Five-Year Safety and Efficacy of a Novel Polymethylmethacrylate Aesthetic Soft Tissue Filler for the Correction of Nasolabial Folds

BACKGROUND A novel soft tissue filler composed of polymethylmethacrylate (PMMA) microspheres suspended in a collagen gel matrix containing 0.3% lidocaine (ArteFill, Artes Medical, Inc.) was recently approved by the Food and Drug Administration for the correction of nasolabial folds. A randomized, multicenter, controlled pivotal trial performed in the United States established the safety and efficacy of this medical device throughout a 12-month study period.
OBJECTIVE The objective was to substantiate the long-term 5-year safety and efficacy of this novel soft tissue PMMA filler.
METHODS AND MATERIALS Attempts were made to contact all subjects treated with the PMMA filler that were enrolled in the original pivotal study. Safety was assessed by standard adverse event reporting methods. Efficacy was determined using a validated six-point facial fold assessment photometric grading scale using blinded observers' assessment of standardized photographs.
RESULTS Subjects ( n =119) demonstrated significant improvement in nasolabial folds comparing baseline (before any treatment) to 5 years after their last treatment ( p <.001). Notably, subjects also demonstrated continued improvement between 6 months after their last treatment and Year 5 ( p =.002). No serious unanticipated device-related adverse events were reported.
CONCLUSION This PMMA filler is the first soft tissue filler to demonstrate continued improvement and persistence of correction over a 5-year period posttreatment.     

Importance of Recording the Right Bundle Branch Deflection in the Diagnosis of His-Purkinje Reentrant Tachycardia

Eight of 120 consecutive patients with inducible sustained ventricular tachycardia who were studied at our institution from September 1, 1988 to January 1, 1991, were found to have reentry within the His-Purkinje System as the mechanism of their tachycardias. Two of the eight patients (25%) required the recording of the right bundle branch potential to elucidate the tachycardia circuits. The electrophysiological findings of these two patients are described. In both instances, the diagnosis of supraventricular tachycardia with aberrancy was excluded. In patient 1, a His-bundle electrogram preceded each QRS complex during tachycardia and the His-to-His interval variation preceded changes in QRS intervals. However, recordings from the right bundle branch allowed for exclusion of bundle branch reentry and evidence was found for reentry restricted to the left fascicles. In patient 2, despite instances of dissociation of the His-bundle deflection from the tachycardia, a right bundle branch potential preceded each QRS and spontaneous changes in the interval between successive activation of the right bundle branch preceded changes in ventricular activation. Catheter ablation of the right bundle branch eliminated the tachycardia. It is concluded that the recording of a right bundle branch potential should be included in electrophysiology study of patients in whom there is suspicion of reentry within the His-Purkinje System. Clinically, recognizing these forms of tachycardias can be important because they can be effectively treated with catheter ablation.