UPDATE STRUKTURELLE INTERVENTIONELLE KARDIOLOGIE

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1 SGK Herbsttagung 17 November 2016, Aarau UPDATE STRUKTURELLE INTERVENTIONELLE KARDIOLOGIE Stephan Windecker Department of Cardiology Swiss Cardiovascular Center Bern University Hospital, Switzerland

2 WHAT DO THESE GENTLEMEN HAVE IN COMMON? Bundesminister des Auswärtigen Amtes US Secretary of State TAVI 2012 TAVI 2014

3 TRANSCATHETER AORTIC VALVE IMPLANTATION PATENT FORAMEN OVALE CLOSURE UPDATE IN STRUCTURAL INTERVENTIONAL CARDIOLOGY MITRAL VALVE INTERVENTIONS LEFT ATRIAL APPENDAGE CLOSURE THERAPIES FOR TRICUSPID REGURGITATION

4 14 YEARS OF TAVI ( ) PROSTHESIS WITH CE MARK APPROVAL EDWARDS SAPIEN THV EDWARDS SAPIEN XT SYMETIS ACURATE TA SJM PORTICO DIRECT FLOW MEDICAL BSC LOTUS EDWARDS SAPIEN 3 MEDTRONIC EVOLUT R TF, TA TF, TA TA TF TF TF TF, TA MEDTRONIC COREVALVE JENAVALVE MEDTRONIC ENGAGER SYMETIS ACURATE NEO TF TF, TS, DA TA TA TF

5 Eggebrecht H et al. EuroIntervention 2015 TRENDS IN TAVI, SAVR AND SAVR+CABG IN GERMANY NUMBER OF PATIENTS

6 TAVI IN SWITZERLAND 2, PROCEDURE VOLUME % 8 30-DAY MORTALITY 1, , ,220 1, Estimated procedure volume for 2016 Death events adjudicated until February Transfemoral access in 2016: 95.6% Courtesy: S Stortecky

7 THE TAVI PATH THROUGH RISK CATEGORIES ADAPTED FROM CAPODANNO ET AL EUROINTERVENTION 2016 Edwards SAPIEN/SAPIEN XT/ SAPIEN 3 Medtronic CoreValve/Evolut R All available TAVR systems Ongoing Studies

8 TAVI VS. CONSERVATIVE TREATMENT: INOPERABLE-EXTREME PATIENTS PARTNER 1B: 5-Year Follow-up CoreValve Extreme-Risk: 2-Year Follow-up Kapadia SR et al. Lancet 2015 Yakubov SJ et al. J Am Coll Cardiol 2015 All-Cause Mortality N=358 All-cause Mortality N=489 NNT= 4 (2-year) NNT= 5 (5-year) 93.6% 71.8% TIME (MONTHS) TIME (MONTHS)

9 TAVI VS. SAVR: HIGH-RISK PATIENTS PARTNER 1A: 5-Year Follow-up CoreValve High-Risk: 3-Year Follow-up Mack MJ et al. Lancet 2015 Deeb M et al. J Am Coll Cardiol 2016 All-cause Mortality All-cause Mortality N=699 N= % 62.4% TIME (MONTHS) TIME (MONTHS)

10 Overall Population TAVI VS. SAVR: INTERMEDIATE-RISK PATIENTS PARTNER 2A Leon MB et al. N Engl J Med 2016 Transfemoral Access Cohort HR: 0.89 (95% CI, ) P= 0.25 HR: 0.79 (95% CI, ) P= 0.05

11 Siontis et al. Eur Heart J 2016 TAVI VS. SAVR: META-ANALYSIS OF 4 RANDOMIZED TRIALS All-cause Mortality at 2 years (N =3,806) Subgroup Trial Trials τ TAVR 2 SAVR HR (95% HR CI) (95% CI) P-inter PARTNER 1A US CoreValve NOTION PARTNER 2A Overall 116/ /351 85/391 99/359 11/145 14/ / / ( ) 0.79 ( ) 0.72 ( ) 0.92 ( ) 0.87 ( ), P=0.038

12 TAVI VS. SAVR - PERI-PROCEDURAL 4 RCTs (N =3,806) ADVERSE EVENTS TAVR SAVR HR (95% CI) Risk reduction: 54% Risk reduction: 43% Risk reduction: 39% Favours TAVR Favours SAVR Siontis et al. Eur Heart J 2016

13 TAVI VS. SAVR HEMODYNAMIC PROSTHETIC VALVE PERFORMANCE PARTNER 2A Leon MB et al. N Engl J Med 2016 CoreValve High-Risk Deeb M et al. J Am Coll Cardiol 2016 FOLLOW-UP DURATION MACK MJ ET AL. LANCET 2015

14 MANAGEMENT OF SEVERE AORTIC STENOSIS FUTURE OUTLOOK Vahl et al J Am Coll Cardiol GUIDELINES ON VALVULAR HEART DISEASE 2014 GUIDELINE FOR THE MANAGEMENT OF PATIENTS WITH VALVULAR HEART DISEASE

15 WHICH PATIENTS BENEFIT FROM TAVI VS. SAVR? Female Restricted mobility Suitable for TF Approach Prior cardiac (non aortic valve) surgery Small Aortic Annulus (<25 MM) Diastole Systole Low-flow lowgradient aortic stenosis Renal Disease GFR <60ML/MIN

16 TRANSCATHETER AORTIC VALVE IMPLANTATION PATENT FORAMEN OVALE CLOSURE UPDATE IN STRUCTURAL INTERVENTIONAL CARDIOLOGY MITRAL VALVE INTERVENTIONS LEFT ATRIAL APPENDAGE CLOSURE THERAPIES FOR TRICUSPID REGURGITATION

17 MEDICAL THERAPY FOR MITRAL REGURGITATION Primary MR Ling et al. NEJM 1996 Secondary MR Rossi et al. Heart 2011

18 SURGICAL REPAIR VS. REPLACEMENT FOR SEVERE ISCHEMIC MR: TWO-YEAR FOLLOW-UP OF CTSN Goldstein et al. N Engl J Med 2016;374: LV End-Systolic Volume Index* All-Cause Mortality 251 Patients with severe ischemic MR randomized to MV Repair vs. Replacement ± ±39.0 P = *Primary endpoint Repair LVESVI Replacement 23.2% 19.0% MACCE, HR=0.97 (95%CI ), P=0.88

19 LIMITATIONS OF MV REPAIR IN SEVERE ISCHEMIC MR Goldstein et al. N Engl J Med 2016;374: Recurrent MR* CV-Rehosp Quality of Life % 100 P < P = % % % % 20 0 Moderate or Severe MR Repair Replacement 0 Rehosp CV Event Repair Replacement Defined with Minnesota Living with HF. No differeces in other measures of QoL *Severe MR was present in 14% MV-repair vs. 0% in MV-replacement

20 RATIONALE FOR TRANSCATHETER MITRAL VALVE INTERVENTIONS EURO HEART SURVEY ON VALVULAR HEART DISEASE Age LVEF 50% of the patients with severe symptomatic MR are denied surgery Mirabel et al. Eur Heart J 2007;28:

21 CLINICAL DEVELOPMENT AND STATUS OF MITRAL DEVICES Mechanism Clinical trials and Status R E P A I R MITRACLIP (ABBOTT) CARDIOBAND (VALTECH) Leaflet Repair Direct Annuloplasty EVEREST II, European Sentinel, ACCESS-EU, TRAMI, MARS CE- Mark Trial, REPAIR (NCT ) MITRALIGN (MITRALIGN) Direct Annuloplasty CE Mark trial completed ACCUCINCH (GDS) ARTO (MVRX) CARILLON (CARDIAC DIMENSIONS) Direct Annuloplasty Indirect Annuloplasty Indirect Annuloplasty FIM (NCT ) MAVERIC (NCT ) AMEDEUS; TITAN; TITAN- II; REDUCE FMR NEOCHORD (NEOCHORD) Chordal Implantation TACT

22 MitraClip The procedure

23 MITRACLIP VS. CONVENTIONAL SURGERY: 5-YEAR RESULTS OF EVEREST II Feldman et al. J Am Coll Cardiol 2015;66: N=279 Pts with Moderate or Severe MR (Randomization ratio 2:1) Death, MV Surgery or Reoperation 64.3% All-Cause Mortality 81.2% P= % P= %

24 MITRACLIP- IMPACT ON FUNCTIONAL STATUS EVEREST STUDIES Analysis of the prohibitve risk DMR cohort (n= 141) HF hospitalization rate per patient year ACCESS-EU REGISTRY 576 patients, 14 European centers 69% functional MI, 31% degenerative MI 6-Min walk test Scott Lim et al, J Am Coll Cardiol 2014;64:182 Maisano et al, J Am Coll Cardiol 2013;62:

25 ANNULOPLASTY: PROCEDURE DIRECT CARDIOBAND INDIRECT CARILLON - Transseptal atrial access - Ring implanted on the atrial side of the mitral annulus - Screw anchors deployed from the posteromedial commissure to the anterolateral commissure in a counterclockwise fashion - Annular circumference reduced by controlling tension on the band - Jugular venous access - Delivery of to anchors into the distal coronary sinus and the coronary sinus ostium - Compression ot the septal-lateral dimension resulting in reduction of the regurgitant orifice Feldman et al, J Am Coll Cardiol May 27;63(20):

26 ANNULOPLASTY: PERFORMANCE MR SEVERITY MR Severity From Baseline to 6 Months in 31 patients with moderate to severe FMR undergoing percutaneous direct annuloplasty with Cardioband CLINICAL STATUS TITAN Trial (Transcatheter Implantation of Carillon Mitral Annuloplasty Device), n= 36 implanted; n= 17 non-implanted Nickenig et al. J Am Coll Cardiol Intv 2016;9: Siminiak et al. European Journal of Heart Failure (2012) 14,

27 RECOMMENDATIONS FOR TRANSCATHETER MV REPAIR Recommendations Class Level Percutaneous edge-to-edge procedure may be considered in patients with symptomatic severe primary MR who fulfil the echo criteria of eligibility, are judged inoperable or at high surgical risk by a heart team, and have a life expectancy greater than 1 year IIb Vahanian et al. European Heart Journal (2012) 33, Recommendations Class Level Transcatheter mitral valve repair may be considered for severely symptomatic patients (NYHA class III to IV) with chronic severe primary MR (stage D) who have favorable anatomy for the repair procedure and a reasonable life expectancy but who have a prohibitive surgical risk because of severe comorbidities and remain severely symptomatic despite optimal GDMT for HF IIb Nishimura et al. J Am Coll Cardiol 2014;63:e C B

28 CLINICAL DEVELOPMENT AND STATUS OF MITRAL DEVICES Mechanism Clinical trials and Status R E P L A C E M E N T TIARA (NEOVASC) CARDIAQ (EDWARDS) INTREPID (MEDTRONIC) TENDYNE (ABBOTT) HIGHLIFE (HIGHLIFE) CAISSON (CAISSON) Anchored to the mitral annulus Self-positioning, selfanchoring Comformable outer fixation ring Valve with left ventricular apical tethering for fixation Transatrial delivery system Transfemoral delivery system TIARA-I (NCT ) FIM, RELIEF Trial (CE Mark) FIM FIM (NCT ) FIM FIM

29 REPLACEMENT: COMPASSIONATE USE AND FEASIBILITY STUDIES Device TIARA 1 CARDIAQ 2 INTREPID 3 FORTIS 4 TENDYNE 5 N. Patients Functional MR 71% 69% 78% 92% 77% Device Success, n (%) 30-day Mortality, n (%) 14 (82) 92% 24 (92%) 10 (77) - 3 (17) 9 (69) 4 (15) 5 (38) 0 Residual MR % Mean MV Gradient (mmhg) Leon MB, TVT 2016; 2 Ussia G, TCT 2016; 3 Bapat V, TCT 2016; 4 Rodés-Cabau J, TVT 2016; 5 Muller D WM, TCT 2016

30 TRANSVENOUS TRANS-SEPTAL MITRAL VALVE-IN-VALVE IMPLANTATION Edwards SAPIEN implantation in 48 patients with degenerated mitral bioprosthesis 9 with previous ring annuloplasty and 6 with severe MAC Transvenous Valve Delivery PROCEDURAL CHARACTERISTICS 48 (100) Procedure time, min 97 ± 30 Contrast volume, ml 11 ± 14 Atrial septal defect closure 30-DAY OUTCOMES 3 (6) Death 4 (8) Mean gradient 7.0 ± 2.7 mmhg Mitral valve area 1.8 ± 0.8 cm 2 Mild prosthetic regurgitation 8 (16) Eleid et al J Am Coll Cardiol Intv 2016;9:

31 TRANSCATHETER AORTIC VALVE IMPLANTATION PATENT FORAMEN OVALE CLOSURE UPDATE IN STRUCTURAL INTERVENTIONAL CARDIOLOGY MITRAL VALVE INTERVENTIONS LEFT ATRIAL APPENDAGE CLOSURE THERAPIES FOR TRICUSPID REGURGITATION

32 TRICUSPID REGURGITATION - CLASSIFICATION Primary Tricuspid Regurgitation - Leaflet Abnormality ~20% CONGENITAL DISEASE Ebstein s Anomaly Dysplasia, Hypoplasia, or Cleft Double Orifice ACQUIRED DISEASE Endocarditis Rheumatic disease Carcinoid, serotonin-active drugs Prolapse, Flail Radiation Cardiac device (PPM, ICD) leads Trauma Degenerated Bioprosthesis Secondary Tricuspid Regurgitation - Functional ~ 80% Right ventricular and tricuspid annular dilatation Left-sided valvular and/or myocardial disease Pulmonary hypertension Right ventricular infarction with remodelling Chronic right ventricular pacing (dyssynchrony) Atrial fibrillation

33 TRICUSPID REGURGITATION AND SURVIVAL TR and Idiopathic or Ischemic Cardiomiopathy Hung et al. Am J Cardiol 1998;82: Operative Mortality After Tricuspid Valve Surgery Arsalan et al. Eur Heart J 2015, in press p= No TR TR 1-year event-free survival No TR 68% TR 30%

34 RATIONALE FOR TRANSCATHETER TRICUSPID VALVE INTERVENTIONS Patients with severe tricuspid regurgitation Patients referred for heart valve surgery Stuge O et al. J Thorac Cardio Surg 2006 Scully et al. J Thorac Cardiovasc Surg 1995 N=1,600,000 Tricuspid 0.5% surgery 1.3% N=4,741 No surgery Other valve surgery

35 TRANSCATHETER THERAPIES FOR TRICUSPID FORMA device REGURGITATION Caval valve implantation (CAVI) Mitralign TriCinch Caval valve implantation (CAVI)

36 TRANSCATHETER AORTIC VALVE IMPLANTATION PATENT FORAMEN OVALE CLOSURE UPDATE IN STRUCTURAL INTERVENTIONAL CARDIOLOGY MITRAL VALVE INTERVENTIONS LEFT ATRIAL APPENDAGE CLOSURE THERAPIES FOR TRICUSPID REGURGITATION

37 PREDICTION OF STROKE AND BLEEDING RISK Camm AJ et al. Eur Heart J 2010 Kirchhof P et al. Eur Heart J 2016 CHA 2 DS 2 -VASc HAS-BLED RR 1.77, 95%CI : High Bleeding Risk

38 Rationale for LAA Occlusion 90% of thrombi in nonvalvular AF are located in the LAA Compliance Limitations of Oral Anticoagulation Discontinuation: 15-30% in NOAC trials Sub-therapeutic INR in 30-50% of VKA No reliable monitoring Bleeding complications Rates of bleeding in NOAC trials: 5-15% Specific patients population Chronic renal failure Patients with CAD under DAPT

39 Percutaneous LAA closure Devices Watchman Amplatzer ACP Amulet WaveCrest Lariat 9-14 F transseptal 14 F transseptal FDA approval expected in the first half of F transseptal 14 F/8.5 F epicardial/transseptal F transseptal

40 LAA CLOSURE VS. VKA IN AFIB: 4-YEAR FOLLOW-UP OF PROTECT-AF Reddy VY et al. JAMA. 2014;312: Primary Efficacy Endpoint CV Death, Stroke, or Systemic Embolism Primary Safety Endpoint Major bleeding or Procedure-related complication

41 PROTECT AND PREVAIL: META-ANALYSIS IPD Meta-analysis (n=1114) Holmes D et al, JACC 2015

42 LAA CLOSURE: PROCEDURAL COMPLICATIONS 5 4 Pericardial Tamponade Procedure-related Stroke Device Embolization PROTECT-AF 1 N= Post-FDA Approval 2 N= ACP Registry 3 N= 1, AMULET Observational Study 4 N= 1,073 1 Reddy VY et al. JAMA. 2014;312: ; 2 Reddy VY et al, JACC 2016 in press; 3 Tzikas A et al, EuroIntervention 2015; 4 Hildick-Smith D, presented at TCT 2016

43 ESC GUIDELINES FOR LAA CLOSURE IN PATIENTS WITH ATRIAL FIBRILLATION 2014 Myocardial Revascularization 2016 Atrial Fibrillation Windecker et al. Eur Heart J 2014;35: Kirchhof et al. Eur Heart J 2016;37:

44 TRANSCATHETER AORTIC VALVE IMPLANTATION PATENT FORAMEN OVALE CLOSURE UPDATE STRUCTURAL INTERVENTIONAL CARDIOLOGY MITRAL VALVE INTERVENTIONS LEFT ATRIAL APPENDAGE CLOSURE THERAPIES FOR TRICUSPID REGURGITATION

45 PATHWAY OF PARADOXICAL EMBOLISM Windecker et al. J Am Coll Cardiol 2014;64:

46 PFO CLOSURE VS. MEDICAL THERAPY: PATIENT-LEVEL DATA META-ANALYSIS Kent et al. J Am Coll Cardiol 2016;67: IPD Meta-analysis of CLOSURE I, RESPECT, and PC (N=2,303) Ischemic Stroke/TIA/Death Recurrent Ischemic Stroke

47 Thaler D, presented at TCT YEAR RESULTS OF THE RESPECT TRIAL Freedom from Recurrent Ischemic Stroke Freedom from Recurrent Ischemic Stroke of Unknown Mechanism

48 TAVI Henry Kissinger, 92, the former secretary of state, has had the procedure (TAVI). I was getting out of breath more easily, and my cardiologist said something had to happen, he said in a telephone interview. He said I would be in a wheelchair if I didn t have it, and my survival rate in a year would be only I am more energetic, people tell me I look better, and I feel much less tired, Mr. Kissinger said. He described the procedure as easier and less debilitating than the open-heart bypass surgery he had previously. There s no comparison. TAVI=Transcatheter aortic-valve implantation. New York Times. Building a Better Valve (June 20, 2015). Available from (Accessed October 2015).