Early outcomes with a single-sided access endovascular stent

Hofmann, Michael; Pecoraro, Felice; Planer, David; Pfammatter, Thomas; Puippe, Gilbert; Béttex, Dominique; Veith, Frank J.; Lachat, Mário; Chaykovska, Lyubov; Kolvenbach, Ralf; Brunkwall, Jan; Coppi, Gioacchino; Chiesa, Roberto; Silingardi, Roberto; Vecchiati, Enrico; Nessi, Franco; Sambeek, Marc van; Davidović, Lazar; Radak, Djordje

doi:10.1016/j.jvs.2017.11.069

Cited by 6 publications

(4 citation statements)

References 21 publications

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“…Few available devices do not require gate cannulation [4,5] or do have technical adjuncts to overcome cannulation issue [6,7]. However most of the devices on the market are bifurcated modular grafts that still require gate cannulation.…”

Section: Introductionmentioning

confidence: 99%

Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair

Pakeliani

Lachat

Blohmé

et al. 2020

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Summary: Background: To present a technique of sheath supported contralateral limb gate (CLG) cannulation of modular bifurcated stent-graft in endovascular abdominal aortic repair. Materials and methods: After totally percutaneous bilateral femoral access, the 9F introducer sheath is exchanged to a 30 cm 12 fr introducer sheath over a stiff wire contralateral to the intended main stent-graft insertion side and advanced into the aorta below the lowest renal artery. Parallel to the stiff wire within the sheath an additional standard J-tip guidewire with a 5 fr Pigtail angiographic catheter is advanced to the level of the renal arteries. After main body deployment, the 12 fr introducer sheath and J-tip wire with pigtail catheter are retracted until the CLG opening level, maintaining the stiff “buddy” wire in position to support the 12 fr sheath, maintaining its distal opening close to the contralateral gate opening to achieve easy cannulation. Results: Retrospective analysis of video archive from July 2016 to February 2018 evidenced 55 recorded EVAR cases. All CLG cannulations were obtained with Standard J-tip or Terumo Glidewire wires and with Pig-Tail or Berenstein catheters. Technical success was 100 %. Mean fluoroscopy time to accomplish CLG cannulation was 37.6 33 (range 1–105) seconds. The aortic carrefour angulation on coronal axis strongly correlates with cannulation time p = <.001, with longer cannulation time for higher carrefour angulations on coronal axis (Pearson correlation coefficient 0.47). Conclusions: The use of 12 fr sheath with parallel wire introduction technique, appears to be a safe and reliable tool to facilitate CLG cannulation during EVAR procedures.

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Section: Introductionmentioning

confidence: 99%

Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair

Pakeliani

Lachat

Blohmé

et al. 2020

Vasa

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“…However, this single-sided ultralow-profile stent graft (14F outer diameter) has been withdrawn from the market. 21 To date, the AFX endovascular AAA system seems the most appropriate device for spontaneous IAAS treatment because it fits the peculiar anatomic findings, and allows the exclusion of the false lumen and the associated aortic dilation.…”

Section: Discussionmentioning

confidence: 99%

“…However, this single-sided ultralow-profile stent graft (14F outer diameter) has been withdrawn from the market. 21…”

Section: Discussionmentioning

confidence: 99%

Outcome Analysis From a Multicenter Registry on Unibody Stent-Graft System for the Treatment of Spontaneous Infrarenal Acute Aortic Syndrome (MURUSSIAS Registry)

et al. 2022

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Purpose: This study reports the outcomes from a Multicenter Registry on unibody stent-graft system for the treatment of spontaneous infrarenal acute aortic syndrome (MURUSSIAS registry). Materials and methods: The retrospective MURUSSIAS registry included spontaneous infrarenal acute aortic dissection (IAAS) managed with the unibody stent-graft system (AFX endovascular AAA system; Endologix Inc., Irvine, California) outside the current instruction for use. IAAS considered aortic dissection (AD), intramural hematoma (IMH), and penetrating aortic ulcer (PAU). Indications to IAAS treatment were symptoms, associated dilated abdominal aorta (>3 cm), rapidly-growing (>0.5 cm/6 months) aorta, IAAS disease progression. Measured results were technical success, early (within 30 days) and midterm outcomes (after 30 days), including mortality, complications, symptoms recurrence, type I/III endoleak occurrence, stent-graft patency, survival, and freedom from reintervention. The mean follow-up was 22.12 ± 17 months. Results: The MURUSSIAS registry included 83 patients from 7 participating centers. IAAS indication to treatment were symptoms in 42 (51%). In 14 (17%) patients, the infrarenal aortic length was <80 mm, and in 28 (34%), the aortic bifurcation diameter was <16 mm. Technical success was 100%. Mortality occurred early in 1 (1%) and at the midterm in 3 (4%) patients. Complications occurred early in 10 (12%) patients (1 severe, 3 moderates, and 6 mild) and at midterm in 2 (2%) (2 moderate). No symptoms’ recurrence or type I/III endoleaks were registered. The 36-month estimated survival and freedom from reinterventions were 89% and 92%, respectively. Conclusions: The MURUSSIAS registry is the largest collection of spontaneous IAAS managed endovascularly using the AFX endovascular AAA system. The IAAS peculiar anatomic features were fitted with the used technique with excellent results. This treatment strategy might be considered in IAAS unless specifically-designed endovascular solutions will be available also in the emergent setting. Further studies are required to assess the longer-term performances and the stability of the reported technique. Clinical Impact The lack of specifically designed devices for infrarenal acute aortic syndrome (IAAS) disease remains an issue principally for its specific anatomic features. The MURUSSIAS registry retrospectively examined the outcomes of spontaneous IAAS treated using the unibody stent-graft system in a spontaneous national study; and reports the largest available data on this topic. The use of the unibody stent-graft system showed to fit the anatomic peculiarities of IAAS with excellent outcomes. This IAAS treatment strategy should be considered unless specifically designed endovascular solutions will be available.

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“…Branched graft devices for aortic arch diseases, including custom-made devices have gained recent attention. 24 , 25 , 26 , 27 , 28 , 29 In this study, we used a Bolton branched endograft that has a large gate, which significantly facilitates the cannulation of cervical devices into the inner tunnel within the main device. This study did not detect 30-day mortality and in-hospital deaths, which were reported by some other studies.…”

Section: Discussionmentioning

confidence: 99%

Early and midterm results of thoracic endovascular aortic repair using a branched endograft for aortic arch pathologies: A retrospective single-center study

et al. 2020

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Background: Zone 0 landing hybrid thoracic endovascular aortic repair (TEVAR) includes a few moderately invasive surgical procedures. To reduce invasiveness, TE-VAR with a branched aortic arch stent-graft can be considered. This study aimed to elucidate the effectiveness of performing TEVAR using a Bolton (Bolton Medical, Inc, Sunrise, Fla) branched endograft by analyzing early and midterm results.Methods: We enrolled 28 patients (mean age, 78.4 years) who underwent TEVAR with the Bolton branched endograft in Osaka University Hospital between October 2012 and June 2018 with a mean follow-up period of 4.0 years. Double-side and single-side branched devices were used in 24 (85.7%) and 4 (14.3%) patients, respectively.Results: All procedures were successful; no cases of endoleak or conversion to open repair were noted during the 30-day postoperative period. The perioperative stroke rate was 14.3% (4 out of 28); midterm stroke was not detected. All patients with perioperative stroke had atheroma grade !2 in the brachiocephalic artery. No type 1a endoleak was reported during the early or midterm results. The cumulative survival rate, aorta-related death-free rate, and aortic event-free survival rate at 5 years were 80.8%, 95.8%, and 81.6%, respectively. Conclusions:We achieved satisfactory early and midterm results by using a Bolton branched endograft for high-risk patients with arch pathologies except for high postoperative stroke. Although this treatment method is associated with postoperative stroke, performing strict evaluation of atheroma may prevent such complication. By preventing intraoperative stroke, TEVAR with this custom-made Bolton branched endograft may be considered a less-invasive treatment. (JTCVS Techniques 2020;4:17-25) Schematic of thoracic endovascular repair using the Bolton branched endograft. CENTRAL MESSAGEEarly and midterm results of thoracic endovascular aortic repair using a Bolton branched endograft show that preoperative strict atheroma evaluation is important for preventing postoperative stroke. PERSPECTIVEWhen using a custom-made Bolton branched endograft, it is essential to prevent perioperative stroke. The development of perioperative stroke may be prevented by performing a strict preoperative evaluation of atheroma. By preventing perioperative stroke, thoracic endovascular aortic repair using a custom-made Bolton branched endograft may become a less-invasive treatment.

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Early outcomes with a single-sided access endovascular stent

Abstract: The results of both the FIM and pivotal studies demonstrated that 39 of 40 procedures were successful for delivery and deployment of the Horizon stent graft. No MAE was registered during the follow-up. The primary safety and performance end points were met in both studies.

Cited by 6 publications

References 21 publications

Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair

Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair

Outcome Analysis From a Multicenter Registry on Unibody Stent-Graft System for the Treatment of Spontaneous Infrarenal Acute Aortic Syndrome (MURUSSIAS Registry)

Early and midterm results of thoracic endovascular aortic repair using a branched endograft for aortic arch pathologies: A retrospective single-center study

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