Colonic perforation by an intrathecal baclofen pump catheter causing delayed Escherichia coli meningitis.

Intrathecal baclofen (ITB) delivery via an implanted pump is frequently used for the treatment of spasticity. This is an effective and safe neurosurgical and pharmacological intervention associated with an improvement in patient quality of life. There is, however, a risk of device-related infection. We present a patient with pump-site infection and Escherichia coli meningitis secondary to transcolonic perforation of an intrathecal baclofen pump catheter. While this is rare, we review the intraoperative precautions and best practices that should be taken to prevent and manage this unusual complication.

Near Death Experience from Placement of an Intrathecal Catheter.

UNLABELLED: The management of pain due to cancer is challenging and often requires invasive therapy in addition to medication management. Intrathecal drug delivery is a form of advanced therapy that delivers medication locally in the intrathecal space while reducing systemic side effects associated with high doses of opioids. Although risks associated with intrathecal drug delivery are low, some common complications include dislodgement, kinking, or fracture of the catheter, bleeding, neurological injury, infection, and cerebrospinal leaks. We present a case of a 38-year-old woman with a medical history significant for stage IV breast cancer, L2 metastatic lesion, opioid tolerance, and chronic neck and low back pain who was admitted to the hospital for intractable pain. She had failed multiple interventional procedures in the past including lumbar medial nerve radiofrequency ablation, epidural steroid injection, and trigger point injections as well as a kyphoplasty at the L2 level. Failing both oral and parenteral opioid treatments, the decision was made to place an intrathecal pump in the patient. After placement of the intrathecal catheter and prior to any bolus of medication being given, the patient became bradycardic with a heart rate in the 20s and experienced a 10 second pause. The patient had intermittent bradycardia over the following days and symptoms resolved only after removal of the intrathecal catheter itself. To our knowledge, this is the first reported case with a complication of recurrent bradycardic and asystolic episodes prior to the administration of intrathecal opioid but shortly after placement of the intrathecal catheter itself. KEY WORDS: Intrathecal drug delivery, complications, cancer pain, intrathecal analgesia, bradycardia, opioids.

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.

A Cross-Sectional Study of Patients' Satisfaction With Totally Implanted Access Ports.

BACKGROUND: Totally implanted access ports (PACs) are valuable tools for the treatment of patients with cancer because they ease the administration of chemotherapy, stem cells, and supportive care by reducing the rate of peripheral vein punctures. OBJECTIVES: The purpose of this study was to evaluate the satisfaction and impairments of activities of daily living of ambulatory patients with PAC systems receiving chemotherapy. METHODS: This cross-sectional, questionnaire-based study evaluated 202 patients with PAC systems in a comprehensive cancer center and cancer rehabilitation center. From November 2012 to August 2013, patients were invited to answer a questionnaire concerning quality of life and satisfaction with their PAC devices. Data regarding PAC-related complications were collected retrospectively by searching patients' medical history. FINDINGS: A total of 202 patients with 230 PAC devices were included. Median time from PAC implantation to inclusion in the study was nine months. Surgical complications occurred in some cases, with bleeding and hematoma being the most frequently observed events. Late complications consisted of infections, drug extravasation, PAC malposition, PAC malfunction, and thrombosis. A third of the patients reported that their PAC interfered with activities of daily living. However, most agreed that PAC systems alleviated the burden of chemotherapy administration, and the vast majority said they would choose the implantation of a PAC system for chemotherapy administration again.

National Perioperative Outcomes for Intrathecal Pump, Spinal Cord Stimulator, and Peripheral Nerve Stimulator Procedures.

BACKGROUND: There is abundant literature on the long-term complications of intrathecal pumps (ITP), spinal cord stimulators (SCS), and peripheral nerve stimulators (PNS) used in the treatment of chronic pain. There is less information, however, on the perioperative complications of these procedures. OBJECTIVE: Exploration of the perioperative outcomes of implantable pain devices. STUDY DESIGN: Observational study. SETTING: University hospitals, community hospitals, specialty hospitals, attached surgery centers, and freestanding surgery centers METHODS: Data were obtained from the National Anesthesia Clinical Outcomes Registry (NACOR) of the Anesthesia Quality Institute (AQI). Information was collected on patient demographics, procedure information, anesthetic administered, diagnosis linked to the procedure, and perioperative outcomes. RESULTS: The search yielded 12,611 ITP, 19,276 SCS, and 15,184 PNS cases from 2010 to 2014. In this sample, the majority of procedures were performed at community hospitals, not university medical centers. The most common diagnosis cited for an ITP was an implant complication (n = 2,570), followed by spasticity, and non-malignant back pain. For SCS, the most common diagnoses were lower back pain (n = 5,515) or radiculopathy (n = 2,398). For PNS, by far the most common diagnosis related to urinary dysfunction (n = 8,745), with painful bladder syndrome a small minority (n = 133). General anesthetics were more often performed for ITP than for SCS and PNS procedures (60.6% vs. 31.8% and 32.2%, respectively). Hemodynamic instability was a common outcome (13.9% for ITP procedures); other common outcomes for all the procedures included case delays, inadequate pain control, and extended PACU stays. LIMITATIONS: Despite the large sample size in this study, not all medical centers transmit their outcome data to NACOR. Furthermore, some institutions do not report clinical outcomes for every case to NACOR, making the sample size of assessing complications smaller and potentially more biased. Finally, procedures identified in the NACOR database using CPT may be similar but not identical and therefore potentially influence outcomes. CONCLUSIONS: Databases such as NACOR can provide rich information on ITP, SCS, and PNS for physicians performing these procedures. In this sample, ITP procedures, performed on the patients with the most severe cormobidities and often-requiring general anesthesia, were the most likely to be associated with hemodynamic instability, inadequate pain control, and extended PACU stays. Complications relating to the ITP are also the most common reason for an operation. These findings underscore the importance of proper patient selection for ITP and other implantable pain devices, in particular for patients with malignant pain or multiple co-morbidities. To identify the root causes of complications, additional information is needed on the procedure performed (e.g., an implant vs a revision), the surgical technique used, and the device implanted, as well as on specific patient comorbidities. Such information will likely become more available as resources like NACOR expand and as electronic medical record systems and coding become more integrated.

Medical devices and procedures in the hyperbaric chamber.

The aim of this paper is to present current controversies concerning the safety of medical devices and procedures under pressure in a hyperbaric chamber including: defibrillation in a multiplace chamber; implantable devices during hyperbaric oxygen treatment (HBOT) and the results of a recent European questionnaire on medical devices used inside hyperbaric chambers. Early electrical defibrillation is the only effective therapy for cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. The procedure of defibrillation under hyperbaric conditions is inherently dangerous owing to the risk of fire, but it can be conducted safely if certain precautions are taken. Recently, new defibrillators have been introduced for hyperbaric medicine, which makes the procedure easier technically, but it must be noted that sparks and fire have been observed during defibrillation, even under normobaric conditions. Therefore, delivery of defibrillation shock in a hyperbaric environment must still be perceived as a hazardous procedure. Implantable devices are being seen with increasing frequency in patients referred for HBOT. These devices create a risk of malfunction when exposed to hyperbaric conditions. Some manufacturers support patients and medical practitioners with information on how their devices behave under increased pressure, but in some cases an individual risk-benefit analysis should be conducted on the patient and the specific implanted device, taking into consideration the patient's clinical condition, the indication for HBOT and the capability of the HBOT facility for monitoring and intervention in the chamber. The results of the recent survey on use of medical devices inside European hyperbaric chambers are also presented. A wide range of non-CE-certified equipment is used in European chambers.

An in vivo canine study to assess granulomatous responses in the MedStream Programmable Infusion System (TM) and the SynchroMed II Infusion System®.

OBJECTIVE: A rare, but consistently reported complication of intrathecal (IT) delivery of opioids via programmable implantable infusion pumps is aseptic granuloma formation around the tip of the IT catheter. In the current study, the incidence and severity of IT granuloma formation was assessed for the MedStream Programmable Infusion and SynchroMed II Infusion pumps when delivering saline, baclofen, or morphine at varying concentrations and daily doses. DESIGN: Randomized study with six groups: 1) MedStream with 0.9% saline; 2) SynchroMed II with 0.9% saline; 3) MedStream with morphine sulfate; 4) SynchroMed II with morphine sulfate; 5) MedStream with baclofen; or 6) SynchroMed II with baclofen. The groups receiving morphine received either low or high concentrations (6 or 12.5 mg/mL) delivered in rates resulting in low to high (1.25-12 mg/day) daily doses. Animals receiving baclofen began at low dose/low concentration and underwent stepwise increases in concentration and dose to a maximum of 2 mg/mL/day. Animals receiving saline received a constant flow rate through either a silicone or a polyurethane IT catheter. SETTING: The study was set as in vivo laboratory experiment. SUBJECTS: 52 (21-32 kg) canines. INTERVENTIONS: Delivering IT saline, baclofen, or morphine through SynchroMed II and MedStream Programmable Infusion pumps. OUTCOME MEASURES: The incidence and severity of IT catheter tip granuloma formation was assessed with paraffin-embedded spinal cord sections by a pathologist without knowledge of treatment and compared between drug type, drug concentration, daily dose, and pump type. RESULTS: Granuloma formation occurred only in animals receiving morphine, with zero incidence in baclofen or saline infusion, regardless of catheter type. Granuloma incidence increased with increasing morphine concentration or daily dose (one [12.5%] low dose/low concentration, 3 [37.5%] low dose/high concentrations, 4 [50%] high dose/low concentration, and 7 [100%] high dose/high concentration). A granulomatous response to morphine was observed in 10 (63%) animals with SynchroMed II pumps and 5 (33%) animals with MedStream pumps, P = 0.156. CONCLUSIONS: In this in vivo canine model of IT drug delivery, catheter tip granuloma formation was associated with higher concentrations and daily doses of morphine infusion while none were seen with baclofen or saline, and was not associated with catheter type. For both pumps, granulomas were only produced in the presence of morphine infusion. These results suggest that the MedStream Programmable Infusion System has a granuloma safety profile at least equivalent to that of the SynchroMed II pump.

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.

Continuous intraventricular infusion of pentosan polysulfate: clinical trial against prion diseases.

Prion diseases are progressive neurological disorders due to abnormal prion protein (PrP(Sc)) deposition in the central nervous system. At present, there is no effective treatment available for any form of prion disease. Pentosan polysulfate (PPS) has been shown to prolong significantly the incubation period in mice with PrP(Sc) infection when administered to the cerebral ventricles in preclinical trials. In human studies conducted in European countries and Japan, intraventricular PPS was administered to patients with different forms of prion disease and was well tolerated. We report 11 patients with prion disease treated with intraventricular PPS at Fukuoka University from 2004. Cases included three familial CJD (two with V180I mutation, one GSS with P102L mutation), two iatrogenic CJD, and six sporadic CJD cases. At present, average survival period after treatment was 24.2 months (range, 4-49). Seven cases died of sepsis and pneumonia. Subdural effusion with various degrees was seen on CT scan in most cases. Except for these, adverse effects did not occur in the treatment period. Although our preliminary study of the new treatment with PPS by continuous intraventricular infusion showed no apparent improvement of clinical features in patients with prion disease, the possibility of extended survival in some patients receiving long-term PPS was suggested.

Controlling chronic pain in the workplace: nerve stimulation and intrathecal drug delivery systems.

Chronic pain can have a major effect on both workers and the workplace. Collaboration among workers, occupational health nurses, and specialist providers is important for ongoing management of mechanism-based therapies for chronic pain. This article examines collaborative care issues relative to nerve stimulation and intrathecal drug delivery systems.

Infusion devices: understanding the patient perspective to avoid errors.

The National Patient Safety Agency (NPSA) has sponsored a project to detect the root causes of problems with infusion devices and to identify ways of preventing errors. It is piloting a number of solutions in six trusts after a project that included a survey of patient views discovered the need for better communication and information for patients about this treatment method.

[Complication of reservoir hepatic artery infusion chemotherapy and additional treatments].

In 54 patients who underwent hepatic artery infusion chemotherapy for hepatic tumors at our hospital between January 1990 and December 1996, we investigated the complications of this therapy and the therapeutic techniques following its discontinuation. The arterial infusion was discontinued in 36 of the 54 patients; 13 due to death (mean survival period: 15.7 months), and 23 in whom occlusion of the reservoir, etc. made it impossible to use arterial infusion (mean period of use: 13.8 months), and the minimum duration of use was 41 days and maximum duration of use 992 days. The most common complication of the reservoir hepatic artery infusion was reservoir occlusion (14.8%). Another serious complication was reservoir deviation outside the blood vessel in two patients; deviation in to the gastric lumen in one case and intraperitoneal deviation in the other. Four hepatocellular carcinoma patients, in whom it became impossible to use the reservoir due to its occlusion, underwent re-hepatectomy. Three of them survived for more than two years following supplemental local therapy, including subarterial injection, TAE, PEIT, microwave tumor coagulation (MTC). Of four patients with colon cancer metastasizing to the liver, one could undergo re-hepatectomy, one received subarterial injection, and two have survived without relapse. Two of three patients with breast cancer underwent systemic chemotherapy and endocrine therapy successfully, while the third one underwent subarterial injection and TAE, and is still under observation. Hepatic artery infusion should sometimes be discontinued owing to complications caused by various factors. Even if it becomes impossible to use the reservoir, local therapeutic techniques, including re-hepatectomy, TAE, PEIT, MTC, etc., may be performed in some patients. These findings suggest that it is necessary to review the interdisciplinary treatment so as to be appropriate to the primary disease.

Comparison between peripherally implanted ports and externally sited catheters for long-term venous access.

In a comparative study, we examined the use of a peripherally implantable venous access system which does not require either central venous cannulation or radiological screening. We compared the complication rate in 85 patients receiving this system with that in 112 similar patients receiving Hickman lines. In addition, we examined the safety and cost implications of using a ward setting instead of full operating facilities for port insertion. There was a 10.7% incidence of early and 37.6% incidence of late complications in the group receiving Hickman lines compared with only 2.4% early complications and 10.6% late complications in those receiving peripherally implantable ports. There was no difference in complication rates between those patients who had the ports inserted in a ward side room compared with those who had their procedure performed in the operating theatre. We have demonstrated the ease and reliability of port insertion in the absence of screening radiology and we therefore suggest the peripheral port as a safe, cost-effective alternative to existing venous access systems.

Effects of hepatic arterial infusion chemotherapy on unresectable or recurrent hepatocellular carcinoma.

We performed hepatic arterial infusion chemotherapy (HAI) on 86 patients with unresectable hepatocellular carcinoma (HCC, 61 patients) or unresectable recurrent HCC after hepatectomy (25 patients). As drug therapy, 250 mg of 5-fluorouracil was injected daily for 14 days using a reservoir embedded in the subcutaneous layer. During this period, 0.4 mg/kg of doxorubicin and 0.12 mg/kg of mitomycin C suspended in Lipiodol Ultra-Fluide were also injected twice intra-arterially. This was defined as one course of HAI, and it was repeated every 3 months. In the patients with unresectable HCC, the 1-, 2-, and 3-year survival rates were 31.5%, 22.4%, and 10.7%, respectively, and the numbers of cases showing a complete response (CR), a partial response (PR), a minor response (MR), no change (NC), and progressive disease (PD) according to the Criteria for the Evaluation of the Clinical Effects of Solid Cancer Chemotherapy established by the Japan Society for Cancer Therapy were 1 (1.6%), 20 (32.8%), 5 (8.2%), 28 (45.9%), and 7 (11.5%), respectively. On the other hand, the 1-, 2-, and 3-year survival rates of the patients with unresectable recurrent HCC were 69.6%, 34.8%, and 14.9%, respectively. The rate of catheter patency after 1 year was 64.1%, and the mean catheter-patency period was 311.9 days. Patients in group A (CR+PR, n = 21) survived significantly longer than those in group B (MR+NC+PD, n = 40; P < 0.05). In conclusion, since responders to HAI achieve longer survival than nonresponders, the selection of effective drugs is important for this therapy.

Infectious morbidity associated with long-term use of venous access devices in patients with cancer.

OBJECTIVE: To evaluate infectious morbidity associated with long-term use of venous access devices. DESIGN: Prospective, observational study. SETTING: Comprehensive cancer center at a university hospital. PARTICIPANTS: 1431 consecutive patients with cancer requiring 1630 venous access devices for long-term use inserted between 1 June 1987 and 31 May 1989. MEASUREMENTS: Quantitative microbiologic tests to identify device-related bacteremia and fungemia, catheter tunnel infection, pocket infection in implantable port devices, and site infections; number of days the device remained in situ and time until infectious morbidity; vessel or device thrombosis and device breakage. RESULTS: At least one device-related infection occurred with 341 of 788 (43% [95% CI, 39% to 47%]) catheters compared with 57 of 680 (8% [CI, 6% to 10%]) completely implanted ports (P < or = 0.001). Device-related bacteremia or fungemia is the predominant infection occurring with catheters, whereas ports have a more equal distribution of pocket, site, and device-related bacteremia. The predominant organisms isolated in catheter-related bacteremia were gram-negative bacilli (55%) compared with gram-positive cocci (65.5%) in port-related bacteremia. The number of infections per 1000 device days was 2.77 (95% CI, 2.48 to 3.06) for catheters compared with 0.21 (CI, 0.16 to 0.27) for ports (P < or = 0.001). Based on a parametric model of time to first infection, devices lasted longer in patients with solid tumors than in those with hematopoietic tumors. Ports lasted longer than catheters across all patient groups. CONCLUSIONS: The incidence of infections per device-day was 12 times greater with catheters than with ports. Patients with solid tumors were the least likely to have device-related infectious morbidity compared with those with hematologic cancers. The reasons for the difference in infectious complications is uncertain but may be attributable to type of disease, intensity of therapy, frequency with which devices are accessed, or duration of neutropenia.

Major long-term complications in 1,422 permanent venous access devices.

A retrospective review was undertaken of 1,422 permanent venous access devices (PVADs) implanted from 1989 to 1991 at Hahnemann University Hospital. This included 730 single-lumen Hickman catheters, 368 double-lumen Hickman catheters, 307 single-lumen Portacath infusion ports, and 17 double-lumen Portacath infusion ports. Indications for placement were as follows: antibiotics in 28%; chemotherapy in 51%; hyperalimentation in 4%; intravenous fluids in 4%; hemodialysis in 3%; and undocumented indications in 10%. There were 60 PVADs removed and/or replaced prior to the completion of intended therapy (4% overall). Indications for removal were catheter infection in 1% of cases and catheter malfunction in 3% of cases. The percentage of Portacath infusion ports removed was significantly greater than the percentage of Hickman catheters that were removed (p < 0.001). However, there was no significant relationship between catheter infection or the malfunction rate, and the number of lumens, initial indication for placement, or number of catheters placed. Life-threatening complications associated with PVAD insertion occurred in fewer than 1% of cases. The insertion of PVADs is a safe and efficient mode of long-term venous access.