Embosphere microspheres block artery blood flow to benign uterine tumors
Tris-acryl gelatin microspheres should be the preferred agent for uterine artery (fibroid) embolization (UAE) versus polyvinyl alcohol microspheres, given the known risk of recurrence in patients with persistent tumor enhancement after UAE, according to a study published in the January 2008 issue of the Journal of Vascular and Interventional Radiology.
Gary P Siskin, MD, chief, division of vascular and interventional radiology, department of radiology, Albany Medical Center in New York, and colleagues conducted the clinical study, "Leiomyoma Infarction after Uterine Artery Embolization: A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres."
The purpose of the study was to determine the degree of leiomyoma infarction after UAE performed with tris-acryl gelatin microspheres using BioSphere's Embosphere Microspheres or using Boston Scientific's Contour SE polyvinyl alcohol (PVA) embolic administered in accordance with Boston Scientific's newly refined treatment protocol. Two of the co-authors of this study received funding for the study from Boston Scientific and BioSphere Medical.
A total of 53 patients, enrolled in this study and scheduled for UAE, were randomized prospectively to receive tris-acryl gelatin microspheres or PVA microspheres. Twenty-seven (mean age, 44.9 years) received PVA microspheres and 26 (mean age, 45.1 years) received tris-acryl gelatin microspheres.
The manufacturers’ recommended technique was used for both products during the UAE procedures. All patients underwent MR imaging of the pelvis with contrast agent enhancement before and after the UAE procedure. On the postprocedural MR study, the degree of tumor infarction was assessed on postcontrast images. These findings were classified as follows: 100 percent infarction, 90–99 percent infarction, 50–89 percent infarction, and less than 50 percent infarction. Treatment failure was defined by enhancement of more than 10 percent of a patient’s entire tumor burden.
According to the results, there were “no significant differences in the preprocedural uterine volume, dominant tumor volume, location of dominant tumor, and presenting symptoms between populations. In the PVA microsphere group, treatment failure was seen in eight patients (29.6 percent). In the tris-acryl gelatin microsphere group, treatment failure was seen in one patient (3.8 percent), which was a significant difference between groups.”
Researchers concluded that UAE performed using BioSphere's Embosphere Microspheres showed significantly better results in blocking the flow of blood from arteries that feed benign uterine fibroids compared to procedures performed using Boston Scientific's Contour SE PVA embolic.
Gary P Siskin, MD, chief, division of vascular and interventional radiology, department of radiology, Albany Medical Center in New York, and colleagues conducted the clinical study, "Leiomyoma Infarction after Uterine Artery Embolization: A Prospective Randomized Study Comparing Tris-acryl Gelatin Microspheres versus Polyvinyl Alcohol Microspheres."
The purpose of the study was to determine the degree of leiomyoma infarction after UAE performed with tris-acryl gelatin microspheres using BioSphere's Embosphere Microspheres or using Boston Scientific's Contour SE polyvinyl alcohol (PVA) embolic administered in accordance with Boston Scientific's newly refined treatment protocol. Two of the co-authors of this study received funding for the study from Boston Scientific and BioSphere Medical.
A total of 53 patients, enrolled in this study and scheduled for UAE, were randomized prospectively to receive tris-acryl gelatin microspheres or PVA microspheres. Twenty-seven (mean age, 44.9 years) received PVA microspheres and 26 (mean age, 45.1 years) received tris-acryl gelatin microspheres.
The manufacturers’ recommended technique was used for both products during the UAE procedures. All patients underwent MR imaging of the pelvis with contrast agent enhancement before and after the UAE procedure. On the postprocedural MR study, the degree of tumor infarction was assessed on postcontrast images. These findings were classified as follows: 100 percent infarction, 90–99 percent infarction, 50–89 percent infarction, and less than 50 percent infarction. Treatment failure was defined by enhancement of more than 10 percent of a patient’s entire tumor burden.
According to the results, there were “no significant differences in the preprocedural uterine volume, dominant tumor volume, location of dominant tumor, and presenting symptoms between populations. In the PVA microsphere group, treatment failure was seen in eight patients (29.6 percent). In the tris-acryl gelatin microsphere group, treatment failure was seen in one patient (3.8 percent), which was a significant difference between groups.”
Researchers concluded that UAE performed using BioSphere's Embosphere Microspheres showed significantly better results in blocking the flow of blood from arteries that feed benign uterine fibroids compared to procedures performed using Boston Scientific's Contour SE PVA embolic.