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 SPSDirettoreDivisione di Chirurgia Addomino-Pelvica e Mini-InvasivaIstituto Europeo di Oncologia, Milano

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 cost-effectiveness 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 US-guided 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.

ANALISI DI COSTO-EFFICACIA DELL’IMPIANTO E DELL’UTILIZZO DI PORTS PER CHEMIOTERAPIA IN PAZIENTI ADULTI

465 Assessed for elegibility

24 Refused to participate 38 Did not meet inclusion criteria

403Randomized

134 internal jugular catheter120 received foreseen insertion site

12 shifted to another arm 2 cancelled operation

136 subclavian catheter135 received foreseen insertion site

1 shifted to another arm

133 cephalic catheter 12 received foreseen insertion site

21 shifted to another arm

2 Withdrew informed consent13 Had no data available 1 Withdrew informed consent

12 Had no data available2 Withdrew informed consent 11 Had no data available

123Assessed for primaryendpoint

Trial profile conforming to CONSORT guidelines

117Assessed for primary endpoint

Roberto Biffi 2008

Roberto Biffi 2008

Internal jugular

Subclavian - US

Cephalic Total

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%)

11 subclavian

3 cephalic

1^ (0.7%)

1 cephalic

21°(15.7)

17 internal jugular

4 subclavian

36 (8.9%)

No. of catheters effectively positoned in each group by insertion site

135§ 150 116 401§

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.

* 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.

Comparisons (Wilcoxon test) : Cephalic vs. Internal Jugular P = 0.026; Cephalic vs. Subclavian P < .001; Internal Jugular vs. Subclavian P = .004;

Procedural time:analysis byactual site ofimplantation

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.

Comparisons (Wilcoxon test) : Cephalic vs. Internal Jugular P = 0.227; Cephalic vs. Subclavian P = .0003;Internal Jugular vs. Subclavian P = .009;

Procedural time:analysis byIntention-to-treat

Late Complications Internal Jugular

(N = 117)

Subclavian

(N= 123)

Cephalic

(N = 120)

Bacteraemia and/or pocket infection

(Port removal)

1 (0.8%)

(1)

3 (2.4%)

(1)

3 (2.5%)

(2)

Migration / malposition

(Port removal)

0 0 6 (5.0%)

(2)

Extravasation 0 4 (3.2%) 1 (0.8%)

Venous thrombosis

(Port removal)

15 (12.8%) 8 (6.5%) 11 (9.2%)

(2)

Fibrine sleeve 5 (4.3%) 1 (0.8%) 1 (0.8%)

Total 21 (17.9%) 16 (13.0%) 21 (17.5%)

Roberto Biffi 2008

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

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

Author Institution / Country

Cost Charge

Biffi et al 1998 IEO Milano / Italy 1591 USD NR

Bow et al 1999 University of Manitoba / Canada

1988 CAD2005 USD

NR

Schuld et al 2009 University of Hamburg / Germany

400.72 EUR local484.86 EUR general

NR

Sticca et al 2009 University of North Dakota / USA

NR 5,301 USD IR4,543 USD Surg

Hancock et al 2010 University of Toronto / Canada

20,762 CAD I.R.20,900 CAD Surg.

NR

Some data about costs from the literature…..*

* 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.