Building an Efficient and Optimized Heart Program at Advocate Aurora Health St Luke’s Medical Center

Advocate Aurora Health operates 27 hospitals, more than 500 sites of care, employs about 3,300 physicians and 70,000 caregivers; it represents the largest health system in the Midwest and ranks amongst the top 10 largest health system in the US.

The vision and strategy of the institution is strongly focused on minimally invasive therapies, and on using artificial intelligence* to improve outcomes. Therefore, they have made significant investments to become one of the top cardiac programs in the country, with clear leadership in TAVR.

*Refers to https://www.biztimes.com/2018/industries/healthcare-wellness/aurora-health-care-to-roll-out-ai-powered-digital-concierge/

The Heart Program Activity in 2018, Procedures and Trials

Dr. Daniel O’Hair: “We started formally working on this heart program in 2008, when it became clear that transcatheter technology was coming forward. We had our first transcatheter valve implantation in 2010. Since then, we have performed more than 1500 transcatheter aortic valve implantations.”

Dr. Bajwa: “Early on, we were part of the initial trials of devices that were not commercially available. We participated in all the trials that assessed the outcomes of the transcatheter approach on high risk patients, as well as in the trials for inoperable and intermediate risk patients. Along with that, we have developed a robust program for the mitral valve as well as the pulmonary valve, and we are starting to work on the tricuspid valve.”

“Last year, we performed 376 TAVR procedures; if we add to that the mitral valve clips, pulmonary and tricuspid valves, we are close to 400 procedures a year. We do all of these procedures together in the hybrid room.”

“The three main trials that we are involved in at this time are Medtronic’s low risk TAVR trial1, which is a global randomized trial, and another Medtronic trial for moderate aortic stenosis2 ; we are also part of the Apollo trial3, which is a mitral valve replacement trial using the Intrepid4 valve.”

“Concerning this last Apollo trial, we were fortunate to enroll the first patient in the world, having previously done about eight cases as a feasibility study.”

Working Together to Build a Heart Program

Dr. O’Hair: “Prior to building this structural heart program, we already had a relationship, since we were working together in the care of heart patients, but we did not have a formal heart team until 2008, when we decided to team up to prepare for these clinical trials. Dr. Bajwa was kind enough to allow me to spend some time in his cathlabs and develop some skills. We did a lot of cases together, and that prepared us very well for the TAVR trials that followed.”

Dr. Bajwa: “Back in 2008, we really believed that partnering with the surgeons was the right thing to do, because we knew that in a structural heart platform, a working heart team involving a surgical team, a cardiothoracic surgeon, and interventional cardiologists, was the perfect set up. It soon became very clear that if we wanted to get into mitral and tricuspid, building a working heart team was going to be very important.”

“Since we embarked on this program, we have our structural heart meetings every Monday morning from 6 to 7 am, driven by the surgeon and interventional cardiologist, assisted by multiple other members of the imaging department, including radiologists, imaging cardiologists, as well as nurses and nurse coordinators. We do believe that this is the key to success for any institution that is embarking on this valvular heart disease program.”

Dr. O’Hair: “Regarding the heart team, other important people we have included in the team are the research people. Research is a big cornerstone of our program, so when we have our heart meeting on Mondays, we also have our research team attend to help us screen all patients for all available options.”

Dr. Bajwa: “All patients are seen by a cardiologist and a surgeon, and we decide as a team which patient is suitable for research and which patient should go with an already commercially available device. As an example, for patients with mitral disease, we have two programs, mitral clip and the Apollo trial. So, we present the cases during our weekly meeting and we decide who is a suitable candidate for surgery, who is a suitable candidate for mitral clip; it’s a collegial discussion.”

Interactions During the Procedure

Dr. O’Hair: “The device requires two people, one to position and one to deploy, so we have changed roles in every possible manner over the years. Currently, I am upfront controlling the position and Dr. Bajwa does the deployment, and we are constantly communicating. We have done this so many times now that few words need to be spoken, but we work together and we are in agreement in everything we do, on the position or valve type and its deployment, so it really is a joint effort.”

GE Technology & Solutions Help Improve Patient Outcomes

Dr Bajwa: “Early on, patients were intubated, it was a very invasive procedure; like surgery. The procedures were longer and we had up to 25 people in the room. One of the main missions of the heart team was to find a way, as technology evolved (sheath size, new generation of devices, new generation of imaging systems), to make these procedures less invasive. We have a coordinator who works with us on how to get these procedures less invasive, in order to send the patient home as quickly as we can.”

“The imaging piece is very important because we are dealing with very ill patients, as well as older patients. Our patient’s age is around 84-85. They have all sort of comorbidities, especially renal insufficiency. Since then, our goal has been to decrease radiation, because we do a lot of procedures, and to reduce contrast because of the contrast-induced nephropathy and increased morbidity."

Indeed, in addition to our regular clinical practice, Valve ASSIST 2 really helped us achieve the lowest contrast use in activity registry in the whole country; our fluoroscopy times are off the chart (graphics above).

"40% of our patients go back home on the second or third day, and imaging was very important for us to progress and make sure we use less contrast, less radiation for the physician and for the patient; imaging also made us more efficient.”

Dr. O’Hair: “I just want to emphasize that in our case, when the procedure goes smoothly, the fluoroscopy time is as short as 5 minutes and the contrast volume is as little as 20cc. We are really proud of that and that has helped us drive excellent outcomes.”

Dr. Bajwa: “Back in the early days of this heart program, Dr. O’Hair and myself went to Buc - France (GE Healthcare, Global Headquarters – Interventional). At that time, we did not know how this procedure was going to evolve; therefore, we wanted a room that would be a real hybrid room in order to be able to switch to an open procedure in case of complications. We went to France, we interacted with the global engineering and product team, and we liked the equipment ; Dr. O’Hair was comfortable that in case of emergency procedure the room could become an OR.”

Dr O’Hair: “That is a key asset of the Discovery IGS 730. We really like that system because we can get it out of the way if we need to do something more invasive. As an example, in the Apollo5 trial, because the access is transapical, there is a bit of surgery first, then we can bring the system in for the procedure, and get it out again at the end to fix everything up. Lastly, the layout of our rooms , which are positioned in tandem with two GE systems and the control rooms in between, enables us to constantly see what is going on in the other room. We can get the next patient prepared for the upcoming procedure, and that setting really helps us improve our efficiency. We are a high-volume program; there are so many physicians and staff involved in these procedures that we want to make sure we do not waste anybody’s time.”

1 Medtronic Transcatheter Aortic Valve Replacement in Low Risk Patients. Source: https://www.aurorahealthcare.org/aurora-research-institute/clinical-trials/nct02701283

2 Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI). Source: https://global.medtronic.com/content/dam/medtronic-com/c/surtavi-ctr-march2017/surtavi-data-acc-2017-reardon.pdf

3 Transcatheter Mitral Valve Replacement With the Medtronic IntrepidTM TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO). Source: https://www.aurorahealthcare.org/ aurora-research-institute/clinical-trials/NCT03242642 zhtml?c=251324&p=irol-newsArticle&ID=2310361

4 IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System

5 Transcatheter Mitral Valve Replacement With the Medtronic IntrepidTM TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO).Source: https://www.aurorahealthcare.org/ aurora-research-institute/clinical-trials/NCT03242642 zhtml?c=251324&p=irol-newsArticle&ID=2310361

6. Effect of a New Enhanced Fluoroscopy Technology (Valve ASSIST2) on Clinical Outcomes in Patients Undergoing Trans-Catheter Aortic Valvular Replacement, TCT 2017 (Oral presentation)