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MISCELLANEOUS Table of Contents   
Year : 2004  |  Volume : 38  |  Issue : 3  |  Page : 178-182
Deep venous thrombosis prophylaxis- A multicentric study


1 Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, India
2 Department of Orthopaedics, Maulana Azad Medical College, New Delhi, India
3 Apollo Hospital, New Delhi, India
4 Sant Parmanand Hospital, New Delhi, India

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   Abstract 

Background : Deep vein thrombosis is a common complication after hip and knee surgery. Ideal prophylaxis is still not available.
Methods : In a controlled trial, 30 patients in group I were not given any thromboprophylaxis while 100 patients in group II were put on mechanical prophylaxis.
Results: Seven patients in group I developed DVT while no patient in group II had this complications.
Conclusion : Mechanical prophylaxis may be a safe tool in preventing DVT.

Keywords:  Deep vein thrombosis; Prophylaxis

How to cite this article:
Bhan S, Dhaon B K, Gulati Y, Aggarwal S. Deep venous thrombosis prophylaxis- A multicentric study. Indian J Orthop 2004;38:178-82

How to cite this URL:
Bhan S, Dhaon B K, Gulati Y, Aggarwal S. Deep venous thrombosis prophylaxis- A multicentric study. Indian J Orthop [serial online] 2004 [cited 2019 Aug 21];38:178-82. Available from: http://www.ijoonline.com/text.asp?2004/38/3/178/37288

   Introduction Top


Deep vein thrombosis or thromboembolism is one of the most common complications in patients who have sustained skeletal injury[1] or who have undergone replacement surgery of hip[2] and knee[3]. Evidences in literature show that after operations of hip replacement arthroplasty, 30 to 50 percent of the cases develop deep vein thrombosis in legs and pelvis [4]. Elderly people who have sustained fracture of hip or lower extremity and pelvis run a greater risk of developing thromboembolism as compared to the younger population group[5]. Deep vein thrombosis after knee replacements has been reported to range from 40% to 80%[3]. Risk factors, which are thought to predispose to this phenomenon, are age over 40 years, increased duration of surgical procedure and severity of underlying systemic disease. It is thought that a hypercoaguable state persists in the body after a trauma or episode of instrumentation in the skeleton. This hypercoaguability is secondary to the release of thromboplastin from marrow fat and medullary sinusoids into the systemic circulation[4]. Propagation of thrombi proximally from vein of calf into the popliteal and femoral veins is well known, as one of the major factors for fatal pulmonary embolism[6]. Prevalence of asymptomatic pulmonary embolism is less certain, but a study of patients undergoing total knee arthroplasty has reported 1.8- 7% prevalence of pulmonary embolism[7]. Mortality rate in patients who have developed P.E. ranges from 0.5% to 2%8 In the absence of proper diagnosis and limitations of adequate therapy the mortality could be as high as 30%9. It is therefore clear that prevention of DVT is much preferable to treating it[10].

Thromboprophylaxis can be achieved by pharmacological and non-pharmacological means. No consensus however exists on the ideal throboprophylactic method. Pharmacological agents such as low molecular weight heparin and oral anticoagulants are commonly used for prophylaxis but may cause bleeding. In cases of polytrauma, institution of anticoagulants or other pharmacological agents may be delayed due to the presence of associated cranial or other visceral bleed. Mechanical means in contrast to pharmacological measures are devoid of hemorrhagic complications. Various mechanical agents, which have been used, include active and passive exercise, elastic stockings, graduated pressure, electrical stimulation of the muscles of the calf, and intermittent compression of calf by pneumatic stockinet. A more recent mechanical prophylaxis has emerged in form of an electrical stimulator (lymphavision), which enhances drainage not only from venous system but also from the lymphatic system due to stimulation of striated, and smooth muscle found in the system network.

This multicenteric study was undertaken to assess the effectiveness of lymphavision in preventing the phenomenon of thromboembolism in patients operated for total knee replacement, total hip replacement, major spine surgery involving instrumented spinal fusion and polytrauma with lower limb fracture. Four different hospitals in the city were involved in the study to remove personal bias and to represent a wider section of patient population.


   Material and methods Top


This prospective study involving 180 patients of over 40 years of age was conducted at four independent hospitals of the city i.e. The All India Institute of Medical Sciences, L.N.J.P. hospital, Sant Parmanand hospital and Apollo hospital from June 2001 to March 2003. The first thirty patients were allocated to Gr. I or control group while the remaining hundred patients were put in Gr. II or study group. Patients who had history of previous thromboembolic phenomenon or pulmonary embolism were not included in the study. All patients undergoing the study were interviewed and comprehensive clinical history and examination was conducted on them to rule out presence of risk factors for thromboembolism such as history of smoking, alcohol consumption, and contraceptive intake, presence of varicose vein, any abdominal tumor, and previous cerebrovascular accident. There were 81 female and 49 men in the study. The average age of the patients was 61 yrs (range 42 to 80yrs). Cases, which were found suitable for study included 75 primary total knee replacement (5 simultaneous bilateral, 65 unilateral), 30 primary total hip replacement (all unilateral), 15 operated lower limb fracture in polytrauma patients and 10 instrumented spinal fusion in traumatic vertebral fractures. The mode of anesthesia for replacement and internal fixation in lower limb fracture was epidural in all the cases while instrumented spinal fusion were performed with general anesthesia. Two-dimensional ultrasound, with color flow mapping and Doppler velocimetry was performed in both the groups to look for course, contour, compressibility, caliber and flow patterns in veins of lower leg using variable frequency real time transducer. Veins which were screened included the common femoral, superficial femoral, deep femoral, popliteal, anterior tibial and the posterior tibial. Written and informed consent was sought in all the cases.

Group I or the control group consisted of thirty patients in whom no thromboprophylaxis in any form mechanical or pharmaceutical was initiated in the postoperative period. Patients who had undergone either unilateral total knee replacement (n = 25) or unilateral total hip arthroplasty (n = 5) were included in this group. Doppler studies to rule out thromboembolic phenomenon were carried out on the fourth and the fifteenth postoperative day. There were 18 females and 12 males in this group.

Group II or the study group consisted of hundred patients in whom mechanical prophylaxis (Lymphavision, Aloha, France) was initiated. Sixty-three females and 37 males participated in this group. The distribution of case being: 50 total knee replacements (5 Bilateral, 40 unilateral), 25 total hip replacements, 15 operated polytrauma patients with lower limb fracture and 10 cases of instrumented spinal fusions.

Technique: To stimulate the muscles small rubber pads in form of electrodes were applied either on the calf or the plantar aspect of foot of the patients on both the legs. Low voltage current with an intensity of 21mA (range 15 27 mA) was used, which could be varied so as stimulate a visible muscle in the lower leg. The intensity was nevertheless kept in the comfort zone of the patients. This treatment was given for a period of 30 minutes, two to three times daily for a period of 10 days. Postoperative rehabilitation program for the patients was initiated on the day of surgery itself. Patients operated with joint replacements and internal fixation were taught quadriceps drill and ankle ROM exercise on the day of surgery, thereafter active range of motion of involved joints, walking with support (partial, full or non weight bearing, depending upon the surgery) were started on the third post operative day. Patients with spinal instrumentation were initiated side turning, sitting and standing with support on 2nd postoperative day itself after application of an appropriate brace.

Ultrasonic Doppler evaluation was performed in patients of both the groups pre operatively and on 4th day and at the end of second week postoperatively. Interpretation of Doppler reports of both the groups was made by the same radiologist who was unaware of the mechanical prophylaxis and the study as a deliberate attempt made to remove observer bias. Thrombi were classified as proximal if they involved the popliteal and or femoral veins. Patients in whom Doppler analysis showed presence of thrombosis, subcutaneous enoxaparin in the dose of 40 mg twice a day was instituted and continued for a period of 6 weeks.

Patients were also evaluated clinically for presence of other signs or symptoms of deep vein thrombosis. Calf tenderness, with swelling, along with increase in local temperature was noted for, if any. Homan's sign or pain in calf with dorsiflexion of ankle was looked for in every patient but its absence was not considered to be predictive of absence of thromboembolic phenomenon. Examination of both the lower limbs for daily measurement the calf and thigh circumference was done.


   Results Top


A comparative analysis was made between the control group and study group with reference to presence of thromboembolism either symptomatic or asymptomatic by means of clinical examination and Doppler evaluation.

In group I or the control seven out of 30 patients developed Doppler evidence of deep venous thrombosis. Five of these patients had undergone total knee replacements while the remaining two had total hip replacements. Three out of five patients in total knee replacement group had a distal thrombosis involving the extremity, which was operated. Two patients had both proximal and distal thrombus. One patient out of these two had evidence of a bilateral involvement. In the total hip replacement category, one of the patients had both proximal and distal vein involvement while the other screened positive only for proximal veins. In both these patients the operated limb was affected. Documentation of calf girth was made on a proforma noting it a day before operation and from the day of operation to the fourteenth postoperative day. One patient was clinically symptomatic in this group. Calf tenderness was apparent in this patient on third postoperative day after a right total knee replacement. There was an increase in calf girth by 2.5 cm as compared to the preoperative status. This further increased to 3.0.cm by tenth postoperative day (preoperative girth 40 cm, 10th postoperative day girth 43 cm) and remained static thereafter. Doppler ultrasound report both on the 4th day and after two weeks confirmed presence of thrombus in the anterior and posterior tibial veins with partial involvement of the popliteal veins with no further progression. Subcutaneous enoxaparin in a dose of 40 mg twice daily was initiated on third postoperative day itself and was continued for six weeks. There was a mean increase of calf girth of 1.78 cm (range 0.5 cm to 2.4cm) on second postoperative day and an overall increase in calf girth by 1.65 cm (range, 0.0 cm to 1.9 cm) was still seen after fourteenth postoperative day in the asymptomatic patients in this group

Group II patients also underwent Doppler screening studies, clinical examination and calf girth measurement as the previous group. None of the patients screened by Doppler ultrasound showed any evidence of presence of thrombus.

This group of patients showed an increase in calf girth by about 1.50 cm (range 0.5 to 1.8 cm) on second postoperative day and by 1.30 cm (range 0.2 to 1.5 cm) on tenth postoperative day. None of the patients in either group developed any signs or symptoms of pulmonary embolism.


   Discussion Top


Following total joint replacement or internal fixation of long bones after skeletal trauma, the most feared complication in the immediate and early postoperative period is probably deep venous thrombosis. The causes of this phenomenon are summarized under Virchow's triad. These include stasis and hypercoagulability of the blood as well as damage to the endothelial wall of venous system[11]. In normal state procoagulants such as thrombin are removed by macrophages in the liver. Clotting is further prevented by endothelial surface factors such as thrombomodulin and anticoagulants like antithrombin III[12]. This condition may be reversed during surgery since stasis and hypoxia, which may be aggravated with application of tourniquet, promotes release of procoagulants and ultimately may promote intra vascular clotting[13]. Incidence of deep venous thrombosis without prophylaxis has been reported to be as high as 88% after total knee replacement[3] and 54% after total hip replacement[14]. Various methods, both mechanical as well as pharmacological are being tried world wide to prevent thromboembolism after surgical intervention. Mechanical devices such as pneumatic compression devices and early post operative mobilization have been used to improve venous blood flow thereby decreasing the risk of having a deep vein thrombosis episode post operatively in elective orthopedic surgery[15]. They also have advantages over pharmacological agents in that hemorrhagic complications do not occur[13].

In the present study a new form of a mechanical device has been employed for thromboprophylaxis in patients undergoing orthopedic surgery to document its efficacy and to compare this form of prophylaxis as against others as illustrated in literature. Our mechanical prophylaxis instrument consisted of non-invasive electrical stimulation lymphavision, which used a very low frequency for stimulating striated and smooth muscles of the limb. Stimulation is provided by means of multiple electrodes, which are placed in the desired area. The current generated by the device reproduces an autonomic nervous system message sent to the smooth muscles located between two contact electrodes, therefore activating the peristalsis of the lymphatic network of lower limb. This peristalsis corresponds to the cyclic contraction and relaxation of the smooth muscles controlled by both the sympathetic and parasympathetic nervous system. As it travels through various body tissues, the current would also stimulate striated skeletal muscles. An increase in current intensity causes an elementary contraction provoking a muscular pump effect. Smooth muscles are found in practically the whole lymphatic system, in all muscular or distributing arteries and in wall of deep vein network.

The smooth muscles do not have striation and take a longer limb to reach peak contraction. However, they remain contracted for a longer period of time. This lymphavision takes into account these periods producing a stimulation time of 6 ms, while the rest time is 650 ms. This allows the smooth muscles to reach peak contraction and to stay there and relax before the next stimulation. This equals to a frequency of 1.52 Hz stimulation of the striated muscle and activation of the muscle helps the venous as well as the lymphatic system to evacuate early by enhancing interstitial drainage, restoring disrupted intercellular exchanges and reducing congestion of muscle pump. Enhanced venous return by this system is brought primarily by the action of current over both plantar venous plexus and the calf muscle pump. The calf muscle pump action is due to contraction of the calf muscle thereby squeezing the veins in the deep calf. This propels the blood in upward direction. Visible contractions of the muscles of calf produced by the system signify the initiation of the calf pump activity. Foot pump activity is also partially activated by the muscular contraction thus created by current. In our patients an intensity of mean 21+ 6.4 MA was sufficient to produce visible muscular twitching, thereby initiating muscle pump action. Results of using the electrical stimulator have been gratifying in our study.

Four different hospitals from both public and private sector used this equipment to have different sets of population belonging to different occupations and social status. Patients who underwent this study included those who underwent mainly hip and knee arthroplasty operation as well as those poly trauma cases where internal fixation of long bones of lower limb were carried out. Patients underwent Doppler ultrasound studies on 4th and 14th postoperative day to screen for course, contour, compressibility, caliber and flow patterns of lower leg. These were compared with a preoperative Doppler study done a day before surgery of the same patient to detect presence of thrombosis. None of the patients included in the study had any evidence of thrombosis preoperatively either clinically or through Doppler ultrasound method. Postoperatively Doppler results in 100 patients where lymphavision was used showed no evidence of thrombosis either in proximal or distal veins in any patient. This 100% complication free result is better than other forms of prophylaxis. Westrich et al13 while reviewing about 138 articles on prophylaxis in total knee replacement found an overall deep vein thrombosis rate of 53% in patients who received aspirin, in 45% of patients who received wafarin, 29% in patients who received LMW Heparin and 17% in patients who received mechanical prophylaxis in form of pneumatic compression devices. Review of literature in regards to thromboprophylaxis of various forms in total hip replacement also shows more or less similar results. While using low dose warfarin in their patients Amstutz et al[17] reported 0.5% of nonfatal pulmonary embolism where as Paiement et al[18] found the incidence to be 16.7% with low doses of warfarin. LMW Heparins have been documented to give better results than other pharmaceutical agents minus the morbidity. Turpie et al[19] found that enoxaparin reduced the incidence of venous thrombosis from 51% to 11% after elective hip surgery. However use of LMW heparin is limited due to the use of epidural or spinal anaesthetic, which are being used more commonly in such patients because of risk of spinal hematoma formation.

The calf diameter of the patients on second and on fourteen day postoperatively in patients where lymphavision was used was lower than those in whom the thromboprophylaxis was not used. The reason for reduction in the over all calf girth probably is due to complementary effect of electrical stimulation both on the lymphatic and venous system. The activation of lymphatic system in principal leads to faster drainage and restores intercellular and interstitial exchanges, which are disrupted intraoperatively. Reduction of edema in turn helps rehabilitation faster thereby promoting muscle pump and foot pump activity. Foot pump activity is principally activated by weight bearing which compresses the veins in the deep layers of plantar surface[20]. It also flattens the arch thus stretching the plantar veins and plexus. This helps in preventing hypercoagulability and stasis during early postoperative stages thus further reducing chances of deep venous thrombosis. Patient compliance in this equipment was also not a problem since intensity of the current could be regulated by a rheostat thus limiting the intensity of the current with in the comfort zone of individual patients. Our experience with mechanical prophylaxis device such as lymphavision has been encouraging both in lowering the incidence of deep venous thrombosis and postoperative limb edema. It can safely be used in patients in whom epidural or spinal anesthesia has been used for elective or emergency operations. Absence of bleeding complications as seen in anticoagulant therapy and its safe use in situations where anticoagulants are contraindicated such as poly trauma with head injury, haemothorax or abdominal bleeding makes it a favoured method for prophylaxis in these conditions. Mechanical prophylaxis in form of low intensity electrical stimulation may be a very helpful and a safe tool in preventing DVT following elective joint replacement surgery and in cases of polytrauma where anticoagulants are contraindicated.

Acknowledgement: The authors wish to thank Dr. E. Krishna Kiran, for his help in conducting the study.

 
   References Top

1.Geerts W, Code K, Jay R, Chen E, Szalai J. A prospective study of venous thromboembolism after major trauma. N Eng J Med. 1994; 24: 1601-1606.  Back to cited text no. 1    
2.Harris WH, Saltzman EW, Desanctis RW, Coutts RD. Prevention of venous thromboembolism following total hip replacement. J Am Med Assoc. 1972; 220: 1319-1322.  Back to cited text no. 2    
3.Mc Kenna A, Bachmann F, Kaushal SP, et al. Thromboembolic disease in patients undergoing total knee replacements. J Bone Joint Surg (Am). 1976; 58: 928-932.  Back to cited text no. 3    
4.Love lW. Venous thrombosis and embolism. J Bone Joint Surg (Br). 1981; 63: 155-167.  Back to cited text no. 4    
5.Tubiana R, Dupare J. Prevention of thromboembolism complication in orthopaedic and accident surgery. J Bone Joint Surg (Br). 1961; 43 : 715.  Back to cited text no. 5    
6.Borow M, Goldson H. Postoperative venous complications. Am J Surg. 1981; 141: 245-251.  Back to cited text no. 6    
7.Clagett GP, Anderson FA, Geerts W et al. Prevention of venous thromboembolism. Chest. 1998; 114 (5 Suppl): 513- 560.  Back to cited text no. 7    
8.Cavendish ME, Charnley J. Review of the complications of low friction arthroplasty in the elderly. Wrighttington Int. publication No.37, 1972.  Back to cited text no. 8    
9.Sikorski JM, Hampson WG, Staddon GE. The natural history and aetiology of deep vein thrombosis after total hip replacement. J Bone Joint Surg (Br). 1981; 63: 171-177.  Back to cited text no. 9    
10.Gallus AS, Hirsh J. Prevention and treatment of venous thromboembolism. Semin Thromb Hemost. 1976; 11:291-331.  Back to cited text no. 10    
11.Virchow R. Neuer fall von tod licher embolic der lungenarterian. Arch Pathol Anat. 1856; 10: 225-228.  Back to cited text no. 11    
12.Gross PL, Aird WC. The endothelium and thrombosis. Semin Thromb Hemost. 2000; 26: 463-478.  Back to cited text no. 12    
13.Westrich GH, Haes SB, Mosca P, et al. Meta analysis of thrombo embolic prophylaxis after total knee arthroplasty . J Bone Joint Surg (Br). 2000; 82: 795-800, 2000.  Back to cited text no. 13    
14.Johnson R, Orth MC, Carmichael JHE et al. Deep venous thrombosis following Charnley arthroplasty. Clin Orthop. 1978; 132:24-30.  Back to cited text no. 14    
15.Tamir L, Hendel D, Neyman C, et al. Sequential foot compression reduces lower limb swelling and pain after total knee arthroplasty. J Arthroplasty. 1999; 14:333-338.  Back to cited text no. 15    
16.Francis CW, Pellegrini VD, Marder V, et al. Comparison of Warfarin and external pneumatic compression in the prevention of venous thrombosis after total hip replacement. J Am Med Assoc. 1992; 267:29112922.  Back to cited text no. 16    
17.Amstutz HC, Friscia DA, Dorey F, Carney BT. Warfarin prophylaxis to prevent mortality from pulmonary embolism after total hip replacement. J Bone Joint Surg (Am). 1989; 71: 321.  Back to cited text no. 17    
18.Paiement G, Wessinger SJ, Waltman AC, Harris WH. Low dose warfarin versus external pneumatic compression for prophylaxis against venous thromboembolism following total hip arthroplasty. J Arthroplasty. 1987; 2: 23.  Back to cited text no. 18    
19.Turpie AGG, Levine MN, Hirsh J, et al. A randomized control trial of a low molecular weight heparin (enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. N Eng J Med. 1966; 315:925.  Back to cited text no. 19    
20.Lundeen S, Lundquist K, Cornwall MW, et al. Plantar pressure during level walking compared to other ambulatory activities. Foot Ankle Int. 1994; 15: 324-328.  Back to cited text no. 20    

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Correspondence Address:
S Bhan
Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi
India
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Source of Support: None, Conflict of Interest: None


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    Abstract
    Introduction
    Material and methods
    Results
    Discussion
    Acknowledgement:
    References
 

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