Outcomes of stent-graft repair for anastomotic femoral pseudoaneurysm. A case series

Abstract

Objective

This study aims to report a case series of anastomotic femoral pseudoaneurysms (PSA) treated with stent-grafting (SG) in patients at high-risk for the open surgical approach.

Methods

It is a retrospective, observational cohort study. Between 1 January 2002 and 1 April 2020, post-hoc analysis of the database including patients who received repair for femoral PSA identified those treated with SG. All but one patient were approached through a contralateral percutaneous transfemoral access, and the SG was always deployed from the common femoral artery to the profunda femoris artery. For this study, primary outcomes of interest were early (≤ 30 days) survival and patency rate.

Results

We identified 10/823 cases of the entire PSA cohort (1.2%). There were 9 men and 1 woman: the mean age was 76 years ± 9 (range: 64–92). Urgent intervention was performed in 4 patients. The median operative time was 30 min (IQR: 25–36). Access-related complication was never observed. In-hospital mortality occurred in 1 patient due to novel coronavirus-19–related pneumonia. Median follow-up was 24 months (IQR: 12–37); 5 patients died. At the last radiologic follow-up available, all SGs were patent without necessity of reintervention.

Conclusion

Stent-graft repair for anastomotic femoral PSA may be considered a reasonable alternative for patients at high-risk for open surgical repair.

Keywords

Profunda femoris artery anastomotic femoral aneurysm femoral pseudoaneurysm

Introduction

Endovascular intervention still has unproven value for native atherosclerotic occlusive disease of the common femoral artery and profunda femoris artery, and surgery is still considered the gold standard treatment.¹ Despite the lack of updated results, open repair represents the traditional management strategy also in case of anastomotic femoral pseudoaneurysms (PSA); nevertheless, reiterative surgery has been associated with increased morbidity and mortality.² While endovascular repair of femoral PSA may be at increased risk of complication due to chronic hip motion, the use of stent-grafts (SGs) may be a valuable alternative to treat patients with anastomotic femoral PSA at high operative risk.³ Herein, we report a case series of anastomotic femoral PSAs treated with SG in high-risk patients.

Materials and methods

Study cohort

This is a retrospective, observational cohort study from two tertiary referral teaching hospitals. Data of patients who underwent repair for femoral PSA were collected in a prospectively maintained database. Post-hoc analysis identified those treated with SG between 1 January 2002 and 1 April 2021 (Figure 1). Information collected includes demographics, comorbidities, medical and surgical history, operative details, and postoperative events during the hospital stay and outpatient follow-up. Data entry was managed by physicians involved in patient care. Medical records were reviewed by two senior surgeons (GP and MF). Owing to the retrospective nature of anonymized data, study approval was not necessary. Informed consent for data recording and intervention was then signed by each patient.

Figure 1.

Consort diagram of all repairs performed for pseudoaneurysm (2002–2020).

Indication for interventions

Given the potential complications of thrombosis, embolization, or rupture, repair has been generally performed for femoral PSA ≥ 2 cm.² All patients underwent computed tomography angiography; also, we obtained a full panel of blood tests, bloodstream, as well as urinary tract cultures. Generally, femoral PSA has been treated by open surgical means; patients at high operative risk have been offered endovascular repair by using self-expanding SG after a multidisciplinary evaluation. Specifically for this cohort, SG repair was employed outside the instructions for use of the manufacturer. Stent-graft oversizing was 10%–20% according to the diameter of the landing zones considering whether they were on a native vessel or inside a previous prosthetic graft. Balloon molding of all SG components was performed in all cases.

Procedural details

Each patient was treated under local anesthesia, antibiotic prophylaxis, and heparinization. All but one patient were approached through a contralateral percutaneous transfemoral access. A left brachial approach was used in case of prosthetic aorto-femoral bypass to overcome technical challenges posed by the steep angulation at the aortic anastomosis (Figure 2). Once the profunda femoris artery was catheterized selectively to identify the most suitable distal landing zone, SG was deployed across the bifurcation in all but one case (Figure 3). In one case, the femoral bifurcation was preserved using a kissing SG configuration because both the superficial femoral artery and the profunda femoris artery were patent⁴ (Figure 4). All SGs were then post-dilated. At the end of the procedure, echo-color-Doppler examination was performed to confirm the exclusion of the femoral PSA. Postoperative anti-thrombotic treatment consisted of dual antiplatelet therapy; preexisting oral anticoagulants were continued when already commenced preoperatively according to comorbidities. Follow-up included clinical visit and echo-color-Doppler ultrasound examination at 1 month and 12 months at least, annually thereafter.

Figure 2.

Computed tomography angiography (A) and 3D volume rendering reconstruction (B) of a right femoral psudoaneurysm developed in a 92-year-old female after femoral endarterectomy and patch angioplasty detected at follow-up because of a groin pulsatile mass. Selective angiography (C) of the right femoral axis shows the giant pseudoaneurysm (PSA) and an intact profunda femoris artery (PFA) outflow (D). Completion angiography (E) after stent-grafting extended from the native common femoral artery to the profunda femoris artery (white arrows). Real-time echo-color-Doppler ultrasound (F) performed at the end of the procedure immediately demonstrated the complete exclusion of the pseudoaneurysm (PSA) with no more flow filling the sac.

Figure 3.

Computed tomography angiography (A) of a giant femoral pseudoaneurysm in a 79-year-old man after aorto-left femoral bypass, occupying the retroperitoneal space as shown by the 3D volume-rendering reconstruction (B). Selective angiography (C) from the prosthetic graft (AoF graft) documented the huge pseudoaneurysm (PSA) and an intact profunda femoris artery (PFA) outflow (white arrow). Completion angiography (D) demonstrated the complete exclusion of the pseudoaneurysm and the excellent run-off to the profunda femoris artery.

Figure 4.

Volume-rendering reconstruction of computed tomography angiography (A) of a left anastomotic pseudoaneurysm (white arrow) in a 79-year-old man after a right-femoral-to-left-femoral prosthetic graft bypass. Completion angiography (B and C) from the bypass (white asterisk) demonstrated the covered endovascular reconstruction of femoral arterial bifurcation (CERFAB) with a kissing stent-graft (C, white arrows) and the disappearance of the anastomotic pseudoaneurysm.

Definition and primary outcomes

Medical comorbidity grading system operative outcomes were defined according to the Society for Vascular Surgery (SVS).⁵ Infected PSA was determined by an association of local and systemic signs in combination with positive bacterial cultures. The Follow-Up Index (FUI) describes follow-up completeness at a given study end date as the ratio between the investigated and the potential follow-up period.⁶ The operative risk profile was estimated using the American College of Surgeons (ACS) Surgical Risk Calculator.⁷ Through March 2021, information on vital status and date of death of individual patients were validated by death certificate, electronic charts managed by the regional healthcare system, or certified data from Emergency Department admission. For this study, primary outcomes of interest were early (≤ 30 days) survival and patency rate.

Statistical analysis

Clinical data were prospectively recorded and tabulated in a Microsoft Excel database (Microsoft Corp, Redmond, WA, USA): statistical analysis was performed by means of SPSS 26.0 for Windows (IBM SPSS Inc.; Chicago, IL, USA).⁸ Categorical variables were presented using frequencies and percentages, continuous variables were presented with mean ± standard deviation (SD) and ranges or median and interquartile range (IQR), based on data distribution. Continuous variables were analyzed with the χ² test and Fisher’s exact test when appropriate. Continuous variables were tested for normal distribution by the Shapiro–Wilk test and compared between groups with the unpaired Student’s T-test for normally distributed values; otherwise, the Mann–Whitney U test was used. The Wilcoxon signed-rank test was used to evaluate the difference in PSA measurements before and after intervention. A two-sided P value < .05 was considered significant.

Results

Study cohort

We identified 10 (1.2%) cases in 10 patients that met the inclusion criteria out of the entire PSA cohort. There were 9 men and 1 woman: the mean age was 76 years ± 9 (range: 64–92). Median delay from the initial prosthetic vascular graft reconstruction was 4 years (IQR: 3–4). According to clinical presentation, 9 PSAs were degenerative, while only 1 was infected in nature. Comorbidities and risk factors are reported in Table 1. Regarding the operative risk profile, the mean SVS score was 15 ± 8 (range: 4–27), while the median ACS score for mortality was 5 (IQR: 2–11). The mean PSA diameter was 5 cm ± 1 (range: 3–7). Iliac inflow was regularly patent in all cases, while the superficial femoral artery was occluded in 8 cases.

Table 1.

Demographics, comorbidities, and operative risk of the cohort (n = 10).

Covariate	n
Comorbidities
Hypertension	10
Cardiac disease	9
CABG	4
Left heart insufficiency	2
Atrial fibrillation	3
Valve disease	1
COPD	8
Chronic kidney disease	2
Diabetes	2
Cerebrovascular disease	2
Carotid stenting	1
AAA	1
Risk factors
SVS score^‡ (mean ± SD)	15 ± 8 (4–27)
ACS score^§ (median ± IQR)	6 (1–12)
Urgent	5
Infection	1

n = number; SD = standard deviation; IQR = interquartile range; CABG = coronary artery bypass graft; COPD = chronic obstructive pulmonary disease; AAA = abdominal aortic aneurysm; SVS = Society for Vascular Surgery; ACS = American College of Surgeons.

^‡J Vasc Surg 2002; 35:1061–1066.

^§ https://riskcalculator.facs.org/RiskCalculator/

Surgical details

Urgent intervention was performed in 5 patients (Table 2). In 2 cases, we used an additional balloon-expandable SG proximally to the SG deployed into the profunda femoris artery to adapt it to the prosthetic graft of previous aorto-femoral bypass. In another case, we used two SGs in a kissing configuration for the reconstruction of the bifurcation due to a PSA of a previous femoro-femoral bypass. In the remaining 7 patients, we used a single SG. An additional intraoperative procedure was performed in 2 cases: surgical drainage of the wound in the case of infected PSA (n = 1) and thrombin injection to seal-off a low-flow gutter-related leak in the patient with the kissing SG in the patient with a femoro-femoral bypass (n = 1).

Table 2.

Clinical and technical chart of the cohort.

Year (intervention)	Vascular			Size (diameter, cm)	Symptomatic	Stent-graft (type, mm)	n. Stent-graft	Stent-graft size (mm x mm)	Follow-up (months)	Patency	Shrinkage	Reintervention
Year (intervention)	Gender, Age	Reconstruction	SVS score	Size (diameter, cm)	Symptomatic	Stent-graft (type, mm)	n. Stent-graft	Stent-graft size (mm x mm)	Follow-up (months)	Patency	Shrinkage	Reintervention
2002	M, 71	FT bp	4	5	No	Hemobahn	1	6 × 100	144	Yes	Yes	No
2002	M, 64	Patch	6	5	Sepsis	Hemobahn	1	6 × 100	38	Yes	Yes	Explant + GSV bp
2008	M, 68	Patch	11	2.5	No	Viabahn	1	6 × 50	132	Yes	Yes	No
2013	M, 79 (Figure 2)	FF bp	27	5	No	Viabahn	1	9 × 100	4	Yes	Yes	No
2015	M, 84	Patch	13	4	Yes	Viabahn	1	5 × 50	24	Yes	Yes	No
2016	M, 64	FF bp	8	3	No	Viabahn	1	7 × 50	37	Yes	Yes	No
2018	M, 79	AxF bp	15	4	Yes	Viabahn	1	8 ×100 (rox)	24	Yes	Yes	No
2018	M, 79	AxF bp	15	4	Yes	Viabahn	1	6 × 100 (dix >)	24	Yes	Yes	No
2020	F, 92 (Figure 3)	Patch	20	5.2	No	Viabahn	1	6 × 100	12	Yes	No	No
2020	M, 79 (Figure 4)	AoF bp	27	6.8	No	Viabahn	2	8 × 100 (prox)	0	Yes	No	No
2020	M, 79 (Figure 4)	AoF bp	27	6.8	No	Viabahn	2	6 × 150 (dix)	0	Yes	No	No
2021	M, 81	AbF	11	7.2	Yes	Viabahn	2	7 × 100 (prox)	3	Yes	Yes	No
2021	M, 81	AbF	11	7.2	Yes	Viabahn	2	6 × 150 (dix)	3	Yes	Yes	No

M = male; F = female; n = number; SVS = Society for Vascular Surgery; FT bp = femoro-tibial bypass; FF bp = femoro-femoral bypass; AoF bp = aorto-femoral bypass; AbF = aorto-bifemoral bypass; GSV bp = great saphenous vein bypass; prox = proximal; dix = distal.

Early outcomes

Intraoperative mortality was never observed. The median operative time was 30 min (IQR: 25–36). No patient required perioperative blood transfusions. Access-related complication was never observed. Median hospitalization time was 4 days (IQR: 4–5). In-hospital mortality occurred in 1 patient: he was a 79-year-old man with an SVS score of 27 and an ACS-predicted mortality score of 17%, who succumbed on postoperative day 6 to novel coronavirus-19–related pneumonia. Limb salvage was obtained in all cases: no patient underwent lower-limb amputation. Five patients were discharged on dual antiplatelet therapy and only 1 on oral anticoagulants.

Late outcomes

No patient was lost at a median follow-up of 24 months (IQR: 12–37), and an FUI of 1. The only patient with an infected PSA underwent SG explant and great saphenous vein replacement on day 52. Four patients died during the follow-up because of cancer (n = 1, at 144 months), left heart insufficiency (n = 1, at 36 months), acute coronary syndrome (n = 1, at 24 months), and chronic respiratory insufficiency (n = 1, at 4 months). Except for the infected PSA that was explanted, no patient required reintervention. The remaining SGs were patent with no fracture/breakage at the last echo-color-Doppler examination available. The PSA maximum diameter was 3 cm ± 2 (range: 0–5) at the last radiological follow-up, which was significantly lower than the preoperative one (P = .043). Limb salvage was preserved in all cases.

Discussion

Notwithstanding the obvious shortcomings characterizing a case series, there is one predominant finding to be underlined from our analysis, that is, the high technical success and the promising durability of profunda femoris SG during the follow-up.

Despite the advancements of endovascular stents, the femoral bifurcation still remains the “last frontier” for their application as the first-line treatment.⁹ However, the decision for repair should always take into consideration the operative risk assessment: specifically, redo surgery in case of femoral PSA after prosthetic vascular graft reconstruction has been associated with increased morbidity and mortality especially in high-risk patients.^1,2 Comorbidities and risk factors posed our patients at very high-risk with a predicted mortality rate of 7% for conventional open repair: this was the main reason why we opted for an endovascular treatment, and we are still convinced it was a reasonable choice since the only mortality we observed was not procedure-related but mainly determined by novel coronavirus-19–related pneumonia.

A common concern associated with SG placement across the hip joint extended into the profunda femoris artery for anastomotic PSA is the chronic hip motion that may cause structural problems (e.g., fracture, breakage, and migration) potentially leading to occlusion.² Looking into the current available literature (Table 3), we identified only 10 patients overall treated with SG for femoral PSA.^3,10–13 Our 10 cases add to the current knowledge on the excellent technical success throughout the mid-term follow-up. Notably, no reintervention was reported to maintain or restore the patency in these cases, also in those treated for isolate PSA of the profunda femoris artery.^12,14–20 The good performance of PFA stent-grafting may be biased by the lack of long-term follow-up on a consistent base: nevertheless, Derom et al³ reported patency rate at 4 years and similarly, in two cases of our series, we have been able to assess the primary patency rate of the SG at 132 and 144 months. Moreover, the fact that limb salvage was obtained in all patients, it could be a real valuable outcome of interest in these challenging scenarios. This excellent result has been obtained using different SGs; considering that some of them are “old-generation” SGs, these encouraging results may be correlated to the absence of occlusive disease in the PFA as well as to the quality of the materials.

Table 3.

Literature summary reporting on stent-graft repair of femoral anastomotic pseudoaneurysm, and isolate profunda femoris artery pseudoaneurysm.

Author	Year	Gender, age	Etiology	Symptomatic	SG (type)	n. SG	SG size (mm)	BMT	Follow-up (months)	Patency	Reintervention
Prosthetic
Brountzos et al¹¹	2000	M, 65	Anastomotic	Yes	Hemobahn	1	13 × 50	DAPT	12	Yes	No
Brountzos et al¹¹	2000	M, 65	(AbF bypass)	Yes	Hemobahn	1	13 × 50	DAPT	12	Yes	No
Derom et al⁴	2005	69–79	Anastomotic	n.r.	n.r.	n.r.	9–16	SAPT	18.6	100%	No
Derom et al⁴	2005	5M:1F	Anastomotic	n.r.	n.r.	n.r.	9–16	SAPT	18.6	100%	No
Klonaris et al¹²	2007	M, 74	Anastomotic	Yes	Advanta	1	8 × 59	SAPT	10	Yes	No
Klonaris et al¹²	2007	M, 74	(FP bypass)	(Infection)	Advanta	1	8 × 59	SAPT	10	Yes	No
Kouvelos et al¹³	2011	M, 75	Anastomotic	Yes	Viabahn	1	7 × 50	n.r.	6	Yes	No
Kouvelos et al¹³	2011	M, 75	(Femoral patch)	Yes	Viabahn	1	7 × 50	n.r.	6	Yes	No
Roundback et al¹⁴	2013	M, 74	Anastomotic	Yes	Viabahn	2	6 × 100	n.r.	4	Yes	No
Roundback et al¹⁴	2013	M, 74	(AbF bypass)	Yes	(+ iCast)	2	6 × 100	n.r.	4	Yes	No
Traumatic
Varastehravan et al¹⁵	2008	M, 18	Road-traffic accident	Yes	Jomed	1	3 × 16	DAPT	1	Yes	No
Dorrucci et al¹⁶	2008	M, 40	Iatrogenic	Yes	Jostent	1	3 × 16	SAPT	3	Yes	No
Dorrucci et al¹⁶	2008	M, 40	(Orthopedic surgery)	Yes	Jostent	1	3 × 16	SAPT	3	Yes	No
Saha et al¹⁷	2010	M, 87	Spontaneous	Yes	Viabahn	1	6 × 100	n.r.	n.r.	n.r.	No
Saha et al¹⁷	2010	M, 87	(Anticoagulation)	Yes	Viabahn	1	6 × 100	n.r.	n.r.	n.r.	No
Kouvelos et al¹³	2011	M, 70	Iatrogenic	No	Viabahn	1	5 × 25	n.r.	18	Yes	No
		M, 70	(Vascular maneuvers)	No	Viabahn	1	5 × 25	n.r.	18	Yes	No
		M, 42	Gunshot	Yes	Viabahn	1	5 × 25	n.r.	12	Yes	No
Ocke Reis et al¹⁸	2016	M, 66	Iatrogenic	Yes	Advanta	2	5 × 22	n.r.	n.r.	Yes	No
Ocke Reis et al¹⁸	2016	M, 66	(Orthopedic surgery)	Yes	Advanta	2	6 × 22	n.r.	n.r.	Yes	No
Pecoraro et al¹⁹	2017	M, 36	Gunshot	Yes	Viabahn	1	8 × 100	DAPT	24	Yes	No
Bakr et al²⁰	2019	M, 54	Spontaneous	No	Viabahn	1	8 × 50	n.r.	24	No	No
Bakr et al²⁰	2019	M, 54	(Mycotic)	No	Viabahn	1	8 × 50	n.r.	24	No	No
Al Wahbi et al²⁰	2019	F, 66	Iatrogenic	Yes	Fluency	1	8 × 40	n.r.	n.r.	n.r.	No
		F, 66	(Femoral vein catheterization)	Yes	Fluency	1	8 × 40	n.r.	n.r.	n.r.	No
		F, 60	Iatrogenic	Yes	Fluency	1	8 × 40	n.r.	n.r.	n.r.	No
		F, 60	(Femoral vein catheterization)	Yes	Fluency	1	8 × 40	n.r.	n.r.	n.r.	No

M = male; F = female; n = number; n.r. = not reported; BMT = best medical anti-thrombotic treatment; SG = stent-graft; CFA = common femoral artery; PFA = profunda femoris artery; AbF = aorto-bifemoral bypass; FP = femoro-popliteal bypass; SAPT = single antiplatelet therapy; DAPT = dual antiplatelet therapy.

In our experience, the procedure was straightforward and did not pose significant technical challenges, as documented by the limited time with which the procedure was completed. However, aside from the indication criteria, there are few other pending questions that the available literature data are not able to clarify. In our opinion, the most challenging aspect could be the mismatch between the proximal and distal landing zones to treat a very short diseased area: although there are not yet dedicated tapered SG to be applied from the common femoral to the profunda femoris artery, this aspect is not so extreme in this area. Not only did we use a single SG in all but one case, but in the only one we needed to adapt the calibers of the landing zones, it was easy to customize the implantation by using two different SGs with a telescope technique.^13–17 Another important aspect is the role of the postoperative anti-thrombotic therapy: although the use of single antiplatelet therapy has been described in half of the cases reported in the literature of the profunda femoris artery SG, in our opinion, dual antiplatelet therapy would have been more protective.^3,11,15 Whether this variable has played a key role in maintaining the patency of the SG or not, we are far from being able to elucidate which is the best medical therapy in such rare scenarios.^10,14,18

Limitations

The present series has several limitations. First, data collection is retrospective. Second, there is sampling bias as patients undergoing repair with other techniques were not included for comparison, but this reflects the careful selection process in our cases. Third, the sample size is small and may not allow for generalizability; thus, currently, it cannot be considered as an alternative to surgical treatment except for very select patients deemed unfit for the conventional open approach.

Conclusion

Notwithstanding the obvious limits of a case series, SG repair for anastomotic femoral PSA seems to be easy-to-use, safe, and durable and may be considered a reasonable alternative for patients at high-risk for open surgical repair.

Footnotes

Author contributions

Study design: GP and FF. Data collection: GP, MF, GM, FP, and RB. Data analysis: GP and FF. Writing: GP and FF. Critical revision and final approval: MF, FF, FP, GM, GP, and RB. Overall responsibility: GP.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Gabriele Piffaretti .

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