University of Miami Hospital: The Elaine and Sydney Sussman Cardiac Catheterization Laboratories

Tell us about your cath lab.

Within the University of Miami’s 560-bed hospital, the cardiac catheterization laboratory holds four hybrid angio suites: one equipped with a computerized magnetic guidance system (Stereotaxis), one regular cath lab, and two interventional radiology suites. One of the hybrid suites is equipped with bi-plane equipment, and two have Artis zeego (Siemens) equipment with a robotic arm. All hybrid suites have DynaCT (Siemens), allowing three-dimensional imaging reconstruction to assist in structural heart procedures such as transcatheter aortic valve replacement (TAVR) and paravalvular leak closures. The holding area has eight bays to prepare and recover our patients.

We are also in the process of setting up a special room with recliners that will serve as our radial lounge for the recovery of patients who have had transradial procedures. Our cath lab functions as a multidisciplinary, minimally invasive unit, in which several medical specialties, including vascular surgery, neuro intervention, interventional cardiology, electrophysiology, interventional radiology, and urology perform percutaneous and open procedures. This service requires specialized personnel, including cardiovascular, interventional radiology, and electrophysiology technologists; operating room scrub techs, radiology practitioner assistants, and registered nurses with specialized training. 

What procedures are performed in your cath lab?  

Our lab performs various procedures, including:

• Diagnostic electrophysiology, supraventricular tachycardia (SVT) ablation, atrial fibrillation ablation, and ventricular tachycardia (VT) ablation; 
• Diagnostic coronary angiograms, coronary intervention, endomyocardial biopsies, complex percutaneous coronary intervention, and insertion of percutaneous left ventricular assist devices, including Impella (Abiomed) and TandemHeart (CardiacAssist); 
• Transcatheter valve replacement, left atrial appendage closure, atrial septal defect (ASD)/ventricular septal defect (VSD) closures, and alcohol septal ablation for hypertrophic cardiomyopathy;
• Intramyocardial stem cell injection;
• Carotid stenting and intracranial neurointervention;
• Endovascular repair of abdominal and thoracic aortic aneurysms, peripheral vascular intervention, and peripheral vascular bypasses;
• Pacemaker and implantable cardioverter-defibrillator (ICD) implants and lead extraction; 
• Tumor embolization;
• Transjugular intrahepatic portosystemic shunt (TIPS);
• Arterial and venous infusion of thrombolytic agents; 
• And a long list of interventional radiology procedures. 
• Our total volume ranges between 100-120 patients per week. 

Can you share your experience with performing TAVR at your institution?

We are very proud of our TAVR program. We have been involved in the PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial, Edwards Lifesciences) from the beginning. In fact, we performed our first procedure in 2008, the first in the state of Florida. Currently, we are participating in the PARTNER 2 and CoreValve (Medtronic) trials. In addition, we have a strong clinical TAVR program, with an average monthly caseload of 8-10 cases. We have been very involved in learning and developing alternative access strategies for patients in whom the transfemoral or the transapical accesses were contraindicated. Our data shows that women are less likely to be transfemoral candidates due to smaller iliofemoral vessel size. We published our experience with transaortic TAVR in JACC earlier this year.¹ Our results suggest that the learning curve is actually shorter with transaortic compared with transapical access. We have also published a series of cases treated with transseptal antegrade TAVR, the initial access approach when TAVR was introduced in 2002.² Our faculty members have published approximately 15 papers on different aspects of TAVR, and our fellows, led by Dr. Carlos Alfonso, have presented more than 30 abstracts at different national meetings over the past three years. Every single case is discussed in-depth during the weekly multidisciplinary valve conference, with the presence of cardiothoracic surgeons, interventional cardiologists, echocardiographers, imaging specialists, vascular surgeons and fellows.

Can you share your experience with radial artery access?

Our lab is very familiar and comfortable with transradial access. Dr. Mauricio Cohen, CCL Medical Director, leads our radial access program. The program has enabled more efficient operations, with faster throughput and decreased nursing workload in the holding area. All fellows trained after 2009 are comfortable with transradial access, and have expanded its use to other hospitals in Miami. Our clinical outcomes have been outstanding and our staff has developed best practices in order to avoid radial artery occlusion, with consistently patent hemostasis. Most of our physicians are comfortable performing complex cases and approximately 50% of our ST-elevation myocardial infarction (STEMI) procedures are performed via transradial access.

Who manages your cath lab? 

The cath lab is managed by:

• Kymberlee Manni, AVP for the Cardiovascular Service Line; 
• George Benelli, RT, RPA/RA, Clinical Director; 
• Mauricio G. Cohen, MD, FACC, FSCAI, Medical Director; 
• Joey Collazo, RCIS, Chief Technologist; 
• Alex Poletto, RT, RPA/RA; and 
• Julie Custode RN, BSN, Clinical Educator. 

Do you have cross-training? Who scrubs, who circulates and who monitors? 

Because our program is truly multidisciplinary, it requires extensive cross-training in all modalities. Registered nurses (RNs), cardiovascular technologists (CVTs), and radiologic technologists (RTs) are trained in all procedures performed in the lab; however, the type of procedure, its complexity, and individual professional credentials determine who will be responsible to scrub, circulate, and monitor a particular case. The person in charge of running operations makes that determination on a daily basis. 

What percentage of your diagnostic caths is normal?

Our rate of normal diagnostic caths is approximately 20%.

Does an RT (radiologic technologist) have to be present in the room for all fluoroscopic procedures in your cath lab?

One member of the radiologic technologist team, led by Alex Poletto, RT, RPA/RA, must be present in all procedures performed outside the cardiopulmonary system to operate the radiological equipment. In these circumstances, the case will be covered with an RN, CVT, and RT.

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? 

Cardiovascular technologists may operate all aspects of the x-ray equipment under the direct supervision of the operating physician for all cardiopulmonary procedures. Radiologic technologists may operate the fluoroscopic equipment under general supervision for all procedures performed; however, the operation of the machine largely depends on the preference of the physicians. Our cardiologists are very comfortable operating the equipment, selecting the views, and panning the table.

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

Radiation safety is a priority in our lab. We provide lead aprons to all our staff, physicians, and visitors. We also follow all radiation safety measures established by our policies and procedures. The entire team is monitored utilizing radiation badges that are regularly sent to an outside company that provides a monthly report. This report is reviewed by the director and shared with the staff. From a physician standpoint, Dr. Claudia Martinez is in charge of monitoring radiation safety and interacting with the institutional radiation safety committee. Our cath reports include air kerma, air kerma area product, and total fluoroscopy time.

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

As an academic institution, we strive to have the latest available technologies, devices, and products. We have two Artis zeego angio suites, Carto 3 (Biosense Webster) and EnSite (St. Jude Medical) mapping systems, the new Impella CP that delivers higher flow than the Impella 2.5, DynaCT for three-dimensional imaging reconstruction to guide structural interventional procedures, and the latest technologies for coronary chronic total occlusions (CTO), such as the Stingray balloon and the CrossBoss catheter (Boston Scientific). In addition to the TAVR trials, we are participating in trials with revolutionary stent technologies such as EVOLVE (bioabsorable polymer, Bsoston Scientific’s Synergy stent) and ABSORB III (bioresorbable vascular scaffolds, Abbott Vascular). We have successfully performed left atrial appendage closures with the LARIAT system (SentreHEART). 

How does your lab communicate information to staff and physicians to stay organized?

We have monthly staff meeting in which the latest information is shared. These meetings include discussions regarding new technologies, processes, protocols, research, trials, in-services, workflow, etc. Physicians have a weekly cath conference chaired by Dr. Mauricio Cohen, in which fellows present interesting cases and complications, and discuss the latest articles in the field. We also have a monthly morbidity and mortality conference as part of our quality efforts. Staff members are always invited and encouraged to attend these meetings. Our physicians are regularly invited to present at major national meetings, including the American College of Cardiology (ACC) Scientific Sessions, Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association and the Society of Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions, and they bring back up-to-date information on the latest advances.

How is coding and coding education handled in your lab? 

All procedures performed in our lab are coded by the coding department. Close communication has been established between both services to review and audit all codes applied to the patient’s account. From the physician side, all professional codes are annually updated following the latest guidelines.

Who pulls the sheaths post procedure, both post intervention and diagnostic? 

All nurses and technologists have competency to remove sheaths after interventional or diagnostic procedures.  The entire clinical staff completes a training session under the supervision of our clinical educator. A competency checklist is reviewed and signed. We follow up on all our patients the day after the procedure, and all complications are documented in our database. Our current hematoma rate using the ACC National Cardiovascular Data Registry (NCDR) definition is less than 1%. 

Where are patients prepped and recovered (post sheath removal)? 

Most of our patients are prepped and recovered in our holding area; however, we have the ability to prep our patients in their respective rooms, if necessary. Hemostasis is accomplished either by the deployment of a closure device at the end of the procedure, or manual compression with a hemostasis patch once the patient is back in the holding area and ACT values are less than 180 seconds. Our large-access cases, such as balloon aortic valvuloplasties and TAVR, are managed with the “preclosure” technique, using two suture-based closure devices.

How is inventory managed at your cath lab? 

Inventory is managed by our supply coordinator, who works closely with the lab director and the hospital purchasing department. We are in the process of purchasing an automated inventory management system, which we hope to have in place very soon.

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

The University of Miami Hospital has taken the initiative of consolidating all minimally invasive areas; currently, we are implementing a plan to merge interventional radiology into our laboratory. Once completed, our service will include interventional radiology, interventional cardiology, vascular surgery, neuro intervention, and electrophysiology.

Can you tell us about your clinical research program?

Our lab is very active in clinical research. We have four research coordinators for multicenter, clinical device trials. We select our trials very carefully to improve the efficiency of our research efforts. We also select trials that may introduce new breakthrough technologies that can help our patients. Our Interdisciplinary Stem Cell Institute, under the leadership of Dr. Josh Hare, is conducting National Institutes of Health-sponsored clinical trials with mesenchymal stem cells for patients with cardiomyopathy. Dr. Alan Heldman performs the injections using different catheter technologies and left ventricular electromechanic mapping. In addition, we have our own procedural databases to study our outcomes for structural procedures. For example, Dr. Claudia Martinez published a University of Miami algorithm for the management of paravalvular leaks after TAVR.³ Furthermore, Dr. Mauro Moscucci, Cardiovascular Division Chief and Chairman of the Department of Medicine, is a recognized  leader in outcome research in interventional cardiology and the editor of two textbooks, including the upcoming  8th edition of Grossman and Baim’s: Cardiac Catheterization, Angiography and Intervention (Figure 8). The book will be released this month and will include several contributions and images from our cath lab.

Can you share your lab’s average door-to-balloon (D2B) times? 

University of Miami Hospital is part of the Miami STEMI network. Within this network, participating sites are required to report their door-to-balloon times to the Fire Rescue. Sites not compliant with a D2B time < 90 minutes are dropped off the network. We have developed our own quality improvement process, in collaboration with the coronary care unit (CCU) and the emergency department (ED). With the implementation of single-page activation process and continuous education for our ED physicians, we have been able to significantly reduce our treatment times. As part of our continuous quality improvement process, we hold a weekly meeting to discuss all aspects of the STEMI activation process and carefully review ECGs and angiograms for each case. We also track access site (femoral or radial). 

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

Most of our STEMI patients are transported to our lab by the ED staff in collaboration with the cath lab team. If a STEMI occurs in the intensive care unit or any other area of the hospital, the patient is brought to our department by the cath lab team along with floor staff assistance, if needed. 

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

In the event that two STEMIs occur at the same time, the nursing supervisor’s office will contact the cath lab director and a second team is deployed if necessary.

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

As with many other institutions, we focus on our supply cost and staffing. We have been able to consolidate most of our “high-ticket” items to one or two vendors, allowing us to purchase these items at a lower cost. We have also improved our daily workflow and “on time” starts; this data is collected daily and managed to ensure an efficient operation that minimizes overtime and excessive staffing. 

What quality control/quality assurance measures are practiced in your cath lab?

We monitor the quality of our work in detail. We have several initiatives in place, such as arterial and venous access follow-ups, infection rates, documentation audits, turn-around times, on-time starts, transducer calibration, complications, and image quality. The medical director conducts random cine reviews, and chairs the monthly morbidity and mortality conference. Our fellows select cases for presentation in our weekly conference with the presence of cardiothoracic surgeons and non-invasive cardiologists, which allows unbiased in-depth case discussions and identification of quality gaps that can further be corrected. Finally, we are fine-tuning an electronic cath reporting system that will soon replace dictated reports and facilitate data collection for the NCDR registries.

Are you recording fluoroscopy times/dosages? If so, how?

Our Siemens systems record air kerma, air kerma area product and total fluoroscopy time automatically into our procedure report. The Axiom Sensis reporting system has the ability to generate reports for each case that are reviewed by administrative and medical directors. Any excessive dosages are reported to the hospital’s radiation committee.

Who documents medication administration during the case?

The nurse assigned to the procedure is responsible to administer and document all medication given during the case.  

Can you tell us more about your use of the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR) or any other outside data collection registry?

Our data abstractors collect and report all pertinent information to the NCDR registries. However, we have not been using the NCDR reports systematically. With the introduction of an electronic reporting system, however, we will be able to consistently upload our data to NCDR, and share the reports with physicians and staff.

How does your cath lab compete for patients? Has your institution formed an alliance with others in the area?

Miami is an extremely competitive market. We have become one of the top market leaders in south Florida. We believe that being an academic institution gives us an edge over our closest competitors. Nevertheless, we have established agreements with several hospital and outpatients centers. Also, because Miami is considered the gateway to Latin America and the Caribbean, the University of Miami brand has an important impact on international patients’ choices when they seek medical care in the United States. Our International Medicine Institute, led by one of our interventional cardiologists, Dr. de Marchena, has developed close relationships with physicians and medical societies in Latin America and the Caribbean. We provide consultative services and continuous education to international providers, who then may choose to refer their patients to University of Miami.

How are new employees oriented and trained at your facility? 

All new employees are required to attend a facility orientation session that may take 2-5 days, depending on the position they hold within the hospital. Once the facility orientation is completed, each employee reports to their respective department, and they complete a departmental orientation program. The length of this program varies by specialty and experience.

What continuing education opportunities are provided to staff members?

Our department offers continuous education opportunities in the form of inservices provided by companies and “ULearn” on-line training, provided by the hospital and led by the organizational learning department. Several of our employees have also attended equipment and system training sessions outside our facility.

How is staff competency evaluated? 

The department’s clinical educator is responsible for evaluating each staff member and determining their level of competency for all procedures and equipment operations. This evaluation takes place annually, and it is reviewed and signed by the lab director. 

Does your lab have a clinical ladder? 

The hospital has developed a clinical ladder for the nursing profession. This ladder was created in cooperation with employee union representation. 

How does your lab handle call time for staff members? Is there a particular mix of credentials needed for each call team? 

Because we developed a multidisciplinary, minimally invasive department, it is imperative that we cover emergencies with the right number of staff members who are competent and licensed in their areas of expertise. We currently have five teams covering STEMI/stroke call, with five staff: two RNs, two CVTs and an RT. Our interventional radiology/vascular surgery on-call carries three teams of four staff: two RNs and two RTs. All teams take on-call responsibilities within a rotational schedule. All call teams are required to be in the facility within 30 minutes from the time they were paged. 

Do you have flextime or multiple shifts? 

At this time, we do not have multiple shifts in our department. All staff is scheduled four days a week (10-hour shifts). We may consider changing this system in the near future. 

How do you handle vendor visits to your lab?

Our lab is a restricted area; therefore, we do not allow vendors to visit our lab without previous authorization from the director or designee. Authorization is based on case support or inservice needs for staff. Business-related meetings are only allowed in the physician or director’s office, located outside the clinical area. 

Has your lab recently undergone a national accrediting agency inspection? 

Over the last eight months, we have been inspected by multiple federal agencies and the Joint Commission. Thankfully, we were able to pass all inspections with very good scores, and obtained a couple of “Best Practice” commendations from the Joint Commission. The hospital has developed internal inspection initiatives that occur routinely and without notice. The goal of these audits is to promote the culture of always being prepared for an inspection. This strategy has paid off. 

Where is your cath lab located in relation to the OR and ED? 

Our lab and the operating room are located in the third floor of the hospital. The ED is located on the first floor; however, the facility has an elevator that communicates directly between the first floor and the third floor. 

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

Perhaps the biggest trend we have noticed is a decline in the number of coronary stents deployed, consistent with the rest of the nation. We have also observed a higher number of cases performed using transradial access. Because we have a mature TAVR program, our patient population age is older than expected. 

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

Although we are equipped with the most advanced technologies, our biggest asset is our staff. We are blessed to have a very talented and young team; each member is cross-trained in different modalities within the lab. The same team can perform at the highest level in many different types of procedures, from a right heart catheterization to a trans-apical valve replacement, to a lower extremity angiogram, to a peripheral vascular bypass and neuro intervention. A multidisciplinary department requires a multidisciplinary team, and we have been able to put together a group of individuals who take pride in their profession and regularly outperform expectations.

Is there a problem or challenge your lab has faced? How was it addressed?

Our biggest challenge has been cross-training staff to all the procedures performed in our lab. We developed a plan implemented and executed within a three-year period, and it is now reaching its final stages.  

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 known for its weather and beautiful beaches; however, it is also a multicultural city, very colorful, and dynamic. This aspect is also reflected in our lab. We have professionals from all over South and Central America, the Caribbean islands, Russia, Pakistan, the Philippines, and other parts of the world. It is wonderful to see all these nurses and technologists, each with their own cultural background, interacting as a team, sharing cath lab experiences, and working towards a common goal.

Two questions from the Society of Invasive Cardiovascular Professionals (SICP):

1. 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?

Our current policy requires that all cardiovascular technologists to be registered under Cardiovascular Credentialing International (CCI), provider of the RCIS credential. We are proud to say that all of our cardiovascular technologists have their RCIS or RCES registry. It took several years to get this accomplished, mainly because we committed to assist our staff members in obtaining such an important designation. Each member of the team is compensated based on their experience and credentials, and salary was adjusted for those who were recently able to pass their registry. 

2. 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?

Our leadership is currently a member of:

• The Society of Invasive Cardiovascular Professionals (SICP)
• Cardiovascular Credentialing International (CCI)
• American Heart Association (AHA)
• American College of Cardiology (ACC)
• The Society for Cardiac Angiography and Interventions (SCAI)
• The American College of Healthcare Executives (ACHE). 

The authors may be contacted as follows:

Mauricio Cohen, MD, FACC, FSCAI/Medical Director, mcohen@med.miami.edu

Kymberlee Manni, RCIS, PhD/AVP Cardiovascular Service and Stroke, kmanni@med.miami.edu

George Benelli RT(ARRT), RPA/RA/Clinical Director, gbenelli@med.miami.edu

References

1. Lardizabal JA, O’Neill BP, Desai HV, Macon CJ, Rodriguez AP, Martinez CA, Alfonso CE, Bilsker MS, Carillo RG, Cohen MG, Heldman AW, O’Neill WW, Williams DB. The transaortic approach for transcatheter aortic valve replacement: initial clinical experience in the United States. J Am Coll Cardiol. 2013 Jun 11;61(23):2341-5. doi: 10.1016/j.jacc.2013.02.076.
2. Cohen MG, Singh V, Martinez CA, O’Neill BP, Alfonso CE, Martinezclark PO, Heldman AW, O’Neill WW. Transseptal antegrade transcatheter aortic valve replacement for patients with no other access approach-A contemporary experience. Catheter Cardiovasc Interv. 2013 Jun 1. doi: 10.1002/ccd.25036.
3. Martinez CA, Singh V, O’Neill BP, Alfonso CE, Bilsker MS, Martinez Clark P, Williams D, Cohen MG, Heldman AW, O’Neill WW. Management of paravalvular regurgitation after Edwards SAPIEN transcatheter aortic valve replacement: management of paravalvular regurgitation after TAVR. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):300-11. doi: 10.1002/ccd.24807.