Corresponding author information:
Email:dr.kloosterman@backonrhythm.com
Fax: 561-392-9781
ORCID Id: https://orcid.org/0000-0002-9715-1096
Funding: None
Conflict of Interest: The author receives modest honoraria as
speaker and advisor to Medtronic and Boston Scientific.
To the Editor,
If an author and for that matter a journal were to title a manuscript:
“First” anything… there should be a due diligence to do at least a
basic literature search to be certain about this claim, which in this
case would have readily shown the following ORIGINAL RESEARCH article:
“Remote Control of Cardiac Implantable Electronic Devices: Exploring
the New Frontier—First Clinical Application of Real-time
Remote-control Management of Cardiac Devices Before and After Magnetic
Resonance Imaging.” Dr. E. Kloosterman et al. J Innov Cardiac
Rhythm Manage. 2019;10(1):3477–3484. DOI: 10.19102/icrm.2019.100102
Of course, it’s possible to consider this a mistake, an oversight. But
when not only the authors, but reviewers and the editorial team appeared
to not have of taken care of a basic principle, it seems deliberate,
particularly when the “first” published seminal paper, preceded COVID
not just as a case report, but as a prospective study involving 100
remote-control transmissions with relevant clinical implications.
Without getting into a full critique of the communication paper content,
it merits at least the following observations on omissions, claims and
practice:
1. Background, given that the authors received Medtronic technical
support and a grant; it would have been important to disclose that
(although not published) the use of remote-control programming in the
described implant setting has been performed by other physicians and
Medtronic in the past. I participated as an observer in one of the
sessions over 5 years ago and therefore not new.
2. The Medtronic SmartSync tablet programmer enables wireless direct
interrogation and management of devices (except the Micra) from outside
the operating room allowing non direct contact with patients.
3. Given that Remote-Control today cannot happen without assistance
of an “EP staffer” to be directed on the setup of the programmer, it
undermines and questions the value of performing remote control
programming in an implant set up when the implanter (a knowledgeable
programmer operator) in the same room with the patient, can direct to do
it himself in a similar number of steps.
4. In none of the cases there is a description of the actual
internet connection used (Ethernet; WiFi, modem, cellular, etc.) which
is a key element to the stability, safety and effectiveness of the
transmission.
5. It seems reaching the boundaries of conflict of interest when the
company that provided economical, technical and iconographic support the
authors of this manuscript, aware of previous literature on the topic,
didn’t take issue with the misleading title and content.
6. The nonchalant comment regarding “off-label” use of the
remote-control with direct industry participation is worrisome
considering that it was not done under an approved study protocol,
emergency basis or compassion indication but seemingly on the spur of
the moment. There was no “benefit” to the patients that couldn’t have
been achieved in alternative ways, but all risk!
Hopefully, this is not one more
sign of the upcoming era of alternative truth and double standards,
which may be taking a toll affecting peer review medical publications,
authors, reviewers, editors and industry.