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.

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.

Acetabular reinforcement ring in primary total hip arthroplasty: a minimum 10-year follow-up

INTRODUCTION: We report the results of a titanium acetabular reinforcement ring with a hook (ARRH) in primary total hip arthroplasty (THA), which was introduced in 1987 and continues to be used routinely in our center. The favorable results of this device in arthroplasty for developmental dysplasia and difficult revisions motivated its use in primary THA. With this implant only minimal acetabular reaming is necessary, anatomic positioning is achieved by placing the hook around the teardrop and a homogenous base for cementing the polyethylene cup is provided. MATERIALS AND METHODS: Between April 1987 and December 1991, 241 THAs with insertion of an ARRH were performed in 178 unselected, consecutive patients (average age 58 years; range 30-84 years) with a secondary osteoarthrosis in 41% of the cases. RESULTS: At the time of the latest follow-up, 33 patients (39 hips) had died and 17 cases had been lost to follow-up. The median follow-up was 122 months with a minimum of 10 years. Eight hips had been revised, leaving 177 hips in 120 living patients without revision. Six cups were revised because of aseptic loosening. Two hips were revised for sepsis. The mean Merle d'Aubigné score for the remaining hips was 16 (range 7-18) at the latest follow-up. For aseptic loosening, the probability of survival of the cup was 0.97 (95% confidence interval, 0.94-0.99). However, analysis of radiographs implied loosening in seven other cups without clinical symptoms. CONCLUSIONS: The results of primary THA using an acetabular reinforcement ring parallel the excellent results of these implants often observed in difficult primary and revision arthroplasty at a minimum of 10 years. Survivorship is comparable to modern cementless implants. Medial migration that occurs with loosening of the acetabular component seems to be prevented with this implant. Radiographic loosening signs can exist without clinical symptoms.

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.

Surgical management of gynecomastia--a 10-year analysis

BACKGROUND: Gynecomastia is defined as the benign enlargement of the male breast. Most studies on surgical treatment of gynecomastia show only small series and lack histopathology results. The aim of this study was to analyze the surgical approach in the treatment of gynecomastia and the related outcome over a 10-year period. PATIENTS AND METHODS: All patients undergoing surgical gynecomastia corrections in our department between 1996 and 2006 were included for retrospective evaluation. The data were analyzed for etiology, stage of gynecomastia, surgical technique, complications, risk factors, and histological results. RESULTS: A total of 100 patients with 160 operations were included. Techniques included subcutaneous mastectomy alone or with additional hand-assisted liposuction, isolated liposuction, and formal breast reduction. Atypical histological findings were found in 3% of the patients (spindle-cell hemangioendothelioma, papilloma). The surgical revision rate among all patients was 7%. Body mass index and a weight of the resected specimen higher than 40 g were identified as significant risk factors for complications (p < 0.05). CONCLUSIONS: The treatment of gynecomastia requires an individualized approach. Caution must be taken in performing large resections, which are associated with increased complication rates. Histological tissue analysis should be routinely performed in all true gynecomastia corrections, because histological results may reveal atypical cellular pathology.

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.

Strategies for routine biopsies in heart transplantation based on 8-year results with more than 13,000 biopsies

The endomyocardial biopsy (EMB) in heart transplant recipients has been considered the "gold standard" for diagnosis of graft rejection (REJ). The purpose of this retrospective study is to develop long-term strategies (frequency and postoperative duration of EMB) for REJ monitoring. Between 1985 and 1992, 346 patients (mean age 44.5 years, female patients = 14%) received 382 heart grafts. For graft surveillance EMBs were performed according to a fixed schedule depending on postoperative day and the results of previous biopsies. In the first year the average number (no.) of EMBs/patient was 20 with 19% positive for REJ in the first quarter, dropping to 7% REJ/EMB by the end of the first year. The percentage of REJ/EMB declined annually from 4.7% to 4.5%, 2.2% and less than 1% after the fifth year. Individual biopsy results in the first 3 postoperative months had little predictive value. Patients with fewer than two REJ (group 1), vs patients with two or more REJ in the first 6 postoperative months (group 2), were significantly less likely to reject in the second half of the first year (group 1: 0.29 +/- 0.6 REJ/patient; group 2:0.83 +/- 1.3 REJ/patient; P < 0.001) and third postoperative year (group 1:0.12 +/- 0.33 REJ/patients; group 2:0.46 +/- 0.93 REJ/patient; P < 0.05). In conclusion, routine EMBs in the first 3 postoperative months have only limited predictive value, however the number of routine EMBs can be drastically reduced later depending on the intermediate postoperative REJ pattern.

Incidence of bullous pemphigoid and pemphigus in Switzerland: a 2-year prospective study

BACKGROUND: Bullous pemphigoid (BP), pemphigus vulgaris (PV) and pemphigus foliaceus (PF) are autoimmune bullous diseases characterized by the presence of tissue-bound and circulating autoantibodies directed against disease-specific target antigens of the skin. Although rare, these diseases run a chronic course and are associated with significant morbidity and mortality. There are few prospective data on gender- and age-specific incidence of these disorders. OBJECTIVES: Our aims were: (i) to evaluate the incidence of BP and PV/PF in Swiss patients, as the primary endpoint; and (ii) to assess the profile of the patients, particularly for comorbidities and medications, as the secondary endpoint. METHODS: The protocol of the study was distributed to all dermatology clinics, immunopathology laboratories and practising dermatologists in Switzerland. All newly diagnosed cases of BP and pemphigus occurring between 1 January 2001 and 31 December 2002 were collected. In total, 168 patients (73 men and 95 women) with these autoimmune bullous diseases, with a diagnosis based on clinical, histological and immunopathological criteria, were finally included. RESULTS: BP showed a mean incidence of 12.1 new cases per million people per year. Its incidence increased significantly after the age of 70 years, with a maximal value after the age of 90 years. The female/male ratio was 1.3. The age-standardized incidence of BP using the European population as reference was, however, lower, with 6.8 new cases per million people per year, reflecting the ageing of the Swiss population. In contrast, both PV and PF were less frequent. Their combined mean incidence was 0.6 new cases per million people per year. CONCLUSIONS; This is the first comprehensive prospective study analysing the incidence of autoimmune bullous diseases in an entire country. Our patient cohort is large enough to establish BP as the most frequent autoimmune bullous disease. Its incidence rate appears higher compared with other previous studies, most likely because of the demographic characteristics of the Swiss population. Nevertheless, based on its potentially misleading presentations, it is possible that the real incidence rate of BP is still underestimated. Based on its significant incidence in the elderly population, BP should deserve more public health concern.

Periodontal disease progression in subjects with orofacial clefts over a 25-year follow-up period

AIMS: To assess rates of periodontal disease progression in subjects with cleft lip, alveolus and palate (CLAP) over a 25-year period without regular maintenance care in a specialist setting and to compare those with those of subjects without alveolar clefts, i.e. cleft lip (CL) or cleft palate (CP). MATERIAL AND METHODS: Ten subjects with CLAP and 10 subjects with CL/CP were examined in 1979, 1987, 1993 and 2004. Probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BoP) and plaque control record (PCR) scores were recorded in all 20 subjects. RESULTS: High plaque and BoP scores were recorded at all examinations in both groups. Over 25 years, a statistically significant loss of mean full-mouth CAL of 1.52 +/- 0.12 mm (SD) and 1.66 +/- 0.15 mm occurred in the CLAP and CL/CP group respectively (p<0.05). A statistically significant increase (p<0.05) in mean full-mouth PPD of 0.35 +/- 0.12 mm was observed in the CL/CP group, whereas only a trend for a mean full-mouth increase in PPD of 0.09 +/- 0.11 mm was observed in the CLAP group. In subjects with CLAP, a statistically significant increase (p<0.05) in PPD of 0.92 +/- 1.13 mm at cleft sites was observed compared with that of 0.17 +/- 0.76 mm at control sites. With respect to CAL, the loss at the corresponding sites amounted to 2.71 +/- 1.46 and to 2.27 +/- 1.62 mm, respectively (p=0.36). CONCLUSIONS: When stringent and well-defined supportive periodontal therapy was not provided, subjects with orofacial clefts were at high risk for periodontal disease progression. Over 25 years, alveolar cleft sites tended to have more periodontal tissue destruction compared with control sites.

Unprotected left main stenting in the real world: two-year outcomes of the French left main taxus registry

BACKGROUND: Cardiac surgery is the reference treatment for patients with left main (LM) disease, although percutaneous coronary intervention with drug-eluting stents is emerging as a possible alternative. The objective of this registry was to evaluate the 2-year outcome of elective percutaneous coronary intervention for unprotected LM disease with paclitaxel-eluting stents. METHODS AND RESULTS: A total of 291 patients were prospectively included from 4 centers. Acute myocardial infarction and cardiogenic shock were the only exclusion criteria. Patients were 69+/-11 years old, 29% were diabetic, and 25% had 3-vessel disease. For distal LM lesions (78%), the provisional side-branch T-stenting approach was used in 92% of cases and final kissing balloon inflation in 97%. Angiographic success was obtained in 99.7% of cases. At 2-year follow-up, the total cardiac death rate was 5.4% (1 EuroSCORE point was associated with a 15% [95% confidence interval 2.9% to 28.2%, P=0.013] higher risk of cardiac death), target-lesion revascularization was 8.7%, and incidence of Q-wave or non-Q-wave myocardial infarction was 0.9% and 3.1%, respectively. The combined end point occurred in 15.8% of cases and stroke in 0.7%. The incidence of definite and probable LM stent thrombosis was 0.7%, whereas the incidence of any stent thrombosis was 3.8%, with a higher risk in patients with side-branch stenting in the presence of LM bifurcation lesions (hazard ratio 9.6, 95% confidence interval 1.2 to 77.7, P=0.035). CONCLUSIONS: Unprotected LM stenting with paclitaxel-eluting stents, with a strategy of provisional side-branch T-stenting for distal lesions, provides excellent acute angiographic results and good mid-term clinical outcomes, with a 15.8% rate of major adverse cardiac events at 2-year follow-up.

Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores

BACKGROUND: To validate the concept of early implant placement for use in the esthetically sensitive anterior maxilla, clinical trials should ideally include objective esthetic criteria when assessing outcome parameters. METHODS: In this cross-sectional, retrospective 2- to 4-year study involving 45 patients treated with maxillary anterior single-tooth implants according to the concept of early implant placement, a novel comprehensive index, comprising pink esthetic score and white esthetic score (PES/WES; the highest possible combined score is 20), was applied for the objective esthetic outcome assessment of anterior single-tooth implants. RESULTS: All 45 anterior maxillary single-tooth implants fulfilled strict success criteria for dental implants with regard to osseointegration, including the absence of peri-implant radiolucency, implant mobility, suppuration, and pain. The mean total PES/WES was 14.7 +/- 1.18 (range: 11 to 18). The mean total PES of 7.8 +/- 0.88 (range: 6 to 9) documents favorable overall peri-implant soft tissue conditions. The two PES variables facial mucosa curvature (1.9 +/- 0.29) and facial mucosa level (1.8 +/- 0.42) had the highest mean values, whereas the combination variable root convexity/soft tissue color and texture (1.2 +/- 0.53) proved to be the most difficult to fully satisfy. Mean scores were 1.6 +/- 0.5 for the mesial papilla and 1.3 +/- 0.5 for the distal papilla. A mean value of 6.9 +/- 1.47 (range: 4 to 10) was calculated for WES. CONCLUSIONS: This study demonstrated that anterior maxillary single-tooth replacement, according to the concept of early implant placement, is a successful and predictable treatment modality, in general, and from an esthetic point of view, in particular. The suitability of the PES/WES index for the objective outcome assessment of the esthetic dimension of anterior single-tooth implants was confirmed. However, prospective clinical trials are needed to further validate and refine this index.

One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial

BACKGROUND: Single photodynamic therapy (PDT) has been effective in initial periodontal therapy, but only improved bleeding on probing (BoP) in maintenance patients after a single use. Repeated PDT has not been addressed. OBJECTIVES: To study the possible added benefits of repeated adjunctive PDT to conventional treatment of residual pockets in patients enrolled in periodontal maintenance. MATERIAL AND METHODS: Ten maintenance patients with 70 residual pockets [probing pocket depth (PPD)>or=5 mm] were randomly assigned for treatment five times in 2 weeks (Days 0, 1, 2, 7, 14) with PDT (test) or non-activated laser (control) following debridement. The primary outcome variable was PPD, and the secondary variables were clinical attachment level (CAL) and BoP. These were assessed at 3, 6 and 12 months following the interventions. RESULTS: Greater PPD reductions were observed in the test (-0.67 +/- 0.34; p=0.01) compared with the control patients (-0.04 +/- 0.33; NS) after 6 months. Significant CAL gain (+0.52 +/- 0.31; p=0.01) was noted for the test, but not in the control (-0.27 +/- 0.52; NS) patients after 6 months. BoP percentages decreased significantly in test (97-64%, 67%, 77%), but not control patients after 3, 6 and 12 months. CONCLUSIONS: Repeated (five times) PDT adjunctive to debridement yielded improved clinical outcomes in residual pockets in maintenance patients. The effects were best documented after 6 months.

A 5-year review of teeth filled with the noninstrumentation technology

AIM: The aim of this Case Series was to evaluate the radiographic quality of root fillings performed 5 years previously using the noninstrumentation technology (NIT)-obturation method and to assess radiographically the outcome of these root canal treatments. METHODOLOGY: Seventeen patients requiring root canal treatment participated in this study and were re-evaluated after 5 years. After instrumentation with K-Flexofiles, Calcium-Hydroxide inter-appointment dressing, re-entry and copious irrigation with NaOCl, the teeth were root filled using the NIT. RESULTS: Immediately after obturation the root fillings were (-0.78 +/- 0.11 mm) short when taking the radiographic apex as a reference point. After 60 months these values were -0.85 +/- 0.11 mm. No statistical difference was found (P > 0.05). In the periapical region, PAI rating 1 and 2 increased from 20.1% to 75.6% after 60 months. CONCLUSIONS: * This prospective Case Series demonstrated the performance of the NIT-obturation method in vivo. * Root canals filled by the reduced-pressure method using sealer combined with gutta-percha cones showed good radiographic quality. * Periapical healing after 5 years was comparable with conventional filling techniques.

Randomized controlled trial comparing a variable-thread novel tapered and a standard tapered implant: interim one-year results

STATEMENT OF PROBLEM: A tapered implant with continuously changing threads purported to provide stable tissue support and allow immediate function has been developed. Treatment success and stabilization of supporting tissues over time require documentation. PURPOSE: The purpose of this prospective, randomized, controlled, multicenter study was to evaluate changes in bone level and soft tissue behavior between the novel implant (NobelActive/NA) and a standard tapered implant (NobelReplace Tapered Groovy/NR) with regard to immediate function. MATERIAL AND METHODS: A total of 177 patients randomly allocated to 3 treatment groups (2 different test implant groups: NA Internal (n=117; internal connection) and External (n=82), and 1 standard treatment group, NR (n=126)) received 325 implants. Implants were placed into healed sites, and all but 6 implants were immediately nonocclusally loaded. Clinical and radiographic evaluations of treatment success, crestal bone levels, and soft tissue changes were performed at the time of placement and after 3, 6, and 12 months. Log-Rank test was used to analyze the differences in survival rate. Marginal bone level was compared using the Kruskal-Wallis test and Mann-Whitney U-test (alpha=.05). RESULTS: One-year cumulative survival rates were comparable (96.6% for NA Internal; 96.3% for NA External; 97.6% for NR; P=.852; Log-Rank). Mean (SD) change in bone level was -0.95 mm (1.37) for NA Internal, -0.64 mm (0.97) for NA External, and -0.63 mm (1.18) for NR (P=.589; Kruskal-Wallis). Stable soft tissues and significantly increased papilla scores (P<.001; Wilcoxon signed-rank) were observed for all implant types. CONCLUSIONS: The novel implants showed high survival rates as well as stable bone and soft tissue levels after 1 year, and may be recommended for clinical use, even under immediate function.