Vacuum Drains versus Passive Drains versus No Drains in Decompressive Craniectomies-A Randomized Controlled Trial on Subgaleal Drain Complication Rates (VADER Trial).

OBJECTIVE: Subgaleal drains are generally deemed necessary for cranial surgeries including decompressive craniectomies (DCs) to avoid excessive postoperative subgaleal hematoma (SGH) formation. Many surgeries have moved away from routine prophylactic drainage but the role of subgaleal drainage in cranial surgeries has not been addressed. METHODS: This was a randomized controlled trial at 2 centers. A total of 78 patients requiring DC were randomized in a 1:1:1 ratio into 3 groups: vacuum drains (VD), passive drains (PD), and no drains (ND). Complications studied were need for surgical revision, SGH amount, new remote hematomas, postcraniectomy hydrocephalus (PCH), functional outcomes, and mortality. RESULTS: Only 1 VD patient required surgical revision to evacuate SGH. There was no difference in SGH thickness and volume among the 3 drain types (P = 0.171 and P = 0.320, respectively). Rate of new remote hematoma and PCH was not significantly different (P = 0.647 and P = 0.083, respectively), but the ND group did not have any patient with PCH. In the subgroup analysis of 49 patients with traumatic brain injury, the SGH amount of the PD and ND group was significantly higher than that of the VD group. However, these higher amounts did not translate as a significant risk factor for poor functional outcome or mortality. VD may have better functional outcome and mortality. CONCLUSIONS: In terms of complication rates, VD, PD, and ND may be used safely in DC. A higher amount of SGH was not associated with poorer outcomes. Further studies are needed to clarify the advantage of VD regarding functional outcome and mortality, and if ND reduces PCH rates.

Trends in the use of cerebrospinal drains and outcomes related to spinal cord ischemia after thoracic endovascular aortic repair and complex endovascular aortic repair in the Vascular Quality Initiative database.

BACKGROUND: Spinal cord ischemia (SCI) is a dreaded complication of thoracic and complex endovascular aortic repair (TEVAR/cEVAR). Controversy exists surrounding cerebrospinal fluid drain (CSFD) use, especially preoperative prophylactic placement, owing to concerns regarding catheter-related complications. However, these risks are balanced by the widely accepted benefits of CSFDs during open repair to prevent and/or rescue patients with SCI. The importance of this issue is underscored by the paucity of data on CSFD practice patterns, limiting the development of practice guidelines. Therefore, the purpose of the present analysis was to evaluate the differences between patients who developed SCI despite preoperative CSFD placement and those treated with therapeutic postoperative CSFD placement. METHODS: All elective TEVAR/cEVAR procedures for degenerative aneurysm pathology in the Society for Vascular Surgery Vascular Quality Initiative from 2014 to 2019 were analyzed. CSFD use over time, the factors associated with preoperative prophylactic vs postoperative therapeutic CSFD placement in patients with SCI (transient or permanent), and outcomes were evaluated. Survival differences were estimated using the Kaplan-Meier method. RESULTS: A total of 3406 TEVAR/cEVAR procedures met the inclusion criteria, with an overall SCI rate of 2.3% (n = 88). The SCI rate decreased from 4.55% in 2014 to 1.43% in 2018. Prophylactic preoperative CSFD use was similar over time (2014, 30%; vs 2018, 27%; P = .8). After further exclusions to evaluate CSFD use in those who had developed SCI, 72 patients were available for analysis, 48 with SCI and prophylactic CSFD placement and 24 with SCI and therapeutic CSFD placement. Specific to SCI, the patient demographics and comorbidities were not significantly different between the prophylactic and therapeutic groups, with the exception of previous aortic surgery, which was more common in the prophylactic CSFD cohort (46% vs 23%; P < .001). The SCI outcome was significantly worse for the therapeutic group because 79% had documented permanent paraplegia at discharge compared with 54% of the prophylactic group (P = .04). SCI patients receiving a postoperative therapeutic CSFD had had worse survival than those with a preoperative prophylactic CSFD (50% ± 10% vs 71% ± 9%; log-rank P = .1; Wilcoxon P = .05). CONCLUSIONS: Prophylactic CSFD use with TEVAR/cEVAR remained stable during the study period. Of the SCI patients, postoperative therapeutic CSFD placement was associated with worse sustained neurologic outcomes and overall survival compared with preoperative prophylactic CSFD placement. These findings highlight the need for a randomized clinical trial to examine prophylactic vs therapeutic CSFD placement in association with TEVAR/cEVAR.

Management of chronic subdural hematoma with the subdural evacuating port system: Systematic review and meta-analysis.

The subdural evacuating port system (SEPS) is a minimally invasive option for treating chronic subdural hematoma (cSDH). Individual case series have shown it to be safe and effective, but outcomes have not been systematically reviewed. We sought to review the literature in order to determine the safety and efficacy of SEPS as a first line treatment for cSDH. A comprehensive literature search for outcomes following SEPS placement as a primary treatment for cSDH was performed. The primary outcome was treatment success, which was defined as a composite of improvement in presenting symptoms and no need for further treatment in the operating room. Additional outcomes included discharge disposition, length of stay (LOS), hematoma recurrence, and complications. A total of 12 studies comprising 953 patients who underwent SEPS placement met the inclusion criteria. The pooled rate of a successful outcome was 0.79 (95% CI 0.75-0.83). Frequency of delayed hematoma recurrence was 0.15 (95% CI 0.10-0.21). The pooled inpatient mortality rate was 0.02 (95% CI 0.01-0.03). Complications rates included 0.02 (95% CI 0.00-0.03) for any acute hemorrhage, 0.01 (95% CI 0.00-0.01) for acute hemorrhage requiring surgery, and 0.02 (95% CI 0.01-0.03) for seizure. SEPS placement is associated with a success rate of 79% and very low rates of acute hemorrhage and seizure. This data supports its use as a first-line management strategy, although prospective randomized studies are needed.

Risk factors for spinal cord injury and complications of cerebrospinal fluid drainage in patients undergoing fenestrated and branched endovascular aneurysm repair.

OBJECTIVE: Spinal cord injury (SCI) is one of the most devastating complications of thoracoabdominal aortic aneurysm (TAAA) repair. Cerebrospinal fluid drainage (CSFD) is routinely used to prevent and to treat SCI during open TAAA repair. However, the risks and benefits of CSFD during fenestrated-branched endovascular aneurysm repair (F/B-EVAR) are unclear. This study aimed to determine the risk of SCI after F/B-EVAR and to assess the risks and benefits of CSFD. METHODS: We analyzed 106 consecutive patients with TAAAs treated with F/B-EVAR from 2014 to 2019 in a prospective physician-sponsored investigational device exemption study (G130193). Data were collected prospectively and audited by an independent external monitor. All patients were treated with Cook manufactured patient-specific F/B-EVAR devices or the Cook t-Branch devices (Cook Medical, Bloomington, Ind). CSFD was used at the discretion of the principal investigator. Risk factors for SCI were identified, and CSFD complications were assessed. RESULTS: Prophylactic CSFD was used in 78 patients (73.6%), and 28 patients (26.4%) underwent F/B-EVAR without CSFD. Four patients (3.8%) with prophylactic CSFD developed SCI, including two patients (1.9%) with permanent paraplegia (Tarlov grade 1-2) and two patients (1.9%) with paraparesis (Tarlov grade 3). Multivariate analysis revealed that greater extent of thoracic aortic coverage (odds ratio, 1.06; 95% confidence interval, 1.00-1.11; P = .02) and intraoperative blood loss (odds ratio, 1.00; 95% confidence interval, 1.00-1.002; P = .04) were the significant risk factors for SCI. Six patients (7.6% [6/78]) experienced major CSFD-related complications, including subarachnoid hemorrhage in 2.6% (2), spinal hematoma in 2.6% (2), cerebellar hemorrhage in 1.3% (1), and spinal drain fracture requiring surgical laminectomy in 1.3% (1). Minor CSFD-related complications occurred in 20 patients (25.6% [20/78]), including paresthesia during CSFD insertion (10), minimal bloody cerebrospinal fluid (7), drain malfunction (2), and reflex hypotension (1). Technical difficulties during CSFD catheter placement were noted in seven patients (9.0%). Excluding four patients with SCI, intensive care unit stay was 3.3 ± 4.0 days in the CSFD group vs 1.2 ± 0.9 days in the no-CSFD group (P = .007). Total hospital length of stay was 6.0 ± 4.9 days in the CSFD group vs 3.5 ± 1.9 days in the no-CSFD group (P = .01). CONCLUSIONS: The incidence of SCI after F/B-EVAR with selective CSFD was low, and risk factors for SCI were greater with extent of thoracic aortic coverage and intraoperative blood loss. However, the incidence of major CSFD-related complications exceeded the incidence of SCI, and CSFD significantly increased both intensive care unit and total hospital length of stay. Therefore, routine prophylactic CSFD may not be justified, and a prospective randomized trial of CSFD in patients undergoing F/B-EVAR seems appropriate.

Protocolized Based Management of Cerebrospinal Fluid Drains in Thoracic Endovascular Aortic Aneurysm Repair Procedures.

BACKGROUND: Spinal cord ischemia (SCI) resulting in paraplegia is a devastating complication associated with thoracic endovascular aortic aneurysm repair (TEVAR) whose incidence has significantly declined over time. In this review, we present our experience with a multidisciplinary clinical protocol for cerebrospinal fluid (CSF) drain management in patients undergoing TEVAR. Furthermore, we aimed to characterize complications of CSF drain placement in a large, single center experience of patients who underwent TEVAR. METHODS: This retrospective review is of patients undergoing TEVAR with and without CSF drain placement between January 2014 and December 2019 at a single institution. Patient demographics, hospital course, and drain-related complications were analyzed to assess the incidence of CSF drain-related complications. RESULTS: A total of 235 patients were included in this study, of which 85 received CSF drains. Eighty patients (94.1%) were placed by anesthesiologists, while 5 (5.9%) were placed under fluoroscopic guidance by interventional neurosurgery. The most common level of placement was L3-L4 in 38 (44.7%) cases followed by L4-L5 in 36 (42.4%) cases. The mean duration of CSF drain was 1.9 ± 1.4 days. Complications due to CSF drainage occurred in 5 (5.9%) patients and included partial retainment of catheter, subdural edema, epidural hematoma, headache, and bleeding near the drain site. The overall 30-day mortality rate was 5.5% and did not differ between those who received a CSF drain and those who did not (P = 0.856). The overall incidence of SCI resulting in paraplegia was 1.7% in the studied patients. CONCLUSIONS: A protocol-based CSF drainage program for spinal cord protection involves a multifaceted approach in identification and selection of patients meeting criteria for prophylactic drain placement, direct closed loop communication, and perioperative management by an experienced team. Despite the inherent advantages of CSF drain placement, it is not without complications, thus risk and benefit need to be weighed in context of the procedure and the patient with close communication and team approach.

Bedside Biliary Drainage without Fluoroscopy for Critically Ill Patients.

BACKGROUND: Bedside biliary drainage by endoscopic retrograde cholangiopancreatography (ERCP) without fluoroscopy for critically ill patients in the intensive care unit (ICU) remains challenging for endoscopists. The present study was to evaluate the efficacy and safety of radiation-free ERCP for these patients. METHODS: Consecutive ICU patients with severe pancreaticobiliary disorders who underwent bedside radiation-free ERCP were retrospectively analyzed. RESULTS: Radiation-free ERCP was performed in 80 patients with acute physiology and chronic health evaluation (APACHE II) score of 24.1 ± 6.2. Cannulation was achieved in 75 (93.75%) patients. Biliary drainage was successfully conducted in 74 (92.5%) patients, including 54 (67.5%) and 20 (25.0%) cases of endoscopic retrograde biliary drainage (ERBD) and endoscopic nasobiliary drainage (ENBD), respectively. Adverse event (mild post-ERCP pancreatitis (PEP)) occurred only in 1 case. The 30-day mortality rate of these patients was 36.25% (29/80) and was much more higher in patients with ERBD in contrast to that of patients with ENBD, 40.7% (22/54) vs. 20% (4/20), OR = 2.750, 95%CI = 0.810 - 9.3405, P = 0.110. The APACHE II score in nonsurvivors was significantly higher than survivors, 27.6 ± 4.3 versus 22.2 ± 6.3, P = 0.009. The APACHE II score > 22 was an independent risk factor for mortality, 50% versus 10.7%, 95%CI = 2.148 - 31.569, P = 0.002. CONCLUSIONS: Radiation-free ERCP guided bedside biliary drainage is effective and safe for critically ill patients, and ENBD may be an optimal procedure due to a low mortality in these patients.

Analysis of treatment methods and prognostic factors in 354 cases of hilar cholangiocarcinoma: A cohort study.

CONTEXT: Better management strategies are needed to improve the survival of patients with hilar cholangiocarcinoma (HCCA). AIMS: This study was designed to examine the effects of different treatment methods on survival and prognostic factors in HCCA. SETTINGS AND DESIGN: We retrospectively analyzed the clinical data of 354 patients with HCCA treated at our institution from 2003 to 2013. MATERIALS AND METHODS: Patients were divided into three groups according to the treatment: the radical resection group, the nonradical resection group, and the biliary drainage-only group. STATISTICAL ANALYSIS USED: The Kaplan-Meier method was used to compare survival rates between the groups, and the independent prognostic factors were assessed using the Cox proportional hazards model. RESULTS: There were 110 patients in the radical resection group, 93 patients in the nonradical resection group, and 151 patients in the biliary drainage-only group, and they showed differing survival rates: 1-year survival rates of 70.7%, 49.5%, and 31.3%; 2-year survival rates of 62.9%, 24.7%, and 9.0%; 3-year survival rates of 34.7%, 4.0%, and 0%; and median survival of 21.7 months, 13.6 months, and 8.7 months, respectively. The radical resection group had the longest overall survival (P< 0.001). Treatment method, albumin (ALB), total bilirubin (TBIL), postoperative pathological T-stage, and distant metastasis were identified as independent prognostic indicators of survival. CONCLUSIONS: Radical resection significantly increases survival in patients with HCCA, and an increase in ALB and a decrease in TBIL improve the prognosis of patients with HCCA.

Minimally invasive surgery and transsulcal parafascicular approach in the evacuation of intracerebral haemorrhage.

Intracerebral haemorrhage (ICH) describes haemorrhage into the brain parenchyma that may result in a decline of the patient's neurological function. ICH is a common cause of morbidity and mortality worldwide. Aggressive surgical treatment for ICH has remained controversial as clinical trials have failed to demonstrate substantial improvement in patient outcome and mortality. Recently, promising mechanical and pharmacological minimally invasive surgery (MIS) techniques for the treatment of ICH have been described. MIS was designed with the objective of reducing morbidity due to complications of surgical manipulation. Mechanical MIS includes the use of tubular retractors and small diameter instruments for ICH removal. Pharmacological methods consist of catheter placement inside the haematoma cavity for the passive drainage of the haematoma over the course of several days. One of the most favourable approaches for MIS is the use of natural corridors for reaching the lesion, such as the transsulcal parafascicular approach. This approach provides an anatomical dissection of the subjacent white matter tracts, causing the least amount of damage while evacuating the haematoma. A detailed description of the currently known MIS techniques and devices is presented in this review. Special attention is given to the transsulcal parafascicular approach, which has particular benefits to provide a less traumatic MIS with promising overall patient outcome.

Factors associated with mortality in patients with infected pancreatic necrosis: the "surgery effect".

Severe acute pancreatitis complicated by infection is associated with high mortality. Invasive treatment is indicated in the presence of infected (suspected) pancreatic and/or peripancreatic necrosis (IPN) in the absence of response to intensive medical support. Step-up approach (SUA) has been demonstrated to lower complication rate compared to upfront open surgery. However, this approach has not been associated with lower mortality, and no factors have been studied that could help to identify the high risk patients. In this study, we aimed to analyse those factors associated with mortality following the invasive treatment of IPN, focusing on the role of surgical necrosectomy. A retrospective and observational study based on a multicentre prospective database was conducted. The database was coordinated by the Hospital General Universitario de Alicante, Spain and the Spanish Association of Pancreatology. Demographics, clinical data, and laboratory and imaging findings were collected. Atlanta 2012 criteria were considered to classify acute necrotizing pancreatitis and for the definition of IPN. Step-up approach was used in all centres with the intention of avoiding surgery whenever possible. Surgical necrosectomy was performed by open approach. From January 2013 to October 2014, a total of 1655 patients with the diagnosis of acute pancreatitis were included in our database. 1081 were recruited for the final analysis. Out of them, 205 (19%) were classified into acute necrotizing pancreatitis. 77 (8.3%) patients underwent invasive treatment of INP and were included in our study. Overall mortality was 29.9%. Upfront endoscopic or percutaneous drainage was performed in 60 (77.9%) patients and mortality was 26.6%. Out of 60, 22 (36.6%) patients subsequently received rescue surgery; mortality in rescue surgery group was 18.3%. Upfront surgery was carried out in 17 (22.1%) patients; mortality in this group was 41%. At univariate analysis, surgical necrosectomy, extrapancreatic infection, immunosuppression and de-novo haemodialysis were associated with mortality. At multivariate analysis, only surgical necrosectomy was significantly associated with mortality (p = 0.002 OR 3.89). Surgical approach for IPN is associated with high mortality rate. However, these data should be interpreted with caution, since we are not able to assess whether this occurs due to the need of surgery as the only resort when the other approaches are not feasible or fail.

Subglottic secretion drainage for preventing ventilator-associated pneumonia: an overview of systematic reviews and an updated meta-analysis.

Although several guidelines recommend subglottic secretion drainage as a strategy for prevention of ventilator-associated pneumonia (VAP), its use is not widespread. With the aim to assess the effectiveness of subglottic secretion drainage for preventing VAP and to improve other outcomes such as mortality, duration of mechanical ventilation and length of stay in the intensive care unit (ICU) or hospital, an electronic search of the Cochrane Library, MEDLINE, Web of Science and Embase was undertaken. Nine systematic reviews with meta-analysis (in the overview of reviews) and 20 randomised controlled trials (in the updated meta-analysis) were included.In the overview of reviews, all systematic reviews with meta-analysis included found a positive effect of subglottic secretion drainage in the reduction of incidence of VAP. In the updated meta-analysis, subglottic secretion drainage significantly reduced VAP incidence (risk ratio (RR) 0.56, 95% CI 0.48-0.63; I2=0%, p=0.841) and mortality (RR 0.88, 95% CI 0.80-0.97; I2=0%, p=0.888).This is the first study that has found a decrease of mortality associated with the use of subglottic secretion drainage. In addition, subglottic secretion drainage is an effective measure to reduce VAP incidence, despite not improving the duration of mechanical ventilation and ICU and/or hospital length of stay.

Drain placement confers no benefit after carotid endarterectomy in the Vascular Quality Initiative.

OBJECTIVE: Whereas bleeding complications requiring a return to the operating room (OR) after carotid endarterectomy (CEA) are infrequent (1%), they are associated with an increased 30-day combined postoperative stroke or death rate. Drain placement after CEA varies among vascular surgeons, and there are limited data to support the practice. The goal of this study was to evaluate factors leading to drain placement and the effect of drains on postoperative outcomes including return to OR for bleeding, stroke, and death. METHODS: There were 47,752 patients identified undergoing CEA using the Vascular Quality Initiative registry from 2011 to 2015. Demographic, preoperative, and intraoperative factors between patients who underwent CEA with (n = 19,425) and without (n = 28,327) drain placement were compared. End points included return to the OR for bleeding, stroke, death, postoperative wound infection, and hospital length of stay. We then compared postoperative outcomes between groups using mixed effect logistic regression models to control for correlation within center. Similar methods were used to show relationship between return to OR for bleeding and other variables. Subgroup analysis of patients with drain placement was compared among centers with high (>66.7% of cases), medium (33.3%-66.7%), and low (<33.3%) use. RESULTS: Patients with drain placement were more likely to be taking a preoperative P2Y12 antagonist (P < .001), to have prior CEA or carotid artery stenting (P < .001), to use dextran (P < .001), and to have a concomitant procedure or coronary artery bypass graft (P < .001) and less likely to use protamine (P < .001) compared with those without drain placement. Drain placement did not prevent return to the OR for bleeding (P < .22). Re-exploration of the carotid artery after closure in the OR (P < .001), preoperative P2Y12 antagonist use (P < .001), and no protamine use (P < .001) were predictors for return to the OR for bleeding among those with drain placement. Of patients requiring return to the OR for bleeding, drain placement did not influence 30-day stroke (P = .82), 30-day mortality (P = .43), or 30-day combined stroke/mortality (P = .42) compared with those without drain placement. Drain placement did not influence postoperative wound infection (P < .3). Hospital length of stay was increased in patients with drain placement (P < .001). Return to the OR for bleeding (P = .24), wound infection (P = .16), and length of stay (P = .94) did not differ between the groups of high, medium, and low drain use. CONCLUSIONS: Drain placement after CEA does not reduce return to the OR for bleeding, nor does it reduce perioperative stroke or death. Drain placement is associated with increased length of stay.

A Comparison of Subperiosteal or Subgaleal Drainage with Subdural Drainage on the Outcomes of Chronic Subdural Hematoma: A Meta-Analysis.

OBJECTIVE: The aim of the present study was to compare the outcomes of patients with chronic subdural hematoma after undergoing burr hole craniotomy with subperiosteal or subgaleal drainage (SPGD) with those of patients who have undergone burr hole craniotomy with subdural drainage. METHODS: We searched 4 databases (PubMed, Web of Science, Embase, and Cochrane Library) for relevant reports from January 1995 to September 2019. Two reviewers recorded the major outcomes data as follows: recurrence, mortality, postoperative seizures, postoperative bleeding events, surgical infection, pneumocephalus, modified Rankin scale scores, and Glasgow outcome scale scores. The pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: A total of 3149 patients from 10 studies were included in our analysis. Compared with the SSD group, the SPGD group had a lower recurrence rate (OR, 0.72; 95% CI, 0.57-0.91) and a smaller risk of postoperative bleeding (OR, 0.41; 95% CI, 0.22-0.78). Also, no significant differences were found in the incidence of mortality (OR, 0.79; 95% CI, 0.54-1.18), postoperative seizures (OR, 0.74; 95% CI, 0.39-1.40), surgical infection (OR, 0.98; 95% CI, 0.55-1.76), pneumocephalus (OR, 0.58; 95% CI, 0.28-1.20), modified Rankin scale score 0-3 (OR, 1.04 at discharge; OR, 1.33 at 6 months), and Glasgow outcome scale score 4-5 (OR, 1.48; 95% CI, 0.82-2.67). CONCLUSIONS: Burr hole craniotomy with SPGD can be recommended as an effective and safe surgical therapy for patients with chronic subdural hematoma owing to its lower recurrence rate and reduced incidence of postoperative brain injuries, in addition to no increase in the rate of some postoperative complications. However, more studies are necessary for further confirmation.

Risk Factors, Management, and Outcomes of Pyogenic Liver Abscess in a US Safety Net Hospital.

BACKGROUND: The causes and management of pyogenic liver abscess (PLA) have undergone multiple changes over the past decades. It is a relatively rare disease in the USA, and its incidence rate in the USA is increasing. The last US community hospital experience of PLA was published in 2005. We performed a retrospective study of patients admitted with PLA to an urban safety net hospital. AIMS: To ascertain risk factors, management approaches, and outcomes of PLA. METHODS: Electronic medical record was queried for diagnosis codes related to PLA during the years 2009-2018. Clinical information was compiled in an electronic database which was later analyzed. Main study outcomes were in-hospital mortality, 30-day readmission rate, and intensive care utilization rate. RESULTS: A total of 77 patients with PLA were admitted in the study period. Most common risk factors were diabetes mellitus (23.4%), previous liver surgery (20.7%), and hepatic malignancy (16.9%). 89% of patients were treated with percutaneous drainage or aspiration, and surgical drainage was reserved for other with other indications for laparotomy. In-hospital mortality, 30-day readmission, and intensive care utilization rates were 2.6%, 7% and 22%, respectively. Median length of stay was 11 days (inter-quartile range 7). Rate of antimicrobial resistance in abscess fluid cultures was 40%; 13 cases of Klebsiella pneumoniae liver abscess were noted in our cohort, most of whom were Hispanic or Asian. CONCLUSIONS: PLA was principally managed by percutaneous drainage or aspiration with good outcomes. Further studies investigating the racial predilection of K. pneumoniae liver abscesses could reveal clues to its pathogenesis.

Medicolegal Characteristics of Cardiac Tamponade Litigation: A Review of the LexisNexis Academic Database.

OBJECTIVE: To review, describe, and analyze medicolegal literature involving cases of cardiac tamponade. BACKGROUND: Currently, there are no studies known to these authors assessing the outcome patterns of medicolegal cases involving patients with cardiac tamponade. This potentially lethal condition may have serious consequences on both patients and clinicians. Thus, the literature was reviewed for patterns of liability and medical outcomes in patients who developed cardiac tamponade. METHODS: Legal case opinions were reviewed from LexisNexis Academic that contained the search term "tamponade"; case characteristics, litigation outcomes, and medical outcomes were identified. RESULTS: 230 case opinions were reviewed. 143 involved cardiac tamponade. Of these cases, 77 were medical malpractice cases, 30 were criminal cases, 11 were insurance claims, and the rest were other types. In malpractice cases, 35 (45%) patients were male, 69 (90%) formally named at least one doctor as a defendant, 54 (70%) claimed iatrogenicity as a cause of tamponade, and surgeons were the most commonly named defendants at 36 cases (47%). Open surgical drainage was the most common treatment at 28 (36%) cases and death was the outcome in 60 (78%) cases. Judgements were in favor of at least one doctor in 29 (42%) cases, against at least one doctor in 13 (19%) cases, and 12 (17%) cases involved a settlement by a physician. CONCLUSIONS: This study describes previously unknown medicolegal characteristics of cardiac tamponade cases.

No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene-Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial.

PURPOSE: To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction. MATERIALS AND METHODS: After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared. RESULTS: Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178-438 d) for covered and 442 d (95% CI, 172-712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68-124 d) with covered stents and 75 days (95% CI, 42-108 d) with uncovered stents (P = .6). CONCLUSIONS: In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.

The use of intra-abdominal drain in minimally invasive right colectomy: a propensity score matched analysis on postoperative outcomes.

PURPOSE: No evidences supporting or not the use of intra-abdominal drain (AD) in minimally invasive right colectomies have been published. This study aims to assess the outcomes on its use after robotic or laparoscopic right colectomies. METHODS: This is a multicenter propensity score matched study including patients who underwent minimally invasive right colectomy with (AD group) or without (no-AD group) the use of AD between February 1, 2007, and January 31, 2018. AD patients were matched to no-AD patients in a 1:1 ratio. Main outcomes were postoperative morbidity and mortality and anastomotic leak. RESULTS: A total of 653 patients were included. Of 149 (22.8%) no-AD patients, 124 could be matched. The rate of postoperative complications (AD n = 26, 21% vs. no-AD n = 26, 21%; p = 1.000), mortality (AD n = 2, 1.6% vs. no-AD n = 1, 0.8%; p = 1.000), anastomotic leak (AD n = 2, 1.6% vs. no-AD n = 5, 4.0%; p = 0.453), and wound infection (AD n = 9, 7.3% vs. no-AD n = 6, 4.8%; p = 0.581) did not significantly differ between the groups. Time to oral feeding was significantly shorter in the no-AD group [2 (1-3) vs. 3 (2-3), p = 0.0001]. The median length of hospital stay was 8 (IQR 7-9) in the AD group while it was 6 (IQR 5-9) in the no-AD group (p = 0.010). CONCLUSIONS: In conclusion, the use of AD after minimally invasive right colectomies has no influence on postoperative morbidity and mortality rates.

Effectiveness of Combined External Ventricular Drainage with Intraventricular Fibrinolysis for the Treatment of Intraventricular Haemorrhage with Acute Obstructive Hydrocephalus.

BACKGROUND: Intraventricular haemorrhage (IVH) patients with acute obstructive hydrocephalus (AOH) who require external ventricular drainage (EVD) are at high risk for poor outcomes. Intraventricular fibrinolysis (IVF) with low-dose recombinant tissue plasminogen activator (rtPA) can be used to improve patient outcomes. Here, we evaluated the impact of IVF on the risk of death and the functional outcomes in IVH patients with AOH. METHODS: This prospective cohort study included IVH patients with hypertensive intracranial haemorrhage complicated by AOH who required EVD. We evaluated the risk of death and the functional outcomes at 1 and 3 months, with a specific focus on the impact of combined EVD with IVF by low-dose rtPA. RESULTS: Between November 30, 2011 and December 30, 2014, 80 patients were included. Forty-five patients were treated with EVD alone (EVD group) and 35 received IVF (EVD+IVF group). The 30- and 90-day mortality rates were lower in the EVD+IVF group than in the EVD group (42.2 vs. 11.4%, p = 0.003, and 62.2 vs. 20%, p < 0.001, respectively). The Graeb scores were significantly lower in the EVD+IVF group than in the EVD group (p ≤ 0.001) during the first 3 days and on day 7 after assignment. The 30-day good functional outcome (modified Rankin Scale [mRS] score 0-3) was also higher in the EVD+IVF group than in the EVD group (6.7 vs. 28.6%, p = 0.008). However, the 90-day good functional outcome (mRS score 0-3) did not significantly increase in the EVD+IVF group (30.8% in the EVD group vs. 51.6% in the EVD+IVF group, p = 0.112). CONCLUSIONS: In our prospective observational study, EVD+IVF was associated with a lower risk of death in IVH patients. EVD+IVF improved the chance of having a good functional outcome at 1 month; however, this result was no longer observed at 3 months.

The effect of technical details of percutaneous catheter drainage on the clinical outcomes of infected necrotizing pancreatitis patients

Background/aim: This study aimed to investigate the effect of technical details of percutaneous catheter drainage (PCD) on the clinical outcomes of patients with infected necrotizing pancreatitis (INP). Materials and methods: A total of 44 INP patients treated in our hospital from October 2013 to October 2015 were included. The correlations of the first PCD treatment data and the clinical outcomes were analyzed. Results: The number of catheters was positively correlated with hospital readmission (r = 0.335, P = 0.032). Receiver operating characteristic curve analysis showed that patients with ≥ 3 catheters were more likely to have hospital readmission. Patients with pleural effusion undergoing thoracentesis were more likely to have new intensive care unit admission (P = 0.025) and bleeding in need of intervention (P = 0.032). Patients with more effusion regions had higher incidences of mortality (P = 0.012) and new intensive care unit admissions (2.44 ± 1.03 vs. 1.88 ± 0.80; P = 0.059). Patients with PCD only were less likely to have new intensive care unit admissions (22.22% vs. 54.55%; P = 0.038) than those with PCD + small incision or/and videoscopic assisted retroperitoneal debridement. Conclusion: Number of catheters greater than three was associated with unfavorable outcomes of PCD treatment in INP patients. Patients that received PCD treatment only had better outcomes.

Endoscopic biliary drainage in unresectable biliary obstruction: the role of endoscopic ultrasound-guidance in a cohort study.

BACKGROUND AND STUDY AIMS: the use of endoscopic ultrasound-guided biliary drainage (EUS-BD) has increased in cases of failed endoscopic retrograde cholangiopancreatography (ERCP) and there are some concerns. The main aim of the study was to determine the role of EUS-BD in a palliative case cohort. The secondary aim was to compare the efficacy, safety and survival of EUS-BD and ERCP procedures. PATIENTS AND METHODS: this was an observational study at a single tertiary institution, with a consecutive inclusion from January 2015 to December 2016. The inclusion criteria were unresectable tumors of the biliopancreatic region with an indication of BD. Statistical comparison analysis was performed between the ERCP and EUS-BD groups. The incidence between groups was compared using the Chi-square and Fisher exact tests. The log rank test was used to compare the risk of death. RESULTS: fifty-two cases with an indication of palliative BD were included in the study. Transpapillary drainage via ERCP was possible in 44 procedures and EUS-BD was required in eight cases; 15.4% of the cohort and seven using lumen apposing metal stent (LAMS). The technical and clinical success of global endoscopic BD was 100% and 88.5% (ERCP: 84.6% and 78.9%; EUS-BD: 100% and 62.5%, respectively). Pancreatitis was the most frequent adverse event (AE) in the ERCP group (9.62%) and bleeding in the EUS-BD (25%). There were fatal AEs in ERCP (1.9%) and EUS-BD (25%) cases. Patient survival was higher with ERCP transpapillary stents compared to EUS-guided stents, which was statistically significant (p = 0.007). CONCLUSIONS: the requirement of EUS-BD in palliative biliopancreatic pathology is not marginal. EUS-BD is associated with a lower survival rate and a higher rate of fatal AE, which argues against its use as a first choice procedure.