Primary intraorbital inflammatory lumpy lesion: A rare case report.

RATIONALE: Eosinophilic angiocentric fibrosis (EAF) is considered to be a kind of benign IgG4-related disease, and it is more often found in the nasal cavity. We present a pretty rare case of orbital EAF that is unlike any other reported case for this case is an IgG4 negative orbital EAF and successfully treated by the fronto orbitozygomatic approach surgery. PATIENT CONCERNS: This is a 68-year-old man from a rural area of Inner Mongolia Autonomous Region, went to our hospital for a 2-month history of vision loss with a local hospital orbital computer tomography which showed that there was a lesion in his left orbit. The inspection of the patient revealed that the patient left eye was protruding outward and the left eyelid unable to complete open or close. And his left eyeball movement had difficulty in all directions. Postoperative pathology diagnosed that this was a case of IgG4-negative EAF case. DIAGNOSES: Orbital EAF. INTERVENTIONS: Surgical radical resection and postoperative glucocorticoid therapy. OUTCOMES: After surgery, the left eye vision of this patient increased to 0.6 tested in the standard logarithmic visual acuity chart. And his left eyeball movement dysfunction and eyeball outward protruding get a partially relief. LESSONS: EAF occurring in the orbit is a very rare disease and immunohistochemical results of EAF can be IgG4 negative.

A rare complication of pediatric liver transplantation: Post-transplant diaphragmatic hernia.

AIM: Acquired post-transplant diaphragmatic hernia (PTDH) is a rare complication of liver transplantation (LT) in children. We aimed to present our experience in PTDH, and a possible causative background is discussed. METHODS: Medical records of patients who had undergone diaphragmatic repair following LT between 2015 and 2023 were reviewed. Demographic information, details of primary diseases necessitating LT, transplantation techniques, and clinical findings associated with PTDH were evaluated. RESULTS: There were seven patients with PTDH. Median age at transplantation was 69 (range: 9-200) months. Five patients received a left lateral sector, one patient had a right lobe, and one had a left lobe graft. Time between LT and PTDH was 9 (2-123) months. One patient who was diagnosed in the postoperative 10th year was asymptomatic. Respiratory distress and abdominal pain were the main symptoms among all. All patients underwent laparotomy, and primary repair was performed in six patients, and one patient required mesh repair because of a large defect. Small intestine herniated in most cases. There were two complicated cases with perforation of the stomach and colonic volvulus. There is no recurrence or long-term complications for the median 60 (20-119) month follow-up period. CONCLUSION: PTDH is a rare but serious complication. Majority of symptomatic cases present within the first postoperative year, whereas some late-presenting cases may not be symptomatic. Inadvertent injury to the inferior phrenic vasculatures due to excessive use of cauterization for control of hemostasis may be a plausible explanation in those cases.

COVID-19 and cancer risk arising from ionizing radiation exposure through CT scans: a cross-sectional study.

BACKGROUND: The surge in the utilization of CT scans for COVID-19 diagnosis and monitoring during the pandemic is undeniable. This increase has brought to the forefront concerns about the potential long-term health consequences, especially radiation-induced cancer risk. This study aimed to quantify the potential cancer risk associated with CT scans performed for COVID-19 detection. METHODS: In this cross-sectional study data from a total of 561 patients, who were referred to the radiology center at Imam Hossein Hospital in Shahroud, was collected. CT scan reports were categorized into three groups based on the radiologist's interpretation. The BEIR VII model was employed to estimate the risk of radiation-induced cancer. RESULTS: Among the 561 patients, 299 (53.3%) were males and the average age of the patients was 49.61 ± 18.73 years. Of the CT scans, 408 (72.7%) were reported as normal. The average age of patients with normal, abnormal, and potentially abnormal CT scans was 47.57 ± 19.06, 54.80 ± 16.70, and 58.14 ± 16.60 years, respectively (p-value < 0.001). The average effective dose was 1.89 ± 0.21 mSv, with 1.76 ± 0.11 mSv for males and 2.05 ± 0.29 mSv for females (p-value < 0.001). The average risk of lung cancer was 3.84 ± 1.19 and 9.73 ± 3.27 cases per 100,000 patients for males and females, respectively. The average LAR for all cancer types was 10.30 ± 6.03 cases per 100,000 patients. CONCLUSIONS: This study highlights the critical issue of increased CT scan usage for COVID-19 diagnosis and the potential long-term consequences, especially the risk of cancer incidence. Healthcare policies should be prepared to address this potential rise in cancer incidence and the utilization of CT scans should be restricted to cases where laboratory tests are not readily available or when clinical symptoms are severe.

Incidence of surgically treated chronic subdural hematoma after head injury with normal initial computed tomography.

PURPOSE: The objective was to determine the incidence of surgically treated chronic subdural hematoma (cSDH) within six months after head trauma in a consecutive series of head injury patients with a normal initial computed tomography (CT). METHODS: A total of 1941 adult patients with head injuries who underwent head CT within 48 h after injury and were treated at the Tampere University Hospital's emergency department were retrospectively evaluated from medical records (median age = 59 years, IQR = 39-79 years, males = 58%, patients using antithrombotic medication = 26%). Patients with no signs of acute traumatic intracranial pathology or any type of subdural collection on initial head CT were regarded as CT negative (n = 1573, 81%). RESULTS: Two (n = 2) of the 1573 CT negative patients received surgical treatment for cSDH. Consequently, the incidence of surgically treated cSDH after a normal initial head CT during a six-month follow-up was 0.13%. Both patients sustained mild traumatic brain injuries initially. One of the two patients was on antithrombotic medication (warfarin) at the time of trauma, hence incidence of surgically treated cSDH among patients with antithrombotic medication in CT negative patients (n = 376, 23.9%) was 0.27%. Additionally, within CT negative patients, one subdural hygroma was operated shortly after trauma. CONCLUSION: The extremely low incidence of surgically treated cSDH after a normal initial head CT, even in patients on antithrombotic medication, supports the notion that routine follow-up imaging after an initial normal head CT is not indicated to exclude the development of cSDH. Additionally, our findings support the concept of cSDH not being a purely head trauma-related disease.

HCC portal hypertension imaging score derived from CT predicts re-bleeding and mortality after acute variceal bleeding.

BACKGROUND/PURPOSE: Risk factors for re-bleeding and death after acute variceal bleeding (AVB) in cirrhotic HCC patients are not fully understood.We aimed to (1) explore how the combination of high-risk esophageal varices, HCC status, and portal vein tumor thrombus (i.e., HCC Portal Hypertension Imaging Score [HCCPHTIS]) helps predict increased risk of variceal re-bleeding and mortality; (2) assess predictability and reproducibility of the identified variceal re-bleeding rules. METHODS: This prospective study included 195 HCC patients with first-time AVB and liver cirrhosis, and conducted multivariable Cox regression analysis and Kaplan-Meier analysis. Receiver operating characteristic curve analysis was calculated to find the optimal sensitivity, specificity, and cutoff values of the variables. The reproducibility of the results obtained was verified in a different but related group of patients. RESULTS: 56 patients (28.7%) had re-bleeding within 6 weeks; HCCPHTIS was an independent risk factor for variceal re-bleeding after AVB (Odd ratio, 2.330; 95% confidence interval: 1.728-3.142, p < 0.001). The positive predictive value of HCCPHTIS cut off value > 3 was 66.2%, sensitivity 83.9%, and specificity 82.3%. HCCPHTIS area under the curve was higher than Child-Pugh score (89% vs. 75%, p < 0.001). 74(37.9%) death occurred within 6 weeks; HCCPHTIS > 4 was associated with increased risk of death within 6 weeks after AVB (p < 0.001). CONCLUSION: HCCPHTIS > 3 is a strong predictor of variceal re-bleeding within the first 6 weeks. However, patients with HCCPHTIS > 4 were at increased risk of death within 6 weeks.

Characterizing imaging radiation risk in a population of 8918 patients with recurrent imaging for a better effective dose.

An updated extension of effective dose was recently introduced, namely relative effective dose ( E r ), incorporating age and sex factors. In this study we extended E r application to a population of about 9000 patients who underwent multiple CT imaging exams, and we compared it with other commonly used radiation protection metrics in terms of their correlation with radiation risk. Using Monte Carlo methods, E r , dose-length-product based effective dose ( E DLP ), organ-dose based effective dose ( E OD ), and organ-dose based risk index ( RI ) were calculated for each patient. Each metric's dependency to RI was assessed in terms of its sensitivity and specificity. E r showed the best sensitivity, specificity, and agreement with RI (R2 = 0.97); while E DLP yielded the lowest specificity and, along with E OD , the lowest sensitivity. Compared to other metrics, E r provided a closer representation of patient and group risk also incorporating age and sex factors within the established framework of effective dose.

The CT-guided percutaneous drainage of pancreatic pseudocyst accompanied by pseudoaneurysm: A case report.

RATIONALE: This case report discusses the CT-guided percutaneous drainage of a pancreatic pseudocyst accompanied by a pseudoaneurysm. Pancreatic pseudocysts can erode the peripancreatic artery and produce pseudoaneurysms. This is rare, but it can be life-threatening. PATIENT CONCERNS: The case presented involves a 58-year-old female who was diagnosed with pancreatic cancer and underwent surgical treatment. She presented with hematochezia, dizziness, and hypodynamic findings with no obvious cause. Imaging revealed a pancreatic pseudocyst and small arterial aneurysms. To reduce the risk of aneurysm rupture, the patient underwent transcatheter arterial coil embolization. Three days later, CT-guided catheter drainage was performed to reduce the erosion of the arterial wall caused by pancreatic fluid. DIAGNOSES: The contrast-enhanced-CT imaging showed a round, slightly high-density lesion in the cyst, suggesting the presence of a pseudoaneurysm. INTERVENTIONS: The patient was sent for another transcatheter arterial embolization with coils and n-butyl-2-cyanoacrylate. OUTCOMES: After receiving the transcatheter arterial embolization, the patient had no serious bleeding or other complications. LESSONS: Early detection and accurate assessment of pseudoaneurysms are essential for appropriate management. This case shows that contrast-enhanced CT is necessary before CT-guided percutaneous drainage of pancreatic pseudocysts. It also shows that, due to the many complications that pancreatic pseudocysts may cause, appropriate treatment of pseudocysts complicated with pseudoaneurysm has important clinical significance.

Bilateral Os Trigonum Fracture Treated With Simultaneous Posterior Ankle Arthroscopy.

This is a case report of a 21-year-old female undergraduate student who sustained bilateral ankle injuries while jumping from a moving van wearing 3-inch high heel shoes. Upon initial presentation, her injury was treated conservatively as an acute bilateral ankle sprain for 6 weeks. However, the patient reported no improvement of pain and remained unable to self-ambulate. Bilateral MRI and CT scans of both ankles demonstrated bilateral os trigonum fractures. She underwent bilateral posterior ankle arthroscopic débridement of both os trigonum. At the postoperative 36-month follow-up, the patient reported notable improvement of all functional outcomes (36-item Short Form survey and Foot and Ankle Ability Measure), reported return to the same level of sports activities, and experienced no pain (visual analog scale) on either ankle. This is the first report in the literature of bilateral os trigonum fracture treated with simultaneous posterior ankle arthroscopic débridement.

Finite-Sample Bias of the Linear Excess Relative Risk in Cohort Studies of Computed Tomography-Related Radiation Exposure and Cancer.

The linear excess relative risk (ERR) is the most commonly reported measure of association in radiation epidemiological studies, when individual dose estimates are available. While the asymptotic properties of the ERR estimator are well understood, there is evidence of small sample bias in case-control studies of treatment-related radiation exposure and second cancer risk. Cohort studies of cancer risk after exposure to low doses of radiation from diagnostic procedures, e.g., computed tomography (CT) examinations, typically have small numbers of cases and risks are small. Therefore, understanding the properties of the estimated ERR is essential for interpretation and analysis of such studies. We present results of a simulation study that evaluates the finite-sample bias of the ERR estimated by time-to-event analyses and its confidence interval using simulated data, resembling a retrospective cohort study of radiation-related leukemia risk after CT examinations in childhood and adolescence. Furthermore, we evaluate how the Firth-corrected estimator reduces the finite-sample bias of the classical estimator. We show that the ERR is overestimated by about 30% for a cohort of about 150,000 individuals, with 42 leukemia cases observed on average. The bias is reduced for higher baseline incidence rates and for higher values of the true ERR. As the number of cases increases, the ERR is approximately unbiased. The Firth correction reduces the bias for all cohort sizes to generally around or under 5%. Epidemiological studies showing an association between radiation exposure from pediatric CT and cancer risk, unless very large, may overestimate the magnitude of the relationship, while there is no evidence of an increased chance for false-positive results. Conducting large studies, perhaps by pooling individual studies to increase the number of cases, should be a priority. If this is not possible, Firth correction should be applied to reduce small-sample bias.

Evaluation of risks of cardiovascular disease from radiation exposure linked to computed tomography scans in the UK.

Epidemiological studies of patient populations have shown that high doses of radiation increase risks of cardiovascular disease (CVD). Results from a recent meta-analysis of 93 epidemiological studies covering a wide range of doses provided evidence of a causal association between radiation exposure and CVD, and indicated excess relative risk per Gy for maximum dose below 500 mGy or delivered at low dose rates. These doses cover the range of organ doses expected from multiple diagnostic computed tomography (CT) scans. Dose-effect factors for the excess absolute risk of mortality from CVD following radiation exposure were derived from the meta-analysis. The present study uses these factors to estimate excess risks of mortality for various types of CVD, including cerebrovascular disease (CeVD), from CT scans of the body and head, assuming that the meta-analytic factors were accurate and represented a causal relationship. Estimates are based on cumulative doses to the heart and brain from CT scans performed on 105 574 patients on 12 CT scanners over a period of 5½ years. The results suggest that the excess number of deaths from CeVD could be 7 or 26 per 100 000 patients depending whether threshold brain doses of 200 mGy or 50 mGy, respectively are assumed. These results could have implications for head CT scans. However, the results rely on the validity of risk factors derived in the meta-analysis informing this assessment and which include significant uncertainties. Further incidence studies should provide better information on risk factors and dose thresholds, particularly for CeVD following head CT scans.

Impact of CT and MRI in the diagnostic workup of malignant triton tumour-a monocentric analysis and review of the literature.

OBJECTIVES: Malignant triton tumours (MTTs) are rare but aggressive subtypes of malignant peripheral nerve sheath tumours (MPNSTs) with a high recurrence rate and 5-year survival of 14%. Systematic imaging data on MTTs are scarce and mainly based on single case reports. Therefore, we aimed to identify typical CT and MRI features to improve early diagnosis rates of this uncommon entity. METHODS: A systematic review on literature published until December 2022 on imaging characteristics of MTTs was performed. Based on that, we conducted a retrospective, monocentric analysis of patients with histopathologically proven MTTs from our department. Explorative data analysis was performed. RESULTS: Initially, 29 studies on 34 patients (31.42 ± 22.6 years, 12 female) were evaluated: Literature described primary MTTs as huge, lobulated tumours (108 ± 99.3 mm) with central necrosis (56% [19/34]), low T1w (81% [17/21]), high T2w signal (90% [19/21]) and inhomogeneous enhancement on MRI (54% [7/13]). Analysis of 16 patients (48.9 ± 13.8 years; 9 female) from our institution revealed comparable results: primary MTTs showed large, lobulated masses (118 mm ± 64.9) with necrotic areas (92% [11/12]). MRI revealed low T1w (100% [7/7]), high T2w signal (100% [7/7]) and inhomogeneous enhancement (86% [6/7]). Local recurrences and soft-tissue metastases mimicked these features, while nonsoft-tissue metastases appeared unspecific. CONCLUSIONS: MTTs show characteristic features on CT and MRI. However, these do not allow a reliable differentiation between MTTs and other MPNSTs based on imaging alone. Therefore, additional histopathological analysis is required. ADVANCES IN KNOWLEDGE: This largest published systematic analysis on MTT imaging revealed typical but unspecific imaging features that do not allow a reliable, imaging-based differentiation between MTTs and other MPNSTs. Hence, additional histopathological analysis remains essential.

Carolyn's window approach for spontaneous frontal sinus meningoencephalocele.

Spontaneous meningoencephaloceles (MECs) are sparsely documented in the literature. Those occurring in the frontal sinus are an exceedingly rare entity. MECs are commonly associated with cerebrospinal fluid (CSF) rhinorrhoea. CSF rhinorrhoea is frequently misdiagnosed, causing delays in diagnosis and management. The subsequently increased risk of bacterial meningitis can be life-threatening to patients. We report the case of a woman in her late 70s with a spontaneous frontal sinus MEC, presenting with a 6-month history of CSF rhinorrhoea. The patient was successfully treated using the novel Carolyn's window approach endoscopically; 9-month follow-up revealed no skull-base breach. Our case emphasises the importance of considering MEC as a differential diagnosis for clear rhinorrhoea and demonstrates successful repair through a novel surgical approach.

Dynamic ultrasonography for optimizing treatment position in superior mesenteric artery syndrome: Two case reports and review of literature.

BACKGROUND: Superior mesenteric artery (SMA) syndrome is a rare cause of duodenal obstruction by extrinsic compression between the SMA and the aorta (SMA-Ao). Although the left lateral recumbent position is considered effective in the treatment of SMA syndrome, individual variations in the optimal patient position have been noted. In this report, we present two elderly cases of SMA syndrome that exhibited rapid recovery due to ultrasonographic dynamic evaluation of the optimal position for each patient. CASE SUMMARY: Case 1: A 90-year-old man with nausea and vomiting. Following diagnosis of SMA syndrome by computed tomography (CT), ultrasonography (US) revealed the SMA-Ao distance in the supine position (4 mm), which slightly improved in the lateral position (5.7-7.0 mm) without the passage of duodenal contents. However, in the sitting position, the SMA-Ao distance was increased to 15 mm accompanied by improved content passage. Additionally, US indicated enhanced passage upon abdominal massage on the right side. By day 2, the patient could eat comfortably with the optimal position and massage. Case 2: An 87-year-old woman with vomiting. After the diagnosis of SMA syndrome and aspiration pneumonia by CT, dynamic US confirmed the optimal position (SMA-Ao distance was improved to 7 mm in forward-bent position, whereas it remained at 5 mm in the supine position). By day 7 when her pneumonia recovered, she could eat with the optimal position. CONCLUSION: The optimal position for SMA syndrome varies among individuals. Dynamic US appears to be a valuable tool in improving patient outcomes.

[Risks of radiodiagnostic examinations in children]. / Risques des examens radiodiagnostiques chez l'enfant.

RISKS OF RADIODIAGNOSTIC EXAMINATIONS IN CHILDREN. The question of cancer risk associated with diagnostic medical exposure during childhood is important in view of the sharp increase in the use of radiological examinations, particularly computed tomography (CT), since the 2000s. Moreover, children represent a population particularly sensitive to ionizing radiation. Although conventional radiology examinations do not seem to be associated with an increased risk of cancer, several epidemiological studies, including some with high statistical power, show an increased risk of leukemia and brain tumors in children exposed to CT scans. These results reinforce the importance of the principles of radiation protection already applied daily in radiology, based on the justification of procedures, substitution as far as possible by techniques that do not expose patients to ionizing radiations (ultrasound and magnetic resonance imaging) and, if the use of CT scanners remains essential, systematic optimization of the doses delivered.

RISQUES DES EXAMENS RADIODIAGNOSTIQUES CHEZ L'ENFANT. La question du risque de cancer associé à l'exposition médicale à visée diagnostique pendant l'enfance est importante face à la forte augmentation de l'utilisation des examens radiologiques, notamment des scanners depuis les années 2000. De plus, les enfants représentent une population particulièrement sensible aux rayonnements ionisants. Si les examens de radiologie conventionnelle ne semblent pas associés à un sur-risque de cancer, plusieurs études épidémiologiques, dont certaines de grande puissance statistique, montrent une augmentation du risque de leucémie et de tumeur cérébrale pour des enfants exposés au scanner. Ces résultats renforcent l'importance du respect des principes de radioprotection déjà appliqués quotidiennement en radiologie reposant sur la justification des actes, la substitution autant que possible par des techniques n'exposant pas aux rayonnements ionisants (échographie et imagerie par résonance magnétique) et, si l'emploi du scanner reste indispensable, l'optimisation systématique des doses délivrées.

Traumatic subcutaneous emphysema following blood donation: A case report.

BACKGROUND: Subcutaneous emphysema is a condition where air becomes trapped under the skin, typically resulting from surgery or skin trauma. It is mostly localized and its occurrence in blood donors is exceedingly rare. Phlebotomy poses minimal risk of subcutaneous emphysema, but procedural errors may lead to such complications. STUDY DESIGN AND METHOD: This is a case report of 29-year-old repeat blood donor who experienced subcutaneous emphysema following blood donation. The donor was vigorously squeezing sponge ball during donation resulting in displacement of the needle which required readjustment. Post-donation, the donor reported a crackling sensation and mild swelling near phlebotomy site. Non-contrast computed tomography (NCCT) scans confirmed subcutaneous emphysema, attributing its development to air trapping in subcutaneous plane due to ball valve mechanism. RESULTS: Computed tomography (CT) imaging revealed subcutaneous emphysematous changes in the right cubital region and no evidence of hematoma. The swelling spontaneously subsided in 10-12 days without any intervention. The case underscores the importance of differentiating subcutaneous emphysema from common complications like hematoma. DISCUSSION: Subcutaneous emphysema in blood donors is exceptionally rare but should be managed with clear communication. Donors should be reassured that the condition, although rare, is benign and self-resolving. Healthcare providers should be equipped to handle such rare complications, offering appropriate care and documenting incidents for future prevention.

Multifocal emphysematous osteomyelitis, a do not miss diagnosis for the emergency radiologist: a case report with literature review.

Emphysematous osteomyelitis (EO) is an uncommon fatal condition with high morbidity and mortality. Simultaneous involvement of the axial and appendicular skeleton with multifocal disease is even rarer, with only a few cases being reported in the literature. We present a case of multifocal emphysematous osteomyelitis in a 56-year-old woman with concurrent emphysematous pyelonephritis complicated by psoas and epidural abscesses. The causative organism in our patient was Escherichia coli. Emergency radiologists should be aware of this condition and differentiate it from other benign entities that can present with intraosseous gas. Prompt diagnosis is important given the high morbidity and mortality with this condition. This case report emphasizes the specific pattern of intraosseous gas seen with EO, which can help diagnose EO with confidence.

Pediatric Traumatic Lumbar Hernias and Associated Injuries: A Case Series.

OBJECTIVE: Traumatic lumbar hernias are a rare entity mostly seen with high-impact, blunt abdominal trauma. This injury occurs when there is disruption of the posterior musculature along with bony structures, allowing for herniation of abdominal contents. There are minimal cases of this entity reported in adults, but even fewer in the pediatric population. METHODS: We describe 3 cases of traumatic lumbar hernia at our institution as well as provide a review of the literature to elucidate the most common mechanisms, severity of injury, and associated injuries. RESULTS: Traumatic lumbar hernia is most commonly seen in restrained passengers involved in motor vehicle collisions. A majority of cases are diagnosed using computed tomography imaging and less frequently during primary surgical exploration. The most common associated injuries were mesenteric and bowel injuries, followed by spinal and chest trauma. Traumatic lumbar hernia often leads to prolonged hospital stays and increased need for posthospital rehabilitation because of associated traumatic comorbidities. CONCLUSIONS: Traumatic lumbar hernia is a rare entity in children, and early suspicion and identification of associated injuries is necessary in the management of these patients.

Spontaneous splenic rupture in a neonate: a case report and literature review.

Splenic rupture in a neonate is a rare but potentially fatal condition that may trigger evaluation for child abuse. It is a diagnosis of exclusion that has been reported in the surgical literature but may be underrecognized by pediatric radiologists. We report a case of a newborn with an unremarkable prenatal, delivery, and nursery course who presented with anemia, abdominal distension, and lethargy. Abdominal ultrasound with Doppler and computed tomography (CT) of the head, cervical spine, chest, abdomen, and pelvis without contrast showed findings of splenic rupture and anoxic brain injury. An extensive workup for traumatic, infectious, coagulopathic, and congenital etiologies was unrevealing, leading to a presumptive diagnosis of spontaneous splenic rupture in a neonate.

Unusual case of 'scorbutic proptosis'.

Proptosis is a frequent presenting symptom/sign of many paediatric malignancies. Acute-onset proptosis is an ophthalmic emergency that can endanger vision if not treated promptly. Appropriate treatment must be instituted only after investigating for the underlying aetiology. Here, we report a developmentally delayed boy in middle childhood who presented with recent onset bilateral proptosis. Clinical examination followed by radiological evaluation suggested scurvy to be the underlying cause and vitamin C supplementation led to prompt reversal of proptosis. The relevant literature has been reviewed and presented here to apprise the paediatric oncologists about this rare but easily treatable cause of proptosis.

Preoperative computed tomography-imaging with patient-specific computer simulation in transcatheter aortic valve implantation: Design and rationale of the GUIDE-TAVI trial.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic valve stenosis, but is still associated with relatively high rates of pacemaker implantation and paravalvular regurgitation. Routine preoperative computed tomography (CT) combined with patient-specific computer modelling can predict the interaction between the TAVI device and the patient's unique anatomy, allowing physicians to assess the risk for paravalvular regurgitation and conduction disorders in advance to the procedure. The aim of this trial is to assess potential improvement in the procedural outcome of TAVI by applying CT-based patient-specific computer simulations in patients with suitable anatomy for TAVI. METHODS: The GUIDE-TAVI trial is an international multicenter randomized controlled trial including patients accepted for TAVI by the Heart Team. Patients enrolled in the study will be randomized into 2 arms of each 227 patients. In patients randomized to the use of FEops HEARTGuide (FHG), patient-specific computer simulation with FHG is performed in addition to routine preoperative CT imaging and results of the FHG are available to the operator(s) prior to the scheduled intervention. In patients randomized to no use of FHG, only routine preoperative CT imaging is performed. The primary objective is to evaluate whether the use of FHG will reduce the incidence of mild to severe PVR, according to the Valve Academic Research Consortium 3. Secondary endpoints include the incidence of new conduction disorders requiring permanent pacemaker implantation, the difference between preoperative and final selected valve size, the difference between target and final implantation depth, change of preoperative decision, failure to implant valve, early safety composite endpoint and quality of life. CONCLUSIONS: The GUIDE-TAVI trial is the first multicenter randomized controlled trial to evaluate the value of 3-dimensional computer simulations in addition to standard preprocedural planning in TAVI procedures.