Considerando tutte le complicanze legate all’impianto della bioprotesi, queste sono state osservate in 31 pazienti (1,54±0,27 % pt-yrs): embolie in 14, endocarditi in 8, degenerazione strutturale valvolare in 4, emorragie in 4 e leak paravalvolare in 1 [Tab. 4]. La libertà attuariale da tutte le complicanze legate alla valvola è dell’86±5% a 10 anni, del 75±6% a 15 anni e del 71±6% a 20 anni [Fig. 59].
% pt-yrs= Percent per patient years; SE= 95% standard error
* numbers indicate patients at risk at corresponding postoperative intervals
Complication N. Linearized
incidence (% pt-yrs)
Actuarial freedom %±SE
10 years 15 years 20 years
n=96* n=28* n=2* Late deaths 107 - 57±5 34±7 19±7 Valve-related deaths 15 0.72±0.19 94±3 87±5 85±6 Thromboembolism 14 0.48±0.15 93±3 88±4 85±5 - fatal 11 0.24±0.11 - - - Hemorrhages 4 0.19±0.10 97±1 97±2 97±2 - fatal 1 0.05±0.05 - - - Endocarditis 8 0.38±0.14 95±2 95±2 95±2 Structural failure 4 0.19±0.10 99±1 95±3 95±3 Reoperation 9 0.43±0.14 96±1 92±4 92±4 Valve-related complications 32 1.54±0.27 86±5 75±6 71±6
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COMMENTO
Questo studio riporta l’esperienza di un singolo centro analizzando le prestazioni complessive della bioprotesi porcina Mosaic (MPB) utilizzata per la sostituzione valvolare aortica con un follow-up di più di 20 anni. La bioprotesi porcina Mosaic è entrata in uso a partire dal 1994 ma nonostante i risultati a breve e medio termine ottenuti sono stati oggetti di vari studi, i dati a lungo termine sono ancora limitati 133,134. Quando si valuta la performance di una protesi biologica un interesse particolare è rivolto alla capacità di resistere alla degenerazione valvolare strutturale e pertanto superare la prova del tempo. È accettato che nei pazienti con stenosi aortica calcifica le protesi biologiche siano particolarmente indicate nei soggetti anziani poiché è probabile che la durata della maggior parte dei modelli attualmente disponibili supererà gli anni rimanenti di vita dei riceventi, che hanno un’aspettativa di vita limitata a causa dell’età e delle comorbidità. Nonostante questo, la dimostrazione di una lunga durata delle protesi valvolari biologiche può contribuire ad abbassare il limite di età per questi dispositivi in particolare nella sostituzione valvolare aortica; di conseguenza, una popolazione più giovane potrebbe beneficiare dal mancato utilizzo delle protesi valvolari meccaniche e quindi dall’evitare le complicanze correlate al
- 93 - trattamento anticoagulante, essendo in seguito candidabile a una procedura “valve-in- valve”.
Questo studio, estendendo il periodo di follow-up, conferma i risultati ottenuti a medio termine da un lavoro precedente dalla Cardiochirurgia Pisana 127 e sembra dare un’impressione ancora più favorevole. Risultati significativi sono stati ottenuti limitando le considerazioni a coloro i quali hanno raggiunto il 15° anno post-operatorio quando un numero più significativo di pazienti è a rischio. I dati sulla sopravvivenza appaiono compatibili con l’età del paziente al tempo dell’intervento, così come quelli relativi alla libertà da complicanze post-operatorie maggiori. Nello studio, comunque, l’attenzione è stata concentrata soprattutto sulla performance emodinamica e sulla durata a lungo termine delle bioprotesi porcine Mosaic, due parametri fortemente correlati tra loro. I dati del controllo ecocardiografico indicano che le MPB, almeno quelle di dimensioni maggiori (23 e 25 mm), hanno una buona funzionalità anche dopo molti anni, come dimostrano i gradienti transprotesici accettabili e l’adeguata EAOI. Inoltre nei pazienti con stenosi aortica si è verificata una significativa regressione dell’ipertrofia del ventricolo sinistro, mantenuta anche all’ultimo follow-up. Questi dati, simili a quelli riportati in altri studi 135, sono una dimostrazione indiretta dell’adeguata funzione della bioprotesi Mosaic che sembra mantenere cuspidi valvolari flessibili anche dopo diversi anni. Durante il periodo di follow-up, solo 4 pazienti hanno avuto necessità di un reintervento per degenerazione valvolare strutturale con una libertà di questa complicanza del 95% a 15 anni nell’intera popolazione a prescindere dall’età; queste cifre sono comparabili o addirittura superiori a quelle riportate in altri studi con la stessa protesi o dispositivi simili 133-138. Le ragioni degli eccellenti risultati in termine di durata possono essere spiegate dalle seguenti considerazioni. Innanzitutto, in questa serie di pazienti, si sono registrati pochi casi di mismatch protesi-paziente anche di moderata gravità, che è riconosciuto avere un impatto significativo sulla durata della bioprotesi 139. Infatti, cercando di
evitare per quanto possibile questa complicanza, le protesi porcine stented sono state utilizzate solamente in presenza di un annulus aortico di dimensioni adeguate (≥23 mm); al contrario, in presenza di un annulus aortico di dimensioni minori (≤ 21 mm) sono state preferite le bioprotesi pericardiche, sia stented che stentless, a causa della
- 94 - loro superiorità emodinamica 140,141. Inoltre, grazie alle procedure di allargamento dell’annulus aortico 117, sono state evitate le bioprotesi stented di 19 mm.
In secondo luogo, l’età media dei pazienti era elevata, con il 75% di essi di età superiore a 70 anni al momento dell’intervento, nonostante non si siano registrate differenze nell’incidenza di SVD tra i soggetti maggiori e minori di 70 anni.
Infine, il trattamento anticalcificante utilizzato per le bioprotesi porcine Mosaic sembra essere vantaggioso nel ritardare la calcificazione delle cuspidi valvolari; va comunque sottolineato che in 3 dei 4 pazienti rioperati per SVD essa era presente con il classico pattern della degenerazione delle valvole porcine. Nonostante questo i risultati dei controlli ecocardiografici sembrano indicare che questo potrebbe essere considerato un evento occasionale per le bioprotesi Mosaic almeno fino a 15 anni dopo la sostituzione valvolare aortica.
Nonostante questo studio si estenda per due decadi, è una revisione retrospettiva di un database compilato prospettivamente e questa è una limitazione maggiore. L’end point principale era quello di verificare la durabilità delle bioprotesi porcine Mosaic a lungo termine. A questo proposito, i dati disponibili per l’intervallo di follow-up più lungo riguardano solo un limitato numero di pazienti e quindi le considerazioni devono essere limitate a un periodo minore ma comunque significativo (15 anni). Tuttavia, la valutazione clinica completa, con stretta aderenza alle linee guida raccomandate, affiancata dai risultati degli esami ecocardiografici ha fornito dati sufficienti per poter stabilire che la sostituzione valvole aortica con una bioprotesi Medtronic Mosaic, soprattutto quando vengono utilizzati calibri di dimensioni adeguate, appare sicura ed efficace anche nel lungo periodo, sia in termini di mortalità che di complicanze legate alla valvola.
- 96 -
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