Adam Cifu, MD quoting one of his patient’s experiences.

Surgeries & Interventions

TAVR Long Term Outcomes Trump Surgery

A new JACC study highlighted the long term benefits of TAVR using the Evolut valve (Medtronic) compared to surgical AVR when it comes to avoiding bioprosthetic valve dysfunction (BVD).

• Now over 20 years since the first TAVR, the method is an established alternative to surgery in patients with symptomatic severe AS, regardless of surgical risk.
• However, while both TAVR and SAVR have their benefits in certain populations, few studies compare long-term valve stability between the two.

Pitting data from the two techniques head-to-head, researchers examined 5.6k patients from the US High Risk Pivotal and SURTAVI randomized controlled trials, finding that TAVR patients experienced significantly lower rates of BVD over the study’s five year follow-up.

• Only 9.7% of patients undergoing TAVR with the Evolut valve experienced BVD, compared to 15.3% of surgical patients. 

Even though prosthetic valves can be replaced, valve dysfunction is still important to keep top of mind considering  the long-term survivability and quality-of-life impacts patients face following valve implantation.

• In the case of this study, patients who experienced BVD faced a 49% greater all-cause mortality risk, 76% greater CV mortality risk, and 48% higher hospitalization rates.

Although TAVR’s benefits are pretty clear, there’s a catch – the study’s patient population consisted of mostly older patients (mean age 82), which could skew results away from surgery and toward TAVR.

• The study’s data analysis also included 3,262 patients from non-randomized controlled trials, which is well over half (58%) of the study population.
• Without built-in control and randomization, this patient data could also cast doubt on the impressive benefits seen.

The Takeaway

While it’s not a definitive slam dunk, the results of this data analysis study do support the trend that older AS patients certainly benefit more from non-invasive TAVR over the riskier surgical approach.

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The Wire

• Small Pacemakers, Big Impact: Medtronic’s pediatric implantable pulse generator pacemakers for infants just proved both safe and effective according to a study in Circulation. Researchers examined data from 29 infant patients who received the pediatric pacemakers at 12 different U.S. hospitals, and found that they were safe for all patients and remained stable for an average of 325 days. Though still an early study, the low complication rate suggests the device could become a new avenue for treating some of the most fragile patients.

• AS Outcomes Vary: We already know about the dangers of aortic stenosis (AS), but a new study in JACC reveals not all forms are created equal. Researchers examined 3.4k patients from the CURRENT AS study and found that those with low-gradient forms of AS paired with reduced LVEF and paradoxical low flow faced significantly higher risk of death or HF hospitalization (HRs: 1.83 & 1.43) compared to patients with high gradient AS.

• Residual Congestion & AHF Risks: New data analysis from the RELAX-AHF-2 trial suggests residual congestion after acute heart failure hospitalization could lead to worse outcomes than previously thought. Among 5.9k AHF patients in the analysis, 57.3% had at least one sign of congestion and 18.1% had over three signs of congestion five days after admission, leading to a 32% and 62% higher composite risk of CV death and rehospitalization for the two groups compared to patients without residual congestion.

• AI Echo Automates Thoracic Measurements: Good news for busy cardiologists, Us2.ai’s AI echo algorithm can accurately automate thoracic measurements acquired to detect signs of aortic dilation in patients with aortic stenosis. A JASE study used Us2.ai’s solution in 306 adults undergoing TTE scans, finding that AI-generated measurements had good agreement with expert cardiologists for various parameters including left ventricular outflow tract, sinuses of Valsalva, sinotubular junction, and proximal ascending aorta.

• Pi-Cardia’s ShortCut Commercial Cases: Pi-Cardia announced that its ShortCut leaflet modification device has been successfully used in the first commercial patients for valve-in-valve TAVRs since its FDA approval in September 2024. ShortCut is used to split valve leaflets for patients who face an increased risk of coronary obstruction. Using the device, doctors are now able to safely split both the right coronary cusp and left coronary cusp leaflets with full control, enabling safer TAVR.

• FDA Approves Corcym SAVR Upgrade: Corcym received FDA approval for a new version of its Perceval Plus surgical aortic heart valve that integrates the company’s advanced LANCELOT features. The upgraded Perceval Plus with LANCELOT surgical heart valve  features a sutureless, collapsible frame for simpler implantation and faster recovery post-surgery, as well as two key new details: laser-cut leaflets and thread holes designed to improve consistency, and a zero-pressure fixation process that reduces stress on the leaflets.

• BSCI’s SCGC Succeeds: A JACC study examining Boston Scientific’s Self-Centering Guide Catheter (SCGC) confirmed the experimental device helps with retrograde crossing of severely stenotic aortic valves during TAVR. The SCGC device uses a self-centering basket with a cone-shaped nitinol frame, polytetrafluoroethylene covering, and silicone coating to help guidewires cross the AV into the left ventricle. This first-in-human early feasibility study included 20 patients with severe aortic stenosis undergoing TAVR with assistance from the SCGC and resulted in a 100% success rate with no adverse events. 

• MedLumics’ PFA Visualization: Making real-time lesion visualization reality, MedLumics announced the results of the first-in-human study of its AblaView Pulsed Field Ablation System for patients with AFib. The top three results of the study were: (1) The use of the AblaView system fiber optic proved both safe and reliable for assessing treated versus untreated tissue is safe and reliable. (2) The device did not lead to any hemolysis or neurovascular complications. (3) AblaView achieved durable lesion prediction with 100% specificity.

• COVID Anticoagulation Discrepancies: Registry data published in JAHA uncovered that prophylactic anticoagulation guidelines for patients hospitalized with SARS-CoV-2 infection weren’t closely followed during the pandemic. Researchers examined data on 27k individuals hospitalized for COVID-19 and found that anticoagulation was not given to 16% of patients indicated for treatment. Rates of anticoagulation across hospitals in the registry ranged from 0 to 98%, highlighting a vast disparity in guideline adherence.

• Philips’ Tack Market Removal: The FDA announced another recall, and this time it’s Philips’ Tack Endovascular System that’s being pulled from the market due to significant patient safety concerns and 20 reports of injuries. Philips will no longer sell the Tack system and is urging interventional cardiologists to stop using it immediately due to serious adverse health consequences including occlusion, dissection, perforation, and restenosis which could all lead to grave injuries or death. 

• First Ever Robotic TMVR: A team in Chile performed the world’s first robotic-assisted transcatheter mitral valve replacement using Capstan Medical’s robotic-enabled technologies. While Capstan’s robotic-enabled transcatheter technology is still under development, it’s unique compared to other surgical robots since its cardiac offerings are designed to be used for minimally invasive procedures, not full surgeries. The successful application of Capstan’s tech follows the company’s $110M Series C funding in December of 2024.

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The Resource Wire

• 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.

• Uncover Cleerly’s Clinical Success: Interested in learning more about the science behind Cleerly’s suite of medical technologies that are revolutionizing cardiac imaging? Read here for all of Cleerly’s recently published clinical studies. 

• 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!

• Automating and Simplifying CMR Imaging: Watch Vista.ai’s demo on how their intelligent software automates and simplifies image acquisition so all technologists can perform a CMR scan with quality, consistency, and efficiency, increasing throughput and improving patient access.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

• A Universal View of Your Patient: Think you’re getting the most out of your viewer? See how GE HealthCare’s Centricity Cardio Enterprise Universal Viewer allows you to quickly review exams, access and compare prior studies, and perform measurements in this 60-second video.

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The Industry Wire

1. CMS rescinds Medicaid’s health-related social needs guidance. 
2. Ownership of HHS and CMS headquarters stuck in limbo. 
3. CVS terminates ACO REACH contracts, sells MSSP business to Wellvana. 
4. HHS workers offered early retirement as high-ranking officials resign. 
5. How health systems are faring in a high-cost environment.
6. Measles Outbreak: Cases In Texas Near 200. 
7. Fewer attendees, more focus on AI at HIMSS 2025.
8. Walgreens to be taken private for $10B. 
9. Bird flu spread is slowing down.
10. Cano Health CEO steps down.