1、IPC對髖關節置換術中術后DVT的預防 Intermittent Pneumatic Compression to Prevent Proximal Deep Venous ThrombosisDuring and After Total Hip ReplacementA PROSPECTIVE, RANDOMIZED STUDY OF COMPRESSION ALONE, COMPRESSION AND ASPIRIN, AND COMPRESSION AND Low-Dose WARFARIN*From Stanford University Hospital, Stanford ABST

2、RACT: A prospective, randomized study of the effectiveness of intraoperative and postoperative use of intermittent pneumatic compression, alone or in combination with oral administration of either aspirin or low-dose warfarin, was done of a consecutive series of patients who had a total hip replacem

3、ent and were more than thirty-nine years old. All patients began walking by the third postoperative day. One hundred and ninety- patients who had 217 total hip arthroplasties were included. Twenty-eight per cent of the procedures were revisions of a previous total hip replacement or of an endoprosth

4、esis, and the remainder were primary arthroplasties. Patients were randomized as to the type of prophylaxis that they received: intermittent pneumatic compression alone, seventy-six hips; intermittent pneuretie compression and aspirin, seventy-two hips; or intermittent pneumatic compression and low-

5、dose warfarin, sixty-nine hips. Before discharge from the hospital, and at an average of seven days after the operation, all patients were evaluated for the presence of proximal deep-vein throm-b0sis with either venography on the side of the operation or with bilateral venous uitrasonography. The re

6、lative frequency with which thrombosis occurred in a proximal vein was not significantly different in the three groups; the over-all relative frequency was 10 per cent. Intermittent compression during and after the operation effectively reduces the rate of proximal-vein thrombosis after total hip re

7、placement. With the number of patients in our study, the effectiveness of this technique could not be shown to be augmented by oral administration of either aspirin or low-dose warfarin. The most common cause of death after an elective total hip replacement is pulmonary embolism7. When an opera-ti0n

8、 is done on the hip and measures for the prevention of deep venous thrombosis are not employed, the risk of fatal pulmonary embolism has been reported to be 2 to 3 per cent2,9 and that of asymptomatic embolism, about 25 per cents. When prophylaxis is given, deep venous thrombosis occurs in 20 to 50

9、per cent of these patients, and proximal deep-vein thrombosis is the major cause of pulmonary embolism12. In 1986, Hull, and Raskob7 stated that prophylaxis against deep venous thrombosis was an important part of the management of patients who have an arthroplasty of the hip. * No benefits in any fo

10、rm have been received or will be received from eommercial vartv related directly or indirectly to the subject of this article. funds were received in support of this study. Suite 202, 1220 University Drive, MeMo Park, California 94025. please address requests for reprints to Dr. Woolson.200 15th Ave

11、nue East, Seattle, Washington 98112 A prospective, randomized study was designed to determine whether intraoperative and postoperative use of intermittent pneumatic compression effectively reduces the rate of proximal venous thrombosis when compared with the rates for historical controls and whether

12、 there is a difference in the relative frequency of proximal deep venous thrombosis after total hip replacement with one of the three prophylactic measures: intermittent pneumatic compression alone, intermittent pneumatic compression and aspirin, or intermittent pneumatic compression and low-dose wa

13、rfarin. Materials and Methods All patients who were more than thirty-nine years old when a primary or revision total hip replacement was done by one of us (S. T. W.) between July 1986 and September 1989 were considered for inclusion in this study. Patients were excluded if they had an allergy to asp

14、irin or warfarin, had recently had a peptic ulcer or other bleeding diathesis, had taken any drug that affects platelet function within two weeks before the operation, or were expected to remain in bed for more than four days after the operation. This left 239 patients (271 total hip arthroplasties)

15、 for the study. An additional fifty patients (fifty-four procedures) were excluded: thirty-four patients (thirty-six procedures) refused to participate; in eleven patients (eleven procedures), a non-elective operation had been done for an acute fracture of the hip or femur; in two patients, bilatera

16、l total hip replacement had been done during one session of anesthesia, after preoperative percutaneous insertion of a filter in the inferior vena cava; in one patient (one hip), a one-stage total hip replacement and contralateral total knee arthroplasty hadbeen done; in one patient (one hip), a pos

17、toperative test for venous thrombosis had not been done because severe medical problems had developed; and one patient (one hip) had continued bed rest for a prolonged period after the operation. Seven of the fifty patients who originally had been excluded were eventually included because an arthrop

18、lasty was done on the contralateral hip later in the study. Bilateral hip replacement was done in twenty patients. In one patient, both procedures were done during the same operative session; in eighteen patients, the procedures were done at least one week apart; and in one other patient, bilateral

19、staged primary hip replacements were done and later one hip was revised because of late hematogenous sepsis and loosening. All three procedures were included in the series. Thus, 196 patients who had 217 total hip arthroplasties participated in the study. All 196 patients consented, in writing, to p

20、articipate in the study and to be assigned at random to one of three groups. The random assignment to a treatment group was carded out with the use of sealed envelopes. During the arthroplasties on the hips, the patients in Group I wore a thigh-high stocking with graduated elasticity and a thigh-hig

21、h six-chambered boot for sequential intermittent compression (Kendall, Mansfield, Massachusetts) on the side of the operation. The stocking was placed only as high as the knee during the operation, because of the need for sterile preparation of the entire thigh. A thigh-high elastic stocking and a n

22、on-sterile sequential-compression boot were placed on the contralateral extremity, as well, before the patient was draped. The patients in Group II wore the elastic stockings and the intermittent pneumatic-compression boots and were given 650 milligrams of aspirin orally twice daily, beginning on th

23、e evening before the operation. The patients in Group III wore the elastic stockings and the compression boots and received 7.5 or ten milligrams of warfarin orally on the evening before the operation. The prothrombin time was determined daily to help in regulation of the dose of warfarin. The proth

24、rombin time was maintained at 1.2 to 1.3 times the control value (a range of fourteen to sixteen seconds, with the control time being twelve seconds). All operations were done with the patient in the lateral decubitus position. A posterolateral approach was used for the primary arthroplasties and a

25、transtrochanteric approach,for the revisions. After preparing the skin over the hip and the proximal part of the thigh and draping the lower extremity with stockinette, wrapped snugly with an elastic bandage, the surgeon placed a sterile, thigh-high compression sleeve around the leg and distal part

26、of the thigh. The end of the sterile tubing from the compression sleeve was passed off the operative field to the circulating nurse, who attached it to the compression pump on the floor near the operating table. The sterile compression sleeve has an extra length (one and a half meters five feet) of

27、sterile connecting tubing to allow the lower extremity to be moved without restriction during the operation. It is,important id attach the sterile connecting tubing to the operative drapes so that the unstefile portion of the tubing cannot be pulled onto the operative field by manipulation of the lo

28、wer limb. The compression pump was started immediately after the draping was completed. The part of the sterile compression sleeve that was over the thigh rarely interfered with the operative incision unless the surgeon found that the distal half of the femur needed to be exposed. For the four thigh

29、s for which this was necessary, the compression sleeve was rolled down and the thigh-chambers of the compression sleeve were not used but compression from the sleeves of the calf continued, Compression was continued throughout the procedure and was interrupted only when the patient was transferred f

30、rom the operating room to the recovery room, where it was resumed. The sequence of the cycle of compression began proximal to the ankle in the two distal chambers over the calf and progressed to the two chambers over the proximal part of the calf and then to the two chambers over the thigh. The pres

31、sure was between thirty-five and fifty-five millimeters of mercury (4.7 and 7.3 kilopascals) for a period of 5.5 seconds, after which there was a period of continued inflation of 5.5 seconds, so that the total period of inflation was eleven seconds. There was then a sixty-seeded period of deflation

32、before the cycle was repeated. Until the test for deep venous thrombosis was done, usually on the day before the patient was discharged from the hospital, the elastic stockings and compression boots were worn continuously except when the patient bathed of walked. After the operation, the limb on the

33、 side of the operation was elevated on a splint in balanced suspension until the patient began walking two days later. Venography or B-mode ultrasonography, or both, was done at an average of seven days (range, four to thirteen days) after the operation, just before the patient was discharged from t

34、he hospital. The patients who had the first 105 procedures were also included in a concurrent study in which the accuracy of B-mode venous ultrasound scans was evaluated by comparison of the results with those of venography. In these patients, unilateral venography of the lower limb on the side of t

35、he operation was done and bilateral venous sonograrms were made. This comparison, reported previously17, showed that the sensitivity of the ultrasonography was 89 per cent and the specificity, 100 per cent. We therefore discontinued using venography as the standard test and began using B-mode ultras

36、onography. One patient (one procedure) who had unilateral venography did not have ultrasonography be cause of the presence of a spica cast. The remaining patients, who had 111 procedures, had bilateral ultrasonography of the proximal veins.All venographic studies were done by one vascular radiologis

37、t. The method of Rabinov and Paulin was used, except that tourniquets were placed proximal to the ankle and distal to the knee.A computed-sonography instrument (model 128; Acuson, Mountain View, California) was used. The foot of the table was lowered 30 degrees (so-called reverse Trendelenburg posit

38、ion). The deep veins of both lower limbs, from the common femoral vein proximally through and including the popliteal vein distally, were examined in the transverse and longitudinal planes. The result of the study was considered to be normal only if the vein was seen and was found to be completely c

39、ompressible. TABLE IDISTRIBUTION WITH REGARD TO SEX, PREOPERATIVE DIAGNOSIS, PRIMARY OR REVISION PROCEDURE, AND TYPE OF FIXATION* Group I Group II Group III(IPC Alone) (IPC and Aspirin) (IPC and Warfarin)No. of hips 76 72 69Male patients (per cent) 37 50 45Female patients (per cent) 63 50 55Diagnosi

40、s (per cent) Osteoarthrosis 47 44 52 Osteoneerosis 7 I 0 7 Rheumatoid arthritis 7 10 3 Failed hip operation 26 28 33 Other 13 8 4Primary total hip replacement 72 75 68 (per cent)Revision arthroplasty 28 25 32 (per cent)Fixation (per cent) Cemented or hybrid 63 65 68 Byingrowth of bone 37 35 32* IPC

41、= intermittent pneumatic compression. No significant difference on chi-square analysis (p = 0.65). The relative frequencies of deep venous thrombosis in the three groups were compared with the use of chi-square analysis. We calculated that a sample size of seventy patients in each group provided an

42、80 per cent probability (beta =0.20) that a 20 per cent difference (from an estimated frequency of l0 per cent) would be detected between groups (p < 0.05). This means that, with the sizes of the samples in tiffs study, a 20 per cent difference in the relative frequency of deep venous thrombosis

43、between the groups might not be discovered 20 per cent of the time. Results Seventy-three patients who had seventy-six total hip replacements were randomly placed in Group I (intermittent Pneumatic compression alone); seventy patients who had seventy-two procedures, in Group II (intermittent compres

44、sion and aspirin); and sixty-nine patients who had sixty-nine procedures, in Group III (intermittent compression and low-dose warfarin). These numbers add up to 212 patients who had 217 operations, but sixteen patients were counted twice: eight patients had one hip in Group I and one hip in Group II

45、I, two patients had one hip in Group II and one hip in Group III, and six patients had one hip in Group I and one hip in Group II. Therefore, there were actual totals of 196 patients and 217 operations. In each group, the distribution with regard to sex, pre-operative diagnosis, primary or revision

46、procedure, and type of fixation of the prosthesis (with cement or hybrid, or without cement) was relatively uniform (Table I). Data on the characteristics of the patients and on the operative parameters were compared for each group with the Student t test (Tables II and III). The average age in Grou

47、p II was significantly younger than that in the other two groups, and the postoperative hematocrit in Group III was significantly higher than in the other two groups. The relative frequency of a history of deep venous thrombosis and of varicose veins was higher in Group III than in Groups I and II,

48、but not significantly so (p = 0.12 and p = 0.3). The relative frequency of proximal deep-vein thrombosis was 12 per cent in Group I, 10 per cent in Group II, 9 per cent in Group III, and 10 per cent over-all (twenty-two of 217 arthroplasties) (Table IV). These frequencies could not be proved to be s

49、ignificantly different (chi square, p = 0.8) for the sizes of the samples; the value of beta was 0.2. In the patients who had revision hip arthroplasty, the frequencies of proximal deep-vein thrombosis were not significantly different among groups (5 per cent for Groups I and III and 6 per cent for

50、Group II). Multiple regression analysis for the factors of age, a history of deep venous thrombosis, and a revision operation on the hip showed that increased age was a significant risk factor for the development of a new thrombus but that revision or a history of deep venous thrombosis was not.One

51、patient who was treated with compression and aspirin had a pulmonary embolus. It was diagnosed on a ventilation-perfusion lung scan on the same day that ultra-sonography demonstrated a thrombus in the thigh. One patient in each of the three groups had a wound hematoma. In the patients who were recei

52、ving aspirin or low-dose warfarin, the hematoma was evacuated, but this was not considered necessary in the patient who was treated with intermittent pneumatic compression alone. No complications were related to the use of the elastic stockings or compression boots.Patients who had a thrombus in a p

53、roximal vein were treated with anticoagulation with heparin or warfarin, or both. Patients who had a thrombus in a vein of the calf were treated with warfarin if they had swelling or tenderness but not if they were asymptomatic. TABLE IICHARACTERISTICS OF THE PAI'IENTS AND OPERATIVE PARAMETERS* Group I Group II Group III Statistical (IPC Alone) (IPC and Aspirin) (IPC and Warfarin) Significancet Age (yrs.) 66.3 62.3 67.6 I-II, p= 0.04 II-III, p = 0.01 I-III, NS Height (cm) 168 169 1 68 NS Weight (kg) 71 74 75 NS Operative time (mins.) 121 124 125 NS Total blood loss (mi) 15