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UMHS Center for Circulatory Support Program Overview

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Presentation on theme: "UMHS Center for Circulatory Support Program Overview"— Presentation transcript:

1 UMHS Center for Circulatory Support Program Overview

2 Ventricular Assist Device Innovation
1st Generation 3rd Generation 2nd Generation Pulsatile Technology Continuous Flow Technology Axial Design Centrifugal Design FDA Approved BTT 1998 DT BTT 2008 DT Investigational Minaturization Durability Bearingless with magnetic levitation Bearings with stator Bearings

3 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

4 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

5 Adult VAD Program Ancillary Groups Support VAD Team
Cardiovascular Center CV Surgeons Jonathan Haft, MD Matthew Romano, MD Center for Circulatory Support Director Francis Pagani, MD, PhD Medical Director of Outpatient Mechanical Circulatory Support Jennifer Cowger, MD Supervisor VAD Program Maureen Daly-Myers RN, BSN Advanced Practice Professional Kevin Knott, MS, PA-C VAD Research Sarah Fox, BA Lydia McGowan, MS Nurse Manager Special Programs Janice Norville, RN MSN, MSBA, VAD Team Advance Heart Failure Program Ancillary Groups Support VAD Coordinators Deb Blissick, RN Teresa Colaianne, RN, BSN Rena Lucier, RN, MS Terry Mayville, RN, BSN Administrative Specialist Mark White, B.S.,MBA Administrative Assistant Lori Brenneman Pre & Post Transplant Nurses Heart Failure Nurses Pharmacy Angela Clark, PharmD Simona Butler, PharmD Ujjaini Khgnderia, PharmD Physical & Occupational Therapy Dietary Social Work Ruth Halben, MSW Jennifer Reinstein- Campbell, LLMSW Erin Spangler. LLMSW Financial Anne Maskill Biomedical David Marlow, CBET Nursing Cardiac Perfusion Jan Aukerman, CCP Russell Butler, CCP Jackie Conliffe, CCP Kevin Griffith, CCP CVICU (CVC 4) Unit Manager Jole’ Mowry, RN, MSN 4C Unit Manager Bethany Lee-Lehner, RN Referring Physicians EMS Family Extended Care Facilities Home Health Cardiac Rehab

6 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).

7 Total Long-term VAD Implants
Includes re-implants Data taken from 10/4/11

8 Highly skilled and experienced team
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

9 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. Anything else? Need to work on wording of each point Think about things we need to do before then (projects, etc…)

10 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.

11 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

12 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.

13 Performance Measures Patient 1yr Survival Rate Length of Stay (Post-op Index Hospitalization) Major Bleeding Major Device Infection

14 Rolling 1-yr Survival Rate 2010-2011

15 Survival Benchmark - Intermacs

16 Index LOS

17 Hospital LOS 2010-2011 Performance Measures
Length of Stay (Index Hospitalization) 2010 (58 Patients) LOS 26 days 2011 (37 Patients) LOS 29 days

18 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%)

19 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

20 INTERMACS: June, 2006 – June, 2011

21 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.


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