MOVING BEYOND HIGH RISK AND INOPERABLE PATIENTS ( A SURGEONS VIEW) - PDF document

10/10/2015 TRANSCATHETER VALVE REPLACEMENT: MOVING BEYOND HIGH RISK AND INOPERABLE PATIENTS ( A SURGEON’S VIEW) Mark J Russo, MD, MS Director, Aortic Center Assistant Professor of Surgery Director, Cardiac Surgery Research Rutgers-New Jersey Medical School Barnabas Heart Hospital/NJ Disclosures Site Principle Investigator • PARTNER II Trial (Edwards Lifesciences) • SURTAVI (Medtronic) • PORTICO (St. Jude) Case Review Board • PARTNER II Trial (Edwards Lifesciences) Speakers Panel and Case Proctor • Edwards Lifesciences I Will Discuss Off-Label and/or Experimental Therapies 1

10/10/2015 Summary Of Points 1. TAVR is not a “new” or “novel” procedure – 250,000+ TAVRs performed worldwide – 5 FDA-approved valves – 5 primary New England Journal of Medicine articles 2. Isolated Surgical AVR (SAVR) will become a historic operation (eg open AAA repairs). . . soon – Today, TAVR remains complementary to SAVR – However, TAVR is a disruptive technology – In the near-term, TAVR will cannibalize SAVR 3. Surgeons need to evolve or . . . THANK YOU!! ANY QUESTIONS? 2

10/10/2015 NOT ONLY IS TAVR IS NOT NEW. . . TAVR IS A MATURE TECHNOLOGY An Explosive Growth Trajectory Estimated Global TAVR Procedures Global TAVR Units 70,000 ROW 60,000 56,000 U.S. EU 50,000 41,000 18,000 40,000 32,000 30,000 20,000 10,000 0 2012 2013 2014 28% 36% 41% YoY Global Growth 3

10/10/2015 In the Next 10 Years, TAVR will Increase 4X Estimated Global TAVR Procedures 7 5 FDA-Approved Devices Sapien XT – 2014 Sapien - 2012 Corevalve - 2013 Sapien 3 – 2015 Evolute-R - 2015 4

10/10/2015 Overwhelming Evidence to Support Its Use TAVR AS A COMPLEMENTARY TECHNOLOGY TO SURGICAL AVR 5

10/10/2015 Barnabas – TAVR Volume by Year 600% increase in TAVR volume in 2 years 180 160 140 120 100 TAVRs 80 60 40 20 0 2012 2013 2014 NBI - Valves vs. CABGs CABG Volume 33%; Cath volume 20% Valve Procedures are 200% Valve:CABG; 1:1 -> 3:1 Surgical Valve Volume 25% iCABG Overall Cardiac Surgery Volume 25% 500 Valves 450 400 350 300 250 200 150 100 50 0 2012 2013 2014 6

10/10/2015 TAVR Increased SAVR Volume Nationally Brennan JM et al. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014 Dec;98(6):2016-22. Greater % TAVR Positively Impacts Cardiac Volume  NJ programs where TAVR constituted >9% of all cases, cardiac surgery volume from ‘13 - > ’14  NJ programs where TAVR constituted <9% of all cases, cardiac surgery volume from ’13 -> ’14 *There were 3 exceptions 7

10/10/2015 Improved SAVR Outcomes in the Post-TAVR ERA Brennan JM et al. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014 Dec;98(6):2016-22. THE IMPENDING SHIFT: TAVR AS A DISRUPTIVE TECHNOLOGY 8

10/10/2015 Treatment Algorithm for Severe Symptomatic AS Predicted risk with STS < 4% STS 4-8% STS > 8% Imminent surgery of death or 0/4 Frailty 1/4 Frailty 2/4 Frailty major morbidity > 50% Death 0 Major Organ System Compromise (MOSC) 1 MOSC <=2 MOSC >=3 MOSC Extreme- Acutely Low-Risk Intermediate-Risk High-Risk Risk Ill Patients Patients Patients Patients Patients Risk SAVR TAVR BAV OMM Nishimura RA. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. TAVR is a Disruptive Technology Predicted risk with STS < 4% STS 4-8% STS > 8% surgery of death or Imminent 0/4 Frailty 1/4 Frailty 2/4 Frailty major morbidity > 50% Death 0 Major Organ System Compromise (MOSC) 1 MOSC <=2 MOSC >=3 MOSC Extreme- Acutely Low-Risk Intermediate-Risk High-Risk Risk Ill Patients Patients Patients Patients Patients Risk In the end, the new product or idea Eventually it moves Typically formed in a completely redefines the industry. upstream (eg niche market that may high/intermediate risk) appear unattractive or disrupting an existing inconsequential to market, displacing an industry incumbents earlier technology (eg inoperable) Nishimura RA. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. 9

10/10/2015 Unattractive or Inconsequential – Extreme/High Risk Moving Upstream – Displacing an Existing Market PARTNER Studies: 30-day survival Avg Age Avg Age 15% 82.6yo 81.9yo Age STS Age STS 8.6% 5.3% 10% O : E = O : E = 0.26 0.21 6.3% 5.2% 5% 4.5% 3.7% 3.5% 2.2% 1.6% 1.1% 1.1% 0% P1B (TF) P1A (All) P1A (TF) P2B (TF) P2B XT (TF) S3HR (All) S3HR (TF) S3i (All) S3i (TF) 175 344 240 271 282 583 491 1072 947 10

10/10/2015 Moderate / Severe PVL at 30 Days Edwards SAPIEN Valves 50% 40% 30% 24.2% 20% 16.9% 12.0% 11.5% 10% 4.2% 2.9% 0% P1B (TF) P1A (Overall) P2B (TF) P2B XT (TF) S3HR (Overall) S3i (Overall) 179 344 276 284 583 1076 SAPIEN SAPIEN XT SAPIEN 3 23 Freedom From All-Cause Mortality 11

10/10/2015 Low Risk TAVR: NOTION Trial Randomized 280 lower-risk patients – TAVR vs SAVR 3 European centers - Dec 2009 and Apr 2013 • Avg Age: 79 years • Avg STS score: 3.0% • STS Score < 4: 80% Søndergaard L. 2-year results from an all-comers randomized clinical trial comparing transcatheter with surgical aortic valve replacement in patients with aortic valve stenosis. Presented at: EuroPCR; May 19, 2015; Paris, France. Redefining the Industry This Shift Will NOT Be Limited to AS  TAVR: From 2006-2011, 3 companies paid a combined $1.1B for 3 startups  w 3000+ human implants In 2006, Edwards paid In 2011, Boston Scientific In 2009, Medtronic paid $125M for PVT paid $197M for Lotus $700M for Corevalve • • 100++ human implants • 100+ implants 2500+ implants • • On going studies in • Completed Feasibility Completed Feasibility Europe and Canada Study in Europe study in Europe; CE Mark granted in 2010  Mitrals: In a 45 day period, 3 companies paid a combined $1.1B for 3 startups  with 19 human implants; 1 incs have 0 implants and no sales 10 Jul, Edwards paid $400M 27 Aug, Medtronic paid $458 3 Aug, Abbott paid $250M for CardiAC for Twelve for Tenedyne • • 0 human implants 9 human implants • 10 human implants 12

10/10/2015 THE SURGEON Admiral James Stockdale/The Stockdale Paradox “You must maintain unwavering faith that you can and will prevail in the end, regardless of the difficulties, . . . AND at the same time have the discipline to confront the most brutal facts of your current reality, • United States Navy vice admiral whatever they might be. ” • He is one of the most decorated Navy officers – Medal of Honor – Navy Distinguished Service Medal (3) – Silver Star Medal (4) ― Jim Collins, Good to Great: Why Some Companies Make the Leap...And – Legion of Merit with Combat "V" Others Don't – Distinguished Flying Cross (2) – Bronze Star (2) with Combat "V" – Purple Heart Medal (2) • In the Vietnam War where he was a prisoner of war for over seven years. 13

10/10/2015 Surgeons Perspective: Brutal Facts • Previous generation of TAVR valves were technically inferior to SAVR, but will not be true in the future (now) – TAVR outcomes may already be better than SAVR across all risk strata – Soon, TAVR will make isolated SAVR a historic procedure • Remaining Role for Surgeons – Be one of 2 surgeon to sign off on TAVR for high-risk/inoperable patients (NCD) = Giving away (sharing) your practice – Back up for catastrophes - CBP for hemodynamic compromise; Root rupture; Perforations = Doing salvage procedures on high risk and inoperable patients – Chest access cases • With current generation > 90% of cases will be TF – 100 TAVRs / year → 15 chest cases / 2 surgeons → 1 case / surgeon / 2 months • TF is generally superior to a chest approach = Relegated to another inferior procedure Surgeons Perspective: Brutal Facts • Surgeons need to learn TF/catheter-based procedures to be relevant – Don’t relive past mistakes – PCI, BiP, AICDs, TEVAR 14

10/10/2015 My Singular Motivation $130,428 Fall 2029- Spring 2030 Surgeons Perspective: Good News 15