Chris Palmer, MD after yet another study reveals an association between artificial sweeteners and poor CV outcomes.

Structural Heart

Edwards’ Strong Five-Year Small Annulus TAVR Outcomes

Edwards Lifesciences and Medtronic’s fight for TAVR supremacy took an interesting turn last week, after Edwards showed that its SAPIEN 3 valve has similar five-year outcomes among patients with both small and large aortic annulus, regardless of their mean gradients and rates of prothesis-patient mismatch (PPM).

The study analyzed 1,355 low or intermediate risk patients with symptomatic aortic stenosis who received an Edwards SAPIEN 3 balloon-expandable valve and were included in the PARTNER 2/S3i registry or PARTNER 3 trial. Roughly a third of those patients (476) had a small aortic annulus (≤ 430 mm2).

After five years, patients with small and large aortic annulus had…

• Similar rates of death/disabling stroke – 36.3% vs. 35.8%
• Similar all-cause mortality – 28.5% vs 29.3%
• A nonsignificant difference in aortic valve reintervention – 2.7% vs. 1.8%
• Similar rates of bioprosthetic valve fracture – 2.9% vs. 2.1%

When analyzing small annulus patients based on PPMs and mean gradients (≥20 mm Hg), there was no difference in stroke and all-cause mortality metrics, nor were there differences in reintervention and bioprosthetic valve fracture. 

Although Medtronic wasn’t mentioned, it’s easy to view these results as a response to the recent SMART trial, which found that Medtronic’s Evolut self-expanding valve had key one-year advantages over Edwards’ SAPIEN 3 valves in patients with small aortic annuli. 

• In the SMART trial, the devices had similar rates of death, disabling stroke, or HF hospitalization (9.4% vs. 10.6%). However, Medtronic’s Evolut had much lower bioprosthetic-valve dysfunction (9.4% vs. 41.6%), hemodynamic structural valve dysfunction (3.5% vs. 32.8%), and aortic-valve mean gradient (7.7 vs. 15.7 mm Hg).

Many people walked away from that ACC Late Breaker with a hunch that the Evolut might prove to be better for people with small aortic annuli. However, we’re going to have to see the SMART trial’s five-year results to know for sure, or better understand whether metrics like gradients and PPM actually affect outcomes.

The Takeaway

While the SMART trial might have shown early signs of the Evolut valve’s hemodynamic advantages in small aortic annuli patients, Edwards new five-year SAPIEN 3 data suggests that there might not be an association between PPM or mean gradients and actual clinical outcomes. At least for now, we don’t have any long-term data that suggests otherwise.

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The Wire

• Xylitol’s CVD Aftertaste: A new study in the European Heart Journal found that the low-calorie sweetener xylitol is associated with major adverse cardiovascular events. In the study, which included a discovery cohort undergoing elective cardiac evaluations (n=1,157) and a validation cohort (n=2,149), xylitol consumption increased patients’ three-year MACE risk by 57%. The results add to previous studies finding that other artificial sweeteners like erythritol, aspartame,  and acesulfame potassium are associated with poor cardiovascular outcomes.

• Insulin’s Heart-Healthy Head Start: A nationwide study in China found that early insulin therapy for newly diagnosed T2DM patients can reduce certain cardiovascular risks. Among 5,424 patients (average age 56), those who began insulin early had a 31% lower stroke risk and a 28% lower risk of heart failure hospitalization, with no significant difference in coronary heart disease. The study suggests that early metabolic control with insulin may be the key to reducing T2DM patients’ heart risk.

• AI-Powered Cardiac MRI Screening: A team of US and Chinese researchers developed an AI workflow that accurately detects and diagnoses cardiovascular diseases from cardiac MRI exams. The two-stage deep learning protocol initially analyzes non-contrast cine MRI scans to screen for anomalies, and if needed uses cine and contrast-based late gadolinium enhancement exams for diagnosis. In 9.7k people, the technique identified scans with any of 11 cardiovascular diseases with a 0.986 AUC, and classified the diseases with a 0.991 AUC.

• Risks of CABG-Refusal: A study of 3,687 patients with heart disease revealed that those who chose PCI over CABG, against their doctors’ advice, faced worse outcomes. One year after PCI, 7% of CABG-refusal patients experienced death, MI, or stroke, compared to 4.1% of patients who were recommended PCI. The risk was even higher (14.8%) in patients who were ineligible for CABG, highlighting the importance of informed shared decision-making.

• UltraSight’s Mayo Collab: Echo AI startup UltraSight and Mayo Clinic will jointly develop algorithms for analyzing and interpreting cardiac ultrasound images, and will specifically look for ways to make cardiac point-of-care ultrasound available to a wider range of caregivers. UltraSight’s echo guidance solution landed FDA clearance in 2023, and is intended to enable medical professionals without sonography experience to acquire cardiac ultrasound exams at the point-of-care.

• EnABELing Safer AFib Treatment: A recent update from Anthos Therapeutics reveals that 84% of eligible AFib patients transitioned to abelacimab in the AZALEA-TIMI 71 extension. In the initial study, abelacimab, a factor XI inhibitor, reduced major or clinically relevant non-major bleeding by 67% and GI bleeding by 93% compared to rivaroxaban. The safety and efficacy of abelacimab on rates of ischemic stroke or embolism in patients with AFib will be further evaluated in the LILAC-TIMI 76 study.

• Climate’s CV Death Toll: A JACC study estimates that nonoptimal temperatures account for almost 9% of the world’s 1.8M annual cardiovascular deaths. In the analysis of 2000-2019 temperature and mortality data, coldness accounted for 8.2% of deaths and heat was to blame for just 0.66% of deaths. Temperature-related CV deaths declined during the study period, with cold-related deaths falling and heat-related deaths increasing. 

• A New Option for Blood Flow Imaging?  Vanderbilt researchers developed a new option for blood flow imaging using a non-contrast fluoroscopy technique, called x-ray pulsatility index (XPI). The researchers tested XPI against the gold standard of contrast pulmonary angiography in a small group of patients with suspected chronic thromboembolic pulmonary hypertension, finding that XPI had good agreement with angiography (Dice score = 0.77).

• Mediterranean Diet and Female Mortality: A cohort study of more than 25k women followed for 25 years touts the benefits of the Mediterranean diet, which is already recommended in cardiology association guidelines. In the study, women with middle and high adherence to the Mediterranean diet had significantly lower all-cause mortality rates (-16% and -23%) compared to women with low adherence. Effects on small molecular metabolites and inflammatory biomarkers were most helpful, accounting for 14.8% and 13% of risk reductions.

• Study Clears CAC/Exercise Connection: A JAMA study found no association between high volumes of physical activity and excessive buildup of coronary artery calcium. Previous research suggested a link between exercise and CAC, so researchers acquired CT-based CAC measurements from 8.8k healthy people who met criteria for high physical activity (vigorous exercise 5 hours/week). They found no association between physical activity and progression to clinically significant CAC, so go ahead and keep working out.

• Hospital Performance Gap: Kaufman Hall’s latest Flash Report revealed that hospital operating margins ticked up to 4.3% in April, breaking a three-month streak of declines. Outpatient revenue increased 10% on-year, while average length of stay dropped 4% and ED visits increased to hit pre-pandemic levels. The story beneath the surface-level margin improvements is that the performance gap continues to widen, with the best performing hospitals now seeing 28.9% margins, versus -16.1% for the worst performers (95th vs. 5th percentile).

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The Resource Wire

• Accurately Measuring Heart Rate Variability: Heart rate variability measurement and analysis involves two critical elements – the ability to accurately discern the R wave in noisy environments, and using the correct analysis method for a given application. Check out how Monebo’s Kinetic HRV ECG Algorithm excels at both of these essential tasks.

• 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!

• 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.

• FFRCT Slashes PAD + CAD Mortality: See how adding HeartFlow’s FFRCT assessments to patient workups prior to peripheral artery disease surgeries can have a massive impact on coronary artery disease outcomes, including major reductions in long term heart attack and mortality risks.

• The Bunkerhill Blueprint: Advancing an AI solution from concept to clinic used to take years, but Bunkerhill Health is closing that gap at lightning speed. See how Bunkerhill is streamlining AI training, validation, approval, and commercialization to get better AI tools into clinical practice, faster.