Akshay Khandelwal, MD on the pursuit of medicine.

LVAD therapy for the treatment of advanced heart failure has improved greatly in the last few years, and the recent Intermacs report gives us even deeper real-world insights into their performance. In the latest Cardiac Wire Show, we sat down with Dr. Manreet Kanwar and Dr. Francis Pagani to explore how LVADs are improving patient lifestyles even in the face of dire diagnoses.

Surgeries & Interventions

Edwards’ Evoque Might Have More Adverse Events Than Previously Known

Over a year after becoming the first FDA-approved transcatheter tricuspid valve replacement system, a new JACC study suggests Edwards Lifesciences’ Evoque TTVR system might have some risks that regulators hadn’t previously considered.

• The pivotal trial that led to Evoque’s approval back in February of 2024 demonstrated that it reduced symptoms and improved quality of life.
• However, a small cohort of patients receiving Evoque (n=267) reported a high incidence of adverse events during the trial, like severe bleeding and conduction disturbances requiring permanent pacing.

Searching for more answers about Evoque’s real world risks, researchers pulled data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database to analyze adverse event reports in the first year following the Evoque system’s approval and found that…

• 150 reports were submitted to MAUDE documenting 158 adverse events. 
• Bradycardia or high-degree atrioventricular block was the most common (n = 70), causing two deaths. 
• Following this complication, 65 patients required permanent pacemaker implantation.
• Evoque leaflet thickening or thrombus was also identified in 20 patients.
• Cardiac tamponade (fluid build-up around the heart) was reported in eight patients while venous injury or bleeding occurred in another eight patients.

But the troubles don’t end with the device itself, as the implantation procedure also showed fatal complications like device malposition, migration, or embolization that occurred in 33 patients and caused six deaths. 

• Mechanical failure of the delivery catheter was also reported in four patients, all due to nose cone separation. 
• It’s worth noting that Edwards has reported this complication in only one case to date, and laboratory simulations have failed to replicate the event.

Researchers also made it clear that their study has some important limitations…

• It’s unknown exactly how many patients have received the Evoque, so there’s no denominator to compare these ADEs to. 
• Causality is also impossible to determine due to a lack of on-site evaluation, and reports reflect submission time without accounting for later clinical events. 
• Additionally, the FDA’s voluntary reporting system introduces biases like underreporting or selective reporting of severe cases.

The Takeaway

If you only evaluated an interventional device based solely on reports from the MAUDE database, it’s bound to seem risky. That said, there are still some unanswered questions about how these complications weren’t picked up on by regulators earlier, and physicians should consider the risks moving forward when selecting patients for TTVR with Evoque.

How Vista AI Helps Solve the Technologist Shortage

Fewer than 2% of MRI scanners are routinely used for cardiac imaging—mainly due to a shortage of trained technologists amid rising demand. Vista AI addresses this challenge by automating CMR scanning, empowering technologists of all experience levels to deliver high-quality cardiac exams consistently and efficiently.

Addressing Coronary Artery Disease

Learn how the AGENT™ Drug-Coated Balloon provides a new treatment option for in-stent restenosis in the U.S. Rx Only. (Sponsored by Boston Scientific)

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.

The Wire

• CMR for Sarcoidosis: Cardiovascular MRI phenotyping could be more accurate than cardiovascular societal recommendations for patients with suspected cardiac sarcoidosis. Researchers examined 1.5k patients and found that patients who had the high-risk CMR phenotype faced higher 5- and 10-year incidences of fatal or life-threatening ventricular arrhythmias (24% and 35%, respectively) compared with those who met societal recommendations. Additionally, CMR phenotyping had the highest adjusted subdistribution hazard ratio (19.8) for ventricular arrhythmias.

• DESKi Raises $6M for Heart AI: French cardiac AI software developer DESKi closed a $6M seed round to support the global launch of its HeartFocus echocardiography AI software. In April DESKi received 510(k) clearance for the solution, which guides healthcare professionals to perform echo exams with just a few hours of training. The new funding will be used for both U.S. and international market launches.

• Philips Recalls Angio System: Philips began a recall of its popular Azurion angiography system due to a software issue that caused a loss of communication between system software and the X-ray generator’s firmware. An FDA notification clarifies that the problem could cause a loss of imaging functionality, and lists corrective actions that should be taken by Azurion users. Philips is working to address the issue through a software update.

• Losing Sleep = Tired Heart: A new study from connected health company Withings revealed that Americans lost an average of 120 nights of sleep over five years, with significant impacts on their longevity and CV health. Withings researchers examined 550k US-based individuals and found that people who slept less had elevated cardiovascular risk and higher weight. Meanwhile people with the lowest cardiovascular mortality risk slept 27.6 minutes more per night.

• CMR Improves MINOCA Diagnosis: Researchers think CMR might improve diagnosis and treatment for myocardial infarction with non-obstructive coronary arteries (MINOCA). Among 320 MINOCA patients, CMR was associated with a change in diagnosis and/or management in 63% of patients and significantly increased diagnostic certainty (8/10 post-CMR vs. 6/10 pre-CMR). In individuals who were initially prescribed DAPT despite no obstructive culprit lesion, CMR greatly reduced the number of unnecessary DAPT prescriptions.

• Forever Chemicals Bad for Baby BP: Prenatal exposure to forever chemicals like PFAS could influence offspring blood pressure, and may lead to intergenerational, long‐term, and latent hypertensive effects. Researchers analyzed 13.4k patients from the Boston Birth Cohort and found that those exposed to forever chemicals in the womb tended to be in a higher systolic BP percentile. In male children, each doubling of forever chemical exposure was associated with a 9% higher risk of elevated BP at ages 6 to 12 years and a 17% higher risk at 13 to 18 years.

• AFib’s Circadian Rhythm: Researchers may have uncovered the circadian patterns of AFib and their impact on an individual’s AFib progression. A post-hoc analysis of the LOOP study identified a total of 41.7k AFib episodes lasting at least six minutes and found that the most frequent onset hour was 9 am. Meanwhile, night-time AFib episodes ( 10 pm–7 am) lasted twice as long (28 vs. 14 minutes) and had a slower ventricular rate ( 75 vs. 85 bpm) compared to daytime episodes.

• Exercise cTn Doesn’t Impact Atherosclerosis: New research suggests the prevalence and magnitude of coronary atherosclerosis isn’t different between recreational athletes with high versus low postexercise cardiac troponin concentrations. Analysis of pre- and postexercise concentrations of hs-cTnT among 1,000 older athletes found that coronary atherosclerosis did not differ between high and low cTn responders. Researchers suggest this means variations in exercise-induced cTn elevations doesn’t lead to occult coronary atherosclerosis.

• FDA Clears Inquis’ Aventus: Inquis Medical received FDA clearance for its Aventus Thrombectomy System as a pulmonary embolism treatment, following its approval for removing peripheral clots. The Aventus Thrombectomy System works by using integrated tissue-sensing technology for precision removal of large clot burdens while streamlining blood return and reducing procedural complexity. The FDA’s decision stems from Inquis’ IDE study that found the Aventus system considerably improved right heart strain and showed no device-related major ADEs.

• AutocathFFR Cleared in Japan: MedHub-AI received PMDA approval in Japan for its AutocathFFR software that uses AI to non-invasively evaluate coronary physiology. AutocathFFR calculates fractional flow reserve values directly from standard X-ray coronary angiograms without guidewires or vasodilatory agents. The software’s PMDA approval is supported by MedHub-AI’s pivotal study across six hospitals in the U.S. and Israel that demonstrated a sensitivity of 90.2%, specificity of 94.9%, and overall diagnostic accuracy of 93.7%. AutocathFFR’s FDA decision is still pending.

• NDD for Uncommon TAVR Access: Good news for more complicated TAVR cases, next-day discharge is still safe and effective when the procedure requires alternative vascular access. A recent EuroIntervention study tracked data from 85 patients who underwent TAVR with alternative access (transapical, subclavian/axillary, and carotid) and found no significant differences in outcomes after 30 days, whether the patients were discharged the next day or after 48 hours. In addition, the study’s mortality rate was 0% after 30 days.

Optum’s CV Imaging Pearls

As populations age, the increasing prevalence of cardiovascular disease means that pressure is mounting for healthcare providers. Watch Optum Insight enterprise imaging CEO Tracy Byers and Chief Product Officer Omer Shalit-Cohen discuss the important role enterprise imaging plays in cardiovascular imaging.

Heartflow Roadmap Analysis For Efficient Care

As Coronary CT scan volumes increase, your entire reading team needs to deliver efficient and consistent reads. Good thing Heartflow’s Roadmap Analysis can help you maintain accuracy and increase CCTA read speeds by up to 25%, with even level 3 readers seeing real efficiency benefits.

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

The Resource Wire

• 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.

• Revolutionize Your Cardiac CT Workflow — See It LIVE at SCCT 2025! Be among the first to experience next-gen CV imaging at Booth #315 during SCCT 2025. Sign up now to find out how Circle CVI’s software enables lightning-fast LAAC, TAVR, and TMVR workflows while providing more accurate heart function insights, and clinician-controlled plaque quantification.

• 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.

• Precision QRS Detection: QRS detection is essential for any ECG algorithm, and Monebo’s Kinetic QRS ECG Algorithm sets the standard for accuracy. Kinetic QRS accurately detects the QRS complex, no matter the amplitude, waveform, or noise levels.

• 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

• Cut Waste with GE HealthCare’s Inventory Management: Want to make your hospital’s inventory practices more efficient? Tune in to this webinar on how GE HealthCare’s data-driven insights can optimize inventory management and reduce cardiac procedure times by 30-45 minutes.

• Merge Hemo Expands to Puerto Rico: Merge partnered with Alpha Biomedical to bring Merge Hemo to Puerto Rico, marking the software’s first expansion outside the 50 U.S. states. Read more about the work Merge is doing to expand access to its award winning solutions beyond the United States.

The Industry Wire

1. AI and mobile devices dominate spring healthcare shows.
2. Insurer coalition will fight Trump’s big budget bill. 
3. Health systems launch new physician residency programs.
4. What are the top specialty pharma companies by revenue?
5. Over 41k older Americans died of falls in 2023.
6. Federal judge okays removing GLP-1s from drug shortage list.
7. FDA approves next best thing to an HIV vaccine.
8. FDA’s top cell and gene therapy regulator forced out. 
9. Sweetened drinks are linked to dementia risk. 
10. What healthcare workers use generative AI the most?