Launching a Successful Transradial Program

ABSTRACT: There is an increasing interest in performing transradial (TR) procedures in the United States, but with so few experienced operators, developing a TR program often means figuring out a lot on one’s own. Certain necessary fundamentals — including a good reason for doing procedures transradially, getting adequate training, gaining the support of cath lab staff, using the right equipment, and having patience and perseverance through learning and change — improve the chances of success. In discussing each of these fundamentals, this article reviews the advantages of a radial approach compared with a femoral approach; describes ways to acquire TR training; stresses the importance of involving nurses, technicians, administrators, and colleagues in the process; encourages the use of designated radial equipment for enhancing success; and demonstrates the learning curve by describing a single operator experience during the first year of launching a TR program. J INVASIVE CARDIOL 2009;21(Suppl a):5A–10A
Interest in performing diagnostic and interventional procedures via the radial artery is growing in the United States. However, transradial (TR) procedures are still infrequently performed, and there are few experienced operators, factors that can make incorporating this technique into practice appear daunting. Finding training can be difficult and may require a transcontinental flight and several days off from work. The training itself, however, is typically brief and sufficient for acquiring the confidence needed to start doing procedures independently. Still, it may not necessarily prepare one for showing technicians how to best set up the table, training nurses on radial artery and upper limb management, or writing post-procedural protocols. As such, a successful TR program requires steadfast determination and the support of staff, fellows, and colleagues. After a year in the trenches of starting a program, I have learned some fundamentals for any operator launching a program. No formula guarantees success, and the challenges will vary based on practice type and size, the personalities and politics, and the support from senior and administrative staff. Further, only an operator who has been doing TR procedures for years can tell you what you need to maintain a program. But if you’re interested in launching a program, you need certain fundamentals to cultivate success, including a good reason for doing what you’re doing, training, the support of your cath lab staff, the right equipment, and patience and perseverance (Table 1). A Good Reason First and foremost, you need a good reason to do procedures transradially. While this seems obvious, its importance cannot be overemphasized. If you don’t have a reason that helps you face failures through a time of learning and change, persevere when the cath lab staff is impatiently drumming their fingers, or go to the administration requesting support, your program will fail. Fortunately, there are many good reasons to change from the groin to the wrist. Fewer Bleeding and Vascular Complications: The most obvious reason for doing TR procedures is the lower risk of bleeding and vascular complications.^1–3 Radial access reduces the relative odds of major bleeding by over 70% compared to femoral access. This equates to an absolute risk reduction of almost 2%, and anyone using the ACC-NCDR Cath PCI Registry knows that such a reduction would bring their bleeding and vascular complications to nearly zero. Some are underwhelmed by the impact of bleeding and vascular complications. They argue that such complications are inherent in what we do, that the rates are not too high, and the outcomes are rarely lethal. Indeed, the overall risk of serious bleeding and vascular complications via the femoral route is relatively low, but it is not trivial. With improvements in technical success at the coronary level, groin complications have become the most common peri-procedural complication of cardiac catheterization.⁴ And while these complications are most often annoying superficial hematomas, retroperitoneal hematomas have a mortality rate of 4–10%,^5,6 and those who survive generally have extra testing with prolonged hospital stays, hypoperfusion complications, and multiple blood transfusions, all of which are associated with increased morbidity and mortality.^7,8 Finally, you might not think much about a little groin bleed, but your patient does. As we all know, patients have a tendency to judge their entire cath lab experience based on what happens after their coronary procedure is completed. For better or worse, they will look at that bruise on their groin and remember the awful back pain they had while they were on bed rest for 6 hours with a nurse standing on their groin rather than idolizing the mind-blowing PCI you performed. Additionally, it remains commonly overlooked that the single biggest sex difference in the cath lab is the higher risk of bleeding and vascular complications in women compared with men. For me, this was my reason. I wanted a way to narrow this gap. Despite improving outcomes for women in the cath lab,⁹ this striking sex difference continues, with women experiencing 2 to 3 times the bleeding and vascular complication rate of men.^10–12 At its worst, being a woman is an independent predictor of retroperitoneal bleeding, with up to 70% of retroperitoneal bleeds occurring in women.6 While both sexes experience lower rates of bleeding and vascular complications with the TR approach, women reap an even greater relative benefit due to their higher risk at baseline.^13–15 Still, women present a particular challenge. Radial access is less likely to be successful in women, with a higher rate of needing to convert to the groin, even for experienced operators.¹⁵ And despite similar procedural duration and complexity, and smaller sheath sizes used, women will still have more hematomas.¹⁴Lower Costs: A second reason to do TR procedures is the reduced cost.^2,16–18 As healthcare costs skyrocket, it is unusual, and quite pleasant, to be able to launch a new approach that actually costs less. Compared to a femoral approach with a vascular closure device, the cost of getting access is higher with a TR approach, but the costs of catheters, closure, and recovery are lower, resulting in an overall lower cost. If no femoral closure device is used, the cost of closure is less with the femoral approach, but the overall cost is still higher than a TR procedure. Access costs more because of the use of radial-specific hydrophilic wires and sheaths, as well as the need for a spasmolytic cocktail. Catheter cost is lower because dedicated radial catheters are able to engage both the left and the right coronary arteries, reducing the number of catheters used. Like femoral vascular closure devices, radial hemostasis devices are not necessary, but have certain convenience advantages. Bed rest duration and patient satisfaction is not clearly impacted by how the radial artery is closed, whereas these factors are significantly improved with the use of femoral vascular closure devices compared with manual compression.^19,20 Still, patients will have some duration of bed rest even with a femoral closure device, no reduction in their bleeding and vascular complication rate, and approximately 5 times the closure cost of a radial hemostasis device. With patients immediately ambulatory after a TR procedure and fewer vascular complications, there is less burden on nursing staff, a reduction in pain medication use, and earlier discharge, all resulting in significantly lower recovery costs. More Patient Satisfaction: Finally, there is the important reason of patient satisfaction.^16,21 Of patients who have had both femoral and radial approaches, 80% are more likely to strongly prefer the TR approach, while only 2% strongly prefer the femoral approach. The preference for a radial approach is related to more favorable rankings of back and body pain, social functioning, mental health, the ability to use the bathroom, and the ability to ambulate. I would have to say that the single biggest surprise for me in starting a TR program was the extent to which patients liked this approach. Their overwhelming enthusiasm made it clear how much they disliked the recovery from a femoral procedure. And happy patients are a good way to ensure a successful practice. Happy patients tell their friends, and their friends come in requesting it. Happy patients also tell their referring doctors, who like that you’ve made their patients happy, and send you more patients. Being able to offer a procedure that is safer, less expensive, and preferred by patients is a strong advertising point, particularly when no one else locally is doing it. Training As of now, most of the formal training is only offered on the east coast. These training courses are hands-on and last about a day, which surprisingly is fully adequate for providing the knowledge and comfort needed to get started. This is what I did, traveling from California to New York for training. Hands-on seems a preferred method, but there may be other options for people who aren’t able to travel for a course. One option is to find a local radialist and invite him or her to your hospital for a day of cases. Alternatively, you could join the radialist in his or her cath lab for the day. Due to varying state laws regarding hospital privileges, you may simply have to be an observer when visiting someone else or, if they visit you, you might not be able to see one, but can do several with an expert talking you through it. Less ideal but still-viable options include watching an instructional video, going to a lecture, or practicing on a simulator. In coming years, our large annual conferences will hopefully improve educational opportunities by holding symposia on the TR approach, demonstrating the technique during live cases, and setting up break-out sessions to ask the experts and share experiences. Back home, having a network of radialists with whom you can discuss cases will ease the transition and help you feel less alone if you run into snags. Fellows: You will quickly find after your training that you are not the only one who needs to be trained. If you are at a teaching hospital, you will need to decide what to do with the fellows. One reason the femoral approach persists in this country is that it’s easy to teach and learn. The TR approach is technically challenging enough, and less forgiving of an inexperienced operator, that it may not be worth training a general fellow who will never touch a catheter after fellowship ends. On the other hand, interventional fellows are eager and capable learners, as are general fellows who want to go into interventional cardiology or who plan on being invasive cardiologists. My interventional fellows quickly became master radialists before my eyes. In addition, they helped teach the nurses and housestaff how to care for these patients after the procedure, and eventually assisted in passing on the technique to other attendings in the lab who were interested in performing it. Nurses and Technicians: Your success will be significantly enhanced by also having a trained and ready staff. You will need to teach them how to set up the patient’s arm on the table, what spasmolytic cocktail to prepare, how to drive the table so that precious fluoroscopy time isn’t wasted “looking for” the arm, and how to monitor the upper extremity after the procedure. Old habits will have to be broken. When we first started, I would walk into the post-procedure area only to find my radial patients lying flat on their backs and being put on bedpans. Nurses and technicians generally need protocols, and you will need to write them (see appendices beginning on p. 9A) — how long does the TR band stay on, what do you do if there’s a hematoma, and what should the patients watch for after they go home? If feasible, take a nurse and/or technician to the training course. As nurses and technicians, they have their own way of viewing the cath lab and understanding what needs to be done to make a case successful. They will likely learn better from their own colleagues than your instruction, and they will be much more interested in what you’re trying to do if they have been personally involved in the process. Cath Lab Support If you have been trained, but haven’t involved your cath lab staff in your new project, you may be fighting an uphill battle. Change comes hard to large groups, particularly if they haven’t felt a part of the process. Because it can be difficult to train everyone at once, consider identifying a small group of skilled and enthusiastic nurses and technicians to be “champions” during this transition. Once the champions have become comfortable with the procedure, they can disseminate the method to others. In addition, within several weeks of launching the program, it’s helpful to hold an in-service for the entire cath lab to get everyone up to speed. Finally, the nursing staff in the cath lab can train the nursing staff on the wards regarding post-procedure care. Support of Colleagues and Administrators: Depending on the environment in which you work, you may need to spend a fair amount of time eliciting support from your colleagues and administrators, as well. I am fortunate to work with a group of interventionalists who are genuinely supportive and thrive on innovation. They made sure the road was cleared for my success, but that will not be the case for everyone. As mentioned, change comes hard and is often perceived as threatening. Colleagues may not like that you are straying from the norm, and possibly giving yourself a competitive edge. Senior colleagues may not like that you will be able to do something they can’t. Hopefully, with open communication, the physicians you work with will see that it benefits everyone, but it may take some time and effort on your part. Support from the administration should be easier. In this era of quality assurance and quality improvement, TR procedures seem an administrator’s dream — a perfect package of fewer complications, lower costs, and higher patient satisfaction. Equipment Like everything else in interventional cardiology, the procedure will be easier with the right equipment. Gone are the days of using femoral equipment to do TR procedures. New hydrophilic wires and sheaths, dedicated radial catheters, and TR bands have simplified the procedure and reduced difficulties that used to be encountered. In addition, various “cocktails” have been studied and enhanced.²² Even the procedure itself has improved. From their experiences, veteran operators have shown us how best to cannulate the radial artery with a minimal amount of lidocaine and a through-and-through puncture; how to more easily maneuver through vascular challenges, such as radial and subclavian loops; and how to perform graft cases with relative ease.^23–25 For operators who tried doing TR procedures in the 1990s and found it too difficult and too unrewarding, consider trying again. The progressive reduction in the size of interventional devices over time has made the majority of procedures conducive to a TR approach. In addition, increased experience and radial-specific equipment appears to have improved the procedural success considerably.²Radiation Exposure. One issue that operators will need to address is the higher risk of radiation exposure that occurs with TR procedures.^26,27 There are two main reasons radiation risk is increased. First, the procedure is more challenging and therefore can take longer. Second, the operator is closer to the patient and the X-ray source during the procedure. This risk of radiation persists even for more experienced operators and when maximal shielding precautions are used. Patience and Perseverance While skills from doing femoral procedures will serve you well, TR procedures are different. Obviously access is different, but there are also new obstacles that must be maneuvered through in the radial, subclavian, and aortic arch. Likewise, engagement of the coronary arteries requires learning a modified set of movements, and it takes time to learn which catheters and guides will fit best when coming from a new location. The differences in engagement are typically more pronounced when coming from the right wrist compared to the left, but the left wrist presents its own challenges, such as how to optimally position the arm and minimize radiation exposure. The more resources you have to learn from, the quicker the process will go, but even if you’re trying to figure out most of it on your own, with patience and perseverance you will get it. The Learning Curve: There is no magic number at which one suddenly becomes a radial expert; the more you do, the better you’ll get.28 Traditionally, 100 TR cases were considered the standard for competency. That number is currently 50, although no clear guidelines have been established. Our first year saw a steady rise in the percentage of cases that we attempted transradially, as well as the percentage of cases in which we were successful (Figure 1). While it is recommended that operators not be selective in doing radial cases, this advice is a goal to aim for, not necessarily a way to begin. When we started, we preferred large men, and avoided unstable/acute coronary syndrome (ACS) patients, patients having planned percutaneous coronary interventions (PCI) or concomitant right heart caths, and patients with bypass grafts (Table 2). Sometimes, the procedures were going so slowly that we did some femoral cases just to move things along. But gradually, we got faster and better, and found fewer reasons to forgo a TR approach. I now do nearly 100% of my cases from the radial artery. I also do right heart catheterizations through the brachial or internal jugular vein, avoiding the groin altogether. Our complications have included only a few mild hematomas, readily treated with ElastiTape. Once competent, being selective in choosing radial cases results in a slower rate of achieving technical excellence and an underestimation of what can be done from the radial artery. Also, it lends itself to choosing the wrong cases. Selective operators will tend to shy away from high-risk ACS patients, the elderly, and small women, while these are the very patients who have the most to gain from a TR approach due to their higher propensity for bleeding complications.^13,29–31 Young men and the obese, the cases one might gravitate toward, will benefit as well, but not nearly as much.³² These are good cases when starting out, but over time, you will want to incorporate the tougher appearing cases. It turns out they’re not always as hard as you might think. For example, I remember my reluctant, but determined, progression with smaller and smaller women culminating in the radial cannulation of a 38-kg woman. I decided to give it a try, but was doubtful of success. To my surprise, we had no problems, and that day I learned that you never know. Unless you’re going straight to 8 French (Fr) (7 Fr in women), or you anticipate needing an intra-aortic balloon pump or left ventricular assist device, everyone should get a try. It is interesting how success emerges. It remains a mystery to me why we couldn’t gain access on some earlier cases. We generally attributed it to spasm or that the vessel was too small, but such problems slipped away — 82% of our failures occurred in the first 6 months (Figure 2). Of all our failures, 76% were due to an inability to gain radial access, while 24% were due to an inability to advance the catheter to, or adequately engage, the coronary arteries. In the first 6 months, the majority of failures due to access were in women; perhaps our expectations contributed to this effect. In contrast, in the last 6 months, access failures were more likely to occur in men. The opposite was seen in engagement failures. Once the coronary artery is engaged, performing PCI is very similar to the femoral approach. Sometimes the guide might not seat as well, but other times, it actually seats better. In our first year, we progressively did everything from the radial artery — bifurcation lesions, chronic total occlusions, bypass grafts, rotational atherectomy, fully anticoagulated patients, and most recently, ST-elevation myocardial infarctions (STEMI). In the last 6 months, our overall procedural failure rate was 6%, compared with 32% during the first 6 months. This is consistent with data showing that with experience, procedural failure from the wrist is about 5%, compared with 2% from the groin,² and after 1000 cases, procedural failure is said to stabilize at about 1%, making the approaches equally successful.²⁸Conclusions Launching a TR program can, particularly in the beginning, be challenging. Soon, however, you forget the tough times, and can’t even recall why they were so difficult. Reflecting on our first year, I remember a lot of firsts — we tended to celebrate every “first” that we had — first successful cannulation, first time around a subclavian loop, first rotational atherectomy, first STEMI … and now that colleagues are increasingly using the technique, we have another whole set of “firsts” to celebrate. I had a strong reason to start doing radial procedures, wanting to reduce bleeding and vascular complications in women. Having a good reason is essential to launching a successful program. A good reason will spark the urge to get training, will foster support in the cath lab, and will encourage you to learn the new equipment. Most importantly, a good reason will remind you when you’re tired and frustrated why you are doing what you are doing, and evoke the patience and perseverance you will need in order to get through. All these fundamentals are necessary for launching a successful program. 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