UMHS Center for Circulatory Support Program Overview.
Post on 29-Mar-2015
223 Views
Preview:
Transcript
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.
top related