Legendary cardiologist Eugene Braunwald, MD regarding cardiology’s advancements during the American Heart Association’s first 100 years, and how much is left to accomplish in its next 100 years.

Cardiology Pharmaceuticals

Strong-HF Analysis Supports Quick HF Medication Optimization

Secondary analysis of STRONG-HF trial data highlighted the benefits of quickly bringing heart failure patients up to full guideline-directed medical therapy (GDMT), showing that rapid uptitration to optimal doses of at least three classes of guideline-directed meds reduces readmissions and mortality, while improving quality of life.

The analysis included 515 acute HF patients who weren’t taking optimal GDMT doses before discharge, and were randomly assigned to be uptitrated within 2 weeks.

• 39 patients achieved “low” doses (<50% of max GDMT), 254 patients achieved “medium” doses (≥50% to <90% of max GDMT), and 222 patients achieved “high” doses (≥90% of GDMT) two weeks after discharge.
  

In general, higher doses meant better outcomes…

• Each 10% average optimal dose increase translated into an 11% reduction in HF readmissions and a 16% decrease in all-cause mortality at 180 days. 
• Quality of Life EQ-5D scores improved by more in patients in the high (from −1.98 to 8.24 points) and medium GDMT group (from −4.88 to 5.07) compared to the low dose group at 90 days.
• Adverse events through 90 days were less common at higher GDMT doses, although that was related to more stable patients receiving higher doses.

Despite this evidence that rapid GDMT uptitration had an outsized impact on HF outcomes, only 43% of the patients reached “high” dosage. 

• However, 90% of patients were able to achieve at least “medium” GDMT doses, suggesting that “a lot” of the GDMT adherence challenges in the real world are due to therapeutic inertia.
• With that in mind, the authors emphasized that “all efforts should be made to rapidly uptitrate” the three or four GDMT medications to optimal doses in all HF patients that can tolerate them.

The Takeaway

The original STRONG-HF trial results already showed that rapid uptitration improved HF patients’ outcomes and quality of life, and these new results add more evidence that clinicians can (and often should) quickly increase many of their HF patients’ GDMT doses.

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Experience the Future of Learning: Medtronic Academy 2.0 is Here!

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Bunkerhill Health’s Forbes Honors

Congratulations to Bunkerhill Health cofounders, David Eng and Nishith Khandwala, who were named to Forbes 30 under 30. Check out how they earned these honors in this Forbes profile.

The Wire

• Cleerly’s ISCHEMIA Clearance: Cleerly significantly expanded its cardiovascular AI portfolio, with the FDA clearance and launch of its new Cleerly ISCHEMIA solution. Available via prescription to users of Cleerly LABS software, Cleerly ISCHEMIA analyzes CCTAs to determine the presence of coronary vessel ischemia based on quantitative measures of atherosclerosis, stenosis, and significant vascular morphology. The launch appears to mark Cleerly’s transition from a focus on plaque analysis to supporting diagnosis across the cardiovascular care continuum.

• Weekend Woes in Patients with ACS and ADHF: In an analysis of 207 ACS patients presenting with ADHF, those admitted on weekends faced double the 1-year mortality risk compared to weekdays (34.6% vs. 17.4%). The “rest-day effect” was notably absent in ACS patients without ADHF, and there were no significant differences between the groups for 30-day or in-hospital mortality. The authors emphasized the need for further research and heightened clinical attention on this high-risk ACS subgroup during weekends.

• Us2.ai’s Home HF Advantage: Access to echocardiography has long been a hurdle for effective HF management, and results from the CUMIN study suggest that echo AI-enabled home exams might help overcome these barriers. Researchers trained seven echo-novice nurses on performing Us2.ai-enhanced cardiac ultrasound exams for one day, and then had them examine 94 Tunisian patients without previous HF diagnosis. The novice at-home AI-POCUS exams achieved higher sensitivity (92% vs. 87%) and AUCs (0.86 vs. 0.64) for detecting the primary endpoint (LVEF <50% or LAVI mL/m2) than NT-proBNP testing.

• Clopidogrel’s Post-PCI Advantages: Follow-up analysis of the STOPDAPT-2 study highlights clopidogrel monotherapy’s potential advantages over aspirin after PCI. In 3,005 patients with five-year follow-up, clopidogrel (after one month DAPT) was noninferior to aspirin (after 12 months DAPT) for the primary endpoint, a composite of CV events, stent thrombosis, stroke, and bleeding (11.75% vs. 13.57%). Clopidogrel was superior to aspirin (8.61% vs. 11.05%, P=.06) for the secondary endpoint of CV, thrombosis, and stroke events. The therapies had similar bleeding rates.

• Novartis’ RNAi Investment: Novartis expanded its RNAi cardiovascular drug pipeline, paying Shanghai Argo $185M up-front and up to $4.165B with potential milestones for outside-of-China rights to one Phase 1/2a cardiovascular asset, exclusive worldwide rights to another Phase 1 RNAi asset, and an option to license compounds for up to two other CVD targets. The deal continues big pharma’s recent push into RNAi cardiovascular drugs, following Roche’s up-to $2.8B deal with Alnylam Pharmaceuticals.

• High-Risk, High Mortality in Patients with PE: A new analysis published in JACC showed that high-risk PE patients in the PERT Consortium Registry faced higher mortality (20.6% vs. 3.7%) and major bleeding (10.5% vs. 3.5%) compared to their intermediate-risk counterparts. Factors such as vasopressor use, ECMO utilization, clot-in-transit identification, malignancy, and hypoxia were associated with in-hospital mortality. Despite advancements, the study emphasizes the need for standardized practices and further research to improve outcomes for high-risk PE patients.

• DASI’s TAVR Planning Code: Ohio State spin-out DASI Simulations announced that CMS added an outpatient code that would provide $1k reimbursements for the use of its PrecisionTAVI solution (HCPCS code: C9793). PrecisionTAVI leverages AI and computer modeling to analyze CCTA exams and generate 3D predictive models for TAVR pre-planning, and is currently the only solution in its class.

• What’s the Cutoff for MI/Anemia Transfusions? New data may help answer debates over what’s best for MI patients with anemia: a liberal treatment approach that provides blood transfusions when hemoglobin is <10 g/dl or a restrictive transfusion cutoff of <7 or <8 g/dl. In the study of 3,504 patients, the liberal threshold didn’t translate into significantly fewer MI or death events in 30 days (14.5% vs. 16.9%), but there were nuances in the data that still favored a liberal approach.

• Medtronic’s Micra EU Approval: Eight months after their FDA approval, Medtronic’s Micra AV2 and Micra VR2 miniaturized leadless pacemakers have gained European CE Mark approval. The new pacemakers are highlighted by their 40% longer battery lifes (to 16yrs & 17yrs), small size (“the world’s smallest pacemakers”), and easier programming than prior Micra pacemakers. The new Micra AV2 also includes advanced algorithms that automatically program AV synchrony, coordinating the heart’s upper and lower chambers, and has a higher available tracking capability for faster heart rates.

• Bundled Payments Letdown In HF Care: The Medicare Bundled Payments for Care Improvement (BPCI) program doesn’t appear to be working for many HF patients. In a study of data from 2008 to 2018, HF outcomes were similar for 8,721 patients in BCPI hospitals and 94,530 in non-BCPI hospitals, except for a 37% decreased chance of being on an evidence-based beta blocker at discharge. What’s more, hospital readmission and mortality rates were similar at 30 and 90 days.

• iRhythm’s CE Marks: iRhythm announced the EU CE Mark approval of its new Zio ambulatory ECG monitor and its new ZEUS System, which supports the capture and analysis of ECG data recorded by the Zio monitor. Intended for 14 days of continuous use, the Zio ECG monitor is significantly smaller (-72%), lighter (-62%), and thinner (-23%) than the previous Zio XT. The new Zio monitor and ZEUS System launched in the US in September.

Monebo’s AF ECG Algorithm

Atrial fibrillation is often difficult to characterize with an automated algorithm due to the changing waveform morphology, system, or muscle noise. This is especially true given the size constraints of ambulatory devices to detect AFib. See how Monebo’s Kinetic AF ECG Algorithm overcomes these size limitations without sacrificing accuracy.

HeartFlow’s FFRCT Milestone

HeartFlow had reason to celebrate as it entered 2024, surpassing 250,000 patients examined with its FFRCT Analysis solution, while helping to avoid a huge number of unnecessary invasive angiographies.

The Resource Wire

• Diagnosis Beyond the Hospital: It’s increasingly clear that healthcare is expanding beyond hospital walls, and recent evidence from Us2.ai suggests that AI-enabled cardiac ultrasound could help drive that expansion. Read these editorials by Izabella Uchmanowicz, RN, PhD and Prof. Blanche J Cupido, MBChB to see how Us2.ai-enabled and nurse-operated mobile ultrasound might both improve and expand heart failure diagnosis.

• Unify Your Cardiovascular Data: In this era of interoperability, it’s time to focus on cardiology. See how Change Healthcare’s enterprise cardiology platform provides a single database for CPACS, Hemo, CVIS, and ECGM — helping to improve data access and integrity while simplifying your IT configuration.

• A CCTA-Based Approach to Heart Attack Prevention: Cardiologists are increasingly relying on cardiac CT angiograms as a heart disease diagnostic tool. See what’s driving this trend in this Cleerly report detailing the key attributes of CCTA exams, evidence of its effectiveness, and CCTA’s medical guideline support.

• The Benefits of Outsourced Post-Processing: Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.

• TeraRecon’s Structural Heart Enhancements: Detecting and addressing mitral valve and LAA conditions can be challenging. Check out TeraRecon’s Structural Heart white paper and discover how improving workflow and pretreatment planning can streamline these processes and potentially improve patient outcomes.