BACKGROUND: The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns.
METHODS: In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post-scaffold implantation at 6 and 12 months.
RESULTS: Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was -0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = -0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: dpost-procedure = 0.41, d6 months = 1.00, d12 months = 0.92). Angiographic median in-scaffold diameter stenosis was significantly different between study groups at 12 months (28.6% [IQR: 21.0% to 40.7%] for the Mirage, 18.2% [IQR: 13.1% to 31.6%] for the Absorb, d = 0.39). Device- and patient-oriented composite endpoints were comparable between the 2 study groups.
CONCLUSIONS: At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage.
BACKGROUND: Prosthesis should be donned and doffed few times during the day and night; thus, it is important to measure ease of donning and doffing.
STUDY DESIGN: A cross-sectional study.
METHODS: The questionnaire was designed and evaluated by a group of experts. The final questionnaire was administered to 50 individuals with trans-tibial amputation. A test-retest study was also conducted on 20 amputees to assess the repeatability of questionnaire items.
RESULTS: The prosthesis donning and doffing questionnaire was developed and tested through a pilot study. Based on Kappa index, the questionnaire items showed correlation coefficients greater than 0.7, which indicate good reliability and repeatability. The majority of the participants had good hand dexterity (80%) and could perform all types of grasps. The mean satisfaction scores with donning and doffing were 69.9 and 81.4, respectively. Most of the respondents needed to don and doff the prosthesis 3.44 times per day. Based on a 7-point score, the total scores ranged between 3 and 7.
CONCLUSION: The prosthesis donning and doffing questionnaire items showed good psychometric properties. A scoring method was suggested based on the pilot sample, which requires further evaluation to be able to differentiate between more suspension types. A larger international multicenter evaluation is required in the future to measure the responsiveness of the scales. This questionnaire will be useful in the evaluation of the ability of amputees to don and doff a trans-tibial limb prosthesis. Clinical relevance Donning and doffing of prostheses are challenging tasks for many lower limb amputees. The prosthesis donning and doffing questionnaire, on its own or combined with other prosthetic evaluation questionnaires, has the potential to help manufacturers, clinicians, and researchers gain knowledge and improve the donning and doffing qualities of prostheses.
BACKGROUND: Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES).
METHODS: Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months.
RESULTS: At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388).
CONCLUSIONS: PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).
METHODS: Retrospective data from clinical worksheets given to participants during two implant courses held between the periods of 2013 to 2014 were evaluated. A total of 61 implants were considered based on the inclusion criteria. The effects of parameters such as implant diameter, implant length, age, gender, implant location and osteotomy protocol on ISQ values were analyzed.
RESULTS: Mean ISQ value for all implants was 67.21±9.13. Age of patients (P=0.016) and location of implants (P=0.041) had a significant linear relationship with the ISQ values. Within the age limit of the patients in this study, it was found that an increase in one year of patient's age results in 0.20 decrease in ISQ value (95% CI: -0.36, -0.04). However, placing an implant in the posterior maxilla may negatively affect the ISQ with a likely decrease in primary stability by 6.76 ISQ value (95% CI: -13.22, -0.30).
CONCLUSIONS: The results suggest that the mean ISQ achieved by the participants were comparable with the range reported for this particular type of implants. The patient's age and location of implants were elucidated as the determinant factors of primary implant stability.
METHODS: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.
RESULTS: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).
CONCLUSIONS: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).
MATERIALS AND METHODS: Twenty-one patients with implants were included in this study and implants were assessed by resonance frequency analysis (RFA). Bone levels of the implants were assessed by measuring mesial and distal bone levels from the periapical radiograph, and soft tissue was assessed from probing depth using a periodontal probe. Implants were assessed for stability and probing depth at pre-loading, at 3 months and 6 months post-loading. RFA and probing depth were statistically compared from different time points. Correlation of probing depth and marginal bone loss with implant stability was also determined.
RESULTS: The average change in implant stability quotient (ISQ) measurements from pre-loading to 6 months post-loading was found to be statistically significant (p <0.005). The average probing depth reduced from 1.767 mm at pre-loading to 1.671 mm at post-loading 3 months, and 1.600 mm at post-loading 6 months. At 6 months of function, radiographic examination yielded 0.786 mm mesial bone loss and 0.8 mm distal bone loss. It was found to be statistically significant (p <0.005) but within an acceptable range. No significant correlation was found between implant stability and bone loss; and implant stability and probing depth.
CONCLUSION: The study revealed an increasing trend in implant stability values with the time that indicates successful osseointegration. Increasing mean values for mesial and distal bone loss were also found.
CLINICAL SIGNIFICANCE: The success of dental implants is highly dependent on the quality of bone and implant-bone interface, i.e., osseointegration. The most important factors that influence the survival rate of an implant is initial stability. The present study found the changes in the peri-implant hard and soft tissues and implant stability. This article, while being a prospective study, may show the evidence of successful osseointegration by increasing trend in implant stability (RFA) values with time which can help to the clinician in the long-term management of implants.
METHODS: Twenty patients with two adjacent missing posterior teeth were recruited. Patients were assigned equally and randomly into two groups; Bicon(®) (6 or 8 mm) and Ankylos(®) (8 mm) implants. A two-stage surgical approach and single crowns were used for implant placement and loading. Outcomes included peri-implant clinical parameters, implant stability (Periotest values; PTVs) and peri-implant bone changes, which were assessed at baseline, 2, 6 and 12 months post-loading.
RESULTS: No implant loss was encountered up to 12 months post-loading. No significant difference in the clinical or radiographic parameters was observed except for PTVs (p < 0.05) that was lower in Ankylos(®) implants.
CONCLUSIONS: The use of short dental implants was associated with excellent 12 months clinical and radiographic outcomes. Ankylos(®) and Bicon(®) implants demonstrated similar peri-implant soft tissue and alveolar bone changes. However, Ankylos(®) implants demonstrated better implant stability at all evaluation intervals.
MATERIALS AND METHODS: Twenty surviving patients with expandable endoprosthesis from 2006 till 2015 were scored using Musculoskeletal Tumour Society (MSTS) outcomes instrument and reviewed retrospectively for range of motion of respected joints, limb length discrepancy, number of surgeries performed, complications and oncological outcomes. Patients with less than 2 years of follow-up were excluded from this study.
RESULTS: Forty-five percentage patients reached skeletal maturity with initial growing endoprosthesis and 25% of patients were revised to adult modular prosthesis. One hundred fifty-seven surgeries were performed over the 9-year period. The average MSTS score was 90.83%. The mortality rate was 10% within 5 years due to advanced disease. Infection and implant failure rate was 15% each. The event-free survival was 50% and overall survival rate was 90%.
CONCLUSION: There is no single best option for reconstruction in skeletally immature. This study demonstrates a favourable functional and survival outcome of paediatric patients with expandable endoprosthesis. The excellent MSTS functional scores reflect that patients were satisfied and adjusted well to activities of daily living following surgery despite the complications.