Can you tell us about your OBL?
We are in phase one of a multi-state office-based laboratory (OBL) program, but right now we are at one pilot lab, which has now been open for two years. We perform peripheral angiograms and peripheral interventions, which include a spectrum of iliac, superficial femoral artery, and below-the-knee procedures, with a focus on critical limb ischemia and limb salvage. We also do upper extremity and carotid angiograms.
How has the Covid-19 pandemic affected your OBL?
Michigan was a hotspot for Covid-19. During that initial time period, we saw a decrease in volume and limited our cases to critical limb ischemia.
How has the Covid-19 pandemic affected your OBL?
Michigan was a hotspot for Covid-19. During that initial time period, we saw a decrease in volume and limited our cases to critical limb ischemia. The governor also issued a mandate to only do essential procedures, which we honored. What we found is that as Covid-19 continued to progress, a lot of patients sought out OBLs in an effort to avoid hospitals as much as possible. Due to the fear of Covid-19 spread, particularly in hot areas such as the hospitals, patients were requesting procedures to be done electively outside of the hospital, in facilities that have less chance of having Covid-19. At the peak of the Covid-19 spread, we established a Covid-free environment in our facility. We were able to do that because of a phased screening process for patients. It takes place initially over the telephone. Then at the entry into the building, patients are screened individually, one by one, while they are in the car and then screened when they enter the facility. We have been able to maintain a Covid-free environment. Since March — so, over the last four months — we have not had a single incident of a Covid-19 patient, staff, or physician in the facility.
Have patients expressed that they are worried about going to the hospital due to Covid-19?
Yes. There is an understandable fear of Covid-19, especially with those patients that do have peripheral disease and cardiovascular disease. These patients are at a higher risk of contracting Covid-19 and having related complications. Since they are high risk, they have to take all the necessary precautions, but these fears, among patients and physicians both, have also resulted in patients not being treated for heart disease, strokes, and other chronic illnesses, perhaps due to an extreme and unnecessary avoidance of care. Patients have a very reasonable fear of Covid-19, however, and to that end, the OBL serves a purpose, offering safety and service for the patient. In fact, because we did not know when the Covid-19 pandemic would end, at one point there was some discussion with Michigan’s governor and state health officials of converting OBLs into ambulatory surgical centers (ASCs) in order to do elective coronary procedures via the granting of a temporary license. Fortunately, the governor has done a good job controlling Covid-19 and we saw a decrease before having to execute this plan.
There has been ongoing discussion around expected new guidelines for ASCs regarding coronary angiography and intervention, with support from the Society for Cardiovascular Angiography and Interventions (SCAI). How do you see this market shift impacting the next 5 years?
OBLs and ASCs have been very successful in providing the same service as hospitals, but with greater efficiency, better patient satisfaction, and a quicker turnaround time, without having a bureaucracy. It is also a much more cost-effective method than going to the hospital. It is one of those scenarios where it’s a win-win for everyone. The patients are more satisfied. The insurance companies pay a lot less than they would in a hospital, because OBLs and ASCs don’t have the extensive overhead of hospitals. Operators work more efficiently and effectively with more controlled settings. The future of ASCs and OBLs is only going to expand. I envision in the next five years that we are going to be very similar to Texas and Florida, where most of these OBLs and acute ambulatory surgical centers will be doing coronary procedures. We anticipate the restrictions on performing coronary interventions will be lifted, and we predict that Michigan will follow Florida and Texas regulations. Covid-19 reinforced the desire for patients and physicians to have an alternative for hospital care. We foresee more OBL/ASCs opening in the near future and subsequently, a fixed system will be most beneficial to meet patient demand.
Can you tell us why you chose a fixed unit versus a mobile C-arm for your OBL?
We did extensive research before starting our OBL. My team and I visited different OBLs and ASCs throughout the country, from the East Coast to the West Coast to the South. We gathered as much data as we could in speaking to operators. After doing our research and looking at the economic impact of the project, we felt that our OBL, in the long term, would be better served with a fixed lab versus a C-arm. First and foremost, we wanted to not only replicate the hospital experience, but do even better than we would in the hospital, and hospitals have fixed labs. The future of coronary procedures is going to be outpatient and investing in a fixed lab prepares you for coronary angiograms. Simply upgrading the software will be a matter of hours in comparison to the extended time and investment for infrastructure changes that it takes to go from a mobile c-arm to a fixed lab. Paying up front for the fixed system is more efficient and cost effective for your overall return on investment. Another reason was integrity of patient care. We wanted to give the utmost in quality care to our patients, and we wanted to personalize care more than it would be at the hospital. The only way to do that is by utilizing the highest levels of technology and equipment to help the operator. We concluded that patient care, image quality, and the ability to maintain a larger patient volume population would be better served with a fixed lab. Our fixed lab (ARTIS zee angiography system, Siemens Healthineers) has the advantages of better imaging and acquisition, collimation, and road mapping, as well as other features that a mobile C-arm does not provide. There are also safety advantages, including less radiation for both the patient and the operator, and the ability to have filters. We can use collimation, there is reduced scatter, and the fluoroscopy is about one-third the dose of cine. These features in fixed labs allow you to reduce the amount of radiation by at least one third, with multiple added accessories that are not available with a C-arm. We felt that the lower cost of having a C-arm is really not as advantageous as it would seem, considering the safety applications available with a fixed lab. The final aspect is important from an efficiency perspective: better workflow and room efficiencies. We are able to complete cases more quickly and cost effectively with a fixed lab, while being safer, than with the use of a C-arm. Turnaround times are much quicker. One less staff member is necessary, because the controls of a fixed lab to pan can be used by a physician. Over an extended period of time, the lower costs from one less employee, as well as the efficiencies of a quick turnaround time, help offset the added cost of having the fixed lab.
How does a fixed lab differ from a mobile C-arm in terms of workflow?
Fixed units offer a larger area to image, so there is less movement required. The operator can maneuver the C-arm because the controls are adjustable and close to the operator, while still maintaining sterility. The controls are in the hand of the physician, so the physician is much faster in completing the procedure, because it’s not necessary to relay to the second operator what images or angles are desired. Turnaround is also very simple as far as the fixed lab, since the camera is designed to move out of the way to allow patients to maneuver on and off of the table, and it is very quick for adjusting the height and the angle of the table. When we did our calculations, we factored in the cost of added staff, the efficiencies of turnover, and the safety of the fixed lab versus a mobile C-arm. Our calculations showed that using a fixed lab in an OBL for less than two years meant it would not be a cost-effective investment. However, for any center that plans on being in business and serving patients for longer than two years, it is much more cost effective to have a fixed lab. We predict that cardiac cases in the near future, such as coronary angiograms, loop recorders, and pacemakers, will be performed as outpatient. Assuming that an OBL will provide service for greater than two years, the rate of return is much more effective with a fixed lab.
Are there specific functions and applications from Siemens that you appreciate in your fixed lab?
In terms of specific applications, Siemens offers a number of features with its Combined Applications to Reduce Exposure (CARE) applications and CLEAR functions, which help enhance image quality. One of the most important features is Advanced Roadmap. As we are performing a procedure, we no longer have to use cine. The DSA Roadmap feature has helped us decrease radiation for both the operator and the patient due to the ability of using a digital subtraction angiography (DSA) image as a vessel roadmap. We have been able to cut the procedure time by at least 15%, because we are no longer using cine. We also have been able to cut the dosage of the contrast agent used for the procedure, because we are doing fewer images and the patient gets less exposure to contrast as a result. Another feature from Siemens is CO2-DSA, used for patients in whom we cannot administer contrast for various reasons, either due to chronic renal failure or a severe allergy to dye. We are able to obtain superior images that were not available prior to having this application. In the past, we had very rarely used CO2, because images were only enough to safely say that we could proceed with the procedure. With the use of the CO2-DSA application, we’ve had no restrictions. The images are very crisp and clear, and it has really changed our practice. Approximately 10% of our cases now incorporate use of the CO2 application without any use of IV contrast and produce very good images.
We have also been able to integrate new technology. Siemens engineers were very helpful in integrating intravascular ultrasound (IVUS) into our lab and it has become a common part of our practice. Now we can use IVUS with smaller sheaths; prior to all this, we had to use IVUS with larger sheaths. These advances have changed our practice model. Now we use IVUS to measure the lesion and also in sizing the vessel for possible intervention. We are also able to use IVUS when crossing chronic total occlusions to evaluate whether or not we are in the true lumen.
Any final thoughts?
In planning our OBL, we considered five cath lab imaging companies. At our particular hospital, we work with five different vendors. After reviewing our experience, we felt that Siemens was probably the most user-friendly towards the operator and consistently dependable. One of the important things we considered when evaluating different vendors was the service agreement. We wondered how quickly each company would move if we experienced any issues with the equipment. The service agreement that we have with Siemens, and this is our experience in the hospital as well as in our OBL, has been outstanding. Siemens engineers are very quick to fix any problem that we have and when we tallied the amount of service that was required of different vendors over the last two years, the service for Siemens was much less than its competitors. They also offer a warranty that can be purchased with the fixed arm. Over the last two years, we have not needed the warranty, which is a testament to their good engineering.
Disclosure: Dr. Elder reports no conflicts of interest regarding the content herein.
Dr. Mahir Elder can be contacted at HeartTeam.com.