Author + information
- Received November 1, 2016
- Revision received April 6, 2017
- Accepted April 11, 2017
- Published online December 4, 2017.
- Theresa A. Strzelczyk, MS, APN, CNS,
- Rachel M. Kaplan, MD,
- Meena Medler, MS, PA-C and
- Bradley P. Knight, MD∗ ()
- Center for Heart Rhythm Disorders, Bluhm Cardiovascular Institute, Northwestern Medicine, Northwestern Memorial Hospital, Chicago, Illinois
- ↵∗Address for correspondence:
Dr. Bradley P. Knight, Center for Heart Rhythm Disorders, Bluhm Cardiovascular Institute, Northwestern Memorial Hospital, Northwestern University, Feinberg School of Medicine, 251 East Huron Street, Feinberg 8-503E, Chicago, Illinois 60611.
Objectives This study sought to determine the feasibility, safety, and efficacy of elective electrical cardioversion (CV) for atrial fibrillation (AF) when performed autonomously by a trained advanced practice provider (APP) using a guideline-directed protocol.
Background APPs have emerged as an integral part of the cardiovascular team.
Methods A licensed advanced practice nurse-clinical nurse specialist was trained and obtained credentials to perform CVs. The advanced practice nurse performed 415 CVs autonomously (APP group) in a noninvasive procedure room with an electrophysiologist (EP) immediately available in an adjacent electrophysiology laboratory. The APP performed a history and physical examination, obtained informed consent, reviewed each patient with the supervising EP, and performed the CV. An anesthesiologist administered sedation. Outcomes were compared with 387 CVs performed by an MD when the APP was not available (MD group). Patient satisfaction scores were compared before and after the APP-directed CVs were performed.
Results The proportion of patients discharged in sinus rhythm was the same in the APP group as it was in the MD group (95% vs. 96%, respectively; p = 0.49). There were 4 adverse events in the CVs performed by the APP: 1 transient ischemic attack and 3 occurrences of bradycardia requiring atropine or other medication. There was 1 adverse event in the MD group, which was hypotension requiring vasopressor initiation. Patient satisfaction scores were stable after initiation of APP-driven cardioversions.
Conclusions With appropriate clinical training, an APP can safely perform CVs autonomously, using a protocol that includes a guideline-directed procedural checklist and physician supervision, with excellent patient satisfaction and outcomes.
Multidisciplinary cardiovascular teams with collaboration among cardiologists, cardiac surgeons, primary care physicians, cardiovascular nurses, and many other specialties have been providing high-quality care to patients with heart disease for decades (1). The role of advanced practice providers (APPs), including advanced practice registered nurses (APNs) and physician assistants (PAs), has increased in cardiology practices, assisting the team to deliver high-quality, cost-effective, cardiovascular care while improving physician efficiency (1–3).
The American College of Cardiology embraces the APP as an integral part of the cardiovascular team, as outlined in a 2015 position statement (1). Previous studies have demonstrated favorable outcomes associated with a nurse-led cardioversion program for atrial fibrillation (AF) (4–7). The purpose of this study was to prospectively determine the feasibility, safety, and efficacy of elective CV for AF performed autonomously by a trained APP using a guideline-directed protocol.
Development of advanced practice nurse-driven CV protocol
A licensed APN-clinical nurse specialist with Advanced Cardiac Life Support certification was trained by a board-certified cardiac electrophysiologist (EP) using core competencies based on the 2014 Clinical Practice Guidelines for Management of Patients with AF (8). A guideline-directed protocol including a pre-procedural, procedural, and post-procedural checklist was developed and used for each patient undergoing CV (Table 1). Prior to being certified by the hospital’s medical staff office to independently perform CV, the APP performed 227 CVs with direct supervision by an attending EP over a 10-month period during 2014.
Once hospital credentialing and privileges were granted for the APP, all electively scheduled CVs for both inpatients and outpatients were performed by the APP autonomously on dedicated days of the week (APP group). Cardioversions were performed in a noninvasive procedure room where an attending EP was immediately available either in an adjacent EP laboratory or office, following a protocol agreed upon by all EP attending physicians (Table 2). An attending anesthesiologist, often with a nurse anesthetist, administered monitored anesthesia care with deep sedation for each procedure. In the rare case when anesthesia services were not available, sedation was administered by a certified cardiac nurse under the direction of an attending EP, using a combination of midazolam and fentanyl.
When a pre-procedural transesophageal echocardiogram (TEE) was required prior to CV, the TEE was performed in a nearby, separate echocardiographic procedure room. Sedation was administered by the team performing the TEE as needed. The patient was subsequently transferred to the CV room in the EP suite.
The APP was accountable for the pre-procedural evaluation of the patient and reviewed each patient with the supervising attending EP prior to CV. The APP autonomously performed a history and physical examination, explained risks and benefits of CV, and obtained informed consent prior to CV. During the procedure, the APP was responsible for proper pad placement, appropriate energy selection, verification of QRS synchronization, and delivery of the shock. The APP coordinated the discharge process and the follow-up care with the patient and family and communicated with the referring physician. After the CV, all patients were observed during a 90-min post-recovery monitoring period in the adjacent cardiac recovery and observation unit.
For patients with a pacemaker or implantable cardioverter-defibrillator (ICD), device interrogation was performed by a cardiology fellow and supervised by an EP attending before and after external shocks were delivered. A commanded internal shock from the ICD was not used for CV procedure in the patients who received cardioversion during the time period when this study was performed. In the event of any significant bradycardia or tachycardia complicating the procedure, the protocol required that immediate care be administered following ACLS guidelines by the APP and anesthesiologist with immediate notification of the supervising EP.
On days when the APP was available, all CVs were performed by the APP, without exception. On days when the APP was not available to perform CV, all CVs were performed by a cardiology fellow under direct supervision by an attending EP (MD group).
The outcomes of all invasive heart rhythm procedures were prospectively collected and reviewed quarterly as part of a regularly held Heart Rhythm Quality Conference at our institution. A major complication was defined as a complication that required intervention of prolonged hospital stay and/or resulted in permanent impairment or death. Examples of major complications associated with CV are listed in Table 3.
When the program began for CVs to be performed by a trained APP autonomously on January 27, 2015, the outcomes of all CVs were prospectively included in the outcome Heart Rhythm Quality Conference data. To supplement these data, a retrospective chart review was subsequently performed of all CVs performed by the APP and by a supervised cardiology fellow between January 27, 2015, and August 18, 2016, so that additional patient demographics and CV-related details could be collected. Left ventricular ejection fraction and left atrial diameter values were obtained from the most recent transthoracic echocardiogram. The study was approved by the Institutional Review Board at Northwestern University.
Patient satisfaction was determined by collecting the results of a patient satisfaction questionnaire (Press Ganey, Wakefield, Massachusetts), which is routinely sent by the hospital’s patient representative department to each patient after discharge. The questionnaire asks patients to rate, on a scale of 1 to 5 (with 5 being “absolutely would recommend” and 1 indicating “absolutely would not recommend”), their “Likelihood to Recommend This Hospital.” Scores during the first 2 years after CVs were performed by an APP (2014 and 2015) were collected and compared with the previous year’s score (2013).
All continuous variables were expressed as mean ± standard deviation. A one-way analysis of variance was used to compare >2 means. Student’s t-test was used to compare continuous variables. Average energy levels delivered for CV were expressed as median joules. A p value of <0.05 was considered significant.
The APP performed 227 CVs under direct supervision during the APP training phase. After certification, the APP autonomously performed a total of 415 CVs between January 27, 2015 and August 18, 2016, using the guideline-directed protocol. During the same time period, an additional 387 CVs were performed by a supervised cardiology fellow. There was no significant difference in baseline demographics, clinical characteristics, presenting rhythm, or medications used between the two groups (Table 4).
Procedural characteristics in both groups are shown in Table 5. In 98% of cases in each group, sedation was administered by an anesthesiology team. Fewer patients in the APP group underwent TEE prior to the CV (40% in the APP group vs. 55% in the MD group; p < 0.0001). The energy levels delivered for each type of atrial arrhythmia was the same in each group. The success rate for CV after the first shock was slightly higher in the APP group than in the MD group (90% vs. 84%, respectively; p = 0.01), but after subsequent shocks were delivered and after accounting for immediate recurrences of the arrhythmia that could not be resolved with additional shocks and, in some cases, after ibutilide administration, the proportion of patients discharged in sinus rhythm was the same as that in the APP group compared to those in the MD group (95% vs. 96% respectively; p = 0.49).
There were 4 adverse events in the APP group—one 65-year-old male (CHA2DS2VASc [congestive heart failure, hypertension, ≥75 years of age, diabetes mellitus, prior stroke, transient ischemic attack, or thromboembolism, Vascular disease, Age 65–74 years, Sex category [females] with a score of 4) receiving uninterrupted oral anticoagulation therapy with a novel agent for 4 weeks prior to CV experienced a transient ischemic attack 2 days post procedure but recovered fully without deficit; and 3 episodes of bradycardia requiring medical intervention. In the cardiology fellow group, there was 1 adverse event of hypotension requiring vasopressor initiation. In no APP case was the supervising physician required to scrub out of a procedure to address an issue during or after the CV.
The average patient satisfaction scores (based on Press Ganey questionnaire responses) obtained during 2013 before implementation of APP-driven CVs were not statistically different than those after implementation obtained during 2014 and 2015 (p = 0.929).
The main finding of this study is that elective CVs for AF can be performed safely and with a 95% success rate autonomously by an APP who has undergone appropriate training under the supervision of an EP who is physically nearby and when sedation is administered by an anesthesiologist. There were few acute complications, and the incidence of thromboembolism was low, 0.24%, when a guideline-directed protocol was followed. The APP demonstrated safe and efficacious outcomes compared to those demonstrated by the physician-directed CV group.
Role of APP in performing cardioversions
For more than a decade, APPs, which include APNs and PAs, have been providing high-quality patient care and have demonstrated improved efficiency with shorter length of inpatient hospitalization stays (3,7). The educational curricula of APPs vary depending on the professional discipline (1). Educational focus, in addition to post-graduate specialty training, in areas such as heart failure, EP, valvular cardiology, and transitional care, define the APP’s role on the cardiovascular team. Chronic and advanced heart failure management including cardiac transplant and mechanical circulatory support has a long history of multidisciplinary cardiovascular team-based care using APPs with excellent patient outcomes (1,9,10). APPs have expanded their roles across the cardiovascular spectrum of care including areas such as inpatient consultative services, hospital transition of care, hypertension clinics, lipid clinics; electrophysiology and structural heart programs including transcatheter aortic valve replacement; and are an essential component of cardiovascular team-based care (1,7,11). Clinical practice of the APP has been closely monitored and critiqued demonstrating “high marks for delivering safe, effective, quality care” (2,7).
At our institution, for the past 5 years, all CVs have been performed in a noninvasive procedure room adjacent to the EP laboratory with the patient in deep sedation administered by the anesthesia team. Prior to the performance of APP-driven CVs 3 years ago, all CV procedures were performed by a general cardiology or clinical cardiac EP fellow under direct supervision of an EP attending physician who was physically present during the key portions of the CV procedure. After the APP obtained credentials to autonomously perform CVs, the responsible EP attending continued to supervise the CVs but was not required to be physically present and was available while performing procedures in one of the adjacent invasive EP laboratories. This has greatly improved the efficiency of the EP fellows and attending physicians. It has also minimized any delays for the anesthesiologists because they no longer have to wait at times for the physical presence of the attending EP doctor in the procedure room.
In the United States, the scope of practice for APNs varies by state. Hospital credentialing of the APN to perform CVs was a major challenge given that CV was a new procedural practice for an APN and that there was no precedent at the time at other hospitals.
The favorable experience in the present study is consistent with prior studies of nurse-driven CVs that have been published recently, but the degree of responsibility, credentials and educational preparation of the nurses who have guided CVs has varied across centers (4–7). In 2014, Moore et al. (4) published their experience with CVs performed over a 7-year period in Australia under the supervision of a nurse described as a trained electrophysiology nurse specialist. As in the present study, the nurse specialist in the study by Moore et al. (4) coordinated the pre-CV care, directed the CV in the presence of a trained anesthetist, and was the first point of contact during recovery. Unlike the present study, however, a junior physician obtained informed consent; it was not made clear if a supervising cardiologist was immediately available in the event of an emergency, and there was no comparison group. Regardless, they found a 90% rate of success with no major complications.
Two studies from the United Kingdom demonstrated safe and effective performance of CVs when directed by nurses with advanced training (5,6). In a study by Boodhoo et al. (5) in 2004, nurses who performed CVs had at least 1 year of coronary care unit experience, were Advanced Cardiac Life Support (ALS) certified, and had performed a minimum of 20 supervised CVs. In their hospital, the nurses administered the sedation without an anesthesiologist present. Although, as the authors suggest, this sedation approach reduces costs, a cardiac registered nurse in the United States would not be granted hospital privileges to independently provide moderate sedation. In the study by Currie (6), an anesthesiologist rather than a nurse administered sedation, but unlike the present study, patients who were considered high risk due to advanced heart disease, presence of a pacemaker, or severe obesity, were excluded from the nurse-directed CV approach.
The only published study based on U.S. experience with nurse-led CVs is a retrospective study by Norton et al. (7) that compared the outcomes of CVs performed by physicians alone, those by physicians with a nurse practitioner, and those of nurse practitioners independently. They found comparable success rates in each group, with a success rate of 93% in the nurse practitioner group, and there were no complications in any of the CV groups. Unlike the present study, however, the nurse practitioner was certified in ICD interrogation and reprogramming, performed the CV completely independently, and billed for the procedures. The APP who performed the CVs in the present study is a salaried employee of the hospital where the procedures were performed and did not bill independently for procedures.
The present study also differs from prior studies in that outcome data were prospectively collected by a single APN who was performing the procedures and were reported as part of a regular quarterly EP quality assurance meeting. Another difference is that patient satisfaction data are presented.
One limitation of this study was that it was designed and implemented based on the practice of one individual APP. Further studies with multiple APP providers, following licensing rules, which vary from state to state, would be beneficial to validate the results across the spectrum of APPs. In addition, the findings of the present study are only applicable to practices where sedation for CVs is administered by an anesthesiologist. Cost effectiveness of APP-driven CV was not assessed.
With appropriate clinical training, a protocol that includes a guideline-directed procedural check list, monitored anesthesia care with deep sedation administered by an attending anesthesiologist, and supervision by an attending EP cardiologist who is readily available, an APP can safely and autonomously perform CVs with excellent patient outcomes while maintaining high patient satisfaction. Elective CV for AF is a procedure that is highly suitable to protocol formation and delegation to an APP. The protocol that was developed by the APP may provide a useful reference for practices interested in adopting APP-driven CVs.
COMPETENCY IN PATIENT CARE AND PROCEDURAL SKILLS: With appropriate clinical training, an APP can safely and autonomously perform CVs with excellent patient outcomes while maintaining high patient satisfaction.
TRANSLATIONAL OUTLOOK: Further studies with multiple APP providers would be beneficial to validate the results across the spectrum of APPs.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Abbreviations and Acronyms
- atrial fibrillation
- advanced practice provider
- advance practice registered nurse
- direct current cardioversion
- implantable cardioverter-defibrillator
- physician assistant
- transesophageal echocardiogram
- Received November 1, 2016.
- Revision received April 6, 2017.
- Accepted April 11, 2017.
- 2017 American College of Cardiology Foundation
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