La consensus WoCoVA-GAVeCeLT sui
sistemi di ancoraggio so7ocutaneo: il
documento finale
Fulvio Pinelli
COSA SONO I SAS
•
SISTEMI DI ANCORAGGIO SOTTOCUTANEO
– ACCESSI VASCOLARI, DRENAGGI PERITONEALI, DRENAGGILIQUORALI, DRENAGGI TORACICI, ECC
•
UNICO IN COMMERCIO E’ IL SECURACATH
TMDISLOCAZIONE
•
Parziale/totale
•
8-10%
SCARSA STABILIZZAZIONE
•
Movimento in&out del presidio
•
Molto diffusi (spec. in Europa)
•
Molto apprezzati da operatori e pazienti efficacia,
confidenza, sicurezza, etc.
STUDI
Author Congress Abstract Type Ballance AVA 2012 Poster
Ballance AVA 2013 Poster Dougherty AVA 2013 Poster Stone AVA 2013 Poster Peveler INS 2013 Poster
Hills WoCoVA 2014 Oral Presentation Sandeluss AVA 2013 Poster
Pittiruti AVA 2015 Oral Presentation Djurcic-Jovan CVAA 2016 Poster
Janssens 2016 Poster McParlan 2016 Poster Pittiruti ESPNIC 2017 Poster
Jones GAVeCeLT 2017 Oral Presentation Culverwell 2017 Poster
Pittiruti WoCoVA 2017 Oral Presentation Pittiruti SMART 2017 Oral Presentation Pittiruti AVA 2017 Oral Presentation McParlan 2018 Poster
STUDI
Cordovani 2013 Multicentre, Prospective, Observational
Egan 2013 Multicentre, Prospective, Observational
Hughes 2014 Observational
Dolcino 2017 Prospective, Observational Retrospectively controlled Zerla 2017 Prospective Observational
Goossens 2018 RCT (StatLockä vs Securacathä): tempi di medicazione
Pittiruti 2019 Prospective, Observational
McParlan 2019 Observational Retrospectively Controlled
Perche’ una Consensus
Scopi della Consensus
1. Esaminare sistematicamente la letteratura esistente;
2. Fornire indicazioni e controindicazioni all’utilizzo dei
sistemi di ancoraggio sottocutaneo (SAS) per gli
accessi venosi;
Metodologia della Consensus
•
Identificazione di un panel di esperti italiani (adulto e pediatrico);
•
Raccolta della bibliografia esistente (2012-2019);
•
Approvazione di quesiti focalizzati sullo scopo della Consensus;
•
Elaborazione delle risposte ai quesiti, da parte di ciascun membro
del panel, in base alla letteratura e alla propria esperienza;
•
Riunione dei panelists il 3 dicembre 2018 a Bologna, per ottenere un
consenso sulle risposte ai differenti quesiti;
•
Elaborazione di un documento preliminare da sottoporre a peer
reviewers, scelti tra esperti europei nell’ambito degli accessi venosi;
•
Approvazione da parte del panel di un documento finale
Esperti invitati a partecipare alla
Consensus
• Panel (gruppo adul.): Roberto Biffi, Giuseppe Capozzoli, Adam Fabiani, Crishna
Garrino, Luca Montagnani, Stefano Elli, Daniele Elisei, Giancarlo Scoppeiuolo, Pietro Zerla
• Panel (gruppo pediatrico): Giovanni Barone, Alessandro Crocoli, Ugo Graziano, Alessio
Pini Prato, Clelia Zanaboni, Nicola Zadra
• Peer Reviewers : Chrishan Breshan (A), Jiri Chavat (Cz), Andrew Jackson (UK), Mai
DOMANDE PER IL PANEL
1. Efficacia dei SAS nel ridurre il rischio di dislocazione
2. Efficacia dei SAS nel ridurre trombosi e infezione
3. Possibili effetti indesiderati dei SAS e come possono
eventualmente essere prevenuti
SAS efficace nel ridurre il rischio di
dislocazione?
Efficacia sulla dislocazione
•
Though
overall scientific quality
of the clinical studies is
poor
(in most cases prospective non-controlled observational
trials), all the literature support the
overall effectiveness of
SAS
in
reducing the risk of dislodgment
when used for
securing PICCs and other types of central VADs in adult
patients,
especially in children and neonates.
•
All the available data suggest a
superiority or at least a
non-inferiority
of SAS if compared to adhesive sutureless
Necessità di ulteriori studi clinici?
Si
Prospective controlled trials, carefully designed:
a) Appropriate choice of the patient population
SAS might be particularly indicated in some clinical situations (oncological
patients with medium-long term central VADs; long term parenteral nutrition;
PICC meant to stay in place for more than 4-6 weeks; patients with skin
abnormalities that limit the use of skin adhesive sutureless devices; pediatrics??);
b) Control group should be carefully defined:
C
ontrols should include a well-defined strategy of sutureless securement (for
example, skin adhesive sutureless system + cyanoacrylate glue + semipermeable
transparent membrane);
c) Endpoint should be carefully defined,
Both partial and complete dislodgment;
d) Health operators participating to the study should be specifically trained in the
SAS efficace nel ridurre trombosi e
infezione?
Efficacia su trombosi e infezione
•
Theoretical rationale
–
Reduced in&out movements, more accurate antisepsis, maximal stabilization
•
No evidence
•
Further studies are warranted
in this area
(a) homogeneity of patient population in terms of risk of infection or CRT;
(b) proper definition of the primary endpoint (reduction of complications such
as infection of the exit site or CRBSI or CRT) and proper criteria of diagnosis
of such complications;
(c) proper definitions of the strategies used for preventing infection and/or CRT
in the study group and in controls;
Quali
sono
i
possibili
effetti
indesiderati dei SAS e come possono
eventualmente essere prevenuti?
Effeq indesiderah
•
Several undesirable local effects
described
in adults (negligible in children
and in neonates)
– in particular acute/chronic inflammation of the exit site and pain at removal.
•
Real incidence
of these local problems is
difficult to quantify
– semi-anecdotical nature of the observations;
– the variety or uncertainty of the techniques used for placement and removal;
– most of these local problems of little clinical relevance, probably less relevant than the local problems derived by the use of adhesive sutureless securement.
•
Further controlled clinical studies are needed
so to optimize:
– technique of SAS placement (local anesthesia, skin antisepsis, proper insertion of the
nitinol bars deeply into the subcutaneous tissue, sealing with cyanoacrylate, etc.), – technique of SAS maintenance (avoidance of traction, definition of the role of
gauze/tissue under the SAS, etc.)
– technique of SAS removal (wise use of local anesthesia when needed, splitting the SAS in
