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Background: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays., Objectives: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity., Methods: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses., Results: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity., Conclusions: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises., Competing Interests: Funding Support and Author Disclosures Dr Lefèvre has served as a proctor for Edwards Lifesciences; and received minor fees from Boston Scientific, Terumo, and Abbott. Dr Pilgrim has received research, travel, or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; and speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Daiichi Sankyo, AstraZeneca, Teleflex; and advisory board fees from Abbott Vascular, Boston Scientific, Inari, JenaValve, Medtronic, Daiichi Sankyo, AstraZeneca, Siemens, Pie Medical, and Teleflex. Dr Swaans has served as a proctor/lecturer for Abbott Vascular, Boston Scientific, Bioventrix Inc, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, Medtronic, and Philips Healthcare. Dr Prendergast has received speaker/consultancy fees from Medtronic, MicroPort, Anteris, and Edwards Lifesciences. Dr Resar has received institutional research funding from Medtronic, Edwards Lifesciences, and Abbott; and served as a TAVR proctor for Medtronic. Dr Chen has served as a consultant for Venus MedTech. Dr Hildick-Smith has received research funds and speaker fees from Medtronic. Dr Spence has received TAVR proctoring and consultancy fees from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Bunc has served as a proctor for Abbott, Meril, Edwards Lifesciences, and Medtronic. Dr Molnár has served as a consultant for Medtronic and Abbott. Dr Toggweiler has served as a consultant and proctor for Medtronic, Boston Scientific, and Biosensors; has served as a proctor for Edwards Lifesciences and Abbott Vascular; has served as a consultant for Medira, Shockwave, Teleflex, atHeart Medical, Cardiac Dimensions, and Polares Medical; has received institutional research grants from Boston Scientific, Fumedica, and Novartis; has received speaker honoraria from Sanofi, AstraZeneca, ReCor Medical, and Daiichi Sankyo; and holds equity in Hi-D Imaging. Dr Ojeda has received consulting fees from Medtronic and Edwards Lifesciences; and speaker fees from Philips and Word Medica. Dr Toutouzas has served as a proctor for Medtronic, Abbott, Myval, and Boston Scientific. Dr AlMerri has served as a TAVR proctor for Medtronic. Dr Noble has served as a proctor for Medtronic; and received institutional grant support from Edwards Lifesciences, Boston Scientific, Abbott Vascular, and Medtronic. Dr Kala has served as a consultant for Boston Scientific; served on the Speakers Bureau for Edwards Lifesciences, Servier, and AstraZeneca; and received research support from Novartis. Dr Kurt has served as a TAVR proctor for Abbott. Dr Yin has served as a TAVR proctor for Medtronic, Edwards Lifesciences, and Abbott. Dr Sztejfman has served as a proctor for Boston Scientific, Edwards Lifesciences, Medtronic, Meril Life Sciences, and MicroPort. Dr Mendiz has served as a proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Gunasekaran has received fees from Medtronic, Meril Life Sciences, Abbott, and Boston Scientific. Dr Kao has served as a proctor for Medtronic and Edwards Lifesciences. Dr Dager has served as a consultant for Medtronic. Dr Ferrero-Guadagnoli has served as a proctor for Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Modine has served as a consultant for and received honorarium from Abbott, Medtronic, and Edwards Lifesciences. Dr Hayashida has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott. Dr Makkar has received research grants from Abbott, Edwards Lifesciences, and Boston Scientific, and served as a consultant for Cordis and Medtronic. Dr Mylotte has received institutional grant funding from Boston Scientific and Medtronic; and personal fees from Boston Scientific, Medtronic, and MicroPort. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients' frailty in parallel with their underlying heart valve disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Existing literature about student-run clinics (SRCs) often focuses on student rather than patient experiences. To begin to gather data on norms and practices at SRCs nationally, this pilot study surveyed faculty leaders from SRCs around the country about metrics such as clinic organization, patient demographics, and care services., Methods: A 38-question survey was distributed via email to members of the Student Run Free Clinic Faculty Association (SRFCFA) in October 2021. All responses were collected electronically via Qualtrics survey software., Results: Most SRCs are held at least once weekly in variable physical locations. All SRCs surveyed use an electronic medical record. Student leadership typically rotates annually. Preceptors skew towards generalists rather than specialists. Clinics have variable patient volumes but see majority uninsured and non-English-speaking patient populations. Responses about consistency of result communication, follow-up visits, referrals to specialty care, and management of high-risk patients were mixed. The majority of respondents did not feel that learner experience was prioritized over patient care., Conclusion: The design and operations of SRCs nationwide is variable and not standardized. There remains a limited understanding of patient experiences and patient-centered outcomes at SRCs, and thus it is difficult to guide best practices. Future efforts to collect patient perspectives and outcomes should be emphasized given the vulnerable populations these clinics serve., (© 2024 by the Society of Teachers of Family Medicine.)

Background: The administration of biological drugs in inflammatory bowel diseases (IBD) is increasingly moving from intravenous to subcutaneous formulations., Aims: To evaluate the efficacy and safety of vedolizumab subcutaneous administration after switching from intravenous administration in ulcerative colitis (UC) patients in corticosteroid-free clinical remission., Methods: An observational, multicentre, prospective study was conducted by the Italian Group for the study of IBD (IG-IBD). UC patients in clinical remission (pMAYO < 2) not receiving steroids for > 8 months before the switch, and with at least 6 months of follow-up were included. Switch from intravenous to subcutaneous vedolizumab was defined as successful in patients not experiencing a disease flare (pMAYO ≥ 2) or needing oral steroids or stopping subcutaneous vedolizumab during the 6 months of follow-up after the switch., Results: Overall, 168 patients were included. The switch was a success in 134 patients (79.8%). Vedolizumab retention rate was 88.7% at month six. C-reactive protein and faecal calprotectin values did not change after the switch (p = 0.07 and p = 0.28, respectively). Ten of the 19 patients who stopped subcutaneous formulation switched back to intravenous formulation recapturing clinical remission in 80%. Side effects were observed in 22 patients (13.1%)., Conclusion: Effectiveness of switching from intravenous to subcutaneous vedolizumab formulation in UC patients in steroid-free clinical remission is confirmed in a real-world setting., Competing Interests: Conflicts of Interest and source of funding Davide Giuseppe Ribaldone Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Biogen. Laura Parisio Nothing to declare. Angela Variola Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Pfizer, Ferring, MSD, Zambon, Abbvie, Celltrion. Fabrizio Bossa Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Biogen, Abbvie, MSD, Celltrion, Mundipharma. Fabiana Castiglione Consultant for Abbvie, Fresenius, Sandoz, Galapagos, Pfizer, Takeda, Janssen, Biogen, Celltrion. Manuela Marzo Nothing to declare. Nicole Piazza Nothing to declare. Annalisa Aratari Advisory Board for Galapagos. Consultant for Abbvie, Galapagos, Pfizer, Takeda, Janssen. Edoardo Vincenzo Savarino Speaker for Abbvie, Agave, AGPharma, Alfasigma, Aurora Pharma, CaDiGroup, Celltrion, Dr Falk, EG Stada Group, Fenix Pharma, Fresenius Kabi, Galapagos, Janssen, JB Pharmaceuticals, Innovamedica/Adacyte, Malesci, Mayoly Biohealth, Omega Pharma, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Tillots, Unifarco. Consultant for Abbvie, Agave, Alfasigma, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr. Falk, Fenix Pharma, Fresenius Kabi, Janssen, JB Pharmaceuticals, Merck & Co, Nestlè, Reckitt Benckiser, Regeneron, Sanofi, SILA, Sofar, Synformulas GmbH, Takeda, Unifarco. He received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, Unifarco, Zeta Farmaceutici. Giorgia Bodini Nothing to declare. Mauro Mastronardi Lecture fees and Advisory Board per Takeda, Galapagos, Biogen, AuroraPharma Abbvie. Silvia Mazzuoli Lecture fees and Advisory Board per Janssen, Galapagos, Takeda, Abbvie, MSD, Pfizer. Federica Micheli Nothing to declare. Silvia Mazzuoli Nothing to declare. Marta Ascolani Nothing to declare. Chiara Viganò Lecture fees and Advisory Board for Janssen-Cilag, Takeda, Galapagos, Pfizer, Celltrion, Alfasigma. Maria Cappello Lecture fees and Advisory Board for Takeda, Janssen-Cilag, Biogen, Galapagos, Pfizer. Cristina Bezzio Lecture fees and Consultant for Ferring, Takeda, Janssen, Abbvie, Galapagos, Pfizer. Nothing to declare. Rachele Ciccocioppo Advisory Board for Galapagos, Takeda; scientific consultant for Revalma, and lecture fee from Fresenius-Kabi and Takeda. Giulia Scardino Nothing to declare. Ennio Sarli Nothing to declare. Daniela Pugliese Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Biogen, MSD, Pfizer. Franco Scaldaferri Lecture fees and Advisory Board per Janssen-Cilag, Takeda, Galapagos, Ferring, Sandoz, MSD, Pfizer, Celltrion. Daniele Napolitano Nothing to declare. Alessia Todeschini. Andrea Geccherle Nothing to declare. Nicoletta Colaci Nothing to declare. Maria Guerra. Nothing to declare. Monica Annese Nothing to declare. Anna Testa Lecture fees and Consultant for Takeda, Janssen, Abbvie, Galapagos, Pfizer. Anna Caiazzo Nothing to declare. Francesco Simone Conforti Nothing to declare. Stefano Festa Advisory Board for Janssen-Cilag. Consultancy fees for Takeda, Pfizer. Greta Lorenzon Nothing to declare. Antonella Marra Nothing to declare. Ambra Magiotta Nothing to declare. Flavia Baccini Nothing to declare. Arnaldo Amato Nothing to declare. Anxhela Poshnjari Nothing to declare. Marta Vernero Nothing to declare. Flavio Caprioli Consultant to Abbvie, MSD, Takeda, Janssen, Roche, Celgene, Bristol-Meyers Squibb, Galapagos, Gilead, Pfizer, Mundipharma, Galapagos, Biogen, Ferring, Eli-Lilly, Nestlè. Lecture fees from Abbvie, Ferring, Takeda, Allergy Therapeutics, Janssen, Pfizer, Biogen, Sandoz, Tillotts Pharma. Unrestricted research grants from Giuliani, Sofar, MSD, Takeda, Abbvie, Celltrion, Pfizer. Gian Paolo Caviglia Nothing to declare., (Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Murray law-based quantitative flow ratio (µQFR) assesses fractional flow reserve (FFR) in bifurcation lesions using a single angiographic view, enhancing the feasibility of analysis; however, accuracy may be compromised in suboptimal angiographic projections. FFR CT is a well-validated non-invasive method measuring FFR from coronary computed tomographic angiography (CCTA). We evaluated the feasibility of µQFR in left main (LM) bifurcations, the impact of the optimal/suboptimal fluoroscopic view with respect to CCTA, and its diagnostic concordance with FFR CT . In 300 patients with three-vessel disease, the values of FFR CT and µQFR were compared at distal LM, proximal left anterior descending artery (pLAD) and circumflex artery (pLCX). The optimal viewing angle of LM bifurcation was defined on CCTA by 3-dimensional coordinates and converted into a 2-dimensional fluoroscopic view. The best fluoroscopic projection was considered the closest angulation to the optimal viewing angle on CCTA. µQFR was successfully computed in 805 projections. In the best projections, µQFR sensitivity was 88.2% (95% CI 76.1-95.6) and 84.8% (71.1-93.7), and specificity was 96.8% (93.8-98.6) and 97.2% (94.4-98.9), in pLAD and pLCX, respectively, with regard to FFR CT . The AUC of µQFR for predicting FFR CT  ≤ 0.80 tended to be improved using the best versus suboptimal projections (0.94 vs. 0.89 [p = 0.048] in pLAD; 0.94 vs. 0.88 [p = 0.075] in pLCX). Computation of µQFR in LM bifurcations using a single angiographic view showed high feasibility from post-hoc analysis of coronary angiograms obtained for clinical purposes. The fluoroscopic viewing angle influences the diagnostic performance of physiological assessment using a single angiographic view., (© 2023. The Author(s).)

Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups., Competing Interests: Funding Support and Author Disclosures Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, and Medira. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, Medtronic, Philips, Shifamed, Siemens, WL Gore, vDyne, and xDot. Dr Cavalcante has received consulting fees/honoraria from Abbott Structural, Anteris, AriaCV, Boston Scientific, Edwards Lifesciences, Medtronic, VDyne, WL Gore, and Xylocor; and has received research grants from Abbott Northwestern Hospital Foundation and Abbott Structural. Dr Sitges has received speaker honoraria and consultant fees for Abbott, Edwards Lifesciences, Medtronic, and General Electric. Dr Taramasso has acted as a consultant and/or received consultancy fees from Abbott, Edwards Lifescience, Boston Scientific, Medtronic, Shenqi Medical, MEDIRA, Cardiovalve, VentriMend, Simulands, MTEx, Occlufit, CoreMedic, and HeD Imaging; has received an institutional educational grant from Edwards Lifescience and Abbott; and has served on the advisory board for Abbott. Dr Messika-Zeitoun has received research grant from Edwards Lifesciences. Dr Dreyfus has served as a proctor for Abbott. Dr Rudski has small holding of shares in General Electric. Dr Bax has received lecture fees from Abbott and Edwards Lifesciences; and has received unrestricted research grants from Edwards Lifesciences and Abbott. Dr Stephan von Bardeleben has received research support for trials from Abbott, Edwards Lifesciences, Jenavalve, Jenscare, Medtronic, and Neochord. Dr Redwood has served as a proctor and received speaker fees from Edwards; he has also served as on the international advisory board member for Medtronic. Dr Bapat has served as a consultant with Edwards Lifescienes, Medtronic, and Abbott; and has received a research grant from Atricure. Dr Nickenig has received honoraria for lectures or advisory boards from Abbott, Cardiovalve, Edwards, Medtronic, and Boston Scientific. Dr Hausleiter has received research support from Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, and Terumo; has received consulting fees, honoraria personal and institutional from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, and Mtex; has received royalty income rights from Edwards Lifesciences; and is a shareholder (including share options) of Cardiogard, Cardiovalve, Magenta, SwissVortex, Transseptalsolutions, 4Tech, and Perifect. Dr Enriquez-Sarano has received consulting fees from Artivion, ChemImage, Edwards Lifescience, HighLife, and Corcym. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: to prospectively assess sleep and sleep disorders during pregnancy and postpartum in a large cohort of women., Methods: multicenter prospective Life-ON study, recruiting consecutive pregnant women at a gestational age between 10 and 15 weeks, from the local gynecological departments. The study included home polysomnography performed between the 23rd and 25th week of pregnancy and sleep-related questionnaires at 9 points in time during pregnancy and 6 months postpartum., Results: 439 pregnant women (mean age 33.7 ± 4.2 yrs) were enrolled. Poor quality of sleep was reported by 34% of women in the first trimester of pregnancy, by 46% of women in the third trimester, and by as many as 71% of women in the first month after delivery. A similar trend was seen for insomnia. Excessive daytime sleepiness peaked in the first trimester (30% of women), and decreased in the third trimester, to 22% of women. Prevalence of restless legs syndrome was 25%, with a peak in the third trimester of pregnancy. Polysomnographic data, available for 353 women, revealed that 24% of women slept less than 6 h, and 30.6% of women had a sleep efficiency below 80%. Sleep-disordered breathing (RDI≥5) had a prevalence of 4.2% and correlated positively with BMI., Conclusions: The Life-ON study provides the largest polysomnographic dataset coupled with longitudinal subjective assessments of sleep quality in pregnant women to date. Sleep disorders are highly frequent and distributed differently during pregnancy and postpartum. Routine assessment of sleep disturbances in the perinatal period is necessary to improve early detection and clinical management., Competing Interests: Declaration of competing interest None., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Background: A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy., Objectives: The aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk., Methods: This prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory., Results: A total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg)., Conclusions: The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363)., Competing Interests: Funding Support and Author Disclosures HighLife SAS is the sponsor of the HighLife feasibility study (HL-2018-01) in Europe and Australia (NCT04029363). Mr Nasr, Mr Verhees, and Prof Rothman are HighLife employees. Dr Piazza and Prof Rottbauer are proctors for HighLife. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Background: Data concerning the outcomes of transcatheter aortic valve replacement in type 0 bicuspid aortic stenosis (AS) are scarce. The study aims to compare the outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy., Methods: We enrolled consecutive patients undergoing transcatheter aortic valve replacement for severe AS between 2012 and 2022 in this single-center retrospective cohort study. The primary outcome was mortality, while secondary outcomes included in-hospital complications such as stroke and pacemaker implantation and transcatheter heart valve hemodynamic performance., Results: The number of patients with AS with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy was 328, 302, and 642, respectively. Self-expanding transcatheter heart valves were used in the majority of patients (n=1160; 91.4%). In the matched population, differences in mortality (30 days: 4.2% versus 1.7% versus 1.7%, P overall =0.522; 1 year: 10% versus 2.3% versus 6.2%, P overall =0.099) and all stroke (30 days: 1.0% versus 0.9% versus 0.0%, P overall =0.765; 1 year: 1.4% versus 1.6% versus 1.3%, P overall =NS) were nonsignificant, and the incidence of overall in-hospital complications was comparable among groups. Ascending aortic diameter was the single predictor of 1-year mortality in type 0 bicuspid patients (hazard ratio, 1.59 [95% CI, 1.03-2.44]; P =0.035). The proportion of patients with a mean residual gradient ≥20 mm Hg was the highest in those with type 0 bicuspid anatomy, although the need for permanent pacemaker implantation was the lowest in this group., Conclusions: Major clinical outcomes of transcatheter aortic valve replacement for AS in patients with type 0 bicuspid, type 1 bicuspid, and tricuspid aortic valve anatomy are equivalent at short- and mid-term follow-up. These observations merit further exploration in prospective international registries and randomized controlled trials., Competing Interests: Disclosures M. Chen and Dr Feng are proctors/consultants of Venus MedTech, MicroPort, and Peijia Medical. Dr Mylotte is a proctor and consultant for Medtronic and Microport and a consultant for Boston Scientific. Dr Piazza is a consultant and proctor for Medtronic and Peijia Medical. Dr Prendergast has received institutional educational and research grants from Edwards Lifesciences and speaker/consultancy fees from Abbott, Anteris, Edwards Lifesciences, Medtronic, and Microport. The other authors report no conflicts.

We report the case of a 64-year-old man with a history of chemotherapy-induced cardiomyopathy requiring heart transplant in 2022 who underwent successful endomyocardial biopsy using patient-specific computed tomographic fluoroscopic projections. ( Level of Difficulty: Beginner. )., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2023 The Authors.)

Background: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited., Aims: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry., Methods: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria., Results: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm 2 , and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies., Conclusions: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Paravalvular leak (PVL) is a shortcoming that can erode the clinical benefits of transcatheter valve replacement (TAVR) and therefore a readily applicable method (aortography) to quantitate PVL objectively and accurately in the interventional suite is appealing to all operators. The ratio between the areas of the time-density curves in the aorta and left ventricular outflow tract (LVOT-AR) defines the regurgitation fraction (RF). This technique has been validated in a mock circulation; a single injection in diastole was further tested in porcine and ovine models. In the clinical setting, LVOT-AR was compared with trans-thoracic and trans-oesophageal echocardiography and cardiac magnetic resonance imaging. LVOT-AR > 17% discriminates mild from moderate aortic regurgitation on echocardiography and confers a poor prognosis in multiple registries, and justifies balloon post-dilatation. The LVOT-AR differentiates the individual performances of many old and novel devices and is being used in ongoing randomized trials and registries., Competing Interests: PWS reports personal fees from Philips/Volcano, SMT, Novartis, Xeltis, Merillife. PCR has no conflict of interest. Aben is an employee of Pie Medical Imaging. MC is employed by and holds shares of Xeltis BV CS is an employee of Philips Healthcare. MA-W reports other from Medtronic, other from Boston Scientific, outside the submitted work. NP is a consultant to Medtronic, Peijia, and MicroPort. RM is an employee of Boston Scientific. AR reports grants and personal fees from Boston Scientific, personal fees from Edwards Lifesciences, outside the submitted work. KK reports personal fees from Abbott, personal fees from Boston Scientific, personal fees from Edwards Lifesciences, personal fees from Medtronic, personal fees from Meril Life Sciences, outside the submitted work. NVR reports grants and personal fees from Abbott, grants from Philips, grants from Biotronik, and personal fees from Microport, outside the submitted work. Rudolph is a proctor, speaker’s honoraria of JenaValve. FJN reports personal fees from Amgen, personal fees from Boehringer Ingelheim, personal fees from Daiichi Sankyo, grants and personal fees from Pfizer, grants and personal fees from Biotronic, grants and personal fees from Edwards Lifesciences, grants from Medtronic, grants and personal fees from Bayer Healthcare, personal fees from Novartis, grants from GlaxoSmithKline, grants and personal fees from Boston Scientific, personal fees from Ferrer, outside the submitted work. IJA-S is a proctor for Medtronic, Boston Scientific and Meril Life. OS and YO report several institutional research grants, outside the submitted work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Abdelshafy, Serruys, Tsai, Revaiah, Grag, Aben, Schultz, Abdelghani, Tonino, Miyazaki, Rutten, Cox, Sahyoun, Teng, Tateishi, Abdel-Wahab, Piazza, Pighi, Modolo, van Mourik, Wykrzykowska, de Wintet, Lemos, de Brito, Kawashima, Søendergaard, Rosseel, Wang, Gao, Tao, Rück, Kim, van Royen, Terkelsen, Nissen, Adam, Rudolph, Wienemann, Torii, Neuman, Schoechlin, Chen, Elkoumy, Elzomor, Amat-Santos, Mylotte, Soliman and Onuma.)

Coronary computed tomographic angiography (CCTA) is becoming the first-line investigation for establishing the presence of coronary artery disease and, with fractional flow reserve (FFR CT ), its haemodynamic significance. In patients without significant epicardial obstruction, its role is either to rule out atherosclerosis or to detect subclinical plaque that should be monitored for plaque progression/regression following prevention therapy and provide risk classification. Ischaemic non-obstructive coronary arteries are also expected to be assessed by non-invasive imaging, including CCTA. In patients with significant epicardial obstruction, CCTA can assist in planning revascularisation by determining the disease complexity, vessel size, lesion length and tissue composition of the atherosclerotic plaque, as well as the best fluoroscopic viewing angle; it may also help in selecting adjunctive percutaneous devices (e.g., rotational atherectomy) and in determining the best landing zone for stents or bypass grafts.

We report the case of an 89-year-old woman with prior transcatheter aortic valve replacement who underwent successful left coronary artery engagement and left circumflex percutaneous coronary intervention using patient-specific computed tomography fluoroscopic projections. ( Level of Difficulty: Advanced. )., Competing Interests: The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2023 The Authors.)

Background: Limited data exist on the use of temporary permanent pacemaker (TPPM) to reduce unnecessary PPM in patients with high-degree atrioventricular block (HAVB) after transcatheter aortic valve replacement (TAVR)., Objectives: This study aims to determine the feasibility of TPPM in patients with HAVB after TAVR to provide prolonged pacing as a bridge., Materials and Methods: One hundred and eleven consecutive patients undergoing TAVR were screened from August 2021 to June 2022. Patients with HAVB eligible for PPM were included. TPPM were used in these patients instead of conventional temporary pacing or early PPM. Patients were followed up for 1 month. Holter and pacemaker interrogation were used to determine whether to implant PPM., Results: Twenty one patients met the inclusion criteria for TPPM, of which 14 patients were third-degree AVB, 1 patient was second-degree AVB, 6 patients were first degree AVB with PR interval > 240 ms and LBBB with QRS duration > 150 ms. TPPM were placed on the 21 patients for 35 ± 7 days. Among 15 patients with HAVB, 26.7% of them ( n = 4) recovered to sinus rhythm; 46.7% ( n = 7) recovered to sinus rhythm with bundle branch block. The remains of 26.7% patients ( n = 4) still had third-degree AVB and received PPM. For patients with first-degree AVB and LBBB, PR interval shortened to < 200 ms in all 6 patients and LBBB recovered in 2 patients. TPPM were successfully removed from all patients and no procedure-related adverse events occurred., Conclusion: TPPM is reliable and safe in the small sample of patients with conduction block after TAVR to provide certain buffer time to distinguish whether a PPM is necessary. Future studies with larger sample are needed for further validation of the current results., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Chang, Liu, Lu, Yao, Yin, Wu, Yuan, Luo, Liu, Yan, Zhang, Pu, Modine, Piazza, Jilaihawi, Jiang and Song.)

Indications for transcatheter aortic valve implantation (TAVI) have expanded in many countries to include patients with aortic stenosis who are at low surgical risk, and a similar expansion to this cohort is anticipated elsewhere in the world, together with an increase in the proportion of patients with bicuspid aortic valve (BAV) morphology as the age of the patients being treated decreases. To date, patients with BAV have been excluded from major randomized trials of TAVI owing to anatomical considerations. As a consequence, BAV has been a relative contraindication to the use of TAVI in international guidelines. Although clinical experience and observational data are accumulating, BAV presents numerous anatomical challenges for successful TAVI, despite advances in device design. Furthermore, in those with BAV, substantial geographical variation exists in patient characteristics, clinical approach and procedural strategy. Therefore, in this Roadmap article, we summarize the existing evidence and provide consensus recommendations from an international group of experts on the application of TAVI in patients with BAV in advance of the anticipated growth in the use of this procedure in this challenging cohort of patients., (© 2022. Springer Nature Limited.)

Most transcatheter aortic valve replacement-related procedures (eg, transcatheter aortic valve replacement implantation depth, commissural alignment, coronary access, bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction, paravalvular leak closure) require an optimal fluoroscopic viewing angle located somewhere along the aortic annulus S-curve. Chamber views, coronary cusp and coronary anatomy, can be understood along the aortic annulus S-curve. A better understanding of the optimal fluoroscopic viewing angles along the S-curve may translate into increased operator confidence and improved safety and efficacy while reducing procedural time, radiation dose, contrast volume, and complication rates., Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Despite easy access to imaging diagnostic procedures and an abundance of spatial data, most cardiac interventions are still performed under two-dimensional fluoroscopy. Incorporating anatomical data from scans into procedures plans has the potential to improve the swiftness and outcomes of percutaneous cardiac interventions. Therefore, procedure planning based on the specific anatomy is becoming a new standard of excellence in interventional cardiology. Still, we often tend to disregard specific spatial relations and the actual direction of catheter tip movement inside the body, relying on a try and error approach. The precise spatial orientation of instruments and prosthetic devices is crucial, especially during structural heart interventions. Here, we present how deliberate movements of objects under fluoroscopy can reveal the spatial orientation of catheters and other devices. We also propose a novel "two-point rule" for identifying three-dimensional relations between points in space. Understanding and applying this rule might substantially increase the spatial awareness of operators performing cardiovascular interventions. Although the concept is pretty simple, using it "live" during interventional cardiology procedures requires thorough understanding and practice. We propose the "two-point rule" as a crucial rule to develop expertise in spatial orientation under fluoroscopy and ensure high-quality outcomes., (© 2022 Wiley Periodicals LLC.)

Background: Success rate of transcatheter aortic valve replacement (TAVR) in aortic regurgitation (AR) patients is relatively low on account of the absence of calcified anchoring structures. Morphological classification and corresponding TAVR strategies for AR are lacking yet., Methods: The AURORA study is a prospective, multicenter, single-arm cohort study to evaluate the safety and efficacy of transfemoral TAVR for severe AR in patients with high or prohibitive risk for surgery. Patients who are ≥ 65 years and diagnosed with severe pure AR as defined by the Echocardiographic Core Laboratory will be consecutively enrolled for further multidetector computed tomography (MDCT) scanning and multiplanar analyses. Based on a new anatomical classification and dual anchoring theory, patients will be classified into 4 types according to the level of the anchoring area. Types 1, 2 and 3 (at least 2 anchoring areas) will undergo the TAVR procedure with a domestic Chinese self-expanding valve (VitaFlow Valve, MicroPort, Shanghai, China), whereas type 4 (0 or 1 anchoring area) patients will be considered unsuitable for TAVR and will receive medical treatment. Our goal is to recruit 100 patients to account for 10% missing data or loss of patients to follow-up. Procedural, 30-day, 6-month and 12-month outcomes will be assessed according to Valve Academic Research Consortium-3 criteria., Discussion: The AURORA study will establish a new AR anatomical classification based on dual anchoring theory through MDCT multiplanar measurement and assess the safety and efficacy of TAVR guided by this new classification and strategy in AR patients., Trial Registration: This Study was registered at Chinses Clinical Trial Registry. The registration number: ChiCTR2200055415; The date of registration: 9, January 2022; The URL of the registration: http://www.chictr.org.cn/showproj.aspx?proj=141209 ., (© 2022. The Author(s).)

Background: This study sought to compare characteristics and outcomes of patients who underwent surgical aortic valve replacement (SAVR) after being referred to a heart team (HT), to those of patients referred directly for SAVR., Methods: An analysis of patients who underwent SAVR from 2015 to 2020 was conducted. Patients were categorized into 3 groups, as follows: (i) H-HT: patients referred to the HT from 2015 to 2017 (historical cohort); (ii) C-HT: patients referred to the HT from 2018 to 2020 (contemporary cohort); and (iii) No-HT: patients referred directly to cardiac surgery from 2018 to 2020. Two subanalyses were performed: H-HT vs C-HT patients, and C-HT vs No-HT patients. The primary outcome was a composite of in-hospital mortality, prolonged intubation, reoperation, sternal wound infection, and stroke., Results: This study consisted of 288 patients, distributed as follows: H-HT (n = 45); C-HT (n = 51); and No-HT (n = 192). The mean ages of H-HT, C-HT, and No-HT patients was 76.3 ± 6.9 years, 73.3 ± 7.6 years, and 69.6 ± 9.7 years, respectively ( P  = 0.0001). H-HT, C-HT, and No-HT patients had average Society of Thoracic Surgeons scores of 4.8 ± 2.2, 3.2 ± 1.6, and 4.2 ± 2 ( P  = 0.002), respectively. The composite outcome rate was more than 5 times higher among H-HT patients compared to that among the C-HT patients (20.0 vs 3.9%, P  = 0.02), and was numerically higher in No-HT compared to C-HT patients (13.0 vs 3.9%, P  = 0.07)., Conclusions: Referral to an HT appears to be primarily driven by higher chronological age rather than overall risk profile. Patients assessed by the HT prior to undergoing SAVR have a low incidence of complications, comparable to that among patients referred directly to cardiac surgery., (© 2022 The Authors.)

Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited., Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial., Design, Setting, and Participants: SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021., Intervention: Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis., Main Outcomes and Measures: The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years., Results: A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention., Conclusions and Relevance: Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

A novel and low-cost framework for food traceability, composed by commercial and proprietary sensing devices, for the remote monitoring of air, water, soil parameters and herbicide contamination during the farming process, has been developed and verified in real crop environments. It offers an integrated approach to food traceability with embedded systems supervision, approaching the problem to testify the quality of the food product. Moreover, it fills the gap of missing low-cost systems for monitoring cropping environments and pesticides contamination, satisfying the wide interest of regulatory agencies and final customers for a sustainable farming. The novelty of the proposed monitoring framework lies in the realization and the adoption of a fully automated prototype for in situ glyphosate detection. This device consists of a custom-made and automated fluidic system which, leveraging on the Molecularly Imprinted Polymer (MIP) sensing technology, permits to detect unwanted glyphosate contamination. The custom electronic mainboard, called ElectroSense, exhibits both the potentiostatic read-out of the sensor and the fluidic control to accomplish continuous unattended measurements. The complementary monitored parameters from commercial sensing devices are: temperature, relative humidity, atmospheric pressure, volumetric water content, electrical conductivity of the soil, pH of the irrigation water, total Volatile Organic Compounds (VOCs) and equivalent CO2. The framework has been validated during the olive farming activity in an Italian company, proving its efficacy for food traceability. Finally, the system has been adopted in a different crop field where pesticides treatments are practiced. This has been done in order to prove its capability to perform first level detection of pesticide treatments. Good correlation results between chemical sensors signals and pesticides treatments are highlighted.

Background: As transcatheter aortic valve (TAV) replacement is increasingly used in patients with longer life expectancy, a sizable proportion will require redo TAV replacement (TAVR). The unique configuration of balloon-expandable TAV (bTAV) vs a self-expanding TAV (sTAV) potentially affects TAV-in-TAV outcome., Objectives: The purpose of this study was to better inform prosthesis selection, TAV-in-TAV outcomes were assessed according to the type of initial and subsequent TAV., Methods: Patients from the Redo-TAVR registry were analyzed using propensity weighting according to their initial valve type (bTAV [n = 115] vs sTAV [n = 106]) and subsequent valve type (bTAV [n = 130] vs sTAV [n = 91])., Results: Patients with failed bTAVs presented later (vs sTAV) (4.9 ± 2.1 years vs 3.7 ± 2.3 years; P < 0.001), with smaller effective orifice area (1.0 ± 0.7 cm 2 vs 1.3 ± 0.8 cm 2 ; P = 0.018) and less frequent dominant regurgitation (16.2% vs 47.3%; P < 0.001). Mortality at 30 days was 2.3% (TAV-in-bTAV) vs 0% (TAV-in-sTAV) (P = 0.499) and 1.7% (bTAV-in-TAV) vs 1.0% (sTAV-in-TAV) (P = 0.612); procedural safety was 72.6% (TAV-in-bTAV) vs 71.2% (TAV-in-sTAV) (P = 0.817) and 73.2% (bTAV-in-TAV) vs 76.5% (sTAV-in-TAV) (P = 0.590). Device success was similar according to initial valve type but higher with subsequent sTAV vs bTAV (77.2% vs 64.3%; P = 0.045), primarily because of lower residual gradients (10.3 mm Hg [8.9-11.7 mm Hg] vs 15.2 mm Hg [13.2-17.1 mm Hg]; P < 0.001). Residual regurgitation (moderate or greater) was similar after bTAV-in-TAV and sTAV-in-TAV (5.7%) and nominally higher after TAV-in-bTAV (9.1%) vs TAV-in-sTAV (4.4%) (P = 0.176)., Conclusions: In selected patients, no association was observed between TAV type and redo TAVR safety or mortality, yet subsequent sTAV was associated with higher device success because of lower redo gradients. These findings are preliminary, and more data are needed to guide valve choice for redo TAVR., Competing Interests: Funding Support and Author Disclosures Dr Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr Kim is a proctor for and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Abdel-Wahab has received speaker honoraria and/or consultancy fees to the hospital on his behalf from Boston Scientific and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and is an advisory board member for Biotronik. Dr Søndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr Redwood is a proctor for and has received lecture fees from Edwards Lifesciences. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Sathananthan is a consultant to Edwards Lifesciences. Dr Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr Castriota is a proctor for Medtronic and Boston Scientific. Dr Nazif is a consultant for or has received honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and is a consultant for and holds equity in Venus Medtech. Dr Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr Latib has received institutional research and grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr Hildick-Smith is a proctor and adviser for Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Colonoscopy represents the most widespread and effective tool for the prevention and treatment of early stage preneoplastic and neoplastic lesions in the panorama of cancer screening. In the world there are different approaches to the topic of colorectal cancer prevention and screening: different starting ages (45-50 years); different initial screening tools such as fecal occult blood with immunohistochemical or immune-enzymatic tests; recto-sigmoidoscopy; and colonoscopy. The key aspects of this scenario are composed of a proper bowel preparation that ensures a valid diagnostic examination, experienced endoscopist in detection of preneoplastic and early neoplastic lesions and open-minded to upcoming artificial intelligence-aided examination, knowledge in the field of resection of these lesions (from cold-snaring, through endoscopic mucosal resection and endoscopic submucosal dissection, up to advanced tools), and management of complications., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.)

This paper presents a multi-professional integrated approach toward the recognition and management of the nutritional and psychological needs of cancer patients. In particular, the patients undertook a multi-professional, multistep process that included the collection of both personal and clinical data, the evaluation of anthropometric measures, nutritional status and psychometric indices, and an ensuing personalized nutritional prescription and psychological support, ultimately leading to combined nutritional and psychological interventions to control their adherence to a nutritional program and to consolidate motivation to change. Overall, 120 patients were recruited for the study. The majority (84.2%) were female. Breast cancer was by far the most frequent malignancy (52.5%), followed by colorectal (17.5%), pancreatic (9.2%), ovarian (9.2%) and lung (5.0%) cancers. The results of the nutritional and psychological screening at baseline indicated that only 35% of patients had a normal BMI, whilst a relatively high proportion (nearly 32%) was overweight or obese (25%). The INRAN and MEDI-LITE questionnaires, which were used to assess the eating habits and adherence to a Mediterranean diet, respectively, revealed a mixed prevalence of cereals/cereal-based, fresh/processed meat, and fish or fishery food, with a medium-low adherence to the Mediterranean diet in nearly 38% of patients. The BUT, HADS and SF-36 tests, which were used to assess psychological disturbances, showed that 37.5% of patients had disorders regarding body image, 29.2% had abnormal anxiety and 20.0% had a depressive state, while no significant association was observed between the SF-36 PCS and MCS and the patients' characteristics. The results of the potential impact of this novel approach on the QoL of patients after completion of the course are awaited with expectation.

Aims: A tailored chelation therapy guided by magnetic resonance imaging (MRI) is a strategy to improve the prognosis in iron-loaded patients, in many cases still hampered by limited MRI availability. In order to address this issue, the Myocardial Iron Overload in Thalassemia (MIOT) network was established in Italy and we aimed to describe the impact of 10-year activity of this network on cardiac burden in thalassemia major (TM)., Methods and Results: Within the MIOT network, 1746 TM patients (911 females; mean age 31.2 ± 9.1 years) were consecutively enrolled and prospectively followed by 70 thalassemia and 10 MRI centres. Patients were scanned using a multiparametric approach for assessing myocardial iron overload (MIO), biventricular function, and myocardial fibrosis. At the last MRI scan, a significant increase in global heart T2* values and a significantly higher frequency of patients with no MIO (all segmental T2* ≥20 ms) were detected, with a concordant improvement in biventricular function, particularly in patients with baseline global heart T2* <20 ms. Forty-seven percentage of patients changed the chelation regimen based on MRI. The frequency of heart failure (HF) significantly decreased after baseline MRI from 3.5 to 0.8% (P < 0.0001). Forty-six patients died during the study, and HF accounted for 34.8% of deaths., Conclusion: Over 10 years, continuous monitoring of cardiac iron and a tailored chelation therapy allowed MIO reduction, with consequent improvement of cardiac function and reduction of cardiac complications and mortality from MIO-related HF. A national networking for rare diseases therefore proved effective in improving the care and reducing cardiac outcomes of TM patients., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: In the last decade, transcatheter aortic valve implantation (TAVI) has developed rapidly in China. As TAVI progresses towards low surgical risk patients, the total number of TAVI procedures will grow exponentially. There is a need to develop a domestic TAVI device designed for Chinese patients., Aims: The aim of this study was to evaluate the safety and efficacy of a self-expanding valve (TaurusOne transcatheter aortic valve system) in the treatment of patients with symptomatic severe aortic stenosis in China., Methods: A prospective, multicentre, single-arm study was designed to enrol 120 patients with symptomatic severe aortic stenosis undergoing TAVI using the TaurusOne valve. The primary endpoint was all-cause mortality at one year., Results: From September 2017 to April 2019, 120 patients were enrolled (35% bicuspid aortic valve, mean Society of Thoracic Surgeons [STS] score 9.95%). One-year mortality in 120 patients (follow-up rate, 100%), was 6.7% (upper 95% confidence interval: 12.9%), which was significantly lower than the performance goal of 30% (p<0.0001). All stroke, myocardial infarction, paravalvular leak ≥moderate, and new pacemaker implantation occurred in 4.4%, 1.8%, 0.8%, and 22.1% of patients, respectively, at one year. The haemodynamic results and quality of life scores also improved significantly. Patients with a bicuspid valve had similar outcomes to those with a tricuspid aortic valve., Conclusions: The one-year clinical results confirm the safety and efficacy of the TaurusOne transcatheter aortic valve system in the treatment of patients with symptomatic severe tricuspid and bicuspid aortic stenosis.

Background: There are limited data on the association of membranous septum (MS) morphology and transcatheter heart valve (THV) implantation depth, and the development of new conduction abnormalities (CA) after transcatheter aortic valve implantation (TAVI)., Aims: The aim of this study was to describe the morphology of the MS and predict the risk of new CA after TAVI based on the MS morphology and THV implantation depth., Methods: Based on preprocedural CT scans, the MS depth was measured for every 25% of the entire MS width in 272 TAVI patients without preprocedural bundle branch block (BBB) or pacemaker. Post-procedural CT scans for THV implantation depth assessment were available in 130 of these patients., Results: The MS depth was a median of 2.5 mm (IQR 1.4-3.8) deeper at the posterior edge when compared to the anterior edge of the MS. New CA developed in 7.1% of patients in whom the THV did not cross the lower MS border at its anterior edge (3.6% with new BBB and high degree CA, respectively), in 18.8% of patients (15.6% with new BBB and 3.1% with new high-degree CA) where the THV overlapped the lower MS border by <2.5 mm and in 47.1% of patients (24.3% with new BBB and 22.9% with new high-degree CA) with THV overlap of the lower MS border by ≥2.5 mm., Conclusions: The difference of the MS depth and THV implantation depth measured at the anterior edge of the MS predicted new CA after TAVI.

Background: the assessment of fibrosis in Crohn's disease (CD) bowel lesions helps to guide therapeutic decisions. Real-time elastography (RTE) and delayed-enhancement magnetic resonance enterography (DE-MRE) have demonstrated good accuracy in quantifying CD-related ileal fibrosis as compared with histological examination. To date no study has compared DE-MRE and RTE., Aims: we aimed to evaluate the agreement between RTE and DE-MRE on quantifying CD-related ileal fibrosis., Methods: consecutive patients with ileal or ileocolonic CD underwent RTE and DE-MRE. Ileal fibrosis was quantified by calculating the strain ratio (SR) at RTE and the 70s-7 min percentage of enhancement gain (%EG) of both mucosa and submucosa at DE-MRE. A SR ≥2 was applied to define severe fibrosis. Clinically relevant outcomes occurring at follow-up were recorded., Results: 40 CD patients were enrolled. A significant linear correlation was observed between SR and submucosal %EG (r = 0.594, p < 0.001). Patients with severe fibrosis (SR ≥2) had significantly higher submucosal %EG values than patients with low/moderate fibrosis (median values 26.4% vs. 9.5%, p < 0.001). During a median 43.8-month follow-up relevant disease outcomes occurred more frequently in the severe-fibrosis group (75% vs. 36%, HR 5.4, 95% CI 1.2-24.6, p = 0.029)., Conclusions: the study demonstrates an excellent agreement between RTE and DE-MRE in assessing ileal fibrosis in CD., Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest., (Copyright © 2021. Published by Elsevier Ltd.)

Psychomimetic behaviors manifest in adult rodents long after neonatal exposure to the noncompetitive NMDA receptor antagonist MK-801. In the present study, we used this neurodevelopmental model of schizophrenia to evaluate the therapeutic potential of positive allosteric modulation of metabotropic glutamate receptor 5 (mGluR5) during adolescence. To this end, we randomly assigned male and female C57BL6 mouse littermates to one of three treatment groups: (i) neonatal and adolescent saline, (ii) neonatal MK-801 (0.25 mg/kg) and adolescent saline, and (iii) neonatal MK-801 and adolescent CDPPB (10 mg/kg), a positive allosteric modulator of mGluR5. When animals reached adulthood, a wide range of behavioral tests were conducted including sucrose preference, anxiety assessment in the elevated plus maze, and a series of food-reinforced operant procedures meant to assess motor activity, motivation, learning, and attention. Neonatal MK-801 exposure produced profound motor hyperactivity in both sexes and attenuated sucrose preference in males, effects that were reversed by CDPPB. MK-801 produced other deficits such as impaired set shifting or response inhibition deficits that were not reversed by CDPPB. Overall, female mice were more susceptible to MK-801's behavioral effects than males. These findings further support the use of neonatal MK-801 exposure as an animal model of schizophrenia and suggest that CDPPB can reverse the neurodevelopmental progression of some schizophrenia-like behaviors., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Although multidimensional frailty scales have been proven to predict mortality and morbidity in cardiac surgery, there is a need for rapid tools that could be easily administered at the point of care. Handgrip strength (HGS) is an attractive option that can be measured in acutely ill and bed-bound patients, although it has yet to be validated in a large cardiac surgery cohort., Methods: This is a post hoc analysis of a multicentre prospective study in older patients undergoing coronary artery bypass grafting and/or valve surgery from 2011 to 2019. HGS was measured before surgery and classified by sex-stratified cutoffs. The primary outcome was 1-year mortality and secondary outcomes were 30-day mortality, discharge disposition, and prolonged length of stay., Results: There were 1245 patients included in the analysis (mean age 74.0 ± 6.6 years; 30% female). Weak HGS was associated with advanced age, heart failure, kidney disease, malnutrition, and various frailty scales. In those with weak vs normal HGS, respectively, 1-year mortality was 17% vs 6%, 30-day mortality was 10% vs 3%, prolonged length of stay was 34% vs 19%, and discharge to a health care facility was 45% vs 26% (all P < 0.001). After adjustment, HGS was predictive of 1-year and 30-day mortalities, with odds ratios of 2.44 (95% confidence interval [CI] 1.39-4.29) and 2.83 (1.38-5.81), respectively. HGS cutoffs of < 26 kg in men and < 16 kg in women had the highest predictive performance., Conclusions: HGS is a simple and effective tool to identify patients at higher risk of mortality and protracted recovery after cardiac surgery., (Copyright © 2021 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Aortic stenosis (AS) is the most common valvular heart disease. In the last decade, transcatheter aortic valve implantation (TAVI) has become the standard of care for symptomatic patients at high surgical risk. Recently, indications to TAVI have also been extended to the low surgical risk and intermediate surgical risk populations. Consequently, in this setting, some aspects acquire greater relevance: surgical risk evaluation, clinical assessment, multimodality imaging of the valve, and management of coronary artery disease. Moreover, future issues such as coronary artery re-access and valve-in-valve interventions should be considered in the valve selection process. This review aims to summarize the principal aspects of a multidimensional (multidisciplinary) and comprehensive preprocedural work-up. The Heart Team is at the center of the decision-making process of the management of aortic valve disease and bears responsibility for offering each patient a tailored approach based on an individual evaluation of technical aspects together with the risks and benefits of each modality. Considering the progressive expansion in TAVI indication and technological progress, the role of a work-up and multidisciplinary Heart Team will be even more relevant.

Background The Essential Frailty Toolset (EFT) was shown to be easy to use and predictive of adverse events in patients undergoing aortic valve replacement procedures. The objective of this study was to evaluate the EFT in patients undergoing coronary artery bypass grafting procedures. Methods and Results The McGill Frailty Registry prospectively included patients ≥60 years of age undergoing urgent or elective isolated coronary artery bypass grafting between 2011 and 2018 at 2 hospitals. The preoperative EFT was scored 0 to 5 points as a function of timed chair rises, Mini-Mental Status Examination, serum albumin, and hemoglobin. The primary outcome was all-cause mortality assessed by Cox proportional hazards regression. The cohort consisted of 500 patients with a mean age of 71.4 ± 6.4 years, of which 27% presented with acute coronary syndromes requiring urgent surgery. The mean EFT was 1.3 ± 1.1 points, 132 (26%) were nonfrail, 298 (60%) were prefrail, and 70 (14%) were frail. Over a median follow-up of 4.0 years, 78 deaths were observed. In nonfrail, prefrail, and frail patients, survival at 1 year was 98%, 95%, and 91%, and at 5 years was 89%, 83%, and 63% ( P <0.001). After adjustment, each incremental EFT point was associated with a hazard ratio of 1.28 (95% CI, 1.05-1.56) and frail patients had a 3-fold increase in all-cause mortality. Conclusions The EFT is a pragmatic and highly prognostic tool to assess frailty and guide decisions for coronary artery bypass grafting in older adults. Furthermore, the EFT may be actionable through targeted interventions such as cardiac rehabilitation and nutritional optimization.

Estrogens are recognized as key players in physiological regulation of various, classical and non-classical, target organs, and tissues, including liver development, homeostasis, and function. On the other hand, multiple, though dispersed, experimental evidence is highly suggestive for the implication of estrogen in development and progression of hepatocellular carcinoma. In this paper, data from our own studies and the current literature are reviewed to help understanding this apparent discrepancy.

Background Recurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges. Methods and Results This international multicenter observational retrospective study collected information for all patients from 16 high-volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class ≥III and MR was moderate or higher in 86% of patients. The cause of MR pre-SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9-9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of ≥1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In-hospital all-cause mortality was 2%, and 86% of patients were in New York Heart Association class ≤II. Conclusions MitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.

With the advent of transcatheter mitral valve replacement (TMVR), the concept of the neo-left ventricular outflow tract (LVOT) was introduced and remains an essential component of treatment planning. This paper describes the LVOT anatomy and provides a step-by-step computed tomography methodology to segment and measure the neo-LVOT while discussing the current evidence and outstanding challenges. It also discusses the technical and hemodynamic factors that play a major role in assessing the neo-LVOT. A summary of expert-based recommendations about the overall risk of LVOT obstruction in different scenarios is presented along with the currently available methods to reduce the risk of LVOT obstruction and other post-procedural complications., Competing Interests: Funding Support and Author Disclosures Dr. Wang has served as a consultant for Edwards Lifesciences and Boston Scientific; has received research grant support from Boston Scientific; and had patents on left ventricular outflow tract prediction modeling software assigned to assigned to her employer (Henry Ford Health System). Dr. Piazza is a consultant for Medtronic, HighLife, MicroPort, and Circle CVI. Dr. Cavalcante has received institutional grants to provide core lab services and consultant services to Boston Scientific, Edwards LifeSciences, and Abbott Structural; and received research support from 3Mensio, Circle CVI, Medis, and Siemens Healthineers. Drs. Blanke and Leipsic have received institutional grants to provide core lab services from Edwards Lifesciences, Medtronic, and Abbott; and served as consultants to Circle CVI and MVRX. Dr. Blanke has served as a consultant to Edwards Lifesciences and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)