Acceso radial frente a femoral y bivalirudina frente a heparina no fraccionada en pacientes vulnerables con síndrome coronario agudo / Radial versus femoral and bivalirudin versus unfractionated heparin in vulnerable patients with acute coronary syndromes

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Lugar de acceso y tipo de anticoagulante en pacientes con síndrome coronario agudo en clase Killip avanzada o con parada cardiaca extrahospitalaria / Choice of access site and type of anticoagulant in acute coronary syndromes with advanced Killip class or out-of-hospital cardiac arrest

INTRODUCCIÓN Y OBJETIVOS: A menudo se excluye de los ensayos clínicos a los pacientes hemodinámica o eléctricamente vulnerables, por lo que escasea la información sobre el acceso vascular y el tratamiento antitrombótico óptimos. En este trabajo se estudia la evolución de los pacientes vulnerables con síndrome coronario agudo tratados invasivamente según el acceso fuera radial o femoral y el tratamiento fuera con bivalirudina o con heparina no fraccionada (HNF). MÉTODOS: El estudio MATRIX aleatorizó a 8.404 pacientes a acceso radial o femoral y a 7.213 pacientes a bivalirudina o a HNF. Se consideró vulnerables a 934 pacientes (11,1%) debido a clase Killip avanzada (808), parada cardiaca (168) o ambas a la vez (42). El objetivo primario compuesto a 30 días fueron los eventos cardiovasculares y cerebrovasculares mayores (MACE: muerte, infarto de miocardio e ictus) y los eventos clínicos adversos netos (NACE: MACE o hemorragia grave). RESULTADOS: El acceso radial, comparado con el femoral, redujo los MACE y NACE de modo similar en pacientes vulnerables y no vulnerables. El acceso radial se asoció con un claro beneficio relativo en la mortalidad total y cardiovascular y las hemorragias BARC 3 o 5, con mayor beneficio absoluto en los pacientes vulnerables. Los efectos de la bivalirudina comparada con la HNF en MACE y NACE concuerdan entre pacientes vulnerables y no vulnerables. La bivalirudina se asoció con menores mortalidad cardiovascular y por todas las causas en pacientes vulnerables, pero no en los no vulnerables, con test de interacción en el límite. La bivalirudina redujo las hemorragias en ambos grupos de pacientes, con un beneficio absoluto mayor en el caso de los pacientes vulnerables. CONCLUSIONES: En pacientes con síndrome coronario agudo sometidos a tratamiento invasivo, los efectos de los tratamientos aleatorizados fueron concordantes entre los pacientes vulnerables y los no vulnerables, pero la reducción del riesgo absoluto del acceso radial y bivalirudina fue mayor en los vulnerables, con una reducción de 5 a 10 veces en el número de pacientes que es necesario tratar

INTRODUCTION AND OBJECTIVES: Patients who are vulnerable to hemodynamic or electrical disorders (VP) are often excluded from clinical trials and data on the optimal access-site or antithrombotic treatment are limited. We assessed outcomes of transradial vs transfemoral access and bivalirudin vs unfractionated heparin (UFH) in VP with acute coronary syndrome undergoing invasive management. METHODS: The MATRIX trial randomized 8404 patients to radial or femoral access and 7213 patients to bivalirudin or UFH. Among them, 934 (11.1%) were deemed VP due to advanced Killip class (n = 808), cardiac arrest (n = 168), or both (n = 42). The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACE: death, myocardial infarction, or stroke) and net adverse clinical events (NACE: MACE or major bleeding). RESULTS: MACE and NACE were similarly reduced with radial vs femoral access in VP and non-VP. Transradial access was also associated with consistent relative benefits in all-cause and cardiovascular mortality or Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding with greater absolute benefits in VP. The effects of bivalirudin vs UFH on MACE and NACE were consistent in VP and non-VP. Bivalirudin was associated with lower all-cause and cardiovascular mortality in VP but not in non-VP, with borderline interaction testing. Bivalirudin reduced bleeding in both VP and non-VP with a larger absolute benefit in VP. CONCLUSIONS: In acute coronary syndrome patients undergoing invasive management, the effects of randomized treatments were consistent in VP and non-VP, but absolute risk reduction with radial access and bivalirudin were greater in VP, with a 5- to 10-fold lower number needed to treat for benefits

Recent Advances in Arteriovenous Access Creation for Hemodialysis: New Horizons in Dialysis Vascular Access.

Recent advances in technology show promise in providing greater vascular access options for hemodialysis patients. This review discusses novel methods for creating an anastomosis for arteriovenous (AV) fistulas and new materials for prosthetic AV grafts. Two technologies for endovascular arteriovenous fistula creation, the Ellipsys and WavelinQ endovascular systems, are discussed. When an AV fistula is not possible, an AV graft or devices to augment the AV fistula may be appropriate. New materials that have been developed that show promise as an alternative to the expanded polytetrafluoroethylene graft are discussed. Such potential conduits include bioengineered vessels and both allogenic or xenogenic biologic grafts. Devices designed to optimize blood flow to reduce maturation failure and improve AV fistula outcomes are explored.

Challenges of Vascular Access in the Pediatric Population.

The incidence and prevalence of renal replacement therapy has continued to increase in the pediatric population. Recent data have shown that hemodialysis was the most frequently used dialysis modality, especially in pediatric ESRD patients (age 0-21 years). A well-functioning vascular access is required for effective hemodialysis and choosing the best vascular access option for pediatric patients can be difficult. Pediatric vascular options include arteriovenous fistula, arteriovenous graft, and central venous catheters (CVCs). There is a national initiative for fistula first-catheter last approach; however, CVCs have been reported as the most conventionally utilized vascular access option in pediatric patients. The use of CVCs should be minimized or avoided as they are associated with high risk of infections, thrombosis, and other complications. Thus, it is important for practitioners to plan appropriately in advance, practice good clinical judgment, and assure that the best vascular access is placed according to the patient's needs. Therefore, this article reviews the different types of pediatric vascular access and the associated benefits and potential complications of each.

Impacto del acceso vascular en el pronóstico tras la angioplastia coronaria en pacientes con alto riesgo hemorrágico: subanálisis predefinido del estudio LEADERS FREE / Impact of vascular access on outcome after PCI in patients at high bleeding risk: a pre-specified sub-analysis of the LEADERS FREE trial

INTRODUCCIÓN Y OBJETIVOS: El objetivo es evaluar el impacto del acceso vascular en las complicaciones hemorrágicas tras una intervención coronaria percutánea en pacientes con alto riesgo de sangrado (ARS) a los 30 días y a los 2 años. MÉTODOS: El presente estudio es un subanálisis predefinido del estudio LEADERS FREE, que incluyó a 2.432 pacientes con ARS y en el que el stent farmacoactivo Biolimus A9 resultó superior al stent convencional en seguridad y eficacia. RESULTADOS: El acceso radial (AR) se utilizó en 1.454 pacientes (59,8%) y el femoral (AF), en 978 (40,2%), ambos a elección del operador. La seguridad y los beneficios del stent farmacoactivo sobre el convencional fueron independientes del acceso vascular. A los 30 días y a los 2 años, habían sufrido un sangrado mayor el 2,4 y el 7,5% de los pacientes con AR y el 4,6 y el 10,9% de los pacientes con AF (p = 0,003), la mayoría en ambos grupos (el 2,1 y el 7,0% del de AR; el 3,2 y el 9,4% del de AF) no relacionados con el sitio de acceso vascular. El AR se asoció con una reducción significativa en las tasas ajustadas de sangrado mayor tanto a 30 días (HR=1,98; IC95%, 1,25-3,11; p = 0,003) como a 2 años de seguimiento (HR=1,51; IC95%, 1,14-2,01; p = 0,003). CONCLUSIONES: Los operadores prefirieron el AR en la mayoría de los pacientes con ARS, lo cual se asoció con una reducción significativa del sangrado mayor. Asimismo, un número significativo de sangrados en el seguimiento de esta población son no relacionados con el acceso vascular

INTRODUCTION AND OBJECTIVES: The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up. METHODS: The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial. RESULTS: Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was driven by both access and nonaccess bleeding. CONCLUSIONS: Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access

Rates of Venous Thromboembolism and Central Line-Associated Bloodstream Infections Among Types of Central Venous Access Devices in Critically Ill Children.

OBJECTIVES: Central venous access devices, including peripherally inserted central catheters and central venous catheters, are often needed in critically ill patients, but also are associated with complications, including central-line associated bloodstream infections and venous thromboembolism. We compared different central venous access device types and these complications in the PICU. DESIGN: Multicenter, cohort study. SETTING: One hundred forty-eight participating Virtual PICU Systems, LLC, hospital PICU sites. PATIENTS: Pediatric patients with central venous access placed from January 1, 2010, to December 31, 2015. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patient and central venous access device variables postulated to be associated with central-line associated bloodstream infection and venous thromboembolism were included. Data were analyzed using Pearson chi-square test or Fisher exact test for categorical variables, Mann-Whitney U test for continuous variables, and logistic regression and classification trees for multivariable analysis that examined significant predictors of venous thromboembolism or central-line associated bloodstream infection. Analysis included 74,196 first lines including 4,493 peripherally inserted central catheters and 66,194 central venous catheters. An increased rate of venous thromboembolism (peripherally inserted central catheter: 0.93%, central venous catheter: 0.52%; p = 0.001) (peripherally inserted central catheter: 8.65/1,000 line days, central venous catheter: 6.29/1,000 line days) and central-line associated bloodstream infection (peripherally inserted central catheter: 0.73%, central venous catheter: 0.24%; p = 0.001) (peripherally inserted central catheter: 10.82/1,000 line days, central venous catheter: 4.97/1,000 line days) occurred in peripherally inserted central catheters. In multivariable analysis, central venous catheters had decreased association with central-line associated bloodstream infection (odds ratio, 0.505; 95% CI, 0.336-0.759; p = 0.001) and venous thromboembolism (odds ratio, 0.569; 95% CI, 0.330-0.982; p = 0.043) compared with peripherally inserted central catheters. CONCLUSIONS: Peripherally inserted central catheters are associated with higher rates of central-line associated bloodstream infection and venous thromboembolism than central venous catheters in children admitted to the PICU.

Comparison of complications with a 1.25-mm versus a 1.5-mm burr for severely calcified lesions that could not be crossed by an intravascular ultrasound catheter.

Since intravascular imaging such as intravascular ultrasound (IVUS) can provide useful information for rotational atherectomy (RA), intravascular imaging should be attempted before RA. However, some calcified lesions do not allow imaging catheters to cross before RA. Although small burrs (1.25 mm or 1.5 mm) should be selected for such tight lesions, it is unknown whether a 1.25-mm burr or 1.5-mm burr is safer as the initial burr. The aim of this study was to compare the incidence of complications with a 1.25-mm versus a 1.5-mm burr as the initial burr for IVUS-uncrossable lesions. This was a retrospective, single-center study. A total of 109 IVUS-uncrossable lesions were included, and were divided into a 1.25-mm group (n =52) and a 1.5-mm group (n =57). The incidence of slow flow just after RA was not different between the 2 groups (1.25-mm group: 25%, 1.5-mm group: 31.6%, P =0.45). The incidence of peri-procedural MI with slow flow was not different and equally low in the 2 groups (1.25-mm group: 1.9%, 1.5-mm group: 3.5%, P =0.61). The use of the 1.5-mm burr as the initial burr was not significantly associated with slow flow after controlling for chronic renal failure on hemodialysis and reference diameter (vs. 1.25-mm: OR 2.34, 95% CI 0.89-6.19, P =0.09). In conclusion, the incidence of complications following RA was comparable between the 1.25-mm and the 1.5-mm burrs as the initial burr for IVUS-uncrossable lesions. The present study provides insights into the selection of an appropriate burr for IVUS-uncrossable lesions.

Feasibility of kissing balloon technique through guide extension catheters: an experimental bench test.

Previous reports showed that GuideLiner (GL) and Guidezilla (GZ) can accommodate bulky and multiple devices beyond the official profiles. However, feasibility of kissing balloon technique (KBT) through these devices is unknown. The tested devices included 7Fr-GL/GZ and respective three types of 2.5 mm semi-compliant (SC) and non-compliant (NC) balloons: conventional model (CM), tapered-tip model (TM) and latest model (LM). First, three experienced operators attempted to advance all 21 combinations of the 2 balloons through GL/GZ on the guidewires and assessed the crossability in 3 grades: easy, difficult and impossible. Second, the only balloon combinations graded as easy by all operators were tested in the polyurethane-made bifurcation model which required KBT following cross-over stenting. Within the total of 42 device combinations, only one balloon combination of double LM-NC balloons was classified as easy in both GL/GZ by consensus opinion of the operators. While two combinations of LM-SC and LM-SC/NC balloons were classified as difficult in both GL/GZ, all four combinations of LM-SC/NC and CM/TM-NC balloons were classified as difficult only in GL. Other 32 combinations were all classified as impossible. In the bifurcation model, the combination of double LM-NC balloons using GL achieved KBT while the same balloon combination with GZ failed. The feasibility of KBT using child-catheter is highly dependent on the device characteristics. The combination of latest small-profile NC balloons through GL could be clinically applicable.

Uso de catéteres venosos de línea media en pacientes hospitalizados / The use of venous catheters of average line in hospitalized patient

En el contexto actual en el que han surgido numerosas alternativas en terapia intravenosa, se hacen necesarios estudios sobre los diferentes dispositivos disponibles para determinar cuál es el sistema más idóneo en cada caso. Las líneas medias surgen como alternativa a la utilización de catéteres venosos periféricos y catéteres centrales de inserción periférica. El objetivo de este estudio es evaluar el uso de los catéteres de línea media en pacientes hospitalizados. Método: Estudio retrospectivo de 1016 pacientes. Se analizaron variables relacionadas con el tiempo medio de utilización del catéter, la tasa de incidencias para cada una de las complicaciones, el número de catéteres retirados y sus causas. Resultados: El 40 % de los catéteres se canalizó por mal acceso venoso del paciente (406), el 42% por tratamiento intravenoso largo (427) y el 18% por tratamiento irritante (183). Respecto a la efectividad de los catéteres, el tiempo medio de utilización fue de 12.1 días (DE 9.4). Finalizaron el tratamiento 854 pacientes, 704 (69.3%) por fin de tratamiento y 150 (14.8%) por fallecimiento. Presentaron complicaciones el 7.4 % de los pacientes (75). Se retiraron por mal funcionamiento del catéter el 4.4% (45), el 1% por complicaciones del paciente (10). El 2% de los catéteres se retiró por fiebre (20). Conclusiones: El catéter de línea media es un dispositivo de acceso venoso con una baja tasa de complicaciones, presenta un tiempo medio de permanencia en torno a los 12 días. Supone una alternativa a los catéteres periféricos cortos en pacientes con mal acceso venoso y ofrece una alternativa a las rotaciones frecuentes en pacientes con tratamientos antibióticos superiores a 7 días

In the current context in which numerous alternatives have emerged in intravenous therapy, studies are needed on the different devices available to determine which is the most suitable system in each case. The midlines arise as an alternative to the use of peripheral venous catheters and central peripheral insertion catheters. The main objective of this study is to evaluate the use of midline catheters in hospitalized patients. Method: Retrospective study of 1016 patients. We analyzed variables related to the mean time of catheter use, the incidence rate for each of the complications, the number of catheters removed and their causes. Results: 46.5% of the catheters were inserted in men (472). The average age was 65 years (SD 16.8), being the youngest of 14 and the oldest of 101 years. 40% of the catheters were channeled due to poor venous access of the patient (406), 42% for long intravenous treatment (427) and 18% for irritant treatment (183). Regarding the effectiveness of the catheters, the average time of use was 12.1 days (SD 9.4). The treatment was terminated by 854 patients, 704 (69.3%) by the end of treatment and 150 (14.8%) by death. 7.4% of patients presented complications (75). 4.4% (45) were removed due to malfunction of the catheter, 1% due to patient complications (10). 2% of the catheters were removed due to fever (20). Conclusions: The middle line catheter is a venous access device with a low complication rate, it has a average residence time of around 12 days. It is an alternative to short peripheral catheters in patients with poor vein access and offers an alternative to frequent rotations in patients with antibiotic treatments longer than 7 days

Long peripheral catheters: Is it time to address the confusion?

Long peripheral catheters are 6-15 cm peripheral dwelling catheters that are inserted via a catheter-over-needle or direct Seldinger (catheter-over-guidewire) technique. When inserted in the upper extremity, the distal tip terminates before reaching the axilla, typically no further than the mid-upper arm. This is distinct from a midline catheter, which is inserted via a modified Seldinger technique and terminates at the axilla. The nomenclature of this catheter is confusing and inconsistent. We have identified over a dozen labels in the literature, all describing the same device. These include '15 cm catheter', 'catheter inserted with a Seldinger method', 'extended dwell/midline peripheral catheter', 'Leaderflex line', 'long catheter', 'long IV catheter', 'long peripheral cannula', 'long peripheral catheter', 'long peripheral venous catheter', 'long polyurethane catheter', 'midline cannula', 'mini-midline', 'peripheral intravenous catheter', 'Seldinger catheter', 'short midline catheter', 'short long line' and 'ultrasound-guided peripheral intravenous catheter'. The purpose of this editorial is to achieve some level of standardisation in the nomenclature of this device. Is it time to address the confusion? We suggest adopting 'long peripheral catheter'. However, we encourage discussion and debate in reaching a consensus.

Association between delivery methods for red blood cell transfusion and the risk of venous thromboembolism: a longitudinal study.

BACKGROUND: Mechanisms of red blood cell delivery and their contribution to the incidence of venous thromboembolism are not well understood in the clinical setting. We assessed whether red blood cell transfusion through peripherally inserted central catheters (PICCs) affects the risk of venous thromboembolism compared with transfusion through non-PICC devices. METHODS: We implemented a prospective study between Jan 1, 2013, and Sept 12, 2015, in patients (age ≥18 years) admitted to a general medicine ward or intensive care unit who received a PICC for any reason during clinical care in 47 hospitals in Michigan, USA, with a maximum follow-up of 70 days. The exposure of interest was route of red blood cell transfusion. The primary outcome was symptomatic, radiographically confirmed, deep-vein thrombosis in the arm or leg or pulmonary embolism. We used Cox proportional hazards regression for analyses. FINDINGS: Venous thromboembolism developed in 482 (5%) of 10 604 patients with PICCs. Of 788 patients who received a red blood cell transfusion through a multi-lumen PICC, 61 had venous thromboembolism. The adjusted hazard ratio (HR) for venous thromboembolism in all patients whose transfusions were administered through a multi-lumen PICC was 1·96 (95% CI 1·47-2·61; p<0·0001) compared with patients not receiving a transfusion, and was 1·79 (1·09-2·95; p=0·022) compared with patients transfused through a peripheral intravenous line. Compared with delivery through a peripheral intravenous line, venous thromboembolism risk was not elevated if transfusions were delivered through a single-lumen PICC (HR 0·98, 95% CI 0·44-2·14; p=0·95) or central venous catheter (1·50, 0·77-2·91; p=0·23). For every red blood cell unit transfused through a PICC, there was a significantly increased risk of venous thromboembolism (adjusted HR 1·24, 95% CI 1·01-1·52; p=0·037). Patients who received a transfusion through a PICC in the left arm were significantly more likely to develop a deep-vein thrombosis in the ipsilateral arm compared with the contralateral side (HR 23·44, 95% CI 2·96-185·83; p=0·0028). Similarly, patients transfused through a right-sided PICC were more likely to develop deep-vein thrombosis in the ipsilateral arm (HR 3·37, 95% CI 1·02-11·14; p=0·047). INTERPRETATION: Red blood cell delivery through a multi-lumen PICC is associated with a greater risk of thrombosis than transfusion through a peripheral intravenous catheter. Careful monitoring for venous thromboembolism when transfusing red blood cells through multi-lumen PICCs seems necessary. FUNDING: Blue Cross Blue Shield of Michigan and Blue Care Network, as part of the BCBSM Value Partnerships program.

A Randomized Study of SheathLess vs Standard Guiding Catheters for Transradial Percutaneous Coronary Interventions.

BACKGROUND: The small diameter of radial arteries remains a major limitation of the transradial approach for percutaneous coronary intervention (PCI). Sheathless guiding catheters (GCs) might offer an advantage over standard GCs. METHODS: Between 2011 and 2013, we randomized 233 transradial PCIs performed in men with ostial or bifurcation lesions and in all women between standard GC (Medtronic Launcher; Minneapolis, MN) and the SheathLess Eaucath GC (Asahi Intecc, Aichi, Japan). RESULTS: Successful PCI using the transradial approach was not different between the groups (P = 0.74), however the rate of successful transradial PCI with the designated GC (ie, without crossover to the opposing GC) was superior in the SheathLess group compared with the standard GC group (96.5% vs 89.9%; P = 0.047). Safety end point (ie, absence of PCI complication, radial artery occlusion, perforation, pseudoaneurysm, and Early Discharge after Transradial Stenting of Coronary Arteries [EASY] hematoma grade ≥ 2) did not differ between the groups (60.5% in both groups). Mean PCI duration (45.1 minutes vs 45.9 minutes), fluoroscopy (20.1 minutes and 19.9 minutes), and cannulation times (3.6 minutes vs 3.7 minutes), contrast media volume (196 mL vs 187 mL) and conversion to transfemoral approach (1.8% vs 0.8%) were not different between the groups. Patients' subjective assessment revealed less arm pain during navigation of the SheathLess GC (1.9 ± 1.9 vs 4.8 ± 3.6; P < 0.001). Operators graded arm crossability as easier with the SheathLess GC (8.7 ± 1.5 vs 5.1 ± 3.5; P < 0.001). CONCLUSIONS: In selected coronary lesions requiring large-bore catheters in men and in all lesions in women, the SheathLess GC was superior to the standard GC for successful transradial PCI with the designated GC. The SheathLess GC was also associated with easier arm navigation and less patient discomfort.

Port type is a possible risk factor for implantable venous access port-related bloodstream infections and no sign of local infection predicts the growth of gram-negative bacilli.

BACKGROUND: Implantable venous access port (IVAP)-related blood stream infections (BSIs) are one of the most common complications of implantable venous ports. The risk factors and pathogens for IVAP-related BSIs are still controversial. METHODS: We retrospectively reviewed all patients who received IVAPs at a Hospital in Taiwan from January 1, 2011 to June 31, 2014. Two types of venous port, BardPort® 6.6 fr (Bard port) and Autosuture Chemosite® 7.5 fr (TYCO port) were used. All patients with clinically proven venous port-related BSIs were enrolled. RESULTS: A total of 552 patients were enrolled. There were 34 episodes of IVAP-related BSIs during the study period for a total incidence of 0.177 events/1000 catheter days. Port type (TYCO vs. Bard, HR = 7.105 (95% confidence interval (CI), 1.688-29.904), p = 0.0075), age > 65 years (HR = 2.320 (95 % CI, 1.179-4.564), p = 0.0148), and lung cancer (HR = 5.807 (95% CI, 2.946-11.447), p < 0.001) were risk factors for port infections. We also found that no local sign of infection was significantly associated with the growth of gram-negative bacilli (p = 0.031). CONCLUSIONS: TYCO venous ports, age > 65 years, and lung cancer were all significant risk factors for IVAP-related BSIs, and no sign of infection was significantly associated with the growth of gram-negative bacilli.

Safety aspects in patients on hemodialysis with catheters.

Central venous catheter (CVC)-related problems, risks and safety hazards are partly caused by different characteristics of the CVC-based access and their performance features. This chapter covers those issues in a chronological order, from factors related to the choice of the CVC, insertion site and insertion procedure itself, over those associated with CVC use and their monitoring up to safety hazards of interventional procedures. Not discussed are CVC infections as they are covered in a separate chapter in this book.

Gastroenterology-urology devices; reclassification of implanted blood access devices. Final rule.

The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.

Flexible tip guides and intermediate catheters: two center experience and a proposed taxonomy.

BACKGROUND: Stable access to target lesions is foundational to endovascular therapy, be it in hemorrhagic or ischemic disease. Continued evolution in access technology has resulted in next generation catheters that afford improved trackability and proximal support. OBJECTIVE: Assess safety and patterns of use at two high volume centers, and conceptualize usage patterns. MATERIALS AND METHODS: A retrospective review of 608 cases in which a 'next generation' catheter was used during 2008-2010 at Cleveland Clinic (Cleveland, Ohio, USA) and throughout 2009-2010 at Emory University Hospital (Atlanta, Georgia, USA) was conducted, and the cases classified by indication. Catheter placement, distal most location, and related complications were recorded and experience summarized. We also reviewed the differences in the catheters and the rationale for catheter selection, as well as relative costs for each approach. RESULTS: 311 Neuron 053, 166 Neuron 070, 36 distal access catheter (DAC) 3.9 F, 61 DAC 4.3 F, and 34 DAC 5.2 F catheters were deployed. Of these, 459 placements were in the anterior circulation, 130 in the posterior circulation, 11 in the external carotid artery, and eight were used intravenously. Complication rates were 9/131 (6.9%) for the DAC catheter group, 16/311 (5.1%) for the Neuron 053 group, and 14/166 (8.4%) for the Neuron 070 group (p=0.37, χ(2) test). CONCLUSIONS: Next generation access catheters possess characteristics that blend qualities of traditional microcatheters and stiff guide catheters. There was no statistically significant difference in complication rates between the various catheter families in this small retrospective review, and the complication rates were similar to historical complication rates.

Transradial intervention via large-bore guide catheters: a study of coronary bifurcation disease treatment using the crush technique.

Transradial access for coronary intervention significantly reduces vascular complications and may be associated with a reduced risk of major adverse cardiovascular events. However, the small caliber of the radial artery has been considered a limitation to performing complex coronary intervention. Fifty-three patients with true bifurcation disease, in whom a two-stent strategy was felt to be indicated, were scheduled to undergo crush stenting via the transradial approach. Procedural outcome was recorded and 6- and 18-month clinical follow-up was performed. Successful crush stenting via the radial artery was performed in 51/55 lesions (93%). Crush stenting was performed in 53 lesions overall and successful final kissing inflation was achieved in 51/53 (96%). There were no in-hospital or procedural complications. The overall rate of death, myocardial infarction, or target vessel revascularization was 9.8% at 18-month follow-up. Complex percutaneous coronary intervention requiring large-bore catheters can be performed successfully in a high proportion of patients via the transradial approach. Crush stenting, with a very high rate of final kissing inflation, was associated in this series with excellent procedural and medium-term outcomes.