Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358248
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-07
Brief Title:
Standardized Physician-modified Fenestrated Endograft Registry
Sponsor:
University Hospital Padova
Organization:
University Hospital Padova
Study Overview
Official Title:
Standardized Physician-modified Fenestrated Endograft Registry
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPHERE
Brief Summary:
Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia Medtronic Minneapolis MN-USA
Detailed Description:
INTRODUCTION
Abdominal aortic aneurysms AAA without an adequate proximal neck length for safe sealing and fixation with a standard EVAR may benefit from complex endovascular repair The most common are short neck AAA juxtapara-renal AAA and type IV thoracoabdominal aneurysm TAAA where incorporation of renal and visceral vessels is required to obtain an adequate proximal sealing Several endovascular options are available with the most effective being represented by incorporation of target vessels by custom-made or off-the-shelf fenestratedbranched endografts
Custom-made devices have shown excellent early and long-term outcomes but due to manufacturing time up to three months they can be used only for elective cases In urgent cases readily available off-the-shelf devices can be used but their anatomical feasibility is not exhaustive and may require long segment of aortic coverage above the celiac trunk Parallel aortic grafts with chimneys or periscopes have been proposed as a timely alternative however gutter endoleaks and lack of proximal sealing are serious concerns for these techniques especially for those cases where more than two target vessels need to be incorporated
In patients presenting with large aneurysm symptomatic or requiring urgent repair the use of physician-modified endograft PMEG represents a valid option It allows for a rapid customization of a standard abdominal or thoracic device with the creation of fenestrations scallops or branches based on patient aneurysm anatomical extent and target vessel position
However these techniques demand high level of skills and experience a recent review showed also that in the literature there is an extreme variability on indication to treatment type of aneurysm and extension type of graft and method of modification thus limiting the possibility to adequately analyze outcomes or drive comparison between different techniques
Here the investigators describe an initial experience on safety and feasibility of a standardized approach with PMEG based on specific anatomical selection criteria measurement method and a standard technique of modification using the Valiant Captivia Medtronic Minneapolis MN-USA thoracic endograft
BACKGROUND AND PRELIMINARY DATA
The vast majority of the literature on PMEG is based on the Cook platform Recently Chait et al reported the long term outcomes of more than 150 Cook PMEGs with excellent results in terms of early mortality freedom from aortic-related mortality and target instability especially for complex AAA compared to TAAA
There is only a single experience using Valiant Captivia PMEG Valiant in the version without free-flow In this experience the authors reported 18 cases after complete unsheathing the graft was introduced in a sterile aortic 3D model for precise fenestration allocation and then re-sheathed The investigators think that leaving the graft on its device may reduce the risk of infection reducing manipulation and contact with other materials as the the printed aortic model The other two case reports using the Valiant platform for the treatment of the paravisceral segment are from Gibello et al that used a Valiant Navion graft and Joseph et al that applied mini-cuff-augmented fenestration using Valiant Captivia
STANDARDIZED DEVICE MODIFICATION
The graft is modified on a sterile back-table in a hybrid operating room while the patient is prepared for general anesthesia A Valiant Captivia thoracic graft with free-flow either with tubular or tapered shape is fully deployed without releasing the free-flow that is maintained retained on its tip After that a vertical dotted line is drawn to mark the graft anterior 0 degree and fabric holes are performed with ophthalmologic cautery in the desired position taking care of not having graft struts within the fenestrations The fenestrations need to be nicely round ideally 6x6 mm for the renals and 8x8 mm for superior mesenteric artery SMA and celiac trunk CT and are reinforced with the tip of a 0018 guidewire V-18 Boston Scientific Marlborough Massachusetts-USA through a continuous 5-0 non-adsorbable locking suture Ti-cron Medtronic Minneapolis Minnesota-USA
A posterior constraining wire is created to temporarily reduce the diameter of the graft by 20-30 in order to allow partial rotation during the deployment phase The back of a 0018 guidewire is routed on the posterior aspect of the graft passing within the external suture of the struts thus not requiring fabric puncture the prolene used to reduce the diameter are tied around the stent struts and subsequently looped to the posterior wire The four 8 markers on the top of the graft are carefully removed with a scalpel one of these is modified as an S and re-sutured on the anterior aspect at 0 degree position with a 5-0 prolene continuous suture This S marker will allow anteroposterior graft orientation Finally the graft is re-sheathed with help of vessel loop
FOLLOW-UP
A postoperative CTA is required within 30 days Further follow-up follow-up is left to each center but ideally includes imaging follow-up at 6 12 24 months and yearly thereafter
Abdominal aortic aneurysms AAA without an adequate proximal neck length for safe sealing and fixation with a standard EVAR may benefit from complex endovascular repair The most common are short neck AAA juxtapara-renal AAA and type IV thoracoabdominal aneurysm TAAA where incorporation of renal and visceral vessels is required to obtain an adequate proximal sealing Several endovascular options are available with the most effective being represented by incorporation of target vessels by custom-made or off-the-shelf fenestratedbranched endografts
Custom-made devices have shown excellent early and long-term outcomes but due to manufacturing time up to three months they can be used only for elective cases In urgent cases readily available off-the-shelf devices can be used but their anatomical feasibility is not exhaustive and may require long segment of aortic coverage above the celiac trunk Parallel aortic grafts with chimneys or periscopes have been proposed as a timely alternative however gutter endoleaks and lack of proximal sealing are serious concerns for these techniques especially for those cases where more than two target vessels need to be incorporated
In patients presenting with large aneurysm symptomatic or requiring urgent repair the use of physician-modified endograft PMEG represents a valid option It allows for a rapid customization of a standard abdominal or thoracic device with the creation of fenestrations scallops or branches based on patient aneurysm anatomical extent and target vessel position
However these techniques demand high level of skills and experience a recent review showed also that in the literature there is an extreme variability on indication to treatment type of aneurysm and extension type of graft and method of modification thus limiting the possibility to adequately analyze outcomes or drive comparison between different techniques
Here the investigators describe an initial experience on safety and feasibility of a standardized approach with PMEG based on specific anatomical selection criteria measurement method and a standard technique of modification using the Valiant Captivia Medtronic Minneapolis MN-USA thoracic endograft
BACKGROUND AND PRELIMINARY DATA
The vast majority of the literature on PMEG is based on the Cook platform Recently Chait et al reported the long term outcomes of more than 150 Cook PMEGs with excellent results in terms of early mortality freedom from aortic-related mortality and target instability especially for complex AAA compared to TAAA
There is only a single experience using Valiant Captivia PMEG Valiant in the version without free-flow In this experience the authors reported 18 cases after complete unsheathing the graft was introduced in a sterile aortic 3D model for precise fenestration allocation and then re-sheathed The investigators think that leaving the graft on its device may reduce the risk of infection reducing manipulation and contact with other materials as the the printed aortic model The other two case reports using the Valiant platform for the treatment of the paravisceral segment are from Gibello et al that used a Valiant Navion graft and Joseph et al that applied mini-cuff-augmented fenestration using Valiant Captivia
STANDARDIZED DEVICE MODIFICATION
The graft is modified on a sterile back-table in a hybrid operating room while the patient is prepared for general anesthesia A Valiant Captivia thoracic graft with free-flow either with tubular or tapered shape is fully deployed without releasing the free-flow that is maintained retained on its tip After that a vertical dotted line is drawn to mark the graft anterior 0 degree and fabric holes are performed with ophthalmologic cautery in the desired position taking care of not having graft struts within the fenestrations The fenestrations need to be nicely round ideally 6x6 mm for the renals and 8x8 mm for superior mesenteric artery SMA and celiac trunk CT and are reinforced with the tip of a 0018 guidewire V-18 Boston Scientific Marlborough Massachusetts-USA through a continuous 5-0 non-adsorbable locking suture Ti-cron Medtronic Minneapolis Minnesota-USA
A posterior constraining wire is created to temporarily reduce the diameter of the graft by 20-30 in order to allow partial rotation during the deployment phase The back of a 0018 guidewire is routed on the posterior aspect of the graft passing within the external suture of the struts thus not requiring fabric puncture the prolene used to reduce the diameter are tied around the stent struts and subsequently looped to the posterior wire The four 8 markers on the top of the graft are carefully removed with a scalpel one of these is modified as an S and re-sutured on the anterior aspect at 0 degree position with a 5-0 prolene continuous suture This S marker will allow anteroposterior graft orientation Finally the graft is re-sheathed with help of vessel loop
FOLLOW-UP
A postoperative CTA is required within 30 days Further follow-up follow-up is left to each center but ideally includes imaging follow-up at 6 12 24 months and yearly thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None