Two abstracts about unapproved heart technology retracted

A group of heart researchers have lost two meeting abstracts after, according to one of the authors, companies said the data were proprietary and couldn’t be published. But it’s not clear the companies did so.

The studies appeared in the journal Heart Rhythm, the official journal of the Heart Rhythm Society, and were presented at the group’s 2021 annual meeting. 

The first author on both abstracts was Andrea Natale, a cardiac electrophysiologist at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin. We wrote about Natale in 2016, after the researcher lost a paper in the Journal of the American College of Cardiology – again based on work he presented at the Heart Rhythm Society conference about which he raised concerns over industry meddling. (Natale disputes that he was the first author on the now-retracted posters, for reasons that aren’t clear to us.)

Both studies involve a technology called pulse field ablation. Medtronic developed one version of the technology, and Farapulse, which is now owned by Boston Scientific, developed another. The systems are not yet approved for marketing in the United States.  

Natale told us that the data from the studies came from patients treated with both companies’ systems. But Laura Aumann, a spokesperson for Boston Scientific, told us that her company’s data were not part of the studies and that it had not demanded retraction.  

Medtronic did not respond to a request for comment.

The notices for the studies – “Esophageal Temperature Monitoring During Atrial Fibrillation Ablation With the Pulsed Field Ablation System,” and “Cerebral Microembolic Signal Burden During pulsed Filed [sic] Ablation: Preliminary Results from Robotically Assisted Transcranial Doppler” – are identical: 

The authors inadvertently specified some ablation settings in the methods section that should not have been reported because they can be potentially linked to a specific pulsed field ablation technology that is currently under investigation for FDA approval. The Authors apologize for the inconvenience caused by this oversight.

Lori Monteleone, a spokesperson for the Heart Rhythm Society, told us: 

The Heart Rhythm Society was contacted by Dr. Natale with a request to withdraw 2 abstracts that were presented at our annual meeting (Heart Rhythm 2021).  Dr. Natale cited the reason that is noted in the retraction.

The abstracts were removed from the Society meeting site, and because all meeting abstracts are published in the journal, a formal retraction was required.

Natale was fatalistic when asked if he agreed with the retractions and the inability of his group to report the findings: 

No but in a trial they own the data.

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