Figure 1. Successful implantation of a No. 23 Evolut™ R valve in the aortic position. Post-proced...

Figure 2. The 18-Fr introducer catheter extracted after surgical release, with visible endothelial t...

Figure 3. Digital subtraction angiography showing the 9-mm Dacron tubular graft positioned in the il...

Figure 4. Sequence showing resolution of distal occlusion in the right lower limb. a) Angiography de...

Introduction

Vascular complications are among the most relevant adverse events of transcatheter aortic valve implantation (TAVI). They are associated with high in-hospital and short-term morbidity and mortality1. Despite advancements in preoperative planning with computed tomography angiography and the use of low-profile introducers, these complications are still a considerable clinical challenge2. Tools such as the sheath-to-femoral artery ratio (SFAR) and its modified version have proven useful in estimating the risk of major vascular events, but they do not eliminate it completely3. We present the case of a patient with favorable vascular anatomy who experienced an uncommon complication characterized by introducer entrapment and distal embolization, which was resolved through an extraperitoneal surgical approach with favorable outcome.

Clinical case

A 69-year-old woman with a history of hypertension, dyslipidemia, and overweight (body mass index [BMI] 29; body surface area: 1.60 m²) was diagnosed in 2018 with severe aortic stenosis. She had a 6-month history of exertional dyspnea, New York Heart Association (NYHA) functional class II. After multidisciplinary evaluation by the Heart Team, a decision was made in favor of TAVI considering the patient’s preference and the potential risk of prosthesis–patient mismatch. Regarding risk scores, the Society of Thoracic Surgeons (STS) mortality score was 1.5% and the EuroSCORE II was 1.49%.

Computed tomography angiography (CTA) showed iliofemoral vessels with no severe tortuosity or significant circumferential calcifications, with adequate calibers for the procedure. On the right side, the common iliac artery diameter was 9.0×9.0 mm, the external iliac artery diameter was 6.9×6.1 mm, and the common femoral artery diameter, 6.6×6.5 mm. On the left side, the values were lower: 7.4×7.1 mm for the common iliac artery, 6.1×5.9 mm for the external iliac artery, and 6.0×5.9 mm for the common femoral artery. Right side access was selected, given its better profile. The calculated SFAR was 0.92 (18-Fr introducer/6.5-mm femoral artery), which suggested a low risk of major vascular complications.

Once the right femoral artery was exposed in layers, a 6-Fr introducer was initially advanced. Subsequently, through a series of progressive dilations, the vascular tract was expanded to allow for the insertion of an 18-Fr introducer. Finally, a No. 23 Evolut™ R valve was implanted without complications (Figure 1).

Upon procedural completion, an attempt was made to remove the introducer. It failed due to entrapment in the right iliac artery. Control angiography confirmed this finding. Mechanical maneuvers were performed to facilitate extraction, including irrigation with temperature-controlled saline solution to induce vasodilation. However, after multiple unsuccessful attempts at releasing the device, intervention by the cardiovascular surgery team was requested.

An extraperitoneal approach was chosen through an oblique incision in the right iliac fossa, exposing the external iliac artery and the common femoral artery. This allowed for controlled sectioning of both arteries and release of the introducer, which showed endothelial tissue adhered to it (Figure 2). A 9-mm Dacron tubular prosthesis was then implanted in the iliofemoral position, with proximal anastomosis at the level of the iliac bifurcation and distal end-to-end anastomosis with the common femoral artery (Figure 3).

Upon assessment of right foot perfusion after the surgery, distal coldness and absence of tibial pulse were noted. Control angiography showed occlusion of the tibioperoneal (tibiofibular) trunk (Figure 4a). Embolectomy with a Fogarty catheter was performed in that segment, retrieving fragments of vascular endothelium adhered to the device (Figure 4b). Subsequent control angiography confirmed restoration of infrapatellar flow to the foot and tibial pulse (Figure 4c).

The patient’s clinical course after the procedure was favorable, with no new complications during hospitalization. After close clinical follow-up and satisfactory postoperative evaluations, she was discharged in good general condition.

Discussion

Vascular complications in TAVI—including dissection, perforation, rupture, fistulae, pseudoaneurysms, and distal embolization—remain associated with increased in-hospital and 30-day postprocedural mortality1-2. The ratio between the outer diameter of the introducer and femoral artery diameter, known as “SFAR”, has been used to quantify this risk. SFAR ≥1.05 is independently associated with a significant increase in major vascular complications (p < 0.001)3.

Recently, a modified SFAR (md-SFAR) has been proposed to adjust manufacturer recommendations to real-world clinical practice. In a multicenter study, the md-SFAR proved to be the only independent predictor of major vascular complications after transfemoral TAVI (odds ratio = 3.71; 95% confidence interval: 1.13-12.53; p=0.031)4. For example, for the Edwards SAPIEN 3 system, the minimum femoral diameter required for a 14-Fr introducer is 5.0 mm, whereas for the Medtronic Evolut R this threshold is 5.5 mm4.

The introduction of low-profile introducers (≤18 Fr) has contributed to a dramatic reduction in the incidence of major vascular complications. In a historical cohort, the use of ≤18-Fr introducers was associated with a complication rate of 0.5% compared with 10.5% with ≥19-Fr introducers5. Nonetheless, anatomical factors such as circumferential calcification, severe tortuosity, and femoral tract depth remain significant predictors of adverse events6.

The SOURCE and TVT registries have shown a sustained decrease in vascular complications as operator and center experience increases, improving selection based on multi-slice computed tomography and percutaneous closure techniques7.

In this case, despite comprehensive preoperative assessment—including CT angiography and SFAR calculation—the patient experienced a major vascular complication that required surgical management. This reinforces the importance of using predictive tools such as SFAR in all preoperative planning, preferring low-profile introducers whenever anatomy allows, and maintaining a multidisciplinary team (interventional cardiologists, vascular surgeons, and anesthesiologists) ready for immediate intervention.

Conclusions

Severe vascular complications related to introducer entrapment during TAVI procedures, while infrequent, can occur even with appropriate preoperative planning and a SFAR within typically safe parameters. This case highlights the usefulness of this index as a guiding tool, but it also demonstrates its limitations in the face of non-quantifiable anatomical factors. It also underscores the importance of having a multidisciplinary team prepared to implement effective surgical strategies, such as the extraperitoneal approach, to resolve these events with good clinical outcomes.

1. Hayashida K, Lefèvre T, Chevalier B, et al. Transfemoral aortic valve implantation: new criteria to predict vascular complications. JACC Cardiovasc Interv. 2011;4(8):851-858. doi:10.1016/j.jcin.2011.03.019.

2. Van Mieghem NM, Tchetche D, Chieffo A, et al. Incidence, predictors, and implications of access site complications with transfemoral transcatheter aortic valve implantation. Am J Cardiol. 2012;110(9):1361-1367.

3. Rahhab Z, Ramdat Misier K, El Faquir N, Van Mieghem NM. Vascular complications after transcatheter transfemoral aortic valve implantation: a systematic review and meta-analysis. Catheter Cardiovasc Interv. 2019;94(4):833–843. doi:10.1002/ccd.28106.

4. Çakal S, Çakal B, Karaca O, et al. Vascular complications after transfemoral transcatheter aortic valve implantation: modified sheath-to-femoral artery ratio as a new predictor. Anatol J Cardiol. 2022;26(1):49-56. doi:10.5152/AnatolJCardiol 2021.147.

5. Barbanti M, Binder RK, Freeman M, et al. Impact of low-profile sheaths on vascular complications during transfemoral transcatheter aortic valve replacement. EuroIntervention. 2013;9(8):929-935. doi:10.4244/EIJV9I8A156.

6. Duran E, Penso M, Hemery T, et al. Standardized measurement of femoral artery depth by computed tomography to predict vascular complications after TAVI. Am J Cardiol. 2021;145:119-127. doi:10.1016/j.amjcard.2020.12.089.

7. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry. Circulation. 2010;122(1):62-69. doi:10.1161/CIRCULATIONAHA.109.907402.

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Vascular complication post-TAVI with sheath entrapment and distal embolization: surgical resolution through extraperitoneal approach. A case report

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