The 2010s in clinical drug-eluting stent and bioresorbable scaffold research: a Dutch perspective.

Dutch researchers were among the first to perform clinical studies in bare metal coronary stents, the use of which was initially limited by a high incidence of in-stent restenosis. This problem was greatly solved by the introduction of drug-eluting stents (DES). Nevertheless, enthusiasm about first-generation DES was subdued by discussions about a higher risk of very-late stent thrombosis and mortality, which stimulated the development, refinement, and rapid adoption of new DES with more biocompatible durable polymer coatings, biodegradable polymer coatings, or no coating at all. In terms of clinical DES research, the 2010s were characterised by numerous large-scale randomised trials in all-comers and patients with minimal exclusion criteria. Bioresorbable scaffolds (BRS) were developed and investigated. The Igaki-Tamai scaffold without drug elution was clinically tested in the Netherlands in 1999, followed by an everolimus-eluting BRS (Absorb) which showed favourable imaging and clinical results. Afterwards, multiple clinical trials comparing Absorb and its metallic counterpart were performed, revealing an increased rate of scaffold thrombosis during follow-up. Based on these studies, the commercialisation of the device was subsequently halted. Novel technologies are being developed to overcome shortcomings of first-generation BRS. In this narrative review, we look back on numerous devices and on the DES and BRS trials reported by Dutch researchers.

Determination of contrast medium dose for hepatic CT enhancement with improved body size dependency using a non-linear analysis based on pharmacokinetic principles.

AIM: To propose a pharmacokinetic non-linear analysis method to determine contrast medium (CM) dose for computed tomography (CT) hepatic enhancement to improve body size dependency and validate the proposed CM dose determination method through a clinical study. MATERIALS AND METHODS: Enhancement data of 105 patients who underwent hepatic dynamic CT with a fixed CM dose were analysed. From the analysis results, CM doses as a function of each of four body size indices (body weight [BW], lean body weight [LBW], blood volume [BV], and body surface area [BSA]) for achieving improved body size dependency were determined (proposed method), and the body size dependencies were simulated using the enhancement data from 105 patients. The proposed method was validated with a two-arm clinical study on BW. Body size dependency was evaluated using p-value of correlation coefficient between Body size indices and enhancements (p<0.05: significant dependency) and mean absolute error (MAE). RESULTS: The simulation showed that significant body size dependencies not considered by the conventional method can be improved by the proposed method. MAEs of BW, LBW, and BV were also significantly reduced (p<0.05). The clinical study with BW demonstrated a similar improvement to that in the simulation result. MAE was also significantly reduced (p<0.001). CONCLUSION: The proposed method demonstrated more improved BW, LBW, and BV dependence compared to the conventional method. Through the two-arm clinical study, the proposed method using BW only, without height information, is a suitable index for improving body size dependency.

Long-term outcomes of an extracorporeal irradiated autograft for limb salvage operations in musculoskeletal tumours: over ten years' observation.

AIMS: We analyzed the long-term outcomes of patients observed over ten years after resection en bloc and reconstruction with extracorporeal irradiated autografts. PATIENTS AND METHODS: This retrospective study included 27 patients who underwent resection en bloc and reimplantation of an extracorporeal irradiated autograft. The mean patient age and follow-up period were 31.7 years (9 to 59) and 16.6 years (10.3 to 24.3), respectively. The most common diagnosis was osteosarcoma (n = 10), followed by chondrosarcoma (n = 6). The femur (n = 13) was the most frequently involved site, followed by the tibia (n = 7). There were inlay grafts in five patients, intercalary grafts in 15 patients, and osteoarticular grafts in seven patients. Functional outcome was evaluated with the Musculoskeletal Tumor Society (MSTS) scoring system. RESULTS: There were no recurrences in the irradiated autograft and the autograft survived in 24 patients (88.9%). Major complications included nonunion (n = 9), subchondral bone collapse (n = 4), and deep infection (n = 4). Although 34 revision procedures were performed, 25 (73.5%) and four (11.8%) of these were performed less than five years and ten years after the initial surgery, respectively. The mean MSTS score at the last follow-up was 84.3% (33% to 100%). CONCLUSION: Considering long-term outcomes, extracorporeal irradiated autograft is an effective method of reconstruction for malignant musculoskeletal tumours Cite this article: Bone Joint J 2019;101-B:1151-1159.

Efficacy of macrolides on gastric motility in extremely low birth weight infants.

BACKGROUND: The efficacy of macrolide treatment on gastrointestinal motility and acquirement of feeding tolerance in extremely low birth weight (ELBW) infants are controversial. This study aimed to evaluate clinical effects of parenterally administered erythromycin (EM) and clarithromycin (CAM) on gastrointestinal motility in ELBW infants. METHODS: ELBW infants treated in Tokyo Medical University Hospital were retrospectively studied. Several outcomes of ELBW infants treated with EM or CAM were compared with those recognized before initiation of the medication, as well as with those of patients with no macrolide treatment. The primary outcomes included average gastric residual volume that was evaluated 3 hours after enteral feeding. Secondary outcomes were the number of patients who developed feeding intolerance, stool frequency, and other adverse events, such as respiratory comorbidities and pyloric stenosis. RESULTS: Among a total of 53 infants, 20 and 13 were treated with EM and CAM, respectively, whereas 20 infants were not administered macrolides. The gastric residual volume was significantly decreased after initiation of medication compared with before medication in the EM group, whereas that of the untreated group showed no change. When the EM and CAM groups were combined, the gastric residual volume was also significantly decreased after treatment compared with before treatment. An increase in stool frequency and pyloric stenosis were not observed in the groups. CONCLUSION: EM might be effective for acquiring feeding tolerance in ELBW infants. A future prospective study with a larger population is required to determine the efficacy of CAM.

Considerable Risk of Restenosis After Endoscopic Treatment for Hepaticojejunostomy Stricture After Living-Donor Liver Transplantation.

BACKGROUND: There are few reports on the short- and long-term follow-up of endoscopic retrograde cholangiography (ERC) in adult patients with hepaticojejunostomy (HJS) stricture after living-donor liver transplantation (LDLT). METHODS: Nine LDLT recipients underwent ERC with the use of double-balloon endoscopy (DBE) for HJS stricture at Nagoya University Hospital. We assessed the rate of reaching biliary anastomosis, procedure success rate, procedure duration, complications, improvement in liver function test results, and biliary anastomosis patency. RESULTS: In total, 19 ERC procedures with the use of DBE were performed for 9 adult LDLT recipients with HJS stricture from June 2006 to September 2014. Balloon dilation with the use of DBE was successfully performed in 5 of the 9 patients during the 1st procedure. Of the 4 patients in whom DBE-ERC failed to be completed, 3 patients underwent 2nd procedures successfully. Liver function test results were significantly improved in the successful cases. Four patients underwent 2nd DBE-ERC for stricture recurrence at a mean time of 2.3 years after the 1st successful procedure. Of those, 2 patients required 3rd procedures for stricture recurrence after the 2nd procedure. CONCLUSIONS: DBE-ERC is promising as a treatment for HJS stricture in adult LDLT recipients in the short term. However, the DBE-ERC procedure may have a considerable risk of restenosis.