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A programmable and implantable pumping system for systemic chemotherapy: a performance analysis in 52 patients
N J Vogelzang1, M Ruane, M J Ratain
1Joint Section of Hematology/Oncology, University of Chicago, Pritzker School of Medicine, IL.
Summary
The Medtronic SynchroMed infusion system demonstrated excellent accuracy and reliability in prolonged low-dose chemotherapy delivery. System complications and procedure issues occurred in 24% of patients, impacting overall usability.
Area of Science:
- Oncology
- Medical Devices
- Pharmacology
Background:
- Continuous infusion chemotherapy offers potential benefits for drug delivery.
- Implantable infusion pumps are used for long-term drug administration.
- The Medtronic SynchroMed system was evaluated for its performance in clinical trials.
Purpose of the Study:
- To prospectively evaluate the performance of the Medtronic SynchroMed infusion system.
- To assess the system's reliability, accuracy, and complication rates during chemotherapy delivery.
- To determine the cost-effectiveness and identify limitations for clinical use.
Main Methods:
- Prospective evaluation of 53 Medtronic SynchroMed pumps implanted in 52 patients.
- Continuous infusion of low-dose doxorubicin or vinblastine for cancer treatment.
- Monitoring pump function duration, drug infusion rates, and complication events over 10,045 patient days.
Main Results:
- No pump mechanism failures were observed during the study period.
- Excellent pump accuracy with a 2.2% error rate in analyzed refills.
- Complications requiring surgery occurred in 24% of systems, including procedure-related issues and hypersensitivity reactions.
Conclusions:
- The Medtronic SynchroMed system is accurate and reliable for prolonged low-dose doxorubicin and vinblastine infusion.
- Careful prevention of extravasation of vesicant agents is crucial.
- High implantation costs and potential complications may limit its use to patients with longer prognoses.