Transcatheter Mitral Valve Implantation in Failed Transventricular Mitral Valve Repair.

An 84-year-old man presented with dyspnea at rest due to severe mitral regurgitation. He first underwent transventricular mitral valve repair with the Harpoon system, which relapsed owing to rupture of neochords. He was definitively treated with transcatheter mitral valve implantation of the Tendyne system 8 months later.

[Review of surgical treatment of suprastomal collapse in tracheostomised children]. / Übersichtsarbeit zur chirurgischen Behandlung des suprastomalen Kollapses bei tracheotomierten Kindern.

BACKGROUND: Suprastomal collapse (SSC) is considered a major late complication of paediatric tracheostomy and can be responsible for decannulation failure in up to 20% of tracheostomised children. Depending on the severity of SSC, surgery may be required. Various strategies and techniques are available, of which the treating with airway team should be aware. OBJECTIVE: This article intends to summarise the aetiology of SSC, its classification, clinical presentation, and the gold standard diagnostic and therapeutic algorithms according to the current literature. MATERIALS AND METHODS: A panel of experts reviewed the available literature on SSC. Published evidence on the different surgical techniques and their advantages and disadvantages was reviewed in detail, and a treatment algorithm created. RESULTS: The gold standard diagnostic procedure for SSC is flexible transnasal laryngotracheoscopy in spontaneous breathing followed by microlaryngoscopy (MLS) under general anaesthesia. Two main types of SSC can be differentiated, which differ in terms of surgical treatment. Purely anterior SSC is usually treated by tracheoplasty using an anterior costal cartilage graft (ACCG). Simple closure of the tracheostomy or excision of SSC with a potassium-titanyl-phosphate (KTP) laser are also described as less invasive approaches. For anterolateral SSC, segmental tracheal resection with end-to-end anastomosis or tracheoplasty with ACCG represent promising treatment options. Tracheal reinforcement with absorbable microplates is also discussed in the literature. With both types of SSC and depending on severity and the age of the child, a watch-and-wait strategy should always be considered. CONCLUSION: Dynamic airway endoscopy in spontaneous breathing followed by MLS in general anaesthesia should always be performed before decannulation. It is particularly important to visualise all segments of the airway during spontaneous breathing. The decision regarding the best surgical option for each child is based on the type and localisation of SSC, as well as on the patient's medical and surgical history and age.

Sternal cleft and pectus excavatum: an overlooked congenital association?

BACKGROUND: Sternal cleft (SC), a rare thoracic malformation, is associated with pectus excavatum (PE) in 2.6-5% of cases. It remains unclear if these conditions are congenitally linked or if SC repair triggers PE. To investigate the potential higher frequency of PE in SC cases, we conducted a retrospective study of our SC patients. METHODS: We assessed PE incidence, progression, and management in SC patients treated at our institute from 2006 to 2022. When available, we collected pre-SC repair CT scan data, calculating the Haller Index (HI) and Correction Index (CI) and compared them to a selected control group. RESULTS: Among 8 SC patients, 7 had concomitant PE (87.5%), varying in severity. PE management ranged from observation to thoracoplasty, depending on its degree. We observed a significant pre-operative CI difference between SC and control group patients (p < 0.00001). In the last two SC repair cases, we attempted concurrent PE prevention or treatment. CONCLUSION: Our findings suggest an underestimated association between PE and SC in the existing literature. SC patients may exhibit a predisposition to PE from birth, which may become more apparent with growth after SC repair. Consequently, PE prevention or treatment should be considered during SC repair procedures.

Risk Score for Prediction of Dialysis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Dialysis is a rare but serious complication after transcatheter aortic valve replacement. We analyzed the large multicenter TRITAVI (transfusion requirements in transcatheter aortic valve implantation) registry in order to develop and validate a clinical score assessing this risk. METHODS AND RESULTS: A total of 10 071 consecutive patients were enrolled in 19 European centers. Patients were randomly assigned (2:1) to a derivation and validation cohort. Two scores were developed, 1 including only preprocedural variables (TRITAVIpre) and 1 also including procedural variables (TRITAVIpost). In the 6714 patients of the derivation cohort (age 82±6 years, 48% men), preprocedural factors independently associated with dialysis and included in the TRITAVIpre score were male sex, diabetes, prior coronary artery bypass graft, anemia, nonfemoral access, and creatinine clearance <30 mL/min per m2. Additional independent predictors among procedural features were volume of contrast, need for transfusion, and major vascular complications. Both scores showed a good discrimination power for identifying risk for dialysis with C-statistic 0.78 for TRITAVIpre and C-statistic 0.88 for TRITAVIpost score. Need for dialysis increased from the lowest to the highest of 3 risk score groups (from 0.3% to 3.9% for TRITAVIpre score and from 0.1% to 6.2% for TRITAVIpost score). Analysis of the 3357 patients of the validation cohort (age 82±7 years, 48% men) confirmed the good discrimination power of both scores (C-statistic 0.80 for TRITAVIpre and 0.81 for TRITAVIpost score). Need for dialysis was associated with a significant increase in 1-year mortality (from 6.9% to 54.4%; P=0.0001). CONCLUSIONS: A simple preprocedural clinical score can help predict the risk of dialysis after transcatheter aortic valve replacement.

Congenital lung malformations: a nationwide survey on management aspects by the Italian Society of Pediatric Surgery.

INTRODUCTION: Over the years, congenital lung malformations (CLM) management remains a controversial topic in pediatric thoracic surgery. The Italian Society of Pediatric Surgery performed a national survey to study the current management variability among centers, trying to define national guidelines and a standardized approach of children with congenital lung malformations. METHODS: Following a National Society approval, an electronic survey including 35 items on post-natal management was designed, focusing on surgical, anesthesiology, radiology and pneumology aspects. The survey was conducted contacting all pediatric surgical units performing thoracic surgery. RESULTS: 39 pediatric surgery units (97.5%) participated in the study. 13 centers (33.3%) were classified as high-volume (Group A), while 26 centers (66.7%) were low volume (Group B). Variances in diagnostic imaging protocols were observed, with Group A performing fewer CT scans compared to Group B (p = 0.012). Surgical indications favored operative approaches for asymptomatic CLM and pulmonary sequestrations in both groups, while a wait-and-see approach was common for congenital lobar emphysema. Surgical timing for asymptomatic CLM differed significantly, with most high-volume centers operating on patients younger than 12 months (p = 0.02). Thoracoscopy was the preferred approach for asymptomatic CLM in most of centers, while postoperative long-term follow-up was not performed in most of the centers. CONCLUSION: Thoracoscopic approach seems uniform in asymptomatic CLM patients and variable in symptomatic children. Lack of uniformity in surgical timing and preoperative imaging assessment has been identified as key areas to establish a common national pattern of care for CLM.

SEM2: Introducing mechanics in cell and tissue modeling using coarse-grained homogeneous particle dynamics.

Modeling multiscale mechanics in shape-shifting engineered tissues, such as organoids and organs-on-chip, is both important and challenging. In fact, it is difficult to model relevant tissue-level large non-linear deformations mediated by discrete cell-level behaviors, such as migration and proliferation. One approach to solve this problem is subcellular element modeling (SEM), where ensembles of coarse-grained particles interacting via empirically defined potentials are used to model individual cells while preserving cell rheology. However, an explicit treatment of multiscale mechanics in SEM was missing. Here, we incorporated analyses and visualizations of particle level stress and strain in the open-source software SEM++ to create a new framework that we call subcellular element modeling and mechanics or SEM2. To demonstrate SEM2, we provide a detailed mechanics treatment of classical SEM simulations including single-cell creep, migration, and proliferation. We also introduce an additional force to control nuclear positioning during migration and proliferation. Finally, we show how SEM2 can be used to model proliferation in engineered cell culture platforms such as organoids and organs-on-chip. For every scenario, we present the analysis of cell emergent behaviors as offered by SEM++ and examples of stress or strain distributions that are possible with SEM2. Throughout the study, we only used first-principles literature values or parametric studies, so we left to the Discussion a qualitative comparison of our insights with recently published results. The code for SEM2 is available on GitHub at https://github.com/Synthetic-Physiology-Lab/sem2.

Chronic respiratory disorders due to aberrant innominate artery: a case series and critical review of the literature.

BACKGROUND: Tracheal compression (TC) due to vascular anomalies is an uncommon, but potentially serious cause of chronic respiratory disease in childhood. Vascular slings are congenital malformations resulting from abnormal development of the great vessels; in this group of disorders the most prevalent entity is the aberrant innominate artery (AIA). Here we provide a report on diagnosis and treatment of AIA in nine children with unexplained chronic respiratory symptoms. We describe the cases, perform a literature review, and provide a discussion on the diagnostic workup and treatment that can help manage AIA. METHODS: Clinical history, diagnostic procedures and treatment before and after the AIA diagnosis were retrospectively reviewed in nine children (5 boys and 4 girls), who were referred for recurrent-to-chronic respiratory manifestations over 10 years (2012-2022). We performed a comprehensive report on the ongoing clinical course and treatment as well as an electronic literature search on the topic. RESULTS: Diagnoses at referral, before AIA was identified, were chronic dry barking cough associated with recurrent pneumonia (n = 8, 89%), lobar/segmental atelectasis (n = 3, 33%), atopic/non atopic asthma (n = 3, 33%); pneumomediastinum with subcutaneous emphysema complicated the clinical course in one case. When referred to our Unit, all patients had been previously treated with repeated antibiotic courses (n = 9, 100%), alone (n = 6, 67%) or combined with prolonged antiasthma medications (n = 3, 33%) and/or daily chest physiotherapy (n = 2, 22%), but reported only partial clinical benefit. Median ages at symptom onset and at AIA diagnosis were 1.5 [0.08-13] and 6 [4-14] years, respectively, with a relevant delay in the definitive diagnosis (4.5 years). Tracheal stenosis at computed tomography (CT) was ≥ 51% in 4/9 cases and ≤ 50% in the remaining 5 subjects. Airway endoscopy was performed in 4 cases with CT evidence of tracheal stenosis ≥ 51% and confirmed CT findings. In these 4 cases, the decision of surgery was made based on endoscopy and CT findings combined with persistence of clinical symptoms despite medical treatment. The remaining 5 children were managed conservatively. CONCLUSIONS: TC caused by AIA may be responsible for unexplained chronic respiratory disease in childhood. Early diagnosis of AIA can decrease the use of expensive investigations or unsuccessful treatments, reduce disease morbidity, and accelerate the path toward a proper treatment.

Posterior Tracheopexy for Tracheomalacia: A Study of Clinical and Radiological Consequences on Esophagus.

INTRODUCTION: Posterior tracheopexy (PT) directly addresses the posterior trachealis membrane intrusion in severe tracheomalacia. During PT, the esophagus is mobilized and membranous trachea is sutured to the prevertebral fascia. Although dysphagia has been reported as a possible complication of PT, in the literature there are no data investigating postoperative esophageal anatomy and digestive symptoms. Our aim was to study clinical and radiological consequences of PT on esophagus. METHODS: Patients with symptomatic tracheobronchomalacia scheduled for PT between May 2019 and November 2022 underwent pre- and postoperative esophagogram. For each patient, we analyzed radiological images and measured esophageal deviation providing new radiological parameters. RESULTS: All 12 patients underwent thoracoscopic PT (n = 3) or robot-assisted thoracoscopic PT (n = 9). For all patients, the postoperative esophagogram showed a right dislocation of the thoracic esophagus (median postoperative deviation = 27.5 mm). We report an esophageal perforation at postoperative day 7 in a patient affected by esophageal atresia, who underwent several surgical procedures before. A stent was placed and esophagus healed. Another patient with severe right dislocation referred transient dysphagia to solids, which resolved gradually in the first postoperative year. All the other patients did not present any esophageal symptoms. CONCLUSION: For the first time, we demonstrate the right dislocation of the esophagus after PT and we propose an objective method to measure it. In most patients, PT is a procedure not affecting esophageal function, but dysphagia can occur if dislocation is important. Esophagus mobilization during PT should be cautious, especially in patients who underwent previous thoracic procedures.

Impact of Right Ventricular Pacing in Patients With TAVR Undergoing Permanent Pacemaker Implantation.

BACKGROUND: Long-term right ventricular pacing (VP) has been related to negative left ventricular remodeling and heart failure (HF), but there is a lack of evidence regarding the prognostic impact on transcatheter aortic valve replacement (TAVR) patients. OBJECTIVES: The aim of the PACE-TAVI registry is to evaluate the association of high percentage of VP with adverse outcomes in patients with pacemaker implantation after TAVR. METHODS: PACE-TAVI is an international multicenter registry of all consecutive TAVR patients who underwent permanent pacemaker implantation for conduction disturbances in the first 30 days after the procedure. Patients were divided into 2 subgroups according to the percentage of VP (<40% vs ≥40%) at pacemaker interrogation. The primary endpoint was the composite of cardiovascular mortality or hospitalization for HF. RESULTS: A total of 377 patients were enrolled, 158 with VP <40% and 219 with VP ≥40%. After multivariable adjustment, VP ≥40% was associated with a higher incidence of the primary endpoint (HR: 2.76; 95% CI: 1.39-5.51; P = 0.004), first HF hospitalization (HR: 3.37; 95% CI: 1.50-7.54; P = 0.003), and cardiovascular death (HR: 3.77; 95% CI: 1.02-13.88; P = 0.04), while the incidence of all-cause death was not significantly different (HR: 2.17; 95% CI: 0.80-5.90; P = 0.13). Patients with VP ≥ 40% showed a higher New York Heart Association functional class both at 1 year (P = 0.009) and at last available follow-up (P = 0.04) and a nonsignificant reduction of left ventricular ejection fraction (P = 0.18) on 1-year echocardiography, while patients with VP <40% showed significant improvement (P = 0.009). CONCLUSIONS: In TAVR patients undergoing permanent pacemaker implantation, a high percentage of right VP at follow-up is associated with an increased risk for cardiovascular death and HF hospitalization. These findings suggest the opportunity to minimize right VP through dedicated algorithms in post-TAVR patients without complete atrioventricular block and to evaluate a more physiological VP modality in patients with persistent complete atrioventricular block.

Acute Modification of Hemodynamic Forces in Patients with Severe Aortic Stenosis after Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) is the established first-line treatment for patient with severe aortic stenosis not suitable for surgery. Echocardiographic evaluation of hemodynamic forces (HDFs) is a growing field, holding the potential to early predict improvement in LV function. A prospective observational study was conducted. Transthoracic echocardiography was performed before and after TAVI. HDFs were analyzed along with traditional left ventricular (LV) function parameters. Twenty-five consecutive patients undergoing TAVI were enrolled: mean age 83 ± 5 years, 74.5% male, mean LV Ejection Fraction (LVEF) at baseline 57 ± 8%. Post-TAVI echocardiographic evaluation was performed 2.4 ± 1.06 days after the procedure. HDF amplitude parameters improved significantly after the procedure: LV Longitudinal Forces (LF) apex-base [mean difference (MD) 1.79%; 95% CI 1.07-2.5; p-value < 0.001]; LV systolic LF apex-base (MD 2.6%; 95% CI 1.57-3.7; p-value < 0.001); LV impulse (LVim) apex-base (MD 2.9%; 95% CI 1.48-4.3; p-value < 0.001). Similarly, HDFs orientation parameters improved: LVLF angle (MD 1.5°; 95% CI 0.07-2.9; p-value = 0.041); LVim angle (MD 2.16°; 95% CI 0.76-3.56; p-value = 0.004). Conversely, global longitudinal strain and LVEF did not show any significant difference before and after the procedure. Echocardiographic analysis of HDFs could help differentiate patients with LV function recovery after TAVI from patients with persistent hemodynamic dysfunction.

Documentation in Pediatric Microlaryngoscopy/Bronchoscopy: International Modified Delphi Consensus.

BACKGROUND: Complete and accurate documentation of surgical procedures is essential for optimizing patient care, yet significant variation in operative notes persists within and across institutions. We sought to reach consensus on the most important components of an operative note for pediatric microlaryngoscopy and bronchoscopy. METHODS: A modified Delphi consensus process was used. A checklist for operative documentation, created by fellowship-trained pediatric otolaryngologists-head and neck surgeons, was sent to surgeons identified as experts in pediatric laryngoscopy and bronchoscopy. In the first round, items were rated as "keep" or "remove". In the second round, each item was rated on a 7-point Likert scale for importance. The mean score of each item was calculated to determine if consensus was reached. RESULTS: Overall, 43/74 (58.1%) surgeons responded to our survey. After two rounds of editing, 28 components reached consensus, 24 were near consensus, and 26 did not reach consensus. Items that reached final consensus had mean (SD) ratings of 6.12 (0.94) (range, 5.31-6.72). CONCLUSION: Pediatric otolaryngologists identified as bronchoscopy experts were able to create a checklist of essential components of an operative note for pediatric laryngoscopy and bronchoscopy using a Delphi method. Items reaching consensus included procedure name, description of breathing, grade of airway view, description of normal anatomic structures, grade of subglottic stenosis if present, presence and description of tracheobronchomalacia, presence of fistulae, cleft and rings, and several special cases including foreign body and tracheostomy management, as well as end of procedure disposition and complications. LEVEL OF EVIDENCE: 5 Laryngoscope, 133:1234-1238, 2023.

Lateral Thoracic Expansion for Jeune's Syndrome, Surgical Approach, and Technical Details.

INTRODUCTION: Jeune's syndrome, or asphyxiating thoracic dystrophy (ATD), is a rare autosomal recessive disorder characterized by skeletal dysplasia. Ribs are typically short and horizontal resulting-in lethal variant-in severe lung hypoplasia, progressive respiratory failure, and death. Lateral thoracic expansion (LTE) consists in staggered bilateral ribs osteotomy leading to chest expansion and lung development. Studies on LTE in ATD patients report encouraging data, but the rarity of ATD implies the lack of a standardized surgical path. The aim of this report is to present our experience with LTE, the technical modification we adopted, and patients' clinical outcome. MATERIALS AND METHODS: We retrospectively reviewed data of 11 LTE performed in 7 ATD patients with lethal variant. Information regarding pre- and postoperative clinical conditions and surgical details was collected. We adopted a single-stage or a two-stage approach based on patient clinical condition. Computed tomography (CT) scan was performed before and after surgery and lung volume was calculated. RESULTS: Five patients are alive, while two died in intensive care unit for other than respiratory cause (sepsis). Most patients experienced clinical improvement in terms of decreased respiratory infections rate, need for ventilation, and improved exercise tolerance. Postoperative CT scan demonstrated a median lung volume increase of 88%. CONCLUSION: Mortality in ADT patients is high. However, LTE is a feasible and safe surgical approach, which could improve clinical conditions and survival rate. Survived patients showed postoperatively less oxygen requirement and improved clinical conditions.

Current progress toward isogeometric modeling of the heart biophysics.

In this paper, we review a powerful methodology to solve complex numerical simulations, known as isogeometric analysis, with a focus on applications to the biophysical modeling of the heart. We focus on the hemodynamics, modeling of the valves, cardiac tissue mechanics, and on the simulation of medical devices and treatments. For every topic, we provide an overview of the methods employed to solve the specific numerical issue entailed by the simulation. We try to cover the complete process, starting from the creation of the geometrical model up to the analysis and post-processing, highlighting the advantages and disadvantages of the methodology.

Cross-contamination by COVID-19 mask microfibers during microlitter analysis of marine biota.

Face masks have been adopted as an essential measure to prevent transmission and spread of the virus infection during the pandemic of Covid-19. The present study evaluates the potential microfibers transfer from face masks to other recipients and the potential cross-contamination of samples by microfibers released from masks worn during the analysis of microlitter ingestion by fish. Results indicated that masks could easily transfer endogenous (originated from the mask tissue itself) and exogenous microfibers (with a different origin than the mask tissue itself) to other recipients (adhesive tape and air in our experiment). Exogenous fibers may be carried from everywhere and potentially released everywhere. Microfibers are also released into the air, driven by the airflow generated by breathing, and can be transferred to blanks and samples. Microfiber contamination by facial masks increases the risk of samples cross-contamination and raises concerns about the results reliability of the microlitter analysis on marine biota.

Valve-in-valve transcatheter aortic valve replacement or re-surgical aortic valve replacement in degenerated bioprostheses: A systematic review and meta-analysis of short and midterm results.

INTRODUCTION: Despite limited to short and midterm outcomes, valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a valid alternative to re-surgical aortic valve replacement (re-SAVR) for high- and intermediate-risk patients with degenerated surgical bioprosthesis. METHODS: All studies comparing multivariate adjustment between ViV TAVI and re-SAVR were screened. The primary end-points were all-cause and cardiovascular (CV) mortality at 30 days and at Midterm follow-up. Short-term complications were the secondary endpoints. RESULTS: We obtained data from 11 studies, encompassing 8570 patients, 4224 undergoing ViV TAVI, and 4346 re-SAVR. Four studies included intermediate-risk patients and seven high-risk patients. 30-day all-cause and CV mortality were significantly lower in ViV (odds ratio [OR] 0.43, 95% confidence intervals [CIs] 0.29-0.64 and OR 0.44, 0.26-0.73 respectively), while after a mean follow-up of 717 (180-1825) days, there was no difference between the two groups (OR 1.04, 0.87-1.25 and OR 1.05, 0.78-1.43, respectively). The risk of stroke (OR 1.03, 0.59-1.82), MI (OR 0.70, 0.34-1.44), major vascular complications (OR 0.92, 0.50-1.67), and permanent pacemaker implantation (OR 0.67, 0.36-1.25) at 30 days did not differ, while major bleedings and new-onset atrial fibrillation were significantly lower in ViV patients (OR 0.41, 0.25-0.67 and OR 0.23, 0.12-0.42, respectively, all 95% CIs). CONCLUSIONS: In high- and intermediate-risk patients with degenerated surgical bioprostheses, ViV TAVI is associated with reduced short-term mortality, compared with re-SAVR. Nevertheless, no differences were found in all-cause and CV mortality at midterm follow-up. PROSPERO CRD42021226488.

A new tool for assessing Pectus Excavatum by a semi-automatic image processing pipeline calculating the classical severity indexes and a new marker: the Volumetric Correction Index.

BACKGROUND: In clinical assessment of Pectus Excavatum (PE), the indication to surgery is based not only on symptoms but also on quantitative markers calculated from Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans. According to clinical routine, these indexes are measured manually by radiologists with limited computer support. This process is time consuming and potentially subjected to inaccuracy and individual variability in measurements. Moreover, the existing indexes have limitations, since they are based on linear measurements performed on single slices rather than on volumetric data derived from all the thoracic scans. RESULTS: In this paper we present an image processing pipeline aimed at providing radiologists with a computer-aid tool in support of diagnosis of PE patients developed in MATLAB® and conceived for MRI images. This framework has a dual purpose: (i) to automatize computation of clinical indexes with a view to ease and standardize pre-operative evaluation; (ii) to propose a new marker of pathological severity based on volumetric analysis and overcoming the limitations of existing axial slice-based indexes. Final designed framework is semi-automatic, requiring some user interventions at crucial steps: this is realized through a Graphical User Interface (GUI) that simplifies the interaction between the user and the tools. We tested our pipeline on 50 pediatric patients from Gaslini Children's Hospital and performed manual computation of indexes, comparing the results between the proposed tool and gold-standard clinical practice. Automatic indexes provided by our algorithm have shown good agreement with manual measurements by two independent readers. Moreover, the new proposed Volumetric Correction Index (VCI) has exhibited good correlation with standardized markers of pathological severity, proving to be a potential innovative tool for diagnosis, treatment, and follow-up. CONCLUSIONS: Our pipeline represents an innovative image processing in PE evaluation, based on MRI images (radiation-free) and providing the clinician with a quick and accurate tool for automatically calculating the classical PE severity indexes and a new more comprehensive marker: the Volumetric Correction Index.

Transcatheter Aortic Valve Implantation With or Without Predilation: A Meta-Analysis.

AIMS: To evaluate the impact of systematic predilation with balloon aortic valvuloplasty (BAV) on transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We performed a systematic meta-analysis investigating patients undergoing TAVI with systematic BAV vs no BAV in RCT or in adjusted studies. Device success was the primary endpoint, while all-cause mortality, 30-day moderate/severe aortic regurgitation (AR), stroke, permanent pacemaker implantation (PPI) and acute kidney injury (AKI) were the secondary endpoints. Subanalysis according to design of the study (RCT and adjusted analysis) and to the type of valve (balloon-expandable [BE] vs self-expanding [SE]) were conducted. We obtained data from 15 studies, comprising 16,408 patients: 10,364 undergoing BAV prior to TAVI and 6,044 in which direct TAVI has been performed. At 30-day follow-up, BAV did not improve the rate of device success in the overall population (OR, 1.09; 95% CI, 0.90-1.31), both in SE (OR, 0.93; 95% CI, 0.60-1.45) and in BE (OR, 1.16; 95% CI, 0.88-1.52) valves. Between BAV and direct TAVI, no differences in secondary outcomes were observed neither in overall population nor according to valve type between BAV and direct TAVI strategies. All endpoints results were consistent between RCTs and adjusted studies except for postdilation rate that did not differ in observational studies (OR, 0.70; 95% CI, 0.47-1.04), while it was lower in BAV when only RCTs were included in the analysis (OR, 0.48; 95% CI, 0.24-0.97). CONCLUSIONS: Direct TAVI is feasible and safe compared to predilation approach with similar device success rates and clinical outcomes. Direct TAVI could represent a first-choice approach in contemporary TAVI procedures.

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.