Effect of sutureless securement on hemodialysis catheter-related bloodstream infection.

The use of sutureless securement devices during catheterization might reduce the risk of catheter-related bloodstream infection (CRBSI) by suppressing catheter-exit infection and catheter dislodgement. However, the effectiveness of these devices in reducing CRBSI risk when securing hemodialysis catheters has not been explored. This single-center retrospective observational study examined 211 non-tunneled hemodialysis catheters (NTHCs) from 110 hemodialysis inpatients, of which 121 were secured using conventional skin sutures (Suture group) and 90 with GRIP-LOK (GRIP-LOK group). The stabilized inverse probability of treatment (SIPT)-weighting method was used to generate a new population (SIPT-weighted model) without group differences for each of the 12 predictors of CRBSI development (i.e., age, sex, dialysis history, concomitant acute kidney injury or diabetes, concurrent use of immunosuppressant drugs or aspirin, NTHC insertion site, methicillin-resistant Staphylococcus aureus, carriage, bacteremia event within 3 months before catheterization, hemoglobin level, and serum albumin titer). The effect of GRIP-LOK compared with sutures on CRBSI in the SIPT-weighted model was evaluated using univariate SIPT-weighted Cox proportional regression analysis, which showed a significant CRBSI suppression effect of GRIP-LOK compared with sutures (hazard ratio: 0.17 [95% CI 0.04-0.78], p = 0.023).　GRIP-LOK affords a lower risk of CRBSI due to indwelling NTHCs than conventional securement using sutures.

Complete percutaneous angio-guided approach using preclosing for venoarterial extracorporeal membrane oxygenation implantation and explantation in patients with refractory cardiogenic shock or cardiac arrest.

BACKGROUND: The approach for veno-arterial extracorporeal membrane oxygenation implantation (VA-ECMO) in patients with cardiogenic shock can be either surgical or percutaneous. Complete angio-guided percutaneous implantation and explantation could decrease vascular complications. We sought to describe the initial results of complete percutaneous angio-guided ECMO implantation and explantation using preclosing. METHODS: All consecutive patients who underwent peripheral femoro-femoral VA-ECMO percutaneous implantation for refractory cardiogenic shock or cardiac arrest were enrolled in a prospective registry (03/2018-12/2020). Percutaneous preclosing using two closing devices (Perclose ProGlide, Abbott) inserted before cannulation was used in both femoral artery and vein. Explantation was performed using a crossover technique under angiographic guidance. The occurrence of vascular complication was recorded. RESULTS: Among the 56 patients who underwent percutaneous VA-ECMO implantation for cardiogenic shock or refractory cardiac arrest, 41 underwent preclosing. Femoral vessel cannulation was successful in all patients and total cannulation time was 20 (10-40) min. Weaning from ECMO was possible in 22/41 patients (54%) and 12 (29%) patients were alive at day 30. Significant vascular complications occurred in 2/41 patients. Percutaneous decannulation was performed in 20 patients with 19/20 technical success rate. All femoral arteries and veins were properly closed using the pre-closing devices without bleeding on the angiographic control except for one patient in whom surgical closure of the artery was required. No patient required transfusion for access related significant bleeding and no other vascular complication occurred. Furthermore, no groin infection was observed after full percutaneous implantation and removal of ECMO. CONCLUSION: Emergent complete percutaneous angio-guided VA-ECMO implantation and explantation using pre-closing technique can be an attractive strategy in patients referred for refractory cardiogenic shock.

Sutureless Closure of Arterial Cannulation Sites.

OBJECTIVE: Percutaneous femoral cannulation for venoarterial extracorporeal membrane oxygenation (ECMO) is commonly performed but percutaneous removal of arterial cannulas has not been broadly accepted. We hypothesized that a system that allows endovascular access to ECMO circuits along with the MANTA® large-bore vascular closure device could be used to successfully close arterial ECMO cannulation sites in a large animal model. METHODS: Yorkshire swine (40 to 60 kg, n = 2) were used for this study. In the first swine, the infrarenal abdominal aorta was exposed. The aorta was cannulated once using a 15 Fr cannula and twice with a 19 Fr arterial cannula. A novel adaptor system that facilitates endovascular access to ECMO circuits was connected, and a 0.035″ Benston wire was placed through the adaptor and guided into the aorta. The cannula was removed over the wire and manual pressure was applied. The MANTA® sheath was inserted over the wire followed by the closure unit and was deployed. The process was repeated at 2 separate sites. A similar experiment was performed in a second swine, but through a median sternotomy to cannulate the ascending aorta. RESULTS: Good hemostasis was achieved at all cannulation sites. Angiography demonstrated unobstructed flow across all closure sites with no evidence of extravasation. CONCLUSIONS: The data presented here support the use of the MANTA® vascular closure device for the closure of arterial cannulation sites following ECMO decannulation and demonstrates utility of a novel adaptor system for establishing endovascular access in this context.

Usefulness of fully covered self-expandable biliary metal stents for the treatment of post-sphyncterotomy ERCP bleeding

Background: post-sphyncterotomy endoscopic retrograde cholangiopancreatography (ERCP) bleeding is an adverse event with an estimated incidence rate of 1.34%. There is no established consensus about how to treat this particular type of gastrointestinal bleed. Placement of fully covered self-expandable biliary metal stents (FCSEBMS) has been evaluated as an alternative treatment with positive outcomes and a low complication rate. Aim: to report the results of a cohort of patients with post-sphyncterotomy bleeding treated in a tertiary care referral hospital with FCSEBMS. Methods: a retrospective cases series study was performed including all post-ERCP bleeds treated with FCSEBMS (immediate or delayed) from January 2015 to June 2017. Clinical data, laboratory results and endoscopic reports were collected in order to evaluate the rebleeding rate after endoscopic treatment. Two different scenarios were considered: a) prophylactic stent placement after effective endoscopic treatment; and b) stents placed for the treatment of an active postsphyncterotomy bleed, refractory to standard endoscopic therapy. Results: twenty-two patients (14 male, eight women) diagnosed with postsphyncterotomy bleeding were treated with FCSEBMS placement. The stents were placed prophylactically in 15 patients, while the stents were placed as a treatment for a refractory bleed in seven patients. No differences were found between both groups except for a higher anticoagulation rate in the treatment group. Clinical success was achieved in all but one patient, with no complications in relation to stent placement. Distal migration was described in two of the 22 patients included in the study. Conclusions: temporary placement of FCSEBMS seems to be a technically feasible treatment option for post-ERCP bleeding with a high clinical success rate. The complication rate was low, although randomized studies are needed

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Clinical and economic outcomes of ProGlide compared with surgical repair of large bore arterial access.

Aim: This study compared real-world complication rates, hospitalization duration and costs, among patients undergoing arterial repair using the Perclose ProGlide (ProGlide) versus surgical cutdown (Cutdown). Materials & methods: Retrospective study of matched patients who underwent transcatheter aortic valve replacement/repair, endovascular abdominal aortic aneurysm repair, thoracic endovascular aortic repair or balloon aortic valvuloplasty with arterial repair by either ProGlide or Cutdown between 1 January 2013 and 24 April 2017. Results: Infections and blood transfusions were lower in the ProGlide cohort. Patients in the ProGlide cohort had a 42.5% shorter index hospitalization, which corresponded to US$14,687 lower costs. Conclusion: The use of ProGlide for arterial repair was associated with significantly lower transfusion rates, shorter index hospitalization and lower hospitalization costs compared with surgical cutdown.

Alternative to the finger in the dike: use of the vascular closure button to control postdialysis bleeding in a haemodialysis access conduit.

OBJECTIVE: The purpose of this case series is to describe the application of a vascular closure button (VCB) for the repair of haemodialysis access bleeding. The VCB's main function is not to assist in bleeding control, but instead to provide easy access for removal of tightly placed sutures in the repair. METHODS: A retrospective review of patients undergoing ED repair of persistent bleeding from puncture sites in haemodialysis access conduits (HACs) using a VCB was conducted. Study patients were collected from ED visits to Our Lady of Lourdes Medical Center in Camden, New Jersey, USA, between May 2013 and August 2017. Patients were followed until the time of definitive repair of the underlying pathology or until the end of the study period. RESULTS: Seventeen VCBs were used to control persistent bleeding from HACs in the ED. Sixteen bleeds were the result of recent haemodialysis punctures, while one was from a bleeding site ulcer. All repairs were successful at controlling the bleeding with preserved HAC function in the ED and no delayed thrombosis. Follow-up time ranged from 1 day to 778 days. CONCLUSION: Vascular control buttons provide an effective means to control HAC postdialysis bleeding and allow for ease of suture removal without disruption of a repair with no long-term complications.

Resultados a largo plazo tras el cierre de la orejuela izquierda: ampliando la perspectiva en la prevención no farmacológica del ictus en pacientes con fibrilación auricular / Long-term outcomes following left atrial appendage closure: gaining perspective on non-pharmacological stroke prevention in atrial fibrillation

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Reducción de eventos a largo plazo tras el cierre de la orejuela izquierda. Resultados del Registro Ibérico II / Long-term event reduction after left atrial appendage closure. Results of the Iberian Registry II

Introducción y objetivos: Muchos pacientes con fibrilación auricular no valvular tienen contraindicados los anticoagulantes orales. El objetivo es estimar la incidencia de eventos tromboembólicos y hemorrágicos en pacientes con fibrilación auricular no valvular y cierre de la orejuela izquierda con seguimiento a largo plazo, y determinar los factores asociados con mayor mortalidad a largo plazo. Métodos: Cohorte prospectiva de pacientes reclutados desde 2009 a 2015. Se compararon los eventos tromboembólicos y hemorrágicos con los esperados según las escalas CHA2DS2-VASc y HAS-BLED. Se realizó un análisis multivariable para determinar las variables asociadas con la mortalidad. Resultados: Se reclutó a 598 pacientes (1.093 pacientes-año) con contraindicación de anticoagulantes (mediana de edad, 75,4 años). La tasa de éxito del cierre de la orejuela izquierda fue del 95,8%; 30 pacientes (5%) presentaron complicaciones. Las tasas de eventos (cada 100 pacientes-año) durante el seguimiento (media, 22,9 meses; mediana, 16,1 meses) fueron: muerte, 7,0%; ictus isquémico, 1,6% (frente al 8,5% esperado según CHA2DS2-VASc; p < 0,001); hemorragia intracraneal, 0,8%; hemorragia gastrointestinal, 3,2%, y hemorragia grave, 3,9% (frente al 6,3% esperado por HAS-BLED; p = 0,002). Estos resultados incluso mejoraron en el subgrupo de 176 pacientes con seguimiento > 24 meses (media, 46,6 meses; 683 pacientes-año) para las hemorragias graves, el 2,6% (frente al 6,3% esperado por HAS-BLED; p < 0,033). La edad (HR = 1,1), las hemorragias intracraneales (HR = 6,8) y el ictus (HR = 2,7) se asociaron con mayor mortalidad. Conclusiones: El cierre de la orejuela izquierda redujo significativamente las incidencias de ictus y de eventos hemorrágicos graves y el beneficio se mantuvo. La edad, las hemorragias intracraneales y el ictus se asociaron con mayor mortalidad

Introduction and objectives: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. Methods: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. Results: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). Conclusions: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality

Ictus criptogénico con un foramen oval permeable: ¿cuándo se debe cerrar? / PFO and cryptogenic stroke: when should it be closed?

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Radial versus femoral vascular access in ST-elevation myocardial infarction: Are the results of femoral operators unfairly represented in observational research?

BACKGROUND: Recent randomized controlled trials comparing femoral and radial access in primary percutaneous coronary intervention (PPCI) have shown conflicting results regarding the incidence of major adverse cardiovascular events (MACE) and major bleeding. METHODS: Using data from the HEAT-PPCI trial, we compared the primary efficacy (all-cause mortality, stroke, new myocardial infarction or unplanned repeat revascularization) and safety (major bleeding BARC 3-5) outcomes at 28 days, by final access site used (radial or femoral) and by default operator type. We then assessed outcomes in femoral cases performed by both operator types. RESULTS: Radial access (RA) was associated with fewer MACE (91/1472 = 6.2% vs. 36/332 = 10.8% P = .003) and major bleeding events (38/1472 = 2.6% vs 22/332 = 6.6% P = .001) when compared to femoral access (FA). When analyzing outcomes by default operator type, there was a similar incidence of MACE (111/1575 = 7% vs 16/229 = 7% P = .97) and major bleeding events (49/1575 = 3.1% vs 11/229 = 4.8% P = .18). In cases where FA was performed by default radial operators, there was a higher rate of MACE (22/122 = 18% vs 14/210 = 6.7% P = .003) and major bleeding events (11/122 = 9% vs 11/210 = 5.2% P < .001), potentially explained by a higher risk profile in these cases. CONCLUSION: Default femoral operators achieved comparable outcomes when compared to default radial operators. The less favorable outcomes observed in FA cases may result from its selective use by radial operators in high risk cases.

Transesophageal echocardiography and fluoroscopy for percutaneous closure of atrial septal defects: A comparative study.

The aim of the study was to compare transesophageal echocardiography (TEE) and fluoroscopy for percutaneous atrial septal defect (ASD) closure.This was a retrospective analysis of children who underwent percutaneous ASD closure. The procedure was guided by TEE without fluoroscopy in 130 patients (TEE group) and by fluoroscopy in 163 patients (fluoroscopy group). Baseline demographic/clinical characteristics were recorded. Patients were followed until hospital discharge. Outcomes were procedure duration, peri/postoperative complications, hospital stay, and costs.The TEE and fluoroscopy groups showed no significant differences in age (71.7 ±â€Š40.7 vs 62.5 ±â€Š38.8 months), male/female ratio (54/76 vs 66/97), weight (22.0 ±â€Š12.0 vs 20.1 ±â€Š9.0 kg), ASD diameter (9.9 ±â€Š4.2 vs 9.3 ±â€Š3.9 cm), distances to the superior vena cava (13.4 ±â€Š4.6 vs 13.3 ±â€Š4.2 cm), inferior vena cava (13.4 ±â€Š4.3 vs 13.9 ±â€Š4.1 cm) and atrial septal roof (12.1 ±â€Š4.0 vs 12.3 ±â€Š3.2 cm), or atrial septal size (38.2 ±â€Š6.2 vs 39.4 ±â€Š26.6 cm); distance to the mitral valve was greater in the TEE group (13.2 ±â€Š4.4 vs 11.3 ±â€Š3.9 cm; P < .001). The TEE and fluoroscopy groups showed no significant differences in occlusion device size (14.3 ±â€Š4.6 vs 13.8 ±â€Š4.0 cm) or sheath size (8.7 ±â€Š1.8 vs 8.7 ±â€Š0.9 cm), but procedure duration was shorter in the TEE group (21.5 ±â€Š14.6 vs 28.6 ±â€Š10.9 minutes; P < .001). Postoperative fever (>38°C) occurred less frequently in the TEE group than in the fluoroscopy group (0.8% vs 9.2%; P < .001); there were no significant differences for the other complications. No patient had postoperative residual shunt, occlusion device shedding/displacement, or pericardial effusion. The TEE group had longer hospital stay (3.2 ±â€Š0.6 vs 2.9 ±â€Š0.6 days; P < .001) and higher procedure cost (29,687 ±â€Š4218 vs 28,530 ±â€Š1668 CNY (China Yuan); P = .002) than the fluoroscopy group.TEE-guided percutaneous ASD closure can be used as an alternative to fluoroscopy-guided procedures and avoids the use of radiation or contrast agents.

Vascular complications after percutaneous mitral valve repair and venous access closure using suture or closure device.

OBJECTIVE: The aim of this study was to assess the impact of different access-site closure strategies, suture or closure device (Proglide, Abbott Vascular), on vascular and bleeding complications after percutaneous mitral valve repair (MitraClip, Abbott Vascular). BACKGROUND: Considering the high-risk profile in patients receiving percutaneous mitral valve repair, complications related to the large 24 Fr access sheath and its relation to the closure technique have not been evaluated so far. METHODS AND RESULTS: Between 2009 and 2015, 277 consecutive high-risk patients with severe mitral valve regurgitation (MR) underwent percutaneous mitral valve repair at our institution using Z-suture (n = 150) or closure device (n = 127) to close the access-site. Duplex sonography was performed in all patients. The primary endpoint was access-site related complications according to the Valve Academic Research Consortium (VARC) criteria. Secondary outcomes were the incidence of bleeding complications and mortality. Access-site related VARC2 major and minor complications were comparable after closure with Z-suture or closure device (2,7% vs 3.1%, P = 0.81 and 15,3% vs 15.7%, P = 0.92). Three patients (2%) in the suture and four patients (3.1%) in the closure device group experienced unplanned endovascular intervention at the access site. Access-site related major bleeding was observed in 4 (2.7%) suture and 4 (3.1%) closure device treated patients (P = 0.81). No access site related mortality occurred. CONCLUSION: Both Z-suture and closure device use after percutaneous mitral valve repair are feasible and safe. However, there is no benefit of one strategy over the other according to VARC2 major and minor complications.

Left atrial appendage closure for prevention of death, stroke, and bleeding in patients with nonvalvular atrial fibrillation.

Nonvalvular atrial fibrillation (AF) is the most frequent arrhythmia with a prevalence of 1%-2% in the general population. Its prevalence increases with age and its diagnosis benefits of improvement and simplification of technologies for its detection. Today, AF affects approximately 7% of individuals age>65years and 15%-20% of octogenarians. Due to stasis and activation of coagulation in a fibrillating atrium, patients are at increased risk of thromboembolism, in particular ischemic stroke, with an overall stroke risk of 5% per year. Since the left atrium itself is round and smooth-walled, thrombi typically do not form there, but almost exclusively in the left atrial appendage (LAA), a blind sac-like heterogeneous structure trabeculated by pectinate muscles. In the past five decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) has been the state-of-the art treatment to prevent stroke and systemic embolism from thrombi in AF. In the last decade, nonvitamin K dependant oral anticoagulants (NOAC) have been shown to be overall superior to VKA with respect to efficacy and safety in large trials and registries. Given the safety issues of indefinite OAC with either VKA or NOAC, it is plausible to consider left atrial appendage closure (LAAC) as an alternative strategy for prevention of all three catastrophes for patients with AF on anticoagulation: death, stroke or other systemic embolization, and bleeding. In the past years, LAAC has been compared to VKA in prospective randomized trials, yielding superior results regarding efficacy and non-inferiority regarding safety in the mid-term. Today, the decision to provide the most appropriate treatment for a patient with AF (OAC, NOAC, or LAAC) is complex and needs to be individualized. This review provides a comprehensive update on the current state of LAAC in the field of prevention of death, stroke and bleedings in patients suffering from nonvalvular AF. We describe the pathophysiology of the LAA with regard to stroke, elucidate the evidence and limitations of anticoagulation as the classical treatment paradigm, and review devices and techniques for LAAC. Most importantly, the current clinical evidence on efficacy and safety is outlined and finally, contemporary recommendations for patient selection are provided.

Firth's logistic regression with rare events: accurate effect estimates and predictions?

Firth's logistic regression has become a standard approach for the analysis of binary outcomes with small samples. Whereas it reduces the bias in maximum likelihood estimates of coefficients, bias towards one-half is introduced in the predicted probabilities. The stronger the imbalance of the outcome, the more severe is the bias in the predicted probabilities. We propose two simple modifications of Firth's logistic regression resulting in unbiased predicted probabilities. The first corrects the predicted probabilities by a post hoc adjustment of the intercept. The other is based on an alternative formulation of Firth's penalization as an iterative data augmentation procedure. Our suggested modification consists in introducing an indicator variable that distinguishes between original and pseudo-observations in the augmented data. In a comprehensive simulation study, these approaches are compared with other attempts to improve predictions based on Firth's penalization and to other published penalization strategies intended for routine use. For instance, we consider a recently suggested compromise between maximum likelihood and Firth's logistic regression. Simulation results are scrutinized with regard to prediction and effect estimation. We find that both our suggested methods do not only give unbiased predicted probabilities but also improve the accuracy conditional on explanatory variables compared with Firth's penalization. While one method results in effect estimates identical to those of Firth's penalization, the other introduces some bias, but this is compensated by a decrease in the mean squared error. Finally, all methods considered are illustrated and compared for a study on arterial closure devices in minimally invasive cardiac surgery. Copyright © 2017 John Wiley & Sons, Ltd.

Transcatheter closure of PFO as secondary prevention of cryptogenic stroke.

This article covers the main unsolved issues regarding the potential role that the patent foramen ovale (PFO) plays in the genesis of so-called cryptogenic stroke. Some brief notions of the anatomy and epidemiology of the PFO are outlined. Subsequently, the results of the three trials on secondary prevention (medical therapy vs. transcatheter closure) in patients with PFO and a history of cryptogenic stroke are presented. The conflicting results of numerous meta-analyses derived from the three randomized controlled trials are discussed. Official scientific guidelines dispute an alleged superior efficacy of transcatheter PFO occlusion in comparison with antithrombotic therapy alone (anticoagulants or antiplatelet agents), except for selected cases of patients with documented PFO and a concomitant clinical-instrumental picture of deep venous thrombosis. Nevertheless, considering recent doubts about the presumptive thrombogenic and arrhythmogenic potential of PFO occlusion, which concerns only one of the septal occluders previously used, further in-depth investigations are warranted, centered on the use of newer dedicated devices to be tested in comparison with antithrombotic regimens alone.

Off-label use of the Angioseal vascular closure device for femoral arteriotomy: retrospective analysis of safety and efficacy.

BACKGROUND: Angioseal, an arteriotomy closure device (ACD), functions as a collagen plug that physically closes arteriotomy sites and can simultaneously induce platelet activation and aggregation. When used 'on-label', the safety and efficacy profile of Angioseal is superior compared with those of other ACDs. However, Angioseal is sometimes deployed in less than ideal situations. Therefore, we sought to assess the safety and efficacy of 'off-label' Angioseal use in patients undergoing femoral arteriotomies. METHODS: We performed a retrospective review of all femoral arterial angiograms executed at our institution between 2008 and 2014. Patients whose femoral punctures did not fit the criteria for on-label Angioseal use were included, and were dichotomized based on vascular closure (off-label Angioseal vs manual compression). RESULTS: Of the 521 patients (1023 angiograms) reviewed, 303 (58.2%) patients had off-label Angioseal groin punctures. Mean patient age was 46.2±14.0 years, and 113 were men. 234 patients (77%) had off-label Angioseal deployment while 69 (22%) individuals received manual pressure, serving as controls. Demographic and procedural variables were nearly identical between the two groups but the Angioseal group comprised mostly patients that underwent neurointerventional procedures and thus received intraprocedural heparinization (41%) more often than the manual compression group (19%). The overall rate of major complications associated with off-label Angioseal deployment was low (<0.85%), and clinical complications were not independently associated with Angioseal use (OR 0.76 (95% CI 0.06 to 8.86); p=0.69). CONCLUSIONS: Off-label use of Angioseal was found to be safe and was not associated with an increased complication rate in our cohort.

[Sealing of the hepatic resection area using hemostat devices does not improve results of adequate surgery]. / Versiegelung der Leberresektionsfläche mit Gewebsklebematerialien bewirkt keine weitere Verbesserung adäquater Chirurgie.

PURPOSE: In hepatic resections, there has been a high quality demand. The aim of this systematic clinical, prospective, unblinded unicenter observational study with two arms in an unselected patient cohort was to investigate whether hemostat device can significantly improve outcome in resective liver surgery, in particular, in high risk patients. METHODS: All consecutive patients (mean age, 60.5 [range, 17 - 96] years) who underwent hepatic resection (ntotal = 770) were prospectively documented in a computer-based registry at a university hospital (tertiary center) over a time period of 10 years and retrospectively evaluated specifically with regard to the use (-/+; in daily practice and intraoperative decision-making) of hemostat device (Tissucol(®), n = 59/Tachocomb(®), n = 202/combination, n = 55) indicated (among others) by drainage volume, inflammatory parameters and rate of specific complications (nvalidated = 541 [100 %]). RESULTS: Most frequently, (a-)/typical segmental resections were used: n = 192/90 (3-segment resection, only n = 38). 1) For the assignment of patients to the two different groups (-/+ hemostat device), weight loss and type of resection were found as significant factors (trend: ASA, cirrhosis), for the amount of drainage volume, ASA, sex, Karnofsky Performance Scale and also type of resections using independent distributed statistical tests (such as χ(2), U test [Mann/Whitney]; H test [Kruskal-Willis]; correlation coefficient by Spearman) - no impact: smoking, diabetes, BMI, ethanol. 2) Not taking into account these parameters, the use of hemostat device was characterized by an increased drainage volume (negative control < Tissucol = Tachocomb < combination). 3) Using multifactorial analysis of variance, it was found even under correction by the factors with significant impact elucidated in the single test that the application of hemostat device onto the hepatic resection area resulted unexpectedly rather in an increase than a decrease of the drainage volume but 4) under accompanying more pronounced increase of the white blood cell count (leucocytosis). 5) General and specific complications such as postoperative bleeding, biliary fistula and subhepatic abscess were not further lowered in a significant manner using hemostat device. CONCLUSION: Adequate surgery in the operative management of hepatic resection area cannot further be improved or optimized using hemostat device. In this context, drainage volume may not be considered a sufficient rather an orienting parameter. However, there is an inflammatory response detectable most likely indicated by a(n un-)specific effusion and increase of white blood cell count, which can be interpreted as a) being characteristic for the problematic group of patients, in whom hemostat device was decided to be useful and was finally used in daily prectice, or b) reactive inflammation to foreign material.

Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal(®) Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study.

PURPOSE: To intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal(®) vascular closure device (VCD) and manual compression (MC) in a prospective study design. METHODS: Patients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal(®)-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)]. Results were analyzed in a cross-over design. RESULTS: 48 patients (29 male, median age 62.5 (32-88) years) were included. An ExoSeal(®)-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0-15) vs. 10 (0-80) and 0 (0-75) vs. 25 (0-90), respectively (p < 0.0001). Bedrest after VCD-use was more comfortable than after MC [1 (range 1-7) vs. 6 (2-10); p < 0.0001]. Satisfaction with the closure procedure and with the intervention in general was higher after VCD-use compared to MC [1 (1-3) vs. 5 (2-10) and 1 (1-2) vs. 2 (1-4), respectively; p < 0.0001]. CONCLUSION: Intra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal(®) use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.

Systematic Review of Randomized Controlled Trials Comparing Manual Compression to Vascular Closure Devices for Diagnostic and Therapeutic Arterial Procedures.

PURPOSE: A multitude of vascular closure devices (VCDs) are currently on the market for femoral arteriotomy closure after diagnostic and interventional angiography. Randomized, controlled trials (RCTs) comparing these devices to manual compression (MC) and their effect on time to hemostasis, time to ambulation, time to discharge, and immediate as well as long term complications have been studied. A systematic and through review of these evaluations and outcomes has not previously been performed. MATERIALS AND METHODS: A systematic review was completed to include all available RCTs comparing vascular closure device use to manual compression. Devices meeting inclusion criteria were as follows: VasoSeal® (Datascope Corporation, Montvale, NJ), AngioSeal™ (Sherwood-Davis & Geck, St Louis, MO/St Jude Medical, St Paul, MN), ProGlide® (Abbott Vascular, Abbott Park, IL), ProStar® (Abbot Vascular, Menlo Park, CA), StarClose SE® (Abbott Vascular, Redwood City, CA), ExoSeal™ (Cordis, Warren, NJ), Boomerang™ Wire (Cardiva Medical, Mountainview, CA), FemoSeal™ (St Jude Medical Systems, Uppsala, Sweden), EVS™ (expanded vascular stapling, Angiolink Co, Taunton, MA), X-PRESS™ (X-Site Medical, Blue Bell, PA), Duett™ (Vascular Solutions, Minneapolis, MN), EpiClose-T® (CardioDex Ltd., Tirat Ha Carmel, Israel), and FISH™ (femoral introducer sheath and hemostasis, FISH Device, Bloomington, IN). Vascular closure devices were compared both to manual compression and across all devices used for the following outcomes: time to hemostasis, time to ambulation, time to discharge, and outcomes such as bleeding, hematoma, pseudoaneurysm, limb ischemia, and overall major and minor complications, as well as impact on quality of life, cost analysis, and trends over time. Both diagnostic and interventional procedures were included. RESULTS: PUBMED and MEDLINE searches were carried out for VCDs identifying 1,363 articles. Manuscripts that included manual compression in the study numbered 176. Of these, 34 randomized controlled trials were included. Studies that met inclusion criteria were published from 1992-2015 and described a total of 14,401 patients, 5,659 patients undergoing MC, and 8,742 patients undergoing VCD placement. Overall, the rate of procedural success for VCD patients was 95.7%. The highest rate of unsuccessful device deployment was seen in the ExoSeal™ subset, which averaged 37.9% failure. The overall median time to hemostasis for manual compression was 22.9 minutes compared to VCDs at 5.95 minutes; FemoSeal™ had the shortest median time to hemostasis of 0.75 minutes. When comparing the type of procedure and its median time to hemostasis, MC versus VCD was 17 minutes versus 3.7 minutes for diagnostic procedures and 29.1 minutes versus 7.6 minutes for interventional procedures with similar sheath sizes at 6 and 7 French, respectively. Similarly, median time to ambulation for MC was eight hours compared to 3.5 hours for patients who received a VCD. Median time to discharge was similar at 1.6 days. However, time to discharge has diminished over the last decade comparing MC to VCD, with a median time to discharge of 3.1 versus 2.2 days compared to current trends at 0.8 versus 0.5 days, respectively. The overall rates of complications were similar between MC at 13.1% versus VCDs at 12.2% but varied significantly according to the VCD that was selected. For patients randomized to the vascular closure device who had undergone prior angioplasty, 94.4% of these patients preferred the use of VCD if a further angioplasty were to be performed in the future. A 13% reduction in overall costs with VCD was demonstrated due to earlier discharge and less required time with physician and nursing staff. CONCLUSION: Overall, the review of 34 RCTs demonstrates the utility of VCDs has shortened time to hemostasis, ambulation, and discharge compared to patients receiving MC. Over the last decade, with emphasis on and implementation of same-day procedures, use of VCDs has resulted in a reduction in time to discharge to half a day and a significant decrease in cost. Overall complication rates are similar, but vary between different devices on the market. Better short-term quality of life has also been described with the use of VCDs compared to MC. Further clinical and financial improvements may be found as newer technological advances of VCDs become available.