Impact of coronary calcium morphology on intravascular lithotripsy.

BACKGROUND: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique. AIMS: We aimed to assess the impact of different calcium morphologies on IVL efficacy. METHODS: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions. RESULTS: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm2 vs 6.2±2.1 mm2; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm2; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%. CONCLUSIONS: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Pediatric Type 1 Diabetes: Is Age at Onset a Determining Factor in Advanced Hybrid Closed-Loop Insulin Therapy?

BACKGROUND: The integration of continuous glucose monitoring systems with insulin infusion pumps has shown improved glycemic control, with improvements in hyperglycemia, hypoglycemia, Hb1Ac, and greater autonomy in daily life. These have been most studied in adults and there are currently not many articles published in the pediatric population that establish their correlation with age of debut. METHODS: Prospective, single-study. A total of 28 patients (mean age 12 ± 2.43 years, 57% male, duration of diabetes 7.84 ± 2.46 years) were included and divided into two groups according to age at T1D onset (≤4 years and >4 years). Follow-up for 3 months, with glucometric variables extracted at different cut-off points after the start of the closed-loop (baseline, 1 month, 3 months). RESULTS: Significant improvement was evidenced at 1 month and 3 months after closed-loop system implantation, with better glycemic control in the older age group at baseline at TIR (74.06% ± 6.37% vs. 80.33% ± 7.49% at 1 month, p < 0.003; 71.87% ± 6.58% vs. 78.75% ± 5.94% at 3 months, p < 0.009), TAR1 (18.25% ± 4.54% vs. 14.33% ± 5.74% at 1 month, p < 0.006; 19.87% ± 5.15% vs. 14.67% ± 4. 36% at 3 months, p < 0.009) and TAR2 (4.75% ± 2.67% vs. 2.75% ± 1.96% at 1 month, p = 0.0307; 5.40% ± 2.85% vs. 3% ± 2.45% at 3 months, p < 0.027). CONCLUSIONS: the use of automated systems such as the MiniMedTM780G system brings glucometric results closer to those recommended by consensus, especially in age at T1D onset >4 years. However, the management in pediatrics continues to be a challenge even after the implementation of these systems, especially in terms of hyperglycemia and glycemic variability.

Early exploration of the economic impact of transradial access (TRA) versus transfemoral access (TFA) for neurovascular procedures in Spain.

INTRODUCTION: Transfemoral access (TFA) is the primary access approach for neurointerventional procedures. Transradial access (TRA) is established in cardiology due to its lower complications, yet, it is at its early stages in neuroprocedures. This study performs an early exploration of the economic impact associated with the introduction of TRA in diagnostic and therapeutic neuroprocedures from the Spanish NHS perspective. METHODS: An economic model was developed to estimate the cost and clinical implications of using TRA compared to TFA. Costs considered access-related, complications and recovery time costs obtained from local databases and experts' inputs. Clinical inputs were sourced from the literature. A panel of eight experts from different Spanish hospitals, validated or adjusted the values based on local experience. Hypothetical cohorts of 10,000 and 1000 patients were considered for diagnostic and therapeutic neuroprocedures respectively. Deterministic sensitivity analysis was performed. RESULTS: TRA in diagnostic procedures was associated with lower costs with savings ranging between €486 and €157 depending on the TFA recovery time considered. TRA is estimated to lead to 158 fewer access-site complications. In therapeutic procedures, TRA resulted in 76.4 fewer complications and was estimated to be cost-neutral with an incremental cost of €21.56 per patient despite recovery times were not included for this group. Variation of the parameters in the sensitivity analysis did not change the direction of the results. LIMITATIONS: Clinical data was obtained from literature validated by experts therefore results generalizability is limited. In therapeutic neuroprocedures, there is an experience imbalance between approaches and recovery times were not included hence the total impact is not fully captured. CONCLUSIONS: The early economic model suggests that implementing TRA is associated with reduced costs and complications in diagnostic procedures. In therapeutic procedures, TRA lead to fewer complications and it is estimated to be cost-neutral, however its full potential still needs to be quantified.

Impact on glucometric variables and quality of life of the advanced hybrid closed-loop system in pediatric and adolescent type 1 diabetes.

BACKGROUND: In recent years, technological advances in the field of diabetes have revolutionized the management, prognosis, and quality of life of diabetes patients and their environment. The aim of our study was to evaluate the impact of implementing the MiniMed 780G closed-loop system in a pediatric and adolescent population previously treated with a continuous subcutaneous insulin infusion pump and intermittent glucose monitoring. METHODS: Data were collected from 28 patients with type 1 diabetes aged 6 to 17 years, with a follow-up of 6 months. We included both glucometric and quality of life variables, as well as quality of life in primary caregivers. Metabolic control variables were assessed at baseline (before system change) and at different cutoff points after initiation of the closed-loop system (48 hours, 7 days, 14 days, 21 days, 1 month, 3 months, 6 months). RESULTS: Time in range 70-180 mg/dL increased from 59.44% at baseline to 74.29% in the first 48 hours after automation of the new system, and this improvement was maintained at the other cutoff points, as was time in hyperglycemia 180-250 mg/dL (24.44% at baseline to 18.96% at 48 hours) and >250 mg/dL (11.71% at baseline to 3.82% at 48 hours). CONCLUSIONS: Our study showed an improvement in time in range and in all time spent in hyperglycemia from the first 48 hours after the automation of the system, which was maintained at 6 months.

Choice of CTO scores to predict procedural success in clinical practice. A comparison of 4 different CTO PCI scores in a comprehensive national registry including expert and learning CTO operators.

BACKGROUND: We aimed to compare the performance of the recent CASTLE score to J-CTO, CL and PROGRESS CTO scores in a comprehensive database of percutaneous coronary intervention of chronic total occlusion procedures. METHODS: Scores were calculated using raw data from 1,342 chronic total occlusion procedures included in REBECO Registry that includes learning and expert operators. Calibration, discrimination and reclassification were evaluated and compared. RESULTS: Mean score values were: CASTLE 1.60±1.10, J-CTO 2.15±1.24, PROGRESS 1.68±0.94 and CL 2.52±1.52 points. The overall percutaneous coronary intervention success rate was 77.8%. Calibration was good for CASTLE and CL, but not for J-CTO or PROGRESS scores. Discrimination: the area under the curve (AUC) of CASTLE (0.633) was significantly higher than PROGRESS (0.557) and similar to J-CTO (0.628) and CL (0.652). Reclassification: CASTLE, as assessed by integrated discrimination improvement, was superior to PROGRESS (integrated discrimination improvement +0.036, p<0.001), similar to J-CTO and slightly inferior to CL score (- 0.011, p = 0.004). Regarding net reclassification improvement, CASTLE reclassified better than PROGRESS (overall continuous net reclassification improvement 0.379, p<0.001) in roughly 20% of cases. CONCLUSION: Procedural percutaneous coronary intervention difficulty is not consistently depicted by available chronic total occlusion scores and is influenced by the characteristics of each chronic total occlusion cohort. In our study population, including expert and learning operators, the CASTLE score had slightly better overall performance along with CL score. However, we found only intermediate performance in the c-statistic predicting chronic total occlusion success among all scores.

Detection and Quantification of Delamination Failures in Marine Composite Bulkheads via Vibration Energy Variations.

This paper proposes a new vibration-based structural health monitoring method for the identification of delamination defects in composite bulkheads used in small-length fiber-based ships. The core of this work is to find out if the variations of vibration energy can be efficiently used as a key performance indicator for the detection and quantification of delamination defects in marine composite bulkheads. For this purpose, the changes of vibrational energy exerted by delamination defects in sandwich and monolithic composite panel bulkheads with different types of delamination phenomenon are investigated using a non-destructive test. Experiments show that the overall vibration energy of the bulkheads is directly dependent on the damage conditions of the specimens and therefore, the variations of this parameter are a good indicator of the incorporation of delamination defects in composite bulkheads. Additionally, the overall vibration energy changes also give interesting information about the severity of the delamination defect in the panels. Hence, this methodology based on vibratory energy can be used to accurately determine delamination defects in medium-sized composite bulkheads with the advantages of being a simple and cost-effective approach. The findings of this research possess important applications for the identification of delamination failures in composite components such as bulkheads, turbine blades, and aircraft structures, among others.

Impact of late-onset cytomegalovirus infection in the development of cardiac allograft vasculopathy in heart transplant recipients.

BACKGROUND: The impact of late-onset cytomegalovirus (CMV) infection (LOCI) on cardiac allograft vasculopathy (CAV) has yet to be established. METHODS: A retrospective study was performed for patients who had undergone heart transplantation (HT) between January 1995 and October 2017 to analyze epidemiology of LOCI (any positive level of CMV pp65 antigenemia or DNAemia after 100 days, without previous CMV replication) and its association with CAV. Our main hypothesis was that LOCI causes less direct and indirect effects compared to early onset infection (EOCI). RESULTS: Late-onset cytomegalovirus infection developed in 57 of 410 patients (13.9%) in a median time of 4.7 months post-transplant. CAV at 10 years was diagnosed in 31.6% of patients with LOCI, 34.6% with EOCI, and in 19.3% of CMV-uninfected patients. In the multivariate analysis, EOCI was an independent variable for developing CAV (HR 1.8, 95% CI 1.13-2.82, P = .01). Patients with LOCI showed a trend toward a higher risk of CAV, but the difference was not statistically significant (HR 1.7, 95% CI 0.95-3.08, P = .07). In the complementary log-log model, LOCI and EOCI had a similar CAV-free survival, and a higher probability of developing CAV than CMV-uninfected patients (P = .02). CONCLUSIONS: Cytomegalovirus infection after HT may result in the same long-term events regardless of its onset, with a higher risk of developing CAV at 10 years than patients without CMV.

Procedural, Functional and Prognostic Outcomes Following Recanalization of Coronary Chronic Total Occlusions. Results of the Iberian Registry.

INTRODUCTION AND OBJECTIVES: There is current controversy regarding the benefits of percutaneous recanalization (PCI) of chronic total coronary occlusions (CTO). Our aim was to determine acute and follow-up outcomes in our setting. METHODS: Two-year prospective registry of consecutive patients undergoing PCI of CTO in 24 centers. RESULTS: A total of 1000 PCIs of CTO were performed in 952 patients. Most were symptomatic (81.5%), with chronic ischemic heart disease (59.2%). Previous recanalization attempts had been made in 15%. The mean SYNTAX score was 19.5 ± 10.6 and J-score was > 2 in 17.3%. A retrograde procedure was performed in 92 patients (9.2%). The success rate was 74.9% and was higher in patients without previous attempts (82.2% vs 75.2%; P = .001), those with a J-score ≤ 2 (80.5% vs 69.5%; P = .002), and in intravascular ultrasound-guided PCI (89.9% vs 76.2%, P = .001), which was an independent predictor of success. In contrast, severe calcification, length > 20mm, and blunt proximal cap were independent predictors of failed recanalization. The rate of procedural complications was 7.1%, including perforation (3%), myocardial infarction (1.3%), and death (0.5%). At 1-year of follow-up, 88.2% of successfully revascularized patients showed clinical improvement (vs 34.8%, P < .001), which was associated with lower mortality. At 1-year of follow-up, the mortality rate was 1.5%. CONCLUSIONS: Compared with other national registries, patients in the Iberian registry undergoing PCI of a CTO showed similar complexity, success rate, and complications. Successful recanalization was strongly associated with functional improvement, which was related to lower mortality.

Genetic basis of familial dilated cardiomyopathy patients undergoing heart transplantation.

BACKGROUND: Dilated cardiomyopathy (DCM) is the most frequent cause of heart transplantation (HTx). The genetic basis of DCM among patients undergoing HTx has been poorly characterized. We sought to determine the genetic basis of familial DCM HTx and to establish the yield of modern next generation sequencing (NGS) technologies in this setting. METHODS: Fifty-two heart-transplanted patients due to familial DCM underwent NGS genetic evaluation with a panel of 126 genes related to cardiac conditions (59 associated with DCM). Genetic variants were initially classified as pathogenic mutations or as variants of uncertain significance (VUS). Final pathogenicity status was determined by familial cosegregation studies. RESULTS: Initially, 24 pathogenic mutations were found in 21 patients (40%); 25 patients (48%) carried 19 VUS and 6 (12%) did not show any genetic variant. Familial evaluation of 220 relatives from 36 of the 46 families with genetic variants confirmed pathogenicity in 14 patients and allowed reclassification of VUS as pathogenic in 17 patients, and as non-pathogenic in 3 cases. At the end of the study, the DCM-causing mutation was identified in 38 patients (73%) and 5 patients (10%) harbored only VUS. No genetic variants were identified in 9 cases (17%). CONCLUSIONS: The genetic spectrum of familial DCM patients undergoing HTx is heterogeneous and involves multiple genes. NGS technology plus detailed familial studies allow identification of causative mutations in the vast majority of familial DCM cases. Detailed familial studies remain critical to determine the pathogenicity of underlying genetic defects in a substantial number of cases.

Influence of cytomegalovirus infection in the development of cardiac allograft vasculopathy after heart transplantation.

BACKGROUND: Cardiac allograft vasculopathy (CAV) is a major cause of long-term morbidity and mortality after heart transplantation (HTx), whose relationship with CMV infection is uncertain. This study evaluated the influence of CMV infection in the development of CAV. METHODS: We enrolled 166 consecutive HTx recipients who underwent their first transplant from January 1995 to July 2002. All patients received 14 days of intravenous ganciclovir and were prospectively monitored for CMV infection during the first year after HTx. CAV was diagnosed by coronary angiography performed at 1, 5, and 10 years after HTx, following the new criteria of the International Society for Heart and Lung Transplantation. We collected all variables potentially related with the development of CAV. Risk factors were studied using a complementary log-log model. RESULTS: After a median follow-up of 11 years (range, 1-17 years), 72 patients (43%) developed CAV (63.8% CAV(1), 15.2% CAV(2), 20.8% CAV(3)). Symptoms secondary to CAV were present in 32% of these patients, and 8% died because of it. In the regression multivariate analysis, independent variables associated with the development of CAV were donor age (hazard ratio [HR], 1.028; 95% confidence interval [CI], 1.002-1.053; p < 0.028), presence of cellular acute rejection ≥ 2R (HR, 1.764; 95% CI, 1.011-3.078; p < 0.0414), CMV infection (HR, 2.334; 95% CI, 1.043-5.225; p < 0.0354), and not having been treated with a calcium channel blocker (HR, 0.472; 95% CI, 0.275-0.811; p < 0.0055). CONCLUSIONS: Standardized angiographic criteria show CMV infection is associated with the development of CAV.