Dr. Shayef Gabasha, MD on why cardiologists’ industry payments might not be as big of a deal as some might suggest.

Cardiology Policy

Cardiology’s Industry Payments Problem

Healthcare watchdogs set their sights on cardiology’s industry payments last week, revealing some key examples of how vendor payments could influence the approval and adoption of major cardiovascular technologies.

A KFF Health News exposé revealed that 10 out of the 14 members of the FDA expert advisory panel that evaluated Abbott’s TriClip G4 System received industry payments from Abbott between 2016 and 2018. 

• Those payments added up to roughly $650k, with at least three panelists each linked to over $100k in payments.
• Most payments came in the form of research funding or smaller consulting fees, the payments weren’t necessarily associated with the TriClip, and all parties assured that they maintained objectivity and followed standards.
• However, most people likely paid more attention to the fact that this panel voted 13-1 in favor of the TriClip G4, leading to its FDA approval within a few months.

Meanwhile, a JAMA paper revealed that cardiologists who received industry payments from Abiomed were far more likely to use the company’s Impella LVAD pump. Analysis of 6,398 cardiologists between 2016 and 2018 (1,871 who placed ≥1 LVAD), revealed that: 

• Cardiologists who received payments from Abiomed were far more likely to have implanted at least one Impella LVAD than cardiologists who didn’t receive payments from the company (23.2% vs. 9.5%). 
• Cardiologists who received payments from Abiomed in a given year were twice as likely to use an Impella device during that year and the following year (ARRs: 2.04 & 1.90).
• Although some CardioTwitter commenters suggested that this is a sign of questionable commercial influence, many others noted that this payment/use correlation is due to the simple fact that LVAD experts are more likely to be paid to do LVAD research and consulting than non-experts.

The Takeaway

US physicians raked in $12.13 billion in industry payments between 2013 to 2022, so these reports don’t necessarily reveal unique problems with Abbott and Abiomed, or even within cardiology. 

They do, however, highlight the fact that the physicians who are most likely to participate in expert panels or adopt cutting-edge technologies are also the most likely to be involved in industry-funded activities like research or consulting. Whether these industry-funded activities cause (or just correlate with) downstream regulatory approvals and device use is far less clear.

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The Wire

• IVUS Balloons over Angiography in Peripheral Disease: Last week brought another big win for intravascular ultrasound. Among 237 patients in the IVUS-DCB trial, IVUS-guided drug-coated balloon angioplasty showed significantly higher primary patency rates for femoropopliteal artery disease at 12 months than angiography alone (83.3% vs. 70.1%). Complex lesions particularly benefited. While IVUS has already shown superiority over angiography in coronary procedures, its better vessel sizing and visualization appears to also enhance outcomes in peripheral interventions.

• Rock Health’s Q1 2024 Recap: Rock Health’s Q1 2024 Digital Health Funding Report made it clear that we’ve now entered a new funding cycle. The first quarter saw $2.7B in digital health venture funding across 133 rounds, marking the lowest quarterly total since 2019, but the most rounds in the last six quarters. AI companies scored a leading 40% share of the funding ($1.1B across 45 deals), and unlike previous quarters Rock Health didn’t highlight cardiology-focused funding (it’s usually among the top-4 clinical indications). Check out our full writeup in Digital Health Wire for the details.

• Complete Revascularization Debatable: A registry-based study in the NEJM suggests that routinely revascularizing stenoses that aren’t related to an infarction in MI patients is unlikely to improve outcomes. In the FULL REVASC study of 1,542 MI patients who had PCI for culprit lesions, participants who also had complete FFR-guided PCI for non-culprit lesions had similar primary outcome rates (death, MI, or unplanned revascularization) as participants who had no further work (19% vs. 20.4%).

• Is Ticagrelor Alone the Ultimate-(D)APT? Results from the Ultimate-DAPT trial provided more evidence that ticagrelor monotherapy may replace conventional DAPT after PCI beyond one month. Among 3,400 patients, ticagrelor plus placebo slashed clinically relevant bleeding by half compared to ticagrelor and aspirin combo therapy (2.1% vs. 4.6%) during 2-12 months post-PCI. With other studies showing that ticagrelor alone reduces major bleeding and is non-inferior to DAPT, we may see a change in the guidelines soon.

• App Directs Patients to Statins: Web applications connected to a direct-shipping system could be effective for guiding high-cholesterol patients to check their eligibility for statins and order the medication without a traditional prescription. Among 1,196 patients in the TACTiC study with a 139.6 mg/dL average LDL-C who accessed the web app from an online advertisement, 90.1% correctly used the app to self-select for statins eligibility, and the new statin-takers went on to achieve a 35.5% LDL reduction in six months.

• Sphere-360 Shines in PFA Trial: The Sphere-360 study highlighted the effectiveness of Medtronic’s new 360-degree pulse field ablation catheter for the treatment of paroxysmal AFib. The multicenter trial showed an average of 81.8% freedom from atrial arrhythmias after one year, including 100% freedom within the optimized pulse configuration subgroup. Regarding safety and efficiency? The Medtronic Sphere-360 PFA patients had zero primary adverse events and an average treatment time of 10 minutes.

• Shorter TAVR Hospital Stays: The multinational European BENCHMARK study highlighted the effectiveness and practical benefits of using a streamlined clinical pathway for TAVR procedures. In a total of 2,388 patients, implementation of a best practice BENCHMARK pathway resulted in a shorter mean length of stay (7.7 to 5.8 days) and a reduced procedure time (47 vs. 95 minutes), with similar >99% success rates. Patient safety at 30 days was not compromised and all-cause mortality rates were similar before and after.

• The ApoC3 Inhibitor Race: The two leading ApoC3 inhibitors, Ionis Pharmaceuticals’ olezarsen and Arrowhead Pharmaceuticals’ plozasiran, each showed how they might help patients with hypertriglyceridemia at ACC24. In olezarsen’s Bridge-TIMI 73a phase IIb trial, the ASO mRNA significantly reduced triglycerides, ApoB, and non-HDL cholesterol levels, without any major safety issues. Meanwhile, plozasiran’s SHASTA-2 phase 2 study showed that the siRNA therapeutic decreased triglyceride levels and improved triglyceride-related lipoprotein parameters, while increasing LDL-C, decreasing non-HDL-C levels, and not changing ApoB levels.

• Sharp Growth in CAC Scoring: Despite all the talk of cardiology’s screening challenges at ACC, a new study presented at the conference highlighted the sharp growth in CT-based coronary artery calcium scoring. Researchers tracked 48k CAC scoring exams, finding that the number of annual exams grew from just 97 in 2008 to 10.7k in 2023, helped by a 2x jump in 2018 after CAC scoring was added to the ACC/AHA guidelines. Gender disparities also evened out during the study period, with women’s share of CAC scans growing from 39% to over 50%.

• AFib Ablation with a SMARTTOUCH: In yet another positive study for AFib catheter ablation, the SmartfIRE study reveals promising outcomes for treating paroxysmal AFib using Biosense Webster’s Dual Energy THERMOCOOL SMARTTOUCH SF Catheter.  The catheter system achieved a 100% acute procedural success rate and 87% vein isolation durability at 75 days, while completing procedures with a median energy application time of 12.8 minutes and fluoroscopy exposure of 4.2 minutes.

• Cardiology Practice Pays $9M for Table Accident: A couple was awarded $9M from a Connecticut cardiology practice for an accident that occurred in 2014 when a gamma camera table collapsed under a patient’s weight. The patient weighed 340 lb at the time of the accident and was concerned whether the table could hold his weight, but the practice staff allegedly told him that the table could support him, before it collapsed and caused permanent injuries.

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The Resource Wire

• 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. 

• Cleerly Transforms Personalized CVD Care: Cleerly is launching perhaps the first large-scale randomized imaging AI trial, as it seeks to prove that AI-guided cardiovascular care reduces heart attacks. The five year TRANSFORM trial will investigate whether CVD patients who receive treatments based on results from Cleerly’s investigational AI-based plaque staging system have better outcomes.

• The Benefits of Outsourced Post-Processing: Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.

• 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.