Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System.

BACKGROUND: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths. METHODS: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure. RESULTS: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88). CONCLUSIONS: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558.

Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry.

OBJECTIVE: Hostile aortic neck anatomies such as proximal short necks are known to put patients at an increased risk for type IA endoleaks, migration, and need for reinterventions. The Heli-FX EndoAnchor System was designed to improve seal of aortic stent grafts. Endosuture aneurysm repair (ESAR) using EndoAnchors with the Endurant stent graft has been shown to be safe and effective for the treatment of patients with short necks through one year. This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory cohort. METHODS: The 70 patients from the ANCHOR Registry were cohort submitted to regulators for approval of the Endurant short neck indication. Patients had an infrarenal neck length of ≥ 4 mm and <10 mm. At 5 years, this short neck cohort had clinical and imaging follow-up compliance rates of 85% (28/33) and 70% (23/33), respectively. RESULTS: The short neck cohort had a mean age of 71.3±8.1 years and was 27.1% (19/70) female. Kaplan Meier freedom from all-cause mortality was 68.5 ± 6.2%, freedom from aneurysm-related mortality was 90.1 ± 4.5%, freedom from any endovascular or surgical secondary procedure was 76.9 ± 7.2%, and freedom from rupture was 95.6 ± 3.2%. Eight patients had a total of nine type IA endoleaks detected through 5 years, of which three resolved spontaneously by the next follow-up visit. There were two patients with renal complications who did not undergo reintervention and there were no device migrations reported through 5 years. After 5 years, 68.2% of patients (15/22) had sac regression, 13.6% (3/22) had stable sacs, and 18.2% (4/22) had increased sac diameter as compared with their 1-month measurements. CONCLUSIONS: After ESAR treatment using Heli-FX EndoAnchors with Endurant, the 5-year outcomes of the short neck cohort from the ANCHOR registry had encouraging results with regards to proximal neck-related complications, secondary procedures, and sac regression. This review of ESAR in patients with short proximal necks showed positive outcomes through 5 years although follow-up of a larger cohort is necessary.

Stent-Graft Fabrics Incorporating a Specific Corona Ready to Fenestrate.

In situ fenestration of endovascular stent-grafts has become a mainstream bailout technique to treat complex emergent aneurysms while maintaining native anatomical visceral and aortic arch blood supplies. Fabric tearing from creating the in situ fenestration using balloon angioplasty may extend beyond the intended diameter over time. Further tearing may result from the physiologic pulsatile motion at the branching site. A resultant endoleak at the fenestrated sites in stent-grafts could ultimately lead to re-pressurization of the aortic sac and, eventually, rupture. In an attempt to address this challenge, plain woven fabrics were designed. They hold a specific corona surrounding a square-shaped cluster with a plain weave fabric structure, a 2/2 twill, or a honeycomb. The corona was designed to stop potential further tearing of the fabric caused by the initial balloon angioplasty and stent or later post-implantation motion. The cluster within the corona was designed with relatively loose fabric structures (plain weave, 2/2 twill weave, and honeycomb) to facilitate the laser fenestration. Two commercial devices, Anaconda (Vascutek, Terumo Aortic) and Zenith TX2 (Cook), were selected as controls for comparison against this new design. All the specimens were characterized by morphology, thickness, and water permeability. The results demonstrated that all specimens with a low thickness and water permeability satisfied the requirements for a stent graft material that would be low profile and resistant to endoleaks. The in situ fenestrations were performed on all fabrics utilizing an Excimer laser followed by balloon angioplasty. The fabrics were further observed by light microscopy and scanning electron microscopy. The dimension of the fenestrated apertures was smaller than the balloon's diameter. The tearing was effectively confined within the corona. The clinical acceptability of this concept deserves additional bench testing and animal experimentation.

Laser Fenestration in TEVAR: Perspectives and Future Directions.

Endovascular aortic repair has been increasingly used to treat a multitude of thoracic aorticpathologies. When placement of a thoracic endograft necessitates coverage of one or more of the great vessels, in situ laser fenestration is a safe and effective option for supra-aortic trunk revascularization. Certain anatomic factors may render laser fenestration more technically challenging, particularly depending on aortic arch type and branch vessel characteristics. Short-term and mid-term outcomes have shown promising results for mortality, stroke, and complication rates. Future developments may extend the utility of this approach and allow it to be applied to a more widespread set of patients with challenging anatomy.

Five-year results of the STABLE II study for the endovascular treatment of complicated, acute type B aortic dissection with a composite device design.

OBJECTIVE: To provide the 5-year outcomes of the use of a composite device (proximal covered stent graft + distal bare stent) for endovascular repair of patients with acute, type B aortic dissection complicated by aortic rupture and/or malperfusion. METHODS: Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE) II was a prospective, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe). Patients were enrolled between August 2012 and January 2015 at sites in the United States and Japan. Five-year follow-up was completed by January 2020. RESULTS: In total, 73 patients (mean age: 60.7 ± 10.9 years; 65.8% male) with acute type B dissection complicated by malperfusion (72.6%), rupture (21.9%), or both (5.5%) were enrolled. Patients were treated with either a composite device (79.5%) or the proximal stent graft alone (no distal bare stent, 20.5%). Dissections were more extensive in patients who received the composite device (408.9 ± 121.3 mm) than in patients who did not receive a bare stent (315.9 ± 100.1 mm). The mean follow-up was 1209.4 ± 754.6 days. Freedom from all-cause mortality was 80.3% ± 4.7% at 1 year and 68.9% ± 7.3% at 5 years. Freedom from dissection-related mortality remained at 97.1% ± 2.1% from 1-year through 5-year follow-up. Within the stent-graft region, the rate of either complete thrombosis or elimination of the false lumen increased over time (82.1% of all patients at 5 years vs 55.7% at first postprocedure computed tomography), with a higher rate at 5 years in patients who received the composite device (90.5%) compared with patients without the bare stent (57.1%). Throughout the follow-up, overall true lumen diameter increased within the stent-graft region, and overall false lumen diameter decreased. At 5 years, 20.7% of patients experienced a decrease in maximum transaortic diameter within the stent-graft region, 17.2% experienced an increase, and 62.1% experienced no change. Distal to the treated segment (but within the dissected aorta), 23.1% of patients experience no change in transaortic diameter at 5 years; a bare stent was deployed in all these patients at the procedure. Five-year freedom from all secondary intervention was 70.7% ± 7.2%. CONCLUSIONS: These 5-year outcomes indicate a low rate of dissection-related mortality for the Zenith Dissection Endovascular System in the treatment of patients with acute, complicated type B aortic dissection. Further, these data suggest a positive influence of composite device use on false lumen thrombosis. Continuous monitoring for distal aortic growth is necessary in all patients.

Left internal mammary artery access for embolization of the left subclavian artery in a patient with type II endoleak after thoracic endovascular aortic repair for a ruptured right-sided aortic arch aneurysm.

A 65-year-old woman had presented with a ruptured type B intramural hematoma associated with a right-sided aortic arch aneurysm, a large Kommerell diverticulum (KD) and an aberrant left subclavian artery (LSA). She underwent total aortic arch replacement with elephant trunk, thoracic endovascular aortic repair, and LSA ligation distal to the left vertebral artery. She subsequently developed a brisk type II endoleak into the KD via retrograde flow from the left vertebral artery. Percutaneous access of the left internal mammary artery with coil embolization of the proximal LSA and KD was performed. At 5 years, computed tomography angiogram showed complete thoracic aortic remodeling without an endoleak. The results from the present case have illustrated the novel use of the left internal mammary artery as an alternative access for LSA embolization in patients with type II endoleak and limited access options.

Impact of thoracic endovascular aortic repair timing on aortic remodeling in acute type B aortic intramural hematoma.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) is increasingly utilized in the management of acute type B aortic intramural hematoma (TBIMH). Optimal timing for intervention has not been described. The aim of this study was to evaluate TEVAR timing on postoperative aortic remodeling. METHODS: A retrospective chart review was performed on patients who underwent TEVAR for TBIMH from January 2008 to September 2018. Imaging was reviewed pre- and postoperatively. Primary data points included true lumen diameter (TLD) and total aortic diameter (TAD) at the site of maximal pathology. Primary endpoint was aortic remodeling evidenced by a TAD/TLD ratio closest to 1.0. Secondary outcome was occurrence of aortic-related adverse events and mortality (AREM): aortic rupture, aortic-related death, progression to dissection, or need for aortic reintervention within 12 months. Patients undergoing emergent TEVAR (within 24 hours, 'eTEVAR') were compared with the remainder - delayed TEVAR ('dTEVAR'). RESULTS: We analyzed 71 patients that underwent TEVAR for TBIMH; 25 underwent emergent TEVAR and 46 patients underwent dTEVAR (median, 5.5 days; range, 2-120 days). There were no differences in demographics and comorbidities, and patients did not differ in presenting IMH thickness (12.6 ± 3.1 vs 11.3 ± 4.1 mm; P = .186) nor presenting TAD/TLD ratio (1.535 ± 0.471 vs 1.525 ± 0.397; P = .928) for eTEVAR and dTEVAR groups, respectively. eTEVAR patients had larger average presenting maximal descending aortic diameter (45.8 ± 14.3 vs 38.2 ± 7.5 mm; P = .018) and higher incidence of penetrating aortic ulcer on presenting computed tomography angiography (52.0% vs 21.7%; P = .033). Thirty-day mortality was 2 of 25 (8.0%) for eTEVAR and 2 of 45 (4.4%) for dTEVAR (P = .602). Postoperative aortic remodeling was more complete in the dTEVAR group (1.23 ± 0.12 vs 1.33 ± 0.15; P = .004). Case-control matching (controlling for presenting descending aortic diameter and penetrating aortic ulcer) on 30 patients still showed better aortic remodeling in the dTEVAR group (1.125 ± 0.100 vs 1.348 ± 0.42; P < .001). The incidence of AREM was higher in the eTEVAR (6/25; 24.0%) group compared with the dTEVAR group (2/46; 4.3%). At 12 months, freedom from AREM was higher in the dTEVAR group (95.7% vs 76.0%; P = .011). Postoperative TAD/TLD ratio was the best predictor for late aortic-related adverse events (area under the receiver operator characteristic = 0.825; P = .003). CONCLUSIONS: TEVAR for acute TBIMH within 24 hours of admission is associated with lower aortic remodeling and higher occurrence of late AREM. Delaying TEVAR when clinically possible could improve aortic remodeling and aortic-related outcomes.

A more proximal landing zone is preferred for thoracic endovascular repair of acute type B aortic dissections.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has become first-line therapy for complicated acute type B aortic dissection (aTBAD). However, the strategy for optimal proximal landing zone remains to be determined. We compared early outcomes and late aortic-related adverse events in patients undergoing TEVAR for complicated aTBAD with endograft deployment in proximal landing zone 2 vs 3. METHODS: We performed a retrospective chart review of adult patients undergoing TEVAR for complicated aTBAD within 6 weeks of diagnosis from January 2008 to December 2018. We excluded patients with connective tissue disorders and prior type A repair. Patients were divided into landing zone 2 TEVAR (Z2T) and zone 3 TEVAR (Z3T) groups. Z2 patients were divided between left subclavian artery (LSA) revascularization (Z2R) vs LSA coverage without revascularization (Z2C). Groups were compared for the need for aortic reintervention within 36 months of initial admission and freedom from aortic-related adverse events and mortality (AREM), defined as the need for aortic reintervention, aortic-related death, or rupture. RESULTS: Eighty-three patients underwent TEVAR for complicated aTBAD within a mean of 4.1 ± 7.8 days; 89.5% of patients had less than 2 cm of healthy proximal descending thoracic aorta. The landing zone was Z3T in 35 patients and 48 underwent Z2T: 10 Z2C and 38 Z2R. There were no differences between Z2T and Z3T in time from diagnosis to TEVAR, demographics, comorbidities, and diameter aortic measurements. The 30-day survival was 87.8%-89.5% for Z2R, 88.6% for Z3, and 80.0% for Z2C (P = .610). The postoperative spinal cord ischemia rate was 3.7%-2.7% for Z2R, 0% for Z3T, and 20.0% for Z2C (P = .012). The postoperative thoracic aortic rupture was 2.2% in Z2 and 0 in Z3. The need for aortic reintervention at 36 months after TEVAR was lower for Z2T (10.4%) vs Z3T (31.4%; P = .025). Freedom from AREM at 36 months was higher in Z2T vs Z3T (87.5% vs 68.6%; P = .048). The freedom from proximal reintervention was higher in Z2T (95.8%) compared with Z3T (80.0%; P = .019). Z3T deployment was predictive for AREM (odd ratio, 3.648; 95% confidence interval, 1.161-11.465; P = .027) and need for proximal reintervention (odds ratio, 5.542; 95% confidence interval, 1.062-28.927; P = .042). CONCLUSIONS: Most patients with aTBAD have less than 2 cm of proximal healthy descending thoracic aorta. In patients treated for complicated aTBAD, Z2T is associated with a lower need for aortic reintervention and aortic-related adverse events than Z3T. Patients may benefit from a more aggressive proximal landing zone with similar perioperative morbidity when Z2T is done with LSA revascularization.

Percutaneous Closure of Iatrogenic Ascending Aortic Pseudoaneurysms Following Surgical Aortic Repair.

We present a case series of 4 iatrogenic ascending aortic pseudoaneurysms that were all successfully repaired with a percutaneous approach. Pre-procedural imaging, device selection, and procedural techniques are described. With careful preparation and patient selection, catheter closure of iatrogenic ascending aortic pseudoaneurysms can be performed reliably and safely. (Level of Difficulty: Advanced.).

A novel approach to high-grade carotid stenosis with concomitant extracranial carotid aneurysms using transcarotid artery revascularization.

We present the novel application of transcarotid artery revascularization (TCAR) in two high-risk patients with high-grade internal artery stenosis and concomitant atherosclerotic extracranial carotid artery aneurysms (ECAAs). ECAAs account for <1% of arterial aneurysms and are usually clinically silent at presentation. Historically, the treatment of ECAAs has been via open reconstruction or stent grafting. TCAR is an effective alternative for carotid revascularization in high-risk patients with high-grade carotid stenosis, but has not been widely used for aneurysmal management. We report two cases to describe our management of concomitant carotid stenoses and ECCA with TCAR.

Endovascular Aortic Repair in Nonagenarian Patients.

BACKGROUND: The increasing proportion of elderly patients being treated for abdominal aortic aneurysm (AAA) in the endovascular era is controversial. OBJECTIVES: This study compared 30-day outcomes of endovascular aortic repair (EVAR) in nonagenarians (NAs) with non-nonagenarians (NNAs). METHODS: This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database included EVAR procedures performed from 2011 to 2017. Multivariate logistic regression in the unadjusted cohort, followed by propensity-score matching (PSM), was performed. Primary outcomes were 30-day mortality and 30-day major adverse events. RESULTS: A total of 12,267 patients were included (365 NAs). Ruptured aneurysms accounted for 6.7% (n = 819): 15.7% (n = 57) in NAs versus 6.5% (n = 762) in NNAs (p < 0.001). Mean aneurysm diameter was 6.5 ± 1.8 cm in NAs versus 5.8 ± 1.7 cm in NNAs (p < 0.001). The unadjusted 30-day mortality was 9.9% in NA versus 2.2% in NNAs (p < 0.001). Multivariate analysis revealed age ≥90 years (odds ratio [OR]: 3.36), male sex (OR: 1.78), functional status (OR: 4.22), pre-operative ventilator dependency (OR: 3.80), bleeding disorders (OR: 1.52), dialysis (OR: 2.56), and ruptured aneurysms (OR: 17.21) as independent predictors of mortality. After PSM, no differences in 30-day mortality (intact AAA [iAAA]: 5.3% NA vs. 3% NNA [p = 0.15]; ruptured AAA [rAAA]: 38% NA vs. 28.6% NNA [p = 0.32]) or 30-day major adverse events (iAAA: 7% NA vs. 4.6% NNA [p = 0.22]; rAAA: 28% NA vs. 36.7% NNA [p = 0.35]) were observed. CONCLUSIONS: Age was identified as an independent predictor of 30-day mortality after EVAR on multivariate analysis. However, no differences were found after PSM, suggesting that being ≥90 years of age but with similar comorbidities to younger patients is not associated with a higher short-term mortality after EVAR. Age ≥90 years alone should not exclude patients from EVAR, and tailored indications and carefully balanced risk assessment are advised.

Distal Revascularization and Interval Ligation for the Management of Dialysis Access Steal Syndrome.

BACKGROUND: Treatment options for dialysis access steal syndrome (DASS) include distal revascularization with interval ligation (DRIL), proximalization of arterial inflow (PAI), access banding, and access ligation. This study examines the efficacy of DRIL in treating DASS and reports short-term bypass patency, access patency, and wound infection rates. METHODS: A retrospective analysis was performed on adults diagnosed with DASS following hemo-dialysis access creation who underwent DRIL procedures between January 1, 2009 and May 11, 2017. Patients <18 years and those with lower extremity accesses or HeRO grafts that developed DASS were excluded. Data was obtained using electronic medical records and analyzed using SPSS software. Residual steal was defined as reintervention for DASS within 60 days of DRIL. Recurrent steal was defined as reintervention beyond 60 days. RESULTS: Eighty-nine DRIL procedures were performed for correction of DASS. Population included 59.6% female (n = 53), 47.2% current/former smokers (n = 42), 76.4% diabetic (n = 68), and 79.8% AVF (n = 71). Symptom resolution was complete for 69.7% (n = 62), and partial for 25.8% (n = 23), with no improvement in 4.5% (n = 4). Following DRIL, mean DBI improved from 0.43 to 0.67 (P= 0.002). Mean steal classification improved from 3.04 to 0.64 (P< 0.001). Five patients required a subsequent procedure for DASS symptoms - 3 for residual steal and 2 for recurrent steal. Bypass patency at 6 months post DRIL was 93.3% (n = 83) primary, 97.8% (n = 87) primary-assisted, and 100% (n = 89) secondary patency. Access patency at 6 months post DRIL was 78.7% (n = 70) primary, 91% (n = 81) primary-assisted, and 94.4% (n = 84) secondary. Twenty-one patients (23.5%) had 24 cases of surgical site infections, with 70.8% (n = 17) occurring at the saphenectomy site. Wound infections re-solved within 60 days postoperatively in 23 out of 24 patients. CONCLUSIONS: DRIL is highly effective in relieving symptoms of DASS and has excellent rates of short-term access and bypass patency. However, consideration must be given to the high wound infection rate and the potential need for subsequent procedures.

Clinical trial outcomes and thoracic aortic morphometry after one year with the Valiant Navion stent graft system.

AUTHORS' NOTE: On February 17, 2021, Medtronic Incorporated issued a global voluntary recall of the Valiant Navion Thoracic Stent Graft System (the device under study in the Valiant Evo Global Clinical Program that is the subject of this publication), and instructed physicians to immediately cease use of the Valiant Navion system and return any unused product. Medtronic initiated the recall in response to three clinical trial subjects recently observed with stent fractures, two of whom have confirmed type IIIb endoleaks. The data collection, analysis, and manuscript submission occurred before the notice of this recall, and, specifically, the 100 procedures reviewed for this series were free of events at 1 year related to the reason for this device recall. The authors of this article and the manufacturer were unaware of the recently detected adverse events at the time of the preparation of the manuscript, and the 1-year trial results, and imaging-based analyses described are unchanged. Management of thoracic aortic aneurysms continues to be a challenging problem and outcomes are dependent on patient anatomy. The present publication focuses on the importance of achieving proximal and distal seals and the consideration of the temporal changes of the aortic morphology as a part of the TEVAR planning process. The authors believe there is still scientific merit in disclosing this information, despite the current nonavailability of the Valiant Navion system. OBJECTIVE: The Valiant Navion stent graft system (Medtronic Inc, Santa Rosa, Calif) is a third-generation device with improved conformability. We have reported the 1-year clinical trial outcomes, with a focus on an imaging-based analysis of the aortic morphology. We assessed the effects of graft implantation on the native anatomy and the effects of the 1-year changes in thoracic aorta morphology on the original seal zones of the stent graft. METHODS: A total of 100 subjects were enrolled in a prospective single-arm clinical trial investigating the Valiant Navion stent graft system. An independent core laboratory (Syntactx, New York, NY) assessed the anatomic characteristics and performance outcomes. RESULTS: Through 1 year of follow-up, the freedom from all-cause mortality, aneurysm-related mortality, and secondary procedures was 89.8%, 97.0%, and 94.8% respectively. Of the 100 patients, 5 had undergone a total of six secondary procedures, and 9 patients had developed an endoleak (type Ia and Ib in 1, type Ia in 1, type Ib in 3, and type II in 4 patients) within the first year. After 1 year, 2 of 76 patients (2.6%) had had an increase in their maximum aneurysm diameter of ≥5 mm, 62 (81.6%) had had stable sacs, and 12 (15.8%) had experienced sac shrinkage. Although no deployment failures had occurred, 36 of the 100 proximal (36%) and 31 of the 100 distal (31%) attachment zones were considered short according to our definitions. The stent graft had conformed to the native anatomy at implantation, because the preprocedural thoracic aorta tortuosity (1.45 ± 0.02) had not significantly changed at 1 month after implantation (1.46 ± 0.02). Despite a natural increase in thoracic tortuosity after 1 year (1.49 ± 0.02), wall apposition had been maintained over time, as evidenced by the low endoleak rates. Aortic elongation and dilation had occurred at the proximal end of the graft by an average of 1.2 mm and 1.6 mm, respectively. Aortic remodeling was more pronounced at the distal end, with an average increase of 4.2 mm in length and 2.8 mm in diameter. CONCLUSIONS: The included patients had had positive 1-year outcomes with high freedom from mortality, endoleak development, and secondary procedures. Aortic elongation and dilation were more prevalent at the distal end, emphasizing the importance of distal attachment zone consideration as part of preoperative planning. Because aortic remodeling can be expected to continue over time, additional follow-up and imaging analysis in the trial will be necessary to assess the aortic morphology and its effects on stent graft performance.

A comparison of stenting versus hemodialysis reliable outflow graft for hemodialysis patients with recurrent central venous obstructions.

BACKGROUND: Central venous occlusive disease is a common cause of upper extremity arteriovenous access dysfunction in hemodialysis patients. When refractory to balloon angioplasty, the treatment options include central venous stenting and hemodialysis reliable outflow (HeRO; Merit Medical, South Jordan, Utah) graft. The purpose of the present study was to evaluate the outcomes of these options. METHODS: A retrospective review was performed of patients who had undergone central venous stenting or HeRO placement for central venous obstruction from December 2008 to March 2018. The primary outcomes were the reintervention rates, patency, and mortality. RESULTS: A total of 75 hemodialysis patients were identified after failed balloon angioplasty for central venous obstruction. Of the 75 patients, 44 underwent central venous stenting comprising coverage of the subclavian vein (n = 27), innominate vein (n = 18), and/or superior vena cava (n = 5). Six stent patients later underwent HeRO placement. The stents used were stent grafts in 65% (Viabahn, n = 9; Fluency/Flair, n = 19; iCast, n = 2; and other, n = 1) and bare metal stents in 35% (Wall-stent, n = 6; Protégé, n = 1; Cobalt, n = 1; and other, n = 9). The remaining 31 patients underwent HeRO graft placement. The venous outflow component insertion sites were the internal jugular (n = 20), external jugular (n = 1), subclavian (n = 6), axillary (n = 2), and other (n = 2). The stent and HeRO groups were similar in the previous central venous intervention rates (median, 0.6 [interquartile range (IQR), 0-3.0]; vs median, 3.5 [IQR, 0-10.1] annually; P = .679). After the index procedure, no difference was found between the two groups in the frequency of dialysis circuit interventions annually (median, 2.0 [IQR, 0-6.0]; vs median, 2.0 [IQR, 0-7.0]; P = .291) nor central venous interventions (ie, angioplasty of the central veins or within the portion of the HeRO inside the central veins) annually (median, 2.0 [IQR, 0-4.1]; vs median, 0 [IQR, 0-2.4]; P = .419). The 1-year access circuit primary patency was 8.1% for stenting and 22.2% for HeRO (P = .109). The 2-year access circuit secondary patency was 40.0% for stenting and 52.4% for HeRO (P = .401). The all-cause mortality was similar at 1 year (3.7% vs 4.8%; P = .856) and 2 years (11.8% vs 23.5%; P = .368). CONCLUSIONS: Central venous stenting and HeRO were shown to have similar rates of reintervention and patency. The results from the present study suggest that the multiple treatment options available for this problematic disease process can yield similar results when careful patient selection is applied.

Optimal In Situ Fenestration Technique With Laser Perforation and Balloon Dilation for Aortic Stent-Grafts.

PURPOSE: To evaluate the response of various stent-grafts after laser fenestration and dilation with noncompliant balloons to determine the optimal therapeutic combination for this treatment technique. MATERIALS AND METHODS: Five aortic stent-grafts were evaluated ex vivo: the Bolton RelayPlus, Jotec E-vita Thoracic 3G, Medtronic Valiant, Cook Zenith Alpha, and Vascutek Anaconda. Small holes were created using an excimer laser with the grafts submerged in saline. Five rows of 5 fenestrations were created, 4 holes in each row were dilated once with a 6-, 8-, 10-, or 12-mm-diameter noncompliant balloon to the specified nominal pressure (one hole served as the control). The saline solution from each stent-graft was collected and qualitatively analyzed for debris. The fenestrations were evaluated under light and scanning electron microscopes. The maximum diameter and area for each fenestration were measured. The direction and length of tears were assessed. RESULTS: The fenestration was feasible and reproducible in all the stent-grafts. The mean area of fenestration ranged from 7.63±1.63 to 14.75±0.73 mm2 when using balloons of 6- and 8-mm diameter, respectively. The 10- and 12-mm-diameter balloons caused a significant increase in area, variability, and tearing. The Anaconda graft tended to tear in the weft direction, while the other devices tore in the warp direction when using the 10- and 12-mm-diameter balloons. Dilation of the RelayPlus and Anaconda grafts with 6- and 8-mm-diameter balloons provided minimal tearing and precise fenestrations. Melted fiber remnants were observed after filtration of the saline solution for all devices. CONCLUSION: Laser fenestration and dilation with noncompliant balloons is a relatively simple and reproducible option for revascularization in urgent, complex aortic endovascular repairs. In our model, large balloons (ie, >10 mm) increased the destruction and tearing of the fabric. The maximum dilation recommended is 6 to 8 mm to avoid significant tears. Development of stent-grafts or novel fabrics designed explicitly for fenestration is needed to reduce potential complications.

Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms.

OBJECTIVE: The short- and mid-term outcomes of endovascular aortic aneurysm repair have made it a standard treatment of abdominal aortic aneurysms. However, newer generation devices have yet to demonstrate improved long-term rates for complications, reinterventions, and survival. The TREO stent graft is a latest generation device and was evaluated for approval in the United States. METHODS: In a multicenter, nonrandomized, investigational device exemption clinical trial, we assessed the safety and effectiveness of the TREO device, with core laboratory assessment of the imaging studies and an independent adjudication of safety. The primary effectiveness endpoint was successful aneurysm treatment at 1 year. The primary safety endpoint was the incidence of major adverse events (MAE) at 30 days. RESULTS: A total of 150 patients (132 men; 88.0%) with infrarenal abdominal aortic (87.3%) or aortoiliac (12.7%) aneurysms were enrolled. The data were normally distributed. The mean age was 71.7 ± 7.4 years. The MAE incidence at 30 days was 0.7%. One subject experienced two MAE: myocardial infarction and procedural blood loss of 1000 mL. The proportion of successful aneurysm treatment at 1 year was 93.1%. Longer term follow-up continues, with no aneurysm-related mortality at the latest follow-up. At 3 years, the cumulative all-cause mortality and incidence of type I and type III endoleaks was 10.7% (n = 16), 2.7% (n = 4), and 0% (n = 0), respectively. In addition, aneurysm sac shrinkage >5 mm at 3 years had occurred in 54.3% of patients, and 9.3% had required a secondary intervention (n = 14). CONCLUSIONS: The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment at 1 year and aneurysm sac shrinkage >5 mm at 3 years in 54.3% of patients. Long-term follow-up continues to determine whether these favorable outcomes will be sustained.

A systematic review of covered balloon-expandable stents for treating aortoiliac occlusive disease.

OBJECTIVE: To evaluate and compare studies reporting the outcomes of the use of covered balloon-expandable (CBE) stents for the treatment of aortoiliac occlusive disease. METHODS: A systematic literature search was conducted to identify studies that investigated the use of CBE stents for the treatment of aortoiliac occlusive disease and were published between 2000 and 2019. Baseline demographic data, procedural variables, and long-term outcomes were extracted from publications for analysis. RESULTS: A total of 15 published articles about 14 studies were included in the review. Of these, eight studies were prospective clinical trials and six studies were retrospective real-world studies. The articles included data regarding five different CBE stents, namely, the iCast/Advanta V12, Viabahn VBX, BeGraft, LifeStream, and JOSTENT. Lesion severity was higher in real-world studies, with more TransAtlantic Inter-Society Consensus Classification class D lesions and a higher percentage of occlusions. All studies showed high rates of technical success and patency over the course of 12 months. Long-term data were only available for the iCast/Advanta V12 device, which had a primary patency rate of 74.7% at 5 years. CONCLUSIONS: CBE stents are a viable treatment option for patients with complex aortoiliac lesions because of their high rates of technical success and favorable patency across all devices at 12 months. However, long-term data are only available for a single device, the iCast/Advanta V12. The results of using this device were favorable over the course of 5 years.