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BIOTRONIK, a leading manufacturer of cardiovascular medical technology, has announced the highly-anticipated results of the REFORM study. The study demonstrates that ICD (implantable cardioverter-defibrillator) patients with BIOTRONIK's Home Monitoring® can enjoy a reduction in follow-up visits by 58%. This in turn leads to patients reporting enhanced quality of life.
"The number of patients with an ICD is rapidly increasing, and the burden of frequent, necessary follow-ups falls on patients, physicians and hospitals," explained Prof. Gerhard Hindricks, MD, Heart Center, University Leipzig, Germany. "REFORM shows an impressive reduction in follow-up visits with BIOTRONIK Home Monitoring®, and is the first trial to indicate that longer intervals between follow-ups contribute to an improved quality of life."
REFORM is a prospective, international, multi-center, randomized study investigating the effects of standard 3-month and 12-month follow-up schemes. 155 ICD patients with MADIT-II indications were randomized into two groups. Both received remote follow up via BIOTRONIK Home Monitoring® with fully automated daily data transmission and physician alerts of clinically relevant events. Compared to the group receiving quarterly follow-ups, the number of visits per patient per year could be reduced in the group with yearly follow-ups from 3.85 to 1.60, i.e. by 58%.
"The REFORM trial demonstrates that, thanks to BIOTRONIK Home Monitoring®, one-year intervals between follow-up visits in primary prevention ICD patients do not compromise safety in any way. Again, this leads to enhanced patient quality of life, as patients feel less ill and less distracted from normal life, as well as a reduced workload for physicians. On the strength of remote monitoring information, they can decide if a follow-up is necessary," Prof. Hindricks commented, adding that in many cases, an in-office follow-up is not needed at all.
The REFORM study's findings are in agreement with results from other trials like the landmark trial TRUST,, which showed a 45% reduction of in-office follow-ups and earlier detection of clinically relevant events.
 Varma et al., Circulation 2010, 122, 325–332.
 Varma et al., Circ Arrhythm Electrophysiol 2010, 3:428–436.
Eur Heart J (2013) doi: 10.1093/eurheartj/eht207 First published online: July 18, 2013
Authors: Gerhard Hindricks, Christian Elsner, Christopher Piorkowski, Milos Taborsky, Jan Christoph Geller4, Burghard Schumacher, Jan Bytesnik and Hans Kottkamp
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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BIOTRONIK. "REFORM study shows BIOTRONIK Home Monitoring® reduces follow-up visits in ICD patients by 58%." Medical News Today. MediLexicon, Intl., 3 Sep. 2013. Web.
12 Dec. 2013. <http://www.medicalnewstoday.com/releases/265527>
BIOTRONIK. (2013, September 3). "REFORM study shows BIOTRONIK Home Monitoring® reduces follow-up visits in ICD patients by 58%." Medical News Today. Retrieved from
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