VALVULOPATIE: NUOVE SOLUZIONI.

Transcription

1 VALVULOPATIE: NUOVE SOLUZIONI

2 Nkomo, Lancet 2006

3 ELDERLY POPULATION PROJECTION IN USA Years Old 85 and Older 77,2 Millions of people 34,8 4,3 30,5 53,8 6, ,3 62, (proj) 2040 (proj)

4 pts>70 y.o. with valve disease %

5 Estimation of the Prevalence of Heart Valve Disease 2.5% of the adult population 1.8% clinically detected by echocardiography

6 Aetiologies of Single Valvular Heart Diseases in the Euro Heart 100% Survey 43% 13% 32% 12% 80% 60% 40% 20% Other Ischemic Congenital Inflammatory Endocarditis Rheumatic Degenerative 0% AS AR MR MS (Iung. Eur Heart J 2003;24: )

7 Severe symptomatic AS Severe AS : Valve Area 0.6 cm²/m² BSA or Mean Gradient 50 mmhg Symptomatic AS : NYHA Class III or IV or Angina Aortic Stenosis 75 years N=408 No Severe AS (n=114) Severe AS (n=284) NYHA III :106 NYHA IV : 36 No Symptoms N=68 Symptoms N=216 Angina : 148 No Intervention N=72 (33%) Intervention N=144 (67%) (Iung. Eur Heart J 2005;26: )

8 Current Management of MR Isolated MR (n=877) No Severe MR (n=347) Severe MR (n=540) No Symptoms n=144 Symptoms N=396 No Intervention n=193 (49%) Intervention n=203 (51%) (Mirabel. Eur Heart J 2007,28; )

9 Estimated structural heart disease opportunity: United States Patient population Currently treated Mitral regurgitation Moderate to severe 2,300,000 48,000 Severe 220,000 Aortic stenosis All grades 749,000 79,000 Severe 125,000 Tricuspid regurgitation Moderate to severe 1,600,000 <8000 Stuge O, Liddicoat J: JTCVS December 2006

10 Euro Heart Survey on Valvular Heart Disease 5001 Patients admitted in 92 centers from April to July 2001 N = % 80% 60% 40% 20% 0% Percut. Int. Valve Repair Bioprosthesis Mech Prosthesis Homograft Autograft AS AR MS MR (Iung. Eur Heart J 2003;24:1231)

11 Patient Characteristics in the Euro Heart Survey Age (years) 70 years (%) 1 comorbidity (%) AS 69± AR 58± MS 58± MR 65± (Iung. Eur Heart J 2003;24: )

12 Comorbidity Euro Heart Survey on Valvular Heart Disease 40 Mortality 30 % _11 >11 EuroScore 16% of patients (Iung. Eur Heart J 2003;24:1231)

13 AORTIC STENOSIS

14 Long term survival: Aortic stenosis Onset of symptoms % Survival 97.2% alive Failure Syncope Angina Surgery 45% alive Years 3 15 NEJM 1997;337;32-41 and UK Heart Valve Registry

15 Surgical Risk vs. Benefit Limited Value Optimum Value? Surgical Risk Poor value: Patient Purchaser Physician Clinical Benefit Increasing age

16 Aortic Stenosis in the Elderly Operative Mortality n= Age (yrs) CABG (%) Operative Mortality (%) Stroke (%) Aranki (Circulation 1993) - isolated AVR AVR + CABG Bouma (Heart 1999) Logeais (Circulation 1994) Freeman (J Am Coll Cardiol 1991) Gehlot (JTCS 1996)

17 22 centres, 67,764 patients, 4,743 octogenarians Complications (%) Mortality Renal failure Stroke Age (years)

18 Aortic valve implantation Modes of delivery Invasiveness Conventional midline sternotomy Surgical through Minimal Incision On pump, arrested heart sutureless valve replacement Transaortic,, beating heart delivery Transapical delivery Percutaneous - antegrade or retrograde

19 TRANSCATHETER AORTIC VALVE IMPLANTATION

20 Transapical Transfemoral No / fewer peripheral access issues No limiting delivery system size Short delivery distance to target Bailout/conversion simpler Avoids atherosclerotic aorta Mitral valve accessible Fewer Strokes No thoracotomy No apical trauma Smaller delivery system Anesthesia option Fewer pain management issues Staged implants (BAV then THV at later date) Reduced risk of bleeding Shorter ICU & hospital stay

21 Trans-apical apical implantation No design constraints Direct access

22 Patients to be considered for TA Suboptimal iliac anatomy Tortuosity,, calcification, size, disease, bilateral iliofemoral bypass Atheromatous disease of the arch (porcelain aorta?) Over-developed arch with horizontal ascending aorta

23 Cribier-Edwards Edwards and Edwards SAPIEN THV* Aortic Implants - Transfemoral/Transapical * The Edwards SAPIEN valve incorporates bovine pericardial tissue and TFX treatment

24 Results of TAVI Procedural success about 90% Mortality at 30 days ranges from 5 to 18% Acute myocardial infarction in 2 to 11% Severe AR in about 5% Vascular complications in 10 to 15% Stroke in 3 to 9% AV bock in 4 to 8% Survival is 70 to 80% at 2 y.

25 Improved Quality of Life NYHA LV Ejection Fraction % Baseline Discharge 3-6 Mo 1 Year

26 Excellent Valve Performance EOA (Core lab) EOA Mean Pressure Gradients (Core lab)

27 Pts.referred for TAVI: 65 HSR Jenuary 1 -April

28 Therapy Allocation 28 di 22

29 MITRAL REGURGITATION

30 THE EVOLVING APPROACH TO MITRAL VALVE REPAIR Sternotomy Minimally Invasive Robotic Open Chest Percutaneous

31 OBJECTIVES OF CATHETER- BASED MITRAL VALVE THERAPY To reproduce surgical results with minimal trauma,short hospital stay and fast recovery Treat the untreated patients (inoperable,too high risk,etc.)

32 Percutaneous Mitral Valve Therapies Mitralign Cardiac Dimensions Vaicor Ample PS3 Myocor Guided Delivery Quantum-Cor >350 Monarc Mobius Evalve

33 Percutaneous Mitral Valve Repair Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA: Beating heart catheter-based-edge-to-edge mitral valve procedure in a porcine model; efficacy and healing response. Circulation 110: , 2004

34 Double orifice repair Edge to edge principle

35 EDGE TO EDGE The only technique suitable to correct percutaneously mitral prolapse,, the leading cause of MR in the western world The only technique which can be used to correct MR due to opposite mechanisms: prolapse and restricted leaflet motion (functional MR)

36 The vision

37

38 EVEREST I & II Registry Enrollment 104 pts with 30 day Core Lab Follow-Up

39 Percutaneous Edge to Edge Applicable only to central MR originating from A2-P2 Not applicable in case of annular dilatation (SL / AL >1.4 ) SL mid esophageal 120 mid esophageal 90 mid esophageal 120 AL

40 ECHO Exclusions <2mm >11mm >10mm >15mm

41 Death- Unrelated to Clip In-Hospital Outcomes Mechanical ventilation > 48 hours Bleeding requiring transfusion Transseptal complication requiring surgery Effusion requiring pericardiocentesis Renal failure or dialysis Post-procedural hospital stay (median days) ICU/CCU time (median days) Discharged home (without home healthcare) (N = 104) EVEREST (N = 104) 1 (1%)* 1 (1%)* 3 (3%) 1 (1%) 1 (1%) 0 (0%) (97%) Repair 1.5% 5% 37% n/a n/a 3% 5 n/a n/a 2002 STS Replaceme nt 6.0% 13% 56% n/a n/a 5% 7 n/a n/a

42 1 hour after the Procedure 1 month after the procedure

43 EVEREST 30 Day Major Adverse Events N = 104 Freedom from Major Adverse Events 94% Death Unrelated to Clip Stroke (>72 hours) Renal failure Non-elective Cardiac Surgery Bleeding requiring transfusion Myocardial Infarction Septicemia /104 (6%)

44 Procedural Results (N = 104) 61% 1+

45 Surgery Following Clip Procedure (N = 104) Surgery After Clip Implanted (n = 20) 15 (75%) Repairs (0-562 days) 5 (25%) Replacements 71% Repaired Surgery After No Clip (n = 8) 5 (63%) Repairs 3 (37%) Replacements 19% 8% SURGERY FREE 76/104 73%

46 Probability of Event Free Clinical Success Event Free Clinical Success Kaplan- 100% 80% 60% 40% 20% 0% Meier Patients with Acute Procedural Success n = % 99% 97% 97% 97% 97% 90% 87% 86% 86% 86% 85% 85% 72% 68% 68% 68% Freedom From Death Freedom From Surgery 67% Freedom From Death, Surgery or MR > Time (months) Freedom from death, mitral valve surgery, & MR>2 n = Reached Endpoint

47 Coronary Sinus annuloplasty 138 pts as of 10/2007 Limitations Atrialization Posterior position Fragility Cx crossing

48 Devices in clinical trial as of 10/2007 MONARC (Edwards Lifesciences LLC) CARILLON (Cardiac Dimensions Inc) Two-anchor design with chronic reshaping (6weeks) by a foreshortening bridge Acute reshaping device acting in P2P3, repositionable, retrievable EVOLUTION trial (69 pts enrolled) AMADEUS trial (43 pts enrolled ) PTMA (Viacor Inc) Tri-lumen catheter, reshapable, possibility of multiple long term adjustment PTOLEMY (24 pts enrolled)

49 SAFETY data of CS devices (10/07) 30 days outcomes Monarc Carillon Viacor n Success implantation % Death % MI % Tamponade % Dissection CS % 0 2 8

50 Monarc System :Primary safety analysis EVENT FREE SURVIVAL: Death, MI, Cardiac Tamponade 90.2% at 30 Days 38 Patients at Risk 32 Patients at Risk 18 Patients at Risk

51 EFFICACY of percutaneous CS devices (10/07) Pre Monarc 6 Mos Pre Carillon (no corelab) Post Viacor Responders (%) 57% 63% NA ERO Cm² NA Rvol ml NA

52 MR reduction (>1grade) over time Monarc System Percent of patients who respond over time (paired data) 100% 90% 80% 70% 6 Weeks 92.3% (n = 13) % MR Responders 60% 50% 40% 48.5% (n = 33) 53.3% (n = 30) 30% 20% 10% 0% 0.0% (n = 46) Baseline 30 Days 90 Days 180 Days Visit Interval Active Device Foreshortening Sustained Device Tension

53 Current results of CS approach Efficacy Low rate of responders Limited reduction of the amount of MR Safety Risk of lesions Ischemic events Applicability Procedure seems feasible in most patients, but selection criteria are still unavailable

54 STATE OF THE ART good Minimally Invasive surgery Convent. surgery effectiveness PVI bad invasiveness