Abstract
Background:
Patients who are candidates to receive an Angioseal® (St. Jude Medical) device for arteriotomy closure are allowed to ambulate 20 min after the deployment of the device. More frequently, however, patients are kept on bed rest for several hours following Angioseal® deployment. The purpose of this study was to prospectively assess patients when ambulating 20 min after Angioseal® deployment instead of prolonged best rest of 2–3 h.
Methods:
Patients undergoing angiography from the common femoral artery approach were included in the study if they received a 6 Fr Angioseal® closure device.
Results:
Twenty-nine patients were successfully enrolled in the study; 27 (93.1%) patients ambulated at 20 min, 1 (3.45%) patient ambulated at 28 min, and 1 (3.45%) patient ambulated at 27 min due to transport times. There were zero complications with regard to hemorrhage or other groin complications. There is a substantial time difference in ambulation times between the conventional and early ambulation groups.
Conclusion:
Our study demonstrates that it is probably safe to ambulate patients who undergo diagnostic cardiac catheterization as early as 20 min after deployment of the 6 Fr Angioseal® closure device.
Introduction
Diagnostic left heart catheterization is the gold standard to assess coronary anatomy. A number of post-procedure closure devices have been used in order to be able to ambulate patients sooner following the procedure when performed via the common femoral artery. 1 Without a closure device of the arterial puncture site, the typical time a patient must remain supine following a diagnostic left heart catheterization is several hours in order to achieve safe hemostasis. 2 This extended time in the supine position is both uncomfortable and time-consuming for patients, and tends to use substantial healthcare facility resources.
The Angioseal® (St. Jude Medical, Saint Paul, Minnesota) closure device is a vascular plug that has been approved by the Food and Drug Administration (FDA) in order to seal the femoral artery arteriotomy site and to allow for an earlier ambulation time following cardiac catheterization. Its safety and efficacy have been previously demonstrated. 3 Currently, the Angioseal® device has been approved for ambulation times of 20 min following diagnostic left heart catheterization. However, previous studies evaluated ambulation safety at least 2 h following device deployment, 4 and a more conservative approach is typically sought following device deployment. A typical strategy after Angioseal® deployment is to keep the patient supine for 2 h prior to ambulation and then to observe the patient for another hour after ambulation to ascertain adequate hemostasis.
The Angioseal® vascular closure device is currently indicated for reducing time to hemostasis and to allow patients to ambulate early after device deployment. The manufacturer advises against routine use of this device in the superficial femoral or deep profundal arteries or if the puncture site is at the bifurcation, or proximal to the inguinal ligament, as this may increase risk of retroperitoneal hematoma.
The reasons for most cardiac catheterization operators to be unaware of the FDA approval for very early ambulation (20 min) are unclear. We conducted a single-center prospective study to assess the safety of ambulation within 20 min of Angioseal® deployment. The goal of our study was to test and confirm the safety and efficacy of using Angioseal® to allow early ambulation. Should our hypothesis be validated, then the ultimate goal would be to improve patient comfort and to reduce global procedural costs.
Methods
The study was conducted at Providence Heart Institute, Southfield, Michigan. A prospective trial was performed on patients undergoing diagnostic coronary angiography from the femoral approach. Inclusion criteria included patients 18 years and older undergoing diagnostic angiography from the femoral approach who consented to the procedure and were candidates for Angioseal® deployment based on accepted clinical and angiographic criteria. Potential candidates were informed of intent to ambulate and discharge home earlier. The Institutional Review Board (IRB) at our institute approved the study (approval number 548976-3) and all patients gave written informed consent approved through the IRB. Patients that qualified were excluded if they did not consent to the procedure or the study, if anticoagulation was given during the procedure (including any percutaneous intervention) or if the patient was not a candidate to have an Angioseal® closure device based on arterial anatomy and puncture site characteristics. Several patients were also excluded because a decision was made to perform the angiography via the radial approach or a venous sheath was placed for right heart catheterization on the ipsilateral side of the arterial sheath. However, the protocol was later modified to include patients undergoing femoral right and left heart catheterization with venous sheath placement. All patients received 324 mg of aspirin prior to the procedure. Those who were taking clopidogrel prior to the procedure were not excluded. Patients were stimulated to participate in the study to ambulate early after the procedure and be discharged home 1 h after that.
Following Angioseal® deployment, patients received the usual post-catheterization care with regard to vital signs, access site assessment, and nursing care, except that they were ambulated at 20 min instead of the standard 120 min. The arteriotomy access site was then assessed clinically for any complications including, but not limited to, visual bleeding (defined as mild, moderate, or severe depending on estimated visual amount 0–10 ml, 11–50 ml, and greater than 51 ml, respectively), presence of bruit or pulsatile mass, hematoma formation, evidence of arterial insufficiency (including loss of pedal pulse, cold limb, etc.), and suspected nerve damage related to the access site. If any patient had clinical signs or symptoms of complications, they would be assessed further. Patients were monitored for 1 h following Angioseal® and were discharged home. Patients were then assessed clinically for any access site complications at the next office visit 2 weeks after the procedure.
Results
Patient demographics are listed in Table 1. Sixty patients consented to the study, with 29 patients enrolled. Thirty-one patients were excluded for various criteria including, but not limited to, decision to perform radial access prior to puncture, high bifurcation of the femoral artery and decision to perform manual compression due to arterial anatomy. In the study patients (who were ambulated early) the average age was 66 years (45–85 years). There were 15 female patients and 14 male patients. Even though the intent overall was to ambulate at 20 min, 27 patients ambulated at 20 min (93.1%), one patient ambulated at 28 min (3.45%) and one patient ambulated at 27 min (3.45%) (Figure 1). Overall, there were no complications with regard to hemorrhage, pseudoaneurysm or other groin complications.
Patient demographics.
Patient selection and results.
Of note, one patient underwent right and left cardiac catheterization with a 7 Fr venous and 6 Fr arterial sheaths on the ipsilateral side, one patient had an International Normalized Ratio (INR) of 1.8 at the time of ambulation and one patient had left femoral venous access with a 7 Fr sheath and only 5 min of manual compression for hemostasis prior to ambulation. Neither of these patients had any complications after ambulation.
Discussion
Our study shows that ambulation after 20 min following Angioseal deployment is safe, reinforcing the FDA’s recommendation. The femoral approach to coronary angiography has been the standard for more than half a century. In the past decade, however, the radial approach has rapidly gained in popularity based on multiple favorable studies. The publishing of the RIFLE-STEACS trial showing the benefit of the radial approach in patients with acute coronary syndromes provided for a paradigm shift to perform more studies radially. 5 While the RIFLE-STEACS trial showed improvement in outcomes for acute coronary syndromes, there is still a debate over whether all studies should be performed radially, with a substantial number of them still performed via the femoral approach.
Another landmark clinical trial with equivocal results was the RIVAL (radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes) trial. The authors’ conclusions were that there were fewer major vascular access site complications with the radial approach. However, there were no major outcome differences with regards to primary endpoints, with a high rate of crossover for the radial group. 6
While the number of patients undergoing diagnostic left heart catheterization from the femoral approach seems to be declining with the advent of radial techniques and operator preference, there remains a significant subset of procedures that are performed from the femoral approach either because of anatomical variants or operator preference. Our study may help validate the femoral approach when chosen. Even though our sample size was small (29 patients), there were no site complications within the study arm. Obviously, the very early ambulation approach to the femoral access patients would be validated if safety and cost effectiveness are demonstrated. Early ambulation has been shown to be cost-effective with the use of other vascular closure devices, such as the ProGlide® (Abbott Vascular, CA) suture-mediated device. 7 A study evaluating early ambulation (within 20 min following hemostasis) following the use of the StarClose® (Abbott Vascular, CA) vascular closure device has proven efficacy and safety. 8 Our study, albeit small, has shown that this approach for early ambulation is safe, with potential significant reduction in healthcare expenditure and human resource utilization. Moreover, patient satisfaction may be related to safety, comfort and early discharge.
Another important measure seen within the study is the ability to ambulate patients 20 min after undergoing a right and left heart catheterization, which is frequently done from the femoral approach due to operator preference. This dramatic decrease in supine time for patients can improve patient comfort along with cutting costs for the hospital and catheterization laboratories, as previously mentioned.
There are several key limitations of our study. This is a single-center study, which may result in bias. All attempts were made to limit that from occurring by enrolling all patients with operators who would be willing to participate regardless of patient comorbidities. We excluded patients who received anticoagulants; therefore, our data may not be applicable to many patients who receive various anticoagulant therapies as part of acute coronary syndrome.
Conclusion
Patients may be safely ambulated following a successful Angioseal® deployment after 20 min from a diagnostic angiographic procedure and discharged home within 1 h.
