How accurate is the soft tissue prediction of Dolphin Imaging for orthognathic surgery?

PURPOSE: The purpose of this retrospective study is to evaluate the accuracy of soft tissue prediction models with Dolphin Imaging. MATERIALS AND METHODS: Preoperative and 1-year postoperative Lateral cephalograms (LCG) of patients undergoing Le Fort I, bilateral sagittal split osteotomy (BSSO) or bimaxillary osteotomy (Bimax) between 2006 and 2009 were retrospectively collected. A hard tissue virtual surgery was performed on the preoperative LCG to match the hard tissue of the 1-year postoperative LCG. The soft tissue changes were then modelled by Dolphin Imaging (version 11.5b) and the differences in x- and y-coordinates of 11 hard tissue and 14 soft tissue landmarks between the predicted model and 1-year postoperative LCG were determined. Statistical analyses were performed using a one-tailed, one-sample t-test for both soft- and hard tissue differences, and a Bland-Altman plot for interobserver bias. RESULTS: A total of 108 patients were included, the mean age was 30 years and 23% were male. The virtual treatment was considered accurate; all hard tissue landmark differences were less than 1mm. The soft tissue model by Dolphin Imaging showed significant differences of more than 2mm for several landmarks, including the vertical positioning of Stomion Inferius (P=0.007), Lower lip (P=0.005) and Pogonion (P=0.03) in the Bimax group and horizontal positioning of Stomion Inferius (P<0.001) in the BSSO group. CONCLUSIONS: Dolphin Imaging gives reasonable predictions of postoperative outcome. There is, however, room for improvement, especially regarding the vertical prediction in the lower lip region.

Four-year clinical follow-up of the rapamycin-eluting stent evaluated at Rotterdam Cardiology Hospital registry.

Although the safety of drug-eluting stents has been under considerable scrutiny, limited real-world follow-up data extending up to 4 years are available. The randomized clinical trials carefully selected patients and are not reflective of everyday practice. From April to October 2002, 508 consecutive patients treated with sirolimus-eluting stents (SES) were enrolled. The control group consisted of 450 patients treated with bare-metal stents during the preceding 6 months. After 4 years of follow-up, the incidence of composite major adverse clinical events (all-cause death, myocardial infarction, or target vessel revascularization) was found to be significantly lower in the SES group (23.0% vs 28.7%, adjusted hazard ratio 0.66, 95% confidence interval 0.51 to 0.86), as were rates of target vessel revascularization (12.2% vs 17.8%, adjusted hazard ratio 0.57, 95% confidence interval 0.39 to 0.83). There were no differences in all-cause mortality (10.5% for SES vs 10.6% for bare-metal stents, p = 0.9) or in the rates of cardiac death (4.5% vs 6.9%, p = 0.1). Although there was no difference in overall stent thrombosis (2.3% vs 2.2%, p = 1.0), SES had a higher rate of very late stent thrombosis (1.4% vs 0%, p = 0.02), balanced by a lower rate of early stent thrombosis (0.4% vs 1.8%, p = 0.05). In conclusion, after 4 years, SES were found to remain safe and effective compared with bare-metal stents. Nevertheless, the higher rate of very late stent thrombosis remains a concern. Longer term follow-up will be required to determine the extent of this problem.

The relative safety and efficacy of bare-metal and drug-eluting stents in low and high-risk patient subsets. An epidemiological analysis of three sequential cohorts of consecutive all comers (n = 6129).

AIMS: Sirolimus- and paclitaxel- eluting stents (SES and PES respectively) have been shown to produce a sustained reduction in restenosis and repeat revascularisations as compared to bare-metal stents (BMS) up to four years. There is still limited data about the long-term safety and efficacy of DES in high-risk subgroups. METHODS AND RESULTS: A total of 6,129 consecutive patients were treated during three sequential periods with BMS (n = 2,428; January, 2000 to April, 2002), SES (n = 866; April 2002 to February 2003) or PES (n = 2,835; February 2003 to December 2005). A stratified analysis (including age, gender, diabetes, clinical presentation, treated vessel, multivessel disease, AHA lesion class, bifurcation, in-stent restenosis, average stent diameter < or = 2.5 mm and total stented length < or = 30 mm) was performed to evaluate possible heterogeneities in treatment effect. At four years, all-cause mortality was identical between the drug-eluting stent (DES) and BMS cohorts (13.5% vs. 13.4%, respectively; Adjusted HR 1.10, 95% CI 0.90 - 1.34) without evidence of heterogeneity in the high-risk patient subsets. Both DES significantly reduced the risk for target vessel revascularisation (TVR) as compared to BMS (TVR: 11.9% vs. 15.7% respectively; Adjusted HR 0.69, 95% CI 0.58 - 0.82) along with a reduced risk for post-operative MI (adjusted HR 0.75, 95% CI 0.57 - 0.98), but counterbalanced by a non-significantly higher risk for stent thrombosis (3.1% vs. 1.6%; adjusted HR 1.26, 95% CI 0.82 - 1.95). DES failed to show superiority to BMS in patients with acute myocardial infarction (TVR 10.5% vs. 9.2% respectively; Adjusted HR 1.26, 95% CI 0.82 - 1.93). CONCLUSIONS: In a real world patient population, after four years, the overall use of DES was associated with similar all-cause mortality rates and a significantly reduced risk for post-operative MI and TVR as compared to BMS.

Impact of sex on 3-year outcome after percutaneous coronary intervention using bare-metal and drug-eluting stents in previously untreated coronary artery disease: insights from the RESEARCH (Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital) and T-SEARCH (Taxus-Stent Evaluated at Rotterdam Cardiology Hospital) Registries.

OBJECTIVES: We investigated the impact of sex on outcomes after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). BACKGROUND: Women have a higher risk of adverse outcomes after PCI than do men. However, long-term outcomes of women after contemporary PCI with DES have not been fully investigated. METHODS: We performed a retrospective cohort study of 4,936 consecutive patients (28.2% women) who underwent PCIs between 2000 and 2004, before and after introduction of DES (bare-metal stent [BMS] group: n = 2,131, DES group: n = 2,805), to assess the impact of sex on long-term PCI outcomes and to compare outcome after PCI of women between the DES and BMS eras. RESULTS: Compared with men, women undergoing PCIs were 5 years older and more frequently have comorbidities such as diabetes mellitus and hypertension. In patients treated throughout the BMS and DES eras, there were no differences by sex for risk of all-cause death, myocardial infarction, or target vessel revascularization 3 years after procedure. The procedural complexity was higher in the DES era, nevertheless, risk for target vessel revascularization and major adverse cardiac event at 3 years were significantly lower in women treated with DES than in women treated with BMS (adjusted hazard ratio [HR] for target vessel revascularization: 0.52 [95% confidence interval (CI): 0.36 to 0.75], adjusted HR for major adverse cardiac event: 0.63 [95% CI: 0.48 to 0.83]). CONCLUSIONS: Although women had worse baseline characteristics, no differences in 3-year outcomes were observed between men and women. Compared with BMS use, DES use has decreased revascularization rate equally in women and men.

Four-year safety and efficacy of the unrestricted use of sirolimus- and paclitaxel-eluting stents in coronary artery bypass grafts.

OBJECTIVES: Recently, concerns were raised about the relative long-term safety and efficacy of drug-eluting stents (DES) in saphenous vein bypass grafts (SVG). Our objective was to assess the 4-year relative safety and efficacy of the unrestricted use of drug-eluting stents (DES) as compared to bare metal stents (BMS) in saphenous vein bypass grafts (SVG). METHODS: Between April 16, 2002 and December 2005 a total of 122 consecutive patients were treated with either sirolimus- or paclitaxel-eluting stents for saphenous vein graft disease. These patients were compared with 128 consecutive patients treated with BMS in the immediate preceding period (January 1, 2000 to April 2002). RESULTS: At 4-years the cumulative survival rate in the DES group was 77.5% versus 73.0% in the BMS group (adjusted HR 1.09; 95% CI 0.63-1.90, Logrank p=0.65). The cumulative survival free of major adverse cardiac events (MACE: death, myocardial infarction and target vessel revascularisation) was 61.5% vs. 46.8% in the DES and BMS groups respectively (adjusted HR 0.77, 95% CI; 0.51-1.16) due to a higher event free survival of clinically driven target vessel revascularisation in the DES group as compared to the BMS group (81.6% vs. 69.0%; adjusted HR 0.53; 95% CI 0.27-1.05). CONCLUSIONS: In the present study, the use of DES for SVG PCI was associated a similar safety profile and there was a trend towards lower rates of TVR and MACE at four years as compared to BMS.