Transhepatic approach to closure of patent foramen ovale: report of 2 cases in adults.

Patent foramen ovale is increasingly diagnosed in patients who are undergoing clinical study for cryptogenic stroke or migraine. In addition, patent foramen ovale is often suspected as a cause of paradoxical embolism in patients who present with arterial thromboembolism. The femoral venous approach to closure has been the mainstay. When the femoral approach is not feasible, septal occluder devices have been deployed via a transjugular approach.Herein, we describe 2 cases of patent foramen ovale in which the transhepatic approach was used for closure. To our knowledge, this is the 1st report of a transhepatic approach to patent foramen ovale closure in an adult patient. Moreover, no previous case of patent foramen ovale closure has been reported in a patient with interrupted inferior vena cava.

Transcatheter closure of recurrent aortic pseudoaneurysm previously treated by Amplatzer occluder device.

Thoracic pseudoaneurysms are a rare variety of aortic disorders that are potentially fatal. Traditionally, these are treated surgically. False aneurysms are usually a late complication of a previous surgical procedure. Surgical management is often complicated by poor outcomes with high morbidity and mortality. We report a patient with recurrence of an aortic pseudoaneurysm after closure with an Amplatzer (AGA Medical Corp, Plymouth, NH) septal occluder that was successfully treated with a second Amplatzer device.

A randomized, double-blind, placebo-controlled, dose-escalation study of intravenous adult human mesenchymal stem cells (prochymal) after acute myocardial infarction.

OBJECTIVES: Our aim was to investigate the safety and efficacy of intravenous allogeneic human mesenchymal stem cells (hMSCs) in patients with myocardial infarction (MI). BACKGROUND: Bone marrow-derived hMSCs may ameliorate consequences of MI, and have the advantages of preparation ease, allogeneic use due to immunoprivilege, capacity to home to injured tissue, and extensive pre-clinical support. METHODS: We performed a double-blind, placebo-controlled, dose-ranging (0.5, 1.6, and 5 million cells/kg) safety trial of intravenous allogeneic hMSCs (Prochymal, Osiris Therapeutics, Inc., Baltimore, Maryland) in reperfused MI patients (n=53). The primary end point was incidence of treatment-emergent adverse events within 6 months. Ejection fraction and left ventricular volumes determined by echocardiography and magnetic resonance imaging were exploratory efficacy end points. RESULTS: Adverse event rates were similar between the hMSC-treated (5.3 per patient) and placebo-treated (7.0 per patient) groups, and renal, hepatic, and hematologic laboratory indexes were not different. Ambulatory electrocardiogram monitoring demonstrated reduced ventricular tachycardia episodes (p=0.025), and pulmonary function testing demonstrated improved forced expiratory volume in 1 s (p=0.003) in the hMSC-treated patients. Global symptom score in all patients (p=0.027) and ejection fraction in the important subset of anterior MI patients were both significantly better in hMSCs versus placebo subjects. In the cardiac magnetic resonance imaging substudy, hMSC treatment, but not placebo, increased left ventricular ejection fraction and led to reverse remodeling. CONCLUSIONS: Intravenous allogeneic hMSCs are safe in patients after acute MI. This trial provides pivotal safety and provisional efficacy data for an allogeneic bone marrow-derived stem cell in post-infarction patients. (Safety Study of Adult Mesenchymal Stem Cells [MSC] to Treat Acute Myocardial Infarction; NCT00114452).

Two brothers with myocardial infarction in the absence of atherosclerotic coronary artery disease: spontaneous coronary thrombosis: case reports of two brothers.

Myocardial infarction in the absence of significant atherosclerotic coronary artery disease is not uncommonly encountered in clinical practice. This has been more often seen with the current sensitive biomarker assays for myocardial necrosis. Acute illnesses, spontaneous coronary dissection, sepsis, pulmonary embolism and coagulation disorders are some of the common clinical situation where elevated cardiac markers are noted. We describe two brothers presenting with acute myocardial infarction due to thrombus without any obvious cause.

Percutaneous closure of aortic pseudoaneurysm by Amplatzer occluder device-case series of six patients.

Thoracic pseudoaneurysms are rare variety of aortic disorders. Although mostly asymptomatic, they represent potentially fatal conditions (Sullivan et al., Chest 1988;93:138-143; Razzouk et al., Ann Surg 1993;59:818-823) that are traditionally treated surgically. False aneurysms of aorta are usually a late complication of previous surgical procedure (Sullivan et al., 1988)-especially reconstructive surgery, trauma (Razzouk et al., 1993), and rarely infection (Sanchez-Recalde et al., J Am Coll Cardiol 2003;41:152-154). Surgical management is often complicated by poor outcomes with high morbidity and mortality (Mulder et al., Arch Surg 1998;133:45-49). Endovascular treatment is emerging as promising options for aortic diseases with fewer complications. We report a series of six cases at a single center where Amplatzer device was used to treat thoracic aortic pseudo aneurysm. To our knowledge only one series of three cases (Kanani et al., Catheter Cardiovasc Interv 2007;69:146-153) and few case reports (Bashi et al., Catheter Cardiovasc Interv 2005;65:547-551) of successful closure have been published previously. Our case series is the largest, so far, including mortality and specifically the preprocedural and postprocedural CT angiographic assessment of the pseudoaneurysms.

Endovascular repair of an ascending aortic pseudoaneurysm with a septal occluder device: mid-term follow-up.

Ascending pseudoaneurysm is an infrequent complication of ascending aortic surgery. Redo operations are often associated with a high surgical morbidity and mortality. Endovascular management of ascending aortic pathologies with endoluminal graft therapies are challenging due to short landing zones and the fear of flow obstruction to the coronaries and brachiocephalic circulation. We report mid-term follow-up of the management of an ascending aortic pseudoaneurysm using a an Amplatz septal occluder (AGA Medical Corp, Golden Valley, MN) in a 51-year-old man considered at high risk for conventional open surgical repair.

Endovascular management of a large post-traumatic iliac arteriovenous fistula: utilization of a septal occlusion device.

We describe the management of a large iliac arteriovenous fistula in a 48-year-old patient presenting with heart failure and pulmonary hypertension. The presumptive etiology was a left-lower back stab wound approximately 20 years earlier. A large communication between the left internal iliac artery and the left internal iliac vein was successfully treated with a septal occlusion device.

A randomized, controlled trial of saphenous vein graft intervention with a filter-based distal embolic protection device: TRAP trial.

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate-large infarction (CKMB >5x) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.