Methods

Over a 40-month period, a total of 380 patients underwent TAVI in our center using the self-expanding CoreValve (Medtronic, Minneapolis, MN). All patients had a computed tomographic (CT) angiography and/or iliofemoral angiography to assess the size (>6 mm), tortuosity, and degree of calcification of the iliofemoral axis. In total, 354 patients were treated by TF approach; this was our study population. In accordance with the institutions’ policies, every patient gave written informed consent for TAVI and the use of anonymous data for research in accordance with the Ethical Committee (Region Hovedstaden) review board approval.

All TF-TAVI procedures were performed under general anesthesia using percutaneous access and conventional suture-mediated closure using the Prostar-XL vascular closure system (Abbott Vascular, Chicago, IL). Vascular access was obtained by a contralateral femoral artery puncture and introduction of a 6Fr sheath. Fluoroscopic and contrast-guided ipsilateral access was supported by an internal mammary artery catheter from the contralateral side through crossover technique above the aortic bifurcation. In this way, a high puncture of the ipsilateral common femoral artery (CFA) above the femoral artery bifurcation was facilitated, and a 6Fr sheath was introduced. After skin incision (10 mm) and careful blunt dissection of the subcutaneous tissue, the Prostar-XL device was advanced over a 0.035-in guidewire into the vessel, and the sutures were deployed according to the instructions for use. Next, the Prostar-XL delivery system was removed over a J-tip guidewire and replaced by a 12Fr sheath to further dilate the femoral arteriotomy. After exchange to an 18Fr sheath over an Amplatz Super Stiff guidewire, CoreValve implantation was performed. At the end of the procedure, the preloaded sutures were tied, and angiographic control of the access vessel was performed through a contralateral internal mammary artery catheter to evaluate vascular injury and hemostasis.

In the event of a vascular access site injury, a predefined protocol was followed. Minor vascular injury at the puncture site was treated with either external compression or balloon angioplasty for 3 to 5 minutes using a Tyshak balloon (NuMED, Hopkinton, NY) introduced through a 6Fr to 8Fr Arrow sheath (Teleflex, Ireland) from the contralateral side (and repeated for 2 to 3 times in some cases). If this strategy failed or when major extravasation was apparent on angiographic control, a 50-mm-long Viabahn endoprosthesis ( Figure 1 ) was inserted covering the vessel lesion, aiming to place the distal part of the stent proximal to the bifurcation of the CFA into superficial femoral artery (SFA) and deep femoral artery (DFA). If endovascular repair was impossible (e.g., because a wire could not pass the lesion), considered not suitable by the operator (too extensive vascular injury), or unsuccessful in achieving vessel patency, surgical vessel repair was performed.

The Viabahn endoprosthesis. This self-expanding covered stent is constructed with a durable, biocompatible, expanded polytetrafluorethylene liner attached to an external nitinol stent structure.

All end points were defined according to the Valve Academic Research Consortium 2 (VARC-2) recommendations, including bleeding, vascular complications, and acute kidney injury. In March 2014, the information contained in our database was re-evaluated to conform to the definitions proposed by the VARC-2. Other end points included procedural variables, units of blood transfusion, length of hospitalization at intensive care unit (ICU) and total length of hospitalization, and 30-day mortality.

All patients who underwent TAVI and received a Viabahn endoprosthesis were invited to participate at the follow-up study. One patient was lost to follow-up, and 1 other patient died before the time of follow-up. The following parameters were assessed: (1) symptoms of claudication according to the Rutherford classification; (2) femoral and pedal (arteria dorsalis pedis [ADP] and arteria tibialis posterior [ATP]) pulses; (3) ankle-brachial index (ABI; normal range 0.9 to 1.3); and (4) a color duplex ultrasound (US) of the external iliac artery (EIA), CFA, proximal DFA, and proximal SFA was performed to ensure stent visualization and perform flow measurements proximal, within, and distal of the stent and also around any plaque, if present. If a patient presented with worsening of symptoms, a significant change in ABI, or a reduced flow in the proximal DFA or SFA, more extensive imaging (CT angio or full SFA and popliteal US) was performed.

All statistical analyses were performed with SPSS version 20 (IBM SPSS Inc., Chicago, Illinois). Categorical variables are reported as absolute values and percentages. Continuous variables are presented as means ± SD or medians and interquartile range (IQR). Comparisons between groups were performed using the chi-square test (categorical variables) and the Student t test (continuous variables). Statistical significance was defined as p <0.05.

Results

Access-related complications (VAC) leading to acute intervention occurred in 72 patients (20.3%) of the study population and were more frequently observed in female patients or patients with diabetes mellitus, a high body mass index, or a high surgical risk score (p <0.05, Table 1 ). Of these, 18 were treated with balloon angioplasty, 48 with a Viabahn endoprosthesis, and 6 needed surgical vessel repair ( Figure 2 ). Viabahn endoprostheses were used for different types of VAC: stenosis (n = 3), dissection (n = 4), incomplete vascular closure due to closure device failure (n = 36), and rupture/perforation (n = 5; Figures 3 and 4 ). The use of a Viabahn endoprosthesis was the primary choice in 38 patients, whereas in 10 other patients, stenting was preceded by balloon angioplasty with unsatisfactory result.

Flowchart of the population with TAVI. More than 90% of TAVI procedures at our center were performed by TF approach. We identified 6 patients with vascular complications involving the left ventricle or aorta. 72 patients presented with vascular access complications leading to acute intervention; of these, 18 were treated with balloon angioplasty, 48 with a Viabahn endoprosthesis, and 6 needed surgical vessel repair.

Management of vascular access complications. The different types of vascular access site injuries, the findings on x-ray angiography, and the therapeutic intervention used. Values are number of patients (n).

Management of vascular access complications by Viabahn stenting. (A) Residual stenosis after balloon angioplasty, (B) resolved after Viabahn implantation. (D) Incomplete vascular closure due to Prostar failure with major extravasation, (E) treated successfully by Viabahn insertion. (G) Vascular rupture at the access site, (H) treated by Viabahn implantation. (C, F, I) US color Doppler imaging a few months after treatment showing patent Viabahn endoprostheses with no signs of stent fracture or in-stent stenosis (peak velocity ratio <2 m/s) or occlusion.

The total procedure length was prolonged with 9 to 11 minutes in case of endovascular repair, whereas in case of surgical intervention, the procedure was extended for >85 minutes. In contrast, almost a double radiation dose was used in case of endovascular repair, whereas extra radiation was hardly used in case of surgical repair ( Table 2 ).

Table 2

Procedural and 30-day outcome

Variable	No acute intervention	Balloon angioplasty	Viabahn ® stenting	Surgical intervention
	(n = 276)	(n = 18)	(n = 48)	(n = 6)
Procedural variables
Contrast volume (mL)	104 ± 47	132 ± 37	136 ± 49	118 ± 71
Radiation (Gy x cm 2 )	102 ± 96	180 ± 162	191 ± 173	123 ± 91
Total procedure length (min)	69 ± 27	78 ± 37	80 ± 28	157 ± 107
Bleeding
Major	2 (0.7%)	1 (5.6%)	3 (6.3%)	1 (16.7%)
Life-threatening	1 (0.4%)	0 (0.0%)	1 (2.1%)	2 (33.3%)
Blood transfusion (units)
≥ 1	44 (15.9%)	4 (22.2%)	11 (22.9%)	5 (83.3%)
≥ 4	1 (0.4%)	0 (0.0%)	1 (2.1%)	2 (33.3%)
Vascular complication
Minor	5 (1.8%)	17 (94.4%)	43 (89.6%)	1 (16.6%)
Major	0 (0.0%)	1 (5.6%)	5 (10.4%)	5 (83.3%)
Acute kidney injury
≥ stage 1	7 (2.5%)	1 (5.6%)	2 (4.2%)	2 (33.3%)
≥ stage 2	3 (1.1%)	0 (0.0%)	1 (2.1%)	1 (16.6%)
Length of hospitalization (days)
Intensive care unit	1.3 ± 0.6	1.5 ± 0.7	1.4 ± 0.7	3.8 ± 1.4
Total length	7.6 ± 3.8	8.9 ± 5.3	7.8 ± 4.3	12.5 ± 6.1
30-day mortality	2 (0.7%)	1 (5.6%)	0 (0.0%)	0 (0.0%)

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