ALBERT

Beschreibung: Background We examined data from acutely ill medical patients enrolled in The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) to determine factors that are independently associated with an increased risk of bleeding during hospitalization. Methods Patients ≥18 years old, hospitalized for ≥3 days with an acute medical illness have been enrolled consecutively since July 2002. Exclusion criteria are: therapeutic antithrombotics/thrombolytics at admission; major surgery or trauma during 3 months prior to admission; and venous thromboembolism (VTE) treatment within 24 hours of admission. Patients with bleeding immediately prior to, or at admission were excluded from this analysis. Factors considered were: age, ICU stay, reduced creatinine clearance, severe infection, cerebrovascular stroke, cancer, diabetes, severe renal failure, hypertension, lower limb paralysis, bleeding disorders, hemorrhagic stroke, thrombocytopenia, gastro-duodenal ulcer, hepatic failure, central venous catheter at admission, hormonal therapy for cancer, platelet count, BMI, immobility, and length of hospital stay. Factors increasing the risk of bleeding were identified by univariate analysis (P≤0.20) and included in a multiple logistic regression model. Factors with significance of P≤0.05 were retained in the model. Bleeding events were defined as major or clinically significant non-major according to published criteria (Büller HR et al. N Engl J Med.2003;349:1695–702). Results . Data were from 2816 patients enrolled up to 30 June 2004 in 34 hospitals in 10 countries. Patients were: 48% female, mean age 64 years, mean weight 72 kg, mean length of hospital stay 12 days, and 37% were immobile for ≥3 days (median duration of immobility 6 days, including immobility immediately prior to admission). Only 89 (3.2%) patients had in-hospital bleeding: 1.2% major, 1.9% clinically significant non-major, 0.1% unspecified. Factors that were independently associated with an increased risk of bleeding (major or non-major) in acutely ill medical patients are shown in Table 1. Conclusion Only 3.2% of acutely ill medical patients in IMPROVE had in-hospital bleeding. Major bleeding (1.2%) was similar to that observed in a major clinical trial on VTE prophylaxis, MEDENOX (1.0%; Samama et al. N Engl J Med.1999;341:793–800). Advanced age, contrary to the belief of many physicians, was not independently associated with an increased risk of bleeding. Final results will be presented with adjustment for the influence of VTE prophylaxis and antiplatelet drugs. Table 1. Factors independently associated with an increased risk of bleeding in acutely ill medical patients Factor OR 95% CI *compared with creatinine clearance 〉60 mL/min (normal renal function) Bleeding disorder 8.38 3.53–19.90 Active gastro-duodenal ulcer 4.26 1.86–9.76 Hepatic failure 2.97 1.26–6.96 Creatinine clearance

Beschreibung: Introduction : Cancer patients undergoing surgery have double the risk for VTE compared with non-cancer patients (Thromb Haemost2003;90:446–55). Current ACCP guidelines advocate the use of VTE prophylaxis in patients with active malignancy undergoing major surgical procedures. The recent ENDORSE survey reported that globally, 64% of patients admitted to surgical wards were at risk for VTE, and only 59% of these received ACCP-recommended prophylaxis (Lancet2008;371:387–94). In this subanalysis of ENDORSE, we evaluated the prevalence of VTE risk and prophylaxis practices in surgical patients with active malignancy. Methods: The ENDORSE study evaluated data from 30,827 patients admitted to surgical wards in 358 hospitals across 32 countries (Lancet2008;371:387–94). The influence of active malignancy on VTE risk and prophylaxis use was assessed in patients who had undergone abdominal, urological or gynecological surgery. Patient data were grouped and analyzed according to whether the surgery was related to a cancer diagnosis (surgery for cancer) or performed in patients without a cancer diagnosis (no cancer). Risk for VTE and use of appropriate prophylaxis was evaluated according to the 2004 ACCP-guidelines (Chest2004;126:338S–400S). Bleeding risk factors considered sufficient to present a contraindication to anticoagulant use included intracranial hemorrhage, bleeding at hospital admission, presence of a known bleeding disorder and clinically relevant hepatic impairment. Results: Of the 30,827 patients in surgical wards evaluated in ENDORSE, 18,461 had undergone major surgery as of the date of the survey, including 6172 patients who had abdominal, urological or gynecological operations and were considered at risk for VTE. All patients with a cancer diagnosis who underwent these types of surgery were considered at-risk for VTE, including 1767 patients whose surgical procedure was related to their diagnosis and 101 patients who underwent surgery unrelated to cancer. The proportion of patients receiving any ACCP-recommended prophylaxis ranged from 60% in patients undergoing surgery for urologic cancer to 86% in patients undergoing surgery for rectosigmoid cancer. Patients who had surgery related to their cancer had a higher rate of ACCP-recommended prophylaxis use, compared with patients who underwent surgery with no cancer diagnosis (Table). The proportion of patients considered to have bleeding risk sufficient to present a contraindication to anticoagulant use was 10.4% (surgery for cancer) and 10.9% (no cancer; Table). Fewer patients without a cancer diagnosis received anticoagulant prophylaxis, compared with those undergoing cancer-related surgery (Table). Table: VTE prophylaxis practice according to the presence of active malignancy. Surgery type At-risk receiving ACCP-recommendedprophylaxis n/N (%) Contrain-dications to anticoagulant use, n (%) Anticoagulant alone, n (%) Mechanical alone, n (%) Both, n (%) *4304 of 5097 patients without a cancer diagnosis were considered at risk for VTE Surgery for cancer (N=1767) 1295/1767 (73.3) 183 (10.4) 820 (46.4) 136 (7.7) 412 (23.3) No cancer (N=5097) 2495/4304* (58.0) 470 (10.9) 1455 (33.8) 426 (9.9) 762 (17.7) Conclusion: The use of any type of ACCP-recommended VTE prophylaxis varied according to the type of cancer for which the surgery was performed. Although all cancer patients who undergo abdominal, urological or gynecological surgery are at risk for VTE, the results suggest that up to 30% of cancer patients where surgery is performed related to a cancer diagnosis do not receive ACCP-recommended prophylaxis. Less than 11% of patients who had surgery regardless of whether it was related to a cancer diagnosis had a bleeding risk sufficient to present a contraindication to anticoagulant use. These findings suggest that despite the existence of clear evidence-based guidelines, the use of VTE prophylaxis in cancer patients remains suboptimal.

Beschreibung: Background While consensus guidelines regarding VTE prophylaxis for hospital inpatients have been available for more than 15 years, the number of US inpatients who are potentially eligible for prophylaxis is unknown. Such data are required for estimating the potential costs and benefits of prophylaxis in reducing VTE incidence. Objective To estimate the number of Y2002 US acute-care hospital inpatients who are potentially eligible for VTE prophylaxis. Methods We applied the 7th (2004) American College of Chest Physician (ACCP) Consensus Conference VTE prophylaxis guidelines (Geerts et al. Chest2004;126:338S–400S) to inpatients with hospital discharge International Classification of Disease (ICD-9) codes for major surgery or medical illness identified from the Healthcare Utilization and Cost Database (HCUP), a national acute-care hospital database supported by the US Agency for Health Care Quality Research. Results Of a total of 37.8 million inpatients discharged from US acute-care hospitals in Y2002, 13.4 million (35%) met ACCP guideline criteria for VTE prophylaxis (Table). Table. Inpatients Discharged from US Acute-Care Hospitals with ACCP Guideline Defined Risk of VTE in Y2002 Surgical VTE Risk N Highest risk surgery 744,465 High risk surgery 3,031,318 Moderate risk surgery 2,019,696 Surgical subtotal 5,795,479 Medical VTE Risk N Heart failure 1,867,576 Cancer 1,017,356 Stroke 515,370 Other medical conditions 4,196,343 Medical subtotal 7,596,645 Grand Total 13,392,124 Among the 37.8 million Y2002 discharged inpatinets, 7.7 million were defined by HCUP criteria as having had a major operative procedure. When ACCP surgical risk criteria were applied to this population, 1.9 (25%) were at low VTE risk, while 5.8 million (75%) were at moderate (26%), high (39%) or highest (10%) VTE risk. Among the patients without a major operative procedure, 7.6 million met the ACCP criteria for VTE prophylaxis based on medical illness risk factors. Conclusions In total, 13.4 million US residents meet ACCP criteria for VTE prophylaxis annually due to hospitalization for either major surgery or medical illness. Given that almost 60% of all VTE events occurring in the community are related to recent acute-care hospitalization, providing universal, safe and effective VTE prophylaxis to this population affords an important opportunity to significantly reduce the incidence of VTE. These data provide support for developing and monitoring compliance with hospital-wide guidelines for VTE prevention.

Beschreibung: Background: Recent observations suggest that upper extremity deep vein thrombosis (DVT) has become more common over the last few decades. However the prevalence of this disorder within the community has not been established. The purpose of this study was to compare the occurrence rate, risk factor profile, management strategies, and hospital outcomes in patients with upper versus lower extremity DVT in a cohort of all Worcester residents diagnosed with venous thromboembolism (VTE) in 1999. Methods: The medical records of all residents from the Worcester, MA statistical metropolitan area (2000 census=478,000) diagnosed with ICD-9 codes consistent with possible DVT and/or pulmonary embolism at all 11 Worcester hospitals during the years 1999, 2001, and 2003 are being reviewed by trained data abstractors. Validation of each case of VTE is performed using prespecified criteria. Results: A total of 483 cases have been validated as acute DVT events - this represents all cases of DVT occurring in residents of the Worcester SMSA in 1999. For purposes of this analysis we have excluded 4 patients with both upper and lower extremity DVT. Upper extremity DVT was diagnosed in 68 (14.2%) of patients versus 411 (85.8%) cases of lower extremity DVT. Patients with upper extremity DVT were younger, more likely to be Hispanic, more likely to have renal disease and more likely to have had a recent central venous catheter, infection, surgery, ICU stay, or chemotherapy than patients with lower extremity DVT. They were less likely to have had a prior DVT or to have developed their current DVT as an outpatient. Although less likely to be treated with heparin, LMWH, or warfarin they were more likely to suffer major bleeding complications. Recurrence rates of VTE during hospitalization were very low in both groups. Conclusions: Patients with upper extremity DVT comprise a small but clinically important proportion of all patients with DVT in the community setting. Their risk profiles differs from patients with lower extremity DVT suggesting strategies for DVT prophylaxis and treatment for this group may need to be tailored. Characteristics of Patients with Upper versus Lower Extremity DVT Upper extremity (n=68) Lower extremity (n=417) P value *Recent = 〈 3 months Demographics Mean Age, yrs 59.3 66.5

Beschreibung: Background Patients with previous or current cancer have an increased risk for venous thromboembolism (VTE). However, little data is available on physician’s practices for providing VTE prophylaxis to these patients. The aim of this analysis of the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) was to characterize VTE prophylaxis practices in acutely ill hospitalized medical patients who had previous cancer or currently active cancer. Methods Patient recruitment began in July 2002. Patients ≥18 years old and hospitalized for ≥3 days with an acute medical illness are enrolled consecutively. Exclusion criteria are: therapeutic antithrombotic agents or thrombolytics at admission, major surgery or trauma during 3 months prior to admission, and VTE treatment within 24 hours of admission. Results Data were from 4315 patients enrolled up to 30 June 2004 in 37 hospitals in 11 countries. 578 (13%) patients had currently active cancer (6% as the primary admission diagnosis). Patients with current cancer, previous cancer only, and no cancer were: 40%, 54% and 51% female, median (IQR) ages 72 (60–79), 77 (64–82) and 66 (47–80) years, median length of hospital stay 9 (5–18), 8 (5–12) and 8 (5–14) days, median duration of immobility 8 (5–19), 5 (4–11) and 6 (4–14) days (including immobility immediately prior to hospital admission). The percentages of patients with current or no cancer who received any pharmacologic prophylaxis were similar (see Table 1). However, aspirin was less likely to be prescribed, and intermittent pneumatic compression (IPC) more likely to be used in patients with current cancer than in those without cancer. Patients with previous cancer were more likely to receive pharmacologic prophylaxis, with increased use of unfractionated heparin (UFH) and aspirin, compared with patients without cancer. Conclusions Despite acutely ill medical patients with previous or current cancer having a higher risk for VTE, less than half received VTE prophylaxis, reflecting poor awareness of the benefits of prophylaxis. Physician’s perceptions of bleeding risks in cancer patients may influence prophylaxis practices; patients with current cancer were less likely to receive aspirin, but more likely to receive IPC, than patients without cancer. However, patients with previous cancer were more likely to receive pharmacologic prophylaxis than those without cancer, reflecting recognition by some physicians that these patients have an increased risk for VTE. Table 1. VTE prophylaxis in acutely ill medical patients with current, previous or no cancer VTE prophylaxis Current cancer (%) n=578 Previous cancer (%) n=266 No cancer (%) n=3471 *P

Beschreibung: Background The total annual number of VTE events and related deaths in the US is unknown, largely because the complete spectrum of disease (including asymptomatic events and sudden deaths) occurring in the community is under-recognized. Objective To estimate the total annual number of non-fatal and fatal deep vein thrombosis (DVT) and pulmonary embolism (PE) events (incident and recurrent) in the US. Methods We developed an incidence-based model that included both hospital- and community-acquired VTE events as well as death from recognized and unrecognized VTE. We estimated the annual number of community-acquired events using the average age-, sex-, and event-specific incidence rates in Olmsted County, MN (1966–1990) and Y2000 US census data. We estimated the annual number of hospital-acquired events using patient age and Y2002 International Classification of Disease (ICD-9) discharge diagnosis codes for major surgery types or acute medical illnesses within the Healthcare Utilization and Cost Database, which includes major discharge diagnoses from all US acute-care hospitals. Patients were included in the hospital model if they were deemed at risk of VTE according to current American College of Chest Physicians definitions. The hospital at-risk population was divided into categories according to type of surgery or medical diagnosis on admission. We estimated the annual number of VTE events based on the published probability of VTE with and without prophylaxis, and US prophylaxis rates, by risk group. Fatal and recurrent events were estimated based on published data. The effects of VTE and prophylaxis rate uncertainty on our estimates were tested using sensitivity analyses. Results The estimated total annual number of symptomatic VTE events in the US exceeded 600,000, (DVT, n=376,365; PE, n=237,058. Table). Table. Annual Number of Non-Fatal and Fatal, Community- and Hospital-Acquired Symptomatic VTE Events in the US Event Type Community Hospital Total Non-Fatal ---------n---------- DVT 108,240 268,125 376,365 PE 85,358 151,700 237,058 Total 193,598 419,825 613,423 Fatal DVT 649 1,609 2,258 PE 105,902 188,210 294,112 Total 106,550 189,819 296,370 VTE-related deaths were estimated at 296,370 annually. Of these deaths, 21,223 (7%) patients were diagnosed with VTE and treated, 101,032 (34%) were sudden fatal PE and 174,115 (59%) followed undetected PE. Approximately two-thirds of symptomatic VTE events were hospital-acquired and one-third were community-acquired. Conclusions Our study confirms that VTE is a major US health problem. Given that effective VTE prophylaxis and expert consensus prophylaxis guidelines are widely available, these data suggest that universal, safe and effective prophylaxis could significantly reduce US VTE incidence and related deaths. Future studies should address the impact of universal VTE prophylaxis on VTE incidence and survival.

Beschreibung: Introduction: Despite the publication of international consensus guidelines for the provision of venous thromboembolism (VTE) prophylaxis, the recent ENDORSE survey reported that 64% of patients admitted to surgical wards in hospitals worldwide are at risk for VTE, and of those only 59% received appropriate prophylaxis (Lancet2008;371:387–94). In this sub-analysis of ENDORSE data, we assess the provision of VTE prophylaxis according to surgery type, and evaluate the key factors associated with the decision to provide VTE prophylaxis to surgical patients. Methods: ENDORSE was a multinational, cross-sectional survey of patients admitted to medical and surgical wards in 358 hospitals across 32 countries (Lancet2008;371:387–94). VTE risk and prophylaxis use were assessed in evaluable patients according to the 2004 American College of Chest Physicians (ACCP) guidelines (Chest2004;126:338S–400S). Major surgery was grouped into the following categories: major orthopedic (hip replacement, knee replacement, hip fracture repair); abdominal/thoracic (colon/small bowel, rectosigmoid, gastric, hepatobiliary, thoracic); vascular; urological/gynecological; and other (curative arthroscopy, other orthopedic trauma, other surgeries). Independent factors associated with the use of ACCP-recommended prophylaxis in surgical patients at risk for VTE were evaluated using multivariable logistic regression analyses. Results: Of the 30,827 patients in surgical wards included in ENDORSE, 18,461 had undergone major surgery as of the date of the survey. Of these, 17,018 (92.2%) were considered to be at risk for VTE, although only 10,710 (58.0%) received ACCP-recommended types of VTE prophylaxis. The proportion of patients at risk for VTE and the use of ACCP-recommended prophylaxis varied according to surgery type (Table). Multivariable analysis confirmed that surgery type was the factor that was most strongly associated with the provision of ACCP-recommended VTE prophylaxis. Patients undergoing major orthopedic surgery were most likely to receive recommended VTE prophylaxis, with patients undergoing hip replacement surgery 6 times more likely to receive ACCP- prophylaxis (OR 6.2; 95% CI 5.0–7.9). Curative arthroscopy and rectosigmoid surgery were also strongly associated with the provision of ACCP-recommended prophylaxis: (OR 3.6; 95% CI 2.3–5.4 and OR 2.3; 95% CI 1.7–3.0, respectively). When surgery type was excluded from the multivariable analysis, obesity (OR 1.9; 95% CI 1.7–2.1), rheumatologic or inflammatory disease (OR 1.7; 95% CI 1.3– 2.2), and previous VTE (OR 1.7; 95% CI 1.3–2.1) were the clinical characteristics most strongly associated with the use of recommended VTE prophylaxis. Conclusion: The provision of ACCP-recommended VTE prophylaxis was primarily driven by the fact that patients underwent a major operation and rates of prophylaxis use varied substantially according to the type of surgery. Patients undergoing major orthopedic surgery are most likely to receive appropriate VTE prophylaxis, however up to 45% of at-risk patients undergoing non-orthopedic procedures do not receive ACCP-recommended prophylaxis. Surgery type was the most important factor associated with the decision to provide ACCP-recommended prophylaxis in surgical patients at risk for VTE. Table: Prevalence of VTE risk and use of ACCP-recommended prophylaxis according to surgery type. Surgery type N Patients at risk For VTE n (%) At-risk receiving ACCP-Recommended prophylaxisn (%) Major orthopedic 2300 2300 (100) 1979 (86.0) Abdominal/thoracic 5028 4527 (90.0) 3023 (66.8) Vascular 1038 946 (91.1) 676 (71.5) Urological/gynecological 2653 2344 (88.4) 1261 (53.8) Other 7442 6901 (92.7) 3771 (54.6)

Beschreibung: Introduction: Findings from the recent EXCLAIM study demonstrate that selected acutely ill medical patients with reduced mobility benefit from extended-duration enoxaparin venous thromboembolism (VTE) prophylaxis (Blood2007;110:1862). However, it is unknown whether the EXCLAIM population is representative of acutely ill medical patients admitted to hospitals worldwide. In this subanalysis, we assessed whether the EXCLAIM population was representative of the medical patients enrolled in the multinational IMPROVE (Chest2007;132:936–45) and ENDORSE (Lancet2008;371:387–94) registries known to be at risk for VTE. Methods: Using patient data from IMPROVE and ENDORSE, we applied the EXCLAIM eligibility criteria to a representative, multinational population of acutely ill medical patients at risk for VTE. The IMPROVE and ENDORSE studies assessed VTE-risk and prophylaxis use of enrolled patients according to the 2004 American College of Chest Physicians (ACCP) guidelines (Chest2004;126:338S–400S). ACCP criteria for VTE risk were met in 46% (6,907/15,156) of IMPROVE and 43% (15,487/36,351) of ENDORSE study patients (Chest2007;132:936–45; Lancet2008;371:387–94). The EXCLAIM eligibility criteria required patients to be confined to total bed rest (level 1 immobility), or bed rest with bathroom privileges (level 2 immobility) and have at least 1 of 3 predefined risk factors for VTE (i.e., age 〉 75 years; history of VTE; active or prior cancer). Results: EXCLAIM eligibility criteria were met in 30% (2,072/6,907) IMPROVE and 36% (5,535/15,487) ENDORSE medical patients considered at risk for VTE by ACCP. During hospitalization, ACCP-recommended prophylaxis was provided to 69% (1,426/2,072) and 46% (2,548/5,535) of EXCLAIM-eligible patients enrolled in IMPROVE and ENDORSE, respectively. Following discharge from hospital (median length of stay 5 days for US, 8 days for non-US), only 9% (153/1,719) of EXCLAIM-eligible patients in the IMPROVE study received any type of ACCP-recommended VTE prophylaxis. Conclusions: Evidence from the EXCLAIM study demonstrated that the benefit-to-risk ratio in selected hospitalized medical patients favors the use of prolonged VTE prophylaxis. This population corresponds to one in three of the representative hospitalized patients with acute medical illness enrolled in IMPROVE and ENDORSE. Data on prophylaxis use from the IMPROVE registry suggest that only 9% of such patients are currently receiving optimal VTE prophylaxis following hospital discharge.

Beschreibung: Introduction Estimates for patients at risk of venous thromboembolism (VTE) in US acute care hospitals total approximately 4 million surgical and 8 million medical patients annually. However, limited data are available regarding practices in VTE prevention in the acute care setting. The ENDORSE (Epidemiologic International Day for the Evaluation of Patients at Risk of Venous Thrombosis in the Acute Hospital Care Setting) study is a worldwide survey of inpatients in acute hospital care. We assessed data from US acute care hospitals to determine the prevalence of VTE risk and proportion of at-risk patients receiving prophylaxis in accordance with current ACCP guidelines. Methods During the period August 2006 to January 2007, 9257 patients were enrolled from 81 randomly-selected US acute care hospitals. All medical patients ≥40 years, surgical patients ≥18 years, or patients ≥18 years admitted for non-surgical trauma were eligible for the study. Patients admitted to an ineligible ward, with missing data, or admitted solely for the treatment of VTE were excluded from the analysis. Patient charts were reviewed during a single day, pre-defined visit, with the evaluation criteria including medical history, admission and post-admission diagnoses, type of surgery, bleeding risks, and initiation and type of prophylaxis. The ACCP consensus guidelines were used to evaluate VTE risk and prophylaxis use in enrolled patients. Results Of the 9257 study patients, 44% and 56% were surgical and medical, respectively. 78% and 52% of surgical and medical patients were judged at risk for VTE, respectively. Of these, 29% of surgical patients and 52% of medical patients failed to receive recommended types of prophylaxis (Table). Among at-risk patients who received recommended types of VTE prophylaxis, a majority received anticoagulants (90% surgical, 97% medical). Table: VTE risk and prescription of recommended types of prophylaxis in US acute care hospitals US patients [X, range*] At-risk for VTE [X, range*] At-risk patients who received ACCP-recommended prophylaxis [X, range*] *Mean and range across all 81 US hospitals All (N=9257) 5885 [64%] 3536 [60%] Surgical (N=4061) [44%,13–94] 3165 [78%, 21–100] 2244 [71%, 0–100] Medical (N=5196) [56%, 6–87] 2720 [52%, 19–100] 1292 [48%, 0–100] Conclusions These data from US acute care hospitals parallel the global ENDORSE study findings of the high prevalence of VTE risk and suboptimal provision of ACCP-recommended prophylaxis. Although a higher proportion of surgical patients were judged to be at risk of VTE, the absolute number of hospitalized medical patients was higher and half of these did not receive adequate VTE prophylaxis. Our data highlight the continued need for strategies to ensure that hospital patients at risk of VTE are identified and provided with adequate VTE prophylaxis.