Performance of the ADAPT-Treated CardioCel® Scaffold in Pediatric Patients With Congenital Cardiac Anomalies: Medium to Long-Term Outcomes.

A Phase II Clinical Trial reviewed the performance (morbidity and calcification) of the tissue-engineered ADAPT® bovine pericardial scaffold (CardioCel®) in pediatric patients ( = 30) with congenital cardiac defects. In that study, CardioCel® demonstrated no graft-related morbidity and mortality in 25 patients, over 12 months. Five patients died due to non-graft-related events.

Efficacy and Safety of Vernakalant for Cardioversion of Recent-onset Atrial Fibrillation in the Asia-Pacific Region: A Phase 3 Randomized Controlled Trial.

Atrial fibrillation (AF) is a common clinically significant cardiac arrhythmia. This phase 3 randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of vernakalant hydrochloride for the pharmacological conversion of AF to sinus rhythm in patients with recent-onset (>3 hours to ≤7 days) symptomatic AF from the Asia-Pacific region. Patients received an infusion of vernakalant (3 mg/kg) or placebo for 10 minutes.

Velaglucerase alfa enzyme replacement therapy compared with imiglucerase in patients with Gaucher disease.

Enzyme replacement therapy for Gaucher disease (GD) has been available since 1991. This study compared the efficacy and safety of velaglucerase alfa with imiglucerase, the previous standard of care. A 9-month, global, randomized, double-blind, non-inferiority study compared velaglucerase alfa with imiglucerase (60 U/kg every other week) in treatment-naïve patients aged 3-73 years with anemia and either thrombocytopenia or organomegaly.

Enzyme replacement therapy with velaglucerase alfa in Gaucher disease: Results from a randomized, double-blind, multinational, Phase 3 study.

Type 1 Gaucher disease (GD1), resulting from glucocerebrosidase deficiency, leads to splenomegaly, hepatomegaly, anemia, thrombocytopenia, and bone involvement. Current standard treatment is enzyme replacement therapy. Velaglucerase alfa is an enzyme replacement product for GD1, with the same amino acid sequence as naturally occurring human glucocerebrosidase.

Phase 1/2 and extension study of velaglucerase alfa replacement therapy in adults with type 1 Gaucher disease: 48-month experience.

Enzyme replacement therapy is the standard of care for symptomatic Gaucher disease. Velaglucerase alfa is a human beta-glucocerebrosidase produced in a well-characterized human cell line. A 9-month phase 1/2 open-label, single-center trial and ongoing extension study were conducted to evaluate safety and efficacy of velaglucerase alfa.

A randomized, parallel-group, open-label trial of recombinant human erythropoietin vs preoperative autologous donation in primary total joint arthroplasty: effect on postoperative vigor and handgrip strength.

This randomized trial assessed the effect of recombinant human erythropoietin (EPO) vs preoperative autologous donation (PAD) on postoperative vigor and handgrip strength in patients undergoing primary total joint arthroplasty. Adults with baseline hemoglobin level of 11 to 14 g/dL received EPO (600 IU/kg once weekly for 4 doses, n = 130) or PAD (n = 121) before primary, unilateral hip or knee arthroplasty. Mean changes in vigor score and handgrip strength from baseline were not significantly different between treatment groups.

Influence of hemoglobin levels on inpatient rehabilitation outcomes after total knee arthroplasty.

This retrospective study examined the influence of hemoglobin (Hb) on the outcomes of 184 acute inpatient rehabilitation patients admitted to a single university-based inpatient rehabilitation facility after primary total knee arthroplasty between 2001 and 2003. Patient function was measured using the Functional Independence Measure (FIM) instrument. Average length of stay was 9.

Stent placement for treatment of central and peripheral venous obstruction: a long-term multi-institutional experience.

Purpose: The clinical success and patency of central and peripheral venous stents in patients with symptomatic venous obstruction (SVO) were assessed.

Methods: The records of patients with SVO treated with venous stents from 1992 to 1999 were reviewed. Demographic and procedural variables were analyzed to determine their effect on clinical success, primary patency, and secondary patency.

The epidemiology of surgically repaired aneurysms in the United States.

Objective: The purpose of this study was to determine the results of surgery for hospitalized cases of aneurysms in the United States, thereby providing a standard of comparison for new techniques proposed to treat aneurysms.

Methods: Data on hospitalized aneurysm cases were collected from the National Hospital Discharge Survey, a comprehensive database of patients hospitalized in the United States for treatment from the years 1984 to 1994. The National Hospital Discharge Survey samples non-federal, acute-care hospitals with an average length of stay of less than 30 days.

An assessment of the current applicability of the EVT endovascular graft for treatment of patients with an infrarenal abdominal aortic aneurysm.

Objective: To determine the percentage of elective abdominal aortic aneurysms (AAAs)/aortoiliac aneurysms that currently can be repaired with endovascular grafts (EVGs), the reasons for rejection of EVGs, and the future role of EVG in the treatment of AAA.

Methods: From January 1997 to May 1998, patients at three hospitals (a university hospital, a university-affiliated teaching hospital, and a Veterans Administration hospital with university faculty and residents) were evaluated for EVGs as part of a national clinical trial with grafts manufactured by Endovascular Technologies (EVT, Menlo Park, Calif). All patients at two hospitals and patients treated by the participating surgeons at the third hospital were screened for EVG.

Effect of outflow level and maximum graft diameter on the velocity parameters of reversed vein bypass grafts.

Objective: The objective of this study was to define a normal range of distal graft velocity (DGV) and peak systolic velocity (PSV) on the basis of outflow level and maximum graft diameter for infrainguinal reversed vein bypass grafting (RVG).

Methods: This study was designed as a prospective study of consecutive patients who underwent infrainguinal RVG from 1994 to 1997 in a university hospital and university-affiliated teaching hospital. All patients who underwent infrainguinal bypass grafting from 1994 to 1997 were placed in a prospective protocol with duplex scanning to better define the hemodynamics of normally functioning RVG.

Left subclavian artery aneurysm: two cases of rare congenital etiology.

Subclavian artery aneurysms are uncommon. The most common causes of these aneurysms are atherosclerosis and traumatic pseudoaneurysm. We report two cases of rare congenial left subclavian artery aneurysms.

Peripheral aneurysms and arteriomegaly: is there a familial pattern?

Purpose: Studies have shown that 11% to 18% of patients with an abdominal aortic aneurysm (AAA) have a first-degree relative with an AAA. A familial pattern among patients with peripheral arterial aneurysms and arteriomegaly has not been reported. The objective of this study was to examine familial patterns among patients with peripheral arterial aneurysm and arteriomegaly and compare them with patterns among patients with AAA.

Incidence, timing, and causes of cerebral ischemia during carotid endarterectomy with regional anesthesia.

Purpose: Controversy exists regarding the best technique to identify cerebral ischemia during carotid endarterectomy (CEA). Regional anesthesia allows continuous evaluation of neurologic function and therefore can help determine the incidence, timing, and causes of cerebral ischemia.

Methods: The timing and clinical manifestations of any neurologic event during CEA and as long as 30 days afterward was determined by review of operative reports, hospital charts, and outpatient records of consecutive patients who underwent CEA under regional anesthesia over a 68-month period.