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News You Need to Know Today
Structural Heart Disease Highlights: A malfunction risk with MitraClip devices | CT imaging for TAVR & TMVR
Tuesday, September 27, 2022
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Editor's Choice: Structural Heart Disease

Regulatory Roundup: FDA clears AI model for RV/LV ratios, approves calcium-blocking TAVR valve and much more

Read our review of some of the biggest FDA-related stories that have hit cardiology in the last month, including news from Viz.ai, Edwards Lifesciences, Abiomed and Medtronic. 

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High-risk percutaneous coronary intervention (PCI) with an Impella heart pump is associated with better outcomes, including a significantly higher survival rate, than high-risk PCI with an intra-aortic balloon pump (IABP), according to new findings published in the American Journal of Cardiology. Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock
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Regulatory Roundup: FDA clears AI model for RV/LV ratios, approves calcium-blocking TAVR valve and much more

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High-risk percutaneous coronary intervention (PCI) with an Impella heart pump is associated with better outcomes, including a significantly higher survival rate, than high-risk PCI with an intra-aortic balloon pump (IABP), according to new findings published in the American Journal of Cardiology. Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock
Read our review of some of the biggest FDA-related stories that have hit cardiology in the last month, including news from Viz.ai, Edwards Lifesciences, Abiomed and Medtronic. 
READ MORE >

FDA warns of a new malfunction risk with Abbott’s MitraClip devices

When these malfunctions occur, the FDA explained, it leads to an increased risk of additional interventions.

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The Abbott MitraClip is the primary structural heart device used in transcatheter edge-to-edge repairs (TEER) of the mitral valve leaflets. The results of the COAPT trial dropped like a thunderclap Sunday at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, with several cardiologists predicting the MitraClip device will have a swift and lasting impact on the treatment of heart failure patients.
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FDA warns of a new malfunction risk with Abbott’s MitraClip devices

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The Abbott MitraClip is the primary structural heart device used in transcatheter edge-to-edge repairs (TEER) of the mitral valve leaflets. The results of the COAPT trial dropped like a thunderclap Sunday at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, with several cardiologists predicting the MitraClip device will have a swift and lasting impact on the treatment of heart failure patients.
When these malfunctions occur, the FDA explained, it leads to an increased risk of additional interventions.
READ MORE >

VIDEO: CT imaging for TAVR and TMVR structural heart interventions

Joao Cavalcante, MD, director, cardiac MRI and structural CT labs, Minneapolis Heart Institute, discusses the use of cardiac CT imaging to plan and guide structural heart procedures. 

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Examples of structural heart transcatheter valve replacement procedure planning CT scans and post procedure followup for TMVR and TAVR.
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VIDEO: CT imaging for TAVR and TMVR structural heart interventions

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Examples of structural heart transcatheter valve replacement procedure planning CT scans and post procedure followup for TMVR and TAVR.
Joao Cavalcante, MD, director, cardiac MRI and structural CT labs, Minneapolis Heart Institute, discusses the use of cardiac CT imaging to plan and guide structural heart procedures. 
READ MORE >

MitraClip and TriClip TEER devices continue to show positive results

Two late-breaking studies at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) meeting provided positive data for Abbott's MitraClip transcatheter mitral valve repair (TMVR) device and the TriClip for transcatheter tricuspid valve repair (TTVR).

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Transcatheter mitral valve repair (TMVr) is associated with “promising” short-term outcomes among patients with a history of cancer, according to new research published in the American Journal of Cardiology. #TEER #TMVR
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MitraClip and TriClip TEER devices continue to show positive results

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Transcatheter mitral valve repair (TMVr) is associated with “promising” short-term outcomes among patients with a history of cancer, according to new research published in the American Journal of Cardiology. #TEER #TMVR
Two late-breaking studies at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) meeting provided positive data for Abbott's MitraClip transcatheter mitral valve repair (TMVR) device and the TriClip for transcatheter tricuspid valve repair (TTVR).
READ MORE >

FDA clears Edwards Pascal device for transcatheter mitral valve repair

This is the second FDA-cleared transcatheter repair device for the mitral valve. Data from pivotal trial comparing Pascal vs. MitraClip will be presented at TCT 2022.

READ MORE >
he U.S. Food and Drug Administration (FDA) granted market clearance ion September 2022 for the Edwards Lifesciences Corp. Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER). It is indicated for the treatment of patients with degenerative mitral regurgitation (DMR).
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FDA clears Edwards Pascal device for transcatheter mitral valve repair

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he U.S. Food and Drug Administration (FDA) granted market clearance ion September 2022 for the Edwards Lifesciences Corp. Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER). It is indicated for the treatment of patients with degenerative mitral regurgitation (DMR).
This is the second FDA-cleared transcatheter repair device for the mitral valve. Data from pivotal trial comparing Pascal vs. MitraClip will be presented at TCT 2022.
READ MORE >

Boston Scientific gains a new FDA approval for Watchman FLX LAAC device

The company can now update its labeling instructions for the device to include a new 45-day dual anti-platelet therapy treatment option when treating non-valvular atrial fibrillation. 

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Watchman FLX left atrial appendage closure (LAAC)
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Boston Scientific gains a new FDA approval for Watchman FLX LAAC device

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Watchman FLX left atrial appendage closure (LAAC)
The company can now update its labeling instructions for the device to include a new 45-day dual anti-platelet therapy treatment option when treating non-valvular atrial fibrillation. 
READ MORE >

VIDEO: Trends in structural heart procedural imaging - a discussion with Rebecca Hahn

Rebecca T. Hahn, MD, Director of Interventional Echocardiography at the Columbia Structural Heart and Valve Center, discusses some of the trends in the growing use of interventional echocardiographic guidance in transcatheter structural heart procedures.

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Interview with Rebecca T. Hahn, MD, Professor of Medicine at Columbia University Irving Medical Center, Chief Scientific Officer of the Echo Core Lab at the Cardiovascular Research Foundation and Director of Interventional Echocardiography at the Columbia Structural Heart and Valve Center. She discusses some of the trends of growing use of interventional echocardiographic guidance in transcatheter structural heart procedures, the growing number of tricuspid valve procedures, and use of 3D ICE.
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VIDEO: Trends in structural heart procedural imaging - a discussion with Rebecca Hahn

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Interview with Rebecca T. Hahn, MD, Professor of Medicine at Columbia University Irving Medical Center, Chief Scientific Officer of the Echo Core Lab at the Cardiovascular Research Foundation and Director of Interventional Echocardiography at the Columbia Structural Heart and Valve Center. She discusses some of the trends of growing use of interventional echocardiographic guidance in transcatheter structural heart procedures, the growing number of tricuspid valve procedures, and use of 3D ICE.
Rebecca T. Hahn, MD, Director of Interventional Echocardiography at the Columbia Structural Heart and Valve Center, discusses some of the trends in the growing use of interventional echocardiographic guidance in transcatheter structural heart procedures.
READ MORE >

TEER safe and feasible for patients with atrial secondary mitral regurgitation

Atrial secondary mitral regurgitation has been linked to higher in-hospital mortality and hospitalization rates. 

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heart patient
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TEER safe and feasible for patients with atrial secondary mitral regurgitation

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heart patient
Atrial secondary mitral regurgitation has been linked to higher in-hospital mortality and hospitalization rates. 
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