NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System.
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
01 02 2023
01 02 2023
Historique:
pubmed:
15
3
2021
medline:
9
2
2023
entrez:
14
3
2021
Statut:
ppublish
Résumé
To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch. The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks. Patients underwent transcatheter aortic arch repair with a single branch, 2 stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the 2 stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk, and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid-carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through 1 year. Survival analysis used the Kaplan-Meier method. Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients, while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5 (17.8%) had combined or other pathologies. At 1 month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all nondisabling), and combined mortality/stroke rate was 10.7%. One-year mortality was 10.7%, without device or aneurysm-related death. Two patients (7.1%) reported stroke or transient ischemic attack at 1 year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were 3 patients (10.7%) that had device-related unplanned reinterventions through 1 year. The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent 1 year safety and performance.
Sections du résumé
OBJECTIVE
To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch.
SUMMARY BACKGROUND DATA
The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks.
METHODS
Patients underwent transcatheter aortic arch repair with a single branch, 2 stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the 2 stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk, and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid-carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through 1 year. Survival analysis used the Kaplan-Meier method.
RESULTS
Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients, while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5 (17.8%) had combined or other pathologies. At 1 month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all nondisabling), and combined mortality/stroke rate was 10.7%. One-year mortality was 10.7%, without device or aneurysm-related death. Two patients (7.1%) reported stroke or transient ischemic attack at 1 year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were 3 patients (10.7%) that had device-related unplanned reinterventions through 1 year.
CONCLUSIONS
The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent 1 year safety and performance.
Identifiants
pubmed: 33714965
doi: 10.1097/SLA.0000000000004843
pii: 00000658-202302000-00055
doi:
Types de publication
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e460-e466Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The other authors declare no conflict of interests.
Références
Rommens KL, Estrera AL. Contemporary management of aortic arch aneurysm. Semin Thorac Cardiovasc Surg. 2019;31:697–702.
Gupta P, Harky A, Jahangeer S, et al. Varying evidence on deep hypothermic circulatory arrest in thoracic aortic aneurysm surgery. Tex Heart Inst J. 2018;45:70–75.
Czerny M, Schmidli J, Adler S, et al. Current options and recommendations for the treatment of thoracic aortic pathologies involving the aortic arch: an expert consensus document of the European Association for Cardio-Thoracic surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Eur J Cardiothorac Surg. 2019;55:133–162.
Pecoraro F, Lachat M, Cayne NS, et al. Mid-term results of chimney and periscope grafts in supra-aortic branches in high risk patients. Eur J Vasc Endovasc Surg. 2017;54:295–302.
Haulon S, Greenberg RK, Spear R, et al. Global experience with an inner branched arch endograft. J Thorac Cardiovasc Surg. 2014;148:1709–1716.
van Bakel TM, de Beaufort HW, Trimarchi S, et al. Status of branched endovascular aortic arch repair. Ann Cardiothorac Surg. 2018;7:406–413.
Diehm N, Vermassen F, van Sambeek MR, et al. Standardized definitions and clinical endpoints in trials investigating endovascular repair of aortic dissections. Eur J Vasc Endovasc Surg. 2013;46:645–650.
Kappetein AP, Head SJ, Genereux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013;145:6–23.
Chaikof EL, Blankensteijn JD, Harris PL, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35:1048–1060.
Roselli EE, Idrees JJ, Johnston DR, et al. Zone zero thoracic endovascular aortic repair: a proposed modification to the classification of landing zones. J Thorac Cardiovasc Surg. 2018;155:1381–1389.
Pecoraro F, Shingaki M, Steuer J, et al. Treatment of isolated ascending aortic aneurysm by off-pump epiaortic wrapping is safe and durable. Interact Cardiovasc Thorac Surg. 2016;23:286–291.
Sood V, Patel HJ, Williams DM, et al. Open and endovascular repair of the nontraumatic isolated aortic arch aneurysm. J Vasc Surg. 2014;60:57–63.
Chakos A, Jbara D, Yan TD, et al. Long-term survival and related outcomes for hybrid versus traditional arch repair-a meta-analysis. Ann Cardiothorac Surg. 2018;7:319–327.
Milewski RK, Szeto WY, Pochettino A, et al. Have hybrid procedures replaced open aortic arch reconstruction in high-risk patients? A comparative study of elective open arch debranching with endovascular stent graft placement and conventional elective open total and distal aortic arch reconstruction. J Thorac Cardiovasc Surg. 2010;140:590–597.
Bosiers MJ, Donas KP, Mangialardi N, et al. European multicenter registry for the performance of the chimney/snorkel technique in the treatment of aortic arch pathologic conditions. Ann Thorac Surg. 2016;101:2224–2230.
Anwar MA, Hamady M. Various endoluminal approaches available for treating pathologies of the aortic arch. Cardiovasc Intervent Radiol. 2020;43:1756–1769.
Tsilimparis N, Detter C, Law Y, et al. Single-center experience with an inner branched arch endograft. J Vasc Surg. 2019;69:977–985.e1.
Czerny M, Rylski B, Morlock J, et al. Orthotopic branched endovascular aortic arch repair in patients who cannot undergo classical surgery. Eur J Cardiothorac Surg. 2018;53:1007–1012.
Moulakakis KG, Mylonas SN, Markatis F, et al. A systematic review and meta-analysis of hybrid aortic arch replacement. Ann Cardiothorac Surg. 2013;2:247–260.
Kudo T, Kuratani T, Shimamura K, et al. Determining the optimal proximal landing zone for TEVAR in the aortic arch: comparing the occurrence of the bird-beak phenomenon in Zone 0 vs Zones 1 and 2. J Endovasc Ther. 2020;27:368–376.
Lee WA. Failure modes of thoracic endografts: prevention and management. J Vasc Surg. 2009;49:792–799.