Early experience with a modified preloaded system for fenestrated endovascular aortic repair.
OBJECTIVE
Preloaded endovascular delivery systems expand the anatomic eligibility for complex aortic repair by requiring only one iliac access vessel and providing a stable platform for guiding sheaths into challenging target vessels. This article reports the lessons learned and early clinical outcomes using a modified preloaded delivery system for fenestrated endovascular aneurysm repair (FEVAR) in three aortic centers in Europe.


METHODS
From October 2015 to March 2016, consecutive patients presenting with extensive aortic aneurysm treated with a modified preloaded FEVAR were prospectively enrolled from three high volume European aortic centers. The new design is a modification of previous designs of preloaded fenestrated stent grafts and of the p-branch device platform. The technical details of implantation are described and perioperative outcomes, including the learning curve, are collected and reported.


RESULTS
All patients (30 patients; 80% men; 70.2 years old) presented for nonurgent repair of either a type Ia endoleak (3/30; 10%), a type I-II-III thoracoabdominal (8/30; 27%), or a type IV thoracoabdominal or pararenal (19/30; 63.%) aneurysm repair of a mean size of 64 ± 13 mm using a custom made device. Primary technical success was achieved in 28 of 30 patients (93%) and assisted primary technical success in 29 of 30 patients (97%). The two technical failures included open conversion to repair a ruptured iliac artery and restenting of a dissected superior mesenteric artery which was recognized hours after the index procedure had finished. The mean procedure time was 277 ± 153 minutes, fluoroscopy time 79 ± 36 minutes, dose area product 112 ± 90 Gy cm2, and contrast volume 87 ± 46 mL. All renal fenestrations were successfully stented without type III endoleak on completion angiogram; the preloaded guiding sheaths were used for 53 of 58 renal arteries (91%). Challenges related to learning to the use of the modified preloaded system were experienced early and had no clinical consequences. Major complications occurred in seven cases (23%), including two perioperative deaths because of stroke and sepsis following primary conversion attributable to iliac rupture. There were no target vessel occlusions or type I/III endoleaks found on postoperative imaging.


CONCLUSIONS
Based on early experience, the modified preloaded system can be safely and effectively used during FEVAR, with good technical result and a short period of learning. This device expands treatment to patients with compromised iliac access, thus, additional patients and more follow-up will be required to determine unique risks of operating in this patient population.
Aortic Team, Royal Free London National Health Service Foundation Trust, London, United Kingdom.
Blandine
B
Maurel
Vascular Center, Malmo University Hospital, Malmo, Sweden.
Tim
T
Resch
Aortic Center, Hôpital Cardiologique, Centre Hospitalier Régional Universitaire de Lille, Lille, France.
Rafaelle
R
Spear
Med Institute, Cook Medical, Inc, West Lafayette, Ind.
Blayne
B
Roeder
Vascular Center, Malmo University Hospital, Malmo, Sweden.
Umberto M
UM
Bracale
Aortic Center, Hôpital Cardiologique, Centre Hospitalier Régional Universitaire de Lille, Lille, France.
Stephan
S
Haulon
Aortic Team, Royal Free London National Health Service Foundation Trust, London, United Kingdom. Electronic address: tara.mastracci@nhs.net.
Tara M
TM
Mastracci
D000368:Aged; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002983:Clinical Competence; D057867:Endoleak / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000601:surgery*; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D005260:Female; D006801:Humans; D059032:Learning Curve; D008297:Male; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome