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Background: The American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level., Methods: The study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation., Discussion: The IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts., Trial Registration: ClinicalTrials.gov NCT06171737. Registered on December 15, 2023., Competing Interests: Declarations. Ethics approval and consent to participate {24}: Ethical approval for the study will be provided by each site individually. The majority of sites approved waiver of written consent to participate in this minimal risk trial, and consent is implied by completion of the survey. Consent for publication {32}: At 6 sites, participants will receive an information sheet reviewing options, benefits, and risks of the trial and consent will be implied by return of the pre-visit survey. At one site, research staff will obtain written consent and at one site research staff will obtain and document verbal consent. Competing interests {28}: NL reports being a consultant for Edwards Lifesciences. CK reports a K23 from NHLBI (K23HL153892). CD reports paid consulting fees from Medtronic and Record Medical. EK reports receiving honoraria from Abbott, Boston Scientific, Edwards, and Medtronic. ND receives research support from the American Heart Association, NIH, AHRQ, and Merck and research funding and consulting for Abiomed. KS reports receiving funding for shared decision-making research from PCORI, AHRQ, and NIH, outside submitted work. KS developed the Shared Decision-Making Process scale (copyright Massachusetts General Hospital) that is being used as an outcome measure in the study. KV reports receiving support for shared decision-making research from PCORI and AHRQ outside submitted work and receiving research funding from Google LLC outside the submitted work. SE reports receiving research funding and consulting fees from Edwards Lifesciences and Medtronic. VT reports advising and research with Artivion, AtriCure, Boston Scientific, Abbott Vascular, CroiValve, Edwards Lifesciences, Medtronic, JenaValve, HighLife, Innovalve, and DASI Simulations. JM reports institutional grant support from the University of Colorado School of Medicine: Philips Medical Systems, Medtronic Corporation. SS reports travel sponsored by the ACC, Global Heart Hub, TCT, and Heart Valve Collaboratory and significant financial interests in Heart Valve Voice US. AN has received institutional research funding and speaker fees from Edwards Lifesciences, which is involved in products for the treatment of aortic stenosis. AB reports receiving honoraria for teaching a course at Edwards Lifesciences. DM, MC, YC, KG, NQ, and DK report no conflicts of interest., (© 2024. The Author(s).)

Background: Transfemoral transcatheter aortic valve replacement (TF-TAVR) has proven superior to alternative access. However, some patients evaluated for TF-TAVR are unfit secondary to peripheral arterial disease (PAD). Peripheral intravascular lithotripsy (IVL) can facilitate femoral access. This study aimed to characterize optimal lesions that can be treated with IVL., Methods: Single-center, retrospective analysis of an institutional database, queried from 1/2018 through 7/2023 for all patients who underwent TAVR. Patients who received IVL-facilitated transfemoral access were analyzed., Results: Of 2862 TAVR cases identified, 92 (3.2 %) underwent lithotripsy. The IVL-facilitated cohort had a mean age of 78 ± 9.2 years and 45 % were female. The right common iliac artery was most treated (47). Most IVL was performed with 7-mm balloons (73.9 %). All cases were successful. 30-day mortality was 1.1 % (1/92)., Conclusions: In our cohort, complications after IVL-facilitated TF-TAVR were more common with small vessel diameter (≤4.7 mm), significant luminal loss (>50 % stenosis), and heavy calcium burden (arc calcification >180°). The findings support the use of IVL to expand the population of patients who can undergo TF-TAVR without the increased risks associated with the various forms of alternative access., Summary for Annotated Table of Contents: IVL-facilitated TF-TAVR is safe and feasible. Despite its introduction to TAVR clinical practice in 2018, IVL-facilitated TF-TAVR is not regularly performed and could increase the population of patients eligible for TF-TAVR., Competing Interests: Declaration of competing interest Grubb is a consultant for Abbott, Boston Scientific, Medtronic, and Edwards Lifesciences. Devireddy is a consultant for Medtronic and Recor Medical. The remaining authors have no disclosures., (Published by Elsevier Inc.)

Mitral regurgitation is the most common valvular disease in the developed world, with approximately 24.2 million people being affected worldwide and a higher prevalence in older age groups. Surgical correction of degenerative mitral regurgitation is the standard of care and can restore cardiac function and provide a lasting result, especially when the mitral valve can be repaired. Secondary mitral regurgitation, or functional mitral regurgitation (FMR), describes atrial or ventricular factors leading to poor coaptation of an otherwise non-diseased valve. For FMR, traditional surgery has not produced the same level of benefit. Transcatheter mitral repair and replacement techniques that mimic surgical correction are under investigation. Transcatheter edge-to-edge repair is the only approved catheter-based therapy for FMR in the US. Here, the transcatheter treatment options for FMR are reviewed., Competing Interests: Disclosure: AG is a consultant for Edwards Lifesciences. KJG is a consultant for Abbott, Boston Scientific, Medtronic, Edwards Lifesciences and 4C Medical. CMD is a paid consultant for Edwards Lifesciences, Medtronic, ReCor Medical and Shockwave Medical. All other authors have no conflicts of interest to declare., (Copyright © The Author(s), 2024. Published by Radcliffe Group Ltd.)

Development of functional tricuspid regurgitation (TR) because of chronic mitral disease and subsequent heart failure is common. However, the effect of TR on clinical outcomes after transcatheter mitral valve replacement (TMVR) remains unclear. We aimed to evaluate the impact of baseline TR on outcomes after TMVR. This was a single-center, retrospective analysis of patients who received valve-in-valve or valve-in-ring TMVR between 2012 and 2022. Patients were categorized into none/mild TR and moderate/severe TR based on baseline echocardiography. The primary outcome was 3 years all-cause death and the secondary outcomes were in-hospital events. Of the 135 patients who underwent TMVR, 64 (47%) exhibited none/mild TR at baseline, whereas 71 (53%) demonstrated moderate/severe TR. There were no significant differences in in-hospital events between the groups. At 3 years, the moderate/severe TR group exhibited a significantly increased risk of all-cause death (adjusted hazard ratio 3.37, 95% confidence interval 1.35 to 8.41, p = 0.009). When patients with baseline moderate/severe TR were stratified by echocardiography at 30 days into improved (36%) and nonimproved (64%) TR groups, although limited by small sample size, there was no significant difference in 3-year all-cause mortality (p = 0.48). In conclusion, this study investigating the impact of baseline TR on clinical outcomes revealed that moderate/severe TR is prevalent in those who underwent TMVR and is an independent predictor of 3-year all-cause mortality. Earlier mitral valve intervention before the development of significant TR may play a pivotal role in improving outcomes after TMVR., Competing Interests: Declaration of competing interest Drs. Gleason, Byku, Xie, Greenbaum, Paone, Keeling, Grubb, Hanzel, Devireddy, and Babaliaros have institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr. Grubb is a physician proctor for Medtronic and Edwards Lifesciences; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, BioVentrics, 4C Medical, W.L. Gore, and Abbott Vascular. Drs. Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have an equity interest in Transmural Systems. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Transcatheter closure of transcatheter heart valve (THV)-related paravalvular leak (PVL) is associated with a high failure rate with available devices due to the complex interaction of THV and aortic/mitral annulus., Objectives: This study reports on novel transcatheter techniques to treat PVL after THV., Methods: The authors describe consecutive patients who underwent PVL closure after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR). A covered self-expanding stent (Viabahn) was deployed in the defect to create a seal between the THV and annulus. A vascular plug (Amplatzer Vascular Plug 2 [AVP2] or AVP4) was then deployed inside the covered stent to obliterate PVL., Results: Eight patients with THV-related PVL were treated using this method (aortic [3 SAPIEN, 1 Evolut], mitral [2 SAPIEN-in-MAC (mitral annular calcification), 2 M3 TMVR). Various combinations of stents and plugs were used (5 mm × 2.5 cm Viabahn + 6 mm AVP4 [n = 2], 8 mm × 2.5 cm Viabahn + 10 mm AVP2 [n = 5], and 10 mm × 5.0 cm Viabahn + 12 mm AVP2 [n = 1]). All had technical success with immediate elimination of target PVL, without in-hospital complications. None had signs of postprocedure hemolysis. All patients were discharged alive (median 3.5 days [Q1-Q3: 1.0-4.8 days]). No residual PVL was seen at discharge, except for 1 patient with mild regurgitation due to another untreated PVL location. One patient died before 30 days due to complication of valve-in-MAC TMVR. In remaining patients, none had recurrence of PVL at 30 days. Symptoms decreased to NYHA functional class I/II in 6 patients. NYHA functional class III symptoms remained in 1 patient with mitral regurgitation awaiting subsequent valve replacement procedure., Conclusions: The technique of sequential deployment of a covered stent and vascular plug may effectively treat THV-related PVL., Competing Interests: Funding Support and Author Disclosures Drs Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have an equity interest in Transmural Systems. Drs Xie, Gleason, Byku, and Hanzel have received institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr Gleason has served on the Speakers Bureau for Edwards Lifesciences. Dr Devireddy has received consulting honoraria from Medtronic, ReCor Medical, and Shockwave Medical; and has served as a proctor for Edwards Lifesciences. 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: Disclosures Drs Xie, Hanzel, Byku, and Gleason have institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr Gleason is a speakers of bureau for Edwards Lifesciences. Dr Paone has institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific, and is a proctor for Edwards Lifesciences. Dr Grubb is a proctor, principal investigator, and serves on the advisory board for Medtronic, and also serves on the advisory board or is a consultant for Ancora Heart, Boston Scientific, Abbott, 4C Medical, and Edwards Lifesciences. Dr Devireddy receives compensation for the following roles: consultant: Medtronic, ReCor Medical, and Shockwave Medical; proctor: Edwards Lifesciences. Drs Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have an equity interest in Transmural Systems. The other author reports no conflicts.

Background: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications., Objectives: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications., Methods: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis., Results: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients., Conclusions: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775)., Competing Interests: Funding Support and Author Disclosures This study was funded by Medtronic. Dr Kandzari has received institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc, Orbus Neich, Teleflex, Medtronic, and Ablative Solutions; and has received personal consulting honoraria from Cardiovascular Systems, Inc, Medtronic, and Abbott Vascular. Dr Townsend is a consultant for Medtronic, Cytel, and Janssen. Dr Kario has received personal fees from Medtronic during the conduct of the study; has received grants from A&D Company, Omron Healthcare, Fukuda Denshi, CureApp, Sanwa Kagaku Kenkyusho, Teijin Pharma, Boehringer Ingelheim Japan, and Fukuda Lifetec; has received consulting fees from A&D Company, JIMRO, Omron Healthcare, CureApp, Terumo, and Fukuda Denshi; has received honoraria from Otsuka Pharmaceuticals and Omron Healthcare; and has participated on the Advisory Board of Fukuda Denshi, outside of the submitted work. Dr Mahfoud is supported by Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Forschungsgemeinschaft (SFB TRR219), and Deutsche Herzstiftung; has received scientific support from Ablative Solutions, Medtronic, and ReCor Medical; and has received speaker honoraria/consulting fees from Ablative Solutions, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor Medical, Servier, and Terumo. Dr Weber has received consulting fees from Medtronic, ReCor, Ablative Solutions, Johnson and Johnson, and Urovant. Dr Schmieder has received grants and personal fees from Medtronic, Recor, and Ablative Solutions. Dr Pocock has received personal fees from Medtronic outside of the submitted work. Dr Tsioufis has received institutional research/grant support from Medtronic and ReCor Medical; and has received personal consulting honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, ReCor Medical, SERVIER, WinMedica, and ELPEN. Dr Konstantinidis receives payments from Medtronic for work as research center secondary investigator. Dr Choi has received consulting fees from Medtronic, outside of the submitted work. Dr East has received consulting fees from Medtronic. Dr Lauder has received speaker fees and honoraria from Medtronic and ReCor Medical. Dr Cohen has received research support and consultant fees from Medtronic and ReCor; and receives fees from Metavention, outside of the submitted work. Dr Kobayashi is on the advisory board and Speakers Bureau for Medtronic and ReCor Medical. Dr Lee has received grants from and serves on the advisory board for Medtronic, outside of the submitted work. Dr Weil has received support from Medtronic, Recor Medical, Novartis, and AstraZeneca. Dr Agdirlioglu receives speaker honoraria from AstraZeneca, Boehringer Ingelheim, and Novartis, outside of the submitted work. Dr Schlaich has received consulting fees and/or travel and research support from Medtronic, Abbott, Novartis, Servier, Pfizer, and Boehringer Ingelheim. Dr Shetty has received consulting and speaker fees from Medtronic. Dr Devireddy has received personal fees from Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical, outside of the submitted work. Dr Sharp has received personal fees from Medtronic, Boston Scientific, Recor Medical, and Philips, outside the submitted work. Dr Anderson has received speaker fees from Shockwave Medical, Edwards Lifesciences, and Medtronic. Mr Fahy, Mrs DeBruin, and Dr Brar are employees of Medtronic. Dr Böhm is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939); and has received personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor, Servier, and Vifor during the conduct of the study. 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: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score., Methods: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis., Results: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001)., Conclusions: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR., (© 2023 Wiley Periodicals LLC.)

Competing Interests: Funding Support and Author Disclosures Dr Dickert has received research funding from the National Institutes of Health, Patient-Centered Outcomes Research Institute, and Agency for Healthcare Research and Quality; and has received consulting and research funding from Abiomed, Inc. Dr Devireddy received consulting fees from Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical.

Background: Postinfarction ventricular septal defect (VSD) is a catastrophic complication of myocardial infarction. Surgical repair still has poor outcomes. This report describes clinical outcomes after a novel hybrid transcatheter/surgical repair in patients with apical VSD., Methods: Seven patients with postmyocardial infarction apical VSD underwent hybrid transcatheter repair via subxiphoid surgical access. A transcatheter occluder (Amplatzer Septal Occluder) with a trailing premounted suture was deployed through the right ventricular wall and through the ventricular septum into the left ventricular apex. The trailing suture was used to connect an anchor external to the right ventricular wall. Tension on the suture then collapses the right ventricular free wall against the septum and left ventricular occluder, thereby obliterating the VSD. Outcomes were compared with 9 patients who underwent surgical repair using either patch or primary suture closure., Results: All patients had significant left-to-right shunt (Qp:Qs 2.5:1; interquartile range [IQR, 2.1-2.6] hybrid repair versus 2.0:1 [IQR, 2.0-2.5] surgical repair), and elevated right ventricular systolic pressure (62 [IQR, 46-71] versus 49 [IQR, 43-54] mm Hg, respectively). All had severely depressed stroke volume index (22 versus 21 mL/m 2 ) with ≈45% in each group requiring mechanical support preprocedurally. The procedure was done 15 (IQR, 10-50) versus 24 (IQR, 10-134) days postmyocardial infarction, respectively. Both groups of patients underwent repair with technical success and without intraprocedural death. One patient in the hybrid group and 4 in the surgical group developed multiorgan failure. The hybrid group had a higher survival at discharge (86% versus 56%) and at 30 days (71% versus 56%), but similar at 1 year (57% versus 56%). During follow-up, 1 patient in each group required reintervention for residual VSD (hybrid: 9 months versus surgical: 5 days)., Conclusions: Early intervention with a hybrid transcatheter/surgical repair may be a viable alternative to traditional surgery for postinfarction apical VSD., Competing Interests: Disclosures Dr Leshnower is a member of scientific advisory board for Artivion Inc and is a consultant for Endospan Inc. Drs Brent Keeling, Guyton, Xie, Gleason, Byku, Devireddy, Greenbaum, and Babaliaros have institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Drs Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have an equity interest in Transmural Systems. The other authors report no conflicts.

Objective: To measure the impact of the covid-19 pandemic on admissions to hospital and interventions for acute ischemic stroke and acute myocardial infarction., Design: A retrospective analysis., Setting: 746 qualifying hospitals in the USA from the Premier Healthcare Database., Participants: Patients aged 18 years and older who were admitted to hospital with a primary diagnosis of acute ischemic stroke or acute myocardial infarction between 1 March 2019 and 28 February 2021., Main Outcome Measures: Relative changes in volumes were assessed for acute ischemic stroke and acute myocardial infarction hospital admissions as well as intravenous thrombolysis, mechanical thrombectomy, and percutaneous coronary intervention (overall and for acute myocardial infarction only) across the first year of the pandemic versus the prior year. Mortality in hospital and length of stay in hospital were also compared across the first year of the pandemic versus the corresponding period the year prior. These metrics were explored across the different pandemic waves., Results: Among 746 qualifying hospitals, admissions to hospital were significantly reduced after the covid-19 pandemic compared with before the pandemic for acute ischemic stroke (-13.59% (95% confidence interval-13.77% to -13.41%) and acute myocardial infarction (-17.20% (-17.39% to -17.01%)), as well as intravenous thrombolysis (-9.47% (-9.99% to -9.02%)), any percutaneous coronary intervention (-17.89% (-18.06% to -17.71%)), and percutaneous coronary intervention for acute myocardial infarction (-14.36% (-14.59% to -14.12%)). During the first year of the pandemic versus the previous year, the odds of mortality in hospital for acute ischemic stroke were 9.00% higher (3.51% v 3.16%; ratio of the means 1.09 (95% confidence interval (1.03 to 1.15); P=0.0013) and for acute myocardial infarction were 18.00% higher (4.81% v 4.29%; ratio of the means 1.18 (1.13 to 1.23); P<0.0001)., Conclusions: We observed substantial decreases in admissions to hospital with acute ischemic stroke and acute myocardial infarction, but an increase in mortality in hospital throughout the first year of the pandemic. Public health interventions are needed to prevent these reductions in future pandemics., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: no support from any organization for the submitted work; RGN reports consulting fees for advisory roles with Anaconda, Biogen, Cerenovus, Genentech, Hybernia, Imperative Care, Medtronic, Phenox, Philips, Prolong Pharmaceuticals, Stryker Neurovascular, Shanghai Wallaby, Synchron, and stock options for advisory roles with Astrocyte, Brainomix, Cerebrotech, Ceretrieve, Corindus Vascular Robotics, Vesalio, Viz-AI, RapidPulse and Perfuze. RGN is one of the Principal Investigators of the “Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW) trial. Funding for this project is provided by Cerenovus. RGN is an investor in Viz-AI, Perfuze, Cerebrotech, Reist/Q’Apel Medical, Truvic, and Viseon. TNN reports research support from Medtronic, Society of Vascular and Interventional Neurology (SVIN) and Data Safety Monitoring Board participation on the TESLA, ENDOLOW, SELECT-2, PROST, CREST-2, and WE-TRUST trials. KE, SI, CW, and RK are employees of Johnson & Johnson and provided analytical support for this manuscript. DCH reports consulting fees from Stryker, Cerenovus and Vesalio and stock options in VizAI. CMD reports consulting fees from Medtronic, ReCor Medical, Vascular Dynamics and Proctor fees from Edwards Lifesciences. ARAB reports consulting fees from Stryker., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The SPYRAL HTN-OFF MED Pivotal trial ( https://clinicaltrials.gov/ct2/show/NCT02439749 ) demonstrated significant reductions in blood pressure (BP) after renal denervation (RDN) compared to sham control in the absence of anti-hypertensive medications. Prior to the 3-month primary endpoint, medications were immediately reinstated for patients who met escape criteria defined as office systolic BP (SBP) ≥ 180 mmHg or other safety concerns. Our objective was to compare the rate of hypertensive urgencies in RDN vs. sham control patients. Patients were enrolled with office SBP ≥ 150 and < 180 mmHg, office diastolic BP (DBP) ≥ 90 mmHg and mean 24 h SBP ≥ 140 and < 170 mmHg. Patients had been required to discontinue any anti-hypertensive medications and were randomized 1:1 to RDN or sham control. In this post-hoc analysis, cumulative incidence curves with Kaplan-Meier estimates of rate of patients meeting escape criteria were generated for RDN and sham control patients. There were 16 RDN (9.6%) and 28 sham control patients (17.0%) who met escape criteria between baseline and 3 months. There was a significantly higher rate of sham control patients meeting escape criteria compared to RDN for all escape patients (p = 0.032), as well as for patients with a hypertensive urgency with office SBP ≥ 180 mmHg (p = 0.046). Rate of escape was similar between RDN and sham control for patients without a measured BP exceeding 180 mmHg (p = 0.32). In the SPYRAL HTN-OFF MED Pivotal trial, RDN patients were less likely to experience hypertensive urgencies that required immediate use of anti-hypertensive medications compared to sham control., (© 2022. The Author(s).)

Purpose of Review: This review summarizes current data supporting a minimalist TAVR approach and identifies the need for additional study to optimize TAVR care. The authors discuss future directions of the TAVR landscape and how this necessitates evolution of minimalist care pathways., Recent Findings: Transcatheter aortic valve replacement (TAVR) has become a mainstay in the treatment of aortic stenosis since the initial procedure in 2002. Recently, attention has shifted to TAVR optimization and the minimalist approach with a focus on minimizing procedural sedation, protocolization of perioperative management, and prioritization on early discharge. This approach has been shown to be safe and reduce procedure time, length of stay, and overall cost for hospital systems. The minimalist care pathway avoids general anesthesia, shortens procedure time and length of stay, and reduces cost without changing mortality or readmission rates at 30 days. A variety of protocols have been proposed without a clear consensus on specific components or patient eligibility. There is a continued need for data regarding patient risk stratification, valve selection, and discharge strategy as TAVR becomes increasingly common., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: The aim of this study was to evaluate the long-term (3-year) safety and effectiveness of endovascular baroreflex amplification (EVBA) from both the European and American CALM-FIM cohorts., Background: The CALM-FIM study demonstrated that EVBA in patients with resistant hypertension significantly lowered blood pressure (BP) with an acceptable safety profile during 6-month follow-up., Methods: The CALM-FIM studies were prospective, nonrandomized, first-in-human studies that enrolled patients with resistant hypertension (office systolic BP ≥160 mm Hg and mean 24-hour ambulatory BP ≥130/80 mm Hg despite a stable regimen of ≥3 antihypertensive medications, including a diuretic agent). The incidence of (serious) adverse events and changes in BP, heart rate, and prescribed antihypertensive medication up to 3 years after implantation were determined., Results: The Mobius device was implanted in 47 patients (30 in Europe, 17 in the United States; mean age 54 years, 23 women). Five serious adverse events (hypotension, n = 2; hypertension, n = 1; vascular access complications, n = 2) and 2 transient ischemic attacks occurred within 30 days postprocedure. Two strokes and 1 transient ischemic attack occurred more than 2 years postimplantation. Mean office BP at baseline was 181 ± 17/107 ± 16 mm Hg and decreased by 25/12 mm Hg (95% CI: 17-33/8-17 mm Hg) at 6 months and 30/12 mm Hg (95% CI: 21-38/8-17 mm Hg) at 3 years. Mean 24-hour ambulatory BP at baseline was 166 ± 16/98 ± 15 mm Hg and decreased by 20/11 mm Hg (95% CI: 14-25/8-15 mm Hg) at 6 months., Conclusions: EVBA with the MobiusHD was effective in reducing BP at 3-year follow-up and appears to have an acceptable safety profile in patients with uncomplicated implantation, although data from randomized sham-controlled trials are needed to further evaluate the risk-benefit profile. (Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM&#95;EUR], NCT01911897; Controlling and Lowering Blood Pressure With the MobiusHD™ [CALM-FIM&#95;US], NCT01831895)., Competing Interests: Funding Support and Author Disclosures This work was supported by Vascular Dynamics, Inc. The study sponsor was involved in study design, data monitoring, and central storage of the data. Data analysis was performed by an external statistician who was hired by the study sponsor and performed the analysis according to the methods as requested by the authors. The authors determined the analytical methodology and data interpretation and prepared the manuscript. The sponsor had no role in data interpretation or manuscript preparation. The authors had final responsibility for the decision to submit the paper for publication. Dr van Kleef is paid through a research grant from Vascular Dynamics. Dr Devireddy is a consultant for Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical. Dr Van der Heyden is a paid proctor for Vascular Dynamics. Dr Bates is a consultant for CeloNova BioSciences, Vascular Dynamics, and W.L. Gore. Dr Bakris is a consultant for Merck, Janssen, Bayer, and Vascular Dynamics; and has received grant or clinical trials research support from Janssen, Bayer, Vascular Dynamics, Vifor, Novo Nordisk, Ionis, and Alnylam. Dr Stone has received speaker or other honoraria from Terumo and Cook; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Reva, Matrizyme, MAIA Pharmaceuticals, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, and Gore; and has equity or options in Ancora, Cagent, Applied Therapeutics, the Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, the MedFocus family of funds. Dr Williams is a consultant for Vascular Dynamics. Dr Spiering is a consultant for Vascular Dynamics; and has received a research grant from Vascular Dynamics., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Limited studies have evaluated regional disparities in the care of acute myocardial infarction (AMI) patients with cardiac arrest (CA). This study sought to evaluate 18-year national trends, resource utilization, and geographical variation in outcomes in AMI-CA admissions., Methods and Results: Using the National Inpatient Sample (2000-2017), we identified adults with AMI and concomitant CA admitted to the United States census regions of Northeast, Midwest, South, and West. Clinical outcomes of interest included in-hospital mortality, use of coronary angiography, percutaneous coronary intervention (PCI), mechanical circulatory support (MCS), hospitalization costs and length of stay. Of 9,680,257 admissions for AMI, 494,083 (5.1%) had concomitant CA. The West (6.0%) had higher prevalence compared to the Northeast (4.4%), Midwest (5.0%), and South (5.1%), p < 0.001. Admissions in the West had higher rates of STEMI, cardiogenic shock, multiorgan failure, mechanical ventilation, and hemodialysis. Northeast admissions had lower use of coronary angiography (52.0% vs. 67.9% vs. 60.9% vs. 61.5%), PCI (38.7% vs. 51.9% vs. 44.8% vs. 46.7%), and MCS (18.4% vs. 21.8% vs. 18.1%, vs. 20.0%) compared to the Midwest, West and South (all p < 0.001). Compared with the Northeast, adjusted in-hospital mortality was higher in the Midwest (odds ratio [OR] 1.06 [95% confidence interval {CI} 1.03-1.08]), South (OR 1.11 [95% CI 1.09-1.13]) and highest in the West (OR 1.16 [95% CI 1.13-1.18]), all p < 0.001. Temporal trends showed a decline in in-hospital mortality except in the West, which showed a slight increase., Conclusions: There remain significant regional disparities in the management and outcomes of AMI-CA., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is now the dominant form of aortic valve replacement in the United States. Continued innovation has allowed the technique to be safe and democratized. New advances will increase the number of patients eligible to receive this therapy while increasing safety and efficiency. Herein, the authors review new TAVR technologies, approaches to valve deployment, and dedicated devices for cerebral embolic protection and vascular closure., Competing Interests: Disclosure C.M. Devireddy: Consultant: Edwards Lifesciences, Medtronic, ReCor Medical, Shockwave Medical., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare 5-year cardiovascular, renal, and bioprosthetic valve durability outcomes in patients with severe aortic stenosis (AS) and chronic kidney disease (CKD) undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)., Background: Patients with severe AS and CKD undergoing TAVR or SAVR are a challenging, understudied clinical subset., Methods: Intermediate-risk patients with moderate to severe CKD (estimated glomerular filtration rate <60 mL/min/m 2 ) from the PARTNER (Placement of Aortic Transcatheter Valve) 2A trial (patients randomly assigned to SAPIEN XT TAVR or SAVR) and SAPIEN 3 Intermediate Risk Registry were pooled. The composite primary outcome of death, stroke, rehospitalization, and new hemodialysis was evaluated using Cox regression analysis. Patients with and without perioperative acute kidney injury (AKI) were followed through 5 years. A core laboratory-adjudicated analysis of structural valve deterioration and bioprosthetic valve failure was also performed., Results: The study population included 1,045 TAVR patients (512 SAPIEN XT, 533 SAPIEN 3) and 479 SAVR patients. At 5 years, SAVR was better than SAPIEN XT TAVR (52.8% vs 68.0%; P = 0.04) but similar to SAPIEN 3 TAVR (52.8% vs 58.7%; P = 0.89). Perioperative AKI was more common after SAVR than TAVR (26.3% vs 10.3%; P < 0.001) and was independently associated with long-term outcomes. Compared with SAVR, bioprosthetic valve failure and stage 2 or 3 structural valve deterioration were significantly greater for SAPIEN XT TAVR (P < 0.05) but not for SAPIEN 3 TAVR., Conclusions: In intermediate-risk patients with AS and CKD, SAPIEN 3 TAVR and SAVR were associated with a similar risk for the primary endpoint at 5 years. AKI was more common after SAVR than TAVR, and SAPIEN 3 valve durability was comparable with that of surgical bioprostheses., Competing Interests: Funding Support and Author Disclosures Edwards Lifesciences funded the PARTNER 2A trial and the SAPIEN 3 Intermediate Risk Registry. Dr Garcia has received institutional research grants from Edwards Lifesciences, Abbott Vascular, BSCI, and Biotronik; is a consultant for NeoChord, Medtronic, BSCI, and Abbott Vascular; and is a proctor for Edwards Lifesciences. Dr Cubeddu is an educational speaker and has conducted proctor-related activities for Edwards Lifesciences and Abbott Vascular. Dr Hahn has received speaker fees from Edwards Lifesciences and Philips Healthcare; has received consulting fees from Abbott Structural, Boston Scientific, Edwards Lifesciences, Gore & Associates, and Medtronic; holds equity with Navigate; and is chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Kapadia has received institutional research grants from Edwards Lifesciences (no direct physician compensation). Dr Kodali is a consultant (honoraria) for Admedus and Dura Biotech; is a scientific advisory board member (equity) for Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve, Supira, Admedus, TriFlo, and Adona; and has received institutional research funding from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, JenaValve, and Keystone Medical. Dr Thourani is a consultant for Abbott Vascular, Boston Scientific, Cryolife, Edwards Lifesciences, JenaValve, Shockwave, and W.L. Gore. Dr Jaber receives monetary institutional support for echocardiography core laboratory in TAVR, with no direct or indirect personal compensation. Dr Elmariah has received institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular; and is a consultant for Edwards Lifesciences. Dr Makkar has received grants from Edwards Lifesciences and Abbott; and has served as a consultant for Cordis and Medtronic. Dr Webb has served as a proctor and consultant for Edwards Lifesciences. Dr Herrmann has received institutional research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting and speaker honoraria from Edwards Lifesciences and Medtronic. Dr Lu is an employee of Edwards Lifesciences. Dr Devireddy has received consulting fees from Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical. Dr Malaisrie has received consulting fees Edwards Lifesciences, Medtronic, and Cryolife. Dr Smith has been reimbursed for travel and other customary expenses related to trial management as a principal investigator of the PARTNER trials. Dr Mack has received consulting fees from Gore; has served as a trial coprimary investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr Sorajja has received institutional research grants from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Medtronic; and is a consultant for Abbott Vascular, Boston Scientific, Medtronic, NeoVasc, TeleFlex, TriFlo, VDyne, and W.L. Gore. Dr Cavalcante has received research grants from and is a consultant for Abbott Vascular, Circle Cardiovascular Imaging, Boston Scientific, Medtronic, Siemens Healthineers, and Edwards Lifesciences; is a consultant for VDyne and Triflo; and is a member of the Speakers Bureau for Circle Cardiovascular Imaging, Medtronic, Siemens Healthineers. Dr Goessl is a consultant for Abbott Vascular. Dr Leon has received institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr Pibarot has received research grants from Edwards Lifesciences and Medtronic for echocardiography core laboratory or in vitro analyses in TAVR, with no personal compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to evaluate the safety, efficacy and feasibility of same-day discharge after uncomplicated, minimalist TAVR., Background: At the start of the COVID-19 pandemic, we created a same-day discharge (SDD) pathway after conscious sedation, transfemoral (minimalist) TAVR to help minimize risk of viral transmission and conserve hospital resources. Studies support that next-day discharge (NDD) for carefully selected patients following minimalist TAVR is safe and feasible. There is a paucity of data regarding the safety of SDD after TAVR., Methods: In-hospital and 30 day outcomes of consecutive patients meeting pre-specified criteria for SDD after minimalist TAVR at our institution between March and July of 2020 were reviewed. Outcomes were compared to a NDD cohort from July 2018 through July 2020 that would have met SDD criteria. Primary endpoints were mortality, delayed pacemaker placement, stroke and cardiovascular readmission at 30 days., Results: Twenty nine patients were discharged via the SDD pathway after TAVR. 128 prior NDD patients were identified who met all criteria for SDD. The STS scores were similar between the two groups (SDD 2.6% ±1.5 vs. NDD 2.3% ± 1.2). There were no deaths at 30 days in either group. There was no significant difference in delayed pacemaker placement (SDD 0% vs. NDD 0.8%, p > .99) or cardiovascular readmission (SDD 0% vs. NDD 5.5%, p = .35) at 30 days., Conclusions: Same day discharge following uncomplicated, minimalist TAVR in selected patients appears to be safe, achieving similar 30 day outcomes as a cohort of next day discharge patients., (© 2020 Wiley Periodicals LLC.)

Background: The effect of transcatheter aortic valve replacement (TAVR) on kidney function stage in patients with aortic stenosis remains poorly understood. We hypothesized that in some patients, TAVR results in improved kidney function by alleviating cardiorenal syndrome., Objectives: The purpose of this study was to assess change in chronic kidney disease (CKD) stage following TAVR, identify variables associated with pre- and post-TAVR estimated glomerular filtration rate (eGFR), and assess association of post-TAVR eGFR with mortality., Methods: Patients (n = 5,190) receiving TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) 1, 2, and PARTNER 2 S3 trials between April 2007 and October 2014 were included. Pre-TAVR and procedural variables associated with post-TAVR eGFR, change in CKD stage at ≤7 days post-TAVR, and association of post-TAVR eGFR on intermediate-term mortality were assessed., Results: At baseline, CKD stage ≥2 was present in 91% of patients. CKD stage either improved or was unchanged following TAVR in the majority of patients (77% stage 1, 90% stage 2, 89% stage 3A, 94% stage 3B, and 99% stage 4). Progression to CKD stage 5 occurred in 1 (0.035%) of 2,892 patients within 7 days post-TAVR. Of 3,546 patients in whom data were available, 70 (2.0%) underwent post-TAVR dialysis. Higher pre-TAVR eGFR and transfemoral approach were strongly associated with higher post-TAVR eGFR. Lower baseline and longitudinal post-TAVR eGFR were associated with lower intermediate-term survival., Conclusions: In patients with severe aortic stenosis undergoing TAVR, even with baseline impaired eGFR, CKD stage is more likely to stay the same or improve than worsen. Aortic stenosis may contribute to cardiorenal syndrome that improves with TAVR., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications., Methods: In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749., Findings: From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months., Interpretation: SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications., Funding: Medtronic., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Intravascular lithotripsy (IVL) may be useful to deliver Impella devices in patients with peripheral arterial disease. Twelve patients were treated with peripheral IVL prior to Impella insertion. A total of 100% of patients underwent successful device implantation with no IVL complications. IVL can facilitate transfemoral access for Impella insertion. ( Level of Difficulty: Advanced. )., (© 2020 The Authors.)

Objectives: Persons living with HIV (PLWH) are at greater risk for acute coronary syndrome (ACS). Practice patterns of ACS management by HIV serostatus are unknown. We examined the presentation and management of ACS in PLWH., Design: Retrospective case-control study., Methods: We included 86 PLWH and 263 sex-matched and race-matched HIV-negative controls hospitalized with ACS between 2004 and 2013. We performed multivariable conditional logistic regression to determine the associations between HIV serostatus and ACS type and management., Results: Both groups were predominantly of black race and male sex. PLWH were significantly younger (53 vs. 60 years) and more likely to smoke (48 vs. 31%). Among PLWH, 30% had CD4 cell count less than 200 cells/μl and 58% had undetectable HIV RNA. PLWH had more single-vessel disease and a higher median Gensini score among those with single-vessel disease (32 vs. 4.25) than controls. HIV serostatus was positively associated with ST-elevation myocardial infarction (STEMI) [adjusted odds ratio (aOR) (95% confidence interval (CI)):5.05 (1.82-14.02)], and any revascularization procedure after ACS [aOR (95% CI): 2.90 (1.01-8.39)] and negatively associated with non-STEMI [aOR (95% CI): 0.33 (0.14-0.79)] presentation. PLWH who underwent stent placement had a higher likelihood of bare metal stent placement compared with controls [70 vs. 15%, aOR (95% CI): 5.94 (1.33-26.55)]. Among PLWH, ACS characteristics were not significantly associated with CD4 cell count, HIV RNA, or antiretroviral therapy., Conclusion: PLWH hospitalized with ACS were more likely to have severe single-vessel disease, present with STEMI rather than non-STEMI, and undergo revascularization, and less likely to have a drug-eluting stent placed than matched HIV-negative controls, suggesting that coronary plaque morphology and/or distribution is different with HIV infection and warrants further investigation.

Objectives: The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR)., Background: TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes., Methods: All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367)., Results: Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p < 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing >15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p < 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p < 0.001), which was similar to its performance in the derivation cohort., Conclusions: A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients' and surrogates' experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context-sensitive approaches to consent is important.

Background: There has been debate about the role of consent in pragmatic trials comparing qualitatively similar interventions. Consent preferences may differ in acute care contexts, given severe illness, time constraints, and other barriers to consent. In addition, studies have not assessed the impact of disclosing financial considerations as a justification for trials. This study was designed to assess preferences of the general public regarding consent for a pragmatic trial in ST-elevation myocardial infarction., Methods: This survey was completed using an online, probability-based panel representative of the US population. It incorporated a randomized, experimental (2 × 2) design assessing (1) preference for written consent versus an alternative (notification after enrollment or brief verbal consent) and (2) impact of including cost as a motivating factor for the trial. The survey used a scenario based on a recent pragmatic trial in ST-elevation myocardial infarction. Primary independent variables were personal preference and recommendation as a member of a review board regarding written consent versus the assigned alternative strategy and personal attitude toward trial enrollment. Descriptive analyses were conducted using post-stratification weights. Regression models were created to examine relationships between demographic variables and consent preference and willingness to enroll. Provision of cost information was incorporated into a regression model to examine its impact on consent preference., Results: The study included 2027 participants. Of those participants, 51.1% versus 45.8% stated a personal preference for written consent versus notification after enrollment; however, 60.0% versus 35.5% preferred brief verbal consent to written consent. Even among respondents stating they would be unlikely to enroll in the trial if asked, more respondents (50.6%) preferred brief verbal consent. The preference for verbal consent was generally shared across demographic categories, although lower educational attainment was associated with reduced acceptance (p = 0.001 for trend). Respondents were more likely to support an alternative to written consent when asked their personal preference than when asked their recommendation as a member of a review board. The provision of cost information did not have a meaningful effect on consent preferences, attitudes toward enrollment, or views about the study., Conclusion: Respondents generally supported prospective involvement in enrollment decisions in the setting of acute myocardial infarction and were particularly supportive of brief verbal consent. This support persisted across demographic categories. The finding that individuals were more likely to support alternatives to written consent when asked for a personal preference rather than as a "committee member" suggests that conservative institutional approaches to consent could hinder implementation of more patient-centered approaches. The role of cost transparency in consent discussions warrants further study.

Objectives: To evaluate the role mitral regurgitation (MR) etiology and severity play in outcomes for patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Multiple prior studies have investigated the influence of MR severity on outcomes for patients undergoing TAVR. Less has been published regarding the effects of MR etiology on outcomes, including its impact on heart failure hospitalization., Methods: Two hundred and seventy patients undergoing TAVR at 2 hospitals were enrolled. Each patient had a baseline and follow-up (within 30 days of TAVR) echocardiogram that was analyzed. MR was graded as none, mild, moderate, or severe, as well as functional or degenerative. We compared patient outcomes, including death and heart failure hospitalization, among none-mild MR, moderate-severe functional MR, and moderate-severe degenerative MR groups., Results: Two hundred and seventy patients underwent TAVR, reducing mean aortic valve gradients from 45 ± 15 mm Hg to 9 ± 4 mm Hg. On multivariable analysis, only patients with moderate-severe degenerative MR had decreased survival free of death or CHF hospitalization compared to those with none-mild MR (P = .011). Subanalysis showed patients with moderate-severe degenerative MR were more likely to be hospitalized for heart failure at 2 years compared to those with moderate-severe functional MR (P = .02). Patients with moderate-severe degenerative MR were also less likely to have improvement in MR severity at follow up (P = .01)., Conclusions: Special consideration should be given to patients with moderate-severe degenerative MR undergoing TAVR. As transcatheter approaches for mitral valve repair and replacement continue to evolve, moderate-severe degenerative MR patients may benefit from consideration of double valve intervention., (© 2018 Wiley Periodicals, Inc.)

Objectives: This study sought to develop a novel technique called bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction (BASILICA)., Background: Coronary artery obstruction is a rare but fatal complication of transcatheter aortic valve replacement (TAVR)., Methods: We lacerated pericardial leaflets in vitro using catheter electrosurgery, and tested leaflet splaying after benchtop TAVR. The procedure was tested in swine. BASILICA was then offered to patients at high risk of coronary obstruction from TAVR and ineligible for surgical aortic valve replacement. BASILICA used marketed devices. Catheters directed an electrified guidewire to traverse and lacerate the aortic leaflet down the center line. TAVR was performed as usual., Results: TAVR splayed lacerated bovine pericardial leaflets. BASILICA was successful in pigs, both to left and right cusps. Necropsy revealed full length lacerations with no collateral thermal injury. Seven patients underwent BASILICA on a compassionate basis. Six had failed bioprosthetic valves, both stented and stent-less. Two had severe aortic stenosis, including 1 patient with native disease, 3 had severe aortic regurgitation, and 2 had mixed aortic valve disease. One patient required laceration of both left and right coronary cusps. There was no hemodynamic compromise in any patient following BASILICA. All patients had successful TAVR, with no coronary obstruction, stroke, or any major complications. All patients survived to 30 days., Conclusions: BASILICA may durably prevent coronary obstruction from TAVR. The procedure was successful across a range of presentations, and requires further evaluation in a prospective trial. Its role in treatment of degenerated TAVR devices remains untested., (Published by Elsevier Inc.)

A 74-year-old man presented with progressive dyspnea on exertion. History included peripheral arterial disease and coronary artery bypass grafting with aortic valve replacement 12 years ago. Subsequently, the surgical valve developed severe stenosis and moderate insufficiency. He underwent a transapical valve-in-valve transcatheter aortic valve replacement 5 years before presentation. This second valve developed a mean gradient of 66 mm Hg with mild insufficiency. The patient was treated with a third aortic valve using an alternative transcaval approach, significantly alleviating his symptoms.

Background: Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications., Methods: SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749., Findings: Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP -5·5 mm Hg (95% CI -9·1 to -2·0; p=0·0031), 24-h DBP -4·8 mm Hg (-7·0 to -2·6; p<0·0001), office SBP -10·0 mm Hg (-15·1 to -4·9; p=0·0004), and office DBP -5·3 mm Hg (-7·8 to -2·7; p=0·0002). No significant changes were seen in the sham-control group: 24-h SBP -0·5 mm Hg (95% CI -3·9 to 2·9; p=0·7644), 24-h DBP -0·4 mm Hg (-2·2 to 1·4; p=0·6448), office SBP -2·3 mm Hg (-6·1 to 1·6; p=0·2381), and office DBP -0·3 mm Hg (-2·9 to 2·2; p=0·8052). The mean difference between the groups favoured renal denervation for 3-month change in both office and 24-h blood pressure from baseline: 24-h SBP -5·0 mm Hg (95% CI -9·9 to -0·2; p=0·0414), 24-h DBP -4·4 mm Hg (-7·2 to -1·6; p=0·0024), office SBP -7·7 mm Hg (-14·0 to -1·5; p=0·0155), and office DBP -4·9 mm Hg (-8·5 to -1·4; p=0·0077). Baseline-adjusted analyses showed similar findings. There were no major adverse events in either group., Interpretation: Results from SPYRAL HTN-OFF MED provide biological proof of principle for the blood-pressure-lowering efficacy of renal denervation., Funding: Medtronic., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Objectives: To evaluate the safety and efficacy of catheter-directed thrombolysis (CDT) in the treatment of acute pulmonary embolism (PE)., Background: The use of CDT for the treatment of acute submassive and massive PE is increasing in frequency. However, its safety and efficacy have not been well elucidated., Methods: This study is made of two parts: one is a two-center registry of acute PE patients treated with CDT. The safety outcome evaluated was any major complication including fatal, intracranial (ICH), intraocular, or retroperitoneal hemorrhage or any overt bleeding requiring transfusion or surgical repair. The efficacy outcome was acute change in invasive pulmonary artery systolic pressure (PASP). The second part is a meta-analysis of all contemporary studies that used CDT for PE. Reported outcomes are the same as in the registry, with the addition of right ventricular to left ventricular (RV/LV) ratio change., Results: In the registry, 137 patients were included (age 59 ± 15, 50% male, 88% submassive PE). ICH occurred in two patients and major complications in 13 (9.4%). PASP decreased post procedure by 19 ± 15 mm Hg (95% CI 16-23). In the meta-analysis, 16 studies were included with 860 patients. Rate of ICH was 0.35% and the major complication rate was 4.65%, most requiring transfusion only. In-hospital mortality was 12.9% in the massive and 0.74% in the submassive group. All studies showed improvement in PASP and/or RV/LV ratio post CDT., Conclusions: CDT is associated with a low major complication rate. Randomized studies are needed to evaluate its efficacy relative to anticoagulation alone. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: Chronic obstructive pulmonary disease (COPD) has been identified as a risk factor for morbidity and mortality after transcatheter aortic valve replacement (TAVR). We hypothesized that a portion of pulmonary dysfunction in patients with severe aortic stenosis may be of cardiac origin, and has potential to improve after TAVR., Methods: A retrospective analysis was made of consecutive TAVR patients from April 2008 to October 2014. Of patients who had pulmonary function testing and serum B-type natriuretic peptide data available before and after TAVR, 58 were found to have COPD (26 mild, 14 moderate, and 18 severe). Baseline variables and operative outcomes were explored along with changes in pulmonary function. Multiple regression analyses were performed to adjust for preoperative left ventricular ejection fraction and glomerular filtration rate., Results: Comparison of pulmonary function testing before and after the procedure among all COPD categories showed a 10% improvement in forced vital capacity (95% confidence interval: 4% to 17%) and a 12% improvement in forced expiratory volume in 1 second (95% confidence interval: 6% to 19%). There was a 29% decrease in B-type natriuretic peptide after TAVR (95% confidence interval: -40% to -16%). An improvement of at least one COPD severity category was observed in 27% of patients with mild COPD, 64% of patients with moderate COPD, and 50% of patients with severe COPD. There was no 30-day mortality in any patient group., Conclusions: In patients with severe aortic stenosis, TAVR is associated with a significant improvement of pulmonary function and B-type natriuretic peptide. After TAVR, the reduction in COPD severity was most evident in patients with moderate and severe pulmonary dysfunction., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) may offer extreme-aged patients a treatment alternative to surgical aortic valve replacement (SAVR). The objective of this study was to describe outcomes of TAVR in nonagenarians using transfemoral and alternative access techniques., Methods: In a retrospective review, we found 95 nonagenarians who underwent TAVR from September 2007 through February 2014 at Emory University using a balloon expandable valve: transfemoral (n = 66), transapical (n = 14), transaortic (n = 14), and transcarotid (n = 1). Morbidity and 30-day and midterm mortality were assessed. Kaplan-Meier plots were used to determine midterm survival rates., Results: The mean age of the patients was 91.8 ± 1.8 years, and 49 (52%) were female. Postoperative morbidity included 1 patient (1%) each with stroke, myocardial infarction, pneumonia, and renal failure. The mean postoperative length of stay was 6.8 ± 5.1 days for all patients. Overall 30-day mortality was 3.2%, much less than The Society of Thoracic Surgeons predicted risk of mortality of 14.5% ± 7.3%. There were no deaths in the transfemoral patients, but there were 2 transapical deaths (14.3%) and 1 transaortic death (7.1%). The Kaplan-Meier estimate of median survival was 2.6 years., Conclusions: Extreme-aged nonagenarian patients may have excellent outcomes from TAVR at 30-day and midterm follow-up. Alternative access TAVR is associated with higher morbidity and mortality than transfemoral TAVR. Referral for TAVR of nonagenarians should not be precluded based on age alone., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Aims: The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results., Methods and Results: Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥ 180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group. Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham; -15.2 ± 23.5 vs. -8.6 ± 24.8 mmHg, respectively (P = 0.012). Greater reductions in office and ambulatory SBP, and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern., Conclusions: Post hoc analyses, although derived from limited patient cohorts, reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups. These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension. CLINICALTRIALS.GOV IDENTIFIER: NCT01418261., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Background: An increasing number of patients with prior coronary artery bypass grafting (CABG) now present with severe aortic stenosis. The proposed benefit of surgical (SAVR) vs transcatheter aortic valve replacement (TAVR) is unknown. The objective of this study was to compare short-term and midterm outcomes of patients undergoing isolated SAVR vs TAVR in those with prior CABG., Methods: A retrospective analysis was performed of 255 patients who underwent isolated SAVR after prior CABG from January 2002 to February 2013 at Emory University. Outcomes of 148 patients undergoing SAVR (2002 to 2013) and 107 undergoing TAVR (2007 to 2013) were compared using multivariable logistic regression and analysis of variance techniques, adjusting for The Society of Thoracic Surgeons (STS) risk score. Kaplan-Meier plots were used to determine survival rates, and midterm survival between groups was compared using the Cox proportional hazards model., Results: TAVR patients were older (79.8 ± 7.9 years vs 72.5 ± 8.8 years, p < 0.001) but were gender equivalent (female: 24% vs 22%, p = 0.61). The preoperative ejection fraction was similar between groups (TAVR: 0.433 ± 0.131 vs SAVR: 0.469 ± 0.148%, p = 0.60). The TAVR group had a significantly higher the STS risk scores (11.8% vs 7.1%, p < 0.001). All-cause 30-day mortality was 1.9% for TAVR and 4.1% for SAVR (p = 0.32), a result that marginally favors TAVR after risk adjustment (adjusted odds ratio, 0.19; p = 0.07). Postoperative morbidity and resource utilization was significantly higher in the SAVR patients. Midterm survival was similar between the two groups after adjustment (adjusted hazard ratio, 0.78, p = 0.46)., Conclusions: Excellent outcomes can be achieved in SAVR or TAVR after prior CABG. Although TAVR improves short-term outcomes and resource utilization compared with SAVR, midterm mortality outcomes are similar., (Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

This article discusses the approach to the management of myocardial infarction (MI) in the intensive care unit setting. It includes an overview of the definition, classification, and underlying pathologic conditions of acute MI and specifically discusses the diagnosis and management of unstable angina, non-ST elevation MI, and ST-segment elevation MI. Diagnosis and treatment of the acute complications of MI are also reviewed., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Studies of endovascular renal denervation (RDN) have demonstrated significant blood pressure reduction in eligible patients with resistant hypertension. These trials have used stringent inclusion and exclusion criteria in patient enrollment, potentially selecting for a small subset of patients with resistant hypertension. In this study, we examined the changes in estimated prevalence of resistant hypertension when using increasingly stringent definitions of resistant hypertension in a fixed population and assessed the generalizability of RDN when applying study criteria to a community-based hypertensive population., Methods: A retrospective chart review was done of hypertensive outpatients. Four increasingly stringent interpretations of the American Heart Association definition of resistant hypertension were used to calculate prevalence estimates. Patients eligible for RDN were identified using criteria from SYMPLICITY HTN-3. Demographic and clinical characteristics were compared., Results: We identified 1,756 hypertensive outpatients; 55.0% were male, 53.9% were white, and subjects had a mean age of 66.6 ± 12.5 years and a body mass index (BMI) of 30.1 ± 10.7 kg/m(2). Only 14 (0.8%) were eligible for RDN. Among these patients, 10 (71.4%) were female and all were black, with a mean age of 69.9 ± 8.8 and BMI of 35.7 ± 6.6. Congestive heart failure was more common in patients eligible for RDN., Conclusions: Patients eligible for RDN based on published studies represent an exceedingly small proportion of the total hypertensive population. Further studies are necessary to determine if the benefits of RDN can be generalized to a broader range of hypertensive patients than those included in previous trials.

Background: Renal impairment portends adverse outcomes in patients undergoing valvular heart surgery. The relationship between renal dysfunction in patients undergoing transcatheter aortic valve replacement (TAVR) is incompletely understood., Methods: A retrospective review of 1336 patients undergoing surgical aortic valve replacement (SAVR; 2002-2012) and 321 patients undergoing TAVR (2007-2012) was performed. Patients were divided into 3 glomerular filtration rate (GFR) groups: GFR greater than 60 mL/min, GFR 31 to 60 mL/min, and GFR 30 mL/min or less. Logistic and linear regression analysis was performed to estimate the TAVR effect on outcomes. Risk adjustments were made using the Society for Thoracic Surgeons (STS) predicted risk of mortality (PROM)., Results: TAVR patients were older (82 vs 65 years; P < .001), had a poorer ejection fraction (48% vs 53%; P < .001), were more likely female (45% vs 41%; P = .23), and had a higher STS PROM (11.9% vs 4.6%; P < .001). In-hospital mortality rates for TAVR and SAVR were 3.5% and 4.1%, respectively (P = .60), a result that marginally favors TAVR after risk adjustment (adjusted odds ratio = .52, P = .06). In SAVR patients, worsening preoperative renal failure was associated with increased in-hospital mortality (P = .004) and hospital (P < .001) and intensive care unit (ICU) (P < .001) lengths of stay. In contrast, worsening renal function did not influence in-hospital mortality (P = .78) and hospital (P < .23) and ICU (P = .88) lengths of stay in TAVR patients., Conclusions: Worsening renal function was associated with increased in-hospital mortality, hospital length of stay, and ICU length of stay in SAVR patients, but not in TAVR patients. This unexpected finding may have important clinical implications in patients with aortic stenosis and preoperative renal dysfunction., (Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives and Background: Recanalization of a chronic total occlusion (CTO) is technically challenging with less than optimum results in arterial disease. Crosser® is a novel technology that utilizes high frequency (20 KHz) vibration energy to fragment occlusive fibrous atherosclerotic plaque and helps in traversing the occluded vessel. We report a single center experience with this catheter as the primary device in peripheral chronic total occlusions., Methods: The catheter was used as the primary device in 25 consecutive patients with peripheral CTOs. The peripheral CTOs in this study are defined as 100% occluded vessels involving any segment of the iliac artery or below the inguinal ligament down to the trifurcation vessels which have been occluded for greater than 3 months judged by patient's history of longstanding symptoms with no worsening in the past 3 months. Procedural success was defined by the ability of the device to facilitate guide wire crossing of the occlusion. All angiograms were evaluated by two operators. Data on demographics, angiographic variables, and patient complications was collected., Results: The device was used in 25 consecutive patients and 27 CTO lesions were treated. Critical limb ischemia and claudication were the indications in 32 and 68% of the patients, respectively. Average lesion length was 117 mm (range 10-300 mm). Superficial femoral artery was the most common lesion site (n = 20, 74%). Crosser-assisted guide wire recanalization was achieved in 11(41%) lesions while the final overall procedure success rate with any device was 63% (n = 17). Perforation occurred in five lesions with one directly attributable to this device., Conclusions: In this single center observational review, the Crosser device in peripheral CTO lesions had a procedural success of 41%. © 2010 Wiley-Liss, Inc.

Previous small series have provided conflicting data on the association between coronary artery aneurysms and traditional cardiac risk factors, as well as limited information on patient outcomes. This investigation sought to determine whether the presence of coronary artery aneurysms has an adverse affect on patient outcomes. The results show that coronary aneurysms were an independent predictor of mortality, and overall 5-year survival in patients with aneurysms was only 71%. We believe that clinicians should aggressively monitor and modify coronary risk factors in patients with coronary aneurysms.