|
Post-LAAO Options | Surmodics Buyout Blocked March 16, 2025
|
|
|
|
Together with
|
|
|
“You can turn those sirens off. What are the odds that a non-randomized study will lead to a game-changing result in cardiology these days?”
|
Bogdan Enache, MD
|
|
Cardiology Pharmaceuticals
|
|
|
|
Real-world data from the EMERGE LAA postapproval study suggests it might be time to rethink the discharge medications prescribed to patients after LAAO.
- Current antithrombotic recommendations call for both aspirin and clopidogrel (or another antiplatelet drug) for six months, with therapy continuation as prescribed by a physician.
- Oral anticoagulation is usually for patients whose residual flow around the LAA implant is more than 5 mm.
Diving deeper into data from Abbott’s 11.5k patient EMERGE LAA postapproval study, researchers compared the adverse events and six month outcomes of single antiplatelet therapy (5.3% of patients), DAPT (81.7%), and oral anticoagulants (13%), finding that there weren’t many differences across the board.
- The composite rate of all-cause death, stroke, major bleeding, or systemic embolism was 5.5% with SAPT, 6.9% with DAPT, and 4.9% with oral anticoagulants after six months.
- Major bleeding was highest in the DAPT group at 3.8%, compared with 3.1% with SAPT and 2.5% with oral anticoagulants.
While oral anticoagulants led to the lowest complication rates following implantation, the close performance of SAPT (which was either just aspirin or a P2Y12 inhibitor) could provide an affordable over-the-counter alternative to prescription drugs.
- While this analysis doesn’t tell us how many patients received which monotherapy, other studies have supported P2Y12 inhibitors over aspirin.
- As a result, the authors of EMERGE LAA are calling for randomized controlled trials that would focus solely on LAAO postprocedure management.
The Takeaway
Based on this analysis, the idea of an OTC discharge therapy sounds possible, but a head-to-dead RCT for all three options is needed to pave a clearer path for the physicians prescribing these treatments. On the bright side, at least we know none of the three treatment options are the wrong answer.
|
|
|
Tracking Your Post-Treatment Plaque
Tune-in to this on-demand Cleerly webinar where preventative cardiologist John Osborne, MD, PhD, FACC, FNLA explores how to use CTA to track plaque progression and identify residual risk post-treatment.
|
|
Offer Hope Not Just Inotrope to Your Patients with Advanced Heart Failure
Left ventricular assist devices (LVADs) have received Level 1A Recommendation from the AHA/ACC/HFSA guidelines.
|
|
CVIS and AI in Structural Heart Treatment
Harnessing the power of CVIS and AI to enhance your heart imaging is crucial in today’s fast-paced health care environment. See how Optum’s CVIS can support clinical workflows and meet the needs of EP and structural heart procedures.
|
|
- FTC Blocks Surmodics Buyout: The FTC blocked GTCR’s $627M acquisition of cardiovascular devicemaker Surmodics due to the PE firm’s plan for combining the company with Biocoat. According to watchdogs, merging Surmodics with GTCR’s Biocoat would result in a single company controlling more than 50% of the market for outsourced hydrophilic coatings for catheters and guidewires. As a result, the FTC’s competition bureau believes “this merger threatens to disrupt competitive dynamics that have ultimately benefited patients.”
- Rivus’ Obesity HFpEF Drug: Rivus Pharmaceuticals announced strong results from its Phase 2a HuMAIN clinical trial for its drug HU6 in patients with obesity-related HFpEF in JAMA Cardiology. HU6 met its body weight reduction primary endpoint with patients losing significantly more weight compared to placebo over the 19-week period (-6.8 lbs vs -0.5 lbs). Beyond weight loss, HU6 also led to significant improvements in LVEF of 3.76% and a decreased LV end-systolic volume of -5.64 ml compared to placebo.
- Macitentan Falls Flat for HF: Dealing a blow to macitentan’s label-expansion hopes, results from the SERENADE trial cast doubt on the drug’s ability to lower NT-proBNP levels or improve HF outcomes. As part of the study, researchers compared 142 randomized patients who received either macitentan or placebo and found that the drug had no effect on NT-proBNP levels or KCCQ scores. When it came to HF progression, worsening HF occurred in 28% of macitentan patients and 18% of placebo, which was not statistically significant.
- Get the Kids to Bed! Results from an AHA study suggest teens who don’t sleep enough could be at greater risk of high blood pressure. Researchers studied over 400 teenagers from the Penn State Child Cohort and found that teens who slept less than 7.7 hours were almost three times more likely to have elevated blood pressure than well-rested peers. Even worse, teens with insomnia who slept less than 7.7 hours were five times more likely to have stage 2 hypertension.
- Stem Cells’ HF Role: Inflammation plays a key role in HFpEF pathophysiology, but the mechanisms that cause it still remain a mystery. Looking for an answer, researchers compared patient samples and animal models of stem cell activity during HFpEF, finding that patients with cardiometabolic HFpEF exhibited higher levels of peripheral blood hematopoietic stem cells. Researchers now believe the increased stem cell activity is partly linked to the systemic inflammation and cardiac diastolic dysfunction seen in HFpEF patients.
- 4C Medical’s Series D: Boston Scientific led a $175M Series D funding round for mitral valve developer 4C Medical, representing a big jump from the company’s previous $35M raise in early 2022. The latest round will help fund development of 4C Medical’s AltaValve which fits entirely inside the left atrium instead of being placed at the mitral valve site like other transcatheter replacements. 4C Medical is currently validating the technology with the Atlas trial following two breakthrough designations from the FDA.
- Roche & Zealand Team-Up: Adding to its robust obesity pipeline, Roche paid $1.65B upfront fees to Zealand Pharma for its long-acting amylin analog, petrelintide. The move follows the start of Zealand’s Phase 2b trial last year, which the company believes will lead to weight loss of 15%-20% in patients taking the drug for one year or more. Zealand is also slated to receive up to $1.2B in development milestones linked to the start of Phase 3 trials.
- A Heart of Titanium: A patient in Australia was the first in the world to be discharged with BiVACOR’s total artificial heart technology while waiting to receive a heart transplant, allowing him to wait for a new heart from the comfort of his home. The patient had the device for a total of 105 days before a donor heart became available, speaking to its ability to safely and comfortably keep him alive.
- Valcare’s AMEND IDE & EFS: Valcare Medical announced that the FDA has granted its AMEND Trans-Septal System an investigational device exemption to commence its early feasibility study. The AMEND System is a transcatheter device that treats mitral insufficiency with a semi rigid, closed, D-shaped annuloplasty ring. Valcare’s EFS study will evaluate AMEND’s safety profile in 15 patients with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation.
- Medical Therapy for PCI vs. CABG: Medical therapy is often overlooked in the PCI versus CABG debate, and results from the REVIVED-BCIS2 (PCI) and STICHES (CABG) trials suggest medical therapy alongside PCI could lead to better outcomes than CABG. Researchers compared data from the two trials and uncovered that patients receiving only medical therapy in REVIVED-BCIS2 had lower all-cause mortality and HF hospitalization rates than those receiving medical therapy in STICHES (aHR: 0.60). While the data analysis isn’t intended to prove which is better, it does highlight the need for more head-to-head RCTs for PCI versus CABG.
- Med Students Watch Match Week 2025: March 17 marks the start of Match Week, when U.S. medical students will learn from the Main Residency Match the residency programs where they will train for their chosen specialty. Residency applicants will learn if they’ve matched on March 17, and will be notified of their specific programs on Friday March 21, an occasion marked by ceremonies and festivities at most medical schools.
|
|
Relieving The Burden of Post-Processing
With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.
|
|
Redefining Percutaneous Coronary Intervention
Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)
|
|
Vista.ai’s Cardiac MRI Results
Are your patients waiting too long for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista.ai’s AI-driven image acquisition software improves image quality, shortens scan times, and increases patient throughput.
|
|
- Merge and Duly Health Streamline Cardiology Reporting: Over the last 10 years, Dr. Sujith Kalathiveetil of Duly Health and Care has seen a significant evolution in cardiovascular imaging and experienced a similar evolution with Merge’s cardiology solutions. See how Merge Cardio has helped make cardiology reporting more consistent, accurate, and easier to obtain for Dr. Kalathiveetil and his colleagues.
- A Better Way to Coordinate Post-Stroke Care: Think your EHR messaging system might be holding back your post-stroke care? See how UC San Diego Medical Center streamlined its neuro and EP teams’ post-stroke workflow with Viz Connect, and the impact it had on cardiac monitor placements in inpatient and outpatient settings.
- Us2.ai’s Echo Automation Impact: Improving clinician efficiency and quality is the goal for most AI solutions, but we rarely see AI achieve both. See how the AI-ECHO RCT used Us2.ai to achieve both of those goals, while reducing sonographer fatigue in the process.
- Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow
- The Efficiency of the Kinetic Rhythms ECG Algorithm: See how you can interpret up to twenty-nine distinct rhythms by embedding the Kinetic Rhythms ECG Algorithm on your device or software suite. Ensure precise ECG interpretations regardless of whether they’re taken at the bedside or in an ambulatory setting.
- Configure Your PCI Study: See for yourself how cardiac imagers use GE HealthCare’s Centricity Cardio Enterprise Universal Viewer to do their PCI studies, including configurable viewport setup and side-by-side comparisons.
- A Single Cardiac Service Line Platform: Transitioning across multiple imaging platforms is a daily reality for many cardiologists, but it doesn’t have to be. See how three leading cardiac imagers are leveraging Circle CVI’s unified multi-modal software across their diverse caseloads, without switching to other platforms.
- Cardiology AI: From Research to Clinical Practice: Explore how AI algorithms are reshaping cardiology with insights from Tempus’ recent webinar, featuring Dr. David Ouyang of UCLA and Cedars-Sinai, alongside Tempus’ Dr. John Pfeifer and Dr. Brandon Fornwalt. This expert panel dives into how AI can bridge diagnostic gaps, enhance patient outcomes, and streamline workflows for conditions like AFib and pulmonary hypertension. Read the full recap to glimpse the future of AI-driven cardiology.
- Plaque Analysis Now Covered by Medicare: HeartFlow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.
- Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!
|
|
|
|
|