AHA issues recommendations for arteriotomy closure device use
The statement, published in the Oct. 4 issue of Circulation, outlines recommendations put forth by the association, which evaluate arteriotomy closure devices (ACDs), their current indications, previous clinical evidence and compare ACDs with manual compression techniques.
Previous studies have reported that vascular complication rates are 3.3 percent for femoral artery access with manual compression.
Although the committee deemed ACD evidence sparse, a previous meta-analysis evaluating 30 clinical trials assessed the safety and efficacy of ACDs compared with manual compression. The studies evaluated 37,066 patients and found that mechanical compression was favored over ACD use.
“In an attempt to reduce some of these potential complications, ACDs have been developed as adjuncts or alternatives to manual compression for hemostasis,” Manesh R. Patel, MD, chair of the AHA Diagnostic and Interventional Cardiac Catheterization Committee of the Council on Clinical Cardiology, and colleagues wrote.
Besides their potential to reduce vascular complications, ACDs have been said to improve patient comfort, time to ambulation, reach hemostasis faster and decrease the duration of hospitalization. However, the authors noted that ACDs also have the potential to increase “unique vascular complications,” including severe groin infections and device embolisms that would require specialized clinical care.
The devices are categorized as either passive-closure devices—FemoStop (St. Jude Medical), SafeGuard (ev3), among others—or active-closure devices—AngioSeal (St. Jude Medical), Perclose (Abbott) or StarClose (Abbott).
Despite the limitations in data, the committee offered the following recommendations regarding ACD use:
- Patients who are being considered for deployment of ACDs at the femoral artery site should undergo a femoral angiogram with identification of sheath-insertion site to ensure anatomic suitability for use;
- Facilities who use standard manual compression should aim to achieve vascular complication rates of less than 1 percent in patients undergoing uncomplicated 5F diagnostic angiography;
- Use of ACDs is reasonable after invasive CV procedures that are performed in the femoral artery to achieve shorter bed rest times, hemostasis and improve patient comfort. Use of ACDs should be weighed against the risk of increased complications in certain patient subsets;
- ACDs should not be used routinely specifically to reduce vascular complications in patients undergoing invasive CV procedures via the femoral artery approach; and
- Data on complications during or after deployment of ACDs should be collected systematically in national registries or in local quality efforts and reported to the FDA.
Additionally, the committee wrote that “the issue of appropriate endpoints for studies of ACDs continues to be controversial and poorly defined.”
The committee offered that future prospective, randomized trials should be conducted and recommended that all future studies:
- Clearly identify the anticipated risk of vascular complications and divide patients into low-risk, moderate-risk and high-risk subsets;
- Use clinical endpoints for vascular complications; and
- Collect data on all vascular complications in all ACD studies, with study primary endpoints commensurate with patient risk.
“Until such clear demonstration of benefit is achieved, use of ACDs remains dependent on the treating physician’s assessment of individual patient risk/benefit analysis,” the authors wrote.
“Novel devices and methods for achieving hemostasis are under investigation. However, the available evidence is limited to specific patient populations, often studied in nonrandomized fashion, without methodological follow-up and standardized clinical outcomes,” the authors concluded. “The goal of future research should be to examine these ACDs using adequately powered randomized studies in relevant populations with varying risk and to evaluate clinically relevant outcomes in a blinded fashion.”