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Background: Belatacept is employed alongside calcineurin inhibitor (CNI) therapy to prevent graft rejection in kidney transplant patients who are Epstein-Barr virus (EBV) seropositive. Preliminary data suggested that rates of post-transplant lymphoproliferative disorder (PTLD) were higher in individuals treated with belatacept compared to CNI therapy alone. Methods: The records of 354 adults who underwent kidney only transplantation from January 2015 through September 2021 at one medical center were evaluated. Patients underwent treatment with either low-doses of mycophenolate, tacrolimus and sirolimus (B0, n = 235) or low-doses of mycophenolate, tacrolimus and belatacept (B1, n = 119). All recipients underwent induction with antithymocyte globulin and a rapid glucocorticosteroid taper. Relevant donor and recipient information were analyzed and endpoints of PTLD were assessed. Results: There were no cases of PTLD in either cohort within the study period. Recipients in the belatacept cohort experienced lower estimated glomerular filtration rates at 12 months (B0: 67.48 vs. B1: 59.10, p = 0.0014). Graft failure at 12 (B0: 1.28% vs. B1: 0.84%, p = 1.0) and 24 months (B0:2.55% vs. B1: 0.84%, p = 0.431) were similar. There was no difference in rejection rates at 12 (B0: 1.27% vs. B1: 2.52%, p = 0.408) or 24 months (B0: 2.12% vs. B1: 2.52%, p = 1.000). Both groups had similar rates of malignancy, mortality and CMV/BK viremia. Conclusion: Non-belatacept (MMF, tacrolimus and sirolimus) and belatacept-based (MMF, tacrolimus and belatacept) regimens do not appear to pose any increased risk of early onset PTLD. Both cohorts benefited from low rates of rejection, malignancy, mortality and graft failure. Recipients will continue to be monitored as PTLD can manifest as a long-term complication. [ABSTRACT FROM AUTHOR]

Competing Interests: Funding Support and Author Disclosures Dr Chung is a consultant for Medtronic and Abbott. Dr Khan is a consultant/proctor for Abbott, Edwards Lifesciences, and Medtronic; holds equity in Transmural Systems; and has received institutional educational grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Phillips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Future electronics call for materials with mechanical toughness, flexibility, and stretchability. Moreover, self-healing and recyclability are highly desirable to mitigate the escalating environmental threat of electronic waste (e-waste). Herein, we report a stretchable, self-healing, and recyclable material based on a mixture of the conductive polymer poly(3,4-ethylenedioxythiophene) doped with polystyrene sulfonate (PEDOT:PSS) with a custom-designed polyurethane (PU) and polyethylene glycol (PEG). This material showed excellent elongation at brake (∼350%), high toughness (∼24.6 MJ m -3 ), moderate electrical conductivity (∼10 S cm -1 ), and outstanding mechanical and electrical healing efficiencies. In addition, it demonstrated exceptional recyclability with no significant loss in the mechanical and electrical properties after being recycled 20 times. Based on these properties, as a proof of principle for sustainable electronic devices, we demonstrated that electrocardiogram (ECG) electrodes and pressure sensors based on this material could be recycled without significant performance loss. The development of multifunctional electronic materials that are self-healing and fully recyclable is a promising step toward sustainable electronics, offering a potential solution to the e-waste challenge.

There are various devices under clinical investigation for transcatheter mitral valve intervention and transcatheter tricuspid valve intervention (TTVI); however, the exclusion rates remain high. We aimed to investigate the exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr), and transcatheter tricuspid valve replacement (TTVR). There were 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. The causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria, and medical futility. In 129 patients, the exclusion rates for TMVr, TMVR, TTVr, and TTVR were 81%, 85%, 91%, and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomic unsuitability. TMVr had the highest rate of patient withdrawal (64%) and the lowest anatomic unsuitability (5%) because of short posterior leaflet length. Replacement interventions have a higher anatomic unsuitability (33%) than repair interventions (17%) (p = 0.04). Most exclusions of anatomic unsuitability were because of mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. A total of 50% of exclusions from TTVr were because of the presence of pacemaker/defibrillator leads. In patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p <0.01 and p = 0.01, respectively). In conclusion, the exclusion rates for transcatheter mitral valve intervention and TTVI trials remain high because of various reasons, limiting patient enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy., Competing Interests: Declaration of competing interest Dr. Khalique has consulting agreements with Edwards, Abbott Structural, Restore medical, Triflo, and Croivalve and has equity in Triflo. Dr. Ali has consulting agreements with Abiomed, Astra Zeneca, Boston Scientific, Cathworks, Opsens, Phillips, and Shockwave; has equity in Elucid, Lifelink, Spectrawave, Shockwave, and VitalConnect; and receives institutional grant from Abbott, Abiomed, Acist, Amgen, Boston Scientific, Cathworks, Canon, Conavi, Heartflow, Inari, Medtronic Inc, National Institute of Health, Nipro, Opsens Medical, Medis, Philips, Shockwave, Siemens, Spectrawave, and Teleflex. Dr. Khan has equity in Transmural Systems and serves as a proctor for Edwards Lifesciences and Medtronic and receives institutional grant from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Philips. Dr. Cohen has consulting agreements with Edwards Lifesciences, Abbott, and Medtronic and receives institutional grant from Edwards Lifesciences, Abbott, and Boston Scientific. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Khan has been a consultant for Transmural Systems; and has received educational grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Phillips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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.

Electroencephalogram (EEG) records the electrical activity of neurons in the cerebral cortex and is used extensively to diagnose, treat, and monitor psychiatric and neurological conditions. Reliable contact between the skin and the electrodes is essential for achieving consistency and for obtaining electroencephalographic information. There has been an increasing demand for effective equipment and electrodes to overcome the time-consuming and cumbersome application of traditional systems. Recently, ear-centered EEG has met with growing interest since it can provide good signal quality due to the proximity of the ear to the brain. In addition, it can facilitate mobile and unobtrusive usage due to its smaller size and ease of use, since it can be used without interfering with the patient's daily activities. The purpose of this mini-review is to first introduce the broad range of electrodes used in conventional (scalp) EEG and subsequently discuss the state-of-the-art literature about around- and in-the-ear EEG.

Objectives: Belatacept may provide benefit in delayed graft function, but its association with infectious complications is understudied. We aim to assess the incidence of CMV and BK viremia in patients treated with sirolimus or belatacept as part of a three-drug immunosuppression regimen after kidney transplantation., Materials and Methods: Kidney transplant recipients from 01/01/2015 to 10/01/2021 were retrospectively reviewed. Maintenance immunosuppression was either tacrolimus, mycophenolate and sirolimus (B 0 ) or tacrolimus, mycophenolate, and belatacept (5.0 mg/kg monthly) (B 1 ). Primary outcomes of interest were BK and CMV viremia which were followed until the end of the study period. Secondary outcomes included graft function (serum creatinine, eGFR) and acute rejection through 12 months., Results: Belatacept was initiated in patients with a higher mean kidney donor profile index (B 0 :0.36 vs. B 1 :0.44, p = .02) with more delayed graft function (B 0 :6.1% vs. B 1 :26.1%, p < .001). Belatacept therapy was associated with more "severe" CMV viremia >25,000 copies/mL (B 0 :1.2% vs. B 1 :5.9%, p = .016) and CMV disease (B 0 :0.41% vs. B 1 :4.2%, p = .015). However, there was no difference in the overall incidence of CMV viremia >200 IU/mL (B 0 :9.4% vs. B 1 :13.5%, p = .28). There was no difference in the incidence of BK viremia >200 IU/mL (B 0 :29.7% vs. B 1 :31.1%, p = .78) or BK-associated nephropathy (B 0 :2.4% vs. B 1 :1.7%, p = .58), but belatacept was associated with "severe" BK viremia, defined as >10,000 IU/mL (B 0 :13.0% vs. B 1 :21.8%, p = .03). The mean serum Cr was significantly higher with belatacept therapy at 1-year follow up (B 0 :1.24 mg/dL vs. B 1 :1.43 mg/dL, p = .003). Biopsy-proven acute rejection (B 0 :1.2% vs. B 1 :2.6%, p = .35) and graft loss (B 0 :1.2% vs. B 1 :0.84%, p = .81) were comparable at 12 months., Conclusions: Belatacept therapy was associated with an increased risk of CMV disease and "severe" CMV and BK viremia. However, this regimen did not increase the overall incidence of infection and facilitated comparable acute rejection and graft loss at 12-month follow up., Competing Interests: Declaration of Competing Interest The authors report no financial or other conflicts of interest. This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Importance: The frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood., Objective: To evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery., Design, Setting, and Participants: This post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Data were collected from December 2010 to June 2016, and data were analyzed from December 2021 to October 2022., Interventions: Patients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI for clinical indications in the nonrandomized studies., Main Outcomes and Measures: The primary end point was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as (1) an increase in mean gradient of 10 mm Hg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mm Hg or greater or (2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more., Results: Of 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years. A total of 2099 RCT patients, including 1128 who received TAVI and 971 who received surgery, and 2663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P < .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008). Predictors of SVD were developed from multivariate analysis., Conclusions and Relevance: This study found a lower rate of SVD in patients undergoing self-expanding TAVI vs surgery at 5 years. Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes., Trial Registration: ClinicalTrials.gov Identifiers: NCT01240902, NCT01586910, and NCT01531374.

Purpose of Review: To provide a review of recent literature on the treatment of moderate-to-severe calcification in coronary and peripheral vasculature with intravascular lithotripsy (Shockwave Medical, Santa Clara, CA)., Recent Findings: Moderate-to-severe calcific plaques constitute a significant proportion of lesions treated with transcatheter interventions in the coronary and peripheral vascular beds and portend lower procedural success rates, increased periprocedural major adverse events, and unfavorable long-term clinical outcomes compared to non-calcific plaques. Intravascular lithotripsy (IVL) is a new technique that uses acoustic shock waves in a balloon-based system to induce fracture in the calcium deposits to facilitate luminal gain and stent expansion. IVL demonstrated high procedural success and low complication rates in the management of moderate-to-severe calcification in coronary and peripheral vascular beds and led to large luminal gain by modification of calcific plaque as assessed by optical coherence tomography. Further studies will determine the role of IVL in an integrated, protocolized approach to the treatment of severely calcified plaques in the coronary and peripheral vascular beds., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Intravascular lithotripsy (IVL) is a new technique for treatment of severely calcified lesions that uses acoustic shockwaves in a balloon-based system to induce fracture in calcific plaque, facilitating luminal gain and vessel expansion. In this review, we provide a concise summary of the available data and clinical experience of IVL in various peripheral vascular beds, including facilitating vascular access for large-bore devices. We discuss the physics and mode of action of IVL in modifying calcified plaques, include several illustrative examples of utility of IVL in peripheral interventions, and discuss the future directions for adoption of the technique in peripheral interventions., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: We report the 30-day outcomes from the roll-in cohort of the CLASP IID trial, representing the first procedures performed by each site., Background: The currently enrolling CLASP IID/IIF pivotal trial is a multicenter, prospective, randomized trial assessing the safety and effectiveness of the PASCAL transcatheter valve repair system in patients with clinically significant MR. The trial allows for up to three roll-in patients per site., Methods: Eligibility criteria were: DMR ≥3+, prohibitive surgical risk, and deemed suitable for transcatheter repair by the local heart team. Trial oversight included a central screening committee and echocardiographic core laboratory. The primary safety endpoint was a 30-day composite MAE: cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, and non-elective mitral valve re-intervention, adjudicated by an independent clinical events committee. Thirty-day echocardiographic, functional, and quality of life outcomes were assessed., Results: A total of 45 roll-in patients with mean age of 83 years and 69% in NYHA class III/IV were treated. Successful implantation was achieved in 100%. The 30-day composite MAE rate was 8.9% including one cardiovascular death (2.2%) due to severe bleeding from a hemorrhagic stroke, one MI, and no need for re-intervention. MR≤1+ was achieved in 73% and ≤2+ in 98% of patients. 89% of patients were in NYHA class I/II (p < .001) with improvements in 6MWD (30 m; p = .054) and KCCQ (17 points; p < .001)., Conclusions: Early results representing sites with first experience with the PASCAL repair system showed favorable 30-day outcomes in patients with DMR≥3+ at prohibitive surgical risk., (© 2021 Wiley Periodicals LLC.)

Objectives: We sought to evaluate the severity and patterns of calcifications in the left main coronary artery (LMCA) and proximal segments of left anterior descending coronary artery (LAD) and left circumflex artery (LCX) using optical coherence tomography (OCT) in patients with and without prior coronary artery bypass grafting (CABG)., Background: CABG may accelerate upstream calcium development., Methods: OCT images (n = 76) of the LMCA bifurcation from either the LAD or LCX in 76 patients with at least one patent left coronary graft, on average 7.0 ± 5.6 years post-CABG, were compared with 148 OCT images in propensity-score-matched non-CABG controls., Results: Minimum lumen areas in the LMCA, LAD, and LCX in post-CABG patients were smaller than non-CABG controls. Maximum calcium arc and thickness as well as calcium length were greater in the LMCA and LCX, but not in the LAD in post-CABG patients versus non-CABG controls. Calcium located at the carina of a bifurcation, calcified nodules (CN), thin intimal calcium, and lobulated calcium were more prevalent in post-CABG patients. After adjusting for multiple covariates, prior CABG was an independent predictor of calcification at the carina of a bifurcation (odds ratio [OR] 5.77 [95% confidence interval, CI: 1.5-21.6]), thin intimal calcium (4.7 [1.5-14.4]), and the presence of a CN (15.60 [3.2-76.2])., Conclusions: Prior CABG is associated with greater amount of calcium in the LMCA and the proximal LCX, as well as higher prevalence of atypical calcium patterns, including CN, thin or lobulated calcium, and calcifications located at the carina of a bifurcation, compared with non-CABG controls., (© 2020 Wiley Periodicals LLC.)

Advances in intravascular imaging have enabled assessment of the underlying plaque morphology in acute coronary syndromes, which allows for the initiation of individualized therapy. The atherothrombotic substrates for acute coronary syndromes consist of plaque rupture, erosion, and calcified nodule, whereas spontaneous coronary artery dissection, coronary artery spasm, and coronary embolism constitute rarer nonatherothrombotic etiologies. This review provides a brief overview of the data from clinical studies that have used intravascular optical coherence tomography to assess the culprit plaque morphology. We discuss the usefulness of intravascular imaging for effective treatment of patients presenting with acute coronary syndromes by percutaneous coronary intervention., Competing Interests: Disclosure K. Karimi Galougahi: None. E. Shlofmitz: Consultant - Abbott Vascular, Medtronic, Opsens Medical. A. Jeremias: Institutional funding (unrestricted education grant) and serves as a consultant for Volcano/Philips and Abbott Vascular; consultant to ACIST Medical and Boston Scientific. G. Petrossian: None. G.S. Mintz: Honoraria - Abiomed, Boston Scientific, Medtronic, and Philips. A. Maehara: Grant support and consultant - Abbott Vascular and Boston Scientific. R. Shlofmitz: Speaker – Shockwave. Z.A. Ali: Institutional research grants to Columbia University – Abbott, Cardiovascular Systems Inc; consultant – Amgen, AstraZeneca, Boston Scientific; equity – Shockwave., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aims: Optical coherence tomography (OCT)-guided external elastic lamina (EEL)-based stent sizing is safe and as effective as intravascular ultrasound in achieving post-procedural lumen dimensions. However, when compared with automated lumen diameter (LD) measurements, this approach is time-consuming. We aimed to compare vessel diameter measurements and stent diameter selection using either of these approaches and examined whether applying a correction factor to automated LD measurements could result in selecting similar stent diameters to the EEL-based approach., Methods and Results: We retrospectively compared EEL-based measurements vs. automated LD in reference segments in 154 OCT acquisitions and derived a correction factor for stent sizing using the ratio of EEL to LD measurements. We then prospectively applied the correction factor in 119 OCT acquisitions. EEL could be adequately identified in 100 acquisitions (84%) at the distal reference to allow vessel diameter measurement. Vessel diameters were larger with EEL-based vs. LD measurements at both proximal (4.12 ± 0.74 vs. 3.14 ± 0.67 mm, P < 0.0001) and distal reference segments (3.34 ± 0.75 vs. 2.64 ± 0.65 mm, P < 0.0001). EEL-based downsizing led to selection of larger stents vs. an LD-based upsizing approach (3.33 ± 0.47 vs. 2.70 ± 0.44, P < 0.0001). Application of correction factors to LD [proximal 1.32 (IQR 1.23-1.37) and distal 1.25 (IQR 1.19-1.36)] resulted in discordance in stent sizing by >0.25 mm in 63% and potentially hazardous stent oversizing in 41% of cases., Conclusion: EEL-based stent downsizing led to selection of larger stent diameters vs. LD upsizing. While applying a correction factor to automated LD measurements resulted in similar mean diameters to EEL-based measurements, this approach cannot be used clinically due to frequent and potentially hazardous stent over-sizing., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR., Methods: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire., Results: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9])., Conclusions: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients., Registration: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.

Introduction: The changes and the prognostic implications of left atrial (LA) volumes (LAV), LA function, and vascular load in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) are less known., Methods: We enrolled 150 symptomatic patients (mean age 82 ± 8 years, 58% female, and pre-TAVI aortic valve area 0.40 ± 0.19 cm/m2) with severe AS who underwent 2D transthoracic echocardiography and 2D speckle tracking echocardiography at average 21 ± 35 days before and 171 ± 217 days after TAVI. The end point was a composite of new onset of atrial fibrillation, hospitalization for heart failure and all-cause death (major adverse cardiac events [MACE])., Results: After TAVI, indexed maximal LA volume and minimum volume of the LA decreased by 2.1 ± 10 mL/m2 and 1.6 ± 7 mL/m2 (p = 0.032 and p = 0.011, respectively), LA function index increased by 6.8 ± 11 units (p < 0.001), and LA stiffness decreased by 0.38 ± 2.0 (p = 0.05). No other changes in the LA phasic volumes, emptying fractions, and vascular load were noted. Post-TAVI, both left atrial and ventricular global peak longitudinal strain improved by about 6% (p = 0.01 and 0.02, respectively). MACE was reached by 37 (25%) patients after a median follow-up period of 172 days (interquartile range, 20-727). In multivariable models, MACE was associated with both pre- and post-TAVI LA global peak longitudinal strain (hazard ratio [HR] 0.75, CI 0.59-0.97; and HR 0.77, CI 0.60-1.00, per 5 percentage point units, respectively), pre-TAVI LV global endocardial longitudinal strain (HR 1.37, CI 1.02-1.83 per 5 percentage point units), and with most of the LA phasic volumes., Conclusion: Within 6 months after TAVI, there is reverse LA remodeling and an improvement in LA reservoir function. Pre- and post-TAVI indices of LA function and volume remain independently associated with MACE. Larger studies enrolling a greater diversity of patients may provide sufficient evidence for the utilization of these imaging biomarkers in clinical practice., (© 2021 S. Karger AG, Basel.)

Background: Cardiac injury is common in COVID-19 patients and is associated with increased mortality. However, it remains unclear if reduced cardiac function is associated with cardiac injury, and additionally if mortality risk is increased among those with reduced cardiac function in COVID-19 patients., Hypothesis: The aim of this study was to assess cardiac function among COVID-19 patients with and without biomarkers of cardiac injury and to determine the mortality risk associated with reduced cardiac function., Methods/results: This retrospective cohort study analyzed 143 consecutive COVID-19 patients who had an echocardiogram during hospitalization between March 1, 2020 and May 5, 2020. The mean age was 67 ± 16 years. Cardiac troponin-I was available in 131 patients and an increased value (>0.03 ng/dL) was found in 59 patients (45%). Reduced cardiac function, which included reduced left or right ventricular systolic function, was found in 40 patients (28%). Reduced cardiac function was found in 18% of patients without troponin-I elevation, 42% with mild troponin increase (0.04-5.00 ng/dL) and 67% with significant troponin increase (>5 ng/dL). Reduced cardiac function was also present in more than half of the patients on mechanical ventilation or those deceased. The in-hospital mortality of this cohort was 28% (N = 40). Using logistic regression analysis, we found that reduced cardiac function was associated with increased mortality with adjusted odds ratio (95% confidence interval) of 2.65 (1.18 to 5.96)., Conclusions: Reduced cardiac function is highly prevalent among hospitalized COVID-19 patients with biomarkers of myocardial injury and is independently associated with mortality., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Objectives: The aim of this registry was to evaluate the feasibility and safety of transcatheter tricuspid valve implantation (TTVI) in patients with extreme surgical risk., Background: Isolated tricuspid regurgitation (TR) surgery is associated with high in-hospital mortality., Methods: Thirty consecutive patients (mean age 75 ± 10 years; 56% women) from 10 institutions, with symptomatic functional TR, had institutional and notified body approval for compassionate use of the GATE TTVI system. Baseline, discharge, and 30-day follow-up echocardiographic data and procedural, in-hospital, and follow-up clinical outcomes were collected., Results: At baseline, all patients had multiple comorbidities, severe or greater TR, and reduced baseline right ventricular function. Technical success was achieved in 26 of 30 patients (87%). Device malpositioning occurred in 4 patients, with conversion to open heart surgery in 2 (5%). Of those who received the device, 100% had reductions in TR of ≥1, and 75% experienced reductions of ≥2 grades, resulting in 18 of 24 of patients (76%) with mild or less TR at discharge. All patients had mild or less central TR. There was continued improvement in TR grade between discharge and 30 days in 15 of 19 patients (79%). In-hospital mortality was 10%. At mean follow-up of 127 ± 82 days, 4 patients (13%) had died. Of patients alive at follow-up, 62% were in New York Heart Association functional class I or II, with no late device-related adverse events., Conclusions: Compassionate treatment of severe, symptomatic functional TR using a first-generation TTVI device is associated with significant reduction in TR and improvement in functional status with acceptable in-hospital mortality. Further studies are needed to determine the appropriate patient population and long-term outcomes with TTVI therapy., Competing Interests: Author Relationship With Industry Drs. Bartus and Rodés-Cabau are consultants for NaviGate Cardiac Structures. Dr. Hahn has received speaking fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; is an advisory board member for Abbott Structural, Edwards Lifesciences, Medtronic, NaviGate Cardiac Structures, and Philips Healthcare; holds equity in NaviGate Cardiac Structures; has received nonfinancial support from 3mensio; and is the 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. Latib is a consultant for Medtronic, Edwards Lifesciences, Abbott, and NeoChord. Dr. Navia is a consultant for NaviGate Cardiac Structures, with equity and royalties for inventor patents of the device. Dr. Sievert is a consultant for 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie, BioVentrix, Boston Scientific, Carag, Cardiac Dimensions, Cardimed, CeloNova Biosciences, Comed, Contego, CVRx, Dinova, Edwards Lifesciences, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech Scientific, Maquet Getinge Group, Medtronic, Mokita, Occlutech, ReCor Medical, Renal Guard, Terumo, Vascular Dynamics, Vectorious Medtech, Venock, Venus, and Vivasure Medical. All other authors have reported that they have no relationships relevant to the content of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Major studies in interventional cardiology in 2019 have added substantial new evidence for pharmaco-invasive management of coronary artery disease. The review highlights the main findings of a selection of these trials and summarizes their impact on clinical practice., Recent Findings: Recent randomized studies examining the efficacy of revascularization or medical treatment in stable ischemic heart disease (SIHD), treatment of acute coronary syndromes, emerging interventional devices, adjunctive pharmacotherapy, and intravascular imaging and physiology guidance have substantially advanced the evidenced-based knowledge in interventional cardiology., Summary: Patients with SIHD and at least moderate myocardial ischemia have similar event-free survival after an initial conservative strategy of optimal medical therapy versus an upfront invasive strategy. Quality of life and angina-free status are significantly improved with revascularization. Percutaneous coronary intervention (PCI) and coronary artery bypass grafting provide similar 5-year outcomes in patients with left main coronary artery disease and low or intermediate disease complexity. An initially conservative management is equally effective as an early invasive approach in patients with out-of-hospital cardiac arrest without ongoing ischemia. Patients with ST-segment elevation myocardial infarction and multivessel disease benefit from staged complete revascularization after primary PCI. Post-PCI, patients with atrial fibrillation requiring anticoagulation can safely and effectively be treated with P2Y12 inhibitor monotherapy without aspirin. Lastly, intravascular imaging guidance improves post-PCI outcomes, warranting increased use in clinical practice.

Objectives: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli., Background: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm 2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak., Methods: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm 2 (range 683.5 to 852.0 mm 2 ) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported., Results: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year., Conclusions: S3 TAVR in annular areas >683 mm 2 is feasible, with favorable mid-term outcomes., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Importance: Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative., Objective: To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery., Design, Setting, and Participants: In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017., Interventions: A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR., Main Outcomes and Measures: The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year., Results: Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04)., Conclusions and Relevance: Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up., Trial Registration: ClinicalTrials.gov identifier: NCT01586910.

Background: Severely calcified lesions present many challenges to percutaneous coronary intervention (PCI). Orbital atherectomy (OA) aids vessel preparation and treatment of severely calcified coronary lesions. Same-day discharge (SDD) after PCI has numerous advantages including cost savings and improved patient satisfaction. The aim of this study is to evaluate the safety of SDD among patients treated with OA in a real-world setting., Methods: This was a single-center retrospective analysis of patients undergoing OA. In-hospital and 30-day outcomes were assessed for major adverse cardiac events (MACE), device-related events and hospital readmissions., Results: There were 309 patients treated with OA of whom 94 had SDD (30.4%). Among SDD patients, there were no acute procedural complications and all patients were safely discharged on the day of the procedure. MACE at 30 days occurred in 1 patient (1.06%) due to major bleeding in the setting of a gastric arteriovenous malformation. There were 8 patients with unplanned 30-day readmissions (8.5%)., Conclusion: SDD after OA in patients with heavily calcified lesions appears to be safe, with low rates of adverse events and readmissions in select patients. In patients with SDD treated with OA, unplanned readmission occurred at a similar rate to the statewide average 30-day PCI readmission rate. Larger studies are needed to confirm the safety of this treatment paradigm and the potential cost savings., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients., Methods: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods., Results: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm 2 vs. 2.0 cm 2 )., Conclusions: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.)., (Copyright © 2019 Massachusetts Medical Society.)

The sensitivity enhancement of piezocomposites can realize new applications. Introducing a cellular structure into these materials decreases the permittivity and thus increases their sensitivity. However, foaming of piezocomposites is challenging because of the high piezoceramic loading required. In this work, heat-expandable microspheres were used to fabricate thermoplastic polyurethane (TPU)/lead zirconate titanate (PZT) composite foams with a wide range of PZT content (0 vol % to 40 vol %) and expansion ratio (1⁻4). The microstructure, thermal behavior, and dielectric properties of the foams were investigated. Composite foams exhibited a fine dispersion of PZT particles in the solid phase and a uniform cellular structure with cell sizes of 50⁻100 μm; cell size decreased with an increase in the PZT content. The total crystallinity of the composites was also decreased as the foaming degree increased. The results showed that the relative permittivity ( ε r ) can be effectively decreased by an increase in the expansion ratio. A maximum of 7.7 times decrease in ε r was obtained. An extended Yamada model to a three-phase system was also established and compared against the experimental results with a relatively good agreement. This work demonstrates a method to foam highly loaded piezocomposites with a potential to enhance the voltage sensitivity.

Background: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients., Objectives: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability., Methods: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned., Results: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years., Conclusions: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve ® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study., Methods: The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline., Results: There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year., Conclusions: Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients., Methods: The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to <26 mm), and small (<23 mm). Hemodynamics, PPM, and clinical outcomes were assessed., Results: At all postprocedure visits, mean gradients were significantly lower for TAVR compared with SAVR in small and medium size annuli (p < 0.001). Annular size was significantly associated with mean gradient after SAVR, with small annuli having the highest gradients (p < 0.05 at all timepoints); gradients were similar across all annular sizes after TAVR. In subjects receiving SAVR, the frequency of PPM was significantly associated with annular size, with small annuli having the greatest incidence. No difference in PPM incidence by annular sizing was observed with TAVR. In addition, TAVR subjects had significantly less PPM than SAVR subjects in small and medium annuli (p < 0.001), with no difference in the incidence of PPM between TAVR and SAVR in large annuli (p = 0.10)., Conclusions: Annular size has a significant effect on hemodynamics and the incidence of PPM in SAVR subjects, not observed in TAVR subjects. With respect to annular size, TAVR results in better hemodynamics and less PPM for annuli less than 26 mm and should be strongly considered when choosing a tissue valve for small and medium size annuli., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)