Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population:A Multicenter Post-Market Surveillance Study

Objective@#To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. @*Materials and Methods@#Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2–5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CDTLR) within 12 months after the procedure. @*Results@#A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56–133 mm).Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. @*Conclusion@#The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

Continuous Positive Airway Pressure Therapy Can Prevent Pulmonary Atelectasis after Laparoscopic Roux-en-Y Gastric Bypass Surgery in Obese Patients

PURPOSE: To compare the prophylactic effects of postoperative continuous positive airway pressure (CPAP) therapy plus conventional postoperatively pulmonary physiotherapy (CPP) and postoperative CPP alone on the development of pulmonary atelectasis after laparoscopic Roux-en-Y gastric bypass (LGBP) in obese patients. MATERIALS AND METHODS: Patients with BMIs>27.5 kg/m2 aged between 20 and 65 years were enrolled in the present study. All subjects received LGBP and were divided into 2 groups. Patients in the CPAP group received both CPAP and CPP therapy postoperatively, and patients in the conventional group received CPP alone. The primary outcome was the incidence of postoperative pulmonary atelectasis as determined by chest X-ray after LGBP, and the secondary outcome was duration of postoperative hospital stay (HS). RESULTS: Seventy-three patients were enrolled in this study. Fifty-seven patients received CPAP plus CPP, and 16 patients received CPP. The CPAP group had an atelectasis incidence of 40.4% (23/57) and the conventional group an incidence of 62.5% (10/16). Multivariate analysis showed the incidence of atelectasis after LGBP was significantly lower in the CPAP group (OR 0.198, 95% CI 0.045–0.874; P=0.033) and that HS was significantly correlated with the developments of atelectasis, pneumonia, and complications (partial correlation coefficients 0.271, 0.444 and 0.382; P-values 0.025, <0.05 and <0.05, respectively). CONCLUSION: Patients that received continuous positive airway pressure therapy plus conventional pulmonary physiotherapy postoperatively were at significantly less risk of developing pulmonary atelectasis after LGBP than patients that received conventional pulmonary physiotherapy postoperatively.

Risk Factors of Amputation in Lower Extremity Trauma with Combined Femoropopliteal Arterial Injury

PURPOSE: The clinical characteristics and results of femoropopliteal artery injury (FPAI) remain unclear. In this study, we evaluated the outcomes and risk factors of limb loss in patients treated for FPAI. MATERIALS AND METHODS: We retrospectively reviewed data from a database of patients who underwent revascularization for an FPAI at a single institution between January 2013 and December 2017. We reviewed and analyzed the characteristics, postoperative results, and factors that influence amputation rates. RESULTS: Twenty-four femoropopliteal arterial reconstructions in 24 patients were included in this study. Among the patients were 20 (83.3%) male with a first-quartile age of 28 years and a third-quartile age of 45 years (range, 15–68 years). The mean injury severity score (ISS) was 16 (range, 4–55), and 5 patients (20.8%) had ISSs of >20 points. The mean mangled extremity severity score (MESS) was 3.8 (range, 1–11), and 8 patients (33.3%) had MESSs of >5 points. In terms of arterial reconstruction methods, autogenous saphenous vein grafting, vein patching, and primary closure were performed in 9 patients (37.5%), 4 patients (16.7%), and 11 patients (45.8%), respectively. Despite arterial reconstruction, 5 patients (20.8%) underwent above-knee amputation. ISSs of >20, MESSs of >7, and orthopedic fixation were statistically significant factors associated with amputation. CONCLUSION: In cases of FPAI with ISSs of >20, MESSs of >7, and orthopedic fixation, amputations should be considered. We were also careful to attempt limb salvage in such cases.

Spontaneous dissections of multiple visceral arteries: an extremely rare case

Spontaneous dissections of visceral arteries without aortic involvement are very rare. The etiologies of these entities are unclear and their clinical managements remain controversial. We report a case of spontaneous multiple dissections affecting 4 visceral arteries including the superior mesenteric artery, the celiac artery and the bilateral renal arteries. The patient was managed conservatively and endovascularly. The clinical manifestation markedly improved and laboratory tests returned to normal limits within 1 week. The regular follow-up suggested a good clinical and radiological outcome until 84 months.

Usefulness of Percutaneous Puncture in Insertion of Totally Implantable Venous Access Devices in Pediatric Patients

PURPOSE: Totally implantable venous access devices (TIVADs) are commonly used in pediatrics for the administration of chemotherapy, antibiotics, or parenteral nutrition. TIVADs can be implanted using various techniques, including surgical cutdown (SC) and percutaneous puncture (PP). Recently, percutaneous TIVAD became popular in adults, but studies comparing between PP and SC group in pediatric patients are rare. MATERIALS AND METHODS: Data were collected and analyzed retrospectively from 23 patients who underwent TIVAD at a single institution between January 2013 and December 2015. We examined the clinical characteristics, insertion techniques, and clinical outcome. We divided the patients into 2 groups and compared PP with ultrasonography and SC using the insertion technique. We compared success rate, procedural time, and the patency rate between the 2 groups. RESULTS: Eleven TIVADS were inserted using PP, and 12 TIVADs were inserted using SC. No statistically significant difference in characteristics was found between the 2 groups. The procedural time in the PP group was shorter than that in the SC group, but the difference was not statistically significant (P=0.685). During follow-up, 1 patient in the SC group had an occlusion, and 1 patient in the PP group had an infection. CONCLUSION: PP of the internal jugular vein with ultrasonography appears to be the method of choice for TIVAD insertion owing to its similar success rate in terms of implantation and complication rate to that in SC, with shorter procedural times in pediatric patients.

Intraoperative Vascular Surgical Consultation during Non-Vascular Surgeries in Tertiary Centers by Vascular Surgeon

PURPOSE: There are many types of intraoperative consultations by vascular surgeons during non-vascular surgery. Therefore, we examined the current state of intraoperative consultations during non-vascular surgery in a single center. MATERIALS AND METHODS: From January 2014 to December 2015, we reviewed records of 40 patients (0.3%) who received an intraoperative consultation from a vascular surgeon for 10,734 non-vascular surgeries in Inha University Hospital. We examined patient characteristics, operative details, and clinical results. RESULTS: There were 40 intraoperative vascular surgical consultations relating to bleeding (n=14, 35.0%), dissection from the vessel (n=13, 32.5%), arterial occlusion (n=10, 25.0%), and retroperitoneal approach (n=3, 7.5%). The locations of surgery were lower extremity (n=10, 25.0%), kidney (n=8, 20.0%), spine (n=6, 15.0%), pelvis (n=6, 15.0%), head and neck (n=4, 10.0%), abdomen (n=4, 10.0%), and upper extremity (n=2, 5.0%). The methods of surgery included primary closure or ligation (n=17, 42.5%), end-to-end anastomosis (n=12, 30.0%), bypass (n=10, 25.0%), thrombectomy (n=4, 10.0%), retroperitoneal approach (n=3, 7.5%), and embolization (n=2, 5.0%). Postoperative treatment was performed in the intensive care unit for 13 patients (32.5%), while 3 patients (7.5%) died following surgery. CONCLUSION: Intraoperative consultation by vascular surgeons during non-vascular surgery occurred in approximately 0.3% of non-vascular surgeries. The region undergoing operation and type of surgery were variable. Therefore, it is necessary for vascular surgeons to have a comprehensive knowledge of vascular anatomy and to make rapid surgical decisions.

Occurrences and Results of Acute Kidney Injury after Endovascular Aortic Abdominal Repair?

PURPOSE: Acute kidney injury (AKI) is an important postoperative complication that may impact mortality and morbidity. The incidence of AKI after elective endovascular aneurysm repair (EVAR) is not known well. The aim of this study is to assess the incidence of AKI after elective EVAR and examine the impact of AKI. MATERIALS AND METHODS: Data were collected and analyzed retrospectively from 78 elective EVARs for abdominal aortic aneurysm (AAA) among 102 total cases of conventional EVAR performed in Inha University Hospital from 2009 to 2015. The primary endpoint was incidence and risk factors of AKI. Secondary endpoints included drop in estimated glomerular filtration rate (eGFR) and the mortality of AKI. RESULTS: We included 78 patients (17 females, 21%; mean age, 73.9±12.5 years; mean AAA diameter, 59.3±8.9 cm), 11 (14.1%) of whom developed AKI. Within 48 hours, those with AKI experienced a decrease in eGFR from 65.5±21.2 to 51.2±19.6 mL/kg/1.73 m2, and those without AKI showed a change from 73.1±9.2 to 74.2±10.7 mL/kg/1.73 m2. There were no patients who required dialysis during follow-up (mean, 24.2±18.0 months). Development of AKI was related to operation time (odds ratio [OR], 2.024; 95% confidence interval [CI], 1.732–4.723; P < 0.010) and contrast dose (OR, 3.192; 95% CI, 2.182–4.329; P < 0.010). There were no differences in mortality between the 2 groups (P=0.784). CONCLUSION: The incidence of AKI after EVAR was related to operation time and contrast dose, but was not associated with medium-term mortality.

Can Pre-Retrieval Computed Tomography Predict the Difficult Removal of an Implementing an Inferior Vena Cava Filter?

PURPOSE: Implementing an inferior vena cava (IVC) filter is a relatively safe procedure but potential negative long-term effects. The complications for filter retrieval have been noted. We examined filter characteristics on pre-retrieval computed tomography (CT) that were associated with complicated retrieval (CR) of IVC filters. MATERIALS AND METHODS: A retrospective review of IVC filter retrievals between January 2008 and June 2014 was performed to identify patients who had undergone a pre-retrieval CT for IVC filter retrieval. CR was defined as the use of nonstandard techniques, procedural time over 30 min, filter fractures, filter tip incorporation into the IVC wall, and retrieval failure. Pre-retrieval CT images were evaluated for tilt angle in the mediolateral and anteroposterior directions, tip embedding into the IVC wall, degree of filter strut perforation, and distance of the filter tip from the nearest renal vein. RESULTS: Of seventy-six patients, twenty-four patients (31.6%) with CRs and 56 patients (73.7%) with non-CR were evaluated for pre-retrieval CT. For IVC filter retrieval with a dwelling time of over 45 days, a tilt of over 15 degrees, the appearance of tip embedding and grade 2 perforation were associated with CR on multivariate analysis. However, for IVC filter retrievals with a dwelling time of less than 45 days, there were no factors associated with CR. CONCLUSION: Pre-retrieval CTs may be more effective for IVC filters with a dwelling time of over 45 days. Therefore, a pre-retrieval CT may be helpful in predicting CR of IVC filters with long dwelling times.

Diagnosis and Treatment of Lower Extremity Deep Vein Thrombosis: Korean Practice Guidelines

Lower extremity deep vein thrombosis is a serious medical condition that can result in death or major disability due to pulmonary embolism or post-thrombotic syndrome. Appropriate diagnosis and treatment are required to improve symptoms and salvage the affected limb. Early thrombus clearance rapidly resolves symptoms related to venous obstruction, restores valve function and reduces the incidence of post-thrombotic syndrome. Recently, endovascular treatment has been established as a standard method for early thrombus removal. However, there are a variety of views regarding the indications and procedures among medical institutions and operators. Therefore, we intend to provide evidence-based guidelines for diagnosis and treatment of lower extremity deep vein thrombosis by multidisciplinary consensus. These guidelines are the result of a close collaboration between interventional radiologists and vascular surgeons. The goals of these guidelines are to improve treatment, to serve as a guide to the clinician, and consequently to contribute to public health care.

Korean Guidelines for Interventional Recanalization of Lower Extremity Arteries

Peripheral arterial occlusive disease caused by atherosclerosis can present with intermittent claudication or critical limb ischemia. Proper diagnosis and management is warranted to improve symptoms and salvage limbs. With the introduction of new techniques and dedicated materials, endovascular recanalization is widely performed for the treatment of peripheral arterial occlusive disease because it is less invasive than surgery. However, there are various opinions regarding the appropriate indications and procedure methods for interventional recanalization according to operator and institution in Korea. Therefore, we intend to provide evidence based guidelines for interventional recanalization by multidisciplinary consensus. These guidelines are the result of a close collaboration between physicians from many different areas of expertise including interventional radiology, interventional cardiology, and vascular surgery. The goal of these guidelines is to ensure better treatment, to serve as a guide to the clinician, and consequently, to contribute to public health care.

One Year Experience of Iliac Bifurcated Device for Aortoiliac Aneurysm in a Korean Single Center

One of the predominant methods for preserving the internal iliac artery (IIA) in aortoiliac aneurysms is to use an iliac bifurcated device (IBD). However, there are a few limitations to the use of IBD in Korea. Our study aims to present the technical aspects of these devices, and to provide a mid-term analysis of IBD. Since 2013, 4 IBDs were used in 4 patients, with a mean follow-up of 14 months (range, 6-22 months). A 100% technical success rate was achieved without mortality and morbidity in our cases. The mean procedural time was 176 min (range, 145-240 min), and the mean contrast dose used was 184 mL (range, 135-220 mL). Type I or III endoleaks and postoperative expansion of the aneurysms weren't observed. Our cases demonstrates that IBD is a relatively safe repair method of aortoiliac aneurysms with preservation of the IIAs. However, a longer follow-up is needed to review the midterm results.

Midterm Outcome of Femoral Artery Stenting and Factors Affecting Patency

PURPOSE: The purpose of this study was to evaluate the early and midterm results of superficial femoral artery (SFA) stenting with self-expanding nitinol stents and to identify the factors affecting patency. MATERIALS AND METHODS: SFA stenting was performed in 165 limbs of 117 patients from January 2009 to December 2013. Patients were followed-up for the first occurrence of occlusion or stenosis based on computed tomography and duplex scan results and a decrease in ankle brachial index of >15%. RESULTS: During the follow-up period (mean, 15.3+/-3.2 months), no early thrombotic reocclusions occurred within 30 days, but in-stent restenosis developed in 78 limbs. The primary patency rates at 6, 12, 18, and 24 months were 78%, 66%, 42%, and 22%, respectively, and the secondary patency rates were 85%, 72%, 58%, and 58%, respectively. TASC II C or D lesions, stent length >8 cm, number of patent tibial arteries and diabetes were significantly associated with reintervention. CONCLUSION: The midterm results of stenting for SFA occlusive disease were disappointing because the primary and secondary patency rates at two years were 22% and 58%, respectively. Reintervention after SFA stenting remains a major problem, particularly in patients with diabetes mellitus or long TASC II C or D lesions.

Multiple visceral artery aneurysms managed by Yasargil aneurysm clips

Here, we present the case of a 37-year-old woman with multiple visceral artery aneurysms in the pancreaticoduodenal, inferior pancreatic and splenic arteries associated with celiac trunk stenosis. An aneurysmectomy and end-to-end anastomosis was performed for two adjacent aneurysms, while clipping with intracranial aneurysm clips were performed for the other three aneurysms. During 36-month follow-up, no recurrence or newly developed lesions were noted, and the celiac artery had been reconstituted spontaneously. We believe that using intracranial aneurysm clips in the treatment of visceral artery aneurysms is feasible and safe and can be considered when endovascular procedures are unlikely to be successful.

Spontaneous Splenic Rupture in a Vivax Malaria Case Treated with Transcatheter Coil Embolization of the Splenic Artery

An enlarged spleen is considered one of the most common signs of malaria, and splenic rupture rarely occurs as an important life-threatening complication. Splenectomy has been recommended as the treatment of choice for hemodynamically unstable patients. However, a very limited number of splenic rupture patients have been treated with transcatheter coil embolization. Here we report a 38-year-old Korean vivax malaria patient with ruptured spleen who was treated successfully by embolization of the splenic artery. The present study showed that angiographic embolization of the splenic artery may be an appropriate option to avoid perioperative harmful effects of splenectomy in malaria patients.

Anatomical Features and Early Outcomes of Endovascular Repair of Abdominal Aortic Aneurysm from a Korean Multicenter Registry

PURPOSE: To introduce a nation-based endovascular aneurysm repair (EVAR) registry in South Korea and to analyze the anatomical features and early clinical outcomes of abdominal aortic aneurysms (AAA) in patients who underwent EVAR. MATERIALS AND METHODS: The Korean EVAR registry (KER) was a template-based online registry developed and established in 2009. The KER recruited 389 patients who underwent EVAR from 13 medical centers in South Korea from January 2010 to June 2010. We retrospectively reviewed the anatomic features and 30-day clinical outcomes. RESULTS: Initial deployment without open conversion was achieved in all cases and procedure-related 30-day mortality rate was 1.9%. Anatomic features showed the following variables: proximal aortic neck angle 48.8+/-25.7degrees (mean+/-standard deviation), vertical neck length 35.0+/-17.2 mm, aneurysmal sac diameter 57.2+/-14.2 mm, common iliac artery (CIA) involvement in 218 (56.3%) patients, and median right CIA length 34.9 mm. Two hundred and nineteen (56.3%) patients showed neck calcification, 98 patients (25.2%) had neck thrombus, and the inferior mesenteric arteries of 91 patients (23.4%) were occluded. CONCLUSION: Anatomical features of AAA in patients from the KER were characterized as having angulated proximal neck, tortuous iliac artery, and a higher rate of CIA involvement. Long-term follow-up and ongoing studies are required.

Mechanical thrombectomy-assisted thrombolysis for acute symptomatic portal and superior mesenteric venous thrombosis

Acute portal vein and mesenteric vein thrombosis (PVMVT) can cause acute mesenteric ischemia and be fatal with mortality rate of 37%-76%. Therefore, early diagnosis and prompt venous revascularization are warranted in patients with acute symptomatic PVMVT. Due to advances in catheter-directed treatment, endovascular treatment has been used for revascularization of affected vessels in PVMVT. We report two cases of symptomatic PVMVT treated successfully by transhepatic percutaneous mechanical thrombectomy-assisted thrombolysis.

Relining technique for continuous sac enlargement and modular disconnection secondary to endotension after endovascular aortic aneurysm repair

Endotension is an unpredictable late complication of endovascular aortic aneurysm repair (EVAR). This case report will discuss the successful treatment of enlarged aneurysmal sac due to endotension using the relining technique. An 81-year-old male complained of nondecreasing huge aneurysm sac. He had undergone EVAR for infrarenal abdominal aortic aneurysm 7 years prior and no endoleak was found through follow-up. Initially computed tomography-guided sac aspiration was tried, but in vain, Relining using the double barrel technique and tubular endograft for modular diconnection, which was unexpectedly found in the original endograft, were performed sucessfully. During follow-up after the relining procedure, the size of aneurysm sac continued to decrease in size. The relining technique is effective mothod for treating endotension.

Internal Iliac Artery Embolization during an Endovascular Aneurysm Repair with Detachable Interlock Microcoils

OBJECTIVE: The purpose of this study was to evaluate the effectiveness of detachable interlock microcoils for an embolization of the internal iliac artery during an endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: A retrospective review was conducted on 40 patients with aortic aneurysms, who had undergone an EVAR between January 2010 and March 2012. Among them, 16 patients were referred for embolization of the internal iliac artery for the prevention of type II endoleaks. Among 16 patients, 13 patients underwent embolization using detachable interlock microcoils during an EVAR. Computed tomographic angiographies and clinical examinations were performed during the follow-up period. Technical success, clinical outcome, and complications were reviewed. RESULTS: Internal iliac artery embolizations using detachable interlock microcoils were technically successful in all 13 patients, with no occurrence of procedure-related complications. Follow-up imaging was accomplished in the 13 cases. In all cases, type II endoleak was not observed with computed tomographic angiography during the median follow-up of 3 months (range, 1-27 months) and the median clinical follow-up of 12 months (range, 1-27 months). Two of 13 (15%) patients had symptoms of buttock pain, and one patient died due to underlying stomach cancer. No significant clinical symptoms such as bowel ischemia were observed. CONCLUSION: Internal iliac artery embolization during an EVAR using detachable interlock microcoils to prevent type II endoleaks appears safe and effective, although this should be further proven in a larger population.

Repair of type I endoleak by chimney technique after endovascular abdominal aortic aneurysm repair

Endovascular aneurysm repair is a minimally invasive, durable and effective alternative to open surgery for treatment of abdominal aortic aneurysms (AAA). However, in patients who do not have an adequate sealing zone, open surgical repair is required, which may increase mortality and morbidity. An alternative treatment in patients with challenging anatomy is the so-called "chimney graft" technique. Here, we describe a case using the chimney graft technique for treatment of juxtarenal type I endoleak followed by a previous conventional stent graft insertion to the AAA with good results.

Endovascular Treatment of Isolated Bilateral Common Iliac Artery Aneurysms Using Iliac Branched Stent Graft

Endovascular treatment of isolated bilateral common iliac artery aneurysm (CIAA) requires salvage of at least one internal iliac artery to prevent complications such as ischemic buttock claudication. We treated a case of bilateral CIAAs using an internal iliac branched stent graft. We report a case of a 58-year-old man who presented with bilateral CIAAs. The left internal iliac artery was occluded with coil embolization. The right internal iliac artery was saved by using a branched stent graft. The aneurysms were excluded with conventional endovascular aneurysm repair. Completion angiography showed technical success. Follow up computed tomography angiogram at three months showed complete exclusion of bilateral CIAAs, no endoleaks, and patent right internal iliac artery. There was no pelvic ischemic complication. We treated successfully a case of isolated bilateral CIAAs using an iliac branched stent graft.