Jafar Golzarian

2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease (Updating the 2005 Guideline) A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

Keeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Task Force on Practice Guidelines (Task Force) has created a “focused update” process to revise the existing guideline recommendations that are affected by the evolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care. Evidence is reviewed at least twice a year, and updates are initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that the ACCF and AHA have developed during their partnership of >20 years. These updated guideline recommendations reflect a consensus of expert opinion after a thorough review primarily of late-breaking clinical trials identified through a broad-based vetting process as being important to the relevant patient population, as well …

2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (Updating the 2005 Guideline)

Keeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Task Force on Practice Guidelines (Task Force) has created a “focused update” process to revise the existing guideline recommendations that are affected by the evolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care. Evidence is reviewed at least twice a year, and updates are initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that the ACCF and AHA have developed during their partnership of >20 years. These updated guideline recommendations reflect a consensus of expert opinion after a thorough review primarily of late-breaking clinical trials identified through a broad-based vetting process as being important to the relevant patient population, as well …

The 6-F nitinol TrapEase inferior vena cava filter: Results of a prospective multicenter trial

PURPOSE The authors report the first results of a new 6-F symmetrically designed permanent nitinol inferior vena cava (IVC) filter, the Cordis TrapEase, evaluated in a multicenter prospective study with 6-months of follow-up. MATERIALS AND METHODS A total of 65 patients (29 men, 36 women) who ranged in age from 37 to 96 years (mean age, 68 years) and who were at high risk of pulmonary embolism (PE) were enrolled in 12 centers in Europe and Canada. The study was approved by the institutional review boards at all centers. Study objectives were to evaluate filter effectiveness, filter stability, and caval occlusion. Indications for filter placement were deep vein thrombosis with recurrent thromboembolism and/or free-floating thrombus with contraindication to anticoagulation in 37 patients, and complications in achieving adequate anticoagulation in 28 patients. Follow-up included clinical examination, plain film, Doppler ultrasound, CT scan, and nuclear medicine. RESULTS The analysis of the data revealed a technical success of 95.4% (three filter-system related implantations not at the intended site, no events of filter tilting) and a clinical success of 100% at 6 months (no cases of symptomatic PE), the study primary endpoint. There were no cases (0%) of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study period, there were two cases of filter thrombosis: one case of early symptomatic thrombosis that was successfully treated in the hospital, and one case of nonsymptomatic filter thrombosis detected at 1-month follow-up, with spontaneous recanalization at 3 months. In the latter patient, some residual thrombus was still detected at 6 months. Of the study population of 65 patients, there were 23 deaths. These deaths were not related to the device or the implantation procedure but to the underlying disease process. CONCLUSION This study demonstrates the new nitinol permanent IVC filter to be a safe and an effective device, with a low overall complication rate, for use in patients with thromboembolic disease at high risk of PE.

Corporeal veno-occlusive dysfunction: Predominantly intracavernous muscular pathology

PURPOSE We investigated whether a relationship exists between the flow to maintain an erection obtained at cavernosometry and the alteration of intracavernous structures in impotent patients with corporeal veno-occlusive dysfunction and normal arterial inflow. MATERIALS AND METHODS Computerized histomorphometric analysis of smooth muscle and elastic fibers, and endothelial cells was compared to the flow necessary to maintain erection after intracavernous vasoactive drug injection in 18 patients with corporeal veno-occlusive dysfunction. RESULTS A significant correlation between percentage of smooth muscle fibers and flow to maintain erection was observed, while no correlation was noted with elastic fibers and endothelial cells. CONCLUSIONS Corporeal veno-occlusive dysfunction seems to be due mainly to smooth muscular alterations. According to this observation treatment of impotent patients with this abnormality should not be restricted to the penile veins but should also include the intracavernous structures, predominantly the muscular component.

In vitro and in vivo evaluation of biodegradable embolic microspheres with tunable anticancer drug release

Natural polymer-derived materials have attracted increasing interest in the biomedical field. Polysaccharides have obvious advantages over other polymers employed for biomedical applications due to their exceptional biocompatibility and biodegradability. None of the spherical embolic agents used clinically is biodegradable. In the current study, microspheres prepared from chitosan and carboxymethyl cellulose (CMC) were investigated as a biodegradable embolic agent for arterial embolization applications. Aside from the enzymatic degradability of chitosan units, the cross-linking bonds in the matrix, Schiff bases, are susceptible to hydrolytic cleavage in aqueous conditions, which would overcome the possible shortage of enzymes inside the arteries. The size distribution, morphology, water retention capacity and degradability of the microspheres were found to be affected by the modification degree of CMC. An anticancer drug, doxorubicin, was successfully incorporated into these microspheres for local release and thus for killing cancerous cells. These microspheres demonstrated controllable degradation time, variable swelling and tunable drug release profiles. Co-culture with human umbilical vein endothelial cells revealed non-cytotoxic nature of these microspheres compared to monolayer control (P>0.95). In addition, a preliminary study on the in vivo degradation of the microspheres (100-300μm) was performed in a rabbit renal embolization model, which demonstrated that the microspheres were compatible with microcatheters for delivery, capable of occluding the arteries, and biodegradable inside arteries. These microspheres with biodegradability would be promising for embolization therapies.

2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline).

Joshua A. Beckman, MD, FACC, FAHA* Laura K. Findeiss, MD‡ Jafar Golzarian, MD† Heather L. Gornik, MD, FACC, FAHA*† Jonathan L. Halperin, MD, FACC, FAHA*¶ Michael R. Jaff, DO, FACC*† Gregory L. Moneta, MD, FACS† Jeffrey W. Olin, DO, FACC, FAHA*# James C. Stanley, MD, FACS† Christopher J. White, MD, FACC, FAHA, FSCAI*,** John V. White, MD, FACS† R. Eugene Zierler, MD, FACS† 2005 Alan T. Hirsch, MD, FACC, Chair WRITING Ziv J. Haskal, MD, FAHA, FSIR, Co-Chair COMMITTEE Norman R. Hertzer, MD, FACS, Co-Chair MEMBERS __________________

Doxorubicin loading and eluting characteristics of bioresorbable hydrogel microspheres: In vitro study

Non-bioresorbable drug eluting microspheres are being increasingly used for the treatment of unresectable liver tumors, whereas bioresorbable microspheres have not received much attention. In this study, bioresorbable microspheres prepared from chitosan and carboxymethyl cellulose were loaded with doxorubicin (Doxo) via ion-exchange interactions with carboxylic groups in the microspheres. With a 25-40% decrease in the microsphere size depending on their size ranges, the microspheres could load a maximum of 0.3-0.7 mg Doxo/mg dry spheres. As confirmed by confocal microscopy, Doxo was mainly concentrated in the outer 20±5 μm surface layer of the microspheres. The loaded microspheres were stable in aqueous dispersions without aggregation for a prolonged period of time but degradable in a lysozyme solution. Furthermore, the loaded microspheres exhibited a noticeable pH-sensitive behavior with accelerated release of Doxo in acidic environment due to the protonation of carboxylic groups in the microspheres. Compared to commercial non-resorbable drug eluting beads, the loaded bioresorbable microspheres showed a sustained release manner in phosphate buffered saline (PBS). The release data were fitted to an empirical relationship, which reveals a non-Fickian transport mechanism (n=0.55-0.59). These results demonstrate that the bioresorbable microspheres are promising as attractive carriers for Doxo.

An in situ forming biodegradable hydrogel-based embolic agent for interventional therapies

We present here the characteristics of an in situ forming hydrogel prepared from carboxymethyl chitosan and oxidized carboxymethyl cellulose for interventional therapies. Gelation, owing to the formation of Schiff bases, occurred both with and without the presence of a radiographic contrast agent. The hydrogel exhibited a highly porous internal structure (pore diameter 17±4 μm), no cytotoxicity to human umbilical vein endothelial cells, hemocompatibility with human blood, and degradability in lysozyme solutions. Drug release from hydrogels loaded with a sclerosant, tetracycline, was measured at pH 7.4, 6 and 2 at 37°C. The results showed that tetracycline was more stable under acidic conditions, with a lower release rate observed at pH 6. An anticancer drug, doxorubicin, was loaded into the hydrogel and a cumulative release of 30% was observed over 78 h in phosphate-buffered saline at 37°C. Injection of the hydrogel precursor through a 5-F catheter into a fusiform aneurysm model was feasible, leading to complete filling of the aneurysmal sac, which was visualized by fluoroscopy. The levels of occlusion by hydrogel precursors (1.8% and 2.1%) and calibrated microspheres (100-300 μm) in a rabbit renal model were compared. Embolization with hydrogel precursors was performed without clogging and the hydrogel achieved effective occlusion in more distal arteries than calibrated microspheres. In conclusion, this hydrogel possesses promising characteristics potentially beneficial for a wide range of vascular intervention procedures that involve embolization and drug delivery.

2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (Updating the 2005 guideline)

published online Sep 29, 2011; J. Am. Coll. Cardiol. J. White, John V. White, and R. Eugene Zierler Michael R. Jaff, Gregory L. Moneta, Jeffrey W. Olin, James C. Stanley, Christopher Laura K. Findeiss, Jafar Golzarian, Heather L. Gornik, Jonathan L. Halperin, W. Rooke, Alan T. Hirsch, Sanjay Misra, Anton N. Sidawy, Joshua A. Beckman, Radiology, Society for Vascular Medicine, and Society for Vascular Surgery, Thom Society for Cardiovascular Angiography and Interventions, Society of Interventional Association Task Force on Practice Guidelines Report of the American College of Cardiology Foundation/American Heart Patients With Peripheral Artery Disease (Updating the 2005 Guideline): A 2011 ACCF/AHA Focused Update of the Guideline for the Management of This information is current as of October 12, 2011 http://content.onlinejacc.org/cgi/content/full/j.jacc.2011.08.023v1 located on the World Wide Web at: The online version of this article, along with updated information and services, is

The arterial distribution of Embozene and Embosphere microspheres in sheep kidney and uterus embolization models.

PURPOSE To compare the in vivo distribution of the new embolic Embozene versus Embosphere as a control in the sheep renal and uterine vasculature. MATERIALS AND METHODS Twelve sheep (three per group of product and size) were selectively embolized with Embozene 700 μm, Embozene 900 μm, Embosphere 500-700 μm, or Embosphere 700-900 μm, in one renal artery (0.5 mL microspheres) and in the two uterine arteries (0.25 mL each) and sacrificed 72 hours later for pathologic examination of kidney and uterus. Partition of microspheres in the vasculature was determined according to a classification of the renal and the uterine vasculatures into several zones. Vascular diameters and microsphere deformation were measured. RESULTS Embozene 700 μm and Embozene 900 μm occluded significantly more distally than Embosphere 500-700 μm and Embosphere 700-900 μm in renal and uterine vasculature. For Embozene, the vessel diameter was not significantly different between the two sizes, for each organ, whereas it was significantly larger for Embosphere 700-900 μm than for Embosphere 500-700 μm in each organ. Embozene deformation was significantly higher than that of Embosphere in renal and uterine vasculature, increased from proximal to distal in location for both organs and correlated negatively with vessel diameter (Rho = -0.623; P < .0001). Embosphere deformation did not vary according to the zone. CONCLUSIONS Embozene microspheres have a higher in vivo deformation, which results in a more distal occlusion within the vascular network compared with reference Embosphere microspheres. The diameter of occluded vessels varied for the tested size range for Embosphere but was independent of the tested microsphere size range used for Embozene. The deformation of Embozene appears to determine the size of the vessels occluded as opposed to the granulometric particle size, which makes level of occlusion unpredictable.