Life on the line - Incidence and management of central venous catheter complications in intestinal failure.

BACKGROUND & AIMS: Loss of venous access is threatening for patients with intestinal failure (IF) under long-term parenteral nutrition (PN). We aimed to identify the incidence of central venous catheter (CVC) complications, compare different devices, and analyze interventional recanalizing procedures to restore the patency of occluded CVCs. METHODS: For this retrospective cohort study, patient data from a prospective IF database spanning 16 years was analyzed at a tertiary referral center. Catheter dwell times (CDTs) were distinguished by Kaplan-Meier survival analysis and subgroup analyses were performed for different CVC types (tunneled/port catheters). Specific complications (occlusion, catheter-related infection (CRI), displacement, and material defect) were analyzed. Explantation rates and CDTs were compared. RESULTS: Overall, 193 CVCs in 77 patients with IF under PN could be enrolled (62.524 "CVC-days"). Broviac type "B" was found to be significantly superior to type "A" regarding occlusion, CRI, and material defects (log-rank test: p = 0.05; p = 0.026; p = 0.005 respectively). Port catheters were displaying the highest incidence of CRI (2.13 events/1000 catheter days). Interventional catheter recanalization was performed 91 times and significantly increased the CDT from a median of 131 days (IQR: 62; 258) to 389 days (IQR: 262; 731) (Mann-Whitney-U-test: p= <0.001) without increasing complications. CONCLUSIONS: Different complication rates and CDT were seen depending on CVC type. Tunneled catheters were significantly superior concerning CRI. Interventional catheter recanalization is a viable alternative to fibrinolytics to restore CVC patency, but long-term patency data is scarce.

Repair of central venous access devices in intestinal failure patients is safe and cost-effective: A retrospective single centre cohort study.

INTRODUCTION: Patients with chronic intestinal failure (IF) require home parenteral nutrition (HPN). Central venous access is needed for prolonged use of PN, usually via a long term central venous access device (CVAD). Post insertion there may be mechanical complications with a CVAD such as catheter rupture or tear. Repair of damaged CVADs is possible to avoid risks associated with catheter replacement in patients with IF. However, catheter related blood stream infections (CRBSI) are a concern when CVAD's are accessed or manipulated. AIMS: To investigate the success of repair of CVADs in patients with IF on HPN, related to repair longevity and incidence of CRBSI following repair. METHOD: Nutrition team records of CVAD repairs carried out in patients with IF were reviewed retrospectively for the period April 2015 to March 2019. RESULTS: Nutrition Clinical Nurse Specialists carried out 38 repairs in 27 patients. Male n = 5, female n = 22; mean age 55 years. Catheter longevity before first repair (n = 27): median 851 days, IQR 137-1484 days. 30/38 (78.9%) of repairs were successful lasting ≥30days. Hospital admission was avoided in 76% of cases. 4 patients in the failed repair group underwent catheter re-insertion where 4 had a further, subsequently successful, repair, an overall success rate of 89.4% (34/38). 30-day CRBSI rate was 0.09/1000 catheter days in repaired catheters. In comparing costs, there is a potential cost saving of 2766GBP for repair compared to replacement of damaged CVADs. CONCLUSION: Repair of tunnelled CVADs in patients with IF is successful and safe with no increased risk of CRBSI. Significant cost savings may be made.

Low molecular weight heparin for prevention of central venous catheter-related thrombosis in children.

BACKGROUND: The prevalence of children diagnosed with thrombotic events has been increasing in the last decades. The most common thrombosis risk factor in neonates, infants and children is the placement of a central venous catheter (CVC). It is unknown if anticoagulation prophylaxis with low molecular weight heparin (LMWH) decreases CVC-related thrombosis in children. This is an update of the Cochrane Review published in 2014. OBJECTIVES: To determine the effect of LMWH prophylaxis on the incidence of CVC-related thrombosis and major and minor bleeding complications in children. Further objectives were to determine the effect of LMWH on occlusion of CVCs, number of days of CVC patency, episodes of catheter-related bloodstream infection (CRBSI), other side effects of LMWH (allergic reactions, abnormal coagulation profile, heparin-induced thrombocytopaenia and osteoporosis) and mortality during therapy. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 7 May 2019. We undertook reference checking of identified trials to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-randomised trials comparing LMWH to no prophylaxis (placebo or no treatment), or low-dose unfractionated heparin (UFH) either as continuous infusion or flushes (low-dose UFH aims to ensure the patency of the central line but has no systemic anticoagulation activity), given to prevent CVC-related thrombotic events in children. We selected studies conducted in children aged 0 to 18 years. DATA COLLECTION AND ANALYSIS: Two review authors independently identified eligible studies, which were assessed for study methodology including bias, and extracted unadjusted data where available. In the data analysis step, all outcomes were analysed as binary or dichotomous outcomes. The effects of interventions were summarised with risk ratios (RR) and their respective 95% confidence intervals (CI). We assessed the certainty of evidence for each outcome using the GRADE approach. MAIN RESULTS: One additional study was included for this update bringing the total to two included studies (with 1135 participants). Both studies were open-label RCTs comparing LMWH with low-dose UFH to prevent CVC-related thrombosis in children. We identified no studies comparing LMWH with placebo or no treatment. Meta-analysis found insufficient evidence of an effect of LMWH prophylaxis in reducing the incidence of CVC-related thrombosis in children with CVC, compared to low-dose UFH (RR 0.68, 95% CI 0.27 to 1.75; 2 studies; 787 participants; low-certainty evidence). One study (158 participants) reported symptomatic and asymptomatic CVC-related thrombosis separately and detected no evidence of a difference between LMWH and low-dose UFH (RR 1.03, 95% CI 0.21 to 4.93; low-certainty evidence; RR 1.17, 95% CI 0.45 to 3.08; low-certainty evidence; for symptomatic and asymptomatic participants respectively). There was insufficient evidence to determine whether LMWH impacts the risk of major bleeding (RR 0.27, 95% CI 0.05 to 1.67; 2 studies; 813 participants; low-certainty evidence); or minor bleeding. One study reported minor bleeding in 53.3% of participants in the LMWH arm and in 44.7% of participants in the low-dose UFH arm (RR 1.20, 95% CI 0.91 to 1.58; 1 study; 158 participants; very low-certainty evidence), and the other study reported no minor bleeding in either group (RR: not estimable). Mortality during the study period was reported in one study, where two deaths occurred during the study period. Both were unrelated to thrombotic events and occurred in the low-dose UFH arm. The second study did not report mortality during therapy per arm but showed similar 5-year overall survival (low-certainty evidence). No additional adverse effects were reported. Other pre-specified outcomes (including CVC occlusion, patency and CRBSI) were not reported. AUTHORS' CONCLUSIONS: Pooling data from two RCTs did not provide evidence to support the use of prophylactic LWMH for preventing CVC-related thrombosis in children (low-certainty evidence). Evidence was also insufficient to confirm or exclude a difference in the incidence of major and minor bleeding complications in the LMWH prophylaxis group compared to low-dose UFH (low and very low certainty respectively). No evidence of a clear difference in overall mortality was seen. Studies did not report on the outcomes catheter occlusion, days of catheter patency, episodes of CRBSI and other side effects of LMWH (allergic reactions, abnormal coagulation profile, heparin-induced thrombocytopaenia and osteoporosis). The certainty of the evidence was downgraded due to risk of bias of the included studies, imprecision and inconsistency, preventing conclusions in regards to the efficacy of LMWH prophylaxis to prevent CVC-related thrombosis in children.

Normal saline (0.9% sodium chloride) versus heparin intermittent flushing for the prevention of occlusion in long-term central venous catheters in infants and children.

BACKGROUND: Guidelines and clinical practice for the prevention of complications associated with central venous catheters (CVC) around the world vary greatly. Most institutions recommend the use of heparin to prevent occlusion; there is debate, however, regarding the need for heparin and evidence to suggest normal saline (0.9% sodium chloride) may be as effective. The use of heparin is not without risk, may be unnecessary and is also associated with increased cost. This is an update of the review published in 2015. OBJECTIVES: To assess the clinical effects (benefits and harms) of intermittent flushing of normal saline versus heparin to prevent occlusion in long-term central venous catheters in infants and children. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases; World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 9 April 2019. We also undertook reference checking, citation searching and contact with study authors to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared the efficacy of intermittent flushing with normal saline versus heparin to prevent occlusion of long-term CVCs in infants and children aged up to 18 years of age. We excluded temporary CVCs and peripherally inserted central catheters (PICC). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial inclusion criteria, trial quality and extracted data. We assessed study quality with the Cochrane 'Risk of bias' tool. For dichotomous outcomes, we calculated the rate ratio (RR) and corresponding 95% confidence interval (CI). We pooled data using a random-effects model; and we used GRADE to assess the overall certainty of the evidence supporting the outcomes assessed in this review. MAIN RESULTS: We identified one new study for this update, bringing the total number of included studies to four (255 participants). The four trials directly compared the use of normal saline and heparin; the studies all used different protocols for the intervention and control arms, however, and all used different concentrations of heparin. Different frequencies of flushes were also reported between studies. In addition, not all studies reported on all outcomes. The certainty of the evidence ranged from moderate to very low because there was no blinding; heterogeneity and inconsistency between studies was high; and the CIs were wide. CVC occlusion was assessed in all four trials. We were able to pool the results of two trials for the outcomes of CVC occlusion and CVC-associated blood stream infection. The estimated RR for CVC occlusion per 1000 catheter days between the normal saline and heparin groups was 0.75 (95% CI 0.10 to 5.51; 2 studies, 229 participants; very low certainty evidence). The estimated RR for CVC-associated blood stream infection was 1.48 (95% CI 0.24 to 9.37; 2 studies, 231 participants; low-certainty evidence). The duration of catheter placement was reported to be similar for the two study arms in one study (203 participants; moderate-certainty evidence), and not reported in the remaining studies. AUTHORS' CONCLUSIONS: The review found that there was not enough evidence to determine the effects of intermittent flushing with normal saline versus heparin to prevent occlusion in long-term central venous catheters in infants and children. It remains unclear whether heparin is necessary to prevent occlusion, CVC-associated blood stream infection or effects duration of catheter placement. Lack of agreement between institutions around the world regarding the appropriate care and maintenance of these devices remains.

Factors associated with early peritoneal dialysis catheter malfunction.

BACKGROUND: Peritoneal dialysis (PD) catheter obstruction often leads to surgical revision and may require transition to hemodialysis. The purpose of this study was to evaluate risk factors (including omentectomy) associated with early PD catheter obstruction (<6 months from insertion). METHODS: A retrospective review of all PD catheters inserted at a single high-volume referral center (2005-2018) was performed. 185 PD catheters were placed in 123 patients (45 female). Potential risk factors for early catheter obstruction were analyzed using Chi-square analysis (p < 0.05 considered statistically significant). RESULTS: Median age at catheter insertion was 3.42 years (3 days-39 years). Early catheter obstruction occurred in 42 cases (22.7%). Median time to early obstruction was 24 days (3-118 days). Previous PD catheter placement (p = 0.9) or prior abdominal surgery (p = 0.89) was not associated with obstruction. Weight ≥ 10 kg (p = 0.011) and age ≥ 1 year (p = 0.048) were associated with a significantly higher incidence of obstruction. Overall, omentectomy was associated with a trend in reduction of early obstruction in patients with weight ≥ 10 kg (p = 0.08) and significantly in patients ≥1 year (p = 0.028). CONCLUSION: Early PD catheter obstruction appears to occur more often in older patients with a higher weight. Concomitant omentectomy seems beneficial at reducing early catheter obstruction events in those patients. TYPE OF STUDY: Retrospective comparative study. LEVEL OF EVIDENCE: III.

Is home parenteral nutrition safe for cancer patients? Positive effects and potential catheter-related complications: A systematic review.

PURPOSE: Total Parenteral Nutrition began to be applied frequently in the houses of patients starting from the 1990s and is stated in literature as Home Parenteral Nutrition (HPN). The purpose of this review is to answer the question of whether or not HPN is safe for cancer patients. METHODS: Searches were conducted in Cochrane, CINAHL, PubMed, Springer, Google Scholar, and the Web of Science databases. RESULTS: The 1,949 articles were accessed in the total, and 20 articles have been included in the review. In the studies being evaluated, it can be determined that HPN has influenced the quality of life, performance status, and the nutrition level of cancer patients positively. Most frequently seen complications were infections relating to the catheter, the mechanical obstruction in the catheter and venous thrombosis. For each 1,000 days with HPN or a catheter, infections in the interval of 0.05 and 3.08, mechanical problems in the interval of 0.07 and 2.13, and thrombosis in the interval of 0.05 and 0.20 were determined. CONCLUSIONS: While HPN influenced quality of life, nutrition, and the personal performance of cancer patients positively, the rate of complications is at a level that can be managed at home.

Peripherally Inserted Central Catheters in the ICU: A Retrospective Study of Adult Medical Patients in 52 Hospitals.

OBJECTIVES: To quantify variation in use and complications from peripherally inserted central catheters placed in the ICU versus peripherally inserted central catheters placed on the general ward. DESIGN: Retrospective cohort study. SETTING: Fifty-two hospital Michigan quality collaborative. PATIENTS: Twenty-seven-thousand two-hundred eighty-nine patients with peripherally inserted central catheters placed during hospitalization. MEASUREMENTS AND MAIN RESULTS: Descriptive statistics were used to summarize patient, provider, and device characteristics. Bivariate tests were used to assess differences between peripherally inserted central catheters placed in the ICU versus peripherally inserted central catheters placed on the ward. Multilevel mixed-effects generalized linear models adjusting for patient and device factors with a logit link clustered by hospital were used to examine the association between peripherally inserted central catheter complications and location of peripherally inserted central catheter placement. Variation in ICU peripherally inserted central catheter use, rates of complications, and appropriateness of use across hospitals was also examined. Eight-thousand two-hundred eighty patients (30.3%) received peripherally inserted central catheters in the ICU versus 19,009 (69.7%) on the general ward. The commonest indication for peripherally inserted central catheter use in the ICU was difficult IV access (35.1%) versus antibiotic therapy (53.3%) on wards. Compared with peripherally inserted central catheters placed in wards, peripherally inserted central catheters placed in the ICU were more often multilumen (59.5% vs 39.3; p < 0.001) and more often associated with a complication (odds ratio, 1.30; 95% CI, 1.18-1.43; p < 0.001). Substantial variation in ICU peripherally inserted central catheter use and outcomes across hospitals was observed, with median peripherally inserted central catheter dwell time ranging from 3 to 38.5 days (p < 0.001) and complications from 0% to 40.2% (p < 0.001). Importantly, 87% (n = 45) of ICUs reported median peripherally inserted central catheter dwell times less than or equal to 14 days, a duration where traditional central venous catheters, not peripherally inserted central catheters, are considered appropriate by published criteria. CONCLUSIONS: Peripherally inserted central catheter use in the ICU is highly variable, associated with complications and often not appropriate. Further study of vascular access decision-making in the ICU appears necessary.

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.

Heparin versus 0.9% sodium chloride locking for prevention of occlusion in central venous catheters in adults.

BACKGROUND: Intermittent locking of central venous catheters (CVCs) is undertaken to help maintain their patency. There are systematic variations in care: some practitioners use heparin (at different concentrations), whilst others use 0.9% NaCl (normal saline). This review looks at the effectiveness and safety of intermittent locking with heparin compared to 0.9% NaCl to see if the evidence establishes whether one is better than the other. This work is an update of a review first published in 2014. OBJECTIVES: To assess the effectiveness and safety of intermittent locking of CVCs with heparin versus normal saline (NS) in adults to prevent occlusion. SEARCH METHODS: The Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched 11 June 2018) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 5). Searches were also carried out in MEDLINE, Embase, CINAHL, and clinical trials databases (11 June 2018). SELECTION CRITERIA: We included randomised controlled trials in adults ≥ 18 years of age with a CVC that compared intermittent locking with heparin at any concentration versus NS. We applied no restriction on language. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed quality, and extracted data. We contacted trial authors to retrieve additional information, when necessary. We carried out statistical analysis using Review Manager 5 and assessed the overall quality of the evidence supporting assessed outcomes using GRADE. We carried out prespecified subgroup analysis. MAIN RESULTS: We identified five new studies for this update (six prior studies were included in the original review), bringing the number of eligible studies to 11, with a total of 2392 participants. We noted differences in methods used by the included studies and variation in heparin concentrations (10 to 5000 IU/mL), time to follow-up (1 to 251.8 days), and the unit of analysis used (participant, catheter, line access).Combined results from these studies showed fewer occlusions with heparin than with NS (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.51 to 0.95; P = 0.02; 1672 participants; 1025 catheters from 10 studies; I² = 14%) and provided very low-quality evidence.We carried out subgroup analysis by unit of analysis (testing for subgroup differences (P = 0.23; I² = 30.3%). When the unit of analysis was the participant, results show no clear differences in all occlusions between heparin and NS (RR 0.79, 95% CI 0.58 to 1.08; P = 0.15; 1672 participants; seven studies). Subgroup analysis using the catheter as the unit of analysis shows fewer occlusions with heparin use (RR 0.53, 95% CI 0.29 to 0.95; P = 0.03; 1025 catheters; three studies). When the unit of analysis was line access, results show no clear differences in occlusions between heparin and NS (RR 1.08, 95% CI 0.84 to 1.40; 770 line accesses; one study).We found no clear differences in the duration of catheter patency (mean difference (MD) 0.44 days, 95% CI -0.10 to 0.99; P = 0.11; 1036 participants; 752 catheters; six studies; low-quality evidence).We found no clear evidence of a difference in the following: CVC-related sepsis (RR 0.74, 95% CI 0.03 to 19.54; P = 0.86; 1097 participants; two studies; low-quality evidence); mortality (RR 0.76, 95% CI 0.44 to 1.31; P = 0.33; 1100 participants; three studies; low-quality evidence); haemorrhage at any site (RR 1.32, 95% CI 0.57 to 3.07; P = 0.52; 1245 participants; four studies; moderate-quality evidence); or heparin-induced thrombocytopaenia (RR 0.21, 95% CI 0.01 to 4.27; P = 0.31; 443 participants; three studies; low-quality evidence).The main reasons for downgrading the quality of evidence were unclear allocation concealment, imprecision, and suspicion of publication bias. AUTHORS' CONCLUSIONS: Given the very low quality of the evidence, we are uncertain whether intermittent locking with heparin results in fewer occlusions than intermittent locking with NS. Low-quality evidence suggests that heparin may have little or no effect on catheter patency. Although we found no evidence of differences in safety (sepsis, mortality, or haemorrhage), the combined trials are not powered to detect rare adverse events such as heparin-induced thrombocytopaenia.

Obstruction of peritoneal dialysis catheter is associated with catheter type and independent of omentectomy: A comparative data analysis from a transplant surgical and a pediatric surgical department.

BACKGROUND: Peritoneal dialysis (PD) catheter occlusion is a common complication with up to 36% of catheter obstructions described in the literature. We present a comparison of complications and outcome after implantation of PD catheters in a transplant surgical and a pediatric surgical department. METHODS: We retrospectively analyzed 154 PD catheters, which were implanted during 2009-2015 by transplant surgeons (TS, University Medical Center Hamburg-Eppendorf, Germany, n=85 catheters) and pediatric surgeons (PS, Charité University Medicine Berlin, Germany, n=69 catheters) in 122 children (median (range) age 3.0 (0.01-17.1) years) for acute (n=65) or chronic (n=89) renal failure. All catheters were one-cuffed or double-cuffed curled catheters, except that straight catheters were implanted into smaller children (n=19) by TS in Hamburg. RESULTS: Patient characteristics and operation technique did not differ between the departments. Peritonitis was the most common complication (33 catheters, 21.4%). Leakage (n=18 catheters, 11.7%) occurred more often in children weighing <10kg (p<0.001). The incidence of obstruction and dysfunction was significantly higher in catheters used in PS than catheters used in TS (30.4% vs. 11.8%, p=0.004). Omentectomy did not reduce the incidence of catheter obstruction (p=1.0). Perforation at the catheter tips was larger and appeared to be rougher in catheters used in PS than the catheters in TS. CONCLUSIONS: The type of catheter and presumably the type of perforation at the catheter tip may influence the incidence of peritoneal dialysis catheter obstruction.

Heparinized saline versus normal saline for maintaining peripheral venous catheter patency in China: An open-label, randomized controlled study.

Objective To evaluate the effects of heparin saline versus normal saline as locking solution for maintaining patency in peripheral venous catheters in Chinese patients. Methods This open-label, randomized controlled study was conducted in two hepatobiliary surgery wards, where patients received identical treatments, at a tertiary referral hospital. Patients were randomly divided into a normal saline group (NS, 3 ml) or a heparin saline group (HS, 50 IU/ml, 3 ml) for catheter sealing. Results The study enrolled 286 patients and 609 peripheral venous catheters were included in the analysis. The patients in the two groups had no local infections or catheter-related bloodstream infections. There were no significant differences between the two groups in terms of the rate of catheter obstruction, duration time, or the rates of phlebitis, infiltration, and accidental catheter removal. Conclusions No significant differences in the peripheral venous catheter sealing effects were observed between normal saline and heparin saline usage in Chinese patients.

Complication-related removal of totally implantable venous access port systems: Does the interval between placement and first use and the neutropenia-inducing potential of chemotherapy regimens influence their incidence? A four-year prospective study of 4045 patients.

BACKGROUND: Totally implantable venous access port systems are widely used in oncology, with frequent complications that sometimes necessitate device removal. The aim of this study is to investigate the impact of the time interval between port placement and initiation of chemotherapy and the neutropenia-inducing potential of the chemotherapy administered upon complication-related port removal. PATIENTS AND METHODS: Between January 2010 and December 2013, 4045 consecutive patients were included in this observational, single-center prospective study. The chemotherapy regimens were classified as having a low (<10%), intermediate (10-20%), or high (>20%) risk for inducing neutropenia. RESULTS: The overall removal rate due to complications was 7.2%. Among them, port-related infection (2.5%) and port expulsion (1%) were the most frequent. The interval between port insertion and its first use was shown to be a predictive factor for complication-related removal rates. A cut-off of 6 days was statistically significant (p = 0.008), as the removal rate for complications was 9.4% when this interval was 0-5 days and 5.7% when it was ≥6 days. Another factor associated with port complication rate was the neutropenia-inducing potential of the chemotherapy regimens used, with removal for complications involved in 5.5% of low-risk regimens versus 9.4% for the intermediate- and high-risk regimens (p = 0.003). CONCLUSION: An interval of 6 days between placement and first use of the port reduces the removal rate from complications. The intermediate- and high-risk for neutropenia chemotherapy regimens are related to higher port removal rates from complications than low-risk regimens.

Treprostinil Administered to Treat Pulmonary Arterial Hypertension Using a Fully Implantable Programmable Intravascular Delivery System: Results of the DelIVery for PAH Trial.

BACKGROUND: The use of systemic prostanoids in severe pulmonary arterial hypertension (PAH) is often limited by patient/physician dissatisfaction with the delivery methods. Complications associated with external pump-delivered continuous therapy include IV catheter-related bloodstream infections and subcutaneous infusion site pain. We therefore investigated a fully implantable intravascular delivery system for treprostinil infusion. METHODS: A multicenter, prospective, single-arm, clinical trial (DelIVery for Pulmonary Arterial Hypertension) was conducted by using an implantable intravascular delivery system. The implanted pumps were refilled percutaneously at least every 12 weeks. The primary end point was the rate of catheter-related complications using the new model 10642 catheter compared with a predefined objective performance criterion of 2.5 per 1,000 patient-days based on the literature. RESULTS: Patients (n = 60) with severe PAH (World Health Organization group 1) receiving a stable dose of IV treprostinil for at least 4 weeks received an implant device and were followed up for 12.1 ± 4.4 months. Six catheter-related complications occurred, corresponding to a complication rate of 0.27 per 1,000 patient-days. The 97.5% upper one-sided confidence bound of 0.59 was less than the predefined criterion of 2.5 per 1,000 patient-days (P < .0001). Plasma treprostinil levels at 1 week postimplantation were highly correlated with baseline levels (r = 0.91; P < .0001). The delivery system management time as reported by the patients was 2.5 ± 1.7 hours per week preimplantation, and this time decreased to 0.6 ± 0.8 hour per week at 6 months' postimplantation (P < .0001). All patients rated overall satisfaction with the implantable system as good, very good, or excellent at 6 weeks and 6 months. There were no catheter-related bloodstream infections or catheter occlusions. CONCLUSIONS: The implantable intravascular delivery system delivered treprostinil to patients with PAH with a low rate of catheter-related complications and a high rate of patient satisfaction. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov.

Peripherally inserted central catheters (PICCs) in cancer patients under chemotherapy: A prospective study on the incidence of complications and overall failures.

BACKGROUND AND OBJECTIVES: The increasing use of peripherally inserted central venous catheters (PICCs) for chemotherapy has led to the observation of an elevated risk of complications and failures. This study investigates PICC failures in cancer patients. METHODS: A prospective study was conducted at a single cancer institution on 291 PICC placement for chemotherapy. The primary study outcome was PICC failure. RESULTS: Median follow-up was 119 days. PICC complications occurred in 72 patients (24.7%) and failures with removal in 44 (15.1%). Reasons for failures were upper extremity deep venous thrombosis (UEDVT) 12 (4.1%), central line associate bloodstream infection (CLABSI) 5 (1.7%) with an infection rate of 0.95 per 1,000 catheter days, exit site infection 9 (3.1%) with a rate of 1.46 per 1,000 catheter days, catheter dislodgment 11 (3.8%), and occlusion 7 (2.4%). Statistically significant risk factors were previous DVT (HR 2.95, 95%CI 1.33-6.53), reason for PICC implant (HR 3.65, 95%CI 1.12-10.34) and 5-fluorouracil, oxaliplatin and bevacizumab based chemotherapy (HR 3.11, 95%CI 1.17-8.26). CONCLUSIONS: PICC is a safe venous device for chemotherapy delivery. Nevertheless, a 15% rate of failure has to be taken in account when planning PICC insertion for chemotherapy purposes. J. Surg. Oncol. 2016;113:708-714. © 2016 Wiley Periodicals, Inc.

Effects of a Novel Peritoneal Dialysis: The Open Versus Laparoscopic Preperitoneal Tunneling Technique.

The key to achieving adequate continuous ambulatory peritoneal dialysis (CAPD) is that a functioning catheter should enable unrestricted inflow and outflow of the dialysate liquid from the peritoneal cavity with an intact peritoneal membrane. Despite its advantages, complications, such as outflow obstruction, catheter-related infection, and dialysate leakage are still problematic. Various laparoscopic techniques for catheter placement have been investigated. The main purpose of this study was to compare the laparoscopic and open surgical peritoneal dialysis (PD) catheter insertion techniques in a retrospective manner according to catheter survival, complications and the safety of both techniques. The study included end stage renal disease patients in our hospital in whom a PD catheter was placed between 2007 and 2014. Patients were divided into two groups: the open technique (OT) group and the laparoscopic preperitoneal tunneling approach (LA) group. Extracted data included patient demographics, operative data, catheter-related complications and follow-up data. Sixty-nine patients were enrolled into the study. CAPD catheters were placed into 35 patients via LA and 34 via OT. We found that the LA group patients had better survival rates compared with the OT group, especially the long-term survivals. All of the CAPD-related complications, (peritonitis, malposition, outflow obstruction, leakage) were lower in the LA group. However, the peritonitis, malposition and groin hernia rates were also statistically significantly lower in the LA group. When compared with the published data, we recommend laparoscopic CAPD catheter placement with a preperitoneal tunneling technique. The technique is safe and offers a better outcome.

Experiences of the first PICC team in the Czech Republic.

The first specialist nursing team placing peripherally inserted central catheters (PICCs) in the Czech Republic was established in September 2012. During 2013 the team placed 167 PICCs and 162 midline catheters. In another 6 patients the insertion was not successful. PICCs were inserted mainly for oncology patients; while midline catheters were inserted for patients admitted to general wards. Average duration of catheter insertion was 91 days (range 7-285 days) for PICCs and 14 days (range 2-40 days) for midline catheters. During follow up of PICCs, catheter infection rate was 0.3/1000 days, vein thrombosis rate 0.4/1000 days, catheter occlusion 0.4/1000 days, and catheter displacement 0.33/1000 days. For midline catheters infection rate was 1.4/1000 days, vein thrombosis 5.2/1000 days, catheter occlusion 2.6/1000 days, and catheter displacement 2.2/1000 days. The authors hope that these results will motivate other hospitals in the Czech republic to establish PICC teams, as in other European countries.

A comparative study of peripherally-inserted and Broviac catheter complications in home parenteral nutrition patients.

BACKGROUND & AIMS: Peripherally inserted central venous catheters (PICC) have become increasingly popular for medium to long-term parenteral nutrition (PN) but there is limited data on the complication rates in this sub-group. We aimed to compare the rates of complications associated with tunneled catheters (Broviac) and PICC in home PN (HPN) patients. METHODS: All adult patients in an HPN program with a new Broviac or new PICC between 2009 and 2011 were included in this prospective observational study. Complication rates were compared by using Poisson regression and Kaplan Meier survival curves were used to compare the first complications that occurred. RESULTS: 204 catheters (133 Broviac and 71 PICC) were inserted in 196 adult patients. Mean follow-up from catheter insertions to their removal was 276 ± 219 days for Broviac (n = 86) vs. 74 ± 140.70 days for PICC (n = 56); p < 0.001. Complications were similar between Broviac and PICC (91/133 vs. 26/71). Catheter infection rate was lower in PICC (1.87 vs. 1.05 per 1000 catheter-days; p = 0.01). Catheter obstruction rates were similar for both catheters. Only PICC experienced venous thrombosis (0.4/1000). The proportion of catheters removed was lower in the Broviac group than in the PICC group (62.4% vs. 78.8%; p = 0.01) but those removed for complications were not different (28.6.7%vs. 25.3%; p = 0.64). CONCLUSIONS: In HPN patients, overall complications were similar in both the PICC and the Broviac groups. However, the Broviac catheter could be associated with an increase in catheter infection.

Peritoneal catheter fixation to the abdominal wall in surgical catheter implantation to prevent malfunction.

BACKGROUND: Catheter failure, especially catheter displacement and obstruction remain the major barriers for peritoneal dialysis. We have developed a new surgery technique of catheter fixation on the lower abdominal wall in the catheter planting to avert the catheter mechanical complications. METHOD: A retrospective study was performed on 93 patients; among them, 52 patients underwent the traditional method of surgery for catheter insertion and 41 patients received additional catheter fixation. Comparisons of complications including infection, leak, infusion pains, catheter displacement, and obstruction occurred during a follow-up period of 6 months, were made between the fixed and non-fixed groups. RESULTS: Catheter fixation cost more time than the conventional operating procedure (94.2 ± 14.6 min vs. 83 ± 13.3 min, p = 0.043). Complications of infection, leak, and infusion pain that occurred in the fixed and unfixed groups are comparable. Catheter fixation reduced the complications of catheter displacement or obstruction to 0 episode in the fixed group, whereas those complications were encountered by 7 patients in the unfixed group (0/41 vs. 7/52, p = 0.022). All these 7 patients received re-exploration and catheter replacement with further catheter fixation. In the following time until now (ranging from 3 to 16 months), no catheter dysfunction was observed. CONCLUSIONS: These results suggest that catheter fixation is effective in preventing catheter displacement and obstruction in peritoneal dialysis.

Heparin versus 0.9% sodium chloride intermittent flushing for prevention of occlusion in central venous catheters in adults.

BACKGROUND: Heparin intermittent flushing is a standard practice in the maintenance of patency in central venous catheters. However, we could find no systematic review examining its effectiveness and safety. OBJECTIVES: To assess the effectiveness of intermittent flushing with heparin versus 0.9% sodium chloride (normal saline) solution in adults with central venous catheters in terms of prevention of occlusion and overall benefits versus harms. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched December 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 11). Searches were also carried out in MEDLINE, EMBASE, CINAHL and clinical trials databases (December 2013). SELECTION CRITERIA: Randomised controlled trials (RCTs) in adults 18 years of age and older with a central venous catheter (CVC) in which intermittent flushing with heparin (any dose with or without other drugs) was compared with 0.9% normal saline were included. No restriction on language was applied. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed trial quality and extracted data. Trial authors were contacted to retrieve additional information, when necessary. MAIN RESULTS: Six eligible studies with a total of 1433 participants were included. The heparin concentrations used in these studies were very different (10-5000 IU/mL), and follow-up varied from 20 days to 180 days. The overall risk of bias in the studies was low. The quality of the evidence ranged from very low to moderate for the main outcomes (occlusion of CVC, duration of catheter patency, CVC-related sepsis, mortality and haemorrhage at any site).Combined findings from three trials in which the unit of analysis was the catheter suggest that heparin was associated with reduced CVC occlusion rates (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.29 to 0.94). However, no clear evidence of a similar effect was found when the results of two studies in which the unit of analysis was the participant were combined (RR 0.21, 95% CI 0.03 to 1.70), nor when findings were derived from one study, which considered total line accesses (RR 1.08, 95% CI 0.84 to 1.40). Furthermore, results for other estimated effects were found to be imprecise and compatible with benefit and harm: catheter duration in days (mean difference (MD) 0.41, 95% CI -1.29 to 2.12), CVC-related thrombosis (RR 1.22, 95% CI 0.74 to 1.99), CVC-related sepsis (RR 1.02, 95% CI 0.34 to 3.03), mortality (RR 0.77, 95% CI 0.45 to 1.32) and haemorrhage at any site (RR 1.37, 95% CI 0.49 to 3.85). AUTHORS' CONCLUSIONS: We found no conclusive evidence of important differences when heparin intermittent flushing was compared with 0.9% normal saline flushing for central venous catheter maintenance in terms of efficacy or safety. As heparin is more expensive than normal saline, our findings challenge its continued use in CVC flushing outside the context of clinical trials.