LVAD UPDATE Axial Flow vs. Centrifugal Pumps

Rob Adamson, M.D. SHARP Memorial Hospital San Diego, CA

DISCLOSURES 

Trainer and Proctor for Thoratec Participated in REMATCH, BTT and DT trials  94 HM I implants since 1991  >200 HM II implants since 2005 



Participant in the HeartWare trial

FEELING DIVIDED?

BLOOD FLOW PATH  Inflow from LV  Inlet Stator

 3 vanes “straighten” the flow before it enters the rotor

 Rotor

 Propel blood toward the exit and spins it radially imparting kinetic energy

 Outlet stator

 “Straightens” flow as leaves rotor and pressure is further increased

HEARTMATE II -- DESIGNED FOR LOW TE & PUMP THROMBOSIS

Optimal flow dynamics reduce damage to blood cells, minimizing the risk of TE formation

A single moving part helps to optimize the blood flow path

Sintered titanium encourages neointima formation and adherence of LV clot and helps reduce the need for anticoagulation

Ruby bearings help dissipate heat and minimize damage to blood cells, reducing the risk of TE formation

INTERNAL VIEW Outlet Housing

Rotor Magnet

Rotor

Bearings

Inlet Stator

Outlet Stator

Rev. 12.0 (3/24/04)

Motor Capsule

Motor Winding

Inlet Housing

PUMP ROTOR AND STATORS Flow

Outflow Stator

Inflow Stator

Rotor Outflow Bearing

Inflow Bearings

HeartWare Update Mike Karim, Director International

The HeartWare® Ventricular Assist System • Miniaturized implantable HVAD® pump •

50 cc displacement volume

•

50 mm outside diameter

•

Smaller and lighter than FDA approved continuous flow LVAD

• 10 liters of flow/min • Hybrid magnetic and hydrodynamic bearings creates a unique wearless impeller • Thin (4.2 mm) driveline with fatigue resistant cables • Small 10 mm outflow graft allows for expanded anastomotic options

Implanted in Pericardial Space Pericardial benefits • No abdominal surgery • No pump pocket • Less surgical time • Smaller BSA patients • Fewer antibodies due to no blood transfusions

CAUTION: Investigational device. Limited by United States law to investigational use.

CENTRIFUGAL PUMP; DESIGNED FOR LONG TERM USE

Primary flow path Washes flow channels and immediately enters outflow graft

Tertiary flow path Provides fluid “cushion”; washes thrust bearings Secondary flow path Washes underside and center post regions

CAUTION: Investigational device. Limited by United States law to investigational use.

OVERALL SURVIVAL COMPARISON TO SEATTLE HEART FAILURE MODEL (SAME PATIENTS)

Wayne C. Levy, et al, ISHLT 2011

CAUTION: Investigational device. Limited by United States law to investigational use.

ADVANCE TRIAL

HEARTWARE OUTCOME

EXPLANTED HVAD™ PUMP FROM FIRST PATIENT PATHOLOGY PICTURES AFTER 427 DAYS

Pump housing

Impeller

Images taken at Texas A&M University by Dr. Fred Clubb, D.V.M., Ph.D., DACLAM, Clinical Professor

HEARTWARE LVAD

THORATEC CORPORATION Lead the use of Mechanical Circulatory Support (MCS) to dramatically  improve outcomes for patients with advanced heart failure

Market leadership across the spectrum of MCS

Our Values / Our Commitments  Continual improvement of  clinical outcomes  Transparent, rigorous clinical research  Increasing awareness and education

Vision for and commitment to the future of MCS*

*In development.  Not approved for clinical use.

 Technology innovation leadership

CentriMag®

HEARTMATE® III*

*In development.  Not approved for clinical use.

HEARTMATE III* Hemotologically Friendly, Proven Full Magnetically Levitated VAD Features • Fully Magnetically Levitated

• Designed to be Hemotologically compatible • Large pump gaps leading to reduced blood trauma • Textured blood contacting surfaces • Artificial pulse

• Wide range of operation • Full support (10L / min)

• Surgically Intelligent • Advanced Implant / Explant – Engineered apical attachment  • Modular Driveline

• Pocket Controller Program Status

• Target CE Mark Clinical trials initiation mid 2013 and US trial  before the end of 2013 *In development.  Not approved for clinical use.

HEARTMATE III*: FULL MAGLEV TECHNOLOGY Key Design Benefits: Optimized Geometry – HeartMate III secondary flow paths are ~0.5 mm along the side, and ~1.0 mm pump above  and below the rotor. – Conversely, hydrodynamic bearings are typically operated with much smaller gaps,  1/20th of a millimeter or so. – HeartMate III pump surfaces are flat and flow is undisturbed, wedging surfaces and other  features required for hydrodynamic bearings are not required. ~ 0.5 mm  along the  side ~ 1.0 mm  top and  bottom

*In development. Not approved for clinical use

HEARTMATE III*: FULL MAGLEV TECHNOLOGY Key Design Benefits: Fluid Dynamics – The HeartMate III rotor and volute have been designed to minimize shear and avoid stasis  over the entire range of operation (2 to 10 L/min). – The relatively large secondary flow paths facilitate smooth flow transitions, generous  washing, and low shear. – Impressively low hemolysis has been demonstrated in both in vitro  and in vivo (plasma‐free  hemoglobin always 11 years. As of July 2013 *Based on clinical trial and device tracking data

HeartMate II—Peer-Reviewed Publications HeartMate II has an unparalleled number of peerreviewed published studies in highly regarded publications including NEJM and JACC. Data featuring HeartMate II has been published in more than 350* peer-reviewed articles including: 

3 in New England Journal of Medicine



17 in Journal of American College of Cardiology



14 in Circulation / Circulation Heart Failure



59 in Journal of Heart and Lung Transplantation



31 in Annals of Thoracic Surgery



20 in Journal of Thoracic Cardiovascular Surgery

CONTINUED POST-MARKET EVALUATION ROADMAP

TRACE

 Studying Class IIIb / IV patients not

 Studying reduced anti-coagulation and

 HeartMate II compared to medical

 Enrolling in both North America and

 Enrollment: 200 / 200

 Enrollment: 200 / 200

SEE-HF

 SSI  Evaluating new techniques to reduce

dependent on inotropic support (INTERMACS profiles 4-6) management

 EU study designed to involve

cardiologists and implant centers in evaluating and implanting HeartMate II in a slightly less sick patient population

 Initiated enrollment in 1H’13

anti-platelet therapy in HeartMate II patients Europe

driveline infection in multi-center registry

 Single-center experiences utilizing these techniques have been highly effective

 Enrollment: 400 / 400 Enrollment statistics as of July 2013.

LOWEST PUBLISHED STROKE RATES* HEARTMATE II: MINIMIZING COMPLICATIONS BTT

BTT

DT

HeartMate II1

HeartMate II2

HeartMate II3

2011 n=169 142 pt years

2011 n=1,496 1,082 pt years

2012 n=281 498 pt years

Ischemic

0.06

0.06

0.05

Hemorrhagic

0.01

0.02

0.03

Unknown Type

0.01

0.02

-

Total

0.08

0.10

0.08

Stroke Rates

1. 2. 3. * *

Starling, Naka, Boyle , et al. J. Am. Coll. Cardiol. 2011;57;1890-1898 John, Naka, Smedira, et al. Ann Thorac Surg 2011;92:1406 –13 Park, Milano, Tatooles, et al. Circulation Heart Failure. 2012; 5:241-248. Boyle AJ, Russell SD, Teuteberg JJ, et al. J Heart Lung Transplant. 2009;28:881-7. Based on published data from multi-center experience and separate studies, which may involve different patient populations and other variables. Please refer to the HeartMate II Instructions for Use about indications, contraindications, adverse events, warnings, and precautions (http:// www.thoratec.com/medical-professionals/resource-library/ifusmanuals/heartmate-lllvad.aspx#levelFour).

PUMP THROMBOSIS PUBLISHED EVIDENCE Study

Cohort

Device Replacement for Pump Thrombosis

Pump Thrombosis Event Rate

Miller, Pagani, Russell, et al. NEJM 2007; 357:885-96.

BTT

0.032 (2 events, 61.7 ptyears, 133 patients)

–

Pagani, Miller, Russell et al. JACC 2009; 54:312-21.

BTT

0.022 (4 events, 181.8 Pt.Years, 281 pts)

–

Boyle, Russell, Teuteberg et al. JHLT 2009; 28:881-87.

BTT

–

0.014 (3 events, 220 Pt.Years, 331 pts) Post Discharge Events

Slaughter, Naka, John et al. JHLT 2010; 29:616-24.

BTT

–

0.027 (9 events, 335.1 Pt.Years, 418 pts)

Slaughter, Rogers, Milano et al. NEJM 2009;361:2241-51.

DT

–

0.024 (5 events, 211 Pt.Years, 133 pts)

–

0.025 (26 events, 1027 Pt.Years, 701 pts) – Post Discharge Events

Russell, Boyle, Sun et al. ISHLT 2011.

BTT + DT

SHARP’S PUMP THROMBOSIS HEMOLYSIS EXPERIENCE Total number of HMII implants : 207 Total duration of support: 331.5 Pt.Years Incidence

Number

Exchanges For thrombus Suspected Thrombus hemolysis

2

0.006/pt- yr

19

0.06/pt- yr

Confirmed Thrombus

12

0.04/pt-yr

Thoratec records: Updated May 31, 2013

HM II DT 2-YEAR POST-APPROVAL OUTCOMES 

Multicenter, prospective, 2 year F/U 

Compared 247 INTERMAC DT patients at 61 centers to 133 patients at 34 centers in the pivotal trial EVENT

Trial

Post-Approval

Length of stay

27 days

21 days

Bleeding (surgery)

30%

11%

Total Strokes

0.13 EPPY

008 EPPY

Ischemic

0.06

0.03

Hemorragic

0.07

0.05

Device Infection

0.48

0.22

1 year survival

68%

76%

2 year survival

58%

62%

Two-Year Outcomes in the Destination Therapy Post-FDA-Approval Study with a Continuous Flow Left Ventricular Assist Device: A Prospective Study Using the INTERMACS Registry. U.P. Jorde, S.S. Khushwaha, A.J. Tatooles, et al. Presented at the ISHLT annual meeting, April 25, 2013.

CLINICAL STRATEGIES AND OUTCOMES IN ADVANCED HEART FAILURE PATIENTS OVER 70 YEARS OF AGE RECEIVING THE HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE: A COMMUNITY HOSPITAL EXPERIENCE Robert M. Adamson, MD, Marcia Stahovich, RN, Suzanne Chillcott, BSN, Sam Baradarian, MD, Joseph Chammas, MD, Brian Jaski, MD, Peter Hoagland, MD, Walter Dembitksy, MD

Presented at the 29th annual meeting and scientific sessions of the International Society for Heart and Lung Transplantation, April 2009, Paris, France.

Event Rate

MAJOR ADVERSE EVENTS

Adamson et al. JACC 2011

SHARP DT EXPERIENCE 

JACC elderly population Low stroke rate  Minimal anticoagulation  Need to maintain BP to avoid syncope in elderly 

HEARTMATE II VS. TRANSPLANT SURVIVAL COMPARISON

39

RESULTS Factor

Transplant

HeartMate II

(N=59)

(N=102)

52

63

P