Two-year outcome with Nobel Direct implants: a retrospective radiographic and microbiologic study in 10 patients

INTRODUCTION: The Nobel Direct implant (Nobel Biocare AB, Göteborg, Sweden) was developed to minimize marginal bone resorption and to result in "soft tissue integration" for an optimized aesthetic outcome. However, conflicting results have been presented in the literature. The aim of this present study was to evaluate the clinical and microbiologic outcomes of Nobel Direct implants. MATERIALS AND METHODS: Ten partially edentulous subjects without evidence of active periodontitis (mean age 55 years) received 12 Nobel Direct implants. Implants were loaded with single crowns after a healing period of 3 to 6 months. Treatment outcomes were assessed at month 24. Routine clinical assessments, intraoral radiographs, and microbiologic samplings were made. Histologic analysis of one failing implant and chemical spectroscopy around three unused implants was performed. Paired Wilcoxon signed-rank test was used for the evaluation of bone loss; otherwise, descriptive analysis was performed. RESULTS: Implants were functionally loaded after 3 to 6 months. At 2 years, the mean bone loss of remaining implants was 2.0 mm (SD +/- 1.1 mm; range: 0.0-3.4 mm). Three out of 12 implants with an early mean bone loss >3 mm were lost. The surviving implants showed increasing bone loss between 6 and 24 months (p = .028). Only 3 out of the 12 implants were considered successful and showed bone loss of <1.7 mm after 2 years. High rates of pathogens, including Aggregatibacter actinomycetemcomitans, Fusobacterium spp., Porphyromonas gingivalis, Pseudomonas aeruginosa, and Tanerella forsythia, were found. Chemical spectroscopy revealed, despite the normal signals from Ti, O, and C, also peaks of P, F, S, N, and Ca. A normal histologic image of osseointegration was observed in the apical part of the retrieved implant. CONCLUSION: Radiographic evidence and 25% implant failures are indications of a low success rate. High counts and prevalence of significant pathogens were found at surviving implants. Although extensive bone loss had occurred in the coronal part, the apical portion of the implant showed some bone to implant integration.

Elective implantation of sirolimus-eluting stents for bifurcated and non-bifurcated unprotected left main coronary artery lesions: clinical outcomes at one year

AIMS: Recent studies of drug-eluting stents for unprotected left main coronary artery (LMCA) disease have been encouraging. We examined the performance of sirolimus-eluting stents (SES) for this indication. METHODS AND RESULTS: This retrospective study included 228 consecutive patients (mean age = 68 +/- 11 years, 80.6% men, 26.3% diabetics) who underwent implantation of SES for de novo LMCA stenoses. The mean additive and logistic EuroSCOREs were 5.2 +/- 3.9 and 8.2 +/- 13.2, respectively. The main objective of this study was to measure the rate of major adverse cardiac events (MACE), including death, myocardial infarction and target lesion revascularisation (TLR) at 12 months. Other objectives were to measure the rates of in-hospital MACE and 12-month TLR. Outcomes in 143 patients with (BIF+ group), versus 84 patients without (BIF-group) involvement of the bifurcation were compared. The pre-procedural percent diameter stenosis (%DS) was 60.1 +/- 11.2 in the BIF+ versus 54.7 +/- 12.2% in the BIF- group (p=0.008), and decreased to 18.0 +/- 9.7 and 13.9 +/- 11.3%, respectively (ns), after SES implant. The overall in-hospital MACE rate was 3.5%, and similar in both subgroups. The 1-year MACE rate was 14.5% overall, 16.8% in the BIF+ and 10.7% in the BIF- subgroup (ns). CONCLUSIONS: SES implants in high-risk patients with LMCA stenoses were associated with a low 1-year MACE rate. Stenting of the bifurcation was associated with significant increases in neither mortality nor 1-year MACE rate.

Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study

OBJECTIVES: We sought to determine the risk of late stent thrombosis (ST) during long-term follow-up beyond 3 years, searched for predictors, and assessed the impact of ST on overall mortality. BACKGROUND: Late ST was reported to occur at an annual rate of 0.6% up to 3 years after drug-eluting stent (DES) implantation. METHODS: A total of 8,146 patients underwent percutaneous coronary intervention with a sirolimus-eluting stent (SES) (n=3,823) or paclitaxel-eluting stent (PES) (n=4,323) and were followed up to 4 years after stent implantation. Dual antiplatelet treatment was prescribed for 6 to 12 months. RESULTS: Definite ST occurred in 192 of 8,146 patients with an incidence density of 1.0/100 patient-years and a cumulative incidence of 3.3% at 4 years. The hazard of ST continued at a steady rate of 0.53% (95% confidence interval [CI]: 0.44 to 0.64) between 30 days and 4 years. Diabetes was an independent predictor of early ST (hazard ratio [HR]: 1.96; 95% CI: 1.18 to 3.28), and acute coronary syndrome (HR: 2.21; 95% CI: 1.39 to 3.51), younger age (HR: 0.97; 95% CI: 0.95 to 0.99), and use of PES (HR: 1.67; 95% CI: 1.08 to 2.56) were independent predictors of late ST. Rates of death and myocardial infarction at 4 years were 10.6% and 4.6%, respectively. CONCLUSIONS: Late ST occurs steadily at an annual rate of 0.4% to 0.6% for up to 4 years. Diabetes is an independent predictor of early ST, whereas acute coronary syndrome, younger age, and PES implantation are associated with late ST.

Simulation in training: one-year experience using an efficiency index to assess interventional radiology fellow training status

PURPOSE: To compare objective fellow and expert efficiency indices for an interventional radiology renal artery stenosis skill set with the use of a high-fidelity simulator. MATERIALS AND METHODS: The Mentice VIST simulator was used for three different renal artery stenosis simulations of varying difficulty, which were used to grade performance. Fellows' indices at three intervals throughout 1 year were compared to expert baseline performance. Seventy-four simulated procedures were performed, 63 of which were captured as audiovisual recordings. Three levels of fellow experience were analyzed: 1, 6, and 12 months of dedicated interventional radiology fellowship. The recordings were compiled on a computer workstation and analyzed. Distinct measurable events in the procedures were identified with task analysis, and data regarding efficiency were extracted. Total scores were calculated as the product of procedure time, fluoroscopy time, tools, and contrast agent volume. The lowest scores, which reflected efficient use of tools, radiation, and time, were considered to indicate proficiency. Subjective analysis of participants' procedural errors was not included in this analysis. RESULTS: Fellows' mean scores diminished from 1 month to 12 months (42,960 at 1 month, 18,726 at 6 months, and 9,636 at 12 months). The experts' mean score was 4,660. In addition, the range of variance in score diminished with increasing experience (from a range of 5,940-120,156 at 1 month to 2,436-85,272 at 6 months and 2,160-32,400 at 12 months). Expert scores ranged from 1,450 to 10,800. CONCLUSIONS: Objective efficiency indices for simulated procedures can demonstrate scores directly comparable to the level of clinical experience.

Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval

AIMS: To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year after obtaining CE mark approval. METHODS AND RESULTS: Patients with symptomatic severe aortic stenosis and logistic Euroscore > or =15%, or age > or =75 years, or age > or =65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. From April 2007, to April 2008, 646 patients with a mean age of 81 +/- 6.6 years, mean aortic valve area 0.6 +/- 0.2 cm2, and logistic EuroSCORE of 23.1 +/- 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 49.4 +/- 13.9 to 3 +/- 2 mmHg. All patients had paravalvular aortic regurgitation < or = grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e, including procedural) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%. CONCLUSIONS: The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.

Diabetic patients treated for unprotected left main coronary artery disease with drug eluting stents: a 3-year clinical outcome study. The diabetes and drug eluting stent for LeFT main registry (D-DELFT)

AIMS: Diabetes mellitus (DM) plays an important role in the development of coronary artery disease. Although previous studies have associated drug-eluting stent (DES) implantation in diabetic patients with favourable clinical and angiographic outcomes, the very long-term efficacy of these devices in diabetic patients undergoing PCI for significant unprotected left main coronary artery (ULMCA) disease has not been established yet. METHODS AND RESULTS: Consecutive diabetic patients (n=100), who underwent elective PCI with DES for de novo lesions in an ULMCA between April 2002 and April 2004 in seven tertiary health care centres, were identified retrospectively and analysed. Consecutive non-diabetic patients (n=193), who underwent elective DES implantation for unprotected ULMCA disease, were selected as a control group. All patients were followed for at least 36 months. At 3-years follow-up, freedom from cardiac death ; myocardial infarction (CDMI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) did not differ significantly between groups. The adjusted freedom from major adverse cardiac events (MACE, defined as the occurrence of CD, MI or TVR) was 63.4% in the DM group and 77.6% in the controls (p<0.001). When divided into IDDM and NIDDM sub-groups, insulin-dependent DM (IDDM) but not non IDDM (NIDDM) patients had significantly lower freedom from CDMI, TLR, TVR and MACE compared to controls. CONCLUSIONS: These results suggest that major improvements in DES technology and pharmacotherapy are still required to improve clinical outcome and that the decision to perform percutaneous revascularisation in this subset of patients should be taken cautiously and on a case by case basis.

Late-onset posttraumatic septal hematoma and abscess formation in a six-year-old Tamil girl--case report and literature review

Nasal septal hematoma with abscess (NSHA) is an uncommon complication of trauma and studies on children are especially rare. We discuss the case of a 6-year-old girl, who was initially evaluated independently by three doctors for minor nasal trauma but had to be re-hospitalized 6 days later with NSHA. Although septal hematoma had initially been excluded (5, 7 and 24 hours after trauma), a secondary accumulation of blood seems to have occured. Delayed hematoma formation has been described in the orbit as a result of possible venous injuries after endoscopic sinus surgery. However, such an observation is new for septal hematoma in children. Thus, we recommend re-evaluation for septal hematoma 48h to 72h after paediatric nasal trauma. Such a scheduled re-examination offers a chance to treat delayed subperichondral hematoma on time before almost inevitable superinfection leads to abscess formation and destruction of the nasal infrastructure. We suggest that parents should be vigilant for delayed nasal obstruction as possible herald of hematoma accumulation within the first week.

Early loading of sandblasted and acid-etched implants: a randomized-controlled double-blind split-mouth study. Five-year results

OBJECTIVES: The aim of the present split-mouth study is to assess the peri-implant conditions around early-loaded sandblasted and acid-etched (SLA) implants, 5 years after abutment connection and to compare, in the same patients, the results obtained with a standard protocol using identical implants with a TPS surface. MATERIAL AND METHODS: Surgical procedure was performed by the same operator and was identical at test (SLA) and control (TPS) sites, in 32 healthy patients. Abutment connection was carried out at 35 N cm 6 weeks postsurgery for test sites and 12 weeks for the controls. Patients were seen regularly, for control and professional cleaning. At 60 months, clinical measures and radiographic bone changes were recorded by the same operator, blind to the type of surface of the implant, on 27 patients, as five patients were lost to follow-up. RESULTS: A total number of 106 implants were examined. No implant was lost. No significant differences were found with respect to the presence of plaque [modified plaque index (mPI) 0.27+/-0.56 vs. 0.32+/-0.54], bleeding on probing (29% vs. 32%), mean pocket depth (3.2+/-1 vs. 3.2+/-1 mm) or mean marginal bone loss (0.32+/-1.04 vs. 0.44+/-1.12 mm) between test and control. Four implants that presented 'spinning' at the time of abutment connection presented no significant differences from the rest of the test sites. CONCLUSION: The results of this prospective study confirm that SLA implants, under defined conditions, are suitable for early loading at 6 weeks in both the mandible and the maxilla. Limited implant spinning, occasionally found at abutment connection, produces no detrimental effect on the clinical outcome when properly handled.

[A 56-year-old patient with Gaucher's disease sustaining a pathologic subcapital fracture of the humerus]

We present a case of a pathologic humerus fracture in a patient with the initial diagnosis of Gaucher's disease, which is the most frequent form of lipidosis transmitted as an autosomal recessive trait. It often results in orthopaedic complications with pain, osteonecrosis, fractures and joint infractions. If there is cause for suspicion, beta-glucocerebrosidase in white blood cells should be measured because of the important consequences for treatment. Therapy with a modified enzyme is effective in managing the disease.

Psychosocial and neurocognitive performance after spontaneous nonaneurysmal subarachnoid hemorrhage related to the APOE-epsilon4 genotype: a prospective 5-year follow-up study

OBJECT: In this study, the authors prospectively evaluated long-term psychosocial and neurocognitive performance in patients suffering from nonaneurysmal, nontraumatic subarachnoid hemorrhage (SAH) and investigated the association between the APOE-epsilon4 genotype and outcome in these patients. METHODS: All patients admitted to the authors' institution between January 2001 and January 2003 with spontaneous nonaneurysmal SAH were prospectively examined (mean follow-up 59.8 months). The APOE genotype was determined in all patients by polymerase chain reaction from a blood sample. Of the 30 patients included in this study, 11 were carriers of the epsilon4 allele. RESULTS: All patients showed a good recovery and regained full independence with no persisting neurological deficits. The patients with the epsilon4 allele, however, scored significantly higher on the Beck Depression Inventory (22.1 +/- 6.3 vs 14.1 +/- 5.1). At follow-up, depression was more persistent in the group with the epsilon4 allele compared with the group that lacked the allele. This finding reached statistical significance (p < 0.05). Selective attention was impaired in all patients during the first year of follow-up, with an earlier recovery noted in the patients without the epsilon4 allele. Moreover, there was a tendency toward a linear relationship between the Beck Depression Inventory and the d2 Test of Attention. Two patients who carried the epsilon4 allele did not return to their employment even after 5 years. CONCLUSIONS: The findings in this study suggest that the APOE genotypes may be associated with the psychosocial and neurocognitive performance after spontaneous nonaneurysmal SAH, even in the absence of neurological impairment. Physicians should consider patient genotype in assessing the long-term consequences of nonaneurysmal SAH.

A 5-year comparison of performance of sentinel and mandatory notification surveillance systems for measles in Switzerland

A sensitive, specific and timely surveillance is necessary to monitor progress towards measles elimination. We evaluated the performance of sentinel and mandatory-based surveillance systems for measles in Switzerland during a 5-year period by comparing 145 sentinel and 740 mandatory notified cases. The higher proportion of physicians who reported at least one case per year in the sentinel system suggests underreporting in the recently introduced mandatory surveillance for measles. Accordingly, the latter reported 2-36-fold lower estimates for incidence rates than the sentinel surveillance. However, these estimates were only 0.6-12-fold lower when we considered confirmed cases alone, which indicates a higher specificity of the mandatory surveillance system. In contrast, the sentinel network, which covers 3.5% of all outpatient consultations, detected only weakly and late a major national measles epidemic in 2003 and completely missed 2 of 10 cantonal outbreaks. Despite its better timeliness and greater sensitivity in case detection, the sentinel system, in the current situation of low incidence, is insufficient to perform measles control and to monitor progress towards elimination.

Hydrogel intraocular lens exchange: five-year experience

BACKGROUND: This study presents an evaluation of the preoperative and postoperative best corrected visual acuity (BCVA), as well as of the incidence of perioperative and postoperative complications after opacified hydrogel intraocular lens (IOL) exchange. PATIENTS AND METHODS: We exchanged opacified hydrogel IOLs (Hydroview H 60 M, Bausch ; Lomb) in 55 patients (55 eyes). Preoperative and postoperative BCVA were compared. Intraoperative and postoperative complications were recorded. Follow-up period ranged from 3 months to 24 months. RESULTS: Mean BCVA improved significantly from 0.05 preoperatively to 0.4 at 3 months postoperatively and to 0.2 at the end of the follow-up period. Forty patients (72.7 %) reported visual improvement. The procedure was uneventful in 30 eyes (54.5 %) with complete removal of the opacified IOL optics and haptics. Intraoperative complications included partial zonular dehiscence in 10 eyes (18.2 %), en block capsular bag-IOL extraction in 2 eyes (3.6 %), posterior capsule rupture in 2 eyes (3.6 %), hyphema in 3 eyes (5.5 %), retained haptics in 8 eyes (14.5 %). Postoperative complications included corneal decompensation in 5 eyes (9.1 %), cystoid macular edema in 15 eyes (27.3 %), elevated intraocular pressure in 6 eyes (10.9 %), and retinal detachment in 1 eye (1.8 %). CONCLUSIONS: Visual acuity improved after opacified hydrogel IOL exchange, however, coexistent ocular morbidity as well as the appearance of serious postoperative complications may not yield the expected results. For these reasons extensive informed consent is mandatory.

Long-term pallidal deep brain stimulation in patients with advanced Parkinson disease: 1-year follow-up study

OBJECT: The goal of this study was to investigate the efficacy of long-term deep brain stimulation (DBS) of the posteroventral lateral globus pallidus internus (GPi) accomplished using a single-contact monopolar electrode in patients with advanced Parkinson disease (PD). METHODS: Sixteen patients suffering from severe PD and levodopa-induced side effects such as dyskinesias and on-off fluctuations were enrolled in a prospective study protocol. There were six women and 10 men and their mean age at surgery was 65 years. All patients underwent implantation of a monopolar electrode in the posteroventral lateral GPi. Initially, nine patients received unilateral stimulation. Three of these patients underwent contralateral surgery at a later time. Ten patients received bilateral stimulation (contemporaneous bilateral surgery was performed in seven patients and staged bilateral surgery in the three patients who had received unilateral stimulation initially). Formal assessments were performed during both off-medication and on-medication (levodopa) periods preoperatively, and at 3 and 12 months postoperatively. There were no serious complications related to surgery or to DBS. Two transient adverse events occurred: in one patient a small pallidal hematoma developed, resulting in a prolonged micropallidotomy effect, and in another patient a subcutaneous hemorrhage occurred at the site of the pacemaker. In patients who received unilateral DBS, the Unified Parkinson's Disease Rating Scale activities of daily living (ADL) score during the off-levodopa period decreased from 30.8 at baseline to 20.4 at 3 months (34% improvement) and 20.6 at 12 months (33% improvement) postoperatively. The motor score during the off period improved from 57.2 at baseline to 35.2 at 3 months (38% improvement) and 35.3 at 12 months (38% improvement) postoperatively. Bilateral DBS resulted in a reduction in the ADL score during the off period from 34.9 at baseline to 22.3 at 3 months (36% improvement) and 22.9 at 12 months (34% improvement). The motor score for the off period changed from 63.4 at baseline to 40.3 at 3 months (36% improvement) and 37.5 at 12 months (41% improvement). In addition, there were significant improvements in patients' symptoms during the on period and in on-off motor fluctuations. CONCLUSIONS: Pallidal DBS accomplished using a monopolar electrode is a safe and effective procedure for treatment of advanced PD. Compared with pallidotomy, the advantages of pallidal DBS lie in its reversibility and the option to perform bilateral surgery in one session. Comparative studies in which DBS is applied to other targets are needed.

The Amplifier - v. 5, no. 6

In this issue...Christmas Formal, Douglas H. Harnish, Geology Seminar, World Oil magazine, Ed Simonich, Butte Civic Center, Butte Copperleafs, Bill of Rights

The Amplifier - v. 9, no. 6

In this issue...Faculty Women's Club, Engineering week, ARMCO, Uuno Sahinen, NASA, MSM library, Flying Club, weightlifting, intramural sports, Theta Tau