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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.)

Background: New postprocessing software facilitates 3-dimensional (3D) echocardiographic determination of mitral annular (MA) and neo-left ventricular outflow tract (neo-LVOT) dimensions in patients undergoing transcatheter mitral valve replacement (TMVR)., Objectives: This study aims to test the accuracy of 3D echocardiographic analysis as compared to baseline computed tomography (CT)., Methods: A total of 105 consecutive patients who underwent TMVR at 2 tertiary care centers between October 2017 and May 2023 were retrospectively included. A virtual valve was projected in both baseline CT and 3D transesophageal echocardiography (TEE) using dedicated software. MA dimensions were measured in baseline images and neo-LVOT dimensions were measured in baseline and postprocedural images. All measurements were compared to baseline CT as a reference. The predicted neo-LVOT area was correlated with postprocedural peak LVOT gradients., Results: There was no significant bias in baseline neo-LVOT prediction between both imaging modalities. TEE significantly underestimated MA area, perimeter, and medial-lateral dimension compared to CT. Both modalities significantly underestimated the actual neo-LVOT area (mean bias pre/post TEE: 25.6 mm 2 , limit of agreement: -92.2 mm 2 to 143.3 mm 2 ; P < 0.001; mean bias pre/post CT: 28.3 mm 2 , limit of agreement: -65.8 mm 2 to 122.4 mm 2 ; P = 0.046), driven by neo-LVOT underestimation in the group treated with dedicated mitral valve bioprosthesis. Both CT- and TEE-predicted-neo-LVOT areas exhibited an inverse correlation with postprocedural LVOT gradients (r 2  = 0.481; P < 0.001 for TEE and r 2  = 0.401; P < 0.001 for CT)., Conclusions: TEE-derived analysis provides comparable results with CT-derived metrics in predicting the neo-LVOT area and peak gradient after TMVR., Competing Interests: Funding Support and Author Disclosures Dr Bartkowiak has received grants from Novartis Foundation. Dr Windecker has received grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson and Johnson, Medalliance, Medicure, Medtronic, Merck Sharp and Dohm, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and has been a member of a steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr George has received consulting fees from Zimmer Biomet, Atricure, Neosurgery, Neptune Medical, Abbvie, Johnson and Johnson, Durvena, Boston Scientific, Edwards Lifesciences, Medtronic, Help-TheraX, 3ive, Encompass, Summus Medical, Abbott SJM, BCI, and Xeltis; has been on advisory boards for Edwards Surgical, Medtronic Surgical, Medtronic Structural Mitral and Tricuspid, Trisol Medical, Valcare Medical, Durvena, Abbvie, Johnson and Johnson, Foldax Medical, Zimmer Biomet, Neosurgery, Abbvie, Boston Scientific, Summus Medical, BCI Equity: 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 Kodali has received institutional 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 Praz has been compensated for travel expenses from Edwards Lifescicences, Abbott Vascular, Medira, Polares Medical, and Siemens Healthineers. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and the 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. 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: Limited data exist on strain changes after transcatheter aortic valve implantation (TAVI) in patients with aortic regurgitation (AR)., Case Summary: Three patients with AR undergoing TAVI showed an initial reduction in global longitudinal strain (GLS), followed by sustained GLS improvement within the first year., Discussion: Findings align with those of surgically treated patients with AR. There is a possible superiority of GLS to left ventricular end-diastolic diameter ratio in assessing patients with severe volume overload., Competing Interests: Conflict of interest: J.B. reports research grant from the Novartis Foundation. I.G. reports the following disclosures: consultant (honoraria)—Zimmer Biomet, Atricure, Neosurgery, Neptune Medical, Abbvie, Johnson & Johnson, Durvena, Boston Scientific, Edwards Lifesciences, Medtronic, Help-TheraX, 3ive, Encompass, Summus Medical, Abbott SJM, BCI, and Xeltis Advisory Boards: Edwards Surgical, Medtronic Surgical, Medtronic Structural Mitral and Tricuspid, Trisol Medical, Valcare Medical, Durvena, Abbvie, Johnson & Johnson, Foldax Medical, Zimmer Biomet, Neosurgery, Abbvie, Boston Scientific, Summus Medical, and BCI Equity: Valcare Medical, Durvena, CardioMech, Vdyne, MitreMedical, MITRx, and BCI institutional funding to Columbia University: Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. S.K. reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott, consulting fees from Abbott, Admedus, and Meril Lifesciences, and equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. T.P.V. reports institutional funding to the Columbia University Irving Medical Center from Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic, and he personally received consulting fees from Abbott Vascular, 4C Medical, and Philips. 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., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

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.)

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: 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: 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.)

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: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure., Aims: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV)., Methods: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV., Results: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69)., Conclusions: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

Transcatheter aortic valve replacement (TAVR) generates significant debris, and strategies to mitigate cerebral embolization are needed. The novel Emboliner embolic protection catheter (Emboline, Inc., Santa Cruz, California) is designed to capture all particles generated during TAVR. This first-in-human study sought to assess the safety and feasibility of the device and to characterize the distribution and histopathology of the debris generated during TAVR. The SafePass 2 study was a prospective, nonrandomized, multicenter, single-arm investigation of the Emboliner device. Primary end points included 30-day major adverse cardiac and cerebrovascular events (MACCE) and technical performance. Computed tomography angiography was analyzed by an independent core laboratory, and filters were sent for histopathology of captured debris. Predictors of particle number were identified using >150 µm and >500 µm size thresholds. Of 31 subjects enrolled, technical success was 100%, and 30-day MACCE was 6.5% (2 cerebrovascular accidents, with 1 attributed to subtherapeutic dosing of rivaroxaban along with atrial fibrillation and the other to possible previous small ischemic strokes on magnetic resonance imaging; neither MACCE event had a causal relation to the Emboliner). All filters contained debris, with a median of 191.0 particles >150 µm and 14.0 particles >500 µm. Histopathology revealed mostly acute thrombus and valve or arterial tissue with lesser amounts of calcified tissue. A history of atrial fibrillation predicted a greater number of particles >500 µm (p = 0.0259) and its presence on admission was associated with 4.1 times more particles >150 µm (p = 0.0130) and 8.1 times more particles >500 µm (p = 0.0086). Self-expanding valves were associated with twice the number of particles >150 µm (p = 0.0281). TASK score was positively correlated with number of particles >500 µm (p = 0.0337). The Emboliner device was safe and feasible. Emboli after TAVR appear more numerous than previously documented. Atrial fibrillation, higher TASK score, and self-expanding valve use conferred higher embolic burden. Notably, none of the tested computed tomography angiography features were able to identify with higher embolic risk. Larger-scale studies are needed to identify high-risk patients for selective embolic protection device use., Competing Interests: Declaration of Competing Interest Dr. Ahmad is a consultant for Cardiovascular Systems Inc and Shockwave; and serves on the medical advisory board of Boston Scientific. Dr. Leipsic serves at Institutional Core Lab - Edwards, Medtronic, Boston Scientific, Abbott, and Pi-Cardia. Dr. Blanke is a consultant to Edwards Lifesciences and LARALAB; Institutional Core Lab – Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, and Pi-Cardia. Dr. Webster receives institutional research funding – Emboline Inc. Dr. Nazif receives consulting fees or honoraria from Medtronic, Boston Scientific, and EnCompass Technologies. Dr. Parise receives consulting fees – Intact Vascular, Inc. (now Philips Image Guided Therapy), TriReme Medical LLC, and Veryan Medical Ltd. Dr. Lansky receives consulting fees from Med Alliance. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Lack of standardization in posttranscatheter aortic valve replacement (TAVR) conduction disturbance (CD) identification and treatment may affect permanent pacemaker implantation (PPI) rates and clinical outcomes. The safety and efficacy of a standardized TAVR CD algorithm has not been analyzed. This study analyzes the Optimize PRO post-TAVR CD management algorithm with Evolut PRO/PRO + valves., Methods: Optimize PRO is a prospective, postmarket study implementing 2 strategies to reduce pacemaker rates: TAVR with cusp overlap technique and a post-TAVR CD algorithm. The 2-hour postprocedural electrocardiogram (ECG) stratified patients to early discharge in the absence of new ECG changes or to CD algorithms for (1) ECG changes with preexisting right or left bundle branch block (LBBB), interventricular conduction delay or first-degree atrioventricular block, (2) new LBBB, or (3) high-degree atrioventricular block (HAVB)., Results: The interim analysis of the CD cohort consisted of 125/400 TAVR recipients. In the CD cohort, the 30-day new PPI rate was higher (28.1% vs 1.5%; P <.001), and 60 (48%) patients were discharged with a 30-day continuous ECG monitor. At 30 days, 90% of patients discharged with a monitor did not require PPI. Clinical outcomes, including mortality, stroke, bleeding, and reintervention, were similar in patients with and without CDs. No patient experienced sudden cardiac death., Conclusions: Effective management of CDs using a standard algorithm following Evolut TAVR provides similar 30-day safety outcomes to patients without CDs who undergo routine next day discharge. The CD algorithm may provide an effective strategy to recognize arrhythmias early, improve PPI utilization, and facilitate safe monitoring of patients after discharge., (© 2023 The Author(s).)

Background: Despite a high rate of in-stent restenosis (ISR) after stenting the right coronary artery (RCA) ostium, the mechanism of ostial RCA ISR is not well understood., Aims: We aimed to clarify the cause of ostial RCA ISR using intravascular ultrasound (IVUS)., Methods: Overall, 139 ostial RCA ISR lesions were identified with IVUS, pre-revascularisation. Primary ISR mechanisms were classified as follows: 1) neointimal hyperplasia (NIH); 2) neoatherosclerosis; 3) ostium not covered by the stent; 4) stent fracture or deformation; 5) stent underexpansion (old minimum stent area <4.0 mm 2 or stent expansion <50%); or 6) a protruding calcified nodule., Results: The median duration from prior stenting was 1.2 (first quartile 0.6, third quartile 3.1) years. The primary mechanisms of ISR were NIH in 25% (n=35) of lesions, neoatherosclerosis in 22% (n=30), uncovered ostium in 6% (n=9) (biological cause 53%, n=74), stent fracture or deformation in 25% (n=35), underexpansion in 11% (n=15), and protruding calcified nodules in 11% (n=15) (mechanical cause 47%, n=65). Including secondary mechanisms, 51% (n=71) of ostial RCA ISRs had stent fractures that were associated with greater hinge motion of the ostial-aorta angle during the cardiac cycle. The Kaplan-Meier rate of target lesion failure at 1 year was 11.5%. When the mechanically caused ISRs were treated without new stents, they suffered a higher subsequent event rate (41.4%) compared with non-mechanical causes or mechanical causes treated without restenting (7.8%, unadjusted hazard ratio 6.44, 95% confidence interval: 2.33-17.78; p<0.0001)., Conclusions: Half of the ostial RCA ISRs were due to mechanical causes. Subsequent event rates were high, especially in mechanically caused ISRs treated without the implantation of a new stent.

Background: Valve-in-valve (VIV) transcatheter aortic valve implantation (TAVI) is a less invasive therapeutic option compared with redo surgical valve replacement for high-risk patients. Relative to procedures within stented surgical valves, VIV-TAVI within stentless valves is associated with a higher complication rate due to challenging underlying anatomy and absence of fluoroscopic landmarks., Aims: We share a single-center experience with VIV-TAVI in stentless valves, discussing our procedural insights and associated outcomes., Methods: Our institutional database was queried, and 25 patients who had undergone VIV-TAVI within a stentless bioprosthesis, homograft, or valve-sparing aortic root replacement between 2013 and 2022 were found. Outcome endpoints were based on the Valve Academic Research Consortium-3 criteria., Results: The mean age of the cohort was 69.5 ± 13.6 years. VIV implantation was performed within a homograft in 11 patients, a stentless bioprothesis in 10 patients, and a valve-sparing aortic root replacement in 4 patients. Nineteen (76%) balloon-expandable valves, 5 (20%) self-expanding valves, and one mechanically-expandable (4%) valve were implanted with 100% procedural success, with no instances of significant paravalvular leak, coronary occlusion, or device embolization. There was one (4%) in-hospitality mortality after an emergency procedure; one (4%) patient experienced a transient ischemic attack; and two (8%) patients required permanent pacemaker implantation. The median length of hospital stay was 2 days. After a median follow-up time of 16.5 months, valve function was acceptable in all patients with available data., Conclusion: VIV-TAVI within stentless valves can be safely performed with methodical procedural technique and can provide clinical benefit in patients at high reoperation risk., (© 2023 Wiley Periodicals LLC.)

Background: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown., Objectives: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology., Methods: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery., Results: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years., Conclusions: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes., Competing Interests: Funding Support and Author Disclosures Dr Bhadra has received travel compensation from Edwards Lifesciences. Dr Tagliari has received research support from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. Dr Leurent has been a consultant and physician proctor for and has received speaker honoraria from Abbott. Dr Asgar has been a consultant for Medtronic, Abbott, Edwards Lifesciences, and W. L. Gore & Associates; and has received research grants from Abbott. Dr Leroux has been a physician proctor for Medtronic and Abbott; and a consultant for Edwards Lifesciences. Dr Dumonteil has received speaker honoraria and travel reimbursement by Edwards Lifesciences; and has been a physician proctor and consultant for Edwards Lifesciences. Dr Geirsson has been a member of the Medtronic Strategic Surgical Advisory Board. Dr Wyler von Ballmoos has served as a consultant for LivaNova, Medtronic, and Boston Scientific. Dr Reardon has been a consultant for Medtronic, Boston Scientific, Abbott, and W. L. Gore & Associates. Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Nazif has equity in Venus Medtech; and has received consulting fees or honoraria from Keystone Heart, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Kaneko has been a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and has been a consultant for 4C Medical. Dr Modine has been a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has been a consultant for InnovHeart. Dr Tang has been a physician proctor for Medtronic; a consultant for Medtronic, Abbott, and NeoChord; and a physician advisory board member for Abbott, Boston Scientific and JenaValve; and has received speaker honoraria from Siemens Healthineers and East End Medical. 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.)

Aims: Paravalvular regurgitation (PVR) after transcatheter aortic valve implantation (TAVI) is associated with increased morbidity and mortality. The effect of transcatheter interventions to treat PVR after the index TAVI was investigated., Methods and Results: A registry of consecutive patients who underwent transcatheter intervention for ≥ moderate PVR after the index TAVI at 22 centers. The principal outcomes were residual aortic regurgitation (AR) and mortality at 1 year after PVR treatment. A total of 201 patients were identified: 87 (43%) underwent redo-TAVI, 79 (39%) plug closure, and 35 (18%) balloon valvuloplasty. Median TAVI-to-re-intervention time was 207 (35; 765) days. The failed valve was self-expanding in 129 (63.9%) patients. The most frequent devices utilized were a Sapien 3 valve for redo-TAVI (55, 64%), an AVP II as plug (33, 42%), and a True balloon for valvuloplasty (20, 56%). At 30 days, AR ≥ moderate persisted in 33 (17.4%) patients: 8 (9.9%) after redo-TAVI, 18 (25.9%) after plug, and 7 (21.9%) after valvuloplasty (P = 0.036). Overall mortality was 10 (5.0%) at 30 days and 29 (14.4%) at 1 year: 0, 8 (10.1%), and 2 (5.7%) at 30 days (P = 0.010) and 11 (12.6%), 14 (17.7%), and 4 (11.4%) at 1 year (P = 0.418), after redo-TAVI, plug, and valvuloplasty, respectively. Regardless of treatment strategy, patients in whom AR was reduced to ≤ mild had lower mortality at 1 year compared with those with AR persisting ≥ moderate [11 (8.0%) vs. 6 (21.4%); P = 0.007]., Conclusion: This study describes the efficacy of transcatheter treatments for PVR after TAVI. Patients in whom PVR was successfully reduced had better prognosis. The selection of patients and the optimal PVR treatment modality require further investigation., Competing Interests: Conflict of interest J.G.W.: consultant to, and has received research funding from, Edwards Lifesciences, Abbott Vascular, and Boston Scientific. W-K.K.: proctor or speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, Medtronic, Meril Life Sciences. M.A-W.: received speaker's honoraria and/or consultancy fees on his behalf from Boston Scientific and Medtronic. M.B.: consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. L.S.: consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. C.H.: Advisory Board Medtronic. J.M. Sinning: speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. J.S.: consultant to Edwards Lifesciences. M. Andreas: proctor/consultant/speaker for Edwards, Abbott, and Medtronic, received institutional grants (Edwards, Abbott, Medtronic, and LSI). Dr. M. Guerrero: research grant support from Abbott Vascular and Edwards Lifesciences. F. Castriota: proctor for Medtronic and Boston Scientific. T.N.: consulting or honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Consulting and equity with Venus MedTech. T.P.: research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; speaker fees/consultancy fees from Boston Scientific, Medtronic, Abbott, Biotronik, and HighLife SAS. V.C. Babaliaros: consultant to Edwards Lifesciences and equity in transmural system. M.M.: consultant fee from Abbott, Boston, Kardia, and Medtronic. N.V.M.: institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi Sankyo, and PulseCath BV and institutional research grant support from Edwards Lifesciences. A.L.: institutional research/grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and personal consulting honoraria from Abbott, Edwards Lifesciences and Medtronic. D.H-S.: proctor and advisory to Boston, Medtronic, Edwards Lifesciences, and Abbott. R.M. received grant support from Edwards Lifesciences Corporation; he is a consultant for Abbott Vascular, Cordis, and Medtronic and holds equity in Entourage Medical. All other authors have no conflict of interest to report in relation with this manuscript., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The extent of extravalvular cardiac damage is associated with increased risk of adverse events among patients with severe aortic stenosis undergoing aortic valve replacement (AVR)., Objectives: The goal was to describe the association of cardiac damage on health status before and after AVR., Methods: Patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by echocardiographic cardiac damage stage at baseline and 1 year as previously described (stage 0-4). We examined the association between baseline cardiac damage and 1-year health status (assessed by the Kansas City Cardiomyopathy Questionnaire Overall Score [KCCQ-OS])., Results: Among 1,974 patients (794 surgical AVR, 1,180 transcatheter AVR), the extent of cardiac damage at baseline was associated with lower KCCQ scores both at baseline and at 1 year after AVR (P < 0.0001) and with increased rates of a poor outcome (death, KCCQ-OS <60, or a decrease in KCCQ-OS of ≥10 points) at 1 year (stages 0-4: 10.6% vs 19.6% vs 29.0% vs 44.7% vs 39.8%; P < 0.0001). In a multivariable model, each 1-stage increase in baseline cardiac damage was associated with a 24% increase in the odds of a poor outcome (95% CI: 9%-41%; P = 0.001). Change in stage of cardiac damage at 1 year after AVR was associated with the extent of improvement in KCCQ-OS over the same period (mean change in 1-year KCCQ-OS: improvement of ≥1 stage +26.8 [95% CI: 24.2-29.4] vs no change +21.4 [95% CI: 20.0-22.7] vs deterioration of ≥1 stage +17.5 [95% CI: 15.4-19.5]; P < 0.0001)., Conclusions: The extent of cardiac damage before AVR has an important impact on health status outcomes, both cross-sectionally and after AVR. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A), NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B [PARTNERII B], NCT02184442; PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3], NCT02675114)., Competing Interests: Funding Support And Author Disclosures The PARTNER 2 and PARTNER 3 Trials were sponsored by Edwards Lifesciences (Irvine, California). Dr Généreux has served as a consultant for Abbott Vascular, Abiomed, BioTrace Medical, Boston Scientific, CARANX Medical, Cardiovascular System Inc (PI Eclipse Trial), Edwards Lifesciences (PI EARLY-TAVR trial, PI PROGRESS trial), GE Healthcare, iRhythm Technologies, Medtronic, Opsens, Pi-Cardia, Puzzle Medical, Saranas, Shockwave, Siemens, Soundbite Medical Inc, Teleflex, and 4C Medical (PI feasibility study); has served as an advisor for Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, and Medtronic; has received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, Edwards Lifesciences, Medtronic, and Shockwave; has served as a proctor for and received an institutional research grant from Edwards Lifesciences; and has equity in Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc. 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. The Cardiovascular Research Foundation (Drs Redfors, Cohen, Alu, Hahn, and Lyon) receives research funding from Edwards Lifesciences (no direct compensation). Dr Bax reports that the Department of Cardiology (LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific; and has received speaker fees from Abbott Vascular. Drs Zhao and Prince are employees of Edwards Lifesciences. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St Jude Medical; and has received consultant fees/honoraria from and served on the speaker’s bureau for Abbott Vascular, Cordis Corporation, and Medtronic. Dr Thourani is on the advisory board of Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Mack served as co-primary investigator for the PARTNER Trial for Edwards Lifesciences; served as co-primary investigator for the COAPT trial for Abbott; and served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Lindman has served on the scientific advisory board for Roche Diagnostics; and has received research grants from Edwards Lifesciences and Roche Diagnostics. Dr Babaliaros has received consulting fees from Edwards Lifesciences and Abbott. Dr Russo has received grants from Edwards Lifesciences; and has served as a consultant for Abbott, Boston Scientific, and Edwards Lifesciences. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. Dr Gillam has served as a consultant for Edwards Lifesciences; and has core lab contracts with Edwards Lifesciences and Medtronic. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifescience; has institutional consulting agreements for which she receives no direct compensation with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has equity with Navigate; and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. Dr Webb is a consultant for Edwards Lifesciences. Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (non-paid); and has received institutional research grants from and has served as a nonpaid advisor for Abbott, Boston Scientific, and Medtronic; has served as a nonpaid advisor for Sinomed; and has equity in Medinol. Dr Cohen has received research grant support and consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. 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.)

Background: The COVID-19 pandemic and iodinated contrast shortage may have affected interventional cardiology (IC) fellowship training., Objectives: The aim of this study was to investigate the educational experience of first-year IC fellows in the United States and Canada., Methods: A 59-question online survey was conducted among 2021-2022 first-year IC fellows in the United States and Canada., Results: Of the 360 IC fellows invited to participate, 111 (31%) responded; 95% were from the United States, and 79% were men. Participants were mostly from university programs (70%), spent 61 to 70 hours/week in the hospital, and had an annual percutaneous coronary intervention case number of <200 (5%), 200 to 249 (8%), 250 to 349 (33%), 350 to 499 (39%), 500 to 699 (12%), or ≥700 (3%). For femoral access, a micropuncture needle was used regularly by 89% and ultrasound-guided puncture by 81%, and 43% used vascular closure devices in most cases (>80%). Intravascular ultrasound was performed and interpreted very comfortably by 62% and optical coherence tomography (OCT) by 32%, and 20% did not have access to OCT. Approximately one-third felt very comfortable performing various atherectomy techniques. Covered stents, fat embolization, and coil embolization were used very comfortably by 14%, 4%, and 3%, respectively. Embolic protection devices were used very comfortably by 11% to 24% of IC fellows. Almost one-quarter of fellows (24%) were warned about their high radiation exposure. Eighty-four percent considered IC fellowship somewhat or very stressful, and 16% reported inadequate psychological support., Conclusions: This survey highlights opportunities for improvement with regard to the use of intravascular imaging, atherectomy techniques, complication prevention and management strategies, radiation awareness and mitigation, and psychological support., Competing Interests: Funding Support and Author Disclosures The authors are grateful for the philanthropic support of their generous anonymous donors and the philanthropic support of Drs Mary Ann and Donald A. Sens, Mrs Diane and Dr Cline Hickok, Mrs Wilma and Mr Dale Johnson, the Mrs Charlotte and Mr Jerry Golinvaux Family Fund, the Roehl Family Foundation, and the Joseph Durda Foundation. The generous gifts of these donors to the Minneapolis Heart Institute Foundation’s Science Center for Coronary Artery Disease helped support this research project. Dr Azzalini has received honoraria from Teleflex, Abiomed, Asahi Intecc, Philips, GE Healthcare, Abbott Vascular, and Cardiovascular Systems. Dr Sandoval previously served on the advisory boards for Roche Diagnostics and Abbott Diagnostics without personal compensation; and has been a speaker without personal financial compensation for Abbott Diagnostics. Dr Brilakis has received consulting and speaker honoraria from Abbott Vascular, the American Heart Association (associate editor, Circulation), Amgen, Asahi Intecc, Biotronik, Boston Scientific, the Cardiovascular Innovations Foundation (Board of Directors), ControlRad, Cardiovascular Systems, Elsevier, GE Healthcare, Interventional Medical Device Solutions, InfraRedx, Medicure, Medtronic, Opsens, Siemens, and Teleflex; is an owner of Hippocrates; and is a shareholder in MHI Ventures and Cleerly Health. 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.)

Loss-of-function CYP2C19 variants are associated with increased cumulative ischemic outcomes warranting CYP2C19 genotyping prior to clopidogrel administration. TAILOR-PCI was an international, multicenter (40 sites), prospective, randomized trial comparing rapid point of care (POC) genotype-guided vs. conventional anti-platelet therapy. The performance of buccal-based rapid CYP2C19 genotyping performed by non-laboratory-trained staff in TAILOR-PCI was assessed. Pre-trial training and evaluation involved rapid genotyping of 373 oral samples, with 99.5% (371/373) concordance with Sanger sequencing. During TAILOR-PCI, 5302 patients undergoing PCI were randomized to POC rapid CYP2C19 *2, *3, and *17 genotyping versus no genotyping. At 12 months post-PCI, TaqMan genotyping determined 99.1% (2,364/2,385) concordance with the POC results, with 90.7-98.8% sensitivity and 99.2-99.6% specificity. In conclusion, non-laboratory personnel can be successfully trained for on-site instrument operation and POC rapid genotyping with analytical accuracy and precision across multiple international centers, thereby supporting POC genotyping in patient-care settings, such as the cardiac catheterization laboratory.Clinical Trial Registration: https://www.clinicalTrials.gov (Identifier: NCT01742117)., (© 2022. The Author(s), under exclusive licence to Springer Nature Limited.)

Background: Although the presence of severe stenosis in the left main coronary artery (LMCA) is a well-established predictor of mortality, whether this extends to nonobstructive atherosclerosis in the LMCA is unknown., Objectives: The aim of this study was to evaluate the association between LMCA disease by intravascular ultrasound (IVUS) and long-term mortality., Methods: Between 2005 and 2013, 3,239 patients with LMCA IVUS imaging without LMCA revascularization (either before angiography or scheduled based on index angiography or IVUS) were included. The primary and secondary endpoints were all-cause and cardiac mortality at a minimum of 5 years obtained from the National Death Index., Results: The IVUS-measured LMCA minimum lumen area (MLA) and plaque burden were 13.1 ± 5.0 mm 2 and 41.7% ± 15.6%, respectively. The median follow-up was 8.2 years. The Kaplan-Meier estimated 12-year all-cause and cardiac death rates were 37.5% and 17.0%, respectively. Greater plaque burden (unadjusted HR per 10%: 1.17; 95% CI: 1.12-1.22; P < 0.0001) and smaller IVUS MLA (unadjusted HR per 1 mm 2 : 0.98; 95% CI: 0.96-0.99; P = 0.0008) were associated with all-cause death. After adjusting for clinical, angiographic, and IVUS factors, plaque burden (adjusted HR per 10%: 1.12; 95% CI: 1.04-1.21; P = 0.003) but not MLA (adjusted HR per 1 mm 2 : 1.02; 95% CI: 0.99-1.04; P = 0.18) was associated with long-term all-cause death. These findings were also consistent for long-term cardiac mortality., Conclusions: In the present large-scale study with a 12-year follow-up, increasing LMCA plaque burden was associated with long-term all-cause and cardiac mortality in patients not undergoing LMCA revascularization, even when the lumen area was preserved., Competing Interests: Funding Support and Author Disclosures This work was supported in part by an unrestricted grant from Boston Scientific. Dr Matsumura is a consultant for Terumo Corporation. Dr Ali has received a grant from Abbott Vascular and Cardiovascular Systems Inc, is a consultant for Amgen, AstraZeneca, and Boston Scientific; and has equity in Shockwave. Dr Karmpaliotis has received honoraria from Boston Scientific and Abbott Vascular; has equity in Saranas Soundbite and Traverse Vascular. Dr Parikh has provided research for Abbott, Boston Scientific, Surmodics, TriReme, Shockwave, and Veryan Medical; is on the advisory board for Abbott, Boston Scientific, Cordis, Medtronic, Cardiovascular Systems Inc, and Philips; and is a consultant for Inari, Penumbra, Terumo, and Abiomed. Dr Leon has received institutional clinical research grants from Abbott Vascular, Boston Scientific, and Medtronic. Dr Stone is a speaker or has received other honoraria from Cook and Infraredx; is a consultant for Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Reva, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and MedFocus family of funds. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems Inc, Siemens, Philips, ReCor Medical, and Neurotronic; has received institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content; has received consulting fees from interventional Medical Device Solutions; and has received travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems Inc, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr Mintz has received honoraria from Boston Scientific, Philips, Abiomed, and Medtronic. Dr Maehara has received research grants from Boston Scientific, Abbott Vascular, Consultant, Boston Scientific, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases)., Methods: Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation., Results: Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV., Conclusions: This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: The impact of aortic valve replacement (AVR) on progression/regression of extravalvular cardiac damage and its association with subsequent prognosis is unknown., Objectives: The purpose of this study was to describe the evolution of cardiac damage post-AVR and its association with outcomes., Methods: Patients undergoing transcatheter or surgical AVR from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by cardiac damage stage at baseline and 1 year (stage 0, no damage; stage 1, left ventricular damage; stage 2, left atrial or mitral valve damage; stage 3, pulmonary vasculature or tricuspid valve damage; and stage 4, right ventricular damage). Proportional hazards models determined association between change in cardiac damage post-AVR and 2-year outcomes., Results: Among 1,974 patients, 121 (6.1%) were stage 0, 287 (14.5%) stage 1, 1,014 (51.4%) stage 2, 412 (20.9%) stage 3, and 140 (7.1%) stage 4 pre-AVR. Two-year mortality was associated with extent of cardiac damage at baseline and 1 year. Compared with baseline, cardiac damage improved in ∼15%, remained unchanged in ∼60%, and worsened in ∼25% of patients at 1 year. The 1-year change in cardiac damage stage was independently associated with mortality (adjusted HR for improvement: 0.49; no change: 1.00; worsening: 1.95; P = 0.023) and composite of death or heart failure hospitalization (adjusted HR for improvement: 0.60; no change: 1.00; worsening: 2.25; P < 0.001) at 2 years., Conclusions: In patients undergoing AVR, extent of extravalvular cardiac damage at baseline and its change at 1 year have important prognostic implications. These findings suggest that earlier detection of aortic stenosis and intervention before development of irreversible cardiac damage may improve global cardiac function and prognosis. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk [PII A], NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B [PARTNERII B], NCT02184442; and PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3], NCT02675114)., Competing Interests: Funding Support and Author Disclosures The PARTNER II and PARTNER 3 Trials were Sponsored by Edwards Lifesciences. Dr Généreux has served as a consultant for, advisor for, and received speaker fees from Abbott Vascular, Abiomed, BioTrace Medical, and Medtronic; has served as a consultant for Boston Scientific, CARANX Medical, GE Healthcare, iRhythm Technologies, Opsens, Teleflex, and Siemens; has served as a consultant and PI for the Eclipse Trial for Cardiovascular System Inc; has served as a consultant, advisor, and proctor, and received speaker fees and institutional research grants for PI EARLY-TAVR and PI PROGRESS trials from Edwards Lifesciences; has received equity from and served as a consultant for Pi-Cardia, Puzzle Medical, Saranas, and Soundbite Medical Inc; has served as a consultant for and received speaker fees from Shockwave; and has served as consultant for and PI of the Feasibility study for 4C Medical. 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. The Cardiovascular Research Foundation (Drs Redfors, Vincent, Alu, Hahn, Leon, and Cohen) receives research funding from Edwards Lifesciences (no direct compensation). Dr Bax’s department (Department of Cardiology, LUMC, the Netherlands) has received research grants from Medtronic, Biotronik, Edwards Lifesciences, and Boston Scientific; and he has received speaker fees from Abbott Vascular. Dr Zhao is an employee of Edwards Lifesciences. Dr Makkar has received grant support/research contracts from Edwards Lifesciences and St. Jude Medical; and has received consultant fees/honoraria from/served on the speaker's bureau for Abbott Vascular, Cordis Corporation, and Medtronic. Dr Thourani has served on the Advisory Board of Edwards Lifesciences, Abbott Vascular, Atricure, Cryolife, Jenavalve, Shockwave, and Boston Scientific. Dr Mack has served as coprimary investigator for the PARTNER Trial for Edwards Lifesciences and COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic (all activities unpaid). Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Lindman has served on the Scientific Advisory Board for Roche Diagnostics; and has received research grants from Edwards Lifesciences and Roche Diagnostics. Dr Babaliaros has received consulting fees from Edwards Lifesciences and Abbott. Dr Russo has received grants from Edwards Lifesciences; and has served as a consultant for Abbott, Boston Scientific, and Edwards Lifesciences. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. Dr Gillam has served as a consultant for Edwards Lifesciences; and has received core laboratory contracts from Edwards Lifesciences and Medtronic. Dr Hahn has received speaker fees from Abbott Vascular, Baylis Medical, and Edwards Lifesciences; has institutional consulting agreements for which she receives no direct compensation with Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; has equity with Navigate; and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation. Dr Webb is a consultant for Edwards Lifesciences. Dr Leon serves on the PARTNER Trial Executive Committee for Edwards Lifesciences (nonpaid); has received institutional research grants from and is a nonpaid advisor for Abbott, Boston Scientific, and Medtronic; has served as a nonpaid advisor for Sinomed; and has equity in Medinol. Dr Cohen has received research grant support and consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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

Purpose: This study quantitatively evaluated the phasic right heart morphology of candidate patients for a transcatheter tricuspid valve intervention (N=32) and of subjects with trace to no tricuspid regurgitation (N = 14)., Methods: Cardiac computed tomography angiography (CCTA) and transthoracic/transesophageal echocardiography (TTE/TEE) images were analyzed using dedicated research and clinical software. Using CCTA, the phasic right atrial and ventricular volumes, annulus dimensions, annulus-to-right coronary artery (RCA) distances, circumferential topography of the annular tissue shelf, vena cava dimensions (inferior and superior), vena cava positions, axis angles, and annular excursions were quantified. Using TTE/TEE, leaflet geometry, regurgitation, hemodynamics, and heart function were quantified. Measurements within and between groups were quantitatively compared with regression analyses to explore relationships between right heart features., Results: The phasic position and orientation of the vena cava and the circumferential topography of the annular tissue shelf were quantitatively presented for the first time. The candidate patient group exhibited greater chamber dimensions, enlarged vena cava, distended vena cava positions, positional shallowing of the annular tissue shelf, geometric annular distortion, leaflet distention, moderate or greater regurgitation, and impaired ventricular function. Atrial volume correlated strongly with directional vena cava positions as well as with annular dimensions. Annulus-to-RCA distances and annular excursions were comparable between groups., Conclusions: This study provides new and further insight to the right heart morphology and functional characteristics of candidate patients for a transcatheter tricuspid valve intervention. These data provide a platform from which these patients can continue to be better understood for further improving transcatheter system design and use., (© 2021. The Author(s).)

Objectives: The purpose of the current study was to use intravascular ultrasound (IVUS) to clarify anatomical and morphological lesion characteristics of uncrossable lesions., Background: Uncrossable lesions are not always severely calcified. The prevalence of uncrossable lesions that are nonseverely calcified as well as other mechanisms for uncrossability has not been well clarified., Methods: A total of 252 de novo uncrossable lesions in native coronary arteries that underwent either rotational or orbital atherectomy due to inability of any balloon to cross the lesion and 38 lesions with severe calcium in which IVUS crossed preatherectomy were included. Severe calcium is defined as maximum arc of calcium ≥270°., Results: Severe calcification was absent in 16% of uncrossable lesions, 83% of which had a significant vessel bend. Compared with crossable lesions with severe calcium, uncrossable lesions with severe calcium more often had a bend in the vessel (71% vs. 21%, p < 0.001) and a longer length of continuous severe calcium (median length of calcium ≥270° 3.8 mm vs. 1.9 mm, p = 0.001). Other than severe calcium (especially long continuous calcium) or a bend in the vessel, anatomical factors associated with uncrossabilty were aorto-ostial lesion location and small vessels., Conclusions: Uncrossable lesions are not always severely calcified. The interaction of lesion morphology (continuous long and large arcs of calcium) and vessel geometry (bend in the vessel or ostial lesion location) affect lesion crossability., (© 2022 Wiley Periodicals LLC.)

Iliofemoral anatomy plays an important role in determining transfemoral (TF) transcatheter aortic valve replacement candidacy. Herein, we present the novelty of endovascular eSheath balloon dilation to facilitate valve delivery. This technique, in addition to or instead of intravascular lithotripsy, may facilitate TF valve delivery in patients who do not otherwise meet traditional criteria for TF access.

To highlight the trends of surgical (open) aortic valve replacement (SAVR) as well as to compare the outcome between transcatheter aortic valve replacement (TAVR) and SAVR in elderly dialysis patients. TAVR has evolved as an effective alternative to surgery (SAVR) for aortic stenosis. We identified dialysis-dependent patients who underwent SAVR or TAVR from 2000 to 2015 from the United States Renal Data System using ICD-9 codes. We defined high-risk surgical patients as age over 70 or older. The primary endpoint was survival at 3 years and we compared the outcome between SAVR and TAVR groups using inverse probability of treatment weighting (IPTW). A total of 4332 and 1280 dialysis patients underwent SAVR and TAVR, respectively, during the study period. Among SAVR cohort, 3312 patients underwent SAVR before June 2012 and 1020 after June 2012. In-hospital mortality was significantly worse before 2012 (14.6% vs. 11.3% after 2012, p = 0.007) as well as estimated 3-year mortality (69.1% vs. 60.3% after 2012, p < 0.001). After June 2012, the TAVR cohort was older and had more comorbidities including coronary artery disease and congestive heart failure compared to the SAVR cohort. After IPTW, in-hospital mortality was significantly lower after TAVR versus SAVR (odds ratio 0.38 [95% confidence interval [CI], 0.27-0.52], p < 0.001). However, TAVR had a significantly higher risk of 3-year mortality than SAVR (hazard ratio 1.24 [95% CI 1.1-1.39], p < 0.001). TAVR may be a reasonable and potentially preferable alternative to SAVR in the elderly dialysis population in the short-term period., (© 2022 Wiley Periodicals LLC.)

Background: The right ventricular (RV)-pulmonary arterial (PA) coupling ratio relates the efficiency with which RV stroke work is transferred into the PA. Lower ratios indicate an inadequate RV contractile response to increased afterload., Objectives: This study sought to evaluate the prognostic significance of RV-PA coupling in patients with tricuspid regurgitation (TR) who were undergoing transcatheter tricuspid valve repair or replacement (TTVR)., Methods: The study investigators calculated RV-PA coupling ratios for patients enrolled in the global TriValve registry by dividing the tricuspid annular plane systolic excursion (TAPSE) by the PA systolic pressure (PASP) from transthoracic echocardiograms performed before the procedure and 30 days after the procedure. The primary endpoint was all-cause mortality at 1-year follow-up., Results: Among 444 patients analyzed, their mean age was 76.9 ± 9.1 years, and 53.8% of the patients were female. The median TAPSE/PASP ratio was 0.406 mm/mm Hg (interquartile range: 0.308-0.567 mm/mm Hg). Sixty-three patients died within 1 year of TTVR, 21 with a TAPSE/PASP ratio >0.406 and 42 with a TAPSE/PASP ratio ≤0.406. In multivariable Cox regression analysis, a TAPSE/PASP ratio >0.406 vs ≤0.406 was associated with a decreased risk of all-cause mortality (HR: 0.57; 95% CI: 0.35-0.93; P = 0.023). In 234 (52.7%) patients with echocardiograms 30 days after TTVR, a decline in RV-PA coupling was independently associated with reduced odds of all-cause mortality (odds ratio [OR]: 0.42; 95% CI: 0.19-0.93; P = 0.032). The magnitude of TR reduction after TTVR (≥1+ vs <1+; OR: 2.53; 95% CI: 1.06-6.03; P = 0.037) was independently associated with a reduction in post-TTVR RV-PA coupling., Conclusions: RV-PA coupling is a powerful, independent predictor of all-cause mortality in patients with TR undergoing TTVR. These data suggest that the TAPSE/PASP ratio can inform patient selection and prognostication following TTVR., Competing Interests: Funding Support and Author Disclosures Dr Brener has received funding from a National Institute of Health grant (NHLBI-T32HL007343). Dr Lurz has received speaker fees from Abbott. Dr Hausleiter has received speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Rodés-Cabau has received institutional research grants from Edwards Lifesciences. 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 owns equity in Dura Biotech, Thubrikar Aortic Valve, Supira, and MID. Dr Gavazzoni has served as a consultant for Abbott Vascular. Dr Nazif has served as a consultant for and received consulting honoraria from Edwards Lifesciences, Boston Scientific, Medtronic, and Biotrace Medical. Dr Latib has served on the advisory board for Medtronic and Abbott Vascular; has served on the Speakers Bureau for Abbott Vascular; has served on the scientific advisory board for Millipede; and has served as a consultant for 4Tech, Mitralign, and Millipede. Dr Alessandrini has received consulting fees from Abbott and Edwards LifeSciences. Dr Braun has received speaker honoraria and travel support from Abbott Vascular. Dr Brochet has received speaker fees from Abbott Vascular. Dr Lubos has received grant support and lecture fees from Abbott; and has received lecture fees from Edwards Lifesciences. Dr Denti has served as a consultant for Abbott Vascular, 4Tech, Neovasc, and InnovHeart; and has received honoraria from Abbott and Edwards Lifesciences. Dr Ludwig has received travel compensation from Edwards Lifesciences. Dr Kalbacher has received lecture fees from Abbott and Edwards Lifesciences. Dr Estévez-Loureiro has received speaker fees from Abbott, Boston, and Edwards Lifesciences. Dr Connelly has received honoraria from Abbott. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. Dr Schofer has served as a consultant for Edwards Lifesciences. Dr Sievert has received study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed BV, Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, PFM Medical, ReCor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr Tang has served as a consultant, physician advisory board member, and faculty trainer for Abbott Structural Heart; has served as a consultant for Medtronic and NeoChord; and has served as a physician advisory board member for JenaValve. Dr Andreas has served as a proctor/consultant for and has received speaking fees from Abbott, Edwards LifeSciences, and Medtronic; and has received institutional grants from Edwards Lifesciences, Abbott, Medtronic, and Life Systems International. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed; has served as an unpaid advisory board member and/or unpaid member of the steering or executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by pharmaceutical companies or device manufacturers; has reported membership on the steering or executive committee group of several investigator-initiated trials that receive funding by industry without an impact on his personal remuneration; and has been an unpaid member of the Pfizer Research Award selection committee in Switzerland. Dr Maisano has served as a consultant for and received consulting fees and honoraria from Abbott Vascular, Edwards Lifesciences, Cardiovalve, SwissVortex, Perifect, Xeltis, Transseptal Solutions, Magenta, Valtech, and Medtronic; has reported being a cofounder of 4Tech; has received research grant support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received royalties and owns intellectual property rights from Edwards Lifesciences (FMR surgical annuloplasty); and has reported being a shareholder in Cardiovalve, Swiss Vortex, Magenta, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Taramasso has served as a consultant for Abbott Vascular, Boston Scientific, 4Tech, and CoreMedic; and has received speaker honoraria from Edwards Lifesciences. Dr Hahn has served as a consultant for Abbott Vascular, Abbott Structural, NaviGate, Philips Healthcare, Medtronic, Edwards Lifesciences, and GE Healthcare; has been the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-supported trials, for which she receives no direct industry compensation; has received speaker fees from Boston Scientific and Baylis Medical; and has received nonfinancial support from 3mensio. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers., Methods and Results: Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5 ± 11.8 years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank = 0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank <0.001 and 0.015, respectively)., Conclusions: Given the overall survival rate and low frequency of pMCS-related complications, our study results support the use of pMCS prophylactically or during the course of TAVI (bailout) in order to improve clinical outcomes in high-risk procedures or in case of acute life-threatening hemodynamic collapse., (© 2021 Wiley Periodicals LLC.)

[Figure: see text].

Objectives: The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER)., Background: Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking., Methods: Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year., Results: From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery., Conclusions: In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes., Competing Interests: Funding Support and Author Disclosures Dr Kaneko is a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and is a consultant for 4C Medical. Dr Lange is an advisory board member for and has received royalties and speaker honoraria from Medtronic; has received speaker honoraria from Abbott; and is a shareholder in Highlife. Dr Kempfert has served as a physician proctor for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Conradi is a physician proctor, consultant, and speaker for Edwards Lifesciences and Medtronic. Dr Hagl has received speaker honoraria from Edwards Lifesciences. Dr Borger has received speaker honoraria and/or consulting fees to his hospital from Edwards Lifesciences, Medtronic, Abbott, and CryoLife. Dr Taramasso has been a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, 4Tech, Mitraltech, Simulands, MTEx, Occlufit, CoreMedic, and Shenqi Medical. Dr Nguyen has received speaker honoraria from Edwards Lifesciences, CryoLife, and Abbott. Dr Ailawadi is a consultant for Abbott, Edwards Lifesciences, Medtronic, and AtriCure. Dr Smith has received grant support from Edwards Lifesciences; and has received speaker honoraria from Edwards Lifesciences, Abbott, and CryoLife. Dr Anselmi is a physician proctor and consultant for Abbott and Edwards Lifesciences. Dr Ben Ali has received research grants from Edwards Lifesciences and Medtronic. Dr Ramlawi is a consultant for Boston Scientific, Medtronic, LivaNova, and Atricure. Dr Grubb is a physician proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, and BioVentrics. Dr Pirelli is a physician proctor for and has received speaker honoraria from Edwards Lifesciences; and is a consultant for Medtronic. Dr Chu has received speaker honoraria from Medtronic, Edwards Lifesciences, and Terumo Aortic. Dr Andreas is a physician 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 Obadia is a consultant for Abbott, Carmat, Delacroix-Chevalier, Landanger, and Medtronic. Dr Gennari is a consultant for Medtronic. Dr Garatti is a physician proctor for Abbott. Dr Nazif has equity in Venus Medtech; and has received consulting fees or honoraria from Keystone Heart, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Modine is a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Denti receives speaker honoraria from Abbott and Edwards Lifesciences; and is a consultant for InnovHeart. Dr Tang is a physician proctor for Medtronic; is a consultant for Medtronic, NeoChord, and Abbott; and is a physician advisory board member for Abbott and JenaValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

[Figure: see text].

Background Aortic stenosis is prevalent in end-stage renal disease. Transcatheter aortic valve replacement (TAVR) is a plausible alternative for surgical aortic valve replacement. However, little is known regarding long-term outcomes in patients with end-stage renal disease who undergo TAVR. Methods and Results We identified all patients with end-stage renal disease who underwent TAVR from 2011 through 2016 using the United States Renal Data System. The primary end point was 5-year mortality after TAVR. Factors associated with 1- and 5-year mortality were analyzed. A total of 3883 TAVRs were performed for patients with end-stage renal disease. Mortality was 5.8%, 43.7%, and 88.8% at 30 days, 1 year, and 5 years, respectively. Case volumes increased rapidly from 17 in 2011 to 1495 in 2016. Thirty-day mortality demonstrated a dramatic reduction from 11.1% in 2012 to 2.5% in 2016 ( P =0.01). Age 75 or older (hazard ratio [HR], 1.14; 95% CI, 1.05-1.23 [ P =0.002]), body mass index <25 (HR, 1.18; 95% CI, 1.08-1.28 [ P <0.001]), chronic obstructive pulmonary disease (HR, 1.25; 95% CI, 1.1-1.35 [ P <0.001]), diabetes mellitus as the cause of dialysis (HR, 1.22; 95% CI, 1.11-1.35 [ P <0.001]), hypertension as the cause of dialysis (HR, 1.17; 95% CI, 1.06-1.29 [ P =0.004]), and White race (HR, 1.17; 95% CI, 1.06-1.3 [ P =0.002]) were independently associated with 5-year mortality. Conclusions Short-term outcomes of TAVR in patients with end-stage renal disease have improved significantly. However, long-term mortality of patients on dialysis remains high.

Background Suprasternal access is an alternative access strategy for transcatheter aortic valve replacement (TAVR) where the innominate artery is cannulated from an incision above the sternal notch. To date, suprasternal access has never been compared with transfemoral TAVR. Thus, we sought to assess safety, feasibility, and early clinical outcomes between suprasternal and transfemoral access for patients undergoing TAVR. Methods and Results We evaluated patients from 2 institutional prospective, observational registries containing 1348 patients. Patients were selected in a 2:1 ratio (transfemoral:suprasternal) on the basis of propensity score matching. The primary outcome was in-hospital mortality, and secondary outcomes included the incidence of ischemic stroke, major bleeding, vascular injury, left bundle-branch block, and permanent pacemaker implantation at 30-day follow-up. Propensity score matching identified 89 patients undergoing suprasternal TAVR and 159 patients undergoing transfemoral TAVR suitable for analysis. There was no significant difference between suprasternal TAVR and transfemoral TAVR with respect to in-hospital mortality (1.1% versus 0.6%; odds ratio [OR], 1.80; 95% CI, 0.11-29.06; P =0.680). No patients in either cohort suffered an ischemic stroke. The incidence of major bleeding (2.2% versus 2.5%; OR, 0.89; 95% CI, 0.16-4.96; P =0.895) and vascular injury (1.1% versus 1.9%; OR, 0.59; 95% CI, 0.06-5.77; P =0.651) did not differ significantly. The frequency of left bundle-branch block (9.4% versus 15.8%; OR, 0.56; 95% CI, 0.24-1.30; P =0.177) and permanent pacemaker implantation (11.2% versus 5.9%; OR, 2.01; 95% CI, 0.75-5.45; P =0.169) were not statistically significantly different. Conclusions Suprasternal TAVR was safe and achieved promising short-term clinical outcomes when compared with transfemoral TAVR. Future studies seeking to identify the optimal alternative access site should evaluate suprasternal TAVR access alongside other substitutes for transfemoral TAVR.

Objectives: The aim of this study was to assess the incidence and prognostic impact of early and late postoperative atrial fibrillation or flutter (POAF) in patients with severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)., Background: There is an ongoing controversy regarding the incidence, recurrence rate, and prognostic impact of early (in-hospital) POAF and late (postdischarge) POAF in patients with AS undergoing TAVR or SAVR., Methods: In the PARTNER (Placement of Aortic Transcatheter Valve) 3 trial, patients with severe AS at low surgical risk were randomized to TAVR or SAVR. Analyses were performed in the as-treated population excluding patients with preexistent atrial fibrillation or flutter., Results: Among 781 patients included in the analysis, early POAF occurred in 152 (19.5%) (18 of 415 [4.3%] and 134 of 366 [36.6%] following TAVR and SAVR, respectively). Following discharge, 58 new or recurrent late POAF events occurred within 1 year following the index procedure in 55 of 781 patients (7.0%). Early POAF was not an independent predictor of late POAF following discharge (odds ratio: 1.04; 95% CI: 0.52-2.08; P = 0.90). Following adjustment, early POAF was not an independent predictor of the composite outcome of death, stroke, or rehospitalization (hazard ratio: 1.10; 95% CI: 0.64-1.92; P = 0.72), whereas late POAF was associated with an increased adjusted risk for the composite outcome (hazard ratio: 8.90; 95% CI: 5.02-15.74; P < 0.0001), irrespective of treatment modality., Conclusions: In the PARTNER 3 trial, early POAF was more frequent following SAVR compared with TAVR. Late POAF, but not early POAF, was significantly associated with worse outcomes at 2 years, irrespective of treatment modality., Competing Interests: Funding Support and Author Disclosures The PARTNER 3 trial was funded by Edwards Lifesciences. Dr Malaisrie is a consultant for Edwards Lifesciences, Medtronic, and Abbott. Dr George is a consultant for Edwards Lifesciences. Dr Thourani does research and is a consultant for Abbott Vascular, Allergen, Boston Scientific, CryoLife, Edwards Lifesciences, Gore Vascular, and JenaValve. Dr Babaliaros has received institutional research funding from Abbott, Edwards Lifesciences, and Medtronic; has received consulting fees from Edwards Lifesciences; and holds equity in Transmural Systems. Dr Kodali has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Life; and holds equity options from Biotrace Medical and Thubrikar Aortic Valve. Dr Nazif is a consultant for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Genereux has received consulting fees from Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular Systems, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, and Tryton Medical; and has equity in Pi-Cardia, Sig.Num, SoundBite Medical Solutions, Saranas, and Puzzle Medical. Drs Lu and Yu are employees of Edwards Lifesciences. Ms Alu has received institutional research support (no direct compensation) from Abbott and Edwards Lifesciences. Dr Webb is a proctor and consultant for Edwards Lifesciences. Dr Mack has received institutional research support (no direct physician compensation) from Edwards Lifesciences. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and is a consultant or advisory board member for Medtronic, Boston Scientific, Gore, Meril Life, and Abbott. Dr Kosmidou has received institutional research support from Amgen; and is a consultant for Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown., Aims: The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function., Methods: We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE <13 mm) RV function. The primary outcome was one-year all-cause mortality., Results: TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57)., Conclusions: TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.

The prognostic impact of preexisting atrial fibrillation or flutter (AF) in low-risk patients with severe aortic stenosis treated with transcatheter (TAVR) or surgical aortic valve replacement (SAVR) remains unknown. In this sub-analysis of the PARTNER 3 trial of patients with severe aortic stenosis at low surgical risk randomized 1:1 to TAVR versus SAVR, clinical outcomes were analyzed at 2 years according to AF status. Among 948 patients included in the analysis (452 [47.7%] in the SAVR vs 496 [52.3%] in the TAVR arm), 168 (17.6%) patients had AF [88/452 (19.5%) and 80/496 (16.1%) treated with SAVR and TAVR, respectively]. At 2 years, patients with AF had higher unadjusted rates of the composite outcome of death, stroke or rehospitalization (21.2% vs 12.9%, p = 0.007) and rehospitalization alone (15.3% vs 9.4%, p = 0.03) but not all cause death (3.8% vs 2.6%, p = 0.45) or stroke (4.8% vs 2.6%, p = 0.12). In adjusted analyses, patients with AF had a higher risk for the composite outcome of death, stroke or rehospitalization (hazard ratio [HR] 1.80, 95% confidence interval [CI] 1.20-2.71, p = 0.0046) and rehospitalization alone (HR 1.8, 95% CI 0.12-2.9, p = 0.015), but not death or stroke. There was no interaction between treatment modality and AF on the composite outcome (Pinter = 0.83). In conclusion, preexisting AF in patients with severe AS at low surgical risk was associated with increased risk of the composite outcome of death, stroke or rehospitalization at 2 years, irrespective of treatment modality., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: The REFLECT II (Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Implantation) trial was designed to investigate the safety and efficacy of the TriGUARD 3 (TG3) cerebral embolic protection in patients undergoing transcatheter aortic valve replacement., Background: Cerebral embolization occurs frequently following transcatheter aortic valve replacement and procedure-related ischemic stroke occurs in 2% to 6% of patients at 30 days. Whether cerebral protection with TriGuard 3 is safe and effective in reducing procedure-related cerebral injury is not known., Methods: This prospective, multicenter, single-blind, 2:1 randomized (TG3 vs. no TG3) study was designed to enroll up to 345 patients. The primary 30-day safety endpoint (Valve Academic Research Consortium-2 defined) was compared with a performance goal (PG). The primary hierarchical composite efficacy endpoint (including death or stroke at 30 days, National Institutes of Health Stroke Scale score worsening in hospital, and cerebral ischemic lesions on diffusion-weighted magnetic resonance imaging at 2 to 5 days) was compared using the Finkelstein-Schoenfeld method., Results: REFLECT II enrolled 220 of the planned 345 patients (63.8%), including 41 roll-in and 179 randomized patients (121 TG3 and 58 control subjects) at 18 US sites. The sponsor closed the study early after the U.S. Food and Drug Administration recommended enrollment suspension for unblinded safety data review. The trial met its primary safety endpoint compared with the PG (15.9% vs. 34.4% (p < 0.0001). The primary hierarchal efficacy endpoint at 30 days was not met (mean scores [higher is better]: -8.58 TG3 vs. 8.08 control; p = 0.857). A post hoc diffusion-weighted magnetic resonance imaging analysis of per-patient total lesion volume above incremental thresholds showed numeric reductions in total lesion volume >500 mm 3 (-9.7%) and >1,000 mm 3 (-44.5%) in the TG3 group, which were more pronounced among patients with full TG3 coverage: -51.1% (>500 mm 3 ) and -82.9% (>1,000 mm 3 )., Conclusions: The REFLECT II trial demonstrated that the TG3 was safe compared with a historical PG but did not meet its pre-specified primary superiority efficacy endpoint., Competing Interests: FUNDING SUPPORT AND Author Disclosures This work was supported by an unrestricted research grant from Keystone Heart. Dr. Nazif has equity in Venus Medtech; and has received consulting fees or honoraria from Keystone Heart, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr. Dhoble has received honoraria from Edwards Lifesciences, Abbott Vascular, and Keystone Heart. Dr. Forrest has received consulting fees from Edwards Lifesciences and Medtronic. Dr. Zivadinov has received personal compensation from Bristol Myers Squibb, EMD Serono, Sanofi, Keystone Heart, Protembis, and Novartis for speaker and consulting fees; and has received financial support for research activities from Sanofi, Novartis, Bristol Myers Squibb, Mapi Pharma, Keystone Heart, Protembis, Boston Scientific, and V-WAVE Medical. Dr. Dwyer has received personal compensation from Novartis, EMD Serono, and Keystone Heart; and has received financial support for research activities from Bristol Myers Squibb, Novartis, Mapi Pharma, Keystone Heart, Protembis, and V-WAVE Medical. Dr. Lansky has equity in Venus Medtech; and has received consulting fees from Keystone Heart, Medtronic, Boston Scientific, and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The healthcare burden posed by the coronavirus disease 2019 (COVID-19) pandemic in the New York Metropolitan area has necessitated the postponement of elective procedures resulting in a marked reduction in cardiac catheterization laboratory (CCL) volumes with a potential to impact interventional cardiology (IC) fellowship training., Methods: We conducted a web-based survey sent electronically to 21 Accreditation Council for Graduate Medical Education accredited IC fellowship program directors (PDs) and their respective fellows., Results: Fourteen programs (67%) responded to the survey and all acknowledged a significant decrease in CCL procedural volumes. More than half of the PDs reported part of their CCL being converted to inpatient units and IC fellows being redeployed to COVID-19 related duties. More than two-thirds of PDs believed that the COVID-19 pandemic would have a moderate (57%) or severe (14%) adverse impact on IC fellowship training, and 21% of the PDs expected their current fellows' average percutaneous coronary intervention (PCI) volume to be below 250. Of 25 IC fellow respondents, 95% expressed concern that the pandemic would have a moderate (72%) or severe (24%) adverse impact on their fellowship training, and nearly one-fourth of fellows reported performing fewer than 250 PCIs as of March 1st. Finally, roughly one-third of PDs and IC fellows felt that there should be consideration of an extension of fellowship training or a period of early career mentorship after fellowship., Conclusions: The COVID-19 pandemic has caused a significant reduction in CCL procedural volumes that is impacting IC fellowship training in the NY metropolitan area. These results should inform professional societies and accreditation bodies to offer tailored opportunities for remediation of affected trainees., (© 2020 Wiley Periodicals, Inc.)

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions., Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs)., Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year., Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm 2 vs. 1.37 ± 0.5 cm 2 ; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003)., Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality., Competing Interests: Author Disclosures Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Kim has received proctor or speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr. Barbanti is a consultant for Edwards; and is an Advisory Board member for Biotronik. Dr. Sondergaard has received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. Redwood is a proctor for and has received lecture fees from Edwards. Dr. Hamm is an Advisory Board member for Medtronic. Dr. Sinning has received speaker honoraria and research grants from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Wood is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, and Boston Scientific. Dr. Sathananthan is a consultant to Edwards Lifesciences. Dr. Schofer has received speaker fees and travel compensation from Boston Scientific; and has received travel compensation from Edwards Lifesciences and Abbott/St. Jude Medical. Dr. Leipsic is a consultant to Circle CVI and Edwards Lifesciences; and provides institutional core laboratory services to Edwards Lifesciences, Abbott, Medtronic, and Neovasc. Dr. Andreas is a proctor for Edwards and Abbott; and is an Advisory Board member for Medtronic. Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Castriota is a proctor for Medtronic and Boston Scientific. Dr. Kodali has received research grants from Edwards Lifesciences, Medtronic, and Boston Scientific; has received grants and personal fees from Abbott Vascular and JenaValve; has received personal fees from Meril Lifesciences; has received personal fees from and holds equity in Admedus; and holds equity in Supira, Microinterventional Devices, Dura Biotech, and Thubrikar Aortic Valve. Dr. Conradi is a consultant to Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Neovasc, and JenaValve. Dr. Nazif has received consulting fees or honoraria from Edwards Lifesciences, Medtronic, Boston Scientific, Biotrace, and Baylis Medical; and has received consulting fees from and holds equity in Venus Medtech. Dr. Pilgrim has received research grants from Boston Scientific, Edwards Lifesciences, and Biotronik; and has received speaker fees from Boston Scientific and Biotronik. Dr. Babaliaros is a consultant to Edwards Lifesciences; and holds equity in Transmural Systems. Dr. Van Mieghem has received institutional research grants and consulting fees from Abbott, Boston Scientific, Medtronic, Daiichi-Sankyo, and PulseCath; and has received institutional research grant support from Edwards Lifesciences. Dr. Latib has received institutional research or grant support from Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences; and has received personal consulting honoraria from Abbott, Edwards Lifesciences, and Medtronic. Dr. Hildick-Smith is a proctor and adviser to Boston Scientific, Medtronic, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has developed into an established therapy for patients with severe aortic stenosis (AS) across the spectrum of surgical risk. Despite improvements in transcatheter heart valve (THV) technologies and procedural techniques, cardiac conduction disturbances, including high degree atrioventricular block (AVB) requiring permanent pacemaker (PPM) implantation and new-onset left bundle branch block (LBBB), remain frequent complications. TAVR-related conduction disturbances occur due to injury to the conduction system from interactions with interventional equipment and the transcatheter valve stent frame. Risk factors for post-TAVR conduction disturbances have been identified and include clinical characteristics, baseline electrocardiogram findings (right bundle branch block), anatomic factors, and potentially modifiable procedural factors (type of transcatheter valve, depth of implantation, over-sizing). New-onset LBBB and PPM implantation after TAVR have been shown to be associated with adverse long-term clinical outcomes, including mortality and heart failure hospitalization. These clinical consequences are likely to be of increasing importance as TAVR is utilized in younger and lower risk population. This review provides an updated overview of the literature regarding the incidence, predictors, and clinical outcomes of TAVR-related conduction disturbances, as well as proposed strategies for the management of this frequent clinical challenge., Competing Interests: Conflicts of Interest: TMN discloses receiving consulting fees or honoraria from Edwards LifeSciences, Medtronic, Boston Scientific, BioTrace Medical, and consulting and equity for Venus Medtech. The other authors have no conflicts of interest to disclose., (2020 Annals of Cardiothoracic Surgery. All rights reserved.)

Objective: Current guidelines support the use of transcatheter mitral valve interventions to treat some selected high-risk patients with significant mitral valvulopathy. As with any other interventional cardiac procedure, concerns have been raised about cerebrovascular event. The aim of this systematic review and meta-analysis was to determine the incidence of cerebrovascular events following (1) transcatheter mitral valve edge-to-edge repair with mitral valve clip and (2) transcatheter mitral valve replacement (TMVR)., Methods: We conducted a systematic review of studies reporting the cerebrovascular adverse events after transcatheter mitral valve edge-to-edge repair and TMVR procedures. The primary endpoint was the incidence of cerebrovascular events as defined by the Mitral Valve Academic Research Consortium. An event that occurred within 30 days or during index hospitalisation was defined as periprocedural; otherwise it was defined as non-periprocedural. This study was designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Aggregated study-level data were pooled using a random effect model. The quality of each study was appraised with the Hawker checklist, a method of systematically reviewing research from different paradigms., Results: Sixty studies totalling 28 155 patients undergoing edge-to-edge repair with mitral valve clip were included in the analysis. Periprocedural stroke and non-periprocedural stroke rates were 0.9% (95% CI 0.6 to 1.1) and 2.4% (95% CI 1.6 to 3.2), respectively. For TMVR procedures, 26 studies including 1910 patients were analysed. The estimated periprocedural stroke incidence was 1% (95% CI 0.5 to 1.8) compared with 7% (95% CI 0.8 to 18.5) for non-periprocedural stroke., Conclusions: Transcatheter mitral valve interventions are associated with low rates of cerebrovascular events. The exact mechanisms of these complications are still poorly understood given the relative paucity of good quality data., Trial Registration Number: CRD42019117257., Competing Interests: Competing interests: SK is a member of Abbott Vascular advisory board and consultant for Claret Medical. JR-C holds the Canadian Research Chair 'Fondation Famille Jacques Larivière' for the Development of Structural Heart Disease Interventions, and has received research grants from Edwards Lifesciences and Medtronic. J-MP has received consulting fees from Abbott Vascular., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The minimalist approach to transcatheter aortic valve replacement (TAVR) focuses on avoiding extraneous invasive measures. Data describing the clinical impact of routine indwelling urinary catheter (IUC) in TAVR patients is limited. We sought to examine outcomes after IUC placement in patients undergoing TAVR., Methods: We performed a retrospective analysis of 773 consecutive patients undergoing TAVR between 2011 and 2015. Patients were excluded who did not receive an IUC, had a pre-existing IUC, had renal replacement therapy, or underwent non-transfemoral TAVR. Patients were classified by presence of the composite of in-hospital urologic adverse events (UAEs), defined as urinary retention, IUC reinsertion, discharge with IUC, new hematuria, or urinary tract infection (UTI). The primary study endpoint was all-cause mortality at 1 year., Results: A total of 520 patients met study criteria and were analyzed. The incidence of UAE was 28.6%. Urinary retention after IUC removal occurred in 14.6% of patients. UTIs occurred in 6.5% and acute kidney injury occurred in 13.6% of IUC patients. UAE was associated with an increased rate of 30-day and 1-year all-cause mortality (hazard ratio [HR], 2.84; 95% confidence interval [CI], 1.09-7.35; P=.02 and HR, 1.96; 95% CI, 1.22-3.16; P<.01, respectively). After multivariable adjustment for important baseline differences, UAEs were associated with significantly greater hazard of 1-year mortality (adjusted HR, 1.79; 95% CI, 1.07-2.99; P=.03) but not 30-day mortality (adjusted HR, 1.96; 95% CI, 0.67-5.49; P=.22)., Conclusion: UAEs were frequent in patients receiving an IUC during TAVR and were associated with substantial morbidity, as well as longer hospital stay. Further research is required to establish whether avoidance of IUC as a component of the minimalist approach will reduce UAEs.

Objectives: To evaluate the safety and accuracy of the Early Bird Bleed Monitoring System (EBBMS; Saranas) for the detection of access-site related bleeds in humans undergoing endovascular procedures., Background: Bleeding complications after endovascular procedures are frequent and associated with poor prognosis. The EBBMS is a novel technology designed to detect in real time the onset, progression, and severity of internal bleeds., Methods: The EBBMS was used during and after endovascular procedures, either as a venous or arterial access sheath. The primary endpoint was the level of agreement in bleed detection between the Saranas EBBMS and postprocedural computed tomography., Results: From August 2018 to December 2018, a total of 60 patients from five United States sites were enrolled and underwent elective endovascular procedures (transcatheter aortic valve replacement [67%], percutaneous coronary intervention [13%], percutaneous ventricular assist device [8%], balloon aortic valvuloplasty [7%], transcatheter mitral valve repair/replacement [4%], and endovascular aneurysmal repair [2%]). The EBBMS detected the absence of bleeds in 21 patients (35%) and bleeds in 39 patients (65%), with bleeding severity level 1 in 20 patients (33%), level 2 in 15 patients (25%), and level 3 in 4 patients (7%). Bleeding detection occurred during the procedure in 31% of patients and post procedure in 69% of patients. The level of agreement between the EBBMS and computed tomography scan was high (Cohen's kappa=0.84). No device-related complications were reported., Conclusions: The EBBMS was safe across a variety of endovascular procedures and detected bleeding events with a high level of agreement with postprocedural computed tomography scan.

Patients with structural heart disease are at increased risk of adverse outcomes from the coronavirus disease-2019 (COVID-19) due to advanced age and comorbidity. In the midst of a global pandemic of a novel infectious disease, reality-based considerations comprise an important starting point for formulating clinical management pathways. The aims of these "crisis-driven" recommendations are: 1) to ensure appropriate and timely treatment of structural heart disease patients; 2) to minimize the risk of COVID-19 exposure to patients and health care workers; and 3) to limit resource utilization under conditions of constraint. Although the degree of disruption to usual practice will vary across the United States and elsewhere, we hope that early experiences from a heart team operating in the current global epicenter of COVID-19 may prove useful for others adapting their practice in advance of local surges of COVID-19., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)