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Liu KC, Bagrodia N, Richardson MK, Piple AS, Kusnezov N, Wang JC, Lieberman JR, Heckmann ND. Risk Factors Associated with Thromboembolic Complications After total Hip Arthroplasty: An Analysis of 1,129 Pulmonary Emboli. J Am Acad Orthop Surg 2024; 32:e706-e715. [PMID: 38626438 DOI: 10.5435/jaaos-d-23-01213] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/14/2023] [Accepted: 02/28/2024] [Indexed: 04/18/2024] Open
Abstract
INTRODUCTION Venous thromboembolism (VTE) remains a dangerous complication after total hip arthroplasty (THA), despite advances in chemoprophylactic measures. This study aimed to identify risk factors of developing pulmonary embolism (PE) and deep vein thrombosis (DVT) after THA using a modern cohort of patients reflecting contemporary practices. METHODS The Premier Healthcare Database was queried for primary, elective THAs from January 1st, 2015, to December 31st, 2021. Patients who developed PE or DVT within 90 days of THA were compared with patients who did not develop any postoperative VTE. Differences in patient demographics, comorbidities, hospital factors, perioperative medications, chemoprophylactic agents, and allogeneic blood transfusion were compared between cohorts. Multivariable logistic regression models were used to identify independent risk factors of PE and DVT. In total, 544,298 THAs were identified, of which 1,129 (0.21%) developed a PE and 1,799 (0.33%) developed a DVT. RESULTS Patients diagnosed with a PE had significantly higher rates of in-hospital death (2.6% vs 0.1%, P < 0.001) compared with those without a PE. Age (adjusted odds ratio: 1.02 per year, 95% confidence interval [CI]: 1.01 to 1.03) and Black race (aOR: 1.52, 95% CI: 1.24 to 1.87) were associated with an increased risk of PE. Comorbidities associated with increased risk of PE included chronic pulmonary disease (aOR: 1.58, 95% CI: 1.36 to 1.84), pulmonary hypertension (aOR: 2.06, 95% CI: 1.39 to 3.04), and history of VTE (aOR: 2.38, 95% CI: 1.98 to 2.86). Allogeneic blood transfusion (aOR: 2.40, 95% CI: 1.88 to 3.06) was also associated with an increased risk of PE while dexamethasone utilization was associated with a reduced risk (aOR: 0.83, 95% CI: 0.73 to 0.95). DISCUSSION Increasing age; Black race; allogeneic blood transfusion; and comorbidities, including chronic pulmonary disease, pulmonary hypertension, and history of VTE, were independent risk factors of PE after THA. Given the increased mortality associated with PE, patients should be carefully evaluated for these factors and managed with an appropriate chemoprophylactic regimen.
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Affiliation(s)
- Kevin C Liu
- From the Department of Orthopaedic Surgery, Keck School of Medicine of USC, Los Angeles, CA
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Kuwauchi A, Yoshida S, Takeda C, Yamashita Y, Kimura T, Takeuchi M, Kawakami K. Validity of Using Japanese Administrative Data to Identify Inpatients With Acute Pulmonary Embolism: Referencing the COMMAND VTE Registry. J Epidemiol 2024; 34:155-163. [PMID: 37088553 PMCID: PMC10918337 DOI: 10.2188/jea.je20220360] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/28/2022] [Accepted: 03/24/2023] [Indexed: 04/25/2023] Open
Abstract
BACKGROUND Acute pulmonary embolism (PE) is a life-threatening in-hospital complication. Recently, several studies have reported the clinical characteristics of PE among Japanese patients using the diagnostic procedure combination (DPC)/per diem payment system database. However, the validity of PE identification algorithms for Japanese administrative data is not yet clear. The purpose of this study was to evaluate the validity of using DPC data to identify acute PE inpatients. METHODS The reference standard was symptomatic/asymptomatic PE patients included in the COntemporary ManageMent AND outcomes in patients with Venous ThromboEmbolism (COMMAND VTE) registry, which is a cohort study of acute symptomatic venous thromboembolism (VTE) patients in Japan. The validation cohort included all patients discharged from the six hospitals included in both the registry and DPC database. The identification algorithms comprised diagnosis, anticoagulation therapy, thrombolysis therapy, and inferior vena cava filter placement. Each algorithm's sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were estimated. RESULTS A total of 43.4% of the validation cohort was female, with a mean age of 67.3 years. The diagnosis-based algorithm showed a sensitivity of 90.2% (222/246; 95% confidence interval [CI], 85.8-93.6%), a specificity of 99.8% (228,485/229,027; 95% CI, 99.7-99.8%), a PPV of 29.1% (222/764; 95% CI, 25.9-32.4%) and an NPV of 99.9% (228,485/229,509; 95% CI, 99.9-99.9%) for identifying symptomatic/asymptomatic PE. Additionally, 94.6% (159/168; 95% CI, 90.1-97.5%) of symptomatic PE patients were identified using the diagnosis-based algorithm. CONCLUSION The diagnosis-based algorithm may be a relatively sensitive method for identifying acute PE inpatients in the Japanese DPC database.
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Affiliation(s)
- Aki Kuwauchi
- Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
| | - Satomi Yoshida
- Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
| | - Chikashi Takeda
- Department of Anesthesia, Kyoto University Hospital, Kyoto, Japan
| | - Yugo Yamashita
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Takeshi Kimura
- Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan
| | - Masato Takeuchi
- Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
| | - Koji Kawakami
- Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan
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Sun W, Zhao K, Wang Y, Xu K, Jin L, Chen W, Hou Z, Zhang Y. Epidemiological Characteristics and Trends of Primary Hip Arthroplasty in Five Tertiary Hospitals: A Multicenter Retrospective Study. Orthop Surg 2023; 15:2267-2273. [PMID: 37431577 PMCID: PMC10475653 DOI: 10.1111/os.13756] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/28/2022] [Revised: 03/20/2023] [Accepted: 03/27/2023] [Indexed: 07/12/2023] Open
Abstract
OBJECTIVE The number of primary hip arthroplasty (PHA) has increased sharply in recent years. Whether the epidemiological characteristics and trends of PHA have changed are unknown. This study aims to analyze the epidemiological characteristics and trends of those patients are urgent for public health institutions. METHODS The data of patients who underwent PHA in five tertiary hospitals from January 2011 to December 2020 were retrospectively reviewed. A total of 21,898 patients were included, most of whom were aged 60-69 years (25.1% males and 31.5% females). According to the hospitalization date, the patients were divided into two groups (Group A and Group B). The patients admitted between January 2011 and December 2015 were designated as Group A (7862), and those admitted between January 2016 and December 2020 were designated as Group B (14036). The patient data of the two groups, including sex, age, disease causes, body mass index (BMI), comorbidities, surgical procedures, hospital stay duration, and hospitalization costs, were analyzed by Pearson chi-Square test, Student t test or Mann-Whitney U test. RESULTS More women were included in Group B than in Group A (58.5% vs 52.5%, P < 0.001). The mean age of Group B was less than that of Group A (62.27 ± 14.77 vs 60.69 ± 14.44 years, P < 0.001). Femoral head necrosis was the primary pathogenic factor in both groups, with a higher proportion in Group B than in Group A (55.5% vs 45.5%, P < 0.001). Significant differences were found between the two groups in BMI, comorbidities, surgical procedures, hospital stay duration, and hospitalization costs. Total hip arthroplasty (THA) was the most common surgical procedure in both groups, with a higher proportion in Group B than in Group A (89.8% vs 79.3%, P < 0.001). The proportion of patients with one or more comorbidities was significantly higher in Group B than in Group A (69.2% vs 59.9%, P < 0.001). In addition, Group B had a shorter hospital stay duration and higher hospitalization costs than Group A. CONCLUSION Femoral head necrosis was the primary etiology for PHA in this study, followed by femoral neck fracture and hip osteoarthritis. Patients who underwent PHA exhibited a higher percentage of femoral head necrosis; underwent THA more often; and had larger BMIs, more comorbidities, higher medical costs, and younger age in the past decade.
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Affiliation(s)
- Weiyi Sun
- Department of EmergencyThird Hospital of Hebei Medical UniversityShijiazhuangChina
- Key Laboratory of Biomechanics of Hebei ProvinceShijiazhuangChina
- Orthopaedic Research Institution of Hebei ProvinceShijiazhuangChina
| | - Kuo Zhao
- Key Laboratory of Biomechanics of Hebei ProvinceShijiazhuangChina
- Orthopaedic Research Institution of Hebei ProvinceShijiazhuangChina
- Department of Orthopaedic SurgeryThird Hospital of Hebei Medical UniversityShijiazhuangChina
| | - Yanwei Wang
- Department of Orthopaedic SurgeryNorth China Medical and Health Group Xingtai General HospitalXingtaiChina
| | - Kuishuai Xu
- Department of Sports MedicineAffiliated Hospital of Qingdao UniversityQingdaoChina
| | - Lin Jin
- Key Laboratory of Biomechanics of Hebei ProvinceShijiazhuangChina
- Orthopaedic Research Institution of Hebei ProvinceShijiazhuangChina
- Department of Orthopaedic SurgeryThird Hospital of Hebei Medical UniversityShijiazhuangChina
| | - Wei Chen
- Key Laboratory of Biomechanics of Hebei ProvinceShijiazhuangChina
- Orthopaedic Research Institution of Hebei ProvinceShijiazhuangChina
- Department of Orthopaedic SurgeryThird Hospital of Hebei Medical UniversityShijiazhuangChina
| | - Zhiyong Hou
- Key Laboratory of Biomechanics of Hebei ProvinceShijiazhuangChina
- Orthopaedic Research Institution of Hebei ProvinceShijiazhuangChina
- Department of Orthopaedic SurgeryThird Hospital of Hebei Medical UniversityShijiazhuangChina
- NHC Key Laboratory of Intelligent Orthopaedic Equipment (The Third Hospital of Hebei Medical University)ShijiazhuangChina
| | - Yingze Zhang
- Key Laboratory of Biomechanics of Hebei ProvinceShijiazhuangChina
- Orthopaedic Research Institution of Hebei ProvinceShijiazhuangChina
- Department of Orthopaedic SurgeryThird Hospital of Hebei Medical UniversityShijiazhuangChina
- NHC Key Laboratory of Intelligent Orthopaedic Equipment (The Third Hospital of Hebei Medical University)ShijiazhuangChina
- Chinese Academy of EngineeringBeijingChina
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Tong K, Liu H, Qin J, Pan Z, Shangguan Y, Xiao H, Wang H, Chen L, Tan Y. Current status survey of the extramural hospital management of venous thromboembolism after total hip and knee arthroplasty in China. BMC Musculoskelet Disord 2021; 22:787. [PMID: 34517870 PMCID: PMC8438984 DOI: 10.1186/s12891-021-04663-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2021] [Accepted: 08/26/2021] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Venous thromboembolism (VTE) is a potentially fatal complication after arthroplasty. Numerous prophylactic strategies and studies to reduce VTEs have focused on the duration of the hospital stay and on few extramural hospitals. This study aimed to investigate extramural hospital management of VTE after total hip/knee arthroplasty (THA/TKA) in China with a novel survey tool. METHODS A total of 180 patients undergoing arthroplasty, including 68 THA patients and 112 TKA patients, were enrolled in this study. All patients received anticoagulant treatment management. A survey querying VTE management and adherence, such as therapy information, understanding of anticoagulation, satisfaction with the ability of medical staff, and satisfaction with health care costs, was administered by a questionnaire (TKA/THA Patients' Experience with Anticoagulation in the Post-discharge Period) for quality improvement. RESULTS The average age of the patients was 65.27 ± 13.62 years. All patients knew their follow-up times. 85 % of them were suggested that re-examine at the next 14 days, and the others at the next 28 days. All patients continued to visit the orthopaedic clinic after discharge without choosing other types of outpatient services, such as an anticoagulant clinic or home visit with a nurse/pharmacist or remote evaluation by telephone. A total of 96.6 % of all patients used new oral anticoagulants, and the most common treatment duration was 2-4 weeks (93.3 %). 48 % informed their physicians that they were taking anticoagulation medications when they visited ophthalmology, dentistry, dermatology, and other departments. The overall rate of satisfaction with anticoagulation management was 81.67 %, and 6.67 % of patients were not unsatisfied with their medical expenses. Patient compliance decreased with increasing follow-up time. Continuous follow-ups after discharge significantly improved patient compliance. CONCLUSIONS These results elucidate how we can improve the quality of anticoagulation. Continuous follow-up appointments for 30 days after discharge, especially for individuals over 65 years old, significantly improved patient satisfaction and reduced the incidence of VTE and medical costs.
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Affiliation(s)
- Kai Tong
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Hankun Liu
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Jun Qin
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Zhengqi Pan
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Yangfan Shangguan
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Hao Xiao
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Hua Wang
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Liaobin Chen
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China
| | - Yang Tan
- Division of Joint Surgery and Sports Medicine, Department of Orthopedic Surgery, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan City, Hubei Province, 430071, PR China.
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Tateiwa T, Ishida T, Masaoka T, Shishido T, Takahashi Y, Nishida J, Yamamoto K. Does intraoperative mechanical prophylaxis prevent venous thromboembolism in total knee arthroplasty? - effectiveness of passive-assisted ankle motion in surgical/non-surgical side. ARTHROPLASTY 2021; 3:35. [PMID: 35236467 PMCID: PMC8796455 DOI: 10.1186/s42836-021-00088-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2021] [Accepted: 07/27/2021] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Gradual compression stocking (GCS) and intermittent pneumatic compression device (IPCD) are used for intraoperative mechanical prophylaxis against venous thromboembolism (VTE) during total knee arthroplasty (TKA). In this study, we applied a passive-assisted ankle motion in combination with GCS and IPCD during TKA and evaluated its effectiveness in preventing postoperative VTE. METHODS We included 77 patients who underwent primary unilateral TKA. Patients were divided into group A (53 patients who underwent GCS and IPCD on their non-surgical side limb) and group B (24 patients who underwent passive ankle dorsiflexion motion in addition to GCS and IPCD on their non-surgical side limb). Deep vein thrombosis (DVT) was assessed using lower extremity ultrasonography (US). The incidence of VTE in each affected limb was compared between the two groups. RESULTS US was performed 4 days after surgery on average. The incidence of DVT in groups A and B was 47.2 and 70.8 %, respectively. In group A, 22.6 % of DVTs were found only on the surgical side, 11.3 % on the non-surgical side, and 13.2 % on both sides. On the other hand, in group B, 41.7 % of DVTs were found only on the surgical side, 4.2 % on the non-surgical side, and 25.0 % on both sides. No significant difference in the incidence of VTE was noted between the 2 groups. CONCLUSIONS The intraoperative application of passive ankle motion plus GCS and IPCD might not further reduce the incidence of postoperative DVT in TKA patients.
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Affiliation(s)
- Toshiyuki Tateiwa
- Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.
| | - Tsunehito Ishida
- Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan
| | - Toshinori Masaoka
- Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan
| | - Takaaki Shishido
- Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan
| | - Yasuhito Takahashi
- Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan.,Department of Bone and Joint Biomaterial Research, Tokyo Medical University, 6-7- 1,Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan
| | - Jun Nishida
- Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan
| | - Kengo Yamamoto
- Department of Orthopedic Surgery, Tokyo Medical University, 6-7-1, Nishishinjuku, Shinjuku-ku, 160-0023, Tokyo, Japan
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Fukushima K, Saito H, Koyama T, Ohashi Y, Uchiyama K, Takahira N, Takaso M. Incidences of deep vein thrombosis and major bleeding under the administration of fondaparinux for thromboprophylaxis after periacetabular osteotomy: a retrospective observational study. J Hip Preserv Surg 2021; 8:293-297. [PMID: 35414948 PMCID: PMC8994105 DOI: 10.1093/jhps/hnab066] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/05/2021] [Revised: 05/12/2021] [Accepted: 07/23/2021] [Indexed: 11/14/2022] Open
Abstract
Periacetabular osteotomy (PAO) is an effective joint-preserving procedure for patients with developmental dysplasia of the hip. Although deep vein thrombosis (DVT) is considered a serious complication of orthopaedic surgery, there is no consensus regarding a thromboprophylaxis strategy after PAO. We have routinely administered fondaparinux for DVT prophylaxis in adult patients undergoing PAO. The aim of this study was to investigate the incidences of DVT and major bleeding under the administration of fondaparinux for thromboprophylaxis after PAO. A total of 95 patients (100 hips) who underwent PAO with post-operative administration of fondaparinux for thromboprophylaxis were retrospectively enrolled. The incidences of DVT on ultrasound, major bleeding, and administration cessation were evaluated. Asymptomatic DVT occurred in one patient, major bleeding occurred in 14 hips and the administration of fondaparinux was stopped in 17 hips. Given the observed incidence of major bleeding, safer DVT prophylaxis modalities should be considered during PAO.
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Affiliation(s)
- Kensuke Fukushima
- Department of Orthopaedic Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374, Japan
| | - Hiroki Saito
- Department of Orthopaedic Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374, Japan
| | - Tomohisa Koyama
- Department of Orthopaedic Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374, Japan
| | - Yoshihisa Ohashi
- Department of Orthopaedic Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374, Japan
| | - Katsufumi Uchiyama
- Department of Patient Safety and Healthcare Administration, Kitasato University School of Medicine, 1-15-1 Kitasato, Sagamihara 252-0374, Japan
| | - Naonobu Takahira
- Department of Rehabilitation, Kitasato University School of Allied Health Sciences, 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0329, Japan
| | - Masashi Takaso
- Department of Orthopaedic Surgery, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374, Japan
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Peng H, Wang L, Weng X, Zhai J, Lin J, Jin J, Qian W, Gao N. Effect of tranexamic acid on symptomatic venous thromboembolism in patients undergoing primary total knee arthroplasty. Arch Med Sci 2020; 16:603-612. [PMID: 32399109 PMCID: PMC7212233 DOI: 10.5114/aoms.2020.92444] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2017] [Accepted: 08/17/2017] [Indexed: 02/07/2023] Open
Abstract
INTRODUCTION This study aimed to investigate the effect of tranexamic acid (TXA) with sequential routine anticoagulation on postoperative symptomatic venous thromboembolism (VTE) in patients undergoing primary total knee arthroplasty (TKA). MATERIAL AND METHODS This was a prospective study with randomized trials. From January 2013 to May 2015, 1880 patients undergoing primary TKA were enrolled in this study. Seven hundred and twenty patients who received TXA injection were included in the TXA group while 1160 patients who received placebo injection were included in the control group. Patients in the TXA group were treated with intravenous TXA or topical intravenous TXA, and all received sequential routine anticoagulation 12 h after the operation. We extracted data of patients' sex, age, primary diagnoses, and comorbidities that could potentially affect the prevalence rate of VTE. To discuss the risk factors of symbolic VTE, comparisons were made within the TXA group between patients with symbolic VTE and non-symbolic VTE. Logistic regression analysis was performed to analyze the concurrent effects of various factors on the prevalence rate of postoperative VTE. RESULTS Thigh perimeter was not closely associated with TXA injection. Within the TXA group, 24 (3.3%) patients had perioperative symptomatic VTE, 16 (2.2%) deep vein thrombosis (DVT) and 8 (1.1%) pulmonary embolism. High body mass index (BMI), low fibrinogen (Fbg) and simultaneous bilateral TKA were significant risk factors in both univariate analysis and multivariate analysis. CONCLUSIONS Increased BMI, low Fbg, and simultaneous bilateral TKA could act as risk factors for postoperative symptomatic VTE treated with TXA.
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Affiliation(s)
- Huiming Peng
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Longchao Wang
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Xisheng Weng
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Jiliang Zhai
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Jin Lin
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Jin Jin
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Wenwei Qian
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
| | - Na Gao
- Department of Orthopedics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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Kim YH, Anil V, Gaurav A, Park JW, Kim JS. Mechanical thromboprophylaxis would suffice after total knee arthroplasties in Asian patients? Arch Orthop Trauma Surg 2019; 139:167-171. [PMID: 30298379 DOI: 10.1007/s00402-018-3045-3] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/30/2018] [Indexed: 11/26/2022]
Abstract
PURPOSE Our prospective study evaluated the incidence and location of deep vein thrombosis (DVT), the risk factors for PE and the natural history of DVT after TKA in patients who have received only mechanical compression device without having any chemical thromboprophylaxis or therapeutic treatment. METHODS We studied 408 consecutive patients (691 knees) who underwent primary TKA; 283 patients had one-stage bilateral TKAs and 125 had unilateral TKAs. Coagulation assays, the full blood count and blood typing tests, and serum chemical profiles were undertaken in all patients on three separate occasions. Molecular genetic testing was performed preoperatively to detect the genetic traits involving DVT. Bilateral simultaneous or unilateral venograms were carried out at 6 or 7 days after operation. Perfusion lung scanning was undertaken before and at 7 or 8 days after operation. RESULTS In the 691 venograms in 408 patients, only 4 knees (0.6%) were positive for fresh thrombi. In the 4 knees with DVT, thrombi were located in the calf veins. We observed factor V Leiden mutation, antithrombin-III level, and prothrombin promoter G20210A mutation were absent in all patients. We saw no relationship between DVT and coagulation or thrombophilic data. No pulmonary embolism (PE) occurred as shown by negative perfusion lung scan and absence of symptoms. CONCLUSION We concluded that the combinations of absent thrombophilic polymorphisms with low clinical prothrombotic risk factors led to low prevalence of DVT and virtually absent PE after TKA in the current series of patients, who had received mechanical compression device only without chemical thromboprophylaxis.
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Affiliation(s)
- Young-Hoo Kim
- The Joint Replacement Center, Seoul Metropolitan SeoNam Hospital, #20, Sinjeongipen 1-ro, YangCheon-Gu, Seoul, 08040, Republic of Korea.
| | - V Anil
- The Joint Replacement Center, Seoul Metropolitan SeoNam Hospital, #20, Sinjeongipen 1-ro, YangCheon-Gu, Seoul, 08040, Republic of Korea
| | - Ashwini Gaurav
- The Joint Replacement Center, Seoul Metropolitan SeoNam Hospital, #20, Sinjeongipen 1-ro, YangCheon-Gu, Seoul, 08040, Republic of Korea
| | - Jang-Won Park
- The Joint Replacement Center, Ewha Womans University MokDong Hospital, Seoul, Republic of Korea
| | - Jun-Shik Kim
- The Joint Replacement Center, Ewha Womans University MokDong Hospital, Seoul, Republic of Korea
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Bateman DK, Dow RW, Brzezinski A, Bar-Eli HY, Kayiaros ST. Correlation of the Caprini Score and Venous Thromboembolism Incidence Following Primary Total Joint Arthroplasty-Results of a Single-Institution Protocol. J Arthroplasty 2017; 32:3735-3741. [PMID: 28734614 DOI: 10.1016/j.arth.2017.06.042] [Citation(s) in RCA: 33] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2017] [Revised: 06/13/2017] [Accepted: 06/26/2017] [Indexed: 02/01/2023] Open
Abstract
BACKGROUND Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis, is a serious complication after total joint arthroplasty (TJA). Risk assessment models are increasingly used to provide patient-specific risk stratification. A recently implemented protocol mandates calculation of a Caprini Score for all surgical patients at our institution. We investigated the accuracy of the Caprini Score in predicting VTE events following TJA. METHODS A retrospective review of patients undergoing primary total hip (THA) and total knee arthroplasty (TKA) over a 1-year time period was performed. The 90-day postoperative incidence of emergency department evaluations, hospital readmissions, medical complications, need for revision surgery, and symptomatic VTE was recorded. "Preoperative" Caprini Scores routinely recorded per protocol and calculated during review ("Calculated") were compared and assessed for relationship with VTE events. A "VTEstimator" Score was calculated for each patient. RESULTS Three hundred seventy-six arthroplasties (151 TKA and 225 THA) meeting inclusion criteria were identified. Ten patients (2.5%) had symptomatic VTE postoperatively, with 3 pulmonary embolism (0.8%) and 7 deep vein thrombosis (1.8%). Eight VTE (5.3%) occurred following TKA and 2 (0.9%) occurred following THA. For each surgical characteristic evaluated, no significant difference was observed between mean Preoperative or Calculated Caprini Scores for patients with and without VTE (P > .05). Additionally, the distribution of VTEstimator Scores for patients with and without VTE was not significantly different (P = .93). CONCLUSION The Caprini risk assessment model does not appear to provide clinically useful risk stratification for TJA patients. Alternative risk stratification protocols may provide assistance in balancing safety and efficacy of thromboprophylaxis.
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Affiliation(s)
- Dexter K Bateman
- Rutgers Robert Wood Johnson Medical School, Department of Orthopaedic Surgery, New Brunswick, New Jersey
| | - Robert W Dow
- Rutgers Robert Wood Johnson Medical School, Department of Orthopaedic Surgery, New Brunswick, New Jersey
| | - Andrzej Brzezinski
- Rutgers Robert Wood Johnson Medical School, Department of Orthopaedic Surgery, New Brunswick, New Jersey
| | - Howard Y Bar-Eli
- Rutgers Robert Wood Johnson Medical School, Department of Orthopaedic Surgery, New Brunswick, New Jersey
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Fuji T, Akagi M, Abe Y, Oda E, Matsubayashi D, Ota K, Kobayashi M, Matsushita Y, Kaburagi J, Ibusuki K, Takita A, Iwashita M, Yamaguchi T. Incidence of venous thromboembolism and bleeding events in patients with lower extremity orthopedic surgery: a retrospective analysis of a Japanese healthcare database. J Orthop Surg Res 2017; 12:55. [PMID: 28376907 PMCID: PMC5381070 DOI: 10.1186/s13018-017-0549-4] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/04/2016] [Accepted: 03/15/2017] [Indexed: 01/07/2023] Open
Abstract
BACKGROUND Orthopedic surgeries of lower extremities such as total knee arthroplasty (TKA), total hip arthroplasty (THA), and hip fracture surgery (HFS) are widely considered to carry a high risk of developing deep venous thrombosis (DVT) and pulmonary thromboembolism (PTE). Growing attention to epidemiological studies using a healthcare database led us to quantify the risks using a Japanese database to reveal recent medical care for such events. METHODS The study comprised 36,947 patients who had undergone orthopedic surgeries of the lower extremities and whose medical information from April 2008 to September 2013 was available. The source population of the database was derived from 100 acute-care hospitals with Diagnosis Procedure Combination. The events were defined by diagnosis, medication, imaging, and laboratory tests. RESULTS A breakdown of patients who underwent orthopedic surgeries by type of surgery showed 13.6% for TKA, 10.4% for THA, 56.8% for HFS, 1.5% for rupture of Achilles tendon, and 18.0% for simple fracture of lower extremities. The incidence for DVT, PTE, and bleeding events by type of surgery was 1.3, 0.2, and 1.0% for TKA; 0.9, 0.2, and 1.1% for THA; and 0.4, 0.1, and 1.8% for HFS, respectively. The population for risk factor analysis consisted of patients with similar background factors who underwent TKA, THA, or HFS. The statistically significant risk factors for PTE analyzed by the backward elimination procedure in a multivariate model were female sex, history of venous thromboembolism (VTE), thrombophilia, and varicose veins of lower extremity. CONCLUSIONS The incidence of DVT, PTE, and bleeding events and the risk factors for DVT and PTE in patients by type of orthopedic surgeries of lower extremities found in our study are considered to be rational as they reflect evidence from real-world cases. TRIAL REGISTRATION University Hospital Medical Information Network Clinical Trials Registry UMIN000012667.
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Affiliation(s)
- Takeshi Fuji
- Department of Orthopaedic Surgery, Japan Community Healthcare Organization Osaka Hospital, 4-2-78 Fukushima, Fukushima-ku, Osaka, 553-0003, Japan.
| | - Masao Akagi
- Department of Orthopaedic Surgery, Kinki University Faculty of Medicine, Osaka-Sayama City, Osaka, Japan
| | - Yasuyuki Abe
- Department of Orthopaedic Surgery, Federation of National Public Service Personnel Mutual Aid Associations, Kumamoto Chuo Hospital, Kumamoto City, Kumamoto, Japan
| | - Eisei Oda
- Medical TOUKEI Corporation, Shinjuku-ku, Tokyo, Japan
| | | | - Kaori Ota
- Medical Data Vision Co., Ltd., Chiyoda-ku, Tokyo, Japan
| | - Masafumi Kobayashi
- Department of Corporate Planning, Linical Co., Ltd., Osaka City, Osaka, Japan
| | - Yasuyuki Matsushita
- EU Biostatistics & Data Management, Daiichi Sankyo Europe GmbH, Munich, Germany
| | - Jumpei Kaburagi
- Medical Science Department, Daiichi Sankyo Co., Ltd., Chuo-ku, Tokyo, Japan
| | - Kei Ibusuki
- Medical Science Department, Daiichi Sankyo Co., Ltd., Chuo-ku, Tokyo, Japan
| | - Atsushi Takita
- Safety and Risk Management Department, Daiichi Sankyo Co., Ltd., Chuo-ku, Tokyo, Japan
| | - Mikio Iwashita
- Medical Science Department, Daiichi Sankyo Co., Ltd., Chuo-ku, Tokyo, Japan
| | - Takuhiro Yamaguchi
- Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai City, Miyagi, Japan
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12
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Does intermittent pneumatic compression increase the risk of pulmonary embolism in deep venous thrombosis after joint surgery? Blood Coagul Fibrinolysis 2016; 27:246-51. [PMID: 26484640 DOI: 10.1097/mbc.0000000000000387] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
The present study aimed to identify the incidence and risk factors of symptomatic pulmonary embolism and evaluate the safety of early intermittent pneumatic compression application in patients with deep venous thrombosis (DVT) after joint surgery. A total of 144 patients with DVT undergoing joint surgery were divided into two groups according to the appearance of symptomatic pulmonary embolism. Venography and computed tomographic pulmonary angiography were utilized as the assessment methods. The total incidence of symptomatic pulmonary embolism was 0.39% after joint surgery. However, the prevalence increased to 3.5% when computed in patients with DVT. Patients with symptomatic pulmonary embolism were older than those without symptomatic pulmonary embolism (69 ± 4 versus 61 ± 15 years, P = 0.04). The occurrence rate of symptomatic pulmonary embolism in patients with diabetes mellitus was much higher than that in the patients without diabetes mellitus (40.0% versus 8.6%, respectively, P = 0.02). The prevalence of symptomatic pulmonary embolism after joint surgery in patients with DVT was not distinctive. Increased age and diabetes mellitus put patients with DVT at risk of suffering symptomatic pulmonary embolism after joint surgery. In addition, early postoperative application of intermittent pneumatic compression was safe in these patients.
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13
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Anticoagulant therapy for venous thromboembolism prophylaxis in orthopaedic surgery in Japan: The evolving role of NOACs. CURRENT ORTHOPAEDIC PRACTICE 2016. [DOI: 10.1097/bco.0000000000000430] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
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Park SH, Ahn JH, Park YB, Lee SG, Yim SJ. Incidences of Deep Vein Thrombosis and Pulmonary Embolism after Total Knee Arthroplasty Using a Mechanical Compression Device with and without Low-Molecular-Weight Heparin. Knee Surg Relat Res 2016; 28:213-8. [PMID: 27595075 PMCID: PMC5009046 DOI: 10.5792/ksrr.2016.28.3.213] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/26/2016] [Revised: 06/30/2016] [Accepted: 07/16/2016] [Indexed: 11/03/2022] Open
Abstract
Purpose To investigate the incidence of thromboembolic events and complications related to bleeding after total knee arthroplasty (TKA) with a mechanical compression device alone or in combination with low-molecular-weight heparin (LMWH). Materials and Methods A total of 489 TKA patients (776 knees) were retrospectively reviewed for the incidence of thromboembolic events and complications related to bleeding. While 233 patients (354 knees) were treated with a mechanical compressive device without LMWH, 256 patients (422 knees) were treated with the mechanical compressive device along with LMWH. Results The incidences of deep vein thrombosis (DVT) and pulmonary embolism (PE) were 15 of 375 knees (4.0%) and 5 of 375 knees (1.3%), respectively, in the group that used only a mechanical compressive device, and 14 of 401 knees (3.4%) and 5 of 401 knees (1.2%), respectively, in the group that used the mechanical compressive device with LMWH. There was no significant difference between the two groups (p=0.125 and p=0.146, respectively). The postoperative hemovac drainage amount was 635±57 mL in the group with a mechanical compressive device only and 813±84 mL in the group with the device and LMWH; therefore, the amount of drainage was significantly greater in the latter group (p=0.013). Conclusions Mechanical compression alone for prophylaxis against DVT and PE after TKA can be an attractive option in Korean patients.
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Affiliation(s)
- Sin Hyung Park
- Department of Orthopedic Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
| | - Joong Hyeon Ahn
- Department of Orthopedic Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
| | - Yong Bok Park
- Department of Orthopedic Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
| | - Sun Geun Lee
- Department of Orthopedic Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
| | - Soo Jae Yim
- Department of Orthopedic Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
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15
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Yamada K, Yasunaga H, Kadono Y, Chikuda H, Ogata T, Horiguchi H, Tanaka S. Postoperative outcomes of major lower extremity amputations in patients with diabetes and peripheral artery disease: analysis using the Diagnosis Procedure Combination database in Japan. Am J Surg 2016; 212:446-50. [DOI: 10.1016/j.amjsurg.2015.08.039] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/06/2015] [Revised: 07/24/2015] [Accepted: 08/09/2015] [Indexed: 10/22/2022]
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Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Fukuzawa M, Abe K, Tachibana S. Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V. Thromb J 2015; 13:27. [PMID: 26269694 PMCID: PMC4534125 DOI: 10.1186/s12959-015-0057-x] [Citation(s) in RCA: 69] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/20/2015] [Accepted: 05/29/2015] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND In the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan. METHODS This was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30 mg once daily (n = 307) or enoxaparin 2000 IU (equivalent to 20 mg) twice daily (n = 303) for 11 to 14 days. The primary efficacy endpoint was the incidence of VTE. Safety endpoints included the incidence of major or clinically relevant nonmajor (CRNM) bleeding. RESULTS The incidence of VTE, based on venography and clinical surveillance, was 2.4 % in the edoxaban group and 6.9 % in the enoxaparin group (P <0.001). The absolute difference in the incidence of VTE was -4.5 % (95 % confidence interval [CI]: -8.6, -0.9), which was within the noninferiority margin set at 8 % for the difference and established the noninferiority of edoxaban to enoxaparin. Since the upper limit of the 95 % CI of the absolute difference was less than 0 %, the superiority of edoxaban over enoxaparin was demonstrated. The incidence of major or CRNM bleeding was 2.6 % in the edoxaban group and 3.7 % in the enoxaparin group (P = 0.475). CONCLUSIONS Oral edoxaban 30 mg once daily was superior to subcutaneous enoxaparin 2000 IU twice daily in the prevention of VTE following THA without increasing the risk for major or CRNM bleeding.
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Affiliation(s)
- Takeshi Fuji
- />Department of Orthopaedic Surgery, Japan Community Healthcare Organization Osaka Hospital, 4-2-78, Fukushima, Fukushima-ku, Osaka 553-0003 Japan
| | - Satoru Fujita
- />Department of Orthopaedic Surgery, Takarazuka Daiichi Hospital, 19-5 Kogetsu-cho, Takarazuka, 665-0832 Japan
| | - Yohko Kawai
- />International University of Health and Welfare, 8-10-16 Akasaka Minato-ku, Tokyo, 107-0002 Japan
| | - Mashio Nakamura
- />Department of Clinical Cardiovascular Research, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507 Japan
| | - Tetsuya Kimura
- />Clinical Planning Department, Daiichi Sankyo Co. Ltd, 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan
| | - Masayuki Fukuzawa
- />Clinical Execution Department, Daiichi Sankyo Co. Ltd, 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan
| | - Kenji Abe
- />Clinical Data & Biostatistics Department, Daiichi Sankyo Co. Ltd, 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan
| | - Shintaro Tachibana
- />Department of Orthopaedic Surgery, Mishuku Hospital, 5-33-12 Shimomeguro, Meguro-ku, Tokyo, 153-0051 Japan
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Wang TY, Sakamoto JT, Nayar G, Suresh V, Loriaux DB, Desai R, Martin JR, Adogwa O, Moreno J, Bagley CA, Karikari IO, Gottfried ON. Independent Predictors of 30-Day Perioperative Deep Vein Thrombosis in 1346 Consecutive Patients After Spine Surgery. World Neurosurg 2015; 84:1605-12. [PMID: 26171892 DOI: 10.1016/j.wneu.2015.07.008] [Citation(s) in RCA: 37] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/08/2015] [Revised: 07/01/2015] [Accepted: 07/02/2015] [Indexed: 12/17/2022]
Abstract
BACKGROUND Deep vein thrombosis (DVT) is a morbid postsurgical complication. Identifying the perioperative DVT risk profile will improve surgeons' ability to assess patients for surgical candidacy. In addition, these data will help to identify patients who would benefit from DVT chemoprophylaxis. METHODS We evaluated all medical records for 1346 consecutive patients who underwent spinal surgery at Duke University for incidence of DVT within 30 days of surgery and documented all demographic, preoperative, operative, and postoperative variables. DVT treatment and long-term outcomes were also documented. Associations between postoperative DVT and individual risk factors in all patients were determined using adjusted logistic regression analysis. Patients were stratified into emergent and elective groups and a similar analysis was performed. RESULTS Overall, 15 patients (1.1%) had a DVT in the 30 days after surgery, 7 patients (0.6%) after elective surgery and 8 patients (4.2%) after emergent surgery (P = 0.03). Overall, multivariate logistic regression determined that previous DVT, postoperative urinary tract infection, and creatinine level >2.0 mg/dL were identified as positive predictors. When stratified by emergent surgery, we found packed red blood cell transfusion, surgical blood loss >2.0 L, and deep surgical site infection to be independently associated with increased risk of postoperative DVT. When stratified by elective surgery, we found that coronary artery disease and atrial fibrillation were associated with increased risk of DVT. No patients died in the 30-day perioperative period and 5 (33.3%) patients died within 1 year. CONCLUSIONS This study identifies patient factors predictive of postoperative DVT. Postoperative DVT prophylaxis may be warranted for patients undergoing emergent spine surgery because these patients have significantly higher risk of developing postoperative DVT.
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Affiliation(s)
- Timothy Y Wang
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Jeffrey T Sakamoto
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Gautam Nayar
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Visakha Suresh
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Daniel B Loriaux
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Rupen Desai
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Joel R Martin
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Owoicho Adogwa
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Jessica Moreno
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Carlos A Bagley
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Isaac O Karikari
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA
| | - Oren N Gottfried
- Division of Neurosurgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.
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Shoda N, Yasunaga H, Horiguchi H, Fushimi K, Matsuda S, Kadono Y, Tanaka S. Prophylactic effect of fondaparinux and enoxaparin for preventing pulmonary embolism after total hip or knee arthroplasty: A retrospective observational study using the Japanese Diagnosis Procedure Combination database. Mod Rheumatol 2015; 25:625-9. [PMID: 25529031 DOI: 10.3109/14397595.2014.997424] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
OBJECTIVES The aim of this study was to estimate the effect of fondaparinux and enoxaparin combined with mechanical prophylaxis (MP) after total hip arthroplasty (THA) and total knee arthroplasty (TKA). We also investigated the occurrence of pulmonary embolism (PE) and its associated risk factors. METHODS Data were retrospectively collected on patients who underwent THA or TKA between 2008 and 2010 from the Japanese Diagnosis Procedure Combination database (n = 49,678). We extracted information on sex, age, main diagnosis, types of anesthesia, duration of anesthesia, comorbidities, hospital volume, the use of MP, and the use of anticoagulant drugs. RESULTS The overall occurrence of PE was 0.41%. Multivariate logistic regression analysis showed that the occurrence of PE was significantly higher in females (odds ratio, 2.17; p < 0.001, compared with males), TKA (1.47; p = 0.039, compared with THA), and longer-duration anesthesia (2.63; p = 0.008 in the ≥ 240-min. group compared with the ≤ 119-min. group). Compared with the MP-alone group, the occurrence of PE was significantly reduced in the fondaparinux group (0.58; p = 0.025) and the enoxaparin group (0.59; p = 0.046). CONCLUSIONS Fondaparinux or enoxaparin combined with MP decreased the occurrence of PE. The risk factors for PE were female patients, TKA, and longer-duration anesthesia (≥ 240 min.).
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Affiliation(s)
- Naoko Shoda
- Department of Orthopedic Surgery, Graduate School of Medicine, The University of Tokyo , Bunkyo-ku, Tokyo , Japan
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Tominaga H, Setoguchi T, Tanabe F, Kawamura I, Tsuneyoshi Y, Kawabata N, Nagano S, Abematsu M, Yamamoto T, Yone K, Komiya S. Risk factors for venous thromboembolism after spine surgery. Medicine (Baltimore) 2015; 94:e466. [PMID: 25654385 PMCID: PMC4602703 DOI: 10.1097/md.0000000000000466] [Citation(s) in RCA: 51] [Impact Index Per Article: 5.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
The efficacy and safety of chemical prophylaxis to prevent the development of deep venous thrombosis (DVT) or pulmonary embolism (PE) following spine surgery are controversial because of the possibility of epidural hematoma formation. Postoperative venous thromboembolism (VTE) after spine surgery occurs at a frequency similar to that seen after joint operations, so it is important to identify the risk factors for VTE formation following spine surgery. We therefore retrospectively studied data from patients who had undergone spinal surgery and developed postoperative VTE to identify those risk factors. We conducted a retrospective clinical study with logistic regression analysis of a group of 80 patients who had undergone spine surgery at our institution from June 2012 to August 2013. All patients had been screened by ultrasonography for DVT in the lower extremities. Parameters of the patients with VTE were compared with those without VTE using the Mann-Whitney U-test and Fisher exact probability test. Logistic regression analysis was used to analyze the risk factors associated with VTE. A value of P < 0.05 was used to denote statistical significance. The prevalence of VTE was 25.0% (20/80 patients). One patient had sensed some incongruity in the chest area, but the vital signs of all patients were stable. VTEs had developed in the pulmonary artery in one patient, in the superficial femoral vein in one patient, in the popliteal vein in two patients, and in the soleal vein in 18 patients. The Mann-Whitney U-test and Fisher exact probability test showed that, except for preoperative walking disability, none of the parameters showed a significant difference between patients with and without VTE. Risk factors identified in the multivariate logistic regression analysis were preoperative walking disability and age. The prevalence of VTE after spine surgery was relatively high. The most important risk factor for developing postoperative VTE was preoperative walking disability. Gait training during the early postoperative period is required to prevent VTE.
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Affiliation(s)
- Hiroyuki Tominaga
- From the Department of Orthopaedic Surgery, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan (HT, FT IK, SN, MA, TY, SK); The Near-Future Locomotor Organ Medicine Creation Course (Kusunoki Kai), Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan (HT, TS); Department of Orthopaedic Surgery, Izumi Regional Medical Center, 4513 Akasegawa, Akune 899-1611, Japan (YT, NK); Division of Medical and Environmental Safety, Kagoshima University Medical and Dental Hospital, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan (KY); and Physical Therapy Department, School of Health Sciences, Faculty of Medicine, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan (KY)
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Yasunaga H, Matsui H, Horiguchi H, Fushimi K, Matsuda S. Clinical Epidemiology and Health Services Research using the Diagnosis Procedure Combination Database in Japan. ACTA ACUST UNITED AC 2015. [DOI: 10.7223/apjdm.7.19] [Citation(s) in RCA: 40] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Affiliation(s)
- Hideo Yasunaga
- Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo
| | - Hiroki Matsui
- Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo
| | - Hiromasa Horiguchi
- Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters
| | - Kiyohide Fushimi
- Department of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine
| | - Shinya Matsuda
- Department of Preventive Medicine and Community Health, University of Occupational and Environmental Health
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21
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Mameli A, Marongiu F. Thromboembolic disease in patients with rheumatoid arthritis undergoing joint arthroplasty: Update on prophylaxes. World J Orthop 2014; 5:645-652. [PMID: 25405093 PMCID: PMC4133472 DOI: 10.5312/wjo.v5.i5.645] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/25/2013] [Revised: 03/26/2014] [Accepted: 05/29/2014] [Indexed: 02/06/2023] Open
Abstract
The risk of venous thromboembolism (VTE) in rheumatoid arthritis (RA) and the higher incidence of RA patients undergoing major orthopedic surgery is well recognized. The objective of the present study is to describe the incidence of VTE and discuss the correct prophylaxis in RA patients undergoing knee or hip replacement. A systematic review of studies on thromboprophylaxis in RA patients undergoing major orthopedic surgery was performed. Detailed information was extracted to calculate the rate of VTE in RA orthopedic patients and analyze the thromboprophylaxis performed and bleeding complications. Eight articles were eligible for full review. No difference in the overall rate of VTE was observed between RA patients and controls. No significant differences were found in RA patients in terms of bleeding complications. The data on the optimal prophylaxis to be used in RA patients were insufficient to recommend any of the several options available. In the absence of dedicated guidelines for the care of RA patients undergoing orthopedic surgery, management must be individualized to obtain favorable patient outcome, weighing up all the factors that might put the patient at risk for higher bleeding and thrombotic events.
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Effects of fondaparinux on pulmonary embolism following hemiarthroplasty for femoral neck fracture: a retrospective observational study using the Japanese Diagnosis Procedure Combination database. J Orthop Sci 2014; 19:991-6. [PMID: 25034972 DOI: 10.1007/s00776-014-0607-2] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/26/2014] [Accepted: 06/19/2014] [Indexed: 10/25/2022]
Abstract
BACKGROUND Pulmonary embolism (PE) is recognized as an important complication in patients undergoing hip fracture surgery. However, clinical evidence demonstrating the effectiveness of pharmacological thromboprophylaxis, including fondaparinux, is limited because the occurrence of postoperative PE after hemiarthroplasty is very low. The goal of this study was to analyze the effect of fondaparinux in reducing PE following hemiarthroplasty for femoral neck fracture using large-scale retrospective data. METHODS Employing data from the Japanese Diagnosis Procedure Combination database from July 1 to December 31 between 2007 and 2010, we retrospectively identified 22,776 patients who underwent hemiarthroplasty for femoral neck fracture; we included those who received mechanical prophylaxis alone (n = 17,984) and those who received both mechanical prophylaxis and pharmacological prophylaxis with fondaparinux (n = 4,792). Logistic regression analysis was performed to compare the occurrence of postoperative PE with adjustment for sex, age, comorbidities, and type and duration of anesthesia. RESULTS The mean age of the patients was 79.5 ± 9.4 years. Overall, postoperative PE occurred in 189 (0.83%) patients. The rate of postoperative PE in the fondaparinux group (0.61%) was lower than in the control group (0.89%), although the difference was not significant in the univariate analysis (odds ratio [OR] 0.68; p = 0.055). In the multivariate analysis, the fondaparinux group showed a significantly lower rate of postoperative PE than the group receiving mechanical prophylaxis alone (OR 0.67; p = 0.047). General anesthesia and a longer duration of anesthesia were significant risk factors for postoperative PE. CONCLUSIONS Fondaparinux combined with mechanical prophylaxis is more effective in preventing postoperative PE following hemiarthroplasty for femoral neck fracture than mechanical prophylaxis alone.
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Abstract
The Diagnosis Procedure Combination (DPC) is a case-mix classification system that is linked with a lump-sum payment system for inpatient care reimbursement. The key objectives of introducing the DPC system are to implement an electronic claim system and to provide transparency of hospital performance. The DPC data include discharge abstract and administrative claims data. The unique advantage of the DPC data is the inclusion of detailed process data and several clinical data that can be applied to clinical studies. In this report, we explain the structure and contents of the DPC database, and discuss the applicability of the DPC data to clinical studies, comparing them with the US Nationwide Inpatient Sample database.
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Migita K, Bito S, Nakamura M, Miyata S, Saito M, Kakizaki H, Nakayama Y, Matsusita T, Furuichi I, Sasazaki Y, Tanaka T, Yoshida M, Kaneko H, Abe I, Mine T, Ihara K, Kuratsu S, Saisho K, Miyahara H, Segata T, Nakagawa Y, Kamei M, Torigoshi T, Motokawa S. Venous thromboembolism after total joint arthroplasty: results from a Japanese multicenter cohort study. Arthritis Res Ther 2014; 16:R154. [PMID: 25047862 PMCID: PMC4223565 DOI: 10.1186/ar4616] [Citation(s) in RCA: 48] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2014] [Accepted: 06/27/2014] [Indexed: 01/13/2023] Open
Abstract
Introduction Real-world evidence of the effectiveness of pharmacological thromboprophylaxis for venous thromboembolism (VTE) is limited. Our objective was to assess the effectiveness and safety of thromboprophylactic regimens in Japanese patients undergoing joint replacement in a real-world setting. Method Overall, 1,294 patients (1,073 females and 221 males) who underwent total knee arthroplasty (TKA) and 868 patients (740 females and 128 males) who underwent total hip arthroplasty (THA) in 34 Japanese national hospital organization (NHO) hospitals were enrolled. The primary efficacy outcome was the incidence of deep vein thrombosis (DVT) detected by mandatory bilateral ultrasonography up to post-operative day (POD) 10 and pulmonary embolism (PE) up to POD28. The main safety outcomes were bleeding (major or minor) and death from any cause up to POD28. Results Patients undergoing TKA (n = 1,294) received fondaparinux (n = 360), enoxaparin (n = 223), unfractionated heparin (n = 72), anti-platelet agents (n = 45), or no medication (n = 594). Patients undergoing THA (n = 868) received fondaparinux (n = 261), enoxaparin (n = 148), unfractionated heparin (n = 32), anti-platelet agents (n = 44), or no medication (n = 383). The incidence rates of sonographically diagnosed DVTs up to POD10 were 24.3% in patients undergoing TKA and 12.6% in patients undergoing THA, and the incidence rates of major bleeding up to POD28 were 1.2% and 2.3%, respectively. Neither fatal bleeding nor fatal pulmonary embolism occurred. Significant risk factors for postoperative VTE identified by multivariate analysis included gender (female) in both TKA and THA groups and use of a foot pump in the TKA group. Only prophylaxis with fondaparinux reduced the occurrence of VTE significantly in both groups. Propensity score matching analysis (fondaparinux versus enoxaparin) showed that the incidence of DVT was lower (relative risk 0.70, 95% confidence interval (CI) 0.58 to 0.85, P = 0.002 in TKA and relative risk 0.73, 95% CI 0.53 to 0.99, P = 0.134 in THA) but that the incidence of major bleeding was higher in the fondaparinux than in the enoxaparin group (3.4% versus 0.5%, P = 0.062 in TKA and 4.9% versus 0%, P = 0.022 in THA). Conclusions These findings indicate that prophylaxis with fondaparinux, not enoxaparin, reduces the risk of DVT but increases bleeding tendency in patients undergoing TKA and THA. Trial registration University Hospital Medical Information Network Clinical Trials Registry: UMIN000001366. Registered 11 September 2008.
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Kaneko T, Hirakawa K, Fushimi K. Relationship between peri-operative outcomes and hospital surgical volume of total hip arthroplasty in Japan. Health Policy 2014; 117:48-53. [DOI: 10.1016/j.healthpol.2014.03.013] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2013] [Revised: 02/10/2014] [Accepted: 03/24/2014] [Indexed: 01/29/2023]
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Kuroda Y, Hirayama C, Hotoda H, Nishikawa Y, Nishiwaki A. Postmarketing safety experience with edoxaban in Japan for thromboprophylaxis following major orthopedic surgery. Vasc Health Risk Manag 2013; 9:593-8. [PMID: 24124376 PMCID: PMC3794866 DOI: 10.2147/vhrm.s51244] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022] Open
Abstract
PURPOSE Edoxaban is an oral, once-daily, selective, direct factor Xa inhibitor approved in Japan for the prevention of venous thromboembolism following major orthopedic surgery. Currently, edoxaban is in Phase III clinical development for the prevention of stroke and systemic embolic events in patients with atrial fibrillation, and for the treatment and prevention of recurrences of venous thromboembolism. This report describes the adverse drug reactions (ADRs) spontaneously reported during early postmarketing phase vigilance from the time of its commercial launch in Japan. MATERIALS AND METHODS All spontaneously reported ADRs following edoxaban use received by Daiichi Sankyo during early postmarketing phase vigilance from July 19, 2011, to January 18, 2012, were entered into the safety database and included in this review. Approximately 20,000 patients were estimated to have been treated with edoxaban. RESULTS The mean age of patients was 74.2 years, their mean weight was 59.4 kg, and approximately 70% were female. A total of 67 ADRs were reported in 56 patients, of which the majority included bleeding events (51 ADRs in 42 patients). Of these, 15 ADRs (in 14 patients) were serious, including cerebral hemorrhage (n = 1), gastric hemorrhage (n = 2; gastric hemorrhage [n = 1] and gastric ulcer hemorrhage [n = 1]), and surgical-site hemorrhage (n = 12; hemorrhage [n = 6], subcutaneous hemorrhage [n = 3], wound hemorrhage [n = 2], and wound hematoma [n = 1]). Most ADRs occurred within the first week of treatment and there were no fatalities. Nonserious ADRs associated with bleeding that occurred in >1 patient included subcutaneous hemorrhage (n = 9), wound hemorrhage (n = 5), postprocedural hematoma (n = 4), anemia (n = 4), and hemarthrosis (n = 3). Other nonserious ADRs not associated with bleeding and occurring in >1 patient included abnormal hepatic function (n = 4) and diarrhea (n = 2). CONCLUSION Safety data from the first 6 months of postmarketing experience with edoxaban did not identify any unforeseen safety signals, consistent with the known safety profile of edoxaban.
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Ogura K, Yasunaga H, Horiguchi H, Ohe K, Kawano H. Incidence and risk factors for pulmonary embolism after primary musculoskeletal tumor surgery. Clin Orthop Relat Res 2013; 471:3310-6. [PMID: 23690155 PMCID: PMC3773132 DOI: 10.1007/s11999-013-3073-9] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/29/2013] [Accepted: 05/13/2013] [Indexed: 01/31/2023]
Abstract
BACKGROUND Limited information is available regarding the incidence, risk factors, and optimal prophylaxis in orthopaedic oncology patients, although malignancy and major orthopaedic surgery are associated with an increased pulmonary embolism (PE) risk. QUESTIONS/PURPOSES We aimed to investigate the incidence of PE after musculoskeletal tumor surgery in Japanese patients and analyze the potential risk factors for PE. METHODS We retrospectively identified 3750 patients (1981 males, 1769 females) who underwent musculoskeletal tumor surgery during 2007 to 2010 using the Japanese Diagnostic Procedure Combination administrative database. Data collected included sex, age, primary diagnosis, type of surgery, duration of anesthesia, and comorbidities that may affect PE incidence. Univariate logistic regression analyses were performed to examine the relationship of each factor with PE occurrence. RESULTS We identified 10 patients with PE during the survey period. A primary malignant bone tumor was associated with a significantly higher risk of PE than a primary malignant soft tissue tumor (odds ratio [OR], 5.58; 95% CI, 1.39-22.42). Bone tumor resection (OR, 7.94; 95% CI, 1.77-35.59) and prosthetic reconstruction (OR, 9.15; 95% CI, 1.52-55.07) were associated with a significantly higher risk of PE than soft tissue tumor resection. CONCLUSIONS Malignant bone tumors and bone tumor resections have a higher risk of PE than malignant soft tissue neoplasms and soft tissue resections. Both populations might require PE prophylaxis as it is likely that the risk is greater than with other major orthopaedic surgery, but data accumulation should continue, and further investigation should be done to clarify details of the incidence, risk factors, and optimal prophylaxis for PE. LEVEL OF EVIDENCE Level II, prognostic study. See Guidelines for Authors for a complete description of levels of evidence.
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Affiliation(s)
- Koichi Ogura
- />Department of Orthopaedic Surgery, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan
| | - Hideo Yasunaga
- />Department of Health Management and Policy, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Hiromasa Horiguchi
- />Department of Health Management and Policy, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kazuhiko Ohe
- />Department of Medical Informatics and Economics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Hirotaka Kawano
- />Department of Orthopaedic Surgery, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan
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Abstract
Use of closed drainage systems after total knee arthroplasty (TKA) is a routine practice. Currently, a debate exists regarding whether temporary or no clamping is optimal. A systematic review of the English literature was conducted, and randomized controlled trials comparing all forms of temporary or no clamping drainage were included. Two authors independently extracted articles and predefined data. Data were pooled using a fixed-effects model to perform the meta-analysis. Nine randomized controlled trials totaling 850 patients were retrieved. The results indicate that temporary clamping could significantly reduce the drainage volume, including total drainage volume, drainage volume within 24 hours postoperatively, and drainage volume within 48 hours postoperatively. Furthermore, patients treated with temporary drainage clamping for 4 hours or more had a higher hemoglobin level 24 hours postoperatively than the patients treated with no clamping, and the number of blood transfusions per patient decreased significantly. No significant difference was identified between the 2 practices regarding postoperative range of motion, wound-related complications, and deep vein thrombosis. More randomized controlled trials are needed to provide robust evidence and to definitively determine which practice is most effective in reducing postoperative blood loss.
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Affiliation(s)
- ZeYu Huang
- Department of Orthopaedics, West China Hospital, Sichuan University, Chengdu, People’s Republic of China
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