2015 PHRS CONSENSUS STATEMENTS ON THE IMPLANTATION AND
FOLLOW-UP OF CARDIAC IMPLANTABLE ELECTRONIC DEVICES
PREAMBLE
The Philippine Heart Rhythm Society, founded in 2012, is a professional
organization of Cardiac Electrophysiologists and experts in management of
cardiac implantable electronic devices (CIEDs). In (date), the PHRS Board of
Directors met with the primary objective of creating local consensus
statements/competency guidelines on the implantation and follow-up of
ICD/CRT systems for implanting physicians.
INTRODUCTION
Implantable cardioverter/defibrillators (ICDs) are widely used for the
management of patients with life-threatening ventricular arrhythmias
(secondary prevention) and patients deemed at high risk of developing
arrhythmic death based on established risk factors (primary prevention). These
resulted from clinical trials, which have proven the superiority of ICDs in the
prevention of sudden cardiac arrest/death over the use of anti-arrhythmic
medications. (1-12)
Another recent development in device-based therapy is the development of
cardiac resynchronization (CRT) indicated in patients with moderate to severe
heart failure and wide QRS duration. (13-17) More recently, there is an
expansion of the indication to patients with milder heart failure (FC II). (18-19)
Clinical trials of cardiac resynchronization have proven its efficacy in heart
failure patients in improvement of functional class, quality of life and longevity
with decrease in heart failure-related deaths.
As increasing numbers of patients receive these devices, it is necessary that
physicians involved in implantation and follow-up of ICDs and CRTs have
knowledge and expertise in the indications, contraindications, techniques for
implantation, complication and programming, trouble-shooting and follow-up of
these devices. (20) Completion of a fellowship program in Cardiac
Electrophysiology is an evidence of such competency. However, with the
increasing interest from non-electrophysiologists to implant such devices, a need
to develop clinical competency statements/guidelines thus arises to ensure safe,
high-quality and evidence-based delivery of these devices.
METHODOLOGY
After online search, eight International Competency guidelines and consensus
statements on the implantation and implantation of ICD and CRT systems (2128) were reviewed and presented to the PHRS Board, which consisted of eight
electrophysiologists. The Board drafted the 2015 PHRS Consensus Statements on
the Implantation and Follow-up of Cardiac Implantable Electronic Devices and
plans to circulate the document to the rest of the members for approval. This will
then be submitted to the Philippine Heart Association for implementation.
RECOMMENDATIONS
LEVELLING
The body recommends the definition of levels of competency to standardize its
recommendations on competency requirements for ICD and CRT implantation.
The levels are based on previously defined levels by both the Heart Rhythm
Society (HRS) and the European Society of Cardiology (ESC) as shown in Table 1.
Level
1
Heart Rhythm Society
(21)
General
Cardiology
training
European Heart Rhythm
Association (EHRA)
Experience of selecting
appropriate diagnostic
modality
and
interpreting the results
or
choosing
an
appropriate
treatment
for which patients should
be referred, this level of
competence does not
include performing a
technique
2
General Cardiology with Practical experience, but
special interest in EP
not
as
independent
operator,
including
assisting
in
or
performing a particular
technique or procedure
under the guidance of a
superior
3
CCEP Training
Is able to independently
perform the technique or
procedure unaided
Based on the above international recommendations, the following levels were
defined, with its corresponding privileging: Level 1 includes all physicians who
have completed a General Cardiology fellowship. Level 1 physicians may not
implant ICDs or CRTs. (Table 2)
Level 2 includes the following: 1) General Cardiology graduates who have
exhibited special interest in Electrophysiology or has assisted in CIED
implantation, 2) TCVS with training in device implantation and 3) Interventional
Cardiology with experience in CIED implantation . Level 2 physicians need to
work with a level 3 physician to implant an ICD or CRT. Alternatively, for ICDs
alone, a level 2 may work with a TCVS and a level 2.5. (Table 2)
A level 2.5 physician is defined as a graduate of the Philippine Heart Center
program on Clinical Cardiac Electrophysiology. He is privileged to implant ICDs
when working with a TCVS and CRT when working with a level 3 physician.
(Table 2)
A level 3 physician is a graduate of a certified Clinical Cardiac Electrophysiology
program. He is privileged to implant both ICDs and CRT. (Table 2)
Level
1
Definition
All physicians who have
successfully completed
an accredited General
Cardiology fellowship
Privilege
Training at this level
does not allow any
implantation of ICD/CRT
2
a)
Board
certified
General Cardiologist with
special
interest
in
Arrhythmia, who has
practical experience or
has
assisted
in
implantation
b) Board certified TCVS
who has
training in
device implantation
3) Interventional Cardio
who has implanted CIEDs
a)General Cardio may not
implant ICDs or CRTs
a.1. must work with level
3 or
a.2. must work with TCVS
+ level 2.5(ICDsonly)
b)TCVS may implant
ICDs but not CRTs as
primary
operator
working with a level 3 or
a level 2.5
c)
Interventional
Cardiologist may not
implant ICDs or CRTs
c.1. must work with level
3 or
c.2. must work with TCVS
+ level 2.5 (ICDs only)
Cardiology
certified
graduates
PHC
board May work with TCVS on
EP ICDs and with level 3 on
CRTs
3
Cardiology
board May
certified graduate of a independently
recognized
EP
and
Cardiac Pacing program
implant
Similarly, a review of existing HRS and EHRA recommendations re requirements
for CCEP led to this definition of a.certified EP program (requirement for level
3), which should encompass but is not necessarily limited to the following :
Knowledge
Skills
• Knowledge of ICD and CRT Must include development of expertise
generator and lead design, in
function,
programming
• Permanent atrial, right and left
principles
ventricular lead and ICD lead
• ICD
indications
and
placement
contraindications
• Threshold testing
• Determination
of
DFT
• Programming
(including management of high
• Principles of surgical asepsis
DFTs)
• Surgical techniques of
• Management of complications
implantation
• Understanding
drugand
• Management of intraoperative
pacemaker-ICD interactions
complications
• Thorough knowledge of ICD
programming and management
of ICD malfunction
Extensive knowledge of
• Left ventricular lead indications
and contraindications
• Management of biventricular
malfunctions and interactions
• Post-operative complications
ICD AND CRT FOLLOW UP
•
•
All device interrogations and reprogramming of CIEDs should be
performed or supervised by a level 2.5 or level 3
In extreme situations where the patient is in a remote area or is
incapacitated and cannot be brought to an EP, follow up may be
conducted by a trained device technical assist, accompanied by a licensed
physician and with communication with a level 2.5 or 3
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