GUIDELINES FOR TRAINING REQUIREMENTS TO INSERT IMPLANTABLE

							              The Cardiac Society of Australia and New Zealand




                                               BACKGROUND
 This document represents the views of the Cardiac Society of Australia and New Zealand and was ratified at the
 Council meeting held on 25th November, 2005.

 This paper was developed by the members of the Electrophysiology & Pacing Working Group of the CSANZ,
 together with Dr Hugh McAlister and co-ordinated by Dr Glenn Young (Chair of the Working Group).




           GUIDELINES FOR TRAINING REQUIREMENTS
          TO INSERT IMPLANTABLE DEFIBRILLATORS FOR
              PRIMARY PREVENTION INDICATIONS

The following guidelines for competency in primary prevention ICD implantation have been
developed after review of the clinical evidence surrounding this issue and in consultation with the
Electrophysiology and Pacing Working Group of the Society.

Background
Implantable defibrillators (ICD’s) have been proven to be highly effective therapy for the
treatment of individuals who have suffered a serious ventricular arrhythmia. Traditionally ICD’s
for this indication have been prescribed by, and to a large extent implanted by, Cardiac
Electrophysiologists. The Cardiac Society would recommend that patients who have sustained a
life threatening arrhythmia and are being considered for ICD therapy should be referred to a
Cardiac Electrophysiologist. More recently trial evidence has shown that ICD’s implanted
prophylactically (ie before an arrhythmia has occurred) in high risk patient groups cannot only
prevent sudden cardiac death but also improve overall survival. With the expanding indications
and demand for ICD implantation there has been a move towards non-EP trained cardiologists
prescribing and implanting ICD’s for primary prevention indications. The basis of this move is
the assumption that appropriate device selection, implantation and follow up in this group
requires less training and experience that in the case of secondary prevention ICD implantation.
There is no evidence to support this fact. The Cardiac Society has reviewed the formal guidelines
issued by the Heart Rhythm Society (formally the North American Society of Pacing and
Electrophysiology (NASPE)) concerning appropriate training requirements for ICD implantation.
This is the preeminent International body in this field. Their documents are exhaustive in their
reasoning and rationale for all their recommendations. These can be accessed on the Heart
Rhythm Society Website at http://www.hrsonline.org/. This information has been utilised to
develop guidelines for practice in Australia and New Zealand with consideration being given to
local factors and conditions.
Guidelines for training requirements to insert implantable defibrillators for primary prevention indications   Page 2



The Cardiac Society considers that the evaluation of patients who might require ICD therapy
requires sub-specialty training in Cardiac Electrophysiology. There are circumstances where
individuals other than Cardiac Electrophysiologists may implant ICD’s. Such an example would
be a Cardio-Thoracic Surgeon who implants the device upon the advice of a Cardiac
Electrophysiologist involved in the patient’s management. In these circumstances The Cardiac
Electrophysiologist would have properly evaluated the patient, assessed their arrhythmia and may
have performed Cardiac Electrophysiologic Studies (EPS) to clarify the diagnosis. The Cardiac
Electrophysiologist would be responsible for Electrophysiologic Testing at the time of the
implantation, would have the knowledge to deal with difficulties encountered at the time of
implantation and would follow up the device. Another example would be the non-EP trained
Cardiologist with extensive pacemaker implantation experience who has undertaken the
appropriate additional training requirements as outlined below (alternative training requirements
for ICD implantation). The Training and Competency Guidelines in Sub-specialty Training in
Cardiac Implantable Electronic Devices: Selection, Implantation and Follow Up makes the
following statement reinforcing the pivotal role of the Cardiac Electrophysiologist in ICD
implantation: “It is recommended that a Cardiac Electrophysiologist be directly involved in the
decision making process, implantation and monitoring of patients who have an ICD implanted.”


Training Requirements For ICD Implantation
    1. Successful completion of a Cardiac Electrophysiology Training Program.
           Confirmation of the candidate’s training should be sought from their supervisor in a
           recognized Electrophysiology Training Program. The CSANZ guideline for
           appropriate training requirements for Cardiac Electrophysiology can be accessed on
           the website.

              OR

    2. Extensive experience in pacemaker implantation and completion of alternative training
       requirements for ICD implantation as outlined below.
          a. Definition of an experienced implanter:
                   i. At least 35 pacemaker implantations per annum and at least 100 in the last
                      three years (documentation required)
          b. Alternative training requirements (completion of all sections required)
                   i. Proctored ICD implantation experience by a Cardiac Electrophysiologist -
                      10 implants and 5 revisions.
                  ii. Completion of a didactic course (such as that offered by the Heart Rhythm
                      Society) or successful completion of an approved examination.
                 iii. Monitoring of patient outcomes and complications.
                 iv. Established patient follow up.
                  v. Maintenance of competency – at least 10 ICD procedures per year and 20
                      patients per year in follow up.

The Cardiac Society believes that adherence to these guidelines will allow frequent pacemaker
implanters who wish to undertake ICD implantation to do so safely, while protecting the interests
of patients undergoing these procedures.