American College Of Cardiology Foundation Research Articles

Percutaneous Closure of the Patent Ductus Arteriosus in Infants ≤2 kg: IMPACT Registry Insights.

Percutaneous patent ductus arteriosus (PDA) closure is becoming the standard of care for definitive closure in progressively smaller and younger neonates. The objective of this study was to assess safety and feasibility of percutaneous PDA closure in patients ≤2 kg. This was a cohort study using the IMPACT Registry (Improving Pediatric and Adult Congenital Treatments) from the American College of Cardiology Foundation's National Cardiovascular Data Registry. Patients who were ≤2 kg at the time of percutaneous PDA closure were included. The primary outcome was the composite of technical failure and/or major adverse event. A total of 1587 attempted PDA closures were included, with a 3% incidence of technical failure and 5.5% incidence of the composite outcome. Major adverse events were observed in 3.8% of the patients; the most common events were device embolization requiring retrieval and unplanned cardiac or vascular surgery in 1.3% and 1.3% of cases, respectively. The incidence of the composite outcome was associated with the need for arterial access (P < .001) as well as annual hospital volume of percutaneous PDA closures in infants ≤2 kg (P = .001). The incidence of the composite outcome has decreased overtime, whereas median weight at the time of procedure has also diminished. Percutaneous PDA closure appears to be safe and feasible procedures in infants ≤2 kg. The incidence of major adverse events has continued to decline over the years and seems to have a strong correlation with individual center case volumes and expertise.

Tenecteplase: A Review of Its Pharmacology and Uses.

Tenecteplase: A Review of Its Pharmacology and Uses.

Paediatric Pulmonary hypertension

Pulmonary hypertension (PH) is a rare disease in newborns, infants, and children that is associated with significant morbidity and mortality. In the majority of pediatric patients, PH is idiopathic or associated with congenital heart disease and rarely is associated with other conditions such as connective tissue or thromboembolic disease. Incidence data from the Netherlands has revealed an annual incidence and point prevalence of 0.7 and 4.4 for idiopathic pulmonary arterial hypertension and 2.2 and 15.6 for pulmonary arterial hypertension, respectively, associated with congenital heart disease (CHD) cases per million children. The updated Nice classification for PH has been enhanced to include a greater depth of CHD and emphasizes persistent PH of the newborn and developmental lung diseases, such as bronchopulmonary dysplasia and congenital diaphragmatic hernia. The management of pediatric PH remains challenging because treatment decisions continue to depend largely on results from evidence based adult studies and the clinical experience of pediatric experts. (J Am Coll Cardiol 2013;62:D117-26) ©2013 by the American College of Cardiology Foundation.

2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee.

2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee.

Integrating Coronary Atherosclerosis Burden and Progression with Coronary Artery Disease Risk Factors to Guide Therapeutic Decision Making

ImportanceAlthough atherosclerosis represents the primary driver of coronary artery disease, evaluation and treatment approaches have historically relied upon indirect markers of atherosclerosis that include surrogates (cholesterol), signs (angina), and sequelae (ischemia) of atherosclerosis. Direct quantification and characterization of atherosclerosis may encourage a precision heart care paradigm that improves diagnosis, risk stratification, therapeutic decision-making, and longitudinal disease tracking in a personalized fashion. ObservationsThe American College of Cardiology Innovations in Prevention Working Group introduce the Atherosclerosis Treatment Algorithms that personalize medical interventions based upon atherosclerosis findings from coronary computed tomography angiography (CTA) and cardiovascular risk factors. Through integration of coronary CTA-based atherosclerosis evaluation, clinical practice guidelines, and contemporary randomized controlled trial evidence, the Atherosclerosis Treatment Algorithms leverage patient-specific atherosclerosis burden and progression as primary targets for therapeutic intervention. After defining stages of atherosclerosis severity by coronary CTA, Atherosclerosis Treatment Algorithms are described for worsening stages of atherosclerosis for patients with lipid disorders, diabetes, hypertension, obesity, and tobacco use. The authors anticipate a rapid pace of research in the field, and conclude by providing perspectives on future needs that may improve efforts to optimize precision prevention of coronary artery disease. Importantly, the Atherosclerosis Treatment Algorithms are not endorsed by the American College of Cardiology, and should not be interpreted as a statement of American College of Cardiology policy. Conclusions and RelevanceWe describe a precision heart care approach that emphasizes atherosclerosis as the primary disease target for evaluation and treatment. To our knowledge, this is the first proposal to use coronary atherosclerosis burden and progression to personalize therapy selection and therapy changes, respectively. DisclosureThe American College of Cardiology Foundation has made an investment in Cleerly, Inc., makers of a software solution that utilizes coronary CT angiography findings to evaluate coronary artery disease.

Association of Electrocardiographic Signs of Right Ventricular Hypertrophy and Clot Localization in Chronic Thromboembolic Pulmonary Hypertension.

The role of electrocardiography (ECG) in chronic thromboembolic pulmonary hypertension (CTEPH) diagnosis and prognosticating has not been yet established. We aimed to assess the relationships of the recommended ECG criteria of right ventricular hypertrophy (RVH) with clot localization in CTEPH patients. ECG patterns of RVH according to the American College of Cardiology Foundation were assessed in patients with newly diagnosed CTEPH. We enrolled 58 (45.3%) patients with proximal and 70 (54.7%) with distal CTEPH. Receiver-operating characteristics curves analysis indicated that the following ECG abnormalities predicted proximal CTEPH localization: RV1 > 6 mm—AUC 0.75 (CI: 0.66–0.84, p < 0.00001); SV6 > 3 mm—AUC 0.70 (CI: 0.60–0.79, p < 0.00001); SI > RI wave—AUC 0.67 (CI: 0.58–0.77, p = 0.0004); RV1:SV1 > 1.0—AUC 0.66 (CI: 0.56–0.76, p = 0.0009); RV1 peak > 0.035 s (QRS < 120 ms)—AUC 0.66 (CI: 0.56–0.75, p = 0.0016); RV1:SV1 > RV3(V4):SV3(V4)—AUC-0.65 (CI: 0.54–0.75, p = 0.0081); RaVR > 4 mm—AUC 0.62 (CI: 0.52–0.71, p = 0.002) and PII > 2.5 mm—AUC 0.62 (CI: 0.52–0.72, p = 0.00162). Pulmonary vascular resistance significantly correlated with amplitudes of RV1 (r = 0.34, p = 0.008), SV6 (r = 0.53, p = 0.000027) and PII (r = 0.44, p = 0.00007). In patients with CTEPH, only 8 out of 23 ECG RVH criteria were useful for differentiating between proximal and distal CTEPH localization and we found that RV1 and SV6 may contribute as potential discriminators.

Morphine in acute coronary syndrome and myocardial infarction: pro et contra

The review summarizes the current literature data on the use of the morphine in patients with acute coronary syndrome and myocardial infarction. It briefly reports on the possibility of prescribing morphine in such clinical situations in accordance with the current guidance of the American College of Cardiology Foundation, the American Heart Association and the European Society of Cardiology. After describing the pharmacological properties of the morphine, including its effect on the heart, the positive effects of the drug are discussed in detail: pain relief, hemodynamic effects, and the alleged effect on myocardial remodeling. To form a complete understanding of the analyzed opioid drug, information on the effect of morphine on clinical outcomes − death, recurrence of myocardial infarction, stroke, bleeding is provided. Equally important is the section describing the interaction of morphine with antiplatelet drugs prescribed to the patients with acute coronary syndrome and myocardial infarction. In conclusion, the article discusses the necessary options for optimal pain relief in the patients with acute coronary syndrome and myocardial infarction, as well as the need to study new antiplatelet drugs.

Natural Language Mapping of Electrocardiogram Interpretations to a Standardized Ontology.

Interpretations of the electrocardiogram (ECG) are often prepared using software outside the electronic health record (EHR) and imported via an interface as a narrative note. Thus, natural language processing is required to create a computable representation of the findings. Challenges include misspellings, nonstandard abbreviations, jargon, and equivocation in diagnostic interpretations. Our objective was to develop an algorithm to reliably and efficiently extract such information and map it to the standardized ECG ontology developed jointly by the American Heart Association, the American College of Cardiology Foundation, and the Heart Rhythm Society. The algorithm was to be designed to be easily modifiable for use with EHRs and ECG reporting systems other than the ones studied. An algorithm using natural language processing techniques was developed in structured query language to extract and map quantitative and diagnostic information from ECG narrative reports to the cardiology societies' standardized ECG ontology. The algorithm was developed using a training dataset of 43,861 ECG reports and applied to a test dataset of 46,873 reports. Accuracy, precision, recall, and the F1-measure were all 100% in the test dataset for the extraction of quantitative data (e.g., PR and QTc interval, atrial and ventricular heart rate). Performances for matches in each diagnostic category in the standardized ECG ontology were all above 99% in the test dataset. The processing speed was approximately 20,000 reports per minute. We externally validated the algorithm from another institution that used a different ECG reporting system and found similar performance. The developed algorithm had high performance for creating a computable representation of ECG interpretations. Software and lookup tables are provided that can easily be modified for local customization and for use with other EHR and ECG reporting systems. This algorithm has utility for research and in clinical decision-support where incorporation of ECG findings is desired.

Appropriate use criteria in myocardial perfusion imaging in a tertiary care hospital in South India: An audit.

Myocardial perfusion imaging (MPI) is an important investigative tool in the diagnosis and management of coronary artery disease. This investigation has seen a manifold increase in number in past decades as compared to other investigations such as cardiac magnetic resonance imaging/positron emission tomography or computed tomography. In 2005, “Appropriate use criteria (AUC) in cardiac radionuclide imaging” was formulated by the American College of Cardiology Foundation and the American Society of Nuclear Cardiology for effective use of this investigation, later revised in 2009. We assessed the appropriateness of indications for MPI in patients presenting to the nuclear medicine department of a tertiary care hospital according to the latest AUC for cardiac radionuclide imaging. This is a retrospective analysis of all cardiac perfusion scans performed from June 2019 to January 2020 in a tertiary care teaching hospital in South India. All patients' indications for MPI were assessed for appropriateness using AUC 2009 as appropriate, inappropriate, and uncertain indications by two experienced nuclear medicine physicians blinded for results of the test and hospital stay of the patients. A total of 1015 cardiac scans were performed in the given period, which were analyzed. This included 613 males and 402 females, with most of the patients aged above 60 years (n = 640; males = 385, females = 255). Most of the patients had diabetes mellitus or hypertension or both except in 161 patients (15.8%) which did not have either of the comorbidities. Chest pain and/or shortness of breath were the most common presenting complaints. The appropriate indication for imaging was found in 784 patients (77.2%), inappropriate in 121 patients (12%), and uncertain in 110 patients (10.8%). Our results showed appropriate indication to be 77.2% and inappropriate indications as 12% for MPI referrals in a tertiary care teaching hospital, similar to Western literature but can be improved further by continued teaching and awareness campaigns.

Indications for Maternal Echocardiography in Detecting Disease and the Impact on Pregnancy Management.

Few obstetric-specific guidelines detail the indications for screening echocardiography in pregnancy. The objective of the study is to examine the association of common indications for maternal echocardiography with the likelihood of abnormality identification, pregnancy management alteration, and conformity with current American College of Cardiology Foundation (ACCF) guidelines. This retrospective cohort analysis categorized all echocardiograms performed within pregnancy and the first month postpartum within a tertiary health system to correlate indications with abnormal findings. Data from 226 echocardiograms were analyzed from 205 women. The most common indication for initial echocardiography was cardiac symptoms (34.6%). History of cardiac disease was the only indication demonstrating a significant association with an abnormal finding on initial echocardiography (odds ratio [OR]: 2.6; p = 0.006). Postpartum status (OR: 4.9; p < 0.001), multiparity (p < 0.001), and tobacco use (OR: 2.2; p = 0.011) were demographic characteristics associated with the identification of abnormal findings on initial echocardiography. Abnormal echocardiographic findings were associated with changes in clinical management but did not correlate with adverse obstetric or neonatal outcomes, which may support the impact of a multidisciplinary programmatic approach. ACCF appropriateness criteria correlated well with identification of abnormal echocardiographic results (p = 0.034). Although the presence of cardiac symptoms or history of diabetes failed to demonstrate association with abnormal echocardiographic findings, a history of prior cardiac disease, tobacco use, multiparity, and postpartum status were factors associated with identification of abnormal findings on initial maternal echocardiography. The ACCF appropriateness criteria for obtaining echocardiography can be applied to pregnant women with consideration for these additional risk factors. · The ACCF criteria are applicable in pregnancy for appropriateness of echocardiography indications.. · Several clinical factors often prompt performance of echocardiography in pregnancy without merit.. · Consideration for multiparty, tobacco abuse, and postpartum state should coincide with ACCF criteria..

The prevalence and clinical characteristics of restless legs syndrome in patients with iron deficiency anemia in Korea.

While the prevalence and clinical characteristics of restless legs syndrome (RLS) are known to vary according to ethnicity, a detailed evaluation of this condition among patients with iron deficiency anemia (IDA) has not yet been reported in an Asian population. We investigated the prevalence and clinical characteristics of RLS in patients with IDA in Korea compared with age- and sex-matched patients diagnosed with idiopathic RLS. This prospective single-center study was performed at a regional university hospital. Consecutive patients with IDA were enrolled over a 4-year period. Clinical interviews and laboratory tests were conducted at the first visit. RLS diagnosis was confirmed through face-to-face interviews. We randomly selected patients with idiopathic RLS without comorbid medical disorders from our sleep center dataset as control patients. The clinical characteristics of both groups were compared. We enrolled 124 patients with IDA. Fifty (40.3%) patients were diagnosed with RLS, with 82% exhibiting severe to very severe symptoms. Patients with IDA and RLS were older and reported more sleep deterioration than patients with IDA without RLS. Patients with IDA and RLS also had a more depressed mood and higher periodic limb movement index scores than patients with idiopathic RLS. The prevalence of RLS among patients with IDA in Korea was high, with the majority having severe to very severe symptoms. Patients with IDA and RLS had poorer sleep quality and more emotional problems than patients with IDA without RLS. Therefore, patients with IDA should be screened for RLS to prevent adverse effects on the quality of sleep and life.

Assessment of proportion and prescribing trends of coronary artery diseases in a tertiary care hospital, Kerala: a prospective observational study

Background: The aim of the study is to assess the proportion of types of coronary artery diseases and to analyze the trends of drug prescribing in coronary artery disease (CAD) by checking the compliance with the standard guidelines provided by the American College of Cardiology Foundation / American Heart Association (ACCF/AHA).Methods: A prospective observational study was conducted in the department of Cardiology for a period of 6 months. A total of 94 patients with varied categories of CAD were screened and analyzed. Study related data was collected from case records and by a structured interview. Data analysis was done by analyzing the prescribing trends of drug and assessing the proportion of CAD.Results: The current study found that most of the patients were of the age group of 61-70 years. The proportion of Non-ST segment elevation myocardial infarction (NSTEMI) was remarkably higher in patients with CAD (55.3%) followed by ST-elevated myocardial infarction (STEMI) (39.4%) and Unstable angina (5.3%). Chi square test shows that prescription of Antiplatelets were apparent in all the prescriptions (100%), followed by Statins (Atorvastatin 98.9%), Antihypertensives (94.7%), Anticoagulants (90.4%), Nitrates (76.6%), Antidiabetics (75.5%) and Potassium channel opener (Nicorandil 36.2%). By analyzing the prescription, it was observed that most of the drugs were prescribed rationally according to the standard treatment guidelines (ACCF/AHA).Conclusions: This study provides an overall insight of proportion of CAD and prescribing pattern in patients with CAD which reveals the rational prescribing of drugs in accordance with the standard guidelines.

2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure

2020 ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure

Underutilization of Peptic Ulcer Disease Prophylaxis Among Elderly Users of Antiplatelets and Anticoagulants.

Peptic ulcer disease (PUD) develops in approximately 25% of chronic users of non-steroidal anti-inflammatory drugs (NSAIDs). The incidence of uncomplicated PUD has been declining over the past 3 decades unlike that of complicated PUD in the elderly. An expert consensus document published jointly in 2008 by the American College of Gastroenterology (ACG), the American College of Cardiology Foundation (ACCF), and the American Heart Association (AHA) provided recommendations on prevention of PUD among users of antiplatelets and anticoagulants. This work aimed to evaluate physicians' compliance with these guidelines in a tertiary academic setting. We examined our medical record database for the 9month period extending from April 2018 until December 2018. Using this database, we identified elderly patients (> 64years old) who were chronic (> 3months) users of low dose aspirin (81mg once daily) and had an indication for PUD prophylaxis as per the ACG-ACCF-AHA guideline document. We performed a retrospective chart review of patients included in this study. Descriptive statistics were compared using χ2 and independent sample t tests. A total of 852 patients were included in this study. The mean age was 75years old, and 43% of patients were females. In addition to aspirin, patients were prescribed P2Y12 inhibitors (45.5%), direct oral anticoagulants (DOACs) (23%), warfarin (12%), steroids (9%) or enoxaparin (1%). Users of DOACs were most commonly prescribed apixaban (16%), followed by rivaroxaban (6%) and dabigatran (1%). Overall, only 40% of patients with an indication for PUD prophylaxis received a proton pump inhibitor. PUD prophylaxis may be underutilized in elderly patients. This finding, along with increasing rates of NSAID use and an aging population, may help explain the increased incidence of complicated PUD in the elderly. Efforts are needed to raise physician awareness of PUD prophylaxis guidelines.

A single-centre audit of request forms and the 2011 appropriate use criteria for transthoracic echocardiography

Background: Transthoracic echocardiography (TTE) is a useful diagnostic tool in cardiology practice. The information provided by the requesting physician is a helpful guide in the interpretation of findings. This study aimed to audit echocardiography request forms (ECFs). Methods: A 3-year retrospective audit of echocardiography request forms (ERFs) received at a community-based echocardiography centre in Delta State, Nigeria. Delta State University Teaching Hospital Health Research Ethics Committee granted ethical approval to conduct this study. Data extracted from the ERFs were patients' name, age, sex, address and indication/background clinical information, the name and signature of requesting physician, name of referring hospital and date of the request. Evaluation of the appropriateness of the indications for echocardiography was done using 2011 Revised American College of Cardiology Foundation's appropriate use criteria (AUC). The corresponding echocardiograms were coded as normal or abnormal reports. Data were anonymised and analysed using the SPSS software version 23. Results: All the 412 ERFs audited had the names of the patients. The patients' age, sex and address were missing in 22.6%, 11.4% and 92.5% of the ERFs, respectively. A total of 119 (28.9%) ERFs lacked indication/clinical information and thus unclassifiable using the 2011 AUC. Of the remaining ERFs, the AUC was appropriate, inappropriate and uncertain in 259 (88.4%), 26 (8.9%) and 8 (2.7%), respectively. Majority of the ERFs with uncertain indications had normal echocardiograms. The echocardiograms of 78% (93/119) of the patients whose ERFs lacked indication/clinical information were abnormal. Conclusion: In this study, ERFs were inadequately filled. However, majority of the stated indications/clinical information for TTE were classified as appropriate.

A Retrospective Analysis of Hospital Electrocardiogram Auto-Populated QT Interval Calculation.

BackgroundThe current electrocardiogram (ECG) standard for rate correction of the QT interval (QTc) is a power function known as the Bazett formula (QTcB). QTc formulae are either power functions or linear functions. QTcB is known to lack reliability, as heart rate (HR) rises from or falls below 60 beats per minute (bpm). The American Heart Association (AHA), the American College of Cardiology Foundation (ACCF), and the Heart Rhythm Society (HRS) have recommended using other formulae in place of QTcB since 2009. The Epic Electronic Health Record System (Epic Systems Corporation, Verona, WI) automatically populates the Fridericia formula (QTcFri) on hospital ECG reports without any provider calculation.MethodsWe aimed to retrospectively investigate the effect of QTcFri on one year of ECGs in the Epic Electronic Health Record (EHR) at a single tertiary care center. Inclusion criteria for ECG reports specified HR 60-120 bpm without QRS duration > 120 ms. Gathered data from Epic EHR ECG reports included patient age, sex, HR, QRS duration (QRSd), QT interval, QTcB, and QTcFri. EHR documented 61,946 ECG reports for the year, with 44,566 meeting criteria for inclusion. General statistical methods included range, median, mean, and standard deviation. Confidence intervals were assessed to maintain the fidelity of analysis. The normality of data distribution was assessed with Kolmogorov-Smirnov testing. The Wilcoxon rank-sum test was then performed to confirm a statistically significant difference between the Bazett and Fridericia formulae. The ∆QTc analysis was conducted on prolonged QTc (males > 450 ms; females > 460 ms) and severely prolonged QTc > 500 ms data subsets. A value of p<0.05 was interpreted as significant. Statistical analysis was performed using SPSS statistical software (IBM Statistics, v. 26; IBM Corp, Armonk, NY).ResultsThe 44,566 ECG reports demonstrated 57% female gender and a mean age of 57 ± 17.5 years. The mean HR was 83 ± 14.7 bpm and the mean ∆QTc was 23 ± 12.9 ms shorter with QTcFri. Mean data showed minimal variation between sexes: age, heart rate, uncorrected QT, QTcB, QTcFri, and ∆QTc varied by less than 2%. Mean QRS varied by 4% between sexes. The Wilcoxon rank-sum test revealed 44,127 ranks with a negative difference, 0 ranks with a positive difference, and 439 ties, p <0.001 (99% CI: 22.5 ms, 23.0 ms). QTcB identified 37.4% (16665/44566) ECGs prolonged. Using QTcFri, 21% (9371/44566) of the total ECGs corrected to normal QTc (<450 ms (men) and 460 ms (women)). QTcFri use reduced the number of ECG reports with QTc > 500 ms by 57.3%. A total of 125 ECG reports, 117 females and eight males, corrected to normal gender-specific QTc with QTcFri. The mean decrease in QTc with the Fridericia formula when QTcB > 500 ms was 31 ± 14.5 ms (99% CI: 30.4 ms, 31.7 ms).ConclusionOur data from the Wilcoxon rank-sum analysis indicated that the EHR QTcFri analysis yields a statistically significant difference (p < 0.001) in QTc calculation of 22 ms over 44,566 ECG reports. The data showed a 21% reduction in inaccurately documented test results. The utilization of this resource will provide the most accurate and clinically relevant data to inform clinical decision-making. Accurate QT interval calculation will better inform downstream clinical decision-making through a wider scope of therapeutic intervention. This analysis is readily available to clinicians without calculation and its awareness will benefit patient care.

Inferior ST-Elevation Myocardial Infarction Presenting When Urgent Primary Percutaneous Coronary Intervention Is Unavailable: Should We Adhere to Current Guidelines?

The pivotal studies that led to the recommendations for emergent reperfusion therapy for ST-elevation myocardial infarction (STEMI) were conducted for the most part over 25 years ago. At that time, contemporary standard treatments including aspirin, statin, and even anticoagulation were not commonly used. The 2013 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) guidelines and the 2017 European Society of Cardiology guidelines give a class I recommendation (with the level of evidence A) for primary percutaneous coronary intervention (pPCI) in patients with STEMI and ischemic symptoms of less than 12 h. However, if the patient presents to a hospital without pPCI capacity, and it is anticipated that pPCI cannot be performed within 120 min of first medical contact, fibrinolytic therapy is indicated (if there are no contraindications) (class I indication, level of evidence A). Our review of the pertinent literature shows that the current recommendation for inferior STEMI is based on the level of evidence lower than A. We can consider level B even C, supporting the recommendation for fibrinolytic therapy if pPCI is not available for inferior STEMI.

Predicting therapies in Japanese hypertrophic cardiomyopathy patients with an implantable cardioverter-defibrillator using the 2014 European Society of Cardiology guidelines.

Previous studies have shown that the sudden cardiac death (SCD) prediction model proposed by the 2014 European Society of Cardiology (ESC) guideline (5-Year Risk-SCD) was validated in European patients with hypertrophic cardiomyopathy (HCM). However, there are limited data on Asian patients with HCM. We assessed the validity of the estimated 5-Year Risk-SCD in Japanese HCM patients with an implantable cardioverter-defibrillator (ICD) using the2014 ESC guidelines. We retrospectively examined data of 492 consecutive Japanese patients with an ICD. Sixty-two Japanese HCM patients with an ICD were enrolled in this study, and 50 patients (81%) were followed up for ≥ 5years. We analyzed the characteristics and outcomes of these 50 patients. We investigated the incidence of appropriate ICD therapy as categorized by the ESC guideline and compared the 5-Year Risk-SCD with the 5-year rate of appropriate shock therapies. Based on the 2012 Japanese Circulation Society guideline and the 2011guidelines of the American Heart Association and American College of Cardiology Foundation, 10 and 40 patients met classes I and IIa of the ICD recommendation, respectively. However, only 18 (36%) patients were classified into class I or IIa of the ESC guideline. Among 50 patients followed up for ≥ 5years after ICD implantation, the incidences of appropriate ICD therapies for classes I, IIa, IIb, and III indications based on the 2014 ESC guideline were 50%, 38%, 17%, and 0%, respectively. Risk stratification for SCD using 5-Year Risk-SCD is valid in Japanese HCM patients with an ICD, and the 2014 ESC guideline might be useful for the indication of ICD implantation in Japan.

Incidence and determinants of QT interval prolongation in COVID-19 patients treated with hydroxychloroquine and azithromycin.

Combined use of hydroxychloroquine and azithromycin was globally adopted, in part due to paucity and high cost of alternative therapies. However the utility of these medications has been questioned; and thus safety becomes a major concern given clinical equipoise regarding efficacy. Both hydroxychloroquine and azithromycin continue to be administered in US clinical trials examining their potential role in prevention of infection, treatment of mild infection in ambulatory patients, and in combination with other medical regimens in treatment of patients with severe disease. These drugs also continue to be clinically utilized in hospitalized patients around the globe, often without continuous telemetry due to lack of resources. Concern regarding use of hydroxychloroquine without adequate rhythm monitoring in clinical trials has been recently expressed.1 A review of clinicaltrials.gov at the time of submission of this correspondence reveals actively recruiting trials of combined hydroxychloroquine/azithromycin with or without additional COVID-19 therapies, for both ambulatory and hospitalized patients within and outside the US. The potential for hydroxychloroquine and azithromycin to cause QT prolongation is counterbalanced by very low risk of pro-arrhythmia in the general population, and emerging evidence of relatively low risk of Torsades de Pointes (TdP) in COVID-19 patients.2,3,4,5 Thus delineation of the determinants of significant QTc prolongation and pro-arrhythmic risk for hydroxychloroquine/azithromycin is very important, especially given mounting evidence of inefficacy in COVID-19 treatment.

Mediators of the effects of canagliflozin on kidney protection in patients with type 2 diabetes

Canagliflozin reduced kidney disease progression in participants with type 2 diabetes in the CANagliflozin cardioVascular Assessment Study (CANVAS) Program. This analysis explored potential mediators of the effects of canagliflozin on kidney outcomes. The percent mediating effect of 18 biomarkers indicative of disease was determined by comparing the hazard ratios for the effect of randomized treatment from an unadjusted model and from a model adjusting for the average post-randomization level of each biomarker. Multivariable analyses assessed the joint effects of biomarkers that mediated most strongly in univariable analyses. The kidney outcome was defined as a composite of 40% estimated glomerular filtration rate decline, end-stage kidney disease, or death due to kidney disease. Nine biomarkers (systolic blood pressure [8.9% of effect explained], urinary albumin:creatinine ratio [UACR; 23.9%], gamma glutamyltransferase [4.1%], hematocrit [51.1%], hemoglobin [41.3%], serum albumin [19.5%], erythrocytes [56.7%], serum urate [35.4%], and urine pH [7.5%]) individually mediated the effect of canagliflozin on the kidney outcome. In a parsimonious multivariable model, erythrocyte concentration, serum urate, and systolic blood pressure maximized cumulative mediation (115%). Mediating effects of UACR, but not other mediators, were highly dependent upon the baseline level of UACR: UACR mediated 42% and 7% of the effect in those with baseline UACR 30 mg/g or more and under 30 mg/g, respectively. The identified mediators support existing hypothesized mechanisms for the prevention of kidney outcomes with sodium glucose co-transporter 2 inhibitors. Thus, the disparity in mediating effects across baseline UACR subgroups suggests that the mechanism for kidney protection with canagliflozin may vary across patient subgroups.