Physician-modified Endovascular Grafts Research Articles

Long-term costs to Medicare associated with endovascular and open repairs of infrarenal and complex abdominal aortic aneurysms

ObjectiveThe vast majority of patients with abdominal aortic aneurysms (AAAs) undergoing repairs receive endovascular interventions (EVARs) instead of open operations (OARs). Although EVARs have better short-term outcomes, OARs have improved longer-term durability and require less radiographic follow-up and monitoring, which may have significant implications on health care economics surrounding provision of AAA care nationally. Herein, we compared costs associated with EVAR and OAR of both infrarenal and complex AAAs. MethodsWe examined patients undergoing index elective EVARs or OARs of infrarenal and complex AAAs in the 2014-2019 Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Network (VQI-VISION) dataset. We defined overall costs as the aggregated longitudinal costs associated with: (1) the index surgery; (2) reinterventions; and (3) imaging tests. We evaluated overall costs up to 5 years after infrarenal AAA repair and 3 years for complex AAA repair. Multivariable regressions adjusted for case-mix when evaluating cost differences between EVARs vs OARs. ResultsWe identified 23,746 infrarenal AAA repairs (8.7% OAR, 91% EVAR) and 2279 complex AAA repairs (69% OAR, 31% EVAR). In both cohorts, patients undergoing EVARs were more likely to be older and have more comorbidities. The cost for the index procedure for EVARs relative to OARs was lower for infrarenal AAAs ($32,440 vs $37,488; P < .01) but higher among complex AAAs ($48,870 vs $44,530; P < .01). EVARs had higher annual imaging and reintervention costs during each of the 5 postoperative years for infrarenal aneurysms and the 3 postoperative years for complex aneurysms. Among patients undergoing infrarenal AAA repairs who survived 5 years, the total 5-year cost of EVARs was similar to that of OARs ($35,858 vs $34,212; −$223 [95% confidence interval (CI), −$3042 to $2596]). For complex AAA repairs, the total cost at 3 years of EVARs was greater than OARs ($64,492 vs $42,212; +$9860 [95% CI, $5835-$13,885]). For patients receiving EVARs for complex aneurysms, physician-modified endovascular grafts had higher index procedure costs ($55,835 vs $47,064; P < .01) although similar total costs on adjusted analyses (+$1856 [95% CI, −$7997 to $11,710]; P = .70) relative to Zenith fenestrated endovascular grafts among those that were alive at 3 years. ConclusionsLonger-term costs associated with EVARs are lower for infrarenal AAAs but higher for complex AAAs relative to OARs, driven by reintervention and imaging costs. Further analyses to characterize the financial viability of EVARs for both infrarenal and complex AAAs should evaluate hospital margins and anticipated changes in costs of devices.

Total aortic arch repair with double-fenestrated physician-modified endografts, at least 3-year follow-up

ObjectiveThis study aims to report the efficacy and safety of double-fenestrated physician-modified endovascular grafts (PMEGs) for total aortic arch repair with at least 3 years of follow-up. MethodsAll consecutive patients with a pathological aortic arch who underwent aortic arch repair combined with a homemade double-fenestrated stent graft from 2017 to 2020 were reviewed. Results74 patients were treated for pathological arch conditions with a double-fenestrated PMEG. Of these, 81% were male, the mean age was 69.9 years, and 59% were classified as American Society of Anesthesiology 3 or 4. Thirty-five percent were treated for a postdissection aneurysm, 36% for a degenerative aneurysm, and 14% for acute type B dissection. Fifteen percent had supra-aortic trunk dissection. Fenestration on the subclavian artery was performed in 96%; if not, a carotid-subclavian bypass was carried out. Technical success was 100%. The proximal landing zone is consistently in zone 0. Early outcomes revealed a 3% occurrence of type 1 endoleak, which was successfully treated by prompt reintervention. One retrograde dissection occurred, and one patient died from hemorrhage on an iliac conduit. A 5% stroke rate was reported. During long-term follow-up (mean time 40.7 months), one type 1 endoleak appeared and was successfully treated; no type 2 or type 3 endoleak requiring intervention occurred. No stent fractures or migrations were reported. Four percent of patients required reintervention, but no surgical conversion to open surgical repair was needed on the aortic arch. No patient died from a cause related to the main procedure. ConclusionsTotal aortic arch repair with double-fenestrated PMEGs is associated with acceptable early and midterm major morbidity and mortality. It is suitable for the main aortic pathologies. Moreover, it is easily available for emergency situations.

Midterm outcomes of physician-modified endovascular stent grafts for the treatment of complex abdominal aortic aneurysms in Korea: a retrospective study.

Physician-modified endovascular stent grafts (PMEG) are a good treatment option for complex abdominal aortic aneurysms (AAAs), especially in high-risk patients not amenable to open repair, and when commercial fenestrated devices are not available. We report our single-center experience with PMEG for the treatment of complex AAAs. We retrospectively reviewed patients who underwent PMEG repair for AAA from November 2016 to September 2020 at our institution. Demographic data, anatomic characteristics, perioperative and postoperative outcomes, major adverse events, and 30-day mortality were analyzed. We identified 12 patients who underwent PMEG for complex AAA. The mean age was 74 years and the mean maximal AAA diameter was 58.1 mm. Indications for treatment included 4 impending or contained ruptures, 2 mycotic aneurysms, and 6 symptomatic cases. The technical success rate was 91.7%. Aneurysm sac regression was observed in 7 patients (58.3%), including 2 cases of complete regression. There was 1 aneurysm-related mortality at 3 months due to mycotic aneurysm. Also, there was 1 postoperative complication case of transient renal failure requiring temporary dialysis. At 1 year, there was 1 branch occlusion from the initial failed cannulation case and 2 type 1A endoleaks, and there was 1 case of open explantation. PMEG showed a low technical failure rate and acceptable midterm stent durability and sac stability, comparable to conventional endovascular aneurysm repair. Despite the small number of cases, there was a tendency for a high sac regression rate, although longer follow-up is needed.

Fenestrated Physician-Modified Endovascular Grafts for Aberrant Right Subclavian Artery and/or Kommerell's diverticulum.

The aim of this case series is to report feasibility, efficiency, and safety of fenestrated physician-modified endografts (PMEGs) in aortic arch pathologies with aberrant right subclavian artery (ARSA) and/or Kommerell's diverticulum (KD). All consecutive patients with ARSA and/or KD who underwent hybrid aortic arch repair combined with homemade fenestrated stent-graft from 2018 to 2022 were reviewed. Six patients with ARSA and/or KD underwent hybrid surgery for aortic repair, 4 of whom were men, with a mean age of 49 years. Furthermore, 2 of them were symptomatic with dysphagia, 1 was taken in emergency, 1 had a bovine arch and a KD, and 2 had right descending thoracic aortas. The mean operation time was 138 (111-216) minutes. In addition, 83% of the homemade grafts were double fenestrated. All the proximal landings were in zone 0; the mean proximal aortic diameter was 29 (23-34) mm. The range of diameters for the endografts were 24 to 38 mm. There was a 100% technical success, with 0% 30 days mortality, no stroke, and no endoleak. During the follow-up, no aortic-related death or secondary intervention was required and all supra-aortic vessels remain patent. Hybrid aortic arch repair, with fenestrated PMEGs for ARSA and/or KD, is associated with acceptable early and midterm major morbidity and mortality. This retrospective case series analyzed outcomes in 6 patients with an aberrant right subclavian artery and/or Kommerell's diverticulum treated with fenestrated PMEGs during an average 16 month follow-up. The case series suggests that the use of these fenestrated PMEGs for the management of patients with an aberrant right subclavian artery is a safe, effective and durable method in the medium-term.

Physician–Modified Endovascular Graft for Left Subclavian Artery Fenestration during Thoracic Endovascular Aortic Repair

This study aimed to evaluate the safety and efficacy of physician-modified endovascular graft for preservation of left subclavian artery during thoracic endovascular aortic repair. From June 2019 to October 2022, 66 patients with a variety of thoracic aortic pathologies were treated with thoracic endovascular aortic repair using physician-modified endovascular graft left subclavian artery fenestration to achieve adequate proximal landing zone. The details of surgical techniques were described. The perioperative morbidity, mortality, and the outcomes of mid-term follow-up were analyzed. Of the 66 patients (men: women, 53:13; age, 55.18 [55.18±10.62] years), 53 (80.30%) presented with type B aortic dissection, 10 (15.15%) with thoracic penetrating aortic ulcer, 2 (3.03%) with thoracic aortic aneurysm, and 1 (1.52%) with left subclavian artery aneurysm. All of them underwent thoracic endovascular aortic repair using physician-modified endovascular graft left subclavian artery fenestration on the sterile back table. The technique success rate was 96.97% (n=64). Total operation time was 92min (interquartile range, 86-118), graft modification time was 19min (interquartile range, 17-21), fluoroscopy time was 49min (interquartile range, 41-62), and contrast agent dosage was 165mL (interquartile range, 155-185). 30-day perioperative morbidities were 3 (4.55%) strokes, 1 (1.52%) retrograde type A aortic dissection, 1 (1.52%) aortic intimal intussusception, 1 (1.52%) left arm ischemia, and 3 (4.55%) type Ia endoleaks. Postoperative 30-day mortality and reintervention rates were 1.52% and 4.55%, respectively. Among the 63 patients included in the follow-up of 17months (interquartile range, 7.75-18.25), the primary patency of left subclavian artery fenestration stents was 100%. Late complications were 1 (1.59%) distal stent graft-induced new entry and 1 (1.59%) death due to retrograde type A aortic dissection during the follow-up. The stent graft-induced new entry patient was observed with stable false lumen. Thoracic endovascular aortic repair with physician-modified endovascular graft for left subclavian artery revascularization is a safe, feasible, and efficacious technique associated with high success rate. Further study is needed for long-term outcome investigation.

Midterm outcomes of physician-modified endovascular grafts for repair of postdissection and degenerative thoracoabdominal aortic aneurysms

Although physician-modified fenestrated and branched endografts (PMEGs) were proposed as an alternative to thoracoabdominal aortic aneurysms (TAAAs) repair in 2012, PMEG use is still limited by the lack of long-term data in large series. We seek to compare the midterm outcomes of PMEGs in patients with postdissection (PD) and degenerative (DG) TAAAs. Data were analyzed for 126 patients (age 68±13years; 101 men [80.2%]) with TAAAs treated by PMEGs from 2017 to 2020, including 72 PD-TAAAs and 54 DG-TAAAs. Early and late outcomes were compared between patients with PD-TAAAs and DG-TAAAs, including survival, branch instability, and freedom from endoleak and reintervention. Hypertension and coronary artery disease were present in 109 (86.5%) and 12 (9.5%) patients. PD-TAAA patients were younger (63±10 vs 75±12years; P<.001), and more likely to have diabetes (26.4 vs 11.1; P=.03), history of previous aortic repair (76.4% vs 22.2%; P<.001), and smaller aneurysm size (52 vs 65mm; P<.001). TAAAs were extent I in 16 (12.7%), II in 63 (50%), III in 14 (11.1%), and IV in 33 (26.2%). Procedural success was 98.6% (71 out of 72) and 96.3% (52 out of 54) for PD-TAAAs and DG-TAAAs (P=.4). The DG-TAAAs group sustained more nonaortic complications than PD-TAAAs (23.7% vs 12.5%; P=.03) in adjusted analysis. Operative mortality was 3.2% (4 out of 126), which didn't differ between the groups (1.4% vs 5.6%; P=.19). The mean follow-up was 3.01 ± 0.96years. There were 2 (1.6%) late deaths (from retrograde type A dissection and gastrointestinal bleeding [n=1 each]), 16 (13.1%) endoleaks, and 12 (9.8%) instances of branch vessel instability. Reintervention was performed in 15 (12.3%) patients. At 3years, survival, freedom from any branch instability, and freedom from endoleak and reintervention were 97.2%, 97.3%, 86.9%, and 85.8% in the PD-TAAAs group, respectively, which did not differ significantly from DG-TAAAs patients (92.6%, 97.4%, 90.2%, and 92.3% all P values > .05). Despite the difference in age, diabetes, prior history of aortic repair, and aneurysm size preoperatively, PMEGs achieved similar early and midterm outcomes in PD-TAAAs and DG-TAAAs. Patients with DG-TAAAs were more prone to early nonaortic complications, which represents an aspect for improvement to optimize outcomes and warrants further study.

Reinterventions after physician-modified endovascular grafts for treatment of juxtarenal aortic aneurysms are non-detrimental to long-term survival

ObjectiveReintervention after endovascular aortic aneurysm repair is common. However, their frequency and impact on mortality after physician-modified endografts (PMEGs) is unknown. This study aims to describe reinterventions after PMEG for treatment of juxtarenal aneurysms and their effect on survival. MethodsData from a prospective investigational device exemption clinical trial (Identifier #NCT01538056) from 2011 to 2022 were used. Reinterventions after PMEG were categorized as open or percutaneous and major or minor by Society for Vascular Surgery reporting standards and as high or low magnitude based on physiologic impact. Reinterventions were also categorized by timing, based on whether they occurred within 30 days of PMEG as well as within 1 week of PMEG. Survival was compared between patients who did and did not undergo reintervention and between reintervention subcategories. ResultsA total of 170 patients underwent PMEG, 50 (29%) of whom underwent a total of 91 reinterventions (mean reinterventions/patient, 1.8). Freedom from reintervention was 84% at 1 year and 60% at 5 years. Reinterventions were most often percutaneous (80%), minor (55%), and low magnitude (77%), and the most common reintervention was renal stenting (26%). There were 10 early reinterventions within 1 week of PMEG. Two aortic-related mortalities occurred after reintervention.There were no differences in survival between patients who underwent reintervention and those who did not. However, survival differed based on the timing of reintervention. After adjusted analysis, reintervention within one week of PMEG was associated with an increased risk of mortality both compared with late reintervention (hazard ratio, 11.1; 95% confidence interval, 2.7-46.5) and no reintervention (hazard ratio, 5.2; 95% confidence interval, 1.6-16.8). ConclusionsReinterventions after PMEG were most commonly percutaneous, minor, and low magnitude procedures, and non-detrimental to long-term survival. However, early reinterventions were associated with increased mortality risk. These data suggest that a modest frequency of reinterventions should be expected after PMEG, emphasizing the critical importance of lifelong surveillance.

Tightrope Technique for facilitating complex endovascular aortic repair in patients with severely angulated neck

An 84-year-old presented with a large, symptomatic juxtarenal abdominal aortic aneurysm. Owing to severe angulation of the infrarenal neck, advancement of the distal bifurcated component caused dramatic lateral movement of the proximal physician-modified endovascular graft (PMEG) fenestrated device. This procedure risked aneurysm sac perforation and possible PMEG device displacement. To avoid this complication, the distal aspect of the PMEG device was tethered in place using endoscopic forceps to provide countertraction, similar to pulling a tightrope. This technique allowed for the uneventful placement of the distal bifurcated component without complication. This technique can overcome device placement challenges within an angulated aorta caused by large aneurysms.

Fenestrated/branched endovascular aortic repair using unilateral femoral access in patients with iliac occlusive disease

ObjectiveFenestrated/branched endovascular aortic repair (F/BEVAR) in patients with occluded iliac arteries is challenging owing to limited access for branch vessel catheterization and increased risk for leg and spinal ischemic complications. The aim of this study was to analyze technical strategies and outcomes of F/BEVAR in patients with unilateral iliofemoral occlusive disease. MethodsWe performed a retrospective review of all consecutive patients treated by F/BEVAR in two institutions (2003-2021). Patients with unilateral iliofemoral occlusive disease were included in the analysis. All patients had one patent iliac artery that was used for advancement of the fenestrated-branch component. Preloaded catheter/guidewire systems or steerable sheaths were used as adjuncts to facilitate catheterization. Primary endpoints were technical success, mortality, major adverse events (stroke, spinal cord injury, dialysis or decrease in the glomerular filtration rate of more than 50%, bowel ischemia, myocardial infarction, or respiratory failure), primary iliac patency, and freedom from reinterventions. ResultsThere were 959 patients treated with F/BEVAR. Of these, 15 patients (1.56%; mean age, 74 years; 80% male) had occluded iliac arteries and 1 patent iliofemoral access and were treated for a thoracoabdominal aortic aneurysm (n = 8) or juxtarenal abdominal aortic aneurysm (n = 7). Brachial access was used in 14 of the 15 patients and preloaded systems in 7 of the 15 patients (47%). The remaining 53% had staggered deployment of stent grafts. There were seven physician-modified endovascular grafts, seven custom-made devices, and one off-the-shelf device used. Thirteen patients (87%) had distal seal using aortouni-iliac stent grafts and two (13%) had distal seal in the infrarenal aorta. Concomitant femoral crossover bypass (FCB) was performed in two patients and six patients had a prior FCB. Technical success was 100%. There were no intraoperative complications or early lower extremity ischemic complications, and all FCB were preserved. There was one mortality (7%) within 30 days owing to retrograde type A dissection. Major adverse events occurred in 20% of patients. The median follow-up was 12 months (range, 0-85 months). Two patients (13%) required three reinterventions. One patient required proximal stent graft extension for an acute type B dissection (3 months) and another required iliac extension for type Ib endoleak of an aortouni-iliac graft (21 months) and thrombolysis of that extension (50 months). At last follow-up, all patients had primary graft patency except one with secondary graft patency without new claudication. One patient had a single renal artery stent occlusion at follow-up with no r-intervention. The overall survival rate was 60%, without aortic-related deaths. ConclusionsAlthough challenging, F/BEVAR with unilateral femoral/brachial approach is feasible in patients with occluded iliac limbs, with an important rate of ischemic complications, but satisfactory outcomes.

Homemade fenestrated physician-modified stent grafts for arch aortic degenerative aneurysms.

We evaluated the early- and medium-term outcomes of single- and double-fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular degenerative aortic arch aneurysm repair. We performed a single-center, retrospective analysis of prospectively collected data from 52 patients from August 2013 through January 2021 who had undergone homemade fenestrated thoracic endovascular aortic repair for degenerative aortic aneurysms. In all cases, a distal smaller fenestration for the left subclavian artery (LSA) was fashioned and was the only one stented. For a double-fenestrated endograft, a proximal larger fenestration that incorporated both the brachiocephalic trunk and the left common carotid artery was added. A total of 52 patients with degenerative aortic arch aneurysms were treated. Of the 52 patients, 36 were men, the mean age was 75± 8years, 31% had received a single LSA fenestration, and 69% had undergone double-fenestrated thoracic endovascular aortic repair. Of the 52 procedures, 5 (10%) were emergent procedures. The technical success was 100%. The median time required for stent graft modification was 22± 6minutes. The 30-day mortality was 2% (n= 1). Five patients (10%) had experienced a cerebrovascular event, including two transient ischemic attacks, one minor stroke with full neurologic recovery, and two with sequelae. Two patients (4%) had experienced perioperative retrograde dissection during follow-up. No patient had developed a type I, II, or III endoleak from the LSA. No patient had required reintervention. All supra-aortic trunks were patent. During a mean follow-up of 18± 11months, no patient had required conversion to open surgical repair, aortic rupture, or paraplegia. Single or double PMEG is a safe and suitable tool for the treatment of high morbidity pathology such as aortic arch degenerative aneurysm repair. In addition, this device can be used in patients requiring elective or emergency repair.

Physician-Modified Stent Graft for Blunt Thoracic Aortic Injuries: Do the Benefits Worth the Trouble?

Obtaining a suitable proximal landing zone in blunt thoracic aortic injuries (BTAI) often necessitates coverage of the left subclavian artery (LSA). This study aimed to evaluate the outcomes of physician-modified endovascular grafts (PMEGs) in this indication. We performed a retrospective analysis of a prospective registry including all patients who had undergone a thoracic endovascular aortic repair (TEVAR) for BTAI from October 2008 to October 2020. Starting in 2015, patients requiring coverage of the LSA were either treated using a physician-modified proximal scalloped or single-fenestrated stent graft. After an early postoperative computed tomography scan, follow-up was performed at 3 months, 6-months, and yearly. Among 58 patients treated with TEVAR for BTAI, 23 (39.6%) patients required a zone 2 landing zone of which 10 (17.2%) patients were treated with PMEGs. The median age was 48 [31-64.5] years, and 78.2% (n=18) patients were male. The median Injury Severity Score was 38 [27-55.5]. Coverage of the LSA was performed in 25.8% (n=15) of the total population in which 5 patients had an LSA transposition. The median modification time was 18 [14-27] minutes. Technical success of PMEGs was 90.0% overall and 100% for fenestrated stent grafts. No stroke, paraplegia, or retrograde dissection was observed. The primary patency of the LSA in the PMEGs group was 90 % at 1year and 28.8 % in the LSA coverage group (P<0.01). The use of PMEGs is feasible and effective in the management of BTAI with a short proximal landing zone. Further evaluation of long-term outcomes and durability are awaited.

Single-Center Experience of Fenestrated Endovascular Aortic Repair Using Physician-Modified Endovascular Grafts Prior to Initiation of an Investigation Device Exemption Trial

Fenestrated endovascular aortic repair (FEVAR) is an important option for complex abdominal aortic aneurysms (AAAs) and thoracoabdominal AAAs in patients high-risk for open repair. While availability of custom-devices is limited, physician-modified endografts (PMEGs) allow surgeons to build grafts for patients’ specific anatomy. Here, we present our PMEG experience, submitted to the US Food and Drug Administration with an Investigation Device Exemption trial application, which is now enrolling (clinicaltrials.gov NCT04746677).

Reinterventions After Physician-Modified Endovascular Grafts for Treatment of Juxtarenal Aortic Aneurysms are Nondetrimental to Long-Term Survival

Reintervention after endovascular aortic aneurysm repair is common. However, the frequency and effects of reintervention on mortality after physician-modified endografts (PMEGs) is unknown. In the present study, we have described the reinterventions after PMEG for treatment of juxtarenal aneurysms and their effect on survival.

Total Arch Thoracic Endovascular Aortic Repair Using Double Fenestrated Physician-Modified Stent-Grafts: 100 Patients

Objective: The aim was to evaluate early and medium-term outcomes of double fenestrated physician-modified endovascular grafts for total endovascular aortic arch repair. Methods: This single-center retrospective analysis of prospectively-collected data included 100 patients, from January 2017 to December 2021, undergoing thoracic endovascular aortic repair (TEVAR) for zone 0. The fenestrations were a proximal larger fenestration that incorporated the brach2iocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented. Results: The median duration for stent-graft modification was 23±6 minutes. Of the 100 patients, 70 were men. The mean patient age was 70±10.5 years. Indications for treatment included degenerative aortic arch aneurysm (n=32), dissecting aortic arch aneurysm after type A dissections (n=23) and (n=19) after type B dissections, acute complicated type B dissection (n=16), and other pathologies (n=10). Technical success rate was 97%. The 30 day mortality was 2% (n=2). Four patients (4%) had minor stroke with full recovery. One patient (1%) had a type IA endoleak, 1 patient (1%) had a type IB endoleak, and 2 patients (2%) have a type II endoleak from the LSA. Eight patients (8%) required reintervention: 1 type IA endoleak, 1 type IB endoleak, 1 retrograde type A dissection, and 5 because of access-related complications. During a mean follow-up of 24±7.2 months, there were no aortic rupture, paraplegia, and all supra-aortic trunks were patent. Conclusions: Double homemade fenestrated TEVAR is both feasible and effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The long-term durability will need to be assessed in studies with long-term follow-up. Clinical Impact Double homemade fenestrated TEVAR is effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The standout feature of this double fenestrated device is its simple handling during operation with the proximal fenestrations being directed to the orifices of the BT and LCCA automatically when the LSA fenestration is catheterized and secured by covered stent placement. The deployment algorithm actively steers the operator away from superfluous manipulations of the device within the arch and avoids guidewire manipulation in carotid arteries. The long-term durability will need to be assessed in studies with long-term follow-up.

Single-Center Experience of Fenestrated Endovascular Aortic Repair Using Physician-modified Endovascular Grafts Before Initiation of an Investigation Device Exemption Trial

Fenestrated endovascular aneurysm repair (FEVAR) is an important option for complex abdominal aortic aneurysms (AAAs) and thoracoabdominal aneurysms in patients high-risk for open repair. Currently, the only US Food and Drug Administration (FDA)-approved fenestrated device is limited to juxtarenal AAAs. Custom-manufactured devices are only available at a handful of US centers. Physician-modified endografts (PMEGs) allow surgeons to build grafts for patients’ anatomy using standard stent grafts. Here, we present our single-center experience with PMEGs, submitted to the FDA with an Investigation Device Exemption trial application, which is now approved and enrolling (clinicaltrials.gov NCT04746677).

Physician-Modified Endovascular Grafts for Zone-2 Thoracic Endovascular Aortic Repair.

Objective This study aims to describe our technique and early experience with physician-modified endovascular grafts (PMEGs) for aortic arch diseases in zone 2. We used a total endovascular technique based on a single fenestrated endograft to preserve left subclavian artery (LSA) patency. Methods From December 2019 to August 2020, six consecutive patients with a variety of thoracic aortic diseases were treated with handmade fenestrated thoracic aortic grafts: four aortic dissections, one penetrating aortic ulcer, and one intramural hematoma. The planning, endograft modification, surgical technique, and follow-up of the patients were described. We evaluated immediate technical success and after 30 days, the LSA patency, Type-1 endoleak, and postoperative complications. Results Thoracic endovascular aortic repair (TEVAR) was performed for zone 2 in all cases. Immediate technical success, defined as successful alignment of the LSA with a covered stent and no Type-1 endoleak, was achieved in all cases. Patients had a 30-day follow-up computed tomography, which demonstrated LSA patency and no Type-I endoleaks. To date, no strokes, left arm ischemia, paraplegia, or conversions to open surgery have been reported; one patient operated for acute Type B dissection died during the early follow-up. Conclusion TEVAR for zone 2 with a PMEG to maintain LSA patency achieved technical success and early durability. It is expected that with longer follow-up and a larger number of cases, these results will be confirmed.

Current role of physician-modified endovascular grafts for fenestrated endovascular aortic aneurysm repair

Fenestrated endovascular aortic aneurysm repair (FEVAR) is becoming the preferred treatment option for complex aortic aneurysms. In the United States, the limited access to fenestrated endografts delayed the adoption of FEVAR. Physician-modified endovascular grafts (PMEGs) were the answer to such limitations. In this issue of the Journal of Vascular Surgery, Hemingway et al1 review their initial experience with the use of modified Treo devices. They report acceptable 30-day outcomes and early technical and clinical success.

Midterm outcomes of fenestrated TEVAR using physician-modified endovascular grafts for zone 2.

To summarize the experience and midterm outcomes of physician-modified endovascular grafts for zone 2 thoracic endovascular aortic repair. A retrospective analysis was conducted of 51 consecutive patients (mean age 57.6 ± 12.5 years, 39 males) treated with thoracic endovascular aortic repair using physician-modified endovascular grafts for reconstructing the left subclavian artery from November 2015 to December 2019. The primary endpoints during follow-up were the overall mortality, aorta-related mortality, and major complications. The secondary endpoints were reintervention and the patency of the target branches, the demographics and technical details were also described and analyzed. Sixty-three thoracic stent-grafts were deployed in 51 patients and emergency surgery was performed in 10 patients (19.6%). Technical success was 94.1% (48/51). The incidence of perioperative complications was 15.7%, and the 30-day mortality was 0%. At a mean follow-up of 42.0 ± 14.4 months (range, 14-63 months), all the left subclavian arteries remained patent. All-cause mortality was 3.9% (2/51) and not aorta-related deaths. Estimated survival at one and three years was 98.0 ± 1.9% and 96.0 ± 2.8%, respectively. The physician-modified endovascular grafts is feasible and effective to preserve left subclavian artery in thoracic endovascular aortic repair for aortic arch pathologies with unhealthy proximal landing zone.

Endovascular aortic arch repair with a pre-cannulated double-fenestrated physician-modified stent graft: a benchtop experiment.

The critical step in total endovascular aortic arch repair is to ensure alignment of fenestrations with, and thus maintenance of flow to, supra-aortic trunks. This experimental study evaluates the feasibility and accuracy of a double-fenestrated physician-modified endovascular graft [single common large fenestration for the brachiocephalic trunk and left common carotid artery and a distal small fenestration for left subclavian artery (LSA) with a preloaded guidewire for the LSA] for total endovascular aortic arch repair. Eight fresh human cadaveric thoracic aortas were harvested. Thoracic endografts with a physician-modified double fenestration were deployed for total endovascular aortic arch repair in a bench test model. A guidewire was preloaded through the distal fenestration for the LSA. All experiments were undertaken in a hybrid room under fluoroscopic guidance with subsequent angioscopy and open evaluation for assessment. Mean aortic diameter in zone 0 was 31.3 ± 3.33 mm. Mean duration for stent graft modification was 20.1 ± 5.8 min. Mean duration of the procedure was 24 ± 8.6 min. The Medtronic Valiant Captivia stent graft was used in 6 and the Cook Alpha Zenith thoracic stent graft in 2 cases. LSA catheterization was technically successful with supra-aortic trunk patency in 100% of cases. The use of a double-fenestrated stent graft with a preloaded guidewire appears to be a useful technical addition to facilitate easy and correct alignment of stent graft fenestrations with supra-aortic trunk origins.

Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients

ObjectiveOur aim was to evaluate the early- and medium-term outcomes of using double fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular aortic arch repair. MethodsThe present single-center retrospective analysis of prospectively collected data included 50 patients from January 2017 through October 2019, who had undergone thoracic endovascular aortic repair (TEVAR). The fenestrations were a proximal larger fenestration that incorporated the brachiocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented. ResultsThe median duration for stent graft modification was 26 ± 6 minutes. Of the 50 patients, 41 were men. The mean patient age was 68 ± 11.5 years. The indications for treatment included degenerative aortic arch aneurysm (n = 17), dissecting aortic arch aneurysm after type A dissection (n = 13), type B dissection (n = 13), aortic ulcer (n = 3), and other pathologies (n = 4). The technical success rate was 94% (47 of 50) overall, and 100% (28 of 28) after a technical modification incorporating a preloaded guide wire for the LSA fenestration (P < .05). The 30-day mortality was 2% (n = 1). Two patients (4%) had a minor stroke with full recovery. One patient (2%) had a type IB and two patients (4%) had a type II endoleak from the LSA. Four patients (8%) required reintervention: one because of a type IB endoleak and three because of access-related complications. All supra-aortic trunks were patent. During a mean follow-up of 16 ± 8.3 months, no conversions to open surgical repair were required and no aortic rupture, paraplegia, or retrograde dissection occurred. ConclusionsUsing double fenestrated PMEGs for TEVAR is both feasible and effective for total endovascular aortic arch repair, avoiding the need for anatomic and extra-anatomic surgical revascularization. The absence of brachiocephalic trunk stenting was not associated with endoleaks or treatment failure and resulted in a lower stroke risk than alternative strategies. The midterm results suggest that stenting of the brachiocephalic trunk and right common carotid artery might not be necessary for a large proportion of patients undergoing total endovascular aortic arch repair. The persistence of the seal and ongoing durability require assessment in studies with long-term follow-up data available.