May 14, 2012 – A retrospective analysis of data from the OMNI Registry, a large-scale, longitudinal registry of nearly 3,000 device patients, revealed that primary prevention non-evidence-based (NEB) implantable cardioverter-defibrillator (ICD) recipients had similar therapeutic benefits and outcomes as evidence-based (EB) ICD recipients. These findings were presented during the Heart Rhythm Society (HRS) annual scientific sessions last week in Boston.
The authors found that compared to the EB group, the NEB group experienced similar outcomes in 1) time to first appropriate ICD therapy, 2) risk of death and 3) time to first inappropriate ICD therapy. Previously, it has been unknown whether NEB ICD recipients were receiving therapeutic benefits compared to the risk of complications.
In order to analyze outcomes reflective of real-world practice, the authors reviewed data of 1,412 OMNI ICD patients, identifying 570 primary prevention ICD patients (based on MADIT II and SCDHeFT criteria, while excluding cardiac resynchronization therapy defibrillator (CRT-D) patients). Of those, 10.4 percent received NEB treatment, as defined by 1) if the implant occurred within 30 days of myocardial infarction (MI), 2) within three months from nonischemic dilated cardiomyopathy (NIDCM) diagnosis or 3) in the setting of New York Heart Association (NYHA) class IV symptoms. Recent evidence has suggested that nearly one in four ICDs implanted for primary prevention were NEB.
“While in real-world practice we see many patients who are either excluded or unaddressed by evidence base, we have observed that some non-evidence-based ICD patients are showing positive outcomes, which until now there was little research to support this anecdotal observation,” said Christian E. Machado, M.D., FHRS, director, cardiac electrophysiology and cardiac rhythm management device clinic, Providence Hospital, Detroit. “We feel this study is a valuable surrogate of real-world clinical practice, where clinical needs require real medical decisions. Additionally, it continues to emphasize the importance of the physician-patient relationship. While guidelines are important, our ultimate mission is to save our patient’s life and know we are giving them a fighting chance. We believe this study provides that knowledge.” This analysis continues to shed light on challenges in the cardiac community, including rates of NEB ICD procedures and the use and implications of guidelines and criteria on medical practice and reimbursement. In Jan. 5, 2011, the Journal of the American Medical Association (JAMA) published, “Non-Evidence-Based Implantable Cardioverter-Defibrillator (ICD) Implantations in the United States,” causing some concern about the use of stringent guidelines around heart device insertion.
The Heart Rhythm Society has openly emphasized – as did the JAMA article – that “the ultimate judgment of the care of a particular patient must be made by the physician and the patient in light of all of the circumstances presented by the patient. There are circumstances in which deviations from these guidelines are appropriate.”
For more information: www.HRSonline.org