Experimental Assessment of Physician Modified Proximal Scalloped Stent Graft to Extend Proximal Landing Zone in the Aortic Arch

Faure, Élodie; Khantalin, Ilya; Peyron, Pierre-Antoine; Canaud, Ludovic; Marty-Ané, Charles-Henri; Alric, Pierre

doi:10.1016/j.ejvs.2017.04.019

Cited by 5 publications

(4 citation statements)

References 24 publications

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Section: Methodsmentioning

confidence: 99%

“…This clinical work was supported by an experimental feasibility study in human cadaveric aortas implanted with PMEGS to extend the proximal landing zone to the aortic arch while preserving flow in the supra-aortic vessels. 16 Patients with zone 2 aortic lesions were considered candidates for TEVAR using a scalloped or fenestrated PMEG if the proximal and distal aortic neck diameters were <40 mm and the landing zones at least 15 mm in length. The minimal acceptable length of healthy proximal aorta between the LCCA and the proximal edge of the lesion was 15 mm; otherwise, the lesion was considered to be in zone 1.…”

Section: Study Design and Patient Samplementioning

confidence: 99%

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Midterm Follow-up of Fenestrated and Scalloped Physician-Modified Endovascular Grafts for Zone 2 TEVAR

Chassin-Trubert

Mandelli²,

Ozdemir

et al. 2019

J Endovasc Ther

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Purpose: To investigate the midterm outcomes of scalloped or fenestrated physician-modified endovascular grafts (PMEGs) for zone 2 thoracic endovascular aortic repairs (TEVAR). Materials and Methods: Between November 2013 and May 2019, 54 consecutive patients (mean age 63 years; 41 men) were treated with thoracic PMEGs modified with 7 scallops or 47 fenestrations for the left subclavian artery (LSA). Indications for aortic repair were acute complicated type B aortic dissection (17, 31%), degenerative aneurysm (13, 24%), acute traumatic rupture of the aortic isthmus (9, 16%), post chronic dissection aneurysmal evolution (8, 15%), penetrating aortic ulcer (3, 6%), intramural hematoma (2, 4%), and floating thrombus (2, 4%). Results: Technical success was 94%; 3 (6%) LSAs were unintentionally covered. An intraoperative type Ia endoleak was treated during the index procedure. One (2%) patient suffered spinal cord ischemia, with irreversible bilateral paraplegia. Three (6%) patients experience postoperative minor strokes with full neurological recovery. Four (7%) patients died in the perioperative period; 2 (2%) were due to aneurysm rupture. Mean follow-up was 26±16 months; 15 (28%) patients had at least 3 years of follow-up. Two (4%) type II endoleaks were identified and successfully treated (4% reintervention rate); no other endoleaks were identified. All the LSAs remained clinically and radiologically patent. There were no conversions to open repair, ruptures, retrograde dissection, stent fracture, migrations, or other aortic complications. Conclusion: Scalloped or single-fenestrated PMEGs for the LSA appear to be durable and safe in the midterm. Combined with low periprocedural morbidity and mortality, these results suggest that this approach can be considered as an off-label alternative to extend proximal seal to zone 2 for TEVAR. Further studies with a larger number of patients and long-term outcomes are needed to fully validate this approach.

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Section: Methodsmentioning

confidence: 99%

Section: Study Design and Patient Samplementioning

confidence: 99%

Midterm Follow-up of Fenestrated and Scalloped Physician-Modified Endovascular Grafts for Zone 2 TEVAR

Chassin-Trubert

Mandelli²,

Ozdemir

et al. 2019

J Endovasc Ther

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“…There are studies reporting the application of Bolton (Bolton Medical, Sunrise, FL, USA), the deployment system of the Gore device (WL Gore & Associates, Inc., Flagstaff, AZ, USA), and Medtronic (Bolton Medical, Sunrise, FL, USA) as f-SMSGs (homemade fenestrated stent-graft, physician-modified fenestrated stent-graft), while none of these abovementioned devices had reported durability after modification, namely, durability after damage to the fabric in their instructions for use (IFU). Several benchtop experiments had been carried out to evaluate the safety and fabric durability after modification, and no malfunction or rapid deterioration was reported, while pathological changes bring about more sophisticated hemodynamic and biomechanical conditions ( 24 , 25 ). Several studies reported promising outcomes after TEVAR with f-SMSGs for aortic arch pathologies, including type A/B aortic dissections, degenerative aneurysms, and penetrating aortic ulcers ( 26 – 28 ).…”

Section: Discussionmentioning

confidence: 99%

Outcomes of thoracic endovascular aortic repair with fenestrated surgeon-modified stent-graft for type B aortic dissections involving the aortic arch

Zhang²,

Song³

et al. 2023

Front. Cardiovasc. Med.

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ObjectivesThis retrospective analysis aimed to evaluate the early and midterm outcomes of thoracic endovascular aortic repair (TEVAR) with fenestrated surgeon-modified stent-graft (f-SMSG) for type B aortic dissections (TBAD) involving the aortic arch.MethodsFrom March 2016 to April 2021, 47 consecutive patients were treated using TEVAR with f-SMSG. All patients were diagnosed with TBAD involving the aortic arch.ResultsIn total, 47 patients with TBAD involving the aortic arch were treated with f-SMSGs. There were 21 zone 1 and 26 zone 2 TEVAR, and 65 arteries were revascularized successfully with fenestrations. Technical success was achieved in 46 patients (97.88%). The 30-day estimated survival (± SE) and reintervention was 93.6 ± 1.0% (95% Confidence Interval [CI], 92.6–94.6%) and 91.5 ± 1.2% (95% CI, 90.3–92.7%), respectively. During a median follow-up of 51 months (range, 16–71 months), 1 patient died of rupture of aortic dissection (AD) and 3 patients died of non-aortic-related reasons. Reintervention was performed for four patients, including two patients of type IA entry flow and two patients of type IB entry flow. No occlusion of the supra-aortic trunk was observed. The estimated survival and reintervention (± SE) at 4 years was 88.7 ± 1.4% (95% CI, 87.3–90.1%) and 84.8 ± 1.5% (95% CI, 83.3–86.3%), respectively.ConclusionThoracic endovascular aortic repair with f-SMSG is an alternative treatment option for TBAD involving the aortic arch in high-volume centers.

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“…Although the technique described is reproducible, the Montpellier group has extensive experience in physician modification of thoracic stent-grafts. Before the total endovascular aortic arch repair series described, the unit gained experience by performing experimental and clinical studies of proximal scalloped PMEGs, 20,21 followed by single fenestrated PMEGs for zone 2 TEVAR, 19 and, finally, single fenestrated PMEGs for TEVAR of zone 0 and zone 1 aortic lesions, combined with cervical debranching procedures. 22 After the initial experience with the double fenestrated technique, the group studied the incorporation of a preloaded guidewire using bench top cadaveric flow models.…”

Section: Journal Of Vascular Surgerymentioning

confidence: 99%

Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients

Chassin-Trubert

Gandet

Lounes

et al. 2021

Journal of Vascular Surgery

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Objective: Our aim was to evaluate the early-and medium-term outcomes of using double fenestrated physicianmodified endovascular grafts (PMEGs) for total endovascular aortic arch repair.Methods: The present single-center retrospective analysis of prospectively collected data included 50 patients from January 2017 through October 2019, who had undergone thoracic endovascular aortic repair (TEVAR). The fenestrations were a proximal larger fenestration that incorporated the brachiocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented.Results: The median duration for stent graft modification was 26 6 6 minutes. Of the 50 patients, 41 were men. The mean patient age was 68 6 11.5 years. The indications for treatment included degenerative aortic arch aneurysm (n ¼ 17), dissecting aortic arch aneurysm after type A dissection (n ¼ 13), type B dissection (n ¼ 13), aortic ulcer (n ¼ 3), and other pathologies (n ¼ 4). The technical success rate was 94% (47 of 50) overall, and 100% (28 of 28) after a technical modification incorporating a preloaded guide wire for the LSA fenestration (P < .05). The 30-day mortality was 2% (n ¼ 1). Two patients (4%) had a minor stroke with full recovery. One patient (2%) had a type IB and two patients (4%) had a type II endoleak from the LSA. Four patients (8%) required reintervention: one because of a type IB endoleak and three because of access-related complications. All supra-aortic trunks were patent. During a mean follow-up of 16 6 8.3 months, no conversions to open surgical repair were required and no aortic rupture, paraplegia, or retrograde dissection occurred.Conclusions: Using double fenestrated PMEGs for TEVAR is both feasible and effective for total endovascular aortic arch repair, avoiding the need for anatomic and extra-anatomic surgical revascularization. The absence of brachiocephalic trunk stenting was not associated with endoleaks or treatment failure and resulted in a lower stroke risk than alternative strategies. The midterm results suggest that stenting of the brachiocephalic trunk and right common carotid artery might not be necessary for a large proportion of patients undergoing total endovascular aortic arch repair. The persistence of the seal and ongoing durability require assessment in studies with long-term follow-up data available.

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Experimental Assessment of Physician Modified Proximal Scalloped Stent Graft to Extend Proximal Landing Zone in the Aortic Arch

Abstract: PMSG to extend the proximal landing zone in zone 2, 1, or 0 in order to treat urgent diseases of the proximal descending aorta or the inner circumference of the aortic arch by a totally endovascular approach while preserving flow in the supra-aortic trunks is experimentally feasible.

Cited by 5 publications

References 24 publications

Midterm Follow-up of Fenestrated and Scalloped Physician-Modified Endovascular Grafts for Zone 2 TEVAR

Midterm Follow-up of Fenestrated and Scalloped Physician-Modified Endovascular Grafts for Zone 2 TEVAR

Outcomes of thoracic endovascular aortic repair with fenestrated surgeon-modified stent-graft for type B aortic dissections involving the aortic arch

Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients

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