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 Cobalt and Crome brands of ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) implanted from February 3, 2020 to the present. The problem is described as a “short circuit protection alert resulting in reduced-energy electric shock delivery instead of delivering a second phase of high voltage therapy.” A reduced energy electric shock may fail to correct an arrhythmia or may cause an irregular heartbeat.
There have so far been only 27 complaints, but no injuries or deaths associated with the issue which impacts 87,709 devices total.
Medtronic is developing a software update to address the issue which should be available in late 2022. In the meantime, Medtronic recommends remote surveillance for these patients along with device reprogramming, if necessary.
To look up your device by product name, model or serial number to see whether it is impacted, click here.
NOTE: You can find the name, model and serial number of your device on the plastic identification card provided to you at the time of your implant.
The box in the upper right corner labeled “Customer Communications 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.
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).
An expert panel comprised of many of the world’s top HCM experts recently published a retrospective analysis in The American Journal of Cardiology which looked at septal myectomy over the last 60 years of practice.
Beginning with the introduction of the procedure at the National Institute of Health in the early 1960s, this paper surveys the history of the procedure until the present day. The conclusion of the paper is that myectomy remains the best treatment for patients with obstructive hypertrophic cardiomyopathy.
Continue reading “Myectomy: Still the Gold Standard for HOCM”
A team of international genetic researchers has just won “The Big Beat Challenge” – a grant from the British Heart Foundation of £30 million ($36 million) payable over a 5 years period to study potentially curative gene therapies to treat genetic cardiomyopathies.
Continue reading “Gene Therapy – Is HCM Cure Possible?”
Social media erupted this week with exciting news for the HCM community A new professional society specifically devoted to the study and treatment of hypertrophic cardiomyopathy has been launched. The name is the HCM Medical Society and its new website can be found here.
Founding members of the Board of Directors include many of the top HCM clinicians and researchers from around the world.
The HCM Society will focus on “clinical excellence, research and education” and will hold its inaugural meeting on Friday, September 30 in Washington D.C.
This is wonderful news for HCM patients, and HCMBeat hopes to have more about the future plans for HCM Society in the coming weeks.
The VALOR-HCM trial results have just been published in the Journal of the American College of Cardiology.
This study enrolled 112 obstructive HCM patients for a 16 week double blind trial of the drug mavacamten (brand name Camzyos). All patients in the trial had been referred for septal reduction therapy – either septal myectomy or septal alcohol ablation – to treat their highly symptomatic obstructive hypertrophic cardiomyopathy. The researchers looked at whether the addition of mavacamten to their other drugs would improve their symptoms enough so that they no longer met the criteria for septal reduction therapy (SRT) under the 2011 ACC/AHA Guidelines.
You can read many more details about the VALOR-HCM study here in this recent blog post on HCMBeat.
Continue reading “Mavacamten vs. Septal Reduction – VALOR-HCM Trial Results Published”
A recent article by several noted HCM experts shares their recommendations for the screening and evaluation of patients with HCM using several scenarios commonly encountered in clinical practice. Notably, this paper makes several recommendations which differ from the 2020 ACC/AHA Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy (2020 Guidelines).
In particular, the article recommends:
- Cardiac MRI with contrast upon initial evaluation, and every 3 – 5 years thereafter. (The 2020 Guidelines recommend Cardiac MRI in certain situations, but not for all patients)
- Genetic testing only in cases where a pathogenic or likely pathogenic mutation has been identified in a family member and in limited other circumstances (the 2020 Guidelines recommends genetic testing for all as part of the initial assessment)
- Screening of family members 12 or older only (the 2020 Guidelines recommend screening of children of any age when genetic HCM is diagnosed in a family member and no later than puberty, in any event)
- That HCM patients be disqualified from competitive sports. (The 2020 guidelines instead recommend a shared decision making approach).
Continue reading “Recommendations for HCM Depart from 2020 ACC/AHA Guidelines”
At two recent meetings, South San Francisco biotech company Cytokinetics presented encouraging data on its experimental drug for hypertrophic cardiomyopathy, aficamten (formerly known as CYK-274).
Continue reading “Aficamten Updates from Cytokinetics”
At long last, there is a FDA approved drug specifically intended for the treatment of hypertrophic cardiomyopathy. After several years of testing, and based on the results of the groundbreaking EXPLORER-HCM trial, Bristol Myers Squibb’s new drug mavacamten, being marketed under the brand name Camzyos, is now available to HCM patients.
Continue reading “FDA Approves Mavacamten under Brand Name Camzyos”
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”