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Purpose: During surgical resection of malignant tumors in the hepatobiliary pancreatic region, portal vein resection and reconstruction may be needed. However, there is no alternative to the portal vein. We therefore developed an artificial portal vein that could be used in the abdominal cavity. Methods: In the experiments, hybrid pigs (n = 8) were included. An artificial portal vein was created using a bioabsorbable polymer sheet (BAPS). Subsequently, the portal vein's anterior wall was excised into an elliptical shape. A BAPS in the form of a patch was implanted at the same site. At 2 weeks (n = 3) and 3 months (n = 5) after the implantation, the BAPS implantation site was resected and evaluated macroscopically and histopathologically. Results: Immediately after the implantation, blood leakage was not detected. Two weeks after implantation, the BAPS remained, and endothelial cells were observed. Thrombus formation was not observed. Three months after implantation, the BAPS had been completely absorbed and was indistinguishable from the surrounding portal vein. Stenosis and aneurysms were not observed. Conclusions: BAPS can replace a defective portal vein from the early stage of implantation to BAPS absorption. These results suggest that it can be an alternative material to the portal vein in surgical reconstruction. [ABSTRACT FROM AUTHOR]

Background: The ideal drug-eluting stent (DES) for the treatment of unprotected left main coronary artery (ULMCA) is unknown. We compared percutaneous coronary intervention (PCI) using durable polymers versus early-generation, thicker strutted and coated bioabsorbable polymers for ULMCA disease.Methods: Patients who underwent ULMCA PCI (893 patients) from April 2008 to November 2014 were identified from the Grand-DES registry. The primary end point was 3-year target lesion failure (TLF) after propensity score matching.Results: The final analysis included 754 patients (84.4%) and 139 patients (15.6%) in the durable and bioabsorbable polymer group, respectively. The groups differed significantly in lesion and procedural characteristics. Propensity score-matched analysis revealed a trend toward a lower 3-year TLF in the durable polymer group (log rank p=0.071). Independent predictors of 3-year TLF were chronic kidney disease, presentation with acute myocardial infarction, and a two-stenting technique for ULMCA lesions. Definite/probable stent thrombosis rates at 3-years were low in both groups (0.8% vs. 0.7%, p=0.925).Conclusions: The safety of ULCMA PCI was excellent, and durable and bioabsorbable polymer DES provided similar clinical outcomes at 3-year follow-up. Landmark analysis revealed that the durable polymer group had a lower TLF rate from 9 months. Further studies are needed to confirm these results. [ABSTRACT FROM AUTHOR]

Objective: In the past five decades, many small caliber vascular grafts have been developed as bypasses for infrapopliteal or coronary arteries. However, reliable grafts have not been obtained owing to poor patency, mainly caused by early thrombosis or neointimal hyperplasia in the intermediate period after implantation. We developed a novel small caliber heparin-loaded polyethylene terephthalate ultrafine microfiber (HL-PET) graft and evaluated the feasibility to overcome those main causes of graft failure in canine carotid artery implantation. Methods: The HL-PET graft with a diameter of 3 mm and length of 30 mm was made with combination of three key technologies: (1) weaving with PET ultrafine microfiber with a high biological porosity allowing for cell ingrowth, (2) heparin loading on microfiber surfaces, and (3) an outer coating with a flexible bioabsorbable polymer for prevention of blood leakage and graft kinking. Kink resistance, water permeability, and loaded heparin were assessed. One HL-PET graft each was implanted into a carotid artery of six animals. Graft patency rate and healing were assessed 24 weeks after implantation. Results: Among the six grafts, five were deemed patent (patency rate of >83%), with one occluded 20 weeks after implantation. Histopathology of the patent grafts showed neointima formation with confluent endothelial cell lining (estimated mean endothelial cell coverage area, 89 ± 18%). Intimal hyperplasia at the anastomotic sites and severe chronic inflammatory responses were not observed. Immunohistochemistry with antibodies to endothelial nitric oxide synthase, alpha 2 smooth muscle actin and calponin 1 revealed luminal surface endothelial cell layer with expression of endothelial nitric oxide synthase and vascular smooth muscle cells with contractile phenotype in the subintimal layer. Conclusions: The HL-PET graft showed no early postoperative thrombosis and was able to demonstrate a high patency rate with no severe biological response observed after 24 weeks. These results strongly suggest the potential of the HL-PET graft to be used for distal bypasses. : Clinical Relevance: The HL-PET graft achieved a high patency rate without early postoperative thrombosis or intimal hyperplasia in a small caliber artery implantation study. The histopathologic analysis demonstrated favorable healing property with a high antithrombogenicity. These results strongly suggested the possible use of the HL-PET graft as a bypass for infrapopliteal or coronary arteries.

The comparison of bioabsorbable-polymer and durable-polymer stents has continued to be debated, and there is ongoing concern regarding vascular healing and late stent thrombosis. This study compared the vascular healing at 8-month follow-up by optical coherence tomography (OCT) between 4 different kinds of new generation drug-eluting stents (DESs). We enrolled 112 patients (112 de novo lesions) who underwent OCT guided percutaneous coronary intervention with 4 kinds of new generation DESs including bioabsorbable-polymer everolimus-eluting stents (BP-EESs), bioabsorbable-polymer sirolimus-eluting stents (BP-SESs), durable-polymer everolimus-eluting stents (DP-EESs), and durable-polymer zotarolimus-eluting stents (DP-ZESs) and an 8-month follow-up angiogram and OCT were performed between July 2016 and April 2018. We divided them into two groups, namely BP and DP groups. We compared the OCT parameters including the percentage of uncovered struts, malapposed struts and the mean neointimal hyperplasia (NIH) thickness between the two groups. BP group consisted of 51 lesions (BP-EESs were used in 27, BP-SESs in 24 lesions) and DP group consisted of 61 lesions (DP-EESs were used in 35 and DP-ZESs in 26 lesions). The percentage of uncovered struts and malapposed struts were significantly lower (7.2 ± 8.9 vs. 15.0 ± 17.1%, p = 0.01, 0.9 ± 1.7 vs. 2.7 ± 5.2%, p = 0.03) and the mean NIH thickness was significantly thicker in BP group than DP group (112 ± 54 vs. 83 ± 31 µm, p < 0.01). The present OCT study demonstrated that uncovered struts and malapposed struts were less common with bioabsorbable-polymer stents than with durable-polymer stents. [ABSTRACT FROM AUTHOR]

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. View large Download slide View large Download slide [ABSTRACT FROM AUTHOR]

Introduction: The biodegradable polymer drug-eluting stents were developed to improve vascular healing. However, further data are needed to confirm the safety and efficacy of these stents in patients with acute myocardial infarction (AMI). Aim: We sought to determine the 1-year clinical follow-up in patients with AMI treated with a thin strut biodegradable polymer-coated sirolimus-eluting stent (BP-SES) versus a durable coating everolimus-eluting stent (DP-EES). Material and methods: We analyzed patients with AMI (STEMI and NSTEMI) treated with either a BP-SES (ALEX, Balton, Poland, n = 886) or DP-EES (XIENCE, Abbott, USA, n = 1054) with available 1-year clinical follow-up using propensity score matching. Outcomes included target vessel revascularization (TVR) as the efficacy outcome and all-cause death, myocardial infarction, and definite/probable stent thrombosis as safety outcomes. Results: After propensity score matching 672 patients treated with BP-SES and 672 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between the groups. In-hospital mortality was similar in both tested groups. Oneyear follow-up demonstrated comparable efficacy outcome TVR (BP-SES 7.1% vs. DP-EES 5.2%, p = 0.14), as well as similar safety outcomes of all-cause death, myocardial infarction, and definite/probable stent thrombosis. Conclusions: The thin-strut biodegradable polymer coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1 year after implantation to the DP-EES. These data support the relative safety and efficacy of BP-SES in AMI patients undergoing percutaneous coronary intervention. [ABSTRACT FROM AUTHOR]

The use of polymeric bioresorbable type devices as fracture repairs is becoming increasingly common, in part due to the great advantages that they present compared with metal implants in not requiring a second surgery for removal. Pins of poly(L-co-D,L lactide-co-trimethylene carbonate acid), PLDLA-TMC containing 30% TMC were obtained and characterized by in vitro and in vivo study, targeting them for use as fracture devices. Pins 2.5 mm in diameter were obtained by melting the polymer and immersing it in phosphate buffer, pH 7.4 at 37 °C to study the in vitro degradation, in addition to being implanted in the tibia of Wistar rats to assess the bone formation after 15, 60, 90, 120, and 150 days. The results from this study showed that for PLDLA-TMC pins, the thermal, mechanical, and morphological properties remained essentially unchanged after 90 days, particularly the glass transition temperature, Young’s modulus, maximum stress in stretching, and mass loss, in spite of the sharp change in molar mass at the beginning of the degradation process. These results corroborate the in vivo study, which showed the occurrence of bone formation in the early days, especially at 60 and 90 days, and the implant group, in general, presented a more mature and organized bone formation, with less fibrosis than the control group. This set of results indicates that the material has the potential to be applied as a device for the recovery of bone lesions in situations where the permanence of the implant over a long period is essential. [ABSTRACT FROM AUTHOR]

Introduction: The implications of novel drug-eluting stent (DES) design modifications including ultra-thin struts and new concepts of polymer coating for procedural efficacy are still unknown. Aim: To evaluate procedural efficacy and short-term safety of a novel DES design. Material and methods: In this all-comers registry, 407 consecutive patients were enrolled upon undergoing percutaneous coronary interventions (PCI) with the thin-strut bioabsorbable abluminal polymer-coated SYNERGY stent. These patients were then compared with the previous 407 patients undergoing PCI performed by the same interventionalists using currently established second- generation DES (Promus Element plus, Xience prime, Resolute Integrity). Several clinical and procedural data were compared, and the coronary artery complexity was assessed by the American College of Cardiology/American Heart Association classification and SYNTAX Score. Results: The study population consisted of 814 patients. A total of 859 Synergy stents were deployed in 480 target vessels in the Synergy group (n = 407), and 904 stents in 469 vessels in the second-generation DES group (n = 407). Coincidentally, target lesions in the Synergy group (A 2.7%, B1 13.8%, B2 38.6%, C 45.0%) were more complex (p < 0.01) than those in the second-generation DES group (A 4.9%, B1 18.7%, B2 42.3%, C 34.2%). In cases with severe lesions (B2/C), the median contrast agent amount and fluoroscopy time were significantly lower in the Synergy group, indicating improved deliverability (110 ml vs. 150 ml; p < 0.01 and 7.2 min vs. 9.1 min; p = 0.01). Rates of in-hospital major adverse cardiovascular events were comparable between the two groups. Conclusions: In an all-comers, real-world PCI population, novel stent design modifications including ultra-thin struts and abluminal bioabsorbable polymer coating are associated with improved procedural performance. [ABSTRACT FROM AUTHOR]

Introduction: Numerous important cardiology clinical trials have been published or presented at major international meetings during 2017. This paper aims to summarize these trials and place them in clinical context.Methods: The authors reviewed clinical trials presented at major cardiology conferences during 2017 including the American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, European Society of Cardiology, European Association for the Study of Diabetes, Transcatheter Cardiovascular Therapeutics, and the American Heart Association. Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice.Results: A total of 75 key cardiology clinical trials were identified for inclusion. New interventional and structural cardiology data include left main bifurcation treatment strategy, multivessel disease management in cardiogenic shock, drug-eluting balloons for in-stent restenosis, instantaneous wave-free physiological assessment, new-generation stents (COMBO, Orsiro), transcatheter aortic valve implantation, and closure devices. New preventative cardiology data include trials of liraglutide, empagliflozin, PCSK9 inhibitors (evolocumab and bococizumab), inclisiran, and anacetrapib. Antiplatelet data include the role of uninterrupted aspirin therapy during non-cardiac surgery and dual antiplatelet therapy following coronary artery bypass grafting. New data are also included from fields of heart failure (levosimendan, spironolactone), atrial fibrillation (apixaban in DC cardioversion), cardiac devices (closed loop stimulation pacing for neuromediated syncope), and electrophysiology (catheter ablation for atrial fibrillation).Conclusion: This paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers. [ABSTRACT FROM AUTHOR]

Introduction: The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016.Methods: The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice.Results: A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter defibrillator in non-ischemic cardiomyopathy), and electrophysiology (cryoballoon vs radiofrequency ablation).Conclusion: This paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers. [ABSTRACT FROM AUTHOR]

Objectives To assess safety and clinical performance of a novel bioabsorbable vascular graft in pediatric patients with univentricular cardiac malformation who received surgical correction via an extracardiac cavopulmonary conduit. Methods The implanted graft material is designed to attract patient's own cells and proteins, which trigger a cascade of physiological events leading to endogenous tissue restoration. As the graft resorbs progressively after implantation, components of native tissue including collagen, endothelial lining, and capillary blood vessels develop and organize into a natural tissue. Five patients (aged 4-12 years) received this new vascular graft as interposition between the inferior vena cava and the pulmonary artery. They were followed up to 12 months after surgery. The conduit was assessed by echocardiography, computed tomography and magnetic resonance imaging, including 4-dimensional flow. Results All patients recovered from the procedure without complications. No device-related adverse events were reported. Two patients required interventional occlusion of aortopulmonary collaterals. At 12 months, there was a significant improvement in the patients' general condition. Imaging studies demonstrated anatomical (conduit diameter, length and wall thickness) and functional (blood flow pattern) stability of the bioabsorbable grafts in all patients with no significant changes at 12 months compared with early postoperative data. Conclusions Initial clinical experience with a novel absorbable graft underlines the potential of this new material to improve cardiac and vascular surgical procedures. In addition, better biocompatibility may reduce permanent implant-related complications. A longer follow-up is needed to assess the long-term effectiveness of biodegradable vascular grafts, including their ability to grow. [ABSTRACT FROM AUTHOR]

Percutaneous coronary interventions will never become obsolete, as evolution is inherent to interventional cardiology. Current drug-eluting platforms have appreciably improved their safety and efficacy profiles in different clinical settings compared to first-generation devices such that it is difficult to consider other alternatives. However, there is definite biological plausibility to consider devices with bioabsorbable polymers and/or scaffolds. It is also an undeniable fact that many patients, based on variety of belief systems, would prefer not to have a permanently implanted device. BP DES with or without bioresorbable scaffolds offer advantages over durable polymer DES in restoring normal coronary physiology and vascular adaptive responses, resulting in late lumen gain and plaque regression. They will likely allow flexibility in treating complex CAD. However, so far, we have been able to prove non-inferiority in a selected population of patients without long-term data. Is 'as good as' good enough? Are we ready to reach for the BRS or a BP DES in our catheterization laboratory based on preclinical and mechanistic data (endothelialization, OCT imaging, vasomotion) with limited human experience? I am not. While I will maximize my efforts to recruit patients in related randomized controlled trials, the technology is not ready for prime time. Randomized controlled trials are needed to determine whether any or all of these devices improve long-term outcome compared to best in class DP DES. Most definitive evidence is likely about a decade away. Until then, we can learn to be disciplined implanters not only in selecting the appropriate patient but also in perfecting implantation techniques [ABSTRACT FROM AUTHOR]

Introduction: Multiple significant, potentially practice changing clinical trials in cardiology have been conducted and subsequently presented throughout the past year. Methods: In this paper, the authors have reviewed and contextualized significant cardiovascular clinical trials presented at major international conferences of 2015 including American College of Cardiology, European Association for Percutaneous Cardiovascular Interventions, American Diabetes Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, Heart Rhythm Congress, and the American Heart Association Scientific Sessions. Results: The authors describe new trial data for heart failure (including eplerenone, finerenone, patiromer, sacubitril/valsartan, the beta 3 agonist mirabegron, sitagliptin, empagliflozin, alginate-hydrogel LV epicardial implant), anticoagulation (idarucizumab and andexanet alfa reversal agents, adherence programmes, practice in ablation), transcatheter aortic valve replacement (long-term data, valve-in-valve use, the TriGuard embolic deflecting device), patent foramen ovale closure, cardiovascular prevention (PCSK9 inhibitors, hypertension treatment) and antiplatelets strategies (extended duration therapy with clopidogrel or ticagrelor). Trial data are also described for contemporary technologies including the Biofreedom polymer-free drug coated stent, bioabsorbable stents, PCI strategies, left main treatment, atrial fibrillation ablation techniques, leadless pacemakers and the role of coronary computed tomographic angiography. Conclusions: This paper summarizes and contextualizes multiple pertinent 2015 clinical trials and will be of interest to both clinicians and cardiology researchers. [ABSTRACT FROM AUTHOR]

Using a large animal model, we examined whether circumferential stricture after esophageal endoscopic submucosal dissection (ESD) can be treated by grafting a bioabsorbable esophageal patch. Circumferential ESD was performed on the thoracic esophagus in pigs (n = 6) to create a stricture, for which one of the following interventions was performed: (1) the stricture site was longitudinally incised, and an artificial esophageal wall (AEW) was grafted after placing a bioabsorbable stent (AEW patch group, n = 3); (2) endoscopic balloon dilation (EBD) was performed every other week after stricture development (EBD group, n = 3). In both groups, esophageal fluoroscopy was performed 8 weeks after the interventions, and the esophagus was excised for histological examination of the patched site. In the AEW patch group, esophageal fluoroscopy revealed favorable passage through the patched site. Histologically, the mucosal epithelium and lamina propria had regenerated as in the normal area. In the EBD group, the circumferential stricture site showed marked thickening, and there were hypertrophic scars associated with epithelial defects on the luminal surface. Histologically, defects of the mucosal epithelium and full-thickness proliferation of connective tissue were observed. AEW patch grafting was suggested to be a potentially novel treatment strategy for post-ESD esophageal circumferential stricture. [ABSTRACT FROM AUTHOR]

Purpose: We studied the incidence of postoperative glenoid rim fractures and analysed the relationships of glenoid rim fracture with osteolysis, fracture pattern, number of anchors and postoperative activity after arthroscopic Bankart repair with suture anchor fixation. Methods: Among 570 patients of the Bankart repair group, nine patients who had undergone revision arthroscopy for glenoid rim fracture after initial Bankart repair with at least two years post-revision follow-up were enrolled. Mean age was 28.8 years (range, 18-49 years), and mean follow-up was 36.4 months (range, 25-64 months). The mean time from Bankart repair to failure of initial surgery following trauma was 27.3 months (range, four to-84 months). Initial suture anchors were made of bioabsorbable composites (poly- d- l-lactic acid, PDLLA) without ceramic osteo-filler (seven cases) and metals (two cases). PDLLA without ceramic osteo-filler suture anchors were used for revision surgery. We reviewed 570 patients for relationship between osteolysis and glenoid rim fracture. Results: Five patients including three and two with bioabsorbable and metal suture anchors, respectively, experienced glenoid rim fracture at more than two years postoperatively. Osteolysis around initial suture anchors groups showed higher glenoid rim fracture incidence compared with the control group (odd ratio =4.186 [95 % CI, 1.108-15.818]; p = 0.037). Conclusions: Osteolysis related to insertion of metal or PLDDA suture anchors may lead to glenoid rim fracture. Remnant metal or bioabsorbable suture anchors without ceramic composite could be a stress riser at two years postoperatively. [ABSTRACT FROM AUTHOR]

Biliodigestive anastomosis between the extrahepatic bile duct and the intestine for bile duct disease is a gastrointestinal reconstruction that abolishes duodenal papilla function and frequently causes retrograde cholangitis. This chronic inflammation can cause liver dysfunction, liver abscess, and even bile duct cancer. Although research has been conducted for over 100 years to directly repair bile duct defects with alternatives, no bile duct substitute (BDS) has been developed. This narrative review confirms our understanding of why bile duct alternatives have not been developed and explains the clinical applicability of BDSs in the near future. We searched the PubMed electronic database to identify studies conducted to develop BDSs until December 2021 and identified studies in English. Two independent reviewers reviewed studies on large animals with 8 or more cases. Four types of BDSs prevail: Autologous tissue, non-bioabsorbable material, bioabsorbable material, and others (decellularized tissue, 3D-printed structures, etc. ). In most studies, BDSs failed due to obstruction of the lumen or stenosis of the anastomosis with the native bile duct. BDS has not been developed primarily because control of bile duct wound healing and regeneration has not been elucidated. A BDS expected to be clinically applied in the near future incorporates a bioabsorbable material that allows for regeneration of the bile duct outside the BDS., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.)

Purpose: Earlier studies have investigated the suitability of various materials and autologous grafts for the repair of diaphragmatic defects. Our group investigated the feasibility of using an artificial diaphragm (AD) to repair wide diaphragmatic defects. Methods: Twelve pigs were laparotomized and, in each pig, a defect was fashioned by resecting a round 8-cm diameter hole in the left diaphragm. Next, the defect was repaired by implanting an AD. The animals were relaparotomized 8 or 24 weeks after implantation for gross, histological and radiological observation of the implanted sites. Results: All recipient animals survived until killing for evaluation. Chest X-ray examinations showed no differences between the preoperative diaphragms and the grafted diaphragms at 8 and 24 weeks after implantation. At 8 weeks after implantation, the implanted sites exhibited fibrous adhesions to the liver and lungs without deformities or penetrations. Parts of the surface tissue at the graft sites had a varnished appearance similar to those of the native diaphragm. Histology performed at 8 weeks detected no trace of the ADs in the graft sites; however, numerous inflammatory cells and profuse fibrous connective tissue were observed. At 24 weeks after implantation, no differences were found in the thorax between the areas with the grafts and the unaffected areas. Histology of the graft sites in the thorax confirmed growth of mesothelial cells similar to that observed in the native diaphragm. Conclusions: Artificial diaphragms can be a novel substitute for diaphragmatic repair. [ABSTRACT FROM AUTHOR]

Abstract: Background: Pancreatoenteric reconstruction often induces severe complications. Although many techniques have been developed to prevent these complications, no standard technique has yet emerged. We developed a novel technique, sutureless pancreatoenteric anastomosis, that uses a bioabsorbable polymer sheet (BAPS) and biocompatible bond (BCB) to prevent the complications associated with pancreatoenteric anastomosis. We used large animals to investigate whether this technique is suitable for clinical use. Materials and methods: Six pigs were laparotomized under general anesthesia. The body of the pancreas was divided, and the proximal stump was closed by suture. A BAPS coated with BCB was rolled and fixed around the distal pancreatic stump to form a cylinder that was anastomosed to the duodenum without suturing the pancreas. Twenty weeks after the initial operation the operated sites were extirpated and evaluated grossly and histologically. Results: All operated pigs survived without pancreatic juice leakage until they were killed. At 20 wk, the BAPS could not be identified. The pancreatic stump was tightly affixed to the duodenum. Histologic study revealed that the pancreatic stump and duodenal wall were continuous and the main pancreatic duct opened into the lumen of the duodenum. Conclusions: Sutureless pancreatoenterostomy with BAPS and BCB may be clinically feasible. [Copyright &y& Elsevier]

Multiple key cardiology trials with the potential to change practice or advance understanding have been presented over the past 12 months at international meetings, including the American College of Cardiology (ACC, Chicago, USA, March 2012), European Association for Percutaneous Cardiovascular Interventions (EuroPCR, Paris, France, May 2012), European Society of Cardiology (ESC, Munich, Germany, August 2012), Transcatheter Cardiovascular Therapeutics (TCT, Miami, USA, October 2012), and the American Heart Association (AHA, Los Angeles, USA, November 2012). In this paper, the authors describe and place in clinical context new acute coronary syndrome data, including use of oral antiplatelets and anticoagulants (prasugrel, rivaroxaban, vorapaxar), personalized antiplatelet therapy guided by platelet aggregometry, glucose-insulin-potassium infusion, and changing trends in myocardial infarction. New trial data are also described for interventional cardiology (revascularization in multivessel disease, fractional flow reserveguided intervention, radial access, bioabsorbable polymer stents, drug-eluting balloons, intraaortic balloon pump use, transcatheter aortic valve implantation), in heart failure (copeptin, angiotensin receptor neprilysin inhibition, aldosterone blockade in diastolic heart failure, biventricular pacing), atrial fibrillation (surgical ablation, antithrombotic strategy after stenting), implantable defibrillator use, and in prevention (renal denervation in hypertension, dalcetrapib, lomitapide, proprotein convertase subtilisin/kexin type 9 in dyslipidemia, insulin glargine/fish oils, and bariatric surgery in diabetes). [ABSTRACT FROM AUTHOR]

Objectives: This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.). Background: Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy. Methods: A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography. Results: The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference −0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference −0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months. Conclusions: The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225) [Copyright &y& Elsevier]

Background: Thus far, no ideal substitutions have been developed for completely replacing the extrahepatic bile duct (EHBD). Methods: We used a bioabsorbable polymer tube (BAPT) for the complete reconstruction of an EHBD in pigs. A 2-cm-long EHBD was resected from the duodenal side, and a 4-cm-long BAPT graft was implanted at that site. The animals were re-laparotomized at 1 or 4 months after the grafting; subsequently, gross, histological, and blood chemical studies were performed. Results: At 1 month after grafting, tubular structure was observed in all resected specimens, and the lumen of the graft site had remnants of degraded BAPT. Gross examination at 4 months after grafting revealed that the BAPT had been completely absorbed, and the graft site was indistinguishable from the native extrahepatic bile duct. The lengths of the graft region at 4 months were 70% of the replaced BAPT. Simultaneously performed histological examination revealed the growth of a neo-bile duct at the graft site, with an epithelium identical to that of the native bile duct. Conclusion: The BAPT graft implanted in this study completely replaced the EHBD defect. Hence, BAPT has the potential for application as a novel treatment modality for hepatobiliary diseases. [ABSTRACT FROM AUTHOR]