Outcomes of total percutaneous endovascular aortic repair for thoracic, fenestrated, and branched endografts

From the Society for Clinical Vascular Surgery

Outcomes of total percutaneous endovascular aortic repair for thoracic, fenestrated, and branched endografts Leonardo R. de Souza, MD,a,b Gustavo S. Oderich, MD,a Peter V. Banga, MD,a,c Janet M. Hofer, RN,a Jean R. Wigham, RN,a Stephen Cha, MS,a and Peter Gloviczki, MD,a Rochester, Minn; Porto Alegre, Rio Grande do Sul, Brazil; and Budapest, Hungary Objective: Percutaneous endovascular aortic repair (PEVAR) has been increasingly used to treat infrarenal abdominal aortic aneurysms, but few studies have evaluated the results in complex aortic aneurysms. We reviewed the technical success and clinical outcomes of PEVAR using large-diameter sheaths for the treatment of complex aortic aneurysms with thoracic, fenestrated, and branched stent grafts. Methods: The clinical data of patients who underwent total PEVAR for descending thoracic aneurysm, thoracoabdominal aortic aneurysm, pararenal, and aortoiliac aneurysms using thoracic, fenestrated, and branched stent grafts between 2009 and 2014 were reviewed. Repairs with fenestrated-branched stent grafts were performed using commercially available or investigational devices under a physician-sponsored investigational device protocols. Percutaneous closure was performed using ultrasound guidance and two Perclose devices (Abbott Vascular, Santa Clara Calif) per femoral puncture site. End points were technical success, access-related complications, morbidity, and mortality. Results: There were 102 patients, 77 male and 25 female, with a mean age of 75 6 8 years. Aneurysm extent was pararenal in 48 patients (47%), thoracoabdominal aortic aneurysm in 27 (26%), descending thoracic aneurysm in 19 (19%), and aortoiliac in 8 (8%). Fenestrated or branched endografts, or both, were placed in 72 patients (71%). Total percutaneous closure was performed in 170 femoral arteries using $20F-diameter sheaths in 163 (96%). Technical success was obtained in 161 femoral arteries (95%). There were no factors associated with technical failure. Access-related complications occurred in five patients (5%), including femoral artery thrombosis in three (3%), and retroperitoneal hematoma or pseudoaneurysm in one patient each (1%). There were no 30-day deaths. Freedom from access-related complications was 97% 6 1% at 30 days and 1 year. No access-related complications occurred >30 days. Conclusions: Total percutaneous technique can be safely performed with a high technical success rate and low rate of access complications in patients with thoracic and complex aortic disease requiring large-diameter sheaths. The rate of accessrelated complications (5%) is similar to that reported for PEVAR of infrarenal abdominal aortic aneurysms using smaller-profile devices. (J Vasc Surg 2015;-:1-8.)

Endovascular aortic aneurysm repair (EVAR) has become the most common treatment approach in patients with thoracic and abdominal aortic aneurysms (AAAs). Development of fenestrated and branched stent grafts has expanded the indications of EVAR to patients with complex From the Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochestera; the Masters in Surgery Program, Universidade Federal do Rio Grande do Sul, Porto Alegreb; and the Department of Vascular Surgery, Semmelweis University, Budapest.c Clinical trial registration: NCT1937949 and NCT02089607 at ClinicalTrials.gov. Author conflict of interest: G.O. is a consultant for W. L. Gore and Cook Medical (all fees paid to Mayo Clinic). Presented at the Forty-third Annual Symposium of the Society for Clinical Vascular Surgery, Miami, Fla, March 30-April 2, 2015. Additional material for this article may be found online at www.jvascsurg.org. Correspondence: Gustavo S. Oderich, MD, Gonda Vascular Center, Mayo Clinic, 200 First St SW, Rochester, MN 55905 (e-mail: oderich.gustavo@ mayo.edu). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2015 by the Society for Vascular Surgery. Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jvs.2015.07.072

aneurysms involving the visceral arteries or the iliac artery bifurcation. Percutaneous vascular closure devices (PVCDs) have been increasingly used for a variety of endovascular procedures, including EVAR and transcatheter aortic valve replacement using large-diameter sheaths. The potential advantages of a percutaneous EVAR (PEVAR) include a lower risk of wound-related complications (eg, seroma, infection, nerve injury) and a reduction in operative time, blood loss, and hospital stay.1-4 Disadvantages are the added cost of PVCDs and the potential risk of inadequate arterial closure or inadvertent injury resulting in excessive hemorrhage, hematoma, pseudoaneurysm, or arterial occlusion. Perioperative hypotension from uncontrolled hemorrhage is also a feared complication in patients with complex aortic disease because of the risk of spinal cord injury. Technical success of PEVAR has been associated with smaller sheath diameter, operator experience, and lower body mass index (BMI). Other factors, such as absence of prior inguinal incision or calcification and normal location of the femoral artery bifurcation, are predictors of a technically successful closure.5-12 Although several retrospective studies and two prospective randomized trials have shown that PEVAR is safe and effective for treatment of infrarenal AAAs, clinical data are lacking on patients treated 1

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2 de Souza et al

with larger-diameter sheaths for placement of thoracic, fenestrated, and branched stent grafts.2,4,5,12-14 This study was reviewed the technical success and clinical outcomes of PEVAR using thoracic, fenestrated, and branched stent grafts. METHODS The study was a retrospective review approved by the Mayo Clinic College of Medicine Institutional Review Board. All patients consented for participation in a minimal-risk clinical research study. We included in the study all consecutive patients treated by PEVAR for descending thoracic aneurysms (DTAs), thoracoabdominal aortic aneurysms (TAAAs), pararenal aneurysms (PRAs), or aortoiliac aneurysms using thoracic, fenestrated, or branched stent grafts between November 2009 and August 2014. Patients treated by fenestrated and branched stent grafts were enrolled in prospective physician-sponsored investigational device exemption protocols. Patient demographics, clinical characteristics, radiologic, and procedural data were reviewed. Clinical risk assessment was determined using standardized scoring systems, including the Society for Vascular Surgery (SVS) cardiac, pulmonary, renal, and age scores, the Eagle criteria, and the American Society of Anesthesiologists Physical Status Classification.15,16 BMI was used to determine overweight (25-30 kg/m2) and obesity (>30 kg/m2). Technical success was defined by successful arterial closure with no evidence of persistent hemorrhage or arterial ischemia requiring immediate conversion to open femoral artery repair. Early and late outcomes were noted. Early outcome was defined as occurring in the hospital stay without regard to the number of days after the procedure or within the first 30 days after stent placement. Late outcome was obtained from the medical records, office visits, correspondence with referring physicians, and patient questionnaire or telephone interview. Access-related complications requiring secondary endovascular procedures, open surgical repairs, or medical interventions were recorded. Patient selection and percutaneous closure technique. Percutaneous access was selected whenever possible at the discretion of the treating physician in all patients with suitable femoral artery anatomy (Supplementary Fig 1, online only), defined by normal location of the femoral artery bifurcation at least 2 cm below the inguinal ligament with no evidence of calcification in the anterior arterial wall or presence of minimal calcification affecting <50% of the posterior wall. The technique has been previously described elsewhere.1 Percutaneous access was established under ultrasound guidance with a 0.018-inch micropuncture needle entrance in the anterior common femoral artery wall 1 to 2 cm proximal to the bifurcation (Supplementary Fig 2, online only). Punctures distal to the femoral bifurcation or in calcified areas were avoided. After access was established, the 0.018inch stiff guidewire was exchanged for a 0.035-inch guidewire and a 6F sheath. A small oblique incision was made, and the subcutaneous tissue was dilated circumferentially

to facilitate placement of the PVCDs (Supplementary Fig 3, online only). For each femoral puncture two Perclose ProGlide closure devices (Abbott Vascular, Santa Clara, Calif) were deployed at the 1:30 and 10:30 o’clock position before the larger-diameter sheath was introduced (Supplementary Fig 4, online only). At the completion of the procedure, a 0.035-inch stiff nonbraided stiff Glidewire (Terumo Medical Corp, Somerset, NJ) was used to maintain access until adequate closure was confirmed. In patients with inadequate hemostasis, an additional PVCD was used. In patients where closure was not deemed successful using the percutaneous technique, the large sheath was reintroduced or proximal control was obtained over the guidewire with balloon occlusion, and a small groin incision was performed to expose and repair the common femoral artery. Our technique of fenestrated repair has been reported elsewhere.17 Statistical analysis. Data were analyzed using definitions proposed by the SVS reporting standards for endovascular aortic and thoracic repair.15,16 End points were technical success, early and late morbidity and mortality, and freedom from access-related complications and major adverse events (MAEs). MAEs were defined according to SVS criteria used in pivotal trials and included any-cause mortality, myocardial infarction, paraplegia, new-onset dialysis, or creatinine increase >50% of the baseline value, pneumonia requiring antibiotics, respiratory failure, stroke, and estimated surgical blood loss >1000 mL. Timedependent outcomes were analyzed using Kaplan-Meier methods, and differences were determined by the logrank test. Univariate and multivariate analysis were used to identify clinical, anatomic, and procedural factors associated with technical failure after PEVAR. Results are reported as percentages or odds ratios (ORs) with the 95% confidence interval (CIs). The Pearson c2 or Fisher exact test was used for analysis of categoric variables. Differences between means were tested with the two-sided t-test, the Wilcoxon rank sum test, or the Mann-Whitney test. Continuous variables that failed to demonstrate normal distribution using the Shapiro-Wilk test are described as median and interquartile ranges (IQRs) and as mean 6 standard deviation. A value of P < .05 was used to determine statistical significance. The statistical analyses were performed using SAS/STAT 9.1.3 software (SAS Institute Inc, Cary, NC). RESULTS Patients. During the study period, 213 patients were treated by endovascular repair for DTA, TAAA, and AIAs. From this group, 102 patients (48%), 77 male and 25 female, with mean age of 75 6 8 years, underwent PEVAR using a thoracic, fenestrated, or branched, or both, stent graft. The most prevalent cardiovascular risk factors were hypertension in 89 patients (87%), cigarette smoking in 84 (82%), and hyperlipidemia in 78% (76%). Eighty-two patients (80%) were considered overweight or

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obese, 44 (43%) had chronic kidney disease stages III to V, and 21 (21%) had peripheral arterial disease (Table I). A total of 170 common femoral arterial punctures were preclosed using PVCDs before placement of the device sheath. These included 68 patients who had bilateral and 34 with unilateral large-sheath access. The sheath diameter was 20F in 117 femoral arteries (69%), 22F in 40 (24%), 24F in 6 (4%), 18F in 6 (4%), and 16F in 1 (1%). Smaller sheaths (5F or 6F) were used in 23 patients (23%) in the contralateral side for diagnostic angiography. Eight patients (8%) had unilateral access using only the large sheath, and three (3%) had an open surgical exposure in the contralateral femoral artery because of anatomic contraindications (Table II). Endovascular repair. Endovascular procedures were performed in a hybrid endovascular room with a fixed imaging unit. General endotracheal anesthesia was used in 100 patients (98%) and regional or local anesthesia in two (2%). Eighty-eight patients (86%) underwent elective procedures for degenerative aneurysms, and 14 (14%) underwent emergency operations to treat acute dissection or rupture. Patients with DTAs were treated using commercially available thoracic stent grafts. Fenestrated and branched stent grafts were used in 72 patients, including 45 with PRAs, 19 with TAAAs, and 8 with AIAs. A total of 214 visceral arteries (mean of 3 6 1 vessels per patient) and nine internal iliac arteries were incorporated by fenestrations or directional branches. Eight repairs (seven for TAAAs and one for PRA) were performed without visceral artery incorporation as part of staged procedures. Two procedures were reinterventions of previous fenestrated repairs. One patient underwent an urgent repair of a contained-ruptured PRA after a failed infrarenal EVAR using a large-diameter device with no fenestrations. Average total operating time was 177 6 94 minutes, with a median estimated blood loss of 225 mL (IQR, 100492 mL). Thirty-six patients (35%) required transfusion of red blood cells. Percutaneous closure and conversions to open femoral artery repair. Technical success of percutaneous closure was obtained in 161 of 170 common femoral arteries (95%) and in 94 of 102 patients (92%). There were no factors that predicted technical failure (P > .05), including age, gender, BMI, obesity status, common femoral artery diameter, presence of femoral artery calcification, prior femoral artery exposure, or sheath diameter. Attempted percutaneous closure failed in nine common femoral arterial punctures (5%), all with $20F sheaths. Although the exact cause of technical failure was not recorded prospectively, a number of factors contributed to inadequate hemostasis, including high punctures into the inguinal ligament, tears in the arterial wall from calcified plaque, or inability to place the percutaneous suture because of scar or dermis within the percutaneous track (Supplementary Fig 5, online only). Technical failures were recognized by the senior operator at completion of the procedure and led to immediate conversion to open repair. The femoral artery puncture

de Souza et al 3

Table I. Clinical characteristics in 102 patients treated by thoracic, fenestrated, and branched stent grafts using percutaneous closure Variable Age, years Gender Male Female Cardiovascular risk factors Hypertension Smoking Hyperlipidemia Coronary artery disease Chronic kidney disease Peripheral arterial disease Diabetes BMI, kg/m2 Overweight (25-30 kg/m2) Obesity (>30 kg/m2) SVS clinical score CFA variables More than minimal calcificationa Previous exposurea Diameter

Mean 6 SD or No. (%) 75.1 6 8.3 77 (75) 25 (25) 89 (87) 84 (82) 78 (76) 59 (58) 44 (43) 21 (21) 14 (14) 29.3 6 5.5 39 (38) 43 (42) 9.48 6 4.63 62 (36) 19 (11) 10.1 6 1.9

BMI, Body mass index; CFA, common femoral artery; SD, standard deviation; SVS, Society for Vascular Surgery. a Expressed as number (% by vessel).

Table II. Aneurysm extent and sheath size in 102 patients treated by thoracic, fenestrated, and branched stent grafts using percutaneous closure Variable Type of repair Pararenal Thoracoabdominal Thoracic Aortoiliac Sheath size (by artery) <20F $20F

No. (%) 48 27 19 8

(47) (26) (19) (8)

7 (4) 163 (96)

required primary closure with interrupted 5-0 Prolene sutures (Ethicon, Somerville, NJ) in 6 puncture sites, interposition polyester graft in 2, and patch angioplasty with bovine pericardium in 1. One patient required conversion from local to general anesthesia for repair of the puncture site. All patients who needed conversion had adequate femoral arterial closure, with no evidence of persistent hemorrhage or ischemia. There were no patients with uncontrolled blood loss associated with systemic hypotension. Patients in whom conversion to open common femoral artery repair was necessary had significantly higher estimated blood loss (median, 500 mL [IQR, 400-2000 ml] vs 200 mL [IQR, 100-400 mL]; P ¼ .005). Total operating time was similar (P > .05) in patients who had successful PEVAR (173 6 85 minutes) compared with patients who experienced a technical failure (215 6 165 minutes).

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There were no factors associated with increased risk of conversion. Early outcomes. No deaths occurred within the hospital stay or the first 30 days. Median length of stay was 4 days (IQR, 3-7 days) and was significantly longer in patients who underwent conversion (6 days [IQR, 4-10 days] vs 4 days [IQR, 2-7 days]; P ¼ .05). MAEs occurred in 19 patients (19%). The most common MAE, in 13 patients (13%), was estimated blood loss >1000 mL, including four (44%) with unsuccessful and nine (10%) with successful percutaneous closures (P ¼ .014). Other MAEs were not affected by successful percutaneous closure (P > .05) and included acute kidney injury in 5 patients (5%), respiratory failure in 4 (4%), and myocardial infarction in 2 (2%). One patient treated for type II TAAA developed a retrograde type A dissection with cardiac arrest 2 days after the procedure. Although one of the percutaneous closures initially failed at the index operation, this was immediately recognized and repaired, with no hemorrhage, hypotension, or neurologic deficit. However, immediately after the open repair of the type A dissection, the patient was noted to have permanent paraplegia. This patient died after discharge from the hospital, 40 days after the procedure, from apparent aspiration pneumonia in a skilled nursing facility. Another patient treated for a type IV TAAA with successful closure developed a mild stroke, with no residual deficit. Five patients (5%) had access-related complications, including three femoral artery thromboses (3%) and retroperitoneal hematoma or pseudoaneurysm in one patient each (1%). There were no factors associated with access complications (P > .05), including age, gender, BMI, obesity status, common femoral artery diameter, presence of femoral artery calcification, prior femoral artery exposure, or sheath diameter. Three arterial occlusions were noted at 16, 7, and 7 days after the operation. In one patient treated for a TAAA, an asymptomatic dissection and occlusion of the femoral artery were incidentally diagnosed by computed tomography angiography before dismissal from the hospital. This patient was treated by open thrombectomy, endarterectomy, and patch angioplasty on postoperative day 7, and a wound infection was treated by surgical débridement, after which he had an uneventful recovery. Another patient treated for a PRA presented with acute limb ischemia on postoperative day 7 after riding in the car home for 2 hours. Femoral artery exploration revealed that the Perclose suture was placed in the arterial wall and inguinal ligament, causing a probable kink at the site. The patient underwent thrombectomy and patch angioplasty of the femoral artery with no other complication. A third patient, treated for an aortoiliac aneurysm, developed claudication 16 days after the procedure, and a kinked and occluded stent was found in the external iliac artery. There was no evidence of puncture site complication upon exploration, and the patient was treated by thrombectomy and restenting of the iliac limb. One patient treated for a ruptured type B dissection required exploration and repair of arterial bleeding adjacent

Fig. Kaplan-Meier analysis shows freedom from access-related complications. The dashed line indicates the 95% confidence interval (CI).

to the puncture site causing retroperitoneal hematoma 1 day after the procedure. The patient required prolonged hospitalization for 23 days, after which no other complications occurred. Another patient treated for PRA aneurysm developed a puncture site pseudoaneurysm, which was successfully treated by thrombin injection on postoperative day 1. Late outcomes. There were no access-related complications >30 days. The median follow-up was 13 months (IQR, 6-21 months). Considering the number of vessels at risk, the freedom from access-related complications was 97% 6 1% at 30 days and 1 year (Fig). There were no significant differences in freedom from access-related complications among patients who had a successful or unsuccessful percutaneous closure (P ¼ .48). Patient survival at 1 year was 91% 6 3% and was not affected by percutaneous closure failure (P ¼ .67) or access-related complication (P ¼ .77). DISCUSSION The risk of vascular complications with thoracic, fenestrated, and branched endografts may be higher due to larger diameter sheaths ranging from 20F to 24F. In prospective pivotal studies, vascular complications occurred in 14% to 23% of patients and wound-related problems in 4% to 6%.18,19 Most operators prefer to perform open exposure and primary repair of the femoral artery in these cases. A specific concern is that inadvertent hemorrhage can be associated with systemic hypotension, which can further increase the risk of spinal cord injury. The ability to perform thoracic, fenestrated, and branched stent grafts using a total percutaneous approach is seductive, because it may decrease or eliminate some of the drawbacks of open surgical exposure and arterial repair.2,5,14 Our results are similar to those that have already been reported for infrarenal devices using smaller diameter sheaths and suggest that PEVAR can be safely and effectively extended to patients with more challenging anatomy. Two PVCDs are currently available in the market for closure of large-diameter sheaths and both have been

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de Souza et al 5

Table III. Contemporary reports of percutaneous vascular closure devices (PVCDs) using >20F sheaths Technique First author (year)

Des

Pts, No.

Rijkee3 (2015)

R

85

Nelson2 (2014) Bechara22 (2013)

RCT

101

Manunga1 (2013) Mousa7 (2013) Skagius23 (2013) Thomas24 (2013)

R

Krajcer25 (2012) Bensley5 (2012) Oguzkurt26 (2012) Eisenack6 (2009) Heyer27 (2009) Jahnke14 (2009)

R

Disease, No.

Multiple US PVCD PVCDs guidance MSD, F

154 AAA (70) PS DTA (10) AIA (4) TAAA (1) 101 AAA PG, PS

TS, No. (%)

Mean, ARE, months No. (%) 12

14 (10)

Yes

NR

21

92 (91)

NR

21 (21) 101 (100)

NR

19 (NR)

e

222

Yes

Yes

NR

377 (96)

30

R

134

267

AAA

PG

Yes

Yes

17

235 (88)

R

118

118

DTA

PS

Yes

Yes

22

R

50

PS

No

NR

PS

No

PG

R

52

P

500

P

14

P

70

Smith28 (2009) Bent29 (2009) Arthurs20 (2008) JeanBaptiste30 (2008) Lee31 (2008) Shim32 (2008)

R

22

R

21

R

88

P

19

R

292

R

66

Dosluoglu33 (2007) Starnes9 (2006)

P

17

R

49

P

29

P

296

NR

85 AAA (33) DTA (19) 904 AAA (403) DTA (97) 28 AAA

7 (11)

144 (94)

NR

168

65 (42)

18

Yes

78 AAA (40) DTA (5) AIA (4) Other (1) 1150 1830 AAA

TS, No. (%)

Yes

Sel

99 NR

$20F, No. (%)

No

AAA (81) PG, PS AIA (13) DTA (5) 391 AAA PG, PS

R

R

Watelet12 (2006) Borner34 (2004) Torsello4 (2004) Howell35 (2002) Rachel8 (2002)

Art, No.

Follow-up

a

92 (91)

NR

NR

15 (4)

62 (16)

59 (95)

NR

32 (12)

NR

NR

108 (92)

20

32 (27) 118 (100) 108 (92)

17

73 (94)

NR

10 (13)

Sel

NR

1727 (94)

NR

Yes

Yes

17

285 (96)

PS

No

Yes

19

PS

No

NR

PS

No

134 AAA (57) PC DTA (10) AIA (3) 38 AAA PG, PS

29 (37)

28 (97)

129 (7)

NR

NR

NR

13 (4)

NR

NR

84 (99)

NR

1 (1)

53 (62)

NR

20

868 (96)

28

71 (8)

501 (55)

482 (96)

Yes

19

27 (96)

12

2 (7)

14 (50)

13 (93)

Yes

NR

18

127 (95)

NR

9 (7)

29 (22)

28 (97)

NR

NR

NR

38 (100)

9

1 (3)

NR

NR

29 DTA (13) AAA (8) 152 AAA DTA 38 AAA

PC

Yes

NR

22

26 (90)

50

3 (10)

24 (83)

23 (96)

PS

No

Sel

NR

145 (95)

9

7 (5)

46 (30)

43 (93)

PS

Sel

No

18

35 (92)

12

3 (8)

16 (42)

NR

432 AAA (167) DTA (125) 92 AAA (39) Other (19) DTA (8) 30 AAA

PG

Yes

No

19

408 (94)

12

27 (6)

223 (52)

206 (92)

CS

Yes

No

16

88 (95)

11

4 (4)

8 (9)

8 (100)

PG

Yes

No

17

27 (90)

3

3 (10)

10 (33)

8 (80)

PS

No

Yes

16

74 (94)

18

6 (8)

18 (23)

14 (78)

PS

Sel

Yes

NR

39 (83)

17

8 (17)

29 (62)

23 (79)

95

79 AAA (46) DTA (2) AIA (1) 47 AAA (20) DTA (9) 190 AAA

PS

Yes

No

18

170 (89)

NE

24 (13)

80 (42)

64 (80)

RCT

15

27 AAA, DTA

PS

No

Yes

19

24 (89)

NR

3 (11)

11 (41)

9 (82)

P

30

60

AAA

PS

No

No

19

58 (97)

1

2 (3)

30 (50)

29 (97)

P

62

100

AAA

PS

Sel

No

19

76 (76)

NR

27 (27)

45 (45)

29 (64)

(Continued on next page)

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Table III. Continued. Technique First author (year)

Des

Pts, No.

Teh10 (2001)

R

44

Traul11 (2000) Haas36 (1999)

R R

Art, No.

Disease, No.

Follow-up

Multiple US PVCD PVCDs guidance MSD, F

TS, No. (%)

Mean, ARE, months No. (%)

$20F, No. (%)

TS, No. (%)

PS

Sel

NR

NR

71 (87)

NR

12 (15)

NR

NR

17

82 AAA (42) DTA (1) AIA (1) 30 AAA

PS

Sel

NR

19

19 (63)

NR

11 (37)

14 (47)

8 (57)

12

13

PS

Sel

NR

NR

13 (100)

1

0

1 (8)

1 (100)

AAA

AAA, Abdominal aortic aneurysm; AIA, aortoiliac aneurysm; ARE, access-related events; Art, arteries; CS, Closer S (Perclose Inc, Redwood City, Calif); Des, study design; DTA, descending thoracic aneurysm; MSD, mean sheath diameter; NR, not reported; P, prospective; Pts, patients; PC, Perclose A-T (Abbott Vascular, Santa Clara, Calif); PG, ProGlide (Abbott Vascular, Santa Clara, Calif); PS, Prostar XL (Abbott Vascular, Santa Clara, Calif); R, retrospective; RCT, randomized clinical trial; Sel, selective; TAAA, thoracoabdominal aortic aneurysm; TS, technical success; US, ultrasound. a Authors describe the technical success rate by patients only (81.8%).

widely used with similar results. In a prospective randomized trial of 151 patients who underwent EVAR, the ProGlide device showed no 1-month primary treatment success inferiority compared with conventional femoral artery exposure (88% vs 78%). However, the study was not able to demonstrate noninferiority of the ProStar device (Abbott Vascular) for the same outcome.2 Despite initially disappointing results,11 the technique of “pre-close” or “dual closure,” as described here, has evolved into a safe and effective method to obtain percutaneous closure. Its main advantage relies on the ability to add extra sutures and direct or orient the puncture relative to adverse anatomic features such as calcified plaque. A number of technical aspects can be emphasized. The use of ultrasound guidance to help select the puncture site reduces the rates of lateral or high punctures, both associated with technical failures.7,20 We prefer to use a stiff Glidewire because of a prior event of a patient in whom a braided wire was entrapped into the suture material of the PVCD. Nonetheless, one has to be careful not to lose guidewire access until hemostasis has been confirmed. The concept that percutaneous approach adds to leg ischemia is incorrect. In fact, we immediately remove the sheath once steps are completed from the femoral approach and leave a wire in place in case access has to be regained. No leg or spinal cord ischemia occurred in our series. Finally, although we have not routinely assessed the anatomic result immediately after closure, others propose use of duplex ultrasound imaging to help identify small technical problems, which when revised can reduce rates of occlusion or pseudoaneurysm.21 Our technical success rate of 95% compares favorably with prior reports (Table III).1-12,14,20,22-36 Despite the use of different devices and some variations on techniques, three meta-analysis have shown >90% technical success with a low incidence of complications.13,37,38 With respect to reports dealing with thoracic or fenestrated and branched endografts, there are limited data. A retrospective analysis of a European center identified 118 endovascular procedures for thoracic aortic aneurysm using the ProStar device.

Technical success was 92%, late complications were rare, and no surgical reintervention was needed.23 Total percutaneous procedures can be associated with potential complications. Although hemorrhage and arterial thrombosis are uncommon, they can still occur and result in secondary problems, including spinal cord injury. Therefore, patient selection is critical, and we have not offered percutaneous closure to patients with extensive calcified plaque involving the anterior wall or high femoral bifurcations below the inguinal ligament. Currently, we consider using this technique in all patients who have noncalcified or minimally calcified common femoral arteries, independent of the anatomy. It is possible that, due to our careful patient selection, we had no power to demonstrate the negative effect of artery calcification in the percutaneous closure outcomes. Prior studies have described the potential negative effect of obesity in total percutaneous interventions. Especially in the earlier series, obesity was associated with higher rates of technical failure, although rarely this reached statistical significance.9,10 Conversely, the obese patient has greater potential to benefit from PEVAR because of the higher rate of wound-related complications associated with groin incisions, especially seromas and infections. In this study, 80% of the patients were obese or overweight, and yet our technical success was 95%, with a low rate of wound-related complications. The one caveat when dealing with the obese patient is the risk of a high puncture through the inguinal ligament, which can lead to unrecognized retroperitoneal bleeding. Contrary to earlier reports,6,10 previous open exposure was not an important factor in the outcomes of percutaneous closure. Although only 11% of access sites in our series had presented previous conventional interventions, there were no initial failures and only one postprocedural complication. Although many still consider sheath size as an important factor associated with risk of failure, our study compares favorably with PEVAR experience using smallerprofile devices to earlier experiences.8,9,11,12

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Our study is subject to many limitations, especially related to its retrospective design and lack of a comparative group without PVCD. The percutaneous approach was not used in >50% of patients for a number of reasons, including beginning of the learning curve, unsuitable femoral anatomy, and complexity of the aortic repair. Retrospectively retrieving the exact reasons for open exposure of the femoral artery is impossible, but our favorable results illustrate the importance of case selection. In addition, our study lacked a comparative group with open exposure of the femoral vessels. The study included patients treated with both thoracic and fenestrated-branched endografts, which could have accounted for the low event rate in the more complex groups; nonetheless, the event rate was equally low in the fenestrated and branched groups, with no significant differences. However, this study is unique for describing complex aortic anatomy treated by percutaneous technique with fenestrated and branched endografts, with similar technical success and outcomes compared with reported results of infrarenal AAAs. CONCLUSIONS This study demonstrates the safety and efficacy of PEVAR using thoracic, fenestrated, and branched stent grafts in selected patients, with results similar to those that have been reported for infrarenal aneurysms. Accessrelated complications occurred in 5% of the patients, with no inadvertent hemorrhage, hypotension, or spinal cord injury associated with percutaneous closure.

de Souza et al 7

6.

7.

8.

9.

10.

11.

12.

13.

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15.

AUTHOR CONTRIBUTIONS Conception and design: LS, GO, PB, JH, JW, SC, PG Analysis and interpretation: LS, GO, PB, JH, PG Data collection: LS, GO, PB, JH, JW Writing the article: LS, GO, PB, JH, JW, SC, PG Critical revision of the article: LS, GO, PB, JH, JW, SC, PG Final approval of the article: LS, GO, PB, JH, JW, SC, PG Statistical analysis: LS, GO, PB, SC Obtained funding: Not applicable Overall responsibility: GO

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32. Shim CY, Park S, Ko YG, Choi D, Jang Y, Shim WH. Percutaneous closure of femoral artery access sites in endovascular stent-graft treatment of aortic disease. Int J Cardiol 2008;130:251-4. 33. Dosluoglu HH, Cherr GS, Harris LM, Dryjski ML. Total percutaneous endovascular repair of abdominal aortic aneurysms using Perclose ProGlide closure devices. J Endovasc Ther 2007;14:184-8. 34. Borner G, Ivancev K, Sonesson B, Lindblad B, Griffin D, Malina M. Percutaneous AAA repair: is it safe? J Endovasc Ther 2004;11:621-6. 35. Howell M, Doughtery K, Strickman N, Krajcer Z. Percutaneous repair of abdominal aortic aneurysms using the AneuRx stent graft and the percutaneous vascular surgery device. Catheter Cardiovasc Interv 2002;55:281-7. 36. Haas PC, Krajcer Z, Diethrich EB. Closure of large percutaneous access sites using the Prostar XL percutaneous vascular surgery device. J Endovasc Surg 1999;6:168-70. 37. Malkawi AH, Hinchliffe RJ, Holt PJ, Loftus IM, Thompson MM. Percutaneous access for endovascular aneurysm repair: a systematic review. Eur J Vasc Endovasc Surg 2010;39:676-82. 38. Georgiadis GS, Antoniou GA, Papaioakim M, Georgakarakos E, Trellopoulos G, Papanas N, et al. A meta-analysis of outcome after percutaneous endovascular aortic aneurysm repair using different size sheaths or endograft delivery systems. J Endovasc Ther 2011;18:445-59.

Submitted Apr 15, 2015; accepted Jul 14, 2015.

Additional material for this article may be found online at www.jvascsurg.org.

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Supplementary Fig 1 (online only). The ultrasound guidance secures a puncture proximal to the femoral bifurcation and in the anterior wall of the artery. Whether to perform the puncture using a (A) transverse or a (B) longitudinal view is the surgeon’s preference. (Reprinted by permission of the Mayo Foundation for Medical Education and Research. All rights reserved.)

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Supplementary Fig 2 (online only). Preoperative imaging evaluation and adequate patient selection are necessary to obtain satisfactory results. A and B, Areas with severe and circumferential calcification are avoided and may be a contraindication to the total percutaneous procedure. C, A high femoral artery bifurcation requires additional care to avoid distal punctures.

Supplementary Fig 3 (online only). A, A small oblique incision is made. B, The subcutaneous tissue is dilated circumferentially to facilitate placement of the percutaneous vascular closure devices (PVCDs) and to avoid the inclusion of subcutaneous tissue in the suture. (Reprinted by permission of the Mayo Foundation for Medical Education and Research. All rights reserved.)

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Supplementary Fig 4 (online only). A, It is important that both of the devices be introduced at the 12:00 o’clock position and at a w45 angle from the skin. B, After confirmation that the device is inside the vessel, the first one should be rotated to the 10:30 o’clock position before the following steps for its complete delivery. C, The second device is introduced in the same fashion as the first one but is rotated to the 1:30 o’clock position. (Reprinted by permission of the Mayo Foundation for Medical Education and Research. All rights reserved.)

Supplementary Fig 5 (online only). A, Obtaining adequate sealing of the large-sheath device arterial puncture is expected when two devices are used; however, a series of mechanisms may act to promote the failure of the technique. Inadequate sealing may result from (B) partial or (C) total inclusion of the inguinal ligament in the suture. D, As it occurs in the open technique, anterior plaques may prevent the effective suture of the puncture. E and F, Similar to the inguinal ligament, the dermis and the subcutaneous tissue may be included in the suture. (Reprinted by permission of the Mayo Foundation for Medical Education and Research. All rights reserved.)