Patient Population and Data Collection

To eliminate the impact of operator learning curve, patients treated before February 2015 were not included in this analysis. Case information for 185 consecutive patients undergoing TAVI with either dual Perclose ProGlide or dual Perclose ProGlide plus Angio-Seal at the research group's institution between February 2015 and December 2019 were analyzed retrospectively. Eight patients were excluded from the analysis because the operators did not use transfemoral access (1 subclavian artery access, 2 transapical access) or surgical access was through femoral iliac artery cutdown (n = 5). Dual Perclose ProGlide was used in 139 patients, and the remaining 46 patients underwent 8F Angio-Seal deployment after dual Perclose ProGlide device failure.

Vascular Access Technique and Description of Complications

Before TAVI, peripheral access evaluation and measurement were performed using contrast-enhanced multislice computed tomography imaging. The tortuosity scores were defined as follows: 0 = no tortuosity; 1 = mild tortuosity (30°–60°); 2 = moderate tortuosity (60°–90°); and 3 = marked tortuosity (≥90°). The calcification scores were defined as follows: 0 = no calcification; 1 = mild calcification; 2 = moderate calcification; and 3 = marked calcification. Before large-bore arteriotomy, routine arterial puncture was performed under fluoroscopic guidance.

The dual Perclose ProGlide is the default, suture-mediated closure device for TAVI procedures in our catheter lab. Both Perclose ProGlide devices were rotated approximately 45° from the midline in opposite directions. At the end of the TAVI procedure, the large-bore sheath was removed, and the predeployed sutures were tightened around the wire. At this stage, if hemostasis was maintained, the knot was locked and cut following wire removal. If significant oozing with incomplete immediate hemostasis was confirmed at this stage, an 8F Angio-Seal device was then used. The Angio-Seal sheath was inserted over the wire, using caution to avoid rupture of the Perclose ProGlide sutures. The device's collagen plug was compressed against the femoral artery adventitia following removal of the wire, and the Angio-Seal was deployed in a conventional manner.

Closure device failure was defined as insufficient or the absence of hemostasis at the arteriotomy site that required surgical conversion rather than manual compression or adjunctive endovascular intervention. Vascular complications and bleeding were defined using the Valvular Academic Research Consortium-2 consensus criteria.¹¹

Statistical Analysis

Continuous variables were expressed as mean (SD); nonnormally distributed variables were reported as median (IQR). Categorical data were expressed as numbers and percentages. The Student t test or Mann-Whitney U test was used to compare continuous variables. Categorical data were compared using the Pearson χ² test or Fisher exact test. Normality of distribution was tested using the Kolmogorov-Smirnov test. Statistical significance was defined as P < .05. All statistical analyses were performed using SPSS, version 20, software (IBM Corporation).

Baseline Clinical Characteristics and Complications Between the 2 Study Groups

The baseline clinical characteristics of 185 patients are summarized in Table I. The groups had similar clinical features. An overview of the TAVI patient cohort with techniques required to achieve access site hemostasis is provided in Figure 1. The primary success rate of the dual Perclose ProGlide device was 71% (131/185) without an additional device or surgical conversion or manual compression. There were no significant differences in the degree of femoral iliac artery calcification, artery tortuosity, or minimum artery lumen diameter among the patients' baseline imaging characteristics (Table II). Sheath-to–femoral artery ratio, sheath outer diameter, and valve type were also similar between the groups, but the incidence of moderate to severe tortuosity and use of larger-bore sheaths (≥18F) tended to be more frequent in the dual Perclose ProGlide+Angio-Seal group. Auxiliary Angio-Seal device use resulted in successful hemostasis in all cases. In the early stage of TAVI procedures, when Angio-Seal had not been adopted as a bailout approach, manual compression was applied to address significant bleeding after tightening Perclose ProGlide sutures in 7 cases, 4 of which required surgical conversion. One patient required surgical repair and peripheral bypass despite use of a GORE VIABAHN endoprosthesis (W. L. Gore & Associates, Inc) following dual Perclose Pro-Glide failure.

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TABLE I Patient Characteristics ^a

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TABLE II Procedural Characteristics

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In-hospital Valvular Academic Research Consortium-2 major vascular complications (9.4% vs 4.3%; P = .36), minor vascular complications (9.4% vs 14.7%; P = .14), major bleeding (11.5% vs 4.3%; P = .25), and minor bleeding (6.5% vs 10.9%; P = .34) did not differ between dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups. A higher rate of hematoma was observed in the dual Perclose ProGlide+Angio-Seal group than in the dual Perclose ProGlide group (2.9% vs 10.9%; P = .044) (Table III). In-hospital mortality was 9.64% and 4.3% for the dual Perclose Pro-Glide and dual Perclose ProGlide+Angio-Seal groups, respectively (P = .52).

TABLE III Clinical Outcomes

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Study Limitations

The present data were obtained retrospectively from a single-center registry; therefore, no randomized comparison between these techniques and other large-bore closing devices could be made. Such confounding factors, including use of oral anticoagulants and antiplatelets, the presence of peripheral vascular disease, variations in active clotting time, and different skill levels with various TAVI systems, may have resulted in incomplete hemostasis. Another limitation is the size of this study, which could preclude direct comparison of rare vascular complications, such as pseudoaneurysm, arteriovenous fistula, and acute limb ischemia. It is possible that use of an ANGIO-SEAL device to aid hemostasis may increase the risk of acute or subacute arterial occlusion or embolization requiring urgent surgery. Additionally, the absence of ultrasound guidance may have precluded precise common femoral artery location/puncture and Perclose ProGlide success. Note that off-label use of the Angio-Seal device should be considered on an individual patient basis and in light of operator experience, device familiarity, and alternative closure approaches. Nevertheless, augmenting dual Perclose ProGlide use with an Angio-Seal device could result in early complete hemostasis and enable patients to ambulate early after TAVI.