• Non ci sono risultati.

11) Protesi valvolare aortica percutanea Cribier Edwards: bioprotesi pallone espandibile di terza

4.10. Limiti dello studio.

Esiste un importante limite del nostro studio; i dati in nostro possesso sono estrapolati da un Registro in cui vengono inseriti tutti i dati dei pazienti, non si tratta quindi di uno studio prospettico o randomizzato.

La popolazione inserita nello studio si presenta tutta ad alto rischio chirurgico e con comorbilità importanti, ciò limita il confronto anche con la letteratura chirurgica, la quale prende in considerazione generalmente soggetti operabili; ossia a basso rischio chirurgico e senza altre gravi patologie associate.

80 5. CONCLUSIONI

Il presente studio espone le principali caratteristiche della stenosi aortica degenerativa, le linee diagnostiche e terapeutiche più attuali, ed i risultati dei 267 interventi di impianto percutaneo della protesi valvolare aortica CoreValve eseguiti, dal settembre 2007 al maggio 2013, presso l’Università di Pisa.

I risultati ottenuti dimostrano che tale intervento è fattibile e con un ottimo successo procedurale nei i pazienti anziani ad alto rischio chirurgico.

La mortalità perioperatoria osservata è stata del 6%, inferiore a quella predetta dagli algoritmi di previsione del rischio chirurgico (20%).

La procedura si è dimostrata in grado di determinare un immediato miglioramento clinico nei pazienti con stenosi aortica degenerativa e ciò è osservabile, mediante la riduzione della classe funzionale NYHA.

La stabilità dei dati clinici a 30 giorni, a 6, 12, e a 24 mesi dall’impianto, in associazione alla scomparsa della sintomatologia nei pazienti trattati, lascia ben presagire sull’efficacia di questo trattamento in pazienti selezionati con stenosi aortica severa.

In conclusione, la TAVI è una nuova opzione terapeutica per i pazienti ad alto rischio con stenosi aortica grave. I tassi delle complicanze sembrano accettabili, considerando l'alta frequenza di malattie coesistenti in tali pazienti. Ulteriori progressi nei criteri di selezione dei pazienti, l'assistenza post-procedurale e la scelta di un accesso ottimale sono essenziali per migliorare i risultati.

La TAVI sembra essere quindi una scelta ragionevole in pazienti inoperabili o ad alto rischio con grave stenosi aortica sintomatica.

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