Journal of the Minneapolis Heart Institute Foundation

Transcription

1 Journal of the Minneapolis Heart Institute Foundation Informs and educates medical professionals about leading cardiovascular research conducted by MHIF and its partners Publishes clinical research, case reports, view points, literature reviews Features topics across spectrum of cardiovascular disease Published 2x year Open access; available in print and digital Submissions always accepted; Instructions for authors on website Increasing the impact and reach of MHIF research! Page 1 of 36

2 MHIF CARDIOLOGY GRAND ROUNDS Title: Transcatheter Valve Therapy (TVT) 2018 Speaker: Paul Sorajja, MD Director, Center for Valve and Structural Heart Disease Minneapolis Heart Institute at Abbott Northwestern Hospital Date: January 22, 2018 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. Recall indications for Transcatheter Aortic Valve Replacement (TAVR). 2. Describe outcomes of Transcatheter Mitral Valve Repair (TMVR). 3. Understand innovations in the field of TVT. ACCREDITATION 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 1.0 hours of credit. However, the nurse is responsible for determining whether this activity meets the requirements for acceptable continuing education. DISCLOSURE STATEMENTS Moderator(s)/Speaker(s) Dr. Sorajja has disclosed that he does not have a conflict of interest in making this presentation. Planning Committee Dr. Alex Campbell, Jake Cohen, Jane Fox, Dr. Mario Goessl, Dr. Kevin Harris, Dr. Kasia Hryniewicz, Rebecca Lindberg, Amy McMeans, Dr. Michael Miedema, Dr. JoEllyn Moore, Pamela Morley, Laura Onstot, 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. David Hurrell declares the following relationship Boston Scientific: Chair, Clinical Events Committee. We gratefully acknowledge the following organization for their commercial support for this activity. Otsuka Pharmaceuticals Pfizer 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 Page 2 of 36

3 MHIF 2017 Transcatheter Valve Therapy Why, How, and What s Coming Paul Sorajja, MD Roger L. and Lynn C. Headrick Family Chair Valve Science Center Minneapolis Heart Institute Foundation Abbott Northwestern Hospital Disclosures Abbott Vascular: research, consulting, speaking Boston Scientific: research, consulting, speaking Edwards Lifesciences: research, consulting, speaking Admedus: consulting Medtronic: research, consulting, speaking Page 3 of 36

4 WHY WHY = long-term success Smaller Footprint is Desirable Page 4 of 36

5 Invasive Medicine Patients in need Only 1 in 3 treated Iung B et al., EHJ 2005 Bach DS et al., Circ CV Qual Out 2009 Page 5 of 36

6 Commercial TAVR in 2018 Sapien S3 Evolut R Pro Tri-leaflet AS that is not low risk 14 to 18 Fr transfemoral Procedural mortality = 1% Pacemaker = 10 to 15% TAVR Approaches Conscious Sedation Transcarotid Transcaval Balloon Valve Fracturing 0.5 mg midazolam 50 mcg fentanyl $$ millions saved Page 6 of 36

7 Essential Frailty Toolkit EFT 3 potential futility Afilalo J, et al. J Am Coll Cardiol 2017;70(6): Low-risk TAVR Trials PARTNER 3 Sapien 3 Medtronic Evolut Key inclusion Primary outcome Age >65 Symptomatic PROM <2% 1-yr death, CVA, re-hospitalization Any age Symptomatic or Asymptomatic PROM <3% 2-yr death or CVA Follow-up Annual for 10 years Annual for 10 years Page 7 of 36

8 Boston Scientific TAVR Lotus Edge Acurate Neo Minneapolis Heart Institute Treated Patients with Severe Aortic Stenosis 1200 Total no. patients AVR % 38% 41% 37% Page 8 of 36

9 Contemporary Patient Needs 366 appropriate AVR candidates 40% low surgical risk 54% no AVR referral 89% no heart team evaluation One-year outcomes 19% hospitalization for heart failure 55% death Tang L, et al. ACC 2018 Mitral Regurgitation Page 9 of 36

10 Prevalence of Mitral Regurgitation Increases with Age Prevalence (%) of moderate to severe valve disease All valve disease Mitral valve disease Aortic valve disease < >75 Age (years) > 9.3% for 75 year olds Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: Survival with Mitral Regurgitation Primary MR Secondary MR Survival (%) ERO <20mm 2 (91 ±3%) ERO 20-39mm 2 (66 ±6%) ERO 40mm 2 (58 ±9%) Survival (%) MI w/o MR 61 ±6 MI with MR 38 ±5 0 P< P< Years Years Enriquez-Sarano M et al. NEJM 2005;352: Grigioni F, et al. Circulation 2001;103: Page 10 of 36

11 Transcatheter Mitral Repair MitraClip >55,000 pts worldwide U.S. approval in 2013 Page 11 of 36

12 Outcomes with MitraClip STS/ACC TVT Registry 100% MR grade % 2 93% 2,952 patients Median age = 82 years STS-PROM (MVR) = 9.2% 60% 40% 4 1/0 61% 20% 0% 3 2 Baseline Post-implant Sorajja P, et al., J Am Coll Cardiol 2017 Clinical Outcomes STS/ACC TVT Registry In-hospital mortality 2.7% Procedure success. 91.8% SLDA % Length-of-stay... 2 d (1,5 d) Home discharge % Sorajja P, et al., J Am Coll Cardiol 2017 Page 12 of 36

13 Challenging Anatomy MitraClip Anatomical Observations Mitraclip in STS/ACC TVT Registry Prior surgical repair. 1.5% FMR.. MVA < 4 cm % 20.5% Gradient 5 mmhg 17.7% Leaflet Ca % Sorajja P, et al., ACC 2017 Page 13 of 36

14 MitraClip Clinical Outcomes at One-Year 40% 35% TVT Registry for MitraClip Either: 37.9% Cumulative incidence (%) 30% 25% 20% 15% 10% 5% Death: 25.9% HF hospitalization: 20.2% Repeat Mitraclip = 6.2% MV surgery = 2.1% 0% Follow-up (months) No. at risk Page 14 of 36

15 Many Developing Repair Options Remaining Challenges Unaddressed MR 100 No MR Recurrence 1,218 surgical pts 15 year FU 13% MR 2 Overall Survival (%) 76 ±1% 80 MR Recurrence 57 ±2% ±5% ±6% 20 HR: 2.06 ( ); p < *HR: P< ( ); p = Follow-up (Years) Suri R et al., J Am Coll Cardiol 2016 Page 15 of 36

16 Post-Procedural MR and Survival TVT Registry for MitraClip 50% 48.9% Cumulative incidence of death 40% 30% 20% 10% Grade III/IV Grade II Grade I or none p< % No. at risk Follow-up (months) III/IV II /I % 21.7% A Procedure of Millimeters Lateral move Page 16 of 36

17 MitraClip and Mitral Surgery Minneapolis Heart Institute (n=604) 140 Annual volumes MitraClip All mitral surgery Isolated MV surgery Procedural mortality <2% for all Niikura H, et al. ACC 2018 Transcatheter Mitral Valves Page 17 of 36

18 First Transcatheter TMVR in U.S. April 8, 2015 The Tendyne Valve Transapical, 34 Fr D-shaped Outer and inner frame Anchoring tether with hemostatic pad Retrievable, repositionable Page 18 of 36

19 Tendyne Global Feasibility Study 30 patients STS-PROM: 7.3% No procedural deaths No MR in 26 of day success: 87% Muller DWM, Sorajja P JACC 2017 Page 19 of 36

20 The Intrepid Prosthesis Self-expanding, nitinol valve 43, 46, or 50 mm Houses a 27 mm bovine valve 35 Fr transapical Images courtesy of Drs. Richard Bae and John Lesser Page 20 of 36

21 Intrepid Global Pilot Study 1-Year Survival 79% NYHA I or II MLWHFQ: 56 ±27 vs. 32 ±22 Bapat V and Sorajja P et al. J Am Coll Cardiol year-old woman HF hospitalization Severe MR Minimal morbidity Sorajja P, Goessl M, Bae R, Tindell L, Lesser J, Askew J, Farivar RS JACC Intv 2017 Page 21 of 36

22 Compassionate Use Tendyne Sorajja P, Goessl M, Bae R, Tindell L, Lesser J, Askew J, Farivar RS JACC Intv 2017 Sorajja P, Goessl M, Bae R, Tindell L, Lesser J, Askew J, Farivar RS JACC Intv 2017 Page 22 of 36

23 Tendyne Valve-in-MAC International Early Feasibility Study Principal Investigators Paul Sorajja, MD Vinod Thourani, MD Launch in Q Next Gen Intrepid TMVR Trans-septal Implant alignment, recapture, and 3x speed Enabled by implant design not requiring rotational alignment or need to capture leaflets One implant platform for both TS and TA Page 23 of 36

24 Treatment of Pathophysiology Aortic Stenosis X Surgery Mitral Regurgitation X? Pressure Hypertrophy Curative Volume Hypertrophy Curative? Accucinch Page 24 of 36

25 Tricuspid Regurgitation Impact of Tricuspid Regurgitation Cumulative incidence of death 50% 40% 30% 20% 10% Severe Moderate Mild/none 38.5% 23.5% 23.4% p< % Follow-up (mos) No. at risk Page 25 of 36

26 Tricuspid Surgery Peri-operative Mortality All patients = 8.8% TV replacement = 13.4% Zack CJ, et al., J Am Coll Cardiol 2017 So many options, a few here Page 26 of 36

27 82 year-old woman Page 27 of 36

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29 MitraClip for TR 64 patients 88% functional TR 22 combined with MV rx 91% with 1 grade reduction Nickenig G, et al., Circulation 2017 Challenges Can t treat if can t see Page 29 of 36

30 Guideline Absence L-sided valve surgery, severe TR (I) L-sided valve surgery, annular dilatation or RHF (IIA) Primary TR refractory to med rx (IIA) L-sided valve surgery with mod TR and PH (IIB) Severe TR and progressive RV enlargement (IIB) No class I indications for isolated TR Lack of Standard Endpoints VARC-II MVARC TVARC? Page 30 of 36

31 What is meaningful? Asymptomatic TRILUMINATE (EU and US) Early Feasibility Study Moderate or severe TR Single-arm therapy with Triclip First 2 patients worldwide treated at MHI U.S. pivotal study planned for 2018 Page 31 of 36

32 The New Generation Active lifestyle Like less invasive Innovative MHIF Valve Science Center A Call to Action Vision A world class research center for valvular heart disease Mission To improve the health of patients with valvular disease through research, education, and innovation Page 32 of 36

33 Establishment of the Valve Science Center OPERATIONS Steering committee creation Complete vision, goals and metrics Establish financial plan Align MHIF and MHI priorities Establish marketing plan Hire Program Director Hire 1 st Implement database sustainable coordinator financial plan Renew scholar funding Apply for AHA, ACC grants Hire 2 nd database coordinator VSC Faculty education seminar Renew scholar Renew scholar Renew scholar funding Renew funding Renew funding Renew internship internship internship program program program VSC Faculty education seminar RESEARCH Begin Valve Scholar program Establish VHD database 10 scientific Determine papers barriers to VHD care Describe economic costs of barriers Underserved population research 30 scientific papers Start internship program Enroll 2,500 patients in VHD database 55 scientific 85 scientific papers papers Enroll 5,000 patients in VHD database 125 scientific papers Enroll 15,000 patients in VHD database INNOVATE FIM triclip therapy SCOUT study ACCUCINCH EFS Evolut LR top Begin Valve 5 enrollment Scholar program Complete valvein-mac compassionate study Operationalize live case courses Partner with Allina for novel pathway tools Serve as training site for feasibility research Multiple VSC faculty presentations at int l meetings Implement novel pathway tools Host KOL summit Lead multicenter study as national P.I. Host KOL summit Host KOL summit EDUCATE Capture >10 patient testimonials Major website revision Establish social media presence Complete patient education materials Public Seminar Capture >50 Public Seminar Public Seminar Public Seminar Public Seminar patient Valvular Heart Valvular Heart Valvular Heart Valvular Heart testimonials Disease Disease Disease Disease Summit Summit Summit Summit 1 st radio PSA 2nd radio PSA 3rd radio PSA 4th radio PSA 5th radio PSA Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q Patient awareness Page 33 of 36

34 Valentine s Day 5K Register Now: Page 34 of 36

35 Thank you! 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 Page 35 of 36

36 Medtronic CoreValve US Pivotal High Risk Study ACC 2016 Page 36 of 36