Presentation on theme: "UMHS Center for Circulatory Support Program Overview."— Presentation transcript:
UMHS Center for Circulatory Support Program Overview
1 st Generation 3 rd Generation 2 nd Generation Pulsatile Technology Continuous Flow Technology Axial Design Continuous Flow Technology Centrifugal Design FDA Approved BTT 1998 DT 2002 FDA Approved BTT 2008 DT 2010 Investigational o Minaturization o 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 Cardiovascular Center Center for Circulatory Support Director Francis Pagani, MD, PhD CV Surgeons Jonathan Haft, MD Matthew Romano, MD Nurse Manager Special Programs Janice Norville, RN MSN, MSBA, Pre & Post Transplant Nurses Heart Failure Nurses VAD Research Sarah Fox, BA Lydia McGowan, MS 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 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 VAD Coordinators Deb Blissick, RN Teresa Colaianne, RN, BSN Rena Lucier, RN, MS Terry Mayville, RN, BSN Referring Physicians EMSFamily Extended Care Facilities Home Health Cardiac Rehab Medical Director of Outpatient Mechanical Circulatory Support Jennifer Cowger, MD Advanced Practice Professional Kevin Knott, MS, PA-C Administrative Specialist Mark White, B.S.,MBA Administrative Assistant Lori Brenneman Financial Anne Maskill Supervisor VAD Program Maureen Daly-Myers RN, 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
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
Survival Benchmark - Intermacs
Hospital LOS Performance Measures –Length of Stay (Index Hospitalization) 2010 (58 Patients) –LOS 26 days 2011 (37 Patients) –LOS 29 days
Major Bleeding Performance Measures –Major Bleeding ( Returned to OR for bleeding or received 4 units PRBCs after original implant ) 2010 –7/61 (11.5%) 2011 –4/39 (10.3%)
Major Device Infection 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
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.