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Aims: We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with biodegradable polymer drug-eluting stents (BP-DES) versus durable polymer drug-eluting stents (DP-DES)., Methods and Results: Among 11 517 PCIs with second-generation DES performed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was target lesion failure, the composite target lesion revascularization (TLR), target vessel myocardial infarction and death. Propensity score matching was used to create a well-balanced cohort. Mean follow-up was 4.8 years. Of the 3413 matched pairs, 21% were females, and the mean age was 66 years. At 1 year, the primary outcome occurred in 8.3% patients versus 7.1% (P = 0.07), and TLR rate was 3% versus 2% (P = 0.006) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in 23.1% versus 23.4% (P = 0.44), and the rate of TLR was 7.2% versus 6.5% (P = 0.07) in patients with DP-DES and BP-DES, respectively., Conclusion: Similar rates of the composite outcome were observed throughout the entire follow-up. Target lesion revascularization rates were lower in the BP-DES group at 1-year but equalized within 5 years., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Ultrathin bioresorbable polymer sirolimus-eluting stents (BP-SESs) may easily lead to acute recoil. This study investigated acute recoil after BP-SES implantation on the basis of intravascular ultrasound (IVUS)., Methods: We enrolled 40 consecutive stents. Absolute acute recoil by quantitative coronary angiography was defined as the difference between the mean diameter of the last inflated balloon (X) and mean lumen diameter of the BP-SES immediately after balloon deflation (Y). Percent (%) acute recoil was defined as (X-Y)×100/X. IVUS was performed within the culprit lesion. Plaque eccentricity, % plaque burden and calcification grade score were assessed using IVUS. Calcification grade was scored on the basis of quadrants. On the basis of the median acute recoil value of 5.0%, the stents were divided into two groups: low (LAR, n = 20) and high % acute recoil (HAR, n = 20)., Results: Mean % acute recoil was 5.8 ± 5.3%. Plaque eccentricity, % plaque burden and stent/artery ratio were significantly higher in the HAR group than in the LAR group. Significant differences in % acute recoil were not observed regarding the types of stent diameter. In multivariate logistic regression and multiple linear regression analysis, plaque eccentricity and % plaque burden in the culprit plaque were significant positive predictors for the occurrence of % acute recoil. No significant differences, including clinical outcomes, were found between both groups at follow-up., Conclusion: Acute recoil of BP-SESs may be influenced by an eccentric plaque with a large burden, which did not affect long-term outcomes. However, the present study might suggest the proper strategy (e.g. a more exhaustive plaque preparation) before BP-SES implantation in a case with these IVUS characteristics., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

A recent thinner strut drug-eluting stent might facilitate early strut coverage after its placement. We aimed to investigate early vascular healing responses after the placement of an ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) compared to those with a durable-polymer everolimus-eluting stent (DP-EES) using optical coherence tomography (OCT) imaging.This study included 40 patients with chronic coronary syndrome (CCS) who underwent OCT-guided percutaneous coronary intervention (PCI). Twenty patients each received either BP-SES or DP-EES implantation. OCT was performed immediately after stent placement (baseline) and at 1-month follow-up.At one month, the percentage of uncovered struts reduced significantly in both the BP-SES (80.9 ± 10.3% to 2.9 ± 1.7%; P < 0.001) and DP-EES (81.9 ± 13.0% to 5.7 ± 1.8%; P < 0.001) groups, and the percentage was lower in the BP-SES group than in the DP-EES group (P < 0.001). In the BP-SES group, the percentage of malapposed struts also decreased significantly at 1 month (4.9 ± 3.7% to 2.6 ± 3.0%; P = 0.025), which was comparable to that of the DP-EES group (2.5 ± 2.2%; P = 0.860). The optimal cut-off value of the distance between the strut and vessel surface immediately after the placement to predict resolved malapposed struts was ≤ 160 μm for BP-SES and ≤ 190 μm for DP-EES.Compared to DP-EES, ultrathin-strut BP-SES demonstrated favorable vascular responses at one month, with a lower rate of uncovered struts and a comparable rate of malapposed struts.

Background: The FLEX-LONG study assessed the safety and clinical outcomes of ultra-long (44 mm/48 mm) biodegradable polymer-coated Supraflex (Sahajanand Medical Technology Pvt. Ltd., Surat, India) sirolimus-eluting stents (SES) in real-world patients with complex, long coronary artery lesions., Methods: It was an investigator-initiated, retrospective, non-randomized, observational and single-center study, which evaluated one-year results of 141 patients who had undergone implantation of at least one ultra-long (44 mm/48 mm) Supraflex SES. The incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one-year follow-up was considered as primary outcome. Stent thrombosis was analyzed as a safety outcome., Results: The mean age of the study population was 56.2±9.6 years and 78.0% (110/141) patients were male. The study analyzed high risk patients, including 62 (44.0%) hypertensive and 60 (42.6%) diabetic patients. Total 147 target lesions were treated, including 25 (17.0%) total occlusions. Total 51 (34.7%) and 96 (65.3%) Supraflex SES of 44 mm and 48 mm were implanted, respectively. Average stent length and diameter were 46.6±1.9 mm and 3.4±0.2 mm, respectively. One-year follow-up was obtained in 100% of patients. There was one probable stent thrombosis after three weeks. At one-year follow-up, 99.3% of patients remained event free., Conclusions: The results of the FLEX-LONG study support the use of ultra-long (44 mm/48 mm) Supraflex SES, in the treatment of high-risk real-world patients. The stent appeared to be safe and effective at one-year with low clinical events in complex, long coronary artery lesions.

Clinical outcomes after percutaneous coronary intervention (PCI) for severely calcified lesions remain poor. The purpose of this study was to investigate the neointimal response after everolimus-eluting stents (EES) for severely calcified lesions treated with rotational atherectomy (RA) using optical coherence tomography (OCT).We retrospectively analyzed 34 lesions in which PCI was performed with EES deployment following RA and OCT was performed immediately after PCI and at follow-up (nine months). The EES was either durable-polymer (DP) EES (22 lesions) or bioabsorbable polymer (BP) -EES (12 lesions). Strut coverage and malapposition were evaluated at 1-mm intervals of cross-section (CS) by serial OCT analysis. Malapposed strut was defined as having the distance from luminal border > 100 μm.A total of 11,823 struts immediately after PCI and 11,720 struts at follow-up were analyzed. Immediately after PCI, the strut-level analysis showed no significant differences in the percentage of malapposed struts between the DP-EES group and the BP-EES group. At follow-up, the BP-EES group showed a more prevalent covered strut compared with the DP-EES group (strut-level analysis: 95% versus 97%, P = 0.045; CS-level analysis: 97% versus 100%, P < 0.01; lesion-level analysis: 27% versus 83%, P < 0.01, respectively).In severely calcified lesions requiring RA, the BP-EES group achieved better neointimal coverage than the DP-EES group at nine months. Additional prospective studies are needed.

Hyperglycemia is an important risk factor for poor clinical outcomes in patients with acute myocardial infarction (AMI). The relative superiority of the long-term clinical outcomes of durable-polymer (DP) -based and biodegradable-polymer (BP) -based newer-generation drug-eluting stents (DESs) after successful percutaneous coronary intervention (PCI) in patients with AMI and prediabetes is not well established. We compared the clinical outcomes in such patients between DP-based and BP-based newer-generation DESs.A total of 4,377 patients with AMI and prediabetes were divided into the following two groups: the DP-DES group (n = 3,775; zotarolimus-eluting stents [ZES; n = 1,546] and everolimus-eluting stents [EES; n = 2,229]) and the BP-DES group (n = 602; biolimus-eluting stents [BES]). The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization. The secondary endpoint was the occurrence of stent thrombosis (ST).The 2-year adjusted hazard ratio (aHR) of MACEs for ZES versus EES, ZES versus BES, EES versus BES, and ZES/EES versus BES (aHR: 1.125; 95% confidence interval [CI], 0.834-1.518; P = 0.440) were similar. The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.

Purpose: Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices., Methods: Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types., Results: Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results., Conclusions: High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.

Aims: Randomized clinical trials have consistently demonstrated the non-inferiority of bioabsorbable polymer drug-eluting stents (BP-DES) with respect to DES having permanent polymers (PP-DES). To date, the comparative performance of BP- and PP-DES in the real world has not been extensively investigated., Methods and Results: From October 2011 to June 2016, we analysed the outcomes associated with newer generation DES use in Sweden. After stratification according to the type of DES received at the index procedure, a total of 16 504 and 79 106 stents were included in the BP- and PP-DES groups, respectively. The Kaplan-Meier estimates for restenosis at 2 years were 1.2% and 1.4% in BP- and PP-DES groups, respectively. Definite stent thrombosis (ST) was low in both groups (0.5% and 0.7% in BP- and PP-DES groups, respectively). The adjusted hazard ratio (HR) for either restenosis or definite ST did not differ between BP- and PP-DES [adjusted HR 0.95, 95% confidence interval (CI) 0.74-1.21; P = 0.670 and adjusted HR 0.79, 95% CI 0.57-1.09; P = 0.151, respectively]. Similarly, there were no differences in the adjusted risk of all-cause death and myocardial infarction (MI) between the two groups (adjusted HR for all-cause death 1.01, 95% CI 0.82-1.25; P = 0.918 and adjusted HR for MI 1.05, 95% CI 0.93-1.19; P = 0.404)., Conclusion: In a large, nationwide, and unselected cohort of patients, percutaneous coronary intervention with BP-DES implantation was not associated with an incremental clinical benefit over PP-DES use at 2 years follow-up., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Importance: Physicians have been criticized for having an overly enthusiastic response to new device approvals, especially for novel technologies. However, to our knowledge, the rates of new product adoption and patterns of new device usage in clinical practice have not been well described., Objective: To characterize the patterns of uptake of bioresorbable vascular scaffolds (BVS) within the United States following device approval and to describe changes in response to subsequent releases of data and US Food and Drug Administration (FDA) warnings., Design, Setting, and Participants: This analysis of the uptake of BVS between January 2016 and June 2017 used CathPCI Registry data; all percutaneous coronary intervention (PCI) procedures with an implant of either a BVS or conventional stent were included. Data analysis was performed in October 2017., Exposures: Implant of BVS., Main Outcomes and Measures: The primary outcome was monthly use of BVS in the United States. In addition, the characteristics of patients who received BVS and of hospitals that used BVS were assessed and comparisons of patient characteristics between BVS recipients and patients who were treated contemporaneously with metallic stents were made., Results: Of 682 951 procedures, 471 064 (69.0%) were done in men, 587 301 (86.0%) were among white people, and the mean (SD) age of those undergoing procedures with BVS vs conventional stents was 62.6 (11.4) years vs 65.7 (11.9) years. Of these, 4265 procedures (0.6%) used BVS overall (after FDA approval of BVS). Procedures with implants of BVS occurred among patients with fewer comorbidities and lower-acuity presentations compared with procedures with implants of conventional stents. The patient characteristics for BVS use were not dissimilar to the inclusion criteria of the ABSORB III FDA approval trial, with notable differences based on trial eligibility (eg, excluding patients with myocardial infarctions). The maximum monthly use of BVS was 1.25% of all PCI procedures that occurred 90 days after FDA approval, but with site-to-site variability. Declines in use were observed coincident with the scientific presentation of adverse event data as well as FDA warnings., Conclusions and Relevance: Most US physicians and hospitals were selective in their use of BVS, primarily using them in patients similar to those in the device's FDA approval trial. In addition, declines in use were evident in the subsequent month following the release of data that reported negative outcomes. These results illustrate an example of an appropriate physician response to adverse data updates and FDA warnings.

Introduction and Objectives: There is little evidence on rates of stent thrombosis (ST) in patients receiving dual antiplatelet therapy (DAPT) with ticagrelor or prasugrel. The aim of this study was to analyze the incidence and predictors of ST after an acute coronary syndrome among patients receiving DAPT with ticagrelor vs prasugrel., Methods: We used data from the RENAMI registry (REgistry of New Antiplatelet therapy in patients with acute Myocardial Infarction), analyzing a total of 4123 acute coronary syndrome patients discharged with DAPT with ticagrelor or prasugrel in 11 centers in 6 European countries. The endpoint was definite ST within the first year. A competitive risk analysis was carried out using a Fine and Gray regression model, with death being the competitive event., Results: A total of 2604 patients received DAPT with ticagrelor and 1519 with prasugrel; ST occurred in 41 patients (1.10%), with a similar cumulative incidence between ticagrelor (1.21%) and prasugrel (0.90%). The independent predictors of ST were age (sHR, 1.03; 95%CI, 1.01-1.06), ST segment elevation (sHR, 2.24; 95%CI, 1.22-4.14), previous myocardial infarction (sHR, 2.56; 95%CI, 1.19-5.49), and serum creatinine (sHR, 1.29; 95%CI, 1.08-1.54)., Conclusions: Stent thrombosis is infrequent in patients receiving DAPT with ticagrelor or prasugrel. The variables associated with an increased risk of ST were advanced age, ST segment elevation, previous myocardial infarction, and serum creatinine., (Copyright © 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

For the suppression of inflammation in the aneurysm development, we focused on inhibition of an important transcription factor, nuclear factor-kappa B (NF-κB), using a decoy strategy. We newly developed a novel bioabsorbable sheet that delivers NF-κB decoy oligodeoxynucleotide (ODN).We treated 5-week-old SD rats that were induced with abdominal aortic aneurysm (AAA) using 0.5 M CaCl 2 with an NF-κB decoy sheet. Four weeks after AAA induction, aortic tissue was excised for further examinations. We showed that this bioabsorbable sheet could deliver the decoy ODN into the target tissues and dissolve within a week. Treatment with the NF-κB decoy sheet reduced the aneurysm size compared with the controls. It also suppressed inflammation due to the effect of NF-κB decoy ODN. Immunohistochemistry revealed that the expression of CD31, CD4, and CD11b in the NF-κB decoy sheet group was significantly lower than in the control sheet group. The NF-κB decoy sheet was absorbed on the target tissue.We have revealed that the bioabsorbable sheet mediated decoy ODN is effective for transfection into target organs. We have also indicated that NF-κB decoy ODN transfection using this sheet has the potential to suppress the dilatation of aneurysm. The bioabsorbable sheet mediated transfection of the decoy ODN can be beneficial for the clinical treatment of AAA and other NF-κB-related cardiovascular diseases.

Background: Absorbable suspension sutures for tissue repositioning represent a minimally invasive approach to facial rejuvenation. With 2015 FDA 510(k) approval of Silhouette InstaLift™ (Sinclair Pharma, Irvine, CA), a completely absorbable device comprised of 82% PLLA/18% PLGA sutures and bi-directional cones, came the challenge of developing optimal technique for achieving effective, precise, and durable tissue repositioning. Here, the authors discuss the importance of straight-line vector planning (SLVP) and positioning of the suture perpendicular to the plane to be elevated in obtaining optimal results for tissue repositioning. Both the scientific underpinnings of SLVP are presented, along with detailed discussion of technique for suture placement in the mid-face, jawline/jowls, and neck., Methods: The authors are some of the earliest adopters of absorbable suspension sutures in the United States and have both used InstaLift™ sutures for tissue repositioning and facial recontouring in treatment of more than 500 patients and developed the principles of SLVP as a method to ensure optimal outcomes., Results: Patient case studies illustrating the importance of SLVP are presented. In over 500 patients treated within the authors' practices since InstaLift approval there have been no serious adverse events and noticeable bruising has occurred in less than 5% of patients. Results of repositioning and recontouring are evident for up to 24 months., Conclusions: Absorbable suspension sutures are a highly adaptable, non-invasive device for lifting and repositioning of descended facial tissue. Outcomes are dependent upon proper technique, including SLVP. J Drugs Dermatol. 2018;17(7):786-793.

Aim: To investigate three-year outcomes of patients presenting with nonSTelevation acute coronary syndrome (NSTE-ACS) treated with bioresorbable everolimus-eluting vascular scaffolds (BRS)., Methods and Results: The study included a total of 488 consecutive patients, enrolled between May 2012 and December 2013 (median age 65 [56-74], 392 men. 269 patients presented with either NSTEMI or unstable angina at the time of enrolling, 219 patients with stable or silent angina. The primary device-oriented endpoint (Target Lesion Failure, TLF) was defined as a combination of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization.Among the cardiac risk factors, NSTE-ACS patients were more frequently smokers (P = 0.028), had less frequently dyslipidemia (P = 0.003) and a history of prior PCI (P < 0.01).The median follow-up was 1070[763-1197] days. The three-years incidence of TLF was slightly higher but did not differ significantly between groups (NSTE-ACS: 16.3% vs. 15.9%, p = 0.163). Accordingly, there was no difference in any of the other endpoints., Conclusion: 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.

Purpose: Various researchers have observed small areas of osteolysis after using bioabsorbable anchors in shoulder surgeries. The purpose of this study is to determine whether radiographic perianchor radiolucent rings after rotator cuff repair are associated with the failure of repair and also assess their clinical implications. Further, the most frequent location of the radiolucent rings in the double-row suture bridge configuration was also assessed., Methods: One hundred and twenty-nine consecutive patients who underwent arthroscopic rotator cuff repair by suture bridge technique were retrospectively evaluated radiographically and clinically. The number and size of the rings that appeared at each follow-up were recorded. Also, the locations of each ring were recorded as anterior, middle or posterior, and medial or lateral according to the construct of the anchors used for suture bridge technique. The size of the tear, the number of anchors used and age of the patients were compared. Re-tear rates according to ultrasound examinations were also analyzed., Results: After rotator cuff repair, the mean American Shoulder and Elbow Surgeons (ASES) score increased from 46.7 to 88.0 and the overall re-tear rate was 8.5% (11 cases). Seventy-three patients (56.6%) showed RR (total number of 99 rings) at least once during the course of their follow-up and the rings appeared at a mean period of 18.2 months after surgery. Mean size of the rings initially was 5.6 mm and the rings increased or decreased in mean size of 0.4 mm during mean follow-up of 37 months. No correlation was seen with the number of RRs and the rate of re-tears, number of anchors, size of tears, and clinical outcome as determined by the ASES score. Radiolucent ring measurement reproducibility was confirmed by independent, repeated measurements. The rings appeared mostly at anteromedial anchors (75 rings, 75.8%) and the authors suggest that mechanical factors may play a role for the cause of radiolucent rings., Conclusions: The number and the size of RRs around bioabsorbable anchors after rotator cuff repair do not appear to adversely affect the healing and clinical outcome of ARCR. Most radiolucent rings appeared at anteromedial anchors, indicating that mechanical factors may play a role for the radiolucencies., Level of Evidence: Case series, level IV.

Background: Many reconstructive techniques and materials have been reported for repair of skull base defects after sinonasal tumor excision, cerebrospinal fluid (CSF) leaks, and coverage of denuded bone. Synthetic materials have been developed for endoscopic skull base repair to avoid donor-site morbidity. Polydioxanone plate is a bioabsorbable implant designed for nasal septal reconstruction and has the ability to retain strength for at least 10 weeks and absorbs in 6 months., Objectives: This study aimed to describe the use of polydioxanone plates in endoscopic skull base defect and CSF leak repair, and to describe our experience with the surgical technique and postoperative management., Methods: This was a retrospective case series of patients who, between May 2013 and December 2015, underwent endoscopic sinus surgery and skull base repair for CSF leak or after excision of a skull base tumor by using polydioxanone plates. Patients who presented with sinonasal inflammatory disease or skull base tumors underwent endoscopic skull base repair by using polydioxanone plates in an underlay fashion and mucosal membrane grafts with or without adjuvant materials in an overlay fashion. The patients were reviewed at 6 days, 6 weeks, and 3 months after surgery. Postoperative adverse events, including CSF leak, infection, bleeding, headache, and graft failure, were recorded., Results: The cases of seven patients (five women, two men; mean age, 53.9 years) were reviewed. Five patients underwent sinonasal tumor resection and two underwent repair for CSF leak. The mean (standard deviation) defect size was 16.4 ± 11.4 mm. There was no evidence of postoperative CSF leak, and lumbar drains were not used. One patient reported transient headache and facial pressure at the 6-week follow-up visit. The surgeons' experience with polydioxanone plate placement, postoperative healing, and follow-up was satisfactory., Conclusion: Polydioxanone could be used to achieve rigid repair of endoscopic skull base defects. These early results, although promising, require validation in clinical trials.

The DESolve® scaffold (Elixir Medical Corporation, Sunnyvale, California, USA) is manufactured from a poly-l-lactide based polymer and elutes an anti-proliferative, anti-inflammatory drug, Novolimus from a poly-l-lactide based topcoat mixture. The strut thickness is 150μm and the scaffold has platinum-iridium radiopaque markers at both ends. Radial support is available during the early time period to prevent recoil. The scaffold biodegrades within 1year (>90% reduction in molecular weight) and then completely bioresorbs within 2years. The DESolve® scaffold permits a wide range of expansion with a consequently reduced risk for strut fracture. Lumen and scaffold enlargement is observed within 3-6months in both preclinical and clinical studies potentially allowing for the scaffolded region to respond to vasoactive stimuli. The device has a unique property of self-correction observed in bench top studies, which in clinical practice has the potential to eliminate minor malapposition following deployment., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Long-term outcome of drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) versus non-ST-elevation acute coronary syndrome (NSTE-ACS) remains unclear. This study sought to compare the long-term outcomes of biodegradable polymer-coated DES in patients with STEMI versus NSTE-ACS., Methods: We explored a post hoc analysis of the 5-year outcome of the CREATE trial in the subgroup of patients with STEMI (n=318) versus NSTE-ACS (n=1223) who were implanted with biodegradable polymer-coated DES. The primary outcome was the rate of major adverse cardiac events (MACE) at 5 years. Clopidogrel and aspirin for 6 months followed by chronic aspirin therapy were recommended., Results: STEMI patients showed a trend of increase in MACE (8.7% vs. 6.8%, log rank p=0.289) compared to NSTE-ACS patients at 5 years, and a greater risk of cardiac death (5.4% vs. 2.1%, log rank p=0.003), mainly driven by the higher cardiac death rate within the first month after stent placement (log rank p=0.003) and the last year of follow-up (log rank p=0.001). No significant difference in stent thrombosis was found between them (3.1% vs. 2.5%, log rank p=0.653). Prolonged clopidogrel therapy (>6 months) showed no effect on risk of MACE or stent thrombosis between the two groups (both p for interaction >0.1)., Conclusions: STEMI patients have a higher risk of cardiac mortality compared with NSTE-ACS patients after biodegradable polymer-coated DES placement, primarily attribute to more cardiac deaths that happened within the first month after the event and the last year of follow-up., (Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Background & Aims: Although Absorb Bioresorbable Vascular Scaffolds (A-BVS) are routinely used in the Asia-Pacific, there is little information on patient selection or deployment technique here. This document investigates the experiences of leading interventional cardiologists from the Asia-Pacific region with a focus on patient characteristics, deployment techniques and management., Methods and Results: A detailed questionnaire was distributed to 28 highly-experienced interventional cardiologists ('Authors') from 13 Asia-Pacific countries. The results were discussed at a meeting on patient selection, technical consideration, deployment practices and patient management. Potential patient benefits of Absorb compared to metallic DES, the learning curve for patient selection and preparation, device deployment, and subsequent patient management approaches are presented., Conclusions: Current practices are derived from guidelines optimized for European patients. Differences in approach exist in the Asia-Pacific context, including limited access to imaging and frequency of occurrence of complex lesions. Nevertheless, the use of the Absorb BVS ('Absorb') in certain Asia-Pacific countries has flourished and practices here are continuing to mature., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The Absorb bioresorbable vascular scaffold (BVS; Abbott Vascular) is a relatively new type of coronary stent designed to provide temporary vessel scaffolding following percutaneous coronary intervention. International use of the device has grown despite a relative paucity of clinical data regarding the performance of the device and the optimal strategy for its use. We report 12-month clinical data on the Absorb BVS from a real-world registry in order to contribute to the overall understanding of the BVS device., Methods and Results: Absorb BVS implantation was attempted in 152 lesions in 100 patients at two Sydney hospitals, as part of the prospective ESHC-BVS registry. Patients selected harbored a range of complex lesions as encountered in real-world practice. Type-C lesions made up 37% of all lesions treated, with 64% of these being long lesions (>20 mm). Device success was achieved in 98.8% of cases. Predilation was performed in all scaffolds and postdilation was performed in 95% of scaffolds to a mean of 19.6 ± 4.6 atm. Twelve-month follow-up data were available for 99% of patients. At 12 months, the cumulative incidence of target-lesion revascularization was 4%, while the incidence of myocardial infarction was 2% and the incidence of scaffold thrombosis was 1%. There were no deaths in the follow-up period., Conclusion: In a cohort including complex lesions encountered in real-world practice, the Absorb BVS was associated with low rates of target-lesion revascularization, myocardial infarction, and scaffold thrombosis at 12 months when used with a strategy of meticulous lesion preparation, routine postdilation, and 12 months of dual-antiplatelet therapy.

The evolution of percutaneous coronary intervention has been considerable. Coronary stents were introduced to avoid vessel recoil and reduce acute and late vessel complications. Later, drug-eluting stents were developed to decrease the neointimal hyperplasia associated with bare metal stents in order to reduce restenosis. However, very late stent thrombosis remains problematic, and the permanent presence of a metal stent could be associated with local inflammation and impaired vascular physiology. Thus, bioresorbable stents have been developed, to prevent recoil initially when this risk is the highest, with subsequent degradation over time, to avoid long-term complications of the presence of stents in the coronary vasculature. Here, we review the current status of bioresorbable stents in percutaneous coronary intervention (PCI), with focus on the platforms that have been studied the most: ABSORB, DESolve, and DREAMS. In terms of clinical outcomes, bioresorbable stents have not yet shown superiority compared with current generation drug-eluting stents, but rather a signal of increased stent thrombosis. Further development and longer-term studies are needed before the routine implementation of bioresorbable stents in clinical practice.

Aim: We aimed to investigate the safety and efficacy of bioresorbable vascular scaffolds (BVS) in daily use in a real-world patient population., Methods and Results: Between March 2013 and September 2014, 224 patients (233 lesions) were treated with BVS at a tertiary care center. Patients underwent follow-up coronary angiography 3-6 months after implantation. Clinical presentations were stable angina in 101 patients (45.1%), unstable angina in 47 (21.0%), NSTEMI in 38 (17.0%), and STEMI in 38 (17.0%) patients. Twenty-two patients (27 lesions) had chronic total occlusion (CTO). Procedural success was achieved in all patients. Two patients died in the follow-up period due to BVS thrombosis (0.9%). In-hospital death occurred in further 3 patients (1.3%) due to other causes not related to the BVS implantation. Total BVS thrombosis was 3.1% (7 patients) and there was only 1 case of relevant restenosis on angiographic follow-up. The overall incidence of major adverse cardiac events was 11 (4.9%)., Conclusions: Mid-term follow-up after implantation of BVS suggests a satisfactory safety profile and low restenosis rate in routine daily practice involving a large range of complex lesions., (© 2016, Wiley Periodicals, Inc.)

Background: Bioresorbable vascular scaffolds (BVS) have been shown to be non-inferior to second generation drug eluting stents in recent clinical trials. However, the trials were not powered for individual endpoints and there is concern for increased device thrombosis with BVS., Methods: We performed a systematic search for randomized clinical trials of BVS versus EES. Efficacy outcomes were target lesion revascularization (TLR) and target vessel revascularization (TVR). Safety outcomes were death, myocardial infarction (MI), and device thrombosis. Meta-regression analyses were performed to evaluate the association of device thrombosis with clinical characteristics (percent patients with acute coronary syndrome) and device deployment characteristics (percent with post stent balloon dilation)., Results: We identified six RCTs that enrolled 3738 patients. When compared with EES, BVS was associated with similar risk of TLR (RR=1.06; 95% CI 0.73-1.54), TVR (RR=1.00; 95% CI 0.74-1.35), death (RR=1.11; 95% CI 0.53-2.33) and cardiovascular death (RR=1.39; 95% CI 0.43-4.43) but numerically higher MI (RR=1.35; 95% CI 0.98-1.86) and definite or probable device thrombosis (RR=2.11; 95% CI 0.99-4.47). In a sensitivity analysis using the Peto odds ratio method, the risk of definite or probable device thrombosis was significantly increased (OR=2.08; 95% CI 1.06-4.08; P=0.03), although this did not reach statistical significance in four other models. The risk of definite or probable device thrombosis with BVS was reduced in trials where more post stent balloon dilation was used and in patients without acute coronary syndrome. Moreover, trial sequential analysis showed that the cumulative z-curve crossed the conventional boundary and not the trial sequential boundary, indicating lack of robust data to support increased definite or probable device thrombosis with BVS., Conclusions: In patients with noncomplex obstructive coronary disease, BVS are comparable to EES for most efficacy and safety outcomes except for a numerical increase in device thrombosis and MI. The risk of the latter outcomes was mitigated in trials where more post stent balloon dilation was used and in patients without acute coronary syndrome. Moreover, with only 3738 patients, the trials are underpowered to detect a difference in rare events such as device thrombosis., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Introduction: The Ultrapro® Advanced™ mesh (Ethicon, Sommerville, NJ) is a new mesh design, using the best characteristics from the previous platform, while adding new, advanced features. Our centre, Imelda Hospital, Bonheiden, Belgium, was chosen as one of the first clinical testing sites. The aim of this study was to present our preliminary data on complication rate and patient satisfaction., Materials and Methods: From October 1, 2015 until January 31, 2016, we treated 57 patients, implementing 67 Ultrapro® Advanced™ meshes. One patient was excluded due to postoperative cerebral haemorrhage with aphasia. Only patients with more than one-month follow-up were included for further analysis, resulting in a population of 41 patients with 51 meshes. Of them, 35 were male and only 6 were female, with an average age of 61.4 years and an average BMI of 25.9. The indications were uni- and bilateral laparoscopic inguinal hernia repair (n = 23 and 10 respectively), open inguinal hernia repair (n = 3), and open incisional hernia repair (n = 5). Quality of life was measured preoperatively and at four weeks postoperatively, using the hernia specific Carolina Comfort Scale (CCS) questionnaire., Results: The primary endpoint was complication rate. Only two patients (4.8%) mentioned a mild scrotal hematoma and two patients (4.8%) demonstrated a seroma. There were no superficial wound infections nor early recurrent hernias. Our secondary endpoint was quality of life, measured by the CCS questionnaire, which differentiates between a symptomatic and an asymptomatic group. A total of 13 patients were asymptomatic, whilst 28 patients reported some sort of discomfort, ranging from mild (n = 25) to moderate and/or daily symptoms (n = 3). No patients were disabled by their symptoms., Conclusion: The Ultrapro® Advanced™ is a sequel of the classic Ultrapro® mesh with similar characteristics: it is a "lightweight", macroporous, partially absorbable mesh built out of thin filaments, while maintaining sufficient strength. Its improvement is due to incorporation of evidence-based characteristics such as an increased mesh elasticity. Furthermore, the surgical manipulation is improved thanks to the increased mesh memory. Our prospective cohort study shows good initial and short-term results after implementation of the Ultrapro® Advanced™. However, further prospective research is mandatory on the long-term outcomes.

Background and Aim: Neuregulin-1 is an essential axoglial signal required for peripheral nerve development, and evidence that neuregulin-1 is also required for effective nerve repair is growing. In this study, the effects of neuregulin-1-impregnated gelatin hydrogels on nerve regeneration and functional recovery after anastomosis of the facial nerve were investigated in a rat model of traumatic facial nerve paralysis., Materials and Methods: Twenty-four adult male rats underwent complete resection of the facial nerve trunk, followed by end-to-end anastomosis with epineural sutures. The animals were then randomly allocated to one of three treatment groups (eight rats/group): no additional intervention (Group I), single-shot injection of neuregulin-1 into the epineurium of the facial nerve at the suture sites (Group II), or implantation of a hydrogel impregnated with neuregulin-1 at the injury site (Group III). After surgery, mimetic muscle movements were evaluated weekly. Eight weeks after surgery, the mimetic muscles were injected with a neural tracer (1,10-dioctadecyl-3,3,30,30-tetramethylindocarbocyanin perchlorate, DiI). Retrograde-labeled neurons were counted in the facial nuclei, and facial nerve specimens were stained with toluidine blue for histological examination of axon density., Results: Group III exhibited significantly faster recovery of mimetic muscle function, a higher density of large-diameter axons (>5 μm) in the facial nerve, and greater numbers of retrogradely labeled neurons in the ipsilateral facial nucleus compared with Groups I and II., Conclusions: Continuous release of neuregulin-1 from impregnated gelatin hydrogels can accelerate facial nerve regeneration., (Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Introduction and Objectives: The Working Group on Cardiac Catheterization and Interventional Cardiology presents its annual report on the data from the registry of the activity in Spain in 2014., Methods: Data were voluntarily provided by participating centers. The information was introduced online and was analyzed by the Steering Committee of the Working Group on Cardiac Catheterization and Interventional Cardiology., Results: Data were reported by 106 hospitals. A total of 140 461 diagnostic procedures (125 484 coronary angiograms) were performed, representing a rate of 3014 diagnostic studies per million population. This year, the number of percutaneous coronary interventions increased to 67 611, giving a rate of 1447 interventions per million population. A total of 94 458 stents were implanted, including 64 057 drug-eluting stents and 2424 biodegradable intracoronary devices. Of the total number of percutaneous coronary interventions, 17 825 were in acute myocardial infarction, representing 26.4% of all coronary interventions. A radial approach was used in 74% of diagnostic procedures and in 70.4% of interventional procedures. The use of renal denervation decreased, whereas over 125 mitral leak closures were performed. Transcatheter aortic valve implantation procedures exceeded 1300 implantations per year, a 27% increase from 2013., Conclusions: The registry for 2014 shows a slight increase in coronary disease activity despite no increase in the management of ST-segment elevation myocardial infarction. Drug-eluting intracoronary devices now comprise over 70% of all intracoronary devices. A continual increase is only seen in certain structural interventional techniques, such as transcatheter aortic valve implantation and perivalvular leak closure., (Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction: Cardiac implantable electronic device (CIED) infections are potentially preventable complications associated with high morbidity, mortality, and cost. A recently developed bio-absorbable antibacterial envelope (TYRX™-A) might prevent CIED infections in high-risk subjects. However, data regarding safety and efficacy have not been published., Methods and Results: In a single-center retrospective cohort study, we compared the prevalence of CIED infections among subjects with ≥2 risk factors treated with the TYRX™-A envelope (N = 135), the nonabsorbable TYRX™ envelope (N = 353), and controls who did not receive an envelope (N = 636). Infection was ascertained by individual chart review. The mean (95% confidence interval) number of risk factors was 3.08 (2.84-3.32) for TYRX™-A, 3.20 (3.07-3.34) for TYRX™, and 3.09 (2.99-3.20) for controls, P = 0.3. After a minimum 300 days follow-up, the prevalence of CIED infection was 0 (0%) for TYRX™-A, 1 (0.3%) for TYRX™, and 20 (3.1%) for controls (P = 1 for TYRX™-A vs. TYRX™, P = 0.03 for TYRX™-A vs. controls, and P = 0.002 for TYRX™ vs. controls). In a propensity score-matched cohort of 316 recipients of either envelope and 316 controls, the prevalence of infection was 0 (0%) and 9 (2.8%), respectively, P = 0.004. When limited to 122 TYRX™-A recipients and 122 propensity-matched controls, the prevalence of CIED infections was 0 (0%) and 5 (4.1%), respectively, P = 0.024., Conclusions: Among high-risk subjects, the TYRX™-A bio-absorbable envelope was associated with a very low prevalence of CIED related infections that was comparable to that seen with the nonabsorbable envelope., (© 2015 Wiley Periodicals, Inc.)

Background: There is a paucity of data reporting the clinical outcomes of biodegradable polymer biolimus-eluting stent (BP-BES) compared with durable polymer everolimus-eluting stent (DP-EES) beyond 1 year after stent implantation when the polymer is fully degraded., Methods and Results: The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BP-BES with DP-EES in patients scheduled for percutaneous coronary intervention using drug-eluting stent (DES) without any exclusion criteria among 98 participating centers in Japan. The trial was designed to evaluate noninferiority of BP-BES relative to DP-EES in terms of any target-lesion revascularization at 1 year and death or myocardial infarction at 3 years. Between May and October 2011, 3235 patients were randomly assigned to receive either BP-BES (1617 patients) or DP-EES (1618 patients). Complete 3-year follow-up was achieved in 97.6% of patients. At 3 years, the primary safety end point of death or myocardial infarction occurred in 159 patients (9.9%) in the BP-BES group and in 166 patients (10.3%) in the DP-EES group, demonstrating noninferiority of BP-BES relative to DP-EES (P noninferiority<0.0001 and P superiority=0.7). Cumulative incidence of target-lesion revascularization was not significantly different between the 2 groups (7.4% versus 7.1%; P=0.8). By a landmark analysis at 1 year, the cumulative incidences of death or myocardial infarction and target-lesion revascularization were also not significantly different between the 2 groups (4.6% versus 5.2%; P=0.46 and 3.3% versus 2.7%; P=0.39, respectively)., Conclusions: Safety and efficacy outcomes of BP-BES were non inferior to those of DP-EES 3 years after stent implantation., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01303640., (© 2015 American Heart Association, Inc.)

Background: The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres., Methods/design: The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413., Conclusions: The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Acute thrombogenicity and re-endothelialization represent clinically relevant end points pertaining to the safety of coronary stents, which have not been compared among biodegradable polymer-based drug-eluting metallic stents and fully bioabsorbable scaffolds to date., Methods and Results: We investigated comparative outcomes with respect to acute thrombogenicity and re-endothelialization among thin-strut biodegradable polymer metallic everolimus eluting stents (EES), thick-strut fully bioabsorbable EES, thick-strut biodegradable polymer metallic biolimus-eluting stents and control bare metal stents. An ex-vivo porcine arterio-venous shunt model was used to assess platelet aggregation, whereas a healthy rabbit model of iliofemoral stent implantation was used to assess re-endothelialization and inflammation. Confocal microscopy was used to detect fluorescently labeled antibody staining directed against CD61/CD42b for the identification of aggregated thrombocytes, CD14/PM-1, and RAM-11 for identification of neutrophils and monocytes/macrophages. Endothelial recovery was assessed by scanning electron microscopy, whereas CD31/PECAM-1 was used to confirm endothelial maturity. EES demonstrated significantly less acute thrombogenicity compared with bioabsorbable EES and biolimus-eluting stents. EES showed greater re-endothelialization at 28 days and reduced inflammatory cell adhesion of monocytes/macrophages at 14 days compared with bioabsorbable EES. Only bare metal stents showed complete re-endothelialization at 28 days., Conclusions: These outcomes indicate differential trends in thrombogenicity and vascular healing among contemporary stents used in clinical practice and suggest a need for long-term adjunct antithrombotic pharmacotherapy for bioabsorbable EES., (© 2015 American Heart Association, Inc.)

Background: Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent., Methods and Results: Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segment-elevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively., Conclusions: In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053., (© 2015 American Heart Association, Inc.)

Introduction: Duration of dual antiplatelet therapy (DAPT) following drug eluting stent (DES) implantation remains poorly defined. Endothelialisation of biodegradable polymer biolimus-eluting stents occurs early, and 6 months DAPT may be adequate., Aims: We evaluated long term outcome in patients treated with biolimus-eluting stents who were treated with 6 months DAPT. Endpoints included cardiac death and non-fatal stent thrombosis occurring 6 to 12 months after stent implantation., Methods: 692 patients (77.2% male), aged 65.6 ± 12.5 years received biolimus-eluting DES (March 2008 -November 2011). Vital status was tracked through the Medical Research Information Service. Episodes of non-fatal stent thrombosis, (Academic Research Consortium definition) between months 6 and 12 were tracked via systematic database searches (5 PCI centres)., Results: Presentations included acute coronary syndrome (47.2%) and stable coronary disease (52.8%). Vessels treated included left main stem (6.8%), left anterior descending (37.4%), circumflex (19.1%), right coronary artery (34.5%) and saphenous vein graft (2.1%) respectively. High-risk subsets included diabetes (15.6%); AHA type C lesions (35.1%) and chronic total occlusions (12.8%). During median follow-up of 700 days (0 to 1392) there were 42 deaths (6.1%); 4.2% at 0-6 months, 1.0% at 6-12 months and 0.9% at >12 months. Of the 7 deaths between 6 and 12 months, one death was adjudicated as possible stent thrombosis. There were no cases of non-fatal known stent thrombosis. All cause mortality accrued with smooth decremental incidence. Statistical examination showed no evidence of event clustering between 6 and 12 months., Conclusions: After implantation of biodegradable polymer biolimus-eluting coronary stents, 6 months DAPT appears to be adequate, safe and effective., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Objective: The objective of the present study was to develop targeted engineered nanoerythrosomes based intravenous formulation of antimalarial drug pyrimethamine., Material and Methods: The nanoerythrosomes formulation was developed by sonication method and optimized for effective drug loading at variable drug concentration, surface morphology, viscosity and sedimentation volume., Results: The in vitro drug release of formulated product was found to be delayed after 8 hours, having good stability at 4 ± 1°C and showing controlled in vivo release. Tissue distribution studies showed higher accumulation of drug in the liver (18.71 ± 1.4 μg/ml) (P < 0.05) at 1 hour in case of pyrimethamine-loaded nanoerythrosomes as compared to that in free drug (12.82 ± 0.7 μg/ml). Higher amount of drug, i.e. 14.18 ± 0.9 μg/ml (P < 0.05), was found after 24 hours in the liver in case of pyrimethamine-loaded nanoerythrosomes as compared to free drug concentration of 9.72 ± 0.5 μg/ml)., Discussion: Data showed that developed pyrimethamine-loaded nanoerythrosomes hold promise for targeting and controlling the release of drug and for improving treatment of malaria when they are combined with rapid acting antimalarials such as artemisinin., Conclusion: A decrease in the concentration of pyrimethamine in kidneys and lungs after 24 hours was observed as compared to that observed after 1 hour, showing no or little involvement of these organs in the clearance of drug-loaded nanoerythrosomes.

The surgical correction of hallux valgus has evolved since it was first described. Many osteotomies and fixation methods have been described and results have improved. Innovative new fixation methods include the Mini TightRope, new absorbable implants, and plating options. This article discusses the evolution of capital osteotomies as well as the evolution of fixation. Also presented is a case study of a novel method of achieving solid fixation across an osteotomy using a high-frequency sonic device to insert a bioresorbable pin., (Copyright © 2013. Published by Elsevier Inc.)

Background: Management of anal fistulas is challenging, because surgeons must aim to obtain complete healing while sparing the sphincter and avoiding fecal incontinence. The optimal treatment method remains unknown., Objective: This study assessed the safety and effectiveness of the use of a new synthetic fistula plug made of bioabsorbable polymers in the treatment of cryptoglandular anal fistulas., Design: This study is a retrospective review of a database of patient records., Setting: : Patients were treated at a general hospital in Italy., Patients: Forty-eight patients (39 men and 9 women; mean age, 49.9 years) with 49 fistulas were treated with the synthetic plug between November 2009 and March 2012. Types of fistula were as follows: 24 superficial transsphincteric, 18 medium transsphincteric, 5 deep transsphincteric, and 1 medium intersphincteric., Interventions: The fistula tract was cleaned by using curettage, and a synthetic plug was sized to fit the tract and inserted. A draining seton was used preoperatively in 1 patient., Main Outcome Measures: The outcome measures were complete closure of the fistula, with no discharge/residual fistula (verified by endoanal ultrasonography), perineal pain level (assessed with a visual analog scale), and fecal continence. Follow-up was conducted at 1 week and 1, 3, 6, and 12 months postoperatively., Results: The overall healing rate was 69.3% (34/49 fistulas, 33/48 patients). Eight patients (24.2%) had healing by 3 months after surgery, 21 patients (63.6%) had healed by 6 months, and 4 patients (12.1%) had healed by 12 months. By 3 months, no patient had perineal pain or fecal incontinence. No plug became dislodged, and no patient had the onset of anal stenosis, bleeding, local infection, or any other complication., Limitations: The number of patients and the retrospective nonrandomized nature of the investigation are limitations of this study., Conclusions: In patients with cryptoglandular anal fistulas, the use of a bioabsorbable synthetic plug provided a high rate of healing without causing fecal incontinence or other major adverse effects. Larger and randomized studies of this treatment are warranted.

Background: Bioabsorbable fixation systems have been widely employed in pediatric patients for cranial reconstruction, obviating the complications of hardware migration and imaging artifact occurring with metallic implants. Recent concern over complications unique to bioabsorbable materials, such as inflammatory reaction and incomplete resorption, necessitates additional conclusive studies to further validate their use in pediatric neurosurgery and craniofacial surgery. Likewise, long-term follow-up in this clinical cohort has not previously been described., Methods: We included consecutive pediatric patients under the age of 2, from Lucile Packard Children's Hospital, who underwent cranial vault reconstruction with the use of a bioabsorbable fixation system between 2003 and 2010. Hospital records were queried for patient characteristics, intraoperative data, and postoperative complications., Results: Ninety-five patients with the following preoperative pathologies were analyzed: craniosynostosis (87), cloverleaf skull (5), frontonasal dysplasia (1), and frontonasal encephalocele (2). Median age was 6 months (range 1-24 months). Average case duration was 204 minutes (range 40-392 min), with median of 154 mL blood loss (range 30-500 mL). Ninety-three percent of patients had 1-4 plates implanted with 48% receiving three plates. The median number of screws used was 59 (range 0-130). The median length of hospital stay was 4 days (range 2-127 days) with an average follow-up of 22 months (five postoperative visits). The complications related to hardware implantation included swelling (1%) and broken hardware (1%), the latter of which required reoperation., Discussion: The bioabsorbable fixation systems for cranial vault reconstruction in children less than 2 years of age is safe with tolerable morbidity rates.

Background: Heart failure (HF) is currently one of the main causes of cardiovascular mortality. In order to collect current epidemiological data on patients with HF, the Heart Failure Pilot Survey (ESC-HF Pilot) registry was initiated., Aim: Primary objective of the study was to compare clinical epidemiology of outpatients and inpatients with HF and investigate currently used diagnostic and therapeutic modalities in Poland and 11 other European countries., Methods: The ESC-HF Pilot Survey study was a prospective multicentre observational registry conducted in 2009-2011 in 136 cardiology centres in 12 European countries selected to represent different health systems and care attitudes across Europe. All outpatients with HF and patients admitted due to acute decompensated HF were included into the registry during the enrolment period (1 day per week for 8 consecutive months). Researchers completed detailed medical data questionnaires for all HF patients recruited to the study., Results: In all participating centres across Europe, 6108 patients were recruited, including 1159 patients from Poland (19% of the survey population). The majority of Polish participants were admitted due to acute HF (73%), while ambulatory chronic HF patients predominated in the remaining European centres (69%). Polish patients develop HF at a younger age compared to other European countries (proportion of patients above 65 years: 54 vs. 65%, respectively) and they are more severely ill (NYHA class III: 44 vs. 34%, respectively; NYHA class IV: 18 vs. 11%; mean BNP level 910 vs. 773 pg/mL). Angiographically documented coronary artery disease was the major aetiology of HF in Poland (39 vs. 33%) which explains a higher rate of invasive revascularisation procedures in the Polish population (13 vs. 7%). In Poland, therapy with implantable cardioverter- -defibrillators was used more frequently during the initial hospitalisation (7 vs. 4%), but the rate of cardiac resynchronisation therapy device implantation was smaller than in other European countries (4 vs. 7%). Drug therapy used in our country was comparable to the rest of Europe, except for more frequent use of aldosterone antagonists. Despite significant differences in the clinical characteristics seen between Polish and other European patients participating in the ESC-HF Pilot study, mortality at 3 months did not differ between Polish and other European centres (2.5 vs. 3%)., Conclusions: The ESC-HF Pilot Survey findings indicate a very high standard of inpatient HF treatment but at the same time unsatisfactory current ambulatory HF therapy in Poland.

The challenges and complications arising from abdominal surgery frequently necessitate soft tissue reconstruction or augmentation. Soft tissue repair generally has been revolutionised by the introduction of synthetic meshes, but their use is contra-indicated in contaminated or infected fields. Biologic materials derived from devitalised allo- or xenogeneic tissues have been proposed as a safer alternative to synthetics and provide an extracellular scaffold necessary for the in-growth of new blood vessels and infiltration of native stromal cells. We review the scientific evidence behind commercially available biologic prostheses in relation to the impact of tissue source, manufacturing processes and supplemental cross-linking on in vitro and in vivo (animal model and clinical) performance. Cross-linked meshes exhibit increased resistance to collagenase activity and degradation whilst still allowing tissue in-growth. Mesh durability may be the most important characteristic in determining optimal clinical outcomes, particularly in the context of the increased collagenase activity seen in contaminated or infected fields. Of all the biologic meshes currently available, HDMI cross-linked acellular porcine dermis has been associated with the best clinical outcomes in contaminated or infected fields., (© 2012 The Authors. Colorectal Disease © 2012 The Association of Coloproctology of Great Britain and Ireland.)

Background: The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly-l-lactic acid., Methods and Results: Between September 1998 and April 2000, 50 patients with 63 lesions were treated electively with 84 Igaki-Tamai stents. Overall clinical follow-up (>10 years) of major adverse cardiac events and rates of scaffold thrombosis was analyzed together with the results of angiography and intravascular ultrasound. Major adverse cardiac events included all-cause death, nonfatal myocardial infarction, and target lesion revascularization/target vessel revascularization. During the overall clinical follow-up period (121 ± 17 months), 2 patients were lost to follow-up. There were 1 cardiac death, 6 noncardiac deaths, and 4 myocardial infarctions. Survival rates free of all-cause death, cardiac death, and major adverse cardiac events at 10 years were 87%, 98%, and 50%, respectively. The cumulative rates of target lesion revascularization (target vessel revascularization) were 16% (16%) at 1 year, 18% (22%) at 5 years, and 28% (38%) at 10 years. Two definite scaffold thromboses (1 subacute, 1 very late) were recorded. The latter case was related to a sirolimus-eluting stent, which was implanted for a lesion proximal to an Igaki-Tamai stent. From the analysis of intravascular ultrasound data, the stent struts mostly disappeared within 3 years. The external elastic membrane area and stent area did not change., Conclusion: Acceptable major adverse cardiac events and scaffold thrombosis rates without stent recoil and vessel remodeling suggested the long-term safety of the Igaki-Tamai stent.

Biodegradable poly(γ-glutamic acid) (γ-PGA) nanoparticles (NPs) are considered to be an excellent antigen carrier. Antigen-carrying γ-PGA NPs were examined for their uptake by murine dendritic cells (DCs) and subsequent induction of antigen-specific immune responses in mice and compared with aluminum (AL) adjuvants. Ovalbumin (OVA)-carrying NPs (FITC-OVA-NPs) were taken up much more efficiently by DCs than OVA alone or its AL-associated form. Both OVA-NPs and OVA+AL were detected in an intracellular lysosome compartment of DCs. Furthermore, the uptake of γ-PGA NPs was inhibited in the presence of pinocytosis and phagocytosis inhibitors. Significantly higher induction of antigen-specific CD8(+) T cells was observed in mice immunized with OVA-carrying γ-PGA NPs than in those immunized with OVA alone, OVA+AL, OVA+3-O-desacyl-4'-monophosphoryl lipid A (MPL), and OVA+AL+MPL. Thus, γ-PGA NPs may have great potential as an effective vaccine carrier and adjuvant for clinical use., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Aims: Recent publications have suggested that cylindrically shaped drug-delivery carriers have an advantage over carriers based on spherical particles in both blood circulation and cell internalization rates. For this reason, this article introduces a method to fabricate hollow, uniform, biodegradable chitosan nano test tubes for applications in drug delivery., Methods: A nanoporous alumina template membrane was used to fabricate hollow chitosan nano test tubes. The chitosan nano test tubes were crosslinked with a disulfide cleavable crosslinker before being removed from the alumina template membrane. We explored two mechanisms for degrading the chitosan nano test tubes--enzymatic degradation by lysozyme and cleavage of the disulfide bond in the crosslinking agent., Results: The template synthesis method resulted in the fabrication of uniform hollow chitosan nano test tubes whose dimensions were easily manipulated based on the dimensions of the pores in the alumina template membrane. The tubes were degraded upon exposure to either lysozyme or sulfhydryl-containing reducing reagents., Conclusion: These tubes have potential for drug-delivery applications. The fact that these tubes degrade upon exposure to a sulfhydryl-containing reducing agent allows for a mechanism for intercellular drug delivery as the tubes should degrade in the presence of intercellular glutathione.