Rakan I. Nazer, MD

Structural Heart

Why Mechanical AVR Valves Still Matter

A presentation at this year’s Society of Thoracic Surgeons (STS) conference suggests mechanical valves might lead to better survival compared to bioprosthetic valves in patients aged 60 or younger undergoing SAVR even though it seems like they’re going out of style.

• Mechanical SAVR valves have been around in one form or another since the 1960s, but have fallen out of favor in recent years.
• Previous analyses suggested mechanical valves have advantages over tissue valves in middle-aged patients, but lifelong anticoagulation requirements makes them a hard sell. 

Researchers examined STS registry data on ~109k patients ages 40 to 75 years who received isolated bioprosthetic (94k) or mechanical (15k) AVR over 11 years and found that mechanical valve use decreased by about half (from 20% in 2008 to below 10% in 2019).

Despite the declining use of mechanical AVR, its benefits were clear over the study’s median 5.4 year follow-up, with patients aged 40-59 seeing the most significant mortality benefits.

• Patients aged 40-49 had a 31% lower all-cause mortality risk when receiving mechanical AVR compared to bioprosthetic.
• For patients aged 50-59, the benefit was less dramatic, but still significant coming in at a 13% lower all-cause mortality risk.

While these mortality risks might seem convincing, there are several caveats to keep in mind, including the significant differences in patient characteristics between mechanical and bioprosthetic recipients.

• Patients receiving bioprosthetic valves tended to be older (65.2 vs 55.7 years).
• They also often had lower BMI (31.0 vs 32.2 kg/m2).
• Bioprosthetic patients also had higher rates of hypertension (78.7% vs 71.8%) or prior PCI (6.7 vs 3.7%).
• However, bioprosthetic recipients had severe aortic insufficiency less often (15.3% vs 23.6%).

The study’s design also wasn’t powered to make any certain conclusions due to its reliance on registry data, meaning a randomized head-to-head trial would be needed to confirm these outcomes.

The Takeaway

When it comes to AVR, it’s pretty clear that it’s not a “one-valve fits all” type of situation, especially in the case of mechanical valves. While the data is still less-than-certain, this presentation suggests that there could be benefits to keeping mechanical AVR on the table, at least for healthier patients under 60.

Transforming Ischemia Detection

CCTA AI is poised to transform ischemia detection, leading to far greater diagnostic efficiencies and far fewer unnecessary invasive procedures. See how ischemia’s AI transformation is unfolding in this Cardiac Wire Show interview with Cleerly’s chief medical officer James Earls, MD.

Innovating AFib Care

The first manifestation of AFib is often stroke, but many hospitals aren’t set up to coordinate these patients’ post-stroke care. See how UCSD is leveraging Viz.ai’s Viz Connect solution to simplify neuro and EP collaboration in this HRX 2024 interview.

Optum’s Cloud ROI E-book

Learn how to measure costs, define your ROI, and what to look for in a potential vendor when moving your enterprise medical imaging to the cloud. Check out Optum’s e-book now!

The Wire

• Neko Nabs New Funds: Spotify founder Daniel Ek’s full-body scan startup Neko Health secured $260M in Series B funding (total funds: $325M) to fuel the global expansion of its Neko Health Scan that examines the whole body for several disease markers including stroke and MI. With a strong track record of 10k scans conducted and a 100k person waitlist, Neko has earmarked the new funds for expanding to the U.S. while ramping up R&D efforts for diagnostic and preventive tools. 

• Driving After STEMI: Driving guidelines following STEMI might be outdated following encouraging results from the DRIVE-STEMI study. Examining ~29k patients across several databases, researchers found that in the year following a STEMI, only 11% of patients experienced a “sudden cardiac incapacitation” primary endpoint (cardiac arrest, stroke, MI, etc.) and the majority of these events occurred within 15 days of the procedure. Based on these results, researchers suggest the ideal driving-restriction time could be between two weeks and one month depending on the patient. 

• FDA Clears Bunkerhill AVC: Bunkerhill Health achieved FDA clearance for its Bunkerhill AVC AI solution that detects and quantifies aortic valve calcification from non-gated, non-contrast chest CTs performed for routine non-cardiac exams (e.g. accidents). BunkerHill AVC is the first FDA-cleared algorithm of its kind, and follows the company’s iCAC solution for opportunistically screening chest CTs for signs of coronary artery calcium.

• Sometimes Aspirin’s Alright: New JAMA research suggests the ACC/AHA guidelines that removed aspirin as a primary prevention in patients at lower risk of ASCVD may have had a bigger impact than intended. Researchers examined 18k patients from the NHANES survey and found that aspirin use declined by 6.3% following the 2019 guideline update. In most subgroups, the decline was appropriate, but in patients with an ASCVD risk ≥10% (a group eligible for aspirin) use declined from 33.6% to 27.8%. 

• AI Improves Cardiac MRIs: Cardiac MRI is a powerful imaging tool for assessing heart function, but it’s difficult and time-consuming to perform – could AI be the answer? A recent study compared Siemens Healthineers’ myExam technology to manual cardiac MR planning and found that the software led to a lower procedural error rate (0.45 vs. 1.13), a higher error-free exam rate (71% vs. 45%), and shorter free-breathing studies (30 vs. 37 minutes), while reducing the error gap between more and less experienced technologists. 

• Meril’s Myval Shows Merit: New subanalysis of the LANDMARK trial suggests Meril Life Sciences’ balloon-expandable Myval THV is noninferior to Medtronic and Edwards’ TAVR valves. LANDMARK compared 768 low-risk patients undergoing transfemoral TAVR for severe AS who received either a Myval (Meril), Evolut (Medtronic), or Sapien valve (Edwards) and found that technical success rates were 96.3%, 94.7% and 98.9%, respectively. Meanwhile, 24.7% of Myval patients experienced complications compared to 30% of Evolut and 24.1% of Sapien patients. 

• LVAD Robo-Implantation: Notching a historic win for robotic surgery, a team at KFSHRC in Saudi Arabia successfully performed the first robotic-assisted implant of Abbott’s HeartMate 3 LVAD on a 35-year-old patient hospitalized for 120 days with advanced HF with kidney and lung deterioration symptoms. Thanks to the robotic method, the patient’s recovery should be much shorter than typical LVAD implantations for advanced HF, with surgeons estimating a 10 day discharge as opposed to usual multiple week recovery. 

• CrossFAST’s First Commercial Cases: Vantis Vascular announced the first commercial use of its CrossFAST Integrated Microcatheter Advanced Delivery System in a series of ten successful complex high-risk coronary interventional procedures (CHiP). The device achieved 100% success with reliable target location delivery, successful stent delivery, and no device-related complications. CrossFAST also showed superior deliverability during several CHiP cases where a traditional guide extension catheter failed to reach the target lesion and was swapped out for Vantis’ device.

• Women’s Virtual CV Care: Systole Health, a virtual care startup for women’s heart health, announced $2M in pre-seed funding to drive U.S. expansion and health system partnerships while building its clinical team. As part of Systole’s program, women at risk for heart disease meet with a doctor and health coach to receive personalized advice, medical care, and a supportive community through hour-long virtual appointments. 

• Hybrid Prosthesis for ADTI: Providing hope for one of the deadliest types of cardiac emergency, Artivion unveiled late-breaking data from the first year of its PERSEVERE IDE clinical trial that explored the effectiveness of aortic arch hybrid prosthesis for treating acute DeBakey Type I dissection using its AMDS device. Data from the trial’s 93 patient cohort showed 80% survived 1-year after AMDS implantation and faced lower risks of new strokes (11.8%), renal failures (20.4%), or MI (2.2%) compared to control data. 

• Neck Photos and Nicotine: A smartphone app could tell you how much vaping impacts your heart health thanks to Huntington Medical Research Institutes’ new way of measuring carotid waveforms. HMRI’s recent study used smartphones to image the neck and an algorithm to extract vessel wall dilation data from skin vibrations, which mirror pressure waveforms in large arteries like the carotid. Using this method, researchers confirmed that nicotine vapes negatively impacted vascular function and left ventricle-arterial coupling ­while accelerating aging of the vascular system.

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. 

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)

Connecting the ECG Monitoring Ecosystem

There’s so much that goes into building the solutions that providers use each week, and that’s definitely true for ECG monitoring. In this Cardiac Wire Show interview with Flipside Media’s president Brad Ummer, we get an insider’s view of what it takes to develop an ECG monitoring solution, including Flipside’s partnership with Monebo Technologies.

The Resource Wire

• Streamlining Cath Lab Hemodynamic Workflows: Is your hemodynamic solution keeping your cath lab efficient? Merge Hemo is a cath lab hemodynamic monitoring solution, providing a Best in KLAS user experience, while enhancing clinical workflows, automating data collection, and streamlining inventory management.

• 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!

• AI-Echo for Cardiac Amyloidosis: Despite advancements in cardiac imaging, cardiac amyloidosis remains significantly underrecognized and underdiagnosed. Discover how Us2.ai’s deep learning diagnostic algorithm uses echocardiography and apical 4-chamber DICOM images to detect CA.

• Automated and Intelligent EP Reporting: EP ablation procedures are difficult, but your EP reporting process shouldn’t be. See how GE HealthCare’s Centricity EP Structured Reporting allows for quick, accurate, and complete reporting in as few steps as possible.

• A New Era of Precision and Efficiency: Ready to enhance your cardiovascular imaging precision and efficiency? See how Circle Cardiovascular Imaging’s new cvi42 6.1 platform is bringing CT and MR imaging under a single platform.

• 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.

• 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 Industry Wire

1. CIA now believes COVID originated from lab leak, China disagrees.
2. Trump federal grant freeze halted by judge. 
3. Everything you need to know about HIPAA’s big security update.
4. Trump taps new FDA, NIH, and CMS leaders.
5. UNC and Duke to build NC’s first freestanding children’s hospital.
6. How payors are charging providers for claim appeals.
7. Trump fires 15 inspector generals, including HHS.
8. NM awards $40.6M to 26 rural care organizations.
9. Union to pay HCA’s Riverside Community Hospital for unlawful strike.
10. PA law voids noncompetes when a physician is dismissed.