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Acute GI bleeding in the setting of supratherapeutic international normalized ratio in patients taking warfarin: endoscopic diagnosis, clinical management, and outcomes.

BACKGROUND: Acute GI bleeding is a life-threatening complication of warfarin therapy. Acute GI bleeding in patients with an international normalized ratio of 4.0 or greater (supratherapeutic) is often attributed to trivial mucosal lesions. The aim of the study was to determine the frequency of potentially significant lesions that would warrant endoscopy in this setting. METHODS: A retrospective review was conducted of patients treated with warfarin who were admitted to a single Veterans Affairs hospital from 1996 to 2000 with acute GI bleeding. Endoscopic findings, clinical management, and outcomes are reviewed for patients with a supratherapeutic international normalized ratio (>or=4.0) and compared with patients with an international normalized ratio in the therapeutic range (2.0-3.9). RESULTS: Fifty-five patients with an international normalized ratio of 4.0 or greater (mean 8.4 [3.9]) and 43 patients with an international normalized ratio between 2.0 and 3.9 (mean 2.9 [0.6]) were hospitalized with acute GI bleeding. Thirty-seven patients (67%) with a supratherapeutic international normalized ratio and GI bleeding underwent upper endoscopy. Of these, 81.1% had positive findings, 18.9% had peptic ulcer disease, and 7.2% required endoscopic treatment. Thirty-eight percent of the patients with a supratherapeutic international normalized ratio underwent lower endoscopy; of these, 57.1% had abnormal findings and 9.5% required endoscopic treatment. Four patients (7.3%) in the supratherapeutic international normalized ratio group died during the index hospitalization. When patients with GI bleeding and a therapeutic international normalized ratio were compared with those with a supratherapeutic international normalized ratio, there were no significant differences between the two groups with regard to days of hospitalization, units of blood transfused, frequency of recurrent bleeding, need for surgery, or in-hospital deaths. CONCLUSIONS: The high frequency of clinically significant lesions in patients taking warfarin with an international normalized ratio in the supratherapeutic range and acute GI bleeding supports a role for endoscopic evaluation.

Acute Disease↗

Initial factors predicting rebleeding and death in bleeding peptic ulcer disease.

OBJECTIVE: Bleeding peptic ulcer constitutes approximately half of the cases admitted with upper gastrointestinal bleeding. Although the bleeding episode stops spontaneously in most of them, rebleeding occurs in as much as 10-30% of them and has a mortality rate of 5-10%. In this study, we have evaluated the possible significant predictors associated with this adverse outcome. METHODS: The records of 205 patients admitted to gastrointestinal bleeding unit (GIBU) in Riyadh Central Hospital, during the period May 1996 through to April 1999, with endoscopic confirmed diagnosis of bleeding peptic ulcer disease were reviewed for demography, clinical presentation, hematology, biochemistry, initial blood pressure, nasogastric lavage color, co-morbid disease and endoscopic findings. All the significant factors found initially (P<0.05) were entered into odds ratio and its 95% confidence interval and finally the unconditioned logistic regression model was used to find out the significant independent predictors for both rebleeding and mortality in these patients. RESULTS: The majority of patients (85%) were males and below the age of 60 (73%). Duodenal ulcer was the source of bleeding in 84%. Endoscopy was performed in all patients within 24 hours of admission. Only 15% were actively bleeding at the time of initial endoscopy. Thirty-six patients (17%) rebelled, majority within 72 hours of initial hemostasis. Overall, 11 patients (5%) died, 6 of them were rebleeders. Initial presentation of systolic blood pressure <100 mm Hg, blood in nasogastric tube and visible vessel within the ulcer in endoscopy were independent predictors of rebleeding while initial systolic blood pressure <100 mm Hg and age >60-years were independent predictors of mortality. CONCLUSION: Improvement of outcome in patients with bleeding peptic ulcer disease can be achieved by early detection of those patients who are at risk of adverse outcome. Patients with the above mentioned independent predictors of rebleeding and mortality are best managed in the intensive care unit with endoscopic hemostasis and proton pump inhibitor (PPI) therapy for a minimum of 5-days of admission.

Adult↗

Bleeding complications associated with peritoneal dialysis catheter insertion.

OBJECTIVE: To identify the incidence of bleeding complications associated with peritoneal dialysis catheter insertion. DESIGN: Retrospective review at a tertiary-care center of all double-cuffed Tenckhoff catheters placed surgically from 1 January 1992 to 1 October 2003 to identify the incidence of major bleeding complications occurring with catheter insertion. Major bleeding episodes were defined as > or = 3% decline in hematocrit, or the need for surgical intervention or blood transfusion within 2 weeks of insertion. RESULTS: 292 catheters had been inserted in 263 patients. Six patients satisfied the criteria for a major bleeding event, for a major bleeding complication rate of 2%. Bleeding was associated with perioperative anticoagulation in 3 patients, uremia and thrombocytopenia in 1 patient, aspirin use and thrombocytopenia in 1 patient, and 1 patient experienced intraoperative bleeding. Coagulation parameters were not obtained prior to the procedure in 2 of the 6 patients. CONCLUSION: The rate of serious bleeding complications related to catheter insertion is low and usually associated with anticoagulation. Holding anticoagulation therapy for a minimum of 24 hours during the postoperative period should eliminate much of the risk. Coagulation parameters should also be obtained and corrected preoperatively.

Catheterization↗

Value of early capsular endoscopy for severe gastrointestinal bleeding.

This case illustrates the importance of early capsule endoscopy in cases of severe rectal bleeding when initial diagnostic tests do not document the site of bleeding. Although this case occurred in a community hospital capable of performing capsule endoscopy, I practice at a city hospital that serves the poor and underserved and currently does not have capsule endoscopy capability. Over the years, we have seen several cases of severe rectal bleeding where the site of bleeding was never identified, despite multiple diagnostic procedures short of capsule endoscopy. Often times, the bleeding stops spontaneously or ends in emergency surgery where morbidity or mortality is increased. Physicians like myself need to be made aware of this relatively new diagnostic tool that provides added value to standard diagnostic tests for evaluating severe rectal bleeding of unknown etiology. Early identification of the site of rectal bleeding may curtail the need for multiple transfusions, resolve economical burden, and reduce morbidity and mortality associated with severe rectal bleeding.

Aged↗

Endoscopy in gastrointestinal bleeding. Are we beginning to realize the dream?

Fiberoptic endoscopy has enabled clinicians to make accurate diagnoses of the cause of acute upper gastrointestinal (GI) bleeding, but, contrary to expectation, that information by itself has not led to improved morbidity or mortality in patients with upper GI bleeding. However, the identification of the so-called stigmata of recent hemorrhage and the subsequent development of effective endoscopic treatments of bleeding lesions have provided hope, based on evidence from numerous clinical trials, that some patients with acute upper GI bleeding will benefit from endoscopic intervention. Injection sclerotherapy, now standard treatment for bleeding esophageal varices, is capable of controlling acute variceal bleeding and is equally effective or better than surgical procedures such as portosystemic shunts and esophageal transection. The question remains whether sclerotherapy of esophageal varices improves survival. With regard to therapeutic endoscopy of bleeding ulcers, multipolar electrocoagulation, laser photocoagulation, and injection of various agents all may be effective and beneficial. All of these methods appear to be capable of controlling acute bleeding and may improve survival, but because of the safety and low cost of injection therapy, that treatment ultimately may be preferred.

Endoscopy, Gastrointestinal↗

[Factors participating in development of bleeding varices in portal hypertension. Part II: Possible impact of kidney damage and malnutrition, mortality].

An acute bleeding from oesophageal varices as a result of portal hypertension is a frequent and serious complication of liver cirrhosis. The development of oesophageal varices and their rupture depends on the portal pressure. However, a range of other factors can contribute to a development of bleeding and its negative prognosis. A sample of 46 patients admitted for the acute bleeding has been compared to 48 cirrhosis patients hospitalised for other conditions in this work. There were significantly higher levels of nitrogenous matters in bleeding patients (urea 14.1 mmol/l vs. 7.78 mmol/l, p < 0.01, creatinine 129.8 micromol/l vs. 106.04 micromol/l, p = 0.09). Perhaps it can't be said that impaired renal functions alone increase the risk of bleeding. From this point of view they could rather be seen as definite prognostic markers of the degree of portal hypertension. Moreover, there was a decreased level of total proteins in bleeding patients (60.7 g/l vs. 69.9 g/l, p < 0.01) at a mild nonsignificant decrease of albumin (26.64 g/l vs. 28.51 g/l). Cirrhotic patients are known to suffer from malnutrition and there is a possibility that malnutrition can contribute to development of bleeding. A prognostic marker of mortality was a considerable impairment of liver function (bilirubin 97.4 micromol/l vs. 57.4 micromol/l; p = 0.1 and prolonged prothrombin time 1.99 INR vs. 1.56 INR; p = 0.09) and impaired kidney function (creatinine 166.7 micromol/l vs. 114.9 micromol/l, p = 0.09). Therefore a care of a good renal function must be a part of the complex care of bleeding patients.

Adult↗

Peptic ulcer bleeding: is Helicobacter pylori a risk factor in an endemic area?

BACKGROUND/OBJECTIVE: A high prevalence of Helicobacter pylori infection has been reported in Iran. Although the importance of H. pylori in the induction of peptic ulcer disease is clearly defined, only few studies have addressed its role in bleeding from peptic ulcers. We evaluated the role of H. pylori in peptic ulcer bleeding. METHODS: Patients with acute peptic ulcer bleeding (PUB) and those with peptic ulcer disease without bleeding ('controls') were enrolled. Upper GI endoscopy and rapid urease test were performed in both groups. Histological study for detection of H. pylori was performed in patients with active bleeding, if RUT was negative. Other variables evaluated included sex, age, smoking, previous history of bleeding, non-steroidal anti-inflammatory drugs use, ulcer size, ulcer location, and duration of acid-peptic disease. Multivariate logistic regression analysis was performed to identify independent risk factors. RESULTS: 161 patients with PUB and 287 control patients were enrolled. H. pylori infection was seen more frequently in patients with duodenal ulcer than gastric ulcer (88.9% vs. 60.5%, p< 0.001). Univariate analysis showed that patients with PUB were more often male, older in age, used NSAID, had history of PUB in the past, had ulcer located in the stomach and not in the duodenum, and more often had large ulcer (>1 cm). Logistic regression analysis showed that H. pylori infection was protective in PUB after controlling for confounders (OR 0.41, 95% CI 0.21-0.79), when ulcer location was not entered in the model. A second model including ulcer location (to test for a residual effect) showed that H. pylori infection was not a significant risk factor in PUB (OR 0.61, 95% CI 0.30-1.24). CONCLUSIONS: H. pylori may not be an independent factor in bleeding from peptic ulcers. The lower frequency of this infection in these patients can be described by the higher frequency of bleeding from gastric ulcers, which are less H. pylori related compared with duodenal ulcer.

Adult↗

Clinical and endoscopic features of peptic ulcer bleeding in Malaysia.

The characteristics of patients and the endoscopic features of 196 patients with bleeding peptic ulcer in a multi-ethnic population were investigated. There was a male preponderance (M: F= 6.3: 1) and their mean age was 63.5 years. The prevalence of peptic ulcer bleeding in the Malays and Indians was similar to the ethnic distribution of population. However, the Chinese were over represented. Nearly 40% of patients studied had at least one co-existing medical illness. Hypertension and ischaemic heart disease were the most common diseases. History of non-steroidal anti-inflammatory drug usage was identified in 48% of the patients and it was the commonest risk factor associated with bleeding ulcers. More than 80% of bleeding ulcers were located in the duodenum and the pylorus. Endoscopic features of active bleeding or recent bleed were identified in more than 60% of the patients. The study notes that bleeding peptic ulcer is a serious and a potentially life threatening condition. It is a disease of the elderly and, with the steadily increasing elderly population in the country, the admissions rates of peptic ulcer bleeding is expected to rise. There is a need to plan for appropriate technical support, critical care facilities and expertise to avoid unacceptable outcomes.

Adult↗

Massive, life-threatening bleeding in Crohn's disease.

BACKGROUND: Acute lower gastrointestinal bleeding is a rare complication in Crohn's disease (CD). MATERIALS AND METHODS: We characterized the clinical features and course of such bleeding in six of 156 patients with CD, treated between 1985 and 2003 at our institution. The data on the patients were gathered through retrospective data analysis. RESULTS: The six patients discussed here consisted of three males and three females, ranging in age from 17 to 42 years. Three patients were known to have CD, whereas three presented with acute bleeding, as the initial symptom of CD. There were 11 separate episodes of severe hemorrhage: three patients bled only once, two bled twice, and one bled four times. The precise bleeding site was correctly identified in four of eleven episodes: twice by colonoscopy and twice by angiography. Primary bleeding episodes subsided without surgery in four of six patients, but three of these four patients re-bled massively, and surgery followed in two of these cases. An emergency surgery was necessary to stop the hemorrhage in four patients; two of them underwent surgery during their first haemorrhagic episodes, and two patients underwent surgery during a repeated episode of hemorrhage. As a consequence, one ileectomy and three ileocolectomies had to be performed. During follow-up of the resected patients, no recurrence of haemorrhagic or non-haemorrhagic CD was observed in three patients two, five, and six years after surgery and only one patient required further therapy three years after surgery for recurrent bleeding. For this, super selective embolization of the periphery branch of the superior mesenteric artery was used. Two non-resected patients are doing well in a course of remission. CONCLUSION: A conservative approach may be suggested as first-line therapy, but surgery is inevitable in patients suffering from massive bleeding and in patients with recurrent bleeding.

Adolescent↗

[Acute bleeding in the Crohn's disease].

Acute bleeding is a rare, however a very serious complication of the Crohn's disease. Stabilization of the circulation, identification of its source and a consecutive therapeutical strategy remain the principal problem of its management. In addition to classical diagnostic methods, such as colonoscopy, enteroscopy, angiography or radionucleotide scanning, several other methods have emerged recently, e.g. capsule endoscopy, angiography in combination with methylene blue application and angio-CT, all of them enabling to identify the source of the bleeding. Although conservative therapeutical methods have advanced considerably, the bleeding relapse rates remain high. Surgical intervention is essential in unstable patients with massive bleeding and is frequently applied in patients with relapsing bleeding. The surgical treatment results with respect to postoperative mortality rates and to bleeding relapse rates and to relapse rates of the disorder itself, are very good. The haemorrhaging form of the Crohn's disease is considered a specific phenotype prone to relapses of bleeding, although in other Crohn's disease patients the massive bleeding does not occur during the course of the disease.

Acute Disease↗

[Clinical analysis of gastrointestinal bleeding after cardiac surgery].

OBJECTIVE: To explore early diagnosis, treatment and prevention of gastrointestinal (GI) bleeding after cardiac surgery. METHODS: In the last 13 years, cases complicated with GI bleeding after cardiac surgeries were analyzed retrospectively. RESULTS: Fourty-four GI bleeding occurred post-operatively in (6 +/- 3) d. The mortality was 23% (10/44). Thirty-eight were located in upper GI tract, of them 26 underwent conservative therapy while 4 died of other than GI bleeding cause; six underwent laparotomy while 1 and 3 died of septicemia and multi-organ failure respectively; six underwent gastric endoscopic hemostasis by electrocautery or clipping the bleeding vessel while all survived. Six were located in lower GI tract, and 2 of them underwent laparotomy without finding bleeding section and died of multi-organ failure. By multivariable logistic regression analysis, deaths were highly related to the post-operative ventilator-dependence, acute renal insufficiency, intra-aortic balloon pump (IABP) assisting and laparotomy. CONCLUSION: The mortality of GI bleeding after cardiac surgeries is very high, early gastrointestinal endoscopic examination and minimally invasive intervention can treat this complication more effectively. GI bleeding must be prevented whenever complicating post-operative ventilator-dependence, acute renal insufficiency, and IABP assisting after cardiac surgery.

Adult↗

Analysis of 1242 cases with upper gastrointestinal system bleeding in Southeastern Turkey: a different etiologic spectrum.

BACKGROUND/AIMS: There are few detailed reports on gastrointestinal system bleeding in Turkey. The aim of this study is to analyze the characteristics of the patients with upper gastrointestinal system bleeding who were hospitalized in our clinic. METHODOLOGY: The patients who were hospitalized in Dicle University Hospital Department of Gastroenterology from March 1992 to June 2002 were analyzed retrospectively. RESULTS: During this period of time, 296 females (23.8%) and 946 males (76.2%), total 1242 patients were hospitalized for upper gastrointestinal system bleeding. Mean age was 47 for both sexes. Distribution of the cases was as follows: 31.6% duodenal ulcer (n: 393), 30.5% esophageal variceal bleeding (n: 379), 13.7% erosive gastritis (n: 171), 6.8% erosive duodenitis (n: 85), 4.9% gastric ulcer (n: 62), 2.8% carcinoma (n: 35), and 3.5% other causes. Peptic ulcer related bleeding was the most encountered reason (37.5%, n: 466). Four percent of the cases other than esophageal variceal bleeding underwent urgent surgical intervention. Eleven percent of the cases (n: 138) resulted in death of which 65.9% were esophageal variceal bleeding (n: 91). CONCLUSIONS: The most striking result is the very high rate of esophageal variceal bleeding. This finding is in concordance with the high prevalence of the viral hepatitis in the region.

Esophageal and Gastric Varices↗

Treatment of peptic ulcer severe bleeding.

The success of a defined management policy op peptic ulcer haemorrhage which incorporates endoscopic therapeutic intervention depends on the early identification of a high risk group of patients and a high risk group of ulcers. The high risk group of patients consists of those likely to experience further bleeding on the basis of clinical prognostic indicators: shock and severe anaemia on admission and the pattern of bleeding; or tolerate rebleeding and emergency surgery poorly: patients over 60 years and those with associated disease. UGI endoscopy should be performed early (within 6-12 hours) in this group in order to identify the bleeding point and provide prognostic information regarding the risk of further haemorrhage. Peptic ulcers with major stigmata of recent bleeding (spurting or non-bleeding visible vessel) have high risk of rebleeding, the risk is even greater when major stigmata of recent haemorrhage (SRH) are associated with shock on admission. Patients with such ulcers should be monitored intensively and receive endoscopic haemostatic treatment in order to terminate active haemorrhage or prevent rebleeding thereby avoiding the need for emergency surgery with its attendant morbidity and mortality. Patients with ulcers with minor or no SRH have a very low risk of rebleeding and don't require intensive monitoring or endoscopic treatment and can be discharged from hospital early. Ulcers which cannot be completely characterized have an intermediate risk of rebleeding and should be managed as high risk lesions. Secondary to the anatomy of the visible vessel any haemostatic endoscopic treatment should be applied around, but avoiding, the sentinel clot. Well-designed randomized controlled trials of endoscopic haemostatic treatment of peptic ulcer haemorrhage in which stratification of risk was based on the SRH, have demonstrated for non-bleeding vessel a significant reduction in rebleeding and in emergency surgery, for spurting bleeding benefit was found only for the rebleeding risk. No advantage was demonstrated in each group of patients in term of mortality. Such studies also demonstrate the superiority of the Nd:YAG laser over the Argon laser. Perforation is a rare complication of Nd:YAG laser photocoagulation (less than 1%). Precipitation or aggravation of arterial haemorrhage during treatment of a visible vessel, as a result of a direct hit, is a more frequent complication (0-29%). Further laser treatment is successful in terminating 75% of these induced bleeds, the remainder requiring surgery. Preinjection of the ulcer with adrenaline does not appear to prevent this complication.(ABSTRACT TRUNCATED AT 400 WORDS)

Gastroscopy↗

Factors identifying higher risk rectal bleeding in general practice.

BACKGROUND: Rectal bleeding is a common symptom. The ability to distinguish those patients having serious underlying pathology from those with self-limiting conditions is a continuing dilemma in general practice. AIM: To determine the factors affecting the predictive and diagnostic value of rectal bleeding for bowel cancer in primary care. DESIGN OF STUDY: One-year prospective observational study. SETTING: Three large general practices. METHOD: Three hundred and nineteen consecutive patients over the age of 34 years consulting their GPs with rectal bleeding were included in the study. Investigation was by flexible sigmoidoscopy or a questionnaire and review of all patients took place after 18 months. The main outcome measures were consultation rates; the prevalence of cancer, colitis and significant polyps in patients presenting with rectal bleeding; its diagnostic value when occurring with or without a change in bowel habit, perianal symptoms and abdominal pain. RESULTS: The consultation rate for rectal bleeding in patients over the age of 34 years was 15 per 1000 per year; 3.4% had colorectal cancer. The prevalence of cancer increased to 9.2% when the rectal bleeding was associated with a change in bowel habit, and to 11.1% when it was without perianal symptoms. Thirty-six per cent of cancer patients had a palpable rectal mass. CONCLUSION: Over 96% of the patients who present to their GPs with rectal bleeding do not have cancer. Greater awareness of the diagnostic value of the different symptom combinations of rectal bleeding could help GPs adopt different management strategies for patients at higher and very low risk of cancer.

Abdominal Pain↗

Endoscopic approaches to upper gastrointestinal bleeding.

Treatment for most patients with upper gastrointestinal bleeding has shifted from the operating room to the endoscopy suite. Endoscopic treatment has resulted in substantial benefit for patients with bleeding from peptic ulcer. Ulcers associated with high-risk stigmata of recent hemorrhage (SRH) not treated endoscopically have 40 per cent to 100 per cent risk of continued or recurrent bleeding and up to a 35 per cent chance of requiring surgical control of bleeding. Endoscopic therapy has reduced the risk of recurrent bleeding to 10 per cent to 20 per cent and the need for surgery to 5 per cent to 10 per cent. These improvements translate to shorter hospital stays, fewer transfusions, lower costs, and less morbidity. Similar progress has been made for patients bleeding from esophageal varices. Mortality for a first variceal bleed is now approximately 20 per cent as compared with 40 per cent to 60 per cent in past decades. Rebleeding after initially successful endoscopic hemostasis is often best treated by a second attempt at endoscopic control. The decision regarding management of recurrent bleeding should be made at the time initial endoscopic control is achieved. Local factors such as experience of the endoscopic team, availability of interventional radiologists, and individual patient characteristics should guide these decisions. Failures of endoscopic control and patients with massive hemorrhage still require operative intervention.

Esophageal and Gastric Varices↗

Factors participating in the development and mortality of variceal bleeding in portal hypertension--possible effects of the kidney damage and malnutrition.

BACKGROUND/AIMS: Acute bleeding from esophageal varices due to portal hypertension is a frequent and severe complication of liver cirrhosis. The development of esophageal varices as well as their rupture depends on the level of portal pressure; however, a number of other factors may play a negative role in the rise of bleeding and its prognosis. METHODOLOGY: The report presented has compared a set of 46 patients admitted to hospital for acute bleeding with 48 cirrhotics hospitalized for other reasons. RESULTS: Bleeding patients had significantly higher level of nitrogenous substances (urea 14.1 mmol/L vs. 7.78 mmol/L, p < 0.01, creatinine 129.8 micromol/L vs. 106.04 micromol/L; p = 0.09). The disturbed renal function in itself probably does not increase the risk of bleeding, it may be rather considered a certain prognostic index of the portal hypertension degree. Bleeding patients had a lower level of total protein (60.7 g/L vs. 69.9 g/L; p < 0.01) with only slight insignificant decrease of albumin (26.64 g/L vs. 28.51 g/L). Cirrhotic patients are known to suffer from malnutrition and it is possible that malnutrition shares negatively and directly in the rise of bleeding. CONCLUSIONS: A prognostic index of mortality was a more conspicuous disorder of hepatic function (bilirubin 97.4 micromol/L vs. 57.4 micromol/L; p = 0.1; prolonged prothrombin time 1.99 INR vs. 1.56 INR; p = 0.01) and again the disorder of renal function (creatinine 166.7 micromol/L vs. 114.9 micromol/L; p = 0.09). Therefore, the maintenance of good renal function must be a component of complex therapy given to bleeding patients.

Adult↗

Bleeding risk in interventional pain practice: assessment, management, and review of the literature.

The rarity of published bleeding complications with respect to the practice of interventional pain medicine suggests two possibilities: techniques are being performed in a manner to minimize bleeding or the process of hemostasis is very forgiving. Hence, bleeding complications may increase if techniques are not performed with due skill or if the process of hemostasis is impaired. Interventional pain physicians may be well acquainted with the technical aspects of procedures, but the degree of their expertise in the field of coagulation is unclear. This monograph will review coagulation physiology, coagulation pathophysiology, common anticoagulants, and minor and major bleeding complications associated with interventional pain and regional anesthetic procedures. This manuscript will present a tool to help stratify the risk of bleeding with specific techniques and specific hemostatic abnormalities. The Overall Risk of Significant Bleeding score may help interventional pain practitioners in their individualized assessment of bleeding risk. If used collectively, this tool may help improve patient safety and data collection, with respect to bleeding complications.

Journal Article↗

Thrombo-embolic and bleeding complications in patients with mechanical valve replacements--a prospective observational study.

BACKGROUND AND OBJECTIVES: Long-term anticoagulation therapy is essential to prevent thrombo-embolic events in patients with mechanical valve replacements. In order to offer indigent patients mechanical heart valve replacement surgery, dedicated anticoagulation clinics are necessary for follow-up. This study assessed the safety and efficacy of lifelong oral anticoagulation therapy in Johannesburg General Hospital mechanical heart valve replacement recipients. The incidence of bleeding and thrombo-embolic complications was documented in three groups of patients with mechanical valve replacements. The groups included patients with aortic valve replacements (AVRs), mitral valve replacements (MVRs) and double (aortic and mitral) valve replacements (DVRs). MATERIALS AND METHODS: A prospective observational study was conducted over a 4-month period. Data on 306 patients attending the Johannesburg General Hospital anticoagulation clinic between 2000 and 2005 were analysed. Of the total patients selected, 205 were assigned to the mechanical valve replacement group (which included 63 patients with AVRs, 93 with MVRs and 49 with DVRs); a control group of 101 nonmechanical valve replacement patients were also included. At each visit the level of anticoagulation was assessed from the international normalised ratio (INR) values, and the presence of bleeding and/or thrombo-embolic complications was documented. RESULTS: There were a total of 51 bleeding and thrombo-embolic complications in the study population. Patients with DVRs had a higher proportion of combined complications (30.61%) than patients with single valve replacements (14.29% in the AVR group and 18.05% in the MVR group) and patients in the control group (12.87%). There were 38 bleeding complications, 30 minor and 8 major. Twelve thrombo-embolic events were documented. Individually, there was no significant difference in thrombo-embolic and bleeding complications between the subgroups. Eighty-two per cent of patients in the mechanical valve replacement group were within the therapeutic range for anticoagulant control (INR 2.5-3.5) v. 54% in the control group (INR 2.0-3.0). Anticoagulant control was of a high quality and was not a contributing factor to the incidence of bleeding and/ or thrombo-embolic complications. CONCLUSION: The finding of a low incidence of bleeding and thrombo-embolic complications in patients with mechanical valve replacements supports the continued placement of mechanical valves in our setting and use of oral anticoagulation therapy at an INR of 2.5-3.5. However the increased risk of both bleeding and thrombo-embolic complications in the DVR group is cause for great concern and warrants further investigation.

Administration, Oral↗