The Double Angio-Seal Technique for Arterial Closure Following Large-Bore Access

Abstract: Off-label “double-wire” technique for closure of large-bore vascular access has been reported in the setting of percutaneous aortic valvuloplasty. We present 5 cases of high-risk percutaneous coronary intervention (HRPCI) supported by a 2.5 LP Impella assist device with 13 and 14 Fr size femoral access. Following successful HRPCI, vessel closure was complicated by unsuccessful deployment of a suture-mediated closure device. Subsequently, deployment of two successive collagen-based closure devices with a “double-wire” technique was performed. Our cases warrant further studies to test the feasibility of using double-closure device as an alternative for vessel closure when left ventricular assist devices are needed to support HRPCI.

J INVASIVE CARDIOL 2013;25(8):412-414

Key words: left ventricular assist devices, LVAD, HRPCI, PLVAD

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The growing utilization of percutaneous left ventricular assist devices (PLVADs), such as the Impella 2.5 LP device (Abiomed), during high-risk percutaneous coronary intervention (HRPCI) has necessitated frequent use of large-caliber arterial sheaths to facilitate device insertion. Previously, large-bore vascular access was performed surgically by means of arterial cut-down to minimize complications such as bleeding. While vascular closure devices (VCDs) are often used during PCI, there are limited data regarding their use following removal of large-caliber (13 or 14 Fr) arterial sheaths. We present 5 cases in which we successfully used two Angio-Seal VCDs (St Jude Medical) to obtain hemostasis following removal of a PLVAD following HRPCI.

Case Series

Five men (age, 69.4 ± 9.2 years) with severe multivessel coronary artery disease (CAD) and ischemic cardiomyopathy (ICM) (left ventricular ejection fraction, ≤25%) underwent Impella 2.5 LP supported HRPCI. All patients had hypertension, hyperlipidemia, diabetes, and peripheral vascular disease (Table 1). In each case, after unsuccessful attempts to “pre-close” the arteriotomy using at least two Perclose suture-mediated VCDs (Abbott Vascular), where the sutures came apart at the beginning of the case right after deployment, the PLVAD was introduced through a 13 or 14 Fr sheath in the left common femoral artery (CFA). Angiography was used to measure the CFA, which ranged between 5 and 7.5 mm, and none had significant angiographic disease. Following device insertion, HRPCI was performed utilizing standard 6 or 8 Fr sheaths in the right CFA. All patients remained hemodynamically stable during coronary intervention. At the end of the procedure, the PLVAD was removed and left CFA hemostasis was successfully obtained using the technique described below. 

The Double Angio-Seal Technique

Two standard 0.035˝ wires are introduced through the 13 or 14 Fr sheath (Figure 1A). Following the large-diameter sheath removal, a 6 Fr sheath is inserted over one wire and an 8 Fr Angio-Seal device is loaded onto the other wire. The VCD is then deployed using standard technique (Figures 1B and 1C). Non-occlusive pressure is held over the access site for short duration (3 to 5 minutes). Following this, the 6 Fr sheath is removed and a second 6 or 8 Fr Angio-Seal device is deployed over the second wire (Figures 1D and 1F). Manual pressure is held for a short duration, and hemostasis is confirmed by visual inspection of the access site and/or angiography performed through the contralateral arterial sheath (Figure 2).

Discussion

Vascular injury has been reported as the most common complication of percutaneous procedures.¹ We report our experience in safely obtaining hemostasis following large-caliber arteriotomy using two collagen-based VCDs that are deployed sequentially. This “double-wire” technique has been previously described in the setting of balloon aortic valvuloplasty with access-site diameters ranging from 8 to 12 Fr. Double Angio-Seal deployment was used in 3 cases where the arteriotomy was 10 Fr.² In contrast, the arterial access was at least 13 Fr in our patients. Also, the use of a Perclose device prior to sheath insertion, which is routinely done in contemporary practice, was unsuccessful in all patients.

The reported rates of VCD failure in current literature widely range from 1.5%-20%.  

A propensity-based analysis suggests that the use of suture-based VCDs confers a 6.6-fold higher risk of failure compared with collagen-based VCDs for both diagnostic and interventional procedures.³ Indeed, results from a randomized trial yielded significantly higher failure rates of suture-based VCDs compared to collagen-plug based devices (15.9% vs 0%, respectively; P<.0001).⁴ Potential complications of the collagen-based VCDs include bleeding secondary to device failure, limb ischemia due to vessel closure, pseudoaneurysm, and infection. However, in our limited series, we did not observe any of these complications despite the use of two VCDs in the same arteriotomy. It is important to emphasize that we optimized our technique by angiographic evaluation of the vessel before access and after closure. 

Conclusion

Our experience demonstrates the feasibility of using multiple collagen-based VCDs in closing large-caliber (up to 14 Fr) arteriotomies, thereby offering an alternative when it is not possible to use suture-based VCDs.   

References

1. Percutaneous balloon aortic valvuloplasty. Acute and 30-day follow-up results in 674 patients from the NHLBI balloon valvuloplasty registry. Circulation. 1991;84(6):2383-2397.
2. Bui QT, Kolansky DM, Bannan A, Herrmann HC. “Double wire” Angio-Seal closure technique after balloon aortic valvuloplasty. Catheter Cardiovasc Interv. 2010;75(4):493.
3. Bangalore S, Arora N, Resnic FS. Vascular closure device failure: frequency and implications: a propensity-matched analysis. Circ Cardiovasc Interv. 2009;2(6):549-556.
4. Martin JL, Pratsos A, Magargee E, et al. A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: the CAP trial. Catheter Cardiovasc Interv. 2008;71(1):1-5.