Venous Access Port Research Articles

Late complications of totally implantable venous access ports in patients with cancer: Risk factors and related nursing strategies.

The aim of this study was to assess the incidence rate and the risk factors for late complications associated with use of central totally implanted venous access devices (TIVAPs) in patients with cancer, and to devise nursing strategies to minimize late complications.This retrospective study included 500 patients with TIVAPs from 2012 to 2015. Multivariable logistic regression analysis was performed to assess the effect of sex, age, primary diagnosis, duration of surgery, and the length of hospital stay on the incidence of late complications of TIVAP.The cumulative maintenance period of TIVAP was 159,605 days. Late complications included catheter-related obstruction (n = 14; 2.8%), infection (n = 3; 0.6%), drug extravasation (n = 1; 0.2%), and catheter exposure (n = 1; 0.2%). Multivariate analyses revealed that age, breast cancer, lung cancer, and gastric cancer were risk factors for the late complications associated with TIVAP.There was a low incidence of late complications with TIVAP use. Catheter-related obstruction is the most frequent late complication of TIVAP. Risk factors for TIVAP-associated late complications include age and certain cancers, such as breast cancer, lung cancer, and gastric cancer.

Effects of individualized comprehensive intervention on complications among patients with implantable venous access port

Objective To explore the effects of individualized comprehensive intervention on complications during indwelling implantable venous access port (IVAP) , so as to provide reasonable suggestion and theory evidence for reducing the incidence of IVAP complications. Methods We selected 400 breast cancer patients with IVAP. All of the patients were completely randomized divided into control group and experimental group. Patients of control group (n=200) received routine intervention including education before implanting IVAP and discharge instruction. On this basis of routine intervention, patients of experimental group (n=200) were treated with the individualized comprehensive intervention and enhancing continuous intervention out hospital aiming at common complications of IVAP. We compared patients'incidences of complications during IVAP between two groups. Results Patients'incidences of complications during IVAP in control group and experimental group were 27.0% and 7.5% respectively with a significant difference (P<0.01) . There were 12 patients with unplanned port drawing due to complications in control group and 3 in the experimental group with a significant difference (P<0.05) . Conclusions Individualized comprehensive intervention can effectively reduce the incidences of complications during IVAP, improve the utilization time and ratio of IVAP. Enhancing continuous intervention out hospital is also the important measure to decrease the incidence of severe complications. Key words: Nursing care; Individualized comprehensive intervention; Implantable venous access port; Complications

The Safety Level of Total Central Venous Access Port Implantation Performed by Residents

The implantation of totally implantable venous access ports (TIVAPs) is one of the first procedures surgical residents learn. Complications after implantation procedures have a major impact on patient outcomes, as it may lead to a delay of chemotherapy regimens or of parenteral nutrition. The aim of this study was to compare the outcomes after totally implantable venous access ports implantations done by resident and attending surgeons. The study was performed as a retrospective analysis. The study took place in primary care at the Department of General and Visceral Surgery at Frankfurt University Hospital. A total of 760 primary totally implantable venous access ports implantations performed between March 2008 and December 2016 were included in a database. Three groups of surgeons doing the implantations were defined: Group A (residents alone), Group B (resident with help), and Group C (attending surgeons). There was a significant difference between the surgeon groups in operation time (p<0.001). The groups differed between Group A (mean, 49; SD, 22) and Group C (mean, 39; SD, 20); p<0.001) and Group B (mean, 53; SD, 23) and Group C (mean, 39; SD, 20; p<0.001). The incidence of surgical site infections between Groups A and C (3.6% vs. 0.3%; p=0.003) and Groups B and C (2.5% vs. 0.3%; p = 0.027) differed also significantly. Based on multivariable logistic regression analysis operation time in minutes (OR, 1.04; 95%CI, 1.03-1.06; p<0.001) was an independent risk factor for any intraoperative complications. For any postoperative complications younger age of the patient (OR, 0.98; 95%CI, 0.97-0.99; p=0.004) and benign primary disease (OR, 3.25; 95%CI, 1.55-6.64; p=0.002) were independent risk factors based on multivariable regression analysis. Based on multivariable regression analysis a lower body mass index of the patient (OR, 0.93; 95%CI, 0.86-0.99; p=0.044), benign primary disease (OR, 2.89; 95%CI, 1.07-7.79; p=0.036), and no chemotherapy (OR, 3.55; 95%CI, 1.50-8.39; p=0.004) were independent risk factors for postoperative catheter infections. Surgeon group was no risk factor, neither for intraoperative and postoperative complications, nor for catheter explantation due to complications. Residents performing alone or residents performing with help can safely handle a central venous access port implantation. In patients with several risk factors, however, an attending should assist.

Efficacy and safety of ultrasound-guided totally implantable venous access ports via the right innominate vein in adult patients with cancer: Single-centre experience and protocol

BackgroundTotally implantable venous access ports (TIVAPs) are widely used and are an essential tool in the efficient delivery of chemotherapy. This study aimed to evaluate the feasibility and safety of implantation of ultrasound (US)-guided TIVAPs via the right innominate vein (INV) for adult patients with cancer. MethodsThis study retrospectively reviewed the medical records of 283 adult patients with cancer who underwent US-guided INV puncture for TIVAPs between September 2015 and September 2017. It also analysed the technical success rate, operation time, and short-term and long-term surgical complications. ResultsTechnical success was achieved in all patients (100%). The mean operation time was 28.31 ± 7.31 min (range: 23–39 min), and the puncture success rate for the first attempt was 99.30% (281/283). Minor complications included artery puncture during the operation in one patient, but no pneumothorax was encountered. The mean TIVAP time was 304.16 ± 42.54 days (range: 38–502 days). The rate of postoperative complications was 2.83% (8/283), including poor healing of the incision in one patient, catheter-related infections in three patients, port thrombosis in one patient, and fibrin sheath formation in three patients; no catheter malposition, pinch-off syndrome, catheter fracture, or other serious complications were observed. ConclusionsTIVAPs are widely employed for chemotherapy. The present study found that the novel approach of using US-guided INV puncture to implant TIVAPs in adult patients with cancer is both short-termly feasible and safe for long-term central venous access.

Comparison between Internal Jugular and Upper Arm Peripheral Veins Approach in Insertion of Totally Implantable Central Venous Ports

Objectives: To compare internal jugular vein approach and Upper arm approach through basilic or cephalic veins in insertion of total implantable central venous port regarding early post-operative complications, patency rate, compliance and patient quality of life. Patients and methods: We identified 50 patients who underwent totally implantable venous access ports (TIVAP) implantation in the arm (25 patients) or chest (25 patients) between November 2015 and November 2017. Implantation via an upper arm (cephalic or basilic) occurred through venous cut down, the internal jugular vein approach was performed using percutaneous technique.1 All approaches were Under fluoroscopic guidance. Early post-operative Complications were evaluated. During follow up, self-compliance and quality of life were assessed as well. Results: Technical success was 100%. Procedure-related arterial injury occurred in 3 patients in central approach only. Post-operative hematoma, stitch inflammation and seroma were observed. Late complications including catheter infection, occlusion, pinch off syndrome, skin dehiscence, thrombophlebitis of the vein and extravasation in both technique was documented, and quality of life was assessed during follow up. Conclusions: Totally implantable venous access ports (TIVAP) can be implanted with high technical success rates and are associated with low rates of complications. Upper arm implantation may benefit clinicians and patients with respect to safety and comfort.

Clinical outcomes of totally implantable venous access port placement via the axillary vein in patients with head and neck malignancy.

To evaluate the clinical outcomes and complications of totally implantable venous access port implantation via the axillary vein in patients with head and neck malignancy. A total of 176 totally implantable venous access ports were placed via the axillary vein in 171 patients with head and neck malignancy between May 2012 and June 2015. The patients included 133 men and 38 women, and the mean age was 58.8 years (range: 19-84 years). Medical records were retrospectively reviewed. This study included a total of 93,237 totally implantable venous access port catheter-days (median 478 catheter-days, range: 13-1380 catheter-days). Of the 176 implanted totally implantable venous access port, complications developed in nine cases (5.1%), with the overall incidence of 0.097 events/1000 catheter-days. The complications were three central line-associated blood-stream infection cases, one case of keloid scar at the needling access site, and five cases of central vein stenosis or thrombosis on neck computed tomography images. The 133 cases for which neck computed tomography images were available had a total of 59,777 totally implantable venous access port catheter-days (median 399 catheter-days, range: 38-1207 catheter-days). On neck computed tomography evaluation, the incidence of central vein stenosis or thrombosis was 0.083 events/1000 catheter-days. Thrombosis developed in four cases, yielding an incidence of 0.067 events/1000 catheter-days. All four patients presented with thrombus in the axillary or subclavian vein. Stenosis occurred in one case yielding an incidence of 0.017 events/1000 catheter-days. One case was catheter-related brachiocephalic vein stenosis, and the other case was subclavian vein stenosis due to extrinsic compression by tumor progression. Of the nine complication cases, six underwent port removal. These data indicate that totally implantable venous access port implantation via the axillary vein in patients with head and neck malignancy is safe and feasible, with a low axillary vein access-related complication rate.

Central venous access port placement by translumbar approach using angio-CT unit in patients with superior vena cava syndrome.

To evaluate the clinical results of central venous access port (CV port) placement by translumbar inferior vena cava cannulation using angio-CT unit for cancer patients with superior vena cava syndrome. A CV port was placed by translumbar inferior vena cava cannulation using an angio-CT unit, in 14 consecutive patients. All patients had occlusion or advanced stenosis of the superior vena cava due to cancer progression. The technical success rate of the percutaneous translumbar CV port placement was 100%. The only complication related to port placement was bleeding in the right iliopsoas muscle seen on CT in one patient, but it stopped with conservative treatment. The mean initial device service interval was 125days (range 6-448days). Complications in the chronic phase occurred in two patients, one with catheter-related infection and the other with catheter breakage, for a rate of 0.44/1000catheter days. In the patient with the broken catheter, the port chamber placement site was cut and replaced with a new catheter by guidewire exchange. CV port placement with translumbar inferior vena cava cannulation using an angio-CT unit for cancer patients with superior vena cava syndrome was safe and effective.

CT-Guided Translumbar Placement of Permanent Catheters in the Inferior Vena Cava: Description of the Technique with Technical Success and Complications Data.

To evaluate indications, technical success rate and complications of CT-guided translumbar catheter placement in the inferior vena cava for long-term central venous access (Port and Hickman catheters) as a bail-out approach in patients with no alternative options for permanent central venous access. This retrospective study included 12 patients with a total of 17 interventions. All patients suffered from bilaterally chronically occluded venous vessels of their upper extremities, without patent internal jugular and/or subclavian veins. Catheter implantation was performed as a hybrid procedure with CT-guided translumbar access into the inferior vena cava with subsequent angiography-guided catheter placement of a Hickman-type catheter (7×) or a Port catheter (10×). All interventions were technically successful. The total 30-day complication rate was 11.8% (n = 2). The two detected complications were bleeding at the subcutaneous port hub and subcutaneous kinking of the venous tube. Mean follow-up time was 68.4 ± 41.4months (range 3.4-160months). Six patients (50%) died during follow-up from non-procedure-related complications associated with the underlying disease. Late complications occurred in 8/17 (47.1%) cases and were infections of the catheter system in 35.3% (n = 6), mechanical defect of the catheter system in 5.8% (n = 1) and dislocation of the catheter system in 5.8% (n = 1). The overall infection rate was 0.77 per 1000 catheter days. CT-guided translumbar placement of permanent catheters is a technically feasible and safe method for permanent central venous access as last resort in chronically occluded veins of the upper extremities.

Removal of totally implanted venous access ports for suspected infection in the intensive care unit: a multicenter observational study

BackgroundWhile no data support this practice, international guidelines recommend the removal of totally implanted venous access ports (TIVAPs) in patients with suspicion of TIVAP-related bloodstream infection admitted in the intensive care unit (ICU) for a life-threatening sepsis.MethodsDuring this multicenter, retrospective and observational study, we included all patients admitted in five ICU for a life-threatening sepsis in whom a TIVAP was removed between January 2012 and December 2014. We aimed (1) at determining the proportion of confirmed TIVAP-related infections and (2) at assessing short- and long-term survival of patients with and without TIVAP-related infections.ResultsOne hundred and fifty-one patients (58 ± 14 years, 62% males) were included between 2012 and 2014. TIVAP-related infections were confirmed in 68 patients (45%). Demographic characteristics were similar between patients with and without TIVAP-related infections. SOFA score on admission per point increase [odd ratio (OR), 0.86 interval confidence (IC) 95% (0.8–0.9), p < 0.01] and local signs of infection [OR 4.0, IC 95% (1.1–15.6), p = 0.04] were significantly associated with TIVAP-related infection. Patients with TIVAP-related infection had lower ICU and 6-month mortality as compared to their counterparts (9 vs. 40%, respectively, p < 0.01; and 50 vs. 66%, respectively, p = 0.04). TIVAP-related infection was significantly associated with ICU survival [OR 0.2, IC 95% (0.05–0.5), p < 0.01].ConclusionsTIVAP-related infection was confirmed in nearly one out of two cases of life-threatening sepsis in patients in whom it has been removed. TIVAP-related infection was associated with a good prognosis, as compared to patients with other causes of infection.

A Port-A-Cath in aorta.

Key Clinical MessageTotally implantable venous access ports are valuable invention for oncological patients. Erroneous arterial malposition rate is estimated from 1.1% to 3.7% (Bowen et al. Am. J. Surg., 2014, 208, 937). Early recognition and management are crucial to prevent further complications.

A Comparison Between Upper Arm and Chest for Optimal Site of Totally Implanted Venous Access Ports in Patients with Female Breast Cancer

The objective of the study was to evaluate the safety, technical feasibility, and complications of totally implanted venous access ports (TIVAPs) in the upper arm, for comparison with transjugular chest ports in patients with breast cancer. In total, 223 consecutive female breast cancer patients who received a TIVAP in the upper arm or chest between July 2014 and February 2016 were included. All procedures were performed via a sonographic and fluoroscopic-guided approach using the Seldinger technique under local anesthesia. We reviewed the medical records to determine technical success, pain scale, and early (≤30days) and late (>30days) complications. In total, 231 devices were implanted in the upper arms (n=176, 76%) and chests (n=55, 24%) of the patients. The mean age was 51.6±10.7years (range 23-78years; upper arm, 52.1±11.0years; chest, 50.1±9.7years, P>0.05). The mean implantation time for TIVAPs was 181.7±109.2days (range, 9-460days; upper arm 175.2±102.7days; chest, 202.4±126.6days, P>0.05), with 41,974 catheter days. The technical success rate was 100%. Fourteen complications (6.1%) occurred in 14 patients (0.33/1,000 catheter days). There was no significant difference in complication-free survival for patients with upper arm TIVAPs and those with transjugular chest TIVAPs. The mean amount of 2% lidocaine, used as local anesthesia, was 3.3±1.7mL and 14.5±4.1mL for upper arm and chest TIVAPs, respectively. (P<0.001). Implantation of TIVAPs in the upper arm is a safe procedure with a low rate of complications. Upper arm TIVAPs can be implanted with less pain compared with transjugular chest TIVAPs.

Thromboembolic (TE) complications in germ cell tumor (GCT) patients: Should use of peripherally inserted central catheters (PICC-Line) be pursued?

571 Background: Patients with GCT receiving cisplatin-based chemotherapy are at high risk of TE events (TEE). Several risk factors have been reported previously, such as cisplatin, Lactate Deshydrogenase, body surf area (BSA)... Methods: we conducted a retrospective study of all patients (pts) with GCT, treated with platinum salts and followed at the university hospital and anticancer center of Bordeaux (June 2007 - January 2015). The following characteristics were recorded: age, performans status, BSA, histological type, site of primitive tumor, stage, prognosis (IGCCCG classification), size of retroperitoneal lymphnode, LDH, type of venous pathway (peripheral vein, implantable venous access port or PICC-Line), prophylaxis of anticoagulant or not, TEE and median time to onset. Results: 206 pts were selected. Thirty-six (17.4%) had one or more venous or arterial TEE during or within 3 months of the end of chemotherapy: 26 deep vein thromboses, 13 pulmonary embolisms and 4 arterial accidents (2 acute limb ischemia and 2 acute coronary syndromes). The median time between treatment initiation and occurrence of TEE was 38.5 days [7-248]. Among the 12 pts with PICC-line, 6 (50%) had a TEE, including 4 cases of pulmonary embolism. In addition to the presence of a PICC-line (OR 4.62 [1.28, 15.56]), factors associated with an increased TE risk in univariate analysis were the use of implantable venous access port (OR: 3.97 [1.81; 9.12]), size of retroperitoneal adenopathy ≥ 2 cm ([2-5 cm]: OR: 24.39 [4.50 - 454.39]; &gt; 5cm : OR : 26.25 [5,00 - 484.5]), stage II (OR : 10.19 [1,9 - 188.96]), stage III (OR :27.2 [5.34 - 479.9]), prognosis group (good : OR : 11.16 [2.16 - 205.04]) ; intermediate : OR : 31.50 [4.81 – 624.20] ; unfavorable : OR : 33.35 [5.7 – 637.34]), VIP (etoposide-ifosfamide-cisplatin) protocol (OR :6.35 [1.51 – 28.15]) and high LDH level (OR :3.88 [1.63 – 10.34]). Conclusions: These results suggest a significant association between PICC-line and the occurrence of TEE in univariate analysis. PICC-line is not risk-free and should be used sparingly in pts with GCT whose treatment objective remains primarily a cure at the cost of less toxicity.

Complications analysis of subcutaneous venous access port for chemotherapy in patients with gastrointestinal malignancy

To describe and analyze the complications of subcutaneous venous access port for patients with gastrointestinal malignancy. Data of 1 912 patients with gastrointestinal malignancy who accepted chemotherapy in our department via subcutaneous venous access ports, including 127 cases in upper arm, 865 cases in subclavicular vein and 920 cases in internal jugular vein, from June 2007 to April 2016 were analyzed retrospectively. Associated complications and risk factors were emphatically investigated. Postoperative complications were confirmed in 233 patients(12.2%), and complication morbidity was 37.0%(47/127), 15.5%(134/865), 6.7%(62/920) in upper arm group, subclavicular vein group, internal jugular vein group respectively, whose difference was statistically significant (χ2=71.060, P=0.000). Sixty-one(3.2%) patients developed early complications (in the day of insertion, including catheter dislocation, pneumothorax, arterial damage). Early complication morbidity of upper arm group (14.2%, 18/127) was higher as compared to subclavicular vein group (3.4%, 29/865) and internal jugular vein group(1.5%, 14/920) with significant difference (χ2=57.867, P=0.000). Postoperative long-term complications (catheter dislocation, thrombosis, pinch-off syndrome, infusion base exposure, catheter detachment) were found in 182(9.5%) patients. Morbidity of long-term complication was 5.2%(48/920) in internal jugular vein group, which was significantly lower than 22.8% (29/127) in upper arm group and 12.1% (105/865) in subclavicular vein group with statistically significant difference (χ2=50.828, P=0.000). Multivariate analysis indicated that subclavicular vein intubation (OR=0.536, 95%CI: 0.341 to 0.843; P=0.007 OR=0.156, 95%CI: 0.096 to 0.253, P=0.000), internal jugular vein intubation (OR=0.156, 95%CI: 0.096 to 0.253, P=0.000), operation time <40 minutes (OR=0.458, 95%CI: 0.342 to 0.613, P=0.000) and standardized training (OR=0.233,95%CI: 0.171 to 0.318, P=0.000) were protective factors of postoperative complication; besides, subclavicular vein intubation (OR=0.458, 95%CI: 0.342 to 0.613, P=0.000), internal jugular vein intubation (OR=0.233, 95%CI: 0.171 to 0.318, P=0.000) and standardized training (OR=0.313, 95%CI: 0.173 to 0.568, P=0.000) were protective factors of thrombosis. Subcutaneous venous access port implantation is a preferable access to central vein. Appropriate intubation approach and standardized training may reduce postoperative complications effectively. Internal jugular vein approach is safer and more reliable than upper arm vein and subclavian vein approach.

Endovascular stent-based revascularization of malignant superior vena cava syndrome with concomitant implantation of a port device using a dual venous approach.

The aim of this paper is to evaluate the safety and efficacy of endovascular revascularization of malignant superior vena cava syndrome (SVCS) and simultaneous implantation of a totally implantable venous access port (TIVAP) using a dual venous approach. Retrospectively, 31 patients (mean age 67 ± 8years) with malignant CVO who had undergone revascularization by implantation of a self-expanding stent into the superior vena cava (SVC) (Sinus XL®, OptiMed, Germany; n = 11 [Group1] and Protégé ™ EverFlex, Covidien, Ireland; n = 20 [Group 2]) via a transfemoral access were identified. Simultaneously, percutaneous access via a subclavian vein was used to (a) probe the lesion from above, (b) facilitate a through-and-through maneuver, and (c) implant a TIVAP. Primary endpoints with regard to the SVC syndrome were technical (residual stenosis < 30%) and clinical (relief of symptoms) success; with regard to TIVAP implantation technical success was defined as positioning of the functional catheter within the SVC. Secondary endpoints were complications as well as stent and TIVAP patency. Technical and clinical success rate were 100% for revascularization of the SVS and 100% for implantation of the TIVAP. One access site hematoma (minor complication, day 2) and one port-catheter-associated sepsis (major complication, day 18) were identified. Mean catheter days were 313 ± 370days. Mean imaging follow-up was 184 ± 172days. Estimated patency rates at 3, 6, and 12months were 100% in Group 1 and 84, 84, and 56% in Group 2 (p = 0.338). Stent-based revascularization of malignant SVCS with concomitant implantation of a port device using a dual venous approach appears to be safe and effective.

Upper Extremity Deep Venous Thrombosis After Port Insertion: What Are the Risk Factors?

In patients requiring an implanted upper extremity (UE) venous access port, multivariate analysis found several factors such as end-stage renal disease, prior deep venous thrombosis (DVT), nonwhite race, metastatic cancer, gastrointestinal or lung cancer and other factors to be associated with upper extremity deep venous thrombosis. The authors believe further studies are needed to evaluate the appropriateness of thromboprophylaxis in patients at increased risk of developing UE DVT.

Investigation of MRI Contrast Release from Vascular Access Ports after Priming

Radiologists are now the most common physician specialist to implant vascular access ports. Many radiologists may not be fully acquainted with how imaging is affected by implantable devices such as vascular access ports, let alone contrast now being considered for use with them. Outside of the clinic, researchers have been attempting to investigate some of these nuances. Although conventional totally implantable venous access ports are not approved for power contrast injections, in laboratory experiments one group examined temperature as a key parameter for the efficiency of specific port types to rid contrast after injection.

Metastatic spread from squamous cell carcinoma of the hypopharynx to the totally implantable venous access port insertion site: Case report and review of literature

The totally implantable venous access port plays a crucial role in delivering chemotherapy in the outpatient setting. Here, we report the first case of a patient with hypopharyngeal tumor who developed chest wall metastasis over the totally implantable venous access port inserted in the internal jugular vein. Our patient, a 58-year-old man with a hypopharyngeal tumor presented with a lump over the totally implantable venous access port site. The port was removed and the lump was biopsied. The CT studies showed that the tumor had spread along the catheter from the hypopharynx to the chest wall. The pathology from the biopsy showed squamous cell carcinoma (SCC). The patient had poor performance status and opted for hospice care. We present a novel case of metastasis over the totally implantable venous access port implanted in a patient with a hypopharyngeal tumor. We also reviewed relevant literature comparing the data from percutaneous endoscopic gastrostomy (PEG) tube site metastasis with our patient and other similar case reports.

Comparative Analysis of Bacterial Community Composition and Structure in Clinically Symptomatic and Asymptomatic Central Venous Catheters.

Totally implanted venous access ports (TIVAPs) are commonly used catheters for the management of acute or chronic pathologies. Although these devices improve health care, repeated use of this type of device for venous access over long periods of time is also associated with risk of colonization and infection by pathogenic bacteria, often originating from skin. However, although the skin microbiota is composed of both pathogenic and nonpathogenic bacteria, the extent and the consequences of TIVAP colonization by nonpathogenic bacteria have rarely been studied. Here, we used culture-dependent and 16S rRNA gene-based culture-independent approaches to identify differences in bacterial colonization of TIVAPs obtained from two French hospitals. To explore the relationships between nonpathogenic organisms colonizing TIVAPs and the potential risk of infection, we analyzed the bacterial community parameters between TIVAPs suspected (symptomatic) or not (asymptomatic) of infection. Although we did not find a particular species assemblage or community marker to distinguish infection risk on an individual sample level, we identified differences in bacterial community composition, diversity, and structure between clinically symptomatic and asymptomatic TIVAPs that could be explored further. This study therefore provides a new view of bacterial communities and colonization patterns in intravascular TIVAPs and suggests that microbial ecology approaches could improve our understanding of device-associated infections and could be a prognostic tool to monitor the evolution of bacterial communities in implants and their potential susceptibility to infections. IMPORTANCE Totally implanted venous access ports (TIVAPs) are commonly used implants for the management of acute or chronic pathologies. Although their use improves the patient's health care and quality of life, they are associated with a risk of infection and subsequent clinical complications, often leading to implant removal. While all TIVAPs appear to be colonized, only a fraction become infected, and the relationship between nonpathogenic organisms colonizing TIVAPs and the potential risk of infection is unknown. We explored bacteria present on TIVAPs implanted in patients with or without signs of TIVAP infection and identified differences in phylum composition and community structure. Our data suggest that the microbial ecology of intravascular devices could be predictive of TIVAP infection status and that ultimately a microbial ecological signature could be identified as a tool to predict TIVAP infection susceptibility and improve clinical management.

Long-term stability of gentamicin sulfate-ethylenediaminetetraacetic acid disodium salt (EDTA-Na2) solution for catheter locks

A lock solution composed of gentamicin sulfate (5mg/mL) and ethylenediaminetetraacetic acid disodium salt (EDTA-Na2, 30mg/mL) could fully eradicate in vivo bacterial biofilms in totally implantable venous access ports (TIVAP). In this study, fabrication, conditioning and sterilization processes of antimicrobial lock solution (ALS) were detailed and completed by a stability study. Stability of ALS was conducted for 12 months in vial (25°C ± 2°C, 60% ± 5% relative humidity (RH), and at 40°C ± 2°C, RH 75% ± 5%) and for 24h and 72h in TIVAP (40°C ± 2°C, RH 75% ± 5%). A stability indicating HPLC assay with UV detection for simultaneous quantification of gentamicin sulfate and EDTA-Na2 was developed. ALS was assayed by ion-pairing high performance liquid chromatography (HPLC) needing gentamicin derivatization, EDTA-Na2 metallocomplexation of samples and gradient mobile phase. HPLC methods to separate four gentamicin components and EDTA-Na2 were validated. Efficiency of sterility procedure and conditioning of ALS was confirmed by bacterial endotoxins and sterility tests. Physicochemical stability of ALS was determined by visual inspection, osmolality, pH, and sub-visible particle counting. Results confirmed that the stability of ALS in vials was maintained for 12 months and 24h and 72h in TIVAP.

Port Implantation in Patients with Severe Thrombocytopenia is Safe with Interventional Radiology.

Platelet counts <50/nl are often considered a contraindication for surgical and interventional radiology procedures. Yet, there are patients requiring totally implantable venous access ports (TIVAP) in whom normalization of the coagulation state is not feasible. This retrospective study evaluates the safety of interventional radiological TIVAP implantation in patients with severe thrombocytopenia. From 12/2010 to 12/2014, a total 1200 consecutive radiological TIVAP implantations were performed and retrospectively analyzed. Among those 181 patients had platelet counts (PC) below the reference value of 150-350 thrombocytes/nl: 55 patients with mild (PC: 100-150/nl), 58 patients with moderate (PC: 50-100/nl) and 68 patients with severe thrombocytopenia (PC <50/nl). All patients diagnosed with severe thrombocytopenia received platelet concentrates before or during the procedure according to a fixed preparation protocol. All patients were assessed at least 2weeks before and up to 12months after intervention. Outcome parameters were recorded with a particular focus on bleeding complications. Data were statistically analyzed with a p value <0.05 considered statistically significant. The technical success rate for TIVAP implantation was 100%. Patients were followed for a mean of 833 indwelling catheter days in patients with thrombocytopenia (total: 150.923days) and for 936 indwelling catheter days in patients with normal platelet counts (total: 953.760days). No significant differences in complication rates between patients with normal platelet counts and patients with mild to severe thrombocytopenia under platelet substitution were found (p>0.05), especially no bleeding complications occurred during acute, early or late phase. With individualized platelet substitution, patients with severe thrombocytopenia may receive radiological TIVAP implantation without an increased risk of bleeding complications. IV.