and physiology 70% smaller* ensures intrapericardial placement across patient populations Full flow to support large BSA and the most advanced heart failure patients Partial flow to enable weaning and lower flow applications Optimized cannula positioning via the Gimbaled Sewing Ring Angle adjustment enabling optimal anatomical alignment Depth adjustment supporting smaller heart chambers Implantation via thoracotomy may lead to Smaller incisions and less surgical trauma Reduced blood product utilization Shorter ICU time, ventilator time, and length of stay *Pump volume compared to HVAD® Pump Exclusively for Clinical Investigation. Investigational device to be used by Qualified Investigators Only. CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.

11 qPulse™ Cycle Customized pulsatility designed to promote aortic valve opening, enable ventricular washing, and reduce bleeding complications Off, low, medium, and high settings to provide patient-specific cycles Exclusively for Clinical Investigation. Investigational device to be used by Qualified Investigators Only. CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.

12 PAL Patient Peripherals
Peripherals to provide improvements in patient quality of life Simplified patient experience with streamlined design Integrated controller and battery system Snap-on, cable-free battery attachment Time-based (hours and minutes) battery run-time display Designed for increased patient safety and confidence Internal battery for back-up power Clear and actionable text-based alerts Enhanced data access on controller for improved remote troubleshooting Durable controller cable with shock absorber feature to support patient activity and reduce stress on driveline Peripherals for an Active Lifestyle CAUTION:  Investigational Device.  Limited by United States law to investigational use.

13 World’s smallest heart pump fitted to British man
Daily Telegraph; 30 Juli 2015

14 MVAD® in-situ CAUTION:  Investigational Device.  Limited by United States law to investigational use.

15 MVAD trial CE trial: Multi-center, prospective, non-randomized, single-arm CE trial 70 patients at 11 sites in up to 5 countries (Germany, UK, Austria, France & Australia) Patients with advanced AHA Stage D/NYHA Class IIIB/IV heart failure who have failed optimal medical management 11 patients implanted (first implant in July 2015) CE Mark clinical trial currently on voluntary pause Company is evaluating MVAD System performance CAUTION – Investigational Device. Limited by United States law to investigational use. Exclusively for Clinical Investigations.

Download ppt "INTERMACS Annual Meeting"

Similar presentations

Community Preparation for Caring for Mechanical Circulatory Device Patients University of Wisconsin Hospital And Clinics Ventricular Assist Device Program.

Community Preparation for Caring for Mechanical Circulatory Device Patients University of Wisconsin Hospital And Clinics Ventricular Assist Device Program.
A Clinical Evaluation of Terumo’s Prescriptive Oxygenation™ Series Capiox® FX15 and FX25 Hollow Fiber oxygenators with Integrated Arterial Filter in the.

A Clinical Evaluation of Terumo’s Prescriptive Oxygenation™ Series Capiox® FX15 and FX25 Hollow Fiber oxygenators with Integrated Arterial Filter in the.
1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications.

1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications.
1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications.

1 CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions For Use” for complete Indications.
BACKGROUND Ventricular assist devices (VADs) are a proven therapy as bridge-to-cardiac transplantation in Class IIIB and Class IV heart failure patients.

BACKGROUND Ventricular assist devices (VADs) are a proven therapy as bridge-to-cardiac transplantation in Class IIIB and Class IV heart failure patients.
LVAD is a battery-operated, mechanical pump-type device that's surgically implanted. Goal of LVAD: providing the patient with as close to a normal lifestyle.

LVAD is a battery-operated, mechanical pump-type device that's surgically implanted. Goal of LVAD: providing the patient with as close to a normal lifestyle.
Hemolysis in Patients Supported with Durable, Long-Term Left Ventricular Assist Device Therapy Jason N. Katz, MD,MHS; Brian C. Jensen, MD; Patricia P.

Hemolysis in Patients Supported with Durable, Long-Term Left Ventricular Assist Device Therapy Jason N. Katz, MD,MHS; Brian C. Jensen, MD; Patricia P.
The Radial Approach to Percutaneous Coronary Intervention Is Associated With a Lower Risk for Complications Regardless of Radial Procedure Volume: A Report.

The Radial Approach to Percutaneous Coronary Intervention Is Associated With a Lower Risk for Complications Regardless of Radial Procedure Volume: A Report.
Sixth Annual Meeting March 12, 2012 8:00am to 4:00pm Crowne Plaza National Airport Arlington, VA INTERMACS Annual Meeting March 2012.

Sixth Annual Meeting March 12, :00am to 4:00pm Crowne Plaza National Airport Arlington, VA INTERMACS Annual Meeting March 2012.
ACC 2015 Michael J Reardon, MD, FACC On Behalf of the CoreValve US Investigators A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic.

ACC 2015 Michael J Reardon, MD, FACC On Behalf of the CoreValve US Investigators A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic.
Equipoise Does Not Exist for REVIVE IT Andrew Boyle, MD Heart and Vascular Center Director, Florida Chairman of Cardiology Medical Director of Heart Failure,

Equipoise Does Not Exist for REVIVE IT Andrew Boyle, MD Heart and Vascular Center Director, Florida Chairman of Cardiology Medical Director of Heart Failure,
Preliminary results from the C-Pulse OPTIONS HF European Multicenter Post-Market Study Holger Hotz, CardioCentrum Berlin, Berlin, Germany; Antonia Schulz,

Preliminary results from the C-Pulse OPTIONS HF European Multicenter Post-Market Study Holger Hotz, CardioCentrum Berlin, Berlin, Germany; Antonia Schulz,
Between May 2013 and June 2014, we implanted the C-Pulse device in 7 male and 1 female patients with a mean age ± SD of 61.1 ± 9.4 years. Four had ischemic.

Between May 2013 and June 2014, we implanted the C-Pulse device in 7 male and 1 female patients with a mean age ± SD of 61.1 ± 9.4 years. Four had ischemic.
11 B169-0313 Assistance ventriculaire Les produits en développement Pr Camille Dambrin Service de chirurgie cardio-vasculaire, CHU Toulouse-Rangueil.

11 B Assistance ventriculaire Les produits en développement Pr Camille Dambrin Service de chirurgie cardio-vasculaire, CHU Toulouse-Rangueil.
INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011.

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc
Professor, Department of Anesthesiology

Professor, Department of Anesthesiology
Advances In LVAD Patient Management

Advances In LVAD Patient Management
Biventricular Failure – Total Artificial Heart Francisco A. Arabía, MD Director, CHSI Center for Surgical Device Management Cedars-Sinai Heart Institute.

Biventricular Failure – Total Artificial Heart Francisco A. Arabía, MD Director, CHSI Center for Surgical Device Management Cedars-Sinai Heart Institute.
Keith Aaronson, Mark Slaughter, Edwin McGee, William Cotts, Michael Acker, Mariell Jessup, Igor Gregoric, Pranav Loyalka, Valluvan Jeevanandam, Allen Anderson,

Keith Aaronson, Mark Slaughter, Edwin McGee, William Cotts, Michael Acker, Mariell Jessup, Igor Gregoric, Pranav Loyalka, Valluvan Jeevanandam, Allen Anderson,
Ventricular Assist Device: An Advanced Surgical Intervention for the Treatment of End Stage Heart Failure Laura Coyle, MSN, ACNP-BC VAD Coordinator Advocate.

Ventricular Assist Device: An Advanced Surgical Intervention for the Treatment of End Stage Heart Failure Laura Coyle, MSN, ACNP-BC VAD Coordinator Advocate.

Similar presentations

Ads by Google