Compressione pneumatica intermittente negli stadi avanzati di arteriopatia periferica: studio delle modificazioni emodinamiche e della perfusione distale indotte da un dispositivo originale e confronto con uno strumento disponibile sul mercato

Introduction: Intermittent pneumatic compression (IPC) is a technique based on the application of pressure at the level of various points of the inferior limb, aimed at provoking haemodynamic modifications starting from the treatment zone. IPC devices, that are mainly used in the area of venous-lymphatic pathologies to reduce edema and for the prevention of venous thromboembolism, have also been applied for treatment of peripheral arterial occlusive disease (PAOD). An IPC device, “Gradient Pump” (GP), based on new haemodynamic concept and technical solutions, has been recently developed by the Vascular Diseases Center of the University of Ferrara-Italy. Aim of the present study in PAOD patients is a) to evaluate the effects of GP on haemodynamic parameters and foot perfusion during a single operative cycle and during a therapeutic cycle and b) to compare efficacy and compliance to the treatment of GP versus a traditional device for PAOD available on the market. Subjects and Methods: In the study were enrolled and evaluated a) 7 patients (12 diseased legs) with PAOD at III-IV Fontaine’s stage and b) 12 patients (21 diseased legs, 12 out of them affected by critical ischemia). The GP device is composed of a single inflatable cuff to be positioned at the thigh, including a rigid element to apply a proper pressure to the femoral vein. The cuff is connected to a compressor which produces periodic sequences of pressure at 1 operative cycle/minute (20 sec of compression, 40 sec of decompression). The therapeutic cycle is composed by a 5min working period followed by a 5min resting period repeated for 3-4 times, modifiable by a manual electromechanical timer. The pressure of cuff inflation is set by a manual pressure regulator to patient’s blood systolic pressure – 20 mmHg with maximal value at 120 mmHg. For the phase A of the study, haemodynamic measurements as Time Average Velocity (TAV) and Blood Flow (BF) were performed by Echo color doppler (ECD) at the femoral vein at different phases of the operative cycle, at rest (basal level), early compression (In1), full compression (In) and full decompression (Out). The haemodynamic measurements during a therapeutic cycle were performed before the start of the first working cycle (basal level), at the end of the second cycle and at the end of the last working period, during the phase Out of both operative cycles. The study of tissue perfusion at the foot was performed using a Near Infrared Spectroscopy (NIRS) device, in order to detect variations in total (tHb), oxygenated (O2Hb) and deoxygenated haemoglobin by means of probes positioned on the dorsum of the foot. The changes of these parameters were recorded and quantified by the calculation of the areas under the curve (AUC). Measurements were performed continuously for a 5min period before the treatment and for the whole treatment. For the phase B of the study, GP was compared to a device available on the market (Art Assist ACI Medical, LLC San Marcos, CA), with cuffs to be positioned at foot and calf sequentially inflating (foot cuff first and calf cuff after 3 seconds, 20 seconds of rest). The device operates for 3 cycles/min at a fixed pressure of inflation of 120 mmHg. Outcome measures: a) Ankle-Brachial Index (ABI) measured according to the standard at rest and after treatment b) Haemodynamic measurements by ECD, including TAV e BF evaluation at femoral vein and at popliteal artery, performed before treatment, after 30 min in the decompression phase of the operative cycle and at the end of the treatment c) Evaluation of Foot perfusion by NIRS device as above described, by measurements performed continuously for a 5 min period before the treatment and for the whole treatment with both devices.4) Compliance, measured by a properly developed questionnaire proposed to the patients before and after the treatment with both devices to evaluate symptoms reduction and satisfaction. The effects of the AA instrument and GP device were measured in the same subjects in supine position in two different days with an interval of 48 ± 2 hours between the two treatments and an alternate order for each device. AA was tested for two consecutive hours of treatment and GP for 35 minutes. Results: A): the treatment with GP was well tolerated, without reported negative symptoms. During a single operative cycle BF and TAV at the femoral vein significantly increased during In e In1 phases (p>0.01). During a therapeutic cycle (25 min) BF and TAV slightly increased during the phase “out” from the beginning to the end of the treatment (p=0,10 n.s.). The foot perfusion was improved, with a significant increase both of tHbAUC and HbO2AUC (p<0.005), correlated to the TAV variations from the basal level recorded at femoral vein during the phase “out” (p<0.05). B): all patients completed the treatment with GP, while three out of them interrupted the treatment for painful symptoms at the foot. ABI increased from the baseline after treatment with GP (n=21, p=0.005), being unmodified after treatment with AA. After 30min of GP treatment the ECD parameters (TAV e BF) increased significantly at the femoral vein (n=21, p<0.05) as well BF at popliteal artery (p=0.011), while no variations were observed after AA treatment. Following compression with GP an improved foot perfusion was observed, with increase of tHbAUC (p<0.0001) and Hb O2AUC (p=0.001) that instead decreased after AA treatment (p=0.03). Compared to the AA treatment, the compression therapy with GP obtained a higher score for compliance, reduction of symptoms, easy use of the device and patients’ satisfaction (p<0.0001). Conclusions: GP, a new device for IPC in PAOD, evokes favourable haemodynamic changes with increased foot perfusion. Haemodynamic changes, distal perfusion and compliance with GP are more relevant than those observed after treatment with a traditional IPC device available on the market

Intermittent claudication: walking disability or cardiovascular disease?

none5---noneManfredini F; Malagoni AM; Mandini S; Felisatti M; Manfredini RManfredini, Fabio; Malagoni, Anna Maria; Mandini, Simona; Felisatti, Michele; Manfredini, Robert

The role of deconditioning in the end stage renal disease (ESRD) myopathy: physical exercise improves altered resting muscle oxygen consumption.

Background: Skeletal muscle dysfunction and poor exercise tolerance are hallmarks of end-stage renal disease (ESRD). Noninvasively measured (near-infrared spectroscopy, NIRS) resting muscle oxygen consumption (rmVO 2 ) is a biomarker of muscle dysfunction, which can be applied to study the severity and the reversibility of ESRD myopathy. We tested the hypothesis that deconditioning is a relevant factor in ESRD myopathy. Methods: The whole dialysis population (n = 59) of two of the eight centers participating into the EXCITE study (ClinicalTrials.gov NCT01255969), a randomized trial evaluating the effect of a home-based exercise program on the functional capacity of these patients was studied. Thirty-one patients were in the active arm (exercise group) and 28 in the control arm (no intervention). Normative data for rmVO 2 were obtained from a group of 19 healthy subjects. Results: rmVO 2 was twice higher (p < 0.001) in ESRDs patients (0.083 ± 0.034 ml/100 g/min) than in healthy subjects (0.041 ± 0.020 ml/100 g/min) indicating substantial skeletal muscle dysfunction in ESRD. rmVO 2 correlated with resting heart rate (r = 0.34, p = 0.009) but was independent of age, dialysis vintage, biochemical, vascular and nutrition parameters. After the 6-month exercise program, rmVO 2 reduced to 0.064 ± 0.024 ml/100 g/min (–23%, p < 0.001) in the exercise group indicating that skeletal muscle dysfunction is largely reversible but remained identical in the control group (0.082 ± 0.032 to 0.082 ± 0.031 ml/100 g/min). Conclusion: Deconditioning has a major role in ESRD myopathy. rmVO 2 is a marker of physical deconditioning and has the potential for monitoring re-conditioning programs based on physical exercise in the ESRD population

Effect of a home based, low intensity, physical exercise program in older adults dialysis patients: A secondary analysis of the EXCITE trial

Background: Older adults dialysis patients represent the frailest subgroup of the End Stage Renal Disease (ESRD) population and physical exercise program may mitigate the age-related decline in muscle mass and function. Methods: Dialysis patients of the EXCITE trial aged > 65 years (n = 115, active arm, n = 53; control arm, n = 62) were submitted in random order to a home based, low intensity physical exercise program. At baseline and 6 months after exercise training 6-min walking distance (6MWD) and 5-time sit-to-stand test (5STS) were performed, and quality of life (QoL) was tested. Results: The training program improved both the 6MWD (6-months: 327 ± 86 m versus baseline: 294 ± 74 m; P < 0.001) and the 5STS time (6-months: 19.8 ± 5.6 s versus baseline: 22.5 ± 5.1 s; P < 0.001) in the exercise group whereas they did not change in the control group (P = 0.98 and 0.25, respectively). The between-arms differences (6 months-baseline) in the 6MWD (+ 34.0 m, 95% CI: 14.4 to 53.5 m) and in the 5STS time changes (- 1.9 s, 95% CI: -3.6 to - 0.3 s) were both statistically significant (P = 0.001 and P = 0.024, respectively). The cognitive function dimension of QoL significantly reduced in the control arm (P = 0.04) while it remained unchanged in the active arm (P = 0.78) (between groups difference P = 0.05). No patient died during the trial and the training program was well tolerated. Conclusions: This secondary analysis of the EXCITE trial shows that a home-based, exercise program improves physical performance and is well tolerated in elderly ESRD patients. Trial registration: The trial was registered in ClinicalTrials.Gov (Clinicaltrials.gov identifier: NCT01255969) on December 8, 2010

Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial

Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; P<0.001 between groups). Similarly, the five times sit-to-stand test time improved in the exercise group (mean time±SD: baseline, 20.5±6.0 seconds; 6 months, 18.2±5.7 seconds) but not in the control group (baseline, 20.9±5.8 seconds; 6 months, 20.2±6.4 seconds; P=0.001 between groups). The cognitive function score (P=0.04) and quality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis