Journal of Clinical Oncology, Vol 5, 1968-1976, Copyright © 1987 by American Society of Clinical Oncology
A programmable and implantable pumping system for systemic chemotherapy: a performance analysis in 52 patients
NJ Vogelzang, M Ruane, MJ Ratain, K Dhowlatshahi and GW Chodak
Joint Section of Hematology/Oncology, University of Chicago, Pritzker School of Medicine, IL.
We have prospectively evaluated the performance of the implanted
battery-powered Medtronic (Minneapolis) SynchroMed infusion system. Between
July 1984 and July 1986, fifty-three SynchroMed pumps were implanted in 52
patients for phase I and II trials of low-dose continuous-infusion
doxorubicin (N = 35) or vinblastine (N = 17). The median duration of pump
function was 145 days (mean, 180; range, 20 to 787 +) and the systems
infused drugs for 61% (range, 32% to 100%) of their patient implant time.
During 10,045 patient days (27.5 years) of implantation, there have been no
failures of the pump mechanism and pump accuracy was excellent (2.2% error
rate in 256 analyzed refills). The median cost of the hospitalization for
implantation was +17,140 in 14 analyzed cases. Complications requiring a
second surgical procedure occurred with 13 systems (24%). Two of the
complications were related to localized cutaneous hypersensitivity to
vinblastine, four were directly related to system complications, and seven
were secondary to implant procedure problems. Seven patients (13%)
requested removal of the device after tumor progression occurred. Based on
this experience, the company has made improvements in certain aspects of
system design and has implemented a comprehensive user training program to
minimize procedure-related problems. The Medtronic SynchroMed is an
accurate and sophisticated system that allows infusion of low-dose
doxorubicin and of vinblastine for prolonged periods. Extravasation of
these vesicant agents must be carefully prevented. The financial cost of
this implanted system may limit its use to patients with an expected
survival of 5 months or longer.
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