[Postpancreatectomy hemorrhage]. / Arrozionnye krovotecheniya posle rezektsionnykh vmeshatel'stv na podzheludochnoi zheleze.

Surgical treatment of pancreatic diseases is always associated with a large number of complications. Postoperative hemorrhage is a specific complication of pancreatic surgery requiring a clear classification and surgical strategy. According to literature data, postoperative hemorrhage occurs in 3-30% of cases. Incidence of hemorrhages depends on intraoperative, anamnestic, histological and postoperative factors. Early postoperative hemorrhage (within 24 hours after surgery) is usually a consequence of technical errors in intraoperative hemostasis, perioperative coagulation disorders. The mechanism of delayed bleeding is more complex and often associated with various arrosive factors: pancreatic fistula, biliary fistula, abscess. Currently, there is no a single treatment algorithm for patients with postpancreatectomy hemorrhage. According to various researchers, contrast-enhanced CT is preferred for diagnosis. In recent years, the role of endovascular hemostasis has significantly increased. This problem requires further study and development of a single treatment and diagnostic algorithm that will reduce mortality in these patients.

The Prognostic Significance of Different Bleeding Classifications in off-pump coronary artery bypass grafting.

BACKGROUND: Perioperative bleeding during cardiac surgery are known to make patients susceptible to adverse outcomes and several bleeding classifications have been developed to stratify the severity of bleeding events. Further validation of different classifications was needed. The aim of present study was to validate and explore the prognostic value of different bleeding classifications in patients undergoing off-pump coronary artery bypass grafting (OPCAB). METHODS: Data on baseline and operative characteristics of 3988 patients who underwent OPCAB in Beijing Anzhen Hospital from February 2008 to December 2014 were available. The primary endpoint was a composite of in-hospital death and nonfatal postoperative myocardial infarction (MI). The secondary endpoint was postoperative acute kidney injury (AKI). We explored the association of major bleeding defined by the European registry of Coronary Artery Bypass Grafting (E-CABG), Universal Definition of Perioperative Bleeding (UDPB), Bleeding Academic Research Consortium (BARC) classification and Study of Platelet Inhibition and Patient Outcomes (PLATO) with primary endpoints by multivariable logistic regression analysis and investigated their significance of adverse event prediction using goodness-of-fit tests of - 2 log likelihood. RESULTS: In-hospital mortality was 1.23% (n = 49) and postoperative MI was observed in 4.76% (n = 190) of patients, AKI in 24.69% (n = 985). The incidence of the primary outcome was 5.99% (n = 239). Multivariable logistic regression analysis showed that BARC type 4 (OR = 2.64, 95% CI: 1.66-4.19, P < 0.001), UDPB class 4 (OR = 3.52, 95% CI: 2.05-6.02, P < 0.001) and E-CABG class 2-3 (class 2: OR = 2.24, 95% CI: 1.36-3.70, P = 0.001; class 3: OR = 12.65, 95% CI: 2.74-18.43, P = 0.002) bleeding but not PLATO bleeding were associated with an increased risk of in-hospital death and postoperative MI. Major bleeding defined by all the four classifications mentioned above was an independent risk factor of AKI after surgery. Inclusion of major bleeding defined by these four classifications improved the predictive performance of the multivariable model with baseline characteristics. CONCLUSIONS: Bleeding assessed by BARC, E-CABG and UDPB classifications were significantly associated with poorer immediate outcomes. These classifications seemed to be valuable tool in the assessment of prognostic effect of perioperative bleeding.

Reappraisal of post-pancreatectomy hemorrhage (PPH) classifications: do we need to redefine grades A and B?

BACKGROUND: Post-pancreatectomy hemorrhage (PPH) remains a major complication. The aim of this study was to reappraise the International Study Group of Pancreatic Surgery (ISGPS) classification. METHODS: The clinical utility of the ISGPS classification was tested on consecutive pancreatic resections performed at the Pancreas Institute of the University of Verona Hospital. RESULTS: PPH occurred in 65 of the 2429 patients (6.8%) undergoing pancreatic resection. Outcome of patients without PPH and with grade A PPH were comparable in terms of mortality, length of stay, ICU stay and readmission. Patients with grade B late and mild and grade B early and severe PPH had similar hospital stay and mortality rates, but differed in relaparotomy rate (10.1 vs. 81.2%, p < 0.01). Replacing "time of PPH onset" criterion with post-operative pancreatic fistula (POPF), severe PPH alone, mild PPH/POPF and severe PPH/POPF differed significantly for hospital stay (14 vs. 23 vs. 35 days, p < 0.01) and mortality rate (0 vs. 4 vs. 25%, p = 0.05). CONCLUSION: Grade A PPH shared the same outcome of patients without PPH. Grade B PPH included two categories of patients with different treatment modalities. The use of "concomitant POPF" instead of "time of onset" segregated three discrete categories that differed significantly in terms of clinical outcomes and management.

The role of titanium-prepared platelet-rich fibrin in palatal mucosal wound healing and histoconduction.

OBJECTIVE: We aimed to determine the clinical effects of titanium-prepared, platelet-rich fibrin (T-PRF) on human palatal mucosal wound healing (PMWH) and to identify its effect on time-dependent changes in palatal soft-tissue thickness (PSTT) in terms of histoconduction, which is a new concept. MATERIALS AND METHODS: Free gingival graft (FGG) donor sites were treated with T-PRF and compared with an untreated control group. The results of colour match and H2O2-bubbling tests for complete wound epithelization (CWE) were recorded on days 3, 7, 14 and 21. Pain level, number of analgesics used and bleeding status were recorded for the first 7 days. PSTT was measured at baseline and after 1 and 6 months. RESULTS: Colour match scores of the test group were significantly higher than those of the control group at 7 and 14 days. CWE was observed at a higher frequency in the test group than in the control group on day 14. Post-operative bleeding prevalence was lower in the test group than in the control group for the first 2 days. A time-dependent decrease in PSTT was observed at 1 and 6 months in the control group compared with baseline (baseline, 4.23 ± 0.62 mm; 1 month, 4.01 ± 0.68 mm; and 6 months, 3.93 ± 0.69 mm). However, no significant difference was found in the test group (baseline, 4.29 ± 0.64 mm; 1 month, 4.61 ± 0.51 mm; and 6 months, 4.51 ± 0.58 mm). CONCLUSION: The T-PRF membrane exhibited positive effects on PMWH. T-PRF, which is a promising autogenous matrix for histoconduction, may also be preferred as an autogenous alternative to connective tissue grafts in the treatment of gingival recessions and peri-implant mucosal recessions.

[Symptoms, Diagnostics, Treatment and Classification of 22 Patients with Postpancreatectomy Haemorrhage (PPH) in a Series of 400 Consecutive Pancreatic Head Resections and Pancreatectomies]. / Symptomatik, Diagnostik, Therapie und Klassifikation von 22 Patienten mit Postpankreatektomie-Hämorrhagien (PPH) in einer Serie von 400 konsekutiven Pankreaskopfresektionen und Pankreatektomien.

Introduction: Postpancreatectomy haemorrhage (PPH) is a dangerous complication after pancreatic resection. Patients and Methods: From 2006 to 2015, 400 consecutive pancreatic head resections and pancreatectomies were performed and prospectively documented. This study analysed incidence, treatment and outcome of patients with PPH. Results: Incidence of PPH was 5.5 % (n = 22). PPH occurred in a median of eight days after pancreatic surgery with an equal frequency of symptoms being caused by gastrointestinal bleeding (n = 11) and abdominal bleeding (n = 11). Postoperative pancreatic fistulas (POPF) were significantly more frequent in case of PPH (45 % POPF in case of PPH vs. 20 % POPF in case of no PPH, p < 0.01). PPH was more frequent after pancreatogastrostomy (8/70; 11 %) than after pancreatojejunostomy (11/281; 4 %; p = 0.01). The majority of bleedings after pancreatogastrostomy came from the intragastric cut surface of the pancreas. During the first week, relaparotomy was significantly more frequent (n = 5; 56 %) than in late PPH (n = 1; 8 %; p = 0.01). In late PPH, interventions (angiography; n = 7, endoscopy; n = 4) were more frequent. In 16 severe cases, surgical/interventional bleeding control (n = 12) or relevant transfusions of more than 3 units of packed red blood cells (n = 4) were performed. Compared with the whole group, mortality was significantly increased in case of PPH (13.6 % in case of PPH vs. 3.7 % in case of no PPH; p = 0.03). Conclusion: PPH is an episodic and potentially life-threatening complication with an increased mortality rate, which is frequently associated with impaired healing of the pancreatic anastomosis. Diagnostic investigation and treatment of PPH requires an experienced surgical centre with a close cooperation with endoscopy and (interventional) radiology.

Delayed Bleeding Rate According to the Forrest Classification in Second-Look Endoscopy After Endoscopic Submucosal Dissection.

BACKGROUND AND AIM: Forrest classification is a valid tool to predict rebleeding rate in peptic ulcer, not in post-endoscopic resection ulcer. We evaluated the delayed bleeding rate in Forrest classification II and III lesions when they were not treated in second-look endoscopy. METHODS: Between July 2011 and February 2012, 706 lesions in 656 consecutive patients who underwent second-look endoscopy performed on the second day after endoscopic submucosal dissection (ESD) were prospectively investigated. Endoscopic findings were described according to Forrest classification, and late delayed bleeding was defined as bleeding from second-look endoscopy to 1 month. We evaluated the rate of late delayed bleeding in untreated Forrest classification II and III lesions during second-look endoscopy. RESULTS: Among the 706 gastric tumors analyzed, late delayed bleeding after ESD occurred in 29 lesions (4.1%). At second-look endoscopy, Forrest I lesions (immediately treated by endoscopic hemostasis) were found in 63 cases [Ia, 8 lesions (1.1%); Ib, 55 lesions (7.8%)]; there was no further bleeding after discharge. Forrest II and III lesions (not treated in second-look endoscopy) were found in 643 cases [IIa, 62 lesions (8.8%); IIb, 119 lesions (16.9%); IIc, 460 lesions (65.2 %); III, 2 lesions (0.3%)]; and there was no significant difference in the late delayed bleeding rate between these groups [IIa, 2/62 (3.2%); IIb, 5/119 (4.2%); IIc and III, 22/462 (4.8%); P = 1.000]. CONCLUSIONS: The rate of late delayed bleeding of post-ESD ulcers with non-bleeding visible vessels was not significantly different from that of ulcers with non-visible vessels ( http://cris.nih.go.kr , identifier KCT0000268).

Coronally advanced flap + connective tissue graft techniques for the treatment of deep gingival recession in the lower incisors. A controlled randomized clinical trial.

AIM: The aim of this study was to compare the clinical and aesthetic outcomes of two different surgical approaches for the treatment of deep gingival recession affecting the mandibular incisors. METHODS: Fifty patients with Miller class I and II gingival recessions (≥ 3 mm) in the lower incisors were enrolled. Twenty-five patients were randomly assigned to the control group and the other 25 patients to the test group. All defects were treated with the coronally advanced flap + connective tissue graft (CAF + CTG) and in the test group the labial submucosal tissue (LST) was removed. Post-operative morbidity was evaluated at 1 week. Clinical and aesthetic evaluations were made at 1 year. RESULTS: Statistically greater recession reduction, probability of CRC (adjusted OR 7.94 95% CI = 1.88-33.50, p = 0.0024) and greater increase in GT were observed in the test group. Greater graft exposure and increase in KTH were demonstrated in the control group. Better aesthetics outcomes were observed in the test group. No statistically significant between groups differences were demonstrated in patient analgesic assumption and post-operative discomfort and bleeding. CONCLUSIONS: LST removal during CAF + CTG surgery is indicated to provide better root coverage and aesthetic outcomes in the treatment of gingival recessions affecting the lower incisors.

Standardization of reporting post-tonsillectomy bleeding.

OBJECTIVES: Postoperative bleeding is a well-recognized complication after tonsillectomy. We believe significant variation exists in how bleeding following tonsillectomy is reported and that a standardized system is needed. Our goal was to develop such a system. METHODS: Relevant literature was found on Ovid Medline. Studies published from 1996 to 2009 involving post-tonsillectomy bleeding were analyzed, and data were collected on the basis of strict criteria. A standardized system for reporting post-tonsillectomy bleeding was then developed. RESULTS: A review of the literature found variation in the reporting of post-tonsillectomy bleeding and found that categorization systems for reporting bleeding are often not used. The following standardization system is proposed. Type I is bleeding, historical or observed, that does not require any intervention or control of the bleeding (except for oral rinses or intravenous administration of fluids). Type II is bleeding that requires control with local measures under topical or local anesthesia. Type III is bleeding that requires control with local measures, suture ligation, and/or aggressive cauterization in the operating room. Type IV is bleeding that requires control that includes external carotid artery ligation or embolization. Type V is bleeding that leads to the patient's death. The postoperative day on which the bleeding occurs is also reported. CONCLUSIONS: The literature on tonsillectomy varies greatly in describing and reporting post-tonsillectomy bleeding. We propose a system to standardize the reporting of post-tonsillectomy bleeding.

[The Austrian Tonsil Study 2010 - Part 2: Postoperative haemorrhage]. / "Die Österreichische Tonsillenstudie 2010" - Teil 2: Postoperative Blutungen.

BACKGROUND: Postoperative haemorrhage is the most common and serious complication of tonsil and adenoid surgery. Definitions, frequency and risk factors of postoperative bleedings are however, controversially discussed in the literature. PATIENTS AND METHODS: In a prospective multicenter cohort study all tonsillectomies (TE), adenotonsillectomies (TE + AE), tonsillotomies (TO), adenotonsillotomies (TO + AE) and adenoidectomies (AE) performed within 9 months from October 1st, 2009 - June 30th, 2010 were collected and evaluated. Postoperative haemorrhage was defined as any bleeding after extubation and was classified into 7 grades A1, A2, B1, B2, C, D and E depending on the therapy needed and the postoperative day. RESULTS: Data from 9 405 patients of 32 ENT-departments in Austria were analysed. Overall postoperative haemorrhage rate for TE was 16.0%, for TE + AE 11.8%, for TO±AE 2.3% and for AE 0.8%. Surgical revision was necessary in almost one third of patients with a postoperative bleeding event (TE 5.3%, TE + AE 4.1%, TO 0.8% und AE 0.3%). Multiple haemorrhage occurred in every 5th patient, who experienced postoperative bleeding (1.7% of all patients). The frequency of haemorrhage depended on the type of surgery and the age of the individual. Severe bleedings requiring surgical revision were more frequent in children between 6 and 15 years and AE. 9 patients (1.2% of all patients with haemorrhage) experienced a dramatic haemorrhage (grade D), with the need of blood transfusions and difficult surgical control. No deaths occurred during the study period. CONCLUSIONS: Due to a new classification postoperative bleeding episodes could be precisely defined and postoperative risk factors were quantified. Considering all postoperative bleedings, including minor and anamnestic ones, the haemorrhage rate over all types of surgeries was 7.9% (2.7% of all patients required a surgical revision). Tonsillectomy (with or without adenoidectomy) carries the highest statistical risk of postoperative bleeding, with 4.9% of all patients requiring surgical intervention. Patients who experience one - albeit minimal - postoperative haemorrhage, have a 5 times higher risk for further bleeding requiring surgical control, and should therefore be carefully monitored.

Critical appraisal of the International Study Group of Pancreatic Surgery (ISGPS) consensus definition of postoperative hemorrhage after pancreatoduodenectomy.

PURPOSE: Postpancreatectomy hemorrhage (PPH) is one of the most serious complications after pancreatoduodenectomy (PD). This study analyzed and validated the International Study Group of Pancreatic Surgery (ISGPS) definition of PPH and aimed to identify risk factors for early (<24 h) and late PPH. METHODS: Patients who underwent PD for pancreatic head tumors between 2001 and 2008 were included and complications were prospectively recorded. Factors associated with PPH were assessed by uni- and multivariate analysis. RESULTS: Complete datasets were available for 796 patients. Classic and pylorus-preserving PD was performed in 13.8% and 86.2% of the patients, respectively. According to the ISGPS definition, PPH occurred in 29.1% of the cases (232 of 796 patients): 4.8% grade A, 15.2% grade B, and 9.2% grade C. The definition is based largely on surrogate markers (e.g., transfusion requirement) that are affected by other critical illnesses and more than 97% of patients with mild PPH had no clinical signs of bleeding. The need for postoperative intensive care as well as the incidence of pancreatic fistula, relaparotomy, and mortality rates significantly increased from grades A to C. Thirty-seven patients (4.6%) required interventional (endoscopy or angiography) and/or relaparotomy for PPH. Relaparotomy for PPH was performed in 3.1% of all patients. Independent risk factors for early PPH were preoperative anemia (hemoglobin, <11 mg/dl) and multivisceral resection while advanced age, chronic renal insufficiency, increased blood loss, and long operation time were associated with late PPH. CONCLUSIONS: The ISGPS definition of PPH is feasible and applicable but produces a high rate of false positive mild PPH cases. The different grades still significantly correlate with relevant outcome variables, thus the definition discriminates postoperative courses, but a minor modification of the definition of mild PPH is suggested. The new results further demonstrate the need to optimize preoperative anemia and chronic renal insufficiency.

Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS).

BACKGROUND: A standardized definition of post-hepatectomy haemorrhage (PHH) has not yet been established. METHODS: An international study group of hepatobiliary surgeons from high-volume centres was convened and a definition of PHH was developed together with a grading of severity considering the impact on patients' clinical management. RESULTS: The definition of PHH varies strongly within the hepatic surgery literature. PHH is defined as a drop in haemoglobin level > 3 g/dl post-operatively compared with the post-operative baseline level and/or any post-operative transfusion of packed red blood cells (PRBC) for a falling haemoglobin and/or the need for radiological intervention (such as embolization) and/or re-laparotomy to stop bleeding. Evidence of intra-abdominal bleeding should be obtained by imaging or blood loss via the abdominal drains if present. Transfusion of up to two units of PRBC is considered as being Grade A PHH. Grade B PHH requires transfusion of more than two units of PRBC, whereas the need for invasive re-intervention such as embolization and/ or re-laparotomy defines Grade C PHH. CONCLUSION: The proposed definition and grading of severity of PHH enables valid comparisons of results from different studies. It is easily applicable in clinical routine and should be applied in future trials to standardize reporting of complications.

Moving towards the New International Study Group for Pancreatic Surgery (ISGPS) definitions in pancreaticoduodenectomy: a comparison between the old and new.

BACKGROUND: The International Study Group for Pancreatic Surgery (ISGPS) has proposed several definitions for postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE) and post-pancreatectomy haemorrhage (PPH). We assessed the effects of implementing these definitions on predicting outcomes. METHODS: A database of 77 patients who underwent pancreaticoduodenectomy between January 2005 and December 2009 was analysed. Morbidities were defined and classified using the ISGPS definitions and recalculated based on the definitions adopted by our institution ('Old' definitions) prior to the implementation of ISGPS definitions. Data for the two groups were then compared. RESULTS: The morbidity rate rose to 70.1% from 27.2% when ISGPS rather than Old definitions were used to define morbidities (P < 0.001). Incidences of DGE, POPF and PPH were 20.7%, 39.0% and 10.4%, respectively. Rates of DGE and POPF were significantly higher according to ISGPS definitions than to Old definitions (20.7% vs. 5.2% [P= 0.001] and 39.0% vs. 15.6% [P= 0.004], respectively). According to the ISGPS definitions, all of the 12 additional patients with DGE and 12 of the 18 additional patients with POPF had grade A morbidities. Patients with ISGPS-defined morbidity had a longer intensive care unit (ICU) stay, longer postoperative stay and longer total stay (P= 0.030, P= 0.007 and P= 0.001, respectively). CONCLUSIONS: The morbidity rate more than doubled when ISGPS definitions were applied (an additional 42.9% of patients demonstrated morbidities). The majority of patients with DGE and POPF had grade A morbidities. The ISGPS definitions correlate well with ICU stay, postoperative stay and total length of stay.

Universal definition of perioperative bleeding in cardiac surgery adults and association with mortality in a Mexican Cardiovascular Critical Care Unit.

Background: Bleeding as a complication is associated with poorer results in cardiac surgery. There is increasing evidence that the use of blood products is an independent factor of increased morbidity, mortality, and hospital costs. Dyke et al. established the universal definition of perioperative bleeding (UDPB). This classification is more precise defining mortality in relation to the degree of bleeding. Methods: A descriptive and analytical retrospective study of a database of patients underwent cardiac surgery from January 1, 2016, to December 31, 2017, was performed. The primary objective of the study was to look at mortality associated with the degree of bleeding using the UDPB. Results: A total of 918 patients who went to cardiac surgery were obtained. Most of the population was classified as insignificant bleeding class (n = 666, 72.9%), and for massive bleeding the lowest proportion (n = 25, 2.7%). For the primary outcome of 30-day mortality, a significant difference was found between the groups, observing that it increased to a higher degree of bleeding. This was corroborated by multivariate logistic regression analysis that was adjusted to EuroScore II and cardiopulmonary bypass (CPB) duration, finding an independent association of the bleeding class with 30-day mortality (OR, 95%, 5.82 [2.22-15.26], p = 0.0001). Conclusions: We found that the higher the degree in UDPB was associated with higher mortality independently to EuroScore II and CPB duration for adult patients undergoing cardiac surgery.

Antecedentes: El sangrado como complicación está asociado a peores resultados en cirugía cardiaca. Existe una evidencia cada vez mayor que la transfusión de productos sanguíneos por si solo es un factor independiente de incremento en la morbilidad, mortalidad, y costos hospitalarios. Dyke y colaboradores establecieron la definición universal de sangrado perioperatorio. Esta clasificación es más precisa en definir mortalidad en relación con el grado de sangrado. Material y métodos: Se realizo un estudio descriptivo y analítico de tipo retrospectivo de una base de datos de pacientes que fueron a cirugía cardiaca del 1 enero del 2016 al 31 de diciembre del 2017. El objetivo primario del estudio fue observar la mortalidad asociada con el grado de sangrado utilizando la definición universal de sangrado perioperatorio. Resultados: Se obtuvieron un total de 918 pacientes que fueron a cirugía cardiaca. La mayor parte de la población fue clasificada como clase de sangrado insignificante (n = 666, 72.9%), y para sangrado masivo la menor proporción (n = 25, 2.7%). En el desenlace primario de mortalidad a 30 días se encontró una diferencia significativa entre los grupos, observando que aumentada a mayor clase de sangrado. Esto fue corroborado mediante un análisis multivariado regresión logística que fue ajustado a con EuroScore II y el tiempo de bomba de circulación extracorpórea, encontrando una asociación independiente de la clase de sangrado con mortalidad a 30 días (OR, 95%, 5.82 [2.22-15.26], p = 0.0001). Conclusiones: Encontramos que cuanto mayor era el grado en la UDPB se asociaba con una mayor mortalidad independientemente de EuroScore II y la duración del bypass cardiopulmonar para pacientes adultos sometidos a cirugía cardíaca.

Validation of a definition of excessive postoperative bleeding in infants undergoing cardiac surgery with cardiopulmonary bypass.

OBJECTIVE: To derive and validate an objective definition of postoperative bleeding in neonates and infants undergoing cardiac surgery with cardiopulmonary bypass. METHODS: Using a retrospective cohort of 124 infants and neonates, we included published bleeding definitions and cumulative chest tube output over different postoperative periods (eg, 2, 12, or 24 hours after intensive care unit admission) in a classification and regression tree model to determine chest tube output volumes that were associated with red blood cell transfusions and surgical re-exploration for bleeding in the first 24 hours after intensive care unit admission. After the definition of excessive bleeding was determined, it was validated via a prospective cohort of 77 infants and neonates. RESULTS: Excessive bleeding was defined as ≥7 mL/kg/h for ≥2 consecutive hours in the first 12 postoperative hours and/or ≥84 mL/kg total for the first 24 postoperative hours and/or surgical re-exploration for bleeding or cardiac tamponade physiology in the first 24 postoperative hours. Excessive bleeding was associated with longer length of hospital stay, increased 30-day readmission rate, and increased transfusions in the postoperative period. CONCLUSIONS: The proposed standard definition of excessive bleeding is based on readily obtained objective data and relates to important early clinical outcomes. Application and validation by other institutions will help determine the extent to which our specialty should consider this definition for both clinical investigation and quality improvement initiatives.

Variation in the definitions of bleeding in clinical trials of patients with acute coronary syndromes and undergoing percutaneous coronary interventions and its impact on the apparent safety of antithrombotic drugs.

BACKGROUND: This review compares and contrasts the various criteria used to characterize bleeding (particularly major bleeding) during recent studies of antithrombotic therapies in acute coronary syndromes (ACSs) and/or percutaneous coronary intervention (PCI). METHODS: This review includes an analysis of recent large randomized clinical trials (published between January 2000 and September 2006; n > 3000 patients) evaluating antithrombotic drugs in patients with ACS or patients undergoing PCI who were identified using Medline searches. RESULTS: Bleeding has been shown to correlate with patient mortality and major cardiovascular events. Different definitions of bleeding, other than Thrombolysis In Myocardial Infarction or Global Utilization of Streptokinase and t-PA for Occluded coronary arteries bleeding criteria, were used in 9 of the 13 randomized trials that were identified and enrolled over 178,000 patients in total. These definitions overlapped to a degree but differed substantially. Bleeding rates according to several bleeding criteria within one trial illustrate that different bleeding definitions can lead to markedly different conclusions about the safety of an antithrombotic regimen. The shift toward identifying therapies that specifically attempt to reduce bleeding while maintaining efficacy at reducing ischemic complications increases the need of standardized bleeding definitions. CONCLUSIONS: A task force should be initiated to formulate an internationally accepted, meaningful, and standardized approach for reporting bleeding events. A fixed definition may not work for all disease states throughout ACS and PCI. Rather, a predefined scale of bleeding can be proposed, which moves from a more liberal definition of bleeding for elective PCI to a more conservative definition in other settings such as rescue angioplasty.

Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition.

BACKGROUND: Postoperative hemorrhage is one of the most severe complications after pancreatic surgery. Due to the lack of an internationally accepted, universal definition of postpancreatectomy hemorrhage (PPH), the incidences reported in the literature vary considerably, even in reports from randomized controlled trials. Because of these variations in the definition of what constitutes a PPH, the incidences of its occurrence are not comparable. METHODS: The International Study Group of Pancreatic Surgery (ISGPS) developed an objective, generally applicable definition of PPH based on a literature review and consensus clinical experience. RESULTS: Postpancreatectomy hemorrhage is defined by 3 parameters: onset, location, and severity. The onset is either early (< or =24 hours after the end of the index operation) or late (>24 hours). The location is either intraluminal or extraluminal. The severity of bleeding may be either mild or severe. Three different grades of PPH (grades A, B, and C) are defined according to the time of onset, site of bleeding, severity, and clinical impact. CONCLUSIONS: An objective, universally accepted definition and clinical grading of PPH is important for the appropriate management and use of interventions in PPH. Such a definition also would allow comparisons of results from future clinical trials. Such standardized definitions are necessary to compare, in a nonpartisan manner, the outcomes of studies and the evaluation of novel operative treatment modalities in pancreatic surgery.

Discrepancies in identification of bleeding events after percutaneous coronary intervention.

STUDY OBJECTIVE: To evaluate the level of agreement between two sets of criteria, the Thrombolysis in Myocardial Infarction (TIMI) criteria and investigator-developed criteria, for identifying bleeding events in patients who had undergone a percutaneous coronary intervention (PCI) and to measure length of hospital stay (LOS) as a surrogate marker of bleeding severity. DESIGN: Retrospective chart review. SETTING: Two university-affiliated medical centers. PATIENTS: Four hundred twenty-two consecutive patients who had undergone PCI from December 1, 2001-June 30, 2002. MEASUREMENTS AND MAIN RESULTS: Data were collected on the number of bleeding events that occurred within 1 week after PCI (limited to one event/patient) and on LOS. Bleeding was assessed by TIMI criteria and by investigator-developed criteria. Bleeding according to TIMI criteria included intracranial hemorrhage, spontaneous hematuria or hematemesis, or decreases in hemoglobin level. Bleeding according to investigator-developed criteria included intracranial, retroperitoneal, intraocular, or clinically overt bleeding without a specified decrease in hemoglobin level. Agreement between criteria was assessed by means of the kappa statistic. Of the 422 patients, 23 (5%) experienced TIMI-defined bleeding events and 229 (54%) investigator-defined bleeding events. A kappa value of 0.09 (95% confidence interval 0.06-0.13) indicated a poor level of agreement between the two sets of bleeding criteria. The effect of this discrepancy on LOS was 66 fewer days of care when TIMI criteria were applied versus investigator-developed criteria in the 206 patients who experienced bleeding events that met investigator criteria (total LOS 645 days) but not TIMI criteria (total LOS 579 days). CONCLUSION: Bleeding assessment with use of TIMI criteria versus investigator-developed criteria yielded discrepant bleeding event rates and LOS, making it difficult to accurately compare bleeding rates and consequences across clinical trials and in practice. Consensus bleeding criteria are needed for applications in clinical evaluations of antithrombotic agents.

Validation of Bleeding Classifications in Coronary Artery Bypass Grafting.

Perioperative bleeding is a determinant of poor outcome in patients undergoing coronary artery bypass grafting (CABG), but there is a lack of adequate stratification of its severity. The ability of the European registry of Coronary Artery Bypass Grafting (E-CABG), Universal Definition of Perioperative Bleeding (UDPB), Study of Platelet Inhibition and Patient Outcomes (PLATO), Clopidogrel and Aspirin Optimal Dose Usage to Reduce Recurrent Events-Seventh Organization to Assess Strategies in Ischemic Syndromes (CURRENT-OASIS 7), Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q Wave Coronary Events (ESSENCE), and SafeTy and Efficacy of Enoxaparin in Percutaneous coronary intervention patients, an internationaL randomized Evaluation (STEEPLE) bleeding classifications to predict early mortality, stroke, acute kidney injury (AKI) stage 3, and deep sternal wound infection/mediastinitis was investigated in 3,730 patients from the prospective, multicentre E-CABG registry. Increasing grades of the E-CABG, UDPB, PLATO, and CURRENT-OASIS 7 classifications were associated with increasing risks of early mortality, had similar receiver-operating characteristic area under the curves (>0.7), and were predictive also when adjusted for EuroSCORE II. The E-CABG and UDPB classifications had satisfactory area under the curves (>0.6) in predicting stroke, AKI stage 3, and deep sternal wound infection/mediastinitis even when adjusted for EuroSCORE II. The PLATO and CURRENT-OASIS 7 classifications had similar predictive ability for stroke and AKI stage 3 as confirmed by multivariate analysis adjusted for EuroSCORE II but showed inferior ability in predicting severe wound infection compared to the E-CABG and UDPB classifications. The STEEPLE and ESSENCE classifications had a poor ability of predicting all these adverse events. Decision curve analysis showed a benefit of the E-CABG bleeding classification over the other classifications in predicting all adverse events. In conclusion, the E-CABG, UDPB, PLATO, and CURRENT-OASIS 7 bleeding classifications have a satisfactory ability in predicting adverse events after CABG. Decision curve analysis showed that the E-CABG bleeding classification had the best predictive performance.

Validation of the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) Bleeding Severity Definition.

BACKGROUND: This study evaluated the prognostic significance of a novel bleeding severity classification in adult patients undergoing cardiac operations. METHODS: The European multicenter study on Coronary Artery Bypass Grafting (E-CABG) bleeding severity classification proposes 4 grades of postoperative bleeding: grade 0, no need of blood products with the exception of 1 unit of red blood cells (RBCs); grade 1, transfusion of platelets, plasma, or 2 to 4 units of RBCs, or both; grade 2, transfusion of 5 to 10 units of RBCs or reoperation for bleeding, or both; grade 3, transfusion of more than 10 units of RBCs. This classification was tested in a cohort of 7,491 patients undergoing CABG or valve operations, or combined procedures. RESULTS: The E-CABG bleeding severity grading method was an independent predictor of in-hospital death, stroke, acute kidney injury, renal replacement therapy, deep sternal wound infection, atrial fibrillation, intensive care unit stay of 5 days or more, and composite adverse events of death, stroke, renal replacement therapy, and intensive care unit stay of 5 days or more. The area under the receiver operating characteristic curve of the E-CABG bleeding severity grading method for predicting in-hospital death was 0.858 (95% confidence interval, 0.827 to 0.889). E-CABG bleeding severity grades 0 to 3 were associated with in-hospital mortality rates of 0.2%, 1.1%, 7.9%, and 29.0%, respectively (p <0.001), and with composite adverse events of 2.7%, 9.6%, 29.7%, and 75.8%, respectively (p <0.001). CONCLUSIONS: The E-CABG bleeding severity classification seems to be a valuable tool in the assessment of the severity and prognostic effect of perioperative bleeding in cardiac operations.