Arizona Arrhythmia Consultants and Leading Device Manufacturer Successfully Collaborate to Prove the Safety of Cardiac Defibrillators and MRIs
Scottsdale, AZ (PRWEB) August 31, 2015 -- It was recently announced by Biotronik that patients with implantable cardioverter-defibrillators (ICDs) who need a magnetic resonance image (MRI) scan can safely undergo the procedure thanks to a successful collaboration with leading Electrophysiologists. Clinical trial results were submitted to the U.S Food and Drug Administration and are awaiting approval. http://www.biotronik.com/files/95EF1822AA924D3FC1257E660053B6B8/$FILE/150615_PhaseC_ProMRI_publication_HRJ.pdf
Approximately five million patients worldwide currently are implanted with a cardiac implantable electronic device including a pacemaker or ICD (1). Approximately 50% of these patients will need an MRI scan over the lifetime of the device (1). MRIs are considered a contraindication with a cardiac implantable electronic device due to potential interference with device programing and function, and the possibility of heart damage (1-2). Patients are therefore left with limited imaging modality options when a clinical situation arises.
Device manufacturers and physicians recognized the problem and began working together to develop a solution for patients undergoing MRIs. In 2011, conventional pacemakers were designed for the MRI environment (3). However, ICDs were not. Therefore, Biotronik and leading Electrophysiologists collaborated to devise an ICD that was safe during MRI scans.
The collaboration materialized into a clinical trial called ProMRI. The purpose of the trial was to evaluate the safety of the ProMRI ICD system when undergoing an MRI. ProMRI was a multi-center, prospective, single arm, non-randomized clinical trial. Thirty-nine leading Electrophysiology centers nation-wide worked on the study and approximately 170 patients were enrolled.
One center that worked on the study was Arizona Arrhythmia Consultants. The trial was led by Thomas Mattioni MD. “The value of MRI scanning in modern medicine has become increasingly obvious over the past decade. Having this imaging technology as an option for our patients with implanted cardiac devices will significantly improve the quality of care.”
Arizona Arrhythmia Consultants is committed to offering patients state of the art technology. “Major advances in arrhythmia management have been made possible by scientific study and participation of patients. Arizona Arrhythmia Consultants has been able to offer state-of-the-art therapy options to our patients due to our on-going research endeavors”, said Dr. Mattioni http://www.aacheart.com/index.html
REFERENCE
1. Kalin R, Stnton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol 2005; 28:326-328.
2. Roguin A, Schwitter J, Vahlhaus C, Lombardi M, Brugada J, Vardas P, Auricchio A, Priori S, Sommer T. Magnetic resonance imaginf in indiciduals with cardiovascular implantable electronic devices. Europace 2008, 10:336-346.
3. Wilkoff B, Bello D, Taborsky M, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm 2011;8:65-73.
Stacey Rorvig, Arizona Arrhythmia Consultants, http://www.aacheart.com/index.html, +1 (480) 246-3085, [email protected]
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