Search

Background: Radial artery access for coronary angiography or percutaneous coronary intervention (PCI) reduces the risk of death, bleeding, and vascular complications and is preferred over femoral artery access, leading to a class 1 indication by clinical practice guidelines. However, alternate upper extremity access such as distal radial and ulnar access are not mentioned in the guidelines despite randomized trials. We aimed to evaluate procedural outcomes with femoral, radial, distal radial, and ulnar access sites in patients undergoing coronary angiography or PCI., Methods: PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials that compared at least 2 of the 4 access sites in patients undergoing PCI or angiography. Primary outcomes were major bleeding and access site hematoma. Intention-to-treat mixed treatment comparison meta-analysis was performed., Results: From 47 randomized clinical trials that randomized 38 924 patients undergoing coronary angiography or PCI, when compared with femoral access, there was a lower risk of major bleeding with radial access (odds ratio [OR], 0.46 [95% CI, 0.35-0.59]) and lower risk of access site hematoma with radial (OR, 0.34 [95% CI, 0.24-0.48]), distal radial (OR, 0.33 [95% CI, 0.20-0.56]), and ulnar (OR, 0.50 [95% CI, 0.31-0.83]) access. However, when compared with radial access, there was higher risk of hematoma with ulnar access (OR, 1.48 [95% CI, 1.03-2.14])., Conclusions: Data from randomized trials support guideline recommendation of class 1 for the preference of radial access over femoral access in patients undergoing coronary angiography or PCI. Moreover, distal radial and ulnar access can be considered as a default secondary access site before considering femoral access., Registration: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: 42024512365.

Background: Acute coronary syndrome (ACS) hospital admissions decreased during the start of the COVID-19 outbreak. Information is limited on how Google searches were related to patients' behaviour during this time., Methods: We examined de-identified data from 2019 through 2020 regarding the following monthly items: (i) admissions for ACS from the Veterans Affairs Healthcare System; (ii) out-of-hospital cardiac arrest (OHCA) from the National Emergency Medical Services Information System (NEMSIS) public dataset; and (iii) Google searches for "chest pain," "coronavirus," "chest pressure," and "hospital safe" from Google Trends. We analyzed the trends for ACS admissions, OHCA, and Google searches., Results: During the early months of the first COVID-19 outbreak, the following occurred: (i) Veterans Affairs data showed a significant reduction in ACS admissions at a national and regional (Florida) level; (ii) the NEMSIS database showed a marked increase in OHCA at a national level; and (iii) Google Trends showed a significant increase in the before-mentioned Google searches at a national and regional level., Conclusions: ACS hospital admissions decreased during the beginning of the pandemic, likely owing to delayed healthcare utilization secondary to patients fear of acquiring a COVID-19 infection. Concordantly, the volume of Google searches for hospital safety and ACS symptoms increased, along with OHCA events, during the same time. Our results suggest that Google Trends may be a useful tool to predict patients' behaviour and increase preparedness for future events, but statistical strategies to establish association are needed., (© 2024 The Authors.)

Objectives: Compared with ST-segment elevation myocardial infarction (STEMI) patients, non-STEMI (NSTEMI) patients have more comorbidities and extensive coronary artery disease. Contemporary comparative data on the long-term prognosis of stable post-myocardial infarction subtypes are needed., Design: Long-Term rIsk, clinical manaGement and healthcare Resource utilisation of stable coronary artery dISease (TIGRIS) was a multinational, observational and longitudinal cohort study., Setting: Patients were enrolled from 350 centres, with >95% coming from cardiology practices across 24 countries, from 19 June 2013 to 31 March 2017., Participants: This study enrolled 8277 stable patients 1-3 years after myocardial infarction with ≥1 additional risk factor., Outcome Measures: Over a 2 year follow-up, cardiovascular events and deaths and self-reported health using the EuroQol 5-dimension questionnaire score were recorded. Relative risk of clinical events and health resource utilisation in STEMI and NSTEMI patients were compared using multivariable Poisson regression models, adjusting for prognostically relevant patient factors., Results: Of 7752 patients with known myocardial infarction type, 46% had NSTEMI; NSTEMI patients were older with more comorbidities than STEMI patients. NSTEMI patients had significantly poorer self-reported health and lower prevalence of dual antiplatelet therapy at hospital discharge and at enrolment 1-3 years later. NSTEMI patients had a higher incidence of combined myocardial infarction, stroke and cardiovascular death (5.6% vs 3.9%, p<0.001) and higher all-cause mortality (4.2% vs 2.6%, p<0.001) compared with STEMI patients. Risks were attenuated after adjusting for other patient characteristics. Health resource utilisation was higher in NSTEMI patients, although STEMI patients had more cardiologist visits., Conclusions: Post-NSTEMI chronic coronary syndrome patients had a less favourable risk factor profile, poorer self-reported health and more adverse cardiovascular events during long-term follow-up than individuals post STEMI. Efforts are needed to recognise the risks of stable patients after NSTEMI and optimise secondary prevention and care., Trial Registration Number: NCT01866904., Competing Interests: Competing interests: SP and RO have received research grant support from AstraZeneca. SGG has received speaker/consulting honoraria and/or research grant support from Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol‑Myers Squibb, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, HLS Therapeutics, JAMP Pharma, Merck, Novartis, Novo Nordisk A/C, Pendopharm/Pharmascience, Pfizer, Regeneron, Sanofi, Servier, Valeo Pharma and salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Centre for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Centre, PERFUSE Research Institute, TIMI Study Group (Brigham Health). CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company. JCN has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, CSL Behringer, DalCor, Esperion, Janssen, Novartis, Novo Nordisk, Sanofi, Servier and Vifor. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi Sankyo, AstraZeneca and Boehringer Ingelheim. DB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. KA and PRH are employees of AstraZeneca. GB-W was an employee of AstraZeneca at the time of this study. SNK and PK declare no competing interests., (© 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.)

Background: Insights on the differences in clinical outcomes, quality of life (QoL) and health resource utilisation (HRU) with different levels of care available to post-acute myocardial infarction (AMI) populations in rural and urban settings are limited., Methods: The long-Term rIsk, clinical manaGement, and healthcare Resource utilisation of stable coronary artery dISease (TIGRIS), a prospective, observational registry, enrolled 8452 patients aged ≥50 years 1-3 years post-AMI from June 2013 to November 2014 from 24 countries in Asia Pacific/Australia, Europe, North America and South America. Differences in QoL (measured using the EuroQol Research Foundation instrument) and HRU between patients in rural and urban settings were evaluated in this post hoc analysis. The incidence of clinical endpoints (cardiovascular (CV) death, AMI, unstable angina with urgent revascularisation and stroke; bleeding; and all-cause mortality) was analysed. Data were collected at baseline and every 6 months for 24 months., Results: There were fewer hospitalisations and visits to general practitioners (GPs) and cardiologists in the rural versus urban populations (adjusted event rate ratio (ERR)=0.90 (95% CI, 0.82 to 1.00, p=0.04); ERR=0.84 (95% CI, 0.78 to 0.92, p<0.001); ERR=0.86 (95% CI, 0.81 to 0.92, p<0.001), respectively). No statistically significant differences were observed between rural and urban populations in all-cause death, AMI, unstable angina with urgent revascularisation, CV death, stroke, major bleeding events and health-related QoL. The adjusted incidence rate ratio was 0.92 (95% CI, 0.74 to 1.15) for the composite of CV death, AMI and stroke., Conclusions: Living in rural areas was associated with fewer GP/cardiologist visits and hospitalisations; no significant differences in clinical outcomes and QoL were observed., Trial Registration Number: NCT01866904., Competing Interests: Competing interests: JCN has received research grants from Amgen, AstraZeneca, Bayer, Esperion, CLS Behring, Dalcor, Daiichi-Sankyo, Janssen, Novartis, Novo Nordisk, Sanofi, Vifor; honoraria/consultation from Daiichi-Sankyo, Novartis, Sanofi; and a scholarship from the Brazilian National Council for Scientific and Technological Development (CNPq #303448/2021/0). RO has received research grant support from AstraZeneca. RHMF reports research grants and personal fees from AstraZeneca, Bayer, Biomm and Servier, and research grants from Pfizer, EMS, Aché, CytoDin, Brazilian Ministry of Health, University Health Network (received from his institution) and Lemann Foundation Research Fellowship. SG has received research grant support (eg, steering committee or data and safety monitoring committee) and/or speaker/consulting honoraria (eg, advisory boards) from Amgen, Anthos Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, HLS Therapeutics, JAMP Pharma, Merck, Novartis, Novo Nordisk A/C, Pendopharm/Pharmascience, Pfizer, Regeneron, Sanofi, Servier and Valeo Pharma, and salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Center for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Centre, PERFUSE Research Institute, and TIMI Study Group (Brigham Health). CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi-Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi-Sankyo, AstraZeneca and Boehringer Ingelheim. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. KH and PRH are employees of AstraZeneca. DBB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. SP has received research grant support from AstraZeneca., (© 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.)

Background: Malpractice lawsuits following percutaneous coronary and peripheral interventions are not uncommon. Understanding the most common causes of medical legal action can inform clinicians and prevent future injury and litigation., Methods: LexisNexis is a legal database that compiles all publicly available court records for state and federal jury verdicts and settlements in the United States. We analyzed LexisNexis for malpractice cases involving percutaneous coronary and peripheral interventions between January 1, 2005 and December 31, 2020., Results: We found a total of 89 cases over the studied period, of which 55 cases were coronary interventions, 18 cases were peripheral interventions, and 16 cases did not specify the vessel location. Procedural error was alleged in 44 (49.4%) cases, complications in 42 (47.2%) cases, failure to monitor in 22 (24.7%) cases, failure to properly treat in 15 (16.9%) cases, incorrect treatment in 15 (16.9%) cases, failure to refer in 10 (11.2%) cases, lack of informed consent in 9 (10.1%) cases, and delay of intervention in 3 (3.4%) cases. The most common procedural error was vessel perforation (34.1%). Death was the most prevalent precipitating medical outcome of the cases (n = 41, 46.1%). Litigation resolution favored the defendant in 43 (48.3%) cases, the plaintiff in 13 (14.6%) cases, and a settlement was reached in 33 (37.1%) cases., Conclusions: Awareness of the most common causes of litigations among interventional cardiologists and vascular specialists may prevent future legal actions and promote implementations of processes to improve patient care. Our results suggest the importance of attentive patient care before, during, and after percutaneous coronary and peripheral interventions. Procedural expectations and risks should be meticulously discussed with patients and families., (© 2023 The Author(s).)

Bruton's tyrosine kinase inhibitors (BTKi), known for their off-target antiplatelet effects and increased bleeding risk, have become more frequently used in patients with cancer with lymphoid malignancies. When encountering patients on BTKi who also require antiplatelet therapies, particularly dual-antiplatelet therapy that is a well-established treatment after percutaneous coronary intervention (PCI), the potential increase in bleeding risk raises concern. The development of new-generation BTKi with a higher selectivity, such as acalabrutinib and zanubrutinib, could be an answer to this conundrum, but bleeding still occurs. It is important that the interventional cardiologist becomes familiar with agents that could affect the management of antiplatelet therapy in patients treated with PCI., (© 2023 The Authors.)

Background: Data on the association of multimorbidity and functional impairment with cardiovascular (CV) and non-CV outcomes among older myocardial infarction (MI) patients are limited., Hypothesis: Multimorbidity and functional impairment among older MI patients are associated with CV and non-CV mortality., Methods: Patients aged ≥65 years, 1-3 years post-MI, and enrolled between June 2013 and Novemeber 2014 from 349 sites in 25 countries in the global TIGRIS registry were categorized by age, number of comorbidities, and presence and degree of functional impairment. Functional impairment was calculated using five-dimension EuroQol based on three domains-mobility, self-care, and usual activities. The association between age, number of comorbid conditions, and degree of functional impairment with 2-year incidence of CV and non-CV death was evaluated using Poisson regression analysis., Results: Older age was associated with higher number of comorbidities and functional impairment; after adjustment, increasing age was significantly associated with non-CV mortality (p = .03) but not CV mortality (p = .38). Greater functional impairment was associated with a higher rate and relatively equal magnitude risk of CV (rate ratios [RR] 1.52, 95% confidence intervals [CI]: 1.29-1.79, per one-step increase) and non-CV mortality (RR 1.42, 95% CI: 1.17-1.73). Multimorbidity was more strongly associated with CV mortality (RR 1.52, 95% CI: 1.38-1.67, per additional comorbidity) versus non-CV mortality (RR 1.29, 95% CI: 1.14-1.47, per additional comorbidity)., Conclusions: Multimorbidity and functional impairment are prevalent among older post-MI patients and are associated with increased CV and non-CV mortality. These findings highlight the importance of considering comorbid conditions and functional impairment as predictors of risk for adverse outcomes and aspects of medical decision making. Clinical Trial Registration: NCT01866904., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Background: Distal trans-radial access (dTRA) is a novel technique of arterial cannulation in coronary interventions. The comparative efficacy of dTRA and conventional trans-radial access (TRA) in attenuating peri-procedural complications is unknown., Methods: Embase and PubMed/MEDLINE were searched from their inception until June 25, 2022, for randomized clinical trials. Outcomes included were radial artery occlusion (RAO), radial artery spasm, hemostasis time, access time, unsuccessful cannulation, crossover rate, and early discharge after trans-radial stenting of coronary arteries (EASY) type I-III hematomas. Statistical analysis was conducted using the random effects model to derive risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs)., Results: A total of 6 randomized clinical trials comprising 3240 patients were included. Subjects were predominantly male (73%) and had a mean age of 66 years. The dTRA group had a lower risk of RAO [RR 0.43 (95% CI, 0.26-0.69); P = 0.0005; I 2 = 0%] and had a shorter hemostasis time [MD -22.85 min (95% CI, -39.06 to -6.65); P = 0.006; I 2 = 99%]. The dTRA group had a higher crossover rate [RR 3.04 (95% CI, 1.88-4.91); P = 0.00001; I 2 = 56%] and a longer access time [MD 0.68 min (95% CI, 0.17-1.18); P = 0.009; I 2 = 99%]. The TRA group had a lower rate of unsuccessful cannulation [RR 0.81 (95% CI, 0.70-0.95); P = 0.01; I 2 = 92%]. There was no significant difference between the groups for radial artery spasm and EASY type I-III hematomas., Conclusion: dTRA is a safe alternative to conventional TRA for coronary interventions with a lower risk of RAO. Future trials are required to further compare both approaches., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Cardiogenic shock (CS) is the final common pathway of impaired cardiovascular performance that results in ineffective forward cardiac output producing clinical and biochemical signs of organ hypoperfusion. CS represents the most common cause of shock in the cardiac intensive care unit (CICU) and accounts for a substantial proportion of CICU patient deaths. Despite significant advances in revascularization techniques, pharmacologic therapeutics and mechanical support devices, CS remains associated with a high mortality rate. Indeed, the prevalence of CS within the CICU appears to be increasing. CS can be differentiated as phenotypes reflecting different metabolic, inflammatory, and hemodynamic profiles, depending also on anatomic substrate and congestion profile. Future prospective studies and clinical trials may further characterize these phenotypes and apply targeted intervention for each phenotype and SCAI SHOCK stage rather than a one-size-fits-all approach. Overall, there are 8 key concepts of CS; 1) the mortality associated with CS; 2) Shock attributed to AMI may be declining in both incidence and associated mortality; 3) providers should think about hemodynamic, metabolic, inflammation and cardiac function in totality to assess CS; 4) CS is a dynamic process; 5) no randomized trials evaluating use of the PAC in patients with CS; 6) most data supporting neosynephrine as first line agent in CS; 7) most registries suggest that almost half of CS patients do not have any mechanical support, and the vast majority of the remainder utilize the IABP; and 8) patients with AMI CS should receive emergent PCI of the culprit vessel., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is well-established for severe symptomatic aortic stenosis (AS), but its use in rheumatic heart disease (RHD) has been limited. We systematically review the use of TAVR for severe symptomatic AS in RHD. Pubmed, Embase, and Scopus were searched for TAVR for symptomatic severe AS and proven or suspected RHD. Procedure characteristics, efficacy, and safety endpoints were collected and all definitions were based on the Valve Academic Research Consortium-2 (VARC-2) criteria. We included 3 case series and 12 case reports, with a total of 43 patients. Mean age was 76 years, 75% were female, and 85% had NYHA class III-IV symptoms. Follow up ranged from 1 to 29 months. Patients were moderate to high risk, with Society of Thoracic Surgery score ranging from 6.1% to 17.6%. The approach was transfemoral in 30 (83%) cases. Procedural success occurred in 37 (86%) patients. Of the 7 patients with periprocedural complications, 4 had valve dislodgement, 1 deployment failure, 1 unplanned cardiopulmonary bypass, and 1 moderate aortic regurgitation. Paravalvular leak was reported in 5 (11.6%) patients. Only 1 patient had heart block requiring pacemaker. Among 13 studies (23 patients), 30-day mortality was 0%. One case series with 19 patients had a 30-day, 1-year, 2-year, and 5-year mortality of 5%, 11%, 31%, and 48%, respectively. TAVR appears feasible for selected patients with rheumatic severe AS, albeit our results indicate a 14% incidence of device failure. Future randomized clinical trials may clarify the role of TAVR in this group., Competing Interests: Disclosure: The authors declare no funding and conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Patterns of dual antiplatelet therapy (DAPT) use beyond 1 year post-myocardial infarction (MI) have not been well studied., Methods: TIGRIS (NCT01866904) was a prospective, multi-center (369 centers in 24 countries), observational study of patients 1 to 3 years post-MI. We sought to identify the prevalence and determinants of DAPT use ≥1 year post-MI in patients enrolled in TIGRIS. We used multivariable logistic regression to identify determinants of DAPT use at 396 days post-MI (365 days plus a 31day overrun period to account for intended DAPT discontinuation at 1 year). Patients treated with an oral anticoagulant were excluded., Results: Of 7708 patients (median age 67 years, women 25%, ST-elevation MI 50%), 39% and 16% were on DAPT at 396 days and 5 years post-MI, respectively. DAPT use at 396 days post-MI was more prevalent in patients <65 years of age, treated with percutaneous coronary intervention (versus coronary artery bypass grafting or medical therapy), and with multivessel disease or a history of angina. Additional clinical determinants of ischemic and/or bleeding events following MI (diabetes, second prior MI, hypertension, peripheral artery disease, heart failure, smoking, and renal insufficiency) were not independently associated with DAPT use at 396 days. There were geographic variations in the use of DAPT at 396 days (p<0.001), with the lowest use in Europe and the highest in Asia and Australia., Conclusion: In a contemporary patient cohort, DAPT use beyond 1 year post MI was prevalent and associated with patient and index event characteristics. There were marked geographical variations in DAPT use beyond 1 year post MI., Competing Interests: Declaration of Competing Interest J.J.R. has received consulting honoraria from AstraZeneca. S.J.P. has received research grant support from AstraZeneca. A.T.Y. has received research grant support from AstraZeneca D.B. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck, and Sanofi. R.O. has received research grant support from AstraZeneca. K.A.S. is an employee of AstraZeneca. C.B.G. has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Hoffmann La Roche, Janssen Pharmaceuticals, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda, and The Medicines Company. M.G.C. has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed, and Merit Medical. S.Y. has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi-Sankyo, AstraZeneca, Boehringer Ingelheim, Bristol-Myers. J.C.N. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, Merck, Novartis, Pfizer, and Sanofi. G.B-W. is an employee of AstraZeneca. D.W. has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin Chemie, Biotronik, and Novartis. T.S. has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, and Sanofi. S.G.G. has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, CSL Behring, Daiichi Sankyo, Eli Lilly, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and Tenax Pharmaceuticals., (Copyright © 2021. Published by Elsevier Ltd.)

Background: The Scoreflex NC scoring angioplasty catheter is designed with a short rapid-exchange tip distal to a non-compliant, high-pressure balloon and an integral wire outside of the balloon, such that the guidewire and the integral wire act as scoring elements during balloon inflation. The external scoring elements enable a focal stress pattern facilitating expansion of resistant lesions at lower pressures using a focused force angioplasty effect., Methods: Patients undergoing elective percutaneous coronary intervention (PCI) were enrolled in a prospective, single-arm study conducted at 12 centers in the United States. The primary endpoint was device procedural success, defined as the composite of successful device delivery to the target lesion with balloon inflation and deflation; absence of vessel perforation, flow-limiting dissection or reduction in TIMI flow from baseline; and achievement of final TIMI 3 flow., Results: Among 200 patients (234 lesions), lesion complexities included: bifurcation disease (37.6%), moderate/severe calcification (36.6%), and total occlusions (5.0%). Successful delivery to the target lesion, inflation and removal of the balloon catheter was achieved in 95.5% of patients (191/200). Procedural success was achieved in 93.5% (187/200) of patients, and final TIMI 3 flow was observed in 99.0% of cases (198/200). No unanticipated device-related events occurred. In-hospital major adverse events were reported in 4.5% of patients (9/200), related to periprocedural myocardial infarction (8/200, 4.0%) and target lesion revascularization (1/200, 0.5%)., Conclusions: Among patients undergoing elective PCI and with varied lesion complexity, these results support the safety and effectiveness of a dilation strategy using the Scoreflex NC scoring catheter., Competing Interests: Declaration of competing interest The following authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Kandzari reports institutional research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Cardiovascular Systems, Inc., OrbusNeich, Medtronic and Ablative Solutions; and personal consulting honoraria from Cardiovascular Systems, Inc., Magenta Medical and Medtronic. Dr. Sanghvi reports institutional research/graft support from Boston Scientific, Cardiovascular system Inc., Recor Medical, Ablative solutions and personal consulting honoraria and royalty payments from Cordis Cardinal Health. Dr. Cohen reports personal consulting honoraria from Medtronic, Merit Medical, Terumo Medical, Astra Zeneca, Zoll, and Abiomed and ownership in Accumed Radial Systems. Dr. Almonacid reports institutional grants from Boston Scientific, Medtronic, Abbott Vascular, COOK, and Terumo. Drs. Hearne, Kumar, Sachdeva, Adams, Blossom, Dahle, Imperi and Riley declare no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Aim: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use., Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.

Aim: The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use., Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered., Structure: Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline., (Copyright © 2022 The American College of Cardiology Foundation and the American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.)

Aim: The guideline for coronary artery revascularization replaces the 2011 coronary artery bypass graft surgery and the 2011 and 2015 percutaneous coronary intervention guidelines, providing a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization as well as the supporting documentation to encourage their use., Methods: A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered., Structure: Coronary artery disease remains a leading cause of morbidity and mortality globally. Coronary revascularization is an important therapeutic option when managing patients with coronary artery disease. The 2021 coronary artery revascularization guideline provides recommendations based on contemporary evidence for the treatment of these patients. The recommendations present an evidence-based approach to managing patients with coronary artery disease who are being considered for coronary revascularization, with the intent to improve quality of care and align with patients' interests., (Copyright © 2022 The American College of Cardiology Foundation and the American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: Atrial fibrillation (AF) and myocardial infarction (MI) are commonly comorbid and associated with adverse outcomes. Little is known about the impact of AF on quality of life and outcomes post-MI. We compared characteristics, quality of life and clinical outcomes in stable patients post-MI with/without AF., Methods/results: The prospective, international, observational TIGRIS (long Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease) registry included 8406 patients aged ≥50 years with ≥1 atherothrombotic risk factor who were 1-3 years post-MI. Patient characteristics were summarised by history of AF. Quality of life was assessed at baseline using EQ-5D. Clinical outcomes over 2 years of follow-up were compared. History of AF was present in 702/8277 (8.5%) registry patients and incident AF was diagnosed in 244/7575 (3.2%) over 2 years. Those with AF were older and had more comorbidities than those without AF. After multivariable adjustment, patients with AF had lower self-reported quality-of-life scores (EQ-5D UK-weighted index, visual analogue scale, usual activities and pain/discomfort) than those without AF. CHA 2 DS 2 -VASc score ≥2 was present in 686/702 (97.7%) patients with AF, although only 348/702 (49.6%) were on oral anticoagulants at enrolment. Patients with AF had higher rates of all-cause hospitalisation (adjusted rate ratio 1.25 [1.06-1.46], p=0.008) over 2 years than those without AF, but similar rates of mortality., Conclusions: In stable patients post-MI, those with AF were commonly undertreated with oral anticoagulants, had poorer quality of life and had increased risk of clinical outcomes than those without AF., Trial Registration Number: ClinicalTrials: NCT01866904., Competing Interests: Competing interests: APC reports grant funding from the National Institutes of Health. RO has received research grant support from AstraZeneca. SJP has received research grant support from AstraZeneca. DBB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi Sankyo, AstraZeneca, Boehringer Ingelheim and BMS. JCN has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, Merck, Novartis, Pfizer and Sanofi. SGG has received research grant support (eg, steering committee or data and safety monitoring committee) and/or speaker/consulting honoraria (eg, advisory boards) from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Esperion, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Merck, Novartis, Novo Nordisk A/C, Pendopharm, Pfizer, Regeneron, Sanofi, Servier and Valeo Pharma, and salary support/honoraria from the Heart and Stroke Foundation of Ontario/University of Toronto (Polo) Chair, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Cleveland Clinic Coordinating Center for Clinical Research, Duke Clinical Research Institute, New York University Clinical Coordinating Center and PERFUSE Research Institute. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. KH and KAS are employees of AstraZeneca. CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward., (© 2021 Wiley Periodicals LLC.)

Objective: To evaluate the impact of COVID-19 pandemic migitation measures on of ST-elevation myocardial infarction (STEMI) care., Background: We previously reported a 38% decline in cardiac catheterization activations during the early phase of the COVID-19 pandemic mitigation measures. This study extends our early observations using a larger sample of STEMI programs representative of different US regions with the inclusion of more contemporary data., Methods: Data from 18 hospitals or healthcare systems in the US from January 2019 to April 2020 were collecting including number activations for STEMI, the number of activations leading to angiography and primary percutaneous coronary intervention (PPCI), and average door to balloon (D2B) times. Two periods, January 2019-February 2020 and March-April 2020, were defined to represent periods before (BC) and after (AC) initiation of pandemic mitigation measures, respectively. A generalized estimating equations approach was used to estimate the change in response variables at AC from BC., Results: Compared to BC, the AC period was characterized by a marked reduction in the number of activations for STEMI (29%, 95% CI:18-38, p < .001), number of activations leading to angiography (34%, 95% CI: 12-50, p = .005) and number of activations leading to PPCI (20%, 95% CI: 11-27, p < .001). A decline in STEMI activations drove the reductions in angiography and PPCI volumes. Relative to BC, the D2B times in the AC period increased on average by 20%, 95%CI (-0.2 to 44, p = .05)., Conclusions: The COVID-19 Pandemic has adversely affected many aspects of STEMI care, including timely access to the cardiac catheterization laboratory for PPCI., (© 2020 Wiley Periodicals LLC.)

Over the past few decades, advances in pharmacological, catheter-based, and surgical reperfusion have improved outcomes for patients with acute myocardial infarctions. However, patients with large infarcts or those who do not receive timely revascularization remain at risk for mechanical complications of acute myocardial infarction. The most commonly encountered mechanical complications are acute mitral regurgitation secondary to papillary muscle rupture, ventricular septal defect, pseudoaneurysm, and free wall rupture; each complication is associated with a significant risk of morbidity, mortality, and hospital resource utilization. The care for patients with mechanical complications is complex and requires a multidisciplinary collaboration for prompt recognition, diagnosis, hemodynamic stabilization, and decision support to assist patients and families in the selection of definitive therapies or palliation. However, because of the relatively small number of high-quality studies that exist to guide clinical practice, there is significant variability in care that mainly depends on local expertise and available resources.

[Figure: see text].

Objective: To assess associations of health-related quality of life (HRQoL) with patient profile, resource use, cardiovascular (CV) events and mortality in stable patients post-myocardial infarction (MI)., Methods: The global, prospective, observational TIGRIS Study enrolled 9126 patients 1-3 years post-MI. HRQoL was assessed at enrolment and 6-month intervals using the patient-reported EuroQol-5 dimension (EQ-5D) questionnaire, with scores anchored at 0 (worst possible) and 1 (perfect health). Resource use, CV events and mortality were recorded during 2-years' follow-up. Regression models estimated the associations of index score at enrolment with patient characteristics, resource use, CV events and mortality over 2-years' follow-up., Results: Among 8978 patients who completed the EQ-5D questionnaire, 52% reported 'some' or 'severe' problems on one or more health dimensions. Factors associated with a lower index score were: female sex, older age, obesity, smoking, higher heart rate, less formal education, presence of comorbidity (eg, angina, stroke), emergency room visit in the previous 6 months and non-ST-elevation MI as the index event. Compared with an index score of 1 at enrolment, a lower index score was associated with higher risk of all-cause death, with an adjusted rate ratio of 3.09 (95% CI 2.20 to 4.31), and of a CV event, with a rate ratio of 2.31 (95% CI 1.76 to 3.03). Patients with lower index score at enrolment had almost two times as many hospitalisations over 2-years' follow-up., Conclusions: Clinicians managing patients post-acute coronary syndrome should recognise that a poorer HRQoL is clearly linked to risk of hospitalisations, major CV events and death., Trial Registration Number: ClinicalTrials.gov Registry (NCT01866904) (https://clinicaltrials.gov)., Competing Interests: Competing interests: SP has received research grant support from AstraZeneca. DBB has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eli Lilly, Merck and Sanofi. RO has received research grant support from AstraZeneca. JC has received research grant support from AstraZeneca and consulting honoraria from MicroPort, APT Medical and JW Medical. MGC has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed and Merit Medical. SG has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, CSL Behring, Daiichi Sankyo/American Regent, Eli Lilly, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Servier and Tenax Pharmaceuticals. CBG has received consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, Janssen, Metronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda and The Medicines Company. JCN has received speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, Merck, Novartis, Pfizer and Sanofi. TS has received speaker/consulting honoraria and/or research grant support from Astellas, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi. DW has received speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik and Novartis. SY has received speaker/consulting honoraria and/or research grant support from Takeda, Daiichi Sankyo, AstraZeneca, Boehringer Ingelheim and BMS. KH, CM and KAS are employees of AstraZeneca., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Diabetes mellitus (DM) is associated with increased cardiovascular (CV) risk. We compared health-related quality of life (HRQoL), healthcare resource utilization (HRU), and clinical outcomes of stable post-myocardial infarction (MI) patients with and without DM., Hypothesis: In post-MI patients, DM is associated with worse HRQoL, increased HRU, and worse clinical outcomes., Methods: The prospective, observational long-term risk, clinical management, and healthcare Resource utilization of stable coronary artery disease study obtained data from 8968 patients aged ≥50 years 1 to 3 years post-MI (369 centers; 25 countries). Patients with ≥1 of the following risk factors were included: age ≥65 years, history of a second MI >1 year before enrollment, multivessel coronary artery disease, creatinine clearance ≥15 and <60 mL/min, and DM treated with medication. Self-reported health status was assessed at baseline, 1 and 2 years and converted to EQ-5D scores. The main outcome measures were baseline HRQoL and HRU during follow-up., Results: DM at enrollment was 33% (2959 patients, 869 insulin treated). Mean baseline EQ-5D score (0.86 vs 0.82; P < .0001) was higher; mean number of hospitalizations (0.38 vs 0.50, P < .0001) and mean length of stay (LoS; 9.3 vs 11.5; P = .001) were lower in patients without vs with DM. All-cause death and the composite of CV death, MI, and stroke were significantly higher in DM patients, with adjusted 2-year rate ratios of 1.43 (P < .01) and 1.55 (P < .001), respectively., Conclusions: Stable post-MI patients with DM (especially insulin treated) had poorer EQ-5D scores, higher hospitalization rates and LoS, and worse clinical outcomes vs those without DM. Strategies focusing specifically on this high-risk population should be developed to improve outcomes., Trial Registration: ClinicalTrials.gov: NCT01866904 (https://clinicaltrials.gov)., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Background: Limited data exist on current cardiogenic shock (CS) management strategies., Methods: A 48-item open- and closed-ended question survey on the diagnosis and management of CS., Results: A total of 211 respondents (3.2%) completed the survey, including 64% interventional cardiologists, 14% general cardiologists, 11% advanced heart failure cardiologists, 5% intensivists, 3% cardiothoracic surgeons; the remainder were internists, emergency medicine, and other physicians. Nearly half (45%) reported practicing at sites without advanced heart failure support/resources, with neither durable ventricular assist devices nor heart transplant available; 16% practice at sites without on-site cardiac surgery and 6% do not offer 24/7 percutaneous coronary intervention (PCI) coverage. The majority (70%) practice in closed intensive care units with multidisciplinary rounding (73%), cardiologists frequently involved in patient care (89%), and involving cardiology-intensivist co-management (41%). Over half (55%) reported use of CS protocols, 61% reported routine arterial line use, 25% reported routine use of pulmonary artery catheter use to guide management and 9% did not. The preferred vasopressor and/or inotrope was norepinephrine (68%). For coronary angiography and PCI, 53% use transradial access, 72% only revascularize the culprit vessel, and 44% institute mechanical circulatory support (MCS) prior to revascularization. Percutaneous MCS availability was as follows: intra-aortic balloon pump (92%), Impella (78%), peripheral veno-arterial extracorporeal membrane oxygenation (66%), and TandemHeart (28%). Most respondents (58%) do not use a scoring system for risk stratification and most (62%) reported that CS-specific cardiac rehabilitation programs were unavailable at their sites., Conclusion: Wide variation exists in the care delivered and/or resources available for patients with CS. Our survey suggests opportunities for standardization of care.

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is highly infectious, carries significant morbidity and mortality, and has rapidly resulted in strained health care system and hospital resources. In addition to patient-related care concerns in infected individuals, focus must also relate to diminishing community spread, protection of staff, case selection, and concentration of resources. The current document based on available data and consensus opinion addresses appropriate catheterization laboratory preparedness for treating these patients, including procedure-room readiness to minimize external contamination, safe donning and doffing of personal protective equipment (PPE) to eliminate risk to staff, and staffing algorithms to minimize exposure and maximize team availability. Case selection and management of both emergent and urgent procedures are discussed in detail, including procedures that may be safely deferred or performed bedside., (© 2020 Wiley Periodicals LLC.)

Background: Restricting transcatheter aortic valve replacement (TAVR) to centers based on volume thresholds alone can potentially create unintended disparities in healthcare access. We aimed to compare the influence of population density in state of Florida in regard to access to TAVR, TAVR utilization rates, and in-hospital mortality., Methods and Results: From 2011 to 2016, we used data from the Agency for Health Care Administration to calculate travel time and distance for each TAVR patient by comparing their home address to their TAVR facility ZIP code. Travel time and distance, TAVR rates, and mortality were compared across categories of low to high population density (population per square miles of land). Of the 6531 patients included, the mean (SD) age was 82 (9) years, 43% were female and 91% were White. Patients residing in the lowest category (<50/square miles) were younger, more likely to be men, and less likely to be a racial minority. Those residing in the lowest category density faced a longer unadjusted driving distances and times to their TAVR center (mean extra distance [miles]=43.5 [95% CI, 35.6-51.4]; P <0.001; mean extra time (minutes)=45.6 [95% CI, 38.3-52.9], P <0.001). This association persisted regardless of the methods used to determine population density. Excluding uninhabitable land, there was a 7-fold difference in TAVR utilization rates in the lowest versus highest population density regions (7 versus 45 per 100 000, P -for-pairwise-comparisons <0.001) and increase in TAVR in-hospital mortality (adjusted OR, 6.13 [95% CI, 1.97-19.1]; P <0.001)., Conclusions: Older patients living in rural counties in Florida face (1) significantly longer travel distances and times for TAVR, (2) lower TAVR utilization rates, and (3) higher adjusted TAVR mortality. These findings suggest that there are trade-offs between access to TAVR, its rate of utilization, and procedural mortality, all of which are important considerations when defining institutional and operator requirements for TAVR across the country.

Background: Evidence is lacking on long-term outcomes in unselected patients surviving the first year following myocardial infarction (MI)., Methods and Results: The TIGRIS (long-Term rIsk, clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients) prospective registry enrolled 9176 eligible patients aged ≥50 years, 1-3 years post-MI, from 25 countries. All had ≥1 risk factor: age ≥ 65 years, diabetes mellitus, second prior MI, multivessel coronary artery disease, chronic kidney disease (CKD). Primary outcome was a composite of MI, unstable angina with urgent revascularization, stroke, or all-cause death at 2-year follow-up. Bleeding requiring hospitalization was also recorded. 9027 patients (98.4%) provided follow-up data: the primary outcome occurred in 621 (7.0%), all-cause mortality in 295 (3.3%), and bleeding in 109 (1.2%) patients. Events accrued linearly over time. In multivariable analyses, qualifying risk factors were associated with increased risk of primary outcome (incidence rate ratio [RR] per 100 patient-years [95% confidence interval]): CKD 2.06 (1.66, 2.55), second prior MI 1.71 (1.38, 2.10), diabetes mellitus 1.63 (1.39, 1.92), age ≥ 65 years 1.53 (1.28, 1.83), and multivessel disease 1.24 (1.05, 1.48). Risk of bleeding events was greater in older patients (vs <65 years) 65-74 years 2.68 (1.53, 4.70), ≥75 years 4.62 (2.57, 8.28), and those with CKD 1.99 (1.18, 3.35)., Conclusion: In stable patients recruited 1-3 years post-MI, recurrent cardiovascular and bleeding events accrued linearly over 2 years. Factors independently predictive of ischemic and bleeding events were identified, providing a context for deciding on treatment options., Competing Interests: Declaration of competing interest D.B. Speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Merck, Novartis, Sanofi. S.J.P. Statistical consulting honoraria from AstraZeneca. S.B. Speaker/consulting honoraria and/or research grant support from Abbott, Abbott Diagnostics, AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Pfizer, Roche, Siemens, Siemens Diagnostics, Thermo Fisher Scientific. J.-Y.C. Research grant support from AstraZeneca; consulting honoraria from MicroPort, APT Medical and JW Medical. M.G.C. Speaker/consulting honoraria and/or research grant support from AstraZeneca, Medtronic, Abiomed, Merit Medical. C.B.G. Consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, Gilead, GlaxoSmithKline, F. Hoffmann-La Roche, Janssen Pharmaceuticals, Metronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda Pharmaceutical Company, The Medicines Company. R.G. None. J.C.N. Speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, CLS Behring, Pfizer, Sanofi. T.S. Speaker/consulting honoraria and/or research grant support from Astellas, Amgen Inc., AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmithKline, Merck, Novartis, Pfizer, Sanofi. D.W. Speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin-Chemie, Biotronik, Novartis. S.Y. Speaker/consulting honoraria and/or research grant support from Takeda Pharmaceutical Company, Daiichi-Sankyo, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb. J.G. Grants from AstraZeneca during the conduct of the study and outside the submitted work. K.L.R. Employee of OXON Epidemiology Ltd., and paid consultant to AstraZeneca in connection with the conduct, data management and analyses of this study. K.H. Employee of AstraZeneca. K.A.S. Employee of AstraZeneca. S.G.G. Speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CSL Behring, Daiichi Sankyo, Eli Lilly and Company, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, Tenax Pharmaceuticals, HLS Therapeutics, Novo-Nordisk., (Copyright © 2020. Published by Elsevier B.V.)

Latinos form the largest U.S. minority and will account for one quarter of the population by 2050. Immigration trends from 1995-2010 challenged health systems in "new destination" regions such as the southeastern U.S., with Latino population increases of 200-400%, and a minimal bilingual health workforce. Academic medical centers and safety net hospitals are challenged to respond beyond the interpreter paradigm of care delivery to provide efficient, cost-effective and compassionate care that complies with the U.S. Title VI mandates. We describe the design and successful implementation of an academic model in the care of Spanish-speaking patients in the pediatric and adult primary care and subspecialty settings in the University of North Carolina Health Care System. This model leverages a limited bilingual workforce to maximize the extent and quality of language-concordant care for this population The innovative features of the UNC Center for Latino Health (CELAH) is based upon five principles: patient navigation, a medical home, a block-scheduling system, a "virtual clinic" model using existing space, and leveraged cost-neutral resources. Patients are scheduled to specific half-day sessions in specialty clinics and matched with bilingual faculty and staff. This facilitates door-to-door care in Spanish for patients, the majority of whom are immigrants from rural Mexico and Central America with limited English and health literacy. CELAH is considered an academic transition model in anticipation of an adequate bilingual health workforce in 1-2 decades. As a hub, this clinical platform supports unique programs in medical education, translational and health equity research, community outreach, and faculty engagement.

Transcatheter aortic valve replacement (TAVR) has become a mainstay in treatment for patients with severe aortic stenosis who are considered high-risk surgical candidates. The use of TAVR in low-risk patients with severe aortic stenosis is being explored as an alternative to surgical aortic valve replacement (SAVR). Recent results from the Medtronic Evolut Low Risk trial and the Placement of Aortic Transcatheter Valves (PARTNER) 3 trial shed light on the use of TAVR in low-risk surgical candidates. The Evolut Low Risk trial compared TAVR with a self-expanding supra-annular bioprosthesis to SAVR in 1468 patients with severe aortic stenosis who were low surgical risk. Patients with a mean age of 74 and a mean Society of Thoracic Surgeons (STS) risk score of 1.9% were randomized to either TAVR or SAVR groups. Using the composite end point of death or disabling stroke at 24 months, the study found an incidence of 5.3% in the TAVR arm and 6.7% in the surgical arm. The Evolut Low Risk trial thus concluded that TAVR was statistically noninferior but not superior to SAVR (difference, -1.4 percentage points; 95% Bayesian credible interval for the difference, -4.9 to 2.1; posterior probability of noninferiority, >0.999). The PARTNER 3 trial assigned 1,000 patients with severe aortic stenosis and low surgical risk to either TAVR with transfemoral placement of balloon expandable valve or SAVR. Patients with a mean age of 73 and a mean STS score of 1.9% were randomized to either TAVR or SAVR groups. With respect to the primary endpoint of composite death from any cause, stroke, or rehospitalization, the study found an occurrence of 8.5% in TAVR and 15.1% in SAVR, confirming both noninferiority and superiority in the TAVR group [absolute difference, -6.6 percentage points; 95% confidence interval (CI), -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority]. Both the Evolut low risk trial and the PARTNER 3 trial provide evidence that the use of TAVR extends beyond the scope of high and intermediate risk surgical patients and is at the very least equivalent to SAVR in the treatment low-risk surgical candidates when using a transfemoral approach in patients without bicuspid aortic valves. In this article we provide an extensive review on the Evolute low risk and PARTNER 3 trials, including a discussion on clinically relevant outcomes., Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare., (2020 Cardiovascular Diagnosis and Therapy. All rights reserved.)

Longevity is increasing, and more adults are living to the stage of life when age-related biological factors determine a higher likelihood of cardiovascular disease in a distinctive context of concurrent geriatric conditions. Older adults with cardiovascular disease are frequently admitted to cardiac intensive care units (CICUs), where care is commensurate with high age-related cardiovascular disease risks but where the associated geriatric conditions (including multimorbidity, polypharmacy, cognitive decline and delirium, and frailty) may be inadvertently exacerbated and destabilized. The CICU environment of procedures, new medications, sensory overload, sleep deprivation, prolonged bed rest, malnourishment, and sleep is usually inherently disruptive to older patients regardless of the excellence of cardiovascular disease care. Given these fundamental and broad challenges of patient aging, CICU management priorities and associated decision-making are particularly complex and in need of enhancements. In this American Heart Association statement, we examine age-related risks and describe some of the distinctive dynamics pertinent to older adults and emerging opportunities to enhance CICU care. Relevant assessment tools are discussed, as well as the need for additional clinical research to best advance CICU care for the already dominating and still expanding population of older adults.

Transradial artery access (TRA) is associated with reduced bleeding risk, length of stay, costs, and increased patient satisfaction. Approximately one-third of TRA failures are due to lack of guiding catheter support. Catheter selection and engagement technique are crucial for obtaining good-quality angiograms and successfully completing percutaneous coronary intervention. The maneuvers required for catheter manipulation and coronary engagement differ between TRA and transfemoral arterial access. One of the advantages of TRA is the ability to use a universal catheter, saving time, radiation, and contrast. This review discusses practical learning points to improve operator understanding of catheter selection and coronary engagement technique., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Risk prediction tools are lacking for patients with stable disease some years after myocardial infarction (MI)., Hypothesis: A practical long-term cardiovascular risk index can be developed., Methods: The long-Term rIsk, Clinical manaGement and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients prospective global registry enrolled patients 1 to 3 years post-MI (369 centers; 25 countries), all with ≥1 risk factor (age ≥65 years, diabetes mellitus requiring medication, second prior MI, multivessel coronary artery disease, or chronic non-end-stage kidney disease [CKD]). Self-reported health was assessed with EuroQoL-5 dimensions. Multivariable Poisson regression models were used to determine key predictors of the primary composite outcome (MI, unstable angina with urgent revascularization [UA], stroke, or all-cause death) over 2 years., Results: The primary outcome occurred in 621 (6.9%) of 9027 eligible patients: death 295 (3.3%), MI 195 (2.2%), UA 103 (1.1%), and stroke 58 (0.6%). All events accrued linearly. In a multivariable model, 11 significant predictors of primary outcome (age ≥65 years, diabetes, second prior MI, CKD, history of major bleed, peripheral arterial disease, heart failure, cardiovascular hospitalization (prior 6 months), medical management (index MI), on diuretic, and poor self-reported health) were identified and combined into a user-friendly risk index. Compared with lowest-risk patients, those in the top 16% had a rate ratio of 6.9 for the primary composite, and 18.7 for all-cause death (overall c-statistic; 0.686, and 0.768, respectively). External validation was performed using the Australian Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events registry (c-statistic; 0.748, and 0.849, respectively)., Conclusions: In patients >1-year post-MI, recurrent cardiovascular events and deaths accrue linearly. A simple risk index can stratify patients, potentially helping to guide management., (© 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.)

Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio-guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio-guided complete revascularization versus infarct-related artery-only revascularization., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Previous studies comparing outcomes between culprit vessel only percutaneous coronary intervention (CV-PCI) versus multivessel percutaneous coronary intervention (MV-PCI) in patients with cardiogenic shock in the setting of acute myocardial infarction have shown conflicting results. This meta-analysis investigates the optimal approach for management of these patients considering recently published data., Methods: Electronic databases including MEDLINE, ClinicalTrials.gov and the Cochrane Library were searched for all clinical studies published until May 1, 2018, which compared outcomes in patients presenting with acute myocardial infarction and cardiogenic shock. Studies comparing CV-PCI versus MV-PCI in patients with multivessel coronary artery disease were screened for inclusion in final analysis. The primary end point was in-hospital/30 day mortality. Secondary endpoints included long term (>6 months) mortality, renal failure requiring renal replacement therapy, stroke, bleeding, and recurrent myocardial infarction. Odds ratio (OR) with 95% of confidence interval (CI) were computed and p values <0.05 were considered significant., Results: Patient who underwent CV-PCI had significantly lower short-term mortality (in-hospital or 30-day mortality) (OR: 0.73, CI: 0.61-0.87, p = 0.0005), and lower odds of severe renal failure requiring renal replacement therapy (OR: 0.76, CI: 0.59-0.98, p = 0.03). There was no statistically significant difference in long-term mortality, stroke, bleeding, and recurrent myocardial infarction between two groups., Conclusion: This meta-analysis showed lower short-term mortality and decreased odds of renal failure requiring renal replacement therapy with CV-PCI compared to MV-PCI. However, subgroup analysis including studies exclusively assessing STEMI patients revealed no statistically significant difference in outcomes. Further randomized trials are needed to confirm these findings and evaluate long term results., (Copyright © 2018 Elsevier Inc. All rights reserved.)