Introduction. The frequency, characteristics and clinical implications of Strut fractures (SFs) remain incompletely understood. Methods and results. A total of 185 (160 patients) newer-generation drug-eluting stents (DES) were imaged. SFs were found in 21 DES (11.4%) and were classified in four patterns: one single stacked strut (41%); two or more stacked struts (23%); deformation without gap (27%); transection (9%). In multivariable analysis, calcific and bifurcation lesions were associated with SF in DES (OR: 3.5 [1.1–11] and 4.0 [2.2–7.2], p < 0.05). Device eccentricity and asymmetry as well as optical coherence tomography (OCT) features of impaired strut healing were also associated with SF. The prevalence of fractures was similar in a set of 289 bioresorbable scaffolds (BRS). In a separate series of 20 device thromboses and 36 device restenoses, the prevalence of SF was higher (61.2% of DES and 66.7% of BRS, p < 0.001 for both), with a higher frequency of complex SF patterns (p < 0.0001). In logistic regression analysis, fractures were a correlate of device complications (p < 0.0001, OR = 24.9 [5.6–111] for DES and OR = 6.0 [1.8–20] for BRS). Discussion. The prevalence of OCT-diagnosed SF was unexpectedly high in the setting of elective controls and it increased by about three-fold in the setting of device failure. Fractures were associated with increased lesion complexity and device asymmetry/eccentricity and were more frequent in the setting of device failure such as restenosis and thrombosis.
BackgroundDiabetes is among the strongest predictors of outcome after coronary artery stenting and the incidence of negative outcomes is still high in this specific group. Data of long-term outcomes comparing diabetic patients with non-diabetic patients treated with bioresorbable scaffolds are still incomplete. This work evaluates the long-term outcomes after implantation of a coronary bioresorbable scaffold (BRS) in diabetic patients compared to non-diabetics.MethodsPatients who received at least one Absorb BRS in the time of May 2012 to December 2014 were enrolled into this single-center registry. Quantitative coronary angiography (QCA) was performed.ResultsSix hundred fifty seven patients including 138 patients (21%, mean age 65 ± 11, 78% male) with diabetes were enrolled.Patients in the diabetic group were significantly older, were more likely to suffer from hypertension and hyperlipidemia and had more often a prior stroke or TIA as well as a reduced renal function (all P < 0.05). The initial stenosis was less severe in the diabetic group (74.8% vs. 79.6%, P = 0.036), but the residual stenosis after BRS implantation exceeded that of the control group (16.7% vs. 13.8%, P = 0.006).History of diabetes had no impact on the incidence of events within one year after BRS implantation. Beyond 1 year, diabetic patients had a higher incidence of cardiovascular death (6.9 vs. 1.4%, HR:5.37 [1.33–21.71], P = 0.001), scaffold restenosis (17.6 vs. 7.8%, HR:3.56 [1.40–9.05], P < 0.0001) and target lesion revascularization (P = 0.016). These results were confirmed in the propensity score analysis.In both diabetics and non-diabetics, there was a strong association (HR:18.6 [4.7–73.3]) between the risk of restenosis and the technique used at implantation; in contrast, the impact of vessel size was more manifest in non-diabetics than in diabetic patients, and an increased risk of restenosis was demonstrated for both large and small vessels.ConclusionAs for metal stents, beyond one year after implantation, diabetes was associated with an increased incidence of scaffold restenosis and related outcomes. This negative impact of diabetes was reset when an optimal implantation technique was used.Electronic supplementary materialThe online version of this article (10.1186/s12872-018-0811-7) contains supplementary material, which is available to authorized users.
Aims:The safety of bioresorbable scaffolds (BRS) has recently been challenged. However, it is unclear whether outcomes depend on the complexity of the lesion or on the technique used to implant the device. The aim of this study was to report on the outcomes after BRS implantation in complex lesions.Methods and results: This investigator-initiated, single-centre, single-arm observational study recruited 657 consecutive patients (79% male, 66.7% acute coronary syndrome, age 63±12 years). Three hundred and twenty-two lesions (42.3%) in 297 (45.2%) patients with type B2 or C lesions were classified as the "complex lesions group". Post-procedural residual stenosis was slightly but significantly greater in the complex lesions group (15.7±11.3% vs. 13.5±10.2%, p=0.0109). The median follow-up was 1,076 (762-1,206) days without difference between groups. The Kaplan-Meier rates of early scaffold thrombosis (3.5% vs. 1.1%, p=0.0478, HR 3.03 [1.06-8.70]) and scaffold restenosis (9.9% vs. 9.1%, p=0.0262, HR 2.34 [1.11-4.94]) were higher in patients with complex lesions than in those with simple lesions. Late/very late thrombosis, death, repeat myocardial infarction, or repeat coronary interventions were not different. In patients in whom strict guidelines for implantation were applied, the incidence of thrombosis was reduced by 76% in complex lesions and by 92% in simple ones, such that there were no differences between groups (2.3% vs. 0.5%, p=0.3899). In contrast, the incidence of scaffold restenosis was reduced by 59% and 89%, and a difference between groups persisted (7.0% vs. 1.6%, p=0.0235).Conclusions: BRS implantation in complex lesions is, as expected, associated with higher incidence of events as compared to simple ones. The technique used at the time of the implantation, however, reduces the incidence of adverse outcomes.
Treatment of NSTE-ACS with BRS appears to be safe and effective. In this group, risk factors for events during follow up did not differ as compared to the general population.
Background A thorough knowledge of sonography is essential in clinical practice. Therefore, sonography training is increasingly incorporated into the medical school curriculum, entailing different course models. The question arises which model is most effective to convey sustained sonographic skills. Methods Two different peer-assisted learning (PAL) sonography course models were developed as part of a clinical prospective study. The course content was based on the national resident curriculum of the German Society for Ultrasound in Medicine (DEGUM). Model A consists of a 10-week course and model B of a two-day compact course. Each model entailed 20 teaching units (TU). A script was used to prepare for each unit. Two modified OSCE exams of the ultrasound skills (max = 50 points per exam) were performed during the last teaching unit to assess the competence level. For subjective self-assessment and model evaluation, a questionnaire with a 7-point Likert scale was employed. Results A total of 888 students of the 3rd year participated as part of a voluntary elective in the study (744 in model A and 144 in model B). In the exams, participants in model A (median 43 points) scored significantly higher than those in model B (median 39; p < 0.01). Participants in model A (mean 1.71 points) obtained significantly higher mean competency gain scores in subject knowledge than model B (mean 1.43 points; p < 0.01) participants. All participants were satisfied with the course concept (A: mean 1.68 vs. B: mean 1.78 points; p = 0.05), the teaching materials (A: mean 1.81 vs. B: mean 1.69 points; p = 0.52), and the tutor’s didactic skills (A: mean 1.24 vs. B: mean 1.15 points; p < 0.05). Conclusion These results suggest that sonography-specific competency may be obtained through different course models, with a model stretching over several weeks leading to a higher competence level. Further research should assess the long-term retention of the skills obtained in different models.
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