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.

Self-occluding Candy-Plug: Implantation Technique to Obtain False Lumen Thrombosis in Chronic Aortic Dissections

“…6,7 Since the first description of this technique, improvements have been developed to the CP device to allow a better occlusion of the FL, avoiding persistent retrograde reperfusion, and limiting concerns about the possibility of narrowing the TL. 4,11 The first device was obtained with a back table modification of a 42 mm Zenith thoracic TX2 Pro-Form stent-graft (Cook Medical, Bloomington, Indiana). 1 After the initial proof of concept, the CP I was developed as a custom-made device, and feasibility studies reported good early outcomes with low morbidity and mortality.…”

“…Recent studies reported the feasibility of the CP III technique with low mortality and morbidity and a high rate of aortic remodeling. 4,7,15 Despite device improvements that allowed avoiding the need for central plug deployment steps and the increased conformability of the 3 nitinol stents to the false aortic wall with better occlusion rates, some possible technical pitfalls deserve further discussion. After implantation in the FL, the sleeve might remain in front of a FL originating reno-visceral arteries.…”

“…[1][2][3] Since its first report, in 2013 by Kölbel et al, 1 the CP technique has increasingly improved from homemade vascular plugs and offlabel devices to dedicated custom-made FL exclusion devices. 1,[4][5][6][7][8][9][10] The first CP generation (CP I) consisted of a doubletapered configuration with greater proximal and distal diameters and a small diameter in the central midsection, enabling the dilator tip retraction. This version required occlusion of the central channel with a plug increasing the procedure complexity.…”

“…The second CP generation (CP II) was based on the Cook Alpha nitinol platform and consisted of a nontapered stent-graft with an internal self-occluding un-stented fabric channel that did not require the deployment of the plug (Figure 1A). 4,7,[9][10][11] This version was soon abandoned due to regulatory problems related to the use of the Cook nitinol platform in dissections. Therefore, a third CP generation (CP III) was designed with the self-occluding un-stented fabric channel, called sleeve, at the distal end of the stent-graft (Figure 1B).…”

“…Therefore, a third CP generation (CP III) was designed with the self-occluding un-stented fabric channel, called sleeve, at the distal end of the stent-graft (Figure 1B). 4 The goal of this technical note is to describe the procedural steps of CP III deployment to obtain immediate occlusion of the distal sleeve and avoid possible interference of its distal end protruding in the abdominal FL.…”