SHA24/048002

VAD Overview Dr. Hani Najm King Abdulaziz Cardiac Center National Guard - Riyadh

The Problem • Heart failure is the most malignant disease in the world, • Worse prognosis than cancer • When medical therapy reaches its limits, heart transplantation becomes the most effective therapy • Availability of healthy hearts for transplantation is a major hurdle • Time of patients awaiting for heart transplant is increasing

The problem • In USA 40 000 new cardiac failure patients awaits donor heart for transplantation • Only 2300 are transplanted (<10%) • Only 1 in 24 pts who desperately need heart transplant receive donor heart • Most these patients die on the waiting list or deteriorate in status • Assist devices is the only way in keeping these patients alive in good health to receive HTX

Indication for assist devices • • • • • • • •

Idiopathic dilated cardiomyopathy Ischemic cardiomyopathy Fulminant myocarditis End-stage Valvular heart disease Cardiogenic shock Right heart failure Acute rejection Post-cardiotomy heart failure

Device selection â&#x20AC;˘ Based on expected duration of support Duration of support

Intent to treat

Short-term (up to 4 wks)

BTB, BTR (post cardiotomy)

mid-term (1-6 mons)

BTT/BTR(myocarditis, postcardiotomy, DCM)

Long-term (>6 mos)

BTT/BTR/DT

Blood Pumps Total Artificial Heart

Assist Devices

Rotary Continuous Blood Pumps Axial Pump

Centrifugal Pump

- Incor - Duraheart - DeBakey - Ventracor - Jarvik 2000 - HeartMate III - HeartMate II - CorAide - Impella - Biopump

Displacement Pulsatile Blood Pumps Paracorporeal

Intracorporeal

- Excor - Novacor - Thoratec VAD - HeartMate I (IP &VE) - MEDOS - Lion Heart - BVS 5000 - Thoratec IVAD - IABP - Roller pump

- AbioCor - Cardiowest

Rotary Continuous Blood Pumps

Advantage / Disadvantage of Rotary Continuous Blood Pumps Advantages: • Smaller size (BSA <1,5m²) • Simplicity of operation • Low power consumption • High durability and reliability • Low infection rate • Silent Disadvantages: • High costs • Flow depends on preload and afterload • Backflow when pump stopped

Axial

vs. centrifugal

• Generate higher flows at lower pressure rise • More rotational speed • Tubular configuration • Less time to implant • Weighs less

• Produce high pressure at lower flow rates • Less rotational speed • Discoid configuration • Larger pocket for implantation • Weighs more

Axial Flow Pumps

INCOR® • • • • • •

LVAD Indication: BTT, BTR, DT CE approved Magnetic bearings (no wear) Placed in the thorax (no abdominal pocket) Possibility of lateral or medial implantation

INCOR速

DeBakey VAD® • • • • • • •

Lvad Indication: BTT, BTR, DT CE approved 7000-12000 rpm 6-10 L / min Mechanical bearing Abdominal placed

Jarvik 2000 • • • • • • •

LVAD indication: BTT, BTR, DT CE approved mechanical bearings 2-7 L/min at pressure of 100 mm gh fits directly into the left ventricle possibility of lateral or medial implantation

HeartMate® II • • • • • • • •

Lvad Indication: BTT, BTR, ATT Mechanical bearings Abdominal placed Up to 10 L of flow Multicenter trial started in US In november 2003 Recently redisigned and reintroduced Currently not available

Impella®Recover • • • • • •

LVAD, RVAD, BIVAD indication: BTR (7days), BTB used in beating heart surgery CE approved Up to 30 000 RPM 3.5-4.5 L/min at a mean presure 50-60 • small size (Ø = 6.4 mm)

Centrifugal Pumps

DuraHeart LVAS ™ • • • • • • •

LVAD indication: BTT, BTR, ATT magnetic bearings (no wear) abdominal placed Jan. 2004: start of europe clinical trial currently not available Few implants

CorAide™ • • • • • • • • •

LVAD indication: BTT, BTR, ATT hydrodynamic bearings abdominal placed fully implantable assist device (TETS) stopped the europe clinical trial after 1 implantation Recently modified new version 3 successful implants of modified version Implants done in Bad Oeynhausen

Pulsatile Pumps

Advantage / Disadvantage of Displacement Pulsatile Pumps Advantages: • • • •

Flow depends not on preload and afterload Lower cost than rotary blood pumps Plenty of experiences No backflow

Disadvantages: • • • • •

Big size (BSA >1,7m²) High infection rate Low durability and reliability High power consumption Noisy

Paracorporeal Pumps

EXCOR® • • • • • •

•

LVAD, RVAD, BIVAD Indication: BTT, BTR CE approved Used for adults and pediatric Pneumatically driven blood pump Two types of drive units: One for stationary and one for Mobile patients > 850 implants

Thoratec®VAD • • • • •

LVAD, RVAD, BIVAD indication: BTT, BTR FDA and CE approved pneumatically driven blood pump two types of drive units: one for stationary and one for mobile patients • > 2300 implants

MEDOS-VAD-System • • • • • • • •

LVAD, RVAD, BIVAD Indication: BTT, BTR CE approved Used for adults and pediatric Pneumatically driven blood pump Two types of drive units: One for stationary and one for mobile patients Limited to 8 wks support > 500 implants

Abiomed BVS-5000® • • • • • • •

LVAD, RVAD, BIVAD Indication: BTR up to 90 days, BTB FDA and CE approved Pneumatically driven blood pump Patient mobility is limited Very simple to operate Used in more than 3000 patients

Intracorporeal Pumps

Novacor®LVAS • • • • • • • • • •

LVAD indication: BTT, BTR, ATT FDA and CE approved electromechanically driven blood pump abdominal placed Bioprosthetic valves PTFE inflow and outflow grafts Low infection rate Acceptable TE events > 1500 implantations

HeartMate I ®

• • • •

•

• •

LVAD Indication: BTT, BTR, ATT FDA and CE approved Pneumatically (IP) driven or electrically (VE) Powered blood pump Textured blood surface have greatly reduced The need of anticoagulation Increased infection rate > 3600 patients

LionHeart™ • • • • • •

LVAD indication: BTT, BTR, ATT fully implantable assist device (TETS) electrically powered blood pump currently under trial evaluation > 25 implantations

Thoratec®IVAD • • • • • • •

LVAD, RVAD, BIVAD indication: BTT, BTR pneumatically driven blood pump small size first implantable biventricular system 32 implants CE approved

Total Artificial Heart

Jarvik 7 = Cardiowest (Total Artificial Heart) • • • • • •

TAH indications: BTT CE approved pneumatically driven blood pump patient mobility is limited big size

Other Systems

ECMO • ECMO is a modification of a heart-lung-machine • Mechanical assistance system for cardiac (LVAD, RVAD, BIVAD) And pulmonary support (in combination with an oxygenator) • Indications: BTR, BTT up to 30 days, BTB • Two types of ECMO pumps: - Roller pump for pediatric support - Centrifugal pump for adults

Device selection Duration of support

Intent to treat

Device

Short-term (up to 4 wks)

BTB, BTR (post cardiotomy)

Abiomed, centrifugal pump

mid-term (1-6 mons)

BTT/BTR(myocarditis, postcardiotomy, DCM)

Thoratec, cardiowest

Long-term (>6 mos) BTT/BTR/ATT

Novacor, Heartmate, Lionheart, Abiocor,

Outcome determinants • • • • • • •

Dedicated team Selection of patient Evaluation of RV function End organ function Control of infection Prevention of thrombo-imbolism Out of hospital program

Conclusions • Assist devices has become very valuable in management of patients with heart failure • Careful selection and detailed management is detrimental • Cost versus benefit has to be weighed • Availability of more than one device to the surgeon is crucial to fit the indication • Knowledge of the available devices with outcome is important

HeartMate II

速

Left Ventricular Assist System (LVAS) The New Era Begins

Contents  Introducing the HeartMate II  Indications for use  Clinical experience

43

HeartMate II LVAS  A surgically implanted, rotary continuous-flow device in parallel with the native left ventricle – Left ventricle to ascending aorta

 Percutaneous driveline  Electrically powered – Batteries & line power

 Fixed speed operating mode  Home discharge 44

Benefits of a Rotary Device  Smaller size – 60% Smaller than HeartMate I (XVE) – 35 mm diameter – 70 mm long – 280 grams

 No requirement for venting ― 40% reduction in the size of percutaneous lead

 Enhanced patient comfort  Silent, vibration-free operation  Ease of surgical implantation ― Standard sternotomy vs. extended midline excision ― Smaller preperitoneal pocket

 Designed for extended durability 45

Key Design Features  Elegant Design – Valveless – Only one moving part, the rotor – Blood immersed bearings designed for minimization of blood damage – All motor drive and control electronics are outside of the implanted blood pump

 Two piece outflow conduit  Speed range: 6,000 to 15,000 rpm  Flow range: 3 – 10 L/min

System Components  Implanted Components: – Implantable titanium blood pump

 External Components: – – – –

System Controller System Monitor Display Module Power Sources Power Module Batteries & Clips Emergency Power Pack

– Accessories 47

HeartMate II LVAS Pump  Flexible inflow conduit  Textured surfaces – Inlet cannula, inflow and outflow elbows – Thrombo-resistant

 Outflow graft with bend relief  Anastomosed to LV apex and ascending aorta  Pump output varies over cardiac cycle – Follows native pulse – Afterload sensitive

Pump Rotor and Stators Flow

Outflow Stator

49

Inflow Stator

Rotor Outflow Bearing

Inflow Bearings

HM II System Controller Microprocessor that:  Delivers power to the pump  Controls pump speed and power  Monitors, interprets & responds to system performance  Performs diagnostic monitoring  Indicates hazard and advisory alarms  Provides complete backup system  Automatic event recording  Data logger capabilities

HeartMate II Power Sources  AC power from Power Module (PM)  DC power from a pair of 14-volt lithium-ion batteries and clips  DC power from the Emergency Power Pack (EPP)

51

14-Volt Lithium-Ion Batteries  Full work day of support on a single charge (10 hours per pair)  Weigh approx 1 pound each  Smart technology results in optimal charging, accurately gauges charge level and ensures battery lifespan (up to three years)  Four hour recharge for fully discharged battery 52

Universal Battery Charger  Rapid charging (4 hours for 4 batteries) minimizes the number of batteries required for excursions – reduces the burden of battery management  Continuous diagnostic testing and automatic calibration delivers consistent battery performance • Intuitive light indicators provide readily-accessible battery status  Highly portable – 8 pounds 53

Power Module  Supplies AC power to HM II  Provides 30 minutes of backup power in case of AC power failure  Simple, effective light indicators and audio alarms give immediate feedback on system operation  Automobile port offers patients the added convenience of “plugging in” while in the car  Repeats alarms generated by the System Controller  Powers the System Monitor and Display Module for system programming and monitoring purposes 54

Emergency Power Pack  Single use battery pack enclosed in a plastic carrying case with a shoulder strap  Provides battery power to the HM II in the event of extended power outage  Approximately 12 hours of support  Must be replaced if used for a period exceeding three hours 55

Shared HeartMate Components System Monitor  Provides data about HM II function when the patient is on tethered operation  Six screens, touch interface  The only place in the system where the fixed rate setpoint and low speed limit can be adjusted  Ability to download HM II data & view system controller event recorder  Appropriate software implemented upon system controller connection

Display Module  Provides a display of system performance (pump rate, pulsatility, flow,and alarms) 56

Contents  Introducing the HeartMate II  Indications for use  Clinical experience

57

Indications for Use  Bridge to Transplant – Non-reversible left heart failure – Imminent risk of death – Candidate for cardiac transplantation

 Destination Therapy — NYHA Class IIIB or IV heart failure — Optimal medical therapy 45 of last 60 days — Not candidate for cardiac transplantation

 For in-patient and out-patient use 58

Contents  Introducing the HeartMate II  Indications for use  Clinical experience

59

Worldwide Clinical Experience* More than 10,000 patients worldwide have now been implanted with the HeartMate II LVAS.

• • • • • • • 60

2-3 years = 1151 3-4 years = 428 4-5 years = 174 5-6 years = 73 6-7 years = 19 7 -8 years = 3 8-9 years = 1 (ongoing) As of June 2012

*Based on clinical trial and device tracking data

Worldwide Clinical Experience > 10,000 Patients Implanted

Pivotal Trial

Commercial

n=1315*

Experience

*as treated

n>9000

Pilot Trial n=53 (+114 XVEs)

Bridge to Transplant

Destination Therapy

n=490

n=825

BTT Approvals

DT Approvals

CE Mark: Nov. 2005

CE Mark: Nov. 2005

FDA: Apr. 2008

FDA: Jan. 2010

Health Canada: May 2009

61

As of Apr 2012

Health Canada: Nov. 2010

BTT Actuarial Survival Post Approval Study

100 90

a

Post-Trial Post-Approval Studyb Late Trialc

Percent Survival

80

Early-mid Triald

70

Early Trial

60 Implant dates a Apr ’08 - Oct ‘10 b Apr ’08 - Aug ‘08 c Mar ’07 - Apr ‘08 d Mar ’05 - Mar ‘07 e Mar ’05 - May ’06

50 40 30 20

30 d 95% 96% 95% 92% 89%

6 Mo 89% 90% 86% 82% 75%

a John et al.ATS 2011

12 mo 85% 85% 80% 73% 68%

ab Starling Johnet aletJACC al 2011 STS 2011 b Starling et al JACC (in press) et al JACC 2009 dd Pagani Pagani et al JACC 2009 et al NEJM 2007 ee Miller Miller et al NEJM 2007

10 0 0 62

n 1496 169 205 281 133

6

12 Months

e

Adverse Events Adverse Event

Trial1 n = 486

Post Approval Study2 n = 169

Stroke Ischemic Hemorrhagic Unknown

0.05 eppy 0.05 eppy 0.0 eppy

0.06 eppy 0.01 eppy 0.01 eppy

0.06 eppy 0.02 eppy 0.02 eppy

0.23 eppy

NR

0.12 eppy

RVAD

7%

3%

1%

Device Replacement (through 12 months)

5%

NR

1%

Bleeding requiring surgery

Posttrial Group1 n= 1496

Patients in the commercial environment experienced a reduced or similar rate of adverse events in a broader patient care environment compared to clinical trial patients.

Only 10% of HM II patients in a commercial setting had GI bleeding 3 1. John R, Naka Y, et. al. Continuous Flow Left Ventricular Assist Device Outcomes in Commercial Use Compared with the Prior Clinical Trial. Ann Thorac Surg 2011; 92:1406-13.

2. Starling RC, Naka Y, Boyle AJ, et al. Results of the Post-U.S. Food and Drug Administration-Approval Study With a Continuous Flow Left Ventricular Assist Device as a Bridge to Heart Transplantation. JACC 2011;

63

57(19): 1890-8.

Quality of Life

Improvements seen here from the post-trial study with ~1500 patients are consistent with the improvements observed during the pivotal trial and the postapproval study 64

John R, Naka Y, et. al. Continuous Flow Left Ventricular Assist Device Outcomes in Commercial Use Compared with the Prior Clinical Trial. Ann Thorac Surg 2011; 92:1406-13.

Discussion/Conclusions • The HM II post-approval & post-trial studies demonstrate a significant improvement in survival outcomes in a broader patient care setting.

• Dramatic improvements in QoL, first seen during the BTT pivotal trial, continue to be observed • Factors contributing to improving trends: – – – – – – –

65

Improved timing of patient referral Better patient selection Enhanced implantation techniques Improved post-op patient management Increased knowledge and team training Higher surgery volume More dedicated coordinators and experienced patient care teams

Summary of DT Outcomes Reference

Study

Enrollment period

n

One-Year Survival

Two-Year Survival

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

HM II Pivotal Trial

3/05- 5/07

134

68%

58%

Park, S, et al Circ Heart Fail 2012.

HM II Pivotal Trial

5/07- 3/09

311

73%

63%

66

Improvements in DT Survival Early Trial vs Mid Trial

Average Support Duration

100

Early Trial = 2.1 ± 1.8 years (Longest: 6 years) Mid Trial = 1.8 ± 1.2 years (Longest : 4 years)

90 80

73 ± 3%

Mid-Trial (N=281)

Survival (%)

70

63 ± 3% 68 ± 4%

60

Early Trial (N=133)

58 ± 4%

50 40 P (Log-Rank)=0.209

30 20

At Risk

10

281 133

0

215 95

187 82

165 69

6

12

18

0

Time (Months) 67

Park, S, et al Circ Heart Fail 2012.

146 62

24 for body surface area * P value adjusted

DT Trial CAP: Background Background

Survival in Destination Therapy Trials2

• Initial HeartMate II Destination Therapy (DT) trial demonstrated significant improvements in outcomes compared to randomized patients with pulsatile LVADs1

– 68% survival at 1 year – 58% survival at 2 years • Over 500 additional DT patients have been enrolled under continued access protocol (CAP) 1 2

68

Slaughter MS, Rogers JG, Milano CA et al: Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51.

Fang JC: Rise of Machines – Left Ventricular Assist Devices as Permanent Therapy for Advanced Heart Failure N Engl J Med. 2009 Dec 3;361(23):2282-84.

Park, S, et al Circ Heart Fail 2012.

DT Trial CAP: Adverse Event Summary Improvements in Adverse Event Rates: Early to Mid Trial Stroke (events per pt-year) Relative Risk Ratio

* Infection (events per pt-year)

*p<0.05 **p<0.01 69

Park, S, et al Circ Heart Fail 2012.

**

*

DT Trial CAP: Functional Class Improvements 6-Minute Walk Test and NYHA Functional Class I & II

NYHA Class I or II

Pts Tested: 125 267

70

Park, S, et al Circ Heart Fail 2012.

85 191

73 161

58 130

59 103

HeartMate II Pivotal Trial 

FDA approved Investigational Device Exemption (IDE) for two clinical studies: 1. Bridge to Transplantation (BTT) – patients enrolled at 33 sites — Primary cohort enrollment completed May, 2006 — Six month follow-up completed November, 2006 — Approved April, 2008

1. Destination Therapy (DT) – patients enrolled at 38 sites ― ― ― ― 71

Randomized 2:1; HeartMate II vs. HeartMate I Primary cohort enrollment completed May, 2007 Two year follow-up completed May, 2009 Approved January, 2010

History of DT – REMATCH Trial

NEJM 2001;345(20):1435-43.

72

History of DT – REMATCH Trial  Randomized clinical trial – optimal medical therapy vs. pulsatile flow LVAD  Non-transplant candidates (n=129) – EF ≤ 25%, – peak VO2 < 12 ml/kg/min, – or continuous infusion inotropes  FDA approval for HM I (XVE) as destination therapy 73

NEJM 2001;345(20):1435-43.

HeartMate II DT Results (n=200)

NEJM 2009;361(23):2241-51.

74

Comparison of HM I (XVE) and HM II HM II with controller and batteries

HM I

HM I

HM II

Weight (gm)

1250

280

Volume (ml)

450

63

Audible

Silent

Moving parts

Many

One

Maximal flow (l/min)*

10

10

1.5

Est. > 5

Noise HM II

Clinical Durability (yr)

* at mean pressure=100 mm Hg

75

HM II DT Clinical Trial Entry Criteria  LVEF ≤ 25%  Peak VO2 < 14 ml/kg/min (or 50% age/sex predicted)  And either

— NYHA Class IIIB or IV heart failure symptoms despite optimal medical therapy for at least 45 of prior 60 days or — Dependence on IV inotropes for at least 14 days, or — Dependence on an IABP for at least 7 days

 Not a candidate for transplantation  No irreversible renal, pulmonary or hepatic dysfunction or active infection NEJM 2009;361(23):2241-51.

76

DT Clinical Trial Design   

Multicenter, non-blinded, randomized, prospective study 200 patients randomized 2:1 (HeartMate II: HeartMate I (XVE)) Primary composite end-point (Intention-to-Treat): –



Survival at 2 years without disabling stroke (Rankin score > 3) or re-operation to replace or repair the device

Secondary endpoints (As-Treated): – – – –

Actuarial survival Functional status: NYHA class, 6 minute walk distance Quality of Life: Minnesota Living with Heart Failure and Kansas City Cardiomyopathy Questionnaires Adverse Events

NEJM 2009;361(23):2241-51.

77

Baseline Characteristics CF LVAD (HM II) (n=134)

PF LVAD (HM I) (n=66)

p

62 ± 12

63 ± 12

0.81

Female

19%

8%

0.04

BSA (m2)

2.0 ± 0.3

2.1 ± 0.3

0.54

Ischemic Etiology

66%

68%

0.75

Prior stroke

16%

17%

0.84

Contraindications to TX Age Obesity Pulmonary Hypertension Diabetes Renal dysfunction Non-compliance/ social issues Recent history of cancer

37% 14% 10% 9% 9% 8% 7%

36% 8% 3% 12% 6% 9% 12%

Characteristic Age (yrs)

NEJM 2009;361(23):2241-51.

78

Baseline Characteristics CF LVAD (n=134)

PF LVAD (n=66)

p

17.0 ± 5.5

16.8 ± 5.4

0.81

Central venous pressure (mmHg)

13 ± 6

13 ± 8

0.67

PCWP (mmHg)

24 ± 8

24 ± 9

0.82

2.0 ± 0.6

2.1 ± 0.6

0.36

134.7 ± 4.3

133.9 ± 6.0

0.31

Serum creatinine (mg/dL)

1.6 ± 0.6

1.8 ± 0.7

0.08

Concomitant therapies Inotropic agents CRT ICD IABP Mechanical ventilation

77% 63% 83% 22% 7%

83% 59% 79% 23% 9%

0.36 0.64 0.56 1.00 0.57

10.4 ± 5.4 18 %

9.9 ± 4.7 8%

0.78 0.06

Characteristic LVEF (%)

Cardiac Index (l/min/m2) Serum sodium (mmol/L)

DT Risk Score high/very high NEJM 2009;361(23):2241-51.

79

Primary Endpoint Survival at 24 months, free from disabling stroke or re-operation for device replacement (intention-to-treat) Primary Composite Endpoint (% of Patients)

Percent of Patients

60

62/134 (46%) P<0.001

50 40

7/66 (11%)

30 20 10 0 CF LVAD

NEJM 2009;361(23):2241-51.

80

PF LVAD

Actuarial Survival

NEJM 2009;361(23):2241-51.

81

Actuarial Survival vs REMATCH

NEJM 2009;361(23):2241-51. NEJM 2001;345(20):1435-43.

82

Adverse Events CF LVAD (n=133) [211 pt-years]

Pump Replacements Stroke Ischemic Hemorrhagic Device-related infection Local non-device infection Sepsis Bleeding Bleeding requiring PRBC Bleeding requiring surgery Other Neurological Right Heart Failure Extended Inotropes RVAD Cardiac Arrhythmias Respiratory Failure Renal Failure Hepatic Dysfunction Device Thrombosis Re-hospitalizations

PF LVAD (n=59) [41 pt-years] Risk Ratio [95% Confidence Interval]

Events/pt yr

Events/pt yr

0.06 0.13 0.06 0.07 0.48 0.76 0.39

0.51 0.22 0.10 0.12 0.90 1.33 1.11

<0.0 0.2 0.3 0.3 0.0 0.0 <0.0

1.66 0.24 0.17

2.45 0.29 0.29

0.0 0.5 0.1

0.14 0.02 0.69 0.31 0.10 0.01 0.02 2.64

0.46 0.07 1.31 0.80 0.34 0.00 0.00 4.25

<0.0 0.1 0.00 <0.0 <0.0

0.0

NEJM 2009;361(23):2241-51.

83

p-va

Favors CF LVAD

Favors PF LVAD

Leading Causes of Death HeartMate II (N=133)

XVE (n=59)

Hemorrhagic stroke

12 (9%)

6 (10%)

Right Heart Failure

6 (5%)

5 (8%)

Sepsis

5 (4%)

3 (5%)

External Power Interruption

5 (4%)

0 (0%)

Respiratory Failure

4 (3%)

1 (2%)

Cardiac Arrest

4 (3%)

1 (2%)

Bleeding

4 (3%)

0 (0%)

Multisystem Organ Failure

2 (2%)

4 (7%)

Pocket Infection

0 (0%)

3 (5%)

Device Thrombosis

2 (2%)

0 (0%)

Device Failure

3 (2%)

2 (3%)

Ischemic Stroke

1 (1%)

3 (5%)

CAUSE OF DEATH

NEJM 2009;361(23):2241-51.

84

Functional Status

NEJM 2009;361(23):2241-51.

85

Quality of Life

NEJM 2009;361(23):2241-51.

86

Summary and Conclusions • Advanced heart failure patients failing optimal therapies have a poor prognosis • The HeartMate II continuous flow LVAD significantly increases survival, free of disabling stroke and reoperation to replace or repair the device at 2 years • Greater than 2 fold improvement in survival at 2 years compared to the XVE LVAD • Continuous flow LVADs were associated with a reduction in clinically meaningful adverse event rates NEJM 2009;361(23):2241-51.

87

Summary and Conclusions â&#x20AC;˘ Continuous flow LVAD patients experienced early and sustained improvement in exercise capacity, functional class and quality of life â&#x20AC;˘ Results support the use of continuous flow LVAD therapy for long term support in advanced heart failure patients

NEJM 2009;361(23):2241-51.

88

Changes in Cardiac Output During Exercise Constant vs Increased Pump Speed; HeartMate II (n=8)

Brassard P et al Circ Heart Failure 2011

N=896

Adverse Events:

Underweight :

Obese:

Bleeding

Infection,

Rehospitalizations

2 BMI (kg/m ) <18.5 18.5-30 30-35 >35

Brewer et al J Heart Lung Transplant 2012;31:167â&#x20AC;&#x201C;72

The HeartMate II Risk Score: •

Predicting Survival in Candidates for LVAD Support Goals

•

•

•

Patients - HeartMate II Clinical Trial

•

Bridge to Transplant (N=489)

•

Destination Therapy (N=633)

•

Total N=1122

1,2

3

Cohorts

•

•

Derive and validate a risk model for predicting short and longer term survival following continuous flow LVAD implantation.

Patients were prospectively and randomly assigned to either the derivation cohort or to the validation cohort.

Analyses

•

Multivariable analyses were performed to identify risk factors of death following LVAD implantation.

Cowger J, Sundareswaran K, Rogers J, et.al., ISHLT 2011.

Estimated Survival on LVAD Support HeartMate II Risk Score Multivariable Risk Factors

Percent Survival by Risk Group

For Death after LVAD implant 84% at

HR 1.9 per sec HR 1.4 per mg/dl HR 1.3 per 10 yrs HR 0.71 per mg/dL HR 0.67

â&#x20AC;

HR 0.52

Cowger, Sundareswaran, Rogers et al ISHLT 2011

2 yr

Patient Selection for Ventricular Assist Device Therapy in the Elderly: Application of the HeartMate II Risk Score

92% at 12 months

81% at 12 months

Cowger, Sundareswaran, Rogers et al Presented AHA 2011