Roberto Silingardi1, Stefano Gennai1, Nicola Leone2, Mauro Gargiulo3, Gianluca Faggioli3, Piergiorgio Cao4, Fabio Verzini5, Arnaldo Ippoliti6, Nicola Tusini7, Carmelo Ricci8, Michele Antonello9, Roberto Chiesa10, Enrico Maria Marone11, Nicola Mangialardi12, Francesco Speziale13, Gian Franco Veraldi14, Stefano Bonardelli15, Luigi Marcheselli16. 1. Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Modena, Italy. 2. Department of Vascular Surgery, Ospedale Civile S. Agostino-Estense, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Modena, Italy. Electronic address: nicola.leone.md@gmail.com. 3. Vascular Surgery, Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna, Policlinico Sant'Orsola-Malpighi, Bologna, Italy. 4. Unit of Vascular Surgery, Hospital S. Camillo-Forlanini, Rome, Italy. 5. Unit of Vascular and Endovascular Surgery, Hospital S. Maria della Misericordia, University of Perugia, Perugia, Italy. 6. Unit of Vascular Surgery, Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Rome, Italy. 7. Unit of Vascular Surgery, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy. 8. Vascular and Interventional Radiology Unit, Azienda Ospedaliera Universitaria Senese, University of Siena, Siena, Italy. 9. Vascular and Endovascular Surgery Unit, Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Padua, Italy. 10. Vascular Surgery, Vita-Salute University School of Medicine, San Raffaele Scientific Institute, Milano, Italy. 11. Department of Clinical-Surgical, Diagnostic, and Pediatric Sciences, University of Pavia, Vascular Surgery Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 12. Department of Cardiovascular Surgery, San Filippo Neri Hospital, Rome, Italy. 13. Vascular and Endovascular Surgery Division, Department of Surgery "Paride Stefanini", Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy. 14. Department of Vascular Surgery, University of Verona-School of Medicine, University Hospital of Verona, Verona, Italy. 15. Vascular Surgery, Department of Surgery, Ospedali Civili Hospital, University of Brescia School of Medicine, Brescia, Italy. 16. Centro Oncologico Modenese, Policlinico di Modena, Azienda Ospedaliero-Universitaria di Modena, University of Modena and Reggio Emilia, Modena, Italy.
Abstract
OBJECTIVE: The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available "off-the-shelf" multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach. METHODS: A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up. RESULTS: Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P = .018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P < .001 and P = .015, respectively), and the staged approach was identified as protective (P = .026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months. CONCLUSIONS: The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.
OBJECTIVE: The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available "off-the-shelf" multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach. METHODS: A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up. RESULTS: Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P = .018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P < .001 and P = .015, respectively), and the staged approach was identified as protective (P = .026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months. CONCLUSIONS: The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.
Authors: Alyssa Ward; David K Klassen; Kate M Franz; Sebastian Giwa; Jedediah K Lewis Journal: Curr Opin Organ Transplant Date: 2018-06 Impact factor: 2.640
Authors: Matthew J Lommen; Jack J Vogel; Angela VandenHull; Valerie Reed; Kathryn Pohlson; Geoffrey A Answini; Thomas S Maldonado; Thomas C Naslund; Murray L Shames; Patrick W Kelly Journal: Ann Vasc Surg Date: 2021-06-25 Impact factor: 1.466