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Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. Three year outcomes of a single branched thoracic endograft following previous publication of peri-operative and one year outcomes are reported.This was a multicentre feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. The first study arm enrolled patients with an intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery (LSA) incorporation (zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularisation of the remaining aortic arch vessels. Outcomes at three years are reported.The cohort comprised 40 patients (31 zone 2, nine zone 0/1). The majority were male (52%). Mean follow up was 1 408 ± 552 days in the zone 2 and 1 187 ± 766 days in the zone 0/1 cohort. During three year follow up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from re-intervention was 97% at one and three years but there were two side branch occlusions. Two patients had aneurysm enlargement5 mm without documented endoleak or re-intervention. Freedom from death at one and three years was 90% and 84%. In the zone 0/1 arm there were no re-interventions, loss of branch patency, or aneurysm enlargement at three years. Cerebrovascular events occurred in three patients during follow up: two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow up period, both unrelated to the procedure or the aneurysm.Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with low rates of graft related complications.

© 2020 Elsevier Ltd. All rights reserved., Background: Hereditary transthyretin-mediated amyloidosis is a rare, inherited, progressive disease caused by mutations in the transthyretin (TTR) gene. We assessed the safety and efficacy of long-term treatment with patisiran, an RNA interference therapeutic that inhibits TTR production, in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Methods: This multicentre, open-label extension (OLE) trial enrolled patients at 43 hospitals or clinical centres in 19 countries as of Sept 24, 2018. Patients were eligible if they had completed the phase 3 APOLLO or phase 2 OLE parent studies and tolerated the study drug. Eligible patients from APOLLO (patisiran and placebo groups) and the phase 2 OLE (patisiran group) studies enrolled in this global OLE trial and received patisiran 0·3 mg/kg by intravenous infusion every 3 weeks with plans to continue to do so for up to 5 years. Efficacy assessments included measures of polyneuropathy (modified Neuropathy Impairment Score +7 [mNIS+7]), quality of life, autonomic symptoms, nutritional status, disability, ambulation status, motor function, and cardiac stress, with analysis by study groups (APOLLO-placebo, APOLLO-patisiran, phase 2 OLE patisiran) based on allocation in the parent trial. The global OLE is ongoing with no new enrolment, and current findings are based on the interim analysis of the patients who had completed 12-month efficacy assessments as of the data cutoff. Safety analyses included all patients who received one or more dose of patisiran up to the data cutoff. This study is registered with ClinicalTrials.gov, NCT02510261. Findings: Between July 13, 2015, and Aug 21, 2017, of 212 eligible patients, 211 were enrolled: 137 patients from the APOLLO-patisiran group, 49 from the APOLLO-placebo group, and 25 from the phase 2 OLE patisiran group. At the data cutoff on Sept 24, 2018, 126 (92%) of 137 patients from the APOLLO-patisiran group, 38 (78%) of 49 from the APOLLO-placebo group, and 25 (100%) of 25 from the phase 2 OLE patisiran group had completed 12-month assessments. At 12 months, improvements in mNIS+7 with patisiran were sustained from parent study baseline with treatment in the global OLE (APOLLO-patisiran mean change -4·0, 95 % CI -7·7 to -0·3; phase 2 OLE patisiran -4·7, -11·9 to 2·4). Mean mNIS+7 score improved from global OLE enrolment in the APOLLO-placebo group (mean change from global OLE enrolment -1·4, 95% CI -6·2 to 3·5). Overall, 204 (97%) of 211 patients reported adverse events, 82 (39%) reported serious adverse events, and there were 23 (11%) deaths. Serious adverse events were more frequent in the APOLLO-placebo group (28 [57%] of 49) than in the APOLLO-patisiran (48 [35%] of 137) or phase 2 OLE patisiran (six [24%] of 25) groups. The most common treatment-related adverse event was mild or moderate infusion-related reactions. The frequency of deaths in the global OLE was higher in the APOLLO-placebo group (13 [27%] of 49), who had a higher disease burden than the APOLLO-patisiran (ten [7%] of 137) and phase 2 OLE patisiran (0 of 25) groups. Interpretation: In this interim 12-month analysis of the ongoing global OLE study, patisiran appeared to maintain efficacy with an acceptable safety profile in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Continued long-term follow-up will be important for the overall assessment of safety and efficacy with patisiran.

Drug-coated balloons (DCB) and drug-eluting stents (DES) have significantly altered treatment paradigms for femoropopliteal lesions. We aimed to describe changes in practice patterns as a result of the infusion of these technologies into the treatment of peripheral arterial disease.We queried the Vascular Quality Initiative registry from 2010 to 2017 for all peripheral vascular interventions involving the superficial femoral artery and/or the popliteal artery. Cases were divided into a PRE and a POST era with a cutoff of September 2016, when specific device identity was first recorded in Vascular Quality Initiative. For each artery, a primary treatment was identified as either plain balloon angioplasty, atherectomy, DCB, bare-metal stent, or DES. The relative distribution of primary treatments between the PRE and POST eras was evaluated, as were lesion characteristics associated with DCB and DES use and regional variability in the adoption of these new technologies.Of 210,666 arteries in the dataset, 91,864 femoropopliteal arteries (across 74,842 procedures in 55,437 patients) were included. Each artery received 1.5 ± 0.6 treatments. Primary treatment use changed from 40% balloon angioplasty, 45% stenting, and 15% atherectomy in the PRE era to 22% plain balloon angioplasty, 26% bare-metal stent, 8% atherectomy, 37% DCB, and 8% DES in the POST era (P .001). Forty-three percent of arteries received a drug-containing device as a primary or adjunctive therapy and 1.3% received both a DCB and DES in the POST era. DCB use as the primary treatment was highest in lesions with length 10.0 to 19.9 cm (42%), TransAtlantic InterSociety A, B, or C lesions (38%), and lesions with mild to no calcification (38%). DES use was highest in lesions with a length of 20 cm or more (12%), TransAtlantic InterSociety D lesions (13%), and lesions with moderate to severe calcification (9%). The range of use across 18 regions was 125 to 40% for DCB and 1% to 14% for DES. Regional variability was greater for DES (SD 4% vs mean 8%) than for DCB (SD 7% vs mean 29%).There has been a rapid dissemination of DCB and DES technology in the femoropopliteal vessels, with nearly one-half of arteries receiving a drug-containing therapy in modern practice. DCBs are most used in medium length, minimally calcified lesions and DESs are most used in longer, more heavily calcified lesions. There is significant regional variability in adoption, especially with DES.

We sought to compare immediate and early mortality among patients undergoing ruptured abdominal aortic aneurysm (RAAA) repair. Evaluation of RAAA has focused on 30-day postoperative mortality. Other emergency conditions such as trauma have demonstrated a multimodal mortality distribution within the 30-day window, expanding the pathophysiologic understanding and allowing for intervention investigations with practice changing and lifesaving results. However, the temporal distribution and risk factors of postoperative morbidity and mortality in RAAA have yet to be investigated.We evaluated factors associated with RAAA postoperative mortality in immediate (1 day) and early (1-30 days) postoperative periods in a landmarked retrospective cohort study using data from the Vascular Quality Initiative (2010-2020).We identified 5157 RAAA repairs (mean age, 72 ± 10 years; 77% male; 88% White; 61% endovascular). The mortality rate in the immediate period was 10.2% (528/5157) and the early mortality rate was 22.1% (918/4163). In multivariable regression analyses, signs of hemorrhagic shock (ie, hemoglobin 7 g/dL: adjusted odds ratio [aOR], 1.87 [95% confidence interval [CI], 1.14-3.06]; any preoperative systolic blood pressure 70 mm Hg: aOR, 1.40 [95% CI, 1.04-1.89]; and estimated blood loss40%: aOR, 3.65 [95% CI, 2.29-5.83]) were associated with an increased risk of immediate mortality. Comorbid conditions (heart failure: aOR, 1.38 [95% CI, 1.00-1.92]; pulmonary disease: aOR, 1.29 [95% CI, 1.05-1.58]; elevated creatinine: aOR 1.26 [95% CI, 1.31-1.41]) were associated with increased risk of early mortality.Immediate deaths were associated predominantly with shock from massive hemorrhage, whereas early deaths were associated with comorbid conditions predisposing patients to multisystem organ failure despite successful repair. These temporal distinctions should guide future mechanistic and intervention evaluations to improve RAAA mortality.

BACKGROUND: No independent comparisons, with midterm follow-up, of standard arteriovenous grafts (SAVGs) and immediate-access arteriovenous grafts (IAAVGs) exist. The goal of this study was to compare “real-world” performance of SAVGs and IAAVGs. METHODS: Consecutive patients who underwent placement of a hemodialysis graft between November 2014 and April 2016 were retrospectively identified from the electronic medical record and Vascular Quality Initiative database at two tertiary centers. Only primary graft placements were included for analysis. Patients were divided into two groups based on the type of graft implanted. Patients’ comorbidities, graft configuration, operative characteristics, and follow-up were collected and analyzed with respect to primary and secondary patency. Additional outcomes included graft-related complications, time to first cannulation, time to tunneled catheter removal, catheter-related complications, and overall survival. Patency was determined from the time of the index procedure; χ(2), Kaplan-Meier, and Cox regression analyses were used, with the P value set as significant at < .05. RESULTS: There were 210 grafts identified, 148 SAVGs and 62 IAAVGs. At baseline, the patients’ characteristics were similar between groups, except for a greater prevalence of preoperative central venous occlusions in the IAAVG group (16.3% vs6.8%; P < .04). Of the IAAVG group, 50 were Acuseal (W. L. Gore & Associates, Flagstaff, Ariz) and 12 were Flixene (Atrium Medical Corporation, Hudson, NH). Primary patency was similar at both 1 year (SAVG, 39.4%; IAAVG, 56.7%; P = .4) and 18 months (SAVG, 29.0%; IAAVG, 43.7%; P = .4). Secondary patency was similar at 1 year (SAVG, 50.7%; IAAVG, 52.1%; P = .73) and 18 months (SAVG, 42.3%; IAAVG, 46.3%; P = .73). Overall survival was 48% at 24 months. IAAVG patients required fewer overall additional procedures to maintain patency (mean number of procedures, 0.99 for SAVGs vs 0.61 for IAAVGs; P = .025). There was no difference in occurrence of steal syndrome (SAVG, 6.8%; IAAVG, 8.1%; P = .74) or graft infection (SAVG, 19.0%; IAAVG, 12.0%; P = .276). Seventy-five percent of all grafts were successfully cannulated, with shorter median time to first cannulation in the IAAVG group (6 days; interquartile range [IQR], 1–19 days) compared with the SAVG group (31 days; IQR, 26–47 days; P < .01). Of all pre-existing catheters, 65.75% were removed, with a shorter median time until catheter removal in the IAAVG cohort at 34 days (IQR, 22–50 days) vs 49 days (IQR, 39–67 days) in the SAVG group (P < .01). Catheter-related complications occurred less frequently in the IAAVG group (16.4% vs 2.9%; P < .045). CONCLUSIONS: IAAVGs allow earlier cannulation and tunneled catheter removal, thereby significantly decreasing catheter-related complications. Patency and infection rates were similar between SAVGs and IAAVGs, but fewer secondary procedures were performed in IAAVGs.

Objective Most type II endoleaks have a benign natural history, but 6% to 8% are associated with sac enlargement and respond poorly to treatment. Our aim was to evaluate whether these enlargements are associated with delayed or occult type I and III endoleaks. Methods Patients with interventions for endoleak after endovascular aortic repair from 2000 to 2016 were reviewed retrospectively. Patient demographics, comorbidities, endoleak type, secondary procedures, aortic sac growth (≥5 mm), and mortality were collected. Successful treatment was defined as endoleak resolution with no further aortic sac growth. Secondary procedures, ruptures, endograft explant, and death were captured. Results There were 130 patients diagnosed with a primary type II endoleak after endovascular aortic repair at a median of 1.3 months (interquartile range, 1.0-13.3 months). One hundred eighteen had their initial treatment for a primary type II. Twelve of the 130 were initially stable and observed, but were treated for a delayed type I or III endoleak. The 130 patients underwent 279 procedures for endoleaks (mean of 2.2 ± 1.3) over 6.9 ± 3.8 years of follow-up. Of the 118 patients treated for primary type II endoleaks, 26 (22.0%) later required interventions for delayed type I and III endoleaks. The mean time to intervention for a delayed type I or III endoleak was 5.4 ± 2.8 years. Overall, there were 16 type IA, 11 type IB, 2 type III, 7 combined type IA/IB, and 2 type IA/III delayed endoleaks. The odds of harboring a delayed type I or III endoleak was 22.0% before the first attempt at type II endoleak treatment, 35.1% before the second, 44.8% before the third, and 66.6% before the fourth attempts. Rapid aortic sac growth of ≥5 mm/y before initial endoleak treatment was associated with increased risk for delayed type I or III endoleak (47.8 vs 14.1%; P = .003). Patients with delayed type I or III endoleaks had a lower successful treatment rate (8.3% vs 52.3%; P = .001) than those with only type II endoleaks. Late rupture was increased with delayed type I or III endoleak (P = .002), whereas mortality (P = .96) and aortic-related mortality (P = .46) were similar. Graft explant (P = .06) trended toward an increase with a delayed type I or III endoleak, but was not statistically significant. Conclusions Failed attempts treating type II endoleaks and/or a rapid aortic sac growth of 5 mm/y or greater should raise the suspicion of a delayed or occult type I or III endoleak. Occult endoleaks are associated with decreased chance of endoleak resolution.

OBJECTIVES: The peroneal artery is a well-established target for bypass in patients with critical limb ischemia (CLI). The objective of this study was to evaluate the outcomes of peroneal artery revascularization in terms of wound healing and limb salvage in patients with CLI. METHODS: Patients presenting between 2006 and 2013 with critical limb ischemia (Rutherford IV- VI) and isolated peroneal runoff were included in the study. They were divided into patients who underwent bypass to the peroneal artery and those who underwent endovascular peroneal artery intervention. Demographics, comorbidities, and follow up data were recorded. Wounds were classified by Wound, Ischemia, foot Infection (WIfI) score. The primary outcome was wound healing; secondary outcomes included mortality, major amputation, and patency. RESULTS: Two hundred limbs with peroneal bypass and 138 limbs with endovascular peroneal intervention were included with mean follow-up of 24.0 ± 26.3 and 14.5 ± 19.1 months, respectively (P = .0001). The two groups were comparable in comorbidities with the exception of the endovascular group having more patients with cardiac and renal disease and diabetes mellitus, but fewer patients with smoking history. Based on WIfI criteria, ischemia scores were worse in bypass patients, but wound and foot infection scores were worse in endovascular patients. Peri-operatively, bypass patients had higher rates of myocardial infarction (4.5% vs. 0%, P = .012) and incisional complications (13.0% vs. 4.4%, P = .008). At 12 months, the bypass group compared to the endovascular group had better primary patency (47.9% vs. 23.4%, P = .002) and primary assisted patency (63.6% vs. 42.2%, P = .003) and a trend toward better secondary patency (74.2% vs. 63.5%, P = .11). There were no differences in the rate of wound healing (52.6% vs. 37.7% at one year, P = .09) or freedom from major amputation (81.5% vs. 74.7% at one year, P = .37). In a multivariate analysis, neuropathy was associated with improved wound healing, while WIfI wound score, cancer, chronic renal insufficiency, and smoking were associated with decreased wound healing. Treatment modality was not a significant predictor (P = .15). CONCLUSIONS: Endovascular peroneal artery intervention results in poorer primary and primary assisted patency rates than surgical bypass to the peroneal artery, but provides similar wound healing and limb salvage rates with a lower rate of complications. In appropriately selected patients, endovascular intervention to treat the peroneal artery is a low-risk intervention that may be sufficient to heal ischemic foot wounds.

Although the current guidelines for the management of blunt traumatic aortic injury (BTAI) have recommended intervention for grade 2 injuries or higher, a national trend has occurred for aggressive endovascular treatment of low-grade BTAIs. Little is known about the natural history of grade 1 and 2 injuries treated nonoperatively. We hypothesized that most of these low-grade injuries would remain stable with nonoperative management.We performed a review of BTAIs at a large referral level 1 trauma center from 2004 to 2020. The injuries were graded using a standard 1 to 4 scale. The outcomes of the nonoperative and thoracic endovascular aortic repair (TEVAR) management strategies were compared, including post-trauma morbidity, mortality, reinterventions, and lesion stability.A total of 176 patients with BTAIs and sufficient imaging studies and follow-up data available were identified during the study period, including 36 with grade 1, 24 with grade 2, 115 with grade 3, and 1 with a grade 4 injury. Of these 176 patients, 112 had undergone TEVAR and 64 had been treated nonoperatively. Most of the patients (90.2%) who had undergone TEVAR had had grade 3 injuries. Nonoperative management was performed for 97.2% of the grade 1 injuries and 62.5% of the grade 2 injuries. Endovascular reintervention after TEVAR was rare (2.7%). The rates of post-trauma morbidity within 30 days (stroke, 3.6% vs 3.1%; myocardial infarction/arrhythmia, 8.9% vs 1.6%; respiratory failure, 31.2% vs 28.1%; acute kidney injury, 9.8% vs 12.5%; urinary tract infection, 2.7% vs 4.8%; gastrointestinal bleeding, 3.6% vs 0.0%; pulmonary embolism, 10.9% vs 4.5%) and 1-year mortality after discharge (1.8% vs 3.1%) were comparable between the operative and nonoperative groups. The median follow-up was 1501 days (interquartile range [IQR], 475.6-2804 days) for the TEVAR group and 1170.5 days (IQR, 317-2173 days) for the nonoperative group. No lesion progression had occurred in the patients with low-grade (grade 1-2) injuries managed nonoperatively. Resolution of grade 1 and 2 injury had occurred in 20% of the patients at 30 days, which had improved to 44% at long-term follow-up. Fourteen patients with grade 3 injuries (12.2% of the grade 3 injuries in our series) were also observed and did not require future intervention. These patients had generally had smaller pseudoaneurysms with minimal periaortic hematoma. None of these 14 patients had experienced progression or rupture during follow-up (median, 454.5 days; IQR, 81-1199 days) using computed tomography.Nonoperative management of low-grade BTAIs did not result in long-term aortic complications or the need for reintervention. We found that grade 3 injuries with smaller pseudoaneurysms and minimal periaortic hematoma can be safely observed if the patients can be appropriately followed up. Thus, the indications for treatment of select grade 3 injuries merit further consideration.