Michael Belkin, on the 32.3% gender pay gap among physicians (in favor of men).

Surgeries & Interventions

Abiomed’s Impella Achievements

Abiomed is celebrating a string of Impella achievements this month, including a new FDA clearance, favorable study results, and, perhaps most importantly, the final wrap-up of Impella’s post-approval studies. 

Post-Approval Studies – Since Impella’s pre-market approval in 2015, Abiomed has run five post-approval studies to satisfy the FDA’s request for additional data, following a series of studies that suggested the Impella pump was inferior to the IABP pump.

• The FDA has now accepted and closed the post-approval studies covering Impella’s use in high-risk PCI, cardiogenic shock, post-cardiotomy cardiogenic shock, and right heart failure. 

New Publication – JACC published an observational study of US claims data that linked Impella to better survival in high-risk PCI patients than the IABP device. The large scale study investigated patients who underwent nonemergent high-risk PCI with Impella (n=1,447) or IABP (n=709).

• Unadjusted in-hospital survival was higher in Impella users compared with IABP (95.3% vs. 91.0%)
• Even after adjusting for baseline clinical and procedure differences, Impella was still associated with improved survival (odds ratio: 1.55), as well as fewer cases of MI (OR: 0.29) and cardiogenic shock (OR: 0.54).  
• Stroke, bleeding requiring transfusion, and acute kidney injury were similar between groups.

FDA Clearance – To top it off, the FDA has granted 510(k) clearance to Abiomed for its Impella Low Profile Sheath, which is specifically engineered to be compatible with the Impella single-access technique. 

The Takeaway

Abiomed’s Impella device started on wobbly ground, but new data coupled with the FDA’s satisfaction should provide renewed confidence in the heart pump. 

Transformation Through Structured Reporting 

Ready to realize the benefits of cardiovascular imaging structured reporting? Check out these quick and powerful Change Healthcare videos detailing the efficiency gains provided by structured reporting and what it takes to drive adoption.

When Your Company Saves Your Life

We’re happy to share a special interview detailing how Cleerly’s CCTA AI solution allowed one of its own team members to catch and treat his asymptomatic, life-threatening atherosclerosis.

The Wire

• Predicting High-Risk ACS Patients: New findings suggest that changes in circulating hsTnT may help predict which acute coronary syndrome (ACS) patients are most at risk of cardiovascular events. The analysis (n=6,035) examined biomarker data at one and four months after ACS hospitalization. Patients whose hsTnT levels increased by 7 ng/L or more were over three times more likely to experience cardiovascular death, heart attack, stroke, or hospitalization for heart failure, compared with those whose levels remained stable. Decreases of 7 ng/L or more were associated with a 50% lower risk of CV events. 

• Medtronic’s Conduction System Pacing Approval: Medtronic received an expanded conduction system pacing indication for its SelectSecure MRI SureScan Model 3830 lead. The device, already indicated for stimulation of the His bundle, can now be also used for pacing and sensing at the left bundle branch area. In contrast to the standard biventricular pacing, CSP relies on one lead to directly stimulate the heart’s native conduction network, closely reproducing what happens naturally.

• Us2.ai Joins Aidoc’s aiOS Platform: Echo AI software company Us2.ai is joining Aidoc’s aiOS medical imaging AI platform, marking Us2.ai’s second AI platform partnership (after Blackford) and expanding Aidoc’s cardiovascular AI capabilities (joining Aidoc’s PE, DVT, aortic dissection, and aortic aneurysm solutions). The alliance continues Us2.ai’s recent momentum following its FDA and CE clearances, Series A, and global commercial launch.

• How Residents View Cardiology: A survey of 840 internal medicine residents revealed that both men and women place a high value on work-life balance – a preference that has intensified, especially for men, over the last decade. The survey also found that negative perceptions of cardiology persist, and are worsening, in male and female residents alike. The authors note that residents’ professional culture preferences are often at odds with cardiology career perceptions, which may hinder the recruitment and retention of a diverse and talented pool of applicants into cardiology.

• Gender Differences in Physician Compensation: Medscape’s latest Female Physician Compensation Report (N=13k physicians) revealed that 52% of female physicians feel unfairly compensated compared to their male counterparts. The report found that, among specialists, men earn 31% more on average (down from the 33% difference in 2021). 

• Cordis Acquires MedAlliance: Interventional CV technology company Cordis is set to acquire MedAlliance in a deal that could reach up to $1.1B over the next seven years. By acquiring MedAlliance, Cordis gains access to the Selution SLR sirolimus drug-eluting balloon, which the company will immediately begin co-promoting in European markets. 

• Cardiac CT Cardioembolism Screening: Netherlands-based researchers found that cardiac CT is a feasible first-line alternative to transthoracic echocardiography (TTE) for cardioembolism detection in acute ischemic stroke patients. The study had 452 acute ischemic stroke patients undergo ECG-gated cardiac CT and a subgroup of 350 patients undergo TTE, finding that high-risk cardioembolism sources were detected at a higher rate with cardiac CT than with TTE (11.4% vs. 4.9%), while cardiac CT achieved a higher diagnostic yield across the whole population (12.2%, 55 of 452).

• Eyenuk Scores a $26M Series A: Startup Eyenuk announced a $26M Series A funding round, bringing the company’s total backing to $43M. The funding will go toward expanding the commercial and diagnostic reach of its fully autonomous AI tool, called EyeArt (FDA-approved, CE-marked). The technology screens retinal images to detect diabetic retinopathy in under 30 seconds, with greater sensitivity than ophthalmologist exams. Eyenuk has other AI technologies in the works, including tools to assess cardiovascular risk. 

• Cardiac Biomarkers in Transgender People: A study in JAMA Cardiology found that concentration differences in cardiac biomarkers between transgender men and women who are taking gender-affirming hormones mirror differences seen between cisgender men and women. The concentration of hs-cTn was significantly higher in transgender men compared to transgender women (0.9 vs. 0.6 ng/L) and NT-proBNP levels were lower in transgender men than transgender women (17 vs. 49 ng/L), mimicing trends between cisgender men and women. 

• Milestone’s Heart Rhythm Nasal Spray: Milestone Pharmaceuticals announced that its experimental nasal-spray hit its Phase 3 trial primary endpoint, setting the company up to file for FDA approval next year. The recent study demonstrated that patients with paroxysmal supraventricular tachycardia who took the spray, which contains the calcium channel blocker etripamil, were more likely to return to a normal sinus rhythm within 30 minutes than those who took placebo (64.3% vs. 31.2%).

• Ochsner RPM Pilot Program: Ochsner Health released promising findings from its remote patient monitoring pilot that equips Medicaid patients with digital BP cuffs and glucose monitor, then provides virtual follow-ups when abnormal readings are detected. Ochsner showed that 50% of hypertensive patients and 59% of type 2 diabetes patients reached their control goals in the first few months of participation, and the health system now plans to expand the program beyond Louisiana through partnerships with employers and payors.

Us2.ai Brings Clarity to Cardiac Imaging

Learn about how Us2.ai is bringing simplicity and clarity to the world of cardiac ultrasound, on the latest episode of The Bleeding Edge of Digital Health featuring Us2.ai’s founders, James Hare and Dr. Carolyn Lam.

HeartFlow Analysis Streamlines Care

Faced with cath lab inefficiencies and an increased reliance on stress testing, Cone Health pursued a more advanced solution. See how the HeartFlow FFRct Analysis allowed Cone Health to improve the patient journey through streamlined CAD testing.