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Evolution from physician-modified to manufactured fenestrated and branched endografts to treat pararenal and thoracoabdominal aortic aneurysms
Gustavo S. Oderich, MD, Leonardo Reis de Souza, MD, Jan Hofer, RN, Peter Banga, MD, Sharon Mueller, RN, Stephen Cha, MS, Thanila Macedo, MD, Peter Gloviczki, MD.
Mayo Clinic, Rochester, MN, USA.
Purpose: To review outcomes of patients treated for pararenal (PRA) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified (PMSGs) or manufactured fenestrated and branched stent-grafts (MSGs).
Methods: We reviewed clinical data of 207 consecutive patients (164 male, mean age 76±9 years old) treated for PRA/ TAAAs using fenestrated and branched stent-grafts. Choice of device evolved from PMSGs (2007-2013) to MSGs (2012-2014) in patients enrolled in prospective physician-sponsored investigational device exemption protocols (PS-IDE). End-points were 30-day mortality, major adverse events (MAEs), patient survival, freedom from type I/III endoleak, sac growth (>5mm), primary target vessel patency and re-intervention.
Results: 138 patients were treated by PMSGs, 69 had MSGs. 131 patients had PRAs (82 PMSGs, 49 MSGs), 76 had TAAAs (56 PMSGs, 20 MSGs). PMSGs patients had larger aneurysms, more cardiac, pulmonary and kidney disease, and higher comorbidity scores (P<0.05). A total of 670 visceral arteries were targeted by fenestrations and branches. Technical success was 98% for PMSGs and 99.6% for MSGs (P=0.9). 30-day mortality was 1% for PRAs (PMSGs 1%, MSGs 0%, P=0.44) and 7% for TAAAs (PMSGs 9%, MSGs 0%; P=0.17). There were more (P<0.05) MAEs among PMSG patients treated for PRAs (44%, 24%) and TAAAs (58%, 25%). Mean follow up was longer in PMSG patients (31±21, 12±7 months; P<0.0001). At 1-year, PMSGs and MSGs had similar freedom from type I/III endoleaks (PRAs: 95±4%, 99±1%; TAAAs: 100%, 100%), sac growth (PRAs: 99±1%, 100%; TAAAs: 97±3%, 100%), primary target vessel patency (PRAs: 97±1%, 98±1%, TAAAs: 98±1, 97±2%) and re-intervention (PRAs: 85±5%, 93±4%; TAAAs: 82±5%, 100%). Survival was lower (P<0.05) in PMSGs patients treated for PRAs (84±3%, 98±2%) and TAAAs (78±5%, 100%). At 5-years, 20 PMSG patients (14%) developed type I/III endoleak and 10 (7%) had sac growth. In the PMSG group, patient survival, freedom from type I/III endoleak, sac growth, primary target vessel patency and re-intervention at 3- and 5-years was 71±4%/63±5%, 87±3%/76±7%, 96±2%/80±6%, 96±1%/96±1%, and 71±5%/57±7%, respectively.
Conclusion: Patients treated by PMSGs had higher clinical risk and larger aneurysms, reflecting the more liberal indication of MSGs under PS-IDE protocols. Despite differences, both devices were implanted with similar technical success, mortality, endoleak, sac growth, vessel patency and re-intervention rates. At late follow up, PMSGs were associated with significant rate (14%) of type I/III endoleaks and sac growth (7%).
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