Yale cardiologist Dr. Harlan Krumholz after a new study showed that tirzepatide (Eli Lilly’s Zepbound) cuts obese patients’ blood pressure – in addition to their weight.

Surgeries & Interventions

Biosense Webster’s Varipulse PFA Data Impresses at AF Symposium

Biosense Webster might be a later entry into the AFib pulsed field ablation segment, but new trial data presented at the AF Symposium suggests that the J&J subsidiary’s Varipulse PFA system could make a big impact when it does hit the market.

Final results from Biosense Webster’s inspIRE study got most of the spotlight. The study performed Varipulse PFA on 226 people with paroxysmal AFib in Canada and Europe, finding that:

• 75.6% of patients saw no atrial arrhythmia recurrence after 12 months.
• 80% who received “optimal” PFA applications were free from atrial arrhythmia recurrence after 12 months.
• Varipulse PFA procedures required just 7.8 minutes of average fluoroscopy time, which Biosense Webster partially attributed to its CARTO 3 Mapping System.
• No patients experienced a primary adverse event.

Preliminary 12-month data from Biosense Webster’s admIRE Pilot study of 20 US patients showed similar results:

• 80% remained free from atrial arrhythmia recurrence at one year.
• 100% were able to avoid future ablations.
• Average procedure and fluoroscopy times were just 90 and 3.5 minutes.
• No patients experienced procedure or device-related primary adverse events. 

The Varipulse’s inspIRE and admIRE results were widely viewed as positive, while adding to the anticipation for the pivotal phase of its admIRE study, which enrolled over 400 patients and should play a huge role in the Varipulse’s FDA approval.

The Varipulse will have company if or when it does hit the market, noting that Medtronic and Boston Scientific’s PFA systems each gained FDA approval within the last few months, and Abbott has its own PFA system in clinical trials.

• Although we’re not supposed to compare different studies, the Varipulse might enjoy a perceived performance advantage considering that its 75.6%-80% recurrence-free results at 12 months are above results for Boston Scientific and Medtronic’s PFA systems (73% & 66%).

The Takeaway

It’s becoming increasingly clear that the pulsed field ablation era is now upon us, and these impressive (and geographically consistent) results suggest that the Varipulse will be a strong PFA competitor once it reaches the market.

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AHA Honors Stanford & Bunkerhill’s Incidental CAC Paper

Stanford University’s paper exploring how Bunkerhill’s incidental CAC algorithm increased statin use won the American Heart Association’s 2023 Willerson Award for the best clinical paper published in Circulation this year. See how Bunkerhill’s incidental CAC impacted patient care here.

ECG Data You Can Trust

Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.

The Wire

• Zepbound’s BP Potential: Adults with obesity who are treated with tirzepatide (Eli Lilly’s Zepbound) can experience substantial blood pressure reductions, in addition to weight loss. That’s from a substudy of the SURMOUNT-1 trial (n=600) that found that obese patients without type 2 diabetes who took 5, 10, and 15 mg of tirzepatide saw major declines in ambulatory 24-hour systolic blood pressure (7.4 mmHg, 10.6 mmHg, and 8.0 mmHg). The results highlight GLP-1s’ multifaceted potential for managing obesity-related cardiovascular complications.

• Biosense Webster’s Zero Fluoro Data: Biosense Webster continued its AFib ablation momentum, releasing a study showing the safety and efficacy of its FDA-approved low and zero fluoroscopy workflow. Among 208 patients from the Real AF Registry cohort, the workflow was associated with three primary adverse events and achieved Acute PV isolation with all patients, satisfying its safety and efficacy primary endpoints. The 299 patients in the Mercy Health cohort showed similar adverse event rates whether they underwent low fluoroscopy or conventional fluoroscopy procedures (0.8% vs. 0.3%).

• Merge Cardiology is Best in KLAS: Merge Cardio and Merge Hemo continued their KLAS hot streak, ranking Best in KLAS 2024 for Cardiology and Hemodynamics for the 9th and 12th years. The Merge by Merative cardiology solutions further expanded their KLAS score leads this year, with Merge Cardio scoring 82.8 (up from 82.7 last year) and Merge Hemo surging to 91.5 (from 85.7 in 2023).

• Universal CVD Risk Predictions: A new JACC paper presented a universal risk prediction model that could change future approaches to CVD prevention. The model, which includes established factors like BMI as well as cardiac biomarkers, was evaluated for predicting MACE risk in 9,138 people (609 with ASCVD). Over 20 years, there were 3,209 major cardiac events, and the model performed well predicting MACE in patients both with and without a history of ASCVD (C-statistics of 0.691 and 0.747).

• Vektor Scores $16M in Commercialization Funding: AI-based AFib ablation mapping leader Vektor Medical added $16M in Series A funding (total raised now $36M) to support the commercialization of its flagship vMap solution. The FDA-cleared vMap solution applies AI to 12-lead ECG data, providing EP teams with automated arrhythmia localization and analysis, and helping to make ablation procedures more effective and efficient.

• Amgen Enters Weight Loss Arena: The weight loss drug segment could welcome yet another pharma heavyweight, after Phase 1 results showed that Amgen’s GLP-1/GIP-agonist maridebart cafraglutide (MariTide) allowed significant weight loss with acceptable adverse events. Among 49 patients with obesity and no underlying conditions (e.g. diabetes), patients on the highest doses of MariTide (21 to 840mg) lost 14.5% of their body weight, while maintaining that weight loss for another 70 days. That’s notable given that GLP-1 patients typically regain weight after they stop treatment.

• Toku’s Retinal AI Approvals: Retina-based cardiovascular risk detection took a major step towards widespread clinical use this week, after Toku’s CLAiR AI technology platform gained regulatory approval in Europe and the United Kingdom. Toku CLAiR is an AI-based system designed to deliver real-time cardiovascular disease risk assessments using routine eye exams. CLAiR gained FDA breakthrough device designation in November and raised $8M from two optical exam heavyweights last July, but wasn’t cleared for clinical use in any major Western regions before now.

• Novo Nordisk’s Oral PCSK9 Data: Phase 2 results for Novo Nordisk’s now-discontinued oral PCSK9 inhibitor NNC0385-0434 showed solid cholesterol reduction in a new Lancet study. Among 267 patients on statins and with a baseline mean LDL of 2.7 mmol/L, cholesterol was cut by 32% to 61.8% after 12 weeks (dosage levels: 15 mg, 40 mg, and 100 mg). NNC0385-0434’s 100 mg dose achieved a similar decrease from baseline as Amgen’s injectable PCSK9i evolocumab (59.6% & 56.2%). 

• AI For Heart Care: Three in five Americans believe AI will lead to better heart care, according to a 1,000-person survey from Cleveland Clinic. Many Americans are taking a positive outlook on AI due to feature improvements they’ve already seen on their wearables, as half of respondents use at least one type of tech to monitor their health, and 53% said their wearables cause them to exercise more regularly. Clinicians on the other hand are more excited about AI’s potential to “help process data for certain studies like echocardiograms, or CT scans, or MRI.”

• Procyrion Adds to Aortix Funding: Heart failure device company Procyrion completed a $57.7M Series E funding round (total raised now $117.2M) to support its Aortix pump’s DRAIN-HF pivotal trial, manufacturability-focused R&D efforts, and commercialization prep. Procyrion’s Aortix percutaneous mechanical circulatory support device is a catheter-deployed pump placed in the descending thoracic aorta. It’s intended to treat patients with acute decompensated heart failure who remain congested despite standard medical therapy (cardiorenal syndrome or CRS).

• Eroding Attitudes About US Healthcare: Jarrard’s latest survey of 1,670 US adults found that attitudes toward the US healthcare system continue to erode. Only 21% of respondents agreed that the US healthcare system delivers good value for the cost (vs. 58% disagreed), while 22% agreed that US healthcare provides equitable care for all (vs. 57% disagreed). When asked what parties are most to blame for rising healthcare costs, payors ranked first with 47% of the vote, while hospitals came in fifth at 13%.

HeartFlow FFRCT Catches Missed Blockages

Karen Moore had always been diligent about her heart health, which is why she was concerned when she began showing symptoms of heart disease but all of her tests came back negative. See how Karen and her physician used HeartFlow FFRCT to catch a 90% blockage and place a stent in the right location, before it was too late.

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.

The Resource Wire

• Start Measuring What Matters: Looking to optimize your cardiovascular imaging services, but don’t know what to measure? Check out this Change Healthcare report for insights on how to track and evaluate your cardiovascular imaging performance, assess quality, and enhance operational efficiency. Read the full article now and start measuring what matters!

• You Can Bet on Cleerly: Cardiovascular AI leader Cleerly is one of Business Insider’s top 44 startups to bet your career on in 2024. See why their combination of mission and innovation earned them this prestigious listing.

• Relieving The Burden of Post-Processing: With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.

• Explore the Potential of Cardio AI: Explore the potential of AI-powered cardiology solutions in this on-demand TeraRecon webinar, detailing how its Cardio Suite solutions help expedite disease diagnosis, care coordination, and provide the data to support cardiac treatment decisions.

• AI-Powered Home Ultrasound: The recently published CUMIN study shows the technical feasibility of AI-POCUS in the hands of novice nurses and opens new possibilities for redefining how we approach cardiac care. Learn more on this page from Us2.ai.