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Mitraclip san raffaele experience
- 1. Trattamento percutaneoTrattamento percutaneo dell'insufficienzamitralicadell'insufficienza mitralica Francesco MaisanoFrancesco Maisano Direttore del programma “trattamentoDirettore del programma “trattamento trans-catetere delle valvulopatie”trans-catetere delle valvulopatie” Ospedale San Raffaele MilanoOspedale San Raffaele Milano
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- 3. Nkomo. Lancet 2006;368:1005-11 4545-54 55-64 65-74 >75 Prevalenza dell’insufficienza mitralica a. L’insufficienza mitralica è la patologia valvolare più frequente nella popolazione generale b. L’incidenza aumenta con l’età c. 1 soggetto su 10 con età superiore a 75 anni è portatore di insufficienza mitralica significativa
- 4. Insufficienza mitralica eprognosi Robbins. Am J Cardiol. 2003;91:360-2 Enriquez-Sarano. N Engl J Med 2005;352:875-83 a. La presenza di insufficienza mitralica si associa a riduzione della sopravvivenza b. Il rischio di eventi cardiovascolari avversi (es. scompenso, decesso, aritmia) è proporzionale alla entità del rigurgito
- 5. Molti pazienti coninsufficienza mitralica non possono essere operati Isolated MR (n=877) No Severe MR (n=331) Severe MR (n=546) No Symptoms n=144 Symptoms n=396 Intervention n=203 (51%) No Intervention n=193 (49%) Symptoms missing n=6 (Mirabel et al. Eur Heart J 2007;28:1358-65)
- 6. Maisano et al,J Am Coll Cardiol 2011;58: 2174–82
- 7. Il Signor TL…. •Ottobre 2010 • 62 anni, cardiomiopatia dilatativa post-ischemica • Pregresso By-pass aortocoronarico e angioplastiche plurime • Portatore di defibrillatore e resincronizzazione biventricolare • Copatologie. Insufficienza epatica, ipertensione, dislipidemia • Sintomatico per dispnea (Classe IV, MLHF 36)
- 8. Il sig TL,62 anni, cardiopatico • EDV 223 ml • ESV 177 ml • EDD 78 mm • ESD 65 mm • EF 25% • Euroscore 36%
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- 10. Intervento versatile FMR DMR SanRaffaele, 2008-2011: 94 pts, 30%DMR, 70%FMR
- 11. 11 Patient Accountability ACCESS EU– HSR MitraClip Patients Preliminary Results Treated Patients Past 6 Month Follow-up N = 518 Total MitraClip Patients Treated* in ACCESS EU N = 567 *Data as of 10/6/2011. ACCESS EU – MitraClip Patients Preliminary 6-Month Results N = 443 6-month follow-up complete 86% patient data available N = 20 Withdrawals N = 55 Data pending Treated Patients Past 6 Month Follow-up N = 62 Total MitraClip Patients Treated** in HSR N = 93 **Data as of 28/11/2011. HSR– MitraClip Patients Preliminary 6-Month Results N = 62 6-month follow-up complete 94% patient data available N = 0 Withdrawals N = 0 Data pending
- 12. 12 Baseline Demographics andCo-Morbidities ACCESS EU – HSR MitraClip Patients Preliminary Results Demographics and Co-morbidities ACCESS EU (518) HSR (93) Age (mean ± SD), years 74 ± 10 71.4±11.4 (Range 25-88 ) Logistic EuroSCORE, (%) Mean ± SD 23 ± 19 21.8 ± 14.6 EuroSCORE ≥ 20%, (%) 44 51.6 Male Gender, (%) 65 76 Coronary Artery Disease, (%) 63 37.4 Previous Cardiovascular Surgery, (%) 37 26.4 Myocardial Infarction, (%) 32 49.5 Cerebro-vascular Disease, (%) 13 12.1 Moderate to Severe Renal Failure, (%) 43 39.3 Atrial Fibrillation, (%) 69 39.6
- 13. 13 Baseline Demographics andCo-Morbidities ACCESS EU – HSR MitraClip Patients Preliminary Results Demographics and Co-morbidities ACCESS EU (518) HSR (93) Mitral Regurgitation Grade ≥ 3+, (%) 97 100 NYHA Functional Class III or IV, (%) 85 73.1 Ejection Fraction < 40%, (%) 52 62.4 Functional MR, (%) 77 67.7 - Ischemic 41 73 - Non-ischemic 59 27 Degenerative MR, (%) 23 32.3
- 14. 14 Kaplan-Meier Freedom fromDeath HSR MitraClip Patients Preliminary Results At Risk N 93 61 31 10 98.8% ± 1.1 At 6 Months 89.1% ± 3.9 At 12 Months 85.8% ± 4.9 at 20 Months Hospital mortality, 1%
- 15. 15 Mitral Regurgitation Grade ACCESSEU – HSR MitraClip Patients Preliminary Results 80%MR≤2+ at6Months 3+ 4+ 3+ 2+ 1+ 0 + p<0.0001 N = 351 Matched Cases 2+ 4+ 79,3%MR≤2+ at6Months 3+ 4+ 3+ 2+ 1+ 0 + p<0.0001 ACCESS EU HSR N = 62 Matched Cases 4+
- 16. 16 0 20 40 60 80 BASELINE 6 MONTHS 41 48 6066 0 50 100 150 200 BASELINE6 MONTHS 107115 157 176 Ventricular Remodeling HSR MitraClip Patients Preliminary Results VTS VTD VTS VTD DTS DTD DTS DTD P=0.003 P=0.01 P<0.001 P=0.02 N = 62 Matched Cases N = 62 Matched Cases mm ml
- 17. 17 NYHA Functional Class ACCESSEU – HSR MitraClip Patients Preliminary Results II III IV II III IV I N = 340 Matched Cases p<0.0001 I 70%NYHA ClassIorII at6Months II III IV II III IV I N = 66 Matched Cases p<0.0001 88,7%NYHA ClassIorII at6Months
- 18. 18 Quality of LifeScore (MLWHF) ACCESS EU – HSR MitraClip Patients Preliminary 6-Month Results Data presented as mean ± 95% confidence interval p<0.0001 Baseline 6 Months N = 277 Matched Cases 41 29 12 point improvement p<0.0001 Baseline 6 Months N = 63 Matched Cases 36,3 21,3 15 point improvement
- 19. 19 6-Minute Walk Distance ACCESSEU – HSR MitraClip Patients Preliminary 6-Month Results Data presented as mean ± 95% confidence intervals Baseline 6 Months N = 233 Matched Cases p<0.0001 66 meter improvement 263 329 Baseline 6 Months N = 63 Matched Cases p<0.0001 110 meter improvement 197 307
- 20. 20 Il signor TL…a 2 anni di follow-up
- 21. MitraClip anatomical patient selectionconsiderations • Moderate to severe MR (Grade 3 or more out of 4 grades) • Pathology in A2-P2 area • Coaptation length > 2 mm (depending on leaflet mobility) • Coaptation depth < 11 mm • Flail gap < 10 mm • Flail width < 15 mm • Mitral valve orifice area > 4cm2 (depending on leaflet mobility) • Mobile leaflet length > 1 cm Recommended criteria1 Maisano et al, recommendations from the Crossroads institute.
- 22. Oltre la MitraClip:Annuloplastica
- 23. Transcatheter MVR • Largerdevice • Anchoring • Asymmetric anatomy • Interaction with the aortic valve and LVOT • PVL more problematic
- 24. 24 Conclusioni MitraClip èuna valida alternativa alla chirurgia in pazienti ad alto rischio o inoperabili MitraClip è versatile: si applica alla FMR e alla DMR nei pazienti che soddisfano i criteri anatomici MitraClip è un device per la terapia dello scompenso, più sicuro della chirurgia, e con efficacia provata in pz non responder alla CRT MitraClip è il primo di una serie di dispositivi per il trattamento percutaneo della insufficienza mitralica
Editor's Notes
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- #12 518 patients have reached their 6-month follow-up - However, AVSH still has not received 6-month visit data on 55 patients AVSH has complete 6-month data on 443 patients 443/518 = 86%