Systematic review: malfunction of totally implantable venous access devices in cancer patients.

PURPOSE: Malfunction of totally implantable venous access devices is a common complication. The purpose was to identify definitions used to describe malfunction and to investigate the incidence of malfunction in different types of port and catheter designs. METHODS: Relevant studies were identified in PubMed that were published between January 1993 and February 2011. Empirical studies reporting functional outcomes in adults and where, at least 95% of the studied population consisted of onco-hematology patients with a newly inserted chest or arm port, were selected. The following data were extracted: patient and totally implantable venous access devices (TIVAD) characteristics, study design, definitions of malfunction, and functional outcomes. Two independent reviewers assessed the methodological quality of the series. RESULTS: Of the 4,886 potentially relevant articles, 57 were selected, involving 14,311 TIVADs. Twenty-nine percent of the studies explicitly defined malfunction. Malfunction incidence rates were expressed in six different ways, including the proportion of affected devices per inserted devices (incidence 0-47%); the number of affected devices per 1,000 catheter days (incidence 0-2.24 per 1,000 catheter days); and the number of malfunctions over the total number of accessing attempts (incidence 0-26%). CONCLUSIONS: Heterogeneity in the definitions used to describe device malfunction was evident. A broad range in the reported incidence of malfunction and in the kind of calculation and reporting methods was also found. Methodological quality of the studies was often poor. Standardization of definitions and accurate outcome measurement is needed. Calculation and report of malfunction incidence should be based on prospective data collected at the moment of an accession attempt.

A pilot trial of microplasmin in patients with long-term venous access catheter thrombosis.

BACKGROUND: Microplasmin, a truncated form of plasmin, degrades fibrin and reacts with the circulating inhibitor alpha(2)-antiplasmin. We investigated the safety and efficacy of intra-catheter microplasmin bolus administration for the restoration of catheter function in long-term venous access catheter thrombosis. METHODS: This open-label, ascending-dose, pilot study enrolled 31 subjects. Two doses of microplasmin were evaluated, (5 mg and 8 mg) administered via a 2 ml intra-catheter bolus injection in 10 and 21 patients respectively. Catheter function was evaluated 30 min after the first bolus administration. In case of incomplete catheter function restoration, a second bolus was administered with reassessment of catheter function 30 min thereafter. RESULTS: After the first bolus, complete restoration of catheter withdrawal function was observed in 5 out of 10 (50%) and 14 of out 21 (66%) subjects treated with 5 mg and 8 mg respectively and in 8 out of 10 (80%) and 18 out of 21 (86%) subjects after a second administration of microplasmin. No bleeding complications nor other adverse events were related to microplasmin. CONCLUSIONS: In this pilot trial, microplasmin restored catheter function in a safe and effective way.

SecurAstaP trial: securement with SecurAcath versus StatLock for peripherally inserted central catheters, a randomised open trial.

OBJECTIVES: To assess the effect on needed nursing time for dressing change. DESIGN, SETTING, PARTICIPANTS: A parallel-group, open-label, randomised controlled trial in patients who are in need for a peripherally inserted central catheter insertion in one teaching hospital in Belgium. The follow-up lasted 180 days or until catheter removal, whatever came first. A computer generated table was used to allocate devices. Randomised patients were 105 adults (StatLock, n=53; SecurAcath, n=52) and primary analysis was based on all patients (n=92) with time measurements (StatLock, n=43; SecurAcath, n=49). INTERVENTIONS: StatLock which has to be changed weekly versus SecurAcath which could remain in place for the complete catheter dwell time. MAIN OUTCOME MEASURE: Needed time for the dressing change at each dressing change (SecurAcath) or at each dressing change combined with the change of the securement device (StatLock). RESULTS: Median time needed for dressing change was 7.3 min (95% CI 6.4 min to 8.3 min) in the StatLock group and in the SecurAcath group 4.3 min (95% CI 3.8 min to 4.9 min) (P<0.0001). The time in the SecurAcath group was reduced with 41% (95% CI 29% to 51%). Incidence rates of migration, dislodgement and catheter-related bloodstream infection were comparable across groups. Pain scores were higher with SecurAcath than with StatLock at insertion (P=0.02) and at removal (P<0.001) and comparable during dressing change (P=0.38) and during dwell time (P=0.995). User-friendliness was scored at insertion and removal. All statements regarding the user-friendliness were scored significantly higher for StatLock than for SecurAcath (P<0.05). Only for the statement regarding the recommending routine use of the device, which was asked at removal, no difference was found between the two devices (P=0.32). CONCLUSION: Use of SecurAcath saves time during dressing change compared with StatLock. Training on correct placement and removal of SecurAcath is critical to minimise pain. TRIAL REGISTRATION NUMBER: NCT02311127; Pre-results.

Prospective clinical evaluation of the Polyperf® Safe, a safety Huber needle, in cancer patients.

PURPOSE: Evaluation of the Polyperf® Safe (PPS) needle on safety and user-friendliness, as experienced by first-time and non-first-time users of the device. METHODS: A prospective, descriptive study was carried out at the University Hospitals Leuven, Belgium. Five hundred PPS needles were individually evaluated in cancer patients. Different aspects of the PPS were assessed: packaging, needle insertion, and needle removal. Nurses were asked whether they had previously inserted or removed this type of needle. We compared the PPS needle with the standard Gripper® needle in terms of safety, ease of use, and ease of training. RESULTS: Three hundred sixty-six evaluation forms were available for analysis (73.2%). Packaging and access evaluations were scored positively, except for two aspects: (1) needle stability, and (2) ease of dressing. Ease of removal was scored unsatisfactory in up to 22.4% of the registrations. Pain at insertion was reported in about 20% registrations, and blood contact was reported by 2.5% of non-first-time users. Safety was scored as good, although ease of use and ease in training scored 25.4% and 43.8%, respectively, lower than the Gripper®. CONCLUSIONS: In general, nurses evaluated the PPS positively, with the exception of needle stability, ease of dressing, and ease of removal. No needlestick accidents were recorded. Aspects of ease of use and ease of training for PPS needles scored less than those for the Gripper® needles in up to one-third of the registrations.

Sensory perceptions of patients with cancer undergoing surgical insertion of a totally implantable venous access device: a qualitative, exploratory study.

PURPOSE/OBJECTIVES: to investigate sensory perceptions of patients who underwent insertion of a totally implantable venous access device (TIVAD) under local anesthesia. RESEARCH APPROACH: qualitative, exploratory study. SETTING: tertiary care center in Belgium. PARTICIPANTS: 20 adult patients with cancer or hematologic disease undergoing a first-time TIVAD insertion. METHODOLOGIC APPROACH: immediately after insertion, patients were asked to describe their sensory perceptions during each of four phases. Descriptions were documented in a sensory information grid (SIG) that was composed of a row and column matrix of entries for the four phases of the procedure and the five sensory modalities. Verbatim descriptions of patients were assigned labels using a descriptive coding process. MAIN RESEARCH VARIABLES: sensory perceptions in the modalities of hearing, sight, touch, smell, and taste. FINDINGS: patients experienced many sensory perceptions that mainly occurred during preparation of the patients and surgical equipment (phase 2) and during the actual TIVAD insertion (phase 3). Patients perceived fewer olfactory sensations. No taste perceptions were mentioned. CONCLUSIONS: patients reported numerous sensory perceptions during TIVAD insertion. The SIG method proved suitable for assessing and documenting patients' sensory perceptions. INTERPRETATION: the reported descriptions can be used (a) to develop a structured questionnaire to quantitatively assess sensory perceptions and (b) to prepare patients for what to expect with regard to sensory information experienced before, during, and after TIVAD insertion. This method for exploring and documenting sensory perceptions might be applicable to other diagnostic or therapeutic interventions.