The validity of validation: A practical assessment.

OBJECTIVE: To assess the time to achieve reliable reporting of electronic health record data compared with manual reporting during validation. DESIGN: Secondary analysis of aggregate data for number of patients present, number of patients with a central venous catheter, and number of patients with an indwelling urinary catheter during validation of an electronic health record reporting tool. SETTING: Mayo Clinic Health System in Wisconsin. PARTICIPANTS: Mayo Clinic infection prevention and control staff, unit champions, and all inpatients. METHODS: We simultaneously collected electronic and manual counts of device data and compared discrepancies to determine their source. If manual data entry was incorrect, manual counts were coded as inaccurate. If electronically abstracted data did not reflect an accurate count, errors were attributed to the system. Data were compared using standard statistical methods. RESULTS: Within 30 days after beginning validation of electronic reporting for central venous catheter days and urinary catheter days, electronic counts were durably more reliable than manual counts. CONCLUSIONS: Manual validation for capturing and reporting electronic data and reporting can be shorter than the 90 days currently mandated by National Healthcare Safety Network criteria. Compared with a longer validation period, a shorter validation period may yield substantial savings while achieving the same validity.

Racial and Sex Disparities in Catheter Use and Dialysis Access in the United States Medicare Population.

BACKGROUND: Despite efforts to increase arteriovenous fistula and graft use, 80% of patients in the United States start hemodialysis on a central venous catheter (CVC). METHODS: To better understand in incident hemodialysis patients how sex and race/ethnicity are associated with time on a central venous catheter and transition to an arteriovenous fistula and graft, our observational cohort study analyzed US Renal Data System data for patients with incident ESKD aged ≥66 years who started hemodialysis on a CVC in July 2010 through 2013. RESULTS: At 1 year, 32.7% of 74,194 patients transitioned to an arteriovenous fistula, 10.8% transitioned to an arteriovenous graft, 32.1% stayed on a CVC, and 24.5% died. Women spent a significantly longer time on a CVC than men. Compared with white patients, patients who were black, Hispanic, or of another racial/ethnicity minority spent significantly more days on a CVC. In competing risk regression, women were significantly less likely than men to transition to a fistula and more likely to transition to a graft. Compared with white patients, blacks were significantly less likely to transition to a fistula but more likely to transition to a graft, Hispanics were significantly more likely to transition to a fistula, and other races/ethnicities were significantly more likely to transition to either a fistula or a graft. CONCLUSIONS: Female patients spend a longer time on a CVC and are less likely to transition to permanent access. Compared with white patients, minorities also spend longer time on a CVC, but are more likely to eventually transition to permanent access. Strategies to speed transition to permanent access should target groups that currently lag in this area.

Cost analysis comparison between peripherally inserted central catheters and implanted chest ports in patients with cancer-A health economic evaluation of the PICCPORT trial.

BACKGROUND: A reliable central venous access device is a cornerstone in the treatment of cancer. Both peripherally inserted central catheters (PICC) and totally implanted chest ports (PORT) are commonly used for the delivery of chemotherapy. Both types of catheter can cause adverse events such as catheter-related deep venous thrombosis (CR-DVT), infection and mechanical complications. METHOD: We conducted a randomized controlled trial including 399 patients with cancer and performed a health economic evaluation investigating the cost related to PICCs and PORTs using several clinically relevant dimensions from a healthcare perspective. The cost was determined using process and cost estimate models. RESULT: PICCs are associated with a higher total cost when compared with PORTs. Combining the costs of all categories, the prize per inserted device was 824.58 EUR for PICC and 662.34 EUR for PORT. When adjusting for total catheter dwell time the price was 6.58 EUR/day for PICC and 3.01 EUR/day for PORT. The difference in CR-DVT was the main contributor to the difference in cost. The daily cost of PICC is approximately twice to that of PORT. CONCLUSION: We have demonstrated that the cost from a healthcare perspective is higher in cancer patients receiving a PICC than to those with a PORT. The difference is driven mainly by the cost related to the management of adverse events. Our findings are relevant to anaesthetists, oncologists and vascular access clinicians and should be considered when choosing vascular access device prior to chemotherapy.

Pediatric Noncerebral Thromboembolism: Etiological Assessment and Outcome.

OBJECTIVE: To report clinical presentation and etiologic investigation findings during pediatric noncerebral thromboembolism. METHODS: Retrospective study of cases of vascular non cerebral thromboses admitted in Medicine infantile A Department of the Children's Hospital of Tunis over 08 years. RESULTS: We confirmed 14 cases of non cerebral vascular thromboses. So that these accidents constitute 0,26 ‰ of the overall etiologies of hospitalizations in the Department. The mean age of our patients was 56±41 months [25 days-12 1/2 years]. The sex ratio was 1.8. The vascular incident was venous in 2/3 of cases. The clinical presentation was mainly painful swelling in four cases, abrupt dyspnea and hematemesis in three cases each and the incident was locally asymptomatic in four cases. Thromboses locations included deep vein thrombosis of limbs (n=6), vena cava thrombosis (n=1), portal thrombosis (n=4) and pulmonary embolism (n=3). The promoting factors identified were: tumors in seven cases, thrombophilias and catheterization in four cases each, trauma, surgery and Behçet disease in one case each. Eleven patients received anticoagulant treatment including unfractioned heparin in three cases and low molecular weight heparin in the other cases. No one died while four patients developed sequelae. CONCLUSION: Vascular thromboses are rare in children. They are mostly venous and diagnosed in ill children especially those having central venous catheters. Outcome of pediatric thromboembolism depends on efficient anticoagulation therapy which is well tolerated by children.

Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial.

BACKGROUND: Bloodstream infection is associated with high mortality and serious morbidity in preterm babies. Evidence from clinical trials shows that antimicrobial-impregnated central venous catheters (CVCs) reduce catheter-related bloodstream infection in adults and children receiving intensive care, but there is a paucity of similar evidence for babies receiving neonatal intensive care. METHODS: This open-label, parallel-group, pragmatic, randomised controlled trial was done in 18 neonatal intensive care units in England. Newborn babies who needed a peripherally inserted CVC (PICC) were allocated randomly (1:1) to receive either a PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC. Random allocation was done with a web-based program, which was centrally controlled to ensure allocation concealment. Randomisation sequences were computer-generated in random blocks of two and four, and stratified by site. Masking of clinicians to PICC allocation was impractical because rifampicin caused brown staining of the antimicrobial-impregnated PICC. However, participant inclusion in analyses and occurrence of outcome events were determined following an analysis plan that was specified before individuals saw the unblinded data. The primary outcome was the time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection between 24 h after randomisation and 48 h after PICC removal or death. We analysed outcome data according to the intention-to-treat principle. We excluded babies for whom a PICC was not inserted from safety analyses, as these analyses were done with groups defined by the PICC used. This trial is registered with ISRCTN, number 81931394. FINDINGS: Between Aug 12, 2015, and Jan 11, 2017, we randomly assigned 861 babies (754 [88%] born before 32 weeks of gestation) to receive an antimicrobial-impregnated PICC (430 babies) or standard PICC (431 babies). The median time to PICC removal was 8·20 days (IQR 4·77-12·13) in the antimicrobial-impregnated PICC group versus 7·86 days (5·00-12·53) days in the standard PICC group (hazard ratio [HR] 1·03, 95% CI 0·89-1·18, p=0·73), with 46 (11%) of 430 babies versus 44 (10%) of 431 babies having a microbiologically confirmed bloodstream or CSF infection. The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1·11, 95% CI 0·73-1·67, p=0·63). Secondary outcomes relating to infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal were similar between the two groups, although rifampicin resistance in positive cultures of PICC tips was higher in the antimicrobial-impregnated PICC group (relative risk 3·51, 95% CI 1·16-10·57, p=0·018). 60 adverse events were reported from 49 (13%) patients in the antimicrobial-impregnated PICC group and 50 events from 45 (10%) babies in the standard PICC group. INTERPRETATION: We found no evidence of benefit or harm associated with miconazole and rifampicin-impregnated PICCs compared with standard PICCs for newborn babies. Future research should focus on other types of antimicrobial impregnation of PICCs and alternative approaches for preventing infection. FUNDING: UK National Institute for Health Research Health Technology Assessment programme.

[Cost analysis of haemodialysis catheter related bloodstream infection through the DRG system, "on behalf of Project Group of Vascular Access of Italian Society of Nephrology"].

Catheter related bloodstream infections (CRBSI) represent a complication that often requires hospitalization and the use of economic resources. In Italy, there is no literature that considers the costs of CRBSI for tunneled catheters (CVCt). The aim of this work is to evaluate the relative costs of CRBSI through the DRG system. From 2012 to 2017 we examined 2.257 hospital discharge forms, 358 of which relating to haemodialysis patients. Patients with CVCt (167), compared to FAVs (157), on average stay in hospital longer (10 vs. 8 days), entail higher costs (+8.5%) and higher admissions rate for infections (+114%). The incidence of CRBSI was 0.67 episodes per 1000 CVCt/days. CRBSI accounts for 23% of the cases of hospitalization of patients with CVCt and 5.2% of total hospitalization costs. Complicated CRBSI involve a 9% increase in average costs compared to simple ones, with patients staying in hospital three times longer. The cost of a CRBSI varies from €4,080 up to €14,800, with an average cost of €5,575. The costs calculated here are less than a third of that reported in American literature but this can be explained by the different reimbursement rates systems. The methodology of CRBSI costs through DRGs appears simple, and its main limit is the correct compilation of the discharge form. This is a reminder that discharge forms are an integral part of the medical record and can become important in recognizing the cost of the medical services provided.

Study on the cost attributable to central venous catheter-related bloodstream infection and its influencing factors in a tertiary hospital in China.

BACKGROUND: Central venous catheters (CVC) have been widely used for patients with severe conditions. However, they increase the risk of catheter-related bloodstream infection (CRBSI), which is associated with high economic burden. Until now, no study has focused on the cost attributable to CRBSI in China, and data on its economic burden are unavailable. The aim of this study was to assess the cost attributable to CRBSI and its influencing factors. METHODS: A retrospective matched case-control study and multivariate analysis were conducted in a tertiary hospital, with 94 patients (age ≥ 18 years old) from January 2011 to November 2015. Patients with CRBSI were matched to those without CRBSI by age, principal diagnosis, and history of surgery. The difference in cost between the case group and control group during the hospitalization was calculated as the cost attributable to CRBSI, which included the total cost and five specific cost categories: drug, diagnostic imaging, laboratory testing, health care technical services, and medical material. The relation between the total cost attributable to CRBSI and its influencing factors such as demographic characteristics, diagnosis and treatment, and pathogenic microorganism, was analysed with a general linear model (GLM). RESULTS: The total cost attributable to CRBSI was $3528.6, and the costs of specific categories including drugs, diagnostic imaging, laboratory testing, health care technical services, and medical material, were $2556.4, $112.1, $321.7, $268.7, $276.5, respectively. GLM analysis indicated that the total cost was associated with the intensive care unit (ICU), pathogenic microorganism, age, and catheter number, according to the sequence of standardized estimate (ß). ICU contributed the most to the model R-square. CONCLUSION: Central venous catheter-related bloodstream infection represents a great economic burden for patients. More attentions should be paid to further prevent and control this infection in China.

Utilization, patency, and complications associated with vascular access for hemodialysis in the United States.

BACKGROUND: This study examines the utilization and outcomes of vascular access for long-term hemodialysis in the United States and describes the impact of temporizing catheter use on outcomes. We aimed to evaluate the prevalence, patency, and associated patient survival for pre-emptively placed autogenous fistulas and prosthetic grafts; for autogenous fistulas and prosthetic grafts placed after a temporizing catheter; and for hemodialysis catheters that remained in use. METHODS: We performed a retrospective study of all patients who initiated hemodialysis in the United States during a 5-year period (2007-2011). The United States Renal Data System-Medicare matched national database was used to compare outcomes after pre-emptive autogenous fistulas, preemptive prosthetic grafts, autogenous fistula after temporizing catheter, prosthetic graft after temporizing catheter, and persistent catheter use. Outcomes were primary patency, primary assisted patency, secondary patency, maturation, catheter-free dialysis, severe access infection, and mortality. RESULTS: There were 73,884 (16%) patients who initiated hemodialysis with autogenous fistula, 16,533 (3%) who initiated hemodialysis with prosthetic grafts, 106,797 (22%) who temporized with hemodialysis catheter prior to autogenous fistula use, 32,890 (7%) who temporized with catheter prior to prosthetic graft use, and 246,822 (52%) patients who remained on the catheter. Maturation rate and median time to maturation were 79% vs 84% and 47 days vs 29 days for pre-emptively placed autogenous fistulas vs prosthetic grafts. Primary patency (adjusted hazard ratio [aHR], 1.26; 95% confidence interval [CI], 1.25-1.28; P < .001) and primary assisted patency (aHR, 1.36; 95% CI, 1.35-1.38; P < .001) were significantly higher for autogenous fistula compared with prosthetic grafts. Secondary patency was higher for autogenous fistulas beyond 2 months (aHR, 1.36; 95% CI, 1.32-1.40; P < .001). Severe infection (aHR, 9.6; 95% CI, 8.86-10.36; P < .001) and mortality (aHR, 1.29; 95% CI, 1.27-1.31; P < .001) were higher for prosthetic grafts compared with autogenous fistulas. Temporizing with a catheter was associated with a 51% increase in mortality (aHR, 1.51; 95% CI, 1.48-1.53; P < .001), 69% decrease in primary patency (aHR, 0.31; 95% CI, 0.31-0.32; P < .001), and 130% increase in severe infection (aHR, 2.3; 95% CI, 2.2-2.5; P < .001) compared to initiation with autogenous fistulas or prosthetic grafts. Mortality was 2.2 times higher for patients who remained on catheters compared to those who initiated hemodialysis with autogenous fistulas (aHR, 2.25; 95% CI, 2.21-2.28; P < .001). CONCLUSIONS: Temporizing catheter use was associated with higher mortality, higher infection, and lower patency, thus undermining the highly prevalent approach of electively using catheters as a bridge to permanent access. Autogenous fistulas are associated with longer time to catheter-free dialysis but better patency, lower infection risk, and lower mortality compared with prosthetic grafts in the general population.

Does the presence of an arteriovenous fistula alter changes in body water following hemodialysis as determined by multifrequency bioelectrical impedance assessment?

Multifrequency bioelectrical impedance assessments (MFBIAs) aid clinical assessment of hydration status for hemodialysis (HD) patients. Many MFBIA devices are restricted to whole body measurements and as many patients dialyze using arteriovenous fistulas (AVFs), we wished to determine whether AVFs affected body water measurements. We reviewed pre- and post-HD segmental MFBIA measurements in 229 patients attending for midweek HD sessions. Up to 144 were dialyzed with a left arm AVF (L-AVF), 42 with a right arm AVF (R-AVF), and 43 by central venous access catheter (CVC). Water content and lean tissue were greater in the left compared to right arm in those patients with L-AVFs both pre and post dialysis (pre 2.1 ± 0.7 vs. 2.0 ± 0.7 L, and post 1.9 ± 0.6 vs. 1.8 ± 0.6 L and pre 2.65 ± 0.9 vs. 2.56 ± 0.8 kg, and post 2.34 ± 0.8 vs. 2.48 ± 0.8 vs. 2.34 ± 0.8 kg, respectively) and were also greater in the right compared to left arm for those patients dialyzing with R-AVFs (pre-HD 1.92 ± 0.5 vs. 1.86 ± 0.6 L and post-HD 1.79 ± 0.5 vs. 1.7 ± 0.5 L, and pre-HD 2.47 ± 0.6 vs. 2.38 ± 0.7 kg and post-HD 2.3 ± 0.74 vs. 1.28 ± 0.7 kg, respectively), all Ps < 0.05. There were no significant differences in arm volumes or composition pre or post dialysis in those dialyzing with CVCs. Segmental MFBIA detects differences in arm water and lean mass in patients with AVFs. The presence on an AVF increases the water content in the ipsilateral arm both pre and post HD. This increased water content of the fistula arm will not be detected by whole body bioimpedance devices.

Barriers to adopting a fistula-first policy in Europe: an international survey among national experts.

PURPOSE: The purpose of this study is to explore how vascular access care was reimbursed, promoted, and organised at the national level in European and neighbouring countries. METHODS: An electronic survey among national experts to collect country-level data. RESULTS: Forty-seven experts (response rate, 76%) from 37 countries participated. Experts from 23 countries reported that 50% or less of patients received routine preoperative imaging of vessels. Nephrologists placed catheters and created fistulas in 26 and 8 countries, respectively. Twenty-one countries had a fee per created access; the reported fee for catheter placement was never higher than for fistula creation. As the number of haemodialysis patients in a centre increased, more countries had a dedicated coordinator or multidisciplinary team responsible for vascular access maintenance at the centre-level; in 11 countries, responsibility was always with individual nephrologists, independent of a centre's size. In 23 countries, dialysis centres shared vascular access care resources, with facilitation from a service provider in 4. In most countries, national campaigns (n = 35) or educational programmes (n = 29) had addressed vascular access-related topics; 19 countries had some form of training for creating fistulas. Forty experts considered the current evidence base robust enough to justify a fistula-first policy, but only 13 believed that more than 80% of nephrologists in their country would attempt a fistula in a 75-year-old woman with comorbidities. CONCLUSIONS: Suboptimal access to surgical resources, lack of dedicated training of clinicians, limited routine use of preoperative diagnostic imaging and patient characteristics primarily emerged as potential barriers to adopting a fistula-first policy in Europe.

Timing of arteriovenous fistula creation in patients With CKD: a decision analysis.

BACKGROUND: The optimal time for arteriovenous fistula (AVF) referral is uncertain. Improving the timeliness of referral may reduce central venous catheter (CVC) use. STUDY DESIGN: Monte Carlo simulation model. SETTING & POPULATION: Patients with chronic kidney disease (CKD) followed up in a multidisciplinary clinic, overall and stratified by age. MODEL, PERSPECTIVE, & TIMEFRAME: Decision analysis, patient, patient's lifetime. INTERVENTION: AVF referral, using 1 of 2 strategies: refer when hemodialysis is anticipated to begin within a certain time frame or refer when estimated glomerular filtration rate (eGFR) drops below a certain threshold. OUTCOMES: A range of values for each strategy are compared to each other with respect to incident vascular access type (AVF or CVC), percentage of patients with an unnecessary AVF creation, and life expectancy after dialysis therapy initiation. RESULTS: A 15-month referral time frame gave 34% with incident CVCs, 14% with unnecessary AVFs, and a life expectancy of 1,751 days. Time frames of 12-18 months performed similarly. Referral at eGFR of 20 mL/min/1.73 m(2) gave 38% with incident CVCs, 20% with unnecessary AVFs, and life expectancy of 1,742 days. Using an eGFR threshold of 15 mL/min/1.73 m(2), 10% had an unnecessary AVF. Policy performance was affected by CKD progression rate and age. For fast progressors (ΔeGFR = -7mL/min/1.73 m(2) per year), referral at eGFR of 25 mL/min/1.73 m(2) achieved a similar incident CVC percentage (~40%) as referral at 15 mL/min/1.73 m(2) in slower progressors (ΔeGFR = -2.78 mL/min/1.73 m(2) per year). For patients aged 70-80 and 80-90 years, time frames of 15-18 months yielded 16%-22% with unnecessary AVFs (vs 9%-11% in 50- to 60-year-olds); an eGFR threshold strategy of 20 mL/min/1.73 m(2) yielded 24% unnecessary AVFs in 80- to 90-year-olds versus 16% in 50- to 60-year-olds. LIMITATIONS: Our model does not consider patients with nonlinear CKD progression or acute kidney injury. We did not include arteriovenous grafts or consider cost or quality of life. CONCLUSIONS: In general, AVF referral within about 12 months of the estimated time to dialysis performed best among time frame strategies, and referral at eGFR < 15-20 mL/min/1.73 m(2) performed best among threshold strategies. The timing of referral should also be guided by the individual rate of CKD progression. Elderly patients with CKD could be referred later to reduce the risk of creating an AVF that is never used.

Central venous access: evolving roles of radiology and other specialties nationally over two decades.

PURPOSE: The aim of this study was to evaluate national trends in central venous access (CVA) procedures over 2 decades with regard to changing specialty group roles and places of service. METHODS: Aggregated claims data for temporary central venous catheter and long-term CVA device (CVAD) procedures were extracted from Medicare Physician/Supplier Procedure Summary Master Files from 1992 through 2011. Central venous catheter and CVAD procedure volumes by specialty group and place of service were studied. RESULTS: Between 1992 and 2011, temporary and long-term CVA placement procedures increased from 638,703 to 808,071 (+27%) and from 76,444 to 316,042 (+313%), respectively. For temporary central venous catheters, radiology (from 0.4% in 1992 to 32.6% in 2011) now exceeds anesthesiology (from 37% to 22%) and surgery (from 30.4% to 11.7%) as the dominant provider group. Surgery continues to dominate in placement and explantation of long-term CVADs (from 80.7% to 50.4% and from 81.6% to 47.7%, respectively), but radiology's share has grown enormously (from 0.7% to 37.6% and from 0.2% to 28.6%). Although volumes remain small (<10% of all procedures), midlevel practitioners have experienced >100-fold growth for most services. The inpatient hospital remains the dominant site for temporary CVA procedures (90.0% in 1992 and 81.2% in 2011), but the placement of long-term CVADs has shifted from the inpatient (from 68.9% to 45.2%) to hospital outpatient (from 26.9% to 44.3%) setting. In all hospital settings combined, radiologists place approximately half of all tunneled catheters and three-quarters all peripherally inserted central catheters. CONCLUSIONS: Over the past 2 decades, CVA procedures on Medicare beneficiaries have increased considerably. Radiology is now the dominant overall provider.

Cerebral herniation associated with central venous catheter insertion: risk assessment.

PURPOSE: Central venous catheters (CVCs) are often necessary to treat acute brain-injured patients. Four cases of cerebral herniation immediately following central venous catheterization were the impetus for an investigation of clinical and radiologic parameters associated with this complication. MATERIALS AND METHODS: This is a case series of 4 consecutive patients who experienced clinical cerebral herniation immediately following CVC placement in Trendelenburg or supine position. Clinical and computed tomography imaging findings were reviewed. RESULTS: All 4 patients developed new-onset clinical signs of cerebral herniation (unilateral or fixed dilated pupil and Glasgow Coma Scale [GCS], 3) within 30 minutes of the procedure. All had radiographic signs of Sylvian fissure and/or basal cistern effacement on the preceding computed tomographic scan secondary to unilateral or bilateral mass lesions. Preprocedure GCS was 8 or more in all cases. Herniation was medically reversed in 3 of 4 patients, and 1 patient died of progressive brainstem ischemia. CONCLUSIONS: Trendelenburg and even flat position during CVC placement can increase intracranial pressure leading to cerebral herniation in patients with significant intracranial mass effect. Careful review of neuroimaging for signs of impending herniation before inserting CVCs and choosing an alternative treatment plan in these cases may avoid this potentially underreported complication.