Can a new design of pneumatic compression device reduce variations in delivered therapy for the mechanical prophylaxis of thromboembolic disease after total hip arthroplasty?
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BACKGROUND: Compression devices have been shown to prevent thromboembolic disease. However, the pressures generated may not be the same as the ones recommended by the manufacturer. The purpose of this study is to investigate a new sequential compression device with feedback to maintain optimal therapy, and to determine whether therapy is improved with this new device. PATIENTS AND METHOD: A series of 50 patients undergoing elective total hip arthroplasty at a major tertiary-care hospital with a special interest in joint replacement were enrolled prospectively. In addition to pharmacological prophylaxis for thromboembolic disease, all patients received compression from a modified device. Maximum pressures generated and the rate of pressure rise in each of the 3 compartments within the device sleeves were measured and the results compared with data from historical controls. RESULTS: We considered therapy to be ideal when in a particular compression cycle all chambers of both right and left sleeves reach within 10% of their target pressures at within 10% of their target pressure rise rates. The average patient received this ideal therapy 88% of the time that the new trial sequential compression device was operating. This represents a dramatic improvement over previous devices. CONCLUSIONS: The new device allows dramatically improved pressures within the device because of a feedback loop that allows dynamic control of each chamber's pressure. Improved consistency of delivery should make it easier to accurately assess the true benefits of mechanical prophylaxis with a sequential compression device. (+info)
Effect of intermittent pneumatic compression of foot and calf on walking distance, hemodynamics, and quality of life in patients with arterial claudication: a prospective randomized controlled study with 1-year follow-up.
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SUMMARY BACKGROUND DATA: Perioperative mortality, graft failure, and angioplasty limitations militate against active intervention for claudication. With the exception of exercise programs, conservative treatments yield modest results. Intermittent pneumatic compression [IPC] of the foot used daily for 3 months enhances the walking ability and pressure indices of claudicants. Although IPC applied to the foot and calf together [IPCfoot+calf] is hemodynamically superior to IPC of the foot, its clinical effects in claudicants remain undetermined. OBJECTIVE: This prospective randomized controlled study evaluates the effects of IPCfoot+calf on the walking ability, peripheral hemodynamics, and quality of life [QOL] in patients with arterial claudication. METHODS: Forty-one stable claudicants, meeting stringent inclusion and exclusion criteria, were randomized to receive either IPCfoot+calf and aspirin[75 mg] (Group 1; n = 20), or aspirin[75 mg] alone (Group 2; n = 21), with stratification for diabetes and smoking. Groups matched for age, sex, initial [ICD] and absolute [ACD] claudication distances, pressure indices [ABI], popliteal artery flow, and QOL with the short-form 36 Health Survey Questionnaire (SF-36). IPCfoot+calf (120 mm Hg, inflation 4 seconds x 3 impulses per minute, calf inflate delay 1 second) was used for 5 months, > or =2.5 hours daily. Both groups were advised to exercise unsupervised. Evaluation of patients, after randomization, included the ICD and ACD, ABI, popliteal artery flow with duplex and QOL* at baseline*, 1/12, 2/12, 3/12, 4/12, 5/12* and 17/12. Logbooks allowed compliance control. Wilcoxon and Mann-Whitney corrected[Bonferroni] tests were used. RESULTS: At 5/12 median ICD, ACD, resting and postexercise ABI had increased by 197%, 212%, 17%, and 64%, respectively, in Group 1 (P < 0.001), but had changed little (P > 0.1) in Group 2; Group 1 had better ICD, ACD, and resting and postexercise ABI (P < 0.01) than Group 2. Inter- and intragroup popliteal flow differences at 5/12 were small (P > 0.1). QOL had improved significantly in Group 1 but not in Group 2; QOL in the former was better (P < 0.01) than in Group 2. QOL in Group 1 was better (P < 0.01) than in Group 2 at 5/12. IPC was complication free. IPC compliance (> or =2.5 hours/d) was >82% at 1 month and >85% at 3 and 5 months. ABI and walking benefits in Group 1 were maintained a year after cessation of IPC treatment. CONCLUSIONS: IPCfoot+calf emerged as an effective, high-compliance, complication-free method for improving the walking ability and pressure indices in stable claudication, with a durable outcome. These changes were associated with a significant improvement in all aspects of QOL evaluated with the SF-36. Despite some limited benefit noted in some individuals, unsupervised exercise had a nonsignificant impact overall. (+info)
Rapid foot and calf compression increases walking distance in patients with intermittent claudication: results of a randomized study.
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OBJECTIVE: The aim of our pilot study was to determine the usefulness of rapid, high-pressure, intermittent pneumatic calf and foot compression (IPCFC) in patients with stable intermittent claudication, with reference to the end points of improvement in initial claudication distance (ICD) (distance at which patient feels pain or discomfort in the legs), and improvement in absolute claudication distance (ACD) (distance at which patient stops walking because the pain or discomfort becomes severe). METHODS: Thirty male patients presenting with stable, intermittent claudication (ACD between 50 and 150 meters on treadmill testing at 3.8 km/h, 10 degrees gradient) were recruited into this pilot study from a single center. Fifteen patients were randomized to treatment with IPCFC (applied for 1 hour twice daily in the sitting position) and were also advised to have daily exercise, and 15 patients served as controls, who were advised exercise alone. All patients received aspirin and had resting and postexercise ankle/brachial index (ABI) measured at enrollment along with ICD and ACD on treadmill testing (3.8 km/h, 10 degrees gradient). The mean age, baseline ICD, and ACD of the treatment and control groups were 70.4 +/- 7 years and 70.7 +/- 9 years, 55.8 +/- 15 meters and 68.4 +/- 17 meters, and 86.7 +/- 19 meters and 103.9 +/- 27 meters, respectively. Both groups were equally matched for risk factors, including smoking, type II diabetes mellitus, and hypercholesterolemia. IPCFC was applied. The study protocol included follow-up visits at 1, 2, 3, 4, 6, and 12 months with the ABI, ICD and ACD being measured at every visit. RESULTS: The percent change from baseline for ICD and ACD for each patient visit and the mean +/- standard deviation (SD), standard error (SE), and median were calculated for the control and treatment groups. The percent change from baseline measurements (mean +/- SD) for ICD and ACD in the control group at 4, 6, and 12 months were 2.2 +/- 18 and 2.3 +/- 18, 2.9 +/- 17 and 5.2 +/- 20, and 3.6 +/- 18 and 5.8 +/- 20, respectively. In contrast, the changes in ICD and ACD at 4, 6, and 12 months in the treatment group were 137.1 +/- 128 (P < .01) and 84.3 +/- 82 (P < .01), 140.6 +/- 127 (P < .01) and 96.4 +/- 106 (P = .01), and 150.8 +/- 124 (P <0.01) and 101.2 +/- 104 (P <0.01), respectively. Although the ABI showed a slight increase in the treatment group, these differences were not statistically significant. CONCLUSIONS: The results of this pilot study show that IPCFC improves walking distance in patients with stable intermittent claudication. A significant increase in ICD and ACD was seen at 4 and 6 months of treatment, respectively, and the improvement was sustained at 1 year. The combination of IPCFC with other treatment such as risk-factor modification and daily exercise may prove useful in patients with peripheral arterial occlusive disease. It may be a useful first line of therapy in patients with disabling claudication who are unfit for major reconstructive surgery. Improved walking on long-term follow-up and experience from different centers may establish a role for this treatment modality in the future. (+info)
The efficacy of a new portable sequential compression device (SCD Express) in preventing venous stasis.
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OBJECTIVE: It has been previously shown that the SCD Response Compression System, by sensing the postcompression refill time of the lower limbs, delivers more compression cycles over time, resulting in as much as a 76% increase in the total volume of blood expelled per hour. Extended indications for pneumatic compression have necessitated the introduction of portable devices. The aim of our study was to test the hemodynamic effectiveness of a new portable sequential compression system (the SCD Express), which has the ability to detect the individual refill time of the two lower limbs separately. METHODS: This was an open, controlled trial with 30 normal volunteers. The new SCD Express was compared with the SCD Response Compression System in the supine and semirecumbent positions. The refilling time sensed by the device was compared with that determined from velocity recordings of the superficial femoral vein using duplex ultrasonography. Baseline and augmented flow velocity and volume flow, including the total volume of blood expelled per hour during compression with the SCD Express, were compared with those produced by the SCD Response compression system in the same volunteers and positions. RESULTS: Both devices significantly increased venous flow velocity as much as 2.26 times baseline in supine position and 2.67 times baseline in semirecumbent position (all P < .001). There was a linear relationship between duplex ultrasonography-derived refill time and the SCD Express-derived refill time in both the supine (r = 0.39, P = .03) and semirecumbent (r = 0.71, P < .001) positions but not with the SCD Response. Refill time measured by the SCD Express device was significantly shorter and the cycle rate higher in comparison with the SCD Response in both positions. The single-cycle flow velocity and volume flow parameters generated by the two devices were similar in both positions. However, median (interquartile range) total volume of blood expelled per hour was slightly higher with the SCD Express device in the supine position (7206 mL/h [range, 5042-8437] vs 6712 mL/h [4941-10,676]; P = .85) and semirecumbent position (4588 mL/h [range, 3721-6252] vs 4262 mL/h [3520-5831]; P = .22). Peak volume of blood expelled per hour by the SCD Express device in the semirecumbent position was significantly increased by 10% in comparison with the SCD Response (P = .03). CONCLUSIONS: Flow velocity and volume flow enhancement by the SCD Response and SCD Express were essentially similar. The latter, a portable device with optional battery power that detects the individual refill time of the lower limbs separately, is anticipated to be associated with improved overall compliance and therefore optimized thromboprophylaxis. Studies testing its potential for improved efficacy in preventing deep vein thrombosis are justified. (+info)
Hemodynamic effects of intermittent pneumatic compression in patients with critical limb ischemia.
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BACKGROUND: Traditional teaching assumes that the distal arterial tree is maximally dilated in patients with critical limb ischemia (CLI). Endovascular or arterial bypass procedures are the commonly used interventions to increase distal perfusion. However, other forms of treatment such as spinal cord stimulation or intermittent pneumatic compression (IPC) have been shown to improve limb salvage rates. This prospective study was designed to determine if the use of IPC increases popliteal, gastrocnemial, collateral arterial, and skin blood flow in patients with CLI. METHODS: Twenty limbs with CLI in 20 patients (mean age, 74 years) were evaluated with duplex ultrasound scans and laser Doppler fluxmetry in the semi-erect position before, during, and after IPC. One pneumatic cuff was applied on the foot and the other on the calf. The maximum inflation pressure was 120 mm Hg and was applied for 3 seconds at three cycles per minute. All patients had at least two-level disease by arteriography. Fourteen limbs were characterized as inoperable, and six were considered marginal for reconstruction. Flow volumes were measured in the popliteal, medial gastrocnemial, and a genicular collateral artery. Skin blood flux was measured on the dorsum of the foot at the same time. RESULTS: Significant flow increase during the application of IPC was found in all three arteries (18/20 limbs) compared with baseline values (P < .02). The highest change was seen in the popliteal, followed by the gastrocnemial and the collateral artery. After the cessation of IPC, the flow returned to baseline. This was attributed to the elevation of time average velocity, as the diameter of the arteries remained unchanged. The skin blood flux increased significantly as well (P < .03). In the two limbs without an increase in the arterial or skin blood flow, significant popliteal vein reflux was found. Both limbs were amputated shortly after. CONCLUSIONS: IPC increases axial, muscular, collateral, and skin blood flow in patients with CLI and may be beneficial to those who are not candidates for revascularization. Patients with significant venous reflux may not benefit from IPC. This supports the theory that one of the mechanisms by which IPC enhances flow is by increasing the arteriovenous pressure gradient. (+info)
Duration and amplitude decay of acute arterial leg inflow enhancement with intermittent pneumatic leg compression: an insight into the implicated physiologic mechanisms.
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PURPOSE: By acutely enhancing the arterial leg inflow, intermittent pneumatic leg compression (IPC) improves the walking ability, arterial hemodynamics, and quality of life of claudicants. We quantified the duration of acute leg inflow enhancement with IPC of the foot (IPC(foot)), calf (IPC(calf)), or both (IPC(foot+calf)) and its amplitude decay in claudicants and controls in relation to the pulsatility index, an estimate of peripheral resistance. These findings are cross-correlated with the features of the three implicated physiologic mechanisms: (1) an increase in the arteriovenous pressure gradient, (2) suspension of peripheral sympathetic autoregulation, and (3) enhanced release of nitric oxide with flow and shear-stress increase. METHODS: Twenty-six limbs of 24 claudicants with superficial femoral artery occlusion or stenoses (>75%) and 24 limbs of 20 healthy controls matched for age and sex, meeting stringent selection criteria, had their popliteal volume flow and pulsating index (peak-to-peak velocity/mean velocity) measured with duplex scanning at rest and upon delivery of IPC. Spectral waveforms were analyzed for 50 seconds after IPC delivery per 5-second segments. The three IPC modes were applied in a true crossover design. Data analysis was performed with the Page, Friedman, Wilcoxon, Mann-Whitney and chi2 tests. RESULTS: The median duration of flow enhancement in claudicants exceeded 50 seconds with IPC(foot), IPC(calf), and IPC(foot+calf) but was shorter (P < .001) in the controls (32.5 to 40 seconds). Among the three IPC modes, the duration of flow enhancement differed (P < .05) only between IPC(foot) and IPC(foot+calf). After reaching its peak within 5 seconds of IPC, flow enhancement decayed at rates decreasing over time (trend, P < .05, Page test), which in both groups were highest at 5 to 20 seconds, moderate at 20 to 35 seconds, and lowest at 35 to 50 seconds (P < .05, Friedman test). Baseline and peak flow with all IPC modes was similar between the two groups. Pulsatility index attenuation in claudicating limbs lasted a median 32.5 seconds with IPC(foot), 37.5 seconds with IPC(calf), and 40 seconds with IPC(foot+calf); duration of pulsatility index attenuation was shorter in the control limbs with IPC(foot) (30 seconds), IPC(calf) (32.5 seconds), or IPC(foot+calf) (35 seconds), yet differences, as well as those among the 3 IPC modes, were not significant. CONCLUSION: Leg inflow enhancement with IPC exceeds 50 seconds in claudicants and lasts 32.5 to 40 seconds in the controls. Peak flow occurs concurrently with maximal pulsatility index attenuation, within 5 seconds of IPC. Irrespective of group or IPC mode, the decay rate (%) of flow enhancement is highest within 5 to 20 seconds of IPC, moderate at 20 to 35 seconds, and lowest at 35 to 50 seconds. Since attenuation in peripheral resistance terminates with the mid time period (20 to 35 seconds) of flow decay, and nitric oxide has a half-life of <7 to 10 seconds, the study's data indicate that all implicated physiologic mechanisms (1, 2, and 3) are likely active immediately after IPC delivery (0 to 20 sec) and all but nitric oxide are effective in the mid time period (20 to 35 seconds). As the pulsatility index has returned to baseline, the late phase of flow enhancement (35 to 50 seconds) could be attributable to the declining arteriovenous pressure gradient alone. (+info)
Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low-dose urokinase in patients with acute proximal venous thrombosis of the leg.
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OBJECTIVE: Catheter-directed thrombolysis (CDT) is a promising treatment of acute proximal deep vein thrombosis (DVT) to prevent the postthrombotic syndrome by early removal of thrombus. During CDT for DVT patients, the calf muscle pump is compromised because of immobility. Intermittent pneumatic compression (IPC) can be used to increase venous flow during bed rest. The CDT with IPC may lyse venous thrombus better than CDT alone. The purpose of this study was to evaluate the efficiency and safety of IPC during CDT for DVT using low-dose urokinase. METHODS: Twenty-four patients with proximal DVT confirmed by duplex ultrasonography underwent CDT alone (10 cases) and CDT with IPC and a temporary inferior vena cava filter (14 cases) for 3 to 6 days. Pulmonary emboli (PEs) were assessed by pretreatment and posttreatment pulmonary angiogram or spiral computed tomography of the chest, and in the CDT/IPC patients, a posttreatment inferior vena cavogram was performed. The initial results were evaluated by venogram immediately after CDT, and the late results were evaluated by venous disability score and duplex ultrasonography 6 to 36 months after treatment. RESULTS: There was no symptomatic PE in either group. In CDT with IPC, one new asymptomatic PE was found, but there was no large thrombus in the inferior vena cava. The initial thrombolytic results of CDT with IPC were better than those of CDT alone (five cases of complete lysis in the CDT/IPC group and none in the CDT alone group). In the follow-up, the deep veins were patent and competent in 43% (6/14) in the CDT/IPC group, compared with 17% (1/6) in the CDT-alone group. The venous disability score showed that the CDT/IPC group had less disability than the CDT-alone group. CONCLUSIONS: This pilot study showed that adding IPC to CDT using low-dose urokinase for DVT treatment of the leg resulted in better early and late outcomes compared with CDT alone and was not associated with an increased risk of symptomatic PEs. (+info)
Compression with or without early ambulation in the prevention of post-thrombotic syndrome: a systematic review.
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INTRODUCTION: The aim of this study was to assess whether there is enough evidence to suggest that compression with or without early ambulation after proximal DVT reduces the risk of post-thrombotic syndrome (PTS). METHODS: Systematic review based on electronic and hand searching of the relevant literature. RESULTS: Four randomized studies were identified and despite the fact that there was lack of uniformity in reporting standards all but one showed significant risk reduction of PTS using compression. No difference in recurrent thromboembolic events (DVT or pulmonary embolism) was observed between the compression and control group. In one study the early outcome from the combination of early ambulation with compression was faster reduction of swelling with better well-being without increased risk of PE compared to the control group. Pooled analysis of all studies showed that PTS developed in 24% (61/254) in the compression group and in 46% (110/239) in the control group (chi2=25.36, p=0.0001; OR: 0.37, 95%CI: 0.25, 0.54; RR: 0.52, 95%CI: 0.40, 0.67; and RRR: 0.48, 95%CI: 0.33, 0.60) with a 48% risk reduction from the use of compression. CONCLUSION: Despite the fact that compression with or without early ambulation appears to be safe and it is more often associated with a decreased rate of PTS, the four existing studies do not permit meaningful data comparison due to lack of uniformity in reporting standards. (+info)