Aorfix™ device for abdominal aortic aneurysm with challenging anatomy.

Anatomical characteristics of abdominal aortic aneurysms (AAA) are the most critical factors for successful endovascular aortic repair (EVAR). Of these, severe proximal aortic neck angulation and iliac axis tortuosity increase the complexity of EVAR. Neck angulation seems to have a pivotal potential for fixation failure, a situation that may lead to complications, including endoleak and late rupture. Bench-test studies identified that the relative stiffness of a stent-graft was responsible for its inability to conform to neck angulation, therefore creating leaks through gaps between the stent graft and the neck. Aorfix™ stent graft (Lombard Medical, Didcot, UK) is a flexible stent-graft designed and manufactured with the purpose of overcoming the issue of stent-graft stiffness. Many studies have shown good results in term of procedural success and mid-term type-I endoleak. PYTHAGORAS trial evaluated mainly patients with highly angulated infrarenal neck and showed that high performance of Aorfix™ stent graft did not present any significant difference between neck >60° and <60°. In the series of 27 patients treated at our Institution we had a primary technical success of 96.3% and an assisted primary technical success of 100%. In this review we will analyze the available data in literature regarding Aorfix™ stent graft and will discuss the outcome of the patients treated with Aorfix™ stent graft at our centre.

Clinical Experience with the NIR Stent: Retrospective Observation on Acute Results and Follow-up in 709 Patients.

The NIR stent is an expandable cellular coronary prosthesis with high flexibility and excellent trackability. The very low crossing profile, associated to the high flexibility, makes this stent suitable for complex and distal lesions. The aim of this study was to evaluate the feasibility, safety, and long-term (clinical follow-up) efficacy of elective and/or urgent deployment of the NIR stent in a broad patient group with coronary artery disease. Between June 1996 and May 1997, 986 NIR stents were implanted in 781 vessels (de novo or restenotic lesions in native vessels, saphenous vein grafts and internal mammary conduits) of 709 consecutive patients (498 men, 211 women) undergoing coronary angioplasty in two Villa Maria Group Catheterization Laboratories. Procedural angiographic success was achieved in 98.4% of all the lesions treated, ranging from 100% success rate in type A lesion to 97.6% in type C lesions (overall procedural success, 98.4%). Major adverse cardiac events (MACE) were considered from PTCA/stenting time to the patient discharge. The in-hospital MACE were limited and occurred in 15 patients: urgent surgical revascularization 0.8%, death 0.7%, sub-acute stent thrombosis 0.5% (overall in-hospital MACE rate 2.1%). Clinical follow-up data were obtained at 8.6 +/- 2.8 months following the stenting procedure. The event-free survival rate was 87.9%. The late MACE rate evaluation showed death, target lesion revascularization 9.9% (over-all late MACE rate 12.1%). The NIR stent performances in this broad patient population were excellent, showing very high procedural success rate both in normal and complex coronary anatomy. On the basis of the previous data, we can define NIR stent a safe multifunctional device suitable both for easy and complex situations. The clinical late results are very promising in term of event-free survivals and late MACE.

The use of coronary angioplasty devices in carotid endovascular interventions: encouraging results in 21 consecutive patients.

Severe atherosclerotic lesion of carotid artery is the main cause of stroke and transient ischemic attack (TIA). Its incidence may reach 5-7% per annum in patients with carotid artery stenosis higher than 70% with or without symptoms. While time-honored carotid endarterectomy is still regarded as the "gold standard" therapy for most of the patients, carotid angioplasty with stent may be the only alternative to this treatment when endarterectomy is too risky or impossible. Although percutaneous angioplasty has been fully acknowledged as far as coronary or peripheral artery disease is concerned, the issue is still controversial in the endovascular treatment of carotid artery disease with regard to its indications, devices to be used and long-term results. Assessment of risk relating to carotid angioplasty with stent in comparison to carotid endarterectomy continues to be difficult, since materials and methods for this approach have not been standardized yet. Our initial experience in carotid angioplasty with stent performed in 21 consecutive patients by using devices for coronary angioplasty is extremely encouraging.

Femoral Arterial Hemostasis using the Angio-Sealª System after Coronary and Vascular Percutaneous Angioplasty and Stenting.

The procedures of left cardiac catheterization and revascularization by angioplasty are associated with a substantial risk of hemorrhagic complications. This risk increases clearly in patients with an intravascular stent who require early high doses of anticoagulant therapy. The first purpose of our study was to evaluate the effectiveness of a mechanical system of femoral hemostasis (Angio-Sealª, Sherwood Davis & Geck, St. Louis, Missouri) deployed in a group of 411 consecutive patients (302 males, 109 females, mean age 59 +/- 15) who successfully underwent percutaneous angioplasty (PA) and application of an intravascular stent (378 coronary, 33 vascular). The arterial closure system consists of a small absorbable anchor and a collagen pad connected to a suture thread which, at the end of the procedure, is positioned by percutaneous introduction at the site of the femoral puncture. All the patients studied received long-term platelet anti-aggregant therapy (ticlopidine 500 mg/day and ASA 150 mg/day) for 3Ð4 days before and for one month after the procedure, and an anticoagulant regimen of heparin sodium administered via intravenous bolus (10,000 IU) during the procedure, followed by subcutaneous heparin calcium (12,500 IU/day) for 21 days. Thirteen patients were treated intravenously with 10 mg abciximab and seven received pre-procedure coumadin. The ACT when the hemostasis system was positioned was 355 +/- 43 seconds. Successful hemostasis was reached in more than 95% of the patients (394/411 pts., 95.86%). In 17 (4.14%) of the 411 patients studied, the system failed; nine (2.19%) of these were attributed by the operator to a failure of the positioning device procedure, and the remaining 8 (1.95%) were attributed to a malfunction of the system. Overall complications were observed in 23/411 (5.6%) of the patients (pts) studied; eighteen were minor non-surgical hemorrhagic complications (bleeding and/or hematoma) which occurred primarily in the first 4 hours. In 4 cases (1%) vascular surgery was necessary for femoral pseudoaneurysm repair (2 pts) and femoral hematoma (2 pts). One patient (0.24%) complained of severe claudication related to a severe stenosis in the femoral artery caused by a malpositioning of the anchor. This patient was successfully treated with balloon angioplasty and stenting of the femoral artery. The average time to early mobilization was 9 hours, and all the patients without complications were completely mobile within 12 hours after the procedure; 380/411 (92.46%) of the patients were discharged 18Ð24 hours after percutaneous angioplasty. The second purpose of our study was to compare data from 411 consecutive patients treated with the Angio-Sealª device after coronary and vascular angioplasty and stenting (Angio-Seal group), to a group of 387 consecutive patients where the femoral arterial hemostasis was obtained using manual compression after coronary angioplasty and stenting (manual compression group). We found significant differences (p < 0.01) in the most important elements concerning general patient management after the interventional procedure, with excellent improvements using the Angio-Seal device, including: successful hemostasis (95.86% vs. 88.37%); reduction of non-surgical hematomas (1.22% vs. 4.65%); reduction of surgical hematomas (0.49% vs. 2.84%); mobilization time (9 +/- 3 hours vs. 19 +/- 8 hours); and discharge within 18Ð24 hours (92.46% vs. 0.00%).

Effect of enoximone alone and in combination with metoprolol on myocardial function and energetics in severe congestive heart failure: improvement in hemodynamic and metabolic profile.

The hemodynamic and myocardial metabolic effects of enoximone (phosphodiesterase III inhibitor), alone or in combination with metoprolol (beta-adrenergic blocker), were studied in patients with congestive heart failure. Ten patients (New York Heart Association Class III-IV) underwent right heart and coronary sinus catheterization, and parameters were assessed at basal condition, at peak enoximone response (mean intravenous loading dose = 2.2 mg/kg), and after the combination with metoprolol (mean intravenous dose = 8.5 mg). Heart rate tended to increase during enoximone administration (from 102 +/- 16 to 107 +/- 16 min-1, ns) and was reduced during enoximone plus metoprolol (to 88 +/- 15 min-1, p < 0.05 vs. basal). Cardiac index was increased during enoximone (from 2.2 +/- 0.2 to 3.8 +/- 0.5 1/min/m2, p < 0.05) and decreased during enoximone plus metoprolol (to 2.8 +/- 0.5 1/min/m2, p < 0.05 vs. enoximone). Mean pulmonary wedge pressure fell during enoximone and remained reduced during enoximone plus metoprolol (from 27 +/- 9 to 9 +/- 3 and to 13 +/- 4 mmHg, respectively, both p < 0.05). Myocardial oxygen consumption did not change during enoximone (from 27 +/- 8 to 25 +/- 13 ml/min, ns) and was reduced during enoximone plus metoprolol (to 19 +/- 8 ml/min, p < 0.05 vs. basal). Myocardial lactate extraction tended to be lower during enoximone and during enoximone plus metoprolol conditions (from 38 +/- 17% to 26 +/- 20% and to 29 +/- 24%, respectively), but no statistical significance was found. Myocardial efficiency was increased during enoximone and during enoximone plus metoprolol (from 9 +/- 3% to 15 +/- 6% and to 14 +/- 6%, respectively, both p < 0.05). Thus in patients with congestive heart failure enoximone improves hemodynamics and, in most cases, it does not influence energetics. The addition of metoprolol to enoximone reduces heart rate, cardiac index, and myocardial oxygen consumption without any other major changes, producing a more physiologic hemodynamic and metabolic profile.