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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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Linee guida e registri nelle procedure aortiche

Linee guida SICVE

Fabio Verzini

Chirurgia Vascolare ed Endovascolare

Università di Perugia

Az.Osp.Perugia

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Perché Linee Guida SICVE?

  • Implementare Linee guida ESVS
  • Aggiornare LG
  • Contestualizzare LG
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Punti critici

Open vs EVAR

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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.
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NICE – National InstituteForClinicalExcellence

Guidance TA 167 – Febbraio 2009

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NICE – National InstituteForClinicalExcellence

Guidance TA 167 – Febbraio 2009

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81.9% open

70.4% EVAR

69.9% open

68.9% EVAR

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DREAM Conclusions

  • Similar survival rates
  • Higher incidence of secondary intervention with EVAR
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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
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DREAM analysis

  • Power calculation based on early (30 days) mortality
  • Few late events
  • Few CTs in Open group after 2 yy
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EVAR 1 Conclusions

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

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

0.5% vs 3.0%; P=.004

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OVER Conclusions

  • Mean follow up 1.8 years
  • Short term EVAR benefit in mortality,& morbidity
  • Similar quality of life & reintervention rates
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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
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survival free of death or major event

survival free of death or reintervention

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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
slide36

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
slide40

April 2004 – February 2011

520 patients with RAAA

116 patients randomized to EVAR or OPEN repair

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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

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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
ad