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Background: Coronary functional testing to formally diagnose coronary microvascular dysfunction (CMD) reduces cardiovascular events and alleviates angina. This study aims to investigate the extensive and complex journey that patients with CMD undergo, from the onset of chest pain to eventual diagnosis., Methods: Data from the Coronary Microvascular Disease Registry (CMDR) were analyzed, including information on the date of first documentation of chest pain, number of non-invasive and invasive tests the patient underwent, emergency department visits, and hospitalizations. In addition, we estimated the total cost per patient. A total of 61 patients with CMD diagnosis were included in this analysis., Results: Most patients in our cohort were older than 50 years of age. The median time from initial chest pain symptoms to diagnosis was 0.62 (interquartile range [IQR]: 0.06-2.96) years. During this period, patients visited the emergency department a median of 1.0 (IQR: 0.0-2.0) times. Diagnostic tests included 3.0 (IQR: 2.0-6.0) electrocardiograms, 3.0 (IQR: 0.0-6.0) high-sensitivity troponin tests, and 1.0 (IQR: 1.0-2.0) echocardiograms. Prior to diagnosis of CMD, 13 (21.3 %) patients had left heart catheterization without coronary functional testing. Non-invasive testing for ischemia was conducted in 43 (70.5 %) patients. Alternative non-cardiac diagnoses were given to 11 (18.0 %) patients during the diagnostic process, with referrals made to gastroenterology for 16 (26.2 %) and pulmonology for 10 (16.4 %) patients. The cost was almost $2000/patient., Conclusion: Timely identification of CMD offers promising opportunities for prompt symptom alleviation, accompanied by reduced visits to the emergency department, cardiovascular testing, invasive medical procedures, and consequently reduced healthcare expenses., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brian C. Case – Speaker: Zoll Medical. Hayder D. Hashim – Advisory Board, Speaker: Abbott Vascular, Boston Scientific, Philips IGT. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Transmural Systems Inc. All other authors – None., (Copyright © 2024. Published by Elsevier Inc.)

Background: Coronary microvascular dysfunction (CMD) is a prevalent condition among patients with cardiovascular risk factors, leading to a reduced quality of life and an increased risk of major adverse cardiovascular events. Novel invasive techniques have emerged to more accurately diagnose CMD. However, CMD's natural history remains poorly understood due to limited data. To address this knowledge gap, the Coronary Microvascular Disease Registry (CMDR) was established with the primary aim of standardizing comprehensive coronary functional testing and understanding of CMD., Design: CMDR is a prospective, multicenter registry enrolling an unlimited number of consecutive subjects who undergo comprehensive invasive hemodynamic assessment of the entire coronary arterial vasculature. Patients undergoing acetylcholine provocation test for coronary vasospasm will also be included. Follow-up assessments will be conducted at 30 days and annually for up to 5 years. The primary endpoint is Canadian Cardiovascular Society angina grade over time. Secondary endpoints, including all-cause mortality, cardiovascular death, acute myocardial infarction, stroke, hospitalizations, medication changes, and subsequent coronary interventions, will be analyzed to establish long-term safety and clinical outcomes in patients undergoing invasive CMD assessment., Summary: CMDR aims to characterize the clinical and physiologic profile of patients undergoing comprehensive invasive coronary functional testing, simultaneously providing crucial longitudinal information on the natural history and outcomes of these patients. This will shed light on CMD's course and clinical implications, which, in turn, holds the potential to significantly improve diagnostic and treatment strategies for CMD patients, ultimately leading to the enhancement of their overall prognosis and quality of life., Clinical Trial Registration: clinicaltrials.gov, NCT05960474., Competing Interests: Declaration of competing interest Brian C. Case, - Speaker: Asahi Intecc USA, Zoll Medical. Hector M. Garcia-Garcia – Institutional Grant Support: MedAlliance, Biotronik, Neovasc, Boston Scientific, Abbott, Shockwave, Chiesi, Philips, Spectrawave, Angiowave, InfraReDx, Medis, Pulse Medical, MedHub; Consultancy: Biotronik and Abbott; Speaker's fee: Abbott, Biotronik, Boston Scientific, InfraReDx. Hayder Hashim – Advisory Board, Speaker: Abbott Vascular, Boston Scientific, Philips IGT. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Transmural Systems Inc. All other authors – None., (Copyright © 2024. Published by Elsevier Inc.)

Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kalyan R. Chitturi – Consultant: Glass Health. Brian C. Case – Speaker: Asahi Intecc Medical, Zoll Medical. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Append Medical, Pi-Cardia Ltd., Transmural Systems Inc. All other authors have no conflicts of interest to declare.

Background: PROTECT IV is a current enrolling randomized controlled trial evaluating high-risk percutaneous coronary intervention (HR-PCI) with prophylactic Impella versus no Impella to reduce the composite primary endpoint of all-cause death, stroke, myocardial infarction (MI), or cardiovascular hospitalization. In a PROTECT IV-like cohort of patients who underwent HR-PCI without Impella, we aimed to report the rate of major adverse events to determine whether the trial is adequately powered., Methods and Results: A total of 700 patients meeting similar inclusion/exclusion criteria of PROTECT IV who underwent HR-PCI without Impella at a single tertiary center from 2008 to 2022 were included in the analysis. The composite rates of all-cause death, MI, target lesion revascularization, and target vessel revascularization at 1, 2, and 3 years were estimated using the Kaplan-Meier method, and the results were used to calculate the sample size under the constant hazard ratio assumption and expected number of events to be observed used in planning PROTECT IV. The primary endpoint occurred in 30.8 % of patients at 2 years. PROTECT IV assumes a hazard ratio of 0.75 using a multivariate Cox regression, which, under a 5 % level and 90 % power, yields 516 events. This implies a 2-year primary outcome rate of 50 % for the non-Impella arm., Conclusion: Therefore, PROTECT IV estimates that a sample size of 1252 patients is required for Impella to be declared superior to the non-Impella group. Using our observed 2-year outcome of 30.8 %, we estimate that PROTECT IV requires 1966 patients, demonstrating that PROTECT IV is probably underpowered., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kalyan R. Chitturi – Consultant: Glass Health. Brian C. Case – Speaker: Asahi Intecc USA, Zoll Medical. Toby Rogers – Consultant: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Anteris, and Transmural Systems; Advisory board: Medtronic, Boston Scientific; Equity: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH, for transcatheter electrosurgery devices. Hayder D. Hashim – Advisory Board, Speaker: Abbott Vascular, Boston Scientific, Philips IGT. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Append Medical, Pi-Cardia Ltd., Transmural Systems Inc. All other authors – None., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Conduction disturbances have uncertain implications for long-term left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR). We aimed to examine LVEF changes in patients up to two years post-TAVR., Methods: We examined patients who underwent TAVR between 2012 and 2020 and underwent echocardiography follow-up. Patients were categorized into four groups: 1) Those without a permanent pacemaker (PPM) or left bundle branch block (LBBB) pre- or post-TAVR; 2) Patients with pre- and post-TAVR LBBB; 3) Individuals with preexisting PPM; and 4) Patients requiring new PPM after TAVR. LVEF was assessed at the outset of TAVR, at 30 days, 1-year, and 2-years post-TAVR., Results: The study included 730 patients: 421 (57.6 %) without conduction abnormalities, 151 (20.7 %) with post-TAVR LBBB (48 pre-existing, 103 new-onset), 63 (8.6 %) with pre-existing PPM, and 95 (13.1 %) requiring new PPM. At discharge, patients without conduction abnormalities exhibited the highest LVEF (57.4 ± 11.5 %), whereas those with pre-existing PPM had the lowest (48.1 ± 15.5 %). Over two years, LVEF remained constant in patients without conduction issues and in those with pre-existing PPM. However, patients with new LBBB experienced a 6.3 % decrease in LVEF, and those requiring new PPM showed a 4.1 % reduction., Conclusion: New conduction abnormalities, such as LBBB or the need for PPM, induce a decline in LVEF post-TAVR. It is imperative to focus on the long-term monitoring of left ventricular function in patients experiencing new conduction disturbances post-TAVR., Competing Interests: Declaration of competing interest Brian C. Case – Speaker: Asahi Intecc USA, Zoll Medical. Kalyan R. Chitturi – Consultant: Glass Health. Toby Rogers – Consultant: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, Anteris, and Transmural Systems; Advisory board: Medtronic, Boston Scientific; Equity: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH, for transcatheter electrosurgery devices. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Append Medical, Pi-Cardia Ltd., Transmural Systems Inc. All other authors – None., (Copyright © 2023. Published by Elsevier Inc.)

Background: Coronary microvascular dysfunction (CMD) is associated with various inflammatory conditions that worsen endothelial dysfunction. This study aimed to investigate the relationship between CMD and inflammation using common inflammatory markers derived from complete blood count (CBC) analysis., Methods: Information was gathered from the Coronary Microvascular Disease Registry to examine the neutrophil-to-lymphocyte ratio (NLR), eosinophil-to-monocyte ratio (EMR), and monocyte-to-high-density lipoprotein ratio (MHR) in a cohort of patients with angina who showed non-obstructive coronary arteries and underwent invasive physiological assessments for CMD., Results: Of the 171 patients studied, 126 were CMD-negative and 45 were CMD-positive, constituting two groups of interest. The average age of all patients was 61.7 ± 11.1 years, and 63.7 % were female. No significant differences were observed between the two groups in terms of baseline characteristics, cardiovascular risk factors, or potential anti-inflammatory medications. Furthermore, there were no statistically significant differences in NLR (2.54 ± 3.71 vs. 2.52 ± 2.28, p = 0.97), EMR (0.3 ± 0.21 vs. 0.34 ± 0.29, p = 0.31), or MHR (0.02 ± 0.01 vs. 0.01 ± 0.01, p = 0.54) between CMD-positive and CMD-negative patients., Conclusion: Our findings did not show a noteworthy connection between CMD and inflammation, as suggested by various simple CBC-based biomarkers., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kalyan R. Chitturi – Consultant: Glass Health. Brian C. Case – Speaker: Asahi Intecc USA, Zoll Medical. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Append Medical, Pi-Cardia Ltd., Transmural Systems Inc. Hayder D. Hashim – Advisory Board, Speaker: Abbott Vascular, Boston Scientific, Philips IGT. All other authors – None., (Copyright © 2024. Published by Elsevier Inc.)

Background: The intricate relationship between mental health disorders, notably anxiety and depression, and chest pain associated with non-obstructive coronary artery disease has become a focus of investigation., Methods: This study from the Coronary Microvascular Disease Registry (CMDR) evaluated the association of mental health disorders and coronary microvascular dysfunction (CMD) among patients with angina with no obstructive coronary artery disease (ANOCA) who had undergone comprehensive invasive physiological testing for CMD. Clinical data regarding baseline characteristics, comorbidities, and noninvasive cardiac testing were obtained from chart review. The primary outcome of interest was the potential relationship between mental health diagnoses and the presence of CMD., Results: Of patients included in the CMDR, 27 % (41/152) had at least one documented mental health disorder diagnosis (International Classification of Diseases, Tenth Revision codes) and CMD. There was no difference in mental health diagnosis prevalence between CMD-positive and CMD-negative patients (21.1 % vs. 28.9 %, p = 0.34). The most common mental health diagnoses were depression (15.8 %) and anxiety (15.8 %). Furthermore, 46.3 % (19/41) of patients with mental health disorders were prescribed psychiatric medications, with the most common being benzodiazepines (26.8 %)., Conclusion: Patients with chest pain not due to CMD did not have an increased prevalence of mental health disorders compared with patients with ANOCA due to CMD, challenging the notion of a psychosomatic component in the pathogenesis of ANOCA., Competing Interests: Declaration of competing interest Kalyan R. Chitturi – Consultant: Glass Health. Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Append Medical, Biotronik, Boston Scientific, JC Medical, MedAlliance/Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional/SIS Medical AG, Transmural Systems Inc.; Institutional Grant Support: Biotronik, Medtronic, Philips IGT; Investor: Append Medical, Pi-Cardia Ltd., Transmural Systems Inc. Hayder D. Hashim – Advisory Board, Speaker: Abbott Vascular, Boston Scientific, Philips IGT. Brian C. Case – Speaker: Asahi Intecc USA, Zoll Medical. All other authors – None., (Copyright © 2024. Published by Elsevier Inc.)

Background: Coronary microvascular dysfunction (CMD) is an etiology for angina with non-obstructive coronary disease. However, the initial adoption of CMD assessment, whether planned or conducted ad hoc, is limited. We characterize planned and ad hoc CMD assessments and highlight evolving trends of a CMD referral center., Methods: We analyzed outpatient data from the Coronary Microvascular Disease Registry from 2021 to 2023. Patients were categorized into planned or ad hoc CMD assessment groups, and baseline characteristics, hospital stay, medications, and physiological measurements were compared. Secondary analysis evaluated a CMD referral center's evolution., Results: Of 101 included outpatients, 67.3 % underwent ad hoc procedures and 32.7 % planned procedures. Average age was 63.1 ± 10.1 years. The planned procedure group was 87.9 % female, and the ad hoc procedure group was 51.5 % female. There were no significant differences in index of microvascular resistance or coronary flow reserve between groups. Hospital stay duration was <1 day for both groups, and neither reported complications. Ad hoc patients were more frequently prescribed aspirin before (64.7 % vs. 36.4 %, p = 0.007) and after the procedure (66.2 % vs. 39.4 %, p = 0.01). CMD rates were higher for planned procedures (30.3 % vs. 10.3 %, p = 0.01). We observed that CMD referral centers have more planned procedures and a higher rate of positive results over time., Conclusion: CMD referral centers' planned procedures, and subsequent positive cases, increased over time. This emphasizes the importance of planned procedures, appropriate patient selection, and increased awareness of CMD among healthcare providers., Clinical Trial Registration: Coronary Microvascular Disease (CMD) Registry, NCT05960474, https://clinicaltrials.gov/study/NCT05960474., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Hayder Hashim reports a relationship with Abbott Vascular Inc. that includes: consulting or advisory and speaking and lecture fees. Hayder Hashim reports a relationship with Boston Scientific Corp that includes: consulting or advisory and speaking and lecture fees. Hayder Hashim reports a relationship with Philips IGT that includes: consulting or advisory and speaking and lecture fees. Ron Waksman reports a relationship with Abbott Vascular Inc. that includes: consulting or advisory. Ron Waksman reports a relationship with Append Medical that includes: consulting or advisory. Ron Waksman reports a relationship with BIOTRONIK Inc. that includes: consulting or advisory and funding grants. Ron Waksman reports a relationship with Boston Scientific Corp that includes: consulting or advisory. Ron Waksman reports a relationship with JC Medical that includes: consulting or advisory. Ron Waksman reports a relationship with MedAlliance/Cordis that includes: consulting or advisory. Ron Waksman reports a relationship with Medtronic that includes: consulting or advisory and funding grants. Ron Waksman reports a relationship with Philips IGT that includes: consulting or advisory and funding grants. Ron Waksman reports a relationship with Pi-Cardia Ltd. that includes: consulting or advisory. Ron Waksman reports a relationship with Swiss Interventional/SIS Medical AG that includes: consulting or advisory. Ron Waksman reports a relationship with Transmural Systems Inc. that includes: consulting or advisory and equity or stocks. If there are other authors, they 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 © 2024. Published by Elsevier Inc.)

Background/purpose: The cusp overlap technique has standardized implantation for self-expanding valves with the goal of achieving more consistent implantation depths and lowering permanent pacemaker (PPM) implantation rates. We retrospectively compared short-term outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve implanted using the cusp overlap technique vs. the traditional coplanar technique in a large tertiary referral center., Methods: We conducted a retrospective study among PPM-naïve patients who underwent TAVR using the CoreValve Evolut PRO/PRO+. We compared in-hospital PPM rates in patients who underwent TAVR using the cusp overlap technique vs. the coplanar technique. Additional outcomes included in-hospital all-cause mortality, stroke, major vascular complications, annular rupture, and >mild paravalvular leak. Furthermore, we compared outcomes over time to see whether there was evidence of a learning curve., Results: Of the 528 patients included, 270 underwent TAVR using the coplanar technique and 258 underwent TAVR using the cusp overlap technique. The rate of new PPM implantation did not differ between cohorts (17.0 % vs. 16.7 %; p = 0.910). Additionally, rates of in-hospital all-cause mortality (0.0 % vs. 0.4 %; p = 0.328), stroke (3.7 % vs. 1.6 %; p = 0.124), major vascular complications (0.7 % vs. 1.2 %; p = 0.617), annular rupture (0.4 % vs. 0.0 %; p = 0.328) and >mild paravalvular leak (0.0 % vs. 0.4 %; p = 0.444) were similar. Our secondary analysis did not identify any evidence of a learning curve., Conclusions: The cusp overlap technique may not yield a reduction in PPM rates when compared with the coplanar technique. Other confounders should be explored to further minimize in-hospital PPM rates., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Consultant: Edwards Lifesciences, Medtronic, Boston Scientific, Abbott; Advisory board: Medtronic, Boston Scientific; Equity: Transmural Systems; Intellectual property: co-inventor on patents, assigned to NIH. Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, and Transmural Systems Inc.; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors have no conflicts of interest to declare., (Copyright © 2023. Published by Elsevier Inc.)

Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors have no conflicts of interest to declare.

Background: Dual-antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the mainstay regimen for acute coronary syndrome (ACS) patients after percutaneous coronary intervention (PCI). We aimed to investigate DAPT compliance and switching patterns in ACS patients prescribed ticagrelor and aspirin. Secondly, we evaluated the impact of a pilot strategy of close surveillance telephone calls., Methods: The study enrolled 150 consecutive ACS patients who underwent PCI and were prescribed DAPT (aspirin and ticagrelor). This cohort, the "close surveillance arm," then received telephone calls from a healthcare professional to inquire about DAPT for up to one year. These findings, and clinical outcomes, were then compared to a "historical arm" of ACS patients (n = 505) who received PCI and were prescribed DAPT before initiation of the program. Finally, healthcare providers were surveyed about their experience with prescribing DAPT., Results: The rate of ticagrelor cessation trended lower in the close surveillance arm (22.00 % versus 31.70 %, p = 0.0783). The most common reasons for ticagrelor cessation were adverse medication reaction (dyspnea), bleeding, and financial burden. Nevertheless, the adverse events were few and similar between the two groups during follow-up. Over 96 % of healthcare providers surveyed stated that they worry about their patients' DAPT compliance post-PCI., Conclusion: Noncompliance and switching medications are still common for patients who undergo PCI for ACS. A close surveillance program identified patients at risk for medication cessation or switching and could potentially mitigate this phenomenon and improve quality of care., Competing Interests: Declaration of competing interest Hayder Hashim reports being a consultant for, and receiving speaker fees from, Abbott, Cardiovascular Systems Inc., and Boston Scientific. Toby Rogers reports being a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; serving on the Advisory Board of Medtronic; and holding equity interest in Transmural Systems Inc. Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and being an investor in MedAlliance and Transmural Systems Inc. All other authors have no competing interests to declare., (Copyright © 2022. Published by Elsevier Inc.)

Background: The Lipid Rich Plaque (LRP) Study established the association between high volume of lipidic content (maximum Lipid Core Burden Index [maxLCBI 4mm ] >400) in the coronary arteries and subsequent non-culprit major adverse cardiac events (NC-MACE). This analysis sought to assess the clinical impact of more than one lipid-rich plaque in the coronary tree., Methods: The LRP patient population was divided into four cohorts: 1) patients with all segments with maxLCBI 4mm = 0; 2) patients with all coronary segments maxLCBI 4mm < 400, but >0; 3) patients with 1 segment maxLCBI 4mm > 400; and 4) patients with 2+ coronary segments with maxLCBI 4mm > 400. Baseline characteristics, plaque-level characteristics, and follow-up outcomes were described., Results: Among 1550 patients, only 3.2 % had all segments with maxLCBI 4mm = 0; 65.1 % had segments with maxLCBI 4mm > 0 but <400; 22.5 % had one segment with maxLCBI 4mm > 400; and 9.5 % had 2+ coronary segments with maxLCBI 4mm > 400. Distribution within the coronary tree (one versus multiple arteries) did not differ. Overall, 1269 patients were allocated to follow-up (per study design). The composite of all-cause death, cardiac death, any revascularization, and NC-MACE was statistically higher in patients with 1 segment maxLCBI 4mm > 400 and numerically even higher in patients with 2+ segments with maxLCBI 4mm > 400. Patients with maxLCBI 4mm = 0 had no events within two years., Conclusion: There is a stepwise increased risk of all-cause death, cardiac death, any revascularization, and NC-MACE according to the number of coronary segments with maxLCBI 4mm > 400. In contrast, maxLCBI 4mm = 0 results in a low event rate., Clinical Trial Registration: The Lipid-Rich Plaque Study (LRP), https://clinicaltrials.gov/ct2/show/NCT02033694, NCT02033694., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman, Carlo Di Mario, Hector Garcia-Garcia, and Rebecca Torguson were Principal Investigator, European Principal Investigator, Responsible Officer Core Laboratory NIRS-IVUS and angiographic analysis, and Worldwide Study Coordinator, respectively, of the Lipid Rich Plaque Study, sponsored by Infraredx-Nipro, Burlington, MA, USA. Carlo Di Mario is the recipient of research grants (through the Department of Clinical & Experimental Medicine of the University of Florence) from Amgen, Behring, Chiesi, Daiichi-Sankyo, Edwards, Medtronic, and Shockwave. Hector Garcia-Garcia reports the following institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Philips, and CorFlow. Gary Mintz reports honoraria from Boston Scientific and Abiomed. Ron Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd.; being a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., and Venous MedTech; receiving grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; serving on the speakers bureau of AstraZeneca; and being an investor in MedAlliance and Transmural Systems Inc. All other authors report no conflicts of interest., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background/purpose: Myocardial injury after noncardiac surgery (MINS) is associated with major adverse cardiac events (MACE), but its significance post-liver and post-kidney transplantation is not well-defined., Methods/materials: We retrospectively studied consecutive patients undergoing single-organ liver or kidney transplantation at a large tertiary transplant center. Liver and kidney transplant patients with troponins drawn within 30 days of transplantation were included. The primary exposure was MINS, defined as troponin elevation above the 99th percentile of the upper reference limit within 30 days of transplantation. The primary outcome was MACE, defined as death, myocardial infarction, revascularization, stroke, or heart failure hospitalization., Results: Overall, 112 patients were included: 58 (51.7%) were liver transplant recipients, and 54 (48.3%) were kidney transplant recipients. Patients with MINS were significantly older (mean age 59 vs. 54 years, p = 0.01) and more likely to have diabetes (35% vs. 17%, p = 0.03). Other baseline characteristics were similar. Sixteen patients (14.2%) developed MACE, including 11 (9.8%) with 1-year MACE. MINS patients were significantly more likely to develop 1-year MACE (adjusted hazard ratio, 10.4; 95% confidence interval, 1.8-198). Kaplan-Meier cumulative MACE was significantly higher in the MINS group (p = 0.03)., Conclusions: Liver and kidney transplant recipients with MINS are significantly more likely to develop 1-year MACE compared to those without MINS. Future prospective studies are needed to further delineate the cardiac risk and outcomes in transplanted patients., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman – Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., Venous MedTech; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, Philips IGT; Speakers Bureau: AstraZeneca; Investor: MedAlliance, Transmural Systems Inc. All other authors – None., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background/purpose: Intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) can identify vulnerable coronary atherosclerotic plaques. We aimed to compare the presence or absence of baseline intravascular imaging of non-culprit lesions and their subsequent adverse events., Methods/materials: We identified patients from the Lipid Rich Plaque (LRP) study who had a non-culprit-lesion adverse event and divided them into 2 cohorts: those with lesions detected with NIRS-IVUS imaging at baseline and those with lesions not imaged at baseline., Results: Overall, 73 patients had an adverse event (99 coronary segments) during the 24-month follow-up period. Among them, 41 patients (56.2%) had a non-culprit-lesion adverse event related to a coronary segment imaged at baseline, and 32 patients (43.8%) had a non-culprit-lesion adverse event adjudicated to a segment that was not scanned at baseline. Angiographic core laboratory analysis suggested that unscanned lesions were more often in the right coronary artery (~50%); branches of the left coronary artery, i.e., diagonal or left obtuse marginal arteries (~20%); smaller vessels; or more tortuous vessels; and less often in the left anterior descending or distal locations. There was a weak trend for acute severe events (adjudicated myocardial infarction and acute coronary syndrome) in patients with lesions not scanned at baseline (50.0% versus 36.6%, p = 0.250)., Conclusions: In patients with follow-up non-culprit-lesion adverse events, nearly half were not imaged with NIRS-IVUS at baseline. Because events related to non-imaged lesions were at least as severe as events related to imaged lesions, future clinical trials and clinical protocols should be designed to minimize this issue., Clinical Trial Registration: The Lipid-Rich Plaque Study (LRP), https://clinicaltrials.gov/ct2/show/NCT02033694, NCT02033694., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Hector M. Garcia-Garcia: Institutional grants from Biotronik, Medtronic, Boston Scientific, CorFlow, Shockwave, Neovasc, InfraRedx, Abbott, Chiesi, and Philips. Gary Mintz: Honoraria from Boston Scientific, Medtronic, Philips/Volcano. Ron Waksman: Advisory Board: Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd., Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc., Venous MedTech; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, Philips IGT; Speakers Bureau: AstraZeneca; Investor: MedAlliance, Transmural Systems Inc. All other authors: No relevant disclosures., (Copyright © 2021. Published by Elsevier Inc.)

Background: We aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses., Materials/methods: We conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable., Results: We included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% (p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99-1.02)., Conclusions: TAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR., (Copyright © 2021. Published by Elsevier Inc.)

Background: Most pivotal transcatheter aortic valve replacement (TAVR) trials have excluded patients with bicuspid aortic stenosis (AS). This study compared TAVR in low-risk patients with bicuspid AS to those with tricuspid AS, incorporating data from prospective trials., Methods: We selected prospective US low-risk TAVR trials containing a bicuspid arm for this meta-analysis, examining outcomes at 30 days. Study results were pooled using a hierarchical Bayesian random-effects model., Results: Included were 3 Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials that enrolled a total of 1810 low-risk patients with symptomatic severe AS for TAVR. We compared 380 bicuspid patients with 1430 tricuspid patients. Event rates at 30 days overall were low, with similar mortality (odds ratio [OR], 0.38; 95% credible interval [CrI]: 0.08, 1.78; I 2 , 0%), non-disabling stroke (OR, 0.45; 95% CrI: 0.15, 1.07; I 2 , 9%), and permanent pacemaker implantation (OR, 0.86; 95% CrI: 0.41, 1.47; I 2 , 59%). There were statistically significant differences in disabling stroke (OR, 0.16; 95% CrI: 0.01, 0.90; I 2 , NA) and coronary obstruction (OR, 0.21; 95% CrI: 0.05, 0.91) that disappeared after sensitivity analysis by adding a single event to the tricuspid arm. Hemodynamics were similar at 30 days., Conclusions: Preliminary data from the FDA-approved IDE trials of low-risk patients with bicuspid AS undergoing TAVR demonstrated 30-day outcomes comparable to low-risk tricuspid patients, except for a trend toward higher stroke in bicuspid patients. Randomized trials are warranted to reassure the safety and long-term outcome of TAVR in patients with severe bicuspid AS., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Peripheral artery disease, along with subsequent critical limb ischemia (CLI), is highly prevalent, increases with age, and carries high morbidity and mortality. Specific devices for treatment of below-the-knee (BTK) lesions are limited. On February 17, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to consider a premarket approval application for the Lutonix 014 Drug-Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Becton, Dickinson and Company, Franklin Lakes, New Jersey) for the treatment of obstructive de novo or non-stented restenotic lesions in BTK vessels (popliteal, tibial, and peroneal arteries) in patients with CLI. We summarize the presentations and the panel deliberations, including voting outcome and recommendations for risk versus benefit., Competing Interests: Declaration of competing interest Ron Waksman– Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Background: Prospective bicuspid low-risk transcatheter aortic valve replacement (TAVR) registries' data demonstrated encouraging short-term results. Detailed data on transcatheter heart valve (THV) geometry after deployment using contemporary devices are lacking. This study sought to examine valve geometry after TAVR in patients with bicuspid aortic stenosis (AS)., Methods: The study population was patients from the LRT (Low Risk TAVR) trial who underwent TAVR using the SAPIEN 3 THV for bicuspid and tricuspid AS. THV geometry measured on 30-day computed tomography (CT) included valve height, angle, depth, and eccentricity. Additionally, THV hemodynamics and outcomes post-TAVR were compared among patients with bicuspid and tricuspid AS., Results: A total of 107 patients from the LRT trial using the SAPIEN 3 THV were included in our analysis. On 30-day CT, the valve height ratio (1.07 vs. 1.07; p = 0.348), depths (right [5.6 mm vs. 6.2 mm; p = 0.223], left [5.3 mm vs. 4.4 mm; p = 0.082] and non [4.8 mm vs. 4.5 mm; p = 0.589] coronary cusps), eccentricities (1.08 vs. 1.07; p = 0.9550), and angles (except the right [3.9 degrees vs. 6.3 degrees; p = 0.003] and left [3.6 degrees vs. 6.0 degrees; p = 0.007]) were similar between bicuspid and tricuspid patients. Hemodynamics, stroke, and mortality were similar at 1 year., Conclusion: Despite challenging bicuspid anatomy of the aortic valve, our comprehensive CT analysis supports similar THV geometry between patients with bicuspid and tricuspid AS undergoing TAVR using the SAPIEN 3 THV in low-risk patients. This translated to excellent short-term clinical outcomes and THV hemodynamics in both aortic valve morphologies., Trial Registry: NCT02628899, https://clinicaltrials.gov/ct2/show/NCT02628899., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. Puja Parikh – Consultant: Medtronic, Inc. Federico Asch – No personal disclosures. Director of the MedStar Health Academic Echocardiography Core Laboratory which has institutional contracts with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, Biotronik and LivaNova. Gaby Weissman – No personal disclosures. Director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Background: Recent meta-analyses have raised concerns about mortality with paclitaxel drug-coated balloons (DCB). This pooled, patient-level analysis of the BIOLUX P-I, P-II, and P-III studies was performed to evaluate the safety and efficacy of Passeo-18 Lux DCB., Materials and Methods: Individual patient-level demographic, clinical, diagnostic, and procedural data from the BIOLUX P-I, BIOLUX P-II, and BIOLUX P-III studies were pooled in a common database. Clinical safety (all-cause mortality and cardiovascular mortality) and efficacy (any amputation, target lesion/vessel revascularization) were extracted. Cox proportional modeling was used to assess the effect of critical limb ischemia at the time of enrollment and the occurrence of new amputation as a time-dependent variable on mortality., Results: A total of 1009 patients were included in the analysis. Sixty-six patients were treated with percutaneous transluminal angioplasty (PTA) and 943 underwent DCB angioplasty. The cumulative incidence of all-cause mortality did not differ between the groups (PTA 6.7%, DCB 6.7%, p = 0.65). The composite efficacy endpoint of freedom from any amputation and target lesion/vessel revascularization was superior in the DCB arm compared to PTA [PTA 28.8%, DCB 16.7%, p = 0.02]. Both in unadjusted and adjusted Cox proportional models (adjusted for critical limb ischemia and amputation), the use of DCB was not associated with any mortality at 1 year., Conclusions: Our patient-level analysis shows that overall, the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with increased mortality at 1 year and reinforces the efficacy of DCB angioplasty in preventing amputation or the need for reintervention., Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Despite contemporary advances in stent technology, in-stent restenosis (ISR) remains a common issue following percutaneous coronary intervention. A novel classification system based on the underlying mechanism of action of restenosis was recently introduced. The Waksman In-Stent Restenosis Classification characterizes different patterns of ISR to best delineate the type of restenosis and help guide treatment. Intravascular imaging with either intravascular ultrasound or optical coherence tomography allows for real-time evaluation of ISR. We herein provide an illustrative review of the Waksman In-Stent Restenosis Classification., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: Evan Shlofmitz: Consultant: Abbott Vascular; Speakers Bureau: Janssen Pharmaceuticals, Medtronic, Opsens Medical. Gary Mintz: Honoraria from Boston Scientific, Medtronic, Philips/Volcano. Ron Waksman: Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Medtronic, Philips, Pi-Cardia Ltd., Cardioset; Consultant: Abbott Vascular, Amgen, Biosensors, Biotronik, Boston Scientific, Medtronic, Philips, Pi-Cardia Ltd., Cardioset; Grant Support: Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors: No relevant disclosures., (Copyright © 2021. Published by Elsevier Inc.)

Background: Cardiac involvement in coronavirus disease 2019 (COVID-19) is known, manifested by troponin elevation. Studies in the initial phase of the pandemic demonstrated that these patients tended to have a worse prognosis than patients without myocardial injury. We sought to evaluate the clinical impact of significant troponin elevation in COVID-19-positive patients, along with predictors of poor outcomes, over the span of the pandemic to date., Methods: We analyzed COVID-19-positive patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the pandemic (March 1-June 30, 2020). We compared clinical course and outcomes based on the presence of troponin elevation and identified predictors of mortality., Results: The cohort included 2716 COVID-19-positive admitted patients for whom troponin was drawn. Of these patients, 250 had troponin elevation (≥1.0 ng/mL). In the troponin-elevation arm, the minimum troponin level was 1.9 ± 8.82 ng/mL; maximum elevation was 10.23 ± 31.07 ng/mL. The cohort's mean age was 68.0 ± 15.0 years; 52.8% were men. Most (68.5%) COVID-19-positive patients with troponin elevation were African American. Patients with troponin elevation tended to be older, with more co-morbidities, and most required mechanical ventilation. In-hospital mortality was significantly higher (48.4%) in COVID-19-positive patients with concomitant troponin elevation than without troponin elevation (12.2%; p < 0.001)., Conclusion: COVID-19 patients with troponin elevation are at higher risk for mechanical ventilation and mortality. Efforts should focus on early recognition, evaluation, and intensifying care of these patients., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:, (Copyright © 2021. Published by Elsevier Inc.)

Background: Cardiac involvement in coronavirus disease 2019 (COVID-19) is known, manifested by troponin elevation, and these patients have a worse prognosis than patients without myocardial injury., Methods: We analyzed COVID-19-positive patients who presented to the MedStar Health system (11 hospitals in Washington, DC, and Maryland) during the pandemic (March 1-September 30, 2020). We compared renal function and subsequent in-hospital clinical outcomes based on the presence or absence of troponin elevation. The primary outcome was the incidence of acute kidney injury in COVID-19 patients with troponin elevation. We also evaluated in-hospital mortality, overall and based on the presence and absence of both troponin elevation and renal dysfunction., Results: The cohort included 3386 COVID-19-positive admitted patients for whom troponin was drawn. Of these patients, 195 had troponin elevation (defined as ≥1.0 ng/mL), mean age was 61 ± 16 years, and 51% were men. In-hospital mortality was significantly higher (53.8%) in COVID-19-positive patients with concomitant troponin elevation than in those without troponin elevation (14.5%; p < 0.001). COVID-19-positive patients with troponin elevation had a higher prevalence of renal dysfunction (58.5%) than those without troponin elevation (23.4%; p < 0.001). Further analysis demonstrated that having both troponin elevation and renal dysfunction carried the worst in-hospital prognosis (in-hospital mortality 57.9%; intensive-care-unit admission 76.8%; ventilation requirement 63.2%), as compared to the absence or presence of either., Conclusion: COVID-19 patients with troponin elevation are at higher risk for worsening renal function, and these patients subsequently have worse in-hospital clinical outcomes. Efforts should focus on early recognition, evaluation, and intensifying care of these patients., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. William S. Weintraub – Research support: Amarin Corporation, National Institutes of Health; Consultant: Amarin Corporation, AstraZeneca, Janssen, SC Pharma, The Medicines Company. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Competing Interests: Declaration of competing interest Gaby Weissman – No personal disclosures. Director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Background: Myocardial injury is a complication of coronavirus disease 2019 (COVID-19). We describe a large multi-center experience of COVID-19 patients with myocardial injury, examining the prognostic role left ventricular function plays on short-term outcomes., Methods/materials: We included adult COVID-19 patients admitted to our health system with evidence of myocardial injury and who underwent a transthoracic echocardiogram (TTE) during index admission. Patients were dichotomized into those with reduced ejection fraction (EF; <50%) and preserved EF (≥50%)., Results: Across our 11-hospital system, 5032 adult patients were admitted with COVID-19 from March-September 2020. Of these, 235 had evidence of myocardial injury (troponin ≥1 ng/mL). Included were 134 patients who underwent TTE, of whom 43.3% (n = 58) had reduced EF and 56.7% (n = 76) preserved EF. A subset of 6 patients had newly reduced EF, with 5 demonstrating evidence of stress cardiomyopathy and subsequently dying. Overall, mortality was high in those with reduced EF and preserved EF (in-hospital: 34.5% vs. 28.9%; p = 0.494; 6 months: 63.6% vs. 50.0%; p = 0.167; Kaplan-Meier estimates: p = 0.2886). Readmissions were frequent in both groups (30 days: 22.2% vs. 26.0%; p = 0.162; 6 months: 52.0% vs. 54.5%; p = 0.839)., Conclusions: Many COVID-19 patients admitted with evidence of myocardial injury did not undergo TTE. For those who did, short-term mortality was high. Patients who survived hospitalization had frequent readmissions. In patients with newly reduced EF, most had evidence of stress cardiomyopathy and expired. Larger studies are needed to fully evaluate the prognosis of COVID-19 patients with evidence of myocardial injury and left ventricular dysfunction., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: William S. Weintraub – Research support: Amarin Corporation, National Institutes of Health; Consultant: Amarin Corporation, AstraZeneca, Janssen, SC Pharma, The Medicines Company. Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors – None.

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None.

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors – None.

Background/purpose: The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania)., Methods/materials: Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports., Results: Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1)., Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD., Competing Interests: Declaration of competing interest Evan Shlofmitz received honoraria from Abbott Vascular and Opsens Medical. Gary Mintz received honoraria from Boston Scientific and Philips. Ron Waksman has served on the advisory board and as a consultant for Philips. All other authors have no relevant disclosures., (Copyright © 2020. Published by Elsevier Inc.)

Background/purpose: Coronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database., Methods/materials: We queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis., Results: Percentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery., Conclusion: An analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality., Competing Interests: Declaration of competing interest RW –Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. TR – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. All other authors: None., (Copyright © 2020. Published by Elsevier Inc.)

Background/purpose: Despite the high prevalence of coronary artery disease (CAD) in patients with severe aortic stenosis (AS), the optimal management of concomitant CAD, including revascularization before transcatheter aortic valve replacement (TAVR), remains controversial. Contemporary, real-world practice patterns have not yet been described. We aimed to characterize the burden of CAD in contemporary TAVR patients and evaluate revascularization practices at a high-volume center., Methods/materials: We retrospectively analyzed all adult patients referred for TAVR at our center between January 2019 and January 2020. Presence of significant CAD and subsequent management were recorded. Presenting symptoms, use of non-invasive and invasive ischemia testing, and pre-TAVR computed tomography (CT) imaging were analyzed., Results: A total of 394 patients with severe AS were referred for TAVR. Thirty-nine patients (9.9%) instead underwent surgery, of whom only 5 (1.3%) received coronary artery bypass grafting. Of the remaining 355 patients, 218 patients (61.4%) had insignificant CAD. Of the 137 patients (38.6%) with significant CAD, only 30 (8.5%) underwent percutaneous coronary intervention (PCI). Of these, less than half had anginal symptoms, a third had CAD in proximal segments, and a third underwent ischemia testing before PCI. Pre-TAVR CT accurately identified significant CAD in 28/30 patients (93.3%) who underwent PCI., Conclusions: Only 1 in 25 contemporary TAVR patients had significant CAD and angina requiring intervention, calling into question the utility of routine invasive coronary angiography before TAVR. A Heart Team approach integrating anginal symptoms, ischemia testing and possibly pre-TAVR CT is needed to guide the need, timing, and strategy of revascularization., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. Toby Rogers – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. All other authors – None., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: We present the novel use of adjunctive intravascular lithotripsy (IVL) before definitive intravascular stenting of a heavily calcified celiac artery ostial occlusion., Case Report: A 79-year-old woman presented with chronic post-prandial abdominal pain and weight loss. Selective angiography revealed a sub-totally occluded celiac artery. Percutaneous endovascular intervention of the celiac artery was attempted but was unsuccessful because of heavy calcification. The patient returned for a repeat procedure. A guidewire was successfully advanced across the sub-totally occluded ostium. A Shockwave Lithotripsy BDC 7.0-mm/60-mm balloon catheter (Shockwave Medical Inc., Santa Clara, California) was successfully used to modify the calcified plaque. Next, a stent was deployed for definitive therapy. The final angiogram showed an excellent result. The patient tolerated the procedure well and was sent home on dual antiplatelet therapy. Nine months after the procedure, she had gained weight and denied any further post-prandial abdominal pain., Conclusion: IVL treatment modality to modify calcified lesions in the splanchnic circulation should be considered as a novel approach to patients in whom traditional endovascular treatment modalities are thought to be suboptimal. Further controlled studies are needed to access the safety, feasibility, and efficacy of the use of this novel technology in this vascular territory., Competing Interests: Declaration of competing interest Ron Waksman — Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors — none., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Competitive flow from a non-critical native vessel leading to longitudinal narrowing/atresia of the left internal mammary artery (LIMA) is described as "the string phenomenon." We describe spontaneous recanalization of an atretic LIMA following coronary artery bypass grafting for multivessel coronary artery disease., Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. Other authors – None., (Copyright © 2020. Published by Elsevier Inc.)

Background: Intravascular lithotripsy (IVL) (Shockwave Medical, Inc., Fremont, California, USA) is a novel technology used to modify heavily calcified atherosclerotic plaque in vessels to help facilitate percutaneous coronary intervention and has been shown to be effective in treating critical lesions within the lower limbs. In addition, studies are currently underway evaluating IVL's feasibility in de novo calcified stenotic coronary arteries before stenting. The use and associated complications of IVL in other vascular territories are underreported. We report our institution's initial experience using IVL for the treatment of complex, heavily calcified lesions within the aortic arch vessels., Methods and Results: We treated five patients with IVL of the aortic arch vessels, including the carotid (2), subclavian (2), and innominate arteries. Four of the five patients underwent successful IVL treatment and intervention without complications. One patient (carotid intervention) developed acute right eye blindness post-procedure, thought to be due to an embolic plaque, which was successfully treated with tissue plasminogen activator and intravenous heparin., Conclusion: IVL offers promising technology to facilitate the treatment of complex lesions in the vessels of the aortic arch. We do not promote the use of IVL but promote prospective clinical trials to assess the safety and efficacy of this technology in this vascular territory., Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors have no conflicts of interest to disclose., (Copyright © 2020 Elsevier Inc. All rights reserved.)

During the novel coronavirus disease 2019 (COVID-19) pandemic, many hospitals have been asked to postpone elective and surgical cases. This begs the question, "What is elective in structural heart disease intervention?" The recently proposed Society for Cardiovascular Angiography and Interventions/American College of Cardiology consensus statement is, unfortunately, non-specific and insufficient in its scope and scale of response to the COVID-19 pandemic. We propose guidelines that are practical, multidisciplinary, implementable, and urgent. We believe that this will provide a helpful framework for our colleagues to manage their practices during the surge and peak phases of the pandemic. General principles that apply across structural heart disease interventions include tracking and reporting cardiovascular outcomes, "healthcare distancing," preserving vital resources and personnel, shared decision-making between the heart team and hospital administration on resource-intensive cases, and considering delaying research cases. Specific guidance for transcatheter aortic valve replacement and MitraClip procedures varies according to pandemic phase. During the surge phase, treatment should broadly be limited to those at increased risk of complications in the near term. During the peak phase, treatment should be limited to inpatients for whom it may facilitate discharge. Keeping our patients and ourselves safe is paramount, as well as justly rationing resources., Competing Interests: Declaration of competing interest Jaffar Khan – Proctor: Edwards Lifesciences, Medtronic. Toby Rogers – Advisory Board: Medtronic; Consultant and Proctor: Medtronic, Edwards Lifesciences. Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors – None., (Copyright © 2020. Published by Elsevier Inc.)