Clinical efficacy of mechanical thromboprophylaxis without anticoagulant drugs for elective hip surgery in an asian population

The Journal of Arthroplasty Vol. 24 No. 8 2009 Nobuhiko Sugano, MD, PhD,* Hidenobu Miki, MD,y Nobuo Nakamura, MD, PhD,z Masaharu Aihara, MD,§ Kengo Yamamoto, MD,O and Kenji Ohzono, MD, PhD§ Abstract: To evaluate the clinical efficacy of mechanical thromboprophylaxis after elective hipsurgery, we reviewed 3016 patients who underwent hip surgery at 5 centers. Primary total hiparthroplasty (THA), revision THA, and pelvic or femoral osteotomies were performed in 2648, 298,and 70 patients, respectively. Epidural anesthesia, intraoperative calf bandage, early mobilization,and intermittent pneumatic compression postoperatively with additional use of elastic stockingswere the basic regimen for thromboprophylaxis. Postoperatively, no cases of fatal pulmonaryembolism (PE) were encountered. One symptomatic PE and 4 symptomatic deep vein thrombosiscases were identified, all of which were successfully treated using heparin and warfarin. By 6months, no deaths had occurred. We conclude that mechanical thromboprophylaxis withoutanticoagulant drugs is safe and effective for elective hip surgeries in our patient population.
Keywords: venous thromboembolism, elective hip surgery, total hip arthroplasty, revision,osteotomy, intermittent pneumatic compression.
2009 Elsevier Inc. All rights reserved.
Pulmonary embolism (PE) is a serious complication after only with mechanical prophylaxis after hip surgery in various orthopedic surgery of the pelvis and lower our Japanese patient population. We hypothesized that extremities. Pulmonary embolism is thought to be the rate of VTE shown as DVT, or PE using only the caused by deep vein thrombosis (DVT) , and the mechanical means for prophylaxis, would be less or patients at highest risk of venous thromboemblism equal to that shown in a Japanese registry There- (VTE) are difficult to identify. Safe and cost-effective fore, we studied a group of patients who underwent prophylaxis against DVT is thus necessary to manage the elective hip surgery retrospectively to determine risk of postoperative VTE. Intermittent pneumatic whether IPC prophylaxis was effective to prevent compression (IPC) is one of the effective mechanical methods for thromboprophylaxis Although the efficacy of IPC has not been well reported in Asian We looked at consecutive elective hip surgeries at 5 countries, we have noticed a low incidence of sympto- affiliated institutes of our university between 2003 matic PE and DVT in patients who have been treated and 2007 using the computer databases at eachinstitute. The medical records of these patients werereviewed as the candidates of this study. The recordsincluded history, age, sex, body mass index (BMI), From the *Department of Orthopedic Medical Engineering, Osaka University Graduate School of Medicine, Osaka, Japan; yDepartment of physical status, diagnosis, anesthesia, patient position Orthopedic Surgery, Osaka Medical Center, Osaka, Japan; zCenter of on the operating table, type of surgery, type of Arthroplasty, Kyowakai Hospital, Suita, Japan; §Department of Orthopedic fixation, medication, laboratory data, and complica- Surgery, Kansairousai Hospital, Amagasaki, Japan; and ODepartment ofOrthopedic Surgery, Hoshigaoka Koseinenkin Hospital, Hirakata, Japan.
tions in the hospitals were reviewed. Patients who Submitted December 25, 2008; accepted May 11, 2009.
used heparin and warfarin for thromboprophylaxis No benefits or funds were received in support of this study.
were excluded from this study. Patients who were Reprint requests: Nobuhiko Sugano, MD, PhD, Department of Orthopedic Medical Engineering, Osaka University Graduate School taking aspirin before surgery stopped it 1 week before of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan.
surgery and resumed it after surgery. These patients 2009 Elsevier Inc. All rights reserved.
were not excluded from the study. For mechanical 0883-5403/09/2408-0022$36.00/0doi:10.1016/j.arth.2009.05.015 prophylaxis against VTE, an A-V Impulse System foot Mechanical Thromboprophylaxis Without Anticoagulant Drugs  Sugano et al 1255 pump (Orthofix Vascular Novamedix, Andover, United Table 2. Summary of Symptomatic VTE Cases Kingdom) was used postoperatively for 1 to 2 days until the patient started to walk with aids. Thigh-high compression stockings were used for 2 weeks. Non- steroidal antiinflammatory drugs were given for post- operative pain control according to the complaints of patients. Clinical signs of DVT such as pain and tenderness in the calf or thigh, unilateral swelling, erythema, and a positive Homan's sign were carefully monitored, and when DVT was suspected, cardiovas- cular physicians were consulted and ultrasonographywas performed. Patients were monitored for 3 weeksin the ward, and outpatient clinic data at the 6-monthfollow-up were reviewed.
stems were used in 218 cases, and cemented stems To evaluate the efficacy of IPC prophylaxis against were used in 64 cases. In the remaining 16 cases, only PE in the subject of this study, we used the data of cups were revised. In osteotomies, modified Chiari the Japanese Guideline Committee for Prevention of (dome) pelvis osteotomy was performed in 38 cases, VTE accumulated from the Japanese literature as rotational acetabular osteotomy was performed in 27 a control without prophylaxis, in which there were cases, and femoral osteotomies were performed in 5 0.2% fatal PE (7/4504 cases) and 0.7% symptomatic cases. In all procedures, the patient was placed in a PE (32/4504 cases) in total hip arthroplasty (THA).
lateral position under general and epidural anesthesia.
We used χ2 test for categorized data and Mann- Demographic characteristics of patients for each type of Whitney U test (2 samples) or Kruskal-Wallis test (3 procedure are shown in Age and BMI differed samples) for continuous data. P values less than .05 significantly among the 3 groups (P b .0001, Kruskal- were considered to be statistically significant.
Wallis test), but no significant difference were seen insex ratio.
In the 3016 subjects of this study, there were no cases of fatal PE. There was only one symptomatic We identified 3025 patients as candidates for this PE in a 70-year-old woman with hip osteoarthritis study. Seven patients who were using warfarin for developed on postoperative day 17 after cementless cardiac disease before surgery and 2 patients with a THA. She had dyspnea, which disappeared soon after history of DVT were excluded from the study because administration of heparin. A lung scan showed partial we used heparin and warfarin for thromboprophylaxis defect of the right lower lobe, but ultrasonography in these patients. The subjects of this study comprised showed no DVT. Four patients who underwent 3016 patients (2603 women, 413 men) in whom we cementless THA developed symptomatic DVT between used mechanical prophylaxis. There were 52 patients postoperative days 7 and 20 (). Two of these who were taking aspirin, and these patients were patients developed proximal DVT, and the remaining included in the study. Mean age at operation was 62 two experienced distal DVT on ultrasonography. All years (range, 12-93 years). Mean BMI was 23.5 (range, these patients were treated with heparin followed by 14.7-42.8). Primary THA was performed in 2648 warfarin medication for 6 months, and none devel- patients, revision hip arthroplasty in 298 patients, and oped symptomatic PE. Mean age of the 5 VTE cases hip osteotomy in 70 patients. In primary THA, all cups was 62.4 years, and mean BMI was 21.7, with no were uncemented. Cementless stems were used in 2321 significant differences from the remaining VTE-free cases. Cement stems were used in 214 cases. Cemented patients (Mann-Whitney U test). We did not find femoral head resurfacing was performed in the remain- any risk factors related to VTE, including hemostatic ing 113 cases. Simultaneous bilateral THA was per- abnormalities (hypercoagulable state) or disorders of formed for 48 patients. In revision THA, cementless plasminogen and plasminogen activation in these 5patients. We were able to review the medical recordsof all 3016 patients at the 6-month follow-up, and Table 1. Demography of Patients Receiving Each Type of no deaths were identified. Moreover, no patients developed new symptomatic VTE after 3 weeks.
Incidences of fatal PE, symptomatic PE, and sympto- matic DVT in this study were 0%, 0.03%, and 0.1%, respectively. When we looked only at the group of 2648 patients who underwent THA, incidences were relatively similar (0%, 0.04%, and 0.2%, respec- tively). When comparisons were made with the data 1256 The Journal of Arthroplasty Vol. 24 No. 8 December 2009 of the Japanese Guideline Committee for Prevention however, toward the use of a pharmacologic agent of VTE accumulated from the Japanese literature , such as low-molecular-weight heparin, fondaparinux, incidences of fatal PE (0%) and symptomatic PE or warfarin, as some guidelines recommend antic- (0.04%) were significantly lower in our study than oagulants over mechanical methods such as IPC due to in the control data, which reported 0.2% fatal PE (7/ the lack of supporting evidence . Our study may 4504 cases; P b .001, χ2 test) and 0.7% symptomatic be seen as supporting the use of IPC in elective hip PE (32/4504 cases; P b .05, χ2 test) in THA without surgery as an effective prophylaxis against symptomatic VTE without the worry of side effects.
We conclude that IPC mechanical thromboprophylaxis without anticoagulant drugs is safe and effective for elective hip surgery in our patient population.
Our subjects showed quite low incidences of fatal PE, symptomatic PE, and symptomatic DVT with IPCprophylaxis after elective hip surgeries. In particular, the incidences of fatal PE and symptomatic PE were The authors would like to thank Dr T. Nishii, Dr significantly lower with IPC prophylaxis than those in T. Sakai, Dr M. Takao, Dr K. Tsuda, and Dr S. Nishihara in THA without prophylaxis in a similar patient popula- tion reported in the literature. Although 7 patientswho used anticoagulant drugs due to cardiac diseaseor who had a history of VTE were not included in this study, the subjects in this study represented 1. Kakkar VV, Howe CT, Flanc C, et al. Natural history of 99.8% of cases who were indicated for THA, revision postoperative deep-vein thrombosis. Lancet 1969;2:230.
2. Moser KM, LeMoine JR. Is embolic risk conditioned by prophylaxis against symptomatic VTE can be said to location of deep venous thrombosis. Ann Intern Med 1981; be effective in our patient population. The IPC prophylaxis was well tolerated in our patients without 3. Lieberman JR, Geerts WH. Prevention of venous throm- boembolism after total hip and knee arthroplasty. J Bone Our study displayed several limitations. First, the 4. Salvati EA, Sharrock NE, Westrich G, et al. The 2007 present investigation was a retrospective multicenter ABJS Nicolas Andry Award: three decades of clinical, study. We did not have a control group without basic, and applied research on thromboembolic disease prophylaxis in our institutes. We did not evaluate after THA: rationale and clinical results of a multimodal asymptomatic VTE. The sample size of this study, prophylaxis protocol. Clin Orthop Relat Res 2007;459: however, was large, and the number of excluded patients was quite small. As all subjects were observed 5. Fordyce MJ, Ling RS. A venous foot pump reduces for at least 6 months, and information on survival status thrombosis after total hip replacement. J Bone Joint Surg was not in doubt; the figures for our results are reliable.
We were thus able to demonstrate the efficacy of IPC 6. Warwick D, Harrison J, Glew D, et al. Comparison of the use prophylaxis against fatal and symptomatic PE by of a foot pump with the use of low-molecular-weight comparison of our results with the data of the Japanese heparin for the prevention of deep-vein thrombosis aftertotal hip replacement. A prospective, randomized trial.
Guideline Committee for Prevention of VTE, which were accumulated from the Japanese literature before 7. Pitto RP, Hamer H, Heiss-Dunlop W, et al. Mechanical prophylaxis of deep-vein thrombosis after total hip Although we did not count asymptomatic VTE, some replacement a randomised clinical trial. J Bone Joint studies have reported that IPC prophylaxis shows the same level of asymptomatic DVT prevention on 8. The Guideline Committee for Prevention of Pulmonary ultrasonography as low-molecular-weight heparin Conversely, the clinical relevance of asympto- Thromboembolism). The first edition guidelines for matic distal DVT remains controversial . Distal prevention of pulmonary thrombo-embolism/deep vein DVT is a relatively common event after joint arthro- thrombosis (venous thromboembolism). Tokyo: Medical plasty, and prevention of such events has not been Front International Limited; 2004 [in Japanese].
9. Kim YH, Oh SH, Kim JS. Incidence and natural history of proven to prevent the clinically more important event— deep-vein thrombosis after total hip arthroplasty. A PE . Moreover, anticoagulation for thrombopro- prospective and randomised clinical study. J Bone Joint phylaxis with low-molecular-weight heparin, ximela- gatran, fondaparinux, or rivaroxaban after total joint 10. Kim YH, Kim JS. The 2007 John Charnley Award. Factors arthroplasty shows a higher incidence of all-cause leading to low prevalence of DVT and pulmonary embolism mortality than mechanical prophylaxis and aspirin after THA: analysis of genetic and prothrombotic factors.
The recent trend in thromboprophylaxis is, Mechanical Thromboprophylaxis Without Anticoagulant Drugs  Sugano et al 1257 11. Parvizi J, Azzam K, Rothman RH. Deep venous thrombosis 13. Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous prophylaxis for total joint arthroplasty. American Acad- thromboembolism: the Seventh ACCP Conference on emy of Orthopaedic Surgeons guidelines. J Arthroplasty Antithrombotic and Thrombolytic Therapy. Chest 2004; 12. Sharrock NE, Gonzalez Della Valle A, Go G, et al. Potent anticoagulants are associated with a higher all-cause mortality rate after hip and knee arthroplasty. Clin Orthop fractures—does it make a difference? Thromb J 2008;


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