Cath Lab Profile: Conquering the New Frontier at UC San Diego

As the first cath lab west of the Mississippi to introduce a robotically-assisted intervention program, the UC San Diego Health System and the Sulpizio Cardiovascular Center embody the pioneer spirit when it comes to interventional techniques. In this edition of our Cath Lab Profile series, CSWN: Interventions spoke with Ehtisham Mahmud, MD, (chief of cardiovascular medicine, co-director of the Sulpizio Cardiovascular Center, and director of interventional cardiology and the cardiac cath lab at UCSD) about robotic PCI, radiation safety, and overall cath lab training.

Cath Lab Profile: Conquering the New Frontier at UC San Diego

In another display of how the West was won, UCSD is the first institution on the West Coast to bring robotically-assisted interventions into the cath lab. How was the program implemented?
I have been working with Corindus CorPath for over a year, and we introduced the program at UCSD in December 2013. Training the team was a fairly detailed process with some of the staff travelling to Boston to receive training at Corindus headquarters. We also worked with our hospital credentialing committee to establish guidelines regarding training and privileging. Initially, we began performing robotic PCI for simple coronary lesions. Subsequently, the scope of the procedures has expanded to include more complex coronary interventions including chronic total occlusions, left main interventions, bifurcation lesions, and vein graft interventions. Though these are not among the initial indications for the robotic system, it has been fascinating to optimize the system for more complicated interventions. Though this is anecdotal and surprising, I find myself actually wiring lesions faster with the robotic system than manually. This is not what I had expected.

I should also mention that radiation safety is an area of interest for our cath lab. Essentially, robotic PCI reduces radiation to the primary operator by 90-95% because he or she is only close to the source of radiation for a small period of time during the procedure. This benefit also exists to a lesser degree for the cath lab personnel.

Radiation safety has also been a topic of interest here at CSWN: Interventions. (See "Fifty Shades of Gy" in the March/April 2014 issue.) Do you have any other special efforts in place to limit exposure?
We are very sensitive to radiation safety for both patients and staff. Given the recent reports of increased head and neck tumors in interventionalists, we partnered with a company (BLOXR) to study the benefits of a bismuth-based, non-lead, lightweight cap to protect the brain during cath lab procedures. Now, with robotic assistance, the primary operator isn't even in the radiation field, but the tech and fellows are still tableside and subject to certain exposure. This cap allows them to minimize radiation to the head.

One of our fellows will be presenting the results from the BRAIN study at the 2014 SCAI meeting. The objective of this study was to evaluate the impact of cranial radiation protection. One of the findings of his work was that the left side of the brain is exposed to about four times more radiation than the right side. This seems intuitive, but has never been clearly demonstrated. Even the secondary operator, who is substantially farther away from the source of radiation, receives a comparable, if not greater, amount of radiation exposure to the head likely due to greater scatter.

The goal is to take every measure possible to minimize radiation exposure to the physicians, staff and patients. The robotic system can certainly play a significant role in this.

Who in your lab is actually involved with the robotics program, and how was their education handled? Did robotic procedures require a steep learning curve?
Not every member of the cath lab team is specifically trained on each procedure. There is a dedicated group of people assigned to the robotic interventions team who have been extensively trained. They keep their skills sharp by regularly and repeatedly performing these procedures.

Actually, we have taken that approach with most of the complex procedures in the cath lab; there are dedicated teams who focus on chronic total occlusions, carotid stents, TAVR, and percutaneous ventricular assist device cases. For any complex procedures performed relatively infrequently, not every single person in the cath lab staff is involved. There are "super users" who are familiar with all of a certain procedure's intricacies and serve as knowledgeable resources for everyone else. Because these individuals are not always available—especially during urgent or emergent cases—we have redundancies within the cath lab staff.

At its core, each team consists of an interventional cardiology fellow, physician's assistant, radiation technologist, and nurse. The teams of nurses and techs work together with primary and secondary users for each of the complicated procedures to ensure that everyone is well-versed in the various procedures.

When you adopt new technology in your labs, how do you ensure staff competency?
We have a technology assessment committee in place. Any new technology that we want to introduce is first presented to this committee, which assesses it to ensure patient-care and financial sense. If it is approved, we follow FDA guidelines or industry requirements for training. In terms of formal educational procedures, we meet every Wednesday morning to review new technology that has been introduced to the cath lab as well as any specific training required—particularly for a procedure that is performed infrequently. I always give the analogy of an airline pilot: we do a lot of dry runs to make sure that everyone is up to speed, not only with the technology but also the policies and procedures. The time required for this education is built into our budget.

In addition, we have a bimonthly cath lab morbidity and mortality conference when the entire team meets to review outcomes data. There are also weekly cath and interventional conferences attended by physicians and staff. Physicians and cath lab staff also serve on the Acute MI Care Committee, so there is a fair amount of formality around the introduction of new technology.

What kinds of clinical research and registries is the cath lab infolved in at UCSD?
In addition to submitting our data to the ACC NCDR®, we also participate in a number of registries, including those for carotid stenting, TAVR, chronic total occlusion PCI, stent thrombosis, and the San Diego County STEMI network.

There is strong interest in clinical and translational research at UCSD and our cath lab is involved in numerous investigational device and pharmacotherapeutic clinical trials. Some of the novel clinical research that our faculty is involved in includes investigating intramyocardial stem cell therapy for chronic ischemic heart disease and heart failure and adenoviral-based gene therapy for heart failure. We are involved in studies of novel stent platforms and anticoagulants for PCI, investigating modalities for reducing contrast-induced nephropathy, and evaluating biomarkers associated with ischemic injury after PCI. Our faculty is also actively engaged in defining the role of oxidized phospholipids in outcomes after coronary and peripheral vascular interventions.

Additionally, we're intensely interested in using robotics for complex coronary and peripheral vascular interventions.

In addition to the growing number of robotic procedures, have you witnessed any other trends in terms of interventions performed or patient populations in your lab?
We are definitely seeing an increase in the use of radial access—it's approaching about 40% of our PCI cases presently. Together with this, we've also grown our same-day discharge program for PCI. I believe our program is pretty unique; we perform 1,000 coronary and peripheral interventions per year; half of those are now potential same-day discharges. To help with this effort, we've built a special same-day 22-bed holding unit adjacent to the cath lab. If a patient has an early-morning procedure and meets our same-day discharge criteria, he or she does not spend the night. However, if a patient has a PCI late in the day, he or she is observed overnight in the holding unit until 6 AM the next morning before being discharged.

Our goal is to get everyone home 8 hours after the intervention. This applies, of course, to patients who have undergone a low-risk, straightforward intervention. Complicated patients or complex interventions are admitted. After 6 hours, elective PCI patients are evaluated clinically, lab work is performed, and, if they are ambulating without adverse event at that evaluation, they are discharged.

Before being discharged, patients receive intensive teaching, follow-up via a phone call, and a follow-up visit the next morning. We have a well-organized method of nurse education with a full-time cardiovascular nurse educator. This ensures excellent patient education by all of our nursing staff.

Finally, the volume of peripheral vascular and structural heart disease interventions has recently grown to such an extent that we have a dedicated separate year of advanced fellowship training for that.

Keywords: Myocardial Ischemia, Nursing Staff, Follow-Up Studies, Robotics, Heart-Assist Devices, Learning Curve, Translational Medical Research, Radiation Protection, Stents, Goals, Cell- and Tissue-Based Therapy, Fellowships and Scholarships, Registries, Genetic Therapy, Thrombosis, Phospholipids, Technology Assessment, Biomedical

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