The Nellix endovascular aneurysm sealing system: current perspectives

Figures & data

Figure 1 Flowchart demonstrating the literature search strategy.

Table 1 Study characteristics

First author, year	Study period/design	Country of the corresponding author	Case type	Study design	Inclusion criteria	Exclusion criteria
Krievins et al, 2011^Citation8	2008–2010/P	USA	M	Case series	Patients with one or more of the following: aneurysm size 4.5 cm or greater, aneurysm size twice the diameter of the infrarenal neck, and documented rate of aneurysm enlargement >10% in 1 year with aortic neck length 10 mm or greater. After review of the clinical results from the first 21 patients, the study protocol was modified to allow inclusion of patients with shorter aortic necks (5 mm or greater)	NR
Donayre et al, 2011^Citation9	2007–2009/R	USA	M	Case series	All patients appropriate for open aortic aneurysm repair with suitable anatomy for endovascular repair using the sac-anchoring endoprosthesis	Patients with iliofemoral arteries unable to accommodate a 21F outer diameter delivery catheter
Zerwes et al, 2015^Citation10	July 2013–August 2014/R	Germany	S	Case series	One or more of the following: aortic aneurysm size 50 mm or larger, symptomatic (non-ruptured) aneurysms, documented aneurysm enlargement of 5 mm in 6 months or 10 mm in 1 year, and common iliac artery aneurysm size of 25 mm or larger	NR
Böckler et al, 2015^Citation11	October 2012–March 2014/R	Germany	M	Case series	Consecutively treated patients who underwent AAA repair with the Nellix EVAS device subsequent to CE marking were included in this study	NR
Brownrigg et al, 2015^Citation12	March 2013–April 2014/R	UK	S	Case series	All patients with non-ruptured infrarenal AAA treated with the Nellix device	NR
Carpenter et al, 2016^Citation13	2015–2016/P	USA	M	Case series	All patients with AAA of the following clinical characteristics: male or female, at least 18 years old, AAA >5.0 cm, or >4.5 cm which has increased by >0.5 cm within the last 6 months, or which exceeds 1.5 times the transverse dimension of an adjacent non- aneurysmal aortic segment, asymptomatic infrarenal AAA, with access artery diameter ≥6 mm, aneurysm blood lumen diameter ≤60 mm, non-aneurysmal aortic neck length ≥10 mm and ≤60° angle and lumen diameter 18–32 mm, common iliac artery blood lumen diameter 9–35 mm, most caudal renal artery to each hypogastric artery length ≥100 mm, and the ability to preserve at least one hypogastric artery	Patients with life expectancy <2 years, condition that may interfere with study, participating in another clinical study, known allergies or CI to any device material, bleeding disorder, ruptured/leaking/infected aneurysm, Serum creatinine level >2.0 mg/dL, CVA or MI ≤3 months of enrollment/treatment, aneurysmal disease of the descending thoracic aorta, clinically significant mural thrombus within the proximal landing zone (minimum 10 mm) of the infrarenal non-aneurysmal neck (>5 mm thickness over >50% circumference), connective tissue diseases, pregnant
Karouki et al, 2016^Citation14	2013–2015/R	UK	S	Cohort study	All patients treated with EVAS in the institution	NR
van Sterkenburg et al, 2016^Citation15	June 2013–May 2015/R	The Netherlands	S	Case series	Patients who were treated with Nellix for an aneurysm in conjunction with iliac artery occlusive disease were selected	NR
Thompson et al, 2016^Citation16	October 2013–September 2014/R	UK	M	Case series	All patients who were treated with the Nellix EVAS system for non-ruptured AAAs, irrespective of whether the aortic anatomy conformed to the Nellix IFU	Ruptured AAA, failing bifurcated endograft, or isolated iliac aneurysm
Silingardi et al, 2016^Citation17	September 2013–July 2014/R	Italy	M	Case series	Patients were eligible for endovascular repair with an infrarenal AAA >5 cm in axial diameter or with rapid growth (>1 cm in the last 12 months), all procedures performed at least 12 months prior to the analysis were included	NR
Youssef et al, 2016^Citation18	May 2013–June 2015/R	Germany	M	Case series	Patients with common iliac artery aneurysms who underwent implantation of Nellix device	NR
Gossetti et al, 2017^Citation19	September 2013–November 2015/R	Italy	M	Cohort study	Patients presenting with juxtarenal or infrarenal aortic aneurysm requiring elective treatment, AAA diameter ≥4.5 cm, and AAA enlargement >1 cm within the previous year	NR
Jeffrey Hing et al, 2018^Citation20	July 2014–August 2016/R	Singapore	S	Case series	All patients treated with EVAS, by the same group of vascular team	NR
Zoethout et al, 2018^Citation21	April 2013–December 2015/R	The Netherlands	M	Case series	All patients treated with first-generation Nellix, inside the IFU of 2013 and 2016a	Symptomatic or ruptured AAA, missing CT scan, patients who were not treated with a regular EVAS procedure

Notes:

a Data reported in Tables 2–6 are outcomes of cohort which fit within IFU 2013.

Abbreviations: AAA, abdominal aortic aneurysm; CI, contraindication; CT, computed tomography; CVA, cerebrovascular accident; EVAS, endovascular aneurysm sealing; IFU, instruction for use; M, multicenter; MI, myocardial infarction; NR, not reported; P, prospective; R, retrospective; S, single.

Table 2 Baseline demographics and clinical characteristics of the study population

First author, year	No. of patients	Male, n (%)	Age, yearsa	ASA grade and type, n (%)	Smoking history, n (%)	HTN, n (%)	DM, n (%)	CAD, n (%)	Angina, n (%)	MI, n (%)	AR, n (%)	CHF, n (%)	COPD, n (%)	CVD, n (%)	CKD, n (%)
Krievins et al, 2011^Citation8	34	31 (91)	71 (53–84)	NR	17 (50)	23 (68)	4 (12)	19 (56)	NR	9 (27)	NR	NR	NR	NR	1 (3)
Donayre et al, 2011^Citation9	21	19 (91)	70±8 (53–84)	NR	12 (57)	15 (71)	2 (10)	11 (52)	NR	11 (52)	NR	NR	NR	NR	1 (5)
Zerwes et al, 2015^Citation10	50	43 (86)	72 (59–90)	ASA I: 0; ASA II: 19 (38); ASA III: 23 (46); ASA IV: 8 (16)	34 (68)	49 (98)	12 (24)	30 (60)	NR	13 (26)	NR	NR	7 (14)	NR	6 (12)
Böckler et al, 2015^Citation11	171	153 (90)	74±7	ASA I: 2 (1); ASA II: 57 (34); ASA III: 79 (47); ASA IV: 30 (18)	77 (49)	130 (76)	15 (9)	27 (16)	41 (24)	54 (32)	33 (19)	15 (9)	47 (28)	18 (11)	32 (19)
Brownrigg et al, 2015^Citation12	105	92 (88)	76±8	NR	74 (71)	82 (78)	13 (12)	36 (34)	NR	NR	NR	NR	NR	NR	13 (12)
Carpenter et al, 2016^Citation13	150	142 (95)	73	ASA I/II: 41 (27); ASA III: 92 (61); ASA IV: 17 (11)	78 (58)	123 (82)	26 (17)	76 (51)	16 (11)	38 (25)	42 (28)	NR	41 (27)	18 (14)	24 (16)
Karouki et al, 2016^Citation14	65	49 (75)	78±7	NR	48 (75)	56 (86)	8 (12)	NR	NR	NR	NR	NR	18 (28)	NR	15 (23)
van Sterkenburg et al, 2016^Citation15	5	3 (60)	NR	NR	3 (60)	3 (60)	1 (20)	NR	NR	3 (60)	NR	NR	NR	2 (40)	NR
Thompson et al, 2016^Citation16	277	228 (82)	75±7	ASA I: 6 (2); ASA II: 93 (34); ASA III: 149 (51); ASA IV: 35 (13)	145 (52)	208 (75)	47 (17)	120 (43)	53 (19)	70 (25)	48 (17)	20 (7)	75 (27)	21 (8)	53 (19)
Silingardi et al, 2016^Citation17	64	61 (95)	77±7	ASA II: 19 (30); ASA III/IV: 29 (45); ASA V: 1 (2)	38 (59)	55 (86)	9 (14)	19 (30)	NR	16 (25)	NR	NR	29 (45)	NR	8 (13)
Youssef et al, 2016^Citation18	50	35 (70)	76 (59–86)	ASA III: 25 (50); ASA IV: 6 (12)	42 (84)	40 (80)	10 (20)	29 (58)	NR	NR	NR	NR	20 (40)	NR	NR
Gossetti et al, 2017^Citation19	335	316 (94)	76±7	ASA I: 2 (1); ASA II: 43 (13); ASA III: 209 (62); ASA IV: 81 (24)	227 (68)	211 (63)	84 (25)	134 (40)	70 (21)	97 (29)	NR	NR	147 (44)	56 (17)	79 (24)
Jeffrey Hing et al, 2018^Citation20	15	15 (100)	73±8 (55–85)	ASA II: 3 (20); ASA III: 12 (80)	8 (53)	13 (87)	3 (20)	NR	NR	NR	NR	NR	3 (20)	NR	NR
Zoethout et al, 2018^Citation21	168	155 (92)	74	ASA II: 107 (64); ASA ≥III: 60 (36); missing information: 1 (1)	78 (46)	112 (67)	27 (16)	NR	NR	NR	NR	NR	47 (28)	NR	34 (20)

Note:

a Mean ± SD (range).

Abbreviations: AR, arrhythmia; ASA, American Society of Anesthesiologists physical status classification; CAD, coronary artery disease; CHF, congestive heart failure; CKD, chronic kidney disease; CVD, cerebrovascular disease; DM, diabetes mellitus; HTN, hypertension; MI, myocardial infarction; NR, not reported.

Table 3 Aneurysm anatomic data

First author, year	Treatment within IFU, n (%)	Aneurysm maximum diameter, mma	Aortic neck diameter, mma	Aortic neck length, mma	Aortic neck angulation (°)a
Krievins et al, 2011^Citation8	17 (50)	58 (34–76)	24 (18–31)	22 (5–50)	37 (9–72)
Donayre et al, 2011^Citation9	NR	57±0.7 (43–74)	26±3.7 (16–28)	25±14 (0–59)	39±15 (10–66)
Zerwes et al, 2015^Citation10	36 (72)	56±7.2 (38–74)	24±3.9 (18–34)	28±13 (10–65)	18±23
Böckler et al, 2015^Citation11	116 (67)	61±9	25±5	28±15	37±22
Brownrigg et al, 2015^Citation12	NR	61 (58–67)	27 (24–30)	22 (14–33)	42 (30–58)
Carpenter et al, 2016^Citation13	NR	58±6.2 (44–82)	25±3 (19–32)	31±14 (10–103)	30±14 (3.3–59)
Karouki et al, 2016^Citation14	43 (66)	77±28b	28±5.1	26±15	30 (0–78)
van Sterkenburg et al, 2016^Citation15	5 (100)	57±4b	20±2b	23±11b	NR
Thompson et al, 2016^Citation16	200 (72)	60±1.7b	25±0.9b	24±4b	31±4.5b
Silingardi et al, 2016^Citation17	53 (83)	57±9.3	22±3.3	27±12	17±19
Youssef et al, 2016^Citation18	NR	NR	NR	NR	NR
Gossetti et al, 2017^Citation19	295 (88)	56±9.4 (45–65)	23±3.5 (20–24)	26±15 (15–35)	41±27 (14–68)
Jeffrey Hing et al, 2018^Citation20	11 (70)	64±167 (41–100)	22 (15–38)	29 (1–64)	42 (10–80)
Zoethout et al, 2018^Citation21	168 (100)	58±1.2b	23±0.6b	18±3.2b	22±3.7b

Notes:

a Mean ± SD (range).

b These data are reported in median with range and/or IQR. The presented value in the table is the mean value after conversion from median to mean using Hozo et al’s suggested method.³⁸

Abbreviations: IFU, instructions for use; NR, not reported.

Table 4 Surgical data

First author, year	Anesthesia, n (%)	Technical success, %	Procedure time, minutesa	Fluoroscopy time, minutesa	Adjunctive procedures, n (%)	Details about adjunctive procedures	Post-op complications, n (%)	Type of complication
Krievins et al, 2011^Citation8	NR	100	70±32	33±17 (17–71)	NR	NR	NR	NR
Donayre et al, 2011^Citation9	NR	100	127 (80–148)	33±17	NR	NR	NR	NR
Zerwes et al, 2015^Citation10	NR	98	101±20	NR	NR	NR	3 (6)	Partial endograft limb thrombosis, retroperitoneal hematoma with prolapse of endobag with low-flow endoleak type Ia, endoleak type II
Böckler et al, 2015^Citation11	NR	99	100 (25–286)	11±11b	NR	NR	NR	NR
Brownrigg et al, 2015^Citation12	NR	100	NR	NR	62 (59)	62 adjunctive iliac stentings	NR	NR
Carpenter et al, 2016^Citation13	GA: 84 (56); LA: 66 (44)	100	88 (50–205)	10	NR	NR	2 (1.3)	Delayed filling of the renal artery, intraoperative iatrogenic AAA rupture during the prefill step
Karouki et al, 2016^Citation14	NR	100	NR	NR	5 (7.7)	Five iliac stents	6 (9.2)	Groin hematoma, T1RF, occlusion due to cancer-induced thrombophilia, paraparesis, popliteal embolus, hemispheric stroke
van Sterkenburg et al, 2016^Citation15	GA: 4 (80); LA: 1 (20)	100	NR	NR	2 (40)	One thrombo- endarterectomy, one chimney graft	3 (60)	Groin hematoma, duodenal bleeding, occlusion of femoral artery
Thompson et al, 2016^Citation16	NR	NR	98±7b	11±1b	NR	NR	NR	NR
Silingardi et al, 2016^Citation17	GA: 40 (63); LA: 24 (38)	98	97±30 (56–182)	8±2	NR	NR	0	0
Youssef et al, 2016^Citation18	GA: 30 (60); LA: 20 (40)	100	151±45	NR	30 (60)	30 iliac stents	3 (6)	Inguinal hematoma, wound infection, respiratory failure
Gossetti et al, 2017^Citation19	GA: 153 (46); RA: 21 (6); LA: 161 (48)	100	101	NR	NR	NR	2 (0.6)	Two incidental hypogastric artery occlusions
Jeffrey Hing et al, 2018^Citation20	GA: 12 (80); RA: 1 (7); LA: 2 (13)	100	139	NR	6 (40)	Three open-access endarterectomies with embolectomy, one coil embolization of internal iliac artery, one bilateral renal artery chimneys, one proximal stent deployment	6 (40)	One severe T1RF, five post- implantation syndrome
Zoethout et al, 2018^Citation21	GA: 143 (85); RA: 25 (15)	98	90±6b	NR	NR	NR	3 (1.8)	Three type Ia endoleaks

Notes:

a Mean ± SD (range) unless stated otherwise.

b These data are reported in median with range and/or IQR. The presented value in the table is the mean value after conversion from median to mean using Hozo et al’s suggested method.³⁸

Abbreviations: GA, general anesthesia; LA, local anesthesia; NR, not reported; RA, regional anesthesia; T1RF, type 1 respiratory failure.

Table 5 Early clinical outcomes (within 30 days)

First author, year	Length of hospital stay, daysa	Presence of endoleak, n (%)	Aneurysm rupture, n (%)	Sac enlargement, n	Device migration, n	Reintervention, n (%)	In-hospital or 30-day mortality (non-device related), n (%)	In-hospital or 30-day mortality (aneurysm/device related), n (%)
Krievins et al, 2011^Citation8	3.8±2.2 (1–9)	Type IA: 2 (5.9)	0	NR	NR	1 (2.9)	0	1 (2.9)
Donayre et al, 2011^Citation9	4.3 (2–11)	Type I: 2 (9.6)	NR	NR	NR	0	1 (4.8)	0
Zerwes et al, 2015^Citation10	9.9±5.4 (4–24)	Type IA: 1 (2), type II: 1 (2)	1 (2.0)	0	0	NR	2 (4)	0
Böckler et al, 2015^Citation11	NR	Type IA: 3 (2), type IB: 3 (2), type II: 3 (2)	0	NR	0	11 (6.4)	0	0
Brownrigg et al, 2015^Citation12	2±0.5b	Type IA: 4 (3.8)	0	NR	NR	3 (2.9)	1 (1)	0
Carpenter et al, 2016^Citation13	NR	Type IA: 1 (0.7), type II: 8 (5.6)	0	NR	NR	NR	NR	2 (1.3)
Karouki et al, 2016^Citation14	NR	0	0	NR	NR	2 (3.1)	0	NR
van Sterkenburg et al, 2016^Citation15	NR	0	NR	0	NR	0	0	NR
Thompson et al, 2016^Citation16	4b	Type IA: 8 (2.9), type IB: 1 (0.4), type II: 5 (1.8)	1 (0.4)	NR	NR	3 (1.1)	3 (1.1)	0
Silingardi et al, 2016^Citation17	3.3±4.6 (1–35)	0	0	0	0	0	0	0
Youssef et al, 2016^Citation18	8±3.5b	0	NR	NR	NR	NR	0	0
Gossetti et al, 2017^Citation19	NR	Type IA: 1 (0.3), type II: 2 (0.6)	NR	NR	1 (0.3)	6 (1.8)	0	0
Jeffrey Hing et al, 2018^Citation20	2b	0	NR	0	1 (6.7)	0	0	0
Zoethout et al, 2018^Citation21	NR	Type I: 3 (1.8), type II: 1 (0.6)	NR	0	NR	3 (1.8)	NR	NR

Notes:

a Mean ± SD (range) unless stated otherwise.

b These data are reported in median with range and/or IQR. The presented value in the table is the mean value after conversion from median to mean using Hozo et al’s suggested method.³⁸

Abbreviation: NR, not reported.

Table 6 Late clinical outcomes (during follow-up)

First author, year	Length of follow-up, monthsa	Aneurysm surveillance protocol	Presence and type of endoleak, n (%)	Aneurysm rupture, n (%)	Sac enlargement, n (%)	Stent migration, n (%)	Reintervention, n (%)	Aneurysm- related mortality, n (%)	Overall mortality, n (%)
Krievins et al, 2011^Citation8	15±6	Follow-up CT scans performed at 6, 12, and 24 months	Type IA: 1 (3.1)	0	0	0	1 (2.9)	0	2 (5.9)
Donayre et al, 2011^Citation9	7.3±10	Clinical results and follow-up contrast CT scans at 30 days and 6 and 12 months were reviewed	0	0	NR	0	0	0	2 (9.6)
Zerwes et al, 2015^Citation10	NR	Contrast-enhanced ultrasound after 3 and 6 months and with CT scans after 12 months	0	0	0	0	NR	0	2 (4)
Böckler et al, 2015^Citation11	5 (0–14)	30-day and 1-year postoperative CT imaging studies and a duplex ultrasound examination at 6 months	Type IA: 2 (2), type IB: 1 (1), type II: 1 (1)	0	NR	0	5 (2.9)	0	1 (2)
Brownrigg et al, 2015^Citation12	1	Postoperative duplex and CTA prior to discharge and within 30 days at 6 and 12 months and yearly thereafter	0	0	NR	NR	NR	NR	0
Carpenter et al, 2016^Citation13	12	CTA scans at 30 days, 6 months, and 1 year	Type IA: 0, type IB: 1 (0.8), type II: 3 (2.3)	2 (1.3)	2 (1.3)	3 (2.3)	5 (3.3)	2 (1.3)	6 (4)
Karouki et al, 2016^Citation14	12 (0–24)	Contrast-enhanced CT and unenhanced duplex ultrasound at 1 month and yearly thereafter	0	0	NR	NR	2 (3.1)	0	1 (1.5)
van Sterkenburg et al, 2016^Citation15	8.5±3.5b	Clinical assessment, duplex ultrasound, and CTA at 6–8 weeks; clinical assessment and duplex at 6 months; and clinical assessment, duplex ultrasound, and CTA at 12 months and yearly thereafter	0	NR	NR	NR	0	0	0
Thompson et al, 2016^Citation16	12	Clinical assessment and imaging follow-up with high-resolution contrast-enhanced CT scans and/or duplex ultrasound	Type IA: 4 (1.4), type III: 1 (0.4)	2 (0.8)	NR	NR	5 (1.8)	1 (0.4)	11 (4)
Silingardi et al, 2016^Citation17	17b	Clinical examination with duplex imaging at 30 days and CTA at 3 months after the procedure in both centers. Thereafter, one center used duplex and the other used CTA surveillance imaging at 6 and 12 months	Type IA: 1 (1.6), type II: 1 (1.6)	0	0	0	1 (1.6)	1 (1.6)	4 (6.2)
Youssef et al, 2016^Citation18	12±4.8b	Physical examination (pulse status and ankle–brachial index), duplex sonography, and CTA at discharge, 6 and 12 months, and yearly thereafter	0	NR	NR	NR	0	0	2 (4)
Gossetti et al, 2017^Citation19	12	Duplex ultrasound or contrast-enhanced ultrasound examination before discharge and at 1, 6, 12, and 24 months	Type IA: 4 (1.4), type IB: 2 (0.7), type II: 3 (1.1)	0	NR	2 (0.7)	12 (3.7)	2 (0.6)	19 (5.6)
Jeffrey Hing et al, 2018^Citation20	14 (2–28)	CTA at 1, 6, 12 months, and annually thereafter	Type IB: 1 (7)	0	0	2 (13)	0	0	3 (20)
Zoethout et al, 2018^Citation21	23±2.3b	CTA at 1–3 and 12 months, and annually thereafter if stable	Type I: 5 (3)	1 (0.6)	8 (4.8)	12 (7.1)	16 (9.5)	NR	14 (8.3)

Notes:

a Mean ± SD (range) unless stated otherwise.

b These data are reported in median with range and/or IQR. The presented value in the table is the mean value after conversion from median to mean using Hozo et al’s suggested method.³⁸

Abbreviations: CT, computed tomography; CTA, computed tomographic angiography; NR, not reported.

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