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🗓️ 18 July 2025
⏱️ 32 minutes
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Finerenone, what not to consider when choosing treatment of AS, brain health after atrial fibrillation ablation, early rhythm control for AF, and Watchman reimbursement cuts are discussed by John Mandrola, MD, in this week's podcast.
This podcast is intended for healthcare professionals only.
To read a partial transcript or to comment, visit:
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I Finerenone
FDA Widens Indication of Finerenone for Heart Failure Patients
https://www.medscape.com/viewarticle/fda-widens-indication-finerenone-heart-failure-patients-2025a1000ive
II Choosing TAVI or Surgical AVR
Carbon Emission when treating AS
III Brain Lesions and Visual Migraine After Left-Sided Ablations
Post-Ablation Visual Auras a Sign of Transient Brain Injury?https://www.medscape.com/viewarticle/post-ablation-visual-auras-sign-transient-brain-injury-2025a1000iro
IV Early Rhythm Control for AF
V Watchman Cuts
CMS Reduces LAAO Value in Proposed Fee Schedule https://www.acc.org/Latest-in-Cardiology/Articles/2025/07/15/20/08/CMS-Reduces-LAAO-Value-in-Proposed-2026
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The Bob Harrington Show with the Stephen and Suzanne Weiss Dean of Weill Cornell Medicine, Robert A. Harrington, MD. https://www.medscape.com/author/bob-harrington
Questions or feedback, please contact [email protected]
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0:00.0 | You're listening to This Week in Cardiology from the heart.org, Medscape Cardiology. |
0:05.7 | This podcast is intended for health care professionals only. Any views expressed are the |
0:10.0 | presenters own and do not necessarily reflect the views of WebMD or Medscape. |
0:14.9 | Hi everyone. This is John Mandrola from the heart.org medscape cardiology, and this is this week in cardiology for July 18, 2025. |
0:24.8 | This week, Phaneranone, what not to consider when choosing the treatment of patients with AS, |
0:31.6 | brain health after AF ablation procedures, early rhythm control of atrial fibrillation, and watchman reimbursement |
0:41.0 | cuts. |
0:42.1 | First up, though, is listener feedback. |
0:44.5 | I received an email from an academic EP doctor who's involved with regulation, and he |
0:50.0 | wrote regarding my coverage of PE devices two shows back. |
0:56.9 | He wanted to clarify my thoughts on the 510K approval pathway where devices get approved by being similar to an already approved device. |
1:04.1 | I called this extremely problematic and called for the FDA to reform the 510 pathway. |
1:15.9 | But my colleague writes that it's not up to FDA to reform the program. |
1:22.7 | He writes the 510K pathway, and the rules around substantial equivalents are in federal law, |
1:25.3 | and Congress would need to change these rules. So he suggested writing our congressman. And then added, |
1:30.0 | speaking of the 510K pathway, he agrees it can be problematic, but works well for devices like |
1:36.5 | blood pressure cuffs and diagnostic catheters in which the underlying technology is well |
1:41.8 | established, but it's much harder in things like AI or machine |
1:46.3 | learning-based devices or anything that is sort of, but not completely new. He said that we spend |
1:52.5 | a lot of time on these and often focus on whether the intended use is the same, whether we have |
1:57.3 | enough bench and clinical data. And quote, substantial equivalence means we need to be assured that the device |
2:04.0 | performs as well as the predicate and that often requires clinical data. |
... |
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