ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO DI PORTS
PER CHEMIOTERAPIA IN PAZIENTI ADULTI.
RISULTATI DI UN TRIAL CLINICO MONOCENTRICO RANDOMIZZATO.
Roberto Biffi, MD,F SPS
Direttore
Divisione di Chirurgia Addomino-Pelvica
e Mini-Invasiva
Istituto Europeo di Oncologia, Milano
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO
DI PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI
Background and Rationale
• Compelling evidence that real-time ultrasound (US) – guided
central veins access is associated with a lower incidence of
complications and a higher rate of success than landmark
blind techniques.
• Meta-analyses addressed the issue of cost-effectiveness of US
guidance in short-term CVCs (Hind BMJ 2003; Calvert
Anaesthesia 2004)
• No randomized trials have so far investigated the costeffectiveness ratio of US guidance in long-term central venous
access ports for oncology patients undergoing chemotherapy.
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO
DI PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI
Methods
• 403 patients eligible for receiving i.v. chemotherapy for solid
tumors were randomly assigned to implantation of a single
type of port (Bard Port, Bard Inc., Salt Lake City, UT) through a
percutaneous landmark access to the internal jugular, a USguided access to the axillary-subclavian or a cut-down access
of the cephalic vein.
• Procedural times and complications were prospectively
recorded.
• Costs were analytically calculated.
465 Assessed for elegibility
Trial profile conforming to
CONSORT guidelines
24 Refused to participate
38 Did not meet inclusion criteria
403
Randomized
134 internal jugular catheter
120 received foreseen insertion site
136 subclavian catheter
135 received foreseen insertion site
133 cephalic catheter
12 received foreseen insertion site
12 shifted to another arm
2 cancelled operation
1 shifted to another arm
21 shifted to another arm
2 Withdrew informed consent
13 Had no data available
1 Withdrew informed consent
12 Had no data available
117
Assessed for primary
endpoint
123
Assessed for primary
endpoint
2 Withdrew informed consent
11 Had no data available
120
Assessed for primary
endpoint
Roberto Biffi 2008
Roberto Biffi 2008
Failed attempts at insertion procedures, number of catheters shifted to another experimental
group as defined by initial randomization, and final layout of catheters positioning by insertion sites.
Internal
jugular
Subclavian
- US
Cephalic
No. of catheters randomized in
each group by insertion site
134
136
133
No. of failed procedures, and
subsequent choice of
alternative insertion sites
14 * (10.4%)
1^ (0.7%)
21°(15.7)
11 subclavian
1 cephalic
17 internal jugular
3 cephalic
No. of catheters effectively
positoned in each group by
insertion site
135§
Total
36 (8.9%)
4 subclavian
150
116
401§
* vs ^ : p = 0.001
^ vs ° : p =0.000
* vs ° : P = NS
§ 2 patients did not undergo the implant; one for intraoperative complication and
one for refusal.
Roberto Biffi 2008
IMPACT OF ULTRASOUND (US) REAL TIME GUIDANCE ON COST-EFFECTIVENESS RATIO
FOR LONG-TERM TOTALLY IMPLANTABLE ACCESS PORTS IN ONCOLOGY PATIENTS.
EVIDENCE FROM A RANDOMIZED THREE-ARM TRIAL.
Procedural time:
analysis by
actual site of
implantation
Comparisons (Wilcoxon test) :
Cephalic vs. Internal Jugular P = 0.026;
Cephalic vs. Subclavian P < .001;
Internal Jugular vs. Subclavian P = .004;
IMPACT OF ULTRASOUND (US) REAL TIME GUIDANCE ON COST-EFFECTIVENESS RATIO
FOR LONG-TERM TOTALLY IMPLANTABLE ACCESS PORTS IN ONCOLOGY PATIENTS.
EVIDENCE FROM A RANDOMIZED THREE-ARM TRIAL.
Procedural time:
analysis by
Intention-to-treat
Comparisons (Wilcoxon test) :
Cephalic vs. Internal Jugular P = 0.227;
Cephalic vs. Subclavian P = .0003;
Internal Jugular vs. Subclavian P = .009;
Late Complications
Bacteraemia and/or pocket infection
(Port removal)
Migration / malposition
Internal Jugular
Subclavian
Cephalic
(N = 117)
(N= 123)
(N = 120)
1 (0.8%)
3 (2.4%)
3 (2.5%)
(1)
(1)
(2)
0
0
6 (5.0%)
(Port removal)
Extravasation
Venous thrombosis
(2)
0
4 (3.2%)
1 (0.8%)
15 (12.8%)
8 (6.5%)
11 (9.2%)
(Port removal)
Fibrine sleeve
Total
(2)
5 (4.3%)
1 (0.8%)
1 (0.8%)
21 (17.9%)
16 (13.0%)
21 (17.5%)
Roberto Biffi 2008
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO
DI PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI
Ann Oncol. 1998 Jul;9(7):767-73.
Totally implantable central venous access ports
for long-term chemotherapy. A prospective
study analyzing complications and costs of 333
devices with a minimum follow-up of 180 days.
Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S,
Goldhirsch A, Nolè F, Andreoni B.
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO DI
PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI
Results-1
• No differences were found for early complication rate in the
three groups (internal jugular: 0%, subclavian: 0%, cephalic:
1.5% ; p = 0.132). US-guided subclavian insertion site had
significantly lower failures (P = 0.001).
• Infections occurred in one, three and one patients (internal
jugular, subclavian and cephalic access respectively, p =
0.464), whereas venous thrombosis was observed in 15, 8 and
11 patients (p = 0.272).
• Mean procedural time was 38.2 min for the internal jugular,
33.7 for subclavian and 39.5 for cephalic vein (p = 0.0003).
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO DI
PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI
Results-2
• Overall mean cost for purchase, implantation,
diagnosis and treatment of early and late
complications in each patient was:
• 2084 Euros for internal jugular
• 1934 Euros for US-guided subclavian
• 2122 Euros for cephalic vein (p = 0.0001 ) .
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO DI
PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI
Limitations
• Single institution data
• Costs of materials and diagnostics might differ from those
gathered at other centres
• Doctors and nurses honoraria might not apply to most
practitioners elsewhere
• High case-load and experience might impact the
complications’ rate
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO DI PORTS PER
CHEMIOTERAPIA IN PAZIENTI ADULTI
Some data about costs from the literature…..*
Author
Institution /
Country
Cost
Charge
Biffi et al 1998
IEO Milano / Italy
1591 USD
NR
Bow et al 1999
University of Manitoba
/ Canada
1988 CAD
2005 USD
NR
Schuld et al 2009
University of Hamburg
/ Germany
400.72 EUR local
484.86 EUR general
NR
Sticca et al 2009
University of North
Dakota / USA
NR
5,301 USD IR
4,543 USD Surg
University of Toronto /
Canada
20,762 CAD I.R.
20,900 CAD Surg.
NR
Hancock et al 2010
* I. Di Carlo, R. Biffi (eds.), Totally Implantable Venous Access Devices,
© Springer-Verlag Italia 2011
ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO DI
PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI
Conclusions
• Central venous insertion modality and sites
had no impact on either early or late
complication rates in an experienced
environment;
• US-guided subclavian insertion showed the
lowest proportion of failures, and the best
cost-effectiveness ratio.