Continuous vs Intermittent Meropenem Administration in Critically Ill Patients With Sepsis: The MERCY Randomized Clinical Trial.

Importance: Meropenem is a widely prescribed ß-lactam antibiotic. Meropenem exhibits maximum pharmacodynamic efficacy when given by continuous infusion to deliver constant drug levels above the minimal inhibitory concentration. Compared with intermittent administration, continuous administration of meropenem may improve clinical outcomes. Objective: To determine whether continuous administration of meropenem reduces a composite of mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria compared with intermittent administration in critically ill patients with sepsis. Design, Setting, and Participants: A double-blind, randomized clinical trial enrolling critically ill patients with sepsis or septic shock who had been prescribed meropenem by their treating clinicians at 31 intensive care units of 26 hospitals in 4 countries (Croatia, Italy, Kazakhstan, and Russia). Patients were enrolled between June 5, 2018, and August 9, 2022, and the final 90-day follow-up was completed in November 2022. Interventions: Patients were randomized to receive an equal dose of the antibiotic meropenem by either continuous administration (n = 303) or intermittent administration (n = 304). Main Outcomes and Measures: The primary outcome was a composite of all-cause mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria at day 28. There were 4 secondary outcomes, including days alive and free from antibiotics at day 28, days alive and free from the intensive care unit at day 28, and all-cause mortality at day 90. Seizures, allergic reactions, and mortality were recorded as adverse events. Results: All 607 patients (mean age, 64 [SD, 15] years; 203 were women [33%]) were included in the measurement of the 28-day primary outcome and completed the 90-day mortality follow-up. The majority (369 patients, 61%) had septic shock. The median time from hospital admission to randomization was 9 days (IQR, 3-17 days) and the median duration of meropenem therapy was 11 days (IQR, 6-17 days). Only 1 crossover event was recorded. The primary outcome occurred in 142 patients (47%) in the continuous administration group and in 149 patients (49%) in the intermittent administration group (relative risk, 0.96 [95% CI, 0.81-1.13], P = .60). Of the 4 secondary outcomes, none was statistically significant. No adverse events of seizures or allergic reactions related to the study drug were reported. At 90 days, mortality was 42% both in the continuous administration group (127 of 303 patients) and in the intermittent administration group (127 of 304 patients). Conclusions and Relevance: In critically ill patients with sepsis, compared with intermittent administration, the continuous administration of meropenem did not improve the composite outcome of mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria at day 28. Trial Registration: ClinicalTrials.gov Identifier: NCT03452839.

The state of vascular access teams: Results of a European survey.

BACKGROUND: Many European health institutions have appointed multidisciplinary teams for the general management of vascular access to help improve efficiency, patient safety and reduce costs. Vascular access teams (VATs), or infusion teams, are specifically trained groups of healthcare professionals who assess, place, manage and monitor various outcomes and aspects of vascular access care. OBJECTIVE: To assess the current landscape of vascular access management as a discipline across Europe. METHODS: A Faculty of European VAT leads and experts developed a survey of 20 questions which was disseminated across several European countries. Questions focused on respondent and institution profile, vascular access device selection and placement, monitoring and reporting of complications, and access to training and education. The 1449 respondents included physicians, nurses, anaesthetists, radiologists and surgeons from public and private institutions ranging in size. RESULTS: Availability of dedicated VATs vary by country, institution size, and institution type. Institutions with a VAT are more likely to utilise a tool (eg, algorithm or guideline) to determine the appropriate vascular access device (55% vs 38%, P < .0002) and to have feedback on systematic monitoring of complications (40% vs 28%, P = .015). Respondents from institutions with a VAT are more likely to have received training on vascular access management (79% vs 53%, P < .0001) and indicated that the VAT was a source of support when difficulties arise. CONCLUSION: The survey results highlight some of the potential benefits of implementing a dedicated VAT including the use of a broader range of vascular access devices, increased awareness of the presence of vascular access policies, increased the likelihood of recent vascular access training, and increased rates of systematic monitoring of associated complications. The study reveals potential areas for further focus in the field of vascular access care, specifically examining the direct impact of vascular access teams.

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.

Cardiac output: a central issue in patients with respiratory extracorporeal support.

The iLA-activve® Novalung is a new extracorporeal device specifically designed for lung support in patients with hypercapnic and/or hypoxemic respiratory failure. To date, only low-flow applications for decompensated hypercapnic chronic obstructive pulmonary disease have been reported in the literature. Here, we briefly report three cases of iLA-activve use in patients with hypercapnic-hypoxemic acute lung failure assisted with mid-flow (up to 2.4 L/min) and different single/double venous cannulation. The main findings of our small case series were: firstly, extracorporeal blood flows over 2.0 L/min across the membrane provided clinically satisfying decarboxylation and improved oxygenation; secondly, the ratio between blood flow through the membrane and the patient's cardiac output (CO) was a major determinant for the oxygen increase. The latter could, therefore, be a useful indicator for understanding performance in the complex and multifactorial evaluation of patients with extracorporeal veno-venous lung support.

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.

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.

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.

Integrated short peripheral intravenous cannulas and risk of catheter failure: A systematic review and meta-analysis.

BACKGROUND: Short peripheral catheters (SPCs) are used to provide intravenous therapies in hospitalized patients. Recently, the category of SPC has become more complex, with the introduction in clinical practice of "integrated" SPCs (ISPCs), renewed regarding the material (polyurethane rather than polytetrafluoroethylene) and design (large wing; pre-assembled extension; preassembled needle-free connector (NFC)). METHODS: This systematic review and meta-analysis aimed to analyze randomized controlled trials (RCTs) and quasi-randomized studies in hospitalized patients, analyzing the risk of overall catheter failure as well as the risk of each type of complication (occlusion, infiltration, thrombophlebitis, and dislodgement) for ISPCs compared to non-integrated SPCs. These systematic review and meta-analysis were registered on PROSPERO (CRD42022322970). DATA SOURCES: We searched PUBMED®, EMBASE®, and the Cochrane Controlled Clinical Trials register from April to November 2022. RESULTS: INCLUDED STUDIES: The research identified 1260 articles. After the abstract review, 13 studies were included for full manuscript review and, after that, six papers (4727 patients) were included in the meta-analysis. DESCRIPTION OF THE EFFECT: We found a significantly reduced risk of catheter failure (pooling all complications) for ISPCs compared to SPCs (p = 0.002 RR 0.65; 95% CI 0.63-0.9). A significant reduction in the risks of occlusion (p = 0.007 RR 0.72; 95% CI 0.56-0.92) was observed. As regards the risk of infiltration, thrombophlebitis, and dislodgement, the analysis showed a trend in favor of ISPCs, though not statistically significant (respectively p = 0.2 RR 0.84; 95% CI 0.64-1.1; p = 0.25 RR 0.91; 95% CI 0.78-1.07; p = 0.06 RR 0.72; 95% CI 0.52-1.01). CONCLUSIONS: ISPCs significantly reduce the risks of catheter failure (overall complications) and occlusion. More RCTs are needed to understand if the preassembled ISPC is better than the composted closed system (non-integrated SPC + extension line + NFC).

The integrated short peripheral cannula: A new peripheral venous access device?

Short peripheral intravenous cannulas have different features, as they may be winged or non-winged, ported or non-ported, equipped or not with needle stick prevention and "blood stop" mechanisms, and integrated or not with preassembled extensions or preassembled needle free connector. In the current range of commercially available short peripheral cannulas, there is one device that is apparently associated with several clinical advantages. In fact, short peripheral cannulas with safety mechanisms, closed system, winged, non-ported, and equipped with preassembled extension and preassembled needle-free connector appear to be associated with prolonged dwell time, reduction of the incidence of several complications (infiltration/extravasation, dislodgement, phlebitis, infection, blood leakage), cost reduction, and increased satisfaction of patients and clinicians. To clarify the current terminology and to identify this device for future clinical studies, the authors advocate the use of the term "integrated short peripheral cannula." A rapid review of the current evidence suggests that this new device may have different clinical performance and different indications if compared to standard short peripheral cannulas. Though, the optimal clinical outcome can be achieved only when the device is inserted and maintained with proper protocols.

Time to abandon chest X-rays in favor of intracavitary ECG or echocardiography for central venous access tip location: A case of a malpositioned CICC into the internal mammary vein.

Central vascular access devices (CVADs) correct tip location is of paramount importance to avoid malposition related complications. Despite recent guidelines recommend avoiding postprocedure radiograph in favor of alternative tip location technology, chest X-rays are still widely used in clinical practice as a CVADs tip location method. We present a clinical case of a central inserted central catheter (CICC) malposition in the right internal mammary vein, erroneously interpreted by chest X-rays as correctly placed, in a critically ill patient.

A GAVeCeLT bundle for PICC-port insertion: The SIP-Port protocol.

In the last decade, a new type of brachial port has been introduced in clinical practice, the so-called "PICC-port." This is a brachial port, but inserted according to the methodologies and technologies currently adopted for the insertion of peripherally inserted central catheters (PICCs). Several studies have shown that PICC-port insertion is safe, not associated with any relevant immediate or early complication, and that the expected incidence of late complications is significantly lower if compared to "traditional" brachial ports (i.e. inserted without ultrasound guidance). Furthermore, PICC-ports yield excellent esthetic results and are associated with optimal patient compliance. This paper describes an insertion bundle-developed by GAVeCeLT, the Italian Group of Long Term Venous Access Devices, and nicknamed "SIP-Port" (Safe Insertion of PICC-Ports)-which consists of few evidence-based strategies aiming to further minimize all immediate, early, or late complications potentially associated with PICC-port insertion. Also, this insertion bundle has been developed for the purpose of defining more closely the differences between a traditional brachial port and a PICC-port. The SIP-Port bundle is currently adopted by all training courses on PICC-port insertion held by GAVeCeLT. It includes eight steps: (1) preprocedural ultrasound assessment utilizing the RaPeVA (Rapid Peripheral Venous Assessment) protocol; (2) appropriate skin antiseptic technique and maximal barrier precautions; (3) choice of appropriate vein, in terms of caliber and site; (4) clear identification of the median nerve and of the brachial artery during the venipuncture; (5) ultrasound-guided puncture and cannulation of the vein; (6) ultrasound-guided tip navigation; (7) intra-procedural assessment of tip location by intracavitary ECG or by trans-thoracic echocardiography; (8) appropriate creation and closure of the subcutaneous pocket.

Assessment of the MAGIC recommendations in context of evolving evidence based on the use of PICC in ICU.

The goal of the 2015 Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) was to define indications and appropriate practices for peripherally inserted central catheters (PICC) use; however, MAGIC recommendations virtually reduced the use of PICC in hospital settings, including critical care. The aim of this review is to present an assessment of the MAGIC guidelines, considering contemporary evidence to date. The validity of the MAGIC recommendations and their applicability to current practice are called into question given important concerns with the methodology for their development (e.g. high volume of clinical scenarios for evaluation) and the supporting evidence used. There is a considerable amount of contemporary evidence not considered in MAGIC that reports on evolving practices, techniques, and technologies targeted to reduce complications associated with central venous access devices (CVADs). Recent evidence dictates that CVADs are necessary in the intensive care unit (ICU), and that PICCs are a safe, reliable, and appropriate type of central lines, which cannot be replaced in several ICU situations. In light of evolving evidence and practice, as well as the methodological concerns identified, the MAGIC guidelines should be revisited. It is also recommended to create a clinical assessment tool that identifies potential uses of specific CVADs, based on patient needs. The choice of the CVAD should be based on unique clinical considerations and current scientific evidence, not on fears informed by antiquated data.

Femoral venous access: State of the art and future perspectives.

In the past 5 years, non-dialysis femoral venous access has changed in terms of indications, techniques of insertion, and expected incidence of complications. To the traditional non-emergency indication for femoral catheters-obstruction of the superior vena cava-many other indications have been added, both in intensive and non-intensive care. The insertion technique has evolved, thanks to ultrasound guided venipuncture, tunneling, and ultrasound based intraprocedural tip location. Insertion of femorally inserted central catheters may be today regarded as a procedure with an extremely low intraprocedural and post-procedural risk. The risk of infection is reduced by the possibility of the exit site at mid-thigh, by the use of cyanoacrylate glue for sealing the exit site, and by appropriate intraprocedural strategies of infection prevention. The risk of catheter-related thrombosis is low, due to several concomitant strategies: a proper match between vein diameter and catheter caliber; an accurate intraprocedural assessment of tip location by ultrasound and/or intracavitary ECG; the consistent use of ultrasound guided venipuncture and micro-introducer kits; an adequate stabilization of the catheter at the exit site. The risk of mechanical complications and the risk of lumen occlusion are minimized when using polyurethane, power injectable catheters. All these novelties have brought a revolution in the field of femoral venous access, so that this route may be considered as safe and effective as other approaches to central venous catheterization.

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.

European recommendations on the proper indication and use of peripheral venous access devices (the ERPIUP consensus): A WoCoVA project.

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.

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.

Management of antithrombotic treatment and bleeding disorders in patients requiring venous access devices: A systematic review and a GAVeCeLT consensus statement.

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.