Vivek Reddy, MD on PFA technology.

Cardiology Business

Biosense Webster’s PFA Milestone

J&J’s Biosense Webster subsidiary is making strides toward the completion of its pulsed field ablation (PFA) clinical trial, joining competitors Medtronic and Boston Scientific in the race for FDA approval. 

PFA devices deliver short electrical pulses to scar tissue in the heart and interrupt irregular electrical pathways that cause AFib. The new approach has gained attention among electrophysiologists because it causes less tissue damage than the current standard ablation procedures.  

The analysis, dubbed inspIRE, evaluated Biosense Webster’s PFA system among 226 patients with drug-refractory paroxysmal AFib (40 in wave I and 186 in wave II).

Here are key findings from during the procedure:  

• Entrance block was achieved in 100% of patients.
• PVI without reconnection was achieved in 96-97% of target veins. 
• Mean procedure time declined from 82.4 minutes in wave I to 70.1 minutes in wave II. 

At one year, the researchers found: 

• 71% of patients experienced no atrial arrhythmia (above the performance goal of 50%)
• 0% of patients experienced procedure-related safety events 

The Takeaway

Pulsed field ablation has had tremendous commercial success in Europe, and now medtech companies are vying to establish their product as effective and be the first to the US market. Biosense Webster’s inspIRE trial was the latest of the three companies to report clinical trial progress and suggests that PFA FDA approval is on the horizon.

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The Wire

• Abbott Acquires CSI for $890M: Abbott plans to acquire medical device company Cardiovascular Systems Inc. (CSI) in a $890M deal that will expand Abbott’s existing cardiovascular disease solutions. Abbott already manufactures a variety of stents, catheters, and imaging systems used to remove arterial plaque build-up. Now the medtech giant will add CSI’s existing guidewires, catheters, and atherectomy devices, as well as a line of minimally invasive blood clot-removal technologies currently under development. 

• Characterizing Vericiguat-Eligible Patients: Data from a large U.S. registry of hospitalized HFrEF patients found that 90% of patients are potential candidates for the newly approved vericiguat drug (Merck Sharp & Dohme/Bayer). Among Medicare beneficiaries eligible for vericiguat, researchers found high rates for 12-month mortality (36-37%), HF hospitalization (33-35%), all-cause hospitalization (64-66%), and mean health care expenditure (about $25k). 

• AI Algorithm Boom: Here’s a cool overview of the growth of FDA cleared AI medical algorithms since the first one was approved in 1995. More than half of the 520 currently cleared algorithms were approved between 2019 and 2022, with most of that stemming from radiology. However, cardiology AI apps were among the most prevalent after radiology.

• Tioga Cardiovascular’s Series C: Tioga Cardiovascular, a portfolio company of Shifamed, raised $30M in Series C financing. Tioga is working to develop a novel, low-profile device for transseptal mitral valve replacement (TMVR) that is adaptable and easy to deliver. The company plans to use the Series C funding to continue product development, support pre-clinical testing, and initiate first-in-human use. 

• Sports-Related Cardiac Arrest: Cardiac arrest awareness has increased following NFL player Damar Hamlin’s recent mid-game collapse. A new study in JACC found that for older adults, there is an extremely low chance that participating in sports will trigger sudden cardiac arrest (SCA). Of 4,078 SCA events in people over 65, only 1.9% were sports-related. People who experienced sports-related SCA were also four-times more likely to survive. The takeaway? The benefits of exercise outweigh the risk of cardiac arrest. 

• Forxiga’s Expanded European HF Approval: The European Commission has expanded the indication for AstraZeneca’s Forxiga, also called dapagliflozin, to include heart failure for people with mildly reduced and preserved ejection fraction. The committee’s decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.

• Automated EAT Measurements Improve CV Risk Prediction: A deep learning model that quantifies epicardial adipose tissue (EAT)–fat on the surface of the myocardium–measured via routine coronary CTAs improved CV risk predictions. The authors trained and validated the model using 3.7k coronary CTAs. When applied to CCTAs from 253 cardiac surgery patients and 1,558 SCOT-HEART trial patients, it yielded an impressive machine vs. human concordance correlation coefficient of 0.97. The authors found that EAT volume was associated with CAD (OR: 1.13), and AFib (OR: 1.25). 

• Left Atrial Strain & Stroke: A new study suggests that reduced left atrial strain (LAS) and left atrial strain rate (LASR) are independently associated with ischemic stroke risk, and may improve stroke risk stratification in older adults. In the study, researchers followed 806 healthy, older adults for 11 years, with 53 participants (7%) experiencing new-onset stroke. Reduced LAS and LASR were independently associated with new ischemic stroke, even after adjusting for left atrial volumes, LV global longitudinal strain, and incident AFib.

• Patient Information Retention: Patients’ perceptions of how well they can retain care information differs drastically from how well they actually retain it. That’s according to a new 53 participant study in the Joint Commission Journal on Quality and Patient Safety, which found that while over 90% of patients felt confident in their knowledge of their treatment plan, fewer patients were able to correctly recall their diagnosis (58.5%), inpatient treatment (64.2%), post discharge plans (50.9%), and medication changes (43.4%).

• Nurse Understaffing Impact: A Michigan Nurses Association survey revealed that nurse understaffing is becoming more deadly for patients, with 42% of nurses reporting knowledge of a patient death caused by nurses being assigned too many patients (up from 22% in 2016). Among 400 nurses surveyed, 25% are assigned unsafe patient loads almost every shift (up from 7% in 2016), and over 90% support the Safe Patient Care Act to limit the number of patients a hospital nurse can be assigned.

• Stroke AI, Ideally Required: Stroke AI vendors celebrated their inclusion in the AHA’s new “ideal foundational requirements” for stroke programs, which specifically call for the “use of advanced neuroimaging with AI” at acute stroke-ready hospitals (among other non-AI recommendations). The scientific statement was unveiled at the 2023 International Stroke Conference, where it was positioned as a “call to action for stroke centers” and a contributor to future stroke care guidelines.

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