Protocols and Daily Management at Mount Sinai Cardiac Cath Lab

 Has Mount Sinai been able to maintain its procedure volume with the overall drop in angioplasty procedures across the country?

Compared to most hospitals across the U.S., we have not seen a volume drop. I personally am still doing over 1,000 procedures per year, coronary as well as structural heart disease procedures, such as valvuloplasties and transcatheter aortic valve replacement (TAVR). Both our peripheral and carotid volumes have increased. Mount Sinai able to maintain its procedural volume since we have recruited more physicians through our outreach program.

And patients with complex coronary disease are specially referred to us for percutaneous coronary interventions (PCIs). Mount Sinai now has satellite clinics over the five boroughs. Geographically, we get patients with complex coronary and valvular disease from the tri-state area, but patients mostly come to us from New York City’s five boroughs.

The procedure themselves have shifted over time.

Yes, but our coronary volume has stayed the same (Figure 2). We are now doing over 800 peripherals (including all percutaneous transluminal angioplasties, carotid and renal).  

Can you tell us about your cath lab protocols?

We are proud to have a set protocol for cath lab procedures. How a cardiac cath should be done, how an intervention should be done, how a diagnostic valve case has to be done, how valvuloplasties have to be done, and so on. Everything is written out in a handbook. When the new fellows start in July every year, it takes close to 4-6 weeks to go over, step by step, how each case has to be done per protocol so these fellows are trained the Mount Sinai way, to do every case with the same routine. We have five full-time core faculty members, but combined with other Sinai faculty and outside visiting faculty, we are about 25 cath lab attendings. Despite many operators who do procedures, the quality, as well as the safety, is maintained due to the protocol. The backbones of the lab are our interventional fellows. Our staff, which includes our nurses, technicians, nurse practitioners (NPs) and physician assistants (PA), are also well trained to go through the protocol, especially with regards to prescreening in the ambulatory area and post procedure care. For example, our protocol covers what has to be done with the regular patient, a patient who comes with a high creatinine or patients who have dye allergy, etc. These written protocols are strictly followed. If any deviation is to occur, staff or fellows always check with the attending physicians prior to the procedure. 

Can you share more about the process of deciding who gets an intervention with more complex coronary artery disease (CAD)?

In the last few years, ever since the appropriateness criteria guidelines were published, every patient gets a SYNTAX score calculated after the coronary angiogram is done.  The attending will read the angiogram with a diagnostic fellow or NP. Our reporting system has the SYNTAX score  integrated, so we immediately get a SYNTAX score. As per the protocol, if a patient has a SYNTAX score >22, we cannot do PCI unless we have defined a reason. If the patient has a SYNTAX >22, the patient has to come out of the cath room to discuss the option of coronary artery bypass graft surgery (CABG). Cases where we can proceed with PCI in patients with high SYNTAX scores are acute MI (STEMI or non-STEMI), age ≥85 years old, prior cerebrovascular accident (CVA)/recent transient ischemic attack (TIA), severe chronic obstructive pulmonary disease (COPD), left ventricular ejection fraction (LVEF) <20%, and/or if the patient has already had a cath and was referred to Mount Sinai for an intervention. Other than these groups, every other patient comes out of the room. A heart team that involves the referring cardiologist along with the cardiothoracic surgeon will discuss the option of CABG with the patient. If the patient refuses, they will come back and have a PCI at a later time or later the same day. 

A cardiologist can be kind of a neutral party.

Yes, when this kind of discussion happens, the interventionalist takes a back seat so the patient doesn’t get a biased opinion from the interventionalist. It is usually the cardiologist who takes the lead to talk to the patient and the cardiologist drives the discussion. If the patient’s cardiologist is not at Sinai, we will have  Sinai cardiologists who will take part in the discussion. Suppose I did a cath and the patient’s SYNTAX score is 29. We let the patient and the family know that both the options for PCI and CABG are available, but emphasize that CABG will save lives in the long run. For example, if there is calcific multivessel disease with a high SYNTAX score, I will indicate that bypass is the best option. Patients’ biggest concerns tend to be the length of the hospital stay and the risks of each procedure. The risk of stroke is higher for CABG. Then, when you tell patients the length of stay for CABG is anywhere between 5 to 7 days, I think they start to back off. No matter what we say with regards to appropriateness and what the right thing to do is, somehow the pendulum in America has swung to the extreme of doing more PCIs. It will take a while for us to switch the pendulum back to the neutral position. For many of these cases with complex CAD, CABG is probably the right thing to do. It will take time for the referring doctors, the interventionalists, and the patients to accept that CABG is also an option. A cardiologist who knows the patient plays a key role in this group discussion. 

SYNTAX scores and appropriateness criteria for PCI are integrated in your reporting system. Is that unique to Mount Sinai?

Yes, it is unique to our reporting system, which is based out of an Indian company, SoftLink. We started working with them many years ago and the reporting system was built by us. We keep updating the reporting system based on any new guideline changes. Therefore, SYNTAX scores and appropriateness criteria have been incorporated. Suppose we have an angiogram of a patient that has a three-vessel coronary artery disease (CAD). A fellow, NP, or PA will enter that information into the reporting system, which will generate a report with the SYNTAX score and appropriateness criteria.  

Let’s say a patient has a SYNTAX score of 20 and class III angina. We can proceed with PCI. Another case with two-vessel CAD, a SYNTAX score of 18 and class I angina with mild ischemia on stress test will get OMT (optimal medical theraphy) and no PCI. In 2010, New York State published data on revascularization by PCI in stable CAD patients. We are proud to say that in stable CAD patients, Mount Sinai had only 3.7% inappropriate PCIs done compared to the New York State average of 13.4% (Figure 3).

Based on the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR), Mount Sinai had only 3.1% inappropriate PCIs done compared to 19.9% at other U.S. hospitals (Figure 4).

Does Mount Sinai measure platelet resistance?

Yes, in few subsets of patients we do measure platelet resistance, including those patients who present with subacute stent thrombosis (SAT), LVEF 25%, and need multi-vessel PCI (high risk for SAT), complex stenting of unprotected left main coronary artery disease, and multi-vessel PCI. We know that various randomized trials have shown no benefit of P2Y12 reaction units (PRU)-guided anti-platelet therapy.

Can you give us an overview of your protocol for intra-aortic balloon pump (IABP) use?

Per protocol, IABP is used in complex PCIs with normal LV or EF up to 35%, acute MIs and/or cardiogenic shock, or any emergency situtations (approximately equal to 30 cases per month).

Do you feel the protocol system at Mount Sinai is scalable to a small lab, or would it be most appropriate for larger academic centers?

 Yes, if possible, a protocol system should be incorporated in every lab. Busy academic centers definitely should have it; a protocol-driven system protects the physicians and the institution. When one is busy and doing a high volume, you are likely to be audited. You need to have a protocol in place to explain how complex and high-volume cases can be done safely, and ensure the same quality of care is provided to every patient.

How do physicians deviate from the protocol?

Deviation is allowed as long as it is within the norm of the bell curve. Perhaps a middle-aged patient has left main and two-vessel CAD with a SYNTAX score of 24, and PCI is appropriate.  The referring cardiologist, who knows the patient well, is in the cath lab and decides on PCI, knowing the patient will refuse CABG.  The patient will not come out of the cath lab room and PCI will be done.

Other deviations might include how to deal with a bifurcation lesion, arterial access in  patients with a high international normalized ratio (INR), and timing of a cath in a patient with chronic kidney disease (CKD). As long as we know that it is within the norm, we will allow deviations for other attendings. 

If changes to the protocol are made, what is the process?

When there is a change in guidelines or hospital policy [including the quality assurance (QA) committee], Dr. Sharma and myself would make the changes in protocol.

How are the protocols distributed?

We will make a memo detailing the new protocol and it will be sent by email to everyone, so that receipt is confirmed. We discuss new protocols/guidelines during our monthly faculty meeting and QA meeting. I meet with the interventional fellows, cath lab staff, and NPs every week. So at various levels and various meetings, everyone will be kept informed of the changes and new protocol.  

Due to the strict protocol implementation, Mount Sinai Cath Lab has been able to perform a high volume of cases with low complications (Figure 5).

What is your involvement in terms of organizing the cath lab on a daily basis?

Our daily cases average around 60, including 6-10 transfers each day. 

Every day at 6:50 am, I do the board rounds for ambulatory patients. We have cardiology fellows rotating to the cath lab who provide history on all the patients.  These patients’ charts include the patient’s clinical notes from the referring doctor and any test, such as a stress test, CT scan, and/or echo, and will be made available by our admitting office. All the details are presented and I make the decision on type of arterial access, need for a right heart cath, and so on. In certain valve cases and in a hemodynamic study, we would like to have the patient exercise on the cath lab table. Everything will be written on the board and we go over every case. In-patients, transfer cases, and emergency department cases will be discussed.  We accommodate most patients same day and do the case in whatever room is available. As the day goes by, we may be getting transfers, and they will also be added on the board. I will coordinate with the transfer center and decide on the arrival time of the transfer cases.

Can you go through a typical day at Mount Sinai Cath Lab?

Patients arrive to Mount Siani Cath Lab registration area. After completing registration, the patient will proceed to the admitting area. They will be seen by the nurse, who will make them comfortable, do their vitals, put in an IV, and draw blood for labs. The NP will approach them, take a full history, and make sure the patient is suitable and understands the procedure, and gets the consent. Everything is documented electronically in the EPIC system. We have an electronic tracking system and a monitor in the cath lab control room. We have initials: “C”, for consent, “E” for EPIC, and “L” for lab, meaning the blood draws have been done. So if the patient’s “CEL” is complete, their name automatically becomes green, which tells me, while I am sitting in the control room, that the patient is ready to go to the room. Every patient’s arrival time in the registration area is noted in the tracking system. 

Next, the patient comes to the holding area of the cath lab, ready to go into the room. Our tracking system allows me to see from the control room how things are moving. The patient might have gone for a cath, then the physician decided to do an intervention. It might have taken longer than we expect, so the next patient outside will be informed by a patient liaison. The liaison will be rounding regularly through various area of cath lab to check with every attending and update family if there is a delay. If the delay will be more than two hours, sometimes even the physician will go and talk to the patient, just to keep the patient and the family aware. 

All the transfers arrive to the holding area. The NPs will evaluate the patient and discuss the case with the attending that will be doing the procedure. If transfer patients have a lot of co-morbidities, these may need to be addressed first, so rather than doing the cath procedure on the same day, we will admit the patient, have the patient tuned up, and probably postpone the procedure by a day or so. 

When do you typically perform your procedures?

Throughout the day, I will have various executive or reseach meetings in the cath lab conference room  between cases.  Wednesday is the only day I am out of the cath lab, seeing patients in my office, but I am connected remotely to the lab. If there are any issues, the in-charge nurse will call me for things they cannot handle, where some executive decision has to be made; otherwise, they just follow the system.

What about training fellows? 

I enjoy training and teaching fellows, who are eager and work hard during the year to get their skills, so they can become independent enough to do the procedures themselves. Mount Sinai also does a regular, live cath lab webcast where we enjoy teaching and sharing all the technical details of the case.  Three days a week, I teach fellows in the morning after the board rounds.

Can you tell us about your mentors?

For the last ten years, I have concentrated on my clinical career. The one person who has really helped me to get to my current level has been Dr. Samin Sharma. I began my fellowship at Mount Sinai after my training in England.  Under his training and guidance, I have stayed at Mount Sinai. I have been able to succeed because of the great support that both Dr. Sharma and the institution of Mount Sinai have given me. 

I took over the directorship of the cardiac cath lab last year. Essentially, over the next five years, my goal is to combine translational research and intracoronary imaging in the cath lab. Our most recent trial was the Reduction in YEllow plaque by aggressive Lipid LOWering therapy (YELLOW) trial. Already, YELLOW trials II, III and IV have been planned with the help of our excellent group of physicians. In the morning, when I go through the cases with the fellows, I screen each case for a trial. In the last year, Mount Sinai has been the highest enroller for the Tryton bifurcation stent trial, the Expert CTO trial (evaluation of the Xience coronary stent, performance, and technique in chronic total occlusions), and right now, the CANARY trial (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow). 

In addition, I am focusing more on women and CAD. CAD risk factors are not the same for women as they are for men, and CAD often doesn’t show up until women are late in age. Women are under-diagnosed. With the help of nursing leadership, we started a program called the HAPPY Woman program: HAPPY (Heart Attack Prevention Program for You). It launched on February 1st in honor of it being Heart and Go Red for Women month. We have to help women realize their risk factors, and focus on education and lifestyle modifications specifically for them. 

I believe in encouraging more women to become cardiologists and interventional cardiologists, so we will be able to help other women across the globe. 

Dr. Kini can be contacted at annapoorna.kini@mountsinai.org.

Reference

1. Cath Lab Digest talks with Annapoorna S. Kini, MD. Cath Lab Digest March 2009; 17 (3). Available online at https://www.cathlabdigest.com/sidebar/Cath-Lab-Digest-talks-Annapoorna-S-Kini-MD-Associate-Director-Cardiac-Catheterization-Lab-Di. Accessed February 8, 2013.