Reprise 3 trial. Large Vessel Closure Landscape. New TAVR Systems - Transfemoral 3/31/2015. Embolic Material. after TAVR

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1 Embolic Material Embolic Material Embolic Material after TAVR Large Vessel Closure Landscape Category Company Technology Emerging Suture Based Technologies Emerging Patch or Plug Technologies Strategic Players Interventional Therapies MediGlobe SpiRx Vivasure epacing Sealing Solutions Vascular Closure Systems Apica Cardiovascular Medtronic, Inc. Abbott Vascular St. Jude Medical Cook/Cardica New TAVR Systems - Transfemoral Direct Flow Sadra St. Jude AorTx HLT EndoTech ABPS PercValve Randomized open label trial to evaluate safety and effectiveness of (Boston Scientific) in symptomatic extreme or high risk AS patient. Compared to CoreValve. Reprise 3 trial 1

2 40 Centers in US (UMP Heart one of sites). Start date ~ Fall 2014 Estimated enrollment 1032 pts. Estimated completion date January 2017 (primary outcome) ClinicalTrials.gov Identifier:NCT Reprise 3 Adaptive Seal Controlled mechanical expansion. No Rapid pacing required. Fully repositionable. Reprise 3 Locking Mechanism Bovine Pericardium Adaptive Seal Conforms to irregular anatomical surfaces and minimizes paravalvular leak Ease of Use Radiopaque Marker To aid precise positioning Nitinol Frame Valve pre-loaded on delivery system Simple handle design enables controlled mechanical expansion Release Mechanism Unsheath, Lock Unlock, Resheath 2

3 Stable Valve and Stable Patient Throughout Implantation Controlled, Accurate, & Predictable Positioning Valve deployed via controlled mechanical expansion. It is neither balloon expandable nor selfexpanding. No rapid pacing during deployment Minimal hypotension Valve functions early No valve movement on release Central radiopaque positioning marker to guide placement Valve is repositionable throughout entire deployment process Fully retrievable prior to release, including after locking in final configuration Conclusion Unresolved issues in TAVR: Valve-in-valve for bio-prosthetic aortic and mitral valve failure Intermediate (moderate) risk AS patients Asymptomatic severe AS Aortic regurgitation UMP HEART TAVR PROGRAM 3

4 TAVR Team Traditional Paradigm Greg Helmer, MD Ganesh Raveendran, MD Tim Biring, MD Demetris Yannopoulos, MD Kenneth Liao,MD Ranjit John, MD Emil Missov, MD Bilal Ali, MD Uma Valeti, MD Ioanna Apostolidou, MD Mojca Konia, MD Lynn Thielen, RN Deb Dempsey, RN Kimberly Schroeder, Lead CT Tech Brandy Flaten, Lead Echo Tech Primary Care Physicians CT Surgery Cardiologist Interventional Cardiologist Collaborative Model TAVR Heart Team Concept Primary Care Physicians Heart Team Cardiologists Interventional Cardiologists CT Surgeons Cardiologist Multidisciplinary approach ensures: Patient centric care Thorough assessment by a team of specialists Collaborative treatment decision 16 4

5 TAVR Evaluation Pathway Pre-screening Review of Records Clinical Evaluation Gated CTA (Chest/Abdomen/Pelvis) RHC/LHC Coronary Angiography Functional Status Assessment (Cognitive Function, Frailty, etc.) STS Score Calculation Isolated AVR in 800 US centers from (67,292 patients) Operative mortality: within 30 days or during operative hospitalization Underestimates risk in high risk patients by factor 0.8 Risk Assessment STS Score Treatment Plan Note: The above is a suggested flow for the patient screening process, however, the order in which screening tests are conducted varies depending on the patient s profile and should be at the discretion of the Heart Team. 17 Risk Assessment STS risk score provides a reasonable preliminary estimate of risk for the majority of patients The STS score fails to account for many important factors affecting surgical risk Some factors not completely considered include: Porcelain aorta Chest wall radiation or deformity (hostile chest) Previous sternotomy with adhesion of IMAs to chest wall Severely compromised respiratory function Severe liver disease Severe pulmonary hypertension Dementia and/or severe cerebrovascular disease Frailty In these inoperable cases, clinical judgment of experienced cardiac surgeons plays a key role in assessment of surgical risk status Multiple Modalities for Assessing Frailty PARTNER II Trial Frailty Index Assessment 15-Foot Walk Grip strength Serum albumin Katz ADLs - (Independence in dressing, bathing, toileting, transferring, feeding, continence) 20 5

6 Frailty: An Important Parameter in Assessing Operative Risk Prevalence of frailty increases with aging; old does not necessarily equal frail Elderly patients achieve measurable benefit from cardiac surgery, particularly in terms of: Quality of life Increased survival Prevention of adverse cardiovascular events The Eyeball Test Same age (90) and predicted risk (12%) One passes the eyeball test, one does not Who Is Too Sick for TAVR? Patients in whom the presence of multiple comorbidities, especially frailty, overwhelm the likelihood of functional recovery despite successful TAVR TAVR Porcelain aorta Hostile chest RIMA/LIMA anatomy Severe COPD Liver cirrhosis Dementia Medical therapy Severe frailty Slide provided courtesy of Todd Dewey, MD, Medical City Dallas ACC/AHA 2014 Risk Assessment Combining STS Risk Estimate, Frailty, Major Organ System Dysfunction, and Procedure-Specific Impediments Low Risk (ALL criteria) Intermediate Risk (any 1) High Risk (any 1 criteria) Prohibitive Risk (any 1 criteria) TAVR CLINIC Weekly clinics 1 st /3 rd at UMMC 2 nd /4 th at Southdale STS PROM* <4% AND Frailty Major organ system compromise not to be improved postop Procedure-specific impediment None AND None AND None 4% to 8% 1 index (mild) 1 organ system Possible procedure-specific impediment >8% 2 or more indices (moderate-severe) No more than 2 organ systems Possible procedurespecific impediment Predicted risk with surgery of death or major morbidity (allcause) >50% at 1 y 3 or more organ systems Severe procedurespecific impediment 6

7 Patient Evaluation UMP - TAVR Outcomes Patients receive a comprehensive, multidisciplinary evaluation in the TAVR Clinic: Interventional Cardiology/CV Surgery Shortens workup times Expedites decision making Fosters collegiality Creates a cohesive approach to valvular heart disease Mortality Stroke Vascular Pacer VARC Partner A U of M Major Complications Valve Team In Action Major Complications Total % of Total Vascular Complications All Stroke Major Strokes Deaths Pacemaker LV Perforations

8 Valve Team In Action TAVR 2015 Final Thoughts TAVR will rapidly become an integral part of the treatment algorithm for Aortic Stenosis. Creation of heart teams necessary to provide optimal care Patient populations for TAVR will be defined by next generation trials and devices Advances in imaging will improve patient selection and procedure planning Structural Heart at UMP TAVR Reprise 3 trial, CoreValve, Edwards sapien XT Contact Information Contact number TAVR clinic Mital Clip one of 3 centers in state Left Atrial appendage closure Lariat device (most experience in state). Active Transplant/LVAD program Parachute IV trial LV restoration therapy for ischemic Caradiomyopathy (FSH) Fairview Southdale Hospital Deb Dempsey, RN ddempsey@umphysicians.umn.edu 8

9 Future is closer than we think On Oct. 9, 1903, the New York Times wrote: "The flying machine which will really fly might be evolved by the combined and continuous efforts of mathematicians and mechanicians in from one million to ten million years." On the same day, in Kill Devil Hill, N.C., a bicycle mechanic named Orville Wright wrote in his diary: "We unpacked rest of goods for new machine." Thank You 9