Tag: icd

Tenaya Therapeutics Gets Go-Ahead for HCM Gene Therapy Trial

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Tenaya Therapeutics announced on Monday that they have received FDA clearance to begin a Phase 1 clinical trial of targeted gene therapy for HCM.

Tenaya is developing TN-201, a first in class adeno-associated virus based therapy being developed to treat HCM caused by mutation(s) in the MYBPC3 gene. They anticipate that the trial will begin in the third quarter of 2023. The therapy delivers one fully functional MYBPC3 gene to the patient via injection with a deactivated virus. Tenaya hopes that this therapy will restore normal levels of the MYBPC3 protein, thereby halting disease progression, and even potentially reversing the course of the disease, after just a single treatment.

The TN-201 Phase 1b clinical trial will be a multi-center, open-label study designed to assess the safety of an intravenous infusion of TN-201. They hope to enroll at least 6 symptomatic, non-obstructive HCM patients who carry the MYBPC3 gene and who already have received an automatic implantable cardioverter defibrillator (ICD) as part of their treatment plan to date.

You can read the full  press release here.

Stay tuned to HCMBeat for updates!

Apical Aneurysms in HCM

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A recent paper published by doctors at Canada’s Peter Munk Cardiac Center looked at the implications of left ventricular apical aneurysms in hypertrophic cardiomyopathy,  This paper recommends that patients with an apical aneurysm of at least 2 centimeters consider prophylactic anticoagulant therapy to prevent stroke, as well as considering surgical placement of an implantable defibrillator to protect against sudden cardiac death.

A companion editorial suggests caution in basing aggressive measures on an aneurysm alone and says that all risk factors be considered together.

In 2017, HCMBeat covered a retrospective study of patients treated at Minneapolis Heart Institute and Tufts which discussed the risks for patients with apical aneurysms.  That can be found here.

Medtronic ICD Recall

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The FDA has announced a Class I recall of certain models of Medtronic implantable defibrillators and cardiac resynchronization therapy defibrillators.  The statement from the FDA can be found here.

Continue reading “Medtronic ICD Recall” →

Sports and HCM – Moving Toward Shared Decision Making

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While competitive sports used to be frowned upon in the HCM literature, there is now some evidence that a patient’s risk from exercise is low when they have been implanted with an implantable cardioverter defibrillator (ICD). This feature from Medpage Today gives an overview of contemporary thinking about exercise in HCM patients.

Continue reading “Sports and HCM – Moving Toward Shared Decision Making” →

Arrhythmia Monitoring in HCM

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Arrhythmia monitoring in HCM patients is used not only for determining risk of sudden death and potential need for an implantable defibrillator, but also for detecting atrial fibrillation (AFib) and implementing anti-coagulation for stroke prevention.

A recent paper provides an overview of the usefulness of arrhythmia monitoring in patients with HCM. 

Continue reading “Arrhythmia Monitoring in HCM” →

HCM Patient Competes on Television Show “The Voice”

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Berritt Haynes, a 19 year old with hypertrophic cardiomyopathy, was chosen for Team Blake Shelton last night on the MGM Television/NBC show THE VOICE.  After Berritt’s mother submitted a tape, Berritt was chosen to audition on stage in front of the coaches.

Berritt had hoped to attend a taping of the show last season through Make-A -Wish Foundation which grants wishes to kids with serious health issues. However, due to COVID, he was not able to make that happen.  Instead, this year his mother helped make his dream come true by making it possible for him to actually perform.

Berritt was diagnosed with HCM when he was 8 and received an implantable defibrillator when he was 14.  Clearly, Berritt’s HCM has not interfered with his performing talents.  Watch him performing on The Voice here.

Good luck Berritt. All of the HCM world will be rooting for you to advance to the next round!

Read more at:

Yahoo Entertainment

USA Today

ET Canada

THE VOICE can be seen on NBC on Monday and Tuesday nights. Check your local schedule for times.

Medtronic ICD Recall

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The FDA has announced a Class I recall of certain models of Medtronic implantable defibrillators and cardiac resynchronization therapy defibrillators.  The statement from the FDA can be found here.

The recall impacts Medtronic’s Evera and Visia brands of ICDs as well as its Viva, Brava, Claria, Amplia and Compia brands of cardiac resynchronization therapy defibrillators (CRT-Ds) implanted from August 31, 2012 to May 9, 2018. The problem is described as “an unexpected and rapid decrease in battery life” caused by a short circuit. The defect may cause devices to go from recommended replacement time (when your alarm sounds to notify you that it is time to schedule a replacement surgery) to full battery depletion in just one day.  Normally, you would have approximately 3 months from the time that the alarm first sounds to schedule a procedure to implant a replacement.

According to this article, there have been 444 complaints and 264 medical device reports about this issue which impacts 239,171 devices.

To look up your device by product name, model or serial number to see whether it is impacted, click here.

The box in the upper right corner labeled “Advisories For This Model” will tell you if there are any advisories for your device.  If this particular recall affects your device, you will see the same advisory which is circled in red in the photo below.

Medtronic recall 1

Patients are advised to continue routine follow ups and use the Care Link Monitoring System.

And, as always, you can call Medtronic Patient Services with any questions at: (800) 551-5544

(M – F, 8am – 5pm Central).

iPhone 12 Can Disable ICD!

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In this study just published in the Heart Rhythm journal of the Heart Rhythm Society, doctors demonstrated that an Apple iPhone 12 (which is built with more magnets than previous iPhone models due to the Mag Safe charging technology) can disable the ability of an implantable defibrillator to deliver therapy.

So, this is a reminder for ICD patients that according to all device manufacturers, in order to avoid a problem, keep your phone at least 6 inches away from your device, and remember that you should NEVER PUT YOUR PHONE (ANY PHONE, NOT JUST AN IPHONE 12) IN YOUR SHIRT POCKET! 

shirt with x

HCM Treatment: The View from OHSU

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If you are looking for a good survey of current practices in the treatment of HCM, a recent article published in the journal Structural Heart by Dr. Ahmad Masri and the team at Oregon Health and Sciences University (OHSU) provides an informative overview of thirty controversies and considerations in the treatment of HCM. This article explains in some detail how the doctors at this HCM Center approach these situations. 

Continue reading “HCM Treatment: The View from OHSU” →

Sudden Death Risk Factors Differ for Children with HCM

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According to a recent paper published in Circulation, children’s risk for sudden death should be evaluated using different risk factors than those used for adults.

Two main differences seen between factors influencing the risk of sudden death of children and adults were that:

  • for children, family history of sudden death was not a risk factor;
  • a left ventricular outflow tract gradient in a child suggested a lower risk of sudden death.

The authors of this study propose that the risk assessment factors highlighted in this study (and not the various risk assessment tools that have been developed for adults) should be used by clinicians to evaluate the need for implantable defibrillators in children.