News
FREEDOM COVID: Therapeutic dose anticoagulation does not reduce MACE in non-critically ill COVID-19 patients
Key Points:
- There have been conflicting data on the role and recommended dosage of anticoagulation in non-critically-ill patients with COVID-19.
- In the open-label FREEDOM COVID study, therapeutic anticoagulation was compared with prophylactic doses of enoxaparin in patients hospitalized for COVID-19. The primary endpoint was a 30-day composite of all-cause mortality, requirement For ICU level-of-care, systemic thromboembolism, or ischemic stroke.
- Therapeutic anticoagulation did not result in any significant differences in the composite endpoint, but it did result in lower 30-day mortality and endotracheal intubation compared with prophylaxis.
STELLAR: Sotatercept improves 6MWD in PAH patients and WHO FC II-III
Key Points:
- Sotatercept is a novel activin signaling inhibitor which was designed to target pulmonary vascular remodeling in PAH.
- In the STELLAR study, sotatercept was tested against placebo on a background of baseline PAH therapy in adults with WHO II/III PAH. The primary endpoint was change in 6MWD at 16 weeks.
- Sotatercept resulted in an improvement in 6MWD, PVR, NT-proBNP, and a composite of time to clinical worsening and all-cause mortality at 16 weeks compared to placebo.
Dapagliflozin Reduces PCWP at Rest and Exercise, Plasma Volume, and Weight in HFpEF patients
Key Points:
- SGLT2i therapy reduces HF hospitalizations and CV mortality in HFpEF, but the mechanism is not yet clear.
- In this single-center, double-blinded RCT, patients with HFpEF were randomized to dapagliflozin or placebo and underwent exercise and resting hemodynamics at baseline and at 24 weeks.
- Dapagliflozin resulted in reduced resting and exercise PCWP, weight, and plasma volume relative to placebo.
BMAD Trial: Use of data from μCor, A Novel Wearable Sensor, reduces HF readmissions following a recent HF hospitalization
Key Points:
- The μCor monitor is a novel device that uses radiofrequency signals to assess the wearer’s thoracic fluid index, which can indicate HF complications.
- The BMAD trial enrolled 522 patients with HF within 10 days of hospitalization and fitted them with the μCor monitor, which was worn continuously for 90 days.
- Results showed that patients whose clinicians monitored their thoracic fluid index using the μCor device had a 38% relative risk reduction compared to those in the control arm.
A Novel, Oral, PSCK-9 Inhibitor Showed Significant and Dose-dependent Reduction of LDL compared to Placebo
Key Points
-Lowering LDL-C is known to reduce the risk of ASCVD
-In patients at very high risk for ASCVD or in those with intolerance to statins, PCSK-9 inhibitors are recommended, however, current PCSK-9 inhibitors are administered subcutaneously, limiting their use
-The findings of this Phase 2 trial suggest that MK-0616, an oral PCSK-9 inhibitor significantly reduced LDL-C at 8 weeks by as much as 60.3% compared to placebo
LIVE HCM Trial: Vigorous Exercise in Patients with HCM Not Associated with Increased Risk of Adverse Cardiac Events
Key Points
-HCM is the most common cause of sudden cardiac death in athletes
-In patient diagnosed with HCM, long-established guidelines have advocated against vigorous exercise with the assumption this decreases the risk of sudden death
-The findings of the LIVE-HCM trial, suggest that vigorous exercise is not associated with an increased risk of death, cardiac resuscitation, ICD shock, or cardiogenic syncope
The future is now: A wrist-worn Sensor Coupled with AI Accurately Predicts Troponin Elevation in ACS Patients
Key Points
– Prompt identification of patients suffering from ACS requires measurements of the blood level of the cardiac troponin biomarker, which is traditionally dependent on laboratory turn-around times.
– A novel wrist-worn, point-of-care test for estimating high-sensitivity cardiac troponin-I (hs-cTnI) based on transdermal infra-red spectrophotometric sensors, and coupled with a machine-learning algorithm, was trained and externally validated on a cohort of 238 patients presenting with ACS across 5 hospitals in India.
– The externally validated model demonstrated an excellent performance with AUC of 0.92 (95% CI, 0.80-0.98; sensitivity, 0.94; specificity, 0.64), and also predicted obstructive coronary disease and regional wall motion abnormalities. As such, this innovative wearable technology may have important implications in real-world settings for diagnosing patients presenting with ACS inside and outside of a hospital.
Low Cardiac Risk for Elite Level Athletes With Genetic Heart Disease
Key Points
-Patients with diagnosed sudden cardiac death (SCD)-predisposing genetic heart diseases (GHDs) have traditionally been restricted from participating in competitive sporting activities.
-This retrospective study was the first to assess the risk of potentially life-threatening arrhythmias among NCAA D1 and professional athletes with a mean age of 22±5 years at the time of return to play.
– Over an average follow-up period of seven years, only three (3) athletes (4%) experienced a non-lethal cardiac episode related to their genetic heart disease, with fainting being the most common event. One of these athletes received an appropriate ICD shock. No athletes died during the study follow-up period.
Individuals diagnosed with sudden cardiac death (SCD)-predisposing genetic heart diseases (GHDs) have traditionally been restricted from participating in competitive sporting activities. There has been a paucity of data available to help clinicians make informed shared-decisions with patients and families. However, the concerns for adverse outcomes after return to play (RTP) include a range of scenarios which include, but are not limited to: cardiogenic fainting or seizures, implantable cardio-defibrillator (ICD) shocks, sudden cardiac arrest or sudden cardiac death. One of the largest, most contemporary studies to address this uncertainty, was a 20-year retrospective Mayo Clinic study on shared decision making (SDM)-mediated return-to-play (RTP). Although this study provided promising evidence of extremely low, non-lethal event rates, it was unfortunately, representative of a very young (<22 year of age) athletic cohort in non-elite level (Division I University or Professional) sporting activities.
In a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology today, Katherine A. Martinez (an undergraduate student at Loyola University, Baltimore, MD) and her team presented their study: “Return-to-play For Elite Level Athletes With Sudden Cardiac Death Predisposing Genetic Heart Diseases”, which is the first to assess s the risk of potentially life-threatening arrhythmias among National Collegiate Athletic Association (NCAA) Division I and professional athletes with heart conditions that can increase the risk of sudden cardiac death.
This was a multi-center, retrospective analysis of 76 elite athletes playing at the Division I or professional level treated for GHD at Mayo Clinic, Morristown Medical Center, Massachusetts General Hospital, and Atrium Health Sports Cardiology Center. About half of the elite athletes with GHD who were cleared for RTP (40 patients, 53%) had hypertrophic cardiomyopathy (HCM), and one-quarter (20 patients, 26%) had Long QT Syndrome (LQTS). Slightly more than half of the athletes (40/76, 52%) had no symptoms prior to their diagnosis and were flagged after an abnormal cardiac evaluation, usually during pre-season screening. Approximately a quarter of athletes were diagnosed after experiencing symptoms suggestive of GHD. The remainder were diagnosed due to family history or an unrelated event. About 28% were female, with a mean age at return to play of 22±5 years. The breakdown of elite level participation was 49 (64%) NCAA D1 level and 27 (36%) at the professional level. Approximately one-third of athletes had an ICD.
The athletes included in the analysis played a range of sports, including basketball, hockey, track and field, triathlon and soccer, representing a variety of racial and ethnic backgrounds. Most athletes three-quarters (55/76, 72%) had been initially disqualified from sports based on their diagnosis but ultimately opted for unrestricted return to play after comprehensive clinical evaluation and implementation of SDM.
Over an average follow-up period of seven years, only three athletes (4%) experienced a non-lethal cardiac episode related to their genetic heart disease, with fainting being the most common event. One of these three patients received an appropriate ICD shock. No athletes died during the study follow-up period.
The results of this study by Katherine A. Martinez and team, provides hope for many patients with GHDs who wish to participate in sporting activities, particularly at the elite level. This study particularly highlights the importance of shared decision-making approaches to clinician-patient interactions as well as the need for multidisciplinary specialist involvement (genetic cardiologists and sports cardiologists among others) in the care of this patient population. This brings focus to the growing importance of an individualized approach to clinical recommendations. The devastating instances of high-profile tragedies naturally influences organizational, clinician and public perceptions of the health risks posed by GHDs in the sporting arena. However, this contemporary analysis stresses the importance of using scientific evidence in informed decision making. Prospective, multi-center data will be prudent to help bolster policy and guideline statements. The authors acknowledged that essential criteria for a comprehensive RTP protocol, must include: patient commitment to adherence to prescribed treatments and follow-up, access to an AED and open communication with relevant stakeholders overseeing elite sporting activities.
In closing, regarding the clinical implications of the study, Katherine Martinez stated: “our study provides scientific evidence, that for athletes competing at an elite level with an ICD, the outcomes are good.”
Macitentan/Tadalafil Fixed Dose Combination reduces PVR compared with monotherapy
Key Points:
- Macitentan and Tadalfil are frequently used in combination for PAH, which opens up the possibility of a fixed-dose combination pill.
- In the DUE study, macitentan/tadalafil FDC therapy was compared against macitentan and tadalafil monotherapy. The primary outcome was PVR reduction at 16 weeks.
- M/T FDC resulted in a significant reduction in PVR at 16 weeks compared to either macitentan or tadalfil monotherapy. There was a non-significant trend towards reduction in 6MWD at 16 weeks.
A Virtual Care Team-Guided Strategy Improved GDMT in Hospitalized HFrEF Patients: the IMPLEMENT-HF Study
Key Points
- Despite an extensive body of evidence supporting the benefit and use of guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF), its implementation remains low
- The IMPLEMENT-HF study explored the efficacy of virtual optimization of GDMT for hospitalized patients, hypothesizing that a dedicated GDMT Team would improve GDMT optimization during admission compared to usual care
- A virtual care team-guided strategy improved GDMT in hospitalized HFrEF patients; this strategy was safe and was not associated with increased hospital length of stay.
Lifelong Endurance Not linked to Favorable Coronary Plaque Composition but Less Vulnerable ones: MASTER at HEART Trial
Key Points
- Cardiovascular risk mitigation strategies such as the recommendation to engage in a more active lifestyle are common in primary care and cardiovascular clinics, yet more nuanced data gauging the association between lifelong endurance exercise and coronary atherosclerosis is lacking
- In this study, investigators examined the association between lifelong endurance exercise with the incidence of coronary plaque as compared to late-onset endurance exercise and a non-athletic lifestyle
- The study showed that lifelong endurance sport participation was not associated with a more favorable coronary plaque composition; however, this group was found to have less vulnerable plaque as assessed by coronary computed tomography
Treat-to-target LDL Strategy Non-inferior to High-Intensity Statin Therapy In CAD Patients: the LODESTAR trial
Key Points
- Appropriate lipid management is of critical importance in preventing further cardiac events in patients with atherosclerotic cardiovascular disease, yet different approaches exist to achieving lipid control
- In this study, investigators sought to assess whether a treat-to-target LDL strategy is noninferior to a strategy of high-intensity statins for long-term clinical outcomes in patients with coronary artery disease
- A targeted approach to reducing LDL-C was noninferior to the high-intensity statin strategy in terms of a 3-year composite outcome of all-cause death, myocardial infarction, stroke, or any coronary revascularization.
Black women with TTR V122I variant have higher risk of CVD and all-cause mortality
Key Points:
The prognostic significance of the V122I variant (associated with wt-ATTR) in Black women has not yet been established.
A substudy of the WHI aimed to establish the association of the V122I variant with a composite of CVD and all-cause mortality in Black Women.
The V122I variant was associated with increased composite CVD and all-cause mortality in Black women; this association was particularly significant for women age 60+.
The Final Word on Transcatheter edge-to-edge Repair with MitraClip– COAPT Five Year Results
Key Points:
- Two-year results showed improved outcomes with the MitraClip device but long-term results had not been reported; TEER was allowed in the control arm only after the 2-year primary endpoint assessment.
- At 5 years, the annual rate of hospitalization for HF was 33.1%/year in the device group and 57.2%/year in the control group (HR 0.53; 95% CI 0.41-0.68).
- All- cause mortality through 5 years was lower at 57.3% in the device group and 67.2% in the control group (HR 0.72; 95% CI 0.58-0.89). MitraClip was safe and led to a lower rate of hospitalization for HF and lower all-cause mortality through 5 years of follow-up as compared with medical therapy alone.
Pulsed Field Ablation Effective to treat Paroxysmal and Persistent AF: The PULSED AF Pivotal Trial
Key Points:
– Pulsed field ablation (PFA) is a novel ablation technology which utilizes electrical pulses to deliver irreversible electroporation and induce thermal cardiac cell death and has shown high cardiac tissue selectivity and safety in preclinical data.
-Over 1 year of follow-up, treatment with PFA to achieve pulmonary vein isolation, achieved freedom from atrial arrhythmias in up to two-thirds of patients.
-Pulse field ablation appears to have an excellent safety profile with only one adverse event occurring in each of the two patient cohorts, for an adverse event rate of 0.7%.
-Patients with both paroxysmal and persistent AF had significant and meaningful improvements in quality of life following their index ablation.
COORDINATE-Diabetes – A Coordinated, Multifaceted Intervention Increases Prescription of Evidence-based Therapies for Adults with T2D and CV Disease
Key Points
- Evidence-based therapies that reduce cardiovascular risk remain underused among individuals with type 2 diabetes and cardiovascular disease
- The COORDINATE-Diabetes cluster-randomized clinical trial included 43 cardiology clinics treating individuals with type 2 diabetes and atherosclerotic cardiovascular disease and randomized them to a multifaceted intervention of assessment, education, and feedback or usual care. The primary outcome was the proportion of participants who were prescribed all three recommended groups of preventative medications (high-intensity statins, ACEIs or ARBs, and SGLT2 inhibitors and/or GLP-1RAs) at the last follow-up visit (either 6-month or 12-month).
- The coordinated, multifaceted intervention increased the prescription of all three therapies as compared to usual care (37.9% vs 14.5%, respectively) in individuals with T2D and atherosclerotic cardiovascular disease
The GCCF Project: Remote monitoring reduces cardiology’s carbon footprint
Key Points
- Cardiac device monitoring is a repetitive, long term activity that can be resource intensive.
- The Global Cardiovascular Carbon Footprint (GCCF) project sought to evaluate the extent to which remote cardiac device monitoring can reduce greenhouse gas emissions.
- Compared to in-person visits, remote monitoring resulted in a net reduction of nearly 12600 metric tons of CO2 among 67 sites over 2 years, the equivalent of 2 million gallons of gasoline or nearly 15,000 acres of forest land saved.
Elevated hs-cTnL levels precede and predict pre-eclampsia
Key Points:
- There have been limited data regarding the biomarkers that may predict the development and severity of preeclampsia.
- hs-cTnI was significantly elevated in pregnant women who would later develop preeclampsia starting at 14 weeks. A cutoff hs-cTnI value of >2.2pg/ml at 14 weeks and >2.6pg/ml at 26 weeks had a combined 100% negative predictive value for predicting severe preeclampsia in women at high a prior risk.
TEER for degenerative MR Safe, Effective: a real world analysis using the STS/ACC TVT registry
Key Points
- While transcatheter edge-to-edge repair (TEER) is FDA approved for treatment of degenerative mitral regurgitation (MR) in patients at high surgical risk, outcomes in this population are not well described.
- This study used registry data to report clinical endpoints including mortality and procedure success over time for patients undergoing TEER for degenerative MR in the United States.
- The safety profile of MitraClip for degenerative MR was excellent despite advanced age (82 years) and significant comorbidities Succesful repair was achieved in 89% of the patients.
STREAM-2 Trial: Half-dose TNK + PCI Provides Effective reperfusion In Elderly STEMI Patients
Key Points:
- Pharmaco-invasive (PI) strategy with half-dose tenecteplase (TNK) is compared to routine primary percutaneous coronary intervention (pPCI) in STEMI patients over 60 years of age who presented within 3 hours and unable to undergo pPCI within 1 hour.
- Primary efficacy endpoints were the percentage of patients with ≥ 50% ST-segment resolution after TNK and before and after PCI, the need for rescue PCI, and the combined clinical endpoint of death, cardiogenic shock, re-infarction, and heart failure at 30 days.
- Composite outcome at 30 days (death, heart failure, MI, shock), for pharmaco-invasive therapy vs. primary PCI, was: 12.8% vs. 13.3% (relative risk 0.96, 95% confidence interval 0.62-1.48)
- The findings of the study suggest that using a pharmaco-invasive strategy with half-dose tenecteplase (TNK) is both secure and efficient in contrast to primary percutaneous coronary intervention (PCI) in older individuals with ST-segment elevation myocardial infarction (STEMI) who could not obtain timely primary PCI within an hour.