High-Temperature Polylactic Acid Proves Reliable and Safe for Manufacturing 3D-Printed Patient-Specific Instruments in Pediatric Orthopedics-Results from over 80 Personalized Devices Employed in 47 Surgeries.

(1) Background: Orthopedic surgery has been transformed by 3D-printed personalized instruments (3DP-PSIs), which enhance precision and reduce complications. Hospitals are adopting in-house 3D printing facilities, using cost-effective methods like Fused Deposition Modeling (FDM) with materials like Polylactic acid (PLA) to create 3DP-PSI. PLA's temperature limitations can be overcome by annealing High-Temperature PLA (ann-HTPLA), enabling steam sterilization without compromising properties. Our study examines the in vivo efficacy of ann-HTPLA 3DP-PSI in pediatric orthopedic surgery. (2) Methods: we investigated safety and efficacy using ann-HTPLA 3DP-PSI produced at an "in-office" 3D-printing Point-of-Care (3DP-PoC) aimed at correcting limb deformities in pediatric patients. Data on 3DP-PSI dimensions and printing parameters were collected, along with usability and complications. (3) Results: Eighty-three ann-HTPLA 3DP-PSIs were utilized in 33 patients (47 bone segments). The smallest guide used measured 3.8 cm3, and the largest measured 58.8 cm3. Seventy-nine PSIs (95.2%; 95% C.I.: 88.1-98.7%) demonstrated effective use without issues. Out of 47 procedures, 11 had complications, including 2 infections (4.3%; 95% CI: 0.5-14.5%). Intraoperative use of 3DP-PSIs did not significantly increase infection rates or other complications. (4) Conclusions: ann-HTPLA has proven satisfactory usability and safety as a suitable material for producing 3DP-PSI in an "in-office" 3DP-PoC.

Virtual Surgical Planning and Patient-Specific Instruments for Correcting Lower Limb Deformities in Pediatric Patients: Preliminary Results from the In-Office 3D Printing Point of Care.

(1) Background: Virtual reality and 3D printing are transforming orthopedic surgery by enabling personalized three-dimensional (3D) models for surgical planning and Patient-Specific Instruments (PSIs). Hospitals are establishing in-house 3D printing centers to reduce costs and improve patient care. Pediatric orthopedic surgery also benefits from these technologies, enhancing the precision and personalization of treatments. This study presents preliminary results of an In-Office 3D Printing Point of Care (PoC), outlining considerations and challenges in using this program for treating lower limb deformities in pediatric patients through Virtual Surgical Planning (VSP) and 3D-printed Patient-Specific Instruments (PSIs). (2) Materials and Methods: Pediatric patients with congenital or acquired lower limb deformities undergoing surgical correction based on VSP, incorporating 3D-printed PSIs when required, were included in this study. The entire process of VSP and 3D printing at the In-Office PoC was illustrated. Data about deformity characteristics, surgical procedures, and outcomes, including the accuracy of angular correction, surgical times, and complications, were reported. (3) Results: In total, 39 bone correction procedures in 29 patients with a mean age of 11.6 ± 4.7 years (range 3.1-18.5 years) were performed according to VSP. Among them, 23 procedures were accomplished with PSIs. Surgeries with PSIs were 45 min shorter, with fewer fluoroscopy shots. Optimal correction was achieved in 37% of procedures, while the remaining cases showed under-corrections (41%) or over-corrections (22%). Major complications were observed in four patients (13.8%). (4) Conclusions: The In-Office 3D Printing Point of Care is becoming an essential tool for planning and executing complex corrections of lower limb deformities, but additional research is needed for optimizing the prediction and accuracy of the achieved corrections.

Side-to-Side Flipping Wedge Osteotomy: Virtual Surgical Planning Suggested an Innovative One-Stage Procedure for Aligning Both Knees in "Windswept Deformity".

(1) Background: The adoption of Virtual Surgical Planning (VSP) and 3D technologies is rapidly growing within the field of orthopedic surgery, opening the door to highly innovative and individually tailored surgical techniques. We present an innovative correction approach successfully used in a child affected by "windswept deformity" of the knees. (2) Methods: We report a case involving a child diagnosed with "windswept deformity" of the knees. This condition was successfully addressed through a one-stage bilateral osteotomy of the distal femur. Notably, the wedge removed from the valgus side was flipped and employed on the varus side to achieve the correction of both knees simultaneously. The surgical technique was entirely conceptualized, simulated, and planned in a virtual environment. Customized cutting guides and bony models were produced at an in-hospital 3D printing point of care and used during the operation. (3) Results: The surgery was carried out according to the VSP, resulting in favorable outcomes. We achieved good corrections of the angular deformity with an absolute difference from the planned correction of 2° on the right side and 1° on the left side. Moreover, this precision not only improved surgical outcomes but also reduced the procedure's duration and overall cost, highlighting the efficiency of our approach. (4) Conclusions: The integration of VSP and 3D printing into the surgical treatment of rare limb anomalies not only deepens our understanding of these deformities but also opens the door to the development of innovative, personalized, and adaptable approaches for addressing these unique conditions.

Coronary Plaque Characteristics Associated With Major Adverse Cardiovascular Events in Atherosclerotic Patients and Lesions: A Systematic Review and Meta-Analysis.

BACKGROUND: The clinical value of high-risk coronary plaque characteristics (CPCs) to inform intensified medical therapy or revascularization of non-flow-limiting lesions remains uncertain. OBJECTIVES: The authors performed a systematic review and meta-analysis to study the prognostic impact of CPCs on patient-level and lesion-level major cardiovascular adverse events (MACE). METHODS: Thirty studies (21 retrospective, 9 prospective) with 30,369 patients evaluating the association of CPCs with MACE were included. CPCs included high plaque burden, low minimal lumen area, thin cap fibroatheroma, high lipid core burden index, low-attenuation plaque, spotty calcification, napkin ring sign, and positive remodeling. RESULTS: CPCs were evaluated with the use of intracoronary modalities in 9 studies (optical coherence tomography in 4 studies, intravascular ultrasound imaging in 3 studies, and near-infrared spectroscopy intravascular ultrasound imaging in 2 studies) and by means of coronary computed tomographic angiography in 21 studies. CPCs significantly predicted patient-level and lesion-level MACE in both unadjusted and adjusted analyses. For most CPCs, accuracy for MACE was modest to good at the patient level and moderate to good at the lesion level. Plaques with more than 1 CPC had the highest accuracy for lesion-level MACE (AUC: 0.87). Because the prevalence of CPCs among plaques was low, estimated positive predictive values for lesion-level MACE were modest. Results were mostly consistent across imaging modalities and clinical presentations, and in studies with prevailing hard outcomes. CONCLUSIONS: Characterization of CPCs identifies high-risk atherosclerotic plaques that place lesions and patients at risk for future MACE, albeit with modest sensitivity and positive predictive value (Coronary Plaque Characteristics Associated With Major Adverse Cardiovascular Events Among Atherosclerotic Patients and Lesions; CRD42021251810).

Is the High Healing Index a Complication of Progressive Long Bone Lengthening? Observations from a Cohort of 178 Children Treated with Circular External Fixation for Lower Limb Length Discrepancy.

The use of external fixators (EFs) for lower limb lengthening is common for treating lower limb length discrepancy (LLD) in children. The concern at present revolves around extended treatment times, with some suggesting a healing index (HI) > 45 days/cm as a major complication. The aim of this study is to assess the factors affecting bone healing and treatment duration in children who undergo limb lengthening for LLD using circular EFs. A total of 240 lengthening procedures on 178 children affected by congenital or acquired LLDs (mean age at surgery 13.8 ± 2.8 years) were retrospectively evaluated. Complications according to Lascombes' classification and treatment duration factors were analyzed. Mean HI was 57 ± 25 days/cm for the femur and 55 ± 24 days/cm for the tibia, with an HI > 45 days/cm in 64% of the procedures. A total of 189 procedures (79%) reported complications; 85 had an HI > 45 days/cm as the sole complication. While reducing the frame time is crucial, revising the classifications is necessary to avoid the overestimation of complications.

Recurrence and Complication Rates of Surgical Treatment for Blount's Disease in Children: A Systematic Review and Meta-Analysis.

BACKGROUND: Blount's disease is a growth disorder of the proximal tibia that causes progressive genu varum in children. Surgical treatment is recommended if the deformity worsens, but which intervention is best remains controversial. This study aims to identify factors influencing outcomes and determine the most effective surgical approach. METHODS: A systematic review was conducted of studies published before January 2022. RESULTS: In total, 63 retrospective studies with CEBM IIIb/IV levels were included (1672 knees in 1234 patients). The most commonly reported treatment was acute correction via osteotomy (47%), followed by hemiepiphysiodesis (22%) and gradual correction (18%). Combined procedures were reported in 13% of cases. The overall recurrence rate was 18%, with a significant difference when comparing the recurrence rates after gradual correction with those after hemiepiphysiodesis (7% and 29%, respectively). Major complications beyond recurrence were observed in 5% of cases. A meta-analysis of the available raw data showed a significantly increased recurrence rate (39%) among treated children who were between 4.5 and 11.25 years of age and were followed for a minimum follow-up of 2.5 years. CONCLUSIONS: Overall, poor evidence with which to establish an optimal treatment for Blount's disease was found. This study remarked on the need for early diagnosis, classification, and treatment of infantile tibia vara, since a significant rate of recurrence was found in neglected cases.

The Flipping-Wedge Osteotomy: How 3D Virtual Surgical Planning (VSP) Suggested a Simple and Promising Type of Osteotomy in Pediatric Post-Traumatic Forearm Deformity.

(1) Background: The application of computer-aided planning in the surgical treatment of post-traumatic forearm deformities has been increasingly widening the range of techniques over the last two decades. We present the "flipping-wedge osteotomy", a promising geometrical approach to correct uniapical deformities defined during our experience with virtual surgical planning (VSP); (2) Methods: a case of post-traumatic distal radius deformity (magnitude 43°) treated with a flipping-wedge osteotomy in an 11-year-old girl is reported, presenting the planning rationale, its geometrical demonstration, and the outcome of the procedure; (3) Results: surgery achieved correction of both the angular and rotational deformities with a neutral ulnar variance; (4) Conclusions: flipping-wedge osteotomy may be a viable option to achieve correction in forearm deformities, and it deserves further clinical investigation.

A 20-Year Retrospective Study of Children and Adolescents Treated by the Three-in-One Procedure for Patellar Realignment.

BACKGROUND: Patellar instability is the most common disorder of the knee during childhood and adolescence. Surgical treatment significantly reduces the rate of redislocation, but the underlying pathologies and pattern of instability may affect the results. We aimed to report the clinical and functional outcomes of the three-in-one procedure for patellar realignment in a cohort of skeletally immature patients with or without syndromes and various patterns of chronic patellar instability. METHODS: We retrospectively investigated 126 skeletally immature patients (168 knees) affected by idiopathic or syndromic patellar instability, who underwent patella realignment through a three-in-one procedure. We classified the instability according to the score proposed by Parikh and Lykissas. RESULTS: Patellar dislocation was idiopathic in 71 patients (94 knees; 56.0%) and syndromic in 55 (74 knees; 44.0%). The mean age at surgery was 11.5 years (range 4-18) and was significantly lower in syndromic patients. Syndromic patients also exhibited more severe clinical pattern at presentation, based on the Parikh and Lykissas score. The mean follow-up was 5.3 years (range 1.0-15.4). Redislocation occurred in 19 cases, with 10 cases requiring further realignment. The Parikh and Lykissas score and the presence of congenital ligamentous laxity were independent predictors of failure. A total of 22 knees in 18 patients required additional surgical procedures. The post-operative Kujala score was significantly lower in patients with syndromic patellar instability. CONCLUSIONS: The type of instability and the presence of underlying syndromes negatively affect the rate of redislocation and the clinical and functional outcome following patellar realignment through the three-in-one procedure. We recommend the consideration of alternative surgical strategies, especially in children with severe syndromic patellar dislocation.

Virtual Surgical Planning, 3D-Printing and Customized Bone Allograft for Acute Correction of Severe Genu Varum in Children.

Complex deformities of lower limbs are frequent in children with genetic or metabolic skeletal disorders. Early correction is frequently required, but it is technically difficult and burdened by complications and recurrence. Herein, we described the case of a 7-year-old girl affected by severe bilateral genu varum due to spondyloepiphyseal dysplasia. The patient was treated by patient-specific osteotomies and customized structural wedge allograft using Virtual Surgical Planning (VSP) and 3D-printed patient-specific instrumentation (PSI). The entire process was performed through an in-hospital 3D-printing Point-of-Care (POC). VSP and 3D-printing applied to pediatric orthopedic surgery may allow personalization of corrective osteotomies and customization of structural allografts by using low-cost in-hospital POC. However, optimal and definitive alignment is rarely achieved in such severe deformities in growing skeleton through a single operation.

A case report of long-term successful stereotactic arrhythmia radioablation in a cardiac contractility modulation device carrier with giant left atrium, including a detailed dosimetric analysis.

Introduction: Catheter ablation (CA) is the current standard of care for patients suffering drug-refractory monomorphic ventricular tachycardias (MMVTs). Yet, despite significant technological improvements, recurrences remain common, leading to increased morbidity and mortality. Stereotactic arrhythmia radioablation (STAR) is increasingly being adopted to overcome the limitations of conventional CA, but its safety and efficacy are still under evaluation. Case presentation: We hereby present the case of a 73-year-old patient implanted with a mitral valve prosthesis, a cardiac resynchronization therapy-defibrillator, and a cardiac contractility modulation device, who was successfully treated with STAR for recurrent drug and CA-resistant MMVT in the setting of advanced heart failure and a giant left atrium. We report a 2-year follow-up and a detailed dosimetric analysis. Conclusion: Our case report supports the early as well as the long-term efficacy of 25 Gy single-session STAR. Despite the concomitant severe heart failure, with an overall heart minus planned target volume mean dosage below 5 Gy, no major detrimental cardiac side effects were detected. To the best of our knowledge, our dosimetric analysis is the most accurate reported so far in the setting of STAR, particularly for what concerns cardiac substructures and coronary arteries. A shared dosimetric planning among centers performing STAR will be crucial in the next future to fully disclose its safety profile.

Diagnostic accuracy of coronary computed tomography angiography for the evaluation of obstructive coronary artery disease in patients referred for transcatheter aortic valve implantation: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the diagnostic accuracy of coronary computed tomography angiography (CCTA) for the evaluation of obstructive coronary artery disease (CAD) in patients referred for transcatheter aortic valve implantation (TAVI). METHODS: EMBASE, PubMed/MEDLINE, and CENTRAL were searched for studies reporting accuracy of CCTA for the evaluation of obstructive CAD compared with invasive coronary angiography (ICA) as the reference standard. QUADAS-2 tool was used to assess the risk of bias. A bivariate random effects model was used to analyze, pool, and plot the diagnostic performance measurements across studies. Pooled sensitivity, specificity, positive ( + LR) and negative (-LR) likelihood ratio, diagnostic odds ratio (DOR), and hierarchical summary ROC curve (HSROC) were evaluated. Prospero registration number: CRD42021252527. RESULTS: Fourteen studies (2533 patients) were included. In the intention-to-diagnose patient-level analysis, sensitivity and specificity for CCTA were 97% (95% CI: 94-98%) and 68% (95% CI: 56-68%), respectively, and + LR and -LR were 3.0 (95% CI: 2.1-4.3) and 0.05 (95% CI: 0.03 - 0.09), with DOR equal to 60 (95% CI: 30-121). The area under the HSROC curve was 0.96 (95% CI: 0.94-0.98). No significant difference in sensitivity was found between single-heartbeat and other CT scanners (96% (95% CI: 90 - 99%) vs. 97% (95% CI: 94-98%) respectively; p = 0.37), whereas the specificity of single-heartbeat scanners was higher (82% (95% CI: 66-92%) vs. 60% (95% CI: 46 - 72%) respectively; p < 0.0001). Routine CCTA in the pre-TAVI workup could save 41% (95% CI: 34 - 47%) of ICAs if a disease prevalence of 40% is assumed. CONCLUSIONS: CCTA proved an excellent diagnostic accuracy for assessing obstructive CAD in patients referred for TAVI; the use of single-heartbeat CT scanners can further improve these findings. KEY POINTS: • CCTA proved to have an excellent diagnostic accuracy for assessing obstructive CAD in patients referred for TAVI. • Routine CCTA in the pre-TAVI workup could save more than 40% of ICAs. • Single-heartbeat CT scanners had higher specificity than others in the assessment of obstructive CAD in patients referred for TAVI.

Congenital Pseudarthrosis of the Clavicle in Children: A Systematic Review.

(1) Background: Congenital pseudoarthrosis of the clavicle is a rare condition due to the failure of the union process of the ossification nuclei of the clavicle. The aim of this study was to conduct a systematic review of relevant case series about the argument to find an up-to-date base of evidence for treatment choice. (2) Methods: an electronic literature research of Ovid, MEDLINE and the Cochrane Library databases was conducted, and articles were selected based on inclusion criteria. Demographic data, clinical features, treatment options, outcomes and complications were analyzed. (3) Results: 21 articles met the inclusion criteria, showing a poor overall study quality; 231 pediatric patients (240 clavicles) were analyzed. The condition was typically right sided, showed no sex predominance and no clear predisposing factors. 156 patients underwent surgical treatment, mainly open debridement and refresh of bony ends, fixation with pin or plate and bone graft, with a successful union rate of 87.4%. The nonunion rate was significantly higher in the allograft group (44.4%, p = 0.019). (4) Conclusions: this paper presents an updated systematic review about treatment of congenital pseudoarthrosis of the clavicle. We confirm the generally satisfactory results of surgery, demonstrating that successful union is achievable in 87.4% of cases with a prevalence of 15.7% of major complications. Nonetheless our results should be interpreted with caution due to several limitations.

Impact of lipid-lowering therapies on cardiovascular outcomes according to coronary artery calcium score. A systematic review and meta-analysis.

INTRODUCTION AND OBJECTIVES: Coronary artery calcium (CAC) score improves the accuracy of risk stratification for atherosclerotic cardiovascular disease (ASCVD) events compared with traditional cardiovascular risk factors. We evaluated the interaction of coronary atherosclerotic burden as determined by the CAC score with the prognostic benefit of lipid-lowering therapies in the primary prevention setting. METHODS: We reviewed the MEDLINE, EMBASE, and Cochrane databases for studies including individuals without a previous ASCVD event who underwent CAC score assessment and for whom lipid-lowering therapy status stratified by CAC values was available. The primary outcome was ASCVD. The pooled effect of lipid-lowering therapy on outcomes stratified by CAC groups (0, 1-100,> 100) was evaluated using a random effects model. RESULTS: Five studies (1 randomized, 2 prospective cohort, 2 retrospective) were included encompassing 35 640 individuals (female 38.1%) with a median age of 62.2 [range, 49.6-68.9] years, low-density lipoprotein cholesterol level of 128 (114-146) mg/dL, and follow-up of 4.3 (2.3-11.1) years. ASCVD occurrence increased steadily across growing CAC strata, both in patients with and without lipid-lowering therapy. Comparing patients with (34.9%) and without (65.1%) treatment exposure, lipid-lowering therapy was associated with reduced occurrence of ASCVD in patients with CAC> 100 (OR, 0.70; 95%CI, 0.53-0.92), but not in patients with CAC 1-100 or CAC 0. Results were consistent when only adjusted data were pooled. CONCLUSIONS: Among individuals without a previous ASCVD, a CAC score> 100 identifies individuals most likely to benefit from lipid-lowering therapy, while undetectable CAC suggests no treatment benefit.

Impact of computed-tomography defined sarcopenia on outcomes of older adults undergoing transcatheter aortic valve implantation.

BACKGROUND: The adoption of Computed tomography (CT)-defined sarcopenia to risk stratify transcatheter aortic valve implantation (TAVI) candidates remains limited by a lack of both standardized definition and evidence of independent value over currently adopted mortality prediction tools. METHODS: 391 consecutive TAVI patients with pre-procedural CT scan were included (81 â€‹± â€‹6 years, 57.5% male, STS-PROM score 4.4 â€‹± â€‹3.6%) and abdominal muscle retrospectively quantified. The two definitions of radiologic sarcopenia previously adopted in TAVI studies were compared (psoas muscle area [PMA] at the L4 vertebra level: "PMA-sarcopenia"; indexed skeletal muscle area at the L3 vertebra level: "SMI-sarcopenia"). The primary endpoint was longer available-term all-cause mortality. Secondary endpoints were Valve Academic Research Consortium-2-defined in-hospital and 30-day outcomes. RESULTS: SMI- and PMA-sarcopenia were present in 192 (49.1%) and 117 (29.9%) patients, respectively. After a median of 24 (12-30) months follow-up, 83 (21.2%) patients died. PMA-(adj-HR 1.81, 95%CI 1.12-2.93, p â€‹= â€‹0.015), but not SMI-sarcopenia (adj-HR 1.23, 95%CI 0.76-2.00, p â€‹= â€‹0.391), was associated with all-cause mortality independently of age, sex and in-study outcome predictors (atrial fibrillation, hemoglobin, history of peripheral artery disease, cancer and subcutaneous adipose tissue). PMA-defined sarcopenia provided additive prognostic value over current post-TAVI mortality risk estimators including STS-PROM (p â€‹= â€‹0.001), Euroscore II (p â€‹= â€‹0.025), Charlson index (p â€‹= â€‹0.025) and TAVI2-score (p â€‹= â€‹0.020). Device success, early safety, clinical efficacy and 30-day all-cause death were unaffected by sarcopenia status regardless of definition. CONCLUSIONS: PMA-sarcopenia (but not SMI-sarcopenia) is predictive of 2 year mortality among TAVI patients. The prognostic information provided by PMA-sarcopenia is independent of the tools currently adopted to predict post-TAVI mortality in clinical practice.

Ultra-Low-Dose Whole-Body Computed Tomography Protocol Optimization for Patients With Plasma Cell Disorders: Diagnostic Accuracy and Effective Dose Analysis From a Reference Center.

BACKGROUND: The whole-body low-dose CT (WBLDCT) is the first-choice imaging technique in patients with suspected plasma cell disorder to assess the presence of osteolytic lesions. We investigated the performances of an optimized protocol, evaluating diagnostic accuracy and effective patient dose reduction using a latest generation scanner. METHODS AND MATERIALS: Retrospective study on 212 patients with plasma cell disorders performed on a 256-row CT scanner. First, WBLDCT examinations were performed using a reference protocol with acquisition parameters obtained from literature. A phantom study was performed for protocol optimization for subsequent exams to minimize dose while maintaining optimal diagnostic accuracy. Images were analyzed by three readers to evaluate image quality and to detect lesions. Effective doses (E) were evaluated for each patient considering the patient dimensions and the tube current modulation. RESULTS: A similar, very good image quality was observed for both protocols by all readers with a good agreement at repeated measures ANOVA test (p>0.05). An excellent inter-rater agreement for lesion detection was achieved obtaining high values of Fleiss' kappa for all the districts considered (p<0.001). The optimized protocol resulted in a 56% reduction of median DLP (151) mGycm, interquartile range (IQR) 128-188 mGycm vs. 345 mGycm, IQR 302-408 mGycm), of 60% of CTDIvol (2.2 mGy, IQR 1.9-2.7 mGy vs. 0.9 mGy, IQR 0.8-1.2 mGy). The median E value was about 2.6 mSv (IQR 1.7-3.5 mSv) for standard protocol and about 1.5 mSv (IQR 1.4-1.7 mSv) for the optimized one. Dose reduction was statistically significant with p<0.001. CONCLUSIONS: Protocol optimization makes ultra-low-dose WBLDCT feasible on latest generation CT scanners for patients with plasma cell disorders with effective doses inferior to conventional skeletal survey while maintaining excellent image quality and diagnostic accuracy. Dose reduction is crucial in such patients, as they are likely to undergo multiple whole-body CT scans during follow-up.

Assessing the Impact of Transcatheter Aortic Valve Implantation on Cardiac Catheterisation: A Multicentric Study.

BACKGROUND: The success rate of coronary angiography (CA) after transcatheter aortic valve implantation (TAVI) is variable. Our aim was to investigate CA difficulty, outcomes, and predictors of difficult CA after TAVI. METHOD: This was an international multicentric retrospective cohort study that included patients with TAVI and subsequent CA between January 2010 and December 2019. Difficulty with CA was graded as 1 (normal), 2 (partial engagement, complete vessel opacification), 3 (partial engagement, incomplete vessel opacification), and 4 (unsuccessful angiography). Patients were grouped as (a) "easy" (grade 1 for left and right) or (b) "difficult" (grade >1 for either). We compared baseline characteristics and outcomes, and performed multivariate logistic regression for predictors of difficult CA. RESULTS: Of 96 patients included (mean age 77.4±8.7 years, 48 [50%] male), 88 (92%) had successful CA. Right CA was successful in 80 (83%) patients and left CA in 91 (95%) (p<0.0001). The "difficult" group (n=41 [43%]) had higher Society of Thoracic Surgery (STS) scores (7.6±4.9 vs 5.4±4.0; p=0.022), smaller annulus perimeters (72.4±5.4 mm vs 76.2±9.4 mm; p=0.049), greater use of self-expanding valves (83% vs 18%; p<0.0001), increased valve size (26.8±2.1 mm vs 25.6±3.0 mm; p=0.032), and increased oversizing for area (44.3%±17.4% vs 23.6%±22.0%; p=0.0002) and perimeter (17.5%±8.2% vs 7.1%±10.8%; p<0.0001). There was no difference in outcomes except for increased major bleeding (7.3% vs 0.0%; p=0.042). The strongest predictor for "difficult" CA was self-expanding valves when compared to balloon-expandable valves (adjusted odds ratio [aOR], 15.23; 95% confidence interval [CI], 2.27-102.40). Society of Thoracic Surgery score was borderline predictive (aOR, 1.26; 95% CI, 1.04-1.52). CONCLUSIONS: Our results show that after TAVI, CA success rate is high, right CA is more difficult than left, self-expanding valves predispose to difficult CA, and STS score weakly predicts difficult CA. This study is hypothesis-generating and more research is required to confirm these findings.

Effects of different levels of CT iterative reconstruction on low-contrast detectability and radiation dose in patients of different sizes: an anthropomorphic phantom study.

PURPOSE: The purpose of this study was to verify the maintenance of low-contrast detectability at different CT dose reduction levels, in patients of different sizes, as a consequence of the application of iterative reconstruction at different strengths combined with tube current modulation. METHODS: Anthropomorphic abdominal phantoms of two sizes (small and large) were imaged at a fixed noise with iterative algorithm ASIR-V percentages in the range between 0 and 70% and corresponding dose reductions in the range of 0-83%. A total of 1400 images with and without liver low-contrast simulated lesions were evaluated by five radiologists, using the receiver operating characteristics (ROC) paradigm and evaluating the area under the ROC curve (AUC). The human observer results were then compared with AUC obtained with a channelized Hotelling observer (CHO). CNR values were also calculated. RESULTS: For the small phantom, the AUC values lie between 0.90 and 0.93 for human evaluations of images acquired without iterative reconstruction, with 30% ASIR-V and with 50% ASIR-V. The AUC decreased significantly to 0.81 (p = 0.0001) at 70% ASIR-V. The CHO results were in coherence with human observer scores. Also, similar results were observed for the large size phantom. CNR values were stable for the different ASIR-V percentages. CONCLUSIONS: The iterative algorithm maintained the low-contrast detectability up to a dose reduction of about 70%, following application of a 50% ASIR-V combined with automatic tube current modulation, regardless of the phantom size. At further dose reductions using greater iterative percentages, a significant decrease in detectability was observed.

Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial.

BACKGROUND: The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis. METHODS AND ANALYSIS: PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome. TRIAL REGISTRATION NUMBER: NCT04144881.