Radiographic assessment of overlengthening of the MoPyC radial head prosthesis: a cadaveric study.

INTRODUCTION: The aim of this study was to evaluate a radiographic measurement method for assessment of overlengthening of the MoPyC radial head prosthesis. MATERIALS AND METHODS: Seven cadaver specimens were studied in ten stages: native specimen (1), radial head resection (2), and implantation of the MoPyC radial head prostheses (Bioprofile, Tornier, Montbonnot-Saint-Martin, France) in four increasing length (correct length, overlengthening of 1.5 mm, 3 mm, and 5 mm) with an intact medial collateral ligament (MCL 3-6) and following transection of the MCL (7-10). The radiographic measurement method according to Athwal et al. was evaluated to detect overlengthening. Statistical analysis included calculation of the diagnostic accuracy of the radiographic method. RESULTS: The radiographic measurement method correctly determined the size of the radial head prosthesis within ± 1 mm in 224 of 336 scenarios (67%) and within ± 2 mm in 320 of 336 scenarios (95%). With a threshold value of ≥ 1 mm, the overall diagnostic sensitivity for detecting overlengthening when it was present and was 90% and the specificity was 79%. The sensitivity was higher with increasing size of the prosthesis: in cases with overlengthening of 1.5 mm, the sensitivity was 76%, with an overlengthening of 3 mm, the sensitivity was 95%, and with an overlengthening of 5 mm, the sensitivity was 100%. CONCLUSION: The radiographic measurement method of Athwal et al. can be used to estimate and to diagnose the magnitude overlengthening of the MoPyC radial head prosthesis. However, the sensitivity is limited (76%) in cases with a small amount of overlengthening of 1.5 mm.

Impact of Physician Education and a Dedicated Inferior Vena Cava Filter Tracking System on Inferior Vena Cava Filter Use and Retrieval Rates Across a Large US Health Care Region.

PURPOSE: To evaluate the effects of physician familiarity with current evidence and guidelines on inferior vena cava (IVC) filter use and the availability of IVC filter tracking infrastructure on retrieval rates. MATERIALS AND METHODS: Fourteen continuing medical education-approved in-hospital grand rounds covering evidence-based review of the literature on IVC filter efficacy, patient-centered outcomes, guidelines for IVC filter indications, and complications were performed across a large United States (US) health care region serving more than 3.5 million members. A computer-based IVC filter tracking system was deployed simultaneously. IVC filter use, rates of attempted retrieval, and fulfillment of guidelines for IVC filter indications were retrospectively evaluated at each facility for 12 months before intervention (n = 427) and for 12 months after intervention (n = 347). RESULTS: After education, IVC filter use decreased 18.7%, with a member enrollment-adjusted decrease of 22.2%, despite an increasing IVC filter use trend for 4 years. Reduction in IVC filter use at each facility strongly correlated with physician attendance at grand rounds (r = -0.69; P = .007). Rates of attempted retrieval increased from 38.9% to 54.0% (P = .0006), with similar rates of successful retrieval (82.3% before education and 85.8% after education on first attempt). Improvement in IVC filter retrieval attempts correlated with physician attendance at grand rounds (r = 0.51; P = .051). IVC filter dwell times at first retrieval attempt were similar (10.2 wk before and 10.8 wk after). CONCLUSIONS: Physician education dramatically reduced IVC filter use across a large US health care region, and represents a learning opportunity for physicians who request and place them. Education and a novel tracking system improved rates of retrieval for IVC filter devices.

Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

Analysis of a five year experience of permanent pacemaker implantation at a Nigerian Teaching Hospital: need for a national database.

INTRODUCTION: Permanent pacemaker implantation is available in Nigeria. There is however no national registry or framework for pacemaker data collection. A pacemaker database has been developed in our institution and the results are analyzed in this study. METHODS: The study period was between January 2008 and December 2012. Patient data was extracted from a prospectively maintained database which was designed to include the fields of the European pacemaker patient identification code. RESULTS: Of the 51 pacemaker implants done, there were 29 males (56.9%) and 22 females (43.1%). Mean age was 68.2±12.7 years. Clinical indications were syncopal attacks in 25 patients (49%), dizzy spells in 15 patients (29.4%), bradycardia with no symptoms in 10 patients (17.7%) and dyspnoea in 2 patients (3.9%). The ECG diagnosis was complete heart block in 27 patients (53%), second degree heart block in 19 patients (37.2%) and sick sinus syndrome with bradycardia in 5 patients (9.8%). Pacemaker modes used were ventricular pacing in 29 patients (56.9%) and dual chamber pacing in 22 patients (43.1%). Files have been closed in 20 patients (39.2%) and 31 patients (60.8%) are still being followed up with median follow up of 26 months, median of 5 visits and 282 pacemaker checks done. Complications seen during follow up were 3 lead displacements (5.9%), 3 pacemaker infections (5.9%), 2 pacemaker pocket erosions (3.9%), and 1 pacemaker related death (2%). There were 5 non-pacemaker related deaths (9.8%). CONCLUSION: Pacemaker data has been maintained for 5 years. We urge other implanting institutions in Nigeria to maintain similar databases and work towards establishment of a national pacemaker registry.

Commissioning a CT-compatible LDR tandem and ovoid applicator using Monte Carlo calculation and 3D dosimetry.

PURPOSE: To determine the geometric and dose attenuation characteristics of a new commercially available CT-compatible LDR tandem and ovoid (T&O) applicator using Monte Carlo calculation and 3D dosimetry. METHODS: For geometric characterization, we quantified physical dimensions and investigated a systematic difference found to exist between nominal ovoid angle and the angle at which the afterloading buckets fall within the ovoid. For dosimetric characterization, we determined source attenuation through asymmetric gold shielding in the buckets using Monte Carlo simulations and 3D dosimetry. Monte Carlo code MCNP5 was used to simulate 1.5 × 10(9) photon histories from a (137)Cs source placed in the bucket to achieve statistical uncertainty of 1% at a 6 cm distance. For 3D dosimetry, the distribution about an unshielded source was first measured to evaluate the system for (137)Cs, after which the distribution was measured about sources placed in each bucket. Cylindrical PRESAGE(®) dosimeters (9.5 cm diameter, 9.2 cm height) with a central channel bored for source placement were supplied by Heuris Inc. The dosimeters were scanned with the Duke Large field of view Optical CT-Scanner before and after delivering a nominal dose at 1 cm of 5-8 Gy. During irradiation the dosimeter was placed in a water phantom to provide backscatter. Optical CT scan time lasted 15 min during which 720 projections were acquired at 0.5° increments, and a 3D distribution was reconstructed with a (0.05 cm)(3) isotropic voxel size. The distributions about the buckets were used to calculate a 3D distribution of transmission rate through the bucket, which was applied to a clinical CT-based T&O implant plan. RESULTS: The systematic difference in bucket angle relative to the nominal ovoid angle (105°) was 3.1°-4.7°. A systematic difference in bucket angle of 1°, 5°, and 10° caused a 1% ± 0.1%, 1.7% ± 0.4%, and 2.6% ± 0.7% increase in rectal dose, respectively, with smaller effect to dose to Point A, bladder, sigmoid, and bowel. For 3D dosimetry, 90.6% of voxels had a 3D γ-index (criteria = 0.1 cm, 3% local signal) below 1.0 when comparing measured and expected dose about the unshielded source. Dose transmission through the gold shielding at a radial distance of 1 cm was 85.9% ± 0.2%, 83.4% ± 0.7%, and 82.5% ± 2.2% for Monte Carlo, and measurement for left and right buckets, respectively. Dose transmission was lowest at oblique angles from the bucket with a minimum of 56.7% ± 0.8%, 65.6% ± 1.7%, and 57.5% ± 1.6%, respectively. For a clinical T&O plan, attenuation from the buckets leads to a decrease in average Point A dose of ∼3.2% and decrease in D(2cc) to bladder, rectum, bowel, and sigmoid of 5%, 18%, 6%, and 12%, respectively. CONCLUSIONS: Differences between dummy and afterloading bucket position in the ovoids is minor compared to effects from asymmetric ovoid shielding, for which rectal dose is most affected. 3D dosimetry can fulfill a novel role in verifying Monte Carlo calculations of complex dose distributions as are common about brachytherapy sources and applicators.

[Prosthetic rehabilitation: needs in Senegalese dental offices]. / La réhabilitation prothétique: évaluation des besoins dans les cabinets dentaires du Sénégal.

Knowledge of dental prosthetic needs will develop strategies for prevention and treatment through a package of individual, community and professional policies. The aim of this study was to evaluate prosthetic needs in Senegalese dental offices. The survey was conducted among people aged 15 years and more attending Senegalese dental clinics. The mean number of missing teeth was 4.4. Only 55.3% of the sample expressed the need for dentures and 81.8% had a diagnosed need for prosthesis. A statistically significant difference was noticed between the needs diagnosed and the expressed needs (p < 0.0001). Finally, this study reveals that the need for prosthetic treatment is real in the Senegalese dental offices.

The Joint Commission's disease-specific care certification for destination therapy ventricular assist devices.

The Centers for Medicare and Medicaid Services announced that all hospitals implanting ventricular assist devices are required to have certification from the The Joint Commission for disease-specific care destination therapy with a ventricular assist device effective March 27, 2009, in order to receive Medicare reimbursement for services rendered to patients who have devices implanted for destination therapy. On February 23, 2007, The Joint Commission released the certification requirements for ventricular assist devices implanted for destination therapy in an 8-page document so that hospitals could prepare to meet the 2009 certification deadline. The Artificial Heart Program of the University of Pittsburgh Medical Center undertook a multidisciplinary project, under the guidance of the nurse coordinator, to prepare the hospital and program for a precertification survey by The Joint Commission for disease-specific destination therapy ventricular assist device certification. The Presbyterian Hospital Artificial Heart Program was awarded The Joint Commission's device-specific certification for destination therapy with ventricular assist devices in June 2008.

A technical evaluation of the Nucletron FIRST system: conformance of a remote afterloading brachytherapy seed implantation system to manufacturer specifications and AAPM Task Group report recommendations.

The Fully Integrated Real-time Seed Treatment (FIRST) system by Nucletron has been available in Europe since November 2001 and is being used more and more in Canada and the United States. Like the conventional transrectal ultrasound implant procedure, the FIRST system utilizes an ultrasound probe, needles, and brachytherapy seeds. However, this system is unique in that it (1) utilizes a low-dose-rate brachytherapy seed remote afterloader (the seedSelectron), (2) utilizes 3D image reconstruction acquired from electromechanically controlled, nonstepping rotation of the ultrasound probe, (3) integrates the control of a remote afterloader with electromechanical control of the ultrasound probe for integrating the clinical procedure into a single system, and (4) automates the transfer of planning information and seed delivery to improve quality assurance and radiation safety. This automated delivery system is specifically intended to address reproducibility and accuracy of seed positioning during implantation. The FIRST computer system includes two software environments: SPOT PRO and seedSelectron; both are used to facilitate treatment planning and brachytherapy seed implantation from beginning to completion of the entire procedure. In addition to these features, the system is reported to meet certain product specifications for seed delivery positioning accuracy and reproducibility, seed calibration accuracy and reliability, and brachytherapy dosimetry calculations. Consequently, a technical evaluation of the FIRST system was performed to determine adherence to manufacturer specifications and to the American Association of Physicists in Medicine (AAPM) Task Group Reports 43, 53, 56, 59, and 64 and recommendations of the American Brachytherapy Society (ABS). The United States Nuclear Regulatory Commission (NRC) has recently added Licensing Guidance for the seedSelectron system under 10 CFR 35.1000. Adherence to licensing guidance is made by referencing applicable AAPM Task Group recommendations. In general, results of this evaluation indicated that the system met its claimed specifications as well as the applicable recommendations outlined in the AAPM and ABS reports.

Chronic, preclinical assessment of the Medtronic Advantage aortic valve prosthesis.

BACKGROUND AND AIMS OF THE STUDY: Medtronic, Inc. has designed and developed a new bileaflet, aortic prosthesis (Advantage) and, following an in-vitro analysis, a chronic in-vivo 20-week evaluation was performed in sheep. METHODS: Fourteen adult male and female sheep underwent implantation of either a 19 mm Advantage or St. Jude Medical (SJM) aortic prosthetic valve for chronic in-vivo evaluation, using a previously reported aortic model technique. RESULTS: There were two operative deaths, and the remaining sheep (eight with Advantage, four with SJM prostheses) underwent chronic hemodynamic and pathologic evaluations at approximately 140 days. One sheep (SJM prosthesis) died unexpectedly at 122 days; postmortem evaluation revealed valvular thrombosis, though the valve was well seated with no excessive pannus formation or paravalvular leaks. Hemodynamic and hematologic data in the remaining sheep were comparable. Pathologic examination of the remaining implanted valves revealed well-seated prostheses, with no evidence of thrombosis, no excessive pannus formation, and no evidence of paravalvular leaks. CONCLUSION: This preclinical animal study showed that the Advantage prosthesis has acceptable features, including equivalent hemodynamic and hematologic data, and a lack of pathological abnormalities when compared with a commercially available prosthetic bileaflet mechanical valve.

Factors associated with implantation of single- versus dual-chamber pacemakers in 1992.

Characteristics of hospitalized patients receiving initial pacemaker implantation were determined using a multistate inpatient discharge database. Analysis revealed a significant association of pacemaker type with patient age and income level, even after controlling for diagnostic factors.