A stated aim of the study | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
Inclusion of consecutive patients | 1 | 1 | 1 | 0 | 2 | 2 | 2 |
Prospective collection of data | 2 | 2 | 2 | 2 | 2 | 2 | 0 |
Endpoint appropriate to the study aim | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
Unbiased assessment of endpoints | 1 | 1 | 1 | 0 | 1 | 1 | 2 |
Follow-up period appropriate to the major endpoint | 2 | 2 | 1 | 2 | 2 | 2 | 1 |
Loss to follow-up not exceeding 5% | 2 | 2 | 2 | 2 | 2 | 0 | 2 |
Prospective calculation of the study size | 0 | 0 | 0 | 0 | 2 | 0 | 1 |
Total | 12 | 12 | 11 | 10 | 15 | 11 | 12 |
Applebaum et al. [ |
United States and India | Pre- and post-procedure comparison (no control group) | Atherosclerotic heart disease, age 55 ± 8 years | 18 (male, 78%) |
Machine: Cardiomedics, Inc., Irvine, California 2 flexible cuffs Cuff pressure up to a point at which the peak diastolic pressure wave reached the height of the systolic pressure wave on the finger plethysmography (150–180 mmHg for most patients) 1 session, duration 30 min |
History of recent lower extremity thrombophlebitis, severe ischemia, or trauma including surgical incision and amputation Moderate to severe aortic regurgitation Severe congestive heart failure Uncontrolled hypertension Uncontrolled arrhythmia Thrombolytic or anticoagulation agents use |
Renal artery blood flow, measured every 5 minutes during and immediately after the counterpulsation with duplex ultrasonography (angle correction of ≤60°) |
Werner et al. [ |
Germany | Pre- and post-procedure comparison (no control group) | Healthy volunteers, age 28 ± 4 years | 16 |
Machine: Vasomedical Inc., Westbury, New York, and Cardiomedics Inc., Irvine, California 2 cuffs (calves and thighs) Cuff pressure of 200 mmHg 1 session, duration 1 h |
No available data | Changes in flow volume in carotid, vertebral, hepatic, renal, and internal iliac arteries, measured by duplex ultrasonography |
Werner et al. [ |
Germany | Pre- and post-procedure comparison in (1) cirrhotic patients and (2) healthy subjects |
Cirrhotic patients diagnosed by hepatologists, age 54.4 ± 10.5 years Healthy subjects, age 23.7 ± 2.5 years |
16 cirrhotic patients and 12 healthy subjects (male, 50%) |
Machine: Vasomedical Inc., Westbury, New York 2 cuffs (calves and upper thighs) Cuff pressure of 250–300 mmHg 1 session (performed in the early afternoon), duration 2 h |
Aortic regurgitation Aortic aneurysm Atrial fibrillation Deep venous thrombosis, leg ulcer, marked peripheral edema INR >2 (Screened by electrocardiogram, echocardiogram, and duplex sonography of the lower extremities) |
GFR by inulin clearance (continuous infusion) Renal plasma flow by aminohippurate sodium clearance (continuous infusion) Continuous radial artery blood pressure, monitored by vascular unloading technique Plasma concentrations of endothelin-1, measured by ELISA kit Plasma concentrations of renin, ANP, ADH, epinephrine and N-epinephrine, measured by radioimmunoassay Urinary volume determined every 30 min Urinary excretion rates of sodium and chloride, measured by flame photometry Urinary osmolality, measured by freezing point depression |
Onuigbo [ |
United States | Case series | Hemodialysis patients with IDH and hypoalbuminemia refractory to conventional treatments | 3 | Using sequential compression device as a mini-EECP
Machine: Flowtron Excel deep venous thrombosis prophylaxis system (Huntleigh Healthcare, Poland) Cuff pressures of 40 mmHg The cuff is applied to the calves throughout the hemodialysis session, and inflation of the cuffs is alternated between both calves every other minute. |
Not stated |
Achieved ultrafiltration volume in the dialysis sessions Patient tolerability and IDH episodes |
Ruangkanchanasetr et al. [ |
Thailand | Longitudinal pre- and post-procedure comparison (no control group) | Age ≥18 years with chronic stable angina and/or heart failure | 30 (male, 76.7%, chronic angina 76.7%, heart failure 23.3%) |
Machine: Vasomedical Inc., Westbury, New York 35 sessions of 1-h daily EECP treatment over a period of 7–8 weeks Cuff pressure and amount: not specify |
Unstable angina, acute myocardial Infarction, decompensated heart failure in the preceding one month Undergoing coronary angiography or coronary artery bypass grafting in the preceding 1 month Blood pressure >180/110 mmHg Severe symptomatic peripheral vascular disease GFR <15 mL/min/1.73 m2 |
Serum creatinine, measured by enzymatic methods Serum cystatin C, measured by particle-enhanced immunonephelometric assay Estimated GFR using combination of serum creatinine and cystatin C NT-proBNP, measured by a sandwich immunoassay Non-invasive blood pressure measurement (The median follow-up time after starting EECP treatment was 16 months) |
Wu et al. [ |
Taiwan | Longitudinal pre- and post-procedure comparison (no control group) | Hemodialysis patients with coronary artery disease and angina refractory to medical treatment and unable or unwilling for revascularization | 36 (male, 61.3%) |
Machine: Vasomedical Inc., Westbury, New York Duration of 1- or 2-h daily EECP treatment for 5 days per week to reach total of 35 h Cuff pressures of 260–300 mmHg to achieve mean peak diastolic augmentation of 1.6 |
Significant aortic regurgitation Abdominal aortic aneurysm (Screened by echocardiography and abdominal sonography) |
Angina symptom, measured by Canadian Cardiovascular Society Angina Grading scale Angina medications Myocardial perfusion, assessed by Thallium-201 imaging with pharmacological stress Cardiovascular events (Assess immediately after complete 35 h of EECP and 1 year after complete the therapy) |
Zhang et al. [ |
China | Randomized, non-sham-controlled | Age >18 years undergoing a diagnostic contrast-enhanced computed tomography with estimated GFR using CKD-EPI of 60–89 mL/min/1.73 m2 | 121 (male, 62%, hypertension 56%, diabetes 27%) |
A 1-h session of EECP therapy at 2 h after exposure to the contrast media Target diastolic/systolic augmentation ratio of 1.0–1.2 |
Blood pressure >180/100 mmHg Hemorrhagic disease or bleeding tendency including INR >2 Uncontrolled tachyarrhythmia Severe aortic insufficiency Acute heart failure Arterial dissection or aneurysm Lower-extremityvenous thrombosis Infection, pregnancy, thyroid disease, tumor Recent exposure to contrast media or nephrotoxic drugs |
Increase of serum cystatin C ≥10% at 24th h after contrast exposure Iopromide contrast clearance measurement using plasma concentration of iopromide at 2nd, and 3rd h Conventional diagnosis of contrast-induced kidney injury using serum creatinine concentration at 48th h Adverse clinical events |
Zeng et al. [ |
China | Prospective cohort, compared with active comparator (standard dose of 0.9% NaCl hydration) | Age ≥18 years with estimated GFR <60 mL/min/1.73 m2 not on dialysis; |
230 (male, 76%, diabetes 36.1%, hypertension 77%, mean estimated GFR 42 mL/min/1.73 m2) | A once daily 1-h session of EECP therapy at 24 h before and 48–72 h after the intervention | (1) patients who had used iodinated contrast medium 30 d before inclusion, (2) patients with AKI due to other clear causes, (3) patients requesting withdrawal, (4) patients who failed to receive the re-examination of renal function indicators on time after surgery, (5) patients who underwent hemodialysis within 48 h after surgery, and (6) patients with uremia who received long-term hemodialysis. | Serum creatinine increase ≥0.3, ≥0.5 mg/dL or ≥25% relative to baseline value within 48–72 h after iodinated contrast exposure |