Journal of Vascular Surgery最新文献

Objective: The EXPAND registry is a post-market, multicenter registry that aims at evaluating the safety and performance of the GORE VIABAHN VBX balloon expandable endoprosthesis (VBX stent) implanted in peripheral vessels. This subgroup analysis assesses the 3-year outcomes of the VBX stent as a bridging stent graft for visceral vessels during branched endovascular aortic repair.

Methods: This prospective, multicenter, observational registry includes 16 European sites. Patients were enrolled from November 2018 to March 2022. Endpoints included 3-year primary patency (PP), secondary patency (SP), and stent graft-related death and serious adverse events.

Results: Seventy-three patients, of whom 57 (78.1%) were male, with a mean age of 73 years (±8.1 years) were included. At 3 years, 42 patients (57.5%) returned for follow-up. Overall, 223 target vessels (TVs) were treated. The estimated freedom from loss of TV PP was 93.6%. Per TV PP rates were 97.0% for the celiac trunk, 93.9% for the superior mesenteric artery, 91.2% for the left renal artery, and 92.5% for the right renal artery. The overall estimated freedom from loss of SP was 96.8%, and freedom from TV instability was 94.5%.

Conclusions: The VBX stent demonstrated excellent sustained results at 3 years with almost 94% PP, 97% SP, and 94.5% freedom from TV instability. Patency in the renal arteries was lower than in the celiac trunk and superior mesenteric artery. The VBX stent appears to be a reliable bridging stent for target vessels in branched endovascular aortic repair.

Objective: We present a review of our hybrid management (endovascular + open surgery) of large thoracic aortic aneurysms (>80 mm). The strategy comprises a primary endovascular repair using thoracic endovascular aortic repair (TEVAR), and/or fenestrated and branched endografts (FBEVAR), followed by open thoracotomy and aneurysmorraphy, specifically without the need for aortic cross-clamping.

Methods: We performed a retrospective review of all patients who had undergone aneurysmorraphy via thoracotomy following TEVAR and FBEVAR in two high-volume aortic centers between December 2017 and March 2024. We performed aneurysmorraphy in two clinical situations: (1) in the setting of a planned staged treatment, shortly after TEVAR or FBEVAR in young patients with aneurysm diameter >100 mm; and (2) as a secondary intervention during follow-up for patients with persistent sac enlargement and aneurysm diameters >80 mm. The primary end points were 30-day survival and aneurysm-related mortality during follow-up. Secondary endpoints were sac size evolution, perioperative and postoperative complications, freedom from further reintervention, and late aortic complications.

Results: Twelve patients underwent aneurysmorraphy following TEVAR and/or FBEVAR during the study period. Mean patient age was 60 ± 12 years, and the mean sac diameter before thoracotomy was 101 ± 25 mm. Endovascular embolization of intercostal arteries prior to aneurysmorraphy was performed in four patients. The 30-day survival rate was 100%. During the mean follow up period of 21 months, two patients died-one of COVID and another of intra-cerebral hemorrhage. No aneurysm-related mortality occurred, and sac regression was achieved in all patients except one experiencing aortic growth below the aneurysmorraphy.

Conclusions: This study demonstrates that thoracic aneurysmorraphy performed after TEVAR and FBEVAR for complex thoracic aneurysms is a safe and effective technique. This procedure allows the eradication of endoleaks and an immediate sac volume reduction, which prevents aorta-bronchial or esophageal fistulation and secures the endovascular repair; the reduction of the aneurysm mass effect restores normal lung parenchyma expansion. This hybrid management strategy drastically reduces the morbidity associated with standard open surgery performed for thoracic endograft explantation.

Objective: There remains a progressive projected deficit in the vascular surgery (VS) workforce for decades. Despite the expanding integrated VS residency pathway, the fellowship training model remains critical in supporting our future workforce. Therefore, it is imperative to understand the resident and program-specific factors that influence VS specialization among general surgery (GS) residents.

Methods: Data from the United States Resident OPerative Experience (ROPE) Consortium, which comprises 20 Accreditation Council for Graduate Medical Education-accredited GS residency programs across the United States, were queried for resident demographics and residency program-related details. Logistic regression analysis was used to identify factors associated with VS specialization.

Results: From 2010 to 2020, a total of 1343 graduating GS residents were included in the study. Of these, 135 (10.1%) pursued VS fellowship training. Residents pursuing VS were more frequently male (80.7% vs 62.8%; P < .0001) and younger (median age, 32 vs 33 years; P = .03) compared with other GS residents. Racial and ethnic group, underrepresented in medicine status, and international medical graduate status were similar between the VS and non-VS groups. Residency program-level details were also similar between groups, including program type (university vs community-based), region, size, resident volume, dedicated research experience, and National Institutes of Health funding. Dedicated vascular rotations were common among all GS programs (95.4%), and total months spent on a VS rotation (median, 4 vs 4.5 months; P = .11) did not differ among residents pursuing VS and all other residents. The presence of a collocated traditional (5 + 2) VS fellowship (91.1% vs 90.4%; P = .79) or integrated (0 + 5) VS residency (56.3% vs 55.0%; P = .77) were also similar between groups. On multivariate analysis, only male sex (odds ratio, 2.34; 95% confidence interval, 1.50-3.81; P < .001) was associated with pursuing VS fellowship. Factors that did not impact VS specialization included resident age, underrepresented in medicine status, international medical graduate status, program volume, dedicated research experience, or total months spent on a VS rotation.

Conclusions: In this multi-institutional study, we did not find any program-specific factors that influence VS specialization among GS residents. Notably, the presence of a collocated 0 + 5 residency or 5 + 2 fellowship program did not appear to deter GS residents from pursuing a VS fellowship. These data suggest that individual factors, such as mentorship, may be more impactful in recruiting GS residents to the VS specialty.

Objective: This study compares chronic limb-threatening ischemia disease characteristics and endovascular revascularization outcomes in a multi-ethnic Asian cohort vs their North American counterparts.

Methods: The Society for Vascular Surgery Vascular Quality Initiative (VQI) registry database from the first and currently the only VQI center in Asia was reviewed to identify patients with chronic limb-threatening ischemia who underwent endovascular revascularization between July 2019 and April 2024. Standardized VQI reporting variables were compared against benchmarks derived from all participating centers in North America.

Results: A total of 2862 endovascular revascularization procedures from our center were benchmarked against 129,347 procedures from 406 North American centers. Our cohort had a higher burden of comorbidities (diabetes mellitus, end-stage renal disease, cardiac disease) and presented with more advanced Wound, Ischemia, and foot Infection stages. Our patients had more heavily calcified and longer (14.8 cm vs 6.0 cm) diseased vessels with higher prevalence of multi-level (87% vs 54.6%), infrapopliteal (52.6% vs 38.9%), and inframalleolar (9.6% vs 2.4%) disease. Rates of technical success (92.7% vs 93%) and symptom improvement (39.1% vs 40.4%) were comparable between cohorts. However, 1-year mortality rates (28.9% vs 25.1%) and major amputation rates (13.3% vs 7.8%) were significantly higher.

Conclusions: Short-term outcomes of technical success and symptom relief in our center were comparable to benchmarked North American outcomes despite having a cohort with more diseased vessels, higher Wound, Ischemia, and foot Infection stages, and more comorbidities. However, this cohort fared worse in longer term outcomes of 1-year mortality and major amputation rates. Further studies are required to elucidate the causes to improve these outcomes.

Objective: To report the investigational device exemption study 1-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAAs).

Methods: This study is a prospective, multicenter clinical trial conducted in the United States and included core laboratory assessment of imaging and independent event adjudication. Anatomical criteria for enrollment in the HNA substudy included infrarenal aortic neck angulation >60° and ≤90° with aortic neck length ≥10 mm. Primary safety end points included estimated blood loss of >1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness end points included technical success, absence from type I and III endoleaks, migration (≥10 mm), sac enlargement (≥5 mm), sac rupture, and conversion to open repair.

Results: Between January 2018 and February 2022, 95 patients were enrolled in the HNA substudy across 35 sites. Of the 95 patients, 71 (74.7%) were male and the cohort average age was 74.4 years. The mean infrarenal proximal aortic neck angle was 71.6° and the mean AAA size was 62.9 mm. Overall technical success was achieved in 93 patients (97.9%). Freedom from a primary safety end point through 30 days was 96.7%; 3 (3.3%) patients had an estimated blood loss of >1000 mL. Freedom from the primary effectiveness at 12 months was achieved in 94.8%. Four patients (4.3%) had a type IA endoleak; intervention after the procedure was not required and no subsequent interventions or sac enlargement were noted in these patients. At 12 months, 29 patients (39.7%) experienced a type II endoleak and 1 (1.3%) patient experienced AAA sac expansion of ≥5 mm. Through 12 months, 1 patient (1.3%) had a conversion to open surgical repair. There were no aneurysm-related deaths, ruptures, or migration through 12 months.

Conclusions: The investigational device exemption study demonstrates safety and effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis device in AAA with highly angulated necks (>60° and ≤90°) are preserved at the 12-month follow-up.

Objective: Patients with peripheral artery disease (PAD) undergo lower extremity revascularization (LER) for symptomatic relief or limb salvage. Despite LER, patients remain at increased risk of platelet-mediated complications, such as major adverse cardiac and limb events (MACLEs). Platelet activity is associated with cardiovascular events, yet little is known about the dynamic nature of platelet activity over time. We, therefore, investigated the change in platelet activity over time and its association with long-term cardiovascular risk.

Methods: Patients with PAD undergoing LER were enrolled into the multicenter, prospective Platelet Activity and Cardiovascular Events study. Platelet aggregation was assessed by light transmission aggregometry to submaximal epinephrine (0.4 μmol/L) immediately before LER, and on postoperative day 1 or 2 (POD1 or POD2) and 30 (POD30). A hyperreactive platelet phenotype was defined as >60% aggregation. Patients were followed longitudinally for MACLEs, defined as the composite of death, myocardial infarction, stroke, major lower extremity amputation, or acute limb ischemia leading to reintervention.

Results: Among 287 patients undergoing LER, the mean age was 70 ± 11 years, 33% were female, 61% were White, and 89% were on baseline antiplatelet therapy. Platelet aggregation to submaximal epinephrine induced a bimodal response; 15.5%, 16.8%, and 16.4% of patients demonstrated a hyperreactive platelet phenotype at baseline, POD1, and POD30, respectively. Platelet aggregation increased by 18.5% (P = .001) from baseline to POD1, which subsequently returned to baseline at POD30. After a median follow-up of 19 months, MACLEs occurred in 165 patients (57%). After adjustment for demographics, clinical risk factors, procedure type, and antiplatelet therapy, platelet hyperreactivity at POD1 was associated with a significant hazard of long-term MACLE (adjusted hazard ratio, 4.61; 95% confidence interval, 2.08-10.20; P < .001).

Conclusions: Among patients with severe PAD, platelet activity increases after LER. Platelet hyperreactivity to submaximal epinephrine on POD1 is associated with long-term MACLE. Platelet activity after LER may represent a modifiable biomarker associated with excess cardiovascular risk.

Objective: Chronic limb-threatening ischemia (CLTI) due to isolated tibial occlusive disease is treated by either popliteal-distal bypass (PDB) or tibial angioplasty (TA), although there is limited data directly comparing efficacy and outcomes between these two treatment modalities. This study compares 30-day mortality and major adverse limb events following infrapopliteal bypass and TA in patients with CLTI.

Methods: Patients who underwent PDB for CLTI were extracted from American College of Surgeons National Surgical Quality Improvement Program targeted lower extremity open database, whereas patient with CLTI who underwent isolated TA were identified in the targeted lower extremity endovascular database. Any case with more proximal angioplasty such as femoral/popliteal/iliac was excluded. The time interval was 2011 through 2022. The two groups were comparable in demographics, and preoperative comorbidities were obtained using propensity matching. Mortality, systemic complications, and major adverse limb events were measured. Multivariable logistic regression was used for data analysis. To obtain granular data on the angiographic characteristics of patients undergoing PDB or TA, The George Washington University institutional data from 2014 to 2019 was used as a supplement to the database.

Results: There were 1947 and 3423 cases identified in the bypass and endovascular groups, respectively. After propensity matching for all preoperative variables, 1747 cases remained in each group. Although bypass was associated with higher major adverse cardiovascular events, pulmonary, renal, and wound complications, bypass had significantly better 30-day limb salvage when compared with TA (major amputation rate, 3.32% vs 6.12%; P < .01). Institutional data identified 69 patients with CLTI due to isolated tibial occlusive disease; 25 (36.2%) underwent PDB and 44 (63.8%) underwent TA. Review of angiographic details revealed patients who underwent PDB had better pedal targets (inframalleolar/pedal score of P0 [24.0% vs 15.9%] or P1 [68.0% vs 61.3%]) than TA patients (inframalleolar/pedal score of P2 [22.7% vs 8.0%]).

Conclusions: PDB was associated with higher morbidity but better limb salvage than endovascular interventions. However, this could be explained by the association with better pedal targets in patients who underwent popliteal-tibial bypass. Prospective studies should be done comparing PDB and TA in cases with similar pedal targets.

Objective: Dialysis access-associated steal syndrome (DASS) is one of the most serious complications of hemoaccess surgery. Treatment algorithms involve significant morbidity; a tool to reliably identify patients at risk who could benefit from interventions at time of operation would be useful. We present a strategy of using perianastomotic pressure (PAP) measurement to identify patients who may be at high risk of developing DASS.

Methods: Patients who underwent dialysis access creation between January 1, 2018, and September 30, 2022, at our institution were reviewed. Beginning in October 2019, we developed a strategy of measuring systolic pressure at the arterial anastomosis intraoperatively. A ratio of this value compared with the systemic systolic pressure was calculated. In patients believed to be at high risk for developing DASS based on clinical findings, selective banding of the access was performed intraoperatively to augment distal perfusion.

Results: Of 857 total patients, 36 (4.2%) developed clinically significant DASS, defined as requiring operative treatment, either intraoperatively or during follow-up (mean, 76 days; range, 0-602 days). DASS was more common for femoral-based accesses (6/12 [46.2%]) compared with upper extremity accesses (30/840 [3.6%]; P < .001). No patients who underwent radiocephalic arteriovenous fistula or infraclavicular axillary arteriovenous graft construction developed DASS. There was no difference in DASS for upper extremity arteriovenous fistulas (20/576, 3.47%) vs AV grafts (10/264, 3.79%; P = .82). There were 216 patients who had PAP measured intraoperatively. Fourteen (6.5%) of these 216 patients developed DASS requiring intervention in follow-up. The mean PAP ratio of these 14 patients was 0.395 vs 0.557 for the 202 patients who did not (95% confidence interval, 0.07-0.25; P = .001). Seventeen patients who had a low PAP ratio with poor distal perfusion underwent intraoperative banding, which improved the mean PAP ratios from a mean of 0.33 to 0.58. Despite banding, 3 of these 17 patients (17.6%) in this high-risk subgroup went on to develop DASS postoperatively. The calculated mean PAP ratio in patients who either developed DASS postoperatively or underwent prophylactic banding intraoperatively was 0.37, which was significantly lower than the mean ratio of 0.57 in the control group (P = .001).

Conclusions: Low PAP ratios (<0.50) identified patients at increased risk for DASS, but prophylactic banding did not always prevent the occurrence of DASS in select patients. Because steal is a dynamic phenomenon, intraoperative conditions are not always going to reflect later adaptation. Nonetheless, PAP measurement may identify a subgroup of patients warranting procedural modification or closer postoperative physiological monitoring.