Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Percutaneous Transluminal Angioplasty in Dysfunctional Hemodialysis Grafts and Native Fistulae.

PURPOSE: to assess the safety and efficacy of APERTO-Paclitaxel-coated balloon angioplasty versus standard angioplasty for the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae. METHODS: consecutive patients with dysfunctional dialysis related to underlying efferent vein stenosis were included and randomized 1:1 to either APERTO-paclitaxel drug-coated balloon (study arm) or standard percutaneous transluminal angioplasty (control arm). Primary endpoint is time from treatment until dialysis access dysfunction according to standardized Kidney Disease Outcomes Quality Initiative (KDOQI)-guidelines and assessed by Kaplan-Meier survival curves and tested for significance with log-rank analysis. Secondary endpoints include device, technical, and clinical success of the index angioplasty procedure. RESULTS: The study included 103 patients (n=51 study-group) with a de novo (n=33) dysfunctional native arteriovenous fistula (n=79) in the forearm (n=60). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm. Device-related complications did not occur in any of the included patients. Functional hemodialysis access without need for re-intervention at 1 year after index procedure was found in n=10 (19.6%) and n=5 (9.6%) of patients treated with, respectively, paclitaxel drug-coated balloon and percutaneous transluminal angioplasty (p=0.612). A nonsignificant benefit of paclitaxel drug-coated balloon (n=5; 25%) over percutaneous transluminal angioplasty (n=1; 11%) was found (p=0.953) in de novo lesions in autologous fistulas. CONCLUSION: APERTO-paclitaxel drug-coated balloon is a safe balloon catheter to manage dysfunctional hemodialysis access; however, longer period of adequate hemodialysis circuit functioning after endovascular index stenosis treatment, using APERTO-paclitaxel drug-coated balloon versus percutaneous transluminal angioplasty could not be demonstrated. CLINICAL IMPACT: APERTO-paclitaxel drug-coated balloon catheter is a safe device to manage dysfunctional hemodialysis access. Compared to conventional angioplasty balloon, the APERTO drug-coated balloon will not result in longer period of adequate hemodialysis circuit functioning. A non-significant benefit of APERTO drug-coated balloon was found in de novo lesions in autologous fistulas.

An unusual case of polydactyly.

Polydactyly is defined as a congenital anomaly of the hand or foot with the presence of supernumerary digits. The frequency of polydactyly varies widely among populations. It can occur as an isolated condition or as a feature of a congenital condition. In the literature, the condition is commonly described in combination with an apparent congenital deformity. We describe a case of polydactyly with no other obvious, macroscopically visible anomaly. A 21-year-old man presented with a sprained left ankle. On examination, a slightly irregularly shaped fifth digit of the left foot that appeared like a tailor's bunion was observed. The patient reported slight weight-bearing pain and tenderness over the navicular bone. No fractures were seen on radiographs, but they revealed an os tibiale externum, an extra metatarsal bone conjoined distally with the fifth metatarsal, and an extra hypoplastic proximal phalanx. No obvious signs of deformity were present. A bunionette, which was an extra hypoplastic proximal phalanx, was observed at the base of the fifth toe. Few published reports have described isolated polymetatarsia, and none of those describe supernumeral digits. A comprehensive search of the literature found no cases identical to ours.

Preoperative diagnosis of carotid artery stenosis: accuracy of noninvasive testing.

BACKGROUND AND PURPOSE: Carotid endarterectomy has been shown to be beneficial in symptomatic patients with a severe stenosis (70% to 99%) of the internal carotid artery (ICA). Digital subtraction angiography (DSA) is the standard of reference in the diagnosis of carotid artery stenosis but has a relatively high complication rate. In a diagnostic study we investigated the accuracy of noninvasive testing compared with DSA. METHODS: In a prospective diagnostic study we performed duplex ultrasound (DUS), magnetic resonance angiography (MRA), and DSA on 350 consecutive symptomatic patients. Stenoses were measured with the observers blinded for clinical information and other test results. Separate and combined test results of DUS and MRA were compared with the reference standard DSA. Only the stenosis measurements of the arteries on the symptomatic side were included in the analyses. RESULTS: DUS analyzed with previously defined criteria resulted in a sensitivity of 87.5% (95% CI, 82.1% to 92.9%) and a specificity of 75.7% (95% CI, 69.3% to 82.2%) in identifying severe ICA stenosis (70% to 99%). Stenosis measurements on MRA yielded a sensitivity of 92.2% (95% CI, 86.2% to 96.2%) and a specificity of 75.7% (95% CI, 68.6% to 82.5%). When we combined MRA and DUS results, agreement between these 2 modalities (84% of patients) gave a sensitivity of 96.3% (95% CI, 90.8% to 99.0%) and a specificity of 80.2% (95% CI, 73.1% to 87.3%) for identifying severe stenosis. CONCLUSIONS: MRA showed a slightly better accuracy than DUS in the diagnosis of carotid artery stenosis. To achieve the best accuracy, however, both tests should be performed subsequently.

Percutaneous thrombolysis of thrombosed haemodialysis access grafts: comparison of three mechanical devices.

BACKGROUND: Percutaneous thrombolysis has become an accepted treatment of thrombosed haemodialysis grafts. Several devices have been developed for mechanical thrombolysis, which macerate the clot using different mechanisms such as aspiration and fragmentation. The aim of our study was to compare the efficacy of three devices for mechanical thrombolysis in removing the thrombus from thrombosed haemodialysis access grafts and to determine the initial technical and clinical success, complication rates of each device, and graft patency after the procedure. METHODS: Thrombolysis (i.e. clot removal followed by percutaneous transluminal angioplasty (PTA)) was performed in 68 thrombosed haemodialysis grafts using the Cragg brush catheter combined with urokinase in 13, the Hydrolyser in 18 and the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) in 37. Clot removal scores (CRS, the ability to thoroughly remove clot from the access), initial technical success, clinical success, patency at 30, 60, and 90 days, and complication rates were evaluated. RESULTS: CRS for the Cragg brush, Hydrolyser and PTD were good in 92, 44, and 95% of cases, respectively. Initial technical (85, 83, and 95%) and clinical success (62, 67, and 86%), mean patency rates at 30 (73, 60, and 55%), 60 (61, 53, and 49%), and 90 (49, 40, and 43%) days, stenosis after PTA (33, 46, and 21%) and complication rates (8, 6, and 0%) were not different for the three devices. Success rates and graft patency depended on the effect of PTA, irrespective of the device used. CONCLUSIONS: The rotational devices removed clots more effectively than the Hydrolyser, with the PTD having the advantage of not requiring urokinase. However, the result of PTA in the treatment of underlying stenoses was the only predictive value for graft patency.