Consideration for Surgical Valves and

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1 Valve Choice: Consideration for Surgical Valves and Rings for Future Valve-in-Valve Kendra J. Grubb, M.D., M.H.A, F.A.C.C. Surgical Director, Structural Heart and Valve Center Division of Cardiothoracic Surgery Emory Healthcare

2 Disclosures Medtronic - Surgical Advisory Board, Speaker, Proctor Boston Scientific - Advisory Board, Speaker Edwards LifeSciences Speaker, Proctor Zimmer-Biomet - Speaker

3 Failed Mitral Replacement

4 2017 FDA Approval for Mitral VIV

5 2017 FDA Approval for Mitral VIV

6 2017 FDA Approval for Mitral VIV The surgical decision you make today may determine what is available to the patient tomorrow. Build a platform for the future

7 Failed Biologic Mitral Valve

8 Failed Biologic Mitral Valve 2012: AVR 19mm Edwards pericardial valve, MVR 23mm Edwards valve, tricuspid repair 23mm ring Echocardiogram EF 65-70% LVOT MG 32 mmhg, PG 65 mmhg AVA 0.7cm2, MG 34 mmhg, PG 60 mmhg MVA 0.9 cm2, MG 8 mmhg, PG 16 mmhg

9 How to Decide Mitral VIV? Dr. Vinayak Bapat

10 Failed Biologic Mitral Valve 27mm Perimount, MG 13 mmhg

11 Failed Biologic Mitral Valve

12 Failed Biologic Mitral Valve

13 Failed Biologic Mitral Valve 26 S3 in 27mm Perimount

14 Failed Biologic Mitral Valve 26 S3 MVIV 27mm Perimount

15 What About LVOT Obstruction??

16 Long Anterior Leaflet Issues The AML physically obstructs the prosthetic leaflet, preventing coaptation The AML obstructs the closing jet, preventing prosthetic leaflet closure Flow through a narrowed LVOT pulls the AML further to the LVOT via the Bernoulli effect JM Khan, JACC Cardiovasc Interv. 2016; Sep 12, 9(17):1835 Greenbaum et al. Cath Card Intv 2017

17 LVOT Obstruction: Mechanism, Prevalence & Risk Prevalence Real prevalence unknown >50% screen failures for LVOT obstruction risk % of patients valve-in-ring and valve-in-mac have fatal LVOT obstruction 2 Mechanism The valve implant displaces the anterior mitral leaflet towards the septum Bernoulli forces drag the long anterior leaflet into the septum 1 Guerrero, Personal Communication JM Khan, JACC Cardiovasc Interv. 2016; Sep 12, 9(17):1835

18 LVOT Obstruction Pre-procedural CT Dvir D, Webb J. EuroIntervention. 2016;12:Y93-6

19 LAMPOON Intentional Laceration of the Anterior Mitral valve to Prevent LVOT ObstructioN - A transfemoral catheter solution to LVOT obstruction

20 EMORY with NIH/NHLBI Partnership Vasilis Babaliaros MD Adam Greenbaum MD Kendra Grubb MD Robert A. Guyton MD Chandan Devireddy MD Bradley G. Leshnower MD Kreton Mavromatis MD James Stewart MD Robert J. Lederman MD Jaffer M. Khan MD Toby Rogers MD Marcus Chen MD

21 LAMPOON: NHLBI IDE trial (NCT ) Viewed from LVOT 3-chamber view Intentional Laceration of Anterior Mitral Leaflet JM Khan.. RJ Lederman, JACC Cardiovasc Interv. 2016;9(17):1835 Babaliaros, Greenbaum, Khan.. RJ Lederman, JACC Cardiovasc Interv. 2017;10(8):798

22 LAMPOON: NHLBI IDE trial (NCT ) JM Khan.. RJ Lederman, JACC Cardiovasc Interv. 2016;9(17):1835 Babaliaros, Greenbaum, Khan.. RJ Lederman, JACC Cardiovasc Interv. 2017;10(8):798

23 Transcatheter Electrosurgery guidewire to wire convertor microcatheter Electrocautery Back end of guidewire

24

25 Participating sites - LAMPOON IDE Emory University (Atlanta, GA) Henry Ford Hospital (Detroit, MI) MedStar Washington Hospital Center (Washington, DC) University of Washington (Seattle, WA) Carilion Medical Center (Roanoke, VA) INOVA Fairfax Hospital (Falls Church, VA) St. John s Hospital (Springfield, IL)

26 30-Day Outcomes for Emory Cohort 14 patients enrolled in IDE 13 reached 30-day follow-up Last patient completed 6/13/ Alive Dead 13 *One patient died of sepsis and heart failure, not LVOTO

27 LAMPOON + Tendyne - Collaboration of novel technologies - Case courtesy of Dr. Vasilis Babaliaros and Dr. Robert Guyton

28 Severe MR with Long AML Severe MR with long anterior mitral leaflet

29 Preparation for LAMPOON + Tendyne GC+GW for LAPMPOON Mitral valve GW inserted from apex

30 LAMPOON + Tendyne LAMPOON Tendyne

31 No LVOT obstruction

32 Failed Mitral Repair

33 Failed Mitral Repair Off label use of TAVR in Ring has been described Much more challenging procedure Ring is not circular Round peg in Square Hole Deforms THV PVL in long dimension Challenging to get coaxial

34 There s an App for That!

35 Ring vs Band for VIR

36 Failure of VIR 4 Aspects Characteristic of the ring Rigid ring will retain noncircular shape Not circular paraprosthetic regurgitation Rings >32mm are often too big for S3 Characteristics of the THV Radial force not great enough to circularize Poor leaflet coaptation Possible thrombus Designed to land in a tube LVOT Obstruction Delayed Embolization

37 VIR A Word of Caution Allende et al. Ann. Thorac. Surg 2015;99: mm Physio Ring + Homograft, 29 mm Sapien

38 VIR A Word of Caution Allende et al. Ann. Thorac. Surg 2015;99: mm Physio Ring + Homograft, 29 mm Sapien

39 VIR A Word of Caution App recommended 26 XT or 23/26 S3 Significant Oversizing 3 jets of PVL Under-expanded valve Constrained leaflets CTA with 3-D Reconstruction could have predicted this Allende et al. Ann. Thorac. Surg 2015;99: mm Physio Ring + Homograft, 29 mm Sapien

40 Severe Mitral Stenosis

41 TMVR Percutaneous, transeptal approach 12mm balloon atrial septostomy 29mm S3 valve

42 TMVR 1

43 TMVR 1 Valve noted to be too atrial Large PVL noted at A3/P3 Post dilate with 30 mm Z-med balloon

44 TMVR 2 Second S3 29mm Positioned more into the ventricle Complete resolution of PVL

45 TMVR 0

46 Mini MVR Bail Out Percutaneous cannulation and initiation of CPB Cooled, fibrillatory arrest Mini-thoracotomy right Removal of embolized valves Mitral valve replacement, 27 mm tissue valve Closure of iatrogenic ASD

47 Failed Alfieri Stitch AVR and Mitral Repair with Alfieri Stitch 2011

48 Failed Alfieri Stitch AVR and Mitral Repair with Alfieri Stitch 2011

49 Failed Alfieri Stitch Through AML AVR and Mitral Repair with Alfieri Stitch 2011

50 THV through AML AVR and Mitral Repair with Alfieri Stitch 2011

51 Totally Percutaneous THV through AML for Failed Alfieri Repair AVR and Mitral Repair with Alfieri Stitch 2011

52 Conclusions Surgical Valve and Ring choice should take into consideration future VIV or VIR Platform for next operation Keep the post of the tissue valve out of the LVOT Should NOT see it from the aorta Dr. Woo s 5:30 rule Bands are the best for future VIR

53 Conclusions Optimal Oversizing is still unknown App helps Minimum 10%, no more than 20% Extreme oversizing = under-expanded valve, higher gradient, suboptimal leaflet coaptation, thrombosis Under-sizing = risk embolization, PVL, hemolysis Improved preoperative imaging and modeling may help with patient selection Opportunity for 3-D Printed heart models, simulated deployment

54 Conclusions Percutaneous Electrosurgery may allow treatment of a wider range of patients Advanced techniques Preoperative imaging/planning is key Equipment needs improvement before wide adoption

55 Acknowledgements and Thank you Dr. Vasilis Babaliaros Co-Director Emory Structural Heart and Valve Center Dr, Adam Greenbaum Co-Director Emory Structural Heart and Valve Center Dr. John Lisko Cardiology Research Fellow Dr. Norihiko Kamioka Cardiac Surgery Research Fellow James Lee Valve Clinic Coordinator Tricia Keegan Emory Structural Heart and Valve Director

56 Thank you!

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