[Drug-coated balloons in the treatment of peripheral artery disease (PAD). History and current level of evidence]. / Medikamentenbeschichtete Ballonkatheter in der PAVK­Behandlung. Entwicklung der Methode und aktuelle Studienlage.

BACKGROUND: Despite initially encouraging technical success after femoropopliteal PTA, restenosis remains the major challenge in patients with peripheral artery disease (PAD). The main cause of restenosis is neointimal hyperplasia which can be suppressed by antiproliferative drugs. Drug-coated balloons (DCB) or drug-eluting stents (DES) are used for the inhibition of restenosis. OBJECTIVES: The present article gives an overview of DCB development, actual DCB systems for femoro- and infrapopliteal use, displays the outcomes of randomized clinical trials and the discusses the evidence for the DCB treatment in PAD. METHODS: A systematic literature search was performed in i) medical journals (i. e. MEDLINE), ii) in international registers for clinical studies (i. e. www.clinicaltrials.gov ) and in iii) scientific session abstracts. RESULTS: The clinical evidence of the PTX-DCB of the first and following generation has been shown in several controlled randomized trials. CONCLUSIONS: Major advantages of the DCBs lie in leaving no stent scaffold behind, the immediate release of high drug concentrations with a single dosage, their efficacy in areas, where stents have been contra-indicated until now and its use for secondary interventions. As their effect seems to be limited in severely calcified lesions, prior plaque preconditioning or removal could be advantageous. First positive results data supporting this hypothesis do exist.

Long-term outcome of femoropopliteal stenting. Results of a prospective study.

AIM: Aim of the study was to assess the long-term clinical results of primary stent placement in patients with femoro-popliteal lesions and intermittent claudication (IC) or critical limb ischemia (CLI). METHODS: Prospectively collected data of 517 patients (543 limbs) treated for IC (N.=422; 77.5%) and CLI (N.=121; 22.5%), between September 2006 and December 2010 were evaluated. Survival, limb salvage and patency rates were analyzed and multivariate analysis was performed to evaluate possible risk factors for the development of restenosis. RESULTS: Mean patients' age was 70.6 years (SD ±10); 64.8% of the patients (N.=335) were male. Angiography revealed TASC A or B lesions in 64.5% (N.=350), TASC C or D lesions in 35.5% (N.=193) of the patients. Two hundred thirty-two patients had evidence of occluded femoropopliteal artery (42.7%) and the remaining patients had evidence of high grade (>70%) stenosis. In total, 827 bare metal nitinol stents (1.53±0.9 per limb) were used. No early (<30-day) procedure-related death was recorded. After a mean follow-up period of 60 months (SD ±13.5), 69 patients died (13.4%). Eight (1.5%) patients underwent major amputation. The amputation rate was significantly higher in the CLI group compared to the IC group (P=0.03). Primary patency rates were 86.2%, 79.1%, 75.1% and 62.2% after 1, 2, 3 and 5 years, respectively. No difference in terms of patency rates was found between the results of the treatment of TASC A/B versus TASC C/D lesions and the patient groups with IC versus CLI. CONCLUSION: The endovascular-first line treatment with use of nitinol stents for patients with femoropopliteal artery lesions is associated with acceptable long-term patency rates, even in patients with long lesions.

[Segmental arterial mediolysis: pathogenesis of aneurysms and dissections in patients younger than 60 years]. / Segmental mediolytische Arteriopathie - Ursachenforschung bei unter 60-jährigen Patienten mit Aneurysmen und Dissektionen.

BACKGROUND: Complications deriving from arterial aneurysm and dissection without signs of atherosclerosis are rare clinical entities. In recent literature case reports show a descriptive similarity of pathological findings summarized as segmental arterial mediolysis (SAM). OBJECTIVE: The purpose of this study was to answer the question whether, among 16 patients suffering from SAM histological findings corresponded and assess causality. MATERIALS AND METHODS: In a prospective prognostic trial sixteen patients were enrolled between 1st January 2008 and 31st October 2011. Inclusion criteria were a lack of atherosclerosis, age under 60 and clinical findings. Most of these sixteen patients were treated as emergency cases of life-threatening blood loss or organ system ischemia. Thirteen of the patients were male, 3 female and their average age was 44 (28-59) years. Localisation of the segmental aneurysm or dissection showed a broad variability from central to renovisceral and peripheral lesions. Imaging diagnostics (e.g., US and CT-A) were complemented by exclusion of positive family history, connective tissue diseases and autoimmune or inflammative disorders. In 8 patients with open vascular reconstructions, it was possible to obtain a biopsy from the target lesion to analyse morphological and immunochemical expression levels (e.g., MMP1-12, vWF, vSMC or CD 68). RESULTS: None of the patients died nor had described familiar associations. Even the examination of twins with sCAD showed no coincidence. Differential diagnostic findings were excluded. All patients agreed to undergo human genetic screening. The 8 biopsy tissues showed homogeneously mediolysis with focal and increasingly confluent lesions. Main findings were that the vessel wall layering was destroyed and that capillarisation was initiated from the adventitial layer. Furthermore, all patients suffered from hypertension associated to the SAM, or developed it during surveillance. CONCLUSION: SAM is a rare, life-threatening diagnosis and has to be taken into consideration in young patients with aneurysm and dissection of unusual locations. Rare vascular diseases should have a forum in future investigations which might highlight molecular genetic triggers and associated diseases, e.g., hypertension and aortic type B dissection.

[Effectiveness of nephroprotection by the selection of contrast media used during vascular interventions in patients with chronic renal failure?]. / Ist Nephroprotektion durch die Auswahl des Röntgen-Kontrastmittels im Rahmen von Gefäßinterventionen bei vorbestehender Niereninsuffizienz möglich?

BACKGROUND: The increasing number of endovascular procedures made aware of a kidney disease induced by contrast media (CM). Contrast-induced nephropathy (= CIN) can develop in 0.6-44 % of the treated patients by angiography and / or endovascular intervention. The incidence in high-risk patients ranges from 50 to 70 %. In most cases CIN is inconspicuous and reversible. But pre-existing chronic kidney disease, diabetes mellitus, age and variable different risk factors (e. g., PAOD) can induce irreversible renal impairment. The purpose of the presented trial is to investigate incidence, predictors, and out-come of CIN in chronic renal failure patients using two different CM; one non-ionic isoosmolar -iodixanol and the other non-ionic low-osmolar iopromide. METHODS: To evaluate the incidence of CIN after endovascular diagnostics and intervention two collectives of 100  patients with chronic renal insufficiency were treated with different contrast media (CM). Inclusion followed prospectively in two collectives. One collective received iopromide (Ultravist™, Bayer Health Care, Lever-kusen, Germany), and the second hundred patients received iodixanol (Visipaque™, Nycomed Amersham, Princeton, New Jersey). Demographics, comorbidities, procedure-related data were completed by serum creatinine levels and GFR (= glomerular filtration rate). Inclusion criteria were a serum creatinine level ≥ 1.5 mg% and a GFR ≤ 60 mL / min. Those parameters were measured twice pre-interventionally, and one time 48-72  hours after the endovascular procedure. RESULTS: Collectives were homogenous and comparable concerning pre-existing risk factors, age and gender. Renal function stayed at a constant level and was independent of contrast medium selection, repectively. Average creatinine levels ranged around 1.77 mg% ±â€Š0.75  standard deviation (SD) pre-interventionally; postinterventional measurement exposed a creatinine level of 1.74 mg% ±â€Š0.74 SD as mean of both collectives. GFR (preinterventional 39.64 mL / min ±â€Š12.48 SD) increased non-significantly to 45.48 mL / min ±â€Š16.82 SD. Pre-existing chronic kidney disease had no effect on renal function parameters; no other risk factors could be evaluated. CONCLUSION: According to cost-effectiveness a low-osmolar monomeric contrast medium (LOCM) is a sufficient selection, under careful renal function control.

[Segmental mediolytic arteriopathy (SMA) of central, visceral and peripheral vessels]. / Segmental mediolytische Arteriopathie der zentralen, viszeralen und peripheren Gefässe.

HISTORY AND CLINICAL FINDINGS: A 27-year-old man had been admitted to hospital with acute neurological defects involving his legs and urinary system. An intervertebral disk was removed surgically, because a herniation had been suspected. But symptoms increased postoperatively. Further imaging showed a ruptured aneurysm of the internal iliac artery which was treated with coil embolization. INVESTIGATIONS: Further diagnostic tests excluded hematological, rheumatic and endocrinological causes for the development of the aneurysm. Genetic differentiation was normal. Imaging then demonstrated "string of beads" small aneurysms of intra- and extracerebral, renal, visceral and peripheral arteries. TREATMENT AND COURSE: During the past three years the patient had repeated ruptures of the intra-abdominal arterial aneurysms for which coil embolization and bypass grafting were performed, also to prevent further ruptures. CONCLUSIONS: Segmental mediolytic arteriopathy is a rare condition requiring careful imaging and histological tests for its diagnosis and acute surgical treatment.

[Long stents for long femoropopliteal lesions--first results of 128 Protégé stents]. / Lange femoro-popliteale Läsionen erfordern lange Stents--erste Erfahrungen mit 128 Protégé-Stents.

BACKGROUND: In the endovascular therapy for the superficial femoral artery (SFA) a variety of stent devices can be used. Indications for endovascular intervention are increasing, since the 2007 TASC II consensus changed. Several, also multicentric -trials, evaluated the use and effectiveness of stent devices. AIM: The present trial studied efficacy of long ev3 Protégé Everflex stents used in the treatment of long and complex occlusive lesions of the -superficial femoral artery (SFA) and the popliteal artery. MATERIALS AND METHODS: The ev3 Protégé Everflex device (ev3 Inc., Plymouth, MN, USA) is a self-expandable nitinol stent consisting of a helical structure with spiral cell interconnections, making high flexibility and low fragility possible. Using a prospective follow-up programme, 103 consecutive patients who received 128 stents (150 mm average length) were included in this study. Pre- and postinterventional parameters were walk-ing distance, ABI, Rutherford categorisation and duplex ultrasound examination. In addition, stent fracture was excluded by radiograms. The mean follow-up period was 6 months. RESULTS: 128 stents were implanted in 103 patients. The average age was 71.1 years (range: 52-90 years). 44 % of the collective suffered from TASC II C and D lesions. The technical success was 100 %. Restenosis was found in 11.8 % of the cases (n = 16) and recanalised (n = 9). 4 bypass implantations and 2 major amputations were performed. A total of 6 stent fractures was found (4.7 %). CONCLUSIONS: The Protégé stent is a safe device with favourable short-term results. Restenosis and fracture rates are low, but long-term results still have to be evaluated in the future.