Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts

Abstract

Objective: The aim of this study was to investigate the midterm outcomes of fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal (PRA) and thoracoabdominal aortic aneurysms (TAAAs). Summary Background Data: FB-EVAR has been associated with decreased morbidity compared to open repair, but there is limited midterm data. Methods: A total of 430 patients (302 males, mean age 74 AE 8 years) treated by FB-EVAR were enrolled in a prospective, nonrandomized investigational device exemption study. Endpoints included 30-day mortality and major adverse events (MAEs), freedom from all cause and aortic-related mortality, target vessel patency, and freedom from secondary intervention and target vessel instability. Results: There were 133 PRAs and 297 TAAAs with 1673 renal-mesenteric arteries incorporated by fenestrations or directional branches (3.9 AE 0.5 vesvessels/patient). At 30 days or within the hospital stay if longer than 30 days, there were 4 (0.9%) deaths. MAEs included new-onset dialysis in 8 patients (2%), permanent paraplegia or stroke in 10 patients each (2%), and respiratory failure requiring tracheostomy in 2 patients (0.5%). After a mean follow-up of 26 AE 20 months, there were 3 (0.7%) aortic-related deaths from SMA stent occlusion, gastrointestinal hemorrhage, or complications of open arch repair. At 5 years, freedom from all-cause and aortic-related mortality were 57% AE 5% and 98% AE 1%, respectively. Freedom from secondary intervention was 64% AE 4%, primary target vessel patency was 94% AE 1%, and freedom from target vessel instability was 89% AE 2% at same interval. One patient (0.2%) had nonfatal aneurysm treated using endovascular repair. Conclusion: FB-EVAR is safe and effective for treatment of PRA and TAAAs with low rate of aortic-related mortality and aneurysm rupture on midterm follow-up.

Complex Aortic Interventions Can Be Safely Introduced to the Clinical Practice by Physicians Skilled in Basic Endovascular Techniques

“…The trends regarding the complexity of our repairs cannot be evaluated due to our very small patient cohort; however, more vessels were incorporated per patient (3.5 ± 0.9) in our present study than in the early period of Mirza et al (2.8 ± 0.9) [ 13 ]. Prior aortic surgery (50%) and postdissectional TAAA repair (20%) occurred with a frequency that is comparable to that reported by Oderich et al very recently, also suggesting that the complexity of our initial cases was somewhat higher than what is usual to start with [ 20 ].…”

Peri-Operative Management of Patients Undergoing Fenestrated-Branched Endovascular Repair for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms: Preventing, Recognizing and Treating Complications to Improve Clinical Outcomes

“…EVAR procedures, associated with adjunctive tools such as parallel grafts (PG) or endostapling systems, are currently used to treat juxtarenal AAA (JAAA) by “off-the-shelf” solutions, especially in case of urgency or emergency conditions or with patients considered “unfit” for OSR [ 2 , 3 , 4 , 5 , 6 , 7 , 8 ]. Nevertheless, fenestrated-branched EVAR (F/BEVAR) represents a feasible and widely adopted technique to treat a wide range of conditions including JAAA, pararenal AAA (PRAA) and thoracoabdominal aortic aneurysms (TAAA), moving the proximal sealing zone above the renal-visceral vessels take-off while preserving their patency [ 9 , 10 , 11 ]. Indeed, it is well known that achieving a seal in a morphologically hostile aortic neck will make the repair more prone to lower durability over time, while the parallel graft technique is only recommended as a bailout alternative.…”

Uso da aorta infrarrenal como zona de selamento distal para o tratamento endovascular do aneurisma da aorta toracoabdominal com endopróteses fenestradas e ramificadas

“…Essa modalidade é o tratamento de escolha para correção endovascular de AAT, sendo primeira opção em diversos centros com experiência. Publicações de centros únicos, estudos multicêntricos e revisões sistemáticas tem demonstrado uma menor morbimortalidade para correção endovascular com endopróteses fenestradas e ramificadas quando comparadas às séries históricas da correção convencional aberta 13,17,[36][37][38][39][40][41] .…”

“…Outras artérias significativas para a perfusão da medula espinhal e que devem ser avaliadas no período pré-operatório e preservadas sempre que possível são as artérias vertebrais, artérias ilíacas internas, também conhecidas como artérias hipogástricas, além de seus inúmeros ramos. O maior preditor do risco de IME é a extensão de aorta coberta pela endoprótese, motivo pelo qual AAT do tipo I e II, com maior extensão, têm maior incidência de paraplegia (Figura 3) 41,43 . Outros fatores também importantes para esse desfecho incluem hipotensão intraoperatória, oclusão ou estenose das artérias hipogástricas e vertebrais, necessidade de diálise pós operatória com variações da pressão arterial, reintervenções, e sangramento.…”

“…As Tabelas 5 e 6 ilustram publicações de impacto na correção endovascular e aberta, respectivamente, com taxa de mortalidade, idade média dos pacientes, acometimento da medula espinhal e paraplegia. Centros de excelência já consideram o tratamento endovascular como primeira opção no tratamento dos aneurismas da aorta mesmo quando é necessária a incorporação de alguma artéria visceral ou renal 41,54 do TC e AMS, rim com posição pélvica ou em ferradura, presença de múltiplas artérias renais acessórias e presença de artérias lombo-sacrais importantes para a perfusão da medula espinhal (Figura 7). Da mesma forma, pacientes com uma aorta infrarrenal saudável como aqueles com AAT do tipo I que necessitarão de uma cobertura extensa da aorta torácica, um motivo ainda mais convincente existe.…”