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Key questions after FDA approval of TAVR in asymptomatic patients | High Lp(a) levels raise risk of repeat cardiovascular events

News You Need to Know Today
Key questions after FDA approval of TAVR in asymptomatic patients | High Lp(a) levels raise risk of repeat cardiovascular events
Thursday, May 8, 2025
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Today's News and Trends

Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients

The approval of certain TAVR valves to be used in asymptomatic patients is expected to make a significant impact on patient care going forward. 

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
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Answering key follow-up questions after the FDA approved TAVR in asymptomatic patients

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
The approval of certain TAVR valves to be used in asymptomatic patients is expected to make a significant impact on patient care going forward. 
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High Lp(a) levels increase risk of repeat cardiovascular events—LDL drugs may help

Researchers evaluated data from more than 273,000 patients with a history of ASCVD, noting that higher Lp(a) levels are consistently linked to worse cardiovascular outcomes.

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The Society of Cardiovascular Computed Tomography developed and published the new document to help educate healthcare providers who regularly treat acute chest pain in the emergency department (ED). 
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High Lp(a) levels increase risk of repeat cardiovascular events—LDL drugs may help

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The Society of Cardiovascular Computed Tomography developed and published the new document to help educate healthcare providers who regularly treat acute chest pain in the emergency department (ED). 
Researchers evaluated data from more than 273,000 patients with a history of ASCVD, noting that higher Lp(a) levels are consistently linked to worse cardiovascular outcomes.
READ MORE >

Featured Articles

Smaller LV dimensions may increase risk of death for HeartMate 3 LVAD patients

Researchers tracked short- and long-term data from nearly 2,000 patients, presenting their findings in JACC: Heart Failure. 

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Abbott’s HeartMate 3 left ventricular assist device (LVAD) has been implanted in thousands of U.S. patients in recent years.According to a new investigative report from CBS News and KFF Health News, however, safety data related to the device have raised questions in certain parts of the healthcare industry.
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Smaller LV dimensions may increase risk of death for HeartMate 3 LVAD patients

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Abbott’s HeartMate 3 left ventricular assist device (LVAD) has been implanted in thousands of U.S. patients in recent years.According to a new investigative report from CBS News and KFF Health News, however, safety data related to the device have raised questions in certain parts of the healthcare industry.
Researchers tracked short- and long-term data from nearly 2,000 patients, presenting their findings in JACC: Heart Failure. 
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World’s first leadless LBBAP procedures linked to ‘promising’ outcomes

Cardiologists are turning to leadless pacemakers more and more for cardiac pacing, but those devices have not previously been able to perform LBBAP. This new analysis includes new data on the world’s very first leadless LBBAP procedures. 

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
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World’s first leadless LBBAP procedures linked to ‘promising’ outcomes

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2024 has been a banner year for structural heart treatments, especially those focused on the tricuspid valve. In February, for example, Edwards Lifesciences made history when its Evoque transcatheter tricuspid valve replacement (TTVR) system became the first device of its kind to gain U.S. Food and Drug Administration (FDA) approval for treating tricuspid regurgitation (TR). Two months later, Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system also gained FDA approval for the treatment of TR.
Cardiologists are turning to leadless pacemakers more and more for cardiac pacing, but those devices have not previously been able to perform LBBAP. This new analysis includes new data on the world’s very first leadless LBBAP procedures. 
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Stenting ‘an important treatment option’ for PCI patients with complete blockages

The study's lead author emphasized that stenting during CTO PCI procedures "should be considered safe and effective in the long term."

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heart-stent.jpg
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Stenting ‘an important treatment option’ for PCI patients with complete blockages

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heart-stent.jpg
The study's lead author emphasized that stenting during CTO PCI procedures "should be considered safe and effective in the long term."
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In Case You Missed It

Cardiologists make history, perform world’s first ventricular ablation guided by real-time MRI

“MRI images provide a better view of the anatomy of the heart and the instruments used for treatment, but also of the changes made to the treated cardiac tissue,” one cardiologist explained. “Unlike X-ray images, the entire area surrounding the heart can be seen, including the blood vessels and valves."

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Imricor Medical Systems ventricular ablation
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Cardiologists make history, perform world’s first ventricular ablation guided by real-time MRI

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Imricor Medical Systems ventricular ablation
“MRI images provide a better view of the anatomy of the heart and the instruments used for treatment, but also of the changes made to the treated cardiac tissue,” one cardiologist explained. “Unlike X-ray images, the entire area surrounding the heart can be seen, including the blood vessels and valves."
READ MORE >

FDA sees potential in new pacemaker-guided hypertension therapy

Orchestra BioMed and Medtronic have worked together on the new therapy, which is designed to work automatically without patients needing to take any additional steps.

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Orchestra BioMed Holdings AVIM Therapy FDA breakthrough device
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FDA sees potential in new pacemaker-guided hypertension therapy

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Orchestra BioMed Holdings AVIM Therapy FDA breakthrough device
Orchestra BioMed and Medtronic have worked together on the new therapy, which is designed to work automatically without patients needing to take any additional steps.
READ MORE >

Proactive CAD strategies fueled by calcium scores lead to benefits for intermediate-risk patients

Up to 50% of all patients face an intermediate risk of developing CAD, and the optimal treatment strategy for that population remains unclear. For this study, researchers explored data from more than 400 intermediate-risk patients with a family history of premature CAD.

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Newsweek ranked the 50 best heart hospitals in the world
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Proactive CAD strategies fueled by calcium scores lead to benefits for intermediate-risk patients

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Newsweek ranked the 50 best heart hospitals in the world
Up to 50% of all patients face an intermediate risk of developing CAD, and the optimal treatment strategy for that population remains unclear. For this study, researchers explored data from more than 400 intermediate-risk patients with a family history of premature CAD.
READ MORE >

In Other News

Researchers identify ‘universal determinants of AI acceptance’ among healthcare workers

What attributes tend to nudge clinicians toward accepting AI into their work lives? Several, of course—but the most broadly determinative can be trimmed to just two. 

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artificial intelligence AI in healthcare
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Researchers identify ‘universal determinants of AI acceptance’ among healthcare workers

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artificial intelligence AI in healthcare
What attributes tend to nudge clinicians toward accepting AI into their work lives? Several, of course—but the most broadly determinative can be trimmed to just two. 
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Lantheus announces plans to divest SPECT imaging business

Janesville, Wisconsin-based nuclear fusion firm Shine Technologies is the buyer, issuing an upfront cash payment under terms of the deal. 

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Lantheus
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Lantheus announces plans to divest SPECT imaging business

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Lantheus
Janesville, Wisconsin-based nuclear fusion firm Shine Technologies is the buyer, issuing an upfront cash payment under terms of the deal. 
READ MORE >

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