Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

Cardiac Tamponade in Patients Treated with Direct Oral Anticoagulants.

BACKGROUND: Direct oral anticoagulants (DOACs) are the treatment of choice for patients with non-valvular atrial fibrillation; however, bleeding risk remains significant. We reported a single-center experience with 11 patients who presented with hemorrhagic cardiac tamponade while treated with DOACs. OBJECTIVES: To evaluate the characteristics and clinical outcomes of patients under DOACs with cardiac tamponade. METHODS: We retrospectively identified 11 patients treated with DOACs admitted with pericardial tamponade in our cardiology unit during 2018-2021. RESULTS: The mean age was 84 ± 4 years; 7 males. Atrial fibrillation was the indication for anticoagulation in all cases. DOACs included apixaban (8 patients), dabigatran (2 patients), and rivaroxaban (1 patient). Urgent pericardiocentesis via a subxiphoid approach under echocardiography guidance was successfully performed in 10 patients. One patient was treated with urgent surgical drainage with a pericardial window. Reversal of anticoagulation using prothrombin complex concentrate and idarucizumab was given before the procedure to 6 patients treated with apixaban and one patient treated with dabigatran. One patient, initially treated with urgent pericardiocentesis, underwent pericardial window surgery due to re-accumulation of blood in the pericardium. The pericardial fluid analysis demonstrated hemopericardium. Cytology tests were negative for malignant cells in all cases. Discharge diagnoses regarding the cause of hemopericardium included pericarditis (3 patients) and idiopathic (8 patients). Medical therapy included non-steroidal anti-inflammatory drugs (1 patient), colchicine (3 patients), and steroids (3 patients). No patient died during hospitalization. CONCLUSIONS: Hemorrhagic cardiac tamponade is a rare complication of DOACs. We found good short-term prognosis following pericardiocentesis.

A missing coronary guidewire mimicking aortic dissection-a case report.

Background: A retained coronary guidewire following coronary angiography is an extremely rare complication. We present a case of a retained coronary guidewire from a percutaneous coronary intervention done 2 years ago. Case summary: An 80-year-old asymptomatic man with a history of ischemic heart disease and moderate aortic stenosis presented to the echocardiography lab for routine follow-up. Transthoracic echocardiography showed Moderate aortic stenosis and a suspected linear echogenic structure in the ascending aorta. trans-esophageal echocardiography was performed to reveal a mobile and linear echogenic structure originating from the sinuses of Valsalva/Sinotubular junction and extending to the ascending aorta. An electrocardiogram gated cardiac computed tomography was performed and showed A linear well-defined structure originating from the ostium of the left main coronary artery and extending to the ascending aorta-a coronary guidewire from an earlier procedure. A second look at the last invasive coronary angiography record demonstrated the same finding. A multidisciplinary heart team discussion was obtained and concluded that the risk of surgical or endovascular intervention outweighed the potential benefit. The patient was discharged home for a close clinical and echocardiographic follow-up. Discussion: A retained coronary guidewire is a rare complication that operators should be aware of. Management should be case-specific depending on clinical presentation.

The impact of on-site cardiac surgical backup on clinical outcomes of acute coronary syndrome-analysis of the ACSIS national registry.

Background: The availability of advanced technologies for mechanical support in hospitals with on-site cardiac surgery (CS), along with the ability to perform urgent coronary artery bypass graft (CABG) surgery, may result in improved clinical outcomes in patients with acute coronary syndrome (ACS). Methods: We conducted a retrospective analysis of the bi-annually Acute Coronary Syndrome Israeli Survey (ACSIS) registry from the year 2000 to 2020, performed in hospitals with and without CS. Mortality rates and major adverse cardiac and cerebrovascular events (MACCE) rates are reported. We evaluated two periods of the study-early (2000-2010) vs. late (2011-2020). Propensity score matching was performed to reduce bias between the two groups. Results: The study included 16,979 patients (52.3% in the on-site CS group). Patients in the on-site CS group were more likely to undergo percutaneous coronary intervention (PCI), (odds ratio [OR], 1.26 [95% CI, 1.18-1.35]; p < 0.001) and CABG [OR, 1.91 (95%CI, 1.63-2.24); P < 0.001], and patients in hospitals without on-site CS had higher 30-day MACCE [OR, 1.17 (95% CI, 1.07-1.27); p < 0.0005]. Overall, there was no difference in 1-year mortality (hazard ratio [HR], 0.98 [95% CI, 0.89-1.08]; p = 0.71) between the groups. During the late period of the study, patients in the group without on-site CS had lower 30-day mortality [OR, 0.69 (95% CI, 0.49-0.97); P = 0.04], yet with no difference in 1-year mortality [HR, 0.81 (95% CI, 0.65-1.01); p = 0.07]. Conclusions: The availability of on-site CS resulted in variations in treatment modality, yet it did not affect the clinical outcomes of ACS. A trend to a better short-term outcomes was noted in hospitals without CS during the late period of the study, which warrants further investigation.

Eyeball Test for the Assessment of Frailty in Elderly Patients With Cardiovascular Disease: A Prospective Study.

Frailty has been associated with poor outcomes in patients with cardiovascular diseases (CVDs). We aimed to assess the accuracy of the Eyeball test for frailty assessment in elderly patients with CVD. This is a prospective study including stable patients ≥75 years old who were followed-up in a cardiology clinic. Frailty assessment was performed separately through the Eyeball test and the Fried test in a blinded way. Cardiologists were asked to rate the frailty status of participants based on their routine clinical assessment and grade frailty on a Fried-type scale (1 to 5, with frailty defined as a score ≥3). Each patient then underwent formal frailty assessment using the Fried test. Included were 300 consecutive patients with a mean age of 81 ± 6 years. Frailty was diagnosed in 109 (36%) and 125 patients (41%) according to the Fried and Eyeball tests, respectively. The Eyeball test demonstrated 86% sensitivity and 82% specificity for the diagnosis of frailty. A receiver operating characteristics curve analysis demonstrated an area under the curve of 0.82 for the diagnosis of frailty. The Eyeball test demonstrated a very high negative predictive value of 90% and a modest positive predictive value of 73% for frailty assessment. Similar results were observed after subgroup analysis according to age and gender. In conclusion, the Eyeball test is an accurate method to rule out frailty in elderly patients with CVD. However, when frailty is suspected based on the Eyeball test, a formal tool such as the Fried test should be used to confirm the diagnosis.

Outcomes of patients with acute coronary syndrome according to COVID-19 vaccination status.

BACKGROUND: COVID-19 vaccination has been associated with reduced risk of acute coronary syndrome (ACS); however, several studies have reported cardiovascular complications following vaccination. We aimed to investigate the effect of COVID-19 vaccination status on the treatment and outcome of ACS patients. METHODS: The study was based on the 2021 Acute Coronary Syndrome Israeli Survey. Patients were stratified into two groups according to COVID-19 vaccination status, vaccinated compared to unvaccinated. Patients who had received at least 2 vaccination doses up to 1 week prior to ACS hospitalization were considered vaccinated. The primary endpoint was 1-year all-cause mortality. RESULTS: A total of 1261 patients with ACS were included, of whom 990 (78.5%) were vaccinated. Vaccinated patients were older and less frequently smokers. There were no significant differences in coronary reperfusion rates and treatment with guideline-based medical therapy during hospital stay and at discharge. The primary endpoint of 1-year all-cause mortality occurred in 38 (3.8%) and 14 (5.2%) patients in the vaccinated and unvaccinated groups respectively (P = 0.42). 30-day MACE occurred in 94 (9.5%) in the vaccinated patients compared to 31 (11.5%) in the unvaccinated group (P = 0.39). These results remained similar following adjustment for confounders. CONCLUSION: There was no association between COVID-19 vaccination status and the outcomes of patients with ACS. Our findings provide support for the cardiovascular safety of COVID-19 mRNA vaccines in patients at high cardiovascular risk.

Temporal Trends in the Prevalence, Treatment and Outcomes of Patients with Acute Coronary Syndrome at High Bleeding Risk.

(1) Background: High bleeding risk is associated with adverse outcomes in ACS patients. We aimed to evaluate temporal trends in treatment and outcomes of ACS patients according to bleeding risk. (2) Methods: Included were ACS patients enrolled in ACSIS surveys. Patients were divided into three groups according to enrolment period: early (2002−2004), mid (2006−2010) and recent (2012−2018). Each group was further stratified into three subgroups according to CRUSADE bleeding risk score. The primary endpoints were 30-day MACE and 1-year all-cause mortality. (3) Results: Included were 13,058 ACS patients. High bleeding risk patients were less frequently treated with guideline-based medications and coronary revascularization. They also had higher rates of 30-day MACE and 1-year all-cause mortality regardless of the enrollment period. Among patients enrolled in early period, 30-day MACE rates were 10.8%, 17.5% and 24.3% (p < 0.001) and 1-year all-cause mortality rates were 2%, 7.7% and 23.6% (p < 0.001) in the low, moderate and high bleeding risk groups, respectively. Among patients enrolled in mid period, 30-day MACE rates were 7.7%, 13.4% and 23.5% (p < 0.001) and 1-year all-cause mortality rates were 1.5%, 7.2% and 22.1% (p < 0.001) in low, moderate and high bleeding risk groups, respectively. For patients enrolled in recent period, 30-day MACE rates were 5.7%, 8.6% and 16.2%, (p < 0.001) and 1-year all-cause mortality rates were 2.1%, 6% and 22.4%, (p < 0.001) in low, moderate and high bleeding risk groups, respectively. These differences remained significant following a multivariate analysis. (4) Conclusions: The percentage of patients at high bleeding risk has decreased over the last years. Despite recent improvements in the treatment of ACS patients, high bleeding risk remains a strong predictor of adverse outcomes.

Transcatheter Left Atrial Appendage Occlusion: A Multi-Center Real Life Experience.

(1) Background: left atrial appendage occlusion (LAAO) is considered an effective and relatively safe treatment for the prevention of thromboembolic events in patients with atrial fibrillation and a contra-indication for anticoagulation. We present a large multicenter real-world experience of transcatheter LAAO implementation in patients with atrial fibrillation who cannot be treated with chronic anti-coagulation; (2) Methods: included were atrial fibrillation patients who underwent transcatheter LAAO between 1 January 2016 and 30 June 2021. The study was conducted using the electronic health record database of Clalit Health Services (CHS). The primary outcomes included hemorrhagic and ischemic stroke following LAAO; (3) Results: included were 389 atrial fibrillation patients. During a median follow-up of 2.1 years, 13% patients had ischemic cerebrovascular accident (CVA), and 4.4% patients had hemorrhagic CVA. While the risk of ischemic stroke increased gradually over time, the risk of hemorrhagic CVA was highest during the first 3 months following the procedure. Moreover, previous ischemic stroke was the only significant predictor for both hemorrhagic and ischemic stroke following LAAO; (4) Conclusions: while the annual performance rate of transcatheter LAAO has increased significantly over the past years, post procedural long-term prognosis remains poor with a substantial risk of both thrombotic and bleeding events.

CHA2DS2-VASc Score, Mortality and Acute Myocardial Infarction in Patients With Nonvalvular Atrial Fibrillation.

Patients with atrial fibrillation (AF) are at increased cardiovascular risk. The CHA2DS2-VASc score (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, previous stroke, vascular disease, age 65 to 74 years, female gender) has been used to predict thromboembolic risk in patients with nonvalvular AF. We aimed to evaluate the association between the CHA2DS2-VASc score and the risk of acute myocardial infarction (AMI) and all-cause mortality in patients with AF treated with direct oral anticoagulants (DOACs). The study was based on the Clalit Health Services database. Included were 21,129 patients with nonvalvular AF treated with DOACs. Patients were stratified into four groups according to the CHA2DS2-VASc score.1-9 The primary end point was the occurrence of AMI and all-cause mortality. During 21,129 patient-years, there were 1,253 incidents (5.9%) of AMI. A higher CHA2DS2-VASc score was associated with a significantly increased risk of AMI (7.8, 14.9, 23.9, and 35.3 cases per 1,000 person-years, for patients with CHA2DS2-VASc score of 1 to 2, 3 to 4, 5 to 6, and 7 to 9, respectively, p <0.001). Each 1-point increase in the CHA2DS2-VASc score was associated with a 27% increased risk of AMI. A higher CHA2DS2-VASc score was also associated with a significantly increased ll-cause mortality rate (21.7, 60.2, 103.9, 162.6 cases per 1,000 person-years, for patients with CHA2DS2-VASc score of 1 to 2, 3 to 4, 5 to 6, 7 to 9, respectively, p <0.001). All associations remained statistically significant after a multivariate analysis. In conclusion, among patients with nonvalvular AF treated with DOACs, the CHA2DS2-VASc score was associated with increased risk of AMI and all-cause mortality.

Metabolomic and microbiome profiling reveals personalized risk factors for coronary artery disease.

Complex diseases, such as coronary artery disease (CAD), are often multifactorial, caused by multiple underlying pathological mechanisms. Here, to study the multifactorial nature of CAD, we performed comprehensive clinical and multi-omic profiling, including serum metabolomics and gut microbiome data, for 199 patients with acute coronary syndrome (ACS) recruited from two major Israeli hospitals, and validated these results in a geographically distinct cohort. ACS patients had distinct serum metabolome and gut microbial signatures as compared with control individuals, and were depleted in a previously unknown bacterial species of the Clostridiaceae family. This bacterial species was associated with levels of multiple circulating metabolites in control individuals, several of which have previously been linked to an increased risk of CAD. Metabolic deviations in ACS patients were found to be person specific with respect to their potential genetic or environmental origin, and to correlate with clinical parameters and cardiovascular outcomes. Moreover, metabolic aberrations in ACS patients linked to microbiome and diet were also observed to a lesser extent in control individuals with metabolic impairment, suggesting the involvement of these aberrations in earlier dysmetabolic phases preceding clinically overt CAD. Finally, a metabolomics-based model of body mass index (BMI) trained on the non-ACS cohort predicted higher-than-actual BMI when applied to ACS patients, and the excess BMI predictions independently correlated with both diabetes mellitus (DM) and CAD severity, as defined by the number of vessels involved. These results highlight the utility of the serum metabolome in understanding the basis of risk-factor heterogeneity in CAD.

Short membranous septum length in bicuspid aortic valve stenosis increases the risk of conduction disturbances.

BACKGROUND: Distinct anatomical features predispose bicuspid AS patients to conduction disturbances after TAVR. This study sought to evaluate whether the incidence of permanent pacemaker implantation (PPMI) and left bundle branch block (LBBB) in patients with bicuspid aortic stenosis (AS) following transcatheter aortic valve replacement (TAVR) is related to an anatomical association between bicuspid AS and short membranous septal (MS) length. METHODS: Sixty-seven consecutive patients with bicuspid AS from a Bicuspid AS TAVR multicenter registry and 67 propensity-matched patients with tricuspid AS underwent computed tomography before TAVR. RESULTS: MS length was significantly shorter in bicuspid AS compared with tricuspid AS (6.2 ± 2.5 mm vs. 8.4 ± 2.7 mm, respectively; p < 0.001). In patients with bicuspid AS, MS length and aortic valve calcification were the most powerful pre-procedural independent predictors of PPMI or LBBB (odds ratio [OR]: 1.38, 95% confidence interval [CI]: 1.15 to 1.55, p = 0.003 and OR: 1.92, 95% CI: 1.1 to 3.34, p = 0.022, respectively). When taking into account pre- and post-procedural parameters, aortic valve calcification and the difference between MS length and implantation depth were the most powerful independent predictors of PPMI or LBBB in patients with bicuspid AS (OR: 1.82, 95%: 1.1 to 3.1, p = 0.027; OR: 1.25, 95% CI: 1.10 to 1.38, p = 0.003). CONCLUSION: MS length, which was significantly shorter in bicuspid AS compared with tricuspid AS, aortic valve calcification, and device implantation deeper than MS length predict PPMI or LBBB in bicuspid AS after TAVR.

Effect of Intramural Course of Coronary Arteries Assessed by Computed Tomography Angiography in Patients With Hypertrophic Cardiomyopathy.

This study evaluated the prevalence, anatomical pattern, and prognostic implications of an intramural course of the coronary arteries in patients with hypertrophic cardiomyopathy (HC). The study population consisted of 92 patients with HC and 100 patients without HC. The presence of an intramural course of the coronary arteries was evaluated by coronary computed tomography angiography (CTA), and its length and depth were measured. During follow-up, the occurrence of unstable angina requiring hospitalization, myocardial infarction, and all-cause mortality was evaluated. An intramural course of the coronary arteries was more common in patients with HC than patients without HC (62% vs 25%, p <0.001). In the patients with an intramural coronary artery course, those with HC had a longer course (29.1 ± 15.3 mm vs 23.0 ± 13.0 mm; p = 0.037) with deeper penetration into the left ventricular myocardium (2.8 ± 1.2 mm vs 2.1 ± 0.8 mm; p = 0.007) and more involvement of multiple coronary arteries (38% vs 4%; p <0.001). During follow-up (mean 5.5 ± 3.5 years), cardiac events occurred in 17 of 57 patients (29.8%) with an intramural course and 11 of 35 (31.4%) without an intramural course (p = 0.87). On Kaplan-Meier survival analysis, there was no difference in cumulative event rate between HC patients with or without an intramural course (p = 0.89, log rank test). In conclusion, patients with HC have a high rate of an intramural course of the coronary arteries on CTA. The number of involved arteries and the length and depth of the intramural course differ between patients with and without HC, but apparently have no association with worse clinical outcomes.

Prevalence and morphology of myocardial crypts in normal and hypertrophied myocardium by computed tomography.

Myocardial crypts can be recognized in patients with hypertrophic cardiomyopathy (HCM) using magnetic resonance imaging, but similar studies using computed tomography (CT) are sparse. The aim of the present study was to evaluate the prevalence and morphology of myocardial crypts in patients with HCM, arterial hypertension, and aortic valve stenosis using contrast-enhanced CT. We also investigated the added value of a finding of myocardial crypts on CT scan to the diagnosis of HCM. The study cohort included 73 patients with HCM, 100 patients with arterial hypertension, 120 patients with aortic valve stenosis, and 100 subjects without cardiovascular disease (normal control group). All underwent evaluation for the presence and dimensions of myocardial crypts using 256-slice CT. Crypts were identified in 18 patients (24.7%) with HCM, 7 patients (7%) with hypertension, 8 patients (6.7%) with aortic valve stenosis, and 4 (4%) normal subjects (P < 0.001). Values of crypt length, width, area, and penetration into myocardium were highest in the HCM group. Crypt area differentiated patients with HCM from patients with arterial hypertension and aortic valve stenosis, and from normal control subjects. Crypt area was an accurate predictor of HCM, with an area under the receiver-operator characteristic curve of 0.88 (95% CI 0.80-0.96). Myocardial crypts identified by CT are more prevalent and larger in area in HCM than in arterial hypertension and aortic valve stenosis. Crypt area could potentially help to improve the diagnosis of HCM by CT beyond the assessment of left ventricular thickness or mass.