The FDA's recent approval of TAVR for asymptomatic aortic stenosis raises questions about trial biases and the necessity of immediate intervention. Innovative diagnostic tools, including machine learning methods to differentiate tachycardia types, are explored for their potential to enhance cardiac care. Additionally, discussions on the implications of the PRAETORIAN-XL trial highlight concerns around methodologies in device therapy, shedding light on how these factors could alter patient outcomes.
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FDA Approval of TAVR Controversial
The FDA approved TAVR for asymptomatic severe aortic stenosis based mainly on the biased EARLY TAVR trial.
The trial mainly showed reduced unplanned hospitalizations without survival benefit, raising concerns about expanding TAVR use.
insights INSIGHT
Machine Learning Sorts Tachycardia Type
Machine learning on PPG signals can distinguish between supraventricular and ventricular tachycardia origins.
This opens new possibilities for noninvasive arrhythmia diagnosis using wrist-worn devices in clinical settings.
insights INSIGHT
Stroke Risk Varies by PFO Status
Traditional risk factors strongly contribute to cryptogenic ischemic stroke in young people without PFO.
In those with PFO, non-traditional factors like migraine with aura play a larger role, indicating different stroke mechanisms.
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The FDA approval of TAVR for asymptomatic AS, digital health, subcutaneous vs transvenous ICD, and cryptogenic stroke in young adults are discussed by John Mandrola, MD.
This podcast is intended for healthcare professionals only.
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I FDA announces approval for TAVR in pts with asymptomatic AS
Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis (EARLY TAVR) https://www.nejm.org/doi/full/10.1056/NEJMoa2405880
EARLY TAVR: A Positive Trial That Fails to Inform Clinical Decisions https://www.medscape.com/viewarticle/early-tavr-positive-trial-fails-inform-clinical-decisions-2024a1000kec
Asymptomatic Aortic Stenosis: 'Time to Act' or Not So Fast? https://www.medscape.com/viewarticle/asymptomatic-aortic-stenosis-time-act-or-not-so-fast-2025a10005o9
II PPG that Can Distinguish source of Tachycardia
Machine-learning guided differentiation between photoplethysmography waveforms of supraventricular and ventricular origin https://doi.org/10.1016/j.cmpb.2025.108798
III PRAETORIAN -XL trial
Device-related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-term Follow-up: the PRAETORIAN-XL Trial https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.125.074576
Subcutaneous or Transvenous Defibrillator Therapy (PRAETORIAN trial) https://www.nejm.org/doi/full/10.1056/NEJMoa1915932
Subcutaneous or Transvenous Defibrillator Therapy Letter to Editor https://www.nejm.org/doi/full/10.1056/NEJMc2034917
The PRAETORIAN Trial: Guarded Approach to Subcutaneous ICD Best https://www.medscape.com/viewarticle/937156
IV Stroke in Young People
Burden of Modifiable Risk Factors in Young-Onset Cryptogenic Ischemic Stroke by High-Risk Patent Foramen Ovale https://www.ahajournals.org/doi/10.1161/STROKEAHA.124.049855
Migraine: A Key Factor in Young Adults With Unexplained Stroke https://www.medscape.com/viewarticle/migraine-key-factor-young-adults-unexplained-stroke-2025a10009jj
U.S. stroke rate declining in adults 75 and older, yet rising in adults 49 and younger ASA statement https://newsroom.heart.org/news/u-s-stroke-rate-declining-in-adults-75-and-older-yet-rising-in-adults-49-and-younger
Increasing stroke in the young https://doi.org/10.1016/j.ajpc.2020.100085
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