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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.

Since several innovations have recently changed the criteria of choice and management of peripheral venous access (new devices, new techniques of insertion, new recommendations for maintenance), the WoCoVA Foundation (WoCoVA = World Conference on Vascular Access) has developed an international Consensus with the following objectives: to propose a clear and useful classification of the currently available peripheral venous access devices; to clarify the proper indication of central versus peripheral venous access; discuss the indications of the different peripheral venous access devices (short peripheral cannulas vs long peripheral cannulas vs midline catheters); to define the proper techniques of insertion and maintenance that should be recommended today. To achieve these purposes, WoCoVA have decided to adopt a European point of view, considering some relevant differences of terminology between North America and Europe in this area of venous access and the need for a common basis of understanding among the experts recruited for this project. The ERPIUP Consensus (ERPIUP = European Recommendations for Proper Indication and Use of Peripheral venous access) was designed to offer systematic recommendations for clinical practice, covering every aspect of management of peripheral venous access devices in the adult patient: indication, insertion, maintenance, prevention and treatment of complications, removal. Also, our purpose was to improve the standardization of the terminology, bringing clarity of definition, and classification.

Insertion of venous access devices (VAD) is usually considered a procedure with low risk of bleeding. Nonetheless, insertion of some devices is invasive enough to be associated with bleeding, especially in patients with previous coagulopathy or in treatment with antithrombotic drugs for cardiovascular disease. The current practices of platelet/plasma transfusion in coagulopathic patients and of temporary suspension of the antithrombotic treatment before VAD insertion are based on local policies and are often inadequately supported by evidence, since many of the clinical studies on this topic are not recent and are not of high quality. Furthermore, the protocols of antithrombotic treatment have changed during the last decade, after the introduction of new oral anticoagulant drugs. Though some guidelines address some of these issues in relation with specific procedures (port insertion, etc.), no evidence-based document covering all the aspects of this clinical problem is currently available. Thus, the Italian Group of Venous Access Devices (GAVeCeLT) has decided to develop a consensus on the management of antithrombotic treatment and bleeding disorders in patients requiring VADs. After a systematic review of the available evidence, the panel of the consensus (which included vascular access specialists, surgeons, intensivists, anesthetists, cardiologists, vascular medicine experts, nephrologists, infective disease specialists, and thrombotic disease specialists) has structured the final recommendations as detailed answers to three sets of questions: (1) which is an appropriate classification of VAD-related procedures based on the specific bleeding risk? (2) Which is the appropriate management of the patient with bleeding disorders candidate to VAD insertion/removal? (3) Which is the appropriate management of the patient on antithrombotic treatment candidate to VAD insertion/removal? Only statements reaching a complete agreement were included in the final recommendations, and all recommendations were offered in a clear and synthetic list, so to be easily translated into clinical practice.

The need for filtering intravenous infusions has long been recognized in the field of venous access, though hard scientific evidence about the actual indications for in-line filters has been scarce. In the last few years, several papers and a few clinical studies have raised again this issue, suggesting that the time has come for a proper definition of the type of filtration, of its potential benefit, and of its proper indications in clinical practice. The WoCoVA Foundation, whose goal is to increase the global awareness on the risk of intravenous access and on patients’ safety, developed the project of a consensus on intravenous filtration. A panel of experts in different aspects of intravenous infusion was chosen to express the current state of knowledge about filtration and to indicate the direction of future research in this field. The present document reports the final conclusions of the panel.

Introduced over 20 years ago, the reverse tapering design for PICC catheters is supposed to have some benefits in terms of both efficacy and safety. In particular, it would ensure less postoperative bleeding at the exit site and greater effectiveness in preventing kinking or twisting of the same. Since its introduction, these hypothesized advantages have never been demonstrated in clinical studies, however very scarce, which have highlighted neither advantages nor disadvantages of reverse tapered catheters when compared to non-reverse tapered ones. This narrative review analyzes some aspects of the use of reverse tapered PICCs, also paying attention to some possible undesirable effects that have arisen from the introduction into clinical practice of new subcutaneous systems of securement of PICCs to the skin. Clinicians should be aware of the fact that reverse tapering design does not represents a sure improvement in terms of safety and efficacy of PICCs and its adoption should be weighed against possible clinical disadvantages.

Background and objectives: The increasing use of arm totally implantable vascular access devices for breast cancer patients who require chemotherapy has led to a greater risk of complications and failures and, in particular, to upper extremity deep vein thrombosis. This study aims to investigate the outcomes of the arm peripherally inserted central catheter-PORT technique in breast cancer patients.Methods: The peripherally inserted central catheter-PORT technique is an evolution of the standard arm-totally implantable vascular access device implant based on guided ultrasound venous access in the proximal third of the upper limb with subsequent placement of the reservoir at the middle third of the arm. A prospective study was conducted on 418 adult female breast cancer patients undergoing chemotherapy. The primary study outcome was peripherally inserted central catheter-PORT failure.Results: Median follow-up was 215 days. Complications occurred in 29 patients (6.9%) and failure resulting in removal of the device in 11 patients (2.6%). The main complication we observed was upper extremity deep vein thrombosis, 10 (2.4%); all patients were rescued by anticoagulant treatment without peripherally inserted central catheter-PORT removal. The main reason for removal was reservoir pocket infection: 4 (0.9%) with an infection rate of 0.012 per 1000 catheter days. Cumulative 1-year risk of failure was 3.6% (95% confidence interval, 1.3%–7.1%). With regard to the patients’ characteristics, body mass index <22.5 was the only significant risk for failure (p=0.027).Conclusion: The peripherally inserted central catheter-PORT is a safe vascular device for chemotherapy delivery that achieves similar clinical results as traditional long-term vascular access devices (peripherally inserted central catheter and arm totally implantable vascular access device, in particular) in breast cancer patients.

Several recent literature reports regarding the flushing technique of TIVADs highlight how the definition of the optimal flushing interval is still a source of controversy. Several recent studies indicate more and more frequently how 4 weeks can be considered a too short interval for the flushing of a totally implantable access device (TIVAD); on the other hand most of the main guidelines and instructions for use provided by the device’s manufacturers still suggest an interval between 4 weeks and 1 month as the ideal one. The recent meta-analysis by Wu et al. on this topic, promotes an important strategy change, indicating the possibility of extending the flushing intervals at least up to 8 weeks. This editorial extensively discusses the flushing methods of TIVADs highlighting the need for important and substantial changes, both in extending the range of flushes and in the solutions and methods to be used. It represents an invitation to the scientific community and device manufacturers for a complete revision of the indications on flushing techniques.

Central venous access devices are essential for the management of critically ill patients, but they are potentially associated with many complications, which may occur during or after insertion. Many evidence-based documents—consensus and guidelines—suggest practical recommendations for reducing catheter-related complications, but they have some limitations. Some documents are not focused on critically ill patients; other documents address only some special strategies, such as the use of ultrasound; other documents are biased by obsolete concepts, inappropriate terminology, and lack of considerations for new technologies and new methods. Thus, the Italian Group of Venous Access Devices (GAVeCeLT) has decided to offer an updated compendium of the main strategies—old and new—that should be adopted for minimizing catheter-related complications in the adult critically ill patient. The project has been planned as a consensus, rather than a guideline, since many issues in this field are relatively recent, and few high-quality randomized clinical studies are currently available, particularly in the area of indications and choice of the device. Panelists were chosen between the Italian vascular access experts who had published papers on peer-reviewed journals about this topic in the last few years. The consensus process was carried out according to the RAND/University of California at Los Angeles (UCLA) Appropriateness Methodology, a modification of the Delphi method, that is, a structured process for collecting knowledge from groups of experts through a series of questionnaires. The final document has been structured as statements which answer to four major sets of questions regarding central venous access in the critically ill: (1) before insertion (seven questions), (2) during insertion (eight questions), (3) after insertion (three questions), and (4) at removal (three questions).

A short peripheral intravenous catheter or cannula (PIVC) is frequently used to deliver chemotherapy in oncology practice. Although safe and easy to insert, PIVCs do fail, leading to personal discomfort for patients and adding substantially to treatment costs. As the procedure of peripheral catheterization is invasive, there is a need for greater consistency in the choice, insertion and management of short PIVCs, particularly in the oncology setting where there is a growing trend for patients to receive many different courses of IV treatment over a number of years, sometimes with only short remissions. This article reviews best practice with respect to PIVCs in cancer patients and considers the necessity for bundling these actions. Two care bundles, addressing both insertion and ongoing care and maintenance, are proposed. These have the potential to improve outcomes with the use of short PIVCs for vascular access in oncology practice.

Background The most appropriate lock solution for central venous access devices is still to be defined. GAVeCeLT – the Italian group for venous access devices – has developed a consensus on the evidence-based criteria for the choice and the clinical use of the most appropriate lock solution for central venous catheters (excluding dialysis catheters).Method After the constitution of a panel of experts, a systematic collection and review of the literature has been performed, focusing on clinical studies dealing with lock solutions used for prevention of occlusion (heparin, citrate, urokinase, recombinant tissue plasminogen activator [r-TPA], normal saline) or for prevention of infection (citrate, ethanol, taurolidine, ethylene-diamine-tetra-acetic acid [EDTA], vancomycin, linezolid and other antibiotics), in both adults and in pediatric patients. Studies on central lines used for dialysis or pheresis, on peripheral venous lines and on arterial lines were excluded from this analysis. Studies on lock solutions used for treatment of obstruction or infection were not considered. The consensus has been carried out according to the Delphi method.Results The panel has concluded that: (a) there is no evidence supporting the heparin lock; (b) the prevention of occlusion is based on the proper flushing and locking technique with normal saline; (c) the most appropriate lock solution for infection prevention should include citrate and/or taurolidine, which have both anti-bacterial and anti-biofilm activity, with negligible undesired effects if compared to antibiotics; (d) the patient populations most likely to benefit from citrate/taurolidine lock are yet to be defined.Conclusions The actual value of heparinization for non-dialysis catheters should be reconsidered. Also, the use of lock with substances with anti-bacterial and anti-biofilm activity (such as citrate or taurolidine) should be taken into consideration in selected populations of patients.

Heparin solution is routinely used to maintain the patency of infusion devices. Literature supports the alternative use of normal saline solution for flushing and locking intravenous infusion devices especially for pediatric patients. There is uncertainty regarding safety and efficacy of this policy for intermittent locking of implanted ports.

The status of axillary nodes is the most important prognostic factor in breast cancer to select patient subgroups for adjuvant chemotherapy; the current standard of care for surgical management of invasive breast cancer is complete removal of the tumor by either mastectomy or lumpectomy followed by axillary lymph node dissection (ALND). The recent introduction of intraoperative lymphatic mapping and sentinel lymph node biopsy (SLND) represents a major new opportunity for appropriate and less invasive surgical management of many tumors. There is an almost uniformly enthusiasm concerning the potential of this technique in breast carcinoma management, shown by published data. A peculiar attention to the so-called “sentinel node debate” in breast cancer surgery is a constant in the last years issues of the major medical journals. Even patients have become more aware about medical enthusiasm and their request of concise information on the topic and the possibilities of this approach is an increasing reality in medical practice.The aim of this paper is to review recent literature to offer an overview about the main controversial methodological aspects and a wide analysis of reported results. The most significative international literature papers from Medline were retrieved from 1993 to September 1999, and 4782 procedures were analysed. This extensive review of the literature has confirmed accuracy, feasibility and reliability of the SN detecting technique in axillary mapping. Provided a good proficiency in SN localisation and pathological evaluation, human resources and efforts should be mainly focused on its clinical validation as an alternative to ALND instead of on further phase I–-II clinical studies.

Subclavian percutaneous access with reservoir placement has been shown to be difficult or contraindicated in some patients. Of 465 cancer patients who required a port placement between January 1992 to January 1995, 41 (8.8%) had alternative percutaneous femoral access with a totally implantable port reservoir located in the abdomen because of the inaccessibility to subclavian or jugular veins and/or the presence of massive cutaneous metastases or severe radiodermitis in the upper part of the torso. Overall implant days was 9880, with an average of 241 days (range: 65–445). Ports were alternatively used for chemotherapy and nutritional purposes in 11 of 41 patients. Late morbidity causing the removal of the implanted ports was observed in two of 41 (4.9%) and in 25 of 424 (5.9%) patients in the femoral and subclavian series, respectively (P=0.86). The femoral percutaneous access for totally implantable port devices appears to be a safe alternative for cancer patients when subclavian and/or jugular vein catheterization and reservoir in the upper part of the torso is contraindicated.

Sixty-four patients with recurrent or metastatic colorectal cancer underwent radioimmunoguided surgery (RIGS). Thirty patients (Group A) were preoperatively injected with radiolabeled monoclonal antibody (MAb) B72.3, a whole IgG1 that reacts with tumor-associated glycoprotein (TAG-72) antigen. Thirty-four patients (Group B) were given monoclonal antibody F023C5, an F(ab')2 which reacts with the carcinoembryonic antigen (CEA). The use of F(ab')2 antibodies ensured a lower time interval from the preoperative injection of the radiolabeled MAb to surgery. This interval was 22.7 days for Group A patients and 10.9 days for Group B patients. The correct RIGS identification of tumor sites occurred in 80.4% of Group A patients and in 92.6 % of Group B patients. Additional information capable of modifying surgical strategy was obtained in 23.3% of Group A patients and in 8.8% of Group B patients. This difference was due to the different patterns of biodistribution and pharmacokinetics of the two MAbs. Although FO23C5 yields an improved diagnostic resolution for macroscopic tumor sites, we believe that B72.3 or other whole IgG1 should be the first choice for RIGS in recurrent or metastatic colorectal cancer patients. Semin. Surg. Oncol. 15:231–234, 1998. © 1998 Wiley-Liss, Inc.

Radioimmunoguided surgery (RIGS) with radiolabeled monoclonal antibodies (MoAbs) has been reported as useful in second-look colorectal cancer procedures to improve surgical decision-making by helping avoid needless extensive surgery and expanding curative resection to sites of recurrence that have been missed previously. Sixteen asymptomatic patients with an history of colorectal cancer surgery underwent second-look surgery using the RIGS system, solely on the basis of rising serum levels of carcinoembryonic antigen (CEA). All patients were injected preoperatively with the anti-tumor-associated glycoprotein (TAG) ¹²⁵I-labeled MoAb B72.3. Both traditional and RIGS exploration were used to determine the extension of a possible recurrence and its resectability for cure. Recurrent disease was observed in 14 of the 16 patients as the result of this combined exploration. Exploration alone showed the presence of recurrent disease in 9 of 16 patients (56.2%). Thus, RIGS found overlooked tumor in five patients (31.2%). All the additional RIGS-detected tumor sites were locoregional recurrences resectable for cure; conversely, no diagnostic improvements were shown in patients with liver metastases. Resection for cure was obtained by this approach in 9 of 16 patients (56.2%). Two patients without disease at the exploratory laparotomy recurred within 2 months at sites away from the abdomen. RIGS improved the results of colorectal cancer CEA-guided second-look procedures in asymptomatic patients by recruiting one-third of patients to curative resections. Semin. Surg. Oncol. 15:263–267, 1998. © 1998 Wiley-Liss, Inc.

One hundred thirty-six patients with colorectal and breast cancer were enrolled in a retrospective study using radioimmunoguided surgery (RIGS) with Iodine-125 (I¹²⁵) radiolabeled B72.3 (Group A, 73 patients) and F023C5 (Group B, 63 patients) monoclonal antibodies (MAbs). The correlation between intraoperative tumor-to-normal tissue (T/NT) gamma-detecting probe (GDP) counts ratio and the expression of tumor-associated glycoprotein (TAG)-72 (Group A patients) and carcinoembryonic antigen (CEA; Group B patients) tumor-associated antigens (TAA) expression of 209 resected or biopsy tumor specimens was assessed. Ex vivo radioimmunolocalization index (R.I.) Was carried out on the same specimens as a control of intraoperative GDP ratio values. RIGS positive definition of tumor occurred in 80/113 (70.8%) tumor sites of Group A patients and in 84/96 (87.5%) tumor sites of Group B patients. Mean percent B72.3 TAA expression of 113 tumor sites of Group A patients was 62.74 ± 28.79% vs. 73.00 ± 26.28% of 96 tumor sites of Group B patients (P &lt; 0.05). The higher incidence of positive RIGS results was observed in tumor sites with the higher expression of the relative TAA. A statistically significant correlation between RIGS ratios and B72.3 and CEA expression was observed in the 113 tumor sites of Group A (P &lt; 0.05) and in the 96 tumor sites of Group B (P &lt; 0.01), respectively. The role of a preoperative evaluation of TAA expression in patients undergoing RIGS is discussed. Its assessment, whenever possible, may help to select those patients who will benefit more from this immunodiagnostic technique. Semin. Surg. Oncol. 15:249–253, 1998. © 1998 Wiley-Liss, Inc.

Twenty-one patients with histologically proven locally advanced breast cancer (LABC) were treated with a combined modality approach based on primary chemotherapy and radical modified mastectomy followed by adjuvant chemotherapy. Surgery was performed by using radioimmunoguided surgery (RIGS) technique with the preoperative injection of Iodine-125 labeled monoclonal antibodies (MoAbs) B72.3 anti-TAG (11 patients, Group A) and FO23C5 anti-carcinoembryonic antigen (CEA; 10 patients, Group B). The role of RIGS was defined at surgery by using an intraoperative hand-held gamma-detecting probe (GDP) to locate the primary tumor, possible clinically occult multicentric foci and ipsilateral lymph node metastases. In Group A, RIGS correctly defined the primary tumor in seven out of 11 patients (63.3%) and was able to find multicentric tumors in two out of four patients (50%). Positive lymph nodes were identified by RIGS in three out of eight patients (37.5%). In Group B, patients RIGS correctly located the primary in 4/10 cases (40%); in two RIGS-positive cases, the tumor was clinically not evident after primary chemotherapy (yT0). RIGS correctly identified multicentric foci of tumor in one out of two cases (50%). Correct lymph nodal RIGS assessment was observed in three out of nine patients (33.3%). No RIGS false-positive findings occurred in the 21 patients included in the study. RIGS appears to be a reliable technique for the intraoperative diagnosis and staging of breast cancer with a potential role especially when conservative surgery is planned after primary chemotherapy in LABC. Semin. Surg. Oncol. 15:245–248, 1998. © 1998 Wiley-Liss, Inc.

Uniform and accurate staging of gastric cancer is essential to predict prognosis and assess the effectiveness of treatment strategies. An appropriate amount of surgical resection of the primary tumor and lymph node dissection appears to be fundamental for such staging. In seven out of 10 patients who were candidates for curative surgery, we assessed the usefulness of radioimmunoguided surgery (RIGS) using B72.2 monoclonal antibody (MoAb) labeled to Iodine-125 (I¹²⁵) for the intraoperative staging of the tumor and the first (N1) and second echelon (N2) lymph nodes. We obtained a correct RIGS identification of primary lesions in four out of seven patients (57.1%), while lymph node staging assessment showed positive results in two out of four patients with lymph node metastases. RIGS correctly identified 26/40 (65%) metastatic nodes of these last two patients. RIGS intraoperative staging of gastric cancer—which may be essential for the assessment of the extension of the primary resection and to modulate lymph node dissection—was unsatisfactory. We believe that other technical approaches and more specific MoAbs should be evaluated for RIGS purposes in gastric cancer surgery. Semin. Surg. Oncol. 15:212–214, 1998. © 1998 Wiley-Liss, Inc.

The role of elective lymph node dissection (ELND) for treatment of cutaneous melanoma is still debated. Initially, lymphatic mapping technique was performed by an intradermic injection of vital blue dye; subsequently, it was improved by the use of radioguided surgery (RGS). Preliminary experience with this technique proved effective for detection of clinical occult lymph node metastasis; it may also enable the surgeon to perform a selective lymph node dissection (SLND) to concentrate on pathologic node-positive patients for the same potential benefits that have been provided by ELND. We performed sentinel node biopsy on 48 patients with stage pT3N0M0 melanoma. Vital blue dye mapping only was carried out on 39 patients; the remaining nine patients had a combined lymphatic mapping with both blue dye and RGS. The sentinel lymph node (SLN) was identified in 46 of 48 patients (95.8%). Ten patients (20.8%) were found to have metastatic melanoma cells in their SLN(s); all these patients underwent SLND of the affected basin. Our findings confirm that the intraoperative lymphatic mapping of the SLN using both blue dye and radiodetection is an appropriate and simple technique for selecting patients who are more likely to benefit from lymph node dissection. Semin. Surg. Oncol. 15:284–286, 1998. © 1998 Wiley-Liss, Inc.

We have recently demonstrated that continuous-infusion (CI) 5-fluororacil (FU) eradicates human colon carcinoma cells made resistant to bolus FU in vitro. In addition, in the same experimental system, the mechanisms of resistance to pulse and CI FU were found to be different. These observations led us to test the clinical activity of a standard regimen of CI FU (300 mg/m2 per day) in a cohort of 15 patients with advanced measurable colorectal cancer who were in progression after having failed to respond to bolus treatment with FU alone (3 patients) of FU combined with high-dose 6-S-leucovorin (LV) (12 patients). The median age of the patients was 68 years, and their median Eastern Cooperative Oncology Group performance status (ECOG PS) was 1. No myelotoxicity was observed. Mild diarrhea, mucositis, and vomiting occurred in 32%, 26%, and 19% of the patients, respectively, with no WHO grade 3 or 4 episodes being noted. In all, 6 of 15 patients complained of hand-foot syndrome, which was severe in 2 instances, lasting approximately 1 week. Overall, 1 partial response and 6 instances of disease stabilization, including 3 minor responses, were obtained both in patients who had been pretreated with pulse FU alone and in patients who had failed first-line treatment with FU+LV. Finally, 8 patients failed CI FU. In conclusion, these results, obtained in patients who were clearly progressing after having failed first-line treatment, support our experimental finding that resistance to bolus FU may be overcome by CI FU and extend this possibility to patients who are resistant to bolus treatment with FU+LV.