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With the aim to explore innovative tools for organ preservation, especially in marginal organs, we hereby describe a clinical trial of ex-vivo hypothermic oxygenated perfusion (HOPE) in the field of liver (LT) and kidney transplantation (KT) from Extended Criteria Donors (ECD) after brain death. A matched-case analysis of donor and recipient variables was developed: 10 HOPE-ECD livers and kidneys (HOPE-L and HOPE-K) were matched 1:3 with livers and kidneys preserved with static cold storage (SCS-L and SCS-K). HOPE and SCS groups resulted with similar basal characteristics, both for recipients and donors. Cumulative liver and kidney graft dysfunction were 10% (HOPE L-K) vs . 31.7%, in SCS group ( p  =  0.05 ). Primary non-function was 3.3% for SCS-L vs . 0% for HOPE-L. No primary non-function was reported in HOPE-K and SCS-K. Median peak aspartate aminotransferase within 7-days post-LT was significantly higher in SCS-L when compared to HOPE-L (637 vs .344 U/L, p  =  0.007 ). Graft survival at 1-year post-transplant was 93.3% for SCS-L vs. 100% of HOPE-L and 90% for SCS-K vs. 100% of HOPE-K. Clinical outcomes support our hypothesis of machine perfusion being a safe and effective system to reduce ischemic preservation injuries in KT and in LT.

PurposePostoperative pain after cardiac surgery, exacerbated by cough and sternal mobilization, limits clearance of bronchopulmonary secretions and may predispose to postoperative pneumonia. In this study, we tested the ability of local anesthetic continuous wound infusion to prevent pneumonia after cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) owing to better analgesia and bronchopulmonary drainage.MethodsIn this randomized, double-blind, placebo-controlled trial conducted in five academic centers, patients undergoing cardiac surgery with sternotomy and CPB were enrolled from February 2012 until November 2014, and were followed over 30 days. Patients were assigned to a 48-h infusion (10 ml h−1) of l-bupivacaine (12.5 mg h−1) or placebo (saline) via a pre-sternal multiperforated catheter. Anesthesia and analgesia protocols were standardized. The primary end point was the incidence of pneumonia during the study period, i.e., until hospital discharge or 30 days. We hypothesized a 30% reduction in the incidence of pneumonia.ResultsAmong 1493 randomized patients, 1439 completed the trial. Pneumonia occurred in 36/746 patients (4.9%) in the l-bupivacaine group and in 42/739 patients (5.7%) in the placebo group (absolute risk difference taking into account center and baseline risk of postoperative pneumonia, − 1.3% [95% CI − 3.4; 0.8] P = 0.22). In the predefined subgroup of patients at high risk, l-bupivacaine decreased the incidence of pneumonia (absolute risk difference, − 5.6% [95% CI − 10.0; − 1.1], P = 0.01).ConclusionsAfter cardiac surgery with sternotomy, continuous wound infusion of l-bupivacaine failed to decrease the incidence of pneumonia. These findings do not support the use of local anesthetic continuous wound infusion in this indication. Further study should investigate its effect in high-risk patients.Trial registrationEudraCT Number: 2011-003292-10; Clinicaltrials.gov Identifier: NCT01648777.

Elastomeric infusion pumps are widely used in colorectal cancer chemotherapy. However, no studies to date have investigated patient preferences regarding different infusion pump types. Twenty patients with unresectable colorectal cancer undergoing chemotherapy were initially treated with a portable hard-shelled continuous infusion pump, followed by a soft-shelled continuous infusion pump. The respondents used a numerical rating scale (0-10) to rate their comfort when using each pump, their ease of carrying it, the pump size and shape, its weight, their ease of reading its memory, and their overall satisfaction with it. They were then asked to determine which pump they would ultimately prefer. In terms of comfort, significantly higher user satisfaction was reported for the soft-shelled pump during the daytime and when going out (P < 0.001, P < 0.001, respectively). For pump portability, size, shape, and weight, the soft-shelled type also outperformed the hard-shelled one (P < 0.001, P=0.0011, P < 0.001, respectively). However, the hard-shelled pump scored significantly better in terms of ease of viewing memory (P < 0.001). Overall satisfaction was significantly higher for the soft-shelled pump than the hard-shelled type (P=0.0095). Finally, 13 patients (65%) indicated that they would prefer a soft-shelled pump for their next treatment, while only one patient (5%) preferred a hard-shelled alternative. A preference for soft-shelled pump was observed, particularly in female patients and those with a body mass index of < 22 kg/m . The selection of portable elastomeric infusion pumps should consider the preferences of patients with colorectal cancer, as these devices have the potential to enhance their quality of life.

ObjectiveThree types of central venous access devices (CVADs) are routinely used in the delivery of intravenous systemic anticancer therapy (SACT): peripherally inserted central catheters (PICCs), subcutaneously tunnelled central catheters (Hickman-type devices) and totally implantable chest wall ports (Ports). This qualitative study, nested within a multicentre, randomised controlled trial, sought to explore patient acceptability and experiences of the three devices.DesignEight focus groups were audio-recorded, transcribed and thematically analysed.SettingSix outpatient cancer treatment centres in the UK.ParticipantsForty-two patients (20 female, mean age 61.7 years) who had taken part or were taking part in the broader trial.InterventionAs part of the larger, randomised controlled trial, participants had been randomly assigned one of three CVADs for the administration of SACT.ResultsAttitudes towards all three devices were positive, with patients viewing their CVAD as part of their treatment and recovery. Participants with PICCs and Hickmans tended to compare their device favourably with peripheral cannulation. By comparison, participants with Ports consistently compared their device with PICCs and Hickmans, emphasising the perceived superiority of Ports. Ports were perceived to offer unique psychological benefits, including a greater sense of freedom and less intrusion in the context of personal relationships.ConclusionsPatient experiences and preferences have not been systematically used to inform policy and practice regarding CVAD availability and selection. Our research identified patterns of patient device preferences that favoured Ports, although this was not universal. Results of this study could improve support for patients and offer greater scope for incorporating patient perspectives into decision-making processes.Trial registration numberISRCTN44504648.

Infusion therapy is widely used in clinical settings, particularly in intensive care units. to explore the influence of simulated cardiac output on “bolus” or “backflow” events that can occur during syringe pump changeover, considering several factors that have been previously outlined in published research. Syringe infusion pumps are commonly used for precise continuous intravenous drug delivery. Syringe pump changeover can be a challenging procedure. Bench-top study in a laboratory setting. An extracorporeal circuit was used to simulate a cardiac output of 5 l/min. The following variables were used: three levels of vertical position of the syringe pump (−50 cm, 0, +50 cm), three levels of Central Venous Pressure (−5, 10, and 15 mmHg), presence/absence of carrier infusion (5 ml/h), and presence/absence of a needle-free connector between the syringe and extension line. A total of 108 syringe pump changes were performed with different combinations of the investigated variables. The mean time for syringe pump changeover was equal to 9.48 ± 2.45 s and the overall fluid displacement was 8 ± 40 µL (microlitres) (range, −262–156 µL). The CVP level and vertical position of the pump always statistically affected the overall displacement during syringe pump changeover. When a second infusion with an equal velocity rate to that of a syringe pump infusion is present in the same lumen, the presence of a needle-free device reduces the overall volume of displacement. Syringe pump changeover can be a critical moment for patients when vasoactive drugs are administered. In a simulated environment with a cardiac output of 5 L/min, the CVP level and vertical position of the syringe pump generated bolus or backflow events during the syringe pump changeover. The application of carrier infusion appeared to intensify these phenomena. Employing a neutral, needle-free system can potentially aid in reducing the development of boluses or backflows.

Microfluidics are widely used in research ranging from bioengineering and biomedical disciplines to chemistry and nanotechnology. As such, there are a large number of options for the devices used to drive and control flow through microfluidic channels. Commercially available syringe pumps are probably the most commonly used instruments for this purpose, but are relatively high-cost and have inherent limitations due to their flow profiles when they are run open-loop. Here, we present a low-cost ($110) syringe pressure pump that uses feedback control to regulate the pressure into microfluidic chips. Using an open-source microcontroller board (Arduino), we demonstrate an easily operated and programmable syringe pump that can be run using either a PID or bang-bang control method. Through feedback control of the pressure at the inlets of two microfluidic geometries, we have shown stability of our device to within ±1% of the set point using a PID control method and within ±5% of the set point using a bang-bang control method with response times of less than 1 second. This device offers a low-cost option to drive and control well-regulated pressure-driven flow through microfluidic chips.

BackgroundPatients with unresectable intrahepatic cholangiocarcinoma (iCCA) have poor survival. This systematic review describes the survival outcomes of hepatic arterial infusion pump (HAIP) chemotherapy with floxuridine for patients with unresectable iCCA.Patients and MethodsA literature search was conducted using the electronic databases PubMed, Medline (Ovid), Embase, Web of Science, Google Scholar, and Cochrane to find studies that reported data on the survival of patients with unresectable iCCA treated with HAIP chemotherapy using floxuridine. The quality of the studies was assessed using the Newcastle–Ottawa quality assessment Scale (NOS). Overall survival (OS) was the primary outcome measure, and progression-free survival (PFS), response rates, resection rates, and toxicity were defined as secondary outcome measures.ResultsAfter removing duplicates, 661 publications were assessed, of which nine studies, representing a total of 478 patients, met the inclusion criteria. Three out of nine studies were phase II clinical trials, one study was a prospective dose-escalation study, and the remaining five studies were retrospective cohort studies. After accounting for overlapping cohorts, 154 unique patients were included for pooled analysis. The weighted median OS of patients with unresectable iCCA treated with HAIP chemotherapy with floxuridine was 29.0 months (range 25.0–39 months). The pooled 1-, 2-, 3-, and 5-year OS were 86.4, 55.5, 39.5, and 9.7%, respectively.ConclusionHAIP chemotherapy with floxuridine for patients with unresectable iCCA was associated with a 3-year OS of 39.5%, which is favorable compared with systemic chemotherapy for which no 3-year survivors were reported in the Advanced Biliary Cancer (ABC) trials.

The first trials of hepatic artery infusion pump (HAIP) chemotherapy occurred in the 1990s. The high percentage of recurrent disease after curative resection of colon cancer and perioperative systemic chemotherapy has renewed.

Background: Intrathecal drug infusion therapy is usually considered when spinal-acting analgesics or antispasmodics administered via the oral or transdermal routes fail to control patients’ pain or are associated with unacceptable side effects. The intrathecal administration of centrally acting agents bypasses the blood-brain-barrier resulting in much higher cerebrospinal fluid (CSF) concentrations while using reduced amounts of medication to achieve equipotent doses. The intrathecal approach is associated with higher rates of satisfactory pain relief and lower rates of treatment failures and technical complications compared to the epidural route. A paucity of randomized controlled trials (RCTs) has led to concern regarding proper use, selection criteria, and safety of these devices. Cost effectiveness and comparative therapies have now also become a focus of discussion. Objective: The purpose of this systematic review is to evaluate and update the available evidence for the efficacy and safety of intrathecal infusions used in long-term management (> 6 months) of chronic pain. This paper will not focus on intrathecal administration for spasticity or movement disorders. Study Design: A systematic review of intrathecal infusion through implanted drug delivery devices for chronic pain. Methods: Literature search through EMBASE, Medline, Cochrane databases, and systematic reviews as well as peer-reviewed non-indexed journals from 1980 to December 2010. Studies are assessed using the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and the Cochrane Musculoskeletal Review Group criteria for randomized trials. The level of evidence was determined using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II, based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Outcome Measures: The primary outcome measure for chronic non-cancer is pain relief (short-term relief ≤ one-year and long-term > one-year), whereas it is 3 months for cancer. Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake. Results: The level of evidence for this systematic review of non-cancer pain studies meeting the inclusion criteria of continuous use of an intrathecal drug delivery system (IDDS) for at least 12 months duration with at least 25 patients in the cohort, is Level II-3 based on USPSTF criteria. The level of evidence for this systemic review for cancer-related pain studies meeting the inclusion criteria of continuous use of IDDS for at least 3 months duration with at least 25 patients in the cohort is Level II-2 based on USPSTF criteria. Conclusion: Based on the available evidence, the recommendation for intrathecal infusion systems for cancer-related pain is moderate recommendation based on the high quality of evidence and the recommendation is limited to moderate based on the moderate quality of evidence from nonrandomized studies for non-cancer related pain. Key words: Intrathecal infusion, intrathecal drug delivery device, intrathecal drug delivery system, intraspinal infusion, programmable infusion systems, spinal infusion, intra-spinal infusion devices, baclofen infusion, intrathecal opioids