Vascular Closure Devices: Have We Caught the Right FISH?

The introduction of vascular closure devices (VCDs) in the mid-1990s has truly made a difference for the interventional cardiologist. Despite a multitude of studies showing either decreased, increased or similar rates of vascular complications, VCDs are used in a large proportion of procedures in the United States.¹ The main advantages include decreased time to hemostasis, early ambulation, greater patient comfort and the ability to remove the introducer regardless of anticoagulation status. For the operator, being able to achieve hemostasis immediately without relying on other personnel to remove sheaths (especially off-hours) has been a great advent. The purist will tell you that complications (albeit rare) from VCDs are preventable, such as infections, arterial lacerations, device embolism and limb ischemia. In fact, in a large American College of Cardiology-National Cardiovascular Data Registry, two-thirds of procedures were still completed with manual compression.²
All current devices have specific particularities and the industry has been ferocious in promoting them. Operators have the option between “stitches, clips and plugs”. In the end, it is mostly a matter of technical preference for most physicians, often not based on solid evidence. There have been some single-center randomized trials involving the primary devices, comparing Angio-Seal^™ (St. Jude Medical, Inc., St. Paul, Minnesota) to PerClose^® (Abbott Vascular, Abbott Park, Illinois) or StarClose^® (Abbott Vascular). Some have favored the Angio-Seal,^3,4 while others stated no significant difference in primary endpoints.5 Furthermore, data on new devices are constantly being reported, each emphasizing distinctiveness. Ideally, the device of choice would be easy to use, require minimal foreign-body introduction, allow early ambulation, permit reaccess readily and, importantly, be cheap.
The new FISH device stands for “femoral introducer sheath and hemostasis”. Its commercial slogan on the manufacturer’s website is: “healed, not scarred”. It is a patching device using porcine biomaterial labeled as small intestinal submucosa (SIS). The uniqueness of the system is that the patch itself is attached to the introducer sheath. Theoretically, the presence of the patch at the arterial entry site during the procedure favors early healing. Following catheterization, a release wire is pulled detaching the patch from the sheath. The vessel wall is advertised to be remodeled within 30 days. In this issue, Bavry et al report on a multicenter randomized clinical trial comparing the FISH device to manual compression.⁶ Close to 300 patients were randomized in a 2:1, fashion with the primary endpoint of time to hemostasis and time to ambulation. The authors report significantly shorter time to hemostasis and mean time to ambulation with the FISH device compared to manual compression. They also report on 5 minor adverse events for the FISH group as opposed to 2 in the manual compression group. There was 1 death in the trial which occurred in a patient from the FISH device group. The authors describe the case in detail and are confident it was unrelated to the device. The authors’ overall conclusions are that the FISH device is superior in achieving time to hemostasis and ambulation, with no significant differences in adverse vascular events.
There are several limitations of the trial, which are well acknowledged by the investigators. The main limitation pertains to the fact that 27 patients converted from the FISH device to manual compression. These withdrawals were due to anticipated suboptimal hemostasis, creating a bias. The study also lacked power to detect infrequent adverse events. Furthermore, the roll-in cases per investigator, as well as the number of devices deployed per investigator, were low, possibly favoring manual compression. The fact that only one-half of the participants underwent ultrasonic examination may have underestimated vascular complications, but these would have been asymptomatic, and a change in outcomes and practice would have been unlikely.
It will be interesting to see the result of the interventional portion of the trial. Anticoagulated patients are at higher risk of vascular complications, regardless of hemostasis method. As lower heparin doses are commonly used, and with the advent of newer molecules claiming lower bleeding rates such as with bivalirudin and fondaparinux, the rate of vascular access bleeding post-VCD use might, in the future, be lower than previously reported. Certainly, from the frequency of VCD use post-PCI, there is an important interest in this subject, and it will be worthy of note to see where the FISH device stands in this population.
Furthermore, radial catheterization is becoming increasingly popular, especially outside of the United States. This is especially true for obese patients where access might be difficult. As challenging femoral punctures are being shifted toward radial access, it is likely that vascular access complications will be reduced in real-life clinical practice. If femoralaccess and vascular closure devices are reserved for the lowrisk access population, the complication rates should be lower than previously reported. The question will then become: Which device is safer? This study introduces the concept of vascular access and closure being combined on the same device. This is a theoretical advantage that will have to be confirmed with larger studies.
This study is a nice first step with this concept, and the authors should be congratulated for introducing it. It will be important to eventually have a multicenter trial directly comparing this new device with the currently most used ones. We will then know if we “caught the right fish”.