Provider and Caregiver Connection Live: Aligning Oncology and Cardiology Care to Identify and Manage ICI-Related Myocarditis

ACC ICI-Associated Myocarditis Archived Webcast 

An expert-led podcast with a focus on clinical trials hosted by Muthiah Vaduganathan, MD, and Stephen Greene, MD

Don't Miss a Beat

The year of 2022 will be remembered as one that brought a slew of new advances in cardiovascular disease management and prevention. With approvals, guidelines, and new trial data dominating headlines, several other advances in the field caught the attention of millions and became topics of discussion. To celebrate the end of 2022 and the advances in cardiometabolic health from the past year, our editorial team has created a list of the top 5 most popular pieces of content from 2022.

Study Details Increased Risk of Kidney Damage with Rosuvastatin

A new study is sounding the alarm on the potential increase in risk of kidney damage observed with use of rosuvastatin that was not observed with other statin therapies.

Funded by the NIDDKD, results of the study, which assessed the nephrotoxicity of rosuvastatin against atorvastatin using deidentified EHR data from the Optum Labs Data Warehouse, demonstrate use of rosuvastatin was associated with an 8% greater risk of hematuria, a 17% greater risk of proteinuria, and a 15% higher risk of developing kidney failure requiring replacement therapy such as dialysis or transplantation over a median follow-up of 3.1 years compared to use of atorvastatin

Dapagliflozin Proves HFpEF Benefit in DELIVER Trial

Use of dapagliflozin (Farxiga) was associated with an 18% reduction in worsening heart failure or cardiovascular death among patients with heart failure with preserved ejection fraction, according to the results of the phase 3 DELIVER trial.

Less than 3 months after AstraZeneca announced the trial had met its primary endpoint back in May, results of the study build on the evidence from EMPEROR-Preserved and contribute to the idea that the benefits seen in HFpEF could be a class effect for SGLT2 inhibitors.

Cardiac CT Provides Reliable, Noninvasive Alternative to Angiography in Diagnosing Coronary Artery Disease

 demonstrate cardiac computed tomography (CT) could provide a safe alternative to catheterization in patients with suspected coronary artery disease.

Aimed at assessing whether cardiac CT could provide a noninvasive alternative to coronary angiography, results of the DISCHARGE trial indicate CT-based examination offered a safe alternative to catherization and could help reduce major procedure-related complications.

CHEST Releases New Guidance for Perioperative Management of Antithrombotic Therapy

The American College of Chest Physicians (CHEST) have released new clinical practice guidance for perioperative management of antithrombotic therapy.

Released on August 11, the guidelines, which include 44 evidence-based recommendations related to perioperative management of antithrombotic therapy, were published with the intent of replacing the organization 2012 guideline on the same topic.

ACC, AHA, and HFSA Partner to Release 2022 Heart Failure Guidelines

The American College of Cardiology, American Heart Association, and Heart Failure Society of America have released a new joint guideline outlining evidence-based strategies for prevention, diagnosis, and management of heart failure.

Published with the intent of replacing previous guidance published in 2013 and 2017, the guideline includes multiple new additions, including a class 2a recommendation for use of SGLT2 inhibitors in HFpEF and revision to ACC/AHA heart failure stages, and also provides recommendations on managing cardiac amyloidosis and cardio-oncology complications.

Articles

To celebrate the end of 2022 and the advances witnessed in the past year, our editorial team has created a list of the 5 most popular pieces of content related to endocrinology from 2022.

Most Popular Cardiology Content of 2022

Our editorial team is celebrating the final week of the year by recapping some of our most popular stories and content from the past year. Here, we are highlighting our most popular content from the American College of Cardiology, European Society of Cardiology, and the American Heart Association annual meetings.

Released on the eve of ACC.22, the 2022 heart failure guidelines represent a collaborative effort by the ACC/AHA/HFSA and include major additions, including a new focus on the use of SGLT2 inhibitors and revisions to the ACC/AHA stages of heart failure.

SODIUM-HF: Reduced Sodium Intake Fails to Reduce Heart Failure Events

Data from SODIUM-HF indicates reduction of dietary sodium intake was not associated with a statistically significant reduction of a composite of all-cause death, cardiovascular-related hospitalizations, and cardiovascular-related emergency department visits.

Mavacamten Can Reduce Need for Surgery in Hypertrophic Cardiomyopathy

Results of the VALOR-HCM trial indicate patients with hypertrophic cardiomyopathy could reduce their need for septal reduction therapy and improve quality of life with use of mavacamten, a selective cardiac myosin inhibitor from Bristol Myers Squibb.

Presented at ESC Congress 22, results of the DELIVER trial indicate use of dapagliflozin (Farxiga) was associated with an 18% reduction in the primary outcome, with a 21% reduction in risk observed for worsening heart failure and a 12% reduction in risk observed for cardiovascular death compared with placebo therapy.

DANCAVAS: Universal CVD Screenings Do Not Reduce Risk of Death in Men

Results of a trial assessing the impact of universal subclinical CVD screenings found increased screenings did not significantly reduce the risk of all-cause mortality in men aged 65-74 years over the next 5 years.

TIME Study: No Added Benefit from Nighttime Dosing of Blood Pressure Medications

Although the Hygia study suggested nighttime dosing could increase the benefit of risk reduction obtained from antihypertensive medications, the TIME study found no significant improvement in risk reduction afforded by nighttime dosing as compared to morning dosing of medication.

STRONG-HF: In-Hospital Initiation of GDMT Reduces Rehospitalization, Mortality Risk in Heart Failure Patients

Results of the STRONG-HF trial provide the first evidence from a randomized clinical trial that rapid, in-hospital initiation of guideline-directed medical therapy in heart failure can improve patient outcomes.

SPORT: Supplements Fail to Lower LDL-C in Primary Prevention Population

Erin Michos, MD, provides further insight in an on-site interview AHA 22 related to results of the SPORT trial, which provide direct comparative insights into the impact of several dietary supplements and placebo therapy relative to low-dose statin therapy in a primary prevention cohort.

Ocean(a)-DOSE: Olpasiran Shows Promise for Lowering Lipoprotein(a)

Results of the Ocean(a)-DOSE trial, a phase 2 dose-finding study presented at AHA 22, suggests use of olpasiran dosed at 75 mg or higher every 12 weeks was associated with a reduction of Lp(a) among 95% of patients.

Our editorial team is celebrating the end of 2022 by recapping our most popular content from the 3 largest cardiology meetings from the past year.

Top News from Cardiology Conferences in 2022

With less than a week to go until the close of 2022, our editorial team is celebrating the final week of the year by recapping some of our most popular stories and content from the past year. Here, we are highlighting our most popular episodes of the 

Most Popular Episodes of Don’t Miss a Beat

Don't Miss a Beat, with Muthiah Vaduganathan, MD, and Stephen Greene, MD

Don't Miss a Beat is Practical Cardiology's expert-led heart failure podcast. The monthly podcast, which is hosted by Drs. Greene and Vaduganathan, will provide a regular news roundup of the latest evidence and clinical trial insights across cardiovascular, renal, and metabolic diseases.

Headed to ACC.22 this weekend or following along virtually? Hear from Don't Miss a Beat co-hosts Drs. Vaduganathan and Greene on their top picks from the late-breaking sessions at the upcoming American College of Cardiology meeting.

Don't Miss a Beat: ACC.22 Recap of DIAMOND, SODIUM-HF, and PROMPT-HF

Don't Miss a Beat: Interpreting New Heart Failure Guidelines

In this episode of Don't Miss a Beat, hosts Drs. Greene and Vaduganathan break down the new ACC/AHA/HFSA heart failure guidelines debuted at ACC.22 and compare the recommendations against those made in the European Society of Cardiology's 2021 heart failure guidelines.

Don't Miss a Beat: oHCM and Mavacamten, with Anjali Owens, MD

In the latest edition of Don’t Miss a Beat, our hostsare joined by special guest Anjali Owens, MD. An assistant professor of medicine and medical director of the Center for Inherited Cardiac Disease at the Perelman School of Medicine, Owens takes our hosts on a deep dive into the current state of management for oHCM and the impact of the US FDA's approval of mavacamten.

In this episode of Don’t Miss a Beat, our hosts provide a recap of the European Society of Cardiology Congress 2022. This recap begins with a discussion on the results of the phase 3 DELIVER trial, in which Vaduganathan served as an investigator, the ADVOR trial, and REVIVED.

With less than a week to go until the close of 2022, our editorial team is celebrating the final week of the year by recapping some of our most popular stories and content from the past year. Here, we are highlighting our most popular episodes of the Don’t Miss a Beat Podcast from 2022.

Top Episodes of Don't Miss a Beat in 2022

With less than a week to go until the close of 2022, our editorial team is kicking off the final week of the year by recapping some of our most popular stories and content from the past year. Here, we are highlighting the most popular pipeline and regulatory news from the past year. For our readers, we’ve broken down this list into top trial news, approvals, and CRLs of note from 2022 in cardiometabolic health. Below, you will find a brief recap of each and links to any associated coverage.

Presented less than 3 months after AstraZeneca announced the trial had met its primary endpoint back in May, results of the study build on the evidence from EMPEROR-Preserved and contribute to the idea that the benefits seen in HFpEF could be a class effect for SGLT2 inhibitors.

8-in-10 Medicare Beneficiaries Hospitalized with HFpEF Could be Considered Candidates for Dapagliflozin

Empagliflozin Significantly Reduces Risk of Kidney Disease Progression, Cardiovascular Disease Mortality 

Data from the EMPA-KIDNEY trial, which was presented during the 2022 American Society of Nephrology Annual Meeting in Orlando, indicates empagliflozin (Jardiance) resulted in a significant reduction in kidney disease progression and cardiovascular disease mortality in patients with chronic kidney disease, regardless of diabetes status.

CLEAR Outcomes: Bempedoic Acid Reduces Cardiovascular Events

Nearly 3 years after approval from the US Food and Drug Administration for lowering LDL-C, data from the CLEAR Outcomes trial confirm bempedoic acid (NEXLETOL) use is associated with a statistically significant and clinically meaningful reduction in risk of major adverse cardiovascular events.

, the company expects to present comprehensive data at a medical conference in the first quarter of 2023 and suggests, with results, bempedoic acid becomes the first ATP citrate lyase inhibitor and first oral non-statin to meet the MACE-4 primary endpoint, which includes cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and unstable angina requiring hospitalization.

Bempedoic Acid to Manage ASCVD and Hypercholesterolemia (Video)

Empagliflozin for the Entire Spectrum of Heart Failure

FDA Approves Empagliflozin for Treatment in Adults with Heart Failure

The US Food and Drug Administration has announced the approval of empagliflozin (Jardiance) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients.

With previous approvals for reducing risk of cardiovascular death in type 2 diabetes and reducing risk of death and hospitalization in HFrEF, the latest approval, which was announced in 

 on February 24, is based on the results of the landmark EMPEROR-Preserved trial.

Q&A on EMPEROR-Preserved With Javed Butler, MD

FDA Approves Mavacamten (Camzyos) for Obstructive Hypertrophic Cardiomyopathy

The US Food and Drug Administration (FDA) has approved mavacamten (Camzyos), granting the first-in-class agent an indication for improving functional capacity and symptoms in patients with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM), according to a 

Announced on April 28, the approval is for treatment of adults with symptomatic NYHA class 2-3 obstructive HCM and is based on the results of EXPLORER-HCM trial, which found use of mavacamten was associated with improved exercise capacity, LVOT obstruction, NYHA functional class, and health status among patients with symptomatic obstructive HCM.

Understanding the Mavacamten Approval: Perspective from an oHCM Specialist

FDA Issues CRL for Vadadustat in Treatment of Anemia Due to CKD

Akebia Therapeutics has announced the US Food and Drug Administration have issued a Complete Response Letter for their New Drug Application for vadadustat for treatment of anemia due to chronic kidney disease in adult patients on dialysis and not on dialysis, according to a 

An investigational oral hypoxia-inducible factor prolyl hydroxyls inhibitor, the FDA’s decision was based on data within the NDA not supporting a favorable risk-benefit assessment for vadadustat in dialysis and non-dialysis patients, with concern over the agent’s failure to meet noninferiority in major adverse cardiovascular events among the non-dialysis patients.

FDA Issues CRL for Bardoxolone Methyl in CKD Caused By Alport Syndrome

A bardoxolone methyl approval has been postponed indefinitely as the US Food and Drug Administration has issued a Complete Response Letter to Reata Pharmaceuticals, Inc. concerning their NDA for bardoxolone methyl as a treatment chronic kidney disease caused by Alport syndrome, according to a February 25 

The subject of a December 8, 2021, Cardiovascular and Renal Drugs Advisory Committee meeting where committee members voted unanimously against approval, Reata Pharmaceuticals stated the FDA concluded it did not believe the submitted data demonstrated bardoxolone’s ability to slow the loss of kidney function in patients with Alport syndrome and reducing the risk of progression to kidney failure. The statement from Reata Pharmaceuticals also noted additional data from the company was requested to support the efficacy and safety of bardoxolone.

For the final week of the year, our editorial team is recapping our the most talked about phase 3 trial news, approvals, and CRLs related to cardiometabolic health in 2022, including empagliflozin, bempedoic acid, mavacamten, and more!

Top Cardiometabolic Pipeline News for 2022

With less than a week to go until the close of 2022, our editorial team is kicking off the final week of the year by recapping some of our most popular stories and content from the past year. Here, we are highlighting our most popular case reports from Brady Pregerson, MD, from the past year. Below, you will find a brief recap of each patient history, the ECG associated with the case report, and a link to find the final diagnosis!

Case Report: Shortness of Breath and Tachycardia

: A man in his mid-60’s with a history of lung cancer presents to the hospital with progressive worsening SOB for 2 months but especially in the past 1 week.

: You get sign out at 6 AM, and one of the patients is a man in his mid-40’s who presented with epigastric pain. He has normal GI labs but is pending an ultrasound with a plan for discharge home if normal. The ultrasound comes back normal, so you go and speak with him. He states that the pain started around 11 PM and peaked around midnight. It was constant and wasn’t getting any better until the nurse gave him an antacid a few hours ago which really seemed to help. He denies any shortness of breath, sweating, nausea, vomiting, chest pain, or other complaints.

Cardiology Case Report: Early Morning Chest Pain

A patient in their mid-70s presents to the hospital with chest pain since 2 AM that became constant at 5 AM and made him vomit. The pain radiates to the back and is pleuritic, but only mildly so. He denies syncope, palpitations, SOB, leg swelling or pain, fever, cough or other complaints.

: An elderly male with a past medical history of diabetes and stage 5 chronic kidney disease is brought to the hospital by medics with 2 days of nausea, vomiting and generalized weakness. He denies any chest pain, difficulty breathing, fever, chills, abdominal pain, diarrhea, melena, or other complaints. He has a dialysis fistula but has not yet started dialysis. His home medications include losartan, amlodipine, Lasix, sitagliptin, and Plavix.

: A woman in her early 60s presents to the hospital with pleuritic midsternal pain radiating from left to right and to left upper back. She has mild SOB but no fever, cough, leg symptoms, or other complaints. She denies syncope, palpitations, or other complaints.

Our editorial team is kicking off the final week of the year by recapping our most popular case reports from Brady Pregerson, MD, from the past year. 

Top Cardiology Case Reports of 2022

Despite 2022 quickly winding to a close, the month of December was host to multiple noteworthy pieces of news in cardiovascular medicine. Our December cardiology month in review highlights the most popular content in the month of December. The December 2022 month in review includes the announcement surrounding CLEAR Outcomes results, a pair of scientific statements from the American Heart Association (AHA), an analysis assessing the utility of NYHA classification for mild forms of heart failure, and a potential link between a Parkinson disease treatment and hypertension in people with type 1 diabetes.

NYHA Class Alone Fails to Accurately Discern Risk Among Heart Failure Patients

A new analysis from the PARADIGM-HF study suggests substantial overlap exists in regard to the objective measures and long-term prognosis of patients with NYHA Class I and II heart failure.

Using data from the PARADIGM-HF trial, investigators produced results that underline the potential limitations of using NYHA classification to differentiate mild forms of heart failure.

Parkinson Disease Treatment, Bromocriptine, Could Reduce Arterial Stiffness, Blood Pressure in Pediatric T1D

An NIH-funded analysis of data from a 34-participant study examining blood pressure and aortic stiffness with the dopamine receptor agonist in adolescents with type 1 diabetes suggests use was associated with a 5-mmHg reduction in systolic and 2-mmHg reduction in diastolic blood pressure after the 4-week intervention period, with results also pointed to reduced ascending aortic pulse wave velocity and distensibility.

AHA Releases Scientific Statement on Acute Coronary Syndromes in Older Patients

The AHA has released a scientific statement offering clinicians with updated age-specific guidance related to diagnosis and management of acute coronary syndromes (ACS) in older patients.

With the proportion of older adults in the US continuing to increase, the AHA’s latest scientific statement provides timely and relevant information centered around diagnosis and management of ACS in people aged 75 years or older.

American Heart Association Releases Scientific Statement on Complementary and Alternative Medicine Use in Heart Failure

In an effort to combat medical misinformation on the subject, the AHA has released a new scientific statement centered around the benefits and risks of using complementary and alternative medicines to manage symptoms of heart failure.

Using data published prior to November 2021, the AHA statement encourages providers to discuss use of complementary and alternative therapies and talk about potential medication interactions as well the benefits and potential side effects of use at every visit, noting use of complementary and alternative therapies is a practice among 30% of people with heart failure in the US.

The December 2022 cardiology month in review features the announcement of CLEAR Outcomes meeting its primary end point, a pair of new scientific statements from the American Heart Association, and more!

Cardiology Month in Review: December 2022

A study of geographically, racially, and ethnically diverse nulliparous women in the US suggests adherence to a Mediterranean diet around the time of conception and during pregnancy could reduce risk of adverse pregnancy outcomes.

An assessment of the influence of diet among women included in the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b), results of the study indicate adherence to a Mediterranean diet was associated with a 20% or greater reduction in odds of gestational diabetes, preeclampsia, and any adverse pregnancy outcome.

“We also looked at the individual components of the Mediterranean diet and found higher intakes of vegetables, legumes and fish were related to lower associated risk of an adverse pregnancy outcome,” said senior investigator Natalie Bello, MD, MPH, director of Hypertension Research in the Smidt Heart Institute,

Launched in 2010 with the intent of learning more about risk factors and mechanisms of common adverse pregnancy outcomes in nulliparous women, the nuMoM2b was designed as a prospective, multicenter, cohort study. With enrollment occurring from October 1, 2010-September 30, 2013, the trial enrolled 10,038 women from 8 clinical research sites and 12 subsites around the US.

The current study included 7798 of the 10,038 who had complete dietary information, which was collected using the modified Block 2005 Food Frequency Questionnaire at the first study visit between 6 weeks and 13 weeks plus 6 days of gestation. This cohort had a mean age of 27.4 (SD, 5.5) years, 9.7% were aged 35 years or older at enrollment, 10.5% were non-Hispanic Black women, 16.6% were Hispanic, and 19.5% had obesity at baseline.

Leveraging data from the food frequency questionnaire, Alternate Mediterranean Diet (aMed) scores were computed for participants. These scores ranged from 0-9, with investigators further stratifying participants into groups based on scores, defined as low (0-3), moderate (4-5), or high (6-9). The study cohort had a mean aMed score of 4.3 (SD, 2.1), with 30.6%, 31.2%, and 38.2% of the cohort being classified as having high, moderate, and low concordance to a Mediterranean diet pattern, respectively.

The primary outcome of interest for the study was incidence of any adverse pregnancy outcomes, which included preeclampsia or eclampsia, gestational hypertension, gestational diabetes, preterm birth, delivery of a small-for-gestational-age infant, or stillbirth. For the purpose of analysis, incidence of the aforementioned outcomes separately served as secondary outcomes of interest. Investigators noted associations of aMed score with adverse pregnancy outcomes were assessed with univariable and multivariable logistic regression models.

In multivariable-adjusted models, results indicated those with high aMed scores had a 21% lower likelihood of experiencing any adverse pregnancy outcome than their counterparts with a low concordance (aOR, 0.79 [95% CI, 0.68-0.92]). Analysis of secondary end points demonstrated a high level of concordance was associated with a 28% reduction in odds of preeclampsia or eclampsia (aOR, 0.72 [95% CI, 0.55-0.93]) and a 37% reduction in odds of gestational diabetes (aOR, 0.63 [95% CI, 0.44-0.90]) relative to those with a low score.

Further analysis examining associations by patient subgroup revealed there were no significant differences by race, ethnicity, and prepregnancy body mass index. However, investigators pointed out stronger associations were observed with high concordance to Mediterranean diet among women aged 35 years or older (aOR, 0.54 [95% CI, 0.34-0.84]; 

=.02). In additional analyses assessing aMed scores as quintiles produced similar associations, with higher scores inversely associated with incidence of any adverse pregnancy outcome.

“This multicenter, population-based study validates that a healthier eating pattern is associated with a lower risk of adverse pregnancy outcomes, the most exciting being a 28% lower risk for preeclampsia,” Bello said. “Importantly, this connection between the Mediterranean diet and lower risk of adverse pregnancy outcomes was seen in a geographically, racially and ethnically diverse population.”

Association of a Mediterranean Diet Pattern With Adverse Pregnancy Outcomes Among US Women

Data from the nuMoM2b study suggests greater adherence to a Mediterranean diet was associated with reductions of 37%, 28%, and 21% in odds of gestational diabetes, preeclampsia, and any adverse pregnancy outcome, respectively, among a cohort of more than 7000 nulliparous women.

Mediterranean Diet Linked to Reduce Risk of Adverse Pregnancy Outcomes in Nulliparous Women

A study from Michigan Medicine suggests assessment of creatine phosphokinase could help identify increased risk of myocarditis and all-cause mortality in patients with cancer treated with immune checkpoint inhibitors (ICI).

An observational cohort study of adults who received ICI over a 7-year period beginning in 2014, results indicate a 100% increase in creatine phosphokinase was associated with an 83% increase in risk of myocarditis and 10% increase in risk of all-cause mortality, with further analysis providing insight into the sensitivity and specificity of the biomarker for identifying myocarditis.

“While immune checkpoint inhibitors have revolutionized the treatment of various cancers, patients who develop the rare complication of myocarditis often present late with at least a 50% chance of death,” said senior investigator Salim Hayek, MD, medical director of the University of Michigan Health Frankel Cardiovascular Center Clinics, in 

a statement from University of Michigan Health

As rates of cancer diagnoses have increased in recent decades, so too has the number of therapeutic options for patients. With these increases, the growing risk of cardiotoxicity associated with many forms of cancer therapy has become a chief concern for cardiologists. With this as a backdrop, Hayek and a team of collaborators from University of Michigan Health launched the current research endeavor to examine where routinely measured biomarkers might improve management and identify those at increased risk of ICI myocarditis.

Investigators designed their study as an observational cohort study of adult patients who received at least one dose of ICI at a Michigan Medicine medical center between June 2014-December 2021. Further limiting their study to those with available information related to systematic serial testing for aspartate aminotransferase, alanine aminotransferase, creatine phosphokinase, and lactate dehydrogenase during ICI therapy, investigators identified a cohort of 2606 patients for inclusion in the study.

The study cohort had a mean age of 64±13 years, 60.7% were men, and 1.0% or 0.14 (95% CI, 0.09-0.21) cases per 10,00 person-years had a diagnosis of myocarditis attributed to ICI therapy. Of these, 5 were classified as definite, 4 were classifiable as probable, and 18 were classified as possible. Investigators pointed out the overall number of patients receiving ICI therapy and the incidence of myocarditis increased steadily each year during the study period. Additionally, the median time from the first dose of ICI to diagnosis of myocarditis was 28.0 (1-209) days, with 55.6% of patients developing myocarditis within 30 days after initiating ICI therapy.

Results of the investigators’ analyses demonstrated the majority of patients who developed myocarditis had elevated high-sensitivity troponin T (100%), alanine aminotransferase (88.9%), aspartate aminotransferase (85.2%), creatine phosphokinase (88.9%), and lactate dehydrogenase (92.6%). Investigators noted these findings were confirmed in an independent cohort of 30 patients with biopsy-confirmed ICI myocarditis.

Further analysis revealed 95% of patients with ICI myocarditis had elevations in at least 3 biomarkers compared to just 5% of the cohort without myocarditis. Additional analysis of noncardiac biomarkers revealed only creatine phosphokinase was associated with increased risk of developing myocarditis and all-cause mortality in multivariable analyses. Of note, these analyses assessed 100% increase in biomarker. Investigators pointed out elevations in creatine phosphokinase had a sensitivity of 99% and a specificity of 23% for identifying ICI myocarditis.

“It makes sense that myocarditis related to immune checkpoint inhibitors does not occur in isolation, given a raging immune system is expected to affect several organs and particularly the muscles,” said study investigator Joe-Elie Salem, MD, PhD, professor of medicine at Sorbonne Université in Paris, in the aforementioned statement. “A large variety of antigens targeted by auto-reactive T-cells boosted by ICIs are shared between the myocardium and the peripheral muscles. Myositis, or muscle injury, is a central component of complications related to this class of drugs.”

Biomarker Trends, Incidence, and Outcomes of Immune Checkpoint Inhibitor–Induced Myocarditis

An observational study of data from patients with cancer treated with immune checkpoint inhibitors provides an overview of prognostic utility of noncardiac biomarkers for predicting myocarditis and all-cause mortality.

Noncardiac Biomarker Could Aid in Predicting Myocarditis, Mortality in Some Cancer Patients

An analysis of data from more than 18,000 adults in Japan suggests consuming 2 cups of coffee or more per day was associated with a doubling in risk of cardiovascular death compared to non-drinkers among people with 

An analysis of the Japan Collaborative Cohort Study for Evaluation of Cancer Risk, data from the analysis suggest increase coffee consumption was associated with a 2-fold increase in cardiovascular mortality among those with grade 2-3 hypertension, but this association was not present among those with optimal blood pressure or grade 1 hypertension.

“Our study aimed to determine whether the known protective effect of coffee also applies to individuals with different degrees of hypertension; and also examined the effects of green tea in the same population,” said senior investigator Hiroyasu Iso, MD, PhD, MPH, director of the Institute for Global Health Policy Research, Bureau of International Health Cooperation, National Center for Global Health and Medicine and professor emeritus at Osaka University, 

. “To the best of our knowledge, this is the first study to find an association between drinking 2 or more cups of coffee daily and cardiovascular disease mortality among people with severe hypertension.”

An age-old question, countless studies have been conducted with the aim of understanding the impact of caffeine consumption on health and well-being. In the current study, Iso, along with a team of collaborators from Osaka University, sought to build on the existing research base by exploring the impacts of coffee and green tea consumption on cardiovascular mortality in people with severe hypertension. To do so, investigators designed the current study as an analysis of data from the Japan Collaborative Cohort Study for Evaluation of Cancer Risk (JACC).

A nationwide, community-based prospective study, the JACC study enrolled patients aged 40-79 years from 1988-1990 from 45 communities in China. In total, the study enrolled 110,585 individuals. Limiting the cohort to those with measured blood pressure and full questionnaire data, investigators obtained data related a cohort of 18,609 individuals for inclusion in their current analyses. This cohort of 18,609 included 6574 men and 12035 women. The cohort had a median follow-up of 18.9 years.

For the purpose of analysis, investigators stratified participants into 4 blood pressure categories with these categories defined as optimal and normal blood pressure, high-normal blood pressure, grade 1 hypertension, and grade 2-3 hypertension. Of the 18,609 included in the study, 8322 had optimal and normal blood pressure,

During the follow-up period, 842 instances of cardiovascular death were recorded. Upon analysis, results suggested increased coffee consumption was associated with an increased risk of cardiovascular mortality among those with grade 2–3 hypertension, who had HRs of 0.98 (95% CI, 0.67-1.43) for less than 1 cup per day, 0.74 (95% CI, 0.37-1.46) for 1 cup per day, and 2.05 (95% CI, 1.17-3.59) compared to non-coffee drinkers. These associations were not observed for those classified as having optimal and normal blood pressure, high-normal blood pressure, and grade 1 hypertension, according to investigators. Additionally, results indicated green tea consumption was not associated with an increased risk of cardiovascular disease across any of the 4 blood pressure categories.

”These findings may support the assertion that people with severe high blood pressure should avoid drinking excessive coffee,” said Iso. “Because people with severe hypertension are more susceptible to the effects of caffeine, caffeine’s harmful effects may outweigh its protective effects and may increase the risk of death.”

Coffee and Green Tea Consumption and Cardiovascular Disease Mortality Among People With and Without Hypertension

Journal of the American Heart Association.

An analysis of data from the Japanese  Collaborative Cohort Study for Evaluation of Cancer Risk suggests those with grade 2-3 hypertension could be increasing their risk of cardiovascular death by consuming 2 or more cups of coffee per day. 

Excessive Coffee Consumption Could Spell Disaster for People with Hypertension

Data from a single-center study of patients hospitalized with heart failure suggests lonely heart failure patients faced a worse prognosis than their counterparts with a greater social support system.

Results of the study, which included data from more than 300 elderly patients with heart failure, suggest those impacted by social frailty were at a more than 2-fold increase in risk of the study’s composite outcome, which included all-cause mortality and cardiovascular events.

“We are the first to show a close association between the loss of perceived social role and long-term poor clinical outcomes in older heart failure patients,” said Satoshi Katano, PhD, PT, first author of this research, based at Sapporo Medical University Hospital, 

. “Our study highlights the real need to develop a management program that includes a social approach to the care of these patients.”

As research focuses have shifted from solely clinical to a more holistic management approach for patients, particularly those with cardiovascular conditions, interest has grown related to impact of social domains on clinical outcomes. In the present study, Katano and a team of colleagues from institutions across Japan sought to assess prognostic ability of social frailty to predict negative clinical outcomes in elderly patients hospitalized with heart failure.

Using data from Sapporo Medical University Hospital from March 1, 2015-December 31, 2020, investigators identified 310 patients hospitalized for heart failure aged 65 years or older for inclusion in their analyses. The study cohort had a median age of 79 (IQR< 72-84) years, 46% were women, and 76% were classified as having NYHA Class III heart failure.

All these patients were given a validated questionnaire using Makizako’s 5 questions to assess social frailty. These 5 questions assessed changes in social activity, social support circle, perceived changes to their social role, living situation, and daily communication tendencies. The primary outcome of interest for the study was defined as. Composite of all-cause or hospitalization for heart failure. Patients were followed for up to 3 years after enrollment of the first patient and 1 year after enrollment of the last patient.

Upon analysis, Investigators found 24% (n=75) had composite events during the follow-up period, which lasted a mean of 1.93±0.91 years. Further analysis revealed Kaplan-Meier curves showed patient with social frailty had significantly higher event rate than those without social frailty. In multivariable Cox regression analyses, results indicated social frailty was independently associated with an increased risk of events after adjustment for prognostic markers (aHR, 2.01 [95% CI, 1.07-3.78]; 

Among the 5 questions assessing domains of social frailty, results suggested “yes” responses to the question about not feeling helpful toward friends or family was an independent predictor of composite events (aHR, 2.28 [95% CI, 1.36-3.82]; 

 <.01). When including this into the baseline prognostic model, accuracy improved for both the continuous net reclassification improvement (0.562 [95% CI, 0.298-0.827]; 

 <.01) and integrated discrimination improvement (0.031 [95% CI, 0.006-0.056]; 

“Recent research has shown that social frailty is present in two thirds of older people that suffer heart failure, and it has been linked to worse outcomes for these patients. However, it hasn’t been clear exactly why social frailty makes the prognosis worse,” explained Katano. “To examine the aspects of social frailty that may contribute to poor outcomes, we measured social frailty using the Makizako questionnaire in over 300 heart failure patients over the age of 65 that were admitted to our hospital for care.”

Loss of perceived social role, an index of social frailty, is an independent predictor of future adverse events in hospitalized patients with heart failure

A single-center, retrospective analysis provides new insight into the role of social isolation and social frailty in the risk of negative outcomes among those hospitalized with heart failure.

Changes in Social Role, Loneliness Could Contribute to Worse Outcomes in Heart Failure Patients

The world’s largest and foremost cardiology organizations are joining together in a call to reinvent randomized clinical trials for the 21st century.

Released on December 16, the joint statement, which was created as a collaborative effort between the European Society of Cardiology (ESC), American Heart Association (AHA), World Heart Federation (WHF), and American College of Cardiology (ACC), was created to serve as a call to action to reinvent randomized clinical trials to be fit for purpose in the 21st century on a global scale.

“Randomized trials are the gold standard method for evaluating new therapies and improving patient care. However, the cost and complexity of trials are becoming prohibitive and the current model is unsustainable,” said Franz Weidinger, MD, ESC President, in 

. “Cardiology provided the foundation for an era of highly successful clinical trials and is well placed to lead the way on modernization.”

A 4-page document, the statement itself was composed by leadership at the aforementioned organizations on behalf of the Clinical Trial Expert Group and ESC Patient Forum. Citing 22 references, the document opens by outlining the most pressing issues in the design and conduct of randomized clinical trials in cardiology own recent years. Following this portion, the writing group provides historic background and perspective on the impact of these issues on trials and, by extension, clinical practice.

Following the sections outlining the problem and background of the issue at hand, the writing groups dedicates a large portion of the document to outlining opportunities for global impact. These areas of opportunity included the streamlining of trial processes with the intent of reinventing simple trials to explore global impact, use of routine data to our advantage in trials and not as an inappropriate replacement, and a collaborative revision of the International Council for Harmonization Good Clinical Practice (ICH-GCP) Guidelines.

At the very start of the document, the writing group details 5 specific pieces of guidance for reinventing randomized clinical trials for the 21st century.

Guidance for 21st century randomized clinical trials:

Based on key scientific and ethical principles and focused on issues that materially influence the well-being of trial participants and reliability of results.

Clear, concise, consistent and proportionate, recognizing apparent risks associated with usual clinical practice and a lack of reliable evidence on intervention effects.

Forward looking, fostering innovation in health intervention and trial methods, including the appropriate use of routine healthcare data, digital technology, and direct-to-patient designs.

Promoting trials that are relevant to a broad and varied population as well as assuring diversity of participants and funded researchers.

Flexible, widely applicable, utilizable, and durable, across disease areas, intervention types, development phases, trial designs, geographies, and time.

“With this document, our societies wish to engage in the development of guidance that allows broader use of real-world data, housed in routine EHRs, to conduct the trials that are needed to improve patient care along with addressing unmet medical needs,” added Michelle Albert, MD, MPH, AHA President, in the aforementioned statement from the ESC. “Pragmatic clinical trials that allow flexibility while promoting innovation are required to address health care needs for different racial, ethnic and socioeconomic groups. This guidance is also an opportunity to have a close look at the real-world implementation of care practices designed to improve health equity."

Randomized trials fit for the 21st century. A joint opinion from the European Society of Cardiology, American Heart Association, American College of Cardiology, and the World Heart Federation

,” was published simultaneously in the 

 Journal of the American College of Cardiology

On December 16, the world's foremost cardiology organizations released a joint opinion statement calling for a reinvention of clinical trials to better suit the needs of the healthcare system in the 21st century. 

Leading Cardiology Organizations Call for Reinvention of Clinical Trials

An analysis of survey data recorded over the past decade from internal medicine residents indicate negative perceptions surrounding cardiology as a specialty, particularly a perceived lack of optimal work-life balance, could be harming the future of the field.

Comparing data from a cohort of 840 internal medicine residents who completed surveys in 2010 or 2020, comparison of results demonstrate the ideals of internal medicine residents had shifted in the last decade and this shift in priorities could spell danger for an overburdened field as it moves into the future.

“In 2020, surveyed IM residents highly valued career development components including (in descending order): (1) positive role models, (2) stimulating career, (3) family friendly, (4) patient focused, (5) stable hours,” wrote investigators. “In contrast residents’ strongest perceptions of cardiology were discordant to the preferences identified, as the residents’ highest rated perception of a cardiology career was that it interferes with family life.”

In the face of a physician shortage and a growing population, maintaining interest in cardiology as a specialty and diversity within the specialty remains a major priority for the field as it moves into the future. With 2020 fellowship data indicated cardiology had the lowest proportion of women fellows among internal medicine specialty fellowships, a team from Beth Israel Deaconess Medical Center sought to develop a more thorough understanding of resident preferences and perceptions of cardiology over time. With this in mind, investigators designed their study as a comparison of survey responses from a pair of surveys administered to members of US internal medicine programs in 2010 and 2020.

The 2020 survey asked respondents to rate 38 professional development preferences and 20 cardiology perceptions. Investigators noted the survey incorporated a 5-point Likert scale for some questions. Investigators also pointed out multivariable models were created for specialty choice using scaled independent variables dichotomized using the top 2 options. For the purpose of analysis, responses were examined according to total group, by gender, by self-reported consideration of entering cardiology as a profession, and by comparison with a decade prior both as a group and by gender.

Investigators obtained responses from a total of 840 residents. This cohort of respondents had a mean age of 29.24 (SD, 2.82) years, 49.8% were males, and 55.4% were White. Analysis of responses demonstrated the most important professional development preferences were presence of positive role models (4.56), stimulating career (3.81), and family friendly (3.78). When assessing cardiology perception statements,the highest levels of agreement among respondents was observed for the idea that cardiology interferes with family life during training (3.93) and having met positive role models or having positive views of cardiovascular disease as a topic (3.85).

Based on results of their multivariable analysis, investigators develop a 22-element model predicting cardiology as a career choice. Further analysis demonstrated the important of work-life balance components had increased for internal medicine residents, regardless of gender, but with the greatest change observed among male residents. Additionally, respondents to the 2020 survey were more likely to agree with negative perceptions of cardiology than their predecessors from a decade earlier.

“In 2020 male and female residents placed higher value on all aspects of work life balance including stability of hours, family friendliness of career, and on having role models exhibiting successful work-life balance. The prioritization of these values in men changed the most over time,” investigators concluded. “The 2020 residents were also more likely to report negative perceptions of cardiology than their predecessors. The ongoing discordance and increasing divergence between the residents’ professional culture preferences and cardiology career perceptions may hinder the recruitment and retention of a diverse and talented pool of applicants into cardiology.”

Professional Preferences and Perceptions of Cardiology Among Internal Medicine Resident

Negative perceptions of cardiology and a shift in preferences among internal medicine residents could be driving potential fellows away from careers in cardiology, according to a new study.

Negative Perceptions of Cardiology Could Be Steering Internal Medicine Residents Away from Field

Use of self-expanding transcatheter aortic valve implantation (TAVI) was associated with a lower rate of structural valve deterioration than surgical aortic valve implantation in patients at intermediate or high risk, according to a recent analysis.

Leveraging data from the CoreValve US High Risk Pivotal and SURTAVI clinical trials, results of the pooled post hoc analysis demonstrate use of self-expanding TAVI was associated with a relative reduction in risk of structural valve deterioration compared with surgery, with this reduction in risk most pronounced in those with smaller annuli.

“We found that the cumulative incidence of SVD was significantly lower among randomized patients treated with a self-expanding supra-annular transcatheter valve than surgery,” wrote investigators. “Doppler-derived [structural valve deterioration] was associated with a 2-fold increased risk of late mortality and hospitalizations for valve disease or worsening heart failure.”

As popularity of transcatheter valve implantation and replacement continues to increase, a greater understanding of incidence, outcomes, and predictors of hemodynamic structural valve deterioration in those undergoing TAVI or surgery stands have a major impact on patient care. Investigators sought to examine these trends from large-scale randomized clinical trials using data from the aforementioned CoreValve US High Risk Pivotal and SURTAVI clinical trials, with supplementation by the CoreValve Extreme Risk Pivotal trial and CoreValve Continued Access Study.

From the randomized lineal trials, investigators obtained data related to 2099 individuals. Of these, 1128 received TAVI and 971 received surgery. When pooled with the non-randomized clinical trial populations, the cohort included 4762 patients, with 3791 receiving TAVI. The 4762-patient cohort had a mean age of 82.1 (SD, 7.4) years.

The primary end point of interest for the investigators’ analyses was the incidence of structural valve deterioration through 5 years from the randomized clinical trials. Investigators pointed out factors associated with structural valve deterioration and its association with clinical outcomes were estimated for the pooled randomized clinical trials and the non-randomized clinical trial population. For the purpose of analysis, structural valve deterioration was defined as an increase in mean gradient of 10 mmHg or greater from discharge or at 30 days to last echocardiography with a final mean gradient of 20 mmHg or greater or new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of 1 grade or more.

Upon analysis, results indicated the cumulative incidence of SVD treating death as a competing risk was more than halved among those with TAVI (2.20%) compared with those who underwent surgery (HR, 0.46 [95% CI, 0.27-0.78]; 

=.004). Investigators pointed out their analysis revealed this decrease in risk was most apparent among those with an annulus of 23 mm in diameter or smaller, with structural valve deterioration occurring among 1.32% with TAVI and 5.84% who underwent surgery (HR, 0.21 [95% CI, 0.06-0.73]; 

Analysis of clinical outcomes indicated structural valve deterioration was associated with increased 5-year all-cause mortality (HR, 2.03 [95% CI, 1.46-2.82]; 

 <.001), cardiovascular mortality (HR, 1.86 [95% CI, 1.20-2.90]; 

An analysis of data from randomized clinical trials and non-randomized trials comparing TAVI and surgery provides an overview of 5-year incidence, outcomes, and predictors of structural valve deterioration with both approaches. 