ItalianoÈ nostra ferma intenzione sottolineare che il trattamento con angioplastica della CCSVI o “Liberazione” in pazienti con sclerosi multipla è ancora in fase sperimentale. Attualmente nella letteratura medica internazionale esistono limitate evidenze scientifiche con, in aggiunta, casistiche non condotte sotto rigidi criteri di studio. È opportuno quindi un approccio estremamente cauto a tale procedura in termini di efficacia a breve, medio e lungo termine.
INOLTRE È ORMAI COMPROVATO CHE CENTRI CON LIMITATA ESPERIENZA OPERATORIA (meno di 800-1000 interventi eseguiti), MATERIALE DI NON ASSOLUTA QUALITÀ E SOPRATTUTTO SENZA UN TEAM MULTIDISCIPLINARE COMPOSTO DA NEUROLOGO, RADIOLOGO E CHIRURGO VASCOLARE RIPORTANO PIÙ FREQUENTEMENTE RISULTATI SUB-OTTIMALI IN TERMINI DI EFFICACIA CLINICA. SONO INFATTI MOLTI I CASI DI PAZIENTI RIOPERATI UNA SECONDA VOLTA CON RISULTATI CLINICI SENSIBILMENTE MIGLIORI DOPO INTERVENTI IN CENTRI CON UNA LIMITATA ESPERIENZA IN QUESTO CAMPO.
Purtroppo solo l’esecuzione della diagnosi e del trattamento della CCSVI in centri dedicati e con un team multidisciplinare esperto potrà validare pienamente l’efficacia dell’intervento di liberazione.
Infine, per dovere di informazione riportiamo qui sotto alcune valutazioni dell’altro gruppo di operatori con un’esperienza significativa in questo campo, che come il Team Brain Flow riferisce un numero di procedure superiore a 1900 casi. Questo, indipendentemente dalle valutazioni più o meno esatte del singolo, nell’ottica di evitare che questa procedura venga fatta troppo velocemente oggetto di facili entusiasmi da parte di pazienti ed operatori stessi.
“Regarding the treatment, we opt for the most safe and the most efficient treatment, which of course is not possible, since those two parameters don’t meet it every case. Balloon angioplasty has already been demonstrated to be very safe in a short time, and most likely safety in long time is also nearly perfect. But balloon angioplasty is not very efficacious. In some cases it doesn’t work at all, in the others there are late restenoses. The short-term efficacy of an alternative treatment – stenting is much higher. But long-term efficacy (risk of late occlusion) is not known. Although occluded stent can be opened, but probably not in every case. And of course there are known early complications related to stents, namely the migration, that exclude some anatomic variants from stenting (at least using currently available stents). There is also possible the open repair of the vein, but risk and efficacy of such procedures are not known. Thus, all treatment modalities should be regarded as experimental, with still unknown efficacy and safety. The doctors always try to balance the risk and the efficacy factors, but the best solution is not always possible and is not always chosen (importantly, we don’t have data on long term consequences of ballooning or stenting).
Now, what about impact of the treatment for CCSVI on clinical course of MS. Our data indicate that the things are far more complicated than it might be suspected.
- CCSVI is not an equivalent for MS; most likely, MS = CCSVI + some (probably more than one) other factors.
- Consequently, treating CCSVI does not mean that MS is gone. Most of the patients experience good and bad days following surgery, importantly, during infection, stress, etc. the symptoms usually go back. But the symptoms also go back in a case of restenosis.
- Treatment of CCSVI does not guarantee improvement. There were some patients (not much, still, they were) who experienced worsening. Most of those patients presented with severly narrowed veins that could not be sufficiently managed with ballooning or stenting, but there were also cases with “perfectly” done surgery. So, a patient can improve after surgery (a majority, especially relapsing remitting patients), but no improvement or even worsening is also possible. A reoperation can improve the symptoms in the latter two groups, but again, not in all cases.
- Probably, surgery for CCSVI + pharmaceutical treatment will improve outcomes. Try to continue your neurological medication if it were working before surgery.
- Many patients who suffered from transient worsening of symptoms, improved after inclined bed therapy. You can try it, even if not efficient, at least it is 100% safe.
- Postoperative Doppler examination is sometimes puzzling. In most of the patients the flow just after the suregery is still pathologic. Threfore we don’t perform it after operation (we don’t want to stress the patients). Even after some days there are still flow abnormalities, especially after ballooning. So, we think that patient should look at his/her symptoms first.
And, importantly, current situation when patients must travel thousands of miles to have the treatment is neither normal nor is it safe. At the moment healthcare systems seem to overregulated. It must be changed. Especially, cooperation with neurological community and big universities with access to big public money is pivotal. Surgery is not the only solution, it must be augmented by something else.”
Marian Simka
Dott. Tommaso Lupattelli
Alla data attuale sono stati eseguite 1900 angioplastiche circa dall’equipe del Dott. Tommaso Lupattelli, prima presso la clinica Salus di Reggio Emilia e successivamente presso la clinica ICC GVM Sanità Casalpalocco, Roma (sede attuale). La procedura purché eseguita da personale competente e adeguatamente preparato appare scevra da complicanze peri e post operatorie importanti, risultando sicura. Le complicanze tuttavia appaiono essere maggiori quando la procedura di angioplastica viene eseguita in centri non sufficientemente attrezzati, con personale ed equipe medica con esperienza inferiore ai 500 casi eseguiti.
L’intervento mostra essere efficace in un alta percentuale di pazienti. In una percentuale, seppur limitata, la procedura non mostra condurre a significativi cambiamenti della qualità di vita del paziente. Infine,nella nostra esperienza, la percentuale di pazienti con evidenza di re-stenosi o richiusura delle vene trattate ad un follow-up di 24 mesi appare essere inferiore al 15%. I risultati della procedura verranno tuttavia presentati a tempo debito nelle sede opportune e negli organi scientifici preposti.