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Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
Percutaneous Mitral Repair The Truth
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Percutaneous Mitral Repair The Truth

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a history of mitral repair from surgery to intervention

a history of mitral repair from surgery to intervention

Published in: Health & Medicine
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  • 1. SICCH 2010, Technocollege percutaneous mitral repair F. Maisano MD, FESC San Raffaele Institute Milano, Italy …The Truth
  • 2. Current status of surgical repair of MR • Mitral repair is a surgical success story  Low operative risk  Recovery of life expectancy  Low rate of recurrence when appropriate procedures are performed  Minimally invasive techniques increasingly performed Everest Peak, Himalaya complex
  • 3. Euro Heart Survey: 50% symptomatic patients with severe MR are denied surgery Isolated MR (n=877) Severe MR (n=546) No Severe MR (n=331) No Symptoms (n=144) Symptoms (n=396) No Intervention (n=193) 49% Intervention (n=203) 51% Mirabel et al, European Heart J 2007;28:1358-1365
  • 4. Transcatheter mitral interventions • Balloon commissurotomy • Annular repair  Sinoplasty (Monarc, Carillon, PTMA)  Direct reshaping (Mitralign, GDS)  Surgical like annuloplasty (ValtechCArdio) • Leaflet repair  Edge-to-edge repair (Mitraclip)  Others (plicating clips, chordal repair)  Cinching devices  Internal (PS3)  External (Coapsys, BACE)  Other  Hybrid devices (Mitral Solutions, Micardia, Valtech)  Occluder (Cardiac Solutions)  Transcatheter MVR (Endovalve, CardiaQ, Mitraltech)  Perivalvular leak closure
  • 5. From surgery to catheter interventions Surgical E2E, open heart, sternotomy
  • 6. From surgery to catheter interventions Robotic E2E, open heart, closed chest
  • 7. From surgery to catheter interventions transcathter E2E, beating heart, closed chest
  • 8. Mitraclip
  • 9. Versatility Functional MR Degenerative MR
  • 10. EVEREST Trial Anatomic Eligibility • Sufficient leaflet tissue for mechanical coaptation • Non- rheumatic/endocarditic valve morphology • Protocol anatomic exclusions  Flail gap >10mm  Flail width >15mm  LVIDs > 55mm  Coaptation depth >11mm  Coaptation length < 2mm Feldman T et al., J Am Coll Cardiol 2009;54:686–94
  • 11. FMR, Log ES 45%, REDO post CABG, recent AMI, EF 20%, CRT-AICD • Before treatment • After mitraclip • The patient was transferred from ICU to the general ward in day 1 and discharged home 4 days after the procedure • At 1 year the MR reduction is stable with mild residual MR, reduction of LV volumes, and the patient is in NYHA class I
  • 12. Confidential European Experience: Number of Patients Treated Per Month 4 10 9 12 7 16 14 19 26 25 30 28 35 35 47 53 54 70 78 80 87 112 97 112 0 20 40 60 80 100 120 Sep 08 Oct Nov Dec Jan 09 Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan 10 Feb Mar Apr May Jun Jul Aug Count # of Patients Treated # of Sites # of Sites Treating Patients * Includes first-time procedures only – not 2nd Clip interventions *Data as of 8/31/2010. Source: EU Case Observation Reports N = 1060 Total Patients
  • 13. GISE Mitraclip User Meeting 22 ACCESS Europe – MitraClip Arm Baseline Echocardiographic Measurements Co-morbidities (MitraClip N) ACCESS MitraClip Patients EVEREST II RCT Device Group (N = 184) MR,% (n=246) None (0) 0.0% 0.0% Mild (1+) 0.0% 0.0% Mild to Moderate (1+-2+) 0.0% 0.0% Moderate (2+) 2.8% 4.3% Moderate to Moderate to Severe (2-3+) 4.1% 0.0% Moderate to Severe (3+) 30.9% 70.7% Moderate to Severe to Severe (3-4+) 26.4% 0.0% Severe (4+) 35.8% 25.0% MR Etiology, % (n=216) DMR 12.5% 73.4% FMR Ischemic 43.1% 26.6% CombinedFMR Non-ischemic 44.4%
  • 14. European/HSR Experience Overall Results *Data as of 8/31/2010. Source: EU Case Observation Reports Overall European experience All Patients – HSR Milan Patients Treated 1060 48 Hospitals/Sites 56 1 Etiology: FMR/DMR/Mixed (%) 64%/29%/8% 64% / 29% / 8% Average Device Time1,2 (hr:min) 1:51 1:23 Clip Implant Rate2 (%) 96% 98% 1 Clip/2 Clip/3 Clip/4 Clip2,3 (%) 67%/30%/2%/<1% 32% / 62% /4% / 0% Site Reported MR Reduction2,3 (%) 98% 100% Clip Embolization (%) 0.01% 0.0% 1Does not include time to perform the transseptal puncture 2Includes first procedures only – not 2nd Clip interventions. 3Applies only to successful implants – does not include non-implants. 4Applies to two patients one clip partial detached each
  • 15. 24 ACCESS Europe – MitraClip Arm Baseline Demographics Characteristic (MitraClip N) ACCESS MitraClip Patients EVEREST II RCT Device Group (N = 184) San Raffaele Milan (N=41) Age, years (n=278) Age, Mean ± SD 72.8 ± 10.2 67.3 ± 12.8 70.7 ± 13.2 F 68.3 ± 10.8 D 75.4 ± 16.4 Patients > 75 years (%) 41.4% 29.9% 43.6% F 33.3% - D 71.4% Gender, % (n=282) Male 65.6% 62.5% 75.6% F 88.9% - D 50.0% Female 34.4% 37.5% 24.4% F 11.1% - D 50.0%
  • 16. Baseline Co-morbidities Co-morbidities (MitraClip N) ACCESS MitraClip Patients EVEREST II RCT Device Group (N = 184) San Raffaele - Milan (N=41) Age, Mean ± SD 72.8 ± 10.2 67.3 ± 12.8 70.7 ± 13.2 F 68.3 ± 10.8 D 75.4 ± 16.4 Logistic EuroSCORE (n=243) 19.8 ± 18.2 NA 25.1 ± 15.7 F 27.9±17.1 - D 19.5±11.1 Coronary Artery Disease (n=248) 62.1% 47.0 % 65.8% (F 81.5% - D 35.7%) Atrial Fibrillation (n=240) 62.1% 33.7% 41.9% (F 50% - D 27.3%) Diabetes (n=251) 28.7% 7.6% 24.0% (F 29.4% - D 12.5%) Previous Cardiovascular Surgery (n=247) 37.7% 22.3% 32.5% (F 33.4% - D 30.1%) Previous Percutaneous Intervention (n=245) 39.6% 24.0% 55.0% (F 70.4% - D 23.1%) ICD 22.7% 7.1% 20% (F 28.6% - D 0.0%) AICD-CRT 18.2% (F 30.0% - D 0.0%) LVEF 10-20% 12.0% Mean EF 60.0% 7.3% (F 11.2% - D 0.0%) LVEF 20-30% 29.3% 29.3% (F 44.4% -D 0.0%) LVEF 30-40% 17.4% 17.1% (37.0% - D 0.0%) LVEF > 40% 41.3% 36.6% (7.4% -D 100%)
  • 17. Discharge Status 26 Discharge Location (n = 238) MitraClip Patients San Raffaele Milan Discharged home without home healthcare 81.1% 82.9% Discharged home with home health care 0.8% 0.0% Discharged to nursing home/skilled nursing facility/hospital 16.0% 17.1% Death prior to discharge 2.1% 2.0% Death prior to 30 days or discharge 3.4% 2.0%
  • 18. 27 Degenerative (n = 14) Functional (n = 26) ACCESS Europe – MitraClip Arm MR Severity at Baseline & Discharge 50% 43% 36% 2% 5% 1% 62% 0% 20% 40% 60% 80% 100% Pre-Clip Discharge Percent 4+ MR 3+ MR 2+ MR 1+ MR 0+ MR Baseline & Discharge MR Severity Matched Data (n = 205) Baseline & Discharge MR Severity Matched Data (n = 40) San Raffaele – MilanACCESS-EU STUDY
  • 19. NYHA Class Functional DMR San Raffaele Milan FMR
  • 20. Beyond Mitraclip - Annuloplasty • Lack of annuloplasty is associated to accelerated failure in the overall surgical population • Current transcatheter annuloplasty solutions are suboptimal • New technologies are developing (GDS, Mitralign, Valtech Cardioband) Maisano F, et al Eur J Cardiothorac Surg. 1999;15:419-25 Gillinov et al J Thorac Cardiovasc Surg 1998;116:734-43
  • 21. Transcatheter annuloplasty Coronary sinus remodeling SL dimensions cinching RF/Ultrasound remodeling External compression Direct annuloplasty
  • 22. Direct annular remodeling • Mitralign • GDS • ValtechCardio • The closest devices to conventional suture annuloplasty • Initial clinical trials
  • 23. Neochord Inc.
  • 24. Transcatheter MVR • Larger device • Anchoring • Asymmetric anatomy • Interaction with the aortic valve and LVOT • PVL more problematic
  • 25. Surgery vs percutaneous treatemtn Where are we?... The truth… • Surgical mitral repair can provide excellent results in most patients • Interventional MR repair is a great opportunity for expanding current treatment options • We need data  Everest trial results are encouraging but not reflecting real world scenario 70 30 EVEREST DMR FMR 10 90 ACCESS DMR FMR
  • 26. Surgery vs Mitraclip Chance of correcting MR with Mitraclip RiskofsurgeryLowHigh Low High Risk of Mitraclip procedure •Risk of Mitraclip procedure •Preservation of surgical option •Long term results of Mitraclip
  • 27. Individualize the therapy • Anatomy and function • Comorbidities, Life expectancy • Compare risk and probability of success • Preservation of surgical option • Patient informed consent for therapy • Transcatheter mitral repair is here to stay • Surgeons will do procedures We need data !!!

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