UMHS Center for Circulatory Support

Program Overview

1st Generation

3rd Generation

2nd GenerationPulsatile Technology

Continuous Flow TechnologyAxial Design

Continuous Flow TechnologyCentrifugal Design

FDA ApprovedBTT 1998DT 2002

FDA ApprovedBTT 2008DT 2010

Investigational

o Minaturizationo Durability

Bearings with stator

Bearingless with magnetic levitation

Ventricular Assist Device Innovation

Bearings

Indications For VAD Implant

• Bridge to Transplant (BTT)– NYHA Class III-IV end-stage left ventricular failure– Received optimal medical therapy for at least 60 of the last 90 days– Life expectancy of less than two years

• Destination Therapy (DT)– All of the above– Not candidates for cardiac transplantation

• Bridge to Recovery– Acute events ie. MI, viral

• Bridge to Decision– Unknown eligibility for cardiac transplantation– Short term devices

Center for Circulatory Support Goals

The Center for Circulatory Support will:

• Be a leading program world-wide for the treatment of cardiogenic shock and advanced heart failure with MCS therapy

• Provide best practice care that is integrated across disciplines offering optimal support of patients and their families

• Be a world leader in research for MCS technologies. As new devices become available, both in clinical trials and after FDA approval, UM patients will be the first to benefit from their use

• Refine our techniques and procedures as a leader in setting the standard for MCS technologies

• Be recognized as the center that “trains the trainers” while training physicians and healthcare providers from around the world

Adult VAD Program

C

CardiovascularCenter

Center for Circulatory SupportDirector

Francis Pagani, MD, PhD

CV SurgeonsJonathan Haft, MD

Matthew Romano, MD

Nurse ManagerSpecial ProgramsJanice Norville, RN

MSN, MSBA,

Pre & PostTransplant

Nurses

HeartFailureNurses

VAD ResearchSarah Fox, BA

Lydia McGowan, MS

PharmacyAngela Clark, PharmDSimona Butler, PharmD

Ujjaini Khgnderia, PharmD

Physical &Occupational

TherapyDietary

Social WorkRuth Halben, MSW Jennifer Reinstein-Campbell, LLMSWErin Spangler. LLMSW

BiomedicalDavid Marlow, CBET

Nursing

Cardiac PerfusionJan Aukerman, CCPRussell Butler, CCPJackie Conliffe, CCP Kevin Griffith, CCP

CVICU (CVC 4)Unit ManagerJole’ Mowry,

RN, MSN

4CUnit Manager

Bethany Lee-Lehner, RN

VAD CoordinatorsDeb Blissick, RN

Teresa Colaianne, RN, BSNRena Lucier, RN, MS

Terry Mayville, RN, BSN

ReferringPhysicians

EMS FamilyExtended

Care Facilities

HomeHealth

Cardiac Rehab

Medical Director of OutpatientMechanical Circulatory

SupportJennifer Cowger, MD

Advanced Practice ProfessionalKevin Knott, MS, PA-C

Administrative Specialist

Mark White, B.S.,MBA

Administrative Assistant

Lori Brenneman

FinancialAnne Maskill

SupervisorVAD Program

Maureen Daly-MyersRN, BSN

VAD Team

Advance Heart Failure Program

Ancillary Groups

Support

Program History

• 1996: Program established under the direction of Dr. Pagani; First HeartMate IP implant

• 1997: First patient to be discharged to home on LVAD support

• 2000: Participated in REMATCH Trial (use of VADs for permanent therapy)

• 2002: First 100 implanted patients

• 2003: First patient to be discharged to an Extended Care Facility

• 2004: First implant of the HeartMate II LVAD; Training center for Thoratec Inc

• 2007: First implant of the DuraHeart LVAD; Training center for TerumoHeart Inc

• 2008: >300 long-term LVAD implants; Program achieves Advanced Certification from The Joint Commission

• 2009: First implant of the HeatWare LVAD

• 2010: Awarded $14.9 million dollar contract from the NHLBI to study the use of LVADs in less advanced stages of heart failure

• 2011: 100+ ongoing patients at home; > 430 primary implants

• 2012: Longest surviving patient in the world on continuous support with the HearMate II LVAD (8 years) was on the initial pump (7 years).

Total Long-term VAD Implants

19961997

19981999

20002001

20022003

20042005

20062007

20082009

20102011

0

10

20

30

40

50

60

70

80

3

1014 13

2520

2824

28 26

35 3641

49

76

40

CCS Total VAD Implants per Year

Program Strengths

• Highly skilled and experienced team• Longevity of staff in multiple disciplines• Internationally recognized faculty and staff• Multidisciplinary team approach• Participation and leader in clinical trials • Exceptional patient outcomes

Program Advancements & Improvements

•Device Proficiency review bi-annually.•Outreach Program development in process.•Internal web page to share and disseminate program

and device information.•New VAD Support Group (Meets 2x/month).•Enhanced Outpatient Ambulatory Services through a

shared collaborative model with Heart Failure

Cardiologist and Cardiac Surgeons.

INTERMACS

• INTERMACS® (Interagency Registry for Mechanically Assisted Circulatory Support)

• National registry for patients who are receiving FDA approved mechanical circulatory support device therapy to treat advanced heart failure. 

• Registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives.

INTERMACS

• Participation in INTERMACS is MANDATORY to receive CMS reimbursement for Destination Therapy (DT)

• Participation as a center in good standing is required by The Joint Commission for Advanced Certification

The Joint Commission Advanced Certification

• For the adult VAD DT population.• Requires strong infrastructure and support from program

administration.• Must be an active continuous member of a national registry

(INTERMACS).• Have a Board Certified Cardiac Surgeon who has implanted at least

10 devices over the last 36 months.• Certification requires on site survey every 2 years with an intra-cycle

review during the off year. • Monthly data collection with quarterly data submission on four

performance measures.• Show continuous improvement activities through regular clinician &

DSC program staff meetings.

Performance Measures

– Patient 1yr Survival Rate

– Length of Stay (Post-op Index Hospitalization)

– Major Bleeding

– Major Device Infection

Rolling 1-yr Survival Rate 2010-2011

Jan

Feb Mar Apr

May

June Ju

lyAug

Sept

OctNov Dec Ja

nFeb M

ar AprM

ayJu

ne July

AugSep

t0

20

40

60

80

100

120

68.3

82.3

73

87

89

89

89.8

98.1

96.2

90.594.1

94.7

90.5

94.6

92.5

91.5

93

92.2

92.8

92.1

91.4

1-yr Survival 2010-July 2011

Months

%

Survival Benchmark - Intermacs

2008-2010 Index LOS

Jan

Feb Mar Apr

May

June Ju

lyAug

Sept

Oct

Nov Dec Jan

Feb Mar Apr

May

June Ju

lyAug

Sept

Oct

Nov Dec

0

10

20

30

40

50

60

42

21

31

16

23 21

26

33

43.5

22 19.5

1518

55

36.5

30

38.5

28

21

1920

26

33

28

Median Index Length of Stay January 2010-December 2011

Goal: 20 days post implant

Months

Da

ys

Hospital LOS 2010-2011

• Performance Measures– Length of Stay (Index

Hospitalization)

• 2010 (58 Patients)– LOS 26 days

• 2011 (37 Patients)– LOS 29 days

10' 11'24

25

26

27

28

29

30

Major Bleeding 2010-2011

• Performance Measures– Major Bleeding (Returned to

OR for bleeding or received 4 units

PRBC’s after original implant)

• 2010– 7/61 (11.5%)

• 2011– 4/39 (10.3%)

10' 11'0

10

20

30

40

50

60

70

Bleed.Non Bleed

Major Device Infection 2010-2011

• Performance Measures– Major Device Infection

• 2010– 1/61(1.64%) Patients with

major device infections• 2011

– 1/39 (2.56%)Patients with major device infection

10' 11'0

10

20

30

40

50

60

70

InfectionNon Infection

INTERMACS: June, 2006 – June, 2011

Program Challenges

• Dissemination of knowledge within institution• Hospital Policy Development (Transport, ACMS, MPU)• Maintaining competency/training

– Education• Patient• Healthcare Providers• Referral Physicians• Community

• Continual communication– Allowing team to optimize care

• Maintaining operational and service management with increasing patient volume– 100+ patients at home.