Physician-modified Endografts Research Articles

Physician-Modified Endografts for Repair of Complex Abdominal Aortic Aneurysms: Clinical Perspectives and Medico-Legal Profiles

Standard endovascular aortic repair (EVAR) has become the standard of care for treating infrarenal abdominal aortic aneurysms (AAAs) in patients with favorable anatomies, while patients with challenging AAA anatomies, and those with suprarenal or thoraco-abdominal aneurysms, still need alternative, more complex, solutions, including custom-made branched or fenestrated grafts, which are constrained by production delay and costs. To address urgent needs and complex cases, physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory patency of visceral vessels. Although physician-modified grafts (PMEGs) have demonstrated high technical success, standardized creation processes and long-term safety data are still lacking, necessitating further study to validate their clinical and legal standing. The aim of this article is to illustrate the state of the art with regard to this surgical technique, summarizing its origin, evolution, and the main clinical evidence supporting its effectiveness. The paper also aims to discuss the main medico-legal issues related to the use of PMEGs, with particular reference to the issue of safety related to the standardization of the surgical technique, medical liability profiles, and informed consent.

Multicenter Study on Physician-Modified Endografts for Thoracoabdominal and Complex Abdominal Aortic Aneurysm Repair.

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.

Current trends and outlook of 3D printing in vascular surgery

Three-dimensional (3D) printing is an additive manufacturing technique capable of the rapid prototyping of objects not feasible by other manufacturing methods. Vascular surgery has welcomed this technology and found use for it in many areas. The integration of 3D-printed models in surgical training offers to bridge existing training gaps and increase exposure to complex pathology, while maintaining patient safety, during this time where the surgical education paradigm is shifting. Sterilizable 3D-printed models are being used to aid in the development of physician-modified endografts with excellent results. Rehearsing with patient-specific anatomical models before surgery has demonstrated evidence in improving operator confidence and decreased operative and fluoroscopy times. Research trends have demonstrated that technology such as printed custom implantable devices with tunable chemical and physical properties may be on the horizon. Despite all of this, the current use of 3D printing in vascular surgery is limited by factors such as materials, time constraints, and initial technical challenges to developing a printing protocol. All of these are areas actively being researched to improve applicability and adaptation of 3D printing. As its use continues to grow, 3D printing may find utility in meeting the global need for safe, timely, and affordable vascular surgical care. The analysis delves into current uses, challenges, and future visions for this technology, emphasizing its transformative influence in the field of vascular surgery.

One-hundred Consecutive Physician-Modified Fenestrated Endovascular Aneurysm Repair of Pararenal and Thoracoabdominal Aortic Aneurysms Using the Terumo TREO Stent Graft

ObjectiveFenestrated endovascular aortic aneurysm repair (FEVAR) has been widely applied for the treatment of pararenal (PAA) and thoracoabdominal aortic aneurysms (TAAA). If custom-made devices or off-the-shelf devices are not available, physician-modified endografts (PMEG) are an alternative device option. Several different endograft platforms have been used for PMEG; however, minimal data exists on utilizing the Terumo TREO Abdominal stent-graft system in this setting. The purpose of this study was to evaluate our single-center experience treating PAA and TAAA with a physician-modified FEVAR using the TREO platform. MethodsA prospective database of consecutive patients with PAA and TAAA treated at a single-center with a FEVAR utilizing a PMEG device between March 2021 and September 2023 was queried for those having a Terumo TREO device implanted. Demographics, operative details, and postoperative complications were analyzed. Rates of technical success, type I or III endoleak, branch vessel status, reintervention, and 2-year survival were also assessed. ResultsOf the 153 patients who underwent FEVAR with a PMEG device during the study period, 100 had repair using a Terumo TREO stent-graft. The mean age of the cohort was 73.7±7.0years with the majority suffering from hypertension (n=94, 94%), coronary artery disease (n=51, 51%), and COPD (n=40, 40%). Thirty-four patients (34%) had a prior failed EVAR device in place. Mean aneurysm size was 66.0±13.7mm, with 58 (50%) patients classified as PAA and 30 (30%) patients as an extent IV TAAA. Six (6%) patients presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8±0.6. Overall technical success was 99%, procedure time was 218±116 minutes, contrast volume was 82±21mL, and cumulative air kerma was 3,054±1,560mGy. Postoperative complications were present in 20 patients (20%) and 2 patients (2%) died within 30-days. Rates of type I or III endoleak, branch vessel stenosis/occlusion, and reintervention were 2%, 1%, and 7%, respectively. Two-year overall survival was 87%. ConclusionsTreatment of pararenal and extent IV TAAA using a physician-modified fenestrated Terumo TREO endograft is safe and effective. This large, early experience using the Terumo TREO platform supports preferential use of this device in this setting due to the device design and low likelihood of type I or III endoleak.

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

Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n= 98). A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P= .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

Use of the Gore Thoracic Branched Endoprosthesis in Combination With Branched/Fenestrated Physician-modified Endografts in the Treatment of Extent I and II Thoracoabdominal Aneurysms

Use of the Gore Thoracic Branched Endoprosthesis in Combination With Branched/Fenestrated Physician-modified Endografts in the Treatment of Extent I and II Thoracoabdominal Aneurysms

Treatment of Iatrogenic Innominate Artery Injury with Physician-modified Endograft

Treatment of Iatrogenic Innominate Artery Injury with Physician-modified Endograft

Long-term Outcomes Among Patients Treated With Physician Modified Endograft for Juxtarenal Aortic Aneurysms

Long-term Outcomes Among Patients Treated With Physician Modified Endograft for Juxtarenal Aortic Aneurysms

Initial Experience With the Punch Card For Multi-vessel Physician-modified Endograft

Initial Experience With the Punch Card For Multi-vessel Physician-modified Endograft

Midterm Results of Physician-Modified Endograft in Juxtarenal Abdominal Aortic Aneurysm Using Three-Dimensional Model-Assisted Planning and Intraoperative Three-Dimensional Image Analysis

Midterm Results of Physician-Modified Endograft in Juxtarenal Abdominal Aortic Aneurysm Using Three-Dimensional Model-Assisted Planning and Intraoperative Three-Dimensional Image Analysis

Ten Years of Physician-Modified Endografts

Ten Years of Physician-Modified Endografts

Trends in hospitalization of patients undergoing endovascular treatment of thoracoabdominal aortic aneurysms based on cerebrospinal fluid drainage strategy

ObjectiveThe aim of this study was to identify trends in hospital length of stay (HLOS) and intensive care unit length of stay (ICULOS), and the relationship with cerebrospinal fluid drainage (CSFD) protocols in patients undergoing fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms (TAAAs). MethodsA retrospective review of patients who underwent elective FB-EVAR for extent I to IV TAAAs between 2008 and 2023 at a single aortic center of excellence was conducted. Patient demographics, cardiovascular comorbidities, surgical risk, technical details, CSFD strategy (prophylactic or therapeutic), procedural success, and perioperative outcomes were collected. Patients were divided into two groups based on CSFD protocol. Group 1 included patients treated before 2020 when prophylactic CSFD was performed widely, and Group 2 consisted of patients treated since 2020 with therapeutic CSFD. Primary end points were HLOS, ICULOS, major adverse events, and perioperative mortality. ResultsFB-EVAR was performed in 702 patients; 412 underwent elective TAAA repair and were included in the analysis. Mean age was 73 ± 8 years and 68% were male. Patient-specific manufactured devices were used in 252 patients (61%), physician-modified endografts in 110 (27%), and 50 patients (12%) were treated with off-the-shelf devices. Demographics, aneurysm extent, major adverse events (including spinal cord ischemia [SCI]), and mortality were similar in both groups. A significant reduction in mean HLOS between the groups (9 ± 9 vs 6 ± 5 days; P = .02) coincided with decreased use of prophylactic CSFD (70% vs 1.2%; P < .001), with similar rates of SCI (7.6% vs 4.9%; P = .627) and ICULOS (3 ± 3 vs 2.5 ± 3; P = .19). Patients in the therapeutic drainage cohort (group 2) had a higher incidence of congestive heart failure (24% vs 11%; P = .003), hypercholesterolemia (91% vs 80%; P = .015), chronic obstructive pulmonary disease (55% vs 37%; P = .004), and peripheral artery disease (39% vs 19%; P < .001) compared with group 1, suggesting treatment of a more complex patient cohort. On adjusted multivariable analysis accounting for American Society of Anesthesiologists score, comorbidities, and device type, the difference in HLOS remained statistically significant (P = .01). ConclusionsHLOS decreased over time in patients undergoing FB-EVAR for TAAA after transition from a prophylactic to a therapeutic CSFD protocol. This transition was the only modifiable, independent risk factor for a shorter HLOS, without an increase in SCI, albeit with similar ICULOS.

Modern management of aortic aneurysms using physician-modified endografts

Modern management of aortic aneurysms using physician-modified endografts

Comparison of the Snare Loop Technique and the Hungaroring Reinforcement for Physician-Modified Endograft Fenestrations-An In Vitro Study.

We conducted an in vitro comparison of the snare loop reinforcement against a closed-loop reinforcement (Hungaroring) for physician-modified endograft (PMEG) fenestrations regarding preparation time and stability during flaring balloon dilatation. The time to complete a PMEG fenestration with reinforcement was measured and compared between the Hungaroring and snare loop groups. The number of stitches was counted. Each fenestration was dilated using a 10 mm high-pressure, non-compliant balloon up to 21 atm in pressure, and fluoroscopic images were taken. The presence of indentation on the oversized balloon at the level of the reinforcement was evaluated at each fenestration. Five fenestrations were created in each group (n = 5) for a total of ten pieces. The completion time in the snare loop group was 1070 s (IQR:1010-1090) compared to 760 s (IQR:685-784) in the Hungaroring group (p = 0.008). Faster completion time was achieved by faster stitching (23.2 s/stitch (IQR 22.8-27.3) for the snare loop group and 17.3 s/stitch (IQR 17.3-20.1) for the Hungaroring group (p = 0.016). None of the fluoroscopic images of the snare loop reinforcement showed an indentation on the balloon during the overexpansion; on the contrary, the Hungaroring showed indentation in every case, even at 21 atm. Fenestrations reinforced with Hungaroring can be completed significantly faster. Furthermore, the Hungaroring resists over-dilation even at high pressures, while snare loop reinforcements dilate at nominal pressure.

Physician Modified Fenestrated Endografts for Endovascular Aortic Arch Repair in Zone 0

This multicentre study aimed to assess the early and midterm outcomes of fenestrated physician modified endografts (PMEGs) for endovascular aortic arch repair in zone 0. Between 2018 and 2022, a retrospective study was conducted in three centres of consecutive patients undergoing endovascular aortic arch repair in zone 0 with PMEGs. Endpoints included technical success, 30 day mortality, major adverse events, secondary interventions, stent stability, target vessel patency, and overall survival. A total of 54 patients (mean age 63 years; 45 males) with aortic arch pathology were included, comprising aortic dissections (n = 32; 59%) and aortic arch aneurysms (n = 22; 41%). Technical success was 98%, and one patient died from stroke within 30 days. Major adverse events included stroke (n = 4; 7%), retrograde type A dissection (RTAD) (n = 3; 6%), and acute kidney injury (n = 2; 4%). During a median follow up of 12 months, there were two deaths (4%) of unknown cause at 1 month and 1.5 months, and no aortic related death. Type Ia, type Ic, and type IIIc endoleaks were observed in 2 (4%), 3 (6%), and 2 (4%) patients, respectively. No vessel stenosis was observed. Re-intervention was required in 10 patients (19%). Estimates of overall survival, freedom from secondary intervention, and freedom from target vessel instability at 1 year were 94.2% (standard error [SE] 3.3%), 81.8% (SE 6.0%), and 92.0% (SE 4.5%), respectively. This study demonstrated the efficacy of PMEGs for zone 0 endovascular aortic arch repair, with acceptable technical success and mortality rate. Stroke, RTAD, and re-intervention rates remain a concern for endovascular therapy. A larger population and long term outcomes are required to assess the safety and durability of this technique as a beneficial choice for endovascular aortic arch repair in specialised centres.

Standardized approach for four-fenestrated physician-modified endograft to treat complex abdominal aortic aneurysms using Valiant Captivia

We describe the feasibility and safety of a standardized approach for four-fenestrated physician-modified endograft (PMEG) placement to treat complex abdominal aortic aneurysms using the Valiant Captivia platform (Medtronic). The standardization is based on specific selection criteria for anatomical feasibility, measurement method, and modification technique of a single endograft type. Six cases (two juxtarenal, two pararenal, and two type IV thoracoabdominal aneurysms) were treated, with 24 target vessels incorporated with fenestrations. Four cases were treated in an urgent setting and two were elective. The time modification required was 121 ± 18 minutes. Technical success was 100%, with no mortality or complications at 30 days. Postoperative computed tomography at 3 months demonstrated complete aneurysm exclusion, without a type I or III endoleak, no main graft- or fenestration-related loss of integrity, and no target vessel misalignment or stent fracture. The present standardized approach seems safe and feasible and might represent an initial benchmark for comparison with future studies.

Early Experience With Physician-Modified Endografts for Treatment of Aortic Arch Disease

Early Experience With Physician-Modified Endografts for Treatment of Aortic Arch Disease

Mid-term outcomes of physician-modified endograft therapy for complex aortic aneurysms.

Our goal was to evaluate early and mid-term outcomes of physician-modified endografting for pararenal and thoraco-abdominal aortic aneurysms from 10 Japanese aortic centres. From January 2012 to March 2022, a total of 121 consecutive adult patients who underwent physician-modified endografting for pararenal and thoraco-abdominal aortic aneurysms were enrolled. We analysed early and mid-term postoperative outcomes, including postoperative complications and mortality. The pararenal and thoraco-abdominal aortic aneurysm groups included 62 (51.2%) and 59 (48.8%) patients, respectively. The overall in-hospital mortality rate was 5.8% (n = 7), with mortality rates of 3.2% (n = 2) and 8.5% (n = 5) in pararenal and thoraco-abdominal aortic aneurysm groups, respectively (P = 0.225). Type IIIc endoleaks occurred postoperatively in 18 patients (14.9%), with a significantly higher incidence (P = 0.033) in the thoraco-abdominal aortic aneurysm group (22.0%, n = 13) than in the other group (8.1%, n = 5). Major adverse events occurred in 7 (11.3%) and 14 (23.7%) patients in pararenal and thoraco-abdominal aortic aneurysm groups (P = 0.074), respectively. The mean follow-up period was 24.2 months. At the 3-year mark, both groups differed significantly in freedom from all-cause mortality (83.3% and 54.1%, P = 0.004), target aneurysm-related mortality (96.8% and 82.7%, P = 0.013) and any reintervention (89.3% and 65.6%, P = 0.002). Univariate and multivariate regression analyses demonstrated that ruptures, thoraco-abdominal aortic aneurysms and postoperative type IIIc endoleaks were associated with an increased risk of all-cause mortality. The mid-term outcomes of physician-modified endografting for pararenal and thoraco-abdominal aortic aneurysms were clinically acceptable and comparable with those in other recently published studies. Notably, pararenal and thoraco-abdominal aortic aneurysms represent distinct pathological entities with different postoperative outcomes.

Novel Strategies for the Hostile Iliac Artery during Endovascular Aortic Aneurysm Repair.

Successful endovascular aneurysm repair can be achieved with favorable aortic and iliac arterial anatomies. However, patients with challenging iliac anatomy, such as stenotic, calcified, tortuous arteries, or concomitant iliac artery aneurysms, are commonly encountered. Such a hostile iliac anatomy increases the risk of intraprocedural complications and worsens long-term outcomes. This review addresses various technical options for treating patients with a hostile iliac anatomy, including innovative endovascular solutions, physician-modified endografts, and hybrid procedures. These considerations demonstrate the wide scope of therapies that may be offered to patients with an unfavorable iliac anatomy.

Thoracoabdominal aneurysm repair using the Unitary Manifold Device

ObjectiveTo present a single-center prospective study of 126 consecutively treated patients who underwent endovascular repair of a thoracoabdominal aortic aneurysm with the physician-modified, nonanatomic-based Unitary Manifold (UM) device. MethodsData were collected from 126 consecutive all-comer patients treated with the physician-modified, nonanatomic-based UM from 2015 to 2023. Treatment was performed at a single center by a single physician under a Physician Sponsored Investigation Exemption G140207. ResultsThe UM was indicated for repair of all Crawford extents including juxtarenal, pararenal, and short-neck infrarenal aneurysms (<10 mm) in 126 consecutive patients. Patients were not excluded from the study based on presentation, extent of aneurysm or dissection, or history of a spinal cord event. Patients with a thoracoabdominal aortic aneurysm were categorized by Crawford classification: types I and V (3.3%, n = 4), type II (3.3%, n = 4), type III (1%, n = 1), and type IV (93.3%, n = 117). The type IV classification patients were further categorized with 33 (28.2%) true type IV, 68 (58.1%) pararenal or infrarenal, and 16 (13.7%) with dissection. Technical success was 99.2% (n = 125). The most common major adverse event within both 30 days and 365 days of all patients was respiratory failure (11.9%, n = 15, and 13.5%, n = 17, respectively). One patient (0.8%) experienced persistent paraplegia at 365 days. Reintervention for patients at 365 days was 5.6% (n = 7). Of the 444 branches stented, the primary patency rate was remarkably high as only three patients (2.4%) required reintervention due to loss of limb patency within 365 days. Aneurysm enlargement (≥5 mm) occurred in 1.6% (n = 2) patients, and no patients experienced aneurysm rupture. No patients underwent conversion to open repair. The aneurysm-related mortality at 365 days for all patients was 4.0% (n = 5), whereas all-cause mortality was 16.7% (n = 21). Physician-modified endograft device integrity failure was not observed in any patient. ConclusionsThe UM device demonstrated remarkable technical surgical success, treatment success, and device patency rates with very reasonable major adverse events and reintervention rates. This study is the most representative example of the general population in comparison with other studies of off-the-shelf devices, with 126 consecutive all-comer patients with diverse pathologies.