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The Power of Low Lifelong LDL-C | Abbott’s Catheter Ablation Approvals February 6, 2023
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Together with
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“Get LDL as low as possible for as long as possible.”
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Sek Kathiresan, MD, reflecting on the implications of the new study (covered below).
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A high-impact genetic association study found that people with certain genetic variants were 50% less likely to develop coronary heart disease. The findings reveal the importance of maintaining low LDL-C (or “bad” cholesterol) levels over a lifetime.
Pharmacological LDL-C management may reduce the risk of developing CHD by 22%, but this study found that people who had variations in either APOB or PCSK9 (two genes known to be associated with LDL-C) were even more protected against CHD.
The authors combined genetic and clinical data from more than 200,000 participants from 5 NHLBI prospective cohorts and the UK Biobank. Of these, 139 (0.7%) carried a truncating mutation in either APOB or PCSK9–switching these genes off.
Over a median of 21.5 years…
- A CHD event (like a heart attack or death) was far less likely in APOB or PCSK9 variation carriers than noncarriers (8.6% vs. 16%), corresponding to a 49% reduced CHD risk (HR: 0.51).
- Carriers had a 45 to 49 mg/dL lower average untreated LDL-C level.
To put the magnitude of the 49% reduced CHD risk into perspective, here is how traditional risk factors affected the likelihood of developing CHD.
- No diabetes reduced risk by 53%
- No hypertension reduced risk by 25%
- Not smoking reduced risk by 43%.
That’s right: a APOB or PCSK9 variation carrier who smokes is more protected against CHD than a noncarrier who does not smoke.
The Takeaway Analysis of DNA variants that turn off APOB or PCSK9 revealed the power of lifelong low LDL-C. For LDL, it’s not only about how low the levels are, but for how long those levels have stayed low.
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How Precision Heart Therapy Advances the Business of Healthcare
Health systems continue to face economic and regulatory pressure to reduce care costs and improve outcomes. See how Cleerly’s precision heart care approach helps enhance patient care, avoid unnecessary and high-cost procedures, and improve the patient and provider experience.
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Reducing Variability in Echo Analysis
What if AI could produce echo measurements that are comparable to expert physicians, but with less variability? That’s precisely what this Nature study revealed about Us2.ai’s solution, finding that its measurements had fewer and smaller differences compared to three human experts than when the experts were compared with each other.
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- Eye Exam Before Semaglutide: A recent meta-analysis revealed that semaglutide, which is part of the hot new class of GLP-1 agonist drugs, may worsen diabetic retinopathy. By combining results of six trials, researchers found that regular subcutaneous semaglutide use was tied to a 73% increased rate of diabetic retinopathy (HR 1.73), with people who have received injections for over a year being the most at-risk. Reassuringly, semaglutide’s cardiac event benefits outweighed the increased retinopathy risk.
- Abbott’s Tactiflex CE Mark: Abbott received a CE mark for its Tactiflex Ablation Catheter, which features a sensor tip to help surgeons identify regions of the heart with abnormal electrical signals and is compatible with Abbott’s EnSite X electrophysiology mapping system. The TactiFlex catheter’s flexible tip can fold when pushed against the interior of the heart wall, keeping it in place while delivering ablations. The TactiFlex is available in Europe, Africa, Japan and Australia, and is currently undergoing FDA review.
- Abbott’s FlexAbility Expanded Indication: In the US, the FDA expanded the indication for Abbott’s older iteration of Tactiflex: the FlexAbility catheter. After previously being approved for atrial flutter, the new approval broadens the catheter’s reach into ventricular tachycardia, and specifically among patients who have non-ischemic cardiomyopathy.
- XylaCor’s Angina Gene Therapy: A one-time gene therapy from XyloCor Therapeutics met both safety and efficacy goals after six months among 28 patients with refractory angina. The gene therapy is designed to promote new blood vessel growth in the heart, boosting blood flow and reducing chest pain. In the phase 2 trial, the candidate drug, dubbed XC001, reduced episodes of chest pain, caused no adverse events or safety issues, and improved many patients’ exercise capacity.
- Heart Inflammation Imaging: After discovering that the investigative LW223 PET radiotracer could “transform” our ability to image and understand tissue inflammation, a team of Scotland-based researchers secured £2M in funding to test the tracer on humans. The LW223 is the first radiotracer to be unaffected by the rs6971 polymorphism, a genetic mutation that has previously limited the efficacy of inflammation imaging to only 40% of the population. The first LW223 trial will measure inflammation in patients who’ve had a heart attack.
- Boston Scientific Fined $42M for Patent Infringement: A federal jury found Boston Scientific guilty of infringing on TissueGen’s patented drug-eluting stent technology, and determined that the company owes $42M in lost royalties. TissueGen founder Kevin Nelson, PhD, designed and patented the stent technology in 2003, and TissueGen launched the system commercially in 2013, two years before Boston Scientific landed FDA clearance for its own similar Synergy system. Boston Scientific disagrees with the decision and plans to appeal.
- Dual Blood Thinners Underprescribed: Evidence shows that starting two antiplatelet medications, such as aspirin or clopidogrel, may reduce the short-term risk of recurrent stroke after a minor stroke or a transient ischemic attack. But research presented at the American Stroke Association’s Stroke Conference found that only 40% of 3,000 discharged stroke survivors were prescribed dual antiplatelet therapy. Women were significantly less likely to receive dual medication treatment compared to men.
- 2022 Hospital Margins: Kaufman Hall’s latest National Flash report revealed that nearly half of hospitals finished 2022 in the red, despite slight margin gains in December (up to 0.2% from -0.2% in November). Although 2022 was the worst year for hospitals since the start of the pandemic, Kaufman Hall outlined how better workforce management and stabilizing supply channels could help lead to a rosier financial outlook for 2023.
- CardiacSense’s Medical Watch FDA Clearance: CardiacSense’s CSF-3 medical watch gained three new FDA clearance indications: measurements of ECGs, beat-by-beat heart rates, and blood oxygen saturation in the arteries. This watch previously received CE mark approval in Europe for four indications, and is currently in the process of finalizing terms with US commercial partners and anticipates a US launch by the end of 2023.
- Incidental CAC’s Short-Term Risks: A new study out of the UK showed that patients with incidentally-detected coronary artery calcification in non-contrast chest CTs have significantly greater CVD risks. Analysis of 717 patients (325 w/ CAC, 0 w/ known CVD) found that CAC patients had 26 CVD events and five deaths over 3.5 years, while non-CAC patients had just one event. Patients with more severe >100 CAC scores also had far greater risks of CVD events and all-cause mortality (HR: 5.7 & 1.7).
- Ransomware Attacks Double: Ransomware attacks on US healthcare organizations more than doubled from 2016 to 2021, climbing from 43 to 91 breaches per year. A University of Minnesota-led study identified 374 attacks that exposed 42M patients’ personal health information–over 10% of the US population. Although only 15.8% of breaches resulted in health information making its way to the dark web, the authors “strongly suspect underreporting for basically everything.”
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PRECISE Trial Rewrites the Patient Pathway
HeartFlow’s landmark PRECISE trial found that their precision approach for evaluating people with stable chest pain avoided unnecessary testing and improved care without putting patients at risk of a missed heart disease diagnosis.
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Making the Leap to Outsource Post-Processing
Interested in how to outsource cardiac image post-processing, but not sure where to start? PIA walks you through how to assess and compare vendors, understand pricing models and payment options, and outline your requirements to identify vendors who meet your clinical needs.
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Transformation Through Structured Reporting
Ready to realize the benefits of cardiovascular imaging structured reporting? Check out these quick and powerful Change Healthcare videos detailing the efficiency gains provided by structured reporting and what it takes to drive adoption.
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