Mendes, Bernardo C.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Objective: The aim of this study is to determine perioperative outcomes and the patency of interposition conduits for visceral arterial reconstruction in this setting. Background: Visceral arterial encasement in locally advanced pancreatic cancer was historically a contraindication for surgery. With modern, effective neoadjuvant strategies, our recent experience has made advanced vascular resection and reconstruction feasible in selected patients. Methods: A retrospective review was performed of patients undergoing pancreatic tumor resection with en bloc arterial resection and interposition revascularization between June 2002 and October 2022. Endpoints included graft patency, vascular-related complications, reinterventions, morbidity, and mortality. Results: Visceral arterial reconstruction with interposition grafting was performed in 111 patients undergoing en bloc arterial resections for pancreatic cancer. Graft types included autologous arterial conduits (n=66, 58 superficial femoral arteries (SFA) and 8 splenic arteries), cryopreserved arterial allografts (n=24), autologous saphenous veins (n=12), synthetic conduits (n=8), and composite autologous artery and synthetic (n=1). Perioperative 90-day mortality decreased significantly over time to 5% in the last 6 years. Vascular complications related to arterial reconstruction occurred in 11% (n=12) and included pseudoaneurysm (n=6), graft thrombus (n=2), stenosis requiring reintervention (n=2), hepatic failure (n=1), and hepatic and intestinal ischemia (n=1). Nine (8%) patients underwent vascular-related reinterventions. After a median follow-up of 17 months, primary patency was 81% for the entire cohort and was highest in the SFA group (95%). The donor limb/harvest site complication rate was 8% with 100% primary patency. Conclusion: Visceral arterial resection with interposition reconstruction for locally advanced pancreatic cancer can be performed with acceptable vascular morbidity and durable patency. Autologous SFA was the most suitable conduit for reconstructions in our experience, with the highest primary patency.

AbstractRuptured mycotic thoracic aortic aneurysms (TAAs) pose complex clinical challenges which are often compounded by existing comorbidities of the typical patient. We present the case of an 85-year-old female presenting emergently with a ruptured mycotic TAA with underlying Streptococcus bacteremia who was successfully treated with a thoracic endograft and antibiotics.

Importance Endovascular aneurysm repair (EVAR) is the dominant treatment strategy for abdominal aortic aneurysms, encompassing 80% of all repairs in the United States. Endoleaks are ubiquitous and affect 30% of patients treated by EVAR, potentially leading to sac enlargement and increased risk of rupture. The care of EVAR patients requires long-term surveillance by a multidisciplinary team. Accordingly, physicians should be familiar with the fundamentals of endoleak management to achieve optimal outcomes, including timely referral for remediation or providing counseling and reassurance when needed. Observations PubMed and the Cochrane database were searched for articles published between January 2002 and December 2022 in English, addressing epidemiology, diagnosis, and management of endoleaks after EVAR. Endoleaks can be detected intraoperatively or years later, making lifelong surveillance mandatory. Type I and III have the highest risk of rupture (7.5% at 2 years and 8.9% at 1 year, respectively) and should be treated when identified. Intervention should be considered for other types of endoleak when associated with aneurysm sac growth larger than 5 mm based on current guidelines. Type II endoleaks are the most common, accounting for 50% of all endoleaks. Up to 90% of type II endoleaks resolve spontaneously or are not associated with sac enlargement, requiring only observation. Although the risk of rupture is less than 1%, cases that require reintervention are challenging. Recurrence is common despite endovascular treatment, and rupture can occur without evidence of sac growth. Type IV endoleaks and endotension are uncommon, are typically benign, and primarily should be observed. Conclusions and Relevance Endoleak management depends on the type and presence of sac expansion. Type I and III endoleaks require intervention. Type II endoleaks should be observed and treated selectively in patients with significant sac expansion. Since endoleaks can appear any time after EVAR, at least 1 contrast-enhanced computed tomographic angiogram or duplex ultrasound by an experienced laboratory is recommended every 5 years.

Objective: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). Background: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. Methods: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006–2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. Results: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P<0.001) and rates of MAEs (34% vs 20%, P<0.001). Median follow-up was 15 months (interquartile range, 7–37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P<0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50–2.44; P<0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63–3.62; P<0.001). Conclusions: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Objective: To describe a single-center experience of “complete aortic repair” consisting of surgical or endovascular total arch replacement/repair (TAR) followed by thoracoabdominal fenestrated-branched endovascular aortic repair (FB-EVAR). Methods: We reviewed 480 consecutive patients who underwent FB-EVAR with physician-modified endografts (PMEGs) or manufactured stent-grafts between 2013 and 2022. From those, we selected only patients treated with open or endovascular arch repair and distal FB-EVAR for aneurysms involving the ascending, arch and thoracoabdominal aortic segments (zones 0-9). Manufactured devices were used under an investigational device exemption protocol. Endpoints included early/in-hospital mortality, mid-term survival, freedom from secondary intervention, and target artery instability. Results: There were 22 patients, 14 men and 8 women with a median age of 72±7 years. Thirteen postdissection and 9 degenerative aortic aneurysms were repaired with a mean maximum diameter of 67±11 mm. Time from index aortic procedure to aneurysm exclusion was 169 and 270 days in those undergoing 2- and 3-stage repair strategies, respectively. The ascending aorta and aortic arch were treated with 19 surgical and 3 endovascular TAR procedures. Three (16%) surgical arch procedures were performed elsewhere, and perioperative details were unavailable. Mean bypass, cross-clamp, and circulatory arrest times were 295±57, 216±63, and 46±11 minutes, respectively. There were 4 major adverse events (MAEs) in 2 patients: both required postoperative hemodialysis, 1 had postbypass cardiogenic shock necessitating extracorporeal membrane oxygenation, and the other required evacuation of an acute-on-chronic subdural hematoma. Thoracoabdominal aortic aneurysm repair was performed with 17 manufactured endografts and 5 PMEGs. There was no early mortality. Six (27%) patients experienced MAEs. There were 4 (18%) cases of spinal cord injury with 3 (75%) experiencing complete symptom resolution before discharge. Mean follow-up was 30±17 months in which there were 5 patient deaths—0 aortic related. Eight patients required ≥1 secondary intervention, and 6 target arteries demonstrated instability (3 IC, 1 IIIC endoleaks; 2 TA stenoses). Kaplan-Meier 3-year estimates of patient survival, freedom from secondary intervention, and target artery instability were 78±8%, 56±11%, and 68±11%, respectively. Conclusion: Complete aortic repair with staged surgical or endovascular TAR and distal FB-EVAR is safe and effective with satisfactory morbidity, mid-term survival, and target artery outcomes. Clinical Impact The presented study demonstrates that repair of the entirety of the aorta - via total endovascular or hybrid means- is safe and effective with low rates of spinal cord ischemia. Cardiovascular specialists within comprehensive aortic teams at should feel confident that staged repair of the most complex degenerative and post-dissection thoracoabdominal aortic aneurysms can be safely performed in their patients with complication profile similar to that of less extensive repairs. Meticulous and intentional case planning is imperative for immediate and long-term success.

Objective: To report mid-term outcomes of renal-mesenteric target arteries (TAs) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal and thoracoabdominal aortic aneurysm. Background: TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. Methods: Data from consecutive patients enrolled in 9 prospective nonrandomized physician-sponsored investigational device exemption studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability. Results: A total of 1681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%), and 194 scallops (3%). Mean follow was 23 ± 21 months. At 5 years, TAs incorporated by fenestrations had higher primary (95 ± 1% vs 91 ± 1%, P < 0.001) and secondary patency (98 ± 1% vs 94 ± 1%, P < 0.001), and higher freedom from TAI (87 ± 2% vs 84 ± 2%, P = 0.002) compared with TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts had significantly lower freedom from TAI (78 ± 4% vs 88 ± 1%, P = 0.006), TA endoleak (87 ± 3% vs 97 ± 1%, P < 0.001), and TA reintervention (83 ± 4% vs 95 ± 1%, P < 0.001) compared with those targeted by self-expandable stent-grafts Conclusions: Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for self-expandable stent grafts as compared with balloon-expandable stent grafts.

Purpose: The Provisional Extension to Induce Complete Attachment Technique (PETTICOAT) uses a bare-metal stent to scaffold the true lumen in patients with acute or subacute aortic dissections. While it is designed to facilitate remodeling, some patients with chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs) require repair. This study describes the technical pitfalls of fenestrated-branched endovascular aortic repair (FB-EVAR) in patients who underwent prior PETTICOAT repair. Technique: We report 3 patients with extent II TAAAs who had prior bare-metal dissection stents treated by FB-EVAR. Two patients required maneuvers to reroute the aortic guidewire, which was initially placed in-between stent struts. This was recognized before the deployment of the fenestrated-branched device. A third patient had difficult advancement of the celiac bridging stent due to a conflict of the tip of the stent delivery system into one of the stent struts, requiring to redo catheterization and pre-stenting with a balloon-expandable stent. There were no mortalities and target-related events after a follow-up of 12 to 27 months. Conclusion: FB-EVAR following the PETTICOAT is infrequent, but technical difficulties should be recognized to prevent complications from the inadvertent deployment of the fenestrated-branched stent-graft component in-between stent struts. Clinical Impact The present study highlights a few maneuvers to prevent or overcome possible complications during endovascular repair of chronic post-dissection thoracoabdominal aortic aneurysm following PETTICOAT. The main problem to be recognized is the placement of the aortic wire beyond one of the struts of the existing bare-metal stent. Moreover, encroachment of catheters or the bridging stent delivery system into the stent struts may potentially cause difficulties.

Objective The aim of this study was to analyze malpractice claims for aortic pathologies and to assess if there has been a change in rate of malpractice lawsuits with evolution of endovascular therapy. Methods Malpractice lawsuits were individually screened and compiled from the Westlaw database from 2000 to 2017 through use of relevant search terms. Data were collected of allegations, diagnoses, and outcomes of each case and compared. Results 268 unique cases were included in this study, with aneurysms (54%, n = 145) and dissection (35%, n = 94) making up the majority. There was a defendant verdict in 53% (n = 141), plaintiff verdict in 24% (n = 65), and settlements in 23% (n = 62) of lawsuits. Litigation was higher in the Midwest and Northeast. There was a gradual decline in litigation overall, however endovascular case numbers remained constant. There was negligible difference in the primary allegation underlying the litigation for various aortic pathologies, time to litigation and award between open and endovascular procedures. Conclusion The proportion of litigation for clinical negligence in endovascular cases amongst all vascular surgical lawsuits is increasing. As novel methods of endovascular therapy emerge, it is imperative that physicians remain vigilant to legal considerations to minimize malpractice risk.

Musculoskeletal disorders and intraoperative pain are prevalent among vascular surgeons which can negatively affect their surgical performance and quality of life. The effectiveness of a lower back support exoskeleton to reduce discomfort of the back, subjective fatigue, and the workload associated with performing vascular surgery was evaluated, as well as the participants’ intraoperative upper body postures. Three vascular surgeons were asked to rate their discomfort and fatigue before, during and after performing surgery, and their subjective workload post-operatively. Inertial measurement units (IMUs) were used to measure their intraoperative body postures. No significant differences were found between exoskeleton and baseline discomfort, fatigue, workload, or intraoperative postures. This indicates that although the exoskeleton did not restrict the vascular surgeons’ postures, this exoskeleton was ineffective at reducing their discomfort or workload. Future studies with exoskeletons specifically designed for healthcare applications may show more efficacy in reducing the ergonomic risks to surgeons.