Retroperitoneal Versus Direct Femoral Artery Approach for Thoracic Endovascular Aortic Repair Access: A Case–Control Study

Retroperitoneal Versus Direct Femoral Artery Approach for Thoracic Endovascular Aortic Repair Access: A CaseeControl Study Vahid Etezadi, Barry T. Katzen, James F. Benenati, Sara Alehashemi, Athanassios I. Tsoukas, and Orlando A. Puente, Miami, Florida

Background: Many individuals who are candidates for thoracic endovascular aortic repair (TEVAR) are found to have iliac artery anatomy and/or disease that preclude transfemoral endovascular access and require retroperitoneal surgical approach through more proximal arteries. This relatively more invasive technique could potentially affect the procedural outcomes. This study compares the retroperitoneal with transfemoral access used for TEVAR in a single center. Method: In this study, 133 consecutive patients (96 men; mean age ± SD: 69.5 ± 14.7 years) who underwent TEVAR between 1994 and 2009 in a single center were retrospectively evaluated. The type of endovascular access was identified in all the patients. The basic demographics, access method, endograft type, 30-day morbidity and mortality rates, as well as procedure recordings including fluoroscopic and procedure duration, estimated blood loss, and duration of hospitalization were compared between the TEVAR procedures performed using a surgical retroperitoneal approach and those using the standard femoral access. Results: Retroperitoneal access was used in 19 (14.3%; 13 women; mean age ± SD: 71 ± 12.2 years) and direct femoral access in 114 (85.7%; 24 women; mean age ± SD: 69 ± 15.4 years) patients. Two of the retroperitoneal accesses were obtained after failure of femoral approach. Techniques that were used included iliac artery conduit (seven patients), aortic artery conduit (eight patients), aortobifemoral artery graft conduit (one patient), and direct sheath introduction through the distal aorta (two patients) or common iliac artery (one patient). Retroperitoneal approach was used more frequently in women (35%) as compared with men (6%) ( p ¼ 0.0001). In all, 79% of the retroperitoneal approaches were associated with use of delivery sheath sizes larger than 24F ( p ¼ 0.049). TEVAR technical success was 100% with retroperitoneal and 97.3% with femoral access ( p > 0.05). Thirty-day mortality rates were 0% and 8.8% and the rates of access artery injury were 5.3% and 4.4% in retroperitoneal and femoral access groups, respectively ( p > 0.05). The incidence of retroperitoneal hematoma was significantly higher with retroperitoneal access (21% vs. 2.6%, p ¼ 0.008). Additionally, retroperitoneal access was associated with significant increase in estimated blood loss and duration of hospitalization ( p < 0.05). Conclusions: Type of access does not affect TEVAR success and the early mortality rate. Retroperitoneal approach is a valuable alternative technique in cases involving failed or impossible femoral access. However, this approach is associated with higher chances of retroperitoneal bleeding and longer procedural time and duration of hospitalization. Thoracic endografts with smaller delivery systems could minimize the need for this approach in the future.

Department of Interventional Radiology, Baptist Cardiac and Vascular Institute, Miami, FL. Correspondence to: Barry T. Katzen, MD, Department of Interventional Radiology, Baptist Cardiac and Vascular Institute, 8900 North Kendall Drive, Miami, FL 33176-2197, USA, E-mail: barryk@ baptisthealth.net

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Ann Vasc Surg 2011; 25: 340-344 DOI: 10.1016/j.avsg.2010.09.015 Ó Annals of Vascular Surgery Inc. Published online: January 28, 2011

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INTRODUCTION

included 133 consecutive patients, 96 men and 37 women (mean age ± SD: 69.5 ± 14.7 years; range: 15-95), who underwent 21 emergency and 112 elective TEVAR. Thoracic artery pathologies included 98 aneurysms (73.7%) and 25 pseudoaneurysms (18.8%), six dissections (4.5%), and four traumatic transections (3%). Surgical retroperitoneal approach was used in 19 patients (13 women; mean age ± SD: 71 ± 12.2 years; range: 36-83). Basic demographics, access method, endograft type, as well as 30-day morbidity and mortality rates were recorded and compared with data obtained from patients who underwent TEVAR using the standard femoral access. Additionally, procedure data including fluoroscopic and procedure duration, estimated blood loss, and duration of postprocedural hospitalization were recorded. Preprocedural evaluation included a minimum of one tomographic imaging modality, such as computed tomographic angiography and magnetic resonance angiography with three-dimensional reconstructions, to determine the exact location and diameters of the diseased aortic segment, proximal and distal anatomic extensions, and suitability of peripheral arterial access. The type of endovascular access was decided at the discretion of the interventionist on the basis of the preprocedural clinical and imaging assessments.

Since its introduction almost two decades ago, thoracic endovascular aortic repair (TEVAR) has rapidly evolved into the predominant treatment option for majority of patients with descending thoracic aortic disease. Several studies have reported successful outcomes and low morbidity and mortality rates with this technique.1 However, there are still unresolved issues related to this treatment. One of them is the challenge related to endovascular access. Achieving safe and successful endovascular access for delivery and deployment of the stentgraft device is a crucial step during TEVAR. Direct access to the femoral artery is the conventional way to deliver the endograft device. This access could be achieved either percutaneously or through a surgical cutdown. However, this approach is only feasible in 70% of cases.2,3 A significant number of patients are found to have iliac artery anatomy and/or disease that may preclude transfemoral access. Inadequate arterial access anatomy in this group of patients often results in access through more proximal and larger vessels, such as iliac and aortic arteries, as the alternative routes. Using these vessels often involves a retroperitoneal approach with or without conduit graft attachment. Most importantly, these techniques involve surgical retroperitoneal exposure of the artery, which could increase periprocedural complications affecting TEVAR outcomes. This has been previously demonstrated in endovascular abdominal aortic aneurysm repairs.4 Until recently, several alternative approaches for achieving adequate TEVAR access have been described.2-6 Although none of them have demonstrated superiority, retroperitoneal approach to the iliac arteries seems to be the most popular approach.5 In this study, we compare the TEVAR procedure using the retroperitoneal approach with those using direct femoral access at our center.

MATERIALS AND METHODS Institutional review board approval for this study was obtained and the need for patient consent for inclusion in the study waived. A retrospective review using a prospectively maintained electronic medical records system was performed, according to Health Insurance Portability and Accountability Act guidelines. All patients who underwent endovascular procedures for the treatment of descending thoracic aortic disease at our tertiary care medical center over 15 years, between March 1994 and September 2009, were identified. The series

Technique Obtaining access to iliac or aortic arteries through a synthetic graft conduit has been previously explained in several articles.2-6 Common iliac artery (CIA) or distal abdominal aorta is exposed through an oblique incision made in the lower quadrant of the abdomen. For CIA access conduit, the least diseased, larger, and longer iliac artery is chosen. End-to-side anastomosis between a 10-mm diameter Dacron graft and the CIA or distal aorta is performed and the conduit is exited through the abdominal wall by making a small stab just above the inguinal ligament. The conduit is then directly punctured to advance the guidewire as well as the endograft deployment system. The conduit is excised at the end of the procedure, leaving behind a short stub that is oversewn with a running polypropylene suture. For direct sheath insertion, two purse-string polypropylene sutures are placed in opposing concentric circles at the intended site of puncture. Arterial puncture is then performed at the center of the sutures, which is then followed by guidewire and delivery sheath introduction. After withdrawal of the sheath, the purse-string sutures are tied.2 Femoral access was obtained either

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percutaneously using the Seldinger technique or through a surgical cutdown of the common femoral artery. Patients were observed within 2 weeks after discharge for evaluation of the access site and general health status. Follow-up was generally carried out at 1, 6, 12 months, and then later annually. The follow-up intervals were adjusted on the basis of developing complications as well as the patient’s availability and compliance. The followup assessment generally consisted of a computed tomographic scan, plain radiography, and physical examination. Statistical Analysis Discrete data are given as counts and percentages. The continuous and categorical variables were compared with paired t-test and Fischer’s exact test, respectively. A p value of <0.05 was considered statistically significant. All calculations were performed with StatsDirect statistical software Version 2.7.7 (StatsDirect, Cheshire, UK).

RESULTS Between 1994 and 2009, 133 patients (96 men) with a mean age of 69 ± 15.1 years underwent TEVAR procedures at the Baptist Cardiac and Vascular Institute. Retroperitoneal access was used in 19 (14.3%) patients (13 women; mean age ± SD: 71 ± 12.2 years; range: 36-83). Techniques that were used included iliac artery conduit (seven patients), aortic artery conduit (eight patients), aortobifemoral artery graft conduit (one patient), and direct sheath introduction through the distal aorta (two patients) or CIA (one patient). Endografts delivered using the retroperitoneal approach included Talent device (Medtronic Vascular, Sunrise, FL; 15 patients), Z stent (Cook, Bloomington, IN; two patients), and Gore/TAG (W.L. Gore & Assoc. Inc, Flagstaff, AZ; two patients). Retroperitoneal approaches were planned before the TEVAR in 17 of 19 patients. Both unplanned cases were performed in 2003. The first patient was a 39-year-old woman with a degenerative thoracic aortic aneurysm. Previous attempt for surgical treatment of her aneurysm in another center was unsuccessful and it had become complicated with intracranial hemorrhage and subsequent left-sided paralysis. The patient underwent epidural anesthesia for TEVAR and surgical cutdown was used to obtain access to the femoral arteries. A 24-F sheath was used to deliver a Talent endograft. However, the iliac artery ruptured as the delivery

Annals of Vascular Surgery

system was being inserted. At this point, the iliac artery was surgically exposed and an iliac conduit was created to successfully complete the procedure. The second case occurred in an 80-year-old woman. Her iliac arteries could not accommodate the passage of a 24-F sheath/Talent system. Therefore, an iliac conduit was required. The basic demographics of the patients who underwent TEVAR with retroperitoneal approach were generally similar to the direct femoral access group. However, the retroperitoneal approach was used more frequently in women (35%) as compared with men (6%) ( p ¼ 0.0001) (Table I). Additionally, 79% of retroperitoneal approaches were used for delivery sheath sizes larger than 24F ( p ¼ 0.049) (Table I). Deployment of endograft through the retroperitoneal approach was successful in all cases. This includes the two unplanned cases that were converted from the standard femoral approach as well. Endograft deployment was successful in 97.7% of all the TEVAR procedures in our patient group, with no significant difference between the two access types (Table II). In addition, there was no difference in 30-day mortality rates and the rate of access artery injury, including rupture or dissection, between direct femoral artery access and retroperitoneal approach (Table II). Retroperitoneal hematoma was detected during the first month after retroperitoneal access in four patients (21%). One hematoma was associated with CIA dissection in a patient who had an episode of seizure immediately after TEVAR. The hematoma was drained and the vascular closure had to be repeated in this case. Another hematoma was aspirated percutaneously. No further interventions were necessary in the other cases. Two of four hematomas occurred after direct retroperitoneal arterial access without conduit. Retroperitoneal access was associated with relatively increased mean estimated blood loss (1,177 ± 1,111 mL vs. 440 ± 648 mL; 95% CI: 379-1,094; p ¼ 0.0001) and duration of hospitalization (12.9 ± 9 days vs. 6.7 ± 7.6 days; 95% CI: 2-10; p ¼ 0.001) (Table II).

DISCUSSION TEVAR has become an important treatment option for several aortic pathologies and will most likely be the predominant form of therapy for many patients in the near future. However, limited data related to its long-term effectiveness and challenging technical issues are available.

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Table I. Patient and procedure characteristics of the TEVAR performed with retroperitoneal versus direct femoral artery access Parameters

Mean age ± SD Female ASA Score 2 3 4 Emergency TEVAR Sheath size <24F 24F General anesthesia Obesity (BMI, >30) Diabetes mellitus Chronic obstructive pulmonary disease Coronary artery disease Renal insufficiency Peripheral vascular disease

Retroperitoneal approach (n ¼ 19)

Femoral artery approach (n ¼ 114)

p-value

71 ± 12.2 13 (68%)

69 ± 15.4 24 (21%)

NS 0.0001

1 9 9 3 (16%)

3 57 54 18 (16%)

NS NS NS NS

52 62 96 31 18 42 57 27 26

0.049 0.049 NS NS NS 0.04 NS NS NS

4 15 17 3 3 12 8 3 5

(21%) (79%) (16%) (16%) (63%) (42%) (16%) (26%)

(46%) (54%) (27%) (16%) (37%) (50%) (24%) (23%)

TEVAR, thoracic endovascular aortic repair; NS, not significant; ASA, American Society of Anesthesiologists; BMI, body mass index.

One of the most important issues with TEVAR is achieving a safe and successful endovascular access for introduction and delivery of the stentgraft device. Despite the advancements in the endograft designs, TEVAR still involves the use of large profile delivery system; for instance, for a 40-mm diameter device, the TAG (W.L. Gore & Assoc. Inc, Flagstaff, AZ) delivery system is 27.6F. For the Zenith TX2 (Cook, Bloomington, IN), the delivery system is a 25.5F and the Talent uses a 24-F device. Therefore, arterial access injury has been, and continues to be, a common incidence, with external iliac artery rupture ranking high as a cause of procedure-related mortality.2 Our study shows that the use of delivery systems larger than 24F was associated with significant increase in incidence of retroperitoneal access. Inadequate femoral arterial access anatomy has been documented in 10-30% of patients undergoing TEVAR.2 In an international survey of physicians performing TEVAR, conduits were needed because of access-related issues in 15% of patients.7 Conduit was also used in 9.4% and 21.1% of patients in the ZenithTX28 and VALOR trials,9 respectively. In our study, the femoral access deemed inadequate for TEVAR in 14.3% of the patients in whom surgical retroperitoneal approach was performed instead. More than 30% of TEVAR patient populations are women.10 These patients generally have notoriously small iliac and femoral arteries, which makes

the TEVAR access more challenging.2 This has been reflected in our study as well, which shows that retroperitoneal approach was used in 35% of the women versus in only 6% of the men. There was no significant difference in technical outcomes and 30-day mortality rates between the two approaches. However, the two cases of unplanned retroperitoneal approach, which were converted after failure of the direct femoral access, highlight the importance of being prepared for performing this alternative technique. Thirty-day morbidity rates were also similar between the two groups, except for the incidence of retroperitoneal hematoma (Table II). Although retroperitoneal approach did not increase the mortality risk, it is not surprising to observe more blood loss, longer procedural time, and duration of hospitalization to be associated with this approach. Whether this could have an effect on the overall costs of the TEVAR could be studied separately. However, considering this approach as an alternative method to achieve endovascular access in patients who would otherwise be suitable for TEVAR would justify these setbacks. This review has all the limitations of a nonrandomized and retrospective study. Despite these limitations, our study supports the effectiveness and low morbidity rate of the retroperitoneal approach and shows that the type of access does not affect TEVAR success and the 30-day mortality rate.

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Table II. TEVAR outcomes based on the type of endovascular access Parameters

Retroperitoneal approach (n ¼ 19)

Femoral artery approach (n ¼ 114)

p-value

Successful endograft deployment 30-day mortality Access artery injury: rupture/dissection Stroke Lower limb ischemia Myocardial infarction Retroperitoneal hematoma Procedural time (minutes) Estimated blood loss (mL) Fluoroscopy time (minutes) In-hospital stay (days)

19 (100%) 0 1 (5.3%) 1 (5.3%) 1 (5.3%) 1 (5.3%) 4 (21%) 188 ± 65a 1,177 ± 1,111a 24 ± 12a 12.9 ± 9a

111 10 5 10 2 2 3 143 440 23 6.7

NS NS NS NS NS NS 0.008 0.01 0.0001 NS 0.001

(97.3%) (8.8%) (4.4%) (8.8%) (1.7%) (1.7%) (2.6%) ± 72a ± 648a ± 18a ± 7.6a

TEVAR, thoracic endovascular aortic repair; NS, not significant. a Mean ± SD.

CONCLUSION Retroperitoneal access is a valuable alternative technique in cases involving failed or impossible femoral access. However, this approach is associated with higher chances of retroperitoneal bleeding and longer procedural time and duration of hospitalization. Thoracic endografts with smaller delivery systems could minimize the necessity of this approach in the future. Further advances in TEVAR access is also anticipated as the stent-graft technology evolves.

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3. Henretta JP, Karch LA, Hodgson KJ, et al. Special iliac artery considerations during aneurysm endografting. Am J Surg 1999;178:212-218. 4. Lee WA, Berceli SA, Huber TS, et al. Morbidity with retroperitoneal procedures during endovascular abdominal aortic aneurysm repair. J Vasc Surg 2003;38:459-463. 5. Murray D, Ghosh J, Khwaja N, et al. Access for endovascular aneurysm repair. J Endovasc Ther 2006;13:754-761. 6. Peterson BG, Matsumura JS. Tips and tricks for avoiding access problems when using large sheath endografts. J Vasc Surg 2009;49:524-527. 7. Matsumura JS. Worldwide survey of thoracic endografts: practical clinical application. J Vasc Surg 2006;43(Suppl. A): 20A-21A. 8. Matsumura JS, Cambria RP, Dake MD, et al. TX2 Clinical Trial Investigators. International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results. J Vasc Surg 2008;47:247-257. 9. Fairman RM, Criado F, Farber M, et al. VALOR Investigators. Pivotal results of the Medtronic vascular talent thoracic stent graft system: the VALOR trial. J Vasc Surg 2008;48: 546-554. 10. Velazquez OC, Larson RA, Baum RA, et al. Gender-related differences in infrarenal aortic aneurysm morphologic features: issues relevant to Ancure and Talent endografts. J Vasc Surg 2001;33(Suppl. 2):S77-S84.