University of Miami Hospital Elaine and Sydney Sussman Cardiac Catheterization Lab

Tell us about your cath lab. The University of Miami Hospital (UMH) has 5 total procedure rooms, including 1 hybrid room, 2 electrophysiology procedure (EP) rooms, and 2 cath labs. We performed 3,409 procedures in 2009. In 2010, we are estimating that we will perform approximately 3,500+ procedures. We have 29 staff members, consisting of registered nurses (RNs), cardiovascular technologists (CVTs) and registered cardiovascular invasive specialists (RCISs). Staff experience in the cath lab ranges from 1-20 years. We also have a hybrid cath lab that gives us tremendous flexibility in the type of procedures and conditions that we can treat. The medical team is truly multidisciplinary, including vascular surgeons, vascular interventional radiologists, interventional cardiologists and electrophysiologists. Procedures we perform include: Coronary artery disease: • Diagnostic coronary angiography and advanced hemodynamic evaluations of complex cardiomyopathies, adult congenital and valvular heart disease • Endomyocardial biopsy • Complex percutaneous coronary intervention (PCI), including left main intervention and 24/7 coverage for primary PCI • Intravascular ultrasound (IVUS) and fractional flow reserve (FFR) assessment. • Rotational atherectomy (Rotablator, Boston Scientific Corp., Natick, MA) • Rheolytic thrombectomy (AngioJet, Medrad Interven-tional/Possis, Warrendale, PA) • Laser atherectomy, implantation of percutaneous left ventricular assist devices (LVAD) including Impella (Abiomed, Inc., Danvers, MA) and TandemHeart (CardiacAssist, Inc., Pittsburgh, PA) • Transradial access for PCI and diagnostic catheterization Electrophysiology (EP): • EP studies, rhythm device implants (pacemakers, implantable cardioverter defibrillators (ICDs), bi-ventricular ICDs, etc.) supraventricular and ventricular tachycardia ablations Structural heart disease: • Aortic and mitral valvuloplasty • Transcatheter aortic valve implantations [(TAVI), either using transfemoral or transapical approach] • Alcohol septal ablation for hypertrophic obstructive cardiomyopathy • Patent foramen ovale (PFO), atrial septal defect (ASD) and ventricular septal defect (VSD) closure • Paravalvular leak closure Peripheral vascular disease: • Diagnostic peripheral vascular catheterization procedures • Complex peripheral vascular interventions, including thoracic and abdominal endovascular aortic aneurysm repair (EVAR), aortic, iliac, superficial femoral artery (SFA), below-the-knee endovascular revascularization. • Carotid stenting, and neurointerventions, including acute treatment of stroke. Miscellaneous: • Intracardiac injection of cell therapy • Closed-chest robotic coronary artery bypass grafting • Renal tumor radiofrequency ablations Who manages your cath lab? George Benelli, RT(R), RPA/RA (Director), Chris Sheffield, RN (Charge Nurse), Joey Collazo, RCIS (Lead Technologist/Supervisor), and Mauricio G. Cohen, MD (Medical Director). What percentage of your diagnostic cath patients goes on to have an interventional procedure and what percentage of your diagnostic caths are normal (i.e. disease-free)? Twenty-five percent (25%) go on to have an intervention and 11% are normal. What percentage of your patients is female? 35.3% Do you have cross-training? Who scrubs, who circulates and who monitors? RNs circulate and CVTs/RCISs scrub and monitor cases. We are not cross-training at this time. Does an RT (radiologic technologist) have to be present in the room for all fluoroscopic procedures in your cath lab? No. RTs need only be present for peripheral endovascular procedures and available for all imaging outside of the heart. Which personnel can operate the x-ray equipment (position the II, pan the table, change angles, step on the fluoro pedal) in your cath lab? For the most part, the cardiologists operate the equipment for the cardiac procedures. For other type of procedures, such as EP and peripheral vascular, RTs, CVTs/RCISs (under direct supervision of the physician) and physicians are able to position, pan the table, change angles and step on the fluoro pedal). How does your cath lab handle radiation protection for the physicians and staff? Radiologic protection is managed by the radiation safety officer who oversees badge counts. A report is generated every month and provided to every staff member. Some safety initiatives include: • Monthly badge distribution • Collar and waist bands • Thyroid collars • Leaded aprons • Leaded goggles What are some of the new equipment, devices and products introduced at your lab lately? Recently introduced devices include the Impella, TandemHeart, Edwards Sapien aortic valve (Edwards Lifesciences, Irvine, CA) for TAVI, the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) for robotic coronary artery bypass graft surgery, and Stereotaxis (St. Louis, MO) for chronic total occlusions (CTOs) in peripheral vascular and EP procedures. We also have the state-of-the-art Artis zeego (Siemens Medical Systems, Malvern, PA) with a multi-axis C-arm, and are using the Pioneer catheter (Medtronic, Inc., Minneapolis, MN) for complex endovascular procedures. Do any of your physicians utilize transradial access? Yes, we do. Approximately 5 physicians can perform transradial procedures. One of them utilizes this access in more than 90% of his cases. Approximately 30% of our cases are done transradially. In addition, we have a policy and a process for transradial catheterization procedures (more information is available at “Transradial Access at the University of Miami,” Cath Lab Digest September 2009, online at https:// tinyurl.com/TransradialUMH). For us, setting up a patient for transradial is as easy and natural as setting up for femoral access. How does your lab handle hemostasis? We use both manual compression and vascular closure devices, with approximately 60% manual compression and 40% vascular closure devices. Preferred devices include the Angio-Seal (St. Jude Medical, Minnetonka, MN), Perclose (Abbott Vascular, Redwood City, CA) (we use two devices for large sheaths in TAVI and aortic valvuloplasties) and the Boomerang Catalyst System (Cardiva Medical, Inc., Mountain View, CA). Patients are managed by trained personnel with appropriate competencies. RNs and CVTs/RCISs, after receiving appropriate training and competencies, are able to manually pull sheaths. We use D-Stat Dry (Vascular Solutions, Inc., Minneapolis, MN) as an adjunct for manual compression in most cases. Only physicians are able to achieve hemostasis using vascular closure devices. For transradial cases, we pull the sheath immediately after concluding the case, regardless of the anticoagulation level. We use the TR Band (Terumo Medical, Somerset, NJ) for radial hemostasis. What is your lab’s hematoma management policy? Hematomas are managed using manual compression for 25-30 minutes, until bleeding is controlled. Once bleeding is controlled, a FemoStop (St. Jude/Radi) or C-clamp (if directed by a physician) may be placed for further management, and a vascular Doppler ultrasound may be ordered to rule out pseudoaneurysm. UMH has vascular surgeons or interventional radiologists available for the management of further complications, such as pseudoaneurysms, arterio-venous (AV) fistulas or uncontrolled bleeding. How is inventory managed at your cath lab? Who handles the purchasing of equipment and supplies? Our department VP, cath lab director and supply coordinator are responsible for ordering equipment and supplies for the department. Has your cath lab recently expanded in size and patient volume, or will it be in the near future? We have experienced an exponential volume increase ever since the University of Miami acquired the hospital in December 2006. Our volume has expanded from 1,469 cases in 2007 to 3,407 in 2009. This growth is unparalleled in the rest of the country. The main reasons for our volume growth include the uniqueness of the procedures we offer, and the excellence and national reputation of our physicians. Is your lab involved in clinical research? We have a number of ongoing clinical research studies. Highlights are the PARTNER (Placement of AoRTic TraNscathetER Valves Trial) trial, testing the percutaneous Edwards-Sapien bovine valve in patients with severe aortic stenosis who are at high risk for open surgical aortic valve replacement, and the PROTECT II trial (a randomized comparison of Impella vs IABP in patients undergoing non-emergent high risk PCI). We have a unique portfolio of NIH-funded, principal investigator (PI)-initiated studies looking at the use of cell therapy for advanced heart disease. One of these studies is the TAC-HFT Trial [the Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial], which involves direct catheter-based injection of stem cells in the left ventricle. Have you had any cath lab-related complications in the past year requiring emergent cardiac surgery? We had a couple of emergencies. One occurred as consequence of a dramatic coronary perforation in a high-risk patient that presented with myocardial infarction, and the second occurred following balloon aortic valvuloplasty. The patient developed acute aortic insufficiency and had to be taken to the catheterization laboratory. Interestingly, emergent insertion of an Impella assist device stabilized the patient and attenuated the degree of aortic regurgitation. The patient tolerated surgery well and was discharged home. What other modalities do you use to verify stenosis? Are you using physiology for lesion assessment? We have IVUS and the pressure wire (Volcano Corporation, Rancho Cordova, CA), and these two modalities are frequently utilized in our lab. We understand the importance of FFR assessment with the pressure wire, and this is why we use a pressure wire in intermediate coronary lesions, either with intracoronary injection or intravenous infusion of adenosine. For the assessment of left main disease, we generally use IVUS. What measures has your cath lab implemented in order to cut or contain costs? We have shelf pricing on high-cost supplies, use limited vendors, and have volume contracts and competitive bidding. How is coding and coding education handled in your lab? Physicians are educated regarding professional coding. Codes are reviewed on a regular basis to update to new procedures. We also have a coding specialist that works with our physicians to ensure that physicians are documenting correctly, so that the coders can code appropriately. Our coding specialist also provides individualized educational sessions for physicians. What types of quality control/quality assurance measures are practiced in your cath lab? We participate in a number of quality improvement (QI) projects and submit core performance measures and patient safety data. We are in the initial stage of deployment of the Epic electronic medical record (EMR) (Verona, WI) throughout the University of Miami Health System. The EMR, locally known as UCHART, will allow us to directly upload data into national QI initiatives such as the American College of Cardiology–National Cardiovascular Data Registry (ACC-NCDR). This is an extremely important objective of our cath lab. We aim for very high quality standards. We are currently dictating reports, but hope that within the next 6 months, our reports will be electronically generated with direct data entry. Once we attain this goal, our quality improvement processes will become more efficient. How does your cath lab compete for patients? Has your institution formed an alliance with others in the area? We are an international destination facility with world-renowned cardiologists. UMH has excellent hospital recognition and our physicians are highly published, with leading research in pioneering medicine and technologies. Our recent volume growth attests to our recognition and abilities. Thanks to our unique programs for percutaneous valve implantation and cell therapy research, and other disruptive technologies, we have been able to develop a statewide referral basis. How are new employees oriented and trained at your facility? Every employee is assigned a preceptor and is required to complete appropriate competencies before working independently. Approximately 20% of our staff has less than 1 year of experience, with the majority having between 3 to 20 years. Nursing experience ranges from ICU, ED and telemetry. Every employee is required to have the appropriate Florida licensures/certifications to work in our department. What types of continuing education opportunities are provided to staff members? Every employee is offered appropriate training for equipment, treatments and procedures with opportunities for receiving CEUs. The University of Miami strives for excellence and provides opportunities for those wanting further training or advance degrees, offering tuition reimbursement and access to the University of Miami programs. How is staff competency evaluated? Staff members are evaluated annually by a supervisor/manager. Does your lab have a clinical ladder? No. The University of Miami Hospital is currently in the process of creating a clinical ladder program. Can you share your lab’s average door-to-balloon (DTB) times and some of the ways employees at your facility have worked together to keep DTB times under the mandated 90 minutes? Since 2007, we have been providing 24/7 on-call ST-elevation myocardial infarction (STEMI) coverage. In the second quarter of 2010, our average door-to-cath lab time was 25 minutes, door-to-access 38 minutes, and door-to-balloon 51 minutes. We have worked in collaboration with emergency department (ED) personnel and the Miami Dade Fire Rescue to achieve our goals. Our hospital is initially contacted before patient arrival. An ECG is faxed to us and the cath lab is directly activated from the ED. Our goal is an ED permanence time of less than 30 minutes and a door-to-balloon time of less than 60 minutes. So far, we have been able to achieve these goals. How does your lab handle call time for staff members? Is there a particular mix of credentials needed for each call team? Call time is equally shared among staff. The team consists of four staff members. All STEMI call teams consist of two CVTs/RCISs and two RNs. The entire team is paged on a group pager (along with the interventional cardiologist) by the ED upon recognition of a STEMI. This may happen as early as in-transit per EMS. Staff takes six to eight call shifts a month. Within what time period are call team members expected to arrive to the lab after being paged? Staff members are expected to arrive within 30 minutes after cath lab activation for STEMI patients. We do not have an interventional cardiologist on site. However, as an academic medical center, we have a cardiology fellow during most of the day on weekends and residents in the coronary care unit that perform the initial assessment of STEMI patients, together with ED physicians. Do you have flex time or multiple shifts? The University of Miami Hospital does use flexible shifts. The majority of the staff works from 7am to 5:30pm, and the call team adjust hours according to the schedule. A later team was created for recovery from 11am-9pm to accommodate later procedures. How do you handle vendor visits to your lab? All vendors are scheduled and processed through administration before entering the cath lab. Vendors are required to wait in the lobby or department lounge until their services are required or a staff member allows them to enter the cath lab area. Where is your cath lab located in relation to the operating room (OR) and emergency department (ED)? We are located on the third floor of University of Miami Hospital, at the same level of the OR. Our emergency department is located on the first floor. How do you see your cardiac catheterization laboratory changing over the next few years? We are continuously evolving. We have a clear vision and understand that minimally invasive therapies are the way of the future. Multidisciplinary collaboration will allow us to grow even stronger and be able to perform unique procedures to offer innovative solutions to our patients. What do you consider unique or innovative about your cath lab and staff? We have a unique multidisciplinary team at the staff and the medical level. We have a vibrant structural heart disease and advanced coronary disease programs. Our research is innovative and draws patients from all over the state. Is there a problem or challenge your lab has faced? Massive growth over the past two years has been a primary challenge. University of Miami Hospital has undergone a massive recruiting effort in order to accommodate the increase in volume. 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”? Miami is a truly multicultural, diverse community. Peoples from different origins, from Latin American to the Far East, blend into a rich melting pot. A few days ago, while taking care of a STEMI patient, we realized that more than 6 languages were spoken by different staff members and physicians in the room (Spanish, English, Chinese, French, Creole, and Urdu). Obviously, communication plays a key role in how we care for our patients. Despite the cultural diversity of our team members, we work as a cohesive team. Nevertheless, we strive to continue to learn about each other’s background to become more culturally competent.

The Society of Invasive Cardiovascular Professionals (SICP) has added two questions to our spotlight:

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? Yes. Currently we provide and encourage staff to take the RCIS registry and provide an incentive upon passing the exam. 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? Currently, our managerial team is involved with the Society of Invasive Cardiovascular Professionals. Our department works as a cohesive team that supports and collaborates with our medical staff. We strive for excellence and make every effort to continuously improve. The authors can be contacted via Dr. Mauricio Cohen at mgcohen@med.miami.edu

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