Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms

Abstract

Objective: Physician-modified fenestrated stent grafts (PMSGs) are a useful option for urgent or semiurgent treatment of complex abdominal aortic aneurysms (CAAAs). The aim of this study was to describe in-hospital outcomes of custommade fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs and thoracoabdominal aortic aneurysms (TAAAs).Methods: In this single-center, retrospective study, all consecutives patients with CAAAs or TAAAs undergoing endovascular repair using Zenith CMSGs (Cook Medical, Bloomington, Ind) or PMSGs between January 2012 and November 2017 were included. End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency, and endoleaks.Results: Ninety-seven patients were included (CMSGs, n ¼ 69; PMSGs, n ¼ 28). The PMSG group included more patients assigned to American Society of Anesthesiologists class 4 (n ¼ 14 [50%] vs n ¼ 16 [23%]; P ¼ .006) and more TAAAs (n ¼ 17 [61%] vs n ¼ 10 [15%]; P < .0001). Intraoperative adverse events were recorded in eight (11%) patients in the CMSG group vs six (21%) patients in the PMSG group. No intraoperative death or open conversion occurred. In-hospital mortality rates were of 4% (n ¼ 3) in the CMSG group and 14% in the PMSG group (n ¼ 4). Chronic renal failure was an independent preoperative risk factor of postoperative death or complications (odds ratio, 4.88; 95% confidence interval, 1.65-14.43; P ¼ .004). Rates of postoperative complications were 22% (n ¼ 15) and 25% (n ¼ 7) in the CMSG and PMSG groups. Spinal cord ischemia rates were 4% (n ¼ 3) and 7% (n ¼ 2) in the CMSG and PMSG groups. Reintervention rates were 16% (n ¼ 11) in the CMSG group and 32% (n ¼ 9) in the PMSG group. At discharge, target vessel patency rate in CMSGs was 98% (n ¼ 207/210). All target vessels (n ¼ 98) were patent in the PMSG group. Endoleaks at discharge were observed in 24% of the CMSG group (n ¼ 16) vs 8% of the PMSG group (n ¼ 2). Conclusions:Our study showed clinically relevant differences of several important in-hospital outcomes in the CMSG and PMSG groups. Larger cohorts and longer follow-up are needed to allow direct comparison. PMSGs may offer acceptable in-hospital results in patients requiring urgent interventions when CMSGs are not available or possible. (J Vasc Surg 2019;-:1-9.)

A Novel Endosurgical Prosthesis to Treat Thoracoabdominal Aortic Aneurysm in Complex Anatomy or Emergency Settings

“…A recent article shows how, in complex aortic aneurysm, clinically relevant differences of several important in-hospital outcomes were found in the use of custom made stent grafts versus physician-modified fenestrated grafts. 8 The combined one step endovascular and surgical procedure is not a new concept and is being practiced in different settings, especially when emergency intervention is required where the vascular anatomy and/or clinical conditions are not favorable for any of the options alone. 9 …”

Commentary: Physician-Modified Fenestrated/Branched EVAR and Hybrid Techniques for Acute Thoracoabdominal Aortic Pathologies: Inequality When Comparing Alternative Options With Different Philosophies Does Not Equal Lower Quality

“…3,8 In a previous systematic review of 23 reports containing 308 patients treated between 1999 and 2015 for complex aortic aneurysm, outcomes overall were similar for off-the-shelf fenestrated/branched stent-grafts and PMEGs, including technical success of 95% and 91%, mortality of 1.1% vs 3.5%, and target vessel patency of 98% vs 97%, respectively. 9 Since that review, many additional studies (those with ≥10 cases) citing the use of PMEGs have been published, [1][2][3][4][5]7,8,[10][11][12][13][14][15] though some updated earlier populations within investigation device exemption (IDE) protocols 2,3,13 or earlier single-center reports. 4,5,7,10 Excluding 4 duplicate studies (103 cases) 8,[13][14][15] and another 101 patients presented earlier, 9 375 new cases not incorporated in the previous review were identified since March 31, 2015 (a 100% increase), even though in some qualified centers the use of PMEGs declined from 66% between 2011 and 2013 to 4% between 2014 and 2016.…”

“…Overall, 9 additional single-center studies were found (Table 1), [1][2][3][4][5]7,[10][11][12] 3 of them conducted within an IDE trial, 2,3,12 with a total of 476 patients (339 men, 71.2%). Few of these compared outcomes between PMEGs and company-manufactured devices 3,5,7 and hybrid techniques. 1 The latter comparison is what the study by Yang et al 1 adds to the literature.…”

“…For this practical perspective, many institutions [2][3][4][5]7,10,11 are actively offering this treatment, some of them outside investigational studies, for a variety of different serious or life-threatening conditions. In the setting of acute thoracic and thoracoabdominal pathology, emergency open surgical repair results in a crude postoperative mortality, calling for development of new repair techniques like f/bPMEG or hybrid repairs in high-risk patients with friendly or hostile aortic anatomy, respectively.…”

“…6 This was also true in the study by Yang et al 1 (renal deterioration 25%, dialysis on discharge 21%) but surprisingly not related to increased mortality even though preoperative renal impairment was high (17.9%), a known risk factor for postoperative major adverse events. 7 The authors also achieved 24-month cumulative survival rates of 96.7% and 92% for the f/bPMEG and hybrid repair groups, respectively, 1 and this fact should not be ignored. In the largest available data from the Mayo Clinic, patient survival estimates at 1 and 3 years using PMEGs were 80%±3% and 68%±4%, respectively, 3 suggesting that PMEGs will continue to play an important role in the care of high-risk patients as a much less morbid approach than hybrid repair.…”