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Spotlight Interview: Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center

Andrea Natale, MD, FHRS, FACC, FESC1, Mitra Mohanty, MD2, and Barbara Thomas, RN, FHRS3
1Executive Medical Director of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David‚Äôs Medical Center; 
HCA National Medical Director, Cardiac Electrophysiology; Professor of Medicine, Dell Medical School; EP Live Course Director; 2Director of Translational Research at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center; 3Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas

Andrea Natale, MD, FHRS, FACC, FESC1, Mitra Mohanty, MD2, and Barbara Thomas, RN, FHRS3
1Executive Medical Director of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David‚Äôs Medical Center; 
HCA National Medical Director, Cardiac Electrophysiology; Professor of Medicine, Dell Medical School; EP Live Course Director; 2Director of Translational Research at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center; 3Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas

What is the size of your EP lab facility? When was the EP program started at your institution? 

We have 4 dedicated EP labs, a shared hybrid OR, and a training facility at St. David’s Medical Center. The EP program started in 1996 and expanded to the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in 2008, with expansions in 2007, 2009, and 2014. There were also remodeling projects in 2010 and 2015.

What is the mix of credentials on staff in your lab?

We have 1 director, 1 manager, 2 supervisors, 1 research and technology coordinator, 1 education coordinator, 15 RNs, 7 scrub technicians, 3 patient-care technicians, 1 environmental services staff member, 1 service-coordinator, and 1 clinical scheduling coordinator.

What types of procedures are performed at your facility? Approximately how many catheter ablations (for all arrhythmias), ICD implants, and pacemaker implants are performed each week? 

Complex ablations including atrial fibrillation (AF), ventricular tachycardia (ischemic and idiopathic), ventricular fibrillation, atrial tachycardia (AT), supraventricular tachycardia, and inappropriate sinus tachycardia (IST) are performed in our lab. We also perform implantation of biventricular devices, ICDs, pacemakers and loop recorders, laser lead extractions, and left atrial appendage occlusion devices. The average number of procedures performed in the lab is between 50-60 cases per week. In the last two years, we have performed more than 2000 AF ablations and around 410-450 VT ablations per year.

Who manages your EP lab?

EP services operate under the direction of Barbara Thomas, director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center (SDMC). She is supported by a management team that consists of 1 manager (Douglas Bishop) and 2 supervisors (Shannon Perez Vazquez and Carlos Monreal).

Do you have cross training inside the EP lab? 

It is our goal to have all staffs trained in each role within the EP lab. Initially, all nurses are trained to circulate. After the nurse is comfortable with EP procedures, they are gradually trained to monitor and eventually scrub. Technicians are trained to scrub procedures and eventually learn to monitor. The law in Texas states that techs cannot administer drugs, which is why they are not trained to circulate cases.

What type of hospital is your EP program a part of?

TCAI is part of St. David’s Medical Center, an acute-care facility. SDMC is part of St. David’s Health Care — one of the largest health systems in Texas, which was recognized with a Malcolm Baldrige National Quality Award in 2014.

What types of EP equipment are most commonly used in the lab? 

We use the CardioLab Recording System (GE Healthcare), Niobe® ES system (Stereotaxis), Sensei X (Hansen Medical) in 2 labs, Odyssey QuadHD (Stereotaxis) in all labs, Odyssey Cinema™ System (Stereotaxis), CARTO 3 v4 (Biosense Webster, Inc., a Johnson & Johnson company), EnSite Velocity (St. Jude Medical), CryoConsole Cardiac CryoAblation System (Medtronic), SmartAblate (Biosense Webster/ Stockert), Ampere RF Ablation Generator (St. Jude Medical), and the NRG RF Transseptal Needle (Baylis Medical). 

How is shift coverage managed? What are typical hours (not including call time)?

Our staff members are assigned to teams for each room, and they stay until the procedures are done. There is a designated late team each day for procedures that go late. Typically, the day starts at 6:30 a.m. and ends, on average, at 5 p.m.; each person has four 10-hour days per week.

Tell us what a typical day might be like in your EP lab.

Staff members arrive at 6:30 a.m. for 7:30 a.m. start time, and the typical day is 10-plus complex ablations along with the device implants and lead extractions. We recently designated a Left Atrial Appendage Occlusion (LAAO) day, during which we perform 8-plus appendage closure procedures. 

What new technology has been recently added to the EP lab? How have these technologies changed the way you perform procedures?

The continued improvement of 3D mapping technologies, combined with a new transseptal access system (Baylis Medical’s NRG system and 3D mapping switchbox), have allowed us to advance our fluoroless procedure techniques. We continue to work with vendors to develop new tools, such as Baylis Medical’s DuoMode Cable, to allow for smoother fluoroless cases and a wider range of fluoroless procedures.

What imaging technology do you utilize?

We use Artis zeego (Siemens Healthcare), Artis zee (Siemens Healthcare) with MediGuide (St. Jude Medical), AlluraClarity FD20 with FlexMove (Philips), Allura Xper FD10 (Philips), ACUSON SC2000 ultrasound system (Siemens Healthcare), ACUSON SC2000 Prime (Siemens Healthcare), ViewMate ultrasound console (St. Jude Medical), and the Vivid E9 (GE Healthcare) for 3D TEE for LAA occlusion.

Do you implant MR conditional pacemakers or ICDs? What about subcutaneous or leadless devices?

Yes, we implant all of these devices.

Who handles your procedure scheduling? Do they use particular software? 

Procedures are referred to our scheduling coordinator from the physician’s office using EPIC and Meditech. Once the case is scheduled, we have a clinical coordinator (RN) who reviews the patient history and pre-op testing, and ensures that the patient is ready for the procedure. Our scheduling coordinator serves as a liaison between the patient, physician, and other departments to provide information or convey appropriate instructions.

How is inventory managed at your EP lab? Who handles the purchasing of equipment and supplies?

One of the managers (Carlos Monreal) handles purchasing and inventory. Capital equipment is managed by the director and technology coordinator.

Has your EP lab recently expanded in size and patient volume? 

Yes, we just announced an entirely new EP center within our hospital to replace our existing EP labs, which is set to open in early 2018. This will consist of 6 EP labs, including a dedicated EP hybrid OR suite, new pre- and post-procedural areas, and a 24-bed telemetry unit.

Have you developed a referral base?

Yes, our group has more than 10 outreach centers in Texas, and some of our doctors also work in other states.

In what ways have you helped to cut/contain costs and improve efficiencies in the lab?

We work very closely with our vendors on pricing, and frequently buy products in bulk to reduce the overall cost of supplies.

How do you ensure timely case starts and patient turnover?

We have ancillary staff, 3 PCTs, and a dedicated environmental services staff member to clean our rooms between cases and to help transport patients.

How are new employees oriented and trained at your facility?

New employees start with a formal orientation that is provided by St. David’s Medical Center, which introduces the policies and practices of the hospital. After the initial 2 days of hospital orientation, they proceed with comprehensive training in the EP lab for 12 weeks. We have a dedicated orientation system that involves learning the basics of electrophysiology, competencies that must be completed which are specific to EP procedures, and training on the equipment, which is an ongoing process for the new employees.

What types of continuing education opportunities are provided to staff members?

In-services are performed by vendors, our education coordinator, and physicians.

How is staff competency evaluated?

We have annual competency evaluations in the lab that are specific to EP training, as well as computerized learning that is assigned by the hospital. Training is evaluated and documented in each employee file for formalized monitoring. Performance and verbal check-offs are conducted by designated preceptors and education coordinators.

Have members of your staff taken the registry exam for the Registered Cardiac Electrophysiology Specialist (RCES)? Does staff receive an incentive bonus or raise upon passing the exam?

Yes, we also have several staff members with IBHRE CEPS; there is no incentive bonus offered for certification.

How do you prevent staff burnout? Do you also practice any team-building exercises?

We prevent staff burnout by cross-training our staff, and we host after-hour get-togethers for the purposes of team building.

What committees, if any, are staff members asked to serve on in your lab?

Staff members are asked to serve on the following: hospital shared governance committee, unit governance, employee advisory council, safety committee, and HIPAA committee.

How do you handle vendor visits to your department? Do you contract with vendors?

Vendors and vendor representatives are credentialed by HCA Parallon to gain access to the EP lab.

Describe a particularly memorable case from your EP lab and how it was addressed.

To name a few, we’ve performed a fluoroless ablation in a pregnant patient with SVT, treated a patient with multiple earlier catheter ablations and a surgical MAZE procedure for AF, as well as treated a VT patient with frequent ICD shocks and 2 previously failed ablations.

How does your lab handle call time for staff members? 

The cath lab staff members cover call for device implants on the weekends.

Approximately what percentage of ablation procedures are done with cryo vs radiofrequency?

Up to 2.5% of procedures are done using cryo energy.

Does your lab use contact force sensing technology during radiofrequency ablation of atrial fibrillation?

Yes.

What are your techniques for LAA occlusion? Do you have a primary approach?

Our primary approaches are with the WATCHMAN device (Boston Scientific), LARIAT Suture Delivery Device (SentreHeart, Inc.) and AtriClip (AtriCure). We will soon start using the WaveCrest (Coherex) and Amplatzer Amulet (St. Jude Medical).

What are your thoughts on the use of the new oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation?

Findings from different studies conducted at our institution have provided evidence about the following: 

  • Performing AF ablation while on uninterrupted apixaban and rivaroxaban without TEE is feasible and safe;
  • Uninterrupted apixaban administration in patients undergoing AF ablation is effective in preventing clinical and silent thromboembolic events without increasing the risk of major bleeding compared to warfarin;
  • Periprocedural dabigatran use is associated with risk of bleeding and thromboembolic complications compared with uninterrupted warfarin therapy, in non-paroxysmal AF patients.

Is hybrid epicardial and endocardial ablation of atrial fibrillation performed at your institution?

It is currently not done; in our experience, it did not provide any additional benefit.

What other innovative EP techniques are being utilized in your lab? 

In addition to providing patients with cutting-edge care, TCAI also strives to advance the field of cardiac electrophysiology through education and clinical research. To further the education portion of our mission, TCAI houses a state-of-the-art multimedia training center. The international training center (ITC) allows visiting physicians, EP lab staff, and industry personnel to observe procedures from a comfortable conference room while still being able to interact with the operating physician and lab staff. This is accomplished with multiple remote control cameras in both the ITC and the labs, full audio integration between the labs and the ITC, and with the use of the Odyssey Cinema System (Stereotaxis). This combination of systems allows visitors to feel like they are in the lab, and at the same time, provides them with a better perspective than if they were actually in the lab. In addition to local viewing, the ITC allows TCAI to broadcast both live and recorded cases around the world, both over the internet and through traditional satellite broadcasts.

Do you perform only adult EP procedures or do you also do pediatric cases? 

The majority of the procedures performed in the lab are on adult patients. We occasionally perform ablations on patients in the pediatric age group. In that case, we communicate with PACU, anesthesia, and the nursing units to facilitate the appropriate pre-, peri-, and post-operative care needed for these patients.

What measures has your lab taken to reduce fluoroscopy time? In addition, what types of radiation protective shielding and technology does your lab use?

Some procedures are conducted using a non-fluoroscopic 3D mapping system. We also always work with the lowest exposure to RF energy. One of our physicians performs completely fluoroless ablation procedures.

What are your methods for device infection prophylaxis?

We administer IV antibiotics within an hour of stick time.

What are some of the dominant trends you see emerging in the practice of electrophysiology? 

Dominant trends include fluoroless and leadless techniques, as well as more AF and VT ablations.

How does your lab handle device recalls?

We receive an advisory notice from the manufacturer, and act according to the guidelines. Devices are checked for integrity and replaced if needed, at that time, or when the generator has reached the elective replacement interval.

How is outpatient cardiac monitoring managed?

Event recorders are used for the first 5 months following ablation, then 7-day Holter monitors at 3, 6, and 12 months post-ablation, and 12-lead ECG and cardiology evaluations at 3-month intervals.

Is your EP lab currently involved in clinical research studies? 

As part of our commitment to clinical research, we are heavily involved in clinical trials. Ongoing clinical trials include DECAAF and multiple IDE studies. In addition to the clinical trials, we strive to contribute to the knowledge base for electrophysiology through presentation of scientific abstracts in national and international conferences, as well as publication of articles in peer-reviewed journals.

Are you ACGME-approved for EP training? What are your thoughts on two-year EP programs?

No, but we have research fellows. Two-year training is required to acquire the knowledge and skill to effectively perform complex ablation procedures. 

Does your heart rhythm service offer patients with a suspected inherited arrhythmia a referral to a cardiovascular genetics clinic?

Yes.

Describe your city or general regional area. How is it unique from the rest of the U.S.?

Austin is the live music capital of the world, 11th-most populated, and one of the fittest cities in the U.S. It is also home to the acclaimed University of Texas at Austin. 

Please tell our readers what you consider special about your EP lab and staff.

TCAI at St. David’s Medical Center is led by internationally recognized electrophysiologist Dr. Andrea Natale and staffed by a team that includes some of the most prominent physicians and researchers in the field, as well as highly trained and competent staff. In addition to caring for patients suffering from cardiac arrhythmias, the Institute is dedicated to furthering the understanding and treatment of cardiovascular disease and serving as a primary educational resource for physicians around the world. 

The Center for Arrhythmias and Atrial Fibrillation is comprised of 6 registered nurses who are specifically assigned with electrophysiologists at TCAI. The primary goal of this group of nurses is to provide guidance for the patients before, during, and after treatment. The nurse provides information regarding arrhythmias, as well as guidance in setting up a consult with an electrophysiologist. All pre-consultation essentials are clearly explained to the patients, including any testing that may be required. To enhance continuity of care, the nurse joins the patient in the consult and reviews any treatment plans discussed. This is an ideal opportunity for the patient to bring up any concerns, as the role of the nurse is to answer questions and assure that they clearly understand the diagnosis and treatment recommendations. The nurses follow-up with the patients for one year after their procedure.

The clinical research team is a key element in the structure of TCAI. This group of individuals brings to TCAI experience in clinical cardiac and electrophysiology studies, data analysis, and statistical modeling. Strong backgrounds in academic and clinical research settings provide the team with a solid foundation for conducting sophisticated electrophysiology studies. Their works are published in medical journals, and team members frequently present their research findings at national and international meetings. Additionally, some of the physicians are affiliated faculty members at The University of Texas at Austin and Dell Medical School, and collaborate closely with researchers from these institutions in several translational and clinical trials. Dr. Mitra Mohanty leads the research team and supervises research fellows, visiting fellows, summer interns, student volunteers from universities and medical schools from throughout the country, research nurses, and a biostatistician. Moreover, she also directs several of our ongoing clinical trials and multiple national and international collaborative efforts.

For more information, please visit http://www.tcainstitute.com/

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