An Investigation of Changes in Physical Properties of Injectable Calcium Hydroxylapatite in a Carrier Gel When Mixed with Lidocaine and with Lidocaine/Epinephrine

INTRODUCTION As physicians incorporate calcium hydroxylapatite (CaHA) into their aesthetic treatment regimens, the question has arisen of whether the addition of anesthetic agents to prefilled CaHA syringes might provide sufficient anesthetic prophylaxis to warrant reduction in conventional anesthetic pretreatment procedures.
STUDY DESIGN Investigators sought to determine changes in the physical properties of CaHA induced by the addition of lidocaine and lidocaine with epinephrine into the prefilled CaHA syringe. The CaHA and gel carrier (CHM) were mixed with varying amounts of lidocaine and lidocaine with epinephrine to measure the number of passes back and forth for optimal homogeneity of lidocaine and CaHA in syringes, changes in viscosity, extrusion force, needle jam rates, elasticity, and pH.
RESULTS Ten mixing passes appeared sufficient for homogeneity. Viscosities and extrusion forces of CHM/lidocaine blends decrease with increasing amount of lidocaine. Needle jams do not increase. The pH and elasticity of the CHM/lidocaine blend are essentially equivalent to those of CHM alone. Epinephrine added to lidocaine did not alter the results enough to reach statistical significance.
CONCLUSIONS Addition of lidocaine to original CHM can be safely added without harmful changes in physical properties of the original soft tissue filler. Further studies are required to explore whether the addition of lidocaine to CHM alters patient discomfort, durability, and efficacy.     

Nutrition and Health Status Assessment of Community-residing Elderly in New York City: A Pilot Study

Ninety-five percent of persons over the age of 65 years live in the community and benefit from community-based health and nutrition services. The purpose of this project was to evaluate diet, function, and mental health in 40 men and women aged 65 years and older who were residing in a large metropolitan community. Nutritional status was assessed using two 24-hour recalls, 5 days of food records, a food frequency, and anthropometric measurements. Participants responded to standardized activities of daily living and instrumental activities of daily living instruments and an investigator-developed, performance-based appraisal of food preparation and management. Cognition and mood were assessed using the Folstein Mini-Mental Examination and the Yesavage Depression Scale. The nutrient intakes for individuals were compared with the Recommended Dietary Allowances (RDAs) and the Food Guide Pyramid. Mean energy intake was 1,625 kcal (range=787 to 2,910 kcal); 7 persons consumed more than 2,000 kcal. The mean vitamin and mineral intake for participants met the RDAs except for calcium, vitamin D, zinc, and magnesium intakes. The average percentages of carbohydrate, protein, and fat were 53%, 16%, and 30%, respectively. Nutritional assessments of subjects with and without congregate meals were contrasted. Six of the 13 congregate-meal participants were at nutritional risk, compared with 6 of 27 not receiving congregate meals. The interrelationships of diet, functional status, and mental health factors were examined along with recommendations for future data collection in similar studies. J Am Diet Assoc. 1998;98:554-558.     

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.     

A Randomized, Bilateral, Prospective Comparison of Calcium Hydroxylapatite Microspheres versus Human-Based Collagen for the Correction of Nasolabial Folds

BACKGROUND Current soft tissue fillers are a compromise between ease of use, duration of correction, reactivity, and cost. A product utilizing calcium hydroxylapatite (CaHA) is currently being used as a soft tissue filler.
OBJECTIVE The objective was to compare the efficacy and safety of CaHA microspheres versus human-based collagen for the correction of nasolabial folds.
MATERIALS AND METHODS Four centers enrolled 117 subjects with moderate to deep nasolabial folds. Subjects received CaHA on one side of the face and human collagen on the other. Up to two touch-ups were allowed. A blinded panel of experts evaluated subject photographs from initial and follow-up visits.
RESULTS Seventy-nine percent of subjects had superior improvement on the CaHA side through 6 months ( p <.0001). For optimal correction, significantly less volume and fewer injections were needed for CaHA than for collagen ( p <.0001). Adverse event rates were comparable, with some increase in bruising and edema for CaHA-treated sides. Adverse event duration was similar for both groups and generally resolved within 14 to 21 days.
CONCLUSION This CaHA-based product gives significantly longer-lasting correction of nasolabial folds compared to human collagen. Less total material and fewer injections are required. The adverse event profile of the product is similar to the collagen-based product.     

The ulnar tunnel: a rare disposition of its contents

The ulnar tunnel is located at the proximal part of the hand radial to the pisiform bone and to the proximal part of the carpal tunnel. Inside it lie the ulnar nerve and artery. Compression of the ulnar nerve in this tunnel is often reported. Cysts, occupational trauma, fractures and muscle variations are among the main causes (Schjelderup, 1964; Kleinert & Hayes, 1971). Damage to the ulnar nerve and artery during the endoscopic decompression of the carpal tunnel has been reported recently (Agee et al. 1992; Nath et al. 1993; De Smets & Fabry, 1995). The structures within the ulnar tunnel are closely related to the medial part of the flexor retinaculum, in particular the ulnar artery which is located lateral to the ulnar nerve. During a study of this region we found a rare disposition of the contents of this tunnel. We believe that knowledge of this variation is important for the surgical anatomy of this region.     

Coronary Flow Reserve Versus Geometric Measurements of Coronary Dimensions: Advantages and Limitations of the Functional Stenosis Assessment

This article reviews the physiopathological background of invasive functional assessment of coronary artery stenoses and the recent developments for clinical decision making based on intracoronary flow and pressure measurements. Limitations of these recordings are stressed, as well as their present clinical application to guide the decision of performing an intervention, or to assess the results of a percutaneous procedure. The additional value over (quantitative) angiography and intravascular ultrasound is discussed. Finally, the potentials of a new method of coronary flow measurement, based on the processing of the radiofrequency IVUS signal, offering combined simultaneous morphological and physiological assessments, are briefly introduced.     

Real‐World Safety and Effectiveness Outcomes of a Zotarolimus‐Eluting Stent: Final 3‐Year Report of the RESOLUTE International Study

Objectives

We evaluated the safety and effectiveness of the Resolute? zotarolimus‐eluting stent (R‐ZES) in real‐world clinical practice through 3 years.

Background

A randomized comparison of the R‐ZES and the XIENCE V? everolimus‐eluting stent showed no difference in any outcomes through 3‐year follow‐up in high‐volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R‐ZES in real‐world clinical practice.

Methods

RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end‐point was the composite of cardiac death and target vessel myocardial infarction (TV‐MI) at 1 year. Secondary end‐points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST).

Results

At 3 years 97.2% of patients completed clinical follow‐up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV‐MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively.

Conclusions

The safety and effectiveness of the R‐ZES through 3 years in this real‐world all‐comer study was consistent with previously reported all‐comer trials. (J Interven Cardiol 2013;26:515‐523)

     

ICD Proarrhythmia as a Consequence of an Interaction with an Algorithm to Prevent Atrial Arrhythmias

An episode of device-related proarrhythmia is reported. Ventricular tachycardia was induced by ventricular pacing in a dual-chamber implantable cardioverter-defibrillator due to an inappropriate interaction of programmed device settings with the atrial preference pacing, an automatic algorithm designed to prevent atrial tachyarrhythmias .