Improved effectiveness of the repositionable GORE EXCLUDER AAA endoprosthesis featuring the C3 delivery system compared with the original GORE EXCLUDER AAA endoprosthesis for within the instructions for use treatment of aortoiliac aneurysms

Tsolakis, Ioannis A.; Kakkos, Stavros K.; Papageorgopoulou, Chrysanthi P.; Zampakis, Peter; Kalogeropoulou, Christina; Papadoulas, Spyros; Lampropoulos, George; Nikolakopoulos, Konstantinos M.; Ntouvas, Ioannis; Kouri, Anastasia

doi:10.1016/j.jvs.2018.05.013

Cited by 16 publications

(8 citation statements)

References 15 publications

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“…Valve delivery and deployment was successful at first pass in all cases. Previous studies have confirmed the 29 mm Edwards SAPIEN XT and SAPIEN 3 valves passed easily through the shorter 33 cm 26Fr Gore Dryseal sheath and bench testing in our cohort had confirmed this was similar in the longer 65 cm sheath. This has also been validated in a recently published communication, although the authors of this report indicated use of the 22Fr delivery system which we found suitable only for the 23 mm diameter valve.…”

Section: Discussionsupporting

confidence: 84%

“…Therefore, there are clear potential advantages of a longer large bore delivery sheath to facilitate valve delivery, not least the possibility of avoiding the in vivo balloon loading required with the SAPIEN XT and SAPIEN 3. The Dryseal sheath (Gore and Associates, Flagstaff, AZ) is a hydrophilic, flexible kink‐resistant delivery sheath designed primarily for delivery of vascular endografts in the setting of abdominal and thoracic aortic aneurysms . We describe our experience using this sheath to facilitate delivery of the Edwards SAPIEN XT and SAPIEN 3 valves to the dysfunctional RVOT in patients requiring pulmonary valve replacement.…”

Section: Introductionmentioning

confidence: 99%

“…The Dryseal sheath (Gore and Associates, Flagstaff, AZ) is a hydrophilic, flexible kink-resistant delivery sheath designed primarily for delivery of vascular endografts in the setting of abdominal and thoracic aortic aneurysms. 7 We describe our experience using this sheath to facilitate delivery of the Edwards SAPIEN XT and SAPIEN 3 valves to the dysfunctional RVOT in patients requiring pulmonary valve replacement.…”

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confidence: 99%

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Use of 65 cm large caliber Dryseal sheaths to facilitate delivery of the Edwards SAPIEN valve to dysfunctional right ventricular outflow tracts

Kenny

Morgan

Murphy

et al. 2019

Cathet Cardio Intervent

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Background The Edwards SAPIEN valve and its delivery system may complicate transit through the right heart during transcatheter pulmonary valve replacement (tPVR). We report our early experience using a large diameter, 65 cm delivery sheath to facilitate delivery of the SAPIEN valve to the right ventricular outflow tract (RVOT). Methods Retrospective analysis of all patients from three large congenital heart centers undergoing tPVR with the Edwards SAPIEN valve delivered with the 65 cm Gore Dryseal Sheath. Results Over a 12 month period, 30 patients (17 female) with median age 17.5 years (range 8–72) underwent attempted tPVR with the SAPIEN valve delivered using the 65 cm Dryseal sheath (20–26Fr). All procedures resulted in successful valve delivery to the target area. Twenty patients had a native RVOT. The most commonly used valve diameter was 29 mm (n = 15) with the majority of cases requiring a 26Fr Dryseal sheath (n = 20). One patient with severe RVOT stenosis underwent prestenting. Median procedure time was 100 min (59–225). No patient had increase in tricuspid valve regurgitation as a consequence of valve delivery. One patient required a synchronous cardioversion for intraprocedural VT and another required ECMO postprocedure due to severe pre‐existing left ventricular dysfunction. On median follow‐up of 5 months, all patients had mild or less pulmonary regurgitation. Median peak Doppler velocity across the pulmonary valve was 2.2 m/s (1.7–4). There were no clinically relevant complications relating to vascular access. Conclusions Using 65 cm Dryseal sheaths facilitates delivery of SAPIEN valves in patients with dysfunctional RVOTs.

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Section: Discussionsupporting

confidence: 84%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Use of 65 cm large caliber Dryseal sheaths to facilitate delivery of the Edwards SAPIEN valve to dysfunctional right ventricular outflow tracts

Kenny

Morgan

Murphy

et al. 2019

Cathet Cardio Intervent

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“…One of the main assets of the Conformable device is the repositionability featuring the C3 delivery system. A retrospective analysis of 2018 ( 49 ) showed that the repositionable GORE EXCLUDER when used in combination with the C3 delivery system had critical safety properties, including precise placement relative to the renal arteries and equivalent long-term efficacy.…”

Section: Resultsmentioning

confidence: 99%

Endografts for the treatment of abdominal aortic aneurysms with a hostile neck anatomy: A systematic review

2022

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BackgroundEndovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs) has emerged as a better alternative to conventional open surgery for AAAs. The purpose of the review is to define the improvement in the clinical management of the patient with hostile neck AAAs due to the introduction of new endografts while giving a thorough description of their instructions for use (IFUs), main characteristics and part sizing, reporting their outcomes from clinical studies and categorizing their usability.MethodsA MEDLINE search was conducted using keyword-specific combinations. Clinical studies were searched via the clinicaltrials.gov website. Relevant articles' references were also hand-searched.ResultsWe retrieved 640 records describing Alto, Ovation iX, Treovance, Aorfix, Anaconda, Conformable, and Endurant II/IIs endografts. Aortic necks >60° can be managed with Anaconda, Aorfix, and Conformable, which can treat up to 90° necks requiring ≥15 mm (Anaconda ≥20 mm), and Treovance, which is eligible for necks ≤75° with ≥15 mm length. Ovation's innovation of combining polymer-filled O-rings with integral anchors can treat conical necked AAAs giving Ovation iX and Alto an advantage. Short-necked AAAs can be treated with Alto, eligible for necks as short as 7 mm, and Endurant II, which can treat ≥10 mm necks or 4 mm if used in conjunction with the EndoAnchors system, respectively. Alto and Conformable report a 100% technical success rate, absence of AAA-related death, migration, ruptures, and limb occlusion during follow-up. Endurant II and Ovation iX report >99% technical success rate and are almost free from the AAA mortality rate, ruptures, migration, and limb occlusion, while Ovation iX has a high rate of sac dilation (15.5%) in a 5-year follow-up. Anaconda is slightly better than Aorfix and Treovance, which are related to the lowest technical success rates, 98.3%, 96.3%, and 96%, respectively. Aorfix has the highest AAA mortality rate, 4% in a 60 month follow-up.ConclusionMost new generation endografts described have comparable results. They broaden the eligibility of patients for EVAR due to their unique technical characteristics described. There is a lack of comparative studies for newer endografts and postmarket clinical studies with long-term results concerning the most recently approved devices described, Alto and Conformable.

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“…The newly introduced device, Gore Excluder Conformable AAA Endoprosthesis with active control (CEXC) system (W. L. Gore & Associates, Flagstaff, Arizona, USA) has been designed to address these issues. 7 The active control system enables repositioning and adaptability of the device to the native aortic wall, thereby facilitating optimal wall apposition and aggressive infrarenal positioning. This, in turn, maximises the likelihood of achieving seal in complex aortic geometries and avoids early and late type 1aEL.…”

Section: Introductionmentioning

confidence: 99%

Endovascular aneurysm repair using the Gore Excluder Conformable Abdominal Aortic Aneurysm Endoprosthesis with active control system in octogenarians with highly angulated aneurysm neck: a UK single-centre experience

Elsharkawy,

Mahmood,

Sirinivasamurthy

et al. 2023

J.Vasc.Soc.G.B.Irel

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Objective: Abdominal aortic aneurysm (AAA) with highly angulated neck (>60°) in octogenarians represents a challenge to treatment with endovascular aneurysm repair (EVAR). In such cases, EVAR may be used outside the manufacturer’s Instructions for Use and attendant higher risk of failure. The new device Gore Excluder Conformable AAA Endoprosthesis with active control (CEXC) system has been designed to achieve optimal aortic wall apposition and seal in these more challenging geometries. This study reports the initial results and technical success of this device in octogenarians with highly angulated aneurysm necks (>60°). Methods: All patients aged >80 years who had AAAs treated with the CEXC device at a single UK centre between January 2020 and July 2023 were analysed. The primary endpoint was technical success, which was defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, type I or III endoleaks or graft limb obstruction. The secondary outcomes included 30-day morbidity, mortality, endoleak and re-intervention rates. Results: Twenty patients were included (17 (75%) males) of median age 81 (range 80–84) years. The median AAA diameter was 60 (57–63) mm and the median infrarenal neck angulation was 80 (70–89)°. The active control system was used in six cases. The median procedural time was 277 (254–316) minutes. The immediate technical success rate was 95%, with one type Ia endoleak (5%). In the 30-day postoperative period, four complications were reported. On the 30-day follow-up CT scan, five type II endoleaks were observed and one initial type Ia endoleak had persisted at 30 days. No re-intervention was required during the first 30-day postoperative period. One hospital death occurred during the coronavirus disease 2019 pandemic; however, the death was unrelated to the surgery. Conclusions: EVAR with the CEXC device in octogenarians with hostile aortic neck anatomy is feasible inside the Instructions for Use, and shows satisfactory initial results.

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Improved effectiveness of the repositionable GORE EXCLUDER AAA endoprosthesis featuring the C3 delivery system compared with the original GORE EXCLUDER AAA endoprosthesis for within the instructions for use treatment of aortoiliac aneurysms

Abstract: Our study has demonstrated that the repositionable GORE EXCLUDER has important safety characteristics compared with the original device and equivalent long-term effectiveness. Additional benefit was obtained with the use of the Gore Dryseal introducer sheath.

Cited by 16 publications

References 15 publications

Use of 65 cm large caliber Dryseal sheaths to facilitate delivery of the Edwards SAPIEN valve to dysfunctional right ventricular outflow tracts

Use of 65 cm large caliber Dryseal sheaths to facilitate delivery of the Edwards SAPIEN valve to dysfunctional right ventricular outflow tracts

Endografts for the treatment of abdominal aortic aneurysms with a hostile neck anatomy: A systematic review

Endovascular aneurysm repair using the Gore Excluder Conformable Abdominal Aortic Aneurysm Endoprosthesis with active control system in octogenarians with highly angulated aneurysm neck: a UK single-centre experience

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