Long-Term Implications of Short-Term Closure Decisions The Evolution to Vascular Access Management and the Boomerang Catalys

For patients requiring percutaneous vascular access procedures, the event is seldom limited to a single occurrence. Frequently, after the procedural catheter is removed and the arteriotomy closed, the event is considered over and done that is, until the next time. Cath lab nurses and technologists know that arterial access is sometimes difficult to obtain on their repeat patients, oftentimes due to scarring from earlier percutaneous access. Recovery and site healing from previous procedures, with or without complications, can compromise future arterial access, whether hemostasis is achieved using manual compression or vascular closure devices. The site closure decisions made during today’s procedure can have long-term implications for the patient’s future access. Protecting the artery for future access should be one of the most important considerations, especially for those patients who will undergo multiple percutaneous access procedures during their lifetimes. Therefore, it is essential that today’s clinician chooses a method of closure that supports a continuum of care, going beyond the end of the first procedure to include site management and healing in all subsequent procedures. Manual compression remains the gold standard of post-procedure care for many cath labs because it leaves nothing behind in the artery when the patient is discharged. However, as a result of the increased volume of percutaneous access procedures and the use of larger sheaths, vascular closure devices (VCD) were developed as an alternative to manual compression, using active fixation and closing the arteriotomy when the patient leaves the procedure table. Regardless of the product type, VCDs always leave something behind, whether it is a suture, or staple, or clip, or collagen plug. These retained materials induce an inflammatory response, leading to scarring, infection or other complications such as vessel thrombosis. Additionally, catastrophic failure requiring surgical removal or repair is a known risk of VCD use.¹ Focusing on a Broader Continuum of Care Hoffer and Bloch summarize arterial access site closure as problematic¦ unglamorous, time-consuming, and potentially lethal.2 Successful arterial closure defined only as time to hemostasis misrepresents what is most relevant to patients and cath lab staff: timely hemostasis, ambulation, discharge, increased throughput and vascular healing without complications. Adopting the long-term perspective of vascular access management, cath lab staff and physicians consider the cumulative effects of vascular access and closure, particularly as it relates to scarring due to repeated femoral access as shown in Figure A, and the potential for complications, including critical limb ischemia.3-5 Gregory Mishkel, MD, stated, Once you close the vessel and achieve hemostasis, you can’t just wipe your hands clean and leave. We really need to rethink this idea of vascular closure as the endpoint because subsequent events may have serious implications for the future care of our patients. Mishkel is the co-director of the cardiac catheterization laboratory at the Prairie Heart Institute in Springfield, Illinois. As the largest cath lab in the state and considered one of the premier facilities in the U.S., Prairie Heart has extensive experience in cutting-edge vascular access management and successful recovery. Mishkel went on to state, Considering the full continuum of care from procedure access to closure through recovery, discharge, and possible reaccess better reflects the realities of the patient’s and the physician’s experience. Nilesh Goswami, MD, an interventional cardiologist at Prairie Heart, described the concept of vascular access management this way: PCI is not primarily an acute event for us. We look at it from a 360-degree view of the world, with everyone involved from the arterial puncture to discharge, to the 30-day follow-up and beyond. We’re making decisions about the patient’s care all along the way to minimize adverse events. It’s important to us that when the patient is discharged, the access site has achieved hemostasis without significant patient discomfort and in a timely fashion. To reduce risks of complications such as infection and vascular injury and to allow for future access, it is important that there’s nothing left behind in that artery. Achieving Hemostasis Using Manual Compression For more than half a century, manual compression has changed little and remains the gold standard for achieving arterial hemostasis. Since the 1980’s, however, the enormous growth in percutaneous vascular access procedures and use of anticoagulants has increased the demand for better closure techniques to manage bleeding, minimize bedrest, increase patient throughput, and reduce staff repetitive stress injuries associated with compression. Wide variations exist in the published literature regarding the rates of major and minor complications for femoral access sites managed with manual compression, ranging from lows of 0.4% to as high as 27%.6-8 It should be noted that complications are likely to be under-reported since most institutions only record complications if they require surgical repair or blood transfusion. Even in the absence of reportable complications, manual compression often results in patient discomfort during recovery due to hand pressure and immobilization. Kelley Weakley, nursing technician at the Prairie Heart Cath Lab, commented, With manual compression, we have to exert a lot of pressure on that tender groin area for at least 20 minutes and even then may use the C-clamp for 10 more minutes. That’s an uncomfortable procedure for patients. Manual compression traditionally is taught through an apprenticeship approach, with senior staff members teaching new staff members. Training inaccuracies and inconsistencies can lead to patient complications as well as staff injuries with long-term negative consequences. Maintaining pressure on the arteriotomy site for long periods of time can result in repetitive stress injuries to the hands and wrists of cath lab staff. Manual compression also requires staff to bend over patients, sometimes leading to back and neck injuries. Kelley Weakley knows this only too well: I’ve worked in the cath lab for 15 years and had one patient who needed over an hour of hand pressure. I injured my neck on that case and needed surgery. These types of injuries can have serious staffing and financial consequences for cath lab operations. Prairie Heart Cath Lab Manager Sheryl Friedrich noted, If we can decrease the hand-hold time for patients, we will decrease the number of staff injuries and workers’ comp cases. I have someone right now who’s out with a wrist injury. Achieving Hemostasis Using Vascular Closure Devices The need to evolve beyond manual compression was exacerbated in recent years due to the use of larger sheaths for new percutaneous access procedures and more patients requiring repeated procedures, which increased the potential for arterial damage. VCDs began to be developed in the late 1980’s to stop femoral artery bleeding immediately following diagnostic or interventional procedures. Clinical trials assessing the safety and effectiveness of these devices compared to manual compression produced mixed results regarding the short-term risk of serious adverse events, such as hemorrhage, since they most often measured only acute endpoints. Although some trials exhibited an equivalent or lower rate of bleeding complications,9 results of two recent meta-analyses10,11 show evidence of no reduction in overall vascular complications with VCD use. Some hospitals cite trials resulting in lower VCD complication rates as a rationale for attempting to decrease patient complications and staff injuries by employing VCDs.9 This strategy seems reasonable if the procedure’s endpoint is short-term arterial hemostasis. Viewed as a long-term continuum of care, however, arterial closure with VCDs, or active fixation devices, may result in complications during the recovery process, the post-discharge period, and beyond to the next procedure. VCDs always leave something behind, and these retained foreign materials induce an inflammatory response, leading to scarring and possible infection, and may impede future access. In addition, this inflammatory response may lead to severe implant-related complications, such as vessel thrombosis and limb ischemia and sometimes leading to amputation.4 The Boomerang Catalyst System In order to protect the femoral artery from scarring that can complicate future vascular access procedures, hemostasis should be achieved with minimal trauma to the access site, leaving nothing behind in the artery when the patient is discharged. Physicians may choose from a variety of closure techniques for vascular access management, from manual and mechanical compression to active fixation devices. With manual compression, the site closure and recovery/ambulation is under the control of the post-care staff. With a VCD, the physician controls site closure and post-care staff supervise only the recovery/ambulation. Physicians hesitate to use VCDs in certain patient subsets, however, because of the higher incidence of vascular complications.1,12-16 Acutely, I want reliable, quick and safe hemostasis, Dr. Goswami commented. Long-term, we wish to avoid potential complications. The Boomerang Catalyst System is designed to promote artery closure by working with the vessel’s natural elasticity. The Catalyst System works in conjunction with gold standard manual compression and the body’s own healing systems, leaving nothing behind in the artery to generate an inflammatory response or cause catastrophic implant-related complications. It employs a low-profile, intra-arterial nitinol disk attached to a coated tension wire to temporarily tamponade the arteriotomy while allowing natural elastic recoil (Figure B) of the vessel wall’s smooth muscle layer. The sheath-dilated arteriotomy is reduced to the 18-gauge profile of the coated wire, approximating the original needle stick. The Catalyst System, a passive fixation device, further promotes hemostasis through a proprietary hemostatic coating on the wire that stimulates the intrinsic coagulation cascade. After a short dwell time, the Boomerang disc is collapsed and removed from the artery, leaving nothing behind in the tissue tract or artery exacerbating an inflammatory response or a hindrance to future arterial access. In recently reported interim clinical trial results from the prospective, randomized BOOMERANG II Trial Prairie Heart results17, the Catalyst System hold time was reduced by an average of 16 minutes in diagnostic patients compared to manual compression, and reduced by an average of 12 minutes in interventional patients. Average time to ambulation was also reduced by 121 minutes in diagnostic patients compared to manual compression, and reduced by an average of 157 minutes in interventional patients. On average, the total access management time in diagnostic patients was reduced more than 50% and in interventional patients by 40%, as shown in Figures C and D. On average, the Catalyst System same-day discharge patients went home 50 minutes earlier. The data subset analyzed for Prairie Heart as part of the BOOMERANG II trial currently includes 204 subjects 166 Boomerang System and 38 manual compression subjects. Reportable complications that met criteria included one (0.5%) pseudoaneurysm that required thrombin injection are shown in Table 1. There were no bleeding complications at Prairie Heart. Cath lab manager Sheryl Friedrich commented, We can get natural closure at the site earlier than with manual compression. Our standard order is for 20 to 30 minutes of hand hold after PCI, but we cut that time in half with the Boomerang while still delivering the same quality of care. Nurse Technician Kelley Weakley agreed: With the Boomerang we hold for less time, but we also have to exert less pressure. In addition to decreasing the rates of patient complications and staff injuries, deployment of the Boomerang may improve cath lab staffing and financial operations. Shorter hold times and faster ambulation mean that patients spend less time in recovery. Sherry Day, Prairie Heart’s post-catheterization charge nurse, commented, As team leader, I know that on a heavy volume day we’re all pulling lines. With the Boomerang, we have a shorter turnaround time for staff and physicians, which is definitely easier on the staff. But shorter turnaround also means the patients are less stressed because they spend a shorter time in recovery with less compression discomfort, their families can come in the room sooner, they’re up and walking earlier, which means they’re discharged more quickly. Kelley Weakley noted: We see less bleeding and fewer hematomas with the Boomerang than with compression alone. Prairie Heart patient Roger A. Pierjok recalled his first catheterization procedure at another hospital 26 years ago when he was 31 years old: When the doctor pulled out the sheath, he put direct pressure on the site and held it until he started getting muscle cramps. Because I’m in mining safety and have EMT training, I could see that he couldn’t hold this much longer, so I slipped my thumbs down there and held the pressure myself. They had to put a couple of stitches in to close the site because the incision was large to accommodate the larger device at that time. Then in the car coming home, the stitches broke open and I could see my leg was black. So when I got home I laid on the driveway and put pressure on that site myself for 30 minutes. I had lots of complications with that first procedure. Pierjok then recounted his recent experience with his third catheterization procedure, performed by Dr. Goswami and the cath lab staff at Prairie Heart in early September of this year. The procedure was three days ago and I had no discomfort, he reported. I’m walking around without even a twinge at that site. Compared with the old system of doing these procedures, this last one was less painful and I experienced less irritation. I’m 57 and the prospect of future procedures is a real one for me. That’s one less thing for me to worry about. Dr. Mishkel summed up his experience: Because this device relies on the body’s natural tendencies to heal itself, the Boomerang is clearly less invasive than other VCDs. Also, we are quite happy that we observe shorter times to achieve hemostasis and ambulation than with manual compression alone. Using the Boomerang results in less discomfort for patients and staff alike, but most important, it leaves nothing behind when the patient is discharged. The physicians and staff named in this article can be contacted at Sheryl.Friedrich@st-johns.org.

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