Open-Source Automated Insulin Delivery in Type 1 Diabetes.

BACKGROUND: Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system. METHODS: In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial). RESULTS: A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues. CONCLUSIONS: In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).

Gemcitabine with Cisplatin Versus Hepatic Arterial Infusion Pump Chemotherapy for Liver-Confined Unresectable Intrahepatic Cholangiocarcinoma.

BACKGROUND: A post-hoc analysis of ABC trials included 34 patients with liver-confined unresectable intrahepatic cholangiocarcinoma (iCCA) who received systemic chemotherapy with gemcitabine and cisplatin (gem-cis). The median overall survival (OS) was 16.7 months and the 3-year OS was 2.8%. The aim of this study was to compare patients treated with systemic gem-cis versus hepatic arterial infusion pump (HAIP) chemotherapy for liver-confined unresectable iCCA. METHODS: We retrospectively collected consecutive patients with liver-confined unresectable iCCA who received gem-cis in two centers in the Netherlands to compare with consecutive patients who received HAIP chemotherapy with or without systemic chemotherapy in Memorial Sloan Kettering Cancer Center. RESULTS: In total, 268 patients with liver-confined unresectable iCCA were included; 76 received gem-cis and 192 received HAIP chemotherapy. In the gem-cis group 42 patients (55.3%) had multifocal disease compared with 141 patients (73.4%) in the HAIP group (p = 0.023). Median OS for gem-cis was 11.8 months versus 27.7 months for HAIP chemotherapy (p < 0.001). OS at 3 years was 3.5% (95% confidence interval [CI] 0.0-13.6%) in the gem-cis group versus 34.3% (95% CI 28.1-41.8%) in the HAIP chemotherapy group. After adjusting for male gender, performance status, baseline hepatobiliary disease, and multifocal disease, the hazard ratio (HR) for HAIP chemotherapy was 0.27 (95% CI 0.19-0.39). CONCLUSIONS: This study confirmed the results from the ABC trials that survival beyond 3 years is rare for patients with liver-confined unresectable iCCA treated with palliative gem-cis alone. With HAIP chemotherapy, one in three patients was alive at 3 years.

Robotic Biliary Stricturoplasty and Roux-en-Y Hepaticojejunostomy After Hepatic Artery Infusion Pump Injury.

BACKGROUND: Hepatic artery infusion pump (HAIP) with floxuridine/dexamethasone and systemic chemotherapy is an established treatment regimen, which had been reported about converting 47% of patients with stage 4 colorectal liver metastasis from unresectable to resectable.1,2 To this effect, HAIP chemotherapy contributes to prolonged survival of many patients, which otherwise may not have other treatment options. Biliary sclerosis, however, is a known complication of the HAIP treatment, which occurs in approximately 5.5% of patients receiving this modality as an adjuvant therapy after hepatectomy and in 2% of patients receiving HAIP treatment for unresectable disease.3 While biliary sclerosis diffusely affects the perihilar and intrahepatic biliary tree, a dominant stricture maybe found in select cases, which gives an opportunity for a local surgical treatment after failure of endoscopic stenting/dilations. While the use of minimally invasive approach to biliary surgery is gradually increasing,4 there have been no descriptions of its application in this scenario. In this video, we demonstrate the use of minimally invasive robotic technique for biliary stricturoplasty and Roux-en-Y (RY) hepaticojejunostomy to treat persistent right hepatic duct stricture after HAIP chemotherapy. PATIENT: A 68-year-old woman with history of multifocal bilobar stage 4 colorectal liver metastasis presented to our office with obstructive jaundice and recurrent cholangitis that required nine endoscopic retrograde cholangiopancreatographies (ERCPs) and a placement of internal-external percutaneous transhepatic biliary drain (PTBD) by interventional radiology within the past 2 years. Her past surgical history was consistent with laparoscopic right hemicolectomy 3 years prior, followed by a left lateral sectorectomy with placement of an HAIP for adjuvant treatment. The patient had more than ten metastatic liver lesions within the right and left lobe, ranging from 2 to 3 cm in size at the time of HAIP placement. The patient had a histologically normal background liver parenchyma before the HAIP chemotherapy treatment. The patient did not have any history of alcohol use, diabetes mellitus, metabolic syndrome, nonalcoholic steatohepatitis, or other underlying intrinsic liver disorders, which are known to contribute to the development of hepatic fibrosis. Despite a radiologically disease-free status, the patient started to have episodes of acute cholangitis 1 year after the placement of HAIP that required multiple admissions to a local hospital. The HAIP was subsequently removed once the diagnosis of biliary sclerosis was made despite dose reductions and treatment with intrahepatic dexamethasone for almost 1 year. In addition to this finding, the known liver metastases have shown complete radiological resolution. Therefore further treatment with HAIP was deemed unnecessary, and pump removal was undertaken. Magnetic resonance imaging showed a dominant stricture at the junction of the right anterior and right posterior sectoral hepatic duct. The location of the dominant stricture was confirmed by an ERCP and cholangioscopy. Absence of neoplasia was confirmed with multiple cholangioscopic biopsies. Multiple endoscopic and percutaneous attempts with stent placement failed to dilate the area of stricture. Postprocedural cholangiographies showed a persistent significant narrowing, which led to multiple recurrent obstructive jaundice and severe cholangitis. While the use of surgical approach is rarely needed in the treatment of biliary sclerosis, a decision was made after extensive multidisciplinary discussions to perform a robotic stricturoplasty and RY hepaticojejunostomy with preservation of the native common bile duct. TECHNIQUE: The operation began with a laparoscopic adhesiolysis to allow for identification of HAIP tubing (which was later removed) and placement of robotic ports. A peripheral liver biopsy was obtained to evaluate the degree of hepatic parenchymal fibrosis. Porta hepatic area was carefully exposed without causing an inadvertent injury to the surrounding hollow organs. Biopsy of perihepatic soft tissues was taken as appropriate to rule out any extrahepatic disease. The common bile duct and common hepatic duct with ERCP stents within it were identified with the use of ultrasonography. Anterior wall of the common hepatic duct was then opened, exposing the two plastic stents. Cephalad extension of the choledochotomy was made toward the biliary bifurcation and the right hepatic duct. The distal common bile duct was preserved for future endoscopic access to the biliary tree. After lowering the right-sided hilar plate, dense fibrosis around the right hepatic duct was divided sharply with robotic scissors, achieving a mechanical release of the dominant stricture. An intraoperative cholangioscopy was performed to confirm adequate openings of the right hepatic duct secondary and tertiary radicles, as well as patency of the left hepatic duct. A 4-Fr Fogarty catheter was used to sweep the potential biliary debris from within the right and left hepatic lobe. Finally, a confirmatory choledochoscopy was performed to ensure patency and clearance of the right-sided intrahepatic biliary ducts and the left hepatic duct before fashioning the hepaticojejunostomy. A 40-cm antecolic roux limb was next prepared for the RY hepaticojejunostomy. A side-to-side double staple technique was utilized to create the jejunojejunostomy. The common enterotomy was closed in a running watertight fashion. Once the roux limb was transposed to the porta hepatic in a tension-free manner, a side-to-side hepaticojejunostomy was constructed in a running fashion by using absorbable barbed sutures. The index suture was placed at 9 o'clock location, and the posterior wall of the anastomosis was run toward 3 o'clock location. This stabilized the roux limb to the bile duct. The anterior wall of the anastomosis was next fashioned by using a running technique from both corners of the anastomosis toward the middle (12 o'clock), where both sutures were tied together. This completed a wide side-to-side hepaticojejunostomy anastomosis encompassing the upper common hepatic duct, biliary bifurcation, and the right hepatic duct. A closed suction drain was placed before closing.5 RESULTS: The operative time was approximately 4 hr with 60 ml of blood loss. The postoperative course was uneventful. The patient was discharged home on postoperative Day 5 after removal of the closed suction drain, confirming the absence of bile leak. The patient had developed periportal/periductal fibrosis, cholestasis, and moderate-severe parenchymal fibrosis (F3-F4) based on liver biopsy, often seen in patients treated with a long course of floxuridine HAIP chemotherapy. The patient is clinically doing well at 1 year outpatient follow-up without any evidence of recurrent cholangitis at the time of this manuscript preparation. CONCLUSIONS: Robotic biliary stricturoplasty with RY hepaticojejunostomy for treatment of biliary sclerosis after HAIP chemotherapy is safe and feasible. Appropriate experience in minimally invasive hepatobiliary surgery is necessary to achieve this goal.

Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy for borderline resectable and unresectable colorectal liver metastases: phase II feasibility study.

BACKGROUND: Hepatic arterial infusion pump chemotherapy combined with systemic chemotherapy (HAIP-SYS) for liver-only colorectal liver metastases (CRLMs) has shown promising results but has not been adopted worldwide. This study evaluated the feasibility of HAIP-SYS in the Netherlands. METHODS: This was a single-arm phase II study of patients with CRLMs who received HAIP-SYS consisting of floxuridine with concomitant systemic FOLFOX or FOLFIRI. Main inclusion and exclusion criteria were borderline resectable or unresectable liver-only metastases, suitable arterial anatomy and no previous local treatment. Patients underwent laparotomy for pump implantation and primary tumour resection if in situ. Primary end point was feasibility, defined as ≥70% of patients completing two cycles of HAIP-SYS. Sample size calculations led to 31 patients. Secondary outcomes included safety and tumour response. RESULTS: Thirty-one patients with median 13 CRLMs (i.q.r. 6-23) were included. Twenty-eight patients (90%) received two HAIP-SYS cycles. Three patients did not get two cycles due to extrahepatic disease at pump placement, definitive pathology of a recto-sigmoidal squamous cell carcinoma, and progressive disease. Five patients experienced grade 3 surgical or pump device-related complications (16%) and 11 patients experienced grade ≥3 chemotherapy toxicity (38%). At first radiological evaluation, disease control rate was 83% (24/29 patients) and hepatic disease control rate 93% (27/29 patients). At 6 months, 19 patients (66%) had experienced grade ≥3 chemotherapy toxicity and the disease control rate was 79%. CONCLUSION: HAIP-SYS for borderline resectable and unresectable CRLMs was feasible and safe in the Netherlands. This has led to a successive multicentre phase III randomized trial investigating oncological benefit (EUDRA-CT 2023-506194-35-00). Current trial registration number: clinicaltrials.gov (NCT04552093).

Does circle priming improve smart infusion pump and electronic health record interoperability for chemotherapy in a pediatric hematology/oncology setting?

INTRODUCTION: The objective of this project was to assess the percentage of interoperability compliance within our pediatric hematology/oncology patient care areas for intravenous chemotherapy medications before and after the implementation of circle priming. METHODS: We conducted a retrospective quality improvement project at an inpatient pediatric hematology/oncology floor and outpatient pediatric infusion center before and after implementation of circle priming. RESULTS: There was a statistically significant increase in percent interoperability compliance for the inpatient pediatric hematology/oncology floor from 4.1% prior to implementation of circle priming to 35.6% after (odds ratio 13.1 (95% CI, 3.96-43.1), p < 0.001), as well as for the outpatient pediatric infusion center from 18.5% to 47.3%, respectively (odds ratio 3.9 (95% CI, 2.7-5.9), p < 0.001). CONCLUSION: Implementation of circle priming has significantly increased the percentage of interoperability compliance for intravenous chemotherapy medications in our pediatric hematology/oncology patient care areas.

Evaluation of oncology infusion pharmacy practices: A nationwide survey.

PURPOSE: Oncology care continues to evolve at a rapid pace including provision of infusion-based care. There is currently a lack of robust metrics around oncology infusion centers and pharmacy practice. The workgroup completed a nationwide survey to learn about oncology-based infusion pharmacy services offered. The objective was to highlight consistent, measureable oncology-based infusion pharmacy metrics that will provide a foundation to describe overall productivity including emphasis on high patient-safety standards. METHODS: A nationwide survey was developed via a workgroup within the Vizient Pharmacy Cancer Care Group beginning in April 2019 and conducted electronically via the Vizient Pharmacy Network from September to November 2020. The survey was designed to capture a number of key metrics related to oncology-based infusion pharmacy services. RESULTS: Forty-one sites responded to the survey. Responses highlighted hours of operation (median = 11.5), number of infusion chairs (median = 45). Staffing metrics included 7.1 pharmacist full-time equivalent (FTE) and 7.6 technician FTE per week. 80.5% of sites had cleanrooms and 95.1% reported both hazardous and nonhazardous compounding hoods. 68.3% of sites reported using intravenous (IV) technology, 50.0% measured turnaround time, and 31.4% prepared treatment medications in advance. CONCLUSION: There was variability among oncology infusion pharmacy practices in regard to survey responses among sites. The survey results highlight the need for standardization of established productivity metrics across oncology infusion pharmacies in order to improve efficiency and contain costs in the changing oncology landscape. The survey provides insight into oncology infusion pharmacy practices nationwide and provides information for pharmacy leaders to help guide their practices.

Evaluation of the venting principle to reduce start-up delays in syringe infusion pumps used for microinfusions.

Start-up delays of syringe pump assemblies can impede the timely commencement of an effective drug therapy when using microinfusions in hemodynamically unstable patients. The application of the venting principle has been proposed to eliminate start-up delays in syringe pump assemblies. However, effectively delivered infusion volumes using this strategy have so far not been measured. This invitro study used two experimental setups to measure the effect of the venting principle compared to a standard non-venting approach on delivered start-up infusion volumes at various timepoints, backflow volumes, flow inversion and zero drug delivery times by means of liquid flow measurements at flow rates of 0.5, 1.0 and 2.0 mL/h. Measured delivered initial start-up volumes were negative with all flow rates in the vented and non-vented setup. Maximum backflow volumes were 1.8 [95% CI 1.6 to 2.3] times larger in the vented setup compared to the non-vented setup (p < 0.0001). Conversely, times until flow inversion were 1.5 [95% CI 1.1 to 2.9] times shorter in the vented setup (p < 0.002). This led to comparable zero drug delivery times between the two setups (p = 0.294). Start-up times as defined by the achievement of at least 90% of steady state flow rate were achieved faster with the vented setup (p < 0.0001), but this was counteracted by the increased backflow volumes. The application of the venting principle to the start-up of microinfusions does not improve the timely delivery of drugs to the patient since the faster start-up times are counteracted by higher backflow volumes when opening the three-way stopcock.

Pressure-adjusted venting eliminates start-up delays and compensates for vertical position of syringe infusion pumps used for microinfusion.

Microinfusions are commonly used for the administration of catecholamines, but start-up delays pose a problem for reliable and timely drug delivery. Recent findings show that venting of the syringe infusion pump with draining of fluid to ambient pressure before directing the flow towards the central venous catheter does not counteract start-up delays. With the aim to reduce start-up delays, this study compared fluid delivery during start-up of syringe infusion pumps without venting, with ambient pressure venting, and with central venous pressure (CVP)-adjusted venting. Start-up fluid delivery from syringe pumps using a microinfusion of 1 mL/h was assessed by means of liquid flow measurement at 10, 60, 180 and 360 s after opening the stopcock and starting the pump. Assessments were performed using no venting, ambient pressure venting or CVP-adjusted venting, with the pump placed either at zero, - 43 cm or + 43 cm level and exposed to a simulated CVP of 10 mmHg. Measured fluid delivery was closest to the calculated fluid delivery for CVP-adjusted venting (87% to 100% at the different timepoints). The largest deviations were found for ambient pressure venting (- 1151% to + 82%). At 360 s after start-up 72% to 92% of expected fluid volumes were delivered without venting, 46% to 82% with ambient pressure venting and 96% to 99% with CVP-adjusted venting. CVP-adjusted venting demonstrated consistent results across vertical pump placements (p = 0.485), whereas the other methods had significant variances (p < 0.001 for both). In conclusion, CVP-adjusted venting effectively eliminates imprecise drug delivery and start-up delays when using microinfusions.

The drug titration paradox: a control engineering perspective.

PURPOSE OF REVIEW: The drug titration paradox describes that, from a population standpoint, drug doses appear to have a negative correlation with its clinical effect. This paradox is a relatively modern discovery in anesthetic pharmacology derived from large clinical data sets. This review will interpret the paradox using a control engineering perspective. RECENT FINDINGS: Drug titration is a challenging endeavor, and the medication delivery systems used in everyday clinical practice, including infusion pumps and vaporizers, typically do not allow for rapid or robust titration of medication being delivered. In addition, clinicians may be reluctant to deviate from a predetermined plan or may be content to manage patients within fixed goal boundaries. SUMMARY: This drug titration paradox describes the constraints of how the average clinician will dose a patient with an unknown clinical response. While our understanding of the paradox is still in its infancy, it remains unclear how alternative dosing schemes, such as through automation, may exceed the boundaries of the paradox and potentially affect its conclusions.

Infusion pump innovation: Embracing change for patients and bottom lines.

Within the infusion delivery landscape, significant room exists for an improved experience with more intuitive and interoperable solutions. The majority of smart infusion pumps still rely on technology developed more than a decade ago. Many Canadian healthcare institutions regularly undergo a comprehensive re-evaluation of infusion fleets, to modernize infusion delivery for patients across the country. Amid the availability of new technologies with evidence demonstrating their ability to elevate the current standards of care, this article argues for the need for healthcare systems to prepare for, and embrace, change when it comes to new technologies. Clinical informatics consultant, Helen Edwards, delves into why new technologies are needed now more than ever. She shares her experience with the Ivenix Infusion System, capturing how it can help redefine clinical workflows, reduce costs across the entire healthcare continuum, and better support patient care. She also offers insights on how to effectively introduce new technologies and cultivate an environment that is likely to be open and adaptive to the change. As the Canadian healthcare landscape continues to evolve, the proactive adoption of new technologies will be a step towards advancing the outcomes for patients and the sustainability of Canadian healthcare infrastructures.

Combined Hepatic Arterial Infusion Pump and Systemic Chemotherapy in the Modern Era for Chemotherapy-Naive Patients with Unresectable Colorectal Liver Metastases.

PURPOSE: Chemotherapy-naive patients with unresectable colorectal liver metastases (CRLM) have been the best responders to hepatic arterial infusion (HAI) therapy. The current treatment paradigm has drifted away from HAI in the first-line setting. We aimed to analyze outcomes of combined first-line systemic therapy with HAI therapy (HAI+SYS) in the modern era. METHODS: We conducted a retrospective study of consecutive chemotherapy-naive patients with unresectable CRLM who received HAI+SYS between 2003 and 2019. Patients were selected from a prospectively maintained database. Outcomes included radiological response rate, conversion to resection (CTR) rate, and overall survival (OS). RESULTS: Fifty-eight chemotherapy-naive patients were identified out of 546 patients with unresectable CRLM managed with HAI. After induction treatment, 4 patients (7%) had a complete radiological response, including two durable responses. In total, 32 patients (55%) underwent CTR. CTR or complete response without resection was achieved after seven cycles of systemic therapy and four cycles of HAI therapy. Median OS for the whole cohort was 53.0 months (95% confidence interval 23.0-82.9). Three- and 5-year OS in patients who achieved CTR or complete response versus patients who did not was 88% and 72% versus 27% and 0% respectively. Of patients who underwent CTR, complete and major pathological response (no and <10% viable tumor cells, respectively) was observed in 7 (22%) and 12 patients (38%). CONCLUSIONS: Combined HAI+SYS in chemotherapy-naive patients resulted in durable and substantial response in a large proportion of patients. Nearly two-thirds of patients achieved a complete response or proceeded to conversion surgery, which was associated with prolonged survival.

Precision and reliability study of hospital infusion pumps: a systematic review.

BACKGROUND: Infusion Pumps (IP) are medical devices that were developed in the 1960s and generate fluid flow at pressures higher than that of normal blood pressure. Various hospital sectors make use of them, and they have become indispensable in therapies requiring continuity and precision in the administration of medication and/or food. As they are classified Class III (high risk) equipment, their maintenance is crucial for proper performance of the device, as well as patient and operator safety. The principal consideration of the pump is the volume infused, and the device demands great attention to detail when being calibrated. A lack of necessary care with this equipment can lead to uncertainty in volume and precision during the administration of substances. Because of this, it is essential to evaluate its reliability, to prevent possible failures at time of execution. This control aims at the quality of the intended infusion result, becoming an indication of quality. METHODS: This systematic review summarizes studies done over the last 10 years (2011 to December 2021) that address the reliability and accuracy of hospital infusion pumps, in order to identify planning of maintenance and/or other techniques used in management of the equipment. The Prisma method was applied and the databases utilized were Embase, MEDLINE/Pubmed, Web of Science, Scopus, IEEE Xplore, and Science Direct. In addition, similar reviews were studied in Prospero and the Cochrane Library. For data analysis, softwares such as Mendeley, Excel, RStudio, and VOSviewer were used, and Robvis helped in plotting risk of bias results for studies performed with Cochrane tools. RESULTS: The six databases selected produced 824 studies. After applying eligibility criteria (inclusion and exclusion), removing duplicates, and applying filters 1 and 2, 15 studies were included in the present review. It was found that the most relevant sources came from the Institute of Electrical and Electronics Engineers (IEEE) and that the most relevant keywords revolved around the terms ("device failure", "infusion pumps", "adverse effects", "complications", etc.). These results made clear that there remains substantial room for improvement as it relates to the study of accuracy and reliability of infusion. CONCLUSIONS: We verified that the reliability and precision analysis of hospital infusion pumps need to be performed in a more detailed and consistent way. New developments, considering the model and IP specification, are intended, clearly explaining the adopted methodology.

Does the use of infusion pumps increase hemolysis during blood transfusion in patients with thalassemia?

BACKGROUND: Patients with thalassemia need regular blood transfusions to maintain normal growth and suppression of ineffective erythropoiesis. Packed red blood cell (RBC) units can be delivered by infusion pumps (IPs); however, IPs may cause mechanical stress-induced RBC lysis. This study aimed to investigate the biomarkers of hemolysis related to transfusion techniques in patients with thalassemia. MATERIAL AND METHODS: Eighty-one thalassemia patients compared to those 42 healthy controls in terms of hemolysis markers (hemoglobin, plasma free hemoglobin (Hb), haptoglobin, potassium (K), lactate dehydrogenase (LDH)) before transfusion. Considering the age and peripheral venous diameter of the patient, the physician decided on the caliber of vascular access device (22 G or 24 G) for transfusion and the method to be used (gravitational method [GM] or IP). Hemolysis markers were repeated after transfusion in thalassemia patients. RESULTS: Packed RBC units were transfused to 24 (30 %) patients by IP and 57 (70 %) patients by GM. Plasma free Hb was significantly increased from 4.76 ± 7.92 mg/dL to 9.01 ± 7.66 mg/dL following transfusion (p < 0.001). There was no significant difference between IP and GM in terms of plasma free Hb increase. Post-transfusion plasma free Hb, LDH, and K levels significantly increased in patients who were transfused with 24 G catheters compared to those transfused with 22 G. CONCLUSION: An elevation in LDH levels was detected after transfusion with volumetric IPs; however, plasma free Hb or K levels were not affected by the transfusion method. Studies are needed to determine the factors associated with hemolysis after transfusion.

Retrospective analysis of failures of ambulatory elastomeric pumps containing 5-FU in a hospital pharmacy unit.

INTRODUCTION: Ambulatory chemotherapy is an important and major advance in clinical oncology practice since it allows the administration of chemotherapy in the comfort of the patient's home without the assistance of a health professional by means of an elastomeric pump. However, these pumps are not without risks and can be the cause of incidents due to technical failures. Our objective is to study the technical failures of elastomeric pumps in the Cytotoxic Preparation Unit and in the patient's home, to evaluate the possible impact of these failures on the patient and on the staff and to propose measures to reduce them. MATERIALS AND METHODS: This is a retrospective study conducted at the pharmacy of the National Institute of Oncology in Rabat. It gathered all the specific reports on elastomeric pumps issued during the period (January 2017-May 2021) by the cytotoxic preparation unit to the materiovigilance cell via a notification form. RESULTS: 205 cases of elastomeric pump materialovigilance were identified during the study period. The main technical failures were: chemotherapy product leakage (44%), flow rate anomalies (30%) and injection difficulties (20%). Following these incidents, certain actions were undertaken such as alerts sent to the supplier and letters sent to the competent health authorities. CONCLUSION: Despite the failures that may have occurred, elastomeric pumps have revolutionized home chemotherapy delivery. They are considered reliable, consistent, easy to use and handle, and are well accepted in the population.

Evaluation of biliary toxicity in patients with hepatic artery infusion pumps.

PURPOSE: Identify risk factors for biliary toxicity in patients with colorectal liver metastases who received floxuridine (FUDR) via a surgically implanted hepatic artery infusion pump (HAIP). Describe the incidence of biliary toxicity and evaluate relevant patterns in the biliary toxicity cohort. METHODS: A single center, retrospective, case-control study included adult colorectal cancer patients with liver metastases who received at least one cycle of FUDR via a surgically implanted HAIP from 1 January 2017, to 1 October 2021. Patients were excluded if they had incomplete records, cholangiocarcinoma diagnosis, or received concurrent mitomycin and FUDR. Biliary toxicity criteria derived from existing HAIP literature were utilized to determine whether patients experienced biliary toxicity. Multiple variables were compared by univariate statistical analysis between the biliary toxicity and non-biliary toxicity cohorts to identify potential risk factors for development of FUDR-induced biliary toxicity. RESULTS: Out of 50 patients who had a HAIP implanted, 39 met the inclusion criteria. Five of the 39 patients (12.7%) included in the analysis met the pre-specified biliary toxicity criteria. No risk factors for biliary toxicity were identified. All five patients who developed biliary toxicity demonstrated elevations in alkaline phosphatase (ALP) prior to meeting the toxicity criteria. CONCLUSION: Biliary toxicity remains a significant and therapy-limiting consequence of FUDR administration. Rising ALP may be an early indicator of subsequent biliary toxicity. Future studies with more patients may identify risk factors that can facilitate risk mitigation strategies.

Effect of vertical pump position on start-up fluid delivery of syringe pumps used for microinfusion.

BACKGROUND: Connection and opening a syringe infusion pump to a central venous line can lead to acute anterograde or retrograde fluid shifts depending on the level of central venous pressure. This may lead to bolus events or to prolonged lag times of intravenous drug delivery, being particularly relevant when administering vasoactive or inotropic drugs in critically ill patients using microinfusion. The aim of this study was to assess the effect of syringe pump positioning at different vertical heights on start-up fluid delivery before versus after purging and connection the pump to the central venous catheter. METHODS: This in vitro study measured ante- and retrograde infusion volumes delivered to the central venous line after starting the syringe pump at a set infusion rate of 1 mL/h. In setup one, the pump was first positioned to vertical levels of +43 cm or -43 cm and then purged and connected to a central venous catheter. In setup two, the pump was first purged and connected at zero level and secondarily positioned to a vertical level of +43 cm or -43 cm. Central venous pressure was adjusted to 10 mmHg in both setups. RESULTS: Positioning of the pump prior to purging and connection to the central venous catheter resulted in a better start-up performance with delivered fluid closer to programmed and expected infusion volumes when compared to the pump first purged, connected, and then positioned. Significant backflow volumes were observed with the pump purged and connected first and then positioned below zero level. No backflow was measured with the pump positioned first below zero level and then purged and connected. CONCLUSIONS: Syringe infusion pump assemblies should be positioned prior to purging and connection to a central venous catheter line when starting a new drug, particularly when administering highly concentrated vasoactive or inotropic drugs delivered at low flow rates.

Effect of central venous pressure on fluid delivery during start-up of syringe infusion pumps for microinfusion.

BACKGROUND: Intravenous administration of highly concentrated and potent drugs at low flow rates is common practice, particularly in critically ill children. Drug delivery during infusion start-up can be considerably delayed by intrinsic factors of syringe infusion pump assemblies. The impact of central venous pressures on the course of start-up fluid delivery of such microinfusions remains unknown. METHODS: Infusion volumes delivered after activation of the start button in a conventional 50 mL syringe infusion pump assembly equilibrated (representing classical in vitro testing) and not equilibrated (representing real clinical conditions) to central venous pressure levels of 0, 10 and 20 mmHg at a set infusion flow rate of 1 mL/h were measured using a fluidic flow sensor. RESULTS: The experimental setup mimicking real life conditions demonstrated considerable differences in fluid delivery during pump start-up depending on central venous pressure. A central venous pressure of 0 mmHg resulted in massive fluid delivery at infusion start-up, while central venous pressure levels of 10 and 20 mmHg resulted in retrograde flows with related mean (95% CI) zero-drug delivery times of 3.22 (2.98-3.46) min and 4.51 (4.33-4.69) min, respectively (p < .0001). CONCLUSION: Depending on central venous pressure level, connection and starting a new syringe pump can result in significant antegrade or retrograde fluid volumes. In clinical practice, this can lead to hemodynamic instability and hence requires clinical alertness. Further research and methods to improve start-up performance in syringe infusion pump systems are desirable.

False ST-segment elevation by artifact due to an infusion pump.

A patient admitted for non-ST-elevation acute coronary syndrome showed an episode of ST-segment elevation on the monitor. These alterations were due to an artifact produced by the administration of a saline bolus through an infusion pump that disappeared at the end of the bolus. Our findings highlight that the interpretation of the electrocardiogram requires careful analysis and correlation with the clinical situation and with other physiological parameters.

Effects of infusion tubing line lengths and syringe sizes on infusion system compliance: an experimental study using a syringe-type infusion pump at low flow rate.

Ideally, the flow delivery of an infusion system is proportional only to the rate of mechanical actuation of the syringe pump plunger. However, in the real world, overall infusion system compliance may be affected by components such as an extension of tubing lines, or different sizes of syringes. With higher compliance, there may be greater chances of flow irregularity. In this experimental study, we investigated the effects of lengths of infusion lines and syringe sizes on the compliance of syringe pumps with low flow rate (2 ml h-1). In the first experiment, infusion system compliance was measured in various settings by occlusion release. As the infusion tubing length and size of the syringe increased, the time to reach each pressure was delayed and the infusion system compliance increased. The contributions to system compliance from syringes were significantly greater compared to those of extended infusion lines. In the occlusion alarm experiment, the occlusion alarm could be delayed by 69.76 ± 3.98 min for the 50-ml syringe with a 560 cm infusion line set-up. In conclusion, the compliance of a syringe pump system increases as the loaded syringe size, or the length of the infusion tubing increases. The occlusion alarm may be much delayed and not useful in highly compliant systems with respect to the potential occlusion of the infusion system, so more attention is required when using a highly compliant infusion system.

SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump.

Blinatumomab (Blincyto® injection solution) is classified as a bispecific T-cell engaging (BiTE) antibody and is intended for the treatment of relapsed/refractory acute lymphoblastic leukemia. It requires continuous infusion to maintain therapeutic levels. Therefore, it is often administered at home. Monoclonal antibodies, which are administered intravenously, have the potential to leak depending on the nature of the administration devices. Therefore, we investigated device-associated causes of blinatumomab leakage. We observed no apparent changes to the filter and its materials after exposure to the injection solution and surfactant. From scanning electron microscopic images, precipitate on the surface of the filters was observed after physical stimulation of the injection solution. Therefore, physical stimulations should be avoided during the prolonged administration of blinatumomab. In conclusion, the findings of this study assist in the safe administration of antibodies using portable infusion pumps, taking into consideration the composition of drug excipients and the choice of filter type and structure.