Blood loss, transfusion requirements and clinical outcomes of fenestrated-branched endovascular aortic aneurysm repair
Indrani Sen, MBBS, Gustavo S. Oderich, MD, Giuliano de Almeida Sandri, MD, Emanuel R. Tenorio, MD, PhD, Aleem K. Mirza, MD, Janet M. Hofer, RN, Jean R. Wigham, RN, Stephen S. Cha, MS.
Mayo Clinic, Rochester, MN, USA.
Objective: Fenestrated-branched endovascular aortic repair (F-BEVAR) requires multiple catheter and sheath manipulations that may result in substantial blood loss and transfusion requirements. The aim of this study was to evaluate the impact of blood loss on clinical outcomes of patients treated by F-BEVAR for pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). Methods: We reviewed the clinical data of 370 consecutive patients (277male, mean age 74±10 years) treated by F-BEVAR between 2007 and 2017. Patients treated by manufactured devices were enrolled in a prospective physician-sponsored investigational device exemption protocol (NCT 1937949 and NCT2089607). End-points were estimated blood loss (EBL), transfusion of packed red blood cells (PRBCs), use of intraoperative blood salvage (IOBS), mortality, transfusion-related acute lung injury (TRALI) and major adverse events (MAEs: any mortality, myocardial infarction, stroke, paraplegia, acute kidney injury, respiratory failure, bowel ischemia, blood loss > 1 Liter). Results: There were 190 patients (51%) treated for PRAs and 180 patients (49%) who had TAAAs (98 Extent I-III and 82 Extent IV). A total of 1270 renal-mesenteric arteries were incorporated by fenestrations or branches with mean of 3.4±0.8 vessels per patient. Thirty-day mortality was 1.8% (7/370) and MAEs occurred in 30% (114/370), including 20% (75/370) with EBL>1L. Transfusion of PRBCs was needed in 37% (137/370) and IOBS was used in 52% (194/370). There were no TRALI or other transfusion-related complications. EBL, PRBC and IOBS transfusion volumes were 750±900, 996±969 and 518±446 ml, respectively. EBL>1L and transfusion of PRBCs were significantly higher (P<0.05) in patients treated in the first half of clinical experience and in those who had physician-modified endografts (PMEGs), larger aneurysms, iliofemoral conduits, bilateral open surgical femoral access and Extent I-III TAAAs. Use of DrySeal sheaths was associated with significantly lower (P<0.05) EBL volume and with lower rates of EBL>1L and transfusion of PRBCs. On multivariate analysis, EBL>1L and transfusion of PRBCs were not associated with mortality or MAEs (P=NS). Conclusions: F-BEVAR was associated with significantly higher volume of blood loss and transfusion requirements in patients treated in the early experience and in those who had PMEGs, conduits, surgical exposure or Extent I-III TAAAs. Use of Dry-Seal sheaths resulted in significant decline in blood loss and transfusion requirements. Blood loss and transfusion requirements were not associated with mortality or MAEs.
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