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Transcatheter closure of atrial septal defects (ASD) and patent foramen ovale (PFO) can be performed with transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance, but data comparing both modalities in contemporary practice is lacking. Using ICD-10 codes, patients who underwent transcatheter ASD/PFO closure between 2016 and 2020 using ICE or TEE in the Nationwide Readmissions Database (NRD) were identified. Propensity-score matching was performed to compare in-hospital adverse events, length of stay (LOS), cost, and 30-day non-elective readmissions. A total of 964 patients underwent ASD/PFO closure with ICE (38.3 %, n = 369) or TEE (61.7 %, n = 595) between 2016 and 2020. Propensity score matching yielded 327 patients in each group, which were well balanced. Median (IQR) age was 59.0 (46.0, 72.0) years and 54.7 % were female. No difference was observed in the rate of in-hospital major adverse events between groups. ICE guidance was associated with a lower median cost (ICE $20,140.1 (14,622.3, 25,027.0) vs TEE $20,740.4 (14,137.5, 33,045.3), p < 0.04). In conclusion, ICE guided ASD/PFO closure was associated with lower hospitalization cost without increasing in-hospital adverse events when compared with TEE guidance., Competing Interests: Declaration of competing interest Dr. Huded reports consulting fees from Boston Scientific, Medtronic, and a research grant from Abbott / SCAI. Dr. Chhatriwalla is a member of the Speakers Bureau of Abbott Vascular, Edwards Lifesciences, and Medtronic; is a consultant for Edwards Lifesciences and Medtronic; and has received research support from Boston Scientific. Dr. J. T. Saxon is a proctor for Edwards Lifesciences and Medtronic Inc. and is on the speaker Bbreau for Abbott Vascular, Medtronic Inc., and Edwards Lifesciences. Dr. Huber is a member of Boston Scientific Watchman Advisory Board and He is a Proctor and Speaker for Boston Scientific., (Published by Elsevier Inc.)

Patients with normal-flow low-gradient (NFLG) severe aortic stenosis present both diagnostic and management challenges, with debate about the whether this represents true severe stenosis and the need for valve replacement. Studies exploring the natural history without intervention have shown similar outcomes of patients with NFLG severe aortic stenosis to those with moderate aortic stenosis and better outcomes after valve replacement than those with low-flow low-gradient severe aortic stenosis. Most studies (all observational) have shown that aortic valve replacement was associated with a survival benefit vs surveillance. Based on available data, the European Society of Cardiology/European Association for Cardio-Thoracic Surgery guidelines and European Association of Cardiovascular Imaging/American Society of Echocardiography suggest that these patients are more likely to have moderate aortic stenosis. This clinical entity is not mentioned in the American Heart Association/American College of Cardiology guidelines. Here we review the definition of NFLG severe aortic stenosis, potential diagnostic algorithms and points of error, the data supporting different management strategies, and the differing guidelines and outline the unanswered questions in the diagnosis and management of these challenging patients., Competing Interests: Funding Support and Author Disclosures This study was self-funded. Dr Huded has received consulting fees from Boston Scientific; and has received grants from Abbott. Dr Saad has received consulting fees from Boston Scientific. Dr Chhatriwalla has been a proctor with Edwards Lifesciences, Medtronic; has been on the Speakers Bureau with Abbott Vascular, Edwards Lifesciences, and Medtronic; and has received grants from Boston Scientific. Dr Abbott has received grants from Boston Scientific and Microport; and has received consulting fees from Philips, Medtronic, Abbott, Penumbra, Shockwave, and Recor. 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.)

Competing Interests: Dr Chhatriwalla: consultant fees/honoraria from Abbott Vascular, Edwards Lifesciences, and Medtronic, Inc; research grant from Boston Scientific. Dr Allen: general disclosures are Abbott, Medtronic, and Edwards; institutional research support, proctoring, and speakers bureau with all payments to the institution and none personally. Dr Saxon: Proctor and consulting support for Edwards Lifesciences and Medtronic, Inc. Dr Huded: consulting at Boston Scientific and Medtronic. Dr Makkar: research grants from Abbott, Edwards Lifesciences, and Boston Scientific; consultant at Cordis and Medtronic; employee at Cedars-Sinai Medical Center. Dr Jilaihawi: grant/research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Inc, and Pi-Cardia; consultant fees/honoraria from Abbott Vascular, Edwards Lifesciences, and Medtronic, Inc. Dr Greenbaum: honoraria from Edwards Lifesciences and Medtronic. Dr Babaliaros: equity in Transmural Systems; consultant at Edwards Lifesciences. Dr Whisenant: consultant at Edwards Lifesciences and Medtronic. Dr Yakubov: proctor at Medtronic, Inc; advisory board at Medtronic, Inc, and Boston Scientific. The other authors report no conflicts.

Background: Patients who experience in-hospital ST-segment elevation myocardial infarction (iSTEMI) represent a uniquely high-risk cohort owing to delays in diagnosis, prolonged time to reperfusion and increased mortality. Quality initiatives aimed at improving the care of this vulnerable, yet understudied population are needed., Methods: This study included consecutive patients with iSTEMI treated with percutaneous coronary intervention (PCI) between 1 January 2011 and 15 July 2019 at a single, tertiary referral centre. A comprehensive iSTEMI protocol (CSP) was implemented on 15 July 2014, incorporating: (1) cardiology fellow activation of the catheterisation lab using standardised criteria, (2) nursing chest pain protocol, (3) improved electronic access to electrocardiographic studies, (4) checklist for initial triage and management, (5) 24/7/365 catheterisation lab readiness and (6) radial-first PCI approach. Key metrics and clinical outcomes were compared before and after CSP implementation., Results: Among 125 total subjects, the post-CSP cohort (n=81) was younger, had more males and were more likely to be hospitalised for cardiac-related reasons relative to the pre-CSP cohort (n=44) who were more likely hospitalised for operative-related aetiologies. After CSP adoption, median ECG-to-first-device-activation time decreased from 113 min to 64 min (p<0.001), goal ECG-to-first-device-activation time increased from 36% to 76% of patients (p<0.001), administration of guideline-directed medical therapy prior to PCI increased from 27.3% to 65.4% (p<0.001), trans-radial access increased from 16% to 70% (p<0.001) and rates of discharge home increased from 56.8% to 76.5% (p=0.04). Statistically insignificant numerical reductions were observed post-CSP in in-hospital mortality (18.2% vs 9.9%, p=0.30), 30-day mortality (15.9% vs 12.3%, p=0.78) and 1-year mortality (27.3% vs 21.0%, p=0.57)., Conclusions: The implementation of a CSP was associated with marked enhancements in key care metrics among patients with iSTEMI. Among a larger cohort, the use of a CSP yielded a significant reduction in ECG-to-first-device-activation time in a particularly vulnerable population at high risk of death., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Mitral valve transcatheter edge-to-edge repair (MTEER) was approved in the United States for treatment of functional mitral regurgitation (FMR) based on results from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial., Objectives: The authors sought to analyze outcomes of MTEER in FMR patients who would have been excluded from COAPT., Methods: MTEER procedures performed for FMR in the TVT (Transcatheter Valve Therapy) Registry between January 1, 2013, and April 30, 2020, were categorized as "trial-ineligible" if any of the following were present: cardiogenic shock, inotropic support, left ventricular ejection fraction <20%, left ventricular end-systolic dimension >7 cm, home oxygen use, or severe tricuspid regurgitation. Trial-ineligible and trial-eligible groups were compared through 1 year using multivariable models. The primary endpoint was 1-year death or heart failure hospitalization (HFH)., Results: Of 6,675 patients who underwent MTEER for FMR, 3,721 (55.7%) were trial-eligible and 2,954 (44.3%) were trial-ineligible. Trial-ineligible patients had lower rates of technical procedural success (86.9% vs 92.6%; P < 0.001) and more frequent in-hospital complications (11.8% vs 5.7%; P < 0.001) compared with trial-eligible patients. A clinically meaningful improvement in health status at 30 days was observed in 78.9% and 77.0% of patients in the trial-ineligible and trial-eligible groups, respectively. There was a higher risk of 1-year death or HFH (HR: 1.73; 95% CI: 1.57-1.91; P < 0.001) in trial-ineligible patients., Conclusions: Among patients who underwent MTEER for FMR in the TVT Registry, nearly one-half would have been ineligible for the COAPT trial. Health status improvement at 30 days was similar in COAPT-ineligible and COAPT-eligible patients, but trial-ineligible patients had higher 1-year rates of death or HFH., Competing Interests: Funding Support and Author Disclosures This research was supported by the ACC/STS TVT Registry. The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the registry or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Chhatriwalla is a proctor for Edwards Lifesciences, and Medtronic Inc; and is on the Speakers Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic. Dr Cohen receives research grant support and consulting income from Abbott, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Vemulapalli has grants from Abbott Vascular, Boston Scientific, HeartFlow, American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health, and Patient Centered Outcomes Research Institute; and serves as a consultant to Boston Scientific, Premiere, Janssen, and Zafgen. Dr Huded has received consulting fees from Boston Scientific; and has received a research grant from Abbott Vascular. Dr Lindenfeld has been a consultant for Abbott, Alleviant, AstraZeneca, Biotronik, Boston Scientific, CVRx, Edwards Lifesciences, Merck, Medtronic, V-wave, Vascular Dynamics, Whiteswell, and Vectorious; and receives research funding from AstraZeneca. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi-Sankyo, CorFlow, Apollo Therapeutics, Cardiomech, Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Miracor, Vectorious, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, and HighLife; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; his daughter is an employee at IQVIA; and his employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Sorajja is a consultant for Abbott Structural, Anteris, Edwards Lifesciences, Evolution Medical, Shifamed, WL Gore, xDot, ValCare, 4C Medical, Medtronic, Boston Scientific, and vDyne., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Little is known about the outcomes of transcatheter aortic valve replacement (TAVR) in minimally symptomatic patients., Objectives: The authors aimed to evaluate the outcomes of patients with minimally symptomatic severe aortic stenosis treated with TAVR in the STS/ACC TVT registry., Methods: Minimally symptomatic status was defined as a baseline Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) ≥75. Clinical and health status outcomes of TAVR in patients with severe aortic stenosis and normal left ventricular ejection fraction were compared between minimally symptomatic patients and those with moderate or severe symptoms., Results: Among 231,285 patients who underwent TAVR between 2015 and 2021 (median age 80.0 years [IQR: 74.0-86.0 years], 47.5% female), 20.0% were minimally symptomatic before TAVR. Survival at 1 year was higher in minimally symptomatic patients vs those with moderate or severe symptoms (adjusted HR for death: 0.70 [95% CI: 0.66-0.75]). Mean KCCQ-OS increased by 2.7 points (95% CI: 2.6-2.9 points) at 30 days and 3.8 points (95% CI: 3.6-4.0 points) at 1 year in minimally symptomatic patients compared with increases of 32.2 points (95% CI: 32.0-32.3 points) at 30 days and 34.9 points (95% CI: 34.7-35.0 points) at 1 year in more symptomatic patients. Minimally symptomatic patients had higher odds of being alive and well at 1 year (OR: 1.19 [95% CI: 1.16-1.23])., Conclusions: Although minimally symptomatic patients treated with TAVR experience only small improvements in health status, their overall outcomes are favorable with a higher likelihood of survival with good health status at 1 year compared with more symptomatic patients., Competing Interests: Funding Support and Author Disclosures This research was supported by the ACC/STS TVT Registry. The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the registry or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Huded has received consulting fees from Boston Scientific; and a grant from Abbott Vascular. Dr Cohen has received institutional research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and has received consulting income from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Vemulapalli has received grants from Abbott Vascular, Boston Scientific, HeartFlow, the American College of Cardiology, the Society of Thoracic Surgeons, and the National Institutes of Health and Patient Centered Outcomes Research Institute; and serves as a consultant to Boston Scientific, Premiere, Janssen, and Zafgen. Dr Saxon is a proctor for Edwards Lifesciences and Medtronic Inc., and is on the Speaker Bureau for Abbott Vascular, Medtronic Inc, and Edwards Lifesciences. Dr Chhatriwalla has received a grant from Boston Scientific; is a proctor for Edwards Lifesciences and Medtronic Inc,; and serves on the Speaker Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic Inc. Dr Kosinski is supported by grants from the American College of Cardiology and the Society of Thoracic Surgeons. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards Lifesciences, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Meyers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the board of directors for Blue Cross Blue Shield of Kansas City. 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.)

Severe aortic stenosis (AS) carries a poor prognosis with the onset of heart failure (HF) symptoms, and surgical or transcatheter aortic valve replacement (AVR) is its only definitive treatment. The management of AS has seen a paradigm shift with the adoption of transcatheter aortic valve replacement (TAVR), allowing for the treatment of AS in patients who would not otherwise be candidates for surgical AVR. Despite improving long-term survival after TAVR in recent years, residual HF symptoms and HF hospitalization are common and are associated with an increased mortality and a poor health status. This review article summarizes the incidence and risk factors for HF after AVR. Strategies for preventing and better managing HF after AVR are necessary to improve outcomes in this patient population. Extensive research is underway to assess whether earlier timing for AVR, prior to the development of severe symptomatic AS and associated extra-valvular cardiac damage, can improve post-AVR patient outcomes.

Background: The effectiveness of cerebral embolic protection devices (CEPD) in mitigating stroke after transcatheter aortic valve implantation (TAVI) remains uncertain, and therefore CEPD may be utilized differently across US hospitals. This study aims to characterize the hospital-level pattern of CEPD use during TAVI in the US and its association with outcomes., Methods: Patients treated with nontransapical TAVI in the 2019 Nationwide Readmissions Database were included. Hospitals were categorized as CEPD non-users and CEPD users. The following outcomes were compared: the composite of in-hospital stroke or transient ischemic attack (TIA), in-hospital ischemic stroke, death, and cost of hospitalization. Logistic regression models were used for risk adjustment of clinical outcomes., Results: Of 41,822 TAVI encounters, CEPD was used in 10.6% (n = 4422). Out of 392 hospitals, 65.8% were CEPD non-user hospitals and 34.2% were CEPD users. No difference was observed between CEPD non-users and CEPD users in the risk of in-hospital stroke or TIA (adjusted odds ratio (OR) = 0.99 [0.86-1.15]), ischemic stroke (adjusted OR = 1.00 [0.85-1.18]), or in-hospital death (adjusted OR = 0.86 [0.71-1.03]). The cost of hospitalization was lower in CEPD non-users., Conclusions: Two-thirds of hospitals in the US do not use CEPD for TAVI, and no significant difference was observed in neurologic outcomes among patients treated at CEPD non-user and CEPD user hospitals., Competing Interests: J. T. Saxon is a proctor for Edwards Lifesciences and Medtronic Inc and is on the speaker Bbreau for Abbott Vascular, Medtronic Inc, and Edwards Lifesciences. Dr A. K. Chhatriwalla has a grant from Boston Scientific, is a proctor for Edwards Lifesciences and Medtronic Inc, and is on the speaker bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic Inc. Dr K. B. Allen is an institutional research supporter for Abbott, Medtronic, Edwards, and Boston Scientific and is a proctor and on speaker bureau for Abbott, Medtronic, and Edwards with all payments to the institution and none to him personally. Dr C. P Huded has consulting fees from Boston Scientific and a grant from Abbott Vascular., (© 2023 The Authors.)

Background: Intracoronary (IC) imaging for percutaneous coronary intervention (PCI) is associated with better patient outcomes and carries a class IIA guideline recommendation, but it remains rarely used. We sought to characterize hospital-level variability in IC imaging for PCI in the United States and to identify factors that may explain this variability., Methods: Patients who underwent PCI, with or without IC imaging, in the Nationwide Readmissions Database (2016-2020) were included. A regression model with a random effect for site was used to generate the median odds ratio (MOR) of IC imaging use for a patient at one site vs another, sequentially adjusting for procedural, patient, and hospital factors to examine the extent to which different factors account for this variability., Results: The analytic cohort included 1,328,517 PCI procedures (patient mean age 65.8 years, 32.4% female, IC imaging used in 9.2%) at 1068 hospitals. The median hospital use of IC imaging increased from 2.7% (IQR, 0.6-7.7) in 2016 to 6.3% (IQR, 1.7-17.8) in 2020. In 2020, the MOR for IC imaging during PCI was 4.6 (IQR, 4.3-5.0), indicating a >4-fold difference in the odds of a patient undergoing IC imaging with PCI at one random hospital vs another. Adjusting for procedure, patient, and hospital factors did not meaningfully alter the MOR., Conclusion: The average US hospital uses IC imaging for <1 in 15 PCI procedures, with marked variability across hospitals. Strategies to increase and standardize the use of IC imaging are needed to improve the quality of PCI in the United States., (© 2023 The Author(s).)

Background: Rehospitalization is a common end point in clinical trials of structural heart interventions, but whether rehospitalization is clinically and prognostically relevant in these patients is uncertain. The aim of this study was to evaluate the risk of rehospitalization events after aortic valve replacement (AVR) and their association with mortality and health status., Methods: The study population included patients who underwent transcatheter or surgical AVR in the PARTNER I' II' and III trials (Placement of Aortic Transcatheter Valves). Health status was assessed with the Kansas City Cardiomyopathy Questionnaire-overall summary score. The primary analysis focused on heart failure hospitalization within 1 year after AVR and its association with mortality, poor outcome (death, Kansas City Cardiomyopathy Questionnaire-overall summary score <60 or decrease by ≥10), and health status at 1 year using adjusted models. Secondary analyses examined the prognostic associations of rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes., Results: Among 3403 patients treated with AVR (2008 transcatheter AVR, 1395 surgical AVR), the 1-year incidence was 6.7% for heart failure hospitalization and 9.7% for rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes. Heart failure hospitalization after AVR was associated with increased risk of 1-year mortality (hazard ratio, 3.97 [2.48 to 6.36]; P <0.001), poor outcome (OR, 2.76 [1.73 to 4.40]; P <0.001), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -9.8 points [-13.8 to -5.8]; P <0.001). Rehospitalization due to a composite of heart failure, valve-related, or procedure-related causes was similarly associated with increased 1-year mortality (hazard ratio, 4.64 [3.11 to 6.92]; P <0.001), poor outcome (OR, 2.06 [1.38 to 3.07]; P =0.0004), and worse health status (Kansas City Cardiomyopathy Questionnaire-overall summary mean difference -8.8 points [-11.8 to -5.7]; P <0.001). There was no effect modification by treatment type (transcatheter AVR versus surgical AVR) for these associations., Conclusions: Heart failure hospitalization and rehospitalization after AVR are associated with increased risk of mortality and worse 1-year health status. These findings confirm the clinical and prognostic relevance of rehospitalization end points for trials of AVR., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT00530894.

Background: Before the development of transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV) was the only potential nonsurgical intervention for patients with aortic stenosis complicated by cardiogenic shock. Emergent TAVR is now an option and has shown acceptable outcomes compared with elective TAVR. We explored how treatment patterns for aortic stenosis and cardiogenic shock among patients received invasive intervention have shifted since TAVR was introduced., Methods: We used the Nationwide In patients Sample to identify nonelective hospitalizations for patient with aortic stenosis complicated by cardiogenic shock who received invasive treatment (TAVR, BAV, or surgical aortic valve replacement [SAVR]). We explored the proportion treated with each treatment modality over time, the patient characteristics and in-hospital mortality associated with each treatment, and used multivariable logistic regression to examine whether changes in in-hospital mortality over time differed by treatment., Results: Between 2010 and 2019, we identified 9899 hospitalizations for decompensated aortic stenosis with cardiogenic shock during which patients received invasive treatment (TAVR 17.7%, BAV 20.2%, SAVR 62.1%). Use of both TAVR and BAV has increased over time compared with SAVR (TAVR 6.6% ≥ 33.8%, BAV 8.4% ≥ 23.2%, SAVR 91.6% ≥ 43.0%; p < 0.001 for trend). The overall in-hospital mortality rate was 21.0%, which decreased over time for all treatments (TAVR 20.0% ≥ 18.8%, BAV 66.0% ≥ 25.5%, SAVR 17.7% ≥ 11.8%; linear trend p < 0.001 for each), with lower mortality for TAVR versus BAV at all time points. Patients treated with TAVR (vs. BAV) were less likely to require mechanical ventilation (36.8% vs. 46.3%, p < 0.001) or mechanical circulatory support (22.5% vs. 29.9%, p < 0.001). In the multivariable analysis, the interaction between treatment and time was not significant (p = 0.245), indicating the reduction in in-hospital mortality over time did not differ among the treatments., Conclusions: Since the introduction of TAVR, there has been a shift toward increased use of nonsurgical invasive treatments (both BAV and TAVR) for aortic stenosis and cardiogenic shock. Although in-hospital mortality has declined, it remains high in all groups, but particularly among patients treated with BAV, where the severity of cardiogenic shock appears to be higher than in those treated with other modalities., (© 2022 Wiley Periodicals LLC.)

Background We evaluated whether a comprehensive ST-segment-elevation myocardial infarction protocol (CSP) focusing on guideline-directed medical therapy, transradial percutaneous coronary intervention, and rapid door-to-balloon time improves process and outcome metrics in patients with moderate or high socioeconomic deprivation. Methods and Results A total of 1761 patients with ST-segment-elevation myocardial infarction treated with percutaneous coronary intervention at a single hospital before (January 1, 2011-July 14, 2014) and after (July 15, 2014- July 15, 2019) CSP implementation were included in an observational cohort study. Neighborhood deprivation was assessed by the Area Deprivation Index and was categorized as low (≤50th percentile; 29.0%), moderate (51st -90th percentile; 40.8%), and high (>90th percentile; 30.2%). The primary process outcome was door-to-balloon time. Achievement of guideline-recommend door-to-balloon time goals improved in all deprivation groups after CSP implementation (low, 67.8% before CSP versus 88.5% after CSP; moderate, 50.7% before CSP versus 77.6% after CSP; high, 65.5% before CSP versus 85.6% after CSP; all P <0.001). Median door-to-balloon time among emergency department/in-hospital patients was significantly noninferior in higher versus lower deprivation groups after CSP (noninferiority limit=5 minutes; P noninferiority high versus moderate = 0.002, high versus low <0.001, moderate versus low = 0.02). In-hospital mortality, the primary clinical outcome, was significantly lower after CSP in patients with moderate/high deprivation in unadjusted (before CSP 7.0% versus after CSP 3.1%; odds ratio [OR], 0.42 [95% CI, 0.25-0.72]; P =0.002) and risk-adjusted (OR, 0.42 [95% CI, 0.23-0.77]; P =0.005) models. Conclusions A CSP was associated with improved ST-segment-elevation myocardial infarction care across all deprivation groups and reduced mortality in those from moderate or high deprivation neighborhoods. Standardized initiatives to reduce care variability may mitigate social determinants of health in time-sensitive conditions such as ST-segment-elevation myocardial infarction.

Transcatheter aortic valve implantation (TAVI) for isolated aortic regurgitation (AR) comprises <1.0% of all TAVI procedures performed in the USA. In this manuscript, we review the challenges, evidence and future directions of TAVI for isolated AR. There are no randomised clinical trials or mid-term data evaluating TAVI for isolated AR, and no commercially available devices are approved for this indication. Challenges in performing TAVI for isolated AR as opposed to aortic stenosis (AS) include: lack of a calcified anchoring zone for valve deployment, large and dynamic size of the aortic annulus and high stroke volume (during systole) and regurgitant volume (during diastole) across the aortic annulus during each cardiac cycle. Observational studies have shown that outcomes of TAVI for AR are worse than outcomes of TAVI for AS. However, newer generation TAVI devices may perform better than older generation devices in patients with AR. Two emerging valves (the JenaValve and the J-Valve) are designed with mechanisms to anchor in a non-calcified annulus, and these valves have shown promise for AR. Data on these devices are limited, and clinical investigation is ongoing. Randomised clinical trials are needed to establish TAVI as a safe and effective treatment for isolated AR., Competing Interests: Competing interests: KBA: Abbott Vascular: Consultant, Research Support, Speakers Bureau; Edwards Lifesciences: Consultant, Research Support, Speakers Bureau; Medtronic Inc: Consultant, Research Support, Speakers Bureau. AC: Abbott Vascular: Speakers Bureau; Boston Scientific: Consultant, Research Grant; Edwards Lifesciences: Proctor, Speakers Bureau; Medtronic Inc: Proctor, Speakers Bureau., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is currently indicated for the treatment of failed surgical tissue valves in patients determined to be at high surgical risk for re-operative surgical valve replacement. VIV TAVR, however, often results in suboptimal expansion of the transcatheter heart valve (THV) and can result in patient-prosthesis mismatch (PPM), particularly in small surgical valves. Bioprosthetic valve fracture (BVF) and bioprosthetic valve remodeling (BVR) can facilitate VIV TAVR by optimally expanding the THV and reducing the residual transvalvular gradient by utilizing a high-pressure inflation with a non-compliant balloon to either fracture or stretch the surgical valve ring, respectively. This article, along with the supplemental video, will provide patient selection, procedural planning and technical insights for performing BVF and BVR., Competing Interests: Conflicts of Interest: KBA: Edwards Lifesciences: Research Support, Proctor, Speakers Bureau; Medtronic: Research Support, Speakers Bureau; Abbott: Research Support, Consulting; Boston Scientific: Consulting; AKC: Abbott Vascular: Speakers Bureau; Boston Scientific: Research support, consulting; Edwards Lifesciences: Proctor, Speakers Bureau; Medtronic Inc: Proctor, Speakers Bureau. JTS: Medtronic Inc: Proctor. CPH: none. JS: Edwards Lifesciences and Medtronic: Consulting; TCN: Edwards Lifesciences: Consulting. BW: Edwards Lifesciences: Consulting. JGW: Consulting for Edwards Lifesciences, Abbott, Boston Scientific., (2021 Annals of Cardiothoracic Surgery. All rights reserved.)

Aims: To determine whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol is associated with reduced sex disparities over 5 years., Methods and Results: This was an observational cohort study of 1833 consecutive STEMI patients treated with percutaneous coronary intervention (PCI) before (1 January 2011-14 July 2014, control group) and after (15 July 2014-15 July 2019, protocol group) implementation of a protocol for early guideline-directed medical therapy (GDMT), rapid door to balloon time (D2BT), and use of trans-radial PCI. In the control group, females had less GDMT (77.1% vs. 68.1%, P = 0.03), similarly low trans-radial PCI (19.0% vs. 17.6%, P = 0.73), and longer D2BT [104 min (79, 133) vs. 112 min (85, 147), P = 0.02] corresponding to higher in-hospital mortality [4.5% vs. 10.3%, odds ratio (OR) 2.44 (1.34-4.46), P = 0.004], major adverse cardiac and cerebrovascular events [MACCE, 9.8% vs. 16.3%, OR 1.79 (1.14-2.84), P = 0.01], and net adverse clinical events [NACE, 16.1% vs. 28.3%, OR 2.06 (1.42-2.99), P < 0.001]. In the protocol group, no significant sex differences were observed in GDMT (87.2% vs. 86.4%, P = 0.81) or D2BT [85 min (64-106) vs. 89 min (65-111), P = 0.06], but trans-radial PCI was used less in females (77.6% vs. 71.2%, P = 0.03). In-hospital mortality [2.5% vs. 4.4%, OR 1.78 (0.91-3.51), P = 0.09] and MACCE [9.0% vs. 11.1%, OR 1.27 (0.83-1.92), P = 0.26] were similar between sexes, but higher NACE in females approached significance [14.8% vs. 19.4%, OR 1.38 (0.99-1.92), P = 0.05] due to higher bleeding risk [7.2% vs. 11.1%, OR 1.60 (1.04-2.46), P = 0.03]., Conclusions: A comprehensive STEMI protocol was associated with sustained reductions for in-hospital ischaemic outcomes over 5 years, but higher bleeding rates in females persisted., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Background: Cardiac arrest (CA) complicating ST-elevation myocardial infarction (STEMI) is associated with a disproportionately higher risk of mortality. We described the contemporary presentation, management, and outcomes of CA patients in the era of primary percutaneous coronary intervention (PCI)., Methods: We reviewed 1,272 consecutive STEMI patients who underwent PCI between 1/1/2011-12/31/2016 and compared characteristics and outcomes between non-CA (N = 1,124) and CA patients (N = 148), defined per NCDR definitions as pulseless arrest requiring cardiopulmonary resuscitation and/or defibrillation within 24-hr of PCI., Results: Male gender, cerebrovascular disease, chronic kidney disease, in-hospital STEMI, left main or left anterior descending culprit vessel, and initial TIMI 0 or 1 flow were independent predictors for CA. CA patients had longer door-to-balloon-time (106 [83,139] vs. 97 [74,121] minutes, p = 0.003) and greater incidence of cardiogenic shock (48.0% vs. 5.9%, p < 0.001), major bleeding (25.0% vs. 9.4%, p < 0.001), and 30-day mortality (16.2% vs. 4.1%, p < 0.001). Risk score for 30-day mortality based on presenting characteristics provided excellent prognostic accuracy (area under the curve = 0.902). However, over long-term follow-up of 4.5 ± 2.4 years among hospital survivors, CA did not portend any additional mortality risk (HR: 1.01, 95% CI: 0.56-1.82, p = 0.97)., Conclusions: In a contemporary cohort of STEMI patients undergoing primary PCI, CA occurs in >10% of patients and is an important mechanism of mortality in patients with in-hospital STEMI. While CA is associated with adverse outcomes, it carries no additional risk of long-term mortality among survivors highlighting the need for strategies to improve the in-hospital care of STEMI patients with CA., (© 2021 Published by Elsevier B.V.)

Outpatient follow-up after hospital discharge improves continuity of care and reduces readmissions, but rates of follow-up remain low. It is not known whether electronic medical record (EMR)-based tools improve follow-up. The aim of this study was to determine if an EMR-based order to secure cardiology follow-up appointments at hospital discharge would improve follow-up rates and hospital readmission rates. A pre-post interventional study was conducted and evaluated 39,209 cardiovascular medicine discharges within an academic center between 2012 and 2017. Follow-up rates and readmission rates were compared during 2 years prior to EMR-order implementation (pre-order era 2012-2013, n = 12,852) and 4 years after implementation (EMR-order era 2014-2017, n = 26,357). The primary endpoint was 90-day cardiovascular follow-up rates within our health system. In the overall cohort, the mean age of patients was 69.3 years [SD 14.7] and 60.7% (n = 23,827) were male. In the pre-order era, 90-day follow-up was 56.7 ± 0.4% (7286 of 12,852) and increased to 67.9 ± 0.3% (17,888 of 26,357, P < 0.001) in the EMR-order era. The use of the EMR follow-up order was independently associated with increased outpatient follow-up within 90 days after adjusting for patient demographics and payor status (OR 3.28, 95% CI 3.10-3.47, P < 0.001). The 30-day readmission rate in the pre-order era was 12.8% (1642 of 12,852) compared with 13.7% (3601 of 26,357, P = 0.016) in the EMR-order era. An EMR-based appointment order for follow-up appointment scheduling was associated with increased cardiovascular medicine follow-up, but was not associated with an observed reduction in 30-day readmission rates.

Background: In recent years, there has been strong evidence to support the regular use of intravascular ultrasound (IVUS) imaging to optimize the results of percutaneous coronary intervention (PCI). This holds particularly true in more complex cases, such as calcific lesions, whereby angiographic evaluation is often insufficient to determine whether a vessel has been adequately prepared or to perform reference vessel sizing. Severe calcific lesions are often treated with coronary atherectomy to debulk the calcific plaque and allow for adequate predilation of the lesion before stenting. As we have become more familiar with the use of IVUS for stent optimization, we postulated whether certain vessel characteristics seen on IVUS could help to anticipate procedural complications. We provide a descriptive analysis, including IVUS findings, of 10 patients who underwent PCI complicated by coronary perforation following coronary atherectomy. Our findings generate the hypothesis that independent mobility of calcium identified on IVUS in patients treated with coronary atherectomy may be a warning sign for impending perforation. Further studies are needed to validate this hypothesis and to potentially identify other IVUS findings that could be associated with increased risk of procedural complications.

Background Lp(a) (lipoprotein (a)) is a risk factor for cardiovascular events, but the mechanism of increased risk is uncertain. This study evaluated the relationship between Lp(a) and coronary atheroma volume by intravascular ultrasound. Methods and Results This was a post hoc analysis of 6 randomized trials of coronary atheroma by intravascular ultrasound. The population was stratified into high (≥60 mg/dL) and low (<60 mg/dL) baseline serum Lp(a). The primary outcome was baseline coronary percent atheroma volume. A mixed model adjusted for baseline low density lipoprotein, ApoB (apoliporotein B100), non-high density lipoprotein, sex, age, race, history of myocardial infarction, statin use, and intravascular ultrasound study was used to provide estimates of baseline plaque burden. Of 3943 patients, 17.3% (683) had Lp(a) ≥ 60 mg/dL and 82.7% (3260) had Lp(a) < 60 mg/dL. At baseline, uncorrected low density lipoprotein level (107.7 ± 32.0 versus 99.1 ± 31.5) and statin therapy (99.0% versus 97.0%) were higher in patients with high Lp(a) levels, but low density lipoprotein corrected for Lp(a) was lower (80.6 ± 32.0 versus 94.0 ± 31.4) in patients with high Lp(a) levels. Percent atheroma volume was significantly higher in the high Lp(a) group in unadjusted (38.2% [32.8, 43.6] versus 37.1% [31.4, 43.1], P =0.01) and risk-adjusted analyses (38.7%±0.5 versus 37.5%±0.5, P <0.001). There was a significant association of increasing risk-adjusted percent atheroma volume across quintiles of Lp(a) (Lp(a) quintiles 1-5; 37.3 ± 0.5%, 37.2 ± 0.5%, 37.3 ± 0.5%, 38.0 ± 0.5%, 38.5 ± 0.5%, P =0.002). Conclusions Elevated Lp(a) is independently associated with increased percent atheroma volume. Further work is needed to clarify the relationship of Lp(a)-lowering treatment with cardiovascular outcomes.

Mortality in patients with STEMI-associated cardiogenic shock (CS) is increasing. Whether a comprehensive ST-elevation myocardial infarction (STEMI) protocol (CSP) can improve their care delivery and mortality is unknown. We evaluated the impact of a CSP on incidence and outcomes in patients with STEMI-associated CS. We implemented a 4-step CSP including: (1) Emergency Department catheterization lab activation; (2) STEMI Safe Handoff Checklist; (3) immediate catheterization lab transfer; (4) and radial-first percutaneous coronary intervention (PCI). We studied 1,272 consecutive STEMI patients who underwent PCI and assessed for CS incidence per National Cardiovascular Data Registry definitions within 24-hours of PCI, care delivery, and mortality before (January 1, 2011, to July 14, 2014; n = 723) and after (July 15, 2014, to December 31, 2016; n = 549) CSP implementation. Following CSP implementation, CS incidence was reduced (13.0% vs 7.8%, p = 0.003). Of 137 CS patients, 43 (31.4%) were in the CSP group. CSP patients had greater IABP-Shock II risk scores (1.9 ± 1.8 vs 2.8 ± 2.2, p = 0.014) with otherwise similar hemodynamic and baseline characteristics, cardiac arrest incidence, and mechanical circulatory support use. Administration of guideline-directed medical therapy was similar (89.4% vs 97.7%, p = 0.172) with significant improvements in trans-radial PCI (9.6% vs 44.2%, p < 0.001) and door-to-balloon time (129.0 [89:160] vs 95.0 [81:116] minutes, p = 0.001) in the CSP group, translating to improvements in infarct size (CK-MB 220.9 ± 156.0 vs 151.5 ± 98.5 ng/ml, p = 0.005), ejection fraction (40.8 ± 14.5% vs 46.7 ± 14.6%, p = 0.037), and in-hospital mortality (30.9% vs 14.0%, p = 0.037). In conclusion, CSP implementation was associated with improvements in CS incidence, infarct size, ejection fraction, and in-hospital mortality in patients with STEMI-associated CS. This strategy offers a potential solution to bridging the historically elusive gap in their care., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: We aimed to study adoption of transradial primary percutaneous coronary intervention (TR-PPCI) for ST elevation myocardial infarction (STEMI) ("radial first" approach) and its association with door-to-balloon time (D2BT)., Background: TR-PPCI for STEMI is underutilized in the United States due to concerns about prolonging D2BT. Whether operators and hospitals adopting a radial first approach in STEMI incur prolonged D2BT is unknown., Methods: In 1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients., Results: With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005), median hospital level D2BT decreased from 102 min [81, 142] in 2011 to 84 min [60, 105] in 2016 (p-trend<.001). TF crossover (10.3%; n = 57) was not associated with unadjusted D2BT (TR-PPCI success 91 min [72, 112] vs. TF crossover 99 min [70, 115], p = .432) or D2BT adjusted for study year and presenting location (7.2% longer D2BT with TF crossover, 95% CI: -4.0% to +18.5%, p = .208). Among 273 propensity-matched pairs, unadjusted D2BT (TR-PPCI 98 [78, 117] min vs. TF-PPCI 101 [76, 132] min, p = .304), and D2BT adjusted for study year and presenting location (5.0% shorter D2BT with TR-PPCI, 95% CI: -12.4% to +2.4%, p = .188) were similar., Conclusions: TR-PPCI can be successfully implemented without compromising D2BT performance., (© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

Importance: Reducing postprocedural stroke is important to improve the safety of transcatheter aortic valve replacement (TAVR)., Objective: This study evaluated the trends of stroke occurring within 30 days after the procedure during the first 5 years TAVR was used in the United States, the association of stroke with 30-day mortality, and the association of medical therapy with 30-day stroke risk., Design, Setting, and Participants: Retrospective cohort study including 101 430 patients who were treated with femoral and nonfemoral TAVR at 521 US hospitals in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry from November 9, 2011, through May 31, 2017. Thirty-day follow-up ended June 30, 2017., Exposures: TAVR., Main Outcomes and Measures: The rates of 30-day transient ischemic attack and stroke were assessed. Association of stroke with 30-day mortality and association of antithrombotic medical therapies with postdischarge 30-day stroke were assessed with a Cox proportional hazards model and propensity-score matching, respectively., Results: Among 101 430 patients included in the study (median age, 83 years [interquartile range {IQR}, 76-87 years]; 47 797 women [47.1%]; and 85 147 patients [83.9%] treated via femoral access), 30-day postprocedure follow-up data was assessed in all patients. At day 30, there were 2290 patients (2.3%) with a stroke of any kind (95% CI, 2.2%-2.4%), and 373 patients (0.4%) with transient ischemic attacks (95% CI, 0.3%-0.4%) . During the study period, 30-day stroke rates were stable without an increasing or decreasing trend in all patients (P for trend = .22) and in the large femoral access subgroup (P trend = .47). Among cases of stroke within 30 days, 1119 strokes (48.9%) occurred within the first day and 1567 (68.4%) within 3 days following TAVR. The occurrence of stroke was associated with a significant increase in 30-day mortality: 383 patients (16.7%) of 2290 who had a stroke vs 3662 patients (3.7%) of 99 140 who did not have a stroke died (P < .001; risk-adjusted hazard ratio [HR], 6.1 [95% CI, 5.4-6.8]; P < .001). After propensity-score matching, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.55%) or were not (0.52%) treated with dual antiplatelet therapy at hospital discharge (HR, 1.04; 95% CI, 0.74-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.71%) or were not (0.69%) treated with dual antiplatelet therapy (HR, 1.02; 95% CI, 0.54-1.95). Similarly, 30-day stroke risk was not associated with whether patients in the femoral cohort were (0.57%) or were not (0.55) treated with oral anticoagulant therapy at hospital discharge (HR, 1.03; 95% CI, 0.73-1.46) nor was it associated with whether patients in the nonfemoral cohort were (0.75%) or were not (0.82%) treated with an oral anticoagulant (HR, 0.93; 95% CI, 0.47-1.83)., Conclusions and Relevance: Between 2011 and 2017, the rate of 30-day stroke following transcatheter aortic valve replacement in a US registry population remained stable.

Background Statins may reduce mortality after transcatheter aortic valve replacement (TAVR) through prevention of atherosclerotic events or pleiotropic effects. However, the competing mortality risks in TAVR patients may dilute any positive effect of statins. We sought to understand the association of statin use with post-TAVR mortality. Methods and Results We included high- or intermediate-surgical risk patients who underwent TAVR as a part of the PARTNER (Placement of Aortic Transcatheter Valves) II and Sapien 3 trials and registries. Outcomes included 2-year all-cause, cardiovascular, and noncardiovascular mortality. We used propensity score matching to generate matched pairs between those discharged on a statin and those not on a statin after TAVR. Bias was explored with falsification end points (urinary infection, hip fracture). Among 3956 patients who underwent TAVR, we matched 626 patients on a statin with 626 patients not on a statin at discharge. Among matched patients, statin use was associated with lower risk of all-cause (hazard ratio [HR] 0.65, 95% CI 0.49-0.87, P=0.001), cardiovascular (HR 0.66, 95% CI 0.46-0.96, P=0.030), and noncardiovascular mortality (HR 0.64, 95% CI 0.44-0.99, P=0.045) compared with no statin use. The survival curves diverged within 3 months and continued to separate over a median follow-up of 2.1 years. The falsification end points were similar among groups (urinary infection, P=0.66; hip fracture, P=0.64). Conclusions In an observational, propensity-matched analysis of TAVR patients, statin use was associated with lower rates of cardiovascular and noncardiovascular mortality compared with no statin use. Given the early emergence of the apparent protective effect of statins, this result may be driven either by pleiotropic effects or by residual confounding despite propensity-matching methodology.

Background: Systems to improve ST-segment-elevation myocardial infarction (STEMI) care have traditionally focused on improving door-to-balloon time. However, prompt guideline-directed medical therapy and transradial primary percutaneous coronary intervention (PCI) are also associated with reduced STEMI mortality. The incremental prognostic value of each facet of STEMI care on clinical outcomes within a STEMI system of care is unknown., Methods and Results: We implemented systems-based strategies at our hospital to improve 3 STEMI care metrics: (1) prompt guideline-directed medical therapy before sheath insertion for PCI, (2) use of transradial primary PCI, and (3) door-to-balloon time. We assessed the incremental association of metrics achieved with in-hospital adverse events and 30-day mortality. Of 1272 consecutive patients with STEMI treated with PCI at our hospital (January 1, 2011, to December 31, 2016), the percentage with achievement of zero, 1, 2, or 3 STEMI care metrics was 7.1%, 24.1%, 43.8%, and 25.1%; and 30-day mortality was 15.6%, 8.6%, 3.6%, and 3.2%, respectively (log-rank P<0.001). After adjusting for known clinical predictors of STEMI in-hospital mortality, achievement of at least 2 STEMI care metrics was associated with significantly reduced in-hospital mortality (odds ratio, 0.39; 95% CI, 0.16-0.96; P=0.041). Each metric provided incremental prognostic value when modeled in stepwise order of their occurrence in clinical practice (final model C statistic, 0.677; P<0.001)., Conclusions: Prompt guideline-directed medical therapy before sheath insertion for PCI, transradial primary PCI, and door-to-balloon time add incremental prognostic value in STEMI care. Expanding STEMI systems of care from a singular focus on door-to-balloon time to a comprehensive focus on multifaceted STEMI care offers an opportunity to further improve STEMI outcomes.

Background: Transfemoral-transcatheter aortic valve replacement (TF-TAVR) is increasingly used to treat aortic stenosis, but risk of post-procedure stroke is uncertain., Objectives: The purpose of this study was to assess stroke risk and its association with quality of life after surgical aortic valve replacement (SAVR) versus TF-TAVR., Methods: The authors performed a propensity-matched study of 1,204 pairs of patients with severe aortic stenosis treated with SAVR versus TF-TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valves) trials from April 2007 to October 2014. Outcomes were: 1) 30-day neurological events; 2) time-varying risk of neurological events early (≤7 days) and late (7 days to 48 months) post-procedure; and 3) association between stroke and quality of life 1 year post-procedure by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score., Results: Thirty-day stroke (5.1% vs. 3.7%; p = 0.09) was similar, but 30-day major stroke (3.9% vs. 2.2%; p = 0.018) was lower after TF-TAVR than SAVR. In both groups, risk of stroke peaked in the first post-procedure day, followed by a near-constant low-level risk to 48 months. Major stroke was associated with a decline in quality of life at 1 year in both SAVR (KCCQ score median [15th, 85th percentile]: 79 [53, 94] without major stroke vs. 64 [30, 94] with major stroke; p = 0.03) and TF-TAVR (78 [49, 96] without major stroke vs. 60 [8, 99] with major stroke; p = 0.04)., Conclusions: Despite similar early-peaking (<1 day post-procedure) neurological risk profiles, SAVR is associated with a higher risk of early major stroke than TF-TAVR. Periprocedural strategies are needed to reduce stroke risk after aortic valve procedures. (Placement of AoRTic TraNscathetER Valve Trial [PARTNER]; NCT00530894)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

We sought to study the incremental prognostic impact of baseline valvuloarterial impedance (Zva) and left ventricular global longitudinal strain (LV-GLS) in patients with severe aortic stenosis and preserved left ventricular ejection fraction (LVEF) treated with surgical aortic valve replacement (AVR). We included 961 consecutive patients (68 ± 13 years; 63% men) with severe aortic stenosis (indexed aortic valve area <0.6 cm 2 ) and LVEF >50% who underwent surgical AVR at our institution between January 2007 and December 2008. The analysis is based on derivation (n = 637) and validation (n = 324) subgroups. Society of Thoracic Surgeons (STS) score was calculated. Zva (systolic arterial pressure + mean aortic valve gradient)/left ventricular stroke volume index and LV-GLS (measured offline using Velocity Vector Imaging; Siemens Medical Solutions, Mountain View, California) were calculated. The primary outcome was death. Median Zva and LV-GLS were 4.5 mm Hg × ml -1  × m 2 and -14.5%, respectively. AVR was performed at a median of 34 days from initial evaluation (isolated AVR in 46%, bioprosthetic AVR in 93%). At 7.5 ± 3 years, 320 patients died (33%; 30 days/in-hospital death in 0.5%). In the derivation subgroup, on multivariate Cox survival analysis, higher STS score (hazard ratio [HR] 1.06), higher Zva (HR 1.13), and worse LV-GLS (HR 1.07) were independently associated with long-term survival (all p <0.01). When Zva and LV-GLS were sequentially added to STS score, the c-statistic improved from 0.63 [0.55 to 0.77] to 0.70 [0.60 to 0.81] and 0.78 [0.69 to 0.83], respectively, all p <0.001). Findings were confirmed in the validation subgroup. In conclusion, in patients with severe aortic stenosis and preserved LVEF treated with surgical AVR, baseline Zva and LV-GLS provide improved risk stratification with synergistic prognostic value., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Women with ST-segment elevation myocardial infarction (STEMI) receive suboptimal care and have worse outcomes than men. Whether strategies to reduce STEMI care variability impact disparities in the care and outcomes of women with STEMI is unknown., Objectives: The study assessed the care and outcomes of men versus women with STEMI before and after implementation of a comprehensive STEMI protocol., Methods: On July 15, 2014, the authors implemented: 1) emergency department catheterization lab activation; 2) STEMI Safe Handoff Checklist; 3) immediate transfer to an immediately available catheterization lab; and 4) radial first approach to percutaneous coronary intervention (PCI). The authors prospectively studied consecutive patients with STEMI and assessed guideline-directed medical therapy (GDMT) before PCI, median door-to-balloon time (D2BT), in-hospital adverse events, and 30-day mortality stratified by sex before (January 1, 2011 to July 14, 2014; control group) and after (July 15, 2014 to December 31, 2016) implementation of the STEMI protocol., Results: Of 1,272 participants (68% men, 32% women), women were older with more comorbidities than men. In the control group, women had less GDMT (77% vs. 69%; p = 0.019) and longer D2BT (median 104 min; [interquartile range (IQR): 79 to 133] min vs. 112 [IQR: 85 to 147] min; p = 0.023). Women had more in-hospital stroke, vascular complications, bleeding, transfusion, and death. In the comprehensive 4-step STEMI protocol, sex disparities in GDMT (84% vs. 80%; p = 0.32), D2BT (89 [IQR: 68 to 106] min vs. 91 [IQR: 68 to 114] min; p = 0.15), and in-hospital adverse events resolved. The absolute sex difference in 30-day mortality decreased from the control group (6.1% higher in women; p = 0.002) to the comprehensive 4-step STEMI protocol (3.2% higher in women; p = 0.090)., Conclusions: A systems-based approach to STEMI care reduces sex disparities and improves STEMI care and outcomes in women., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In asymptomatic patients with severe aortic stenosis and preserved left ventricular ejection fraction, we sought to assess the incremental prognostic value of resting valvuloarterial impedence (Zva) and left ventricular global longitudinal strain (LV-GLS) to treadmill stress echocardiography., Methods and Results: We studied 504 such patients (66±12 years, 78% men, 32% with coronary artery disease who underwent treadmill stress echocardiography between 2001 and 2012. Clinical and exercise variables (% of age-sex predicted metabolic equivalents [%AGP-METs]) were recorded. Resting Zva ([systolic arterial pressure+mean aortic valve gradient]/[LV-stroke volume index]) and LV-GLS (measured offline using Velocity Vector Imaging, Siemens) were obtained from the baseline resting echocardiogram. Death was the primary outcome. There were no major adverse cardiac events during treadmill stress echocardiography. Indexed aortic valve area, Zva, and LV-GLS were 0.46±0.1 cm 2 /m 2 , 4.5±0.9 mm Hg/mL per m 2 and -16±4%, respectively; only 50% achieved >100% AGP-METs. Sixty-four percent underwent aortic valve replacement. Death occurred in 164 (33%) patients over 8.9±3.6 years (2 within 30 days of aortic valve replacement). On multivariable Cox survival analysis, higher Society of Thoracic Surgeons score (hazard ratio or HR 1.06), lower % AGP-METS (HR 1.16), higher Zva (HR 1.25) and lower LV-GLS (HR 1.12) were associated with higher longer-term mortality, while aortic valve replacement (HR 0.45) was associated with improved survival (all P <0.01). Sequential addition of ZVa and LV-GLS to clinical model (Society of Thoracic Surgeons score and %AGP-METs) increased the c-statistic from 0.65 to 0.69 and 0.75, respectively, both P <0.001); findings were similar in the subgroup of patients who underwent aortic valve replacement., Conclusions: In asymptomatic patients with severe aortic stenosis undergoing treadmill stress echocardiography, LV-GLS and ZVa offer incremental prognostic value., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Statin therapy is associated with improved survival in patients at high risk for cardiovascular mortality, but the impact of statin therapy in patients treated with transcatheter aortic valve replacement (TAVR) is unknown. We reviewed 294 consecutive cases of TAVR performed at a single tertiary care medical center. We defined high-intensity statin therapy as atorvastatin 40 to 80 mg/day or rosuvastatin 20 to 40 mg/day. Study outcomes included post-TAVR adverse events, 30-day mortality, and overall survival. At the time of TAVR, 14% (n = 41) were on high-intensity statin therapy, 59% (n = 173) were on low- or moderate-intensity statin therapy, and 27% (n = 80) were not on statin therapy. There was no association between statin therapy and the rate of post-TAVR stroke, myocardial infarction, acute kidney injury, in-hospital mortality, or 30-day mortality. At 2 years, 83% of patients in the high-intensity statin group were alive, 70% in the low/moderate-intensity statin group were alive, and 57% in the no statin group were alive (log-rank p = 0.016). In a risk-adjusted model, high-intensity statin therapy was associated with a 64% reduction in all-cause mortality (hazard ratio 0.36, 95% CI 0.14 to 0.90, p = 0.029) compared with no statin therapy. In conclusion, statin therapy is associated with improved overall survival after TAVR in a dose-dependent manner., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: We assessed whether post-operative delirium is associated with healthcare utilization and overall survival after trans-catheter aortic valve replacement., Background: Delirium, a common syndrome among hospitalized older adults, is associated with increased morbidity and mortality., Methods: We reviewed 294 transcatheter aortic valve replacement cases between June 2008 and February 2015 at a tertiary care academic medical center. Post-operative delirium was identified by confusion assessment method screening and clinician diagnosis., Results: Delirium was identified in 61 patients (21%). Non-femoral access for trans-catheter aortic valve replacement was more common in delirious patients than in non-delirious patients (41% vs. 27%, P = 0.04). Delirious patients had diminished overall survival after trans-catheter aortic valve replacement compared to non-delirious patients (1-year survival 59% vs. 84%, log-rank P = 0.002). After adjusting for age, Society of Thoracic Surgeons predicted 30-day mortality, and access type; delirium remained independently associated with diminished overall survival (hazard ratio 2.01, 95% confidence interval 1.21-3.33, P = 0.007). The delirium group had longer mean hospital stay (13.3 ± 9.5 days vs. 6.7 ± 3.8 days, P < 0.001) and a higher rate of discharge to a rehabilitation facility (61% vs. 27%, P < 0.001), but there was no difference in 30-day hospital re-admission rates or 30-day mortality based on delirium status., Conclusions: Delirium occurs in one out of five patients after trans-catheter aortic valve replacement and is associated with diminished survival and increased healthcare utilization. Further studies are needed to clarify whether strategies aimed at reducing delirium after trans-catheter aortic valve replacement may improve outcomes in this high-risk subset. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objectives: We studied the impact of operator experience on trans-radial (TR) cardiac catheterization performance in contemporary practice., Background: TR cardiac catheterization offers advantages over trans-femoral (TF) cardiac catheterization, but the TR approach has been slowly adopted in the United States., Methods: We reviewed all cases of attempted TR cardiac catheterization at a single tertiary care medical center from May 2008 until April 2015. We classified the attending operator TR case experience at the time of each case, and the control group constituted cases performed by operators with >300 TR cases. Study endpoints were TR cannulation failure, TF cross-over, contrast medium dose, and fluoroscopy time., Results: Over the study period, 4177 attempted TR cardiac catheterization cases were performed. The percentage of TR cases performed with percutaneous coronary intervention (PCI) increased from 14.0% in 2009 to 30.2% in 2015 (P-trend <0.001). The rate of TR cannulation failure decreased from 4.3% in 2009 to 2.0% in 2015 (P-trend = 0.071), and the rate of TF cross-over decreased from 4.3% in 2009 to 3.2% in 2015 (P-trend = 0.034). Operators with over 100 cases had the lowest odds of TR cannulation failure, while operators with over 200 cases had the lowest odds of TF cross-over. Operators with over 200 cases used the lowest mean contrast medium dose and mean fluoroscopy time., Conclusions: Increasing operator TR experience is associated with lower odds of TR cannulation failure and TF cross-over, as well as lower contrast medium dose and fluoroscopy time. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Background: Carotid artery stenosis is a risk factor for stroke after surgical aortic valve replacement, but it is unknown whether carotid and vertebral artery disease impacts the risk of stroke after transcatheter aortic valve replacement (TAVR)., Methods: We reviewed 294 consecutive cases of TAVR at a tertiary care medical centre. Thirty-one patients without preoperative carotid/vertebral duplex ultrasonograms were excluded. Carotid or vertebral artery disease was defined on the basis of >50% stenosis. Outcomes were stroke within 30 days after TAVR, 30-day mortality, and overall survival., Results: Fifty-one patients (19%) had at least 50% stenosis of a carotid or vertebral artery. The carotid and vertebral artery disease group had higher rates of coronary artery disease, previous coronary artery bypass surgery, and peripheral artery disease compared with the control group. Transfemoral access was less common in the carotid and vertebral artery disease group (55% vs 77%; P < 0.01). Stroke occurred in 6.8% of patients (n = 18) within 30 days after TAVR, but no patients in the carotid and vertebral artery disease group had a stroke. The presence of at least 50% stenosis of a carotid or vertebral artery was not predictive of stroke by logistic regression. There was no difference in 30-day mortality (10% vs 4%; P = 0.11) and overall survival (log-rank test P = 0.84) between the groups., Conclusions: The presence or absence of carotid or vertebral artery stenosis was not significantly related to the occurrence of stroke after TAVR. Routine screening for carotid and vertebral artery disease before TAVR does not appear justified., (Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Frailty is a syndrome of older adults associated with increased morbidity and mortality. We aimed to assess the impact of frailty status on outcomes after transcatheter aortic valve implantation (TAVI). We reviewed all 191 patients who underwent a modified Fried frailty assessment before TAVI between February 2012 and September 2015 at a single academic medical center, and we assessed the impact of preoperative frailty status on morbidity, mortality, and health care utilization after TAVI. Frailty, pre-frailty, and nonfrailty were present in 33% (n = 64), 37% (n = 70), and 30% (n = 57) of patients, respectively. Slowness (75% vs 54%, p = 0.003) and low physical activity (55% vs 31%, p = 0.001) were more common in women than men. With increasing frailty status, the proportion of women increased (35% nonfrail, 44% pre-frail, and 66% frail, p = 0.002) and stature decreased (1.68 ± 0.11 m nonfrail, 1.66 ± 0.11 m pre-frail, 1.62 ± 0.12 m frail, p = 0.028). There was no difference in post-TAVI 30-day mortality, stroke, major vascular injury, major or life-threatening bleeding, respiratory failure, mean hospital length of stay, 30-day hospital re-admission, or overall survival between groups. The rate of discharge to a rehabilitation facility increased with increasing frailty status (14% nonfrail, 22% pre-frail, and 39% frail, p = 0.005). Frailty was independently associated with discharge to a rehabilitation facility (odds ratio 4.80, 95% confidence interval 1.66 to 13.85, p = 0.004). In conclusion, the safety of TAVI is not affected by frailty status, but patients with frailty are less likely to be discharged directly home after TAVI., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Transradial (TR) cardiac catheterization is effective and offers lower rates of vascular complications and bleeding compared with transfemoral cardiac catheterization. We sought to describe the safety and feasibility of TR cardiac catheterization in liver transplant candidates (LTCs). We retrospectively reviewed 1,071 consecutive cases of TR cardiac catheterization in 1,045 patients from May 2008 to December 2011 at a single institution. The primary end point was radial approach failure. Ten percent of TR cases (n = 107) were performed in LTCs and 90% (n = 964) were performed in non-LTCs. The LTC group had lower rates of cardiovascular diseases and cardiovascular risk factors. The LTC group had a significantly lower platelet count (75,000 vs 237,000/mm(3), p <0.01), higher international normalized ratio (1.7 vs 1.1, p <0.01), and lower mean arterial pressure (78 vs 89 mm Hg, p <0.01). The mean Model for End-Stage Liver Disease score was 21 in LTCs. Percutaneous coronary interventions were performed in 4% of LTCs and 15% of non-LTCs (p <0.01). The radial approach failure rate was 10% in LTCs and 7% in non-LTCs (p = 0.15). In conclusion, radial approach failure was similar between the LTC and non-LTC groups. Despite significant differences in platelet count and international normalized ratio, there was no difference in the incidence of adverse events between the groups, suggesting that TR cardiac catheterization is safe and effective in LTCs., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objectives: Most reports of femoral-femoral bypass (FFB) were published before the era of endovascular intervention. This study examines the utilization and impact of adjunctive endovascular intervention on FFB in contemporary practice., Methods: We reviewed 253 FFB performed in 247 patients between 1984 and 2010. Primary endpoints, including graft patency, primary-assisted patency, limb salvage, and survival, were assessed using Kaplan-Meier life-table analysis. Univariate and multivariate analyses were performed to determine predictors of primary endpoints., Results: The indication for FFB included claudication (27%; n = 69) and critical limb ischemia (72%; n = 184). Forty-eight patients (19%) were treated urgently for acute ischemia. Mean follow-up was 5.6 ± 5.5 years. Over the study interval, adjunctive iliac percutaneous transluminal angioplasty (PTA)/stent placement increased significantly from 0% to 54% (P trend < .001), while the rate of axillofemoral bypass or no inflow procedure decreased from 100% to 46% (P trend < .001). Despite increased utilization, iliac PTA/stenting was associated with decreased 5-year primary graft patency of 44% compared with 74% for axillofemoral bypass patients and 71% in patients with no adjunctive inflow procedure (P = .004). Patients with inflow iliac PTA/stents also had diminished 5-year assisted primary patency of 61% compared with 85% for axillofemoral bypass patients and 87% in patients without inflow revascularization (P = .002). Adjunctive iliac PTA/stenting did not impact limb salvage or overall survival. Five-year primary patency among claudicants and critical leg ischemia patients was 65% and 68%, respectively., Conclusions: The incidence of iliac PTA/stent placement in conjunction with FFB has increased significantly over time in contemporary practice. Reliance on iliac stent placement for FFB inflow is paradoxically associated with both diminished primary and assisted primary graft patency when compared with historical controls. These findings highlight the importance of patient selection and inflow consideration when performing FFB., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Carotid artery stenting (CAS) is a developing intervention for carotid artery stenosis, and long-term outcomes remain unclear. We examined the prevalence and clinical significance of carotid stent fractures or deformations following CAS., Methods: Two hundred thirty-one CAS performed in 219 patients at one academic institution between August 2000 and March 2009 were reviewed. One hundred sixteen stents (57 closed cell, 59 open cell) were evaluated with multiplanar plain films of the neck to assess for stent fracture or deformation. Stent fracture was identified by wire strut disruption. Deformation was defined as an increase in stent-cell area from stent strut distortion. Study endpoints included rate of stent fracture or deformation determined using Kaplan-Meier and life table analysis. Factors associated with stent fracture or deformation were identified by Cox regression. Effect of stent fracture or deformation on recurrent carotid artery stenosis >70% requiring reintervention and postoperative stroke was studied., Results: There were five stent fractures (4%) and 27 deformed stents (23%). Rate of stent fracture or deformation was 15% at 2 years and 50% at 4 years. Deformations were significantly more common in open cell stents than in closed cell stents (58% vs 5% at 4 years, P < .00005). Presence of calcified plaque on plain film was significantly associated with increased rate of stent fracture or deformation (P = .0006). At median follow-up of 25 months, restenosis requiring treatment occurred in four (5%) and late stroke in one (1%). Neither stent fracture nor deformation was associated with late stroke or reintervention., Conclusions: Stent fracture and deformation is not uncommon following CAS and is associated with the presence of heavy calcification. Whether a carotid stent fractures or deforms correlates with stent design. Larger studies are necessary to determine the possible clinical significance of carotid stent fracture and deformation., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

We used short-term selection to produce outbred mouse lines with differences in contextual fear conditioning. Within two generations of selection all low selected mice were homozygous for the recessive tyrc allele and showed the corresponding albino coat color. Freezing differed in the high and low selected lines across a range of parameters. We identified several QTLs for the selection response, including a highly significant QTL at the tyr locus (p < 9.6(-10)). To determine whether the tyrc allele was directly responsible for the response to selection, we examined B6 mice that have a mutant tyr allele (tyr(c-2j-)) and an AJ congenic strain that has the wild-type B6 allele for tyr. These studies showed that the tyr allele had a small influence on fear learning. We used Affymetrix microarrays to identify many differentially expressed genes in the amygdala and hippocampus of the selected lines. We conclude that tyr is one of many alleles that influence fear conditioning.