Physician-Modified Endografts for Complex Aortic Aneurysms in Japan: Current Status, Clinical Outcomes, and Guideline Integration

National trends in utilization of surgeon-modified grafts for complex and thoracoabdominal aortic aneurysms

Physician-modified endografts (PMEGs) remain an option to treat complex aortic aneurysms with fenestrated endovascular aortic repair (FEVAR) if they are unsuitable for commercial endografts or open surgery. FEVAR traditionally involves uniform diameter reduction for graft alignment and target vessel cannulation, after which diameter reduction is released before the delivery of bridging stent grafts. We describe the results of an advanced PMEG design using nonuniform constraints to mold the graft to the inner shape of the visceral aorta with delayed-release diameter reduction. This method allows for sequential vessel cannulation and thus sequential stent graft delivery without the need to have all targets concurrently cannulated. Patients were treated with PMEG-FEVAR under a physician-sponsored investigational device exemption trial (NCT06501872, IDE#G240122, including lead-in cohort) from 2015 to 2025 at one institution. Cook Zenith Alpha Thoracic endografts (proximal/distal components/extensions) were modified with reinforced fenestrations and diameter reduced posteriorly with 5-0 chromic suture at the perivisceral portion to just 1 mm smaller than the aortic diameter at each Z-stent level. Intraoperatively, grafts were aligned, unsheathed completely, and diameter reduction ties were left intact with the graft achieving near apposition of the aortic wall at each level. The first target vessel is cannulated, and a bridging stent graft is placed; the graft is then released from the delivery mechanism. Then, in a sequential fashion, target vessels were cannulated through each fenestration and bridged with a stent graft one at a time via small-bore contralateral percutaneous groin access. The diameter reduction sutures are left intact and expected to dissolve over the following 14 days. We analyzed Society for Vascular Surgery-prescribed 30-day and 1-year reporting standards on safety and effectiveness for complex aortic endografting. Inclusion criteria were met by 203 patients who underwent PMEG-FEVAR (mean age, 75.3 years; 71% male; 94% White) for juxtarenal (25%), pararenal (42%), extent IV (13%), or extent II/III/V (20%) thoracoabdominal aortic aneurysms. The mean aneurysm diameter was 59.9 mm and target vessels included celiac (83%), superior mesenteric (98%), right renal (96%), and left renal (94%) arteries. Target vessel cannulation and delivery of bridging stent grafts was achieved in 100% of vessels. There were no intraoperative deaths. Safety and effectiveness outcomes include a 30-day mortality rate of 2.5%, access site complication rate of 5.4%, and no limb ischemia; at 1 year, outcomes included 0.9% paraplegia, 1.8% paraparesis, 6.7% target vessel instability, 7.6% aneurysm-related reintervention, 7.8% all-cause mortality, 1.5% aneurysm-related mortality, and no open conversions. Delayed-release diameter reduction molds PMEGs to the aortic anatomy, which allows for sequential target vessel cannulation and stent graft delivery without compromising safety or effectiveness. This technique avoids multiple concurrent wires in target vessels, allowing for smaller contralateral sheath access and less risk to target vessels intraoperatively.

Long-term comparison of physician-modified endografts with and without low-profile fabric designs for repair of complex abdominal and thoracoabdominal aortic aneurysms.

PTFE Cuff Fenestration Reinforcement Demonstrates Low Endoleak Rates in PMEGs, Independent of Bridging Stent Type.

Modern Physician-Modified Endograft Techniques for Renal and Mesenteric Vessel Incorporation.

364 Background: Lenvatinib(LEN) has been approved as a single agent for patients with unresectable hepatocellular carcinoma (u-HCC) since Mar 2018 in Japan. A few results from a large sample size cohort of LEN therapy in real world practice has been reported. Therefore, we performed a retrospective nationwide multicenter study. Methods: A total of 116 u-HCC patients received LEN from March 2018 at 14 sites in Japan were registered. Tumour assessments in accordance with RECICT ver1.1 and modified RECIST were done using dynamic CT or MRI within 4-8 weeks and every 6-8 weeks thereafter. Adverse events (AEs) were graded according to the CTCAE ver4.0. Results: Median age was 72 (46-91)years, 88 (75.9%) patients were male, and median body weight was 60 (30-94) kg. The baseline liver function was Child-Pugh class A in 106 (91.4%) patients. Seventy-three (62.9%) patients were BCLC stage C. As the 2nd-line therapy (after sorafenib), 28 (24.1%) patients received LEN and 17 (14.7%) patients did as the 3rd-line (after regorafenib). Median observation time was 2.5 months and one patient died from HCC progression. The imaging findings of 49 (42.2%) patients were evaluated at 4-8weeks. Based on mRECIST, CR was shown in 3 (6.1%), PR in 14 (28.6%), SD in 23 (46.9%), and PD in 6 (12.2%). In the 3 patients, target lesions of liver showed PR, however bone metastases had progressed. [overall response rate (ORR) 34.7%, disease control rate (DCR) 81.6%]. ORR and DCR of tyrosine kinase inhibitor (TKI) naïve patients (n = 26) were 34.6% and 80.8%, while those of TKI experienced (n = 23) were 34.8% and 82.6%. The most common any-grade AEs were hypertension (52.0%), diarrhoea (32.1%), decreased appetite (63.5%) and fatigue (49.4%). Hand-food skin reaction (HFSR) was observed in 28% of patients. Conclusions: The efficacy of LEN therapy in real world practice in Japan was similar to the phase 3 clinical trial, even though elderly patients with lower body weight were included in this study. The incidence of HFSR during LEN in real world practice was lower than that of the sorafenib group in the phase 3 trial of LEN. Decrease appetite and fatigue must be carefully monitored and managed during LEN therapy.

Midterm outcomes of off-the-shelf multibranched versus physician-modified endografts for endovascular repair of complex and thoracoabdominal aortic aneurysms: A systematic review and meta-analysis.

Fenestrated Endovascular Aortic Repair (F-EVAR) using Physician-Modified Endografts (PMEGs) has become an important option in the treatment of complex aortic aneurysms, particularly when custom-made devices are not available. However, difficult target vessel (TV) cannulations, notably with misalignment, often limit total transfemoral repair. To address this condition, we developed the Gap Steering (GPS) technique, which is a transfemoral-only adjunctive method using a steerable sheath to create a controlled gap between the stent graft and the aortic wall, enabling on-demand cannulation. In this study, we aimed to evaluate the technical feasibility and procedural features, outcomes, and risks associated with the GPS technique in difficult target vessel cannulation owing to fenestration misalignment. We retrospectively reviewed 42 patients (14 thoracoabdominal, 28 complex abdominal aortic aneurysms) undergoing F-EVAR using PMEGs with bridging stent placement between October 2020 and January 2025. Although not designed as a comparative study, patients were stratified by treatment period: Pre-GPS technique group (n = 10, TV = 30) and Post-GPS technique group (n = 32, TV = 114). The GPS technique was used as the primary bailout for difficult cannulations in the Post-GPS technique group. Among the 114 TVs, the GPS technique was selectively applied to 18 challenging vessels (15.8%). Among 18 target vessels treated with the GPS technique, successful cannulation was achieved in 14 (77.8%), with no GPS technique-related complications. At the per patient level, the Post-GPS technique group showed significantly higher technical success (96.8% vs 60.0%, p=0.008) and a higher target vessel success rate (100% vs 80.0%, p=0.052). TV instability was significantly lower (3.1% vs 30.0%, p=0.03). At the per-vessel level, TV technical success was higher (100% vs 93.3%, p=0.042), with lower rates of TV occlusion (0.0% vs 6.7%, p=0.042) and TV instability (0.9% vs 13.3%, p=0.007). All GPS technique-treated vessels remained patent at the 14 month median follow-up. The GPS technique is a feasible adjunct for difficult cannulations in F-EVAR using PMEGs. It avoids additional devices and is particularly suited for total transfemoral repair using currently available steerable sheaths.Clinical ImpactDifficult renovisceral target vessel cannulation remains a major limitation to achieving total transfemoral F-EVAR using physician-modified endografts (PMEGs). This challenge often necessitates upper-extremity access or complex adjunctive maneuvers, increasing procedural invasiveness and access-related risks. The Gap Steering (GPS) technique offers a practical adjunctive strategy using a commercially available steerable sheath to achieve controlled directional guidewire manipulation at the fenestration-aortic wall interface. It enables selective cannulation without additional access routes, larger delivery systems, or device modification. This reproducible and fully transfemoral approach has the potential to improve procedural efficiency and expand the applicability of PMEG-based F-EVAR in complex aortic repair.

A national census for the off-label treatment of complex aortic aneurysms

To compare outcomes of fenestrated (FEVAR) and open repairs of complex abdominal aortic aneurysms (cAAA). FEVAR has emerged as an alternative to open surgery for treating cAAA, but direct comparisons are limited. We studied all repairs of intact or symptomatic cAAA in the Vascular Quality Initiative between 2012 and 2018, excluding chimney/snorkels and any devices implanted under Investigational Device Exemption studies. We compared open repairs, commercially available FEVAR devices and physician-modified endografts (PMEG) using inverse probability weighting. As a secondary analysis, we compared PMEG separately. We identified 3253 cAAA repairs: 2125 open (65%), 877 FEVAR (27%), and 251 PMEG (8%). Patients undergoing FEVAR were older, with larger aneurysms, and more comorbidities. Propensity-weighted perioperative mortality was similar between open repair and FEVAR (4.7% vs 3.3%, respectively, P = 0.17), but open repair was associated with higher rates of myocardial infarction (5.0% vs 3.0%, P = 0.03), acute kidney injury (25% vs 16%, P < 0.001), and new dialysis (4.3% vs 2.1%, P = 0.003). However, propensity-weighted long-term mortality was higher following FEVAR [Hazard Ratio (HR) 1.7 (1.1-2.6), P = 0.02]. Although outcomes of commercially available FEVAR and PMEG were similar, there was a trend toward higher long-term mortality with PMEG compared to FEVAR [HR 1.7 (0.9-3.1), P = 0.09). In patients undergoing cAAA repair, open surgery was associated with higher overall survival than FEVAR and similar perioperative mortality, but longer lengths of stay, and higher rates of postoperative renal dysfunction and MI. PMEG were associated with similar perioperative results as commercially available FEVAR, but further study is needed to establish their long-term durability.

Five-year outcomes of physician-modified endografts for repair of complex abdominal and thoracoabdominal aortic aneurysms

Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

Historical Evolution of Physician-Modified Endografts (PMEGs) for Treatment of Complex Aortic Aneurysms.

Contemporary indications, techniques, and outcomes of physician-modified endografts for the treatment of complex abdominal and thoracoabdominal aortic aneurysms

The state of complex endovascular abdominal aortic aneurysm repairs in the Vascular Quality Initiative