Oct 11, 2024 This Week in Cardiology Podcast

Reader feedback on cardiac devices and PFA, a new paradigm in the language of MI, sudden cardiac death, and measuring blood pressure are the topics John Mandrola, MD, discusses in this week’s podcast.
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-- TRANSCRIPT --
In This Week’s Podcast
For the week ending Oct 11, 2024, John Mandrola, MD, comments on the following news and features stories: Listener feedback on cardiac devices and pulsed field ablation (PFA) for atrial fibrillation (AF), a new paradigm in the language of myocardial infarction (MI), sudden cardiac death (SCD), and measuring blood pressure (BP).
Listener feedback on Cardiac Devices
Sep 20, 2024 This Week in Cardiology Podcast
On the Sept 20 TWIC podcast, I reported on a survey observational study from Harvard and published in the Annals of Internal Medicine. The study reported sobering results regarding cardiac device approval. The authors focused on class 1 recalls from 2013 to 2022. They noted 137 recalls involving 157 devices.
Nearly three-quarters were moderate risk devices that were approved through the softer 510k pathway. Here were the important findings:
Most studies of devices used surrogate and composite measures as primary end points, as well as being non-randomized and open label.
Only half of the premarket approval (PMA) devices required post-approval studies, with 14 reporting delays.
No 510(k) devices were subject to postmarket surveillance.
The senior author, Dr Kushal Kadakia, sent me an email summarizing the main findings, and these were that it was surprising that most cardiac devices that had class I recalls were approved through the much less rigorous 510k pathway wherein the device only has to be shown similar to previous devices.
I would add from my memory-- SentreHEART first received 510k US Food and Drug Administration (FDA) approval of its LARIAT for suture-based soft tissue approximation in June 2006. LARIAT is far more complex than a “suture-based soft tissue approximater.”
Dr Kadakia added that over half of the PMA devices were so-called "supplements," meaning that testing was not required. The reason this is important is that an ongoing GAO investigation requested by Congress is specifically focused on how the design of regulatory pathways (PMA, 510k) affects the risk of recalls; our work provides empirical evidence for these policy reforms.
The significant lack of postmarket surveillance is a sub-finding that further reinforces the need for unique device identifiers (UDIs), which Dr. Emanuel highlighted in his editorial. It is shocking to me that we do not have any standardized method of tracking devices in the real world. Proposals to advance UDIs onto claims are currently stuck in the Department of Health and Human Services bureaucracy, with the obscure advisory committee, the National Committee on Vital and Health Statistics committee, currently blocking adoption, to the detriment of patients and clinicians.
Again, my friends, be careful with new devices. Some are advances, but this paper, and this feedback, reiterates that we should not rely on our regulatory system.
Transcript in its entirety can be found by clicking here:
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