Percutaneous Treatment of Mitral Insufficiency: Present and Future

Transcription

1 Percutaneous Treatment of Mitral Insufficiency: Present and Future Larry S. Dean, MD, MSCAI Past President SCAI Professor of Medicine and Surgery University of Washington School of Medicine Seattle, WA USA

2 Percutaneous Treatment of Mitral Insufficiency: Present and Future ACC/AHA Valvular Heart Disease Guidelines Mitral Valve Regurgitation TMVR MitraClip Coronary sinus devices Percutaneous repair and replacement The Future (and near present) Conclusions

3 ACC/AHA Guidelines: Mitral Regurgitation and Treatment Nishimura RA, et al ACC/AHA Valvular Heart Disease Guidelines JACC 2014

4 Percutaneous Approach to Mitral Regurgitation

5 EVEREST II CONCLUSIONS Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. Feldman T, et al. NEJM 2011

6 EVEREST II: Outcomes

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8 EVEREST II: Subgroup Analysis at 12 Months Feldman T, et al. NEJM 2011

9 Subgroup Analysis EVEREST Trials: Degenerative MR and Prohibitive Risk ACCEPTED MANUSCRIPT ACCEP TED MANUS CRIP T Lim SD, et al. JACC /j.jacc

10 Subgroup Analysis EVEREST Trials: Degenerative MR and Prohibitive Risk ACCEPTED MANUSCRIPT Lim SD, et al. JACC /j.jacc PTED MANUSCRIP

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13 Percutaneous Treatment of MR: Other Devices

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15 Coronary Sinus- Indirect Annuloplasty CARILLON Mitral Contour System

16 Procedure Overview and Highlights CARILLON Mitral Contour System TM Perform Venogram Deploy Distal Anchor Therapy Highlights Coronary Sinus Position Straightforward Access Adjustable Accomodates Variable Anatomy Apply Tension to Plicate Tissue Release Device Recapturable Peri-procedural FMR Assessment Peri-procedural Coronary Artery Assessment CAUTION: Investigational Device. Limited to European Investigational Use Only 16

17 TITAN Patient Enrollment European Journal Heart Failure;14:931 < 1 grade MR Reduction n=9 Transient coronary compromise n=7 < 1 grade MR reduction + coronary compromise n=1 17

18 Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial Tomasz Siminiak 1, Justina C. Wu 2, Michael Haude 3, Uta C. Hoppe 4, Jerzy Sadowski 5, Janusz Lipiecki 6, Jean Fajadet 7, Amil M. Shah 2, Ted Feldman 8, David M. Kaye 9, Steven L. Goldberg 10, W ayne C. Levy 10, Scott D. Solomon 2, and David G. Reuter 11 * 1 Department of Cardiology, Poznan University, Poznan, Poland; 2 Department of Cardiovascular Medicine, Brigham and Women s Hospital, Boston, MA, USA; 3 Medical Clinic I, Städtische Kliniken Neuss, Neuss, Germany; 4 Department of Cardiology, Paracelsus Medical University, Salzburg, Austria; 5 Department of Cardiac Surgery, John Paul II Hospital, Krakow, Poland; 6 Department of Cardiology, University Hospital, Clermont-Ferrand, France; 7 Department of Cardiology, La Clinique Pasteur, Toulouse, France; 8 Cardiology Division, Northshore University Health System, Evanston, IL, USA; 9 Division of Heart Failure Research, Alfred Hospital, Melbourne, Australia; 10 Department of Cardiology, University of Washington, Seattle, WA, USA; and 11 Division of Pediatric Emergency Medicine, Seattle Children s Hospital, Seattle, WA, USA Received 26 April 2012; accepted 27 April 2012; online publish-ahead-of-print 21 May 2012 A im s Functional mitral regurgitation (FMR) contributes to morbidity and mortality in heart failure (HF) patients. The aim of this study was to determine whether percutaneous mitral annuloplasty could safely and effectively reduce FMR and yield durable long-term clinical benefit.... Met hods The impact of mitral annuloplasty (Carillon Mitral Contour System) was evaluated in HFpatients with at least moderate FMR. Patients in whom the device was placed then acutely recaptured for clinical reasons served as a compara- and r esult s tor group. Quantitative measures of FMR, left ventricular (LV) dimensions, New York Heart Association (NYHA) class, 6 min walk distance (6MWD), and quality of life were assessed in both groups up to 12 months. Safety and key functional data were assessed in the implanted cohort up to 24 months. Thirty-six patients received a permanent implant; 17 had the device recaptured. The 30-day major adverse event rate was 1.9%. In contrast to the comparison group, the implanted cohort demonstrated significant reductions in FMR as represented by regurgitant volume [baseline ml to ml at 12 months (P, 0.001)]. There was a corresponding reduction in LV diastolic volume [baseline ml to ml at 12 months (P¼ 0.015)] and systolic volume [baseline ml to ml at 12 months (P¼ 0.015)], compared with progressive LV dilation in the comparator. The 6MWD markedly improved for the implanted patients by m at 12 months (P¼ 0.014) and m at 24 months (P, 0.001).... Conclusion Percutaneous reduction of FMR using acoronary sinus approach is associated with reverse LV remodelling. Significant clinical improvements persisted up to 24 months Keywor ds Mitral regurgitation Percutaneous mitral annuloplasty Heart failure Transcatheter mitral valve repair

19 19 Major Adverse Events Long-term (12 mo) safety profile Modified Intention to Treat Analysis, CEC Adjudicated 1 month 12 months Event MAE Incidence MAE Incidence Rate Device Related Rate Device Related Death Early 1.9 % (1/53) * 0 % 0 % Late 19 % (10/53)** Implanted: 19% Non-Implantd:24% 0 % MI Early 0 % (0/53) 0 % 0 % (0/53) 0 % Late 0 % (0/53) 0 % 4 % (2/53)** Cardiac Perforation 0 % (0/53) 0 % 0 % (0/53) 0 % Device Embolization 0 % (0/53) 0 % 0 % (0/53) 0 % Surgery or PCI Related to Device 0 % 0 % (0/53) 0 % 0 % (0/53) 0 % MAE Rate 1.9 % (1/53) 0 % 25 % (13/53) 0 % * Contrast-related acute renal failure in non-implanted patient. ** MAE s reviewed with DSMB; No relation to device identified

20 cm ml cm ml TITAN LV Remodeling Results ** ** * ** * ** Implanted Non-Implanted *p<0.05, **p<0.01, ***p<0.001 Between groups comparison of absolute differences from baseline 20

21 secs Points meters NYHA Class TITAN Efficacy Results ** * * *** ** * ** Implanted Non-Implanted *p<0.05, **p<0.01, ***p<0.001 Between groups comparison of absolute differences from baseline 21

22 Trial Observations Coronary Artery Management 15% (8 / 53) precluded from therapy at time of implant due to transient coronary artery compromise FMR Reduction 17% (9 / 53) not implanted due to < 1 grade FMR reduction acutely Wireform Fracture (n=8) No adverse events linked to observation Fracture limited to anchor wire. Longitudinal integrity maintained. Devices remained positioned within coronary sinus. Clinically silent (e.g., efficacy maintained) Discharge 1 month F/U 22

23 23 Clinical Trial Conclusions Percutaneous reduction of FMR in the TITAN trial was associated with a 1.9% 30 day MAE rate Averaging 4 quantitative echocardiographic parameters, there was a 40% reduction in FMR in the implanted population Functional improvement, as measured by exercise tolerance and quality of life, was greater in the implanted patients compared to the non-implanted patients Reverse remodeling noted in implanted patients

24 TMVR

25 Tiara

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27 Edwards Fortis Valve and Tendyne Mitral Prosthesis Fortis First in Man reported EuroPCR 2014 Tendyne FIM JACCI 2014:7;1077

28 Tiara Valve: Animal Implantation 150 Days Banai S, et al. JACCI 2014;7:154

29 TMVR: Valve in Valve is Here Now

30 Valve in Valve TMVR

31 Valve in Valve TMVR

32 Valve in Valve TMVR

33 Valve in Valve TMVR

34 Valve in Valve TMVR

35 Valve in Valve TMVR

36 Conclusions The percutaneous treatment of severe symptomatic degenerative MR is here: EVEREST Trials with MitraClip The treatment of functional MR is less clear, even with surgery: COAPT Trial The MitraClip is the first but will not be the last CS approaches are complicated by impact on the coronary circulation and the complexity of the mitral apparatus TMVR Valve in Vale is here today Transapical TMVR is on the near horizon