Coverage of the annual AHA Scientific Sessions

American Heart Association Scientific Sessions 2021

: A woman in her mid-50’s presents to the hospital with vomiting, generalized weakness and 35 pound weight loss over a 3 month period. She denies any pain, fever, diarrhea or other complaints. She reportedly was diagnosed with some type of abdominal mass 2 months ago and was unable follow up with a specialist due to insurance issues so returns to the ER.

: Vital signs are normal. Here exam is fairly unremarkable. Oropharynx is moist and she does not appear cachectic

Computer Read: Sinus bradycardia at 59 with 1st degree AVB, Left axis deviation, nonspecific ST abnormality

Articles

Check out the latest cardiology case report from Brady Pregerson, MD. This case features a woman in her mid-50s presenting with generalized weakness, vomiting, and a 35-pound weight loss in the last 3 months. Can you determine the correct diagnosis?

Cardiology Case Report: Weight Loss

AHA/ASA Release Guidance for Treatment of COVID-19 Vaccine-Related Clotting, Low Platelet Counts


The American Heart Association and American Stroke Association have released a special report related to the treatment of blood clots or low platelet counts related to the COVID-19 vaccine, which has garnered mass amounts of attention despite being a rare complication.


Israeli Study Details Myocarditis Risk Associated with Pfizer COVID-19 Vaccine


An analysis of more than 9 million patients, including more than 5 million receiving both doses, provides insight into the risks of myocarditis associated with the BNT162b2 COVID-19 vaccine.


FDA Approves Vericiguat (Verquvo) for Treatment of Heart Failure


The US FDA has approved vericiguat (Verquvo) for reducing the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in patients with HFrEF.


Meta-Analysis Raises Questions Around Risk of Atrial Fibrillation Associated with Omega-3 Supplements


A meta-analysis and systematic review of 7 RCTs suggests consuming more than 1 gram of marine omega-3 fatty acid supplements per day could increase a patient's risk of atrial fibrillation.


FDA Approves Twice-Yearly Inclisiran (Leqvio) for Lowering Cholesterol in ASCVD, HeFH


Announced on December 22, the approval of inclisiran (Leqvio) comes nearly a year after the original PDUFA date. With approval, inclisiran becomes the first and only siRNA therapy approved to lower LDL-C with twice-yearly dosing.

Practical Cardiology has compiled a list of the 5 most popular stories of the past year to celebrate the end of 2021. 

Cardiology Year in Review: Most Popular Content of 2021

Cardiology's Top 5 FDA Approvals from 2021


Announced on December 22, the approval of inclisiran (Leqvio) comes nearly a year after the original PDUFA date. With approval, inclisiran becomes the first and only siRNA therapy approved to lower LDL-C with twice-yearly dosing.



Finerenone (Kerendia) Gets FDA Nod for Chronic Kidney Disease in Type 2 Diabetes


With approval on July 9, finerenone became the first nonsteroidal mineralocorticoid receptor antagonist approved by the FDA for treatment of chronic kidney disease associated with type 2 diabetes.



FDA Expands Label for Sacubitril/Valsartan (Entresto) to Include Some HFpEF Patients


Novartis announced the US FDA has expanded the label for sacubitril/valsartan (Entresto) to include reducing the risk of CV death and hospitalizations for heart failure among patients with chronic heart failure.




The US FDA has approved vericiguat (Verquvo) for reducing the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in patients with HFrEF.



Dapagliflozin (Farxiga) Receives Historic FDA Approval for Chronic Kidney Disease


The US FDA announced dapagliflozin (Farxiga) received approval for reducing the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression in a statement on April 30.

To celebrate the end of 2021, Practical Cardiology has created a list of the top FDA approvals from the past year based on popularity and relevance to current standards of care.

Cardiology's Top FDA Approvals in 2021

Editor's note: Clicking on a slide will redirect you to that article. 

Decemeber Month in Review



Announced on December 22, the approval of inclisiran (Leqvio) comes nearly a year after the original PDUFA date. With approval, inclisiran becomes the first and only siRNA therapy approved to lower LDL-C with twice-yearly dosing.


AHA Releases New Statement on Diagnosing, Managing Hypertensive Disorders of Pregnancy



Released on Dec. 15, the latest scientific statement from the American Heart Association provides a comprehensive overview of the available evidence on topics related to diagnosis, management, and pharmacotherapy for hypertension during pregnancy.


Noteworthy Cardiology Posters from the World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease



The Practical Cardiology editorial staff has compiled a list of 6 noteworthy posters related to cardiology from the Metabolic Institute of America's 19th annual World Congress on Insulin Resistance, Diabetes, and Cardiovascular Disease.


New Revascularization Guidelines Released by ACC, AHA, and SCAI



The ACC/AHA/SCAI 2021 guideline recommendations for coronary artery revascularization were released on December 9, which they hope will replace or retire recommendations from half a dozen previous guidelines.


American Heart Association Report Raises Alarm on Blood Pressure Increases During Pandemic



A report published in Circulation details per month increases in both systolic and diastolic blood pressure observed during the pandemic as compared with prepandemic periods.

Each month, our editorial staff compiles a month in review highlighting the most popular content from the past month. December's month in review features new guidelines, FDA news, and more.

Cardiology Month in Review: December 2021

Patrick Campbell is the senior editor of Practical Cardiology, as well as its sister publication Endocrinology Network. Prior to joining these brands, he led coverage of cardiology and diabetes with HCPLive. Before joining parent company MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a freelance multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

New research from an analysis of data from the Centers for Disease Control and Prevention (CDC) is underling the need for public health interventions to improve cardiovascular outcomes in people younger than 65 years of age.

Results of their study, which included data from more than 600,000 participants, demonstrate rates of heart attacks among younger patients in the US declined by more than 50% from 1999-2019, but the deceleration in premature death rates appears to have plateaued beginning in 2011.

“The cardiovascular risks among adults younger than age 65 has become increasingly complex during the last two decades. Our study focused explicitly on premature deaths due to a heart attack to identify demographic and regional differences, which may help to inform targeted interventions,” said Safi U. Khan, MD, MS, a cardiology fellow at the DeBakey Heart and Vascular Institute at Houston Methodist Hospital, 

The success made in reducing the risk of cardiovascular disease among US patients has been regarded as one of, if not, the most successful public health efforts of all time. Since the turn of the century, cardiologists, PCPs, advocacy groups, and more have worked in collaboration to address what was a growing crisis. In the past 2 decades, these efforts have led to remarkable progress in reducing rate of cardiovascular disease on a population level.

The current study was designed by Khan and colleagues at United Methodist Hospital to explore the incidence of premature mortality as a result of acute myocardial infarction based on demographic and regional characteristics in the US. With this in mind, investigators designed their study as an analysis of data from the CDC’s WONDER database from 1999-2019. The primary outcomes of interest for the study were the age-adjusted acute myocardial infarction mortality rates per 10,000 persons and the mean annual percentage change from during the study period.

Upon analysis, investigators identified a total of 615,848 premature deaths, which translates to an age-adjusted mortality rate of 13.4 (95% CI, 13.3-13.5) per 100,000 patients. In 1999, the age-adjusted mortality rate was 20.4 per 1000,000 and this decreased to 9.9 per 100,000 in 2019. From 1999-2011, the average annual percent change was -3.4 (95% CI, -4.6 to -4.1) per year and this rate slowed to -2.1 (95% CI, -2.4 to -1.8) per year from 2011-2019, with this decrease consistent across both sexes, all ethnicities, and races, and urban/rural counties.

When assessing rates according to ethnicity and race, results indicated the age-adjusted mortality rates were greater among non-Hispanic Black adults (17.5 [905% CI, 17.4-17.6]) than non-Hispanic White adults (13.7 [95% CI, 13.6-13.8]). When assessing rates according to sex, results indicated the age-adjusted mortality rates were higher run men (20.0 [955 CI, 19.9-20.1]) than women (7.3 [95% CI, 7.2-7.4]), with an average annual percentage change of -3.3 (95% CI, -3.6 to -3.1) per year in women and -3.5 (95% CI, -3.7 to -3.4) in men.

Results indicated the average annual percentage change suggested greater declines in age-adjusted mortality rates were present among large (-4.2 per year [95% CI, -4.4 to -4.0]), and medium/small metros (-3.3 per year [95% CI, -3.5 to -3.1]) than rural counties (-2.4 per year [95% CI, -2.8 to -1.9]). Further analysis suggested age-adjusted mortality rates above the 90th percentile were distributed in Southern states, while those with mortality rates in the 10th percentile or lower were clustered in Western and Northeastern states.

“Recent medical advancements have reduced major adverse cardiovascular outcomes for patients who have had a heart attack, so we were surprised by the deceleration in the decline of premature death rates during the last decade. This concerning trend reflects the growing burden of cardiovascular disease among younger adults,” Khan added.

Trends in Premature Mortality From Acute Myocardial Infarction in the United States, 1999 to 2019,

Journal of the American Heart Association.

New research published in the Journal of the American Heart Association provides an overview of the changes in the rate of premature death due to acute myocardial infarction among patients in the US younger than 65 years of age. 

Rates of Premature Death from CVD Beginning to Plateau after Decades of Progress

Inclisiran (Leqvio) has received approval from the US Food and Drug Administration (FDA) for lowering LDL-C in patients with atherosclerotic cardiovascular disease or heterozygous hypercholesterolemia, according to 

Nearly a year after the original PDUFA date, inclisiran becomes the first and only small interfering RNA therapy approved to lower LDL-C with twice-yearly dosing. The indication from the FDA is for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical ASCVD or HeFH who require additional lowering of LDL-C.

“ASCVD is a substantial public health burden affecting 30 million Americans,” said Norman Lepor, MD, a Los Angeles-based cardiologist and a clinical investigator in the Phase III clinical program for Leqvio, in the aforementioned statement. “As a first-of-its-kind siRNA therapy, Leqvio works differently than other cholesterol treatments, with twice-yearly dosing that makes it a compelling option for the millions of people with ASCVD already on cholesterol-lowering medications struggling to reach their LDL-C target.”

Among the most highly anticipated approvals in recent memory, inclisiran has remained in the spotlight since Novartis acquired The Medicines Company in 2019 for $9.7 billion. The road to approval has been longer than Novartis may have initially hoped for, with the company 

 ahead of their original December 2020 PDUFA date. A statement from Novartis noted the FDA did not cite concerns related to the efficacy or safety of inclisiran, but FDA expressed concerns related to unresolved facility inspection-related conditions. About 7 months later in July 2021, the company announced their 

Complete Response resubmission for inclisiran

The December 22, 2021, approval for inclisiran is based on data from the ORION-9, -10, and -11 clinical trials, which enrolled more than 3400 participants with ASCVD or HeFH. In these trials, inclisiran was associated with a sustained reduction of LDL-C up to 52% compared to placebo therapy.

The most common side effects observed in the ORION program were mild to moderate injection site reaction, joint pain, urinary tract infection, diarrhea, chest cold, pain in legs or arms, and shortness of breath. 

Novartis noted twice-yearly maintenance doses of inclisiran can be administered following an initial dose and an additional dose at 3 months. Novartis expects inclisiran to be available in early January 2022.

“Leqvio is a revolutionary approach to lower LDL-C, and creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time,” said Vas Narasimhan, Novartis CEO. “We now have the opportunity, working together with partners, to provide this first-ever approved LDL-C–lowering siRNA-based therapy to tackle ASCVD at scale across the United States.”

Announced on December 22, the approval of inclisiran (Leqvio) comes nearly a year after the original PDUFA date. With approval, inclisiran becomes the first and only siRNA therapy approved to lower LDL-C with twice-yearly dosing. 

The US Food and Drug Administration has approved the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive present for patients with severe pulmonary regurgitation, according to a 

statement from Edwards Lifesciences Corporation

The approval of the Sapien 3 with Alterra, which was announced on December 20, is for pediatric and adult patients with severe pulmonary regurgitation as measured by echocardiography, who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.

"The FDA approval of the SAPIEN 3 with Alterra is great news for patients around the world, many of whom have endured numerous surgical procedures to treat their congenital heart disease," said Evan Zahn, MD, director of the Guerin Family Congenital Heart Program at the Smidt Heart Institute at Cedars-Sinai Medical Center and principal investigator for the ALTERRA clinical trial, in the aforementioned statement. "The outstanding outcomes achieved by SAPIEN 3 with Alterra will expand the range of patients who require pulmonary valve replacement that we can now treat with minimally invasive therapy. This will result in significant improvements in quality of life and a reduction in the number of surgeries and procedures that a congenital heart patient requires over the course of their lifetime."

According to Edwards Lifesciences Corporation, the SAPIEN 3 Transcatheter Pulmonary Valve system combines the SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to further expand transcatheter therapy options for patients with congenital heart valve disease. The release from Edwards Lifesciences Corporation also noted it is generally required to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve defects.

"I'm very proud of this advancement, which exemplifies the important work of our team at Edwards to develop life-saving innovations addressing urgent needs of this important patient group," said Larry Wood, corporate vice president of transcatheter aortic valve replacement at Edwards Lifesciences Corporation. "Many of these patients endure repeated open-heart surgeries to address heart conditions present since birth, which takes a huge toll on their ability to lead normal lives. The SAPIEN 3 with Alterra provides a new treatment option that can reduce the number of invasive procedures these patients face in their lifetimes."

For more on the SAPIEN 3 transcatheter heart valve check out 

Announced on Dec. 20, the US FDA awarded approval to the Sapien 3 with Alterra from Edwards Lifesciences Corporation for pediatric and adult patients with severe pulmonary regurgitation.

FDA Approves SAPIEN 3 with Alterra from Edwards Lifesciences Corporation

 has approved rivaroxaban (Xarelto) for a pair of new pediatric indications, according to 

a release from the Janssen Pharmaceutical Companies of Johnson & Johnson

Announced on December 20, the factor Xa inhibitor is now indicated for use in treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients younger than 18 years of age after at least 5 days of initial parenteral anticoagulant treatment and for thromboprophylaxis in children aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.

"Historically, there has been limited guidance and options for healthcare providers on how to help reduce potentially serious, even fatal, blood clots and related events in young children," said Andrew Van Bergen, MD, a pediatric cardiologist at Advocate Children's Hospital, in the aforementioned press release. "We have had to adjust adult doses of standard anticoagulation therapies, which are both burdensome and uncomfortable for patients, and require frequent monitoring. Now that XARELTO® is FDA-approved with weight-based dosing options, either as tablets or liquid formulation, a convenient option is available allowing flexibility to tailor the treatment for my patients. This is a major advancement in antithrombotic care for those patients under the age of 18."

With the approvals marking the 10th and 11th indications for rivaroxaban in the US, the latest approvals were based on data from 2 phase 3 pediatric studies within the EXPLORER program—the EINSTEIN-Jr study, which was the largest study to date evaluating pediatric patients from birth to less 18 years of age with previously diagnosed VTE, and the UNIVERSE study, which was the first clinical trial to examine a DOAC for the prevention of VTE in pediatric patients after recently undergoing the Fontan procedure.

 500 children were enrolled and randomized to bodyweight-adjusted rivaroxaban or standard anticoagulants. The primary efficacy and safety outcomes of the study were symptomatic recurrent venous thromboembolism and major or clinically relevant non-major bleeding, respectively. Results indicated use of rivaroxaban was associated with a similarly low recurrence risk and reduced thrombotic burden as use standard anticoagulants.

The UNIVERSE study, which was published in the 

Journal of the American Heart Association, 

was a randomized, multicenter, 2‐part, open‐label study. The first part of the study assessed the pharmacokinetics/pharmacodynamics and safety of rivaroxaban in 12 participants and the second part randomized 100 post-Fontan procedure participants in a 2:1 ratio to open‐label rivaroxaban or acetylsalicylic acid. Results of the study indicated those who received rivaroxaban for thromboprophylaxis had a similar safety profile and fewer thrombotic events than those who received acetylsalicylic acid.

"Today's FDA approval marks two new XARELTO® indications for pediatric patients, an often underrecognized, but especially important patient population," said James List, MD, PhD, Global Therapeutic Area Head, Cardiovascular, Metabolism, & Retina, Janssen Research & Development, LLC. "At Janssen, we are committed to addressing unmet medical needs and the approval of the 10th and 11th indications for XARELTO® underscores its capability in reducing the risk of blood clots and cardiovascular events in patients from young to old and with a variety of conditions."

Announced on Dec. 20, the latest approvals for rivaroxaban (Xarelto) mark the 10th and 11th indications for the factor Xa inhibitor in the US.

FDA Approves Rivaroxaban for 2 New Pediatric Indications


New research from investigators in Italy suggests use of a multiparametric computed tomography (CT) protocol, including late contrast enhancement (LCE) CT, could improve the diagnosis of troponin-positive acute chest pain.

 the use of triple-rule-out (TRO) CT diagnosed half of the 84 patients in the study with 35 patients being diagnosed with obstructive coronary artery disease (CAD). For the remaining 42 patients who had negative findings with TRO CT, the study authors obtained a LCE CT scan. This led to a diagnosis in 34 of those patients, including 22 patients diagnosed with myocarditis. In other words, the use of LCE CT improved the initial diagnosis rate of TRO CT from 50 percent (42 of 84 patients) to 90 percent (76 of 84 patients).

“Troponin-positive chest pain with unobstructed coronary arteries represents a diagnostic dilemma, and the identification of its cause is of pivotal importance for the management, treatment, and prognostication of patients,” wrote Anna Palmisano, M.D., who is affiliated with the Clinical and Experimental Radiology Unit in the Experimental Imaging Center at the IRCCS San Raffaele Scientific Institute in Milan, Italy, and colleagues. “ … In our study, LCE CT provided a diagnosis in 81 percent of participants with negative findings at TRO CT (34 of 42), similar to what has previously been reported for cardiac MRI.”

The study authors said the findings demonstrate a “significant improvement in CT capability” to achieve a definitive diagnosis for patients with acute chest pain. Palmisano and colleagues also suggested in the study that implementation of the aforementioned CT protocol could result in a quicker diagnosis because it enables radiologists to employ a single CT study to obtain “several pieces of information commonly derived from combined CT and MRI examinations.”

Limitations of the study included a limited contrast-to-noise ratio (CNR) and small increase in radiation exposure associated with the use of LCE CT as well as a limited patient sample size, according to the study authors. They suggested that larger trials are necessary to assess the cost-effectiveness and clinical value of the study’s CT protocol.

A recent study found the addition of LCE CT reportedly bolsters the diagnosis rate among patients with acute chest pain who have negative findings on TRO CT.

Enhanced CT Protocol Could Improve Diagnosis of Acute Chest Pain

A new study with more than 110,000 participants from 21 countries on 5 continents is providing what could be the most comprehensive overview yet of the effects of stress on development of cardiovascular disease events and mortality.

Results of the population-based cohort study, which assessed psychosis stress as a composite score of self-perceived stress, life events, and financial stress, suggest patients considered to have high stress levels had a 22% greater risk of cardiovascular disease, a 24% greater risk of congestive heart disease, and a 30% greater risk of stroke compared to their counterparts with no stress.

“It’s not known exactly what causes the elevated risk of cardiovascular disease among the severely stressed people. But many different processes in the body, such as atherosclerosis and blood clotting, may be affected by stress,” said Annika Rosengren, MD, PhD, Professor of Medicine at the Institute of Medicine at Sahlgrenska Academy at University of Gothenburg, 

. “If we want to reduce the risk of cardiovascular disease globally, we need to consider stress as another modifiable risk factor.”

To provide a more thorough consensus on stress as a potential risk factor for cardiovascular disease, Rosengren and a team of investigators designed the current study as an analysis of data from the Prospective Urban Rural Epidemiological (PURE) population study. With data collected from January 2003-March 2021, PURE followed 225,000 participants in detail from more than 1000 urban and rural communities in 27 high, middle, and low-income countries

For the purpose of analysis, countries were classified based on gross national income per capita. Canada, Saudi Arabia, Sweden, and the United Arab Emirates were considered high-income, Argentina, Brazil, Chile, China, Colombia, Iran, Malaysia, Occupied Palestinian Territory, Philippines, Poland, South Africa, and Turkey were considered middle-income, and Bangladesh, India, Pakistan, Tanzania, and Zimbabwe were considered low-income.

Stress was assessed using a composite score calculated by summing the score of psychological stress, major life event, and financial stress. Each individual component of the composite stress score was assessed and, based on responses, participants were either given a score of 0 or 1, with 1 indicating presence of stress. Scores ranged from 0-3, with 0 considered no stress, 1 considered low stress, 2 considered moderate stress, and 3 considered high stress.

After exclusion of those with prior cardiovascular disease and those without complete baseline and follow-up data, investigators identified a cohort of 118,705 participants from 21 countries for inclusion. The cohort consisted of 15,588 participants from high-income countries, 86,937 from middle-income countries, and 16,181 from low-income countries.

The study cohort had a mean age of 50.4 (SD, 9.6) years and 58.8% were women. Of the 118,705 participants included in the study, 8699 participants (7.3%) were categorized as having high stress, 21,797 participants (18.4%) were categorized as having moderate stress, 34,958 (29.4%) were categorized as having low stress, and 53,252 participants (44.8%) were categorized as having no stress.

Compared to those with no stress, those with high stress were more likely to be younger (mean age: 48.9 [SD, 8.9] years vs 51.1 [SD, 9.8] years), have abdominal obesity (34.3% vs 19.9%), be current (26.7% vs 19.7%) and former smokers (18.1% vs 7.5%), report alcohol use (48.5% vs 24.8%), and have family history of cardiovascular disease (62.5% vs 38.0%).

The primary outcomes of interest were major cardiovascular disease, major congestive heart disease, stroke, and all-cause mortality. Major cardiovascular disease was defined as a composite of cardiovascular death, stroke, myocardial infarction, and heart failure. Major congestive heart disease was defined as acute myocardial infarction and coronary death.

During the follow-up period, which lasted a median of 10.2 (IQR, 8.6-11.9) years, 7248 deaths occurred among the study cohort. A total of 5934 major cardiovascular disease events, 4107 major congestive heart disease events, and 2880 stroke events. In analyses adjusted age, sex, education, marital status, location, abdominal obesity, hypertension, smoking, diabetes, and family history, increased stress levels were associated with increased risk of mortality (low stress: HR, 1.09 [95% CI, 1.03-1.16]; high stress: 1.17 [95% CI, 1.06-1.29]) and congestive heart disease (low stress: HR, 1.09 [95% CI, 1.01-1.18]; high stress: HR, 1.24 [95% CI, 1.08-1.42]). However, in these same models, only high stress was associated with major cardiovascular disease and stroke (HR, 1.30 [95% CI, 1.09-1.56]).

Investigators noted the need for further studies examining the association of increased stress with cardiovascular risk and means of intervention to alleviate this potential burden.

“Substantial evidence has accumulated with respect to the associations of stress and other psychosocial factors with CVD, mainly CHD and stroke, which is supported by our findings. How these factors should be assessed and quantified in a more reliable and reproducible manner across different settings remains to be determined,” wrote investigators.

Psychosocial Risk Factors and Cardiovascular Disease and Death in a Population-Based Cohort From 21 Low-, Middle-, and High-Income Countries

An analysis of data from the PURE study suggests those with high stress levels had a 22% greater risk of cardiovascular disease, a 24% greater risk of congestive heart disease, and a 30% greater risk of stroke compared to their counterparts with no stress.

Global Analysis Finds High Stress Levels Raise Risk of Cardiovascular Disease

With the recent explosion in use of implantable loop records (ILRs), the FDA’s clearance of a novel medical algorithm from Implicity could help improve care of patients using these devices.

 was awarded to Implicity’s IRL ECG Analyzer, which is compatible with all Medtronic ILRs previous to the LINQ II model, including Reveal LINQ, Reveal XT, and Reveal DX.

"This is an important step for Implicity as we expand in the US market," said Arnaud Rosier, MD, PhD, the CEO and founder of Implicity. "With FDA clearance, our AI product can now be used in combination with implantable loop recorders to improve arrhythmia detection and help electrophysiologists and their teams avoid wasting time reviewing non-actionable events.”

According to Implicity, the device uses artificial intelligence to heart rhythm data collected by Medtronic ILRs to provide additional signal processing and analysis to improve the accuracy of irregular heartbeat detection. Information collected is automatically classified by the device to help prioritize true events, which manufacturers suggest could help provide more meaningful and efficient event management.

"Excessive false positives from ILRs are very common. There's a high positive rate with many events that are considered arrhythmias, that in fact, are not arrhythmias. These false positives significantly burden clinicians who need to sift through the noise and adjudicate misclassified abnormalities. Implicity's algorithm significantly reduces this workload," said Arnaud Lazarus, MD, an electrophysiologist at Clinique Ambroise Paré.

underlines the potential impact use of the ILR ECG Analyzer could have on reducing the number of false-positives episodes without compromising sensitivity. In the study, which included 370 patients from 20 medical centers in Europe, Implicity’s novel algorithm reduced the number of false-positive episodes by 79% in patients implanted with Medtronic ILRs while maintaining 99% sensitivity.

"I am excited by the potential this technology has to transform the practice of remote patient monitoring," said Niraj Varma, MD, PhD, a professor of medicine and consultant electrophysiologist at the Cleveland Clinic, in the aforementioned statement. "The true promise of remote monitoring is that we can see patients who need to be seen earlier. Even if the patient is not experiencing a symptom, we can detect their condition and let them know they need to be seen. Implicity's innovative solutions will enable us to direct our attention to clinically actionable data better so we can do just that."

Implicity announced their ILR ECG Analyzer received 510(k) clearance from the FDA in a statement released on December 16.

Implicity's ILR ECG Analyzer Receives 510(k) Clearance from FDA

This article was originally published on 

A new retrospective cohort study presented at the American Society of Hematology 2021 Meeting suggests patients with sickle cell disease had a greater risk of developing atrial fibrillation and having the disease present earlier in life. 

Presented by a team of Chicago-based investigators, results indicate the increased incidence among patients with the hematologic disorder may be a contributing factor to the patient population’s plateaued life expectancy, as well as their increased use of cardiovascular and nephrological medications.

Investigators, led by Chinonso Michelle Ukeje, MD, of the University of Illinois at Chicago School of Medicine, sought to determine the prevalence, incidence, and key clinical characteristics of atrial fibrillation in a cohort of patients with sickle cell disease. As they noted, the prevalence and risk factors for atrial fibrillation remains unclear in these patients.

“Life expectancy amongst individuals with sickle cell disease has plateaued, with cardiopulmonary complications now becoming a leading cause of death,” they wrote. “Indeed, sickle cell disease is associated with increased rates of pulmonary hypertension and diastolic dysfunction.”

Ukeje and colleagues conducted a retrospective, longitudinal cohort trial observing adult patients with sickle cell disease treated at the university’s care center from 2008 – 2017. Sickle cell disease was identified via automated direct chart review; atrial fibrillation was identified via manual review of approximately 17,000 available electrocardiograms of subjects assessed for the condition.

The final cohort included 763 adults with sickle cell disease; median patient age was 27.95 years old, with 59.5% being female. Approximately three-fourths (72.4%) had Hb SS or Sβ0-thalassemia genotype; another two-thirds (61.2%) were treated with hydroxyurea. Mean observation time for the cohort was 8.3 years.

Among the cohort, atrial fibrillation was identified in 30 patients (3.9%; 3.02 per 1000 patient-years). Mean age of onset was 51 years. Investigators observed no differences in gender, ethnicity, or sickle cell disease genotype between sickle cell patients with and without atrial fibrillation.

On average, patients with sickle cell disease and atrial fibrillation were older at initial care (40 vs 25 years; 

 <.0001) and follow-up visits (53 vs 35 years; 

 <.0001), and were observed for nearly 4 years longer (13.3 vs 9.5 years; 

 = .0014) than sickle cell patients without atrial fibrillation.

What’s more, patients with atrial fibrillation and sickle cell disease were more likely to carry chronic disease diagnoses:


Though hydroxyurea use was not associated with increased risk of atrial fibrillation, sickle cell patients with atrial fibrillation were more likely to receive diuretics, atrioventricular nodal blocking agents, antihypertensives, antiplatelets, and statins. Such patients were also more likely to have worse anemia and renal function.

“We showed that the prevalence and incidence of atrial fibrillation is high in patients with sickle cell disease with the median age of onset occurring 1-2 decades earlier than in the general populace,” investigators wrote.

Atrial fibrillation in patients with sickle cell disease was associated with older age, worsened renal function and anemia, and increased use of medications. Ukeje and colleagues concluded that further analysis is warranted on the basis of these findings.

“The high incidence of atrial fibrillation in patients with sickle cell disease may contribute to the plateauing of life expectancy and identifying the causative risk factors and the underlying mechanisms may not only improve life expectancy but also the quality of life,” they wrote.

The Burden of Atrial Fibrillation in Sickle Cell Disease

A retrospective analysis of data from a Chicago School of Medicine care center provides insight into the apparent increase in risk of atrial fibrillation among patients with sickle cell disease.

AFib More Common Among Patients with Sickle Cell Disease

The American Heart Association (AHA) has released a new scientific statement aimed at addressing diagnosis, treatment goals, and pharmacotherapy for 

Released on December 15, the 21-page document was prepared by a volunteer writing group on behalf of the AHA’s Council on Hypertension, Council on the Kidney in Cardiovascular Disease Science Subcommittee, Council on Arteriosclerosis, Thrombosis and Vascular Biology, Council on Lifestyle and Cardiometabolic Health, Council on Peripheral Vascular Disease, and the Stroke Council.

“For decades, the benefits of blood pressure treatment for pregnant women were unclear. And there were concerns about fetal well-being from exposure to antihypertensive medications,” said Chair of the statement writing group Vesna D. Garovic, MD, PhD, chair of the division of nephrology and hypertension with a joint appointment in the department of obstetrics and gynecology at Mayo Clinic in Minnesota, in 

. “Through our comprehensive review of the existing literature, it is reassuring to see emerging evidence that treating high blood pressure during pregnancy is safe and effective and may be beneficial at lower thresholds than previously thought. Now, we have the current statement focused on hypertension during pregnancy to help inform optimal treatment and future research.”

Composed by Garovic and team of 8 colleagues from multiple US-based institutions, the statement’s writing team contained experts representing obstetrics and gynecology, maternal-fetal medicine, cardiology, nephrology, hypertension, and internal medicine. In the opening portion of the statement, the authors noted the timeliness of the statement given current trends in prevalence of hypertensive disorders of pregnancy (HDP) and the potential influence on long-term cardiovascular health.

Using data from a review of evidence published through August 31, 2020, the statement cites more than 200 references and is broken down into sections addressing epidemiology, prevention of preeclampsia and adverse maternal and fetal outcomes, blood pressure measurement in pregnancy, treatment of hypertension in pregnancy, postpartum screenings, importance of a multidisciplinary team approach, and racial disparities.

The document also includes 4 tables outlining the risks of immediate maternal and fetal complications of HDP, long-term maternal and offspring complications of HDP, risk factors for preeclampsia, and a summary of previously published guidelines for diagnosis and treatment of HDP. Statement authors highlighted the importance of individualizing treatment decisions through team-based care due to the complex nature of managing HDP.

“Future clinical trials are needed to address questions about when to begin treatment for high blood pressure during pregnancy,” Garovic said. “Also, close collaboration between the American Heart Association and American College of Obstetricians and Gynecologists will be instrumental in optimizing diagnosis and treatment of hypertension during pregnancy and in improving immediate and long-term outcomes for many women who develop hypertension during pregnancy.”

Hypertension in Pregnancy: Diagnosis, Blood Pressure Goals, and Pharmacotherapy

Released on Dec. 15, the latest scientific statement from the American Heart Association provides a comprehensive overview of the available evidence on topics related to diagnosis, management, and pharmacotherapy for hypertension during pregnancy.

A recent study from an international team of investigators suggests postmenopausal women with a history of adverse pregnancy outcomes could be at an increased risk of 

An analysis of the Women’s Health Initiative (WHI), results of the study demonstrate hypertensive disorders of pregnancy were independently associated with increased risk of incident heart failure, but this association was not observed for other adverse pregnancy outcomes, such as gestational diabetes, low birth weight, and preterm delivery.

“In this large cohort study of postmenopausal women, a history of HDP was independently associated with a 1.75-fold odds of developing subsequent heart failure. This association was significant after adjustment for multiple confounding factors, including other APOs, without evidence of modification by sociodemographic or reproductive factors or comorbidities,” wrote investigators.

With the intent of developing a more thorough understanding of the risks surrounding incident heart failure in women, a team led by Nisha Parikh, MD, MPH, of the University of San Francisco, carried out a cohort study using data from within the Women’s Health Initiative. The study was designed with the intent of assessing associations between 5 adverse pregnancy outcomes and incident adjudicated heart failure. The adverse pregnancy outcomes of interest were gestational diabetes, hypertensive disorders of pregnancy, low birth weight high birth weight, and preterm delivery.

Of the 161,808 women included in WHI, 44,174 participants were included in an incident heart failure subcohort. The cohort of interest for the current study was women who had completed the 2017 follow-up survey, which assessed adverse pregnancy outcomes. Investigators identified 10,292 women who had a history of pregnancy lasting for more than 6 months and responded to the 2017 survey for inclusion in their analyses.

Of note, the 2017 WHI follow-up survey was administered to all surviving WHI participants and included 6 questions related to adverse pregnancy outcomes, with possible responses of yes, no, and I do not know. This survey defined preterm delivery as less than 37 weeks gestation, low birth weight as less than 5.5 pounds, and high birth weight as more than 9 pounds and 14 ounces.

The study cohort had a mean age of 60 (IQR, 55-64) years, 3185 women who reported 1 or more adverse pregnancy outcome, and 336 with a diagnosis of incident heart failure. The cohort of women heart failure included 180 with HFpEF and 111 with HFrEF. Women who reported any adverse pregnancy outcomes ewer more likely to have hypertension, diabetes, coronary heart disease, or report smoking compared to their counterparts who did not report pregnancy outcomes.

The most commonly reported adverse pregnancy outcome was preterm delivery (n=1509), followed by low birth weight (n=1424), hypertensive disorders of pregnancy (n=759), high birth weight (n=644), and gestational diabetes (n=260). The most common combination of adverse pregnancy outcomes was preterm delivery and low birth weight, which was reported by 732 women.

Logistic regression was used to evaluate the association of each adverse pregnancy outcome with incident heart failure. Investigators noted testing was performed using both unadjusted and fully adjusted models. Further analysis was planned to assess associations with specific heart failure subtypes.

Upon analysis, only hypertensive disorders of pregnancy was significantly associated with heart failure in fully adjusted models (OR, 1.75; 95% CI, 1.22 to 2.50). When assessing heart failure subtypes, results incited hypertensive disorders of pregnancy was associated with HFpEF (OR, 2.06; 955 CI, 1.29 to 3.27), but not HFrEF (OR, 1.17; 95% CI, 0.59 to 2.30). In mediation analysis, results suggested hypertension explained 24% (95% CI, 12 to 73) of the association with hypertensive disorders of pregnancy with heart failure, coronary heart disease explained 23% (95% CI, 11 to 68), BMI explained 20% (95% CI, 10 to 64), and diabetes explained 1% (95% CI, -3.6 to 7.3).

“Further research is needed to better understand the potential mechanisms that link HDP with later development of HF. Dedicated studies are needed to establish effective interventions to mitigate long-term risk of HF and other CVD in women with APOs,” added investigators in their conclusion.

Adverse Pregnancy Outcomes and Incident Heart Failure in the Women’s Health Initiative

An analysis of data from the Women's Health Initiative suggests a history of hypertensive disorders of pregnancy was associated with an almost doubling in odds of developing heart failure later in life.