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Background: Drug-eluting stents (DESs) with controlled antiproliferative drug release reduce restenosis risk, but durable polymers can delay healing and inhibit reendothelialization. The Firehawk biodegradable polymer sirolimus-eluting stent (BP-SES) has a fully biodegradable sirolimus-containing polymer coating localized to recessed abluminal grooves on the stent surface and delivers roughly one-third the drug dose of other DESs., Objectives: We report the primary results of the TARGET-IV NA (Firehawk Rapamycin Target Eluting Coronary Stent North American Trial) randomized controlled trial comparing clinical outcomes with BP-SES vs currently used second-generation DESs., Methods: The TARGET-IV NA study was a prospective, multicenter, single-blind, 1:1 randomized noninferiority trial comparing the BP-SES with control in North America and Europe among patients undergoing percutaneous coronary intervention for chronic or acute coronary syndromes. The primary endpoint was target lesion failure (TLF) at 12 months (composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization). The primary analysis (intention-to-treat) tested noninferiority of BP-SES vs control using an absolute margin of 3.85% and 1-sided α of 0.025. Noninferiority-powered secondary endpoints were tested in an optical coherence tomography substudy (endpoint: mean neointimal hyperplasia thickness) and an angiography substudy (endpoint: in-stent late lumen loss)., Results: A total of 1,720 patients (mean age 66 years; 74% male) with 2,159 lesions were randomly allocated to receive either BP-SES (860 patients, 1,057 lesions) or control second-generation DES (860 patients, 1,084 lesions). A total of 61% of patients presented with stable coronary disease, 32% had unstable angina, and 7% had non-ST-segment elevation myocardial infarction (NSTEMI) or recent ST-segment elevation myocardial infarction. The rate of TLF with BP-SES was noninferior to control at 12 months (3.4% vs 3.3%, absolute risk difference 0.13%, upper bound 97.5% CI: 2.03, P noninferiority  < 0.0001). Cardiac death, myocardial infarction, and stent thrombosis rates were similar between groups. Angiographic follow-up was available in 104 patients (97.2% of those enrolled in the angiographic substudy) and 128 (94.1%) lesions. At 13 months, the powered secondary endpoint of mean in-stent late lumen loss was 0.149 ± 0.263 mm for BP-SES and 0.327 ± 0.463 mm for control (least squares mean difference: -0.178; 90% CI: -0.2943 to -0.0632; P noninferiority  < 0.0001). The optical coherence tomography substudy included 37 patients (42 lesions) with no difference in mean neointimal hyperplasia thickness between groups at 13 months (P noninferiority  = 0.01)., Conclusions: The biodegradable polymer sirolimus-eluting stent was noninferior to currently used second-generation DES with regard to TLF at 1 year. (Firehawk® Rapamycin Target Eluting Coronary Stent North American Trial; NCT04562532)., Competing Interests: Funding Support and Author Disclosures Funding was provided by Microport Medical Ltd (Shanghai, China). Dr Yeh has served as a consultant for Abbott Vascular, Boston Scientific, Medtronic, CathWorks, Elixir Medical, Shockwave, and Zoll; and has received investigator-initiated research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr Bertrand owns equity in Nanostent Inc; has served as a consultant for Boston Scientific, Microport, and Opsens Medical; and has received investigator-initiated research grant support from Opsens Medical. Dr Mahmud has received research grant support from Boston Scientific, Abbott Vascular, Microport, and Pulnova; and has received consultant fees from Microport, Siemens, and CRF and Pulnova. Dr Redfors has received consultant fees from Pfizer and Boehringer Ingelheim. Dr Popma’s spouse is an employee of Medtronic. Dr van Royen has received research grants from Abbott, Biotronik, Medtronic, and Philips; and has received lecture fees from Abbott, Bayer, and Microport. Dr Choi has received consulting fees from Medtronic. Dr Maehara is a consultant for Boston Scientific, SpectraWave, Amgen, Philips, and Abbott Vascular; and has received lecture fees from Nipro. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has served as a consultant/advisory board participant for Foldax, Anteris, JenaValve, Medinol, SoloPace, and Bain Capital. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025. Published by Elsevier Inc.)

Aims: This study aims to assess the changes in cardiac damage stage in a real-world cohort of patients undergoing transcatheter aortic valve implantation (TAVI) and to investigate the prognostic value of cardiac damage stage evolution., Methods and Results: Patients with severe AS undergoing TAVI were retrospectively analyzed. A 5-stage system based on the presence and extent of cardiac damage assessed by echocardiography was applied before and 6 months after TAVI. Multivariable Cox regression analyses were used to examine independent prognostic value of the changes in cardiac damage after TAVI. A total of 734 patients with severe AS (mean age 79.8±7.4 years, 55% male) were included. Before TAVI, 32 (4%) patients did not show any sign of extra-valvular cardiac damage (Stage 0), 85 (12%) had left ventricular damage (Stage 1), 220 (30%) left atrial and/or mitral valve damage (Stage 2), 227 (31%) pulmonary vasculature and/or tricuspid valve damage (Stage 3), and 170 (23%) right ventricular damage (Stage 4). Six months after TAVI, 39% of the patients improved at least 1 stage in cardiac damage. Staging of cardiac damage at 6 months after TAVI (HR per 1-stage increase 1.391; P = 0.035) as well as worsening in the stage of cardiac damage (HR 3.729, P = 0.005) were independently associated with 2-year all-cause mortality., Conclusion: More than one third of patients with severe AS showed an improvement in cardiac damage 6 months after TAVI. Staging cardiac damage at baseline and follow-up may improve risk stratification in patients undergoing TAVI., (© The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Importance: Guidelines advise heart team assessment for all patients with aortic stenosis, with surgical aortic valve replacement recommended for patients younger than 65 years or with a life expectancy greater than 20 years. If bioprosthetic valves are selected, repeat procedures may be needed given limited durability of tissue valves; however, younger patients with aortic stenosis may have major comorbidities that can limit life expectancy, impacting decision-making., Objective: To characterize patients younger than 65 years who received transcatheter aortic valve replacement (TAVR) and compare their outcomes with patients aged 65 to 80 years., Design, Setting, and Participants: This retrospective registry-based analysis used data on 139 695 patients from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, inclusive of patients 80 years and younger undergoing TAVR from August 2019 to September 2023., Intervention: Balloon-expandable valve (BEV) TAVR with the SAPIEN family of devices., Main Outcomes and Measures: Comorbidities (heart failure, coronary artery disease, dialysis, and others) and outcomes (death, stroke, and hospital readmission) of patients younger than 65 years compared to patients aged 65 to 80 years., Results: In the years surveyed, 13 849 registry patients (5.7%) were younger than 65 years, 125 846 (52.1%) were aged 65 to 80 years, and 101 725 (42.1%) were 80 years and older. Among those younger than 65, the mean (SD) age was 59.7 (4.8) years, and 9068 of 13 849 patients (65.5%) were male. Among those aged 65 to 80 years, the mean (SD) age was 74.1 (4.2) years, and 77 817 of 125 843 patients (61.8%) were male. Those younger than 65 years were more likely to have a bicuspid aortic valve than those aged 65 to 80 years (3472/13 755 [25.2%] vs 9552/125 001 [7.6%], respectively; P < .001). They were more likely to have congestive heart failure, chronic lung disease, diabetes, immunocompromise, and end stage kidney disease receiving dialysis. Patients younger than 65 years had worse baseline quality of life (mean [SD] Kansas City Cardiomyopathy Questionnaire score, 47.7 [26.3] vs 52.9 [25.8], respectively; P < .001) and mean (SD) gait speed (5-meter walk test, 6.6 [5.8] seconds vs 7.0 [4.9] seconds, respectively; P < .001) than those aged 65 to 80 years. At 1 year, patients younger than 65 years had significantly higher readmission rates (2740 [28.2%] vs 23 178 [26.1%]; P < .001) and all-cause mortality (908 [9.9%] vs 6877 [8.2%]; P < .001) than older patients. When propensity matched, younger patients still had higher 1-year readmission rates (2732 [28.2%] vs 2589 [26.8%]; P < .03) with similar mortality to their older counterparts (905 [9.9%] vs 827 [10.1%]; P = .55)., Conclusions and Relevance: Among US patients receiving BEV TAVR for severe aortic stenosis in the low-surgical risk era, those younger than 65 years represent a small subset. Patients younger than 65 years had a high burden of comorbidities and incurred higher rates of death and readmission at 1 year compared to their older counterparts. These observations suggest that heart team decision-making regarding TAVR for most patients in this age group is clinically valid.

Background: Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR)., Objectives: The authors performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients., Methods: The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models., Results: The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95% CI: 7.4-16.3 points) at 30 days, 20.8 points (95% CI: 16.1-25.5 points) at 6 months, and 17.8 points (95% CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P = 0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS ≥60 points and no decline of ≥10 points from baseline) compared with 31.0% with OMT alone., Conclusions: Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30 days after TTVR, continued to increase through 6 months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062)., Competing Interests: Funding Support and Author Disclosures The TRISCEND II pivotal trial and this analysis were funded by Edwards Lifesciences. Analyses were designed and conducted independently by the academic investigators. Dr Arnold has received research grants from the U.S. Food and Drug Administration and National Institutes of Health/National Heart, Lung, and Blood Institute. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts with no direct compensation with Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry sponsored valve trials with no direct industry compensation. Dr Thourani has received research/advisor fees from Abbott Vascular, Artivion, CroíValve, Boston Scientific, and Edwards Lifesciences; has received research grants from Medtronic, Highlife, Innovalve, JenaValve, and HalfMoon; and owns equity in Dasi Simulation. Dr Makkar has received research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, JenaValve, and Medtronic; and has received travel support from Edwards Lifesciences, JenaValve, Abbott Vascular, and Boston Scientific. Dr Makar has received consulting fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, GE Healthcare, and PiCardia. Dr Sharma has received consulting fees from Edwards Lifesciences. Dr Haeffele has received consulting fees from Edwards Lifesciences and Shifamed. Dr Davidson has served as an uncompensated advisor for and received research grant support from Edwards Lifesciences. Dr Narang has received speaker fees from Edwards Lifesciences, Abbott Laboratories, and Bristol Myers Squibb. Dr O’Neill has received consulting fees from Edwards Lifesciences. Dr Lee has received consulting fees from Edwards Lifesciences. Dr Yadav has received consulting and speaker fees from Edwards Lifesciences, Abbott Vascular, and Boston Scientific; has received advisory board honoraria from Dasi Simulations and Trisol; and owns equity in Dasi Simulations and Opus. Dr Zahr has received consulting fees, research grants, and educational grants from Edwards Lifesciences and Medtronic. Dr Chadderdon has received consulting fees from Edwards Lifesciences and Medtronic; and has received research funding from GE Healthcare and Siemens Healthineers. Dr Smith has received research grants from Edwards Lifesciences, Medtronic, and Artivion, which are managed through the Baylor Scott & White research institute; has received speaker fees from Edwards Lifesciences and Medtronic; and has received advisory board honoraria from Edwards Lifesciences and Enable CV. Dr Szerlip has received consulting fees from Edwards Lifesciences; has received speaker fees from Edwards Lifesciences, Cardiovascular Innovations, the Society for Cardiovascular Angiography and Interventions, and Boston Scientific; and has received advisory board honoraria from Abbott Vascular. Dr Whisenant has received consulting fees from Edwards Lifesciences and Abbott Vascular. Dr Garcia has received consulting and proctor fees from Edwards Lifesciences, Medtronic, Abbott Structural Heart, JC Medical, and Boston Scientific. Dr Grayburn has received research grants from Abbott Vascular, CardioValve, Cardiomech, Edwards Lifesciences, Medtronic, NeoChord, Restore Medical, and 4C Medical; and has received advisory board honoraria from Abbott Vascular, CardioValve, Edwards Lifesciences, Medtronic, and 4C Medical. Dr Sannino has received research grants from Edwards Lifesciences and Venus Medtech. Dr Mack has received consulting fees and research grants from Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim; and owns stock options in Innoventric. Dr Kodali has received consulting fees from Anteris, TriCares, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, Moray Medical, and Nyra; has received advisory board honoraria from Dura Biotech, Thubrikar Aortic Valve, Philips, Medtronic, Boston Scientific, and Abbott; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Cohen has received research grants from the U.S. Food and Drug Administration, National Institutes of Health/National Heart, Lung, and Blood Institute, Edwards Lifesciences, Abbott, Boston Scientific, Medtronic, Philips, Corvia, Zoll Medical, and iRhythm; and has received consulting income from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: For patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction, current guidelines recommend routine clinical surveillance every 6 to 12 months. Data from randomized trials examining whether early intervention with transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients are lacking., Methods: At 75 centers in the United States and Canada, we randomly assigned, in a 1:1 ratio, patients with asymptomatic severe aortic stenosis to undergo early TAVR with transfemoral placement of a balloon-expandable valve or clinical surveillance. The primary end point was a composite of death, stroke, or unplanned hospitalization for cardiovascular causes. Superiority testing was performed in the intention-to-treat population., Results: A total of 901 patients underwent randomization; 455 patients were assigned to TAVR and 446 to clinical surveillance. The mean age of the patients was 75.8 years, the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.8% (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after surgery), and 83.6% of patients were at low surgical risk. A primary end-point event occurred in 122 patients (26.8%) in the TAVR group and in 202 patients (45.3%) in the clinical surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). Death occurred in 8.4% of the patients assigned to TAVR and in 9.2% of the patients assigned to clinical surveillance, stroke occurred in 4.2% and 6.7%, respectively, and unplanned hospitalization for cardiovascular causes occurred in 20.9% and 41.7%. During a median follow-up of 3.8 years, 87.0% of patients in the clinical surveillance group underwent aortic-valve replacement. There were no apparent differences in procedure-related adverse events between patients in the TAVR group and those in the clinical surveillance group who underwent aortic-valve replacement., Conclusions: Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104.)., (Copyright © 2024 Massachusetts Medical Society.)

Background: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed., Methods: In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy., Results: A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001)., Conclusions: For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.)., (Copyright © 2024 Massachusetts Medical Society.)

Importance: Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated., Objective: To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR., Design, Setting, and Participants: This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024., Intervention: TAVR with or without CEP., Main Outcomes and Measures: The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes., Results: The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort., Conclusion and Relevance: The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy., Trial Registration: ClinicalTrials.gov Identifier: NCT04149535.

Background: Understanding the conduction axis location aids in avoiding iatrogenic damage and guiding targeted heart rhythm therapy., Objective: Cardiac structures visible with clinical imaging have been demonstrated to correlate with variability in the conduction system course. We aimed to standardize and assess the reproducibility of predicting the location of the atrioventricular conduction axis by cardiac computed tomography., Methods: We evaluated 477 patients with acquired aortic valve disease by cardiac computed tomography to assess variability in cardiac structures established to relate to the conduction system. We standardized 3 points (points A-C) to estimate the course from the atrioventricular node to the nonbranching bundle and left bundle branch origin and further compared this with measures of variability in the aortic root and membranous septum., Results: The mean distances between the aortic valve virtual basal ring and points A, B, and C were 9.5 ± 3.5 (0.3-20.1) mm, 5.0 ± 2.6 (-1.7 to 15.9) mm, and 2.8 ± 2.4 (-5.2 to 12.0) mm, respectively. The midpoint of the membranous septum deviated posteriorly a median of -4.4 (interquartile range, -12.4 to +3.0) degrees relative to the commissure between the right coronary and noncoronary leaflets. Intraclass coefficients for both intraobserver and interobserver variability for all measured points were excellent (≥0.78)., Conclusion: These findings further infer the intimate yet highly variable relationship between the conduction axis and aortic root. This reproducible and standardized approach needs validation in populations of patients, requiring accurate identification of the atrioventricular components of the conduction axis, which may serve as a noninvasive means for estimating its location., Competing Interests: Disclosures Justin Tretter is a consultant for Cara Medical, Ltd. Ander Regueiro is a consultant for Cara Medical, Ltd and has received speaker/consultant fees from Abbott, Edwards Lifesciences, and Meril. Josep Rodés-Cabau has received institutional research grants and speaker/consultant fees from Edwards Lifesciences and Medtronic. Shlomo Ben-Haim is the founder of Cara Medical, Ltd., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: There is a little evidence regarding long-term safety and efficacy for atrial shunt devices in heart failure (HF)., Methods: The REDUCE LAP-HF I (n = 44) and II (n = 621) trials (RCT-I and -II) were multicenter, randomized, sham-controlled trials of patients with HF and ejection fraction >40%. Outcome data were analyzed from RCT-I, a mechanistic trial with 5-year follow-up, and RCT-II, a pivotal trial identifying a responder group (n = 313) defined by exercise PVR <1.74 WU and no cardiac rhythm management device with 3-year follow-up., Results: At 5 years in RCT I, there were no differences in cardiovascular (CV) mortality, HF events, embolic stroke, or new-onset atrial fibrillation between groups. After 3 years in RCT II, there was no difference in the primary outcome (hierarchical composite of CV mortality, stroke, HF events, and KCCQ) between shunt and sham in the overall trial. Compared to sham, those with responder characteristics in RCT-II had a better outcome with shunt (win ratio 1.6 [95% CI 1.2-2.2], P = .006; 44% reduction in HF events [shunt 9 vs. control 16 per 100 patient-years], P = .005; and greater improvement in KCCQ overall summary score [+17.9 ± 20.0 vs. +7.6 ± 20.4], P < .001), while nonresponders had significantly more HF events. Shunt treatment at 3 years was associated with a higher rate of ischemic stroke (3.2% vs. 0%, 95% CI 2%-6.1%, P = .032) and lower incidence of worsening kidney dysfunction (10.7% vs. 19.3%, P = .041)., Conclusions: With up to 5 years of follow up, adverse events were low in patients receiving atrial shunts. In the responder group, atrial shunt treatment was associated with a significantly lower HF event rate and improved KCCQ compared to sham through 3 years of follow-up., Gov Registration: NCT02600234, NCT03088033., Competing Interests: Conflict of Interest None., (Published by Elsevier Inc.)

Background: Surgery remains an important treatment for low-risk patients with severe symptomatic aortic stenosis (AS). This study evaluated 5-year outcomes in low-risk patients undergoing isolated surgical aortic valve replacement (SAVR) or SAVR with concomitant procedures within the randomized Placement of Aortic Transcatheter Valves (PARTNER) 3 trial., Methods: In the PARTNER 3 trial, 454 patients underwent surgery for severe, symptomatic, trileaflet AS and were followed up for 5 years. Patients were stratified into those undergoing isolated SAVR (n = 334; 73.6%) vs concomitant SAVR (n = 120; 26.4%). Short- and long-term morbidity was adjudicated by a Clinical Events Committee. Hemodynamic valve performance was evaluated by an echocardiographic core laboratory. Patient-reported health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ)., Results: The mean age of participants was 73.6 ± 6.1 years; 71.1% of these patients were male. The median SAVR implant size was 23 mm overall. Five-year all-cause mortality (with vital status sweep) was 9.0% for all patients (8.5% isolated SAVR; 10.2% concomitant SAVR; P = .58), comparable to a recent analysis of low-risk isolated SAVR-treated patients in the STS database (overall mortality, 7.1%). The average 5-year mean gradient was 11.7 ± 5.6 mm Hg overall. Reintervention rates were low in both groups (isolated SAVR, 2.3% vs concomitant SAVR, 5.0%; P = .21), and most patients (isolated SAVR, 87.9%; concomitant SAVR, 86.1%) were alive with no evidence of bioprosthetic valve failure at 5 years., Conclusions: SAVR in low-risk patients in the PARTNER 3 trial demonstrated excellent 5-year outcomes. Five-year mortality was similar in patients undergoing isolated SAVR vs concomitant SAVR. This result was comparable to recently published national SAVR outcomes, thus demonstrating the generalizability of these findings., Competing Interests: Disclosures Vinod H. Thourani reports a relationship with Abbott Vascular that includes: consulting or advisory; with AtriCure that includes: consulting or advisory; with Artivion that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; with Edwards Lifesciences that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with JenaValve Technology that includes: consulting or advisory; with Highlife that includes: consulting or advisory; with Croivalve that includes: consulting or advisory; and with Dasi Simulations that includes: equity or stocks. Martin B. Leon reports a relationship with W.L. Gore & Associates Medical Products Division that includes: consulting or advisory; with Meril Life Sciences that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; and with Abbott that includes: consulting or advisory. Raj Makkar reports a relationship with Cordis that includes: consulting or advisory; and with Medtronic that includes: consulting or advisory. Wilson Y. Szeto reports a relationship with Terumo Interventional Systems that includes: consulting or advisory; with MicroInterventional Devices that includes: consulting or advisory; and with Cardiac Dimensions that includes: consulting or advisory. Susheel K. Kodali reports a relationship with Philips that includes: consulting or advisory; with Admedus that includes: consulting or advisory and equity or stocks; with TriCares that includes: consulting or advisory; with Dura Biotech that includes: consulting or advisory and equity or stocks; with Thubrikar Aortic Valve that includes: equity or stocks; with MicroInterventional Devices that includes: equity or stocks; with Supira that includes: equity or stocks; with TriFlo that includes: equity or stocks; with Adona that includes: equity or stocks; and with Tioga that includes: equity or stocks. Rebecca T. Hahn reports a relationship with Abbott that includes: speaking and lecture fees; with Baylis Medical Company that includes: speaking and lecture fees; with Edwards Lifesciences that includes: speaking and lecture fees; with Medtronic that includes: speaking and lecture fees; with Philips that includes: speaking and lecture fees; and with Siemens that includes: speaking and lecture fees. S. Chris Malaisrie reports a relationship with Medtronic that includes: funding grants; with Edwards Lifesciences that includes: consulting or advisory; with Terumo Interventional Systems that includes: consulting or advisory; and with Artivion that includes: consulting or advisory. Howard C. Herrmann reports a relationship with Abbott that includes: consulting or advisory; with Edwards Lifesciences that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with Johnson & Johnson that includes: consulting or advisory; with Prolifagen that includes: consulting or advisory; and with MicroInterventional Devices that includes: equity or stocks. Vasilis Babaliaros reports a relationship with Edwards Lifesciences that includes: consulting or advisory; and with Transmural Systems that includes: equity or stocks. Philippe Genereux reports a relationship with Abbott that includes: consulting or advisory; with AbioMed that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; with Caranx Medical that includes: consulting or advisory; with Cardiovascular Systems that includes: consulting or advisory; with Edwards Lifesciences that includes: consulting or advisory; with Egnite that includes: consulting or advisory; with GE Healthcare that includes: consulting or advisory; with iRhythm Technologies that includes: consulting or advisory; with Medtronic that includes: consulting or advisory; with Shockwave Medical that includes: consulting or advisory; with Siemens that includes: consulting or advisory; with Teleflex that includes: consulting or advisory; with 4C Medical Technologies that includes: consulting or advisory; with Pi-Cardia that includes: equity or stocks; with Puzzle Medical that includes: equity or stocks; with Soundbite Medical that includes: equity or stocks; and with Saranas that includes: equity or stocks. David J. Cohen reports a relationship with Abbott that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; and with Edwards Lifesciences that includes: consulting or advisory; and with Elixir Medical that includes: consulting or advisory. Molly Szerlip reports a relationship with Edwards Lifesciences that includes: consulting or advisory; with Boston Scientific that includes: consulting or advisory; and with Abbott that includes: consulting or advisory. Julien Ternacle reports a relationship with Edwards Lifesciences that includes: consulting or advisory; with Abbott that includes: consulting or advisory; with GE Medical that includes: consulting or advisory; and with Philips that includes: consulting or advisory. Jonathon Leipsic reports a relationship with HeartFlow Inc that includes: consulting or advisory; and with Circle CVI that includes: consulting or advisory. Philipp Blanke reports a relationship with Edwards Lifesciences that includes: consulting or advisory; and with Laralab that includes: consulting or advisory. John G. Webb reports a relationship with Edwards Lifesciences that includes: consulting or advisory., (Copyright © 2025 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Real-world data regarding clinical outcomes according to aortic stenosis (AS) management are scarce. Therefore, we aimed to investigate long-term management across the spectrum of outpatients with AS., Methods and Results: Between May 2016 and December 2017, consecutive outpatients with mild (peak aortic velocity, 2.5-2.9 m/s), moderate (3-3.9 m/s), and severe AS (≥4 m/s) were included by 117 cardiologists in the VALVENOR (Follow-Up of a Cohort of Patients With Valvular Aortic Stenosis in the Nord-pas-de-Calais Region) study and followed-up for aortic valve replacement (AVR) and modes of death. Among 2704 patients included, 1156 (42.7%) had mild, 1121 (41.5%) moderate, and 427 (15.8%) severe AS. After a median follow-up of 5 years, 993 AVRs (488 surgical and 505 transcatheter) and 1098 deaths occurred. The 5-year cumulative incidence of AVR or of the composite of death or AVR was 13.3% and 45.2% in mild AS, 45.5% and 75.3% in moderate AS, and 62.8% and 90.6% in severe AS, respectively. Of the 292 patients who met the criteria for AVR but were not treated, AVR was considered futile in 137 patients and 155 patients refused AVR. Mortality rates after 3 years were high: 86% for anticipated futility and 72.3% for refusal. While patients at anticipated futility showed a well-balanced proportion of cardiovascular and noncardiovascular deaths, cardiovascular deaths predominated among those who refused AVR., Conclusions: At 5-year follow-up, only two thirds of patients with severe AS underwent AVR. Patients with untreated severe AS experienced high mortality rates, mostly cardiovascular for patients who declined AVR. This advocates for better patient education based on shared decision making and for optimizing AS quality of care, from diagnosis to treatment.

Background: Current guidelines recommend a strategy of clinical surveillance (CS) for patients with asymptomatic severe aortic stenosis (AS) and a normal left ventricular ejection fraction., Objectives: The aim of this study was to conduct a study-level meta-analysis of randomized controlled trials (RCTs) evaluating the effect of early aortic valve replacement (AVR) compared with CS in patients with asymptomatic severe AS., Methods: Studies were quantitatively assessed in a meta-analysis using random-effects modeling. Prespecified outcomes included all-cause and cardiovascular mortality, unplanned cardiovascular or heart failure (HF) hospitalization, and stroke. The meta-analysis is registered at the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY202490002)., Results: Four RCTs were identified, including a total of 1,427 patients (719 in the early AVR group and 708 in the CS group). At an average follow-up time of 4.1 years, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization (pooled rate 14.6% vs 31.9%; HR: 0.40; 95% CI: 0.30-0.53; I 2  = 4%; P < 0.01) and stroke (pooled rate 4.5% vs 7.2%; HR: 0.62; 95% CI: 0.40-0.97; I 2  = 0%; P = 0.03). No differences in all-cause mortality (pooled rate 9.7% vs 13.7%; HR: 0.68; 95% CI: 0.40-1.17; I 2  = 61%; P = 0.17) and cardiovascular mortality (pooled rate 5.1% vs 8.3%; HR: 0.67; 95% CI: 0.35-1.29; I 2  = 50%; P = 0.23) were observed with early AVR compared with CS, although there was a high degree of heterogeneity among studies., Conclusions: In this meta-analysis of 4 RCTs, early AVR was associated with a significant reduction in unplanned cardiovascular or HF hospitalization and stroke and no differences in all-cause and cardiovascular mortality compared with CS., Competing Interests: Funding Support and Author Disclosures Edwards Lifesciences is the sponsor of the EARLY TAVR (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis) trial, one of the studies included in the meta-analysis, and facilitated data integration and analysis. Dr Généreux has received institutional research grants from Edwards Lifesciences; has received consulting fees Abbott, Cordis, Edwards Lifesciences, Egnite, Haemonetics, Medtronic, Opsens, Puzzle Medical, Pi-Cardia, and 4C Medical; holds equity in Puzzle Medical and Pi-Cardia; and is the principal investigator of the EARLY TAVR trial and the PROGRESS trial, both sponsored by Edwards Lifesciences. Dr Prendergast has received consulting fees from Anteris and MicroPort; has received speaker fees from Edwards Lifesciences; and is a data and safety monitoring board member for Valvosoft and Medtronic. Dr Lindman has received consulting fees from AstraZeneca, Medtronic, and Edwards Lifesciences; has received investigator-initiated research grants from Edwards Lifesciences; and is principal investigator of the biobank core laboratory for the EARLY TAVR trial, sponsored by Edwards Lifesciences. Dr Newby has received institutional research grants from the British Heart Foundation (CH/09/002, RG/F/22/110093, and RE/24/130012). Dr Pibarot has received institutional funding for echocardiography core laboratory analyses and research studies on transcatheter valve therapies from Edwards Lifesciences, with no personal compensation; has received payments to his institution from Edwards Lifesciences for lectures, presentations, and educational events; has received institutional funding for research studies on transcatheter valve therapies from Medtronic, with no personal compensation; has received institutional funding for echocardiography core laboratory analyses on the pharmacotherapy of valvular heart disease from Pi-Cardia, with no personal compensation; and has received institutional funding for echocardiography core laboratory analyses on HF therapy from Cardiac Success, with no personal compensation. Dr Seyedin is an employee of Edwards Lifesciences. Dr Cohen has received research grants to the institution and personal consulting fees from Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Leon holds equity or interest in Ancora, CroíValve, Concept Medical, East End Medical, Laminar, Mirus, Medinol, Pi-Cardia, Trajectory, SoloPace, Valve Medical, xDot, and XenterMD; has received institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, and Medtronic; and has received consulting fees from Anteris, Bain Capital, Foldax, and MicroPort. Dr Dweck has received consultancy fees from AstraZeneca, Novartis, and Silence Therapeutics; has received speaker fees from Silence Therapeutics and AstraZeneca; and is an advisory board member for Novartis, AstraZeneca, and Silence Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Over a decade of randomized controlled trial data demonstrate excellent outcomes with transcatheter aortic valve replacement or surgical aortic valve replacement for patients with symptomatic severe aortic stenosis regardless of surgical risk. The 2020 American College of Cardiology/American Heart Association guidelines recommend both options for low-risk AS patients aged 65 to 80 years. However, the fastest growing population of patients receiving transcatheter aortic valve replacement in the United States is <65 years old, with little data to support the practice. The American College of Cardiology's Cardiac Surgery Team Section Leadership and Interventional Cardiology Councils, a multidisciplinary collaboration of cardiologists and cardiac surgeons, sought to summarize the relevant data into a decision-making tool for heart valve teams. A literature review was completed, and guidelines, randomized controlled trials, and large observational studies were summarized into a pragmatic decision-making approach to treating young and low-risk patients with AS., Competing Interests: Funding Support and Author Disclosures Dr Gupta has received consulting fees from Medtronic; Dr Malaisrie has received honoraria from Edwards Lifesciences, Artivion, and Atricure; and has received research grants from Edwards Lifesciences, Medtronic, Artivion, and Terumo. Dr Batchelor has received consultant and Speakers Bureau fees and research grant support from Abbott; has received consultant fees and research grant support from Boston Scientific; and is a consultant for V-Wave and Medtronic. Dr Davidson has received research support from Edwards Lifesciences. Dr Kpodonu has received National Institutes of Health (National Institute of Biomedical Imaging and Bioengineering) funding (R33 grant). Dr Sultan has received institutional research funding from Abbott, Artivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Terumo Aortic. Dr Theroit serves on the Speakers Bureau for Edwards Lifesciences. Dr Reardon has received research support from Abbott, Boston Scientific, Jena Valve, Medtronic, and St. Jude Medical; and has received honoraria from Abbott, Boston Scientific, and Medtronic. Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Grubb has received consulting fees from Medtronic, Abbott, Boston Scientific, Ancora Heart, 4C Medical, Edwards Lifesciences, and OpSens. 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.)

Background: Neurohormonal modulation and afterload reduction are key for treatment of heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), treatment with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT)., Objectives: This study sought to determine whether TAVR for moderate AS provides clinical benefit in patients with HFrEF on top of GDMT., Methods: We performed an investigator-initiated, international, randomized controlled trial in patients with HFrEF on GDMT with moderate AS who were suitable for transfemoral TAVR with a balloon-expandable valve. Patients were randomized 1:1 to TAVR or clinical aortic stenosis surveillance (CASS) with aortic valve replacement upon progression to severe AS. The primary endpoint was the hierarchical occurrence of: 1) all-cause death; 2) disabling stroke; 3) disease-related hospitalizations and heart failure equivalents; and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analyzed using the win ratio., Results: From January 2017 to December 2022, 178 patients were randomized to TAVR (n = 89) or AS surveillance (n = 89). The mean age was 77 years, 20.8% were female, and 55.6% were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months). A total of 38 (43%) patients in the CASS group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months postrandomization. TAVR was associated with wins in 47.6% of pairs, compared with 36.6% in the CASS group, resulting in a win ratio of 1.31 (95% CI: 0.91-1.88; P = 0.14). At 1 year, TAVR resulted in a greater improvement in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the CASS group (12.8 ± 21.9 points vs 3.2 ± 22.8 points; P = 0.018)., Conclusions: TAVR was not superior to AS surveillance for the primary hierarchical composite endpoint in patients with moderate AS and HFrEF on GDMT. Preemptive TAVR for moderate AS was safe and may provide clinically meaningful quality-of-life benefits., Competing Interests: Funding Support and Author Disclosures The TAVR UNLOAD trial was funded by an investigator-initiated grant from Edwards Lifesciences. The funder had no role in the study design, data collection or management, or the statistical analyses. The principal investigators had unrestricted access to the study data, wrote the manuscript, and vouched for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. All the authors reviewed and approved the manuscript. Dr Van Mieghem has received grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received advisory fees from Abbott, Boston Scientific, Pulse Cath BV, and Medtronic. Dr Elmariah has received research grants from Edwards Lifesciences and Medtronic; and has received consulting fees from Edwards Lifesciences. Dr Spitzer has held institutional contracts/grants for which he receives no direct compensation from Abbott, Biosensors Europe SA, Boston Scientific, Edwards Lifesciences, Medtronic, Mixin Medtech (Suzhou), Shanghai Microport Medical, NVT GmbH, Philips Healthcare, Pie Medical Imaging, Shanghai Shenqi Medical Technologies, and Siemens Healthcare GmbH. Dr Pibarot has received funding from Edwards Lifesciences, Pi-Cardia, and Cardiac Success for echocardiography core laboratory analyses in the field of transcatheter valve therapies and Medtronic for in vitro analyses, with no personal compensation. Dr Nazif has received consulting fees or honoraria from Medtronic, Boston Scientific, Teleflex, Encompass Technologies, and Opsens Medical; and has received institutional research grants from Edwards Lifesciences, Boston Scientific, Medtronic, and Abbott. Dr Bax has received speaker fees from Abbott and Edwards Lifesciences. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; has held institutional consulting contracts for which she receives no direct compensation from Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr Popma’s spouse is a Medtronic employee. Dr Ben-Yehuda has received consulting fees from Edwards Lifesciences, Medtronic, Cardiovalve, and Bioventrix. Dr Redfors has received consulting fees from Pfizer and Boehringer Ingelheim. Dr Kodali has received grant support, paid to his institution, from Medtronic, Boston Scientific, and Abbott Vascular; has received consulting fees from Abbott Vascular, Claret Medical, Admedus, and Meril Life Sciences; and holds equity options in BioTrace Medical, Dura Biotech, and Thubrikar Aortic Valve. Dr Hermanides has received lecture fees from Abbott Vascular, Amgen, and Novartis. Dr Cohen has received research grant support from Edwards Lifesciences, Abbott, Boston Scientific, Corvia Medical, Philips, Brain-Q, Saranas, Zoll Medical, CathWorks, and ANCORA; and has received consulting fees from Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, Corvia Medical, Impulse Dynamics, AngioInsight, and HeartBeam. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards, and Medtronic. 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.)

Background and Aims: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction., Methods: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board., Results: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%-100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%-100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%-99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%-99.0%)], without any cardiovascular deaths., Conclusions: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Evaluation of left and right ventricular (RV) longitudinal systolic function may enhance risk stratification following aortic valve replacement (AVR). The study objective was to evaluate the changes in left and RV longitudinal systolic function and RV-pulmonary artery (RV-PA) coupling from baseline to 30 days and 1 year after AVR., Methods and Results: Left ventricular (LV) longitudinal strain (LS), tricuspid annulus plane systolic excursion (TAPSE), and RV-PA coupling were evaluated in patients from the PARTNER 2A surgical AVR (SAVR) arm (n = 985) and from the PARTNER 2 SAPIEN 3 registry (n = 719). TAPSE and RV-PA coupling decreased significantly following SAVR, but remained stable following TAVR. Lower LV LS, TAPSE, or RV-PA coupling at baseline was associated with increased risk of the composite of death, hospitalization, and stroke at 5 years [adjusted hazard ratios (HRs) for LV LS < 15%: 1.24, 95% confidence interval (CI) 1.05-1.45, P = 0.001; TAPSE < 14 mm: 1.44, 95% CI 1.21-1.73, P < 0.001; RV-PA coupling < 0.55 mm/mmHg: 1.32, 95% CI 1.07-1.63, P = 0.011]. Reduced TAPSE at baseline was the most powerful predictor of the composite endpoint at 5 years. Patients with LV ejection fraction <50% at baseline had increased risk of the primary endpoint with SAVR (HR: 1.34, 95% CI 1.08-1.68, P = 0.009) but not with TAVR (HR: 1.12, 95% CI 0.88-1.42). Lower RV-PA coupling at 30 days showed the strongest association with cardiac mortality., Conclusion: SAVR but not TAVR was associated with a marked deterioration in RV longitudinal systolic function and RV-PA coupling. Lower TAPSE and RV-PA coupling at 30 days were associated with inferior clinical outcomes at 5 years. In patients with LVEF < 50%, TAVR was associated with superior 5-year outcomes., Competing Interests: Conflict of interest: J.T. is consultant for Abbott, Philips Healthcare, and General Electric. R.T.H. reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. M.-A.C. has research grant with Medtronic and core laboratory contract with Edwards Lifesciences without direct compensation. W.J. is consultant for Boston Scientific and BridgeBio. F.M.A. and N.J.W. have institutional research grants as directors of an academic core lab from Edwards, Abbott, Medtronic, Boston Scientific, Biotronik, Corcyn, and Foldax. They have no personal disclosures. N.A. received speakers fees from Abbott Vascular, GE Healthcare, and Philips ultrasound and research grants from Alnylam and Pfizer. H.C.H. reports institutional research funding from Abbott, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, and WL Gore; consulting fees from Edwards Lifesciences, Medtronic, Wells Fargo, and WL Gore; and equity in Holistick Medical and Micro Interventional Devices. M.J.M. has served as a Co-Pi for clinical trials for Abbott and Edwards Lifesciences and as Study Chair for a trial for Medtronic. All roles were uncompensated. V.T. is consultant or researcher for Abbott Vascular, Boston Scientific, CryoLife, Edwards Lifesciences, Medtronic, and Shockwave. The other authors have nothing to disclose., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Acute brain infarction detected by diffusion-weighted magnetic resonance imaging (DW-MRI) is common after transcatheter aortic valve replacement (TAVR), but its clinical relevance is uncertain., Objectives: The authors investigated the relationship between DW-MRI total lesion number (TLN), individual lesion volume (ILV), and total lesion volume (TLV) and clinical stroke outcomes after TAVR., Methods: Patient-level data were pooled from 4 prospective TAVR embolic protection studies, with consistent predischarge DW-MRI acquisition and core laboratory analysis. C-statistic was used to determine the best DW-MRI measure associated with clinical stroke., Results: A total of 495 of 603 patients undergoing TAVR completed the predischarge DW-MRI. At 30 days, the rate of clinical ischemic stroke was 6.9%. Acute ischemic brain injury was seen in 85% of patients with 5.5 ± 7.3 discrete lesions per patient, mean ILV of 78.2 ± 257.1 mm 3 , and mean TLV of 555 ± 1,039 mm 3 . The C-statistic was 0.84 for TLV, 0.81 for number of lesions, and 0.82 for maximum ILV in predicting ischemic stroke. On the basis of the TLV cutpoint as defined by receiver operating characteristic (ROC), patients with a TLV >500 mm 3 (vs TLV ≤500 mm 3 ) had more ischemic stroke (18.2% vs 2.3%; P < 0.0001), more disabling strokes (8.8% vs 0.9%; P < 0.0001), and less complete stroke recovery (44% vs 62.5%; P = 0.001) at 30 days., Conclusions: Our study confirms that the number, size, and total volume of acute brain infarction defined by DW-MRI are each associated with clinical ischemic strokes, disabling strokes, and worse stroke recovery in patients undergoing TAVR and may have value as surrogate outcomes in stroke prevention trials. (A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI [DEFLECT III]; NCT02070731) (A Study to Evaluate the Neuro-embolic Consequences of TAVR [NeuroTAVR]; NCT02073864) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT I]; NCT02536196) (The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation [REFLECT II]; NCT02536196)., Competing Interests: Funding Support and Author Disclosures This study was supported, in part, by a generous grant from the Robert J. & Claire Pasarow Foundation and the Yale Cardiovascular Research Group. Dr Lansky has received consulting fees from Emboline; has received honoraria from Boston Scientific; and has received institutional research support from Filterlex Medical Ltd. Dr Dwyer has received grant support from Novartis, Bristol Myers Squibb, Mapi Pharma, Merck Serono, Keystone Heart Ltd, Protembis GmbH, V-Wave Ltd, and Filterlex Medical Ltd; and has received consulting fees from Bristol Myers Squibb, Merck Serono, Keystone Heart Ltd, and Mapi Pharma. Dr Zivadinov has received personal compensation from Bristol Myers Squibb, EMD Serono, Sanofi, Janssen, Biogen, Filterlex Medical Ltd, and Mapi Pharma; has received speaking and consultant fees and financial support for research activities from Novartis, Bristol Myers Squibb, EMD Serono, Octave, Mapi Pharma, CorEvitas, Protembis, and V-Wave Ltd. Dr Parise has received consulting fees from CroíValve and Veryan Medical; and has previously received consulting fees from Keystone Heart Ltd. Dr Moses has held equity in Orchestra BioMed and 4C Medical. Dr Leon has received institutional clinical research funding from Edwards Lifesciences, Boston Scientific, Abbott, and Medtronic. Dr Nazif has received consulting fees or honoraria from Boston Scientific, Medtronic, and EnCompass Technologies. Dr Messé has received consulting fees from Terumo, EmStop, VST Bio, and Filterlex Medical Ltd; has served on the Data and Safety Monitoring Board for the Gore REDUCE PFO closure post-marketing study, the clinical events committee for the Novo Nordisk ZEUS and ONWARDS trials, and the subject selection committee for the Terumo RelayBranch trial; and holds equity in Neuralert Technologies. 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.)

Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). The TRISCEND II pivotal trial studies the transcatheter EVOQUE (Edwards Lifesciences, Irvine, California) tricuspid valve replacement system using a United States Food and Drug Administration Breakthrough Device Designation-a program intended to provide timely access to medical devices by speeding up development, assessment, and review. The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness end points for the first 150 patients in the initial phase and a 1-year safety and effectiveness end point for the full cohort of 400 patients in the second phase. The TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. In conclusion, the design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials., Competing Interests: Declaration of competing interest Dr. Grayburn receives grant support from Abbott Vascular, CardioMech, Cardiovalve, Edwards Lifesciences, Medtronic, Neochord, Restore Medical, and 4C Medical and Advisory Board/Consultant fees from Abbott Vascular, Edwards Lifesciences, Medtronic, and 4C Medical. Dr. Kodali reports institutional research grants from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and is a consultant to Admedus, TriCares, TriFlo, X-Dot, MicroInterventional Devices, Supira, Adona, Tioga, Helix Valve Repair, and moray Medical and serves on advisory boards for Dura Biotech, Thubrikar Aortic Valve Inc., Phillips, Medtronic, and Boston Scientific. Dr. Hahn reports 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, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr. Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor, honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Boehringer Ingelheim, and has stock options with Innoventric. Dr. Thourani is an advisor or researcher for Artivion, AtriCure, Abbott Vascular, Boston Scientific, Edwards Lifesciences, JenaValve, and Shockwave. Dr. Mack reports consulting fees and research grants from Edwards Lifesciences. Dr. Leon reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Efraim Kozorovitsky, Suzanne Gilmore, Chandan Vinekar, Bonnie Zhang, Kristin Boulware, Ann Krzmarzick, Don Nguyen, Minh Vu, and Dr Feldman are employed by Edwards Lifesciences., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Coronary angiography and percutaneous coronary intervention (PCI) in patients with chronic kidney disease (CKD) is associated with increased risk of contrast induced nephropathy (CIN) and requirement for renal replacement therapy (RRT)., Objectives: We aimed to evaluate our single center experience of ultra-low contrast PCI in patients with CKD and to characterize 1 year outcomes., Methods: We performed a retrospective analysis of ultra-low contrast PCI at our institution between 2016 and 2022. Patients with CKD3b-5 (eGFR <45 mL/min/1.73m 2 ), not on RRT who underwent ultra-low contrast PCI ( < 30 mL of contrast during PCI) were included. Primary outcomes included change in eGFR post-procedurally, and death, RRT requirement, and major adverse cardiac events (MACE) at 1 year follow-up., Results: One hundred patients were included in the study. The median age was 67 years old and 28% were female. The median baseline eGFR was 21.5 mL/min/1.73m 2 (IQR 14.08-32.0 mL/min/1.73m 2 ). A median of 8.0 mL (IQR 0-15 mL) of contrast was used during PCI. Median contrast use to eGFR ratio was 0.37 (IQR 0-0.59). There was no significant difference between pre-and postprocedure eGFR (p = 0.84). At 1 year, 8% of patients died, 11% required RRT and 33% experienced MACE. The average time of RRT initiation was 7 months post-PCI. Forty-four patients were undergoing renal transplant evaluation, of which 17 (39%) received a transplant., Conclusions: In patients with advanced CKD, ultra-low contrast PCI is feasible and safe with minimal need for peri-procedural RRT. Moreover, ultra-low contrast PCI may allow for preservation of renal function in anticipation of renal transplantation., (© 2024 Wiley Periodicals LLC.)

Background: The REDUCE LAP-HF II (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II) trial found that, compared with a sham procedure, the Corvia Atrial Shunt did not improve outcomes in heart failure with preserved or mildly reduced ejection fraction. However, after 12-month follow-up, "responders" (peak-exercise pulmonary vascular resistance <1.74 WU and absence of a cardiac rhythm management device) were identified., Objectives: This study sought to determine: 1) the overall efficacy and safety of the atrial shunt vs sham control after 2 years of follow-up; and 2) whether the benefits of atrial shunting are sustained in responders during longer-term follow-up or are offset by adverse effects of the shunt., Methods: The study analyzed 2-year outcomes in the overall REDUCE LAP-HF II trial, as well as in responder and nonresponder subgroups. The primary endpoint was a hierarchical composite of cardiovascular death or nonfatal ischemic/embolic stroke, total heart failure events, and change in health status., Results: In 621 randomized patients, there was no difference between the shunt (n = 309) and sham (n = 312) groups in the primary endpoint (win ratio: 1.01 [95% CI: 0.82-1.24]) or its individual components at 2 years. Shunt patency at 24 months was 98% in shunt-treated patients. Cardiovascular mortality and nonfatal ischemic stroke were not different between the groups; however, major adverse cardiac events were more common in those patients assigned to the shunt compared with sham (6.9% vs 2.7%; P = 0.018). More patients randomized to the shunt had an increase in right ventricular volume of ≥30% compared with the sham control (39% vs 28%, respectively; P < 0.001), but right ventricular dysfunction was uncommon and not different between the treatment groups. In responders (n = 313), the shunt was superior to sham (win ratio: 1.36 [95% CI: 1.02-1.83]; P = 0.037, with 51% fewer HF events [incidence rate ratio: 0.49 [95% CI: 0.25-0.95]; P = 0.034]). In nonresponders (n = 265), atrial shunting was inferior to sham (win ratio: 0.73 [95% CI: 0.54-0.98])., Conclusions: At 2 years of follow-up in REDUCE LAP-HF II, there was no difference in efficacy between the atrial shunt and sham groups in the overall trial group. The potential clinical benefit identified in the responder group after 1 and 2 years of follow-up is currently being evaluated in the RESPONDER-HF (Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction Heart Failure) trial. (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II [REDUCE LAP-HF II]; NCT03088033)., Competing Interests: Funding Support and Author Disclosures The REDUCE LAP-HF II trial was funded by Corvia Medical, Inc. Dr Gustafsson has served as an unpaid advisor to Corvia; has received consulting fees from Bayer, AstraZeneca, Abbott, Ionis, Alnylam, Pfizer, FineHeart, CorWave, and AdjuCor; and has received speaker fees from Novartis. Dr Petrie has received research funding from Boehringer Ingelheim, Roche, SQ Innovations, AstraZeneca, Novartis, Novo Nordisk, Medtronic, Boston Scientific, and Pharmacosmos; and has served as a consultant and on trial committees for Akero, Applied Therapeutics, AnaCardio, Biosensors, Boehringer Ingelheim, Novartis, AstraZeneca, Novo Nordisk, Abbvie, Bayer, Horizon Therapeutics, Takeda, Cardiorentis, Pharmacosmos, Siemens, Lilly, Vifor, New Amsterdam, Moderna, and Teikoku. Dr Komtebedde is an employee of Corvia Medical, Inc. Dr Borlaug has received research support from the National Institutes of Health, and the U.S. Department of Defense; has received research grants from AstraZeneca, Axon, GlaxoSmithKline, Medtronic, Mesoblast, Novo Nordisk, Rivus, and Tenax Therapeutics; has served as a consultant for Actelion, Amgen, Aria, Axon Therapies, BD, Boehringer Ingelheim, Cytokinetics, Edwards Lifesciences, Eli Lilly, Imbria, Janssen, Merck, Novo Nordisk, NGM, NXT, and VADovations; and is a named inventor (US Patent number 10,307,179) for the tools and approach for a minimally invasive pericardial modification procedure to treat heart failure. Dr Mohan has received research funds paid to his institution from Corvia, Alleviant Medical, and V-Wave; has received consulting fees from Corvia, Alleviant Medical, AstraZeneca, Pfizer, and Boston Scientific, and has received speaker honoraria from Bristol-Myers Squibb, Pfizer, and AstraZeneca. Dr Sverdlov has received support from the National Heart Foundation of Australia Future Leader Fellowship (Award ID 106025); has received research grants from the Department of Health and Aged Care (Australia) Medical Research Future Fund (MRF2017053), New South Wales (NSW) Health (Australia), AstraZeneca, Novartis, Biotronik, RACE Oncology, Bristol-Myers Squibb, Roche Diagnostics, and Vifor; and has received personal fees from Novartis, Bayer, Bristol-Myers Squibb, AstraZeneca, Janssen, and Boehringer Ingelheim. Dr Chung has received consulting fees from Abbott, Medtronic, InterShunt, Cardionomic, EBR, CVRx, LivaNova; and has served on the Speakers Bureau for Boehringer Ingelheim. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor; and Boehringer Ingelheim; and has held stock options with Innoventric. Dr Cikes has received investigator-initiated research grants to her institution from Novartis, Abbott, and Pfizer; has received clinical study contracts for her institution from Novo Nordisk and Corvia; and has served in an advisory role and received speaker honoraria and/or travel grants from Abbott, Abiomed, Amgen, Amicus Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, GE Healthcare, Livanova, Krka Pharma, Novartis, Novo Nordisk, Pfizer, Pulsify Medical, Roche, Swixx, Takeda, Teva Pharmaceutical Industries, and Viatris. Dr Shah has received grant support from the National Heart, Lung and Blood Institute (grants U54 HL160273, R01 HL107577, R01 HL127028, R01 HL140731, and R01 HL149423), AstraZeneca, Corvia, and Pfizer; and has received consulting fees from Abbott, Alleviant, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, ReCor, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and Ultromics. 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.)

Background: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study., Methods: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year., Results: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients., Conclusions: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801., Competing Interests: Dr Malaisrie reports institutional research grants from Edwards Lifesciences, Medtronic, and Terumo Medical Corporation and consulting/speaker fees from Edwards Lifesciences, Terumo Medical Corporation, and Artivion; Dr Guerrero reports institutional research grants from Edwards Lifesciences; Dr Davidson reports institutional research grants from Edwards Lifesciences and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Williams reports institutional research grants from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific and consulting/speaker fees from Medtronic; Dr de Brito is a proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; Dr Shah reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Kaneko reports consulting/speaker fees from Edwards Lifesciences, Medtronic, and Abbott Vascular; Dr Poon reports institutional research grants from Edwards Lifesciences and consulting/speaker fees from Edwards Lifesciences and Anteris; Dr Yu is an employee of Edwards Lifesciences; Dr Pibarot reports institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; Dr Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation; Dr Blanke reports consulting/speaker fees from Edwards Lifesciences and LARALAB; Dr Leon reports institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; Dr Mack has served as trial coprimary investigator for Edwards Lifesciences and Abbott Vascular and has served as a study chair for Medtronic; Dr Zajarias reports consulting/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Transcatheter aortic valve replacement (TAVR) has become more common than surgical aortic valve replacement since 2016, with over 200,000 procedures globally each year. As patients increasingly outlive their TAVR devices, managing these cases is a growing concern. Treatment options include surgical removal of the old TAVR device (transcatheter aortic valve [TAV] explant) or implantation of a new transcatheter aortic valve (redo TAV). Redo TAV is complex because of the unique designs of TAV devices; compatibility issues; and the need for individualized planning based on factors such as implant depth, shape, and coronary artery relationships. This review serves as a comprehensive guide for redo TAV, detailing the design characteristics of TAV devices, device compatibility, standardized terminology, and a structured approach for computed tomography analysis. It aims to facilitate decision making, risk identification, and achieving optimal outcomes in redo TAV procedures., Competing Interests: Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, Abbott, Anteris, Meril Lifesciences, and Boston Scientific. Dr Jilaihawi has received institutional research grants and consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic Inc; and has received institutional research grants from Boston Scientific and Pi-Cardia. Dr Rogers is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Transmural Systems; serves on advisory boards for Medtronic and Boston Scientific; holds an equity interest in Transmural Systems; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Khalique is a consultant for Edwards Lifesciences, Restore Medical, Croivalve, Heartflow, and Vdyne; and holds equity in Triflo. Dr Cavalcante is a consultant for 3Mensio, 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, JenaValve, Medtronic, and Siemens Healthineers. Dr Landes has received consulting fees from Edwards Lifesciences. Dr Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific; is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris; and serves as chief medical officer for structural division of Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientifics. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Blackman is a consultant, proctor, and advisory board member for Medtronic and Abbott Vascular; and has received institutional research grants from Medtronic. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Mack served as co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. 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.)

Background: Complete revascularization with percutaneous coronary intervention improves outcomes compared with culprit revascularization following myocardial infarction (MI) with multivessel coronary artery disease. An all-cause mortality reduction has never been demonstrated. Debate also remains regarding the optimal timing of complete revascularization (immediate or staged), and method of evaluation of nonculprit lesions (physiology or angiography)., Objectives: This study aims to perform an updated systematic review with frequentist and Bayesian network meta-analyses including the totality of randomized data investigating revascularization strategies in patients presenting with MI and multivessel coronary artery disease., Methods: The primary comparison tested complete vs culprit revascularization. Timing and methods of achieving complete revascularization were assessed. The prespecified primary outcome was all-cause mortality. Outcomes were expressed as relative risk (RR) (95% CI)., Results: Twenty-four eligible trials randomized 16,371 patients (weighted mean follow-up: 26.4 months). Compared with culprit revascularization, complete revascularization reduced all-cause mortality in patients with any MI (RR: 0.85; 95% CI: 0.74-0.99; P = 0.04). Cardiovascular mortality, MI, major adverse cardiac events and repeat revascularization were also significantly reduced. In patients presenting with ST-segment elevation myocardial infarction, the point estimate for all-cause mortality with complete revascularization was RR: 0.91 (95% CI: 0.78-1.05; P = 0.18). Rates of stent thrombosis, major bleeding, and acute kidney injury were similar. Immediate complete revascularization ranked higher than staged complete revascularization for all endpoints., Conclusions: Complete revascularization following MI reduces all-cause mortality, cardiovascular mortality, MI, major adverse cardiac events, and repeat revascularization. There may be benefits to immediate complete revascularization, but additional head-to-head trials are needed., Competing Interests: Funding Support and Author Disclosures Dr Howard has received grants from the British Heart Foundation (FS/ICRF/22/26039). Dr Ahmad has received consulting fees from Cardiovascular Systems Inc and Shockwave; and has served on the Medical Advisory Board of Boston Scientific. 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.)

Aortic stenosis (AS) is the most common age-related valvular condition with a prevalence of 13.1% in patients older than 75 years of age. Based on the severity of AS and symptoms, current guidelines recommend interval monitoring with transthoracic echocardiogram (TTE). However, no guidelines exist regarding screening asymptomatic persons for AS. Prevalence of AS is comparable to conditions such as colorectal cancer, lung cancer, breast cancer, and abdominal aortic aneurysm where dedicated screening programs are offered resulting in reduction of overall morbidity and mortality. We review recent advancements in treatment options, and we propose an AS screening program for high-risk individuals without known history of AS including all persons over age 75 and persons aged 70 years and older with dialysis dependent end-stage renal disease (ESRD)., (Copyright © 2023. Published by Elsevier Inc.)

Importance: The use of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been rapidly expanding as an alternative treatment to redo surgical aortic valve replacement (SAVR) for failed bioprosthetic valves despite limited long-term data., Objective: To assess mortality and morbidity in patients undergoing intervention for failed bioprosthetic SAVR., Design, Setting, and Participants: This was a retrospective population-based cohort analysis conducted between January 1, 2015, and December 31, 2020, with a median (IQR) follow-up time of 2.3 (1.1-4.0) years. A total of 1771 patients with a history of bioprosthetic SAVR who underwent ViV-TAVR or redo SAVR in California, New York, and New Jersey were included. Data were obtained from the California Department of Health Care Access and Information, the New York Statewide Planning and Research Cooperative System, and the New Jersey Discharge Data Collection System. Exclusion criteria included undergoing TAVR or redo SAVR within 5 years from initial SAVR, as well as infective endocarditis, concomitant surgical procedures, and out-of-state residency. Propensity matching yielded 375 patient pairs. Data were analyzed from January to December 2023., Interventions: ViV-TAVR vs redo SAVR., Main Outcomes and Measurements: The primary outcome was all-cause mortality. Secondary outcomes were stroke, heart failure hospitalization, reoperation, major bleeding, acute kidney failure, new pacemaker insertion, and infective endocarditis., Results: From 2015 through 2020, the proportion of patients undergoing ViV-TAVR vs redo SAVR increased from 159 of 451 (35.3%) to 498 or 797 (62.5%). Of 1771 participants, 653 (36.9%) were female, and the mean (SD) age was 74.4 (11.3) years. Periprocedural mortality and stroke rates were similar between propensity-matched groups. The ViV-TAVR group had lower periprocedural rates of major bleeding (2.4% vs 5.1%; P = .05), acute kidney failure (1.3% vs 7.2%; P < .001), and new pacemaker implantations (3.5% vs 10.9%; P < .001). The 5-year all-cause mortality rate was 23.4% (95% CI, 15.7-34.1) in the ViV-TAVR group and 13.3% (95% CI, 9.2-18.9) in the redo SAVR group. In a landmark analysis, no difference in mortality was observed up to 2 years (hazard ratio, 1.03; 95% CI, 0.59-1.78), but after 2 years, ViV-TAVR was associated with higher mortality (hazard ratio, 2.97; 95% CI, 1.18-7.47) as well as with a higher incidence of heart failure hospitalization (hazard ratio, 3.81; 95% CI, 1.57-9.22). There were no differences in 5-year incidence of stroke, reoperation, major bleeding, or infective endocarditis., Conclusions and Relevance: Compared with redo SAVR, ViV-TAVR was associated with a lower incidence of periprocedural complications and a similar incidence of all-cause mortality through 2 years' follow-up. However, ViV-TAVR was associated with higher rates of late mortality and heart failure hospitalization. These findings may be influenced by residual confounding and require adjudication in a randomized clinical trial.

Background: Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated., Objectives: The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical risk., Methods: Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory., Results: The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n = 95) or APOLLO trial (primary cohort noneligible + TA roll-ins, n = 157). Mean age was 74.2 years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had ≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day ≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had ≤mild MR., Conclusions: This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk ≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years., Competing Interests: Funding Support and Author Disclosures This work was funded by Medtronic. Dr Bapat has received personal fees for consultancy and speaker service from Medtronic; and has served as a consultant for Edwards Lifesciences, 4C, and Boston Scientific. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. Dr Bajwa has received personal and institutional consulting fees from Medtronic. Dr Thourani has been an advisor to or received research grants from Artivion, Atricure, Abbott Vascular, Boston Scientific, Dasi Simulations, Edwards Lifesciences, Medtronic, and JenaValve. Dr Yadav is a proctor and speaker for Edwards Lifesciences; and a consultant for and holds stock in Shockwave Medical. Dr Thaden has received institutional consulting fees from Medtronic; and speaker fees from Edwards Lifesciences. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, NXT, V Wave, and WL Gore; and has received consulting fees from Philips, Valgen Medtech, and Venus. Dr Reardon has received institutional consulting fees from Medtronic, W.L. Gore & Associates, Boston Scientific, and Abbott Vascular. Dr Pinney has received consulting fees from Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech. Dr Adams is national coprincipal investigator for Medtronic APOLLO FDA Pivotal Trial, the NeoChord ReChord FDA Pivotal Trial, the Medtronic CoreValve US Pivotal Trial, and the Abbott TRILUMINATE Pivotal Trial; and his institution, the Icahn School of Medicine at Mount Sinai, receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr Yakubov has received research grants from Medtronic and Boston Scientific; serves on advisory boards for Medtronic and Boston Scientific; and is a principal investigator, steering committee member, and screening committee member for the CoreValve clinical trials. Dr Modine is a consultant for Abbott, Boston Scientific, Cephea, Edwards Lifesciences, GE Healthcare, Medtronic, and MicroPort; and is a proctor for and receives speaker fees from Medtronic. Dr Redwood has received speaker fees from Edwards Lifesciences. Dr Walton has served as a proctor and received advisory board fees and grant support from Medtronic, Abbott, and Edwards Lifesciences. Dr Spargias has received grant support and proctor fees from Medtronic, Abbott Vascular, and Edwards Lifesciences. Ms Zhang is an employee of Medtronic. Dr Mack is on the executive board for the APOLLO trial sponsored by Medtronic; and is coprincipal investigator for the PARTNER 3 and COAPT trials sponsored by Edwards Lifesciences and Abbott Vascular. Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: For high bleeding-risk patients (HBR) undergoing percutaneous coronary intervention (PCI), the LEADERS FREE (LF) and LEADERS FREE II (LF II) trials established the safety and efficacy of a stainless steel polymer-free biolimus-coated stent (SS-BCS) with 30 days of dual antiplatelet treatment (DAPT). The LEADERS FREE III (LF III) trial investigated clinical outcomes after PCI with the next-generation cobalt-chromium thin-strut polymer-free biolimus-coated stent (CoCr-BCS) in HBR patients., Aims: To report the final 3-year results of the LF III trial and compare them to LF II., Methods: LF III was a prospective, multicentre, open-label single-arm study to evaluate the safety and efficacy of the CoCr-BCS stent. The primary safety endpoint was the composite of cardiac death (CD), myocardial infarction(MI) or definite/probable stent thrombosis (ST). The primary efficacy endpoint was clinically driven target lesion revascularisation (cd-TLR). We performed a propensity-matched comparison to the 3-year outcomes of LF II., Results: After 3 years, CD/MI/ST had occurred in 57 patients (15%, 95% CI 11.8% to 19%) and cd-TLR in 23 (6.2%, 95% CI 4.1% to 9.2%) patients. In a propensity-matched comparison of patients treated with the CoCr-BCS versus the SS-BCS, there were similar rates of CD (6.6% vs 7.8%, p=0.50), MI (7.1% vs 8.3%, p=0.47) and definite/probable ST (1.1% vs 2%, HR 0.56, 95% CI 0.16 to 1.93, p=0.35). The rates of cd-TLR were 5.3% with CoCr-BCS versus 9.8% with SS-BCS (HR 0.54, 95% CI 0.31 to 0.96, p=0.03)., Conclusion: LF III confirms the long-term safety and efficacy of the CoCr-BCS in HBR patients treated with 1 month of DAPT., Trial Registration Number: NCT02843633, NCT03118895., Competing Interests: Competing interests: KGO, and SSS are employees of the sponsor. DS has a consultant relationship with Biosensors. MWK reports grants and personal fees from Biosensors during the conduct of the study and grants and personal fees from Abbott Vascular, Medtronic, OrbusNeich, Terumo, and Cordis/Johnson & Johnson outside the submitted work. PU reports personal fees from Biosensors and others from Centre Européen de Recherche Cardiovasculaire (CERC), Massy, France, during the conduct of the study. J-FT reports grants from the Duke Clinical Research Institute during the conduct of the study; grants from Abbott Vascular, Bayer and Biosensors; other from BMS-Pfizer Alliance; and grants from Novartis outside the submitted work. M-CM reports being the CEO of CERC, Massy, France. MBL reports grants from Edwards Lifesciences, Medtronic and Boston Scientific outside the submitted work. The other authors report no conflicts., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV)., Objectives: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV., Methods: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR., Results: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02)., Conclusions: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth., Competing Interests: Funding Support and Author Disclosures The PARTNER 2 trial was funded by Edwards Lifesciences. Dr R.T. Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic and Philips Healthcare, Siemens Healthineers; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Anteris, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored valve trials, for which she receives no direct industry compensation. P Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Dr George has received consulting fees from Edwards Lifesciences. Dr Zhao is an employee of Edwards Lifesciences. Dr Blanke has institutional core laboratory contracts with Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, PI Cardia, and Conformal; he is a Consultant for Edwards Lifesciences and Laralab Imaging. Dr Babaliaros has received consulting fees from Abbott and Edwards Lifesciences. Dr Szeto has received grant support from Edwards Lifesciences and Medtronic; and is a consultant for MicroInterventional Devices. Dr Makkar has received research support from Edwards Lifesciences and Abbott; and consultant fees/honoraria from Abbott, Cordis Corporation, and Medtronic. Dr Thourani serves on advisory boards for Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Webb is a consultant for Edwards Lifesciences. Michael Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (unpaid); has received institutional research grants from Abbott, Boston Scientific, and Medtronic; has been an unpaid advisor for Abbott, Boston Scientific, Sinomed, and Medtronic; and holds equity in Medinol. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Nazif has received consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024. Published by Elsevier Inc.)

Background: Our objective was to compare the impact of patient-prosthesis mismatch (PPM) for 2 years after surgical aortic valve replacement within the prospective, randomized Placement of Aortic Transcatheter Valves (PARTNER) trials., Methods: Surgical aortic valve replacement patients from the PARTNER 1, 2, and 3 trials were included. PPM was classified as moderate (indexed effective orifice area ≤0.85 cm 2 /m 2 ) or severe (indexed effective orifice area ≤0.65 cm 2 /m 2 ). The primary endpoint was the composite of all-cause death and heart failure rehospitalization at 2 years., Results: By the predicted PPM method (PPM P ), 59.1% had no PPM, 38.8% moderate PPM, and 2.1% severe PPM; whereas by the measured PPM method (PPM M ), 42.4% had no PPM, 36.0% moderate, and 21.6% severe. Patients with no PPM P (23.6%) had a lower rate of the primary endpoint compared with patients with moderate (28.2%, P = .03) or severe PPM P (38.8%, P = .02). Using the PPM M method, there was no difference between the no (17.7%) and moderate PPM M groups (21.1%) in the primary outcome (P = .16). However, those with no PPM M or moderate PPM M were improved compared with severe PPM M (27.4%, P < .001 and P = .02, respectively)., Conclusions: Severe PPM analyzed by PPM P was only 2.1% for surgical aortic valve replacement patients. The PPM M method overestimated the incidence of severe PPM relative to PPM P , but was also associated with worse outcome. There was higher all-cause mortality in patients with severe PPM, thus surgical techniques to minimize PPM remain critical., (Copyright © 2024 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Importance: Although the results of A Study to Evaluate the Corvia Medical Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure (REDUCE LAP-HF II) trial were neutral overall, atrial shunt therapy demonstrated potential efficacy in responders (no latent pulmonary vascular disease and no cardiac rhythm management device). Post hoc analyses were conducted to evaluate the effect of shunt vs sham stratified by responder status., Objective: To evaluate the effect of atrial shunt vs sham control on cardiac structure/function in the overall study and stratified by responder status., Design, Setting, and Participants: This was a sham-controlled randomized clinical trial of an atrial shunt device in heart failure with preserved ejection fraction (HFpEF)/HF with mildly reduced EF (HFmrEF). Trial participants with evaluable echocardiography scans were recruited from 89 international medical centers. Data were analyzed from April 2023 to January 2024., Interventions: Atrial shunt device or sham control., Main Outcome Measures: Changes in echocardiographic measures from baseline to 1, 6, 12, and 24 months after index procedure., Results: The modified intention-to-treat analysis of the REDUCE LAP-HF II trial included 621 randomized patients (median [IQR] age, 72.0 [66.0-77.0] years; 382 female [61.5%]; shunt arm, 309 [49.8%]; sham control arm, 312 [50.2%]). Through 24 months, 212 of 217 patients (98%) in the shunt arm with evaluable echocardiograms had patent shunts. In the overall trial population, the shunt reduced left ventricular (LV) end-diastolic volume (mean difference, -5.65 mL; P <.001), left atrial (LA) minimal volume (mean difference, -2.8 mL; P =.01), and improved LV systolic tissue Doppler velocity (mean difference, 0.69 cm/s; P <.001) and LA emptying fraction (mean difference, 1.88 percentage units; P =.02) compared with sham. Shunt treatment also increased right ventricular (RV; mean difference, 9.58 mL; P <.001) and right atrial (RA; mean difference, 9.71 mL; P <.001) volumes but had no effect on RV systolic function, pulmonary artery pressure, or RA pressure compared with sham. In the shunt arm, responders had smaller increases in RV end-diastolic volume (mean difference, 5.71 mL vs 15.18 mL; interaction P =.01), RV end-systolic volume (mean difference, 1.58 mL vs 7.89 mL; interaction P =.002), and RV/LV ratio (mean difference, 0.07 vs 0.20; interaction P <.001) and larger increases in transmitral A wave velocity (mean difference, 5.08 cm/s vs -1.97 cm/s; interaction P =.02) compared with nonresponders randomized to the shunt, suggesting greater ability to accommodate shunted blood through the pulmonary circulation enabling LA unloading., Conclusions and Relevance: In this post hoc analysis of the REDUCE LAP-HF II trial, over 2 years of follow-up, atrial shunting led to reverse remodeling of left-sided chambers and increases in volume of right-sided chambers consistent with the shunt flow but no change in RV systolic function compared with sham. Changes in cardiac structure/function were more favorable in responders compared with nonresponders treated with the shunt, supporting the previously identified responder group hypothesis and mechanism, although further evaluation with longer follow-up is needed., Trial Registration: ClinicalTrials.gov Identifier: NCT03088033.

Orthotopic transcatheter tricuspid valve replacement (TTVR) devices have been shown to be highly effective in reducing tricuspid regurgitation (TR), and interest in this therapy is growing with the recent commercial approval of the first orthotopic TTVR. Recent TTVR studies report preexisting cardiac implantable electronic device (CIED) transvalvular leads in ∼35% of patients, with entrapment during valve implantation. Concerns have been raised regarding the safety of entrapping leads and counterbalanced against the risks of transvenous lead extraction (TLE) when indicated. This Heart Valve Collaboratory consensus document attempts to define the patient population with CIED lead-associated or lead-induced TR, describe the risks of lead entrapment during TTVR, delineate the risks and benefits of TLE in this setting, and develop a management algorithm for patients considered for TTVR. An electrophysiologist experienced in CIED management should be part of the multidisciplinary heart team and involved in shared decision making., Competing Interests: Funding Support and Author Disclosures Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, Philips Healthcare, and Siemens Healthineers; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis. Dr Wilkoff has served as a consultant, speaker, and researcher for Abbott, Biotronik, Boston Scientific, Medtronic, Philips, Cook, and Xcardia. Dr Kodali has served on the scientific advisory board for Microinterventional Devices, Dura Biotech, Thubrikar Aortic Valve, and Supira; has served as a consultant for Meril Lifesciences, Admedus, Medtronic, and Boston Scientific; has served on the steering committee for Edwards Lifesciences and Abbott Vascular; has received honoraria from Meril Lifesciences, Admedus, Abbott Vascular, and Dura Biotech; and has owned equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. Dr Birgersdotter-Green has received speaker honoraria from Abbott, Biotronik, Boston Scientific, Medtronic, and Philips Healthcare. Dr Ailawadi has served as a consultant for Edwards Lifesciences, Medtronic, Abbott Structural, Philips Healthcare, Anteris, W.L. Gore & Associates, Jena Valve, and Arthrex. Dr Andreas has served as a proctor and consultant for and has received speaker honoraria from Edwards Lifesciences, Abbott, and Medtronic; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Auricchio has received consulting fees from Boston Scientific, Cairdac, EP Solutions, Medtronic, Philips, Radcliffe Publishers, and XSpline; has received payment or honoraria from Boston Scientific, Medtronic, Microport CRM, and Philips; and has patents with Boston Scientific, Biosense Webster, and Microport CRM. Dr George has received consulting honoraria from Zimmer Biomet, Atricure, Neosurgery, Neptune Medical, Abbvie, Johnson & Johnson, DurVena, Boston Scientific, Edwards Lifesciences, Medtronic, Help-TheraX, 3ive, Encompass, Summus Medical, Abbott St Jude Medical, BCI, and Xeltis; has served on the advisory board for Edwards Surgical, Medtronic Surgical, Medtronic Structural Mitral & Tricuspid, Trisol Medical, Valcare Medical, DurVena, Abbvie, Johnson & Johnson, Foldax Medical, Zimmer Biomet, Neosurgery, Abbvie, Boston Scientific, Summus Medical, and BCI; has held equity in Valcare Medical, DurVena, CardioMech, VDyne, MitreMedical, MITRx, and BCI; and has received institutional funding to Columbia University from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Harrison has served as a speaker for Philips Healthcare. Dr Ho has received institutional consulting contracts for which he receives no direct compensation with Edwards Lifesciences, Abbott, and GE Healthcare; has received research support from Philips; and has served as an advisor for which he receives no direct compensation for Medtronic, NeoChord, Tioga, Laza Medical, ValGen, Half Moon Medical, VDyne, and Anteris. Dr Latib has served as a consultant and/or advisory board member for Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, Shifamed, NeoChord, VDyne, and Philips. Dr O’Gara has received consulting agreements from Edwards Lifesciences, and Medtronic. Dr Pinney has received consulting fees from Abbott, ADI, Ancora Heart, CareDx, Cordio, Medtronic, Procyrion, Restore Medical, Transmedics, and ValGen; and has received speaker fees from Impulse Dynamics. Dr Zeitler has received consulting and travel support from Medtronic and Biosense Webster; has received nonfinancial research support from Biosense Webster and Sanofi; and has received research support from the National Institutes of Health. Dr Mack has served as the co-principal investigator or study chair for clinical trials sponsored by Abbott, Edwards Lifesciences, and Medtronic. Dr Leon has received institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has served as a consultant or advisory board member for Abbott, Boston Scientific, W.L. Gore & Associates, Medtronic, and Meril Life, Dr Epstein has received consultant fees from Boston Scientific, Medtronic, and The Spectranetics Corp. 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.)

The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI..

Background: Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve., Methods: The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing., Findings: Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (p non-inferiority <0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (p non-inferiority <0·0001)., Interpretation: This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary., Funding: JenaValve Technology., Competing Interests: Declaration of interests TPV reports institutional funding to Columbia University Irving Medical Center from JenaValve Technology, Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and he personally received consulting fees from 4C Medical and Philips. OKK reports that he is part of a core laboratory contracting with JenaValve Technology but he has not received any direct compensation; he further reports consulting fees from Edwards Lifesciences, VDyne, Siemens, Philips, Laralab, and Restore Medical. NH reports that she is part of a core laboratory contracting with JenaValve Technology but she has not received any direct compensation. JMM reports consulting fees and honoraria from Edwards Lifesciences, Medtronic, Abbott, Shockwave, and Equity in Excision Medical, and Conkay Medical. IG reports consulting fees from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott SJM, and Atricure. SKK reports consultant fees (honoraria) from Admedus, Meril Lifesciences, JenaValve Technology, and Abbott Vascular; scientific advisory board participation (equity) with Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, and Admedus; and institutional funding to Columbia University and the Cardiovascular Research Foundation from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve Technology. NA reports medical advisory board fees and consultant and proctor fees from Nininger Medical, Edwards Lifesciences, V-wave, JenaValve Technology, Abbott, Vdyne, and Boston Scientific, and participation in industry-sponsored trials and research funding from Edwards Lifesciences, JenaValve Technology, Boston Scientific, V-wave, AccuCinch, Highlife, Tendyne, and preCardia. DSP is the Chief Medical officer of JenaValve Technology and a consultant for Abiomed, Abbott Vascular, Magenta, NuPulseCV, and Terumo. MBL reports institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and JenaValve Technology. HG reports consulting fees from Medtronic and Boston Scientific. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Purpose: There are concerns that transcatheter or surgical aortic valve replacement (TAVR/SAVR) procedures are preferentially available to White patients. Our objective was to examine differences in utilization of aortic valve replacement and outcomes by race/ethnicity in the US for patients with aortic stenosis., Methods: We performed a serial cross-sectional cohort study of 299,976 Medicare beneficiaries hospitalized with principal diagnosis of aortic stenosis between 2012 and 2019 stratified by self-reported race/ethnicity (Black, Hispanic, Asian, Native American, and White). Outcomes included aortic valve replacement rates within 6 months of index hospitalization and associated procedural outcomes, including 30-day readmission, 30-day and 1-year mortality., Results: Within 6 months of an index admission for aortic stenosis, 86.8% (122,457 SAVR; 138,026 TAVR) patients underwent aortic valve replacement. Overall, compared with White people, Black (HR 0.87 [0.85-0.89]), Hispanic (0.92 [0.88-0.96]), and Asian (0.95 [0.91-0.99]) people were less likely to receive aortic valve replacement. Among patients who were admitted emergently/urgently, White patients (41.1%, 95% CI, 40.7-41.4) had a significantly higher aortic valve replacement rate compared with Black (29.6%, 95% CI, 28.3-30.9), Hispanic (36.6%, 95% CI, 34.0-39.3), and Asian patients (35.4%, 95% CI, 32.3-38.9). Aortic valve replacement rates increased annually for all race/ethnicities. There were no significant differences in 30-day or 1-year mortality by race/ethnicity., Conclusions: Aortic valve replacement rates within 6 months of aortic stenosis admission are lower for Black, Hispanic, and Asian people compared to White people. These race-related differences in aortic stenosis treatment reflect complex issues in diagnosis and management, warranting a comprehensive reassessment of the entire care spectrum for disadvantaged populations., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: Implantation of a transcatheter valve-in-mitral annular calcification (ViMAC) has emerged as an alternative to traditional surgical mitral valve (MV) replacement. Previous studies evaluating ViMAC aggregated transseptal, transapical, and transatrial forms of the procedure, leaving uncertainty about each technique's advantages and disadvantages. Thus, we sought to evaluate clinical outcomes specifically for transatrial ViMAC from the largest multicenter registry to-date., Methods: Patients with symptomatic MV dysfunction and severe MAC who underwent ViMAC were enrolled from 12 centers across the United States and Europe. Clinical characteristics, procedural details, and clinical outcomes were abstracted from the electronic record. The primary end point was all-cause mortality., Results: We analyzed 126 patients who underwent ViMAC (median age 76 years [interquartile range {IQR}, 70-82 years], 28.6% female, median Society of Thoracic Surgeons score 6.8% [IQR, 4.0-11.4], and median follow-up 89 days [IQR, 16-383.5]). Sixty-one (48.4%) had isolated mitral stenosis, 25 (19.8%) had isolated mitral regurgitation (MR), and 40 (31.7%) had mixed MV disease. Technical success was achieved in 119 (94.4%) patients. Thirty (23.8%) patients underwent concurrent septal myectomy, and 8 (6.3%) patients experienced left ventricular outflow tract obstruction (7/8 did not undergo myectomy). Five (4.2%) patients of 118 with postprocedure echocardiograms had greater than mild paravalvular leak. Thirty-day and 1-year all-cause mortality occurred in 16 and 33 patients, respectively. In multivariable models, moderate or greater MR at baseline was associated with increased risk of 1-year mortality (hazard ratio, 2.31; 95% confidence interval, 1.07-4.99, P = .03)., Conclusions: Transatrial ViMAC is safe and feasible in this selected, male-predominant cohort. Patients with significant MR may derive less benefit from ViMAC than patients with mitral stenosis only., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Atrial fibrillation (AF) is common in patients undergoing transcatheter aortic valve replacement (TAVR) and is associated with increased risk of bleeding and stroke. While left atrial appendage occlusion (LAAO) is approved as an alternative to anticoagulants for stroke prevention in patients with AF, placement of these devices in patients with severe aortic stenosis, or when performed at the same time as TAVR, has not been extensively studied., Methods: WATCH-TAVR (WATCHMAN for Patients with AF Undergoing TAVR) was a multicenter, randomized trial evaluating the safety and effectiveness of concomitant TAVR and LAAO with WATCHMAN in AF patients. Patients were randomized 1:1 to TAVR + LAAO or TAVR + medical therapy. WATCHMAN patients received anticoagulation for 45 days followed by dual antiplatelet therapy until 6 months. Anticoagulation was per treating physician preference for patients randomized to TAVR + medical therapy. The primary noninferiority end point was all-cause mortality, stroke, and major bleeding at 2 years between the 2 strategies., Results: The study enrolled 349 patients (177 TAVR + LAAO and 172 TAVR + medical therapy) between December 2017 and November 2020 at 34 US centers. The mean age of patients was 81 years, and the mean scores for CHA 2 DS 2 -VASc and HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly) were 4.9 and 3.0, respectively. At baseline, 85.4% of patients were taking anticoagulants and 71.3% patients were on antiplatelet therapy. The cohorts were well-balanced for baseline characteristics. The incremental LAAO procedure time was 38 minutes, and the median contrast volume used for combined procedures was 119 mL versus 70 mL with TAVR alone. At the 24-month follow-up, 82.5% compared with 50.8% of patients were on any antiplatelet therapy, and 13.9% compared with 66.7% of patients were on any anticoagulation therapy in TAVR + LAAO compared with TAVR + medical therapy group, respectively. For the composite primary end point, TAVR + LAAO was noninferior to TAVR + medical therapy (22.7 versus 27.3 events per 100 patient-years for TAVR + LAAO and TAVR + medical therapy, respectively; hazard ratio, 0.86 [95% CI, 0.60-1.22]; P noninferiority <0.001)., Conclusions: Concomitant WATCHMAN LAAO and TAVR is noninferior to TAVR with medical therapy in severe aortic stenosis patients with AF. The increased complexity and risks of the combined procedure should be considered when concomitant LAAO is viewed as an alternative to medical therapy for patients with AF undergoing TAVR., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03173534., Competing Interests: Disclosures Dr Kapadia holds stock options for Navigate and stocks for Anteris (no longer held, but within the past 12 months). Dr Whisenant consults for Boston Scientific, Edwards, and Medtronic. Dr Iyer is a member of the medical advisory board for Boston Scientific. Dr Leonardi is a speaker for Edwards Lifesciences and Medical and a physician proctor for Edwards Lifesciences. Dr Agarwal is a speaker and proctor for Medtronic, Abbott, and Boston Scientific, and a proctor for Edwards Lifesciences. The other authors report no disclosures related to this study.

Background: Intravascular ultrasound (IVUS) studies show that one-quarter of left anterior descending (LAD) arteries have a myocardial bridge. An MB may be associated with stent failure when the stent extends into the MB., Objectives: The aim of this study was to investigate: 1) the association between an MB and chronic total occlusion (CTO) in any LAD lesions; and 2) the association between an MB and subsequent clinical outcomes after percutaneous coronary intervention in LAD CTOs., Methods: A total of 3,342 LAD lesions with IVUS-guided percutaneous coronary intervention (280 CTO and 3,062 non-CTO lesions) were included. The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, definite stent thrombosis, and ischemic-driven target lesion revascularization)., Results: An MB by IVUS was significantly more prevalent in LAD CTOs than LAD non-CTOs (40.4% [113/280] vs 25.8% [789/3,062]; P < 0.0001). The discrepancy in CTO length between angiography and IVUS was greater in 113 LAD CTOs with an MB than 167 LAD CTOs without an MB (6.0 [Q1, Q3: 0.1, 12.2] mm vs 0.2 [Q1, Q3: -1.4, 8.4] mm; P < 0.0001). Overall, 48.7% (55/113) of LAD CTOs had a stent that extended into an MB after which target lesion failure was significantly higher compared to a stent that did not extend into an MB (26.3% vs 0%; P = 0.0004) or compared to an LAD CTO without an MB (26.3% vs 9.6%; P = 0.02)., Conclusions: An MB was more common in LAD CTO than non-CTO LAD lesions. If present, approximately one-half of LAD CTOs had a stent extending into an MB that, in turn, was associated with worse outcomes., Competing Interests: Funding Support and Author Disclosures Dr Karmpaliotis has received honoraria from Boston Scientific and Abbot Vascular; and holds equity in Saranas Soundbite and Traverse Vascular. Dr Matsumura is a consultant for Terumo Corporation and Boston Scientific. Dr Fall is a consultant for INFRAREDX and Boston Scientific. Dr Prasad is a consultant for CONAVI, Neovasc, Abbott Vascular, Cardinol, Chiesi, and Boehringer Ingelheim; and is on the Speakers Bureau for CONAVI, Neovasc, Abbott Vascular, Cardinol, Chiesi, and Boehringer Ingelheim. Dr Ng has received honoraria from Edwards Lifesciences and Medtronic. Dr Parikh has received research grants from Abbott, Boston Scientific, Medtronic, Phillips, Cordis, Jannsen; is a consultant for Inari, Penumbra, Terumo, and Canon; and holds equity in eFemoral, Advanced Nano Therapies, and Encompass Vascular. Dr Ali has received grants from Abbott Vascular and CSI; is a consultant for Amgen, AstraZeneca, and Boston Scientific; and holds equity for Shockwave. Dr Leon has received institutional clinical research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr McEntegart has received honoraria from Boston Scientific, Abbot Vascular, Shockwave Medical, Teleflex, and Biosensors. Dr Moses holds equity in Orchestra Biomed and Xenter. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Siemens, Philips, ReCor Medical, and Neurotronic; has received institutional funding including fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; is a consultant for IMDS; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Ochiai has received consulting fees from Abbott, Asahi Intecc, Boston Scientific, and Terumo. Dr Mintz has received honoraria from Boston Scientific, Philips, SpectraWave, and Gentuity. Dr Maehara has received research grants from Boston Scientific and Abbott Vascular; and is a consultant for Boston Scientific and Philips. 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.)

Background: While not available for clinical use in the United States, dedicated drug-coated balloons (DCB) are currently under investigation for the management of coronary in-stent restenosis (ISR). Peripheral drug-coated balloons (P-DCB) have been used off-label for coronary ISR. Further data regarding this practice are needed. We aimed to describe outcomes in patients who underwent off-label P-DCB angioplasty for coronary ISR., Methods: We analyzed data on P-DCB angioplasty for coronary ISR at a single high-volume center between April 1, 2015, and December 30, 2017. Demographic and procedural details were collected, with systematic follow-up as clinically indicated., Results: Data from 31 patients treated with P-DCB angioplasty (mean age 68.0 ± 10.7 years) with coronary ISR (17 recurrent and 14 first time) were analyzed. Most patients presented with high-grade angina (81%) or myocardial infarction (13%). Treated ISR lesions were in native coronary arteries (68%), saphenous vein grafts (SVG, 23%), and the left internal mammary artery (10%). Diffuse intrastent ISR was common (69%) with a mean lesion length of 21.7 ± 12.4 mm. No postprocedural myocardial infarction occurred and 1 nonprocedural mortality occurred during index admission. At follow-up (median: 283, interquartile range [IQR]: 354 days), repeat angiography was performed in 19 patients (median: 212, IQR: 188 days), and 11 patients had target lesion recurrent ISR (Kaplan-Meier event-free survival estimate: 44.7%, 95% CI, 26.1%-76.5%)., Conclusions: In the absence of availability of dedicated coronary DCB, treatment of coronary ISR using P-DCB angioplasty was feasible, although follow-up demonstrated continued risk for recurrent ISR in this high-risk population., (© 2023 The Author(s).)

Background: Low stroke volume index <35 ml/m 2 despite preserved ejection fraction (paradoxical low flow [PLF]) is associated with adverse outcomes in patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). However, whether the risk associated with PLF is similar in both sexes is unknown., Objectives: The purpose of this study was to analyze the risk associated with PLF in severe aortic stenosis for men and women randomized to TAVR or SAVR., Methods: Patients with ejection fraction ≥50% from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were stratified by sex and treatment arm. The impact of PLF on the 2-year occurrence of the composite of death or heart failure hospitalization (primary endpoint) and of all-cause mortality alone (secondary endpoint) was analyzed. Analysis of variance was used to assess baseline differences between groups. Multivariate Cox regression analysis was used to identify predictors of the endpoint., Results: Out of 2,242 patients, PLF was present in 390 men and 239 women (30% vs 26%, P  = 0.06). PLF was associated with a higher rate of NYHA functional class III to IV dyspnea (60% vs 54%, P  < 0.001) and a higher prevalence of atrial fibrillation (39% vs 24%, P  < 0.001). PLF was a significant predictor of the primary endpoint among women undergoing SAVR in multivariate analysis (adjusted HR: 2.25 [95% CI: 1.14-4.43], P  = 0.02) but was not associated with a worse outcome in any of the other groups (all P  > 0.05)., Conclusions: In women with PLF, TAVR may improve outcomes compared to SAVR. PLF appears to have less impact on outcomes in men., Competing Interests: Statistical analyses were performed by employees of Edwards Lifesciences. Dr Carter-Storch has received a travel grant from AstraZeneca. 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, Edwards Lifesciences, Medtronic, and Novartis; and is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation. Dr Abbas has received research support from and consulting for Edwards Lifesciences. Dr Mack has served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic; no direct compensation for any of these activities. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and consulting/advisory board participation for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. Dr Clavel has received core laboratory contract with Edwards Lifesciences; and research grants with Edwards Lifesciences and Medtronic, both without direct compensation. The PARTNER trials were funded by Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

Background: Augmented reality (AR) guidance holds potential to improve transcatheter interventions by enabling visualization of and interaction with patient-specific 3-dimensional virtual content. Positioning of cerebral embolic protection devices (CEP) during transcatheter aortic valve replacement (TAVR) increases patient exposure to radiation and iodinated contrast, and increases procedure time. AR may enhance procedural guidance and facilitate a safer intervention., Objectives: The purpose of this study was to develop and test a novel AR guidance system with a custom user interface that displays virtual, patient-specific 3-dimensional anatomic models, and assess its intraprocedural impact during CEP placement in TAVR., Methods: Patients undergoing CEP during TAVR were prospectively enrolled and assigned to either AR guidance or control groups. Primary endpoints were contrast volume used prior to filter placement, times to filter placement, and fluoroscopy time. Postprocedure questionnaires were administered to assess intraprocedural physician experience with AR guidance., Results: A total of 24 patients presenting for TAVR were enrolled in the study (12 with AR guidance and 12 controls). AR guidance eliminated the need for aortic arch angiograms prior to device placement thus reducing contrast volume (0 mL vs 15 mL, P  < 0.0001). There was no significant difference in the time required for filter placement or fluoroscopy time. Postprocedure questionnaires indicated that AR guidance increased confidence in wiring of the aortic arch and facilitated easier device placement., Conclusions: We developed a novel AR guidance system that eliminated the need for additional intraprocedural angiograms prior to device placement without any significant difference in time to intervention and offered a subjective improvement in performance of the intervention., Competing Interests: This work was supported by the 10.13039/100000001National Science Foundation under Grant IIS-1514429 (S. Feiner, PI), the 10.13039/100000002National Institutes of Health under Grant 10.13039/100000050NHLBI: 5T35HL007616-37 (R. Leibel, PI), and Columbia University Vagelos College of Physicians and Surgeons under Dean’s Research Fellowships to S. Sadri, G. Loeb, and S. Sun. Alon Grinshpoon is Founder and Chief Executive Officer of echoAR, Inc., which is unrelated to the contents of this paper. Dr Khalique has received speaker fees from Edwards Lifesciences and has received consulting fees from Abbott Structural and Boston Scientific. Dr Einstein has served as a consultant to W. L. Gore and Associates; his institution receives funding from 10.13039/100000002NIH, International Atomic Energy Agency, 10.13039/100020498Canon Medical Systems USA, Roche Medical Systems, 10.13039/100020453W. L. Gore and Associates, and 10.13039/100006775GE Healthcare. Dr George has served as a consultant for Atricure, WL Gore, MitreMedical, VDyne, CardioMech, and Neptune Medical. Dr Hahn reports speaker fees from Edwards Lifescience; consulting for Abbott Vascular, Boston Scientific, Gore&Associates, Medtronic; Equity with Navigate; 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 Nazif has served as a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and BioTrace. Dr Leon has received institutional research support from 10.13039/100006520Edwards Lifesciences, 10.13039/100004374Medtronic, 10.13039/100008497Boston Scientific, and 10.13039/100000046Abbott; and has served on the consulting/Advisory Board for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott. Dr Kirtane has received institutional research support and personal fees from 10.13039/100004374Medtronic, 10.13039/100011949Abbott Vascular, 10.13039/100008497Boston Scientific, 10.13039/100020297Abiomed, CathWorks, 10.13039/100005333CSI, 10.13039/100004340Siemens, Philips, 10.13039/100015371ReCor Medical, and Spectranetics. Dr Kodali has received institutional research grants or honoraria from 10.13039/100006520Edwards Lifesciences, 10.13039/100008497Boston Scientific, 10.13039/100019998JenaValve, 10.13039/100004374Medtronic, and 10.13039/100000046Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options in Biotrace Medical, Thubrikar Aortic Valve, Inc., Dura Biotech, Microinterventional Devices, Supira, and Admedus. Dr Feiner serves on the Advisory Board for Contextere (New York, NY) and Infiniverse, Inc. (Wilmington, DE). Dr Vahl has received grant and research support from 10.13039/100006520Edwards Lifesciences, 10.13039/100004374Medtronic, 10.13039/100019998JenaValve Technology, and 10.13039/100015696Siemens Healthineers; and has received consulting fees from JenaValve, Siemens Healthineers, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

This consensus of nomenclature and classification for congenital bicuspid aortic valve and its aortopathy is evidence-based and intended for universal use by physicians (both pediatricians and adults), echocardiographers, advanced cardiovascular imaging specialists, interventional cardiologists, cardiovascular surgeons, pathologists, geneticists, and researchers spanning these areas of clinical and basic research. In addition, as long as new key and reference research is available, this international consensus may be subject to change based on evidence-based data1.

Background: Outcomes after percutaneous coronary intervention (PCI) for de novo ostial right coronary artery (RCA) lesions are poor., Aims: We used intravascular ultrasound (IVUS) to clarify the morphological patterns of de novo ostial RCA lesions and their associated clinical outcome., Methods: Among 5,102 RCA IVUS studies, 170 de novo ostial RCA stenoses (within 3 mm from the aorto-ostium) were identified. These were classified as 1) isolated ostial lesions (no disease extending beyond 10 mm from the ostium and without a calcified nodule [CN]); 2) ostial CN, typically with diffuse disease (disease extending beyond 10 mm); and 3) ostial lesions with diffuse disease but without a CN. The primary outcome was target lesion failure (TLF: cardiac death, target vessel myocardial infarction, definite stent thrombosis, and ischaemia-driven target lesion revascularisation)., Results: The prevalence of an isolated ostial lesion was 11.8% (n=20), 47.6% (n=81) were ostial CN, and 40.6% (n=69) were ostial lesions with diffuse disease. Compared to ostial lesions with diffuse disease, isolated lesions were more common in women (75.0% vs 42.0%; p=0.01), and CN were associated with older age (median [first, third quartile] 76 [70, 83] vs 69 [63, 81] years old; p=0.002). The Kaplan-Meier rate of TLF at 2 years was significantly higher in patients with CN (21.6%) compared to diffuse lesions (8.2%) (p=0.04), and patients with isolated lesions had no events. A multivariable Cox proportional hazard model revealed that CN were significantly associated with TLF (hazard ratio 6.63, 95% confidence interval: 1.28-34.3; p=0.02)., Conclusions: Ostial RCA lesions have specific morphologies - detectable by IVUS - that may be associated with long-term clinical outcomes.

Background: For patients with asymptomatic, severe aortic stenosis (AS) and preserved left ventricular ejection fraction, current guidelines recommend clinical surveillance every 6 to 12 months. To date, no randomized trials have examined whether an early intervention with transcatheter aortic valve replacement (TAVR) will improve outcomes among these patients., Study Design and Objectives: EARLY TAVR is a prospective, randomized, controlled, and multicenter trial, with an event-based design. Asymptomatic severe AS patients (n = 900) are randomized 1:1 to either clinical surveillance or TAVR with the Edwards SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve. Patients are stratified by whether they are able to perform a treadmill stress test. The primary end point is death, stroke, or unplanned cardiovascular hospitalization. Patients who are asymptomatic but have a positive stress test will be followed in a registry and undergo aortic valve replacement as per current guidelines., Conclusions: EARLY TAVR is the largest randomized trial to date assessing the role of early intervention among patients with asymptomatic severe AS compared to clinical surveillance and the first to study the role of TAVR., Trial Registration Number: NCT03042104., Competing Interests: Disclosure Philippe Généreux: Abbott Vascular: Consultant, advisor, speaker fees; Abiomed: Consultant, advisor, speaker fees; Boston Scientific: Consultant; CARANX Medical: Consultant; Cardiovascular System Inc: Consultant, PI eclipse trial; Edwards LifeSciences: Consultant, advisor, speaker fees, proctor, institutional research grant, PI EARLY-TAVR trial, PI PROGRESS trial; GE Healthcare: Consultant; iRhythm technologies: Consultant; Medtronic: Consultant, advisor, speaker fees; Opsens: Consultant; Pi-Cardia: Equity, consultant; puzzle medical: equity, consultant; Saranas: Equity, consultant; Shockwave: Consultant, speaker fees; Siemens: Consultant; Soundbite Medical Inc: Equity, consultant; Teleflex: Consultant; 4C medical: Consultant, PI feasibility study. Heather Prince and Yanglu Zhao are employees of Edwards Lifesciences. David J. Cohen: Research grant support from Edwards Lifesciences, Abbott, Boston Scientific. Consulting income from Edwards Lifesciences, Abbott, Boston Scientific, Medtronic. Brian Lindman: consulting payments and investigator-initiated research grants from Edwards Lifesciences. Philippe Pibarot: Institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Martin B. Leon: Institutional clinical research grants from Abbott, Boston Scientific, Edwards, and Medtronic. All other authors have no disclosures., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Despite the initial evidence supporting the utility of intravascular imaging to guide percutaneous coronary intervention (PCI), adoption remains low. Recent new trial data have become available. An updated study-level meta-analysis comparing intravascular imaging to angiography to guide PCI was performed. This study aimed to evaluate the clinical outcomes of intravascular imaging-guided PCI compared with angiography-guided PCI., Methods and Results: A random-effects meta-analysis was performed on the basis of the intention-to-treat principle. The primary outcomes were major adverse cardiac events, cardiac death, and all-cause death. Mixed-effects meta-regression was performed to investigate the impact of complex PCI on the primary outcomes. A total of 16 trials with 7814 patients were included. The weighted mean follow-up duration was 28.8 months. Intravascular imaging led to a lower risk of major adverse cardiac events (relative risk [RR], 0.67 [95% CI, 0.55-0.82]; P <0.001), cardiac death (RR, 0.49 [95% CI, 0.34-0.71]; P <0.001), stent thrombosis (RR, 0.63 [95% CI, 0.40-0.99]; P =0.046), target-lesion revascularization (RR, 0.67 [95% CI, 0.49-0.91]; P =0.01), and target-vessel revascularization (RR, 0.60 [95% CI, 0.45-0.80]; P <0.001). In complex lesion subsets, the point estimate for imaging-guided PCI compared with angiography-guided PCI for all-cause death was a RR of 0.75 (95% CI, 0.55-1.02; P =0.07)., Conclusions: In patients undergoing PCI, intravascular imaging is associated with reductions in major adverse cardiac events, cardiac death, stent thrombosis, target-lesion revascularization, and target-vessel revascularization. The magnitude of benefit is large and consistent across all included studies. There may also be benefits in all-cause death, particularly in complex lesion subsets. These results support the use of intravascular imaging as standard of care and updates of clinical guidelines.

Background: The safety and efficacy of coronary orbital atherectomy (OA) for treatment of ostial lesions are not yet fully established. We sought to evaluate (OA) treatment of severely calcified ostial and non-ostial lesions., Methods: A retrospective analysis of subjects treated with OA for severely calcified ostial and non-ostial lesions, at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) from January 2014 to September 2020, was completed. Study baseline characteristics, lesion and vessel characteristics, procedural outcomes, and in-hospital major adverse cardiovascular events (MACE) were analyzed and compared., Results: A total of 609 patients that underwent PCI with OA were identified. The majority of patients (81.9 %) had non-ostial lesions, while 16.6 % had ostial lesions (of which 2.8 % classified as aorto-ostial) and 1.5 % had unknown lesion anatomy. The mean age of the overall cohort was 74.0 ± 9.3 years, and 63.5 % were male. All patients received drug-eluting stent (DES) placement, and the overall freedom from MACE was 98.5 %, with no significant difference observed between the ostial and non-ostial groups. The freedom from cardiac death and MI was also similar between the two groups. There were low rates of bleeding complications and severe angiographic complications, and no persistent slow flow/no reflow was reported., Conclusions: This study demonstrated no significant differences in in-hospital MACE outcomes between patients with ostial versus non-ostial lesions, indicating that OA is a safe and effective treatment option for both lesion types, including those classified as aorto-ostial., Competing Interests: Declaration of competing interest NB, MBL, and AJK report receiving consulting fees from Cardiovascular Systems, Inc. (CSI). BJM is employed by and owns stock in CSI. No other potential conflict of interest relevant to this article was reported., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Aims: Obesity is causally related to the development of heart failure with preserved ejection fraction (HFpEF) but complicates the diagnosis and treatment of this disorder. We aimed to determine the relationship between severity of obesity and clinical, echocardiographic and haemodynamic parameters in a large cohort of patients with documented HFpEF., Methods and Results: The REDUCE LAP-HF II trial randomized 626 patients with ejection fraction ≥40% and exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg to atrial shunt or sham procedure. We tested for associations between body mass index (BMI), clinical characteristics, cardiac structural and functional abnormalities, physical limitations, quality of life and outcomes with atrial shunt therapy. Overall, 60.9% of patients had BMI ≥30 kg/m 2 . As the severity of obesity increased, symptoms (Kansas City Cardiomyopathy Questionnaire score) and 6-min walk distance worsened. More severe obesity was associated with lower natriuretic peptide levels despite more cardiac remodelling, higher cardiac filling pressures, and higher cardiac output. Lower cut points for E/e' were needed to identify elevated PCWP in more obese patients. Strain measurements in all four chambers were maintained as BMI increased. Pulmonary vascular resistance at rest and exercise decreased with higher BMI. Obesity was associated with more first and recurrent heart failure events. However, there was no significant interaction between obesity and treatment effects of the atrial shunt., Conclusions: Increasing severity of obesity was associated with greater cardiac remodelling, higher right and left ventricular filling pressures, higher cardiac output and increased subsequent heart failure events. Despite significant obesity, many HFpEF patients have preserved right heart and pulmonary vascular function and thus, may be appropriate candidates for atrial shunt therapy., (© 2023 European Society of Cardiology.)

Background: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients., Objectives: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR., Methods: The Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria., Results: A total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores., Conclusions: The early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function., Competing Interests: Funding Support and Author Disclosures This work was funded by Medtronic. Dr Zahr has received institutional grant support from Edwards Lifesciences and Medtronic. Dr Song has received consulting fees from Medtronic and Edwards Lifesciences. Dr Chadderdon has received consulting fees from Medtronic and Edwards Lifesciences; and grant support from Medtronic and GE Healthcare. Dr Gada has received consulting fees from Medtronic, Boston Scientific, and Bard Medical. Dr Mumtaz has received consulting fees and grant support from Medtronic and Edwards Lifesciences; and consulting fees from Z Medica and from the Japanese Organization for Medical Device Development. Dr Byrne has received consulting fees from Medtronic and Abbott Vascular. Dr Kirshner has received consulting fees from Medtronic. Dr Sharma has served as a proctor for Medtronic; and received research grant support from the Norton Healthcare Foundation. Dr Kodali has received consultant fees from Admedus and Dura Biotech; holds equity in Dura Biotech, Microinterventional Devices, Thubrika Aortic Valve, Supira, Admedus, TriFlo, and Anona; and has received institutional grant support from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr George has received consulting fees from Cardiomech, Mitremedical, Atricure, Zimmer Biomet, Durvena, and Valcare Medical. Dr Sorrajja has received grant support from Medtronic for participation in the Steering Committee of the APOLLO trial; and consulting fees from 4C Medical, Abbott Structural, Anteris, BioSense Webseter, Edwards Lifesciences, Foldax, Medtronic, Phillips, Shifamed, Siemens, vDyne, W.L. Gore xDOT. Dr Bapat has received personal fees for consultancy and speaker service from Medtronic; and served as a consultant for Edwards Lifesciences, 4C, and Boston Scientific. Dr Bajwa has received personal and institutional consulting fees from Medtronic. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. Dr Thaden has received institutional consulting fees from Medtronic and speaker fees from Edwards Lifesciences. Ms. Gearhart is an employee of Medtronic. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and consulting fees from Keystone, Pipeline, Valgen, and Venus. Dr Reardon has received institutional consulting fees from Medtronic, W.L. Gore & Associates, Boston Scientific, and Abbott Vascular. Dr Adams’s institution (Icahn School of Medicine at Mount Sinai) has received royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to the development of valve repair rings; and he has served as the national co-principal investigator of the Medtronic APOLLO Food and Drug Administration pivotal trial, the NeoChord ReChord Food and Drug Administration pivotal trial, the Medtronic CoreValve US pivotal trial, and the Abbott TRILUMINATE pivotal trial. Dr Mack has served as a trial co-principal investigator for Abbott Vascular; as the study chair for Medtronic; and as a trial co–principal investigator for Edwards Lifesciences (both personal and institutional). Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)