The American College of Cardiology’s Annual Scientific Session will be in Atlanta this March. Tell us about the launching of the radial lounge at Saint Joseph’s, planned for the beginning of the meeting.
Dr. King: Saint Joseph’s has made a commitment to develop a comprehensive system for transradial patients with same-day discharge to ensure safety, comfort and hopefully, cost savings. Under the direction of Dr. Jack Chen, we are developing a post procedure radial lounge. After prep, the patient has the cath and then, if needed, intervention. Once the procedure is completed, the patient gets off the table and comes to the transradial lounge. There, they can sit in a La-Z-Boy and watch TV, read, work on their computer, etc., for a period of time, and if everything checks out, they are discharged home with follow up. For radial procedures that go smoothly without any complications, this post procedure process, we feel, is the wave of the future.
The radial approach almost completely obviates bleeding risk. The major reason patients are held in hospital with the femoral approach is late bleeding. Unrecognized bleeding from the femoral puncture site can lead to rare but devastating consequences, whereas from the radial approach, bleeding is almost nonexistent. If it does occur, it is easily visible and it is not life-threatening.
In some parts of the world, the radial approach has been embraced as the default strategy, but in the U.S. it has remained low single-digit penetration and only now is beginning to gain a great deal of interest. The ACC is going to feature Saint Joseph’s and the transradial procedure. We are hosting a small group of physicians attending ACC to tour our radial lounge — in essence, it is an opportunity to assist other hospitals in the country that are interested in the transradial approach. We’ll be a beta site, a place where others can view what is possible. We also plan to host a roundtable discussion focusing on healthcare challenges and opportunities with a focus on transradial access. We think it’s a good step forward for quality and safety, while hopefully remaining cost conscious.
Dr. Chen: Just imagine patients walking off the table and being escorted to an internet café or bistro, where they are free to ambulate. They can surf online or check their emails (with one-hand typing), enjoy fresh cappuccino, watch HD television, or catch up on some reading. They then go home after 2-6 hours, depending on whether the procedure was diagnostic or interventional. Dr. Kiemeneij built a similar lounge in the Netherlands. The idea is for patients to not feel like they are actually in the hospital, but simply “hanging out” at a Starbucks.
The ACC is introducing a Learning Lab that will be held in the exhibit area. It is a hands-on opportunity involving procedures and process. These peer-to-peer lab sessions involve one to two physician proctors. We will support the Transradial Learning Lab, which will include sections on access, simulation, hemostasis and recovery. I am particularly excited to be able to share our view on the future of transradial, including recovery and our implementation of the transradial lounge.
Dr. King: Jack and others have identified how the flow can be dramatically improved from the traditional recovery areas in cath labs and shared it with the hospital architectural group. The radial lounge will have more resemblance to a luxury lounge in an airport than it will to a recovery area. It will be fully staffed with nurses and have similar observation, but since these patients are ambulatory immediately after the procedure, there is no need for them to be put into an uncomfortable environment. The environment will be comfortable and people will be allowed to interact and do as they choose, whether they want to knit or surf the internet.
What about implementing same-day discharge, which goes hand-in-hand with transradial access?
Dr. Chen: I like your expression “hand-in-hand”! CMS has determined that, for the most part, uncomplicated percutaneous coronary interventions are now outpatient procedures; they will no longer pay for an overnight stay for an inpatient. If, after an uncomplicated intervention, the patient stays overnight, the hospital potentially could lose money when reimbursed as an outpatient procedure. The hospital will be paid the same whether the patient goes home in six hours or the next day.
We reported on STRIDE: the Same-day TransRadial Intervention and Discharge Evaluation1 in the American Heart Journal in 2008. In this study, we retrospectively assessed patients who had transradial procedures. Study patients stayed overnight in the traditional manner. We looked at post-procedure complications from hour zero (when the procedure ended), until hour 6 (6 hours after the procedure). During that time, if any complication occurred, the patient would obviously not go home, regardless. Even if you planned to discharge them and a sudden complication were to occur, you would not send them home at that point, regardless of the initial planned discharge strategy. We also looked at hour 6 to hour 24, which is really the golden period. It’s the critical time differentiating between ambulatory discharge and overnight stay. If I send the patient home at hour 6 and something were to happen between hour 6 and hour 24, then keeping that patient overnight would have potentially impacted the patient’s management and outcome. What we found was that absolutely no complications occurred in transradial patients from hour 6 until hour 24. After hour 24, a complication would not be altered by choice of discharge strategy, as the patient would have been home anyway. Even if the patient had been kept overnight, a complication at hour 25 would not have been preempted by an overnight stay. From a retrospective standpoint, we were able to show that the discharge strategy made no difference in terms of complication rates and patient outcomes.
Right now, we are embarking on a prospective evaluation, not simply of the safety of ambulatory transradial intervention, because that has already been established (not only by our study, but by multiple studies across the world), but of cost. We plan to look at how much cost saving occurs from discharging someone in 6 hours versus keeping them overnight. Now, intuitively, it seems obvious that less time in the hospital means less cost; but it’s still something that needs to be demonstrated objectively and quantitatively.
Dr. King: The use of the radial approach is quite limited in the U.S. and extensive elsewhere. Yet we are anticipating a dramatic upturn in the U.S., and the question is, why? Is it because of patient satisfaction, which is obviously high? Is it because of decreased complications? There is a current study from Germany published in JACC Intervention in November 2009 documenting that even in today’s environment, with femoral closure devices, smaller French sizes, and so on, there is still a dramatic decrease in complication rates using the radial approach rather than the femoral.2 However, the overriding question that people now have is, if we have a procedure as safe as, maybe safer than, femoral access, why aren’t we doing it? Since transradial enables us to send the patient home the same day, are we actually saving money? Yes, you probably save money, but no one knows the amount actually saved. We will be conducting a pivotal study in order to obtain a very careful cost accounting of patients who are equivalent, but who are treated either with the transradial approach and sent home, or the femoral approach, and would have been eligible to go home had they been done transradial. Femoral patients are kept overnight, so the study will provide important data that hospitals are anxious to hear about — what is the cost saving we could obtain by moving from 3-5% transradial use up to a much higher percentage? We anticipate over the next few years U.S. transradial procedures will go in the direction of European numbers, not up to 50%, but a much higher percentage than it is now.
How do femoral closure devices balance out the argument?
Dr. Chen: There has never been any clear-cut evidence that femoral closure devices offer any safety advantage over manual hold. That’s very important. The advantages of femoral closure devices are of patient comfort and recumbency time. You can ambulate patients faster with a closure device than you can with a manual hold; however, there has never been any study to conclusively show that the former are safer.
The best argument for transradial seems to be the reduction in bleeding complications.
Dr. Chen: There’s no question. The Hippocratic Oath states, “Do no harm.” Think of someone who has had a normal cath, who has no heart problems; and then all of a sudden we give them a retroperitoneal bleed or a pseudoaneurysm. Safety is reason number one, two and three. Even the critics and naysayers do not argue this point. Every evaluation has demonstrated a safety benefit for transradial access over that of the transfemoral approach.
Dr. Sunil Rao conducted a study using a huge data set from the ACC National Cardiovascular Data Registry, and he quoted about an 80% reduction in major bleeding by using transradial access. An 80% reduction! If I came to you with a device or a new drug and told you that I can cut your bleeding risk from PCI by 80%, but it’s going to cost you $2,000 per patient, would you use it? Well, you may not use it in everybody; but you would have to consider using it in high-risk patients. What about if it cost $1,000? You’d probably consider using it in a few more patients. Well, here we have a procedure, not even a device or a new drug, that is free. Not only is it free, but it actually costs less. It’s going to save you money. We have something much safer — no one argues about that, and no one argues about the cost savings.
Another advantage of transradial access is clearly patient preference. There is absolutely no question that patients prefer radial access over femoral, especially when one has undergone both procedures. These patients are the biggest advocates for transradial PCI. There are people who absolutely would never let me touch their leg again. It is also one way you can set yourself apart in your area.
Patients don’t know what happens during the procedure inside their heart. Whether it’s an incredibly complicated rotoblator, laser, bifurcation case, etc. — they don’t know. All they know is that they feel better. Yet even if you do a successful, incredibly complicated case, if the patient goes on to develop a groin complication, this is something they do notice. They don’t know all the great life-saving techniques you performed in their heart. All they know is you caused a bleed in their leg and now they need vascular surgery or a transfusion. This argument is not primary — that is always safety, but it’s still important. Ask the average person: which would they prefer, a procedure on their wrist or their groin? Clearly, the wrist. The groin is a very private part of the body.
The final argument for radial access relates to its use in women. Women have more serious complications from bleeding after PCI. They don’t necessarily bleed more; but when they do bleed, it is more serious and life-threatening. For all of these reasons, transradial access needs to be more prevalent. There has been some talk at CMS that severe bleeding after PCI may one day be considered what they call a “never event.” A never event is an event that should never occur, and CMS will not pay for any care and stay originating from that event. If the patient has vascular surgery and stays in the hospital for another week, CMS may potentially deny all of those charges, if they do decide on that designation in the future.
What do we know about patients who do experience bleeding complications with femoral access?
Dr. Chen: The ACUITY trial3 by Dr. Manoukian truly underscored the danger of bleeding. There is an increase in independent endpoints of mortality, ischemia, and stent thrombosis in patients who bleed. It is interesting that it actually required a major prospective trial to show us that bleeding is bad.
Why would stent thrombosis occur if someone bleeds? You would think the opposite should occur. The reason is that when bleeding occurs, we may withhold the medications the patient needs. In other words, if someone clearly needs to be on a IIb/IIIa inhibitor, but suddenly develops a bleed, that drug will be stopped. The patient may need it for his heart to keep his stent open during an acute coronary syndrome, but that therapeutic intervention has now been withheld to avoid aggravating the bleeding. It is often the withdrawal of antiplatelet or anticoagulant therapy in response to bleeding that actually causes the problem. That’s not an issue with transradial access. For instance, I routinely cath people with therapeutic INRs on warfarin.
Could you discuss your experience with transradial?
Dr. Chen: I’ve been doing transradial cath/PCI procedures for approximately 8 years. I learned on my own; and it all began when I attended a talk at a TCT meeting by Dr. Ferdinand Kiemeneij, the father of transradial intervention. It seemed to make a lot of sense, so I came back and started doing them. There’s no question that there is a steep learning curve in the very beginning; this is especially true for intervention, because the vast majority of guide catheters are shaped for the femoral approach. You actually have to learn your own techniques of adapting the curvature of the transfemoral guide catheters for the transradial approach, which comes in from the opposite side.
What’s your percentage rate of use?
Dr. Chen: I would estimate 95%. My techs prep the patient transradially unless I tell them otherwise for some reason. I did one transfemorally recently in a patient who had an arterio-venous graft in her right arm and a mastectomy in the left breast. I couldn’t use either upper extremity, so I went femoral.
If people are interested in learning the transradial technique, there are a lot of training programs available. Dr. John Coppola runs a great program at St. Vincent’s Hospital in New York. Saint Joseph’s will be launching a course with Terumo, as well. I recently had the chance to visit a few institutions and to preceptor physicians interested in learning the technique. I have since heard that some have gone from 0% transradial to 50%. It does require time and experience, but anybody can do this. It is time that the U.S. caught up to the rest of the world and embraced this strategy in the interest of safety, patient preference, and cost-savings.
Dr. Jack Chen can be contacted at email@example.com.
Dr. Spencer King can be contacted at firstname.lastname@example.org.
1. Jabara R, Gadesam R, Pendyala L, et al. Ambulatory discharge after transradial coronary intervention: Preliminary US single-center experience (Same-day TransRadial Intervention and Discharge Evaluation, the STRIDE Study). Am Heart J 2008 Dec;156(6):1141–1146.
2. Brueck M, Bandorski D, Kramer W, et al. A randomized comparison of transradial versus transfemoral approach for coronary angiography and angioplasty. JACC Cardiovasc Interv 2009 Nov;2(11): 1047–1054.
3. Manoukian SV, Feit F, Mehran R, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial. J Am Coll Cardiol 2007 Mar 27;49(12):1362–1368.