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  • 1
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    Stent-assisted coil embolization of anterior communicating artery aneurysms: safety, effectiveness, and risk factors for procedural complications or recanalization
    BMJ ; 2019
    In:  Journal of NeuroInterventional Surgery Vol. 11, No. 1 ( 2019-01), p. 49-56
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 11, No. 1 ( 2019-01), p. 49-56
    Abstract: Stent-assisted coil (SAC) embolization is an alternative treatment option for anterior communicating artery (AcoA) aneurysms. This study was undertaken to assess the safety and effectiveness of SAC embolization in treating AcoA aneurysms and to determine risk factors for related procedural complications or recanalization. Methods Between August 2008 and December 2016, 184 patients with AcoA aneurysms were treated with SAC embolization. Cumulative medical record and radiologic data were analyzed using binary logistic regression to identify factors predisposing to procedural complications or recanalization. Results Contralateral A1 segment hypoplasia was observed in 59 patients (32.1%). Three types of stents (LVIS, Enterprise, and Neuroform) were variably placed by one of two routes: (1) ipsilateral A1 to ipsilateral A2 (75.5%) or (2) ipsilateral A1 to contralateral A2 (24.5%). Procedural complications occurred in 17 patients (thromboembolism 12; procedural leakage 3; both 2), showing a significant relation to subarachnoid hemorrhage at presentation (OR 57.750; P 〈 0.01). Occlusion was documented immediately after embolization in 130 aneurysms (70.6%) and, in 23 (13.1%) of 175 AcoA aneurysms followed by angiography (median 25.9±18.5 months), recanalization developed (minor, 15; major, 8). Stent configuration (ipsilateral A1 to contralateral A2, P=0.024), maximum aneurysm size ( 〉 7 mm, P 〈 0.01), and A1 segment hypoplasia (P=0.039) were identified as risk factors for recanalization. Conclusion SAC embolization is a safe and effective method of treating unruptured AcoA aneurysms, regardless of anatomic or clinical features. However, in the event of rupture, procedural complications are likely. Stent configuration, aneurysm size, and A1 segment hypoplasia were identified as significant risk factors for recanalization.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/neurintsurg-2018-013943
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 2
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    Selective compromise of hypoplastic posterior communicating artery variants with aneurysms treatable by coil embolization: clinical and radiologic outcomes
    BMJ ; 2019
    In:  Journal of NeuroInterventional Surgery Vol. 11, No. 4 ( 2019-04), p. 373-379
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 11, No. 4 ( 2019-04), p. 373-379
    Abstract: Posterior communicating artery (PcoA) compromise may serve as adjunctive treatment in patients with hypoplastic variants of PcoA who undergo coil embolization of PcoA aneurysms. However, procedural safety and the propensity for later recanalization are still unclear. Objective To evaluate clinical and radiologic outcomes of coil embolization in this setting, focusing on compromise of PcoA. Methods As a retrospective review, we examined 250 patients harboring 291 aneurysms of hypoplastic PcoAs, all consecutively treated by coil embolization between January 2004 and June 2016. PcoA compromise was undertaken in conjunction with 81 of the treated aneurysms (27.8%; incomplete 53; complete 28). Medical records and radiologic data were assessed during extended monitoring. Results During the mean follow-up of 33.9±24.6 months (median 36 months), a total of 107 (36.8%) coiled aneurysms showed recanalization (minor 50; major 57). Recanalization rates were as follows: PcoA preservation 40.5% (85/210); incomplete PcoA occlusion 34.0% (18/53); complete PcoA occlusion 14.3% (4/28). Aneurysms 〉 7 mm (HR 3.40; P 〈 0.01), retreatment for recanalization (HR 3.23; P 〈 0.01), and compromise of PcoA (P 〈 0.01) emerged from multivariate analysis as significant risk factors for recanalization. Compared with PcoA preservation, complete PcoA compromise conferred more favorable outcomes (HR 0.160), whereas incomplete compromise of PcoA fell short of statistical significance. Thromboembolic infarction related to PcoA compromise did not occur in any patient. Conclusion PcoA compromise in conjunction with coil embolization of PcoA aneurysms appears safe in hypoplastic variants of PcoA, helping to prevent recanalization if complete occlusion is achieved.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/neurintsurg-2018-014233
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 3
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    Newly occurring cranial nerve palsy after endovascular treatment of cavernous sinus dural arteriovenous fistulas
    BMJ ; 2019
    In:  Journal of NeuroInterventional Surgery Vol. 11, No. 11 ( 2019-11), p. 1168-1172
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 11, No. 11 ( 2019-11), p. 1168-1172
    Abstract: Cranial nerve palsy (CNP) is rarely reported after endovascular intervention for cavernous sinus dural arteriovenous fistulas (CS DAVFs). Our aim was to evaluate the treatment outcomes of CS DAVFs, and the clinical course and risk factors of newly occurring CNPs, with a review of the literature. Methods 121 patients with 134 lesions treated in our institution were selected. They were retrospectively analyzed in terms of baseline characteristics, radiologic results, clinical outcome, and newly occurring CNPs after treatment. Angiographic and clinical follow-up data were available for 104 lesions (77.6%) and 130 lesions (97.0%), respectively. Results The angiographic results showed partial:complete obliterations in 13:91 (87.5%) at the final follow-up. Clinical outcomes were deteriorated or no change:improved or completely recovered (3:126 (96.9%)) at the final follow-up. New CNPs occurred in 24 patients (19.8%), including the sixth CNP alone or mixed in 23 patients (95.8%). 23 cases were completely recovered or improved (21 and 2 cases, respectively), and 19 (90.4%) of 21 were completely recovered within 6 months after treatment. In the multivariate analysis, pretreatment cranial nerve symptoms (OR=0.33; 95% CI 0.14 to 0.76; P=0.010) and complete obliteration immediately after treatment (OR=0.32; 95% CI 0.12 to 0.85; P=0.021) were significant preventive factors for new CNPs. Embolization in the posterior compartments of the CS (OR=5.15; 95% CI 1.71 to 15.47; P=0.004) was a significant risk factor. Conclusions Endovascular intervention was satisfactory in patients with CS DAVFs. The prognosis of newly occurring CNPs was favorable.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/neurintsurg-2018-014704
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 4
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    Comparative analysis of coil embolization in posterior and anterior communicating artery aneurysms
    BMJ ; 2019
    In:  Journal of NeuroInterventional Surgery Vol. 11, No. 8 ( 2019-08), p. 790-795
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 11, No. 8 ( 2019-08), p. 790-795
    Abstract: Recanalization rates after coil embolization are known to be higher in cerebral aneurysms of the posterior (vs anterior) circulation. Although often grouped with anterior lesions, aneurysms of the posterior communicating artery (PcoA) may nevertheless behave differently. Objective We performed a comparative analysis to explore differences in recanalization rates of PcoA and anterior communicating artery (AcoA) aneurysms, both integral to the circle of Willis. Methods Between October 2012 and July 2017, 699 AcoA (n=427) and PcoA (n=272) aneurysms were treated by endovascular coil embolization, monitoring 667 (95.4%) via radiologic imaging for ≥ 6 months. Cumulative recordings of medical and imaging data were retrospectively reviewed, conducting propensity score matching and binary logistic regression analysis. Results In the 667 aneurysms followed longer term, recanalization occurred in 111 (16.6%; minor 72; major 39) and was significantly more frequent in PcoA (25.5%) than in AcoA (11.0%; P 〈 0.01) aneurysms during similar follow-up periods. After 1:1 propensity score matching, an even greater proclivity for recanalization was evident at PcoA sites (PcoA 23.0%; AcoA 12.2%; P 〈 0.01). Although A1 segment dominance was linked to recanalization in AcoA aneurysms (18.2% vs 7.6%; P=0.01), the PcoA counterpart had no bearing on recanalization (27.7% vs 24.1%; P=0.51). Conclusions Despite a clear preponderance of AcoA aneurysms, recanalization of PcoA aneurysms proved significantly greater, attesting to posterior circulation behavior.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/neurintsurg-2018-014490
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 5
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    Impact of fetal-type posterior cerebral artery on recanalization of posterior communicating artery aneurysms after coil embolization: matched-pair case–control study
    BMJ ; 2020
    In:  Journal of NeuroInterventional Surgery Vol. 12, No. 8 ( 2020-08), p. 783-787
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 12, No. 8 ( 2020-08), p. 783-787
    Abstract: It is well known that hemodynamic stress may impact the recanalization of coiled aneurysms. One of the most common sites for aneurysms to develop is the posterior communicating artery (PcoA), the variants of which are defined by diameter ratios (PcoA/P1 segment). Objective This study was undertaken to investigate the impact of a fetal-type posterior cerebral artery (PCA) on recanalization of PcoA aneurysms after coil embolization based on matched-pair (fetal vs non-fetal PCA) analysis. Methods A total of 480 consecutive PcoA aneurysms (PCA: fetal, n=156; non-fetal, n=324) subjected to coil embolization between January 2007 and June 2017 were selected for study. All lesions were followed for ≥6 months via radiologic imaging, grouped by adjacent PCAs as fetal (PcoA/P1 〉 1) or non-fetal (PcoA/P1 ≤1) type. Paired subjects were matched (1:1) for several relevant variables. Results Of the 480 coiled aneurysms, 159 (33.1%) showed recanalization (minor, 76; major, 83) in the course of follow-up (mean 33.8±21.9 months), developing significantly more often in fetal (37.8%) than in non-fetal (26.9%; p=0.020) PCA types. Once matched, however, 6-month and cumulative recanalization rates did not differ significantly by group (p=0.531 and p=0.568, respectively). Complications (hemorrhage, p=0.97; thromboembolism, p=0.94) during endovascular coil embolization also showed similar rates in these groups. Conclusions The chances of recanalization after coil embolization seem to be greater in PcoA aneurysms than in intracranial aneurysms overall, thus calling for careful follow-up monitoring. Surprisingly, PcoA type appeared unrelated in this regard.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/neurintsurg-2019-015531
    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 6
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    Prospective multicentre randomised clinical trial comparing survival rates, quality of life and nutritional status between advanced gastric cancer patients with different follow-up intensities: study protocol for the STOFOLUP trial
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 12 ( 2021-12), p. e056187-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 12 ( 2021-12), p. e056187-
    Abstract: Patients who underwent curative gastrectomy for gastric cancer are regularly followed-up for the early detection of recurrence and postoperative symptom management. However, there is a lack of evidence with regard to proper surveillance intervals and diagnostic tools. This study aims to evaluate whether frequent surveillance tests have a survival benefit or improve the quality of life in patients who underwent curative resection for advanced gastric cancer. Methods and analysis The STOFOLUP trial is an investigator-initiated, parallel-assigned, multicentre randomised controlled trial involving 16 hospitals in the Republic of Korea. Patients (n=886) diagnosed with pathological stage II or III gastric adenocarcinoma will be randomised to either the 3-month or the 6-month group at a 1:1 ratio, stratified by trial site and tumour stage. Patients allocated to the 3-month group will undergo an abdominal CT scan every 3 months postoperatively and those allocated to the 6-month group will undergo CT every 6 months. The primary endpoint is 3-year overall survival and the secondary endpoints are quality of life, as assessed using KOrean QUality of life in Stomach cancer patients Study group-40, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the stomach cancer-specific module (STO22), and nutritional outcomes. Other survival data including data concerning 3-year disease-free survival, recurrence-free survival, gastric cancer-specific survival and postrecurrence survival will also be estimated. The first patient was enrolled on July 2021 and active patient enrolment is currently underway. Ethics and dissemination This study has been approved by the Institutional Review Board of eight of the participating hospitals (NCC 2021-0085, KBSMC2021-01-059, SMC 2021-01-140, KC21OEDE0082, 4-2021-0281, AJIRB-MED-INT-20-608, 2021-0515 and H-2102-093-1198). This study will be disseminated through peer-reviewed publications, national or international conferences. Trial registration number NCT04740346 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2021-056187
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 7
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    KMBARC registry: protocol for a multicentre observational cohort study on non-cystic fibrosis bronchiectasis in Korea
    BMJ ; 2020
    In:  BMJ Open Vol. 10, No. 1 ( 2020-01), p. e034090-
    Details
    In: BMJ Open, BMJ, Vol. 10, No. 1 ( 2020-01), p. e034090-
    Abstract: Despite the significant disease burden of bronchiectasis in Korea, no large-scale, representative prospective cohort studies have been conducted to evaluate the clinical characteristics of Korean patients with bronchiectasis, indicating an urgent need for cohort studies on bronchiectasis. Methods and analysis The Korean Multicenter Bronchiectasis Audit and Research Collaboration (KMBARC) is a prospective, non-interventional observational cohort study on bronchiectasis in Korea. The inclusion criteria of this registry are as follows: (1) adult patients (aged ≥18 years) with or without respiratory symptoms (cough, chronic sputum and/or recurrent respiratory infection) and chest computed tomography revealing bronchiectasis affecting one or more lobes and (2) stable status at the time of registration: patients with bronchiectasis who were admitted for a respiratory aetiology can be enrolled at least 4 weeks after hospital discharge. The exclusion criteria are as follows: (1) bronchiectasis due to cystic fibrosis; (2) traction bronchiectasis associated with interstitial lung disease; (3) patients actively being treated for pneumonia, pulmonary tuberculosis or non-tuberculous mycobacterial infection; (4) patients who are unable or unwilling to provide informed consent; and (5) pregnant patients. Although the KMBARC questionnaires for baseline and annual follow-up data are similar to the European Multicentre Bronchiectasis Audit and Research Collaboration questionnaires, KMBARC has distinctive features such as use of Bronchiectasis Health Questionnaires, measurement with fatigue and depression scales, blood tests, use of consensus definition of exacerbations and information on emergency room or hospitalisation. We aim to recruit at least 1200 patients over the study period from more than 26 hospitals in South Korea. Patients will undergo a detailed baseline and yearly assessment for up to 5 years. The study objectives of the KMBARC registry are as follows: (1) uncovering the natural course of bronchiectasis; (2) aiding in establishing evidence-based bronchiectasis guidelines in Korea; and (3) encouraging and facilitating studies on bronchiectasis in Korea. Ethics and dissemination This study received necessary approval from the Institutional Review Boards of all participating institutions. The Asan Medical Center Institutional Review Board gave overall approval for the study. Results will be disseminated via peer-reviewed publications and conference presentations. Trial registration number KCT0003088.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-034090
    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 8
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    A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis
    BMJ ; 2017
    In:  Annals of the Rheumatic Diseases Vol. 76, No. 3 ( 2017-03), p. 566-570
    Details
    In: Annals of the Rheumatic Diseases, BMJ, Vol. 76, No. 3 ( 2017-03), p. 566-570
    Abstract: To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents. Methods In this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration–time curve from time zero to last quantifiable concentration (AUC 0–last ) and maximum serum concentration after second infusion (C max ). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24. Results 103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%–125% (AUC 0–last : 97.7% (90% CI 89.2% to 107.0%); C max : 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles. Conclusions CT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety. Trial registration number NCT01534884.
    Type of Medium: Online Resource
    ISSN: 0003-4967 , 1468-2060
    URL: Article
    DOI: 10.1136/annrheumdis-2016-209540
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2017
    detail.hit.zdb_id: 1481557-6
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  • 9
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    Coronary artery bypass graft versus percutaneous coronary intervention in acute heart failure
    BMJ ; 2020
    In:  Heart Vol. 106, No. 1 ( 2020-01), p. 50-57
    Details
    In: Heart, BMJ, Vol. 106, No. 1 ( 2020-01), p. 50-57
    Abstract: Myocardial ischaemia is a leading cause of acute heart failure (AHF). However, optimal revascularisation strategies in AHF are unclear. We aimed to compare two revascularisation strategies, coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI), in patients with AHF. Methods Among 5625 consecutive patients enrolled prospectively in the Korean Acute Heart Failure registry from March 2011 to February 2014, 717 patients who received CABG or PCI during the index hospitalisation for AHF were included in this analysis. We compared adverse outcomes (death, rehospitalisation for HF aggravation or cardiovascular causes, ischaemic stroke and a composite outcome of death and rehospitalisation for HF aggravation or cardiovascular causes) with the use of propensity score matching. Results For the propensity score-matched cohort with 190 patients, CABG had a lower risk of all-cause mortality than PCI (83 vs 147 deaths per 1000 patient-years; HR 0.57, 95% CI 0.34 to 0.96, p=0.033) during the median follow-up of 4 years. There was also a trend towards lower rates of rehospitalisation due to cardiovascular events or HF aggravation. Subgroup analysis revealed that the adverse outcomes were significantly lower in the CABG group than in PCI group, especially in patients with old age, three-vessel diseases, significant proximal left anterior descending artery disease and those without left main vessel disease or chronic total occlusion. Conclusions Compared with PCI, CABG is associated with significant lower all-cause mortality in patients with AHF. Further studies should evaluate proper revascularisation strategies in AHF. Clinical trial registration NCT01389843 ; Results.
    Type of Medium: Online Resource
    ISSN: 1355-6037 , 1468-201X
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/heartjnl-2018-313242
    DOI: 10.1136/heartjnl-2018-313242.supp1
    DOI: 10.1136/heartjnl-2018-313242.supp3
    DOI: 10.1136/heartjnl-2018-313242.supp2
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2378689-9
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  • 10
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    Korean OBEsity Surgical Treatment Study (KOBESS): protocol of a prospective multicentre cohort study on obese patients undergoing laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass
    BMJ ; 2017
    In:  BMJ Open Vol. 7, No. 10 ( 2017-10), p. e018044-
    Details
    In: BMJ Open, BMJ, Vol. 7, No. 10 ( 2017-10), p. e018044-
    Abstract: Bariatric surgery effectively induces long-term weight loss in Western populations. However, its effectiveness in Asians remains to be confirmed objectively. The Korean Society for Metabolic and Bariatric Surgery proposes the first prospective cohort study on Koreans undergoing bariatric surgery. Methods and analysis The Korean OBEsity Surgical treatment Study (KOBESS) is a prospective, multicentre, single-arm, observational, cohort study on morbidly obese patients who undergo primary sleeve gastrectomy or Roux-en-Y gastric bypass in Korea. In total, 100 consecutive obese Asian patients who will undergo bariatric surgery will be recruited in 2016–2017; follow-up will be for 1 year. Primary outcomes are change in body weight and waist circumference at 1 year. All patients will undergo anthropometry, laboratory tests, bioelectrical impedance analysis, gastrofibroscopy, polysomnography and fat-measuring CT before and after surgery. Patients with diabetes will also undergo perioperative oral glucose tolerance and endocrinological hormone tests. Hypertensive patients will also undergo perioperative echocardiography and carotid Doppler ultrasonography. Female patients suspected of having polycystic ovarian syndrome will also undergo perioperative hormone tests and abdominal ultrasonography. Visceral and subcutaneous fat will be harvested during surgery. Blood, stool and urine samples will be taken at various perioperative time points. Although the cohort is small and the follow-up duration is relatively short, this study will determine whether bariatric surgery induces satisfactory weight loss in obese Koreans. Significantly, the tissue samples will also facilitate many studies examining the effects of bariatric surgery and their mechanisms. Ethics and dissemination Ethics approval was obtained from the institutional review board of each participating hospital. All findings arising from this cohort study will be published in open-access peer-reviewed journals and will be presented at national and international meetings. All KOBESS investigators will be able to propose research studies and potential publications based on KOBESS data and tissue samples. Trial registration number NCT03100292 ; Pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2017-018044
    Language: English
    Publisher: BMJ
    Publication Date: 2017
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