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Chirurgia Vascolare ed Endovascolare Università di Perugia Az.Osp.Perugia

Linee guida e registri nelle procedure aortiche Linee guida SICVE. Fabio Verzini. Chirurgia Vascolare ed Endovascolare Università di Perugia Az.Osp.Perugia. SIGN Scottish Intercollegiate Guideline Network, http://www.sign.ac.uk. METODOLOGIA AHA-ACC. Perché Linee Guida SICVE?.

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Chirurgia Vascolare ed Endovascolare Università di Perugia Az.Osp.Perugia

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  1. Linee guida e registri nelle procedure aortiche Linee guida SICVE Fabio Verzini Chirurgia Vascolare ed Endovascolare Università di Perugia Az.Osp.Perugia

  2. SIGN Scottish Intercollegiate Guideline Network, http://www.sign.ac.uk

  3. METODOLOGIA AHA-ACC

  4. Perché Linee Guida SICVE? • Implementare Linee guida ESVS • Aggiornare LG • Contestualizzare LG

  5. Chi deve fare cosa

  6. Punti critici Open vs EVAR

  7. Nuovi HTA? • l’EVAR riduce la mortalità a 30 giorni, ma non offre nessun beneficio significativo nella mortalità associata all’aneurisma e nella mortalità totale a lungo termine • L’EVAR, infine, risulta associato ad un numero di re-interventi più elevato rispetto alla CA, non compensato da un miglioramento dell’HRQoL. • L’unico studio che ha analizzato l’EVAR rispetto alla CA nei pazienti con AAA rotto trattati in urgenza, non ha osservato la differenza ipotizzata, sulla base di studi osservazionali precedenti, nella mortalità e nelle complicanze gravi tra i pazienti trattati con EVAR e con CA.

  8. NICE – National Institute For Clinical Excellence Guidance TA 167 – Febbraio 2009

  9. NICE – National InstituteForClinicalExcellence Guidance TA 167 – Febbraio 2009

  10. NICE – National InstituteForClinicalExcellence Guidance TA 167 – Febbraio 2009

  11. 81.9% open 70.4% EVAR 69.9% open 68.9% EVAR

  12. DREAM Conclusions • Similar survival rates • Higher incidence of secondary intervention with EVAR

  13. DREAM analysis • Mostly men (94%) • ASA I 6 & II = 85% • Erollment target (400 pts.) not achieved • > 10% AneuRx, Ancure, Quantum, Lifepath • Cluster of reinterventions after 5 yy in EVAR

  14. DREAM analysis • Power calculation based on early (30 days) mortality • Few late events • Few CTs in Open group after 2 yy

  15. EVAR 1 Conclusions • Lower per-operative mortality • Equal total & AAA related mortality • EVAR : increased graft related complications & reinterventions • EVAR more costly

  16. EVAR 1 Analysis • Loss in the early benefit mainly due to increased late fatal graft ruptures • “Early” 2°-3° generation endografts, scarce recognition of intra operative problems leading to late complcations • Center experience (> 20 EVAR) issue • Too aggressive treatment of complications (type 2 endoleaks) • “Old” & costly surveillance program

  17. EVAR 2 Conclusions • Lower EVAR AAA-related mortality • Equal total mortality • EVAR : increased graft related complications & reinterventions • EVAR more costly

  18. EVAR 2 Analysis • Per-protocol analyses: greater benefit of EVAR in AAA related mortality. • A non-significant benefit in total mortality was also shown. • High rate of crossover = it is difficult to withhold endovascular repair in the future.

  19. perioperative mortality 0.5% vs 3.0%; P=.004

  20. OVER Conclusions • Mean follow up 1.8 years • Short term EVAR benefit in mortality,& morbidity • Similar quality of life & reintervention rates

  21. OVER Analysis • 43 % small AAA • very low mortality rates in both groups • 20% AneuRx • Early Conversion rate <1.5% • Mostly, reintervention after EVAR were endovascular, • after Open Surgery were Hernia repair

  22. survival free of death or major event survival free of death or reintervention

  23. ACE Conclusions • Median follow up 3 years • Operative mortality: • open surgery 0.6%, EVAR 1.3 % • Reinterventions: 2.7% vs 16% • In low risk patients, Open repair is as safe as EVAR

  24. ACE Analysis • Small number of enrolled pts., below target • Very low Open surgery mortality: patient & Center selection, most recent trial • Incisional complications (24%) & hernia repairs not accounted for

  25. Aneurismi rotti?

  26. RUPTURED AAA

  27. 41 studies for analysis 59941 patients

  28. April 2004 – February 2011 520 patients with RAAA 116 patients randomized to EVAR or OPEN repair

  29. Primary endpoint rate (death+severe complications) at 30 days: 42% EVAR vs 47% OPEN (ARR 5.4, 95% CI:-13% +23%) 30 dd Mortality: 21 % EVAR, 25% Open

  30. Conclusioni • SICVE ha il dovere di produrre LG • E’ una opportunità per aggiornare l’esistente • Evidenza attuale spesso di grado non elevato = raccomandazioni in classe 2

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