1.Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation–Positive Non–Small Cell Lung Cancer
Jang Ho LEE ; Eun Young KIM ; Cheol-Kyu PARK ; Shin Yup LEE ; Min ki LEE ; Seong-Hoon YOON ; Jeong Eun LEE ; Sang Hoon LEE ; Seung Joon KIM ; Sung Yong LEE ; Jun Hyeok LIM ; Tae-Won JANG ; Seung Hun JANG ; Kye Young LEE ; Seung Hyeun LEE ; Sei Hoon YANG ; Dong Won PARK ; Chan Kwon PARK ; Hye Seon KANG ; Chang Dong YEO ; Chang-Min CHOI ; Jae Cheol LEE
Cancer Research and Treatment 2023;55(1):112-122
Purpose:
Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (EGFR) T790M mutation–positive non–small cell lung cancer, real-world evidence on the efficacy of osimertinib is not enough to reflect the complexity of the entire course of treatment. Herein, we report on the use of osimertinib in patients with EGFR T790M mutation–positive non–small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor (TKI) treatment in Korea.
Materials and Methods:
Patients with confirmed EGFR T790M after disease progression of prior EGFR-TKI were enrolled and administered osimertinib 80 mg daily. The primary effectiveness outcome was progression-free survival, with time-to-treatment discontinuation, treatment and adverse effects leading to treatment discontinuation, and overall survival being the secondary endpoints.
Results:
A total of 558 individuals were enrolled, and 55.2% had investigator-assessed responses. The median progression-free survival was 14.2 months (95% confidence interval [CI], 13.0 to 16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1 to 15.9). The median overall survival was 36.7 months (95% CI, 30.9 to not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary EGFR mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma EGFR T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten patients (1.8%), including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.
Conclusion
Osimertinib demonstrated its clinical effectiveness and survival benefit for EGFR T790M mutation–positive in Korean patients with no new safety signals.
2.Optimal Duration of Dual Antiplatelet Therapy after Stent- Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial
Seung Pil BAN ; O-Ki KWON ; Young Deok KIM ; Bum-Tae KIM ; Jae Sang OH ; Kang Min KIM ; Chang Hyeun KIM ; Chang-Hyun KIM ; Jai Ho CHOI ; Young Woo KIM ; Yong Cheol LIM ; Hyoung Soo BYOUN ; Sukh Que PARK ; Joonho CHUNG ; Keun Young PARK ; Jung Cheol PARK ; Hyon-Jo KWON ;
Journal of Korean Neurosurgical Society 2022;65(6):765-771
Objective:
: Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and shortterm dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs).
Methods:
: This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (longterm group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 topperforming, high-volume Korean institutions specializing in coil embolization.
Results:
: The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up.
Conclusion
: This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.
3.Does the COVID-19 Screening Test Affect the Postoperative Prognosis of Patients Who Undergo Emergency Surgery for Cerebral Hemorrhage?
Chang Ho LEE ; Young Ha KIM ; Bu Kwang OH ; Chi Hyung LEE ; Chang Hyeun KIM ; Soon Ki SUNG ; Sang Weon LEE ; Geun Sung SONG
Korean Journal of Neurotrauma 2022;18(2):198-207
Objective:
The coronavirus disease 2019 (COVID-19) pandemic has affected all medical fields, including neurosurgery. Particularly, performing preoperative screening tests has become mandatory, potentially extending the time from admission to the emergency room and operating room, thus possibly affecting patients’ prognosis. This study aimed to determine the influence of COVID-19 screening time on patients’ postoperative prognosis.
Methods:
From September 10, 2020, to May 31, 2021, we retrospectively evaluated 54 patients with cerebral hemorrhage who underwent emergency surgery in the emergency room after the screening test. The control group included 89 patients with cerebral hemorrhage who underwent emergency surgery between January 2019 and March 2020, i.e., the period before the COVID-19 pandemic. Prognosis was measured using the Glasgow Coma Scale scores, which were obtained preoperatively, postoperatively, and at discharge, and the modified Rankin Scale (mRS). Additionally, unfavorable outcomes (mRS score 3–6) and in-hospital mortality rates were investigated for postoperative prognostic assessments.
Results:
No remarkable differences were observed in the time to surgical intervention and prognostic evaluation scores between patients with cerebral hemorrhage who underwent COVID-19 screening tests and subjects in the control group.
Conclusion
This study confirmed that patient treatment and prognosis were not significantly affected by additional preoperative screening testing times during the pandemic. We believe that our results are informative for the evaluation and performance of emergency neurosurgery during the pandemic.
4.A case of an unruptured duplicated middle cerebral artery aneurysm–An unusual presentation of the distal internal carotid artery aneurysm
Bu Kwang OH ; Young Ha KIM ; Chang Hyeun KIM ; Sang Weon LEE ; Soon Ki SUNG ; Geun Sung SONG
Journal of Cerebrovascular and Endovascular Neurosurgery 2021;23(3):240-244
The duplicated middle cerebral artery (DMCA) is an anatomic variation that arises from the distal internal carotid artery (ICA) and supplies blood to the middle cerebral artery (MCA) territory. Aneurysms of the DMCA have been reported in 36 cases in 2020. We also report a case of a 3.7 mm saccular aneurysm originating from the DMCA. A 52-year-old woman visited our hospital with worsening headache. She had no neurological abnormalities. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) revealed a right distal ICA aneurysm at the anterior choroidal artery. Cerebral angiography was performed to confirm the shape and the size of the aneurysm. Cerebral angiography revealed that the vessel that was originally identified as the anterior choroidal artery by the MRA was actually the duplicated MCA that was originating from the aneurysm neck and was supplying the MCA territory. The patient’s aneurysm was clipped using a transsylvian approach and she recovered without any neurological symptoms. DMCAs are rare and often associated with aneurysms and require preoperative evaluation to confirm the vascular status, aneurysm characteristics, and the shape of the parent artery.
5.A case of an unruptured duplicated middle cerebral artery aneurysm–An unusual presentation of the distal internal carotid artery aneurysm
Bu Kwang OH ; Young Ha KIM ; Chang Hyeun KIM ; Sang Weon LEE ; Soon Ki SUNG ; Geun Sung SONG
Journal of Cerebrovascular and Endovascular Neurosurgery 2021;23(3):240-244
The duplicated middle cerebral artery (DMCA) is an anatomic variation that arises from the distal internal carotid artery (ICA) and supplies blood to the middle cerebral artery (MCA) territory. Aneurysms of the DMCA have been reported in 36 cases in 2020. We also report a case of a 3.7 mm saccular aneurysm originating from the DMCA. A 52-year-old woman visited our hospital with worsening headache. She had no neurological abnormalities. Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) revealed a right distal ICA aneurysm at the anterior choroidal artery. Cerebral angiography was performed to confirm the shape and the size of the aneurysm. Cerebral angiography revealed that the vessel that was originally identified as the anterior choroidal artery by the MRA was actually the duplicated MCA that was originating from the aneurysm neck and was supplying the MCA territory. The patient’s aneurysm was clipped using a transsylvian approach and she recovered without any neurological symptoms. DMCAs are rare and often associated with aneurysms and require preoperative evaluation to confirm the vascular status, aneurysm characteristics, and the shape of the parent artery.
6.Flow Diverter Devices for the Treatment of Unruptured Vertebral Artery Dissecting Aneurysm
Chang Hyeun KIM ; Chi Hyung LEE ; Young Ha KIM ; Soon Ki SUNG ; Dong Wuk SON ; Sang Weon LEE ; Geun Sung SONG
Journal of Korean Neurosurgical Society 2021;64(6):891-900
Objective:
: Vertebral artery dissecting aneurysm (VADA) is a very rare subtype of intracranial aneurysms; when ruptured, it is associated with significantly high rates of morbidity and mortality. Despite several discussions and debates, the optimal treatment for VADA has not yet been established. In the last 10 years, flow diverter devices (FDD) have emerged as a challenging and new treatment method, and various clinical and radiological results have been reported about their safety and effectiveness. The aim of our study was to evaluate the clinical and radiological results with the use of FDD in the treatment of unruptured VADA.
Methods:
: We retrospectively evaluated the data of all patients with unruptured VADA treated with FDD between January 2018 and February 2021 at our hybrid operating room. Nine patients with unruptured VADA, deemed hemodynamically unstable, were treated with FDD. Among other parameters, the technical feasibility of the procedure, procedure-related complications, angiographic results, and clinical outcomes were evaluated.
Results:
: Successful FDD deployment was achieved in all cases, and the immediate follow-up angiography showed intra-aneurysmal contrast stasis with parent artery preservation. A temporary episode of facial numbness and palsy was noted in one patient; however, the symptoms had completely disappeared when followed up at the outpatient clinic 2 weeks after the procedure. The 3–6 months follow-up angiography (n=9) demonstrated completeear-complete obliteration of the aneurysm in seven patients, and partial obliteration and segmental occlusion in one patient each. In the patient who achieved only partial obliteration, there was a sac 13 mm in size, and there was no change in the 1-year follow-up angiography. In the patient with segmental occlusion, the cause could not be determined. The clinical outcome was modified Rankin Scale 0 in all patients.
Conclusion
: Our preliminary study using FDD to treat hemodynamically unstable unruptured VADA showed that FDD is safe and effective. Our study has limitations in that the number of cases is small, and it is not a prospective study. However, we believe that the study contributes to evidence regarding the safety and effectiveness of FDD in the treatment of unruptured VADA.
7.Case Series of Ventriculoatrial Shunt placement in Hybrid Room: Reassessment of Ventriculoatrial Shunt
Young Ha KIM ; Sang Weon LEE ; Dong Hyun KIM ; Chi Hyung LEE ; Chang Hyeun KIM ; Soon Ki SUNG ; Dong Wuk SON ; Geun Sung SONG
Korean Journal of Neurotrauma 2020;16(2):181-189
Objective:
Ventriculoatrial shunt (VAS) remains an alternate option for treatment of hydrocephalus in patients with ventriculoperitoneal shunt (VPS) failure. Unfamiliar anatomy for a neurosurgeon has resulted in the VAS falling out of favor as a treatment option. However, there are unsatisfactory reports on the long-term result of VPS, and VAS has been recently re-evaluated. We are to report the simple way to do the VAS using a peel-away sheath in a hybrid operation room.
Methods:
A jugular vein path was drawn by ultrasound, a small incision was made above the clavicle, and a shunt catheter was tunneled into it. The jugular vein was punctured beside the tunneled catheter with a Seldinger needle under ultrasound guidance. A flexible guide wire was introduced into the vein and 6-Fr peel-away sheath was advanced into the vein along the wire. Under fluoroscopic guidance, the catheter was cut to position approximately midlevel in the atrium. After the guide wire was removed, the distal shunt catheter was passed down. After confirming proper position of the distal catheter under the fluoroscope, the catheter-guiding sheath was pulled out as a peeling-away manner. We performed this surgical procedures in 5 cases.
Results:
All the procedures of the VAS using a peel-away sheath were performed in a hybrid operation room Of 5 patients, 3 patients had the distal catheter failures in the peritoneal cavity and 2 patients had shunt A distal catheter was successfully indwelling in all the cases without any difficulties. After the surgery, neither shunt infection nor thromboembolic event happened.
Conclusion
VAS using fluoroscopy and a peel-away sheath is a good alternative option for hydrocephalus patients with shunt failure related to peritoneal cavity complications.
8.The experience of surgery and endovascular procedure of cerebrovascular disease in the hybrid operating room; Multi-axis robotic C-arm DSA system
Chang Hyeun KIM ; Sang Weon LEE ; Young Ha KIM ; Soon Ki SUNG ; Dong Wuk SON ; Geun Sung SONG
Journal of Cerebrovascular and Endovascular Neurosurgery 2020;22(4):258-266
Objective:
To report on combined surgical and/or endovascular procedures for cerebrovascular disease in a hybrid operating room (OR).
Methods:
Between October 2016 and June 2020, 1832 neurosurgical procedures were performed in a hybrid OR. Our institution’s hybrid OR consists of a multi-axis robotic C-arm monoplane digital subtraction angiography (DSA) system with an operating table, 3D-rotational DSA, cone-beam computed tomography (dyna CT), and real-time navigation software. Procedures were categorized into six categories according to purpose: (1) simple diagnosis and follow-up, (2) simple endovascular procedure, (3) combination of surgery and endovascular procedures, (4) rescue surgery after endovascular procedures, (5) frameless stereotactic procedure, and (6) other surgeries requiring C-arm.
Results:
Of 1832 neurosurgical procedures in the hybrid OR, 1430 were simple diagnosis and follow-up cases, 330 simple endovascular procedures, 8 combination of surgery and endovascular procedures, 15 rescue after endovascular procedure, 40 frameless stereotactic procedures, and 9 other surgeries. Eight cases of combination of surgery and endovascular procedures, safely performed without wasting time on patient transfer, were performed in seven bypass end endovascular procedures and one case of bow-hunter syndrome in complex cerebrovascular disease. After embolization, craniotomy (or craniectomy) and intracerebral hemorrhage removal were performed in eight patients in-situ. Of the 40 frameless stereotactic procedure, 37 were extraventricular drainage before/after coil embolization in subarachnoid hemorrhage patients. They all mounted conduits in their planned locations.
Conclusions
A hybrid OR for combined endovascular and surgical procedures represents a safe and useful strategy for cerebrovascular disease. In hybrid ORs various neurosurgical procedures can be safely and conveniently performed. Hybrid OR will pioneer a new era in neurosurgical procedures.
9.Clinical Safety and Effectiveness of Stent-Assisted Coil Embolization with Neuroform Atlas Stent in Intracranial Aneurysm
Chang Hyeun KIM ; Young Ha KIM ; Soon Ki SUNG ; Dong Wuk SON ; Geun Sung SONG ; Sang Weon LEE
Journal of Korean Neurosurgical Society 2020;63(1):80-88
Objective:
: Stent-assisted coil embolization (SAC) is commonly used for treating wide-neck intracranial aneurysms. In this study, we aimed to assess the clinical safety and efficacy of the NeuroForm Atlas Stent during SAC of intracranial aneurysms.
Methods:
: We retrospectively analyzed data from patients with ruptured and unruptured cerebral aneurysms, who underwent SAC using the NeuroForm Atlas between February 2018 and July 2018. Favorable clinical outcomes and degree of aneurysm occlusion were defined as a modified Rankin scale score of ≤2 and a Raymond-Roy occlusion classification (RROC) class I/II during the immediate postoperative period and at the 6-month follow-up, respectively.
Results:
: Thirty-one consecutive patients with 33 cases, including 11 ruptured and 22 unruptured cases were treated via NeuroForm Atlas SAC. Among the 22 unruptured cases with 24 unruptured aneurysms had favorable clinical outcome. Complete occlusion (RROC I) was achieved in 16 aneurysms (66.7%), while neck remnants (RROC II) were observed in six aneurysms (25%). Among the 11 patients with ruptured aneurysms, two died due to re-bleeding and diabetic ketoacidosis. In ruptured cases, RROC I was observed in eight (72.7%) and RROC II was observed in three cases (27.3%). At the 6-month follow-up, no clinical events were observed in the 22 unruptured cases. In the ruptured nine cases, five patients recovered without neurologic deficits, while four experienced unfavorable outcomes at 6 months. Of the 29 aneurysms examined via angiography at the 6-month follow-up, 19 (65.5%) were RROC I, eight (27.6%) were RROC II and two (6.9%) were RROC III. There were no procedure-related hemorrhagic complications.
Conclusion
: In this study, we found that stent-assisted coil embolization with NeuroForm Atlas stent may be safe and effective in the treatment of wide-neck intracranial aneurysms. NeuroForm Atlas SAC is feasible for the treatment of both ruptured and unruptured wide-neck aneurysms.
10.Predictors of Hematoma Enlargement in Patients with Spontaneous Intracerebral Hemorrhage Treated with Rapid Administration of Antifibrinolytic Agents and Strict Conservative Management
Chang Hyeun KIM ; Sang Weon LEE ; Young Ha KIM ; Soon Ki SUNG ; Dong Wuk SON ; Geun Sung SONG
Korean Journal of Neurotrauma 2019;15(2):126-134
OBJECTIVE: Spontaneous intracerebral hemorrhage (ICH) is caused by the rupture of small blood vessels and other health problems. In ICH patients, hematoma enlargement is the most critical risk factor for poor outcomes. Tranexamic acid, an anti-fibrinolytic agent, has been used to reduce hematoma expansion. We analyzed the risk factors for hematoma expansion in ICH patients and compared the predictability of hematoma expansion in ICH patients with the use of tranexamic acid. METHODS: We performed retrospective analysis of ICH patients who underwent follow-up computed tomography scans from October 2008 to October 2018. Of the 329 included patients, 67 who received tranexamic acid and 262 who did not receive tranexamic acid were compared. We also analyzed the risk factors of 45 and 284 patients who did and did not experience hematoma expansion, respectively. RESULTS: Hematoma expansion was observed in 7 (10.4%) of 67 patients in the tranexamic acid group and 38 (14.5%) of the 262 patients who did not receive tranexamic acid. There was no statistically significant difference between patients who did and did not received tranexamic acid (p=0.389). In the multivariate logistic regression analysis of risk factors for hematoma expansion, spot sign and a maximal diameter of 40 mm were identified as risk factors. CONCLUSION: We could not confirm the effect of tranexamic acid on hematoma expansion in ICH patients. Spot sign and the maximal diameter of hematomas were confirmed as risk factors of hematoma expansion. If the maximal diameter is greater than 40 mm, the hematoma should be closely monitored.
Antifibrinolytic Agents
;
Blood Vessels
;
Cerebral Hemorrhage
;
Follow-Up Studies
;
Hematoma
;
Humans
;
Logistic Models
;
Retrospective Studies
;
Risk Factors
;
Rupture
;
Tranexamic Acid

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