Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

A Contemporary Medicolegal Analysis of Implanted Devices for Chronic Pain Management.

BACKGROUND: Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. METHODS: We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service. These cases were identified using the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS), a database containing more than 300,000 malpractice claims from more than 400 academic and community institutions, representing approximately 30% of malpractice cases in the United States. The clinical narratives, which included medical files, claims files, depositions, and expert witness testimony, were reviewed by the authors, as were the CRICO coded variables, which included algorithmically determined contributing factors to the patient injury. RESULTS: Intrathecal drug delivery systems represented 17 of the closed claims; spinal cord stimulators represented 11 of the closed claims. The most common chronic pain diagnoses for which a device was implanted included failed back surgery syndrome and spasticity. The average total incurred for pain medicine claims was $166,028. Damaging events included IDDS refill errors (eg, subcutaneous administration of medication, reprogramming errors), intraoperative nerve damage, and postoperative infection (eg, epidural abscess, meningitis). High-severity outcomes included nerve damage (eg, paraplegia) and death. Medium-severity outcomes included drug reactions (eg, respiratory arrest from opioid overdose) and the need for reoperation. For both IDDS and SCS, deficits in technical skill were the most common contributing factor to injury, followed by deficits in clinical judgment, communication, and documentation. CONCLUSIONS: Implanted devices used for pain management involve a significant risk of morbidity and mortality. Proper education of providers and patients is essential. Providers must acquire the technical skills required for the implantation and refilling of these devices and the clinical skills required for the identification and management of complications such as intrathecal granuloma. Proper patient selection and clear communication between the provider and the patient about these possible complications are of paramount importance.

Injury and Liability Associated with Implantable Devices for Chronic Pain.

BACKGROUND: Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. METHODS: After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. RESULTS: The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). CONCLUSIONS: Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

Respiratory failure following delayed intrathecal morphine pump refill: a valuable, but costly lesson.

BACKGROUND: Spinal analgesia, mediated by opioid receptors, requires only a fraction of the opioid dose that is needed systemically. By infusing a small amount of opioid into the cerebrospinal fluid in close proximity to the receptor sites in the spinal cord, profound analgesia may be achieved while sparing some of the side effects due to systemic opioids. Intraspinal drug delivery (IDD) has been increasingly used in patients with intractable chronic pain, when these patients have developed untoward side effects with systemic opioid usage. The introduction of intrathecal opioids has been considered one of the most important breakthroughs in pain management in the past three decades. A variety of side effects associated with the long-term usage of IDD have been recognized. Among them, respiratory depression is the most feared. OBJECTIVE: To describe a severe adverse event, i.e., respiratory failure, following delayed intrathecal morphine pump refill. CASE REPORT: A 65-year-old woman with intractable chronic low back pain, due to degenerative disc disease, and was referred to our clinic for an intraspinal drug delivery evaluation, after failing to respond to multidisciplinary pain treatment. Following a psychological evaluation confirming her candidacy, she underwent an outpatient patient-controlled continuous epidural morphine infusion trial. The infusion trial lasted 12 days and was beneficial in controlling her pain. The patient reported more than 90% pain reduction with improved distance for ambulation. She subsequently consented and was scheduled for permanent intrathecal morphine pump implantation. The intrathecal catheter was inserted at right paramedian L3-L4, with catheter tip advanced to L1, confirmed under fluoroscopy. Intrathecal catheter placement was confirmed by positive CSF flow and by myelogram. A non-programmable Codman 3000 constant-flow rate infusion pump was placed in the right mid quandrant between right rib cage and right iliac crest. The intrathecal infusion consisted of preservative free morphine, delivering 1.0 mg /day. Over the following 6 months, the dosage was gradually titrated up to 4 mg/day with satisfactory pain control without significant side effects. However, the patient was not able to return to the clinic for pump refill until 12 days later than the previously scheduled pump-refill date. Her pump was accessed and was noted to be empty. Her intrathecal pump was refilled with preservative free morphine, delivering 4 mg/day (the same daily dose as her previous refill). However, on the night of pump refill, 10 hours after the pump refill, the patient was found to be unresponsive by her family members. 911 was called. Upon arriving, paramedics found her in respiratory failure, with shallow breathing at a rate of 5/min, pulse oxymetry showing oxygen saturation about 55-58%. She was emergently intubated on site and rushed to local hospital ER. The on call physician for our clinic was immediately contacted, and advised the administration of intravenous Naloxone. Her respiratory effort improved dramatically after receiving a total of 0.6 mg IV Naloxone IV over 25 minutes. Her intrathecal pump was immediately accessed by clinic on call physician and the remainder of the medication in the catheter space was aspirated. The pump infusate was immediately diluted with preservative free normal saline, to deliver preservative free morphine at 1mg/day. She was transferred to the intensive care unit and extubated the next morning. She recovered fully without any sequelae. CONCLUSION: Loss of opioid tolerance due to delayed pump refill may subject patients to the development of severe respiratory depression. Meticulous approach should be employed when refilling pumps in these patients when their pumps are completely empty. To our knowledge, this is the first reported case of this type.

Mortality associated with implantation and management of intrathecal opioid drug infusion systems to treat noncancer pain.

BACKGROUND: In 2006, the authors observed a cluster of three deaths, which circumstances suggested were opioid-related, within 1 day after placement of intrathecal opioid pumps for noncancer pain. Further investigation suggested that mortality among such patients was higher than previously appreciated. The authors performed investigations to quantify that mortality and compare the results to control populations, including spinal cord stimulation and low back surgery. METHODS: After analyzing nine index cases--three sentinel cases and six identified by a prospective strategy--the authors used epidemiological methods to investigate whether mortality rates reflected patient- or therapy-related differences. Mortality rates after intrathecal opioid therapy and spinal cord stimulation were derived by correlating Medtronic device registration data with de-identified data from the Social Security Death Master File. Aggregate demographic and comorbidity data were obtained from Medicare and United Healthcare population databases to examine the influence of demographics and comorbidities on mortality. RESULTS: Device registration and Social Security analyses revealed an intrathecal opioid therapy mortality rate of 0.088% at 3 days after implantation, 0.39% at 1 month, and 3.89% at 1 yr-a higher mortality than after spinal cord stimulation implants or after lumbar diskectomy in community hospitals. Demographic, illness profile, and mortality analyses of large databases suggest, despite limitations, that excess mortality was related to intrathecal opioid therapy, and could not be fully explained by other factors. These findings were consistent with the nine index cases that revealed that respiratory arrest caused or contributed to death in all patients. No device malfunctions associated with overinfusion were identified among cases where data were available. CONCLUSIONS: Patients with noncancer pain treated with intrathecal opioid therapy experience increased mortality compared to similar patients treated by using other therapies. Respiratory depression as a consequence of intrathecal drug overdosage or mixed intrathecal and systemic drug interactions is one plausible, but hypothetical mechanism. The exact causes for patient deaths and the proportion of those deaths attributable to intrathecal opioid therapy remain to be determined. These findings, although based on incomplete information, suggest that it may be possible to reduce mortality in noncancer intrathecal opioid therapy patients.

Practice choices and challenges in the current intrathecal therapy environment: an online survey.

OBJECTIVE: The objective of this study was to evaluate current practice characteristics, treatment choices, clinical experiences, and economic concerns associated with intrathecal therapy. DESIGN: Health care professionals in the United States, who were known to actively use intrathecal therapy in their practices, were recruited to participate in an online survey; contact information was obtained via Internet searches, university Websites, association memberships, industry databases, and personal contacts. Survey responses were summarized descriptively. RESULTS: Of the 329 practitioners who were contacted, 87 participated in the survey. Most participants specialized in anesthesiology (77.0%), worked in a private practice or private hospital (74.7%), and had been practicing pain management for more than 10 years (64.4%). Morphine was the most frequently used opioid for the initiation of intrathecal therapy (80.7% of practitioners), and 81.9% had used ziconotide in their practice. Most practitioners (63.9%) had treated at least one patient who developed a granuloma, and 66.0% of those practitioners had a patient experience permanent or temporary neurological injury due to a granuloma. Fewer than half of practitioners were satisfied with reimbursement from private insurance companies (25.3%) or workers compensation (34.9%), and 90.5% believed reimbursement rates for filling, refilling, and programming patient pumps are not adequate to cover practice costs. The majority of practitioners (56.6%) use fewer pumps in their practices because of reimbursement issues. CONCLUSIONS: Intrathecal pain management practices continue to evolve as the options for treatment increase, and the body of applicable scientific literature grows; however, economic considerations can influence clinical decisions and may interfere with treatment choice and patient access to therapy.

[Management of increase in spasticity in patients with intrathecal baclofen pumps]. / Conduite à tenir devant une recrudescence de spasticité chez un patient porteur d'une pompe à baclofène.

INTRODUCTION: The incidence of complications after baclofen pump implantation is relatively high. Diagnosis of these complications can be difficult. A diagnostic tree would be a useful tool in cases of suspected malfunctioning of the intrathecal bacolfen infusion system and would standardise the diagnostic procedure. METHOD: From results in the literature and the experience of our department, we designed a diagnostic tree to aid in finding the cause of a recrudescence of spasticity in patients with implanted baclofen pumps. RESULTS: The potential causes of recrudescence of spasticity are described and a diagnostic pathway is proposed. DISCUSSION: The aim of a standardised hierarchical method of diagnosis of the cause of increased spasticity in patients with intrathecal baclofen pumps is to gain time in the diagnosis and treatment. Such diagnosis should improve patient care by permitting rapid restoration of an adequate level of baclofen infusion as well as decreasing the length of hospital stay and, as a consequence, the cost relating to malfunctioning pumps.

Insulin pump therapy in type 1 diabetes mellitus.

OBJECTIVES: To review the current experience with insulin pump therapy in children and adolescents in order to guide pediatricians regarding indications and complications. SOURCES OF DATA: Systematic review of articles published in the literature referring to the use of insulin pump therapy, indications, complications and response to treatment. All articles published between 1995 and 2005 and appearing in the MEDLINE and LILACS databases were reviewed. The keywords were: insulin pump, type 1 diabetes mellitus and diabetes mellitus. The articles covering the subject of interest and referring to children and adolescents were selected. SUMMARY OF THE FINDINGS: Insulin pump therapy is not required for all patients with type 1 diabetes, since intensive treatments produce very similar results in terms of glycated hemoglobin and control of complications over the medium and long terms. However, the pump allows for greater comfort for patients, with less rigid meal schedules and better quality of life. The first requirement for patients intending to use the pump is getting used to having a device attached to the body and following strict glucose control; otherwise, pump therapy is not advantageous. Complications are rare due to the technologies currently available. The cost, however, is greater than with conventional treatments. CONCLUSION: The development of infusion pumps and glucose monitors, including continuous monitoring systems, will lead to "intelligent pumps," so that a true "artificial pancreas" will be available, which can even be implanted in the patient, allowing non-diabetic persons to lead a normal life.

Insulin pump therapy in type 1 diabetes mellitus

OBJETIVO: Rever a experiência com a utilização da bomba de infusão de insulina em crianças e adolescentes, a fim de orientar o pediatra quanto às suas indicações e complicações. FONTE DOS DADOS : Foi realizada revisão sistemática de artigos publicados em literatura que abordassem a utilização da bomba de infusão de insulina, suas indicações, complicações e resposta ao tratamento. Dessa forma, todos os artigos publicados entre 1995 e 2005 foram resgatados através do levantamento em banco de dados MEDLINE e LILACS. As palavras-chave utilizadas foram: insulin pumps, type 1 diabetes mellitus e diabetes mellitus. Foram separados os artigos que, além disso, versassem sobre o assunto na faixa etária descrita SíNTESE DOS DADOS: O uso da bomba de infusão de insulina em pacientes com diabetes melito tipo 1 não é uma necessidade para todos os pacientes, visto que, com tratamentos intensivos, os resultados conseguidos são muito parecidos, em termos de hemoglobina glicada e de controle de complicações a médio e longo prazo. No entanto, a bomba permite um maior conforto ao paciente, no sentido de que ele não precisa ficar tão restrito a horários rígidos de refeição e pode levar uma vida com melhor qualidade. Um primeiro requisito para quem pretenda usar a bomba é adaptar-se a aparelhos conectados ao corpo e a ter uma rotina de monitorização glicêmica rigorosa, pois, sem isso, as vantagens da bomba serão anuladas. As complicações, com os avanços tecnológicos de que dispomos atualmente, são muito infreqüentes. O custo, no entanto, é maior que nos tratamentos convencionais. CONCLUSÃO: Com a evolução das bombas de infusão e dos monitores de glicemia, incluindo sistemas de monitorização contínua, abre-se caminho para as "bombas inteligentes", e estaremos com um verdadeiro "pâncreas artificial", que pode mesmo ser implantado no paciente, permitindo uma vida com todas as regalias de uma pessoa não diabética.

OBJECTIVE: To review the current experience with insulin pump therapy in children and adolescents in order to guide pediatricians regarding indications and complications. SOURCES OF DATA : Systematic review of articles published in the literature referring to the use of insulin pump therapy, indications, complications and response to treatment. All articles published between 1995 and 2005 and appearing in the MEDLINE and LILACS databases were reviewed. The keywords were: insulin pump, type 1 diabetes mellitus and diabetes mellitus. The articles covering the subject of interest and referring to children and adolescents were selected. SUMMARY OF THE FINDINGS : Insulin pump therapy is not required for all patients with type 1 diabetes, since intensive treatments produce very similar results in terms of glycated hemoglobin and control of complications over the medium and long terms. However, the pump allows for greater comfort for patients, with less rigid meal schedules and better quality of life. The first requirement for patients intending to use the pump is getting used to having a device attached to the body and following strict glucose control; otherwise, pump therapy is not advantageous. Complications are rare due to the technologies currently available. The cost, however, is greater than with conventional treatments. CONCLUSION: The development of infusion pumps and glucose monitors, including continuous monitoring systems, will lead to "intelligent pumps," so that a true "artificial pancreas" will be available, which can even be implanted in the patient, allowing non-diabetic persons to lead a normal life.

A prospective randomized trial demonstrating valved implantable ports have fewer complications and lower overall cost than nonvalved implantable ports.

BACKGROUND: The purpose of the current study was to evaluate whether a totally implanted valved subcutaneous port system would have fewer complications as compared to a standard nonvalved port. METHODS: Study subjects requiring port placement were randomized to receive a valved port (PASV; Boston Scientific, Natick, MA) or a nonvalved port (BardPort; Bard Accesss Systems, Salt Lake City, UT). Each port was placed with standard operative technique. Difficulty with blood return, excess time spent accessing the port, and required interventions were reported over the initial 180 days of port usage. RESULTS: Seventy-three patients were randomized to receive either a valved port (n = 37) or a nonvalved port (n = 36). No major complications were identified from port placement, and there were no differences in rates of infection between the 2 ports. A reported inability to withdraw blood was noted in the valved port group on 21 of 364 (5.8%) port accessions and in the nonvalved port group on 37 of 341 (11%) accessions (P = 0.02). Significantly more total time was spent ensuring adequate blood draw from nonvalved ports as opposed to valved ports (750 minutes vs. 1545 minutes, respectively) (P <0.03). CONCLUSIONS: This study revealed that the PASV valved port is associated with significantly fewer instances of poor blood return and less nursing access time, indicating that a port with a PASV valve may be superior to a nonvalved device.

[Implantable drug pumps for spinal opioid analgesia: technical solutions and problems]. / Implantierbare Medikamentenpumpen für die Opioid-Analgesie: Technische Lösungen und Probleme.

Among the many technical appliances for pain therapy which are currently available, the use of implantable drug pumps for prolonged pain treatment is of increasing importance. Since this kind of pain therapy can be used without any problems outside the hospital, it improves the quality of life of the patient. Furthermore, it is combined with a reduction of side-effects which frequently occur when analgesics are given orally or parenterally in big single doses. High initial costs are compensated by a good cost-benefit ratio of this kind of pain treatment, which enables the use of analgesics in low doses in out-patients. Based on the use of gas mixtures which can be compressed repeatedly, implantable mechanically-driven pumps are a nearly inexhaustible propulsion unit for drug infusions. The development of new gas mixtures and of innovative control mechanisms allows greater independence from surrounding influences and higher precision regarding infusion rates. Mechanically-driven pumps are characterized by prolonged functioning and low cost of purchase. Therefore, they will continue to be available on the medical market in future. Special progress in cardiac pacemaker therapy as well as further miniaturization of portable infusion pumps with peristaltic propulsion have led to the development of programmed implantable pumps with lithium batteries as energy sources. The advantages of these pumps, particularly those with "externally" programmable infusion rates (continuous, bolus, periodical bolus, etc.) point to the future. With these devices, evacuation and refilling of the pumps due to necessary changes of drug concentrations, as has to be done with mechanically working pumps with fixed infusion rates, are no longer necessary. Therefore, these programmable pumps can also be used for infusion of drug concentrates. At present, however, high costs and the battery-dependent limited duration of functioning of these devices are disadvantageous. As with cardiac pacemakers, battery exchange is necessary. Using implantable drug pumps, relevant changes of body temperature and atmospheric pressure lead to more or less considerable deviations of the infusion rates. These deviations differ from product to product and can be studied in the informative material published by the manufacturer.

[Home anti-cancer therapy with a venous port].

Home anti-cancer chemotherapy and palliation in the terminal stage were performed for patients with advanced cancer of the digestive system, using a venous port implanted beneath the skin via the subclavian vein. Patients under 75 years of age (5 with esophageal, 61 gastric, 59 colorectal, 5 cholangio, 5 pancreatic, 1 hepatic and 1 ileal cancer) were treated. With two portable balloon pumps, continuous intravenous infusion of 5-FU (300 or 400 mg/body/day) combined low-dose injection of cisplatin (5 mg/body/day) was continued for 10 days, and repeated 3 times for 6 weeks. The response rate was 17.9% in 78 patients according to valuation of the tumor mass. In 119 patients also undergoing a tumor marker evaluation, an effect was seen in 26.1%. No severe side effects such as renal dysfunction or bone marrow suppression were seen, and no special infusion was needed. Therefore, such treatment can be continued for a long time. Use of a venous port should make easy the switchover to HPN and the amelioration of the symptoms of the terminal stage, such as pain, and helps patients cope with the worry. Therefore, the present technique is useful in a series of cancer treatments including surgery, chemotherapy and the amelioration of symptoms.

Hepatic arterial chemotherapy in metastatic colorectal patients.

Hepatic metastases are a major cause of morbidity and mortality for patients with colorectal cancer (CRC). The rationale for hepatic arterial chemotherapy has both an anatomical and pharmacological basis. Several randomized clinical studies of fluoropyrimidine showed higher response rates in all trials when the drug was given as an hepatic arterial infusion (HAI) versus systemic administration. However, the studies did not accurately define survival for the following reasons: (1) some allowed a crossover; (2) some were too small; and (3) some used inadequate systemic chemotherapy. Patients who have failed to respond to previous systemic chemotherapy have an approximately 50% response rate with HAI treatment. Hepatic toxicity, especially biliary sclerosis, is the dose-limiting toxicity, occurring in 6% to 25% of patients. Adding dexamethasone to HAI fluoropyrimidine decreases the hepatobiliary toxicity. The therapeutic benefit of HAI in one study was also demonstrated by an increased time with normal quality of life. To truly define the role of regional therapy in patients with CRC confined to the liver, the current Cancer and Leukemia Group B (CALGB) study is randomizing patients to HAI versus systemic therapy without a crossover to demonstrate if HAI improves survival and/or quality of life in addition to response rates.

Hepatic arterial infusion chemotherapy using percutaneous catheter placement with an implantable port: assessment of factors affecting patency of the hepatic artery.

OBJECTIVE: To assess the factors affecting patency of the hepatic artery during hepatic arterial infusion chemotherapy (HAIC) with an implantable port system inserted percutaneously. PATIENTS AND METHODS: Ninety patients with malignant hepatic tumours were given HAIC using percutaneous catheter placement. An end-hole catheter was inserted into the hepatic artery (conventional method) in 41 patients. An end-closed and side-hole catheter was used in 49 patients, in which the catheter tip was fixed in the gastroduodenal artery and the side hole was placed in the common hepatic artery (fixed catheter-tip method). The patency of the hepatic artery was evaluated with computed tomography (CT) arteriography using the implantable port system and angiography. Then, the factors affecting hepatic arterial patency were analysed. RESULTS: Hepatic arterial occlusion was observed in 15 patients (17%). The overall patency of the hepatic artery was 86.9%, 78.4% and 51.5% at 6 months, 1 year and 2 years, respectively. The patency rate of the hepatic artery was significantly higher in patients with catheter placement using fixed catheter-tip method than those using conventional method (P = 0.01), and in patients without transcatheter arterial chemoembolization (TACE) prior to catheter placement than those with prior TACE (P = 0.01). When the variables affecting patency of the hepatic artery were studied together by multivariate analyses, the important factors were the method of catheter placement and the presence or absence of prior TACE. CONCLUSION: We consider that it is important for long-term patency of the hepatic artery during HAIC to use fixed catheter-tip method for percutaneous catheter placement instead of conventional method, and to select patients without prior TACE.

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.

BACKGROUND: A few data are available from analyses of the complications and costs of central venous access ports for chemotherapy. This prospective study deals with the complications and global costs of central venous ports connected to a Groshong catheter for deliverance of long-term chemotherapy. PATIENTS AND METHODS: Patients with a variety of solid neoplastic diseases requiring chemotherapy who were undergoing placement of implantable ports over a 30-month period (1 October 1994 to 31 March 1997) have been prospectively studied. Follow-up continued until the device was removed or the study was closed (30 September 1997); patients with uneventful implant experience and subsequent follow-ups of less than 180 days were not considered for this study. A single port, constructed of titanium and silicone rubber (Dome Port, Bard Inc., Salt Lake City, USA), was used, connected to an 8 F silastic Groshong catheter tubing (Bard Inc., Salt Lake City, USA). Two-hundred ninety-six devices were placed in the operating room under fluoroscopic control even in the patients treated and monitored in a day-hospital setting: 37 of them were in an angiographic suite. A central venous access form was filled in by the operator after the procedure and all ports were followed prospectively for device-related and overall complications. The average purchase cost of the device was obtained from the hospital charges, based on the costs applied during the 30-month period of the study. Insertion and maintenance costs were estimated by obtaining the charges for an average TIAP implant and its subsequent use; the costs of complication management were assessed analytically. The total cost of each device was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications, if any. The cost of removing the TIAP was also included in the economic analysis when required by the treatment of the complication. RESULTS: Three hundred thirty-three devices, for a total of 79,178 days in situ, were placed in 328 patients. Five patients received second devices after removal of the first. In all cases the follow-up was appropriate (median 237 days, range 180-732). Early complications included 10 pneumothoraxes (3.4%; six tube-thoracostomies were applied, 1.8%) and six revisions for port and/or catheter malfunction (overall early complications = 16, 4.48%). Late complications comprised five instances of catheter rupture and embolization (1.5%, 0.063 episodes/1000 days of use), five of venous thrombosis (1.5%, 0.063 episodes/1000 days of use), one of pocket infection (0.3%, 0.012 episodes/1000 days of use), and eight of port-related bacteremia (2.4%, 0.101 episodes/1000 days of use). The infections were caused by coagulase-negative Staphylococcus aureus (five cases), Bacillus subtilis (one case), Streptococcus lactaceae (one case) and an unknown agent (one case); port removal was necessary in six of eight cases. The total cost per patient treated for a six-month period, consisting of the costs of purchase and implantation, treatment of early and late complications, and of maintenance of the device, is US$1,970. CONCLUSIONS: This study represents the largest published series of patients with totally implantable access ports connected to a Groshong catheter. We have shown that US$2,000 are sufficient to cover six months of chemotherapy in one patient using the most expensive commercially available implantable port. According to the present study, totally implantable access ports connected to a Groshong catheter are associated with high purchase and insertion costs, a low complication rate and low maintenance costs. These data support their increasing use in current oncologic medical practice.

Ambulatory infusion pumps: application to oncology.

OBJECTIVE: To provide an overview of the various types of ambulatory pumps available in relation to mechanism of delivery, patient selection criteria, potential complications, and educational support. CONCLUSIONS: Ambulatory pumps are an important means of drug delivery in a wide range of clinical conditions. Technologies permitting drug self-administration and automated drug delivery outside the hospital have become increasingly more sophisticated and adaptable; more than 600 models are available. With the shift of health care delivery from the hospital setting to the outpatient and home settings, reliable effective ambulatory pumps are necessary to safely deliver medications. IMPLICATIONS FOR NURSING PRACTICE: The use of ambulatory pumps is becoming more common as they are initiated as a part of front-line patient therapy. The nurse involved in the selection and management of ambulatory pumps is challenged to be familiar with the large variety available. Selecting the best type of pump is based on several factors, such as the type of therapy, disease state, reimbursement, and the ability to operate and troubleshoot complications.

Subcutaneous morphine pump for postoperative hemorrhoidectomy pain management.

PURPOSE: Many anorectal procedures are currently being performed on an outpatient basis, hemorrhoidectomy being the exception because of the need for parenteral narcotics postoperatively. We investigated the effectiveness of a subcutaneous morphine pump (SQMP) for outpatient posthemorrhoidectomy pain control. METHODS: In Phase 1 of our study, 22 patients undergoing radical hemorrhoidectomy were started on an SQMP protocol postoperatively. Twenty-nine patients received conventional postoperative narcotic dosing. In Phase 2, 19 patients enrolled in an SQMP protocol underwent hemorrhoidectomy in an ambulatory setting. Length of hospitalization, catheterization rate, and pain control were evaluated. RESULTS: In Phase 1, zero patients in the study group and two in the control group required additional hospitalization beyond 23 hours for pain control. The rates of catheterization were similar between the two groups. Pain control was considered satisfactory in 21 of 22 study patients. There was no correlation between pain level and morphine dose. Eighteen of 22 patients experienced minor side effects, necessitating pump removal in two patients. In Phase 2, 18 of 19 patients on the SQMP were discharged from the recovery room. Cost analysis shows the combination of outpatient hemorrhoidectomy and the SQMP to be cost-effective in comparison with an inpatient stay. CONCLUSIONS: The SQMP enables hemorrhoidectomy to be done on an outpatient basis. It provides effective pain control, enjoys high patient acceptance, and is cost-effective.

Circadian continuous chemotherapy of renal cell carcinoma with an implantable, programmable infusion pump.

The authors treated 42 metastatic renal cell carcinoma (RCC) patients who had received no previous chemotherapy or radiation therapy with circadian venous continuous infusion of 5-fluoro-2-deoxyuridine (FUDR). The drug was delivered by Medtronic Synchromed implantable pump (Medtronic, Inc., Minneapolis, MN) in 14-day cycles alternating with 14-day intervals of heparinized physiologic saline infusion. In the course of 24 months 444 cycles of therapy have been given for a total of 12449 days of pump function. Of the patients observed for at least 3 months (range, 3 to 23 months; median, 7 months) three showed complete response (7%; 95% confidence interval, 0% to 15%), three partial response (7%; confidence interval, 0% to 15%), 18 stable disease, and 18 showed progression. Eighteen patients, all with advanced disease at the time of implantation, were living 6 months after treatment started. Circadian continuous central venous infusion of FUDR is minimally toxic. The FUDR can be delivered safely and conveniently in this way for long spans. This therapy is as active as any currently available treatment, is administered in an entirely outpatient setting, and is associated with a normal quality of life.