Electrophysiology Roundtable Forum: A Candid Conversation About Profits, Procedures and Patients

Cardiovascular Business invited some of the most prominent physicians in the field of electrophysiology to talk about the current and future state of the subspecialty. Participants in the roundtable discussion are:

• David Cannom, MD, director of cardiology at Good Samaritan Hospital, Los Angeles, Calif.
• David. E. Haines, MD, chairman of cardiovascular medicine at William Beaumont Hospital, Royal Oak, Mich.
• Daniel Morin, MD, staff electrophysiologist and director of electrophysiology research at Ochsner Health System, New Orleans, La.
• Andrea Natale, MD, executive medical director for the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas
• Jonathan S. Steinberg, MD, chief of the division of cardiology and Al-Sabah Endowed Director of the Arrhythmia Institute, St. Luke’s-Roosevelt Hospital Center, New York, N.Y.
• Bruce L. Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic, Cleveland, Ohio
• Moderator: C.P. Kaiser, Editor, Cardiovascular Business

It’s been said that the electrophysiology lab is a loss leader for cardiology departments. Given the current economic climate, what can be done to ensure the EP lab remains a viable economic success?

Jonathan S. Steinberg, MD: I don’t agree with the statement, although it’s been an historical canard that was bandied about, often by hospital administrators. It relates to an era that doesn’t exist anymore, when patients spent much more time in the hospital. Nowadays, on the contrary, EP is very lucrative for institutions. The procedures are complex but reasonably well reimbursed. Hospital stays are short or ambulatory. In general, they can be a profit leader for hospitals or cardiology divisions.  

Bruce L. Wilkoff, MD: I agree that it is not the case any longer. The volume in the electrophysiology laboratory, although not growing robustly, has the potential to continue to grow as we have advances in both implantable devices and ablative therapies. In years past, coronary disease ran cardiovascular medicine in the hospitals, but coronary disease definitely is not what’s leading things now.

David Cannom, MD: It’s a complicated question. Los Angeles is an economic environment unto itself. We have a very high HMO penetration. If you depend on HMO reimbursement for complicated procedures, particularly atrial fibrillation (AF) ablation, you would have a very difficult time economically. What we have been forced to do, as have other places, is renegotiate contracts with the HMOs. Routine ablations, such as simple AVNRT (AV nodal reentrant tachycardia), bypass tracts and atrial flutter, are clearly disappearing or being done at other places. When you depend on atrial fibrillation, as we do, it really can be very dicey because of the expense of the equipment and the time it takes to do the procedure.

Daniel Morin, MD: I’d like to provide a regional contrast to Dr. Cannom’s view. We are the major EP force down here in Louisiana, and at a place historically very cath heavy. Recently, we had a consulting group that came into our place and identified—among all the different cardiology and hospital services—electrophysiology as a source of future revenue growth.

David. E. Haines, MD: At our institution in Michigan, the interventional volume is falling. We get some backfill from peripheral intervention, but those numbers are flat. The only growth area within cardiology is noninvasive imaging, predominantly CT angiography, and EP—and A-fib is driving EP. The device numbers are flat right now. One of the things about the profitability, or lack thereof, is that it’s very dependent on the cost accounting in the individual institution. There is no question that heart rhythm services have a substantial contribution margin and how you determine the profitability is all in the calculation of overhead expenses. We are way lopsided in terms of devices being a huge component of the cost of providing our service. If your hospital does a percentage overhead based on inventory cost, it looks very expensive. If you use other formulas for assessing overhead, then it looks relatively profitable. Depending on how the cost accounting is done at the individual institutions determines whether heart rhythm is an area that they want to support or not.

Andrea Natale, MD: The big potential for growth is in ablative therapies, especially in complex arrhythmias. Device therapy has reached a plateau, as has been mentioned. Also, the success of the EP lab depends on the experience of the operator and we have increasingly more and more highly trained electrophysiologists who are able to manage these complexities. With highly trained operators, advanced technologies and a better understanding of the pathology involved with complex arrhythmias, the potential for growth is vast.

Wilkoff: I’d like to add that there is something that happens with implantable devices that doesn’t happen with most of the other parts of cardiovascular medicine. Once a person receives an implantable device, if the center is set up appropriately, these patients come back again and again. It becomes a relationship builder. So, while atrial fibrillation tends to recur, and maybe needs repeat business, a patient with an implantable device is your patient for life—if you develop that relationship properly.

What other ways can an EP center become more profitable?

Morin: You have to be sure that you are billing appropriately. Whether or not patients get appropriately coded as inpatient admission or inpatient observation makes a big difference in reimbursement—$1200 per case at our institution.

Wilkoff: The Recovery Audit Contractors (RACs) of the Centers for Medicare & Medicaid Services (CMS) have focused on the inpatient/outpatient status of defibrillator implantations. But they are not making decisions based on published criteria. The Heart Rhythm Society has been working with CMS to establish criteria, but since there is no national coverage decision—since nobody had ever imagined that you needed to have a national coverage decision to say whether somebody is an inpatient or an outpatient—then it’s up to local carriers to decide what’s appropriate. I would make sure you document the comorbidities and have justification for inpatient status.

What should electrophysiologists pay attention to when planning to open a lab?

Steinberg: It’s good to ensure that your capacity is proportional to your projected volume. Especially as you initiate a program, you want to ensure you don’t overbuild or oversupply equipment. It is often necessary to educate referring physicians about proper indications for procedures and devices, proper indications for consultations and referrals.

Cannom: I am very concerned that institutions are performing more procedures than they can safely do, particularly in atrial fibrillation ablation, without the experience or infrastructure to take care of patients who have a rare complication. I am not that interested anymore in seeing more programs open up in large cities. If you are going to set up a program in an underserved area, you need a huge institutional commitment to do these difficult procedures and you need someone that’s very experienced.

Haines: Fellows just out of training generally build their EP practice with bread-and-butter activities. Just for growing the business, the quick turnaround procedures are obviously the most profitable. A 90-minute AV node reentry ablation doesn’t pay a whole lot less than a five-hour A-fib ablation.

Natale: That will change, however, in 2009 when new Medicare rules will reimburse significantly less for outpatient procedures. CMS has criteria that you have to follow in terms of patient complexity. Therefore, an AV node reentry is probably going to be an outpatient procedure and is going to be paid less than a complex ablation.

Wilkoff: Another part for people who are looking ahead is the ability  prove outcomes, being able to measure quality and ensure compliance with national standards. It’s always easier if you do it systematically from the beginning. Adhering to national standards, quality reporting and keeping track of complications—such as deep vein thrombosis, pulmonary emboli, perforations, surgery, death and infections—are going to become essential to opening up a lab, and for operating experienced labs as well.

How do you handle device recalls and the fear they might instill in potential candidates for ICDs?

Wilkoff: It’s a complex question. It’s as much a problem with the language as anything else. It’s not so trivial a distinction to call it a safety alert instead of a recall. Studies have shown that people respond differently depending on what words you use. The Heart Rhythm Society has been working to get the FDA to change the language. A recall implies patients can bring it in, EPs can take it out and the problem is fixed. We know it’s much different than that. We have found that in almost all cases continuing to monitor the patient for an actual failure, even in an identified at-risk situation, is less risky to the patient than changing the device.

How has newer imaging technology helped in the EP lab

Natale: Intracardiac echo imaging (ICE) has been important in reducing the risk of perforation. Obviously, the cost of ICE has been a deterrent for many labs and it is a choice people have to make in terms of how much they care about increasing safety or otherwise taking the risk. We also use 3D CT and MRI reconstruction. There is some retrospective data showing that these might increase success, but they don’t reduce the complication rate.

Steinberg: Electro-anatomic mapping has made complex ablations much easier, much more reliable and safer. We use it on all our complex cases. I agree with Dr. Natale regarding the use of intracardiac ultrasound to reduce risk. A successful atrial fibrillation ablation depends on proper positioning of the catheter for both mapping and ablation. Fluoroscopy only gives you an indirect image of catheter position relative to heart anatomy. With an ultrasound, you can visualize simultaneously the various structures of the heart and the catheters.

Haines: There are a number of new technologies that are in trials right now, a variety of balloon ablation catheters for pulmonary vein isolation and preformed catheters that are going to potentially aid the less-experienced operator in pulmonary vein isolation. It’s going to get down to safety versus cost.

Intracardiac echo imaging is the one tool we use on every A-fib case that truly enhances our understanding of the minute-to-minute changes in the anatomy, catheter relationships and transseptal puncture, but it does add cost. The tradeoff with any new ablation tool, such as the cryo-balloon, is that it will be very expensive. A simple pulmonary vein isolation procedure, for example, might take three hours with a conventional cooled-tip catheter. With newer technology, you might be able to reduce lab time to two hours, but you may end up spending twice as much for the equipment. The per-case cost with A-fib ablation can get very high very quickly, particularly, if you add in robotic navigation and amortize the cost of those devices over the case load.

What is a typical per-case disposable cost for an atrial fibrillation procedure?

Natale: Usually, I use the Thermocool catheter and the Lasso circular mapping catheter. I use robotic navigation in some instances, but there are some in my group who use robotic almost routinely. So, the official cost of the robotic sheath is close to $3,000. We get it for $1,600 because we use many of them. Then you have to use the ablation catheter and the Lasso on top of that. So, the robotic sheath becomes an extra cost.

Is there any reimbursement associated with robotics?

Natale: There is a code, but I don’t know if it is actually being paid because most of the insurance companies, especially Medicare, pay a fixed amount. It doesn’t make sense. To improve your chances of success, you have to use newer technology and image integration, which costs more, but the trend of reimbursement is going the other way.

How important is patient selection and what knowledge have we gained in recent years?

Wilkoff: Part of it is patient selection and part of it is setting expectations and that’s an educational component that happens between the operator, the patient and the patient’s family, but also the operator and the referring doctors. For instance, a patient with an implantable defibrillator has to be followed—and followed under certain protocols that he or she must understand and accept. Setting expectations for somebody who has chronic atrial fibrillation in a large atrium is much different from somebody who has paroxysmal atrial fibrillation and has a normal sized atrium. Those are completely different patients and you can get a good result with both, but you have to set the expectations appropriately.

Steinberg: If we look at the supraventricular arrhythmias, including the many forms of supraventricular tachycardia (SVT), Wolff-Parkinson-White syndrome and atrial flutter, those are clear-cut indications. Many of these patients who are symptomatic with arrhythmias are candidates for ablation, certainly, if they are refractory to medications, but often patient preference dictates that the ablation be a first-line therapy as well, and that is reasonable. When you get into realm of atrial fibrillation, it becomes more complicated. In general, these patients need to be refractory to anti-arrhythmic drug medications before being referred to a lab and they need to be symptomatic. There are some infrequent exceptions to that rule. The success rates are not as good and the risks are greater, so we are more judicious in whom we perform the ablation.

How do you make the choice between ablative therapy and anti-arrhythmic drug therapy?

Morin: Essentially, some patients are candidates for both and it’s going to depend on the risk/benefit analysis. If patients are a candidate for both, they may be cured permanently by their ablation, whereas medication sometimes will need to be taken for the rest of the patient’s life. Going along with that are the risks of taking a medicine for rest of your life or the potential risks of having a device implanted or an ablation performed.

Natale: The guidelines suggest that patients fail at least one medication before trying ablative therapy. The success rate of a second drug after the failure of the first is much less than what people would expect, in the range of 20 percent or less. Even with drugs as the first-line therapy, the success rate of controlling A-fib is much lower than what people think. Drugs are the answer for some patients, but might not be the preferred choice for others, especially young people who are active. Ablation, if properly done, is certainly the best long-term solution. There are studies looking at ablation as a first-line therapy, but it will take another three or four years to have the results.

Where do you see the specialty of electrophysiology in five to 10 years?

Wilkoff: I see EP being part of the main economic engine of the cardiovascular department or division. It’s going to be a larger part of what’s going on and it’s going to focus on two major areas: devices and ablation. You should expect to see important trial results in that timeframe including the MADIT-CRT trial, which is looking at people with less severe heart failure symptoms (NYHA FC I and II), but wide QRS for cardiac resynchronization therapy, and the DETERMINE Trial, which will help us determine whether an ICD can help prevent sudden cardiac death in people with mildly impaired ejection fractions and coronary disease when MRI determines that there is significant left ventricular scar.

Morin: I agree with a lot what Dr. Wilkoff said. I am particularly interested in identifying patients who don’t presently meet guidelines for implantation of ICDs, patients with preserved ejection fractions who may be at risk for sudden cardiac death. The DETERMINE Trial, as mentioned, is going to be very interesting, using MRI to look at the scar burden of patients with preserved ejection fractions who have had an MI. This has the potential to identify an enormous number of patients who might meet future criteria for ICD implantation. Also, as we advance the safety and efficacy of atrial fibrillation ablation, we may reach a point—perhaps in 10 years—where ablation becomes the primary therapy, particularly for those patients with paroxysmal AF. Finally, as we train more electrophysiologists and they go into underserved areas, we will have enough trained doctors so that general cardiologists won’t have to provide these therapies, thereby reducing the complication rate.

Natale: I agree with what has been said so far. The only addition that I can make is there would be probably an increased attention to ventricular tachycardia and ablative therapies, especially in the presence of structural heart disease, and perhaps studies showing that earlier intervention is something that we should consider.

Steinberg: I see us making headway in refining AF ablation techniques, making them more efficient, perhaps more successful, and probably safer. We also may see an era of remote magnetic navigation, where catheters are manipulated by a magnetic field. This also may improve safety and efficacy measures because the catheters are extremely soft, thereby causing less perforation; the catheters can be manipulated into difficult-to-reach areas; lesions that are more connected and contiguous can be ablated; and there’s better contact with tissue, making the lesions more durable and deeper.