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Background: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFRangio) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFRangio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFRangio.Methods: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFRangio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFRangio for predicting pressure wire-derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity.Results: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFRangio values correlated well with FFR measurements ( r=0.80, P<0.001) and the Bland-Altman 95% confidence limits were between -0.14 and 0.12. The device success rate for FFRangio was 99%.Conclusions: FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR. FFRangio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes.Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262. [ABSTRACT FROM AUTHOR]

Background: New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. Methods: In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. Results: At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (±SD) of in-stent stenosis (21.65±14.42% for zotarolimus vs. 19.76±14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27±0.43 mm in the zotarolimus-stent group versus 0.19±0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events. Conclusions: At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.) N Engl J Med 2010;363:136-46. [ABSTRACT FROM AUTHOR]

Myocarditis and pericarditis are inflammatory conditions of the heart that present a range of symptoms, often including chest pain, fatigue, breathlessness and palpitations that may be irregular due to cardiac rhythm disturbances. Myocarditis has been proposed to account for a fraction of cardiac injury among patients infected with SARS-CoV-2 and associated systemic inflammation; and it might be one of the reasons for the high mortality seen in COVID-19 patients. Furthermore, following vaccination with mRNA COVID-19 vaccines (ie, Comirnaty and Spikevax), myocarditis and pericarditis can develop within a few days of vaccination, particularly following the second dose. Based on recent reviewed data, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have determined that the risk for both of these conditions is overall 'very rare' (~1 in 10 000 vaccinated people may be clinically affected), with the highest risk among younger males. Both EMA and FDA agree that the benefits of all authorised COVID-19 vaccines continue to outweigh their risks, given the threat of serious COVID-19 illness and related complications. Since myocarditis has a very wide clinical spectrum, ranging from mild to fulminant life-threatening disease, we present in this review a sum of the latest findings and considerations for the proper diagnosis and management of affected patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFR angio ) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFR angio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFR angio ., Methods: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFR angio using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFR angio for predicting pressure wire-derived FFR using a cutoff value of 0.80. The study was powered to meet prespecified performance goals for sensitivity and specificity., Results: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFR angio was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFR angio values correlated well with FFR measurements ( r=0.80, P<0.001) and the Bland-Altman 95% confidence limits were between -0.14 and 0.12. The device success rate for FFR angio was 99%., Conclusions: FFR angio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR. FFR angio has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.

The Impella is a mechanical circulatory support device that supports ventricular function. Since 2008, when the first Impella device received Food and Drug Administration clearance, its use has become increasingly prevalent. A variety of Impella devices are available, and are differentiated by size, power, and insertion techniques. These versions of the Impella have been used in a multitude of clinical scenarios, both emergent and elective, including high-risk coronary interventions, acute myocardial infarction complicated by cardiogenic shock, decompensated left and right heart failure, high-risk ventricular tachycardia ablations, and aortic valvuloplasty. However, the available evidence supporting its use is less than robust, primarily consisting of case reports and registries, with a limited number of randomized-controlled trials comparing the Impella with the intra-aortic balloon pump. Although these trials show that the Impella provides better hemodynamic support compared with the intra-aortic balloon pump, they failed to show a survival benefit for the Impella. This finding may have a number of explanations, foremost the inherent difficulty of selecting appropriate patients for trials that are conducted in extreme clinical settings. In this study, we discuss the mechanism of the Impella and the different types of Impella devices available, and review the medical literature for evidence of its efficacy in treating cardiac patients. Although the Impella has become ubiquitous in certain markets, such as in the USA, it has yet to be a part of the standard of care for patients in Israel.

It is not known whether the extent and severity of nonculprit coronary lesions correlate with outcomes in patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention (PCI). We sought to quantify complex plaques in patients with STEMI referred for primary PCI and to determine their effect on short- and long-term clinical outcomes by examining the core laboratory database for plaque analysis from the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction study. Baseline demographic, angiographic, and procedural details were compared between patients with single versus multiple complex plaques who underwent single-vessel PCI. Multivariable analysis was performed for predictors of long-term major adverse cardiac events (MACEs), a combined end point of death, reinfarction, ischemic target-vessel revascularization, or stroke, and for death alone. Single-vessel PCI was performed in 3,137 patients (87%): 2,174 (69%) had multiple complex plaques and 963 (31%) had a single complex plaque. Compared with those with a single complex plaque, patients with multiple complex plaques were older (p <0.0001) and had more co-morbidities. The presence of multiple complex plaques was an independent predictor of 3-year MACE (hazard ratio 1.58, 95% confidence interval 1.26 to 1.98, p <0.0001), and death alone (hazard ratio 1.68, 95% confidence interval 1.05 to 2.70, p = 0.03). In conclusion, multiple complex plaques are present in the majority of patients with STEMI who underwent primary PCI, and their presence is an independent predictor of short- and long-term MACE, including death (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966)., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Statin therapy is indicated after ST-segment elevation myocardial infarction (STEMI) to reduce recurrent ischemic events, but approximately 6% of patients with STEMI do not receive a statin prescription at discharge. This substudy aimed to define the clinical outcomes and patient characteristics associated with statin nonprescription after STEMI. We compared clinical, angiographic, and procedural characteristics and in-hospital, 30-day, 1-year, 2-year, and 3-year outcomes in 3,512 patients discharged after STEMI with and without (6%) statin prescriptions in the harmonizing outcomes with revascularization and stents in acute myocardial infarction trial (www.clinicaltrials.gov, NCT00433966). Statin nonprescription was associated with female sex, nonwhite race, previous bypass surgery, heart failure, renal impairment, anemia, thrombocytopenia, care in the United States, lower prescription rates of antiplatelets and neurohormonal antagonists, less percutaneous coronary intervention and stents, and, in 26% of cases, angiographically normal or nonobstructed coronary arteries. At every time point of follow-up after discharge, patients with no discharge statin prescription had significantly higher rates of net adverse clinical events, major adverse cardiac events, major bleeding unrelated to bypass surgery, and death. After multivariable adjustment, absence of a discharge statin prescription independently predicted 3-year major adverse cardiac event (hazard ratio 1.54, 95% confidence interval 1.15 to 2.07, p=0.0037) and death (hazard ratio 2.30, 95% confidence interval 1.41 to 3.77, p=0.0009). In conclusion, within the framework of this randomized trial of patients presenting with STEMI, approximately 6% of patients were discharged without statin therapy. Absence of a discharge statin prescription after STEMI was an independent predictor of ischemic events including death., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Restoring degenerated bioprosthetic valves by transcatheter valve implantation may obviate the need for redo surgery in carefully selected patients. We present our initial experience with valve-in-valve (VIV) procedures for failed aortic and mitral bioprosthetic valves., Methods: Data were collected for all patients who underwent VIV procedures at a tertiary medical center (n = 6). Findings were analyzed and compared with those for transcatheter valve implantation in native valves at the same center during the last 3 years (n = 84)., Results: Six patients of mean age 78.3 ± 13.8 years (range, 51-87) underwent VIV procedures with the CoreValve (n = 4) or Edwards-SAPIEN device (n = 2). Four (66%) had a failed prosthetic aortic valve, and 2 (33%) had a failed prosthetic mitral valve. Regurgitation accounted for valve failure in 83.3% of the VIV group versus 1.2% of the comparison group (p < 0.001). Procedural success and 30-day survival rates were 100%. Patient functional class improved significantly from 0% class I/II, 50% class III, and 50% class IV before the procedure to 66% class I, 33% class II, and 0% class III/IV after (p < 0.001)., Conclusion: This preliminary experience demonstrates that in carefully selected cases, transcathether valve implants can be safely and effectively deployed in stenotic and/or regurgitant degenerated bioprosthetic valves. Further evaluations in larger series are needed.