The Heart Rhythm Society recently sent letters to hospitals urging them to adhere to competency standards from the 2004 Clinical Competency Statement: Training Pathways for Implantation of Cardioverter Defibrillators (ICD) and Cardiac Resynchronization (CRT) Devices and 2005 Addendum (see sidebar). I recently asked Anne B. Curtis, MD, President of the Heart Rhythm Society, about the current state of the guidelines. Dr. Curtis is also Chief, Division of Cardiology, and Director and CEO, Cardiovascular Services, University of South Florida in Tampa, Florida.

Approximately how many hospitals and institutions were not adhering to the guidelines? How was HRS able to come across the information that these institutions were not following the minimum competency standards for implantation?
We heard from several members (probably around five) that hospitals in their area were not adhering to the guidelines. These Heart Rhythm Society members contacted us to let us know this was going on.

Why was the 2004 Clinical Competency Statement: Training Pathways for Implantation of Cardioverter Defibrillators (ICD) and Cardiac Resynchronization (CRT) Devices and 2005 Addendum initially put together? What do they mandate? Why was it needed, and who does it benefit, as well as protect?
The two statements were developed because we were aware that some physicians who were not electrophysiologists were implanting ICDs. For patient safety and optimal care, we developed the guidelines to say that only physicians with proper training should be implanting these devices. One should either be a board-certified or board-eligible cardiac electrophysiologist, or else meet a specific set of criteria. These criteria included physicians who already implant a substantial number of permanent pacemakers (defined as at least 100 devices over the preceding three years) who would then attend a didactic course, be proctored for a minimum of 10 ICD implants, and take and pass NASPExAM, an examination of competency in pacing and defibrillation.

Isn't it slightly dangerous for those who have not been adequately trained to be independently implanting ICDs and CRTs? For what reasons might hospitals not follow the competency guidelines suggested by the HRS and CMS?
Only physicians with proper training should be implanting ICDs. The same is true for any invasive procedure on a patient — properly trained physicians are best qualified to perform the procedure. It is possible that some hospitals have not been fully aware about the type and level of training needed to do ICD implantations well. For that reason, the Heart Rhythm Society has been sending letters to hospitals explaining these guidelines in detail.

Where can one get more information about guidelines for device implantation? In addition, briefly describe HRS's upcoming program "ICDs and Cardiac Resynchronization Devices: Fundamentals of Patient Selection, Implantation and Follow-Up".
The guidelines were published in our journal, Heart Rhythm (Curtis AB et al., Heart Rhythm 2004;1:371–375), as was the addendum (Day JD et al., Heart Rhythm 2005;2:1161–1163) and can also be found online at our website, www.HRSonline.org. The upcoming program is the third time we have given this didactic course, which is one of the key components of the guidelines. It is a two and a half day course that covers indications, implantation techniques, programming, troubleshooting, and follow-up of ICD and CRT devices. After the April course, we plan to give it one more time in the fall, and that will be the final time we give it. With four opportunities to take the course over two years, we believe we will have given physicians in practice sufficient time to take the course to meet that component of the guidelines. Physicians in training should get the training they desire during their fellowship programs, and there will neither be the need nor the opportunity to use the alternate pathway to attain competency.

IN THE NEWS:

- Heart Rhythm Society Asks Hospitals to Follow Competency Standards for Implantation **i**The Heart Rhythm Society has begun sending advisory letters to hospitals and other institutions that are allowing physicians without sufficient training to independently implant Cardiac Resynchronization (CRT) devices and implantable cardioverter defibrillators (ICDs). The letters “strongly” encourage the institutions to adhere to the competency standards for implantation of ICDs and CRT devices established by the Society in 2004. **i**“We want these institutions to understand that experience with these devices and industry-sponsored courses do not provide adequate training to implant these devices,” says Anne B. Curtis, MD, president of the Heart Rhythm Society. “The best way for patients to receive safe, competent and efficient device implantation is for physicians to be fully trained and meet these competency guidelines.” **i**The 2004 Clinical Competency Statement: Training Pathways for Implantation of Cardioverter Defibrillators (ICD) and Cardiac Resynchronization (CRT) Devices and subsequent 2005 Addendum explain the minimum standards for hospital credentialing bodies to ensure appropriate patient care. The publications establish minimum competency standards for safe and competent ICD and CRT device implantations. The standards include testing and course work for the non-board certified electrophysiologist, define proctoring and proctorship, outline unique pediatric considerations, and provides requirements for those able to be grandfathered to independently implant devices. The letters reiterate last year’s Final Coverage Decision for ICD implantations from the Centers for Medicare and Medicaid Services (CMS) which stated “CMS strongly encourages credentialing and certification of physicians who insert ICDs by appropriate national organizations, such as the Heart Rhythm Society (HRS)…” **i**The 2004 Clinical Competency Statement, 225 Addendum and full text of the letter can be found at http://www.hrsonline.org/icd.

For more information about the guidelines or about the Heart Rhythm Society, please visit this website: www.HRSonline.org