Initial Experience of Removal of 10-French Sheaths Using the 8-French Angio-Seal Vascular Closure Device

ABSTRACT: Objectives. We studied the use of 8 Fr Angio-Seal in closure of access sites up to 10 Fr. Background. The use of larger French catheters for procedures such as valvuloplasty and percutaneous valve replacement has required the use of better methods for arterial closure. The use of 6 and 8 Fr Angio-Seal hemostatic devices (St. Jude Medical, St. Paul, Minnesota) has been well described and are routinely used for diagnostic and interventional procedures up to 8 Fr in size. However, no data are available for the use of an 8 Fr Angio-Seal device in the closure of access sites up to 10 Fr. Methods. In our center, we evaluate the incidence of vascular complications following the use of an 8 Fr Angio-Seal device with 10 Fr sheaths in patients undergoing aortic valvuloplasty. Results. Of 53 procedures, there was only 1 vascular complication, a ruptured pseudoaneurysm, which required vascular repair. Conclusions. Our data suggest that an 8 Fr Angio-Seal device can be utilized effectively and safely in procedures requiring larger access sites up to 10 Fr. J INVASIVE CARDIOL 2010;22:130–131 One of the most common adverse events following coronary angiography and percutaneous coronary intervention (PCI) is complications of vascular access ranging between 1.5% to 9%.1–3 The Angio-Seal (St. Jude Medical, Inc., St. Paul, Minnesota) is a device that uses a bioabsorbable anchor of polyglycolide and polylactide which is placed against the interior wall of the artery, connected via an absorbable suture and a bovine plug. This is pressed on the outer surface of the artery which subsequently forms a hemostatic plug.4 The Angio-Seal closure device has been shown to decrease the time to ambulation and discharge in diagnostic catheterization patients. The use of vascular closure devices such as Angio-Seal has been shown to reduce vascular complications compared to manual compression and has an even more pronounced effect when used in patients receiving glycoprotein IIb/IIIa antagonists.5-7 Procedures such as balloon aortic valvuloplasty and percutaneous valve repair require large-French (Fr) catheters for access and involve complex vascular closures. While the use of the 6 and 8 Fr Angio-Seal device has been well described in closing up to 8 Fr sheaths in diagnostic and interventional catheterization procedures,5,8,9 no data are available for the use of an 8 Fr Angio-Seal device in closing 10 Fr sites. In this study we looked at all patients who have undergone balloon aortic valvuloplasty with vascular closure using an 8 Fr Angio-Seal device for 10 Fr access sites and describe their vascular complications.

Materials and Methods

Patients. This was a single-center retrospective study of all patients who underwent balloon aortic valvuloplasty with arterial closure using an 8 Fr Angio-Seal device. All patients were referred for aortic valvuloplasty based on severe symptomatic disease and were evaluated by cardiothoracic surgery previously. Patients deemed too high-risk for aortic valve replacement had valvuloplasty performed for symptom management. Patients who had a low-profile Tyshak balloon to dilate the aortic valve during the procedure were those who underwent arterial closure using an 8 Fr Angio-Seal VIP. Patients who underwent multiple valvuloplasty procedures were also included. Patient characteristics are shown in Table 1. Arterial closure. Femoral angiography confirmed that the puncture site was in the common femoral artery above the bifurcation of the superficial femoral artery and profunda femoris artery and below the inferior epigastric artery. This allowed for a sufficiently large vessel to obtain access and deploy the device. All patients in this study underwent balloon aortic valvuloplasty using a low-profile Tyshak balloon, which allowed placement of a 10 Fr sheath at the end of the case. An 8 Fr Angio-Seal device was then deployed using standard techniques. The size of the device anchor was 10 mm in length by 1.95 mm in width with a height at the dome of 1.75 mm. All patients received a 5,000-unit heparin bolus during the procedure. All patients received approximately 1 minute of manual compression to the access site after the device was deployed as part of the protocol. No patients received periprocedural heparin. In most cases ambulation was initiated approximately 6 hours after arterial closure. Outcomes. Patients receiving an 8 Fr Angio-Seal device were retrospectively studied for post-procedural adverse outcomes. We looked at whether patients developed large hematomas > 10 cm, pseudoaneurysms, death and vascular complications requiring surgical repair.

Results

A total of 53 aortic valvuloplasties using an 8 Fr Angio-Seal device were performed between December 2004 and December 2008. Of the 53 procedures, 1 had a vascular complication (1.8%) of a ruptured pseudoaneurysm requiring surgical repair (Table 2). Discussion The major finding of this study is that the use of an 8 Fr Angio-Seal device is safe for use in procedures requiring large-caliber catheters. The one complication was in an 80-year-old patient who developed a ruptured pseudoaneurysm 2 days post procedure. The use of large-bore catheters in percutaneous interventions such as balloon valvuloplasty, valve repair and replacement has necessitated better vascular closure devices and techniques. In a meta-analysis of sixteen randomized, prospective studies totaling 5,048 patients, Angio-Seal was associated with a reduction in vascular complications, while Perclose™ (Abbott Vascular, Redwood City, California) was equivalent to manual compression.10 The CAP trial showed that Angio-Seal was superior to Perclose Proglide and allowed for earlier hemostasis and ambulation. While a Perclose technique or Prostar (Abbott Vascular) closure device has been used successfully for large-vessel access sites, no study has shown the efficacy of using an 8 Fr Angio-Seal device in closing larger access sites up to 10 Fr. The results of our study show an 8 Fr Angio-Seal device is an effective and safe means of closing 10 Fr access sites, even in patients receiving anticoagulation with heparin. There were several caveats in our study. The use of arterial closure devices is routinely used at our institution and operators had experience with the Angio-Seal device. Thus, in low- volume centers the complication rate may be higher. In our study we also looked at the number of interventions, with some patients undergoing multiple interventions. In individual patients, depending on their comorbidities, they may have higher inherent rates of vascular complications, thus confounding our results. The mean age of our patients was 82 ± 12 years, and all received balloon valvuloplasty. However, previous studies have shown that vascular complications were not increased with devices other than stents.2 Our patient population tended to be elderly and it is possible that in a younger subset, complication rates may be lower.

Conclusions

The use of an 8 Fr Angio-Seal device is safe in procedures requiring large-caliber catheters, with a relatively low complication rate. Our data show that this is the case even in a very elderly subset of patients with multiple comorbidities.

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From Mount Sinai School of Medicine, Department of Medicine, New York, New York. The authors report no conflicts of interest regarding the content herein. Manuscript submitted September 24, 2009, provisional acceptance given November 17, 2009, final version accepted December 3, 2009. Address for correspondence: Michael C. Kim, MD, Assistant Professor of Medicine, Mount Sinai School of Medicine, Mount Sinai Heart, P.O. Box 1030, One Gustave L. Levy Place, New York, NY 10029. E-mail: arzhang.fallahi@mssm.edu

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References

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