Quality of life in women with breast cancer undergoing neoadjuvant chemotherapy: comparison between PICC and PICC-port.

BACKGROUND: Peripherally inserted central catheters (PICCs) and new type of arm-port, the PICC-port, are currently used for neoadjuvant chemotherapy treatment in patients with breast cancer. We aimed to compare Quality of Life (QoL) of patients receiving one of these two devices investigating overall satisfaction, psychological impact, as well as the impact on professional, social and sport activities, and local discomfort. METHODS: We did a prospective observational before-after study of PICCs versus PICC-ports. Adult (aged ≥ 18 years) females with breast cancer candidate to neoadjuvant chemotherapy were included. The primary outcome was QoL according to the Quality-of-Life Assessment Venous Device Catheters (QLAVD) questionnaire assessed 12 months after device implantation. RESULTS: Between May 2019 and November 2020, of 278 individuals screened for eligibility, 210 were enrolled. PICC-ports were preferred over PICCs with a QLAVD score of 29 [25; 32] vs 31 [26; 36.5] (p = 0.014). Specifically, most QLAVD constructs related to psychological impact, social aspects, and discomfort were in favor of PICC-ports vs PICC, especially in women under the age of 60. Overall, pain scores at insertion and during therapy administration were not significantly different between the two groups, as well as infection, secondary malpositioning, thrombosis, or obstruction of the device. CONCLUSIONS: In women with breast cancer undergoing neoadjuvant chemotherapy, PICC-ports were overall better accepted than PICCs in terms of QoL, especially in those who were younger. Device-related complications were similar.

A 5-year experience with midline catheters in the management of major head and neck surgery patients.

BACKGROUND: In the perioperative management of major head and neck surgery (HNS) patients, the performance of midline catheters (MCs) has been never tested. We present here our 5-year experience by reporting MC-related complications and by identifying the preoperative risk factors associated with their development. METHODS: Clinical variables were extracted and the dwell time, the number, and the type of postprocedural complications of MCs were retrieved. Complications were classified into major (needing MCs removal and including catheter-related bloodstream infection or deep vein thrombosis or catheter occlusion) and into minor (accidental dislodgement, leaking, etc.). Descriptive statistics and logistic regression models were used in order to identify the predictors of complications. RESULTS: A total of 265 patients were included, with a mean age of 67.4 years. Intraprocedural complications occurred in 1.1% of cases, while postprocedural complications occurred in 13.9% of cases (12.05/1000 days), but they were minor in more than 7.0% (5.4/1000 catheter-days). There were 19 minor complications (7.1% or 5.4/1000 catheter-days) while 18 (7%, 5.1/1000 catheter-days) patients experienced at least one major complication. Female sex (OR = 1.963, 95% CI 1.017-3.792), insertion in the right arm (OR = 2.473, 95% CI 1.150-5.318), and an ACE-27 score >1 (OR = 2.573, 95% CI 1.295-5.110) were independent predictors of major complications. CONCLUSIONS: MCs appear to represent an effective option in the setting of major HNS. The identification of patients most at risk for MC-related complications should prompt a postoperative watchful evaluation.

A multicenter retrospective study on 4480 implanted PICC-ports: A GAVeCeLT project.

BACKGROUND: PICC-ports may be defined as totally implantable central venous devices inserted in the upper limb using the current state-of-the-art techniques of PICC insertion (ultrasound-guided venipuncture of deep veins of the arm, micro-puncture kits, proper location of the tip preferably by intracavitary ECG), with placement of the reservoir at the middle third of the arm. A previous report on breast cancer patients demonstrated the safety and efficacy of these devices, with a very low failure rate. METHODS: This retrospective multicenter cohort study-developed by GAVeCeLT (the Italian Group of Long-Term Venous Access Devices)-investigated the outcomes of PICC-ports in a large cohort of unselected patients. The study included 4480 adult patients who underwent PICC-port insertion in five Italian centers, during a period of 60 months. The primary outcome was device failure, defined as any serious adverse event (SAE) requiring removal. The secondary outcome was the incidence of temporary adverse events (TAE) not requiring removal. RESULTS: The median follow-up was 15.5 months. Device failure occurred in 52 cases (1.2%), the main causes being local infection (n = 7; 0.16%) and CRBSI (n = 19; 0.42%). Symptomatic catheter-related thrombosis occurred in 93 cases (2.1%), but removal was required only in one case (0.02%). Early/immediate and late TAE occurred in 904 cases (20.2%) and in 176 cases (3.9%), respectively. CONCLUSIONS: PICC-ports are safe venous access devices that should be considered as an alternative option to traditional arm-ports and chest-ports when planning chemotherapy or other long-term intermittent intravenous treatments.

In defense of the use of peripherally inserted central catheters in pediatric patients.

Central venous access devices have revolutioned the care of children affected by malignancies, facilitating management of complex and prolonged infusive therapies, reducing pain and discomfort related to repeated blood samples and indiscriminate venipunctures, thus reducing also psychological stress of both patients and families. In this respect, peripherally inserted central catheters have been disseminated for use, even in pediatric oncology patients, for their many advantages: easy and non-invasive placement with no risk of insertion-related complications, as well as easy removal; reduced need for general anesthesia both for insertion and removal; adequate prolonged performance also for challenging therapies (e.g. stem cell transplantation); and low rate of late complications. Nonetheless, concerns have been recently raised about use of such devices in children with cancer, especially regarding a presumed (but not demonstrated) high risk of catheter-related venous thrombosis. Are we facing a new witch (or peripherally inserted central catheter) hunt? The choice of the central venous access device-particularly in oncologic children-should be based on an evaluation of clinical advantages and risks, as provided by appropriate and scientifically accurate clinical studies.

GAVeCeLT-WoCoVA Consensus on subcutaneously anchored securement devices for the securement of venous catheters: Current evidence and recommendations for future research.

BACKGROUND: Subcutaneously anchored securement devices (or subcutaneous engineered securement devices) have been introduced recently into the clinical practice, but the number of published studies is still scarce. The Italian Group of Long-Term Central Venous Access Devices (GAVeCeLT)-in collaboration with WoCoVA (World Congress on Vascular Access)-has developed a Consensus about the effectiveness, safety, and cost-effectiveness of such devices. METHODS: After the definition of a panel of experts, a systematic collection and review of the literature on subcutaneously anchored securement devices was performed. The panel has been divided in two working groups, one focusing on adult patients and the other on children and neonates. RESULTS: Although the quality of evidence is generally poor, since it is based mainly on non-controlled prospective studies, the panel has concluded that subcutaneously anchored securement devices are overall effective in reducing the risk of dislodgment and they appear to be safe in all categories of patients, being associated only with rare and negligible local adverse effects; cost-effectiveness is demonstrated-or highly likely-in specific populations of patients with long-term venous access and/or at high risk of dislodgment. CONCLUSION: Subcutaneously anchored securement is a very promising strategy for avoiding dislodgment. Further studies are warranted, in particular for the purpose of defining (a) the best management of the anchoring device so to avoid local problems, (b) the patient populations in which it may be considered highly cost-effective and even mandatory, (c) the possible benefit in terms of reduction of other catheter-related complications such as venous thrombosis and/or infection, and-last but not least-(d) their impact on the workload and stress level of nurses taking care of the devices.

Peripherally inserted central catheter-related thrombosis rate in modern vascular access era-when insertion technique matters: A systematic review and meta-analysis.

BACKGROUND: Technical factors at the moment of catheter insertion might have a role in peripherally inserted central catheter-related thrombotic risk. We performed a systematic review and meta-analysis to define the actual rate of peripherally inserted central catheter-related symptomatic deep vein thrombosis in patients in whom catheter insertion was performed according to ultrasound guidance, appropriate catheter size choice, and proper verification of tip location. METHODS: We searched Medline, Embase, and Cochrane Library. Only prospective observational studies published in peer-reviewed journals after 2010 up to November 2018 reporting peripherally inserted central catheter-related deep vein thrombosis rate were included. All studies were of adult patients who underwent peripherally inserted central catheter insertion. Results were restricted to those studies which included in their methods ultrasound guidance for venipuncture, catheter tip location, and a catheter size selection strategy. Random-effect meta-analyses and arcsine transformation for binomial data were performed to pool deep vein thrombosis weighted frequencies. RESULTS: Of the 1441 studies identified, 15 studies involving 5420 patients and 5914 peripherally inserted central catheters fulfilled our inclusion criteria. The weighted frequency of peripherally inserted central catheter-related deep vein thrombosis was 2.4% (95% confidence interval = 1.5-3.3) and remained low in oncologic patients (2.2%, 95% confidence interval = 0.6-3.9). Thrombotic rate was higher in onco-hematologic patients (5.9%, 95% confidence interval = 1.2-10). Considerable heterogeneity (I2 = 74.9) was observed and all studies were considered at high risk of attrition bias. CONCLUSIONS: A proper technique is crucial at the moment of peripherally inserted central catheter insertion. Peripherally inserted central catheter-related deep vein thrombosis rate appears to be low when evidence-based technical factors are taken into consideration during the insertion procedure.

In-Line Filtration Reduces Postoperative Venous Peripheral Phlebitis Associated With Cannulation: A Randomized Clinical Trial.

BACKGROUND: Peripheral venous cannulation is an everyday practice of care for patients undergoing anesthesia and surgery. Particles infused with intravenous fluids (eg, plastic/glass/drugs particulate) contribute to the pathogenesis of peripheral phlebitis. The aim of this study is to demonstrate the efficacy of in-line filtration in reducing the incidence of postoperative phlebitis associated with peripheral short-term vascular access. METHODS: In this controlled trial, 268 surgical patients were randomly assigned to in-line filtration and standard care (NCT03193827). The incidence of phlebitis (defined as visual infusion phlebitis [VIP] score, ≥2) within 48 hours was compared between the 2 groups, as well as the onset and severity of phlebitis and the reasons for removal of the cannula. The lifespan of venous cannulae was compared for the in-line filter and no-filter groups through a Kaplan-Meier curve. RESULTS: The incidence of phlebitis within 48 hours postoperatively was 2.2% and 26.9% (difference, 25% [95% confidence interval {CI}, 12%-36%]; odds ratio, 0.05 [0.01-0.15]), respectively, for the in-line filter and no-filter groups (P < .001). From 24 to 96 hours postoperatively, patients in the no-filter group had higher VIP scores than those in in-line filter group (P < .001). Venous cannulae in the in-line filter group exhibited prolonged lifespan compared to those in the no-filter group (P = .01). In particular, 64 (47.8%) of cannulae in the in-line filter group and 56 (41.8%) of those in the no-filter group were still in place at 96 hours postoperatively. At the same time point, patients with a VIP score <3 were 100% in the in-line filter group and only 50% for the no-filter group. In-line filtration was a protective factor for postoperative phlebitis (hazard ratio, 0.05 [95% CI, 0.014-0.15]; P < .0001) and cannula removal (hazard ratio, 0.7 [95% CI, 0.52-0.96]; P = .02). CONCLUSIONS: In-line filtration has a protective effect for postoperative phlebitis and prolongs cannula lifespan during peripheral venous cannulation in surgical patients.

Hepatocellular carcinoma on cirrhosis complicated with tumoral thrombi extended to the right atrium: results in three cases treated with major hepatectomy and thrombectomy under hypothermic cardiocirculatory arrest and literature review.

BACKGROUND: Hepatocellular carcinoma (HCC) with the presence of tumor thrombus in hepatic veins and vena cava, until the atrium (RATT), is correlated with poor prognosis and with risk of tricuspid valve occlusion, congestive heart failure, and pulmonary embolism. METHODS: Three patients with HCC on cirrhotic liver with RATT were studied. Operative technique, pre-operative and post-operative liver function tests, blood loss and transfusions, post-operative morbidity and mortality, and the overall survival and the disease free survival were analyzed. RESULTS: Mean operative time was 336 ± 66 min. Intra-operative blood loss was 926.6 ± 325.9 ml. No major complications occurred. The times of hospital stay were 10, 21, and 19 days, respectively. The survival times were 90, 161, and 40 days, and the disease-free survival times were 30, 141, and 30 days, respectively. CONCLUSIONS: The complete removal of HCC with RATT may be achieved with cardiopulmonary by-pass (CPB) and total hepatic vascular exclusion (THVE). Adding the hypothermic cardiocirculatory arrest (HCCA) to the use of CPB allowed us to have minimal blood loss and hemostasis of the resectional plane. So the use of CPB and HCCA should be considered a good therapeutic alternative to the normothermic CPB with THVE.

The experience of setting up a resident-managed Acute Pain Service: a descriptive study.

BACKGROUND: The benefits of an Acute Pain Service (APS) for pain management have been widely reported, but its diffusion is still limited. There are two APS models: anesthesiologist-based and a nurse-based model. Here we describe the development of a different APS model managed by anesthesia residents, and we report the first year of activity in a tertiary Italian university hospital (Careggi University Hospital, Florence, IT). METHODS: Patients were included in the APS were those undergoing abdominal and urologic surgery causing moderate or severe postsurgical pain. The service was provided for patients, beginning upon their exit from the operating room, for 4, 12, 24 and 48 h for iv, and up to 72 h for epidural therapy. Vital signs, static/dynamic VAS, presence of nausea/vomiting, sedation level, and Bromage scale in case of epidural catheter, were monitored. RESULTS: From September 2013 to April 2015, a total of 1054 patients who underwent major surgery were included in the APS: 542 from abdominal surgery and 512 from urological surgery. PCA and epidural analgesia were more adopted in general surgical patients than in urology (48% vs 36% and 15% vs 2%, respectively; P < 0.0001). Patients who underwent to abdominal surgery had a significantly higher self-administration of morphine (30.3 vs 22.7 mg; P = 0.0315). Elastomeric pump was the analgesic of choice in half of the urologic patients compared to a quarter of the general surgical patients (P < .0001). Among the different surgical techniques, epidural analgesia was used more in open (16.5%) than in videolaparoscopic (1.9%) and robotic technique (1.1%), whereas PCA was predominant in videolaparoscopic (46.5%) and robotic technique (55.5%) than in open technique (31.4%). CONCLUSIONS: The creation of APS, managed by anesthesia residents, may represent an alternative between specialist-based and nurse-based models.

Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial.

IMPORTANCE: No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery. OBJECTIVE: To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy. We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury (≥50% increase of serum creatinine level from baseline or oliguria for ≥6 hours) to receive fenoldopam (338 patients) or placebo (329 patients). We used a computer-generated permuted block randomization sequence for treatment allocation. All patients completed their follow-up 30 days after surgery, and data were analyzed according to the intention-to-treat principle. INTERVENTIONS: Continuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 µg/kg/min (range, 0.025-0.3 µg/kg/min). MAIN OUTCOMES AND MEASURES: The primary end point was the rate of renal replacement therapy. Secondary end points included mortality (intensive care unit and 30-day mortality) and the rate of hypotension during study drug infusion. RESULTS: The study was stopped for futility as recommended by the safety committee after a planned interim analysis. Sixty-nine of 338 patients (20%) allocated to the fenoldopam group and 60 of 329 patients (18%) allocated to the placebo group received renal replacement therapy (P = .47). Mortality at 30 days was 78 of 338 (23%) in the fenoldopam group and 74 of 329 (22%) in the placebo group (P = .86). Hypotension occurred in 85 (26%) patients in the fenoldopam group and in 49 (15%) patients in the placebo group (P = .001). CONCLUSIONS AND RELEVANCE: Among patients with acute kidney injury after cardiac surgery, fenoldopam infusion, compared with placebo, did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00621790.

Spinal cord injury after ascending aorta and aortic arch replacement combined with antegrade stent grafting: role of postoperative cerebrospinal fluid drainage.

Ascending aorta and aortic arch replacement combined with antegrade stent grafting of the descending thoracic aorta represents an emerging hybrid surgical approach for complex and extensive thoracic aortic disease. We present a case of a patient at low risk for spinal cord ischemia who underwent hybrid thoracic aortic surgery (aortic arch replacement and E-vita prosthesis implantation) and developed a spinal cord injury (SCI) after the intervention. Treatment aimed at increasing spinal cord perfusion pressure with the aid of cerebrospinal fluid (CSF) drainage was effective in recovering neuromuscular function.