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Mineralocorticoid receptor antagonists have beneficial effects on left ventricular remodeling, cardiac fibrosis, and arrhythmia in heart failure, but efficacy and safety in dialysis patients is less clear. We evaluated the effect of spironolactone on left ventricular mass (LVM), an independent predictor of all-cause and cardiovascular mortality, in hemodialysis patients. In this placebo-controlled, parallel-group trial, 97 hemodialysis patients (23% female; mean age 60.3 years) were randomized to spironolactone 50 mg once daily (n=50) or placebo (n=47). The primary efficacy endpoint was change in LVM index (LVMi) from baseline to 40 weeks as determined by cardiac magnetic resonance imaging. Safety endpoints were development of hyperkalemia and change in residual renal function. There was no significant change in LVMi in participants randomized to spironolactone compared to placebo (-2.86±11.87 vs. 0.41±10.84 g/m2). There was also no difference in the secondary outcomes of mean 24-hour systolic or diastolic ambulatory blood pressure, left ventricular ejection fraction, 6-minute walk test distance, or New York Heart Association functional class. Moderate hyperkalemia (pre-dialysis potassium levels of 6.0-6.5 mmol/L) was more frequent with spironolactone treatment (155 vs. 80 events), but severe hyperkalemia (≥6.5 mmol/L) was not (14 vs. 24 events). Changes in residual urine volume and measured glomerular filtration rate did not differ between groups. There were no deaths in the spironolactone group and 4 deaths in the placebo group. Thus, treatment with 50 mg spironolactone did not change left ventricular mass index, cardiac function, or blood pressure in hemodialysis patients. Spironolactone increased the frequency of moderate hyperkalemia, but did not increase severe hyperkalemia.

Background and objective: Restenosis-rate after balloon-angioplasty of long segment tibial arterial disease is largely unknown. We investigated the restenosis-rates angiographically in patients with critical limb ischemia (CLI) due to extensive infrapopliteal lesions. Methods: Angioplasty for infrapopliteal lesions exclusively ≥80 mm in length was performed using dedicated 80–120 mm long low-profile balloons. Follow-up included angiography at 3 months and clinical assessment at 3 and 15 months. Results: Angioplasty was performed in 77 infrapopliteal arteries of 62 limbs of 58 CLI patients with a Rutherford class 4 in 16 (25.8%) limbs and Rutherford class 5 in 46 limbs (74.2%). Average lesion length was 18.4 cm. Treated arteries were stenosed in 35.1% and occluded in 64.9%. After 3 months, a clinical improvement (marked reduction of ulcer-size or restpain) was seen in 47 (75.8%) limbs, 14 (22.6%) limbs were clinically unchanged and 1 (1.6%) limb showed a clinical deterioration. Angiography at 3 months showed no significant restenosis in 24 of 77 (31.2%) treated arteries, a restenosis ≥50% in 24 (31.2%) arteries and a reocclusion in 29 of 77 (37.6%). At 15 months death rate was 10.5%. After repeat angioplasty in case of restenosis cumulative clinical results at 15 months were minor amputations in 8.1%, no major amputations resulting in a limb-salvage rate of 100% with no patient requiring bypass surgery. Conclusions: Restenosis-rate after angioplasty of extensive infrapopliteal arterial disease is high and occurs early after treatment. Despite this the clinical results are excellent, especially given the length of the arterial segments diseased. © 2010 Wiley-Liss, Inc.

Factitious anticoagulant-resistance as a cause of recurrent arterial bypass graft occlusions

Controlled reperfusion of ischemic limbs has been found to be protective in limiting ischemia-reperfusion injury. We aimed to analyze local hemodynamic effects of prostaglandin E1 (PGE1) administrated during controlled reperfusion in an in vivo setting.Twenty-four pigs underwent exposure of the infrarenal aorta and iliac vessels. Pigs were observed for 7.5 h without limb ischemia (group I). In the others, limb ischemia was produced by clamping the aorta for 6 h. Reperfusion was conducted in uncontrolled (group II), controlled (group III), and controlled fashion with addition of PGE1 (group IV) for the initial 30 min. We evaluated regional blood flow in the left common iliac artery, cardiac output, systemic vascular resistance, oxygen and glucose consumption, muscle adenosine triphosphate (ATP), and potassium levels in iliac vein.Benefits after reperfusion were observed in group IV compared with group III regarding regional blood flow at 60 min (P0.01) and 90 min (P0.01), glucose consumption at 30 min, (P0.05) and potassium regulation at 30 (P0.05) and 90 min (P0.05).The addition of PGE1 to controlled reperfusion further reduces local hemodynamic effects of ischemia-reperfusion injury compared with standard controlled and uncontrolled reperfusion in an animal model.