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Dagmar F Hernandez-Suarez,1 Mariana R Botton,2 Stuart A Scott,2 Matthew I Tomey,3 Mario J Garcia,4 Jose Wiley,4 Pedro A Villablanca,5 Kyle Melin,6 Angel Lopez-Candales,7 Jessicca Y Renta,8 Jorge Duconge9 1Cardiovascular Medicine Division, Department of Medicine, University of Puerto Rico School of Medicine, San Juan, PR, USA; 2Department of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 3Cardiovascular Medicine Division, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 4Division of Cardiovascular Diseases, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine New York, NY, USA; 5Division of Cardiology, Department of Medicine, New York University Langone Medical Center, New York, NY, USA; 6Department of Pharmacy Practice, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA; 7Cardiovascular Medicine Division, Department of Medicine, University of Puerto Rico School of Medicine, San Juan, PR, USA; 8Department of Biochemistry, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA; 9Pharmaceutical Sciences Department, University of Puerto Rico Medical Sciences Campus, San Juan, PR, USA Introduction: High on-treatment platelet reactivity (HTPR) to clopidogrel imparts an increased risk for ischemic events in adults with coronary artery disease. Platelet reactivity varies with ethnicity and is influenced by both clinical and genetic variables; however, no clopidogrel pharmacogenetic studies with Puerto Rican patients have been reported. Therefore, we sought to identify clinical and genetic determinants of on-treatment platelet reactivity in a cohort of Puerto Rican patients with cardiovascular disease. Methods: We performed a retrospective study of 111 patients on 75 mg/day maintenance dose of clopidogrel. Patients were allocated into 2 groups: Group I, without HTPR; and Group II, with HTPR. Platelet function was measured ex vivo using the VerifyNow® P2Y12 assay and HTPR was defined as P2Y12 reaction units (PRU) ≥230. Genotyping testing was performed using Taqman® Genotyping Assays. Results: The mean PRU across the cohort was 203±61 PRU (range 8–324), and 42 (38%) patients had HTPR. Multiple logistic regression showed that 27% of the total variation in PRU was explained by a history of diabetes mellitus, hematocrit, CYP2C19*2, and PON1 p.Q192R. Body mass index (odds ratio [OR]=1.15; 95% CI: 1.03–1.27), diabetes mellitus (OR=3.46; 95% CI: 1.05–11.43), hematocrit (OR=0.75; 95% CI: 0.65–0.87), and CYP2C19*2 (OR=4.44; 95% CI: 1.21–16.20) were the only independent predictors of HTPR. Conclusion: Moreover, we propose a predictive model to determine PRU values as measured by VerifyNow P2Y12 assay for the Puerto Rican Hispanic population. This model has the potential to identify Hispanic patients at higher risk for adverse events on clopidogrel. Keywords: clopidogrel, platelet reactivity, genotyping, Hispanics, Puerto Rico

Competing Interests: Funding Support and Author Disclosures Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. Dr B.P. O’Neill is a consultant for and has received research support from Edwards Lifesciences. Dr Wang is a consultant for Edwards Lifesciences, Abbott, and Boston Scientific. Dr Lee is a consultant for Edwards Lifesciences. Dr W. O’Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and serves on the Board of Directors of Neovasc Inc. Dr Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures Dr B.P. O’Neill is a consultant for and receives research support from Edwards Lifesciences. Dr T. Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr D.D. Wang is a consultant for Edwards Lifesciences, Abbott, Neochord, and Boston Scientific and receives research grant support from Boston Scientific assigned to employer Henry Ford Health System. Dr W.W. O’Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and serves on the Board of Directors of Neovasc Inc. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Up to 20 % of patients presenting with acute heart failure and cardiogenic shock have a structural etiology. Despite efforts in timely management, mortality rates remain alarmingly high, ranging from 50 % to 80 %. Surgical intervention is often the definitive treatment for structural heart disease; however, many patients are considered high risk or unsuitable candidates for such procedures. Consequently, there has been a paradigm shift towards the development of novel percutaneous management strategies and temporizing interventions. This article aims to provide a comprehensive review of the pathophysiology of valvular and structural heart conditions presenting in cardiogenic shock, focusing on the evolving landscape of mechanical circulatory support devices and other management modalities., Competing Interests: Declaration of competing interest The authors do not have any conflicts of interest or relationships to disclose. All authors have read and approved this manuscript and this submission. The paper is not under consideration elsewhere and none of the paper's content have been previously published., (Copyright © 2024. Published by Elsevier Inc.)

Competing Interests: Funding Support and Author Disclosures Dr B. P. O’Neill is a consultant to and receives research support from Edwards Lifesciences. Dr T. Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr D. D. Wang is a consultant for Edwards Lifesciences, Abbott, and Boston Scientific. Dr J.C Lee is a consultant for Edwards Lifesciences. Dr W. O’Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical and serves on the Board of Directors of Neovasc Inc. Dr P. A. Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Conflict of interest: B.P.O. is a consultant to and receives research support from Edwards Lifesciences. T.M.F. is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. D.D.W. is a consultant for Edwards Lifesciences, Abbott, Neochord, and Boston Scientific and receives research grant support from Boston Scientific assigned to employer Henry Ford Health System. W.W.O. has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical and serves on the Board of Directors of Neovasc Inc. P.A.V. is a consultant for Edwards Lifesciences and Teleflex. The other authors had no conflicts to declare. The other authors have no potential conflict of interest to declare.

Background: The clinical efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) have been well-established; however, less is known about outcomes in patients undergoing preemptive ASA before transcatheter mitral valve replacement (TMVR)., Aims: The goal of this study is to characterize the procedural characteristics and examine the clinical outcomes of ASA in both HCM and pre-TMVR., Methods: This retrospective study compared procedural characteristics and outcomes in patient who underwent ASA for HCM and TMVR., Results: In total, 137 patients were included, 86 in the HCM group and 51 in the TMVR group. The intraventricular septal thickness (mean 1.8 vs. 1.2 cm; p < 0.0001) and the pre-ASA LVOT gradient (73.6 vs. 33.8 mmHg; p ≤ 0.001) were higher in the HCM group vs the TMVR group. The mean volume of ethanol injected was higher (mean 2.4 vs. 1.7 cc; p < 0.0001). The average neo-left ventricular outflow tract area increased significantly after ASA in the patients undergoing TMVR (99.2 ± 83.37 mm 2 vs. 196.5 ± 114.55 mm 2 ; p = <0.0001). The HCM group had a greater reduction in the LVOT gradient after ASA vs the TMVR group (49.3 vs. 18 mmHg; p = 0.0040). The primary composite endpoint was higher in the TMVR group versus the HCM group (50.9% vs. 25.6%; p = 0.0404) and had a higher incidence of new permanent pacemaker (PPM) (25.5% vs. 18.6%; p = 0.3402). The TMVR group had a higher rate of all-cause mortality (9.8% vs. 1.2%; p = 0.0268)., Conclusions: Preemptive ASA before TMVR was performed in patients with higher degree of clinical comorbidities, and correspondingly is associated with worse short-term clinical outcomes in comparison to ASA for HCM patients. ASA before TMVR enabled percutaneous mitral interventions in a small but significant minority of patients that would have otherwise been excluded. The degree of LVOT and neoLVOT area increase is significant and predictable., (© 2024 Wiley Periodicals LLC.)

Background: Percutaneous closure of aortic and ventricular pseudoaneurysms (PSA) has only been reported on a case report and series basis. In previous case reports, percutaneous closure has been performed successfully in patients of prohibitive surgical risk. This case series aims to show feasibility of percutaneous closure of aortic and ventricular pseudoaneurysm secondary to perivalvular leak (PVL) in a small patient population and the utility of multimodality imaging as an integral tool in procedural planning. This is the largest complex case series to date describing the feasibility and success rate of complex PSA closure, with a follow-up period of up to 4 years., Material and Methods: We performed institutional review and systemic literature review to identify all paravalvular leak cases with associated pseudoaneurysm formation for which a closure procedure was performed. Ten patients were identified. Pooled analysis for cases from institutional review (n = 10) and systemic literature review (n = 39) was performed. The success rate was 100 %. At 30-days, the mortality was 0 %., Conclusion: In paravalvular leak patients with subsequent pseudoaneurysm formation, exhaustive imaging evaluation is required for closure. However, it can be achievable with favorable rates of success., Competing Interests: Declaration of competing interest Disclosures: Dr. Wang is a consultant to Edwards Lifesciences, Abbott, Neochord, Boston Scientific, and receives research grant support from Boston Scientific assigned to employer Henry Ford Health System. Dr. Villablanca is a consultant for Edwards Lifesciences, Abiomed, Angiodynamics and Teleflex. Dr. Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr. B O'Neill is a consultant to and receives research support from Edwards Lifesciences. Dr. W O'Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and serves on the Board of Directors of Neovasc Inc. All other authors report no relevant financial disclosures., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr B. O’Neill is a consultant for Abbott, Edwards Lifesciences, and Medtronic; and has received research support from Edwards Lifesciences assigned to employer Henry Ford Health. Dr Wang is a consultant for Abbott, Boston Scientific, and Edwards Lifesciences; and has received research grant support from Boston Scientific assigned to her employer Henry Ford Health. Dr Frisoli is a clinical proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr W. O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures Dr B.P. O’Neill is a consultant to and receives research support from Edwards Lifesciences. Dr Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Wang is a consultant for Edwards Lifesciences, Abbott, Neochord, and Boston Scientific; and receives institutional research grant support from Boston Scientific. Dr W. O’Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and serves on the board of directors of Neovasc Inc. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Aortic valve lithotripsy can fragment aortic valve calcium deposits and potentially restore leaflet pliability in animal model and ex-vivo, but clinical data is limited. Transcatheter aortic valve implantation (TAVR) might not be feasible as an urgent procedure in critically ill patients. Balloon valvuloplasty has the major limitation of valve recoil and inducing aortic regurgitation., Aims: To determine the clinical feasibility of aortic valve lithotripsy-facilitated balloon valvuloplasty in patients with severe aortic stenosis unsuitable for valvular replacement., Methods: We performed lithotripsy as adjunctive therapy to balloon aortic valvuloplasty in ten consecutive patients, most of whom were deemed unfit for TAVR. Lithotripsy of the aortic valve was performed with simultaneous inflation of one to three peripheral lithotripsy balloons to deliver ultrasound pulses. Rapid pacing was not used during lithotripsy. Aortic valve velocity, gradient, and valve area were measured before and after the procedure by echocardiogram. Transvalvular pressure gradient was recorded intra-procedurally. Periprocedural and ninety-day clinical outcomes were followed., Results: Procedure was technically successful in 9 out of 10 patients and aborted in one patient due to cardiogenic shock. One patient had femoral closure device related complication. There was a statistically significant decrease in valvular gradient and increase in aortic valve area. 9 out of 10 patients recovered from acute episode and were discharged. 6 patients had improvement in NYHA class. 4 patients were subsequently able to receive TAVR. 90-day mortality occurred in 3 patients. There was no stroke or bradyarrhythmia peri-procedurally and no heart failure hospitalization at 90 days., Conclusion: Aortic valve lithotripsy-facilitated balloon valvuloplasty has reasonable feasibility, safety and technical reproducibility and acute clinical result. Hemodynamic effect is similar to that of balloon valvuloplasty reported in the literature. Subsequent Prognosis is not altered in critically ill patients., Competing Interests: Declaration of competing interest Dr. B. P. O'Neill is a consultant to and receives research support from Edwards Lifesciences. Dr. T. Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr. D. D. Wang is a consultant for Edwards Lifesciences, Abbott, Neochord, and Boston Scientific and receives research grant support from Boston Scientific assigned to employer Henry Ford Health System. Dr. W. O'Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical and serves on the Board of Directors of Neovasc Inc. Dr. P. A. Villablanca is a consultant for Edwards Lifesciences and Teleflex. The other authors had no conflicts to declare. The other authors have no potential conflict of interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

The treatment of severe aortic stenosis (SAS) has evolved rapidly with the advent of minimally invasive structural heart interventions. Transcatheter aortic valve replacement has allowed patients to undergo definitive SAS treatment achieving faster recovery rates compared to valve surgery. Not infrequently, patients are admitted/diagnosed with SAS after a fall associated with a hip fracture (HFx). While urgent orthopedic surgery is key to reduce disability and mortality, untreated SAS increases the perioperative risk and precludes physical recovery. There is no consensus on what the best strategy is either hip correction under hemodynamic monitoring followed by valve replacement or preoperative balloon aortic valvuloplasty to allow HFx surgery followed by valve replacement. However, preoperative minimalist transcatheter aortic valve replacement may represent an attractive strategy for selected patients. We provide a management pathway that emphasizes an early multidisciplinary approach to optimize time for hip surgery to improve orthopedic and cardiovascular outcomes in patients presenting with HFx-SAS., Competing Interests: Funding support was received from the Section of Cardiology, John W. Deming Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA. Dr George is a consultant (honoraria) for Zimmer Biomet, Atricure, Neosurgery, Neptune Medical, Abbvie, Johnson & Johnson, Boston Scientific, Edwards Lifesciences, Medtronic, Help-TheraX, 3ive, Encompass, Summus Medical, and Abbott SJM; is on the advisory boards for Edwards Surgical, Medtronic Surgical, Medtronic Structural Mitral & Tricuspid, Trisol Medical, Abbvie, Johnson & Johnson, Foldax Medical, Zimmer Biomet, Neosurgery, Abbvie, Boston Scientific, and Summus Medical; has equity in Valcare Medical, Durvena, CardioMech, Vdyne, MitreMedical, and MITRx; and has received institutional funding to Columbia University: Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, JenaValve. Dr Latib is on the advisory board for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024 The Authors.)

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

Left ventricular pseudoaneurysm (PSA) after surgical aortic valve replacement (AVR) is a known but uncommon complication. It is associated with risks such as thromboembolism and life-threatening rupture. Surgical repair has traditionally been utilized in low-risk patients but transcatheter closure has become a promising therapeutic option. This case report describes the utility of multimodality imaging in pre-, intra-, and post-procedural evaluation of transcatheter PSA closure and is among the first to demonstrate the utility of 3D print model., (© 2023 Wiley Periodicals LLC.)

Competing Interests: Funding Support and Author Disclosures Dr Brain O’Neill has been a consultant to and has received research support from Edwards Lifesciences. Dr Wang has been a consultant to Edwards Lifesciences, Abbott, Neochord, and Boston Scientific; and has received research grant support from Boston Scientific assigned to employer Henry Ford Health System. Dr Frisoli has been a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr William O’Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and has served on the Board of Directors of Neovasc Inc. Dr Villablanca has been a consultant for Edwards Lifesciences, Abiomed, Angiodynamics, and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Early readmissions significantly impact on patient-wellbeing, burden the health-care system, and are important quality metrics. Data on 30-day readmission following Impella mechanical circulatory support (MCS) are unknown. We aimed to assess the rates, causes and clinical outcomes associated with 30-day unplanned readmissions after Impella mechanical circulatory support (MCS)., Methods: Discharged patients who underwent Impella MCS between 2016 and 2019 in the U.S. Nationwide Readmission Database were analyzed. Incidence, causes, and outcomes associated with 30-day unplanned readmissions were assessed., Results: Of 22,055 patients who received Impella MCS, 2685 (12.2%) experienced 30-day readmissions. Cardiac readmissions accounted for 51.7% compared to 48.3% of non-cardiac readmissions, and most (70%) patients were readmitted back to the index hospital. Heart failure was the leading cause of cardiac readmissions accounting for 25% of them, whereas infections were the most common cause among non-cardiac readmissions. Patients who were readmitted were significantly older (median age 71 versus 68 years), more likely to be female (31% versus 26%) and had a shorter length-of-stay (index hospitalization, median 8 versus 9 days) compared to those who were not readmitted. Factors independently associated with 30-day readmissions were chronic renal (aOR: 1.46, 95% CI: 1.35-1.57), pulmonary (aOR: 1.23, 95% CI: 1.15-1.33), and liver disease (aOR: 1.38, 95% CI: 1.17-1.63), anemia (aOR: 1.35, 95% CI: 1.26-1.46), female sex (aOR: 1.21, 95% CI: 1.12-1.30), index admission on weekends (aOR: 1.23, 95% CI: 1.13-1.34), STEMI diagnosis (aOR: 1.16, 95% CI: 1.02-1.31), major adverse event during index hospitalization (aOR: 1.11, 95% CI: 1.00-1.24), prolonged length-of-stay (median 9 vs. 8 days, P < 0.001), and discharge against medical advice (aOR: 2.06, 95% CI: 1.37-3.09). Significantly higher mortality rates were overserved during readmissions to a hospital different than the MCS implanting hospital (12% versus 5.9%, P < 0.001)., Conclusion: Thirty-day readmissions after Impella MCS are relatively common and relate to sex, baseline comorbidities, presentation, expected primary payer, discharge destination and initial length of hospital stay. Heart failure was the leading cause of cardiac readmissions, whereas infections were the most common cause among non-cardiac readmissions. Most patients were readmitted to the same hospital as their index admission for MCS. Higher mortality rates were observed when patients were readmitted to a different hospital., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Dr. Azzalini received consulting fees from Teleflex, Abiomed, GE Healthcare, Asahi Intecc, Philips, Abbott Vascular, and Cardiovascular Systems, Inc. The remaining authors have no conflicts of interest inherent to the content of this manuscript., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The 30-day rate of stroke after transcatheter aortic valve replacement (TAVR) has been suggested as a hospital quality metric. Thirty-day stroke rates for nonsurgical, high, and moderate-risk TAVR trials were 3.4% to 6.1%, whereas those in the national Transcatheter Valve Therapy (TVT) Registry for the same patient population were much lower. Hospital comprehensive stroke center (CSC) is the highest designation for integrated acute stroke recognition, management, and care., Objectives: Using Michigan TVT data, we assessed whether in-hospital post-TAVR stroke rates varied between CSC and non-CSC institutions., Methods: TVT data submitted from the 22 Michigan Transcatheter Aortic Valve Replacement Collaborative participating institutions between January 1, 2016, and June 30, 2019, were included (N = 6,231). Bayesian hierarchical regression models accounting for patient clinical characteristics and hospital clustering were fitted to assess the association between hospital CSC accreditation and in-hospital post-TAVR stroke. Adjusted ORs and 95% credible intervals were estimated. The University of Michigan Institutional Review Board has waived the need for the approval of studies based on the data collected by the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry., Results: There were 3,882 (62.3%) patients at 9 CSC sites and 2,349 (37.7%) patients at 13 non-CSC sites. CSC sites had significantly higher rates of in-hospital post-TAVR stroke (CSC: 2.65% vs non-CSC: 1.15%; P < 0.001). After adjustment, patients who underwent TAVR at a CSC hospital had a significantly higher risk of in-hospital stroke (adjusted OR: 2.21; 95% CI: 1.03-4.62). However, CSC designation was not significantly associated with other important post-TAVR clinical outcomes including 30-day mortality., Conclusions: Reported Michigan Transcatheter Aortic Valve Replacement Collaborative TVT stroke rates were significantly higher at sites with Joint Hospital Commission stroke designation status; however, other reported important clinical outcomes did not differ significantly based on this designation. CSC designation is a possible factor in stroke rate detection differences between TAVR institutions and might be a factor in the observed differences in stroke rates between TAVR trials and those reported in TVT. In addition, these data suggest that comparison between hospitals based on post-TAVR stroke rates is potentially problematic., Competing Interests: Funding Support and Author Disclosures Michigan TAVR is supported by Blue Cross Blue Shield of Michigan. Dr Grossman is a consultant for Medtronic Cardiovascular and Edwards Lifesciences; provides research support for Medtronic Cardiovascular, Edwards Lifesciences; Cardiovascular Systems Inc, and National Institutes of Health; and provides registry support for Blue Cross Blue Shield of Michigan. Dr Sukul provides registry support for Blue Cross Blue Shield of Michigan. Dr Seth provides registry support for Blue Cross Blue Shield of Michigan. Dr Chetcuti is a consultant for Medtronic Cardiovascular and Edwards Lifesciences; provides research support for Medtronic Cardiovascular and Edwards Lifesciences; and provides registry support for Blue Cross Blue Shield of Michigan. Dr Patel provides registry support from Blue Cross Blue Shield of Michigan. 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.)

Introduction: Acute MR due to mechanical mitral valve (MV) complications frequently results in cardiogenic shock and requires emergency surgical intervention. There was limited evidence for alternative treatment like MitraClip for patients at prohibitive surgical risk. We aimed to study the technical features and outcomes of emergency transcatheter edge-to-edge repair (TEER) using the MitraClip system for patients with cardiogenic shock (CS) secondary to acute mitral regurgitation (MR) and mechanical MV complication., Material and Methods: We performed institutional review and systemic literature review to identify all TEER for CS patients due to acute mitral regurgitation and mechanical MV complication. Clinical endpoints included device success rate assessed at the end of procedure, ability to wean off MCS, all-cause and cardiovascular mortality at 30-day., Results: Eight patients were identified from institutional review. Detail anatomical analysis found that patients with mechanical MV complications related to myocardial infarction had a lower transseptal height achieved during MitraClip (3.6 ± 0.1 cm vs 4.3 ± 0.3 cm, p = 0.03) than those not related. Pooled analysis for cases from institutional review (n = 8) and systemic literature review (n = 16) was performed. The device success rate was 68.8 %. Seventy-five percent (n = 18) cases required mechanical circulatory support (MCS), and 94.4 % were able to wean off MCS. At 30-day, the cardiovascular mortality was 4.5 % and the all-cause mortality was 9.1 %., Conclusions: In CS patients due to acute MR and mechanical MV complications, TEER with/without MCS was feasible with a reasonable device success rate., Competing Interests: Declaration of competing interest Dr. Frisoli is a clinical proctor for Abbott. Dr. O'Neill is a consultant to Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Veno-arterial extracorporeal membrane oxygenation is used in patients requiring biventricular support; however, its use increases the afterload. In patients with severe aortic insufficiency or severe left ventricular disfunction, it will increase left-side filling pressures, hence the need for left ventricle unloading with an additional mechanical circulatory support device. We present a case of a patient with cardiogenic shock and severe aortic insufficiency who underwent left atrial veno-arterial extracorporeal membrane oxygenation and provide a step-by-step explanation of the technique., (© 2022 The Author(s).)

Background: As transcatheter aortic valve replacement (TAVR) procedures increase, more data is available on the development of conduction abnormalities requiring permanent pacemaker (PPM) implantation post-TAVR. Mechanistically, new pacemaker implantation and incidence of associated tricuspid regurgitation (TR) post-TAVR is not well understood. Studies have evaluated the predictability of patient anatomy towards risk for needing permanent pacemaker (PPM) post-TAVR; however, little has been reported on new PPM and TR in patients post-TAVR., Methods: This retrospective study identified patients at our health system who underwent PPM following TAVR from January 2014 to June 2018. Data from both TAVR and PPM procedures as well as patient demographics were collected. Echocardiographic data before TAVR, between TAVR and PPM placement, and the most recent echocardiogram at the time of chart review were analyzed., Results: Of 796 patients who underwent TAVR between January 2014 and June 2018, 89 patients (11%) subsequently required PPM. Out of the 89 patients who required PPM implantation, 82 patients had pre-TAVR and 2-year post-TAVR echocardiographic imaging data. At baseline, 22% (18/82) of patients had at least moderate TR. At 2-year post-TAVR echocardiographic imaging follow-up; 27% (22/82) of patients had at least moderate TR. Subgroup analysis was performed according to the TAVR valve size implanted. In patients who received a TAVR device < 29 mm in diameter in size, 25% (11/44) had worsening TR. In patients who received a TAVR device ≥ 29 mm in diameter, 37% (14/38) had worsening TR., Conclusion: We have demonstrated a patient population that may be predisposed to developing worsening TR and right heart function after TAVR and Pacemaker implantation., (© 2021 Wiley Periodicals LLC.)

Competing Interests: Funding Support and Author Disclosures Dr Basir is a consultant for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Saranas, and Zoll. Dr B. O'Neill is a consultant to and receives research support from Edwards Lifesciences. Dr Frisoli is a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Wang is a consultant to Edwards Lifesciences, Abbott, Neochord, and Boston Scientific; and receives institutional research grant support from Boston Scientific. Dr W. O'Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and serves on the board of directors of Neovasc Inc. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Patent foramen ovale (PFO) closure is a very common procedure, and unfavorable femoral venous access is not uncommonly encountered. The ability to treat this common condition in a minimally invasive manner via a different access is important in our daily practice. The transjugular venous approach has been successfully reported, with 1 main difficulty when faced with the angulation of the PFO septum primum during the crossing, as well as less operator-friendly in terms of positioning. Hence, we adopted the bilateral transbrachial approach in this patient. We consider this to be the first reported case of intracardiac echocardiography-guided PFO closure via bilateral transbrachial approach. The authors believe their experience serves an important role in the following: (1) steps and equipment needed for bilateral transbrachial PFO closure; (2) tips and tricks for a successful procedure; and (3) safety and feasibility of bilateral transbrachial approach as an alternative approach for minimally invasive PFO closure.

Objective: We aim to report on the efficacy and safety of large bore venous access (LBVA) preclosure with Perclose™ (Abbott Vascular Devices) suture-mediated device use following transcatheter edge-to-edge (TEER) and replacement (TMVR)., Background: Patients requiring TEER and TMVR require LBVA. Clinical outcome data on the use of suture-mediated devices for LBVA site closure are limited., Methods: Between 2012 and 2019, 354 consecutive high-risk patients with mitral valvular heart disease underwent TEER (n = 287) with MitraClip and TMVR (n = 67) with Edwards Sapien Valves. Patients had LBVA with 24 or 16 French sheaths. All patients underwent preclosure of LBVA except for one that underwent manual hemostasis., Results: There were no closure device failures. None of the cases required surgical repair of the access site following venous preclosure. Two cases had large hematomas (>6 cm) following Perclose in each group. Six cases had small hematomas (<6 cm and >2 cm) with three in each group. There was one major bleeding using Mitral Valve Academic Research Consortium 2 definition (retroperitoneal bleed from arterial puncture) unrelated to the venous closure. Transfusion related to vascular access complication was required in five cases. There were two immediate acute deep venous thromboses postprocedure; one of which occurred after preclosure. There were no arteriovenous malformations, pseudoaneurysms, or access site infections reported following Perclose., Conclusion: In this large sample size analysis, Proglide preclosure technique is a feasible and safe alternative approach to achieving hemostasis after removal of LBVA sheaths in patients undergoing TEER and TMVR. Randomized trials are needed to compare the different modalities of hemostasis., (© 2022 Wiley Periodicals LLC.)

Competing Interests: Funding Support and Author Disclosures Dr Villablanca has served as a consultant for Edwards Lifesciences and Teleflex. Dr O'Neill is a consultant to and has received research support from Edwards Lifesciences. Dr Frisoli has served as a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Wang has served as a consultant to Edwards Lifesciences, Abbott, NeoChord, and Boston Scientific; and has received research grant support from Boston Scientific assigned to her employer, the Henry Ford Health System. Dr Eng has served as a proctor for Medtronic and Edwards Lifesciences. Dr O'Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and has served on the Board of Directors of Neovasc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Introduction: Sex disparities exist in coronary artery disease (CAD) in terms of risk profile, clinical management and outcome. It is unclear if differences are also present in coronary aneurysms, a rare variant of CAD., Methods: Patients were selected from the international Coronary Artery Aneurysm Registry (CAAR; ClinicalTrials.gov: NCT02563626), and differences between groups were analysed according to sex. The CAAR database is a prospective multicentre registry of 1565 patients with coronary aneurysms (336 females). Kaplan-Meier method was used for event-free survival analysis for death, major adverse cardiac events (MACE: composite endpoint of death, heart failure and acute coronary syndrome) and bleeding., Results: Female patients were older, were more often hypertensive and less frequently smoker. They were treated conservatively more often compared to male patients and received significantly less frequently aspirin (92% vs 88%, p = 0.002) or dual antiplatelet therapy (DAPT) (67% vs 58%, p = 0.001) at discharge. Median DAPT duration was also shorter (3 vs 9 months, p = 0.001). Kaplan-Meier analysis revealed no sex differences in death, MACE or bleeding during a median follow-up duration of 37 months, although male patients did experience acute coronary syndrome (ACS) more often during follow-up (15% vs 10%, p = 0.015)., Conclusions: These CAAR findings showed a comparable high-risk cardiovascular risk profile for both sexes. Female patients were treated conservatively more often and received DAPT less often at discharge, with a shorter DAPT duration. ACS was more prevalent among male patients; however, overall clinical outcome was not different between male and female patients during follow-up., (© 2021. The Author(s).)

Cardiogenic shock (CS) is associated with significant morbidity and mortality. Differentiating the etiologic factors driving CS has epidemiological significance and aids in optimization of therapeutic strategies, prognostication, and resource utilization. The aim herein is to investigate the epidemiology and clinical outcomes of CS in those with ischemic and nonischemic CS etiologies. Using International Classification of Diseases codes, we queried the national inpatient sample for CS hospitalization from 2007 to 2018 and divided the study sample into cohorts of ischemic (I-CS) and nonischemic cardiogenic shock (NI-CS). We then compared the primary outcome of in-hospital mortality between these 2 cohorts. Two groups of secondary outcomes (clinical and procedural) were also assessed between the 2 cohorts. CS was present in 557,860 hospitalizations; 84% of these were I-CS and 15.8% NI-CS. Patients with I-CS were older, more commonly males, with more risk factors for coronary artery disease (P < 0.05). NI-CS had higher prevalence of preexisting systolic heart failure and atrial fibrillation. The in-hospital mortality was significantly higher in patients with I-CS (32.2% vs. 29.5%, adjusted odds ratio 1.10, P < 0.001). Frequencies of acute ischemic stroke, mechanical ventilation, ventricular arrhythmias, and vascular complications were higher in I-CS versus NI-CS, while acute kidney injury and acute liver failure were more common in NI-CS (P < 0.05). The use of mechanical circulatory support devices was higher in the I-CS group. In conclusion, patients with I-CS comprise the vast majority of CS and are associated with higher mortality and higher resource utilization. Conversely, patients with NI-CS appear to have higher survival but with a higher prevalence of end-organ dysfunction., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Cerebrovascular events that occur during structural and interventional procedures are a well known risk which is associated with increased mortality. The FDA has approved the use of the Sentinel device in TAVR. Hereby we report on our experience on the safety and efficacy of using Sentinel in a patient population undergoing non-TAVR transcatheter procedures., Methods: Retrospective analysis of a single center experience with using the Sentinel device for non-TAVR transcatheter procedures., Results: We identified 33 patients (average age was 73.8 years, 36.7% females, and 30% with history of a prior stroke) felt to be at high risk for cerebroembolic events that underwent Sentinel device placement. Sentinel placement was successful in all patients. Examples of high risk features included high atheroma burden in the aortic arch, left sided valve vegetations, intra-cardiac thrombi and severe left sided valve calcifications/thrombi. No patients developed periprocedural stroke or vascular complications., Conclusion: Overall, the use of Sentinel for non-TAVR indications appears feasible and safe. The use of cerebral protection devices should be studied further in non-TAVR patients to establish its role and its benefits, especially with expanding the number of non-TAVR transcatheter interventions., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Frisoli has served as a proctor for Edwards Lifesciences, Boston Scientific, Abbott, and Medtronic. Dr B. O’Neill has served as a consultant for and received research grant from Edwards Lifesciences. Dr Lee is a consultant for HeartFlow. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. Dr Wang has served as a consultant to Edwards Lifesciences, Boston Scientific, and Materialize; and has received research grant support from Boston Scientific. Dr Eng has served as clinical proctor for Edwards Lifesciences. Dr W.W. O’Neill has served as a consultant to Abiomed, Medtronic, and Boston Scientific.

Objective: This manuscript aims to explore the impact of race/ethnicity and socioeconomic status on in-hospital complication rates after left atrial appendage closure (LAAC)., Methods: The US National Inpatient Sample was used to identify hospitalisations for LAAC between 1 October 2015 to 31 December 2018. These patients were stratified by race/ethnicity and quartiles of median neighbourhood income. The primary outcome was the occurrence of in-hospital major adverse events, defined as a composite of postprocedural bleeding, cardiac and vascular complications, acute kidney injury and ischaemic stroke., Results: Of 6478 unweighted hospitalisations for LAAC, 58% were male and patients of black, Hispanic and 'other' race/ethnicity each comprised approximately 5% of the cohort. Adjusted by the older Americans population, the estimated number of LAAC procedures was 69.2/100 000 for white individuals, as compared with 29.5/100 000 for blacks, 47.2/100 000 for Hispanics and 40.7/100 000 for individuals of 'other' race/ethnicity. Black patients were ~5 years younger but had a higher comorbidity burden. The primary outcome occurred in 5% of patients and differed significantly between racial/ethnic groups (p<0.001) but not across neighbourhood income quartiles (p=0.88). After multilevel modelling, the overall rate of in-hospital major adverse events was higher in black patients as compared with whites (OR: 1.60, 95% CI 1.22 to 2.10, p<0.001); however, the incidence of acute kidney injury was higher in Hispanics (OR: 2.19, 95% CI 1.52 to 3.17, p<0.001). No significant differences were found in adjusted overall in-hospital complication rates between income quartiles., Conclusion: In this study assessing racial/ethnic disparities in patients undergoing LAAC, minorities are under-represented, specifically patients of black race/ethnicity. Compared with whites, black patients had higher comorbidity burden and higher rates of in-hospital complications. Lower socioeconomic status was not associated with complication rates., Competing Interests: Competing interests: DH is on the Advisory Board for Boston Scientific, unpaid., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Transcatheter mitral edge-to-edge repair (TEER) is an increasingly common procedure performed on patients with severe mitral regurgitation. This study assessed the impact of race/ethnicity and socioeconomic status on in-hospital complications after TEER., Methods: Cohort-based observational study using the National Inpatient Sample between October 2013 and December 2018. The population was stratified into 4 groups based on race/ethnicity and quartiles of neighborhood income levels. The primary outcome was in-hospital complications, defined as the composite of death, bleeding, cardiac and vascular complications, acute kidney injury, and ischemic stroke., Results: 3795 hospitalizations for TEER were identified. Patients of Black and Hispanic race/ethnicity comprised 7.4% and 6.4%, respectively. We estimated that White patients received TEER with a frequency of 38.0/100,000, compared to 29.7/100,000 for Blacks and 30.5/100,000 for Hispanics. In-hospital complications occurred in 20.2% of patients and no differences were found between racial/ethnic groups (P = 0.06). After multilevel modelling, Black and Hispanic patients had similar rate of overall in-hospital complications (OR: 0.84, CI:0.67-1.05 and OR: 0.84, CI:0.66-1.07, respectively) as compared to White patients, however, higher rates of death were observed in Black patients. Individuals living in income quartile-1 had worse in-hospital outcomes as compared to quartile-4 (OR: 1.19, CI:0.99-1.42)., Conclusion: In this study assessing racial/ethnic disparities in TEER outcomes, aged-adjusted race/ethnicity minorities were less underrepresented as compared to other structural heart interventions. Black patients experienced a higher rate of in-hospital death, but similar overall rate of post-procedural adverse events as compared to White patients. Lower income levels appear to negatively impact on in-hospital outcomes., Brief Summary: This study appraises race/ethnic and socioeconomical disparities in access and outcomes following transcatheter mitral edge-to-edge repair. Racial minority groups were less underrepresented as compared to other structural heart interventions. While Black patients experienced a higher rate of in-hospital death, they experienced similar overall rate of post-procedural complications compared to White patients. Lower income levels also appeared to negatively impact on outcomes., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Objective: To determine the rate and clinical outcomes of post-TAVR VSD., Background: Transcatheter aortic valve replacement (TAVR) is a safe and established procedure for patients with severe symptomatic aortic stenosis. Ventricular septal defect (VSD) is a rare complication of TAVR. The rate of post-TAVR VSD and patient outcomes are not well known., Methods: A retrospective record review of VSD cases occurring after all TAVRs performed between January 2012 and September 2020 at one urban US tertiary hospital. VSD rate and early- and long-term outcomes were analyzed. Computed tomography images taken before TAVR and transthoracic echocardiograms done before and after each procedure were analyzed., Results: Of the 1908 patients who underwent TAVR in the study period, 7 patients (0.37%) had post-procedure VSD. The average patient age was 77 ± 11 years with average society of thoracic surgeons short-term risk score of 6%. All 7 implanted valves were balloon-expandable. Of the 7 TAVR procedures, 5 were performed on a native tricuspid valve, 1 was performed on a native bicuspid valve, and 1 was done as a "valve-in-valve" procedure on a prior surgical bioprosthetic valve. All VSDs were small and restrictive in nature. Right heart failure in a patient with preexisting right ventricular dysfunction occurred in 1 (13%) patient who died. The remaining 6 patients (86%) were discharged. All 6 patients (86%) were alive and stable at 1 year follow-up, reporting improvement in symptoms (NYHA class I-II), with no evidence of right ventricular dysfunction., Conclusion: VSD is a rare complication of TAVR. Hemodynamic and clinical sequelae in majority of the patients in this study did not result in mortality. Proper imaging techniques and appropriate pre-procedure planning are needed to decrease the incidence of VSD formation post-TAVR., (© 2021 Wiley Periodicals LLC.)

Background: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery., Methods: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes., Results: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted ( P <0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex., Conclusions: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Percutaneous ventricular assist devices (pVAD) are frequently utilized in high-risk percutaneous coronary intervention (HR-PCI) to provide hemodynamic support in patients with complex cardiovascular disease and/or multiple comorbidities who are poor candidates for surgical revascularization. Using the National Inpatient Sample we identified pVAD-assisted PCI (excluding intra-aortic balloon pump) in patients without cardiogenic shock from January 2008 to December 2018. We evaluated the trends in patient and procedural characteristics, and complication rates across the 11-year study period. A total of 26,661 pVAD-PCI was performed. From 2008 to 2018 there has was a 27-fold increase in the number of pVAD-PCIs performed annually. There has also been an increase in the proportion of procedures performed in small to medium sized hospitals. The use of atherectomy, image-guided PCI, FFR/iFR, drug-eluting stents, and multi-vessel intervention has significantly increased. Patients undergoing pVAD-PCI had a higher burden of comorbidities, without a significant difference in mortality over time. There were decreased rates of acute stroke and blood transfusions over time, while vascular complications and acute kidney injury (AKI) requiring dialysis remained mostly unchanged. In conclusion, the use of pVAD for HR-PCI has increased significantly, along with adjunctive PCI techniques such as atherectomy, intravascular imaging, and physiologic lesion assessment. With increasing use of this device, there appeared to be lower rates of peri-procedural stroke, and blood transfusions. Despite a higher burden of comorbidities, adjusted mortality remained stable over time., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background Transesophageal echocardiogram is currently the standard preprocedural imaging for left atrial appendage occlusion. This study aimed to assess the additive value of preprocedural computed tomography (CT) planning versus stand-alone transesophageal echocardiogram imaging guidance to left atrial appendage occlusion. Methods and Results We retrospectively reviewed 485 Watchman implantations at a single center to compare the outcomes of using additional CT preprocedural planning (n=328, 67.6%) versus stand-alone transesophageal echocardiogram guidance (n=157, 32.4%) for left atrial appendage occlusion. The primary end point was the rate of successful device implantation without major peri-device leak (>5 mm). Secondary end points included major adverse events, total procedural time, delivery sheath and devices used, risk of major peri-device leak and device-related thrombus at follow-up imaging. A single/anterior-curve delivery sheath was used more commonly in those who underwent CT imaging (35.9% versus 18.8%; P <0.001). Additional preprocedural CT planning was associated with a significantly higher successful device implantation rate (98.5% versus 94.9%; P =0.02), a shorter procedural time (median, 45.5 minutes versus 51.0 minutes; P =0.03) and a less frequent change of device size (5.6% versus 12.1%; P =0.01), particularly device upsize (4% versus 9.4%; P =0.02). However, there was no significant difference in the risk of major adverse events (2.1% versus 1.9%; P =0.87). Only 1 significant peri-device leak (0.2%) and 5 device-related thrombi were detected in follow-up (1.2%) with no intergroup difference. Conclusions Additional preprocedural planning using CT in Watchman implantation was associated with a higher successful device implantation rate, a shorter total procedural time, and a less frequent change of device sizes.

Background: Detailed procedural analysis and long-term data is limited for coronary protection (CP) during transcatheter aortic valve replacement (TAVR) for patients with high anatomical risk for coronary occlusion (CO). We aim to assess the procedural and mid-term outcomes of CP during TAVR., Methods: We retrospectively analyzed patients who underwent TAVR at Henry Ford Hospital, USA from January 2015 to August 2019 and identified those considered at risk of CO and underwent pre-emptive CP with or without subsequent "chimney" stenting (i.e. coronary stenting with intentional protrusion into the aorta). Procedural features, immediate and mid-term clinical outcomes were reviewed., Results: Twenty-five out of 1166 (2.1%) patients underwent TAVR with CP, including 10 (40%) valve-in-valve procedures. Twenty-eight coronary arteries (Left: n = 11, Right: n = 11; Left + Right: n = 3) were protected. Eleven coronaries (39.3%) were electively "chimney"-stented due to angiographic evidence of coronary impingement (63.6%), tactile resistance while withdrawing stent (27.3%) and electrocardiogram change (9.1%). Twenty-four patients (24/25, 96%) had successful TAVR without CO. Procedure-related complications included stent-balloon entrapment (n = 1), stent entrapment (n = 1) and occlusive distal stent edge dissection (n = 1). After a mean follow-up of 19.1 months, there was 1 cardiac death but no target vessel re-intervention or myocardial infarction., Conclusions: Our study found that angiographic evidence of coronary impingement (63.6%) was the most common reason for stent deployment during TAVR with CP. The mid-term clinical outcome of CP with TAVR was favorable., Competing Interests: Declaration of competing interest Dr Frisoli is a clinical proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr. Wang has served as a consultant to Edwards Lifesciences, Boston Scientific, and Materialise; and received research grant support from Boston Scientific. Dr. O'Neill is a consultant to Abiomed, Medtronic, and Boston Scientific. Dr. Eng is a clinical proctor for Edwards Lifesciences, Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve repair (TMVR) utilization has increased significantly in the United States over the last years. Yet, a risk-prediction tool for adverse events has not been developed. We aimed to generate a machine-learning-based algorithm to predict in-hospital mortality after TMVR., Methods: Patients who underwent TMVR from 2012 through 2015 were identified using the National Inpatient Sample database. The study population was randomly divided into a training set (n = 636) and a testing set (n = 213). Prediction models for in-hospital mortality were obtained using five supervised machine-learning classifiers., Results: A total of 849 TMVRs were analyzed in our study. The overall in-hospital mortality was 3.1%. A naïve Bayes (NB) model had the best discrimination for fifteen variables, with an area under the receiver-operating curve (AUC) of 0.83 (95% CI, 0.80-0.87), compared to 0.77 for logistic regression (95% CI, 0.58-0.95), 0.73 for an artificial neural network (95% CI, 0.55-0.91), and 0.67 for both a random forest and a support-vector machine (95% CI, 0.47-0.87). History of coronary artery disease, of chronic kidney disease, and smoking were the three most significant predictors of in-hospital mortality., Conclusions: We developed a robust machine-learning-derived model to predict in-hospital mortality in patients undergoing TMVR. This model is promising for decision-making and deserves further clinical validation., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Percutaneous ventricular assist devices and extracorporeal membrane oxygenation (ECMO) are increasingly used for mechanical circulatory support (MCS) in patients with acute myocardial infarction with cardiogenic shock (AMI-CS) in hospitals throughout the United States., Methods: Using the National Inpatient Sample from October 2015 to December 2017, we identified hospital admissions that underwent percutaneous coronary intervention (PCI) and non-elective Impella or ECMO placement for AMI-CS using ICD-10 codes. Propensity-score matching was performed to compare both groups for primary and secondary outcomes., Results: We identified 6290 admissions for AMI-CS who underwent PCI and were treated with Impella (n = 5730, 91%) or ECMO (n = 560, 9%) from October 2015 to December 2017. After propensity-match analysis, the ECMO cohort had significantly higher in-hospital mortality (43.3% vs 26.7%, OR: 2.10, p = 0.021). The incidence of acute respiratory failure and vascular complications were significantly lower in the Impella cohort. We observed a shorter duration of hospital stay and lower hospital costs in the Impella cohort compared to those who received ECMO., Conclusions: In AMI-CS, the use of Impella was associated with better clinical outcomes, fewer complications, shorter length of hospital stay and lower hospital cost compared to those undergoing ECMO placement., Competing Interests: Declaration of competing interest Dr Basir has the following disclosures: Abbott Vascular, Abiomed, Chiesi, Cardiovascular Systems, and Zoll. Dr Kapur has the following disclosures: Abbott, Abiomed, Boston Scientific, Medtronic, LivaNova, MD Start, and Precardia. Dr O'Neill has the following disclosures: Abiomed and Abbott. The rest of the authors have nothing to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Patients ≥75 years old presenting with acute myocardial infarction (AMI) have complex coronary anatomy in part due to prior coronary artery bypass grafting (CABG), percutaneous coronary interventions (PCI), calcific and valvular disease. Using the National Readmission Database from January 2016 to November 2017, we identified hospital admissions for acute myocardial infarction in patients ≥75 years old and divided them based on a history of CABG. We evaluated in-hospital outcomes, 30-day mortality, 30-day readmission and predictors of PCI in cohorts. Out of a total of 296,062 patients ≥75 years old presenting with an AMI, 42,147 (14%) had history of previous CABG. Most presented with a non-ST segment elevation myocardial infarction, and those with previous CABG had higher burden of co-morbidities and were more commonly man. The in-hospital mortality was significantly lower in those with previous CABG (6.7% vs 8.8%, adjusted odds ratio, 0.88, 95% confidence interval, 0.82 to 0.94). Medical therapy was more common in those with previous CABG and 30-day readmission rates were seen more frequently in those with prior CABG. Predictors of not undergoing PCI included previous PCI, female, older ager groups, heart failure, dementia, malignancy, and higher number of co-morbidities. In conclusion, in patients ≥75 years old with AMI the presence of prior CABG was associated with lower odds of in-hospital and 30-day mortality, as well as lower complications rates, and a decreased use of invasive strategies (PCI, CABG, and MCS). However, 30-day MACE readmission was higher in those with previous CABG., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Competing Interests: Author Relationship With Industry The authors have reported that they have no relationships relevant to the contents of this paper to disclose.