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March's Top Stories: Transplant ends in tragedy | Device recalls | A new drug for AS | ACS guidelines | Medicare covering TTVR

News You Need to Know Today
March's Top Stories: Transplant ends in tragedy | Device recalls | A new drug for AS | ACS guidelines | Medicare covering TTVR
Tuesday, April 1, 2025
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The Month in Review

Family files lawsuit after transplant ends in tragedy—says son ‘got the heart of a meth addict’

A Florida family is suing Mayo Clinic for allegedly performing a heart transplant without communicating certain risks associated with the donated organ. Mayo Clinic has pushed back against those claims, saying it acted appropriately every step of the way. 

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A gavel and a stethoscope
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Family files lawsuit after transplant ends in tragedy—says son ‘got the heart of a meth addict’

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A gavel and a stethoscope
A Florida family is suing Mayo Clinic for allegedly performing a heart transplant without communicating certain risks associated with the donated organ. Mayo Clinic has pushed back against those claims, saying it acted appropriately every step of the way. 
READ MORE >

FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

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The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA
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FDA announces catheter recall for Johnson & Johnson PFA system due to stroke risk

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The late-breaking U.S. multicenter admIRE clinical trial at the Heart Rhythm Society 2024 meeting, showed positive data on the long-term safety and effectiveness of the the Biosense Webster Varipulse pulsed field ablation (PFA) system in patients with paroxysmal atrial fibrillation. #HRS #HRS2024 #PFA
The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.
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Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

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Bard Peripheral Vascular Rotarex Atherectomy System recall
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Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

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Bard Peripheral Vascular Rotarex Atherectomy System recall
The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.
READ MORE >

Surgeons make history, perform world’s first living mitral valve replacement

The historic heart procedure was part of a series of operations that saved the lives of three young girls. “The whole situation is extraordinary, whether you look at it from the standpoint of a scientific breakthrough or the average person’s point of view,” one parent said. 

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Douglas Overbey, MD, an assistant professor in the department of surgery at Duke University School of Medicine, checks in with 9-year-old Kensley Frizzell as she recovers from heart surgery. Image courtesy of Duke Health and Duke University School of Medicine.
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Surgeons make history, perform world’s first living mitral valve replacement

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Douglas Overbey, MD, an assistant professor in the department of surgery at Duke University School of Medicine, checks in with 9-year-old Kensley Frizzell as she recovers from heart surgery. Image courtesy of Duke Health and Duke University School of Medicine.
The historic heart procedure was part of a series of operations that saved the lives of three young girls. “The whole situation is extraordinary, whether you look at it from the standpoint of a scientific breakthrough or the average person’s point of view,” one parent said. 
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Philips pulls endovascular devices from market after safety issues prompt Class I recall

Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately. 

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FDA Recall
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Philips pulls endovascular devices from market after safety issues prompt Class I recall

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FDA Recall
Philips is recalling all sizes of its Tack Endovascular System after 20 patient injuries were reported. Interventional cardiologists are urged to stop using the device immediately. 
READ MORE >

Cannabis use increases risk of heart attack, stroke in young adults

“Asking about cannabis use should be part of clinicians' workup to understand patients' overall cardiovascular risk, similar to asking about smoking cigarettes,” one researcher said. Additional details will be presented at ACC.25 in Chicago.

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The new analysis, based on data from 1.6 million patients, found that a medical marijuana prescription for chronic pain may increase a person's overall arrhythmia risk. Medical marijuana
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Cannabis use increases risk of heart attack, stroke in young adults

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The new analysis, based on data from 1.6 million patients, found that a medical marijuana prescription for chronic pain may increase a person's overall arrhythmia risk. Medical marijuana
“Asking about cannabis use should be part of clinicians' workup to understand patients' overall cardiovascular risk, similar to asking about smoking cigarettes,” one researcher said. Additional details will be presented at ACC.25 in Chicago.
READ MORE >

New drug shows early potential to treat aortic stenosis in some patients without TAVR, SAVR

The drug in question, ataciguat, could help heart patients avoid aortic valve replacement—or at least put it off until later in life.

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heart patient
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New drug shows early potential to treat aortic stenosis in some patients without TAVR, SAVR

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heart patient
The drug in question, ataciguat, could help heart patients avoid aortic valve replacement—or at least put it off until later in life.
READ MORE >

Cardiologists make history, complete world’s first robotic transcatheter mitral valve replacements

One of the cardiologists involved in the procedures said they represent "a significant leap forward in structural heart intervention."

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Capstan Medical robotic transcatheter mitral valve replacement. Capstan Medical, a California-based medtech company focused on developing new structural heart disease treatments, announced the news, noting that its robotic-enabled technologies were used to complete two successful robotic TMVR procedures at Hospital Clínico Universidad Católica in Santiago, Chile.
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Cardiologists make history, complete world’s first robotic transcatheter mitral valve replacements

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Capstan Medical robotic transcatheter mitral valve replacement. Capstan Medical, a California-based medtech company focused on developing new structural heart disease treatments, announced the news, noting that its robotic-enabled technologies were used to complete two successful robotic TMVR procedures at Hospital Clínico Universidad Católica in Santiago, Chile.
One of the cardiologists involved in the procedures said they represent "a significant leap forward in structural heart intervention."
READ MORE >

Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines

The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies. 

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
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Cardiologists recommend complete revascularization, intravascular imaging in new ACS guidelines

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
The American College of Cardiology and American Heart Association published the new guidelines with assistance from other leading U.S. medical societies. 
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CMS approves Medicare coverage for transcatheter tricuspid valve replacement

CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.

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Edwards Lifesciences Corporation has shared new one-year data on the safety and effectiveness of its Evoque transcatheter tricuspid valve replacement (TTVR) system among patients with tricuspid regurgitation (TR)
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CMS approves Medicare coverage for transcatheter tricuspid valve replacement

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Edwards Lifesciences Corporation has shared new one-year data on the safety and effectiveness of its Evoque transcatheter tricuspid valve replacement (TTVR) system among patients with tricuspid regurgitation (TR)
CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.
READ MORE >

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