Aortic Remodeling After Custom-Made Candy-Plug for Distal False Lumen Occlusion in Aortic Dissection

Abstract

Purpose:

To report a single-center experience with the use of a custom-made Candy-Plug (CP) for distal false-lumen (FL) occlusion in subacute and chronic aortic dissection (AD).

Materials and Methods:

A retrospective single-center analysis was conducted on consecutive patients with subacute and chronic AD who were treated with a custom-made CP for distal FL occlusion using 3 design generations (CP I to CP III) from October 2013 to September 2019.

Results:

A custom-made CP was used in 57 patients. Of these, 34 patients (29 males, mean age 62±10 years) were treated with a CP I vs 23 patients (16 males, mean age 59±17 years) with CP II/III. Technical success was achieved in 57 (100%) patients. Clinical success was achieved in 54 (95%) patients; 33 (97%) in CP I group vs 21 (91%) patients in CP II/III group, p=0.116. The mean hospital stay was 10±8 days (9±5 days in CP I group vs 13±9 days in CP II/III, p=0.102). The 30-day computed tomography angiography (CTA) confirmed successful CP placement at the intended level in all patients within both groups. Early complete FL occlusion was achieved in 50 (88%) patients; 30 (88%) patients in CP I group vs 20 (87%) in CP II/III group, p=0.894. Follow up CTA was available in 44 (77%) patients. Of these; 30/34 (88%) patients in CP I group with mean follow-up 29±17 months) vs. 14/23 (61%) patients with mean follow-up 14±5 months in CP II/III group. Thoracic aortic remodeling was achieved in 34/44 (77%) patients; 25/30 (83%) patients in CP I group vs 9/14 (64%) patients in CP II/III group, p=0.197. The aneurysm size remained stable in 9/44 (20%) patients; 5/30 (17%) patients in CP I group vs 4/14 (29%) patients in CP II/III group, p=0.741. The thoracic aneurysm increased size was seen in 1/44 (2%) patient. This patient was in CPII/III group.

Conclusion:

CP technique using custom-made devices is technically feasible with a low mortality and morbidity, and a high rate of aortic remodeling. Both, the original design (CP I) and newer designs with a self-closing central sleeve (CP II and CP III) showed similar excellent outcomes.

Keywords

aneurysm aortic dissection aortic remodeling embolization endovascular repair false lumen occlusion

Introduction

Thoracic endovascular aortic repair (TEVAR) has become the first line of treatment for chronic aortic dissection (AD).¹ However, persistent retrograde flow through distal false lumen (FL) has a major impact on failure of TEVAR to achieve remodeling in chronic AD.^2,3 Fenestrated and branched endovascular aortic repair (F/BEVAR) to seal further distal entry tears has been reported as a strategy to abolish false lumen backflow, but these procedures are challenging, have a high rate of endoleak and a relevant risk for spinal cord ischemia (SCI) due to long segment coverage.^4,5 Embolization of the distal FL during TEVAR in chronic AD has been described as a low invasive alternative strategy for achieving durable aortic remodeling in AD.⁶ Loubert et al⁷ in 2003 described the “cork in the bottle neck” strategy. Coils, plugs, glue, and iliac occluders have been used for false lumen embolization,^8–11 but the applicability of these materials is limited as they are not suitable for large false lumen diameters.¹²

The Candy-Plug (CP) technique, first described in 2013 as a surgeon-modified thoracic stent-graft¹³ is today available as a custom-made device (Cook Medical, Bjaverskov, Denmark).^14–16 The technical aspects and early results of Candy-Plug generation I and II (CP I and CP II) have been reported with high technical success and good remodeling rates. Candy-Plug generations II and III include a self-closing sleeve, which obviates a procedural step to occlude the narrow part of the CP, which enables removal of the dilator tip.^14–16

This study reports early and mid-term outcomes of a single center with three generations of CP for distal FL occlusion in TEVAR for subacute and chronic AD.

Materials and Methods

Study Design and Patient Cohort

A retrospective single-center analysis was conducted including all consecutive patients with subacute and chronic AD who were treated with the CP technique using 3 design generations of the device (CP I to CP III) from October 2013 to September 2019. Treatment indications included FL aneurysm >5.5 cm, rapid diameter progression (>5 mm/6 months) or ruptured FL-aneurysm.¹ The patients were divided into 2 groups for comparison; CP I group included patients treated with the first generation of CP and CP II/III group included patients treated with the second or third generation of CP.

Candy-Plug Generations

The design of the CP I, II, and III (Cook Medical, Bjaeverskov, Denmark), its planning and use have previously been described.^14–16

CP I has a narrow 18-mm central mid-section that allows retrieval of the dilator tip after deployment and is occluded using either a 22-mm Amplatzer Vascular Plug Type II (AVP; St Jude Medical, St Paul, MN, USA) or a 20-mm Iliac ZIP Occluder (Cook Medical, Bjaeverskov, Denmark).

CP II and III have a self-occluding sleeve and do not require occlusion of the central channel with a plug thus simplifying the procedure. This 14-mm wide sleeve allows retraction of the dilator tip. In CP II, 2 opposing sutures are attached to the sleeve from opposing sides and fixated to the inner nitinol stent of the graft. The two sutures are loose before deployment of the CP. They become tensed by deployment as the nitinol stent expands. The tensed sutures pull the central channel from each side thereby closing it. The central fabric channel is inside the graft in CP II and outside in CP III.

The CP placement in the distal thoracic FL is usually simultaneously done with TEVAR in the true lumen (TL) including fenestrated and branched arch stent-grafts.^14–16 Figure 1 illustrates a case with chronic AD who was treated with TEVAR and CP II.

Definitions and Endpoints

Subacute and chronic AD are defined as between 15 and 90 days and >90 days after the initial event, respectively. Urgency was defined as symptomatic aneurysm (thoracic pain) and ≥8 cm diameter. Emergency was defined as ruptured false lumen aneurysm.

Endpoints included technical, clinical success and early (30-day) computed tomography angiography (CTA) findings. Technical success was defined as correct placement of the true lumen stent-graft and the CP at the intended level in the FL. Clinical success was defined as prevention of FL backflow at the CP level on final angiography. Early (30-day) CTA findings included the correct placement of CP and stent-graft with no FL back beyond the CP.

Other endpoints were early (30-day) mortality and adverse events including minor and major stroke, paraplegia, and aortic remodeling in patients with available CTA follow-up of more than 6 months. Aortic remodeling was based on the largest thoracic perpendicular aortic diameter including false and true lumens on the first postoperative CT scan compared with the most recent CT scan. A >3-mm decrease in aortic diameter was defined as aortic remodeling, and diameter changes ≤3 mm was considered as stable.

Demographics, past medical history, cardiovascular risk profile, pre-, intra-, and post-operative details were analyzed reviewed for both groups (CP I vs. CP II/III). Preoperative, postoperative, and follow-up CTA examinations were analyzed for both groups (CP I vs CP II/III).

Results

Table 1.

Patient Characteristics and Comorbidities of All Patients CP and CP I Group vs CP II/III Group.

Variables	All Patients, n=57 (%) or Mean ± SD	CP I, n=34 (%) or Mean ± SD	CP II/III, n=23 (%) or Mean ± SD	p
Demographics
Age (years)	60±15	62±10	59±17	0.314
Male gender	45 (79)	29 (85)	16 (70)	0.153
Cardiovascular risk factors
Cigarette smoking	17 (30)	12 (35)	5 (22)	0.272
Active smoking	9 (16)	5 (15)	4 (18)	0.785
Hypertension	51 (89)	32 (94)	19 (83)	0.289
Hypercholesterolemia	8 (14)	6 (18)	2 (9)	0.340
CAD	8 (14)	6 (18)	2 (9)	0.340
Myocardial infarction	1 (2)	0	1 (4)	0.220
COPD	5 (9)	3 (9)	2 (9)	0.987
PAD	2 (4)	1 (3)	1 (4)	0.777
Dialysis	3 (5)	2 (6)	1 (4)	0.799
Diabetes mellitus	4 (7)	2 (6)	2 (9)	0.425
Prior aortic intervention
TEVAR	12 (21)	8 (34)	4 (17)	0.421
Aortic root/arch repair	28 (49)	16 (47)	12 (52)	0.390
Endovascular aortic arch repair	5 (9)	2 (6)	3 (13)	0.337

Abbreviations: CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; CP, Candy-Plug; PAD, peripheral arterial disease; TEVAR, thoracic endovascular aortic repair.

Twenty-nine (51%) patients experienced residual type A aortic dissection (TAAD); 20 (59%) patients in CP I group vs 9 (39%) patients in CP II/III group, p=0.256. While 28 (49%) patients experienced type B AD (TBAD); 14 (41%) patients in CP I group vs 14 (61%) patients in CP II/III group, p=0. 215. Forty-eight (84%) patients had chronic AD; 30 (88%) patients in CP I group vs 18 (78%) patients in CP II/III group, p=0.275, and 9 patients had subacute AD; 4 (12%) patients in CP I group vs 5 (22%) patients in CP II/III group, p=0.281.

The mean maximum aortic aneurysm diameter was 57±13 mm. The maximum aortic aneurysm diameter tended to be larger in CP I group compared with CP II/III group (66±15 vs 54±10 mm, p=0.096).

Forty-three (75%) patients presented with elective conditions; 24 (71%) patients in CP I group vs 19 (83%) patients in CP II/III group, p=0.215. Eight (14%) patients presented with urgent conditions; 7 (21%) patients in CP I group vs 1 (4%) patients in CP II/III group, p=0.07. Six (11%) presented with emergent conditions; 3 (9%) patients in CP I group vs 3 (13%) patients in CP II/III group, p=0.137. Table 2 illustrates the anatomical, pathological criteria, and status of aortic aneurysm of all patients with CP and CP I group vs CP II/III group.

Table 2.

Anatomical, Pathological Criteria, and Status of Aortic Aneurysm of All Patients CP and CP I Group vs CP II/III Group.

Variables	All Patients, n=57 (%) or Mean ± SD	Candy-Plug I, n=34 (%) or Mean ± SD	Candy-Plug II/III, n=23 (%) or Mean ± SD	p
Type A AD	29 (51)	20 (59)	9 (39)	0.256
Type B AD	28 (49)	14 (41)	14 (61)	0.215
Subacute AD	9 (16)	4 (12)	5 (22)	0.275
Chronic AD	48 (84)	30 (88)	18 (78)	0.281
Maximum aortic diameter (mm)	57±13	66±15	54±10	0.096
Status of the aneurysm
Elective	43 (75)	24 (71)	19 (83)	0.215
Urgent	8 (14)	7 (21)	1 (4)	0.071
Emergent	6 (11)	3 (9)	3 (13)	0.137

Abbreviations: AD, aortic dissection; CP, Candy-Plug.

Fifty-four (95%) patients were treated simultaneously with TEVAR in the TL to the coeliac trunk before CP-placement. Of these; 33 (97%) patients with CP I vs 21 (91%) patients with CP II/III, p=0.449. Fenestrated/branched aortic arch stent-grafts were used in 25 (44%) patients; 14 (41%) patients in CP I group vs 11 (48%) patients in CP II/III group, p=0.447. Left common carotid artery (LCCA) to left subclavian artery bypass was done for 32 (56%) patients; 21 (62%) patients in CP 1 group vs 11 (48%) patients in CP II/III group, p=0.620.

Central lumen occlusion in CP I group was performed using a 22-mm AVP and a 20-mm Iliac ZIP in 11/34 (32%) and 23/34 (68%) patients, respectively.

Additional intraprocedural FL embolization at the CP level was needed in 2 (4%) patients; 1 (3%) patient in CP I group vs 1 (4%) patient in CP II/III group, p=0.536, due to persisting false lumen backflow on final angiography.

The mean operating time was 169±76 minutes (170±97 minutes in CP I group vs 163±90 minutes in CP II/III group, p=0.453). The mean fluoroscopy time was 30±18 minutes (29±16 minutes in CP I group vs 37±27 minutes in CP II/III group, p=0.172). The mean radiation dose area product was 313±443 Gy·cm² (355±533 Gy·cm² in CP I group vs 238±339 Gy·cm² in CP II/III group, p=0.370). The mean contrast volume was 161±52 mL (162±50 mL in CP I group vs 159±56 mL in CP II/III group, p=0.881).

Technical success was achieved in 57 (100%) patients. Clinical success was achieved in 54 (95%) patients; 33 (97%) in CP I group vs 21 (91%) patients in CP II/III group, p=0.116.

The mean hospital stay was 10±8 days (9±5 days in CP I group vs 13±9 days in CP II/III group, p=0.102). The longer hospital stay was not related to the CP procedure but to the complexity of the proximal repair in both groups. Table 3 summarizes the procedural details of all patients with CP and CP I group vs CP II/III group.

Table 3.

Procedure Details of All Patients CP and CP I Group vs CP II/III Group.

Variables	All Patients, n=57 (%) or Mean ± SD	CP I, n=34 (%) or Mean ± SD	CP II/III, n=23 (%) or Mean ± SD	p
TEVAR with FL occlusion	54 (95)	33 (97)	21 (91)	0.449
F/B-TEVAR	25 (44)	14 (41)	11 (48)	0.477
LCCA-LSA bypass	32 (56)	21 (62)	11 (48)	0.620
FL backflow at level of CP in final angiography	2 (4)	1 (3)	1 (4)	0.536
Adjuvant periprocedural FL embolization at CP level	2 (4)	1 (3)	1 (4)	0.536
Adjuvant periprocedural FL embolization beyond CP level	4 (7)	1 (3)	3 (13)	0.137
Total operating time (min)	169±76	170±97	163±90	0.453
Total fluoroscopy time (min)	30±18	33±16	27±23	0.172
Amount of contrast used (mL)	161±52	162±50	159±56	0.881
Dose area product (Gy·cm²)	313±443	355±533	238±339	0.370
Technical success	57 (100)	34 (100)	23 (100)	0.850
Clinical success	54 (95)	33 (97)	21 (91)	0.116
Hospital stay (d)	10±8	9±5	13±9	0.102

Abbreviations: CP, Candy-Plug; F/B-TEVAR, fenestrated and branched thoracic endovascular aortic repair; FL, false lumen; LCCA, left common carotid artery; LSA, left subclavian artery; TEVAR, thoracic endovascular aortic repair.

The 30-day mortality rate was (4%; 2/57); 1 (3%) patient died in CP I group due to stroke vs 1 (4%) patient in CP II/III group due to retrograde TAAD with pericardial effusion and lung dystelectasis that was not related to the CP procedure, p=0.828.

Fifteen (26%) patients had early adverse events. Of these, 9 (26%) patients in CP I group vs 6 (26%) patients in CP II/III group, p=0.883. Early adverse events after CP I included (1) 1 intermittent partial spinal cord ischemia, (2) 1 acute renal insufficiency, (3) 1 stroke, and (4) 6 wound complications (2 cervical hematomas, 2 infections, 1 pseudoaneurysm, 1 lymph fistula). Early adverse events after CP II/III included (1) 1 intermittent partial spinal cord ischemia, (2) 1 hypertensive crisis, (3) 1 arrhythmia, (4) 1 acute respiratory distress syndrome with prolonged weaning, and (5) 2 wound hematomas.

The 30-day CTA confirmed successful CP placement at the intended level in all patients within both groups. Early complete FL occlusion was achieved in 50 (88%) patients; 30 (88%) patients in CP I group vs 20 (87%) in CP II/III group, p=0.894.

Early (30-day) CP-related reintervention occurred in 3 (5%) patients. Of these, 1 (3%) patient in CP I group vs 2 (9%) patients in CP II/III group, p=0.317. All 3 reinterventions were coil embolization due to retrograde flow around the CP. There was no flow through the central part of the CP. Early (30-day) stent-graft related re-intervention rate was 4 (7%) patients; 3 (9%) patients in CP I group vs 1 (4%) patient in CP II/III group, p=0.379. Reintervention in CP I group included (1) 1 proximal stent-graft extension to treat type I endoleak, (2) 1 chimney graft of the left common carotid artery (LCCA) due to intentional coverage detected on early postoperative CTA, and (3) 1 aortic valve repair and frozen elephant trunk repair due to retrograde TAAD. Reintervention in CP II/III included 1 patient with type I endoleak that was treated through LCCA–left subclavian artery bypass and proximal stent-graft extension. Planned distal aortic extension with fenestrated/branched stent-grafts during follow-up due to abdominal false lumen aneurysm was done in 4 (7%) patients; 2 (6%) in CP I group vs 2 (9%) patients in CP II/III group, p=0.142. Table 4 summarizes the early mortality, morbidity, and early CTA results.

Table 4.

Early Outcome and Follow-up Aortic Remodeling of All Patients CP and CP I Group vs CP II/III Group.

Variables	All Patients, n=57 (%) or Mean ± SD	CP I, n=34 (%) or Mean ± SD	CP II/III, n=23 (%) or Mean ± SD	p
Early death	2 (4)	1 (3)	1 (4)	0.828
Early adverse events	15 (26)	9 (26)	6 (26)	0.883
Early complete FL occlusion (CTA)	50 (88)	30 (88)	20 (87)	0.894
Early reintervention	7 (12)	4 (12)	3 (13)	0.615
CP related	3 (5)	1 (3)	2 (9)	0.317
Aortic stent-graft related	4 (7)	3 (9)	1 (4)	0.379
Planned distal extension F/B-EVAR	4 (7)	2 (6)	2 (9)	0.142
Last aortic diameter (mm)	49±9	52±12	46±8	0.090
Aortic aneurysm sac
Decrease (remodeling)	34/44 (77)	25/30 (83)	9/14 (64)	0.197
Increase	1/44 (2)	0	1/14 (7)	0.185
Stable	9/44 (20)	5/30 (17)	4/14 (29)	0.741

Abbreviations: CP, Candy-Plug; CTA, computed tomography angiography; F/B-EVAR, fenestrated/branched endovascular aortic repair.

Follow-up CTA of at least 6 months was available in 44 (77%) patients. Of these, 30 (88%) patients in CP I group with mean follow-up 29±17 months vs 14 (61%) patients with mean follow-up 14±5 months in CP II/III group. The mean diameter of thoracic aneurysm at last follow-up was 49±9 mm; 52±12 mm in CP I group vs 46±8 mm in CP II/III group, p=0.090.

Thoracic aortic remodeling was achieved in 34/44 (77%) patients; 25/30 (83%) patients in CP I group vs 9/14 (64%) patients in CP II/III group, p=0.197. And, the aneurysm size remained stable in 9/44 (20%) patients; 5/30 (17%) patients in CPI group vs 4/14 (29%) patients in CP II/III group, p=0.741. The thoracic aneurysm increased size was seen in 1/44 (2%) patient. This patient was in CP II/III group. Figure 2 summarizes the fate of thoracic aneurysm sac in both groups.

Discussion

Retrograde FL perfusion with its impact on aortic remodeling is the Achilles heel of TEVAR in patients with chronic AD.^1,17,19 A failure rate of 35% and 38% is reported in TEVAR for chronic AD.^20,21 To overcome this problem, the CP technique has been used with a variety of designs to occlude the distal false lumen.^10–13

This study reports favorable aortic remodeling after CP embolization for chronic AD with aneurysmal evolution. Aortic remodeling was achieved in 77% of patients, and, 20% had stable aneurysm size. In addition, only 5% patients were required early further embolization. Hofferberth et al²² reported 60% aortic remodeling and 90% decrease or stabilization with coil embolization of FL in chronic AD. Others reported 78% and 65% of complete FL thrombosis.^23,24 Cleveland Clinic group published about embolization of the FL using an iliac occluder with thrombosis achieved in 90% after 19% further embolization.^8,25 A limiting factor for FL occlusion-techniques is the diameter of distal thoracic FL as the maximum diameter of a commercially available iliac occluders and other materials is 24 mm. The custom-made CP has been manufactured with a maximum diameter of 50 mm offering FL occlusion of much larger diameters.

Compared with the earlier generation the new CP II/III design includes a self-closing mechanism without the need of an additional procedural step to close the central channel of CP I. However, there was no difference in procedure time, fluoroscopy time and radiation dose detected in this study between device generations. This can be explained by the fact that the procedural step of CP deployment, which is improved in the newer device designs, constitutes a relative short part of the overall procedure, which included complex endovascular aortic arch TEVAR in almost half of the patients.

Technical feasibility, clinical success, and early complete FL thrombosis of CP technique were reported previously in smaller series of our group.^14,15 This study confirmed the high rate of technical success (100%), clinical success (95%) and early complete FL thrombosis (88%) of CP technique using different generations, CP I to CP III, in a larger sample of patients than previous reports. Prompt reintervention in patients with contrast enlargement at distal FL with aneurysm growth is recommended to avoid continued FL pressurization and risk of rupture. Morbidity and mortality in CP I and CP II/III groups were low and not related to the CP technique itself.

Persistent retrograde FL perfusion can prevent thoracic FL thrombosis, jeopardizing spinal cord preconditioning after proximal entry tear coverage and possibly explaining the higher SCI incidence in fenestrated/branched repair in postdissecting thoracic abdominal aortic aneurysms despite staging.¹⁸ In 4 patients with additional abdominal FL aneurysm, the CP technique was used as a staging procedure to exclude the thoracic FL and lower the risk of spinal cord ischemia during subsequent F/B EVAR as recently described by Carta et al.¹⁶

The limitations of this study include its retrospective nature and the small number of patients for comparison according to CP generation. We did not have data on the number of small branches that may have played a role in the FL thrombosis.²⁶ A multicentric larger cohort with a longer follow-up is warranted to confirm our single-center experience of CP technique and its effect on aortic remodeling in chronic AD.

Conclusion

The CP technique is technically feasible with a low mortality and morbidity. High aortic remodeling and FL thrombosis rates support the concept of FL occlusion in subacute and chronic AD.

Footnotes

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Tilo Kölbel has intellectual property with Cook Medical, receives royalties, research, travel and educational grant, speaking fees and is consultant and proctor with Cook Medical. Nikolaos Tsilimparis receives travel and educational grants, speaking fees, and is proctor with Cook Medical.

Funding

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

ORCID iDs

Ahmed Eleshra

Fiona Rohlffs

Konstantinos Spanos

Giuseppe Panuccio

Franziska Heidemann

Tilo Kölbel

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