CARDIOLOGY GRAND ROUNDS

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1 CARDIOLOGY GRAND ROUNDS Title: Valvular Heart Disease at the Minneapolis Heart Institute: Practice and Innovation Speaker: Robert S. Farivar, MD, PhD Chief, Cardiothoracic Surgery, Abbott Northwestern Hospital Chairman, Allina Cardiothoracic; Paul Sorajja, MD Director of the Center for Valve and Structural Heart Disease Mario Goessl, MD, FACC, FAHA, FESC, FSCAI Interventional Cardiologist Minneapolis Heart Institute at Abbott Northwestern Hospital Date: Monday, March 14, 2016 Time: 7:00 8:00 AM Location: ANW Education Building, Watson Room OBJECTIVES At the completion of this activity, the participants should be able to: 1. Describe the underserved population of patients with valvular heart disease. 2. Recall indications and outcomes for minimally invasive valvular heart disease therapies. 3. Recall current innovation trends in the surgical and catheter based therapy of valvular heart disease. Physician: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Allina Health and Minneapolis Heart Institute Foundation. Allina Health is accredited by the ACCME to provide continuing medical education for physicians. Allina Health designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s) TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse: This activity has been designed to meet the Minnesota Board of Nursing continuing education requirements for 1.2 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education. DISCLOSURE STATEMENTS Speakers(s): Dr. Farivar declares the following relationships; Consultant: Abbott Vascular, Edwards LifeSciences, LLC., & Medtronic. Dr. Sorajja declares the following relationships; Consultant & Speaker Bureau: Abbott Vascular; Consultant: Medtronic & Lake Region Medical. Dr. Goessl has declared that he does not have any conflicts of interest to disclose. Planning Committee Dr. Michael Miedema, Dr. Scott Sharkey and Jolene Bell Makowesky have declared that they do not have any conflicts of interest associated with the planning of this activity. Dr. Robert Schwartz declared the following relationship consultant: Boston Scientific. PLEASE SAVE A COPY OF THIS FLIER AS YOUR CERTIFICATE OF ATTENDANCE Signature: My signature verifies that I have attended the above stated number of hours of the CME activity. Allina Health - Learning & Development Chicago Ave - MR Minneapolis MN 55407

2 Grand Rounds: Mitral Update 2016 (Bileaflet and anterior leaflet prolapse) Robert S. Farivar, MD PhD Chief, Cardiac Surgery Minneapolis Heart Institute at Abbott Northwestern Hospital Chair, Allina Health Cardiac Surgical Services Disclosures Dr Farivar is a consultant to Abbott Vascular Edwards Lifesciences Medtronic 1

3 Cardiac Volumes at Abbott Northestern Hospital # Cases # Cases STS Mitral Numbers 140 Surgical Mitral Cases at Abbott Repair Replacement Combined 2

4 Mortality from in mitral repair Zero Expected ~1% Thus Approximately 2 expected with none Complexities of Valve Surgery Aortic Valve Replacement Mitral Valve Repair Cessna Fighter Jet 3

5 ANATOMY What are the 5 parts of the mitral valve? 1. Leaflets (anterior and posterior) 2. Annulus 3. Chordae 4. Papillary muscles 5. Ventricle 4

6 Fibrous Skeleton 5

7 Annuloplasty Suture placement PATHOLOGY 6

8 Carpentier Mitral Functional Classification Based on an assessment of opening and closing motions of both leaflets Type 1- Normal Leaflet Motion - Annular Dilatation - Leaflet Defect 7

9 Type 2 Leaflet Prolapse - Chordal rupture - Chordal elongation - Papillary muscle rupture Type 3a Restricted Leaflet Motion Valvular apparatus systole and diastole 8

10 Type 3b Restricted Leaflet Motion Ventricular - systole Movement towards simplification 9

11 Evolution, not revolution (Semi) Rigid Complete Rings 10

12 Case #1 Early repair in my career: Very complicated 65 y.o. male Severe MR Bileaflet prolapse Repair with resection, plication and neochordae Early in my career, overly complex Case #1 11

13 Case #2 36 y.o. police officer Severe MR Bileaflet prolapse: Barlowe valve Mini rt thor repair Repair with upsized ring, 38 Physio II Pre Repair Post Repair 12

14 Follow Up Case #3 53 yo Karate black belt and electrical engineer Bileaflet prolapse Central to anteriorly directed jet Repair with 34 Physio II 13

15 Pre Repair Post Repair Case #4 65 yo yugoslavian male Anterior leaflet prolapse, ruptured chordae Severe MR Repair Goretex neochordae anterior leaflet and 34 Physio II ring 14

16 Case #4 - Neochordae Pre Repair Post Repair Case # 5 61 yo male Father had MR and a mitraclip Severe MR, bileaflet prolapse 38 Physio II ring repair 34 min XC Contrast with case #1 15

17 Case #5 Intraoperative preop > 1year echo 16

18 MHIF Grand Rounds 2016 Valvular Heart Disease at MHI Practice and Innovation Paul Sorajja, MD Director, Center for Valve and Structural Heart Disease Minneapolis Heart Institute at Abbott Northwestern Hospital Disclosures: Abbott Vascular, Medtronic, Lake Regions Medical, Boston Scientific Key Points Valvular Heart Disease Minimally invasive surgery is the standard Transcatheter therapy is becoming safer beyond high risk, and beyond aortic Despite advancements, valve population is at risk, with huge unmet needs a call to action is needed 1

19 A Look Back into PARTNER Inoperable All-cause mortality (%) 80 Standard Rx TAVI p< Months NNT to save one life: 5 Leon et al., NEJM

20 Bleeding Stroke PVL 16 procedures in one visit Complications in vulnerable patients The Present 30-day outcomes for TF S All-cause mortality Cardiac mortality HR IR PVL = 3.7% 1.6% and 1.1% mortality Risks like PCI 3

21 The Present 14 Fr Evolut R CE mark Mod PVL = 3.4% (no severe) No procedural mortality Repositioning = 25% Next Generation Valves Most 14 to 18 Fr Repositionable, retrievable Sealing skirt 4

22 Innovation in Practice Skipping the ICU at ANW 6 ICU obs No ICU Hospital LOS (d) 0 Home discharge (%) Variable Costs ($) Conscious Sedation Less is More 0.5 mg midazolam 50 mcg fentanyl Next day 5

23 Durability PARTNER 5-yr Follow-Up HR [95% CI] = 1.04 [0.86, 1.24] p (log rank) = % 62.4% No. at Risk TAVR SAVR Tie Goes to the Runner (?) 6

24 Waiting on the Science in TAVR Surgical risk High Intermediate Low Indication Yes This year (?) Trials soon Transcatheter MV Repair MitraClip >30,000 pts worldwide 7

25 MitraClip in the U.S. STS = 10.0% Mortality: 2.3% Success: 91.8% LOS: 3 days Sorajja et al. JACC

26 Tertiary referrals Research Grants MitraClip Training Center MHI at Abbott Northwestern Hospital Basic and Advanced Live Case Courses 9

27 First Transcatheter TMVR in U.S. April 8,

28 With all of these advances, how are we doing? Population at Risk True or False? Survival of symptomatic AS is worse than breast cancer AS is more malignant, yet treatable Johnstone PA, et al. J Surg Oncol 2000;73:

29 Population at Risk How many patients with severe aortic stenosis were evaluated at the Minneapolis Heart Institute in 2015? a) 443 b) 928 c) 1,918 Who are we responsible for? Annual Patients with Severe AS ,918 pts seen pts treated 0 More than we thought, growing, and underserved 12

30 Who are we responsible for? Annual patients with severe MR More than we thought, and growing A disease with poor prognosis that is curable + Vast majority not treated = We can do a lot better 13

31 Guideline Adherence Asymptomatic severe AS Survival free of death or HF hospitalization Not adherent Adherent p= Ahmed and Sorajja ACC Follow-up (mos) Best Practice Alerts 14

32 Valve Dashboard Population management Patient-level, sortable data Who are my patients? Demographics, Diagnosis, Treatment, Costs 15

33 Population Monitoring Survival with severe MR Population Monitoring Timing Intervals 16

34 600 The Halo Abbott Northwestern Hospital 500 surgical valve cases mitral repair surgery transcatheter Halo of Better Outcomes Abbott Northwestern Hospital No AVR AVR 17

35 MHIF Valve Science Center A Call to Action Mission To study and develop methods of care that improve the health of patients with valvular disease MHIF Valve Science Center Objectives 1. Study and gain insight into the barriers to care 2. Design, develop, and implement novel therapies and care pathways 3. Expand the delivery of state-of-the-art care 4. Educate the public on the needs of this population 18

36 MHIF Valve Science Center Research KOL Conference Travel Awards Awareness Trials, ISS Studies Valve Scholar Program Patient, MD Awareness Campaign Staff and Funding MHIF Valve Science Center Major Focus of 2016 They need our support! 19

37 2016 MHIF Gala Keynote Speakers Mark Kelly Scott Kelly Key Points Valvular Heart Disease Minimally invasive surgery is the standard Transcatheter therapy is becoming safer beyond high risk, and beyond aortic Despite advancements, valve population is at risk, with huge unmet needs a call to action is needed Help support the MHIF Valve Science Center! 20

38 Center for Valve and Structural Heart Disease - Research Update - Mario Gössl, MD, FACC, FAHA, FESC, FSCAI Director Research and Education March 14 th 2016 RESEARCH Ongoing trials Overview Mitral valve Aortic valve Upcoming trials / registries / open access Research projects EDUCATION Publications/Presentations Courses 1

39 Research Participating in 7 research trials Participating in 2 open access registries MHI V&SHD program has enrolled: 141 patients into trials 30patients into continued open access MITRAL VALVE TRIALS 2

40 L-M Ongoing trials COAPT Mitraclip for FUNCTIONAL mitral valve regurgitation 1:1 randomization Mitraclip + optimal medical Tx vs. optimal medical Tx alone Enrollment #: 6 Ongoing trials TENDYNE Tendyne Valve for functional or degenerative mitral valve regurgitation 4/8/2015 first transcatheter valve replacement in the US Enrollment #: 9 (2 April) Top enroller 3

41 AORTIC VALVE TRIALS/CAP L Ongoing trials PORTICO St. Jude Medical TAVR for high risk patients (STS 8-15) 1:1 randomization Portico vs any commercially available TAVR valve Enrollment #: 3 (+2 in March) 4

42 L-M Ongoing trials LOTUS REPRISE Boston Scientific Lotus TAVR in high risk patients (STS 8-14) No randomization, now continued open access Enrollment #: 12 (Reprise 3) + 1 H Ongoing trials S3i CAP 2 Edwards S3 TAVR for intermediate risk patients (STS 4-8) No randomization, open access Enrollment #: 7 Edwards total # 78 5

43 M Ongoing trials SURTAVI Medtronic Evolute R, CoreValve TAVR in intermediate risk patients (STS 3-15) 1:1 randomization TAVR vs SAVR Enrollment #: 11 Upcoming trials REFLECT Keystone Heart, Cerebral protection by deflection device, no research TAVR 2:1 Randomization? Reduction of cerebral embolic events during TAVR, impact on cognitive function MRI / Neuro 6

44 Upcoming trials LOW RISK TAVR Medtronic Evolute R, CoreValve 31 1:1 randomization TAVR vs SAVR Non-inferiority trial, safety and effectiveness measured by all-cause mortality and disabling stroke at 2 years H Ongoing CVS trials TRIFECTA & PERIGON Surgical bovine bioprostheses for AVR St. Jude (TRIFECTA) long-term f/u Medtronic (PERIGON) new solo implants Enrollment #: 25 & 13 7

45 RESEARCH Active Intern Projects: 5 Fellow Projects: 4 Investigator led projects: 3 Completed projects that need to be published: 20/22 Publications

46 Publications Manuscripts published: 6 Book chapters: 1 Manuscripts in submission: 3 ACC 16: 5 SCA 16: 7 Education MitraClip 101 and 202 courses (Abbott) Dedicated transseptal access course (Boston Scientific) Structural Fellowship (1 fellow/year) 9

47 Questions? THANK YOU Valve QlikView (Dashboard) Outcomes Research (valvular heart disease) Economic analyses 10

48 Upcoming Watchman 11

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