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

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.

Preoperative predictors of nonhome discharge after fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

BACKGROUND: Nonhome discharge (NHD) has significant implications for patient counseling and discharge planning and is frequently required following fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms (CAAA) and thoracoabdominal aortic aneurysms (TAAA). We aimed to identify preoperative predictors of NHD after elective FB-EVAR for CAAA and TAAA and develop a risk calculator able to predict NHD. METHODS: A retrospective review of prospectively collected data on all patients undergoing FB-EVAR between January 2007 and December 2021 at a single institution was performed. Exclusion criteria were admission from a nonhome setting, emergency and repeat FB-EVAR, and discharge to an unknown destination. The cohort was randomly split into separate development (70% of patients) and validation (30%) cohorts to develop a predictive calculator for NHD. Independent variables associated with NHD were assessed in a series of logistic regression analyses from 100 bootstrapped samples of the development set, and a model was developed using the most predictive variables. Resulting parameter estimates were applied to data in the validation set to assess model discrimination and calibration. RESULTS: From the initial cohort of 712 FB-EVAR patients, 644 were included in the study (74% male; mean age, 75.4 ± 7.6 years), including 452 with CAAA (70%) and 192 with TAAA (30%). Early mortality occurred in eight patients (1.2%; 5 in CAAA and 3 in TAAA) and the median hospital stay was 5 days (4 for CAAA and 7 for TAAA). Ninety-seven patients (15%) had a NHD. On multivariable analysis, older age (per year, odds ratio [OR], 1.08; P < .001), female gender (OR, 3.03; P < .001), smoking (OR, 2.86; P = .01), congestive heart failure (OR, 3.05; P = .004), peripheral artery disease (OR, 1.81; P = .07), and extent I (OR, 3.17), II (OR, 2.84), and III (OR, 2.52; all P = .08) TAAAs were associated with an increased likelihood of NHD in the development set. Based on these factors, the risk calculator was developed which accurately predicts NHD in the validation set with an area under the curve of 0.7. CONCLUSIONS: Older, female smokers with congestive heart failure and peripheral artery disease and more extensive aneurysms are at highest risk of NHD after FB-EVAR. Using only preoperative factors, our risk calculator can predict accurately who will have a NHD, allowing enhanced preoperative patient counselling and accelerated hospital discharge.

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

OBJECTIVE: The 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). METHODS: A 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. RESULTS: FB-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). CONCLUSIONS: HLOS 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.

Effect of fenestration configuration on renal artery outcomes during fenestrated-branched endovascular aortic repair.

OBJECTIVE: The aim of this study was to evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8 × 6 mm) and 2 (6 × 6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level. RESULTS: A total of 796 patients were included in this study, 71.7% male, with a mean age of 73.3 ± 8.1 years. The mean follow-up was 30.0 ± 20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8 × 6 mm, and 52.4% were 6 × 6 mm. At the 30-day landmark, primary patency (99.9% vs 98.0%; P value < .001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%; P value < .001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%; P value = .022 for groups 1 and 2, respectively) were higher in 8 × 6 compared with 6 × 6 fenestrations, and the incidence of acute kidney injury was similar across the groups (92.6% vs 92.7%; P value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8 × 6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, P values = .010 and .021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6 × 6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, P value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3% and 1.6% for 8 × 6 and 6 × 6mm fenestrations, respectively, P = .689). The 6 × 6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8 × 6 fenestrations (7.6%) at 5 years (P < .001). The risk of type IIIc endoleak was significantly higher among 8 × 6 fenestrations at 5 years (4.9% and 2% for 8 × 6 and 6 × 6 mm fenestrations, respectively; P = .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857; P < .001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929; P < .001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921; P = .034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979; P < .001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948; P = .572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938; P = .036). CONCLUSIONS: Fenestration configuration for the renal arteries impacts outcomes. The 8 × 6 small fenestrations have better patency at 30 days, 1 year, and 5 years, whereas 6 × 6 small fenestrations are associated with lower rates of SIs, primarily due to a lower incidence of type IIIc endoleaks. FG ≥5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak, and 5-year patency independently of the fenestration size or vessel diameter.

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

OBJECTIVE: There is paucity of data on the durability of physician modified endografts (PMEGs) for complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) despite widespread use. The aim of this study was to evaluate and compare the early and long-term outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) for CAAAs and TAAAs using PMEGs. METHODS: We reviewed clinical data and outcomes of patients treated by FB-EVAR using PMEGs for CAAAs (defined as short-neck infrarenal, juxtarenal, and pararenal AAAs) and TAAAs between 2007 and 2019. All patients were treated by a dedicated team with extensive manufactured device experience. Endpoints included 30-day mortality and major adverse events, patient survival and freedom from aortic-related mortality (ARM), freedom from secondary intervention, target artery (TA) patency, and freedom from TA endoleak and TA instability. RESULTS: Of 645 patients undergoing FB-EVAR, 156 patients (24%) treated with PMEG (121 males; mean age, 75 ± 8 years) were included. There were 89 CAAAs, 33 extent IV TAAAs and 34 extent I to III TAAAs. A total of 452 renal-mesenteric targets (3.1 ± 1.0 vessels/patient) were incorporated. Patients with TAAAs had significantly (P < .05) larger aneurysms (73 ± 11 vs 68 ± 14 mm), more TAs incorporated (3.4 ± 0.9 vs 2.8 ± 1.0), and more often had previous aortic repair (54% vs 27%). Technical success was higher in patients treated for CAAAs (99% vs 91%; P = .04). Thirty-day and/or in-hospital mortality was 5.7% and was significantly lower for CAAAs compared with TAAAs (2% vs 10%; P = .04), with three of nine early mortalities (33%) among patients treated emergently. After a mean follow-up of 49 ± 38 months, there were 12 aortic-related deaths (7.6%), including nine early deaths (5.7%) from perioperative complications and three late deaths (1.9%) from rupture. At 5 years, patient survival was 41%. Patients treated for CAAAs had higher 5-year freedom from ARM (P = .016), TA instability (P = .05), TA endoleak (P = .01), and TA secondary interventions (P = .05) with a higher, but non-significant, freedom from sac enlargement ≥5 mm (P = .11). Primary and secondary TA patency was 91% ± 2% and 99% ± 1%, respectively. Sac regression ≥5 mm occurred in 67 patients (43%) and was associated with increased survival (hazard ratio, 0.54; 95% confidence interval, 0.37-0.80) compared with those without sac regression. CONCLUSIONS: FB-EVAR using PMEGs was performed with acceptable long-term outcomes. Overall patient survival was low due to significant underlying comorbidities. Patients treated for CAAAs had higher freedom from ARM, TA instability, TA endoleak, TA secondary interventions, and a trend towards higher freedom from sac enlargement compared with patients treated for TAAAs. Sac regression was associated with improved patient survival.

Mid-Term Outcomes of "Complete Aortic Repair": Surgical or Endovascular Total Arch Replacement With Thoracoabdominal Fenestrated-Branched Endovascular Aortic Repair.

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.

Impact of gap distance between fenestration and aortic wall on target artery instability following fenestrated-branched endovascular aortic repair.

OBJECTIVE: Target artery (TA) instability has been the most frequent indication for secondary intervention after fenestrated and branched endovascular aortic repair (FB-EVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). The aim of the present study was to evaluate the effect of the gap distance between the endograft reinforced fenestration and TA origin at the aortic wall (fenestration gap [FG]) on target-related outcomes after FB-EVAR. METHODS: The clinical data and imaging studies of 430 patients enrolled in a prospective, nonrandomized study to evaluate FB-EVAR using manufactured stent grafts were reviewed. Of the 430 patients, 340 (79%) had had more than one vessel incorporated by fenestration. The FG was retrospectively measured on postoperative imaging studies and classified into three groups: no gap (FG, 0 mm), FG 1 to 4 mm, and FG ≥5 mm. The primary outcome was freedom from TA instability. The secondary end points included TA-related endoleak, TA secondary intervention, and TA patency. RESULTS: A total of 1558 renal-mesenteric TAs were incorporated by 1104 reinforced fenestrations and 454 directional branches (DBs), with a mean of 3.9 ± 0.5 vessels per patient. The mean FG was 2.8 ± 4.5 mm, with an FG of 0 mm for 646 TAs, 1 to 4 mm for 209 TAs, and ≥5 mm for 249 TAs. An FG of ≥5 mm was associated with significantly lower (P < .001) freedom from TA instability, type Ic or IIIc endoleak, and secondary interventions at 5 years. Compared with DBs, fenestrations with an FG of ≥5 mm had similar primary patency and freedom from TA instability but significantly lower freedom from type Ic or IIIc endoleak (91% ± 2% vs 95% ± 1%; log rank, P = .02) and secondary interventions (87% ± 3% vs 93% ± 2%; log-rank, P = .02) at 5 years. The independent predictors of TA instability included postdissection TAAAs (hazard ratio, 2.5; 95% confidence interval, 1.2-5.4) and FG ≥5 mm (hazard ratio, 1.6; 95% confidence interval, 1.2-1.8). TAs incorporated by reinforced fenestrations had higher primary (99% ± 0.8% vs 97% ± 1.0%; P = .039) and secondary (100% vs 98% ± 1.0%; P = .012) patency rates at 5 years compared with DBs, with the lowest primary patency observed for renal DBs (80% ± 6% vs 92% ± 2%; P = .008). CONCLUSIONS: An FG of ≥5 mm was independently associated with an increased risk of TA instability, type Ic or IIIc endoleaks, and secondary interventions for patients treated by FB-EVAR using fenestrated designs. TAs incorporated by DBs had lower 5-year primary and secondary patency compared with those with reinforced fenestrations, with the lowest 5-year patency of 80% for renal branches. Compared with DBs, fenestrations with an FG of ≥5 mm carried a greater risk of type Ic or IIIc endoleak and secondary interventions. Independent predictors of TA instability included postdissection TAAAs and a greater FG. In contrast, dual antiplatelet therapy and larger TA diameters were protective.

Sphygmomanometer-induced hemostasis following iatrogenic guidewire perforation during lower extremity angioplasty.

OBJECTIVES: Iatrogenic guidewire perforation is a well-known complication of lower extremity angioplasty that is often benign or can be easily treated with endovascular techniques. However, perforations that occur in arterial side branches may be more challenging to manage. If bleeding persists, open surgery and fasciotomy may be required to evacuate the resulting hematoma and prevent compartment syndrome. These subsequent procedures increase morbidity and, if the angioplasty was performed in the outpatient setting, necessitate patient transfer to a hospital. To address these challenges, we describe a non-invasive hemostasis technique involving serial sphygmomanometer cuff inflations over the affected site in a series of five patients who experienced this complication at our office. METHODS: We retrospectively reviewed the medical records of consecutive patients undergoing lower extremity angioplasty that were found to have an arterial guidewire perforation on completion angiogram at our outpatient center between February 2012 and February 2017. Patients found to have iatrogenic guidewire perforations were administered intravenous protamine sulfate and were transferred to the surgical recovery room. Patients received ibuprofen or acetaminophen for pain management. A blood pressure cuff was placed around the site of perforation, and patients received serial cuff inflation cycles with repeated examinations of both limbs until patients reported cessation of pain and there were no signs of a developing hematoma. Patients were observed for two hours before they were discharged home. A follow-up duplex ultrasound examination was completed within one week of the intervention. RESULTS: Over the course of five years, 536 angioplasties were performed at our outpatient office. Five of these patients experienced iatrogenic guidewire perforation (0.93%). Perforations occurred in branches of the anterior or posterior tibial artery. All of these patients were successfully managed with the aforementioned hemostasis technique. None of these patients required transfer to a hospital for further management, and no complications were reported at follow-up. CONCLUSIONS: Complications of iatrogenic guidewire perforations in lower extremity arterial side branches can be safely and effectively managed by applying external compression around the affected site with an automatic blood pressure cuff.

Safety of vascular interventions performed in an office-based laboratory in patients with low/moderate procedural risk.

OBJECTIVE: An exponential increase in number of office-based laboratories (OBLs) has occurred in the United States, since the Center for Medicare and Medicaid Services increased reimbursement for outpatient vascular interventions in 2008. This dramatic shift to office-based procedures directed to the objective to assess safety of vascular procedures in OBLs. METHODS: A retrospective analysis was performed to include all procedures performed over a 4-year period at an accredited OBL. The procedures were categorized into groups for analysis; group I, venous procedures; group II, arterial; group III, arteriovenous; and group IV, inferior vena cava filter placement procedures. Local anesthesia, analgesics, and conscious sedation were used in all interventions, individualized to the patient and procedure performed. Arterial closures devices were used in all arterial interventions. Patient selection for procedure at OBL was highly selective to include only patients with low/moderate procedural risk. RESULTS: Nearly 6201 procedures were performed in 2779 patients from 2011 to 2015. The mean age of the study population was 66.5 ± 13.31 years. There were 1852 females (67%) and 928 males (33%). In group I, 5783 venous procedures were performed (3491 vein ablation, 2292 iliac vein stenting); with group II, 238 arterial procedures (125 femoral/popliteal, 71 infrapopliteal, iliac 42); group III, 129 arteriovenous accesses; and group IV, 51 inferior vena cava filter placements. The majority of procedures belonged to American Society of Anesthesiology class II with venous (61%) and arterial (74%) disease. A total of 5% patients were deemed American Society of Anesthesiology class IV (all on hemodialysis). There was no OBL mortality, major bleed, acute limb ischemia, myocardial infarction, stroke, or hospital transfer within 72 hours. Minor complications occurred in 14 patients (0.5%). Thirty-day mortality, unrelated to the procedure, was noted in 9 patients (0.32%). No statistically significant differences were noted in outcomes between the four groups. CONCLUSIONS: Our data suggest that it is safe to use OBL for minimally invasive, noncomplex vascular interventions in patients with a low to moderate cardiovascular procedural risk.

Dyeless iliac vein stenting.

OBJECTIVE: Iliac vein stenting is increasingly being explored for the treatment of chronic venous insufficiency. While venography is considered the gold standard for assessing iliac veins, some have proposed that intravascular ultrasound should be utilized instead due to its greater sensitivity at detecting stenotic lesions. Routinely, our service uses both intravascular ultrasound and venography, but we have noted that some patients cannot tolerate dye due to allergy, renal insufficiency, or deemed high-risk by the interventionalist due to uncontrolled medical co-morbidities. This study aimed to investigate whether forgoing dye had an impact on iliac vein stent thrombosis. METHODS: From 2012 to 2016, 1482 iliac vein procedures (91 intravascular ultrasound-only and 1391 intravascular ultrasound plus venography) were performed on 992 patients who failed conservative treatment for chronic venous insufficiency. Our mean patient age was 65.8 years (range 21-99; SD ± 14.3) with 347 male and 645 female patients. The clinical presenting symptoms per clinical-etiology-anatomy-pathophysiology classification for the intravascular ultrasound-only cohort were C1:0, C2:3, C3:31, C433, C5:5, C6:20 and for the intravascular ultrasound plus venography cohort were C1:0, C2:24, C3:566, C4:583, C5:30, C6:188. Stent thrombi that developed within or at 30 days of stenting were categorized as early and greater than 30 days as late. Transcutaneous duplex ultrasound classified stent thrombi as either partial or occlusive. Our average follow-up time was 19.4 months (0-42, SD ± 12.5). RESULTS: A total of 2.2% intravascular ultrasound-only patients versus 2.75% intravascular ultrasound plus venogram patients developed early stent thrombosis, p = 0.35. Early partial stent thrombosis occurred in 1.1% of the intravascular ultrasound-only group versus 2.6% of the intravascular ultrasound plus venogram group, p = 0.38. Early occlusive stent thromboses occurred in 1.1% of intravascular ultrasound-only patients and 0.15% of intravascular ultrasound plus venogram patients, p = 0.06. Late stent thromboses developed in 4% of patients in the intravascular ultrasound-only cohort and 4% in the intravascular ultrasound plus venogram cohort, p = 0.97. Late partial stent thromboses occurred in 2.7% of intravascular ultrasound-only patients versus 2.6% in intravascular ultrasound plus venogram patients, p = 0.99. Late occlusive stent thromboses occurred in 1.3% of intravascular ultrasound-only patients versus 1.4% of intravascular ultrasound plus venogram patients, p = 0.95. Moreover, the formation of any stent was 6.2% in the intravascular ultrasound-only versus 6.75% in the intravascular ultrasound plus venogram group, p = 0.55. CONCLUSION: Results of our study show no significant difference in stent thrombosis between the intravascular ultrasound-only and intravascular ultrasound plus venogram cohorts. This concludes that using intravascular ultrasound alone is safe for iliac vein stenting.

Iliac Vein Stent Placement and the Iliocaval Confluence.

OBJECTIVE: Prior literature has recommended routine iliac vein stent extension into the inferior vena cava (IVC) to assure adequate outflow for iliac vein stenting procedures. Our bias was that only the lesion should be stented without routine stent extension up to the IVC. We report our experience with this limited stenting technique. METHODS: From 2012 to 2015, 844 patients (1,216 limbs) underwent iliac vein stenting for nonthrombotic iliac vein lesions (NIVLs). All limbs were evaluated in accordance with the presenting sign of the Clinical-Etiology-Anatomy-Pathophysiology (CEAP) score, and duplex scans and intravascular ultrasound (IVUS) showing more than 50% cross-sectional area or diameter reduction. All study patients had failed 3 months of conservative management. The procedures of iliac vein stenting were all office based. Two techniques were compared: (1) placement of the iliac vein stent to cover the lesion and terminating cephalad into the IVC if the lesion involved the common iliac vein and (2) placement of the iliac vein stent to cover the lesion only and not passing the iliocaval confluence if the lesion only involved the external iliac vein. Complications were assessed during 30-day follow-up using the duplex scan technique to look for thrombosis. RESULTS: Of the total 844 patients, 543 (64%) were women. The average age was 66 (±14.2) years (range, 21-99 years). The stent was placed in the left lower limb in 474 patients and bilaterally in 370 patients. The presenting sign in accordance with the CEAP classification was C3 = 626, C4 = 404, C5 = 44, and C6 = 141. The average iliac vein stenosis by IVUS was 62% (±12% standard deviation [SD]). We had 715 patients with the iliac vein stent extending into the IVC, and of these, 8 patients had thrombosis within 30 days after the procedure. On the other hand, 501 patients had the iliac vein stent without crossing the iliocaval confluence, and of these, 4 patients had thrombosis within 30 days of the procedure. There was no difference between these 2 groups in regard to gender (P = 0.1) or age (P = 0.3). Laterality was statistically different (P < 0.0001) with more stents to be extended into the IVC if the lesion is in the left lower limb. Comparing these 2 groups in regard to 30-day thrombosis as a complication was not statistically significant (P = 0.6). There was no statistical difference between the 2 groups in regard to the presenting sign CEAP (P = 0.6). CONCLUSIONS: These results question the need for routine iliac vein stent extension into the IVC in patients with NIVLs. We were not able to demonstrate a significant risk of thrombosis with just placing the stent to cover the lesion only with short-term follow-up.

Radiofrequency Ablation Increases the Incidence of Endothermal Heat-Induced Thrombosis.

BACKGROUND: Endovenous thermal ablation has become the procedure of choice in the treatment of superficial venous reflux disease. The current armamentarium of devices and techniques aimed at the elimination of saphenous reflux offers surgeons and interventionalists a variety of treatment options; however, there is a lack of data comparing the safety of these products. The most concerning complication after endovenous thermal ablation is endothermal heat-induced thrombosis (EHIT) due to the risk of progression to deep venous thrombosis. This study aimed to compare the incidence rate of EHIT between radiofrequency ablation (RFA) and endovenous laser therapy (EVLT). METHODS: This was a single-center, office-based, retrospective study over the course of 5 years, in which 3,218 consecutive patients underwent 10,029 endovenous saphenous ablations. The patient cohort was 66.2% female, with an average age of 61.9 years. At the time of each individual intervention, 24, 212, 3,620, 4,806, 200, and 1,167 patients had Clinical-Etiology-Anatomy-Pathophysiology disease 1, 2, 3, 4, 5, and 6, respectively. RESULTS: There was a total of 3,983 EVLT and 6,091 RFA procedures. The most common vessel treated was the great saphenous vein, 63.6% of the time, followed by the small saphenous vein (25.6%), accessory saphenous vein (6.1%), and perforator vein (4.6%). There were 186 cases of EHIT, with 137 (73.6%) identified as type 1 as per the Kabnick classification. Endovenous ablation performed via RFA resulted in significantly more cases of EHIT than of EVLT (109 vs. 77; P = 0.034; odds ratio = 1.52), which was confirmed by a multivariate analysis. CONCLUSIONS: In the largest single-center study of endovenous saphenous ablations to date, RFA was shown to pose a significantly higher risk of EHIT than of EVLT.

Iliac Vein Stenting for Chronic Proximal Venous Outflow Obstruction in a Predominantly Asian-American Cohort.

BACKGROUND: We investigated the outcome of vein stenting placement for chronic proximal venous outflow obstruction (PVOO) in a predominantly Asian-American cohort to improve patient selection, enhance technical approach, and better define quality measurements of this emerging vascular intervention. METHODS: A total of 462 consecutive patients, 73% Asian American (n = 336), who underwent iliac vein stenting for chronic PVOO from October 2013 to July 2016 were reviewed. Postoperative outcomes at five follow-up visits were assessed. Wilcoxon-Mann-Whitney and Kruskal-Wallis tests were run for demographic and operative variables. Ordered logistic regressions were run for the outcome at each time point, and Chi-squared tests as well as Fisher's exact tests were used for categorical variables. RESULTS: Follow-up was maintained in 90% of patients, with a mean follow-up time of 695 days. Asian-American patients were more likely to present with varicose veins (77.4% vs. 54.8%, P < 0.001), and non-Asian patients were more likely to present with active ulceration (26.2% vs. 5.1%, P < 0.001). Asian-American patients were more likely to have bilateral stents placed (61.6% vs. 50%, P = 0.026) and were less likely to have reinterventions (11.3% vs. 27.8%, P < 0.001), a history of deep vein thrombosis (8.3% vs. 29.4%, P < 0.001), or intraoperative findings of chronic postphlebitic changes (17.6% vs. 33.3%, P < 0.001). Kruskal-Wallis tests were significant for improvement in patients of all the Clinical, Etiology, Anatomy, Pathophysiology classes at 30 days (P = 0.041), 90 days (P = 0.045), 6 months (P = 0.041), and 1 year (P < 0.01). The Asian-American population had improved but comparatively lower follow-up scores at the 30-day mark (48% significantly improved or better vs. 63%, P = 0.008) but higher follow-up scores at the >1 year mark (80% significantly improved or better vs. 59%, P < 0.001). CONCLUSIONS: Asian-American patients undergoing vein stent placement for chronic PVOO had comparatively worse outcomes than non-Asian patients at 30 days and better outcomes after one year. These patient groups had different outcomes postoperatively and outcomes which evolve differently over time.

Clinical Experience and Management of Squat-Induced Lower Extremity Arterial Ischemia.

Popliteal artery entrapment syndrome (PAES) is a rare cause of intermittent claudication in young patients. Unlike the atherosclerotic and degenerative etiologies typically associated with arterial disease, PAES is primarily of anatomic origin. PAES is rarely associated with aneurysmal disease. We present a case and subsequent surgical management of a 47-year-old male who experienced acute limb ischemia secondary to thrombosis of a popliteal artery aneurysm (PAA), who was found to have bilateral PAES and PAAs.

Celiac Artery Vasculitis.

Isolated celiac artery vasculitis is an uncommon disease rarely reported in the Western literature. In this case report, we describe a 52-year-old Chinese male presenting with abdominal pain who was diagnosed with nonspecific celiac artery vasculitis and was successfully treated with a short course of oral corticosteroids.

Superior Mesenteric Artery Thrombosis after Necrotizing Pancreatitis.

Vascular complications secondary to acute pancreatitis carry a high morbidity and mortality, often because of their hemorrhagic or thrombotic effects. When thrombosis presents, it is typically localized to the splanchnic venous system. In this report, we present a case of acute superior mesenteric artery thrombosis secondary to necrotizing pancreatitis after a laparoscopic cholecystectomy. The patient was successfully treated with catheter-directed thrombolysis and mechanical thrombectomy.

Early Results of Duplex-Guided Transradial Artery Fistuloplasties.

BACKGROUND: Although arteriovenous fistulae (AVFs) are the preferred mode of hemodialysis access because of their high patency rates, they are associated with an appreciable rate of nonmaturation. Balloon-assisted maturation (BAM) has been described to treat this issue. BAM is defined as repeated sequential graduated dilatation of the outflow vein. This study aims to evaluate the short-term complications of using the radial artery as an access for BAM procedures and fisutloplasties. Transradial access was used preferentially with multiple lesions in the AVF that were difficult to access with a single venous puncture. METHODS: Data were collected over 3 years on 44 office-based duplex-guided transradial access BAM procedures in 27 patients of whom 19 were men. BAM with ultrasound guidance was performed in 324 cases using a venous puncture during this period. The indication for the procedures was a failure of AVF maturation, and 5 cases were with short segment thrombectomy. All procedures were performed with local anesthesia only. Access site puncture, vessel cannulation, wire placement, and balloon advancement and insufflation were duplex-guided. The radial artery was punctured with ultrasound guidance and a 4-5 French low-profile sheath was placed. After crossing the lesion(s), 5,000 units of heparin was given. The radial artery was used as the access vessel for all procedures except one, in which the brachial artery was used in addition. Vascular injuries were classified based on the postprocedural duplex assessment. All patients had follow-up duplex scans within a week. RESULTS: The average age was 79 years (±14 SD, range 39-99 years). The types of AVF were 35 radio-cephalic, 1 radio-basilic, 2 brachio-brachial, 2 brachio-cephalic, and 4 brachio-basilic. The number of sites of lesions was 17 on the venous outflow, 7 perianastomotic, and 6 in the radial artery. In the remaining 14 failing AVFs, we were not able to identify any lesion. The balloon size ranged from 3-6 mm (28 patients) and 7-12 mm (16 patients). The most common injury was outflow vein wall injury (25), the formation of wall hematoma of the outflow vein (11), localized extravasation or rupture at the balloon site (4), spasm of the AVF (3), the formation of a puncture-site hematoma (2), and intimal flap (3). Extravasation was controlled with duplex-guided compression. There were no radial artery thromboses, and all the AVFs were patent on completion duplex and follow-up duplex. CONCLUSIONS: These data suggest that the radial artery could be used as a safe access route for BAM procedures with relatively low rates of complication. This approach can be considered as an adjunct in the armamentarium for angioplasty of AVF.