Spotlight: The Cardiac Catheterization Laboratory at the University of North Carolina Medical Center, Chapel Hill

Our extensive participation in clinical research trials allows our patients to have access to advanced therapies that otherwise might not be available for many years. In addition to performing these advanced treatments, we help develop them. Research by our physicians has been recognized by organizations such as the American Heart Association (AHA), the American College of Cardiology (ACC), and the National Institutes of Health. In fact, one of our cardiologists, Sidney C. Smith, MD, is a past president of the American Heart Association.

Our catheterization department has 2 dedicated adult procedural suites and 1 dedicated pediatric cath suite, 1 shared cath/electrophysiology (EP) suite, and 1 hybrid/operating room (OR) lab shared with surgical services and used for transcatheter aortic valve replacement (TAVR) procedures. We have a diverse staff, both professionally and culturally. We have 31 staff members: 3 registered cardiovascular invasive specialists (RCISs), 5 registered radiologic technologists (RT[R]s), 1 cardiovascular technologist (CVT), 18 registered nurses (RNs), 1 inventory manager, 1 procedure flow coordinator, 1 administrative assistant, 1 administrative coordinator, 1 coder, 2 RNs to coordinate scheduling, and 1 quality and organizational excellence analyst.

What procedures are performed in your cath lab?

In our adult cath labs, we perform the full spectrum of complex coronary and peripheral diagnostic and interventional procedures, including right heart catheterizations, right ventricular biopsies, peripheral vascular procedures, TAVR, valvuloplasty including aortic, mitral, and pulmonary, complex higher risk (and indicated) patients (CHIP), chronic total occlusions (CTOs), orbital and rotational atherectomy, physiological assessment of lesion significance using fractional flow reserve (FFR) (both wire- and catheter-based), intracoronary imaging using intravascular ultrasound (IVUS) and optical coherence tomography (OCT), and left ventricular (LV) hemodynamic support.

In the pediatric cath lab, we perform diagnostic right and left heart catheterizations, valvuloplasty including aortic, pulmonary, and conduit, pulmonary arterial angioplasty and/or stenting, congenital diagnostic catheterization procedures, atrial septal defect (ASD), patent ductus arteriosus (PDA), patent foramen ovale (PFO) and ventricular septal defect (VSD) closures, aortic angiography, coarctation angioplasty and/or stenting, and transcatheter pulmonic valve (TPV) replacement (Melody, Medtronic).

UNC Heart & Vascular has seen a significant growth in structural heart interventions under the leadership of co-directors John Vavalle, MD, MHS, FACC, and Thomas Caranasos, MD. Our TAVR team consists of cardiothoracic surgeons, interventional cardiologists, cardiac anesthesiologists, cardiac radiologists, and cath lab and OR staff. The procedure is performed in both the hospital surgical hybrid OR suites as well as in the cath lab. We have performed TAVR cases via femoral, subclavian, and apical approaches. We have also performed the first suprasternal-approach TAVR in the world. On the pediatric side, our Melody valve team has performed a significant number of Melody valve procedures.

Tell us about the availability of surgical backup.

Surgical backup is available 24/7 for both our adult and pediatric patient population, emergent and otherwise. The University of North Carolina at Chapel Hill is home to UNC Hospitals’ American College of Surgeons (ACS)-verified Level I Trauma Center. In addition, UNC Hospitals’ North Carolina Children’s Hospital has been verified by the ACS as a Level I pediatric trauma center, the highest verification offered by the ACS Committee on Trauma. It is the first hospital in the Triangle (a geographic area in North Carolina with companies and universities committed to high levels of research), and one of only two in the entire state, to receive ACS recognition for having the highest level of expertise in treating critically injured children.

How many of your diagnostic caths are normal?  

Approximately 20% of our diagnostic procedures at UNC demonstrate “normal” coronary arteries. The balance (80%) require medical management, intervention (percutaneous coronary intervention [PCI]) and/or coronary artery bypass graft surgery (CABG). 

Do any of your physicians regularly gain access via the radial artery?

We have seen a significant increase in transradial procedures. All of our faculty perform transradial interventions, and over half of our interventionalists are “radial first” operators that routinely perform complex coronary interventions, including primary PCI for ST-elevation myocardial infarction (STEMI), CTOs, and high-risk cases via the radial approach. We also routinely perform our right heart catheterizations via an antecubital vein.

Who manages your cath lab?

Prashant Kaul, MD, FACC, FSCAI, is the Director of the Cardiac Catheterization Laboratory and Interventional Cardiology, and George A. “Rick” Stouffer, III, MD, FACC, FSCAI, is Chief of the Division of Cardiology. Cathy Rege, RN, MS, is Director of Cardiac Services and Brenda McClure, RN, BSN, is Manager of Invasive Cardiology Laboratory.

Who scrubs, circulates, and monitors?

In each procedure room, we have 1 nurse and 2 cardiovascular (CV) technologists or cath lab specialists per case. Our drug administration policy is that only RNs administer sedation/medications, so the RN in the lab circulates, and the technologists/specialists scrub and monitor during the procedures. There currently are 2 cath RNs who are also trained to monitor. We have cath lab staff who are cross-trained in the pediatric cath lab, EP staff who are cross-trained in the adult cath lab, cath lab staff who are cross-trained in the EP lab, and cath lab nurses, specialists, and technologists who support pre and post procedure. All staff in the cath lab work together to load patients on the table, monitor/assess patient vitals, pull sheaths, hold pressure, and assist the physicians as needed.

Which personnel can operate the x-ray equipment (position the image intensifier, pan the table, change angles, step on the fluoro pedal) in your cath lab?

UNC’s radiation policy states that RT(R)s, CVTs, and RCISs may perform fluoro and serial radiographic imaging under the immediate supervision of a physician. This includes positioning the image intensifier, panning the table, camera angulation, fluoro pedal, and manual switch operation (e.g. peripheral run-offs). The primary operators of the fluoro pedal in our cath labs are the interventional attending and cardiology fellow. All staff that operates fluoro must demonstrate annual competency by meeting all requirements of the competency checklist developed by our radiation safety officer. All staff must successfully complete an online module on radiation safety on an annual basis.

How does your cath lab handle radiation protection for the physicians and staff?

Lead aprons, radiation eye protection, additional shielding, and Radpads are provided in the cath suites to all staff. Dosimeters are provided and monitored monthly. The adult labs are equipped with Philips DoseAware, which provides real-time feedback on scattered x-ray dose so the staff can change their behavior if necessary, taking secondary shielding or distance precautions during the case. Several years ago, we decreased our frame rate for both fluoroscopy and cineangiography from 15 frames to 7.5 frames per second. This simple intervention allowed us to reduce our overall radiation dose by 40%.

What are some of the new equipment, devices and products introduced at your lab lately?

As a leading academic medical facility, we are fortunate to be regularly invited to participate in clinical trials for new and cutting-edge technologies. We were the world’s number-one enrolling site in the Volcano Corporation-sponsored ADVISE II trial using the new Instant Wave-Free Ratio (iFR) physiology assessment and continue to use the technology in clinical practice. We routinely use St. Jude Medical’s OCT, CSI orbital atherectomy, peripheral drug-coated balloons, and CrossBoss and Stingray devices (Boston Scientific) for CTO cases. We are implanting the MitraClip (Abbott Vascular), CardioMEMS (St. Jude Medical), and the Watchman left atrial appendage closure device (Boston Scientific).

How does your cath lab communicate information to staff and physicians to stay organized and on top of change?

We use the SharePoint website, which provides a central storage and collaboration space for documents, information, and ideas. It is how we collaborate, communicate and “meet”. Through the site, we: 1) coordinate projects, calendars, and schedules; 2) discuss ideas and review documents or proposals; and 3) share information and keep in touch with each other. We also have monthly staff meetings with peer presentations. Regular supplier and vendor inservices keep us current and competent with equipment, techniques, and medications. 

How is coding and coding education handled in the lab?

We have a dedicated coder in the department who reviews all charting for accuracy, and to confirm all procedures and equipment used have been captured. Weekly, ongoing feedback to cath lab staff keeps all staff apprised of changes in coding/charting, and reduces incorrect documentation and billing. A revenue and usage report is checked weekly to ensure all charges are crossing correctly. The coder checks the work queues in our electronic medical record (EPIC) to make sure all charges are addressed appropriately.

Who pulls the sheaths post procedure?

Fellow physicians, cath lab nurses, and specialists/technologists may remove femoral sheaths, including pre/post holding nursing staff. All staff must pull 10 sheaths under supervision in order to achieve competency. Once they have demonstrated competency, they may pull sheaths unsupervised. As a result of our increasing radial access, more hemostasis bands are being used. Typically, the interventional attending or fellow will remove the radial sheath and apply the radial compression device. In the pediatric cath lab, manual pressure is the standard. Sheaths are pulled by the pediatric interventional cardiologist and pressure is held by cath lab staff.

Where are patients prepped and recovered, post sheath removal? 

All patients (adult and pediatric) are prepped, have sheaths pulled, and are recovered in the holding area of the cardiac cath lab. Due to the growing number of radial procedures, fewer cases are being done via the femoral approach. We use manual pressure in the majority of femoral cases to achieve hemostasis, but also use Mynx (Cardinal Health), Perclose (Abbott  Vascular) and Angio-Seal (St. Jude Medical) devices in select cases. Patients are recovered in the cath lab holding area or on their inpatient unit. Holding nurses or unit nurses take responsibility for post PCI care, involving interventional fellows and attendings as needed.

How is inventory managed at your cath lab?

Britt Oldham, our inventory manager, monitors procedure room and stock room par levels, expiration dates, and unique equipment requirements. He communicates regularly with physicians, lab staff, and the cath lab manager to ensure that equipment needs are met and appropriate inventory is ordered. Lab staff also plays a role in inventory stocking. Vendors meet with the cath lab manager before bringing a product into the department. All contracts must go through purchasing before any equipment can be brought into the institution.

Has your cath lab recently expanded in size and patient volume, or will it be in the near future?

We have had a steady growth in cath lab volume each year over the last 5 years. We have seen growth in coronary, peripheral, and structural cases. We have had to increase our capabilities by maximizing the resources currently available. We share lab space with the OR where we perform our TAVR and MitraClip procedures, and also share lab space with EP, where we have the ability to perform right heart and minor diagnostic procedures. We are currently completely renovating an existing cath lab that will become a shared lab for both EP and cardiac cath procedures. The lab will feature state-of-the art Philips equipment in line with our 5 existing cath lab suites (after the renovation, we will have 6 cath lab suites). This lab will be a welcome addition to support our growing volume and is expected to be ready in September 2016.

Is your lab involved in clinical research?

We have been actively involved in multiple site-based and investigator-initiated clinical trials and research studies, including:

• NORDICA (Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography); 
• FAME 3 (A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease); 
• TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of Tryton Side Branch Stent Used With DES Treatment of de Novo Bifurcation Lesions in MB & SB in Native Coronaries); 
• RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension); 
• SYMPLICITY (Renal Denervation in Patients With Uncontrolled Hypertension); 
• ADVISE II (iFR, ADenosine Vasodilator Independent Stenosis Evaluation II); 
• and SAFE-PCI (efficacy and feasibility of transradial vs transfemoral approach in women), among others. We have a clinical trials team with 5 clinical research coordinators and a clinical trials supervisor.

Can you share your lab’s average door-to-balloon (D2B) times and some of the ways employees at your facility have worked together?

We are recipients of the AHA Mission: Lifeline Gold Plus Receiving Award in recognition of outstanding treatment of STEMI patients. This award is given to centers that are able to demonstrate a composite score of at least 85% on quality and performance metrics for STEMI systems of care, for at least 24 consecutive months. This award is the third Gold Receiving Award from AHA Mission: Lifeline for the UNC Medical Center. Our median time from arrival to primary PCI for the last 12 months was 38 minutes for patients presenting directly to UNC. For patients transferred from other non-PCI capable facilities, our median time from arrival at the referral facility to primary PCI at UNC was 94 minutes. We have a multi-disciplinary committee that meets monthly and includes representatives from Emergency Medical Services (EMS), the emergency department (ED), the cath lab, and administrative leadership. Every STEMI case is reviewed and there is ongoing quality improvement.

Who transports the STEMI patient to the cath lab during regular and off hours?

STEMI patients are transported to the cath lab by the ED staff and a cardiology fellow during all hours. When a STEMI patient is brought directly to UNC via EMS, a 12-lead electrocardiogram (ECG) is transmitted from the field via the LIFENET alert system. Patients often bypass the ED and are brought directly to the cardiac cath lab. For patients presenting to the ED or who are brought to us by Carolina Air Care (CAC) air ambulance (UNC’s critical care transport system), there is direct communication between the ED or CAC, and the cardiology fellow and/or the interventional cardiologist. The patient is then transported to the cath lab by the ED or CAC staff and cardiology fellow.

What do you do when the call team is already busy doing a procedure and a STEMI comes into the ED?

An assessment is made by the interventional cardiology attending of the expected delay to treatment of the second patient. If we are able to treat the patient and meet our quality time metrics, we will hold the patient in an ED room and stabilize the patient under the supervision of a senior cardiology fellow and with nursing assistance from our cardiac intensive care team before we bring the patient to the cath lab. If we are not able to treat the second patient in a timely fashion due to the team being busy with another patient, we have a system in place to either administer thrombolytic therapy or transfer the patient to another hospital within the area depending on the time of symptom onset, although we have never had to do this.

What measures has your cath lab implemented in order to cut or contain costs?

UNC Health Care System has 9 hospital locations across the state of North Carolina, with more than 30,000 employees and revenues of more than $3.2 billion. Despite our rapid growth and strong financial health, UNC Health Care is not immune from downward reimbursement pressures facing the health care providers in our state and throughout the country. Thus, the executive board has instituted “Carolina Value”, a system-wide initiative to improve our operational efficiency, enhance the quality of our system processes, and strengthen our financial stability. One of the objectives is the “streamlining and simplifying of our processes,” which includes utilizing the purchasing power of our 9 hospital locations to get best vendor pricing. In addition, cath lab management monitors daily staff worked hours to minimize overtime expense. 

We believe quality is no longer a metric that can be discussed in isolation without an assessment of cost. In order to define value in the cath lab (quality per unit cost), we have created a dashboard that reports quality and cost, with granular data to the individual operator and case level. We aim to bring increased value by increasing quality and decreasing cost. With the help of the dashboard, we are able to review data on a monthly basis to guide physicians towards high quality, low cost procedures.

What quality control measures are practiced in your cath lab?

We have a monthly meeting of the interdisciplinary STEMI team that reviews STEMI monthly and aggregate data, acute myocardial infarction (AMI) Core Measure compliance, outreach, and accreditation updates. We have a separate monthly cath lab quality meeting for continuous quality improvement that is attended by all cath lab faculty and includes case reviews for all PCI procedures that may be outliers. We review appropriate use criteria for all PCI procedures and perform peer review of any procedures that may be listed as “rarely appropriate”, as well as any cases deemed to be process outliers or with unexpected patient outcomes. In addition to our AHA Mission: Lifeline Gold Plus Receiving award, we have also received the Platinum Performance Achievement Award from the NCDR ACTION Registry-Get With The Guidelines (GWTG). We are also accredited by the Society of Cardiovascular Patient Care (SCPC) as a Chest Pain Center with PCI.

Who documents medication administration during the case?

The staff member in the monitor role documents all events during the case, including medication administration, fluoroscopy times, and radiation dose. In addition, the nurse charts all medications administered during the procedure in the EPIC system.

Are your physicians dictating their cath procedure reports, or do they use a structured reporting tool?

Our physicians use a customized standardized structured procedure report within the EPIC EMR system that we have developed ourselves. It includes still angiographic images from the procedure. Data can be input either manually using pull-down menus or dictated using the Dragon dictation system. Registry data for the National Cardiovascular Data Registry (NCDR) is uploaded using the Lumedx system. We participate in the ACTION-GWTG, CathPCI, and IMPACT registries.  

How are patients referred to your facility from within your 9-hospital network? 

Through our Open Access physician referral service, created by the UNC Center for Heart & Vascular Care, we coordinate all admissions and transfers through a single phone call. We guarantee immediate acceptance for patients. Designed for the convenience of our referring physicians and their staff, the Open Access service also facilitates consultation and collaboration with our team of Heart & Vascular physicians. Our Open Access vision is to simplify the process for our referring providers and ultimately offer easy access for patients to the world-class Heart & Vascular resources at UNC Health Care.

How are new employees oriented and trained at your facility?

A new employee is paired with a preceptor and follows their schedule exactly. If they are assigned to the cath lab procedure room, they will take call with the preceptor only after they have been in the role for 4 to 6 weeks. They will take call with their preceptor for another 4 weeks, but this can vary, depending on their prior experience. If they are orienting to the holding area, they are usually in orientation for 6 to 8 weeks. Each new employee is given an orientation that includes the mission statement, policies and procedures, and competency checklists.

How do you handle vendor visits to your lab?

UNC Health Care allows staff personnel to interface with outside vendor representatives in order to provide staff with required training for new devices and equipment. Each vendor must check in through the Reptrax system in the hospital lobby. Vendor representatives must have a previously scheduled appointment. Representatives are not allowed to be in any patient care area. An exception is made only for prearranged appointments with a member of the medical staff. The hospital issues a temporary badge to each representative that must be prominently displayed during the visit, along with their own identification tag showing their name and company. Sales representatives arrive just prior to their appointment and depart immediately after. 

How is staff competency evaluated? 

We hold an annual mandatory skills day where competency with all equipment used in the lab is reviewed. This usually takes place on a Saturday morning to prevent interruption in case volume. Vendors come in and review all equipment. Staff assists in the education as well. Vendors are also brought in at least once a year to assist in competency with equipment such as the Impella (Abiomed) and intra-aortic balloon pump (IABP).

We also have a regular inservice event that provides education on new equipment and procedures. Our physicians, fellows, peers, and vendors present pertinent hemodynamic, anatomical, and technical information. UNC also has numerous continuing education (Con Ed) symposiums. In addition, staff is chosen to attend regional conferences such as the Pediatric and Adult Interventional Cardiac Symposium (PICS-AICS).  

Does your lab have a clinical ladder?

We have a clinical ladder for nurses. They start out as a Clinical Nurse II and can work up to a Clinical Nurse IV with administrative functions.

How does your lab handle on-call? 

Our department manager generates a 4-week schedule. Most call team members have the responsibility to cover approximately 7 call days in that 4-week schedule, including 1 weekend. The staff mix is 2 specialists/technologists to 1 registered nurse. In addition, there is a fellow and an attending physician on call. All call team members are expected to be in the lab, in scrubs, and ready for the STEMI in less than 30 minutes.

Do you have flextime or multiple shifts?

We do have 3 staff members who work 8-hour shifts and 5 staff members who work 10-hour shifts. The 8-hour staff rotates working a week of 10-hour shifts in order to make sure that there is enough staff to keep 2 labs open until 5:30 pm daily. The holding staff work 12-hour shifts.

Has your lab recently undergone a national accrediting agency inspection?

We were inspected by the Joint Commission in November 2014 and passed our inspection with no infractions. During a time-out procedure it is very important that all staff are paying attention and are not doing anything else but being involved in the time out. The patient should also be involved in the time out.

Where is your cath lab located in relation to the operating room (OR) and emergency department (ED)?

The cath lab is located down the hall from the OR, but at the opposite end of the hospital from the ED.

What trends have you seen in your procedures and/or patient population?

We have seen a trend towards older and sicker patients. Consequently, we are treating patients with more complex coronary and valvular disease who are often not surgical candidates. 

What is unique or innovative about your cath lab and staff?

The staff is very motivated to learn a new skill or procedure. They enjoy learning about structural heart procedures in the adult and pediatric lab, and being involved in these procedures. They also enjoy the comradery with the fellows.

We have started a same-day discharge program for select PCI cases, overseen by our team of advanced practice providers, who facilitate the discharge and follow-up on these patients. This has been a source of great satisfaction for our patients and their families.

Is there a problem or challenge your lab has faced? 

The hospital is often on critical bed status and as a result, we had a very difficult time getting beds for our patients, so we started a night shift in our holding area last year. We care for patients overnight and discharge them the following morning. This allowed us to free up a hospital bed and provide continuity of care for our patients within the cath lab. This has also allowed the hospital to take more Open Access patients referred from outside facilities and place them in beds on nursing units. 

This has been in place since September 2015, and we have received many accolades from patients and their family members. Having a night shift in our holding area has also improved staff satisfaction, because they know that when they are scheduled to go home at 7:30 pm, they will be actually be able to leave on time. In the past, they had to stay until the patient was assigned a bed, no matter how late it was. 

What’s special about your city or general regional area in comparison to the rest of the U.S.? How does it affect your “cath lab culture”?

We are located in Chapel Hill, North Carolina, and are part of the famed “Research Triangle.” Many people transfer in and out of this area on a constant basis. When we have position openings, people from all over the United States apply due to spouses being transferred or their desire to move closer to the coast. We are only 2½ hours from the Atlantic Ocean and to the west are mountains. Our area is a very desirable one for many people. 

Questions from the Society of Invasive Cardiovascular Specialists (SICP):

Do you require your clinical staff members to take the registry exam for Registered Cardiovascular Invasive Specialist (RCIS)? Does staff receive an incentive bonus or raise upon passing the exam?

No, we do not require the RCIS, and there is no incentive or bonus for taking the exam. We do have the Wes Todd educational system (www.westodd.com) on the computers in the lab for those who would like to pursue this route. 

Are your clinical and/or managerial team members involved with any professional organizations that support the invasive cardiology service line, such as the SICP, ACVP, or regional organizations?

A number of our staff members are SICP members.

The authors can be contacted at pkaul@med.unc.edu or at brenda.mcclure@unchealth.unc.edu.