Transitioning from EP Diagnostic to Therapeutics: What are the Essential Considerations? by Barbara Sallo, RN, MBA and Marsha MacIntyre, RN, BSN

Staffing for ablations should consist of at least three team members in addition to the attending physician. It is “recommended that staff utilized for ablative procedures have experience with at least 30 catheter ablations before working independently in the EP lab, and that they continue to assist on 30 cases per year.”3 The number of physicians involved in the case, their experience, and the difficulty of the case can change the staff composition to include more or less personnel.

The team should consist of a scrub person, a circulating nurse and a cardiovascular technician (CVT) monitoring person. Normal cath lab responsibilities for these positions remain the same with the exception of the CVT monitoring person. Ideally, the staff member monitoring the case will be CVT certified and have familiarity with ablative procedures. Additional responsibilities charged to the CVT monitoring person, besides observing the patient and recording and documenting clinical information, will be operating the radiofrequency generator used during the ablation. The monitoring staff person will turn the equipment on and off and feed information to the physician throughout the case. It is vital to have excellent communication between the CVT monitoring person and the physician. While operation of the equipment on is not difficult, it requires intense concentration. It is vitally important not to activate the ablator until instructed by the physician. The ablator permanently destroys viable cells. This can be especially significant in AV ablations, where ablating the inappropriate area can place the patient into permanent heart block requiring a pacemaker. Unlike cardiac catheterization procedures, the CVT staff member monitoring the case needs to be informing the physician every few seconds of the measured value and the length of time the machine has been operating. The information the physician needs to be aware of includes: the power or temperature, impedance, and the length of time the generator is active. Any changes in these values need to be reported immediately. “If the catheter loses contact with the myocardium, blood around the catheter tip may become superheated and boil.”4 For this reason, the CVT monitoring person needs to be prepared to turn the ablator off immediately by keeping his/her finger on or in close proximity to the power button. If discontinued early, the ablator can always be reactivated, but if left on too long, the damage becomes permanent.

Having an experienced staff on board is just one piece of the puzzle. Electrophysiology labs performing ablations should maintain a high volume for proficiency. The NASPE Policy Statement provides information on the success of ablation procedures as related to volume.

Today, most institutions do not require board certification in Clinical Competency in Electrophysiology (CCEP) as a credentialing requirement. However, CCEP recommends applicants should have met board requirements as described on the AHA journal Circulation website.5 Respondents to the CCEP Training Program Directors’ Survey uniformly indicated that two years were required to achieve training in all aspects (diagnostic and therapeutic) of CCEP.1 Additionally, there is general consensus among EP practitioners that one year of specialized training in EP is needed to gain the knowledge and technical skills necessary to become proficient in EP. In addition to general cardiology fellowship training, the Clinical Competency Electrophysiology Training Program Directors’ Survey1 indicates that a minimum of 90 cases are required to acquire clinical competency in ablation. Furthermore, the NASPE Ad Hoc Committee1 on catheter ablation recommends that a physician be the primary operator on >= 30 procedures, including 15 accessory pathway ablations.

Not surprisingly, the majority of EP physicians are located at high-volume academic centers. According to the NASPE website,6 the state of California has the most EP physicians at 161, while Wyoming has only one. More rural areas suffer a dearth of these specialists, and patients must often rely on referrals from their cardiologists to be evaluated at tertiary centers. The wait time to see these highly demanded specialized EP cardiologists can be two months or more. The Cardiovascular Roundtable7 notes that while the number of electrophysiologists has doubled between 1996 and 2001, the number of patients receiving EP therapy remains small due to an EP physician workforce being unable to meet the demand.

In conclusion, hospitals must consider a number of clinical issues when deliberating the feasibility of implementing a full-service EP program. Having open-heart surgery back-up on site is one of the most important considerations and must be carefully thought-out. Offering open-heart surgery can be a very expensive proposition, and often there are regulatory challenges and barriers to entry. Twenty-five states require hospitals to file Certificate of Need (CON) applications for acute care services. Each of these states has established a specific criterion for the clinical and/or financial threshold that would trigger the need to file the CON application, but all require an application for open-heart surgery at this time.

States also have established Department of Health Regulations that vary within each jurisdiction. Some states require hospitals to make notification of new services, and others will review services on inspection tours.

Gathering information from clinical resources, developing financial projections, and researching state-specific regulations regarding EP and open-heart surgery are all essential elements of a thorough due diligence. Preparation and presentation of all available information to the stakeholders — including hospital administration and medical staff — will set the stage for a well thought-out decision that will meet patients’ needs with a successful, high-quality EP program.

This article was written by Marsha MacIntyre RN, BSN, consultant, and Barbara Sallo, President of Health Care Visions, Ltd., a cardiovascular consulting firm based in Pittsburgh, Pennsylvania. The firm brings extensive knowledge and expertise in this area of clinical care. Health Care Visions, Ltd. has assisted a multitude of hospitals in all phases of cardiovascular programs for market assessments, program assessments and feasibility studies to business planning and implementation.

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BIO:

Barbara Sallo, RN, MBA is the President of Health Care Visions, Ltd. a cardiovascular consulting firm based in Pittsburgh, Pennsylvania. The firm brings extensive knowledge and expertise in this area of clinical care. Health Care Visions, Ltd. has assisted a multitude of hospitals in all phases of cardiovascular programs from market assessments, program assessments and feasibility studies to business planning and implementation.

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