[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.

Zenith TX2LowProfile TAA Endovascular Graft: a next generation thoracic stent-graft.

AIM: The aim of the present article is to describe a new thoracic stent graft (Zenith TX2 Low-Profile TAA Endovascular Graft). METHODS: Feasibility of endovascular repair of thoracic aortic aneurysms depends on several anatomic factors. A primary limitation is an adequate arterial approach. Since most currently used endografts require large introducer sheaths, patients with severely diseased iliofemoral vessels are often excluded from this less-invasive technique. Attempts to overcome access difficulties increase the risk for arterial access-site complications such as aortoiliac rupture. In addition, highly angulated proximal landing zones provide challenges in obtaining proximal graft conformance and sealing. RESULTS: The introduction of next-generation endografts such as the Zenith TX2LowProfile TAA Endovascular Graft provides a solution for a larger number of patients, including those with small vessels, vascular access problems and tortuous aortic anatomy. CONCLUSION: The ongoing Zenith TX2 Low-Profile Endovascular Graft trial will build further understanding of the performance of the device allowing for treatment of a wider patient population.

Rupture of abdominal aortic aneurysm previously treated by endovascular stentgraft.

We describe a case of abdominal aortic aneurysm (AAA) with rupture 16 months after treatment by an endograft. A 76-year-old patient on Coumadin after aortic valve replacement had initially successful exclusion by stentgraft. There was no evidence of an endoleak seven months after stentgraft repair, although a computed tomography scan detected an enlargement of the aneurysm sac. Sixteen months after initial endograft surgery, rupture of the aneurysm occurred and we performed open emergency surgery. We treated the aneurysm by conventional technique, and the patient survived the rupture. This case emphasized the fact that patients after endograft AAA repair require a close follow-up. An expansion of the aneurysm sac after the procedure should signal failed exclusion, even if a computed tomography scan does not demonstrate an endoleak. Anticoagulation can be an important factor in failure after endoluminal graft treatment. Supravisceral aortic cross clamping is helpful in dealing with a stented aorta.

Experimental studies with absorbable and nonabsorbable sutures in infected canine arterial anastomoses.

Vascular anastomoses are usually performed with nonabsorbable synthetic suture material. In an infected wound suture material may have a negative effect on the healing of vascular anastomoses, leading to leakage and formation of false aneurysms. In a canine model 40 neck wounds and 40 groin wounds were contaminated with a standard suspension of Staphylococcus aureus. Subsequently 80 end-to-end anastomoses were performed in both carotid and femoral arteries with the absorbable polydioxanone (PDS) or the nonabsorbable polypropylene (PPL) suture material in one of either side. After wound infection or hemorrhage occurred, or at least 7 days to 6 months after vascular surgery, the dogs were put to death and the contaminated vessels were removed to determine the extent of infection with light and scanning electron microscopy. Macroscopic (presence of pus, anastomotic rupture, or aneurysm) and microscopic findings (absorption, tissue reaction) were compared statistically with the McNemar test. There was no difference in the incidence of wound infection between the sutures examined. Bacteriologic cultures revealed no other microorganism than the inoculated staphylococcus strain or occasional skin contaminants. In the PPL group hemorrhages occurred more frequently (n = 6) than in the PDS group (n = 2; p = 0.125). Anastomotic aneurysms (n = 5) were found only in the PPL group (p = 0.375). These differences, although statistically not significant (because of the small number of the studied anastomoses), suggest the use of monofilament absorbable suture material for autogenous anastomoses in a contaminated area.