Comparing Mobile C-Arm with a Hybrid Operating Room for Imaging in Fenestrated Stent-Graft Endovascular Abdominal Aortic Aneurysm Repair

Background: To evaluate the advantages of a hybrid operating room (OR) (group 2) compared with a fluoroscopic mobile C-arm (group 1) during fenestrated stent-graft endovascular aneurysm repair (f-EVAR). Methods: This single-center study retrospectively analyzed prospectively collected data of consecutive patients treated with f-EVAR for short-necked, juxtarenal, and suprarenal aortic aneurysms between January 2006 and July 2016. Primary end points were technical success and perioperative complications. Secondary end points included 30-day and 1-year mortality as well as target vessel patency. Results: About 96 patients were treated (85 men; 74.1 +/- 6.3 years); 46 patients (48%) belonging to group 1 and 50 (52%) patients belonging to group 2. Technical success was achieved in 92.7% of the procedures (group 1 91.3% vs. group 2 94%, P = 0.72). Significantly more complex interventions were performed in group 2 (n = 38 of 50) compared with group 1 (n = 14 of 46; P <0.001), in which primarily renal f-EVAR interventions were performed. In group 2, significantly less contrast was used (median 150 mL vs. 100 mL; P <0.001). The 30-day mortality in group 1 was 9% and 2% in group 2 (P = 0.14), and 1-year survival was also not significantly different between both groups. Target visceral vessel primary patency was significantly higher in group 1 (87.6% vs. 85.5% [P = 0.006] and 83.8% vs. 78.3% [P = 0.03]) at 6 and 12 months, respectively). There was no significant difference in renal artery primary patency at 6 and 12 months. Conclusions: Immediate and 1-year outcomes after f-EVAR for abdominal aortic aneurysm were comparable using a hybrid OR compared with a mobile C-arm, despite the use of significantly more complex stent grafts in the patients treated in the hybrid OR. The use of a hybrid OR may assist in achieving satisfying results in complex f-EVAR

Editor's Choice - Outcomes After One Stage Versus Two Stage Open Repair of Type II Thoraco-abdominal Aortic Aneurysms

Objective: This study compared the outcomes of open one stage with open two stage repair of type II thoraco-abdominal aortic aneurysms (TAAA). Methods: This retrospective study included 94 patients (68 men) with a mean +/- SD age of 54.5 +/- 14 years who underwent open type II TAAA repair from March 2006 to January 2016. The mean aneurysm diameter was 65 +/- 14.4 mm. The median follow up was 42 months (range 12-96). Seventy-six patients received one stage open repair and 18 patients were treated in two steps: 12 received two open procedures (thoracic and abdominal) and six received hybrid repair (one open and one endovascular procedure). This study focused on the comparison of open one stage and open two stage TAAA repair. The median time between the two steps was 31.5 days (range 1-169). Results: In hospital mortality after open one stage repair versus open two stage type II repair was 22.4% versus 0% (odds ratio 7.352, 95% confidence interval [CI] 0.884-959.1]; p = .19). The one year survival rate after one stage repair versus open two stage repair was 74.7% (95% CI 62.7-83.3) versus 90.9% (95% CI 50.8-98.7 [p = .225]). The five year survival rate after one stage repair versus open two stage repair was 53.0% (95% CI 37.2-66.5) versus 90.9% (95% CI 50.8-98.7 [p = .141]). The hazard ratio for survival after one stage repair and after open two stage repair was 4.563 (95% CI 96.9-81.4 [p = .137]). Paraplegia was observed after open one stage repair versus open two stage in 10.5% vs. 8% (p = 1). Acute kidney injury requiring permanent dialysis and myocardial infarction were assessed for after open one stage repair and open two stage and were seen in 3.9% vs. 0% (p = 1) and in 5.3% vs. 0% (p = 1), respectively. Conclusion: Open two stage repair may be recommended as a treatment option for type II TAAAs if anatomically feasible, as it has a lower mortality and similar complication rates to one stage repair

Perioperative and long-term outcome after ascending aortic and arch repair with elephant trunk and open thoracoabdominal aortic aneurysm repair

OBJECTIVE: To describe the outcome of open thoracoabdominal aortic aneurysm (TAAA) repair following previous aortic arch repair including elephant trunk (ET) or frozen elephant trunk (FET) for acute and chronic pathologies. METHODS: This was a retrospective, observational, multicenter study including 32 patients treated between 2006 and 2019 in two aortic centers using identical surgical protocols. Assessment focused on perioperative and long-term outcome, namely in-hospital morbidity and mortality, as well as procedure-related reintervention rate and aortic-related mortality rate. Kaplan-Meier curves with 95% confidence intervals were used to analyze the overall survival after surgery within the cohort. RESULTS: Thirty-two patients (mean age, 45.0 ± 13.6 years; 20 males [62.5%]) were treated because of acute (34.38% [n = 11]) or chronic (65.62% [n = 21]) aortic pathologies, including residual dissection following acute, symptomatic type A dissection (n = 7) and symptomatic mega aortic syndrome (n = 4), as well as post-dissection TAAA (n = 18) and asymptomatic mega aortic syndrome (n = 3). Twenty-eight patients (87.5%) received type II repair, and 4 patients (12.5%) received type III repair after previous ascending aorta and arch repair including ET/FET. Concomitant infrarenal and iliac vessel repair was performed in 38.7% (n = 12) and 29.4% (n = 10), respectively. The in-hospital mortality rate was 18.75% (n = 6). Spinal cord ischemia occurred in two cases, both after one-stage emergency procedure with one case of permanent paraplegia. Temporary acute kidney injury occurred in 41.94% (n = 13). The estimated 1-year survival rate was 78.1% (95% confidence interval, 63.9%-95.6%), with a median follow-up time of 1.29 years (interquartile range, 0.26-3.88 years). No procedure-related reinterventions and one case of aortic-related mortality, namely sepsis because of graft infection, was observed. CONCLUSIONS: Open TAAA repair following aortic arch repair including ET or FET because of acute or chronic aortic pathologies is associated with a relevant perioperative morbidity and mortality rate. During follow-up, a low aortic-related mortality rate and procedure-related reintervention rate were observed

An International, Multicenter Retrospective Observational Study to Assess Technical Success and Clinical Outcomes of Patients Treated with an Endovascular Aneurysm Sealing Device for Type III Endoleak

Introduction: Type III endoleaks post-endovascular aortic aneurysm repair (EVAR) warrant treatment because they increase pressure within the aneurysm sac leading to increased rupture risk. The treatment may be difficult with regular endovascular devices. Endovascular aneurysm sealing (EVAS) might provide a treatment option for type III endoleaks, especially if located near the flow divider. This study aims to analyze clinical outcomes of EVAS for type III endoleaks after EVAR. Methods: This is an international, retrospective, observational cohort study including data from 8 European institutions. Results: A total of 20 patients were identified of which 80% had a type IIIb endoleak and the remainder (20%) a type IIIa endoleak. The median time between EVAR and EVAS was 49.5 months (28.5–89). Mean AAA diameter prior to EVAS revision was 76.6±19.9 mm. Technical success was achieved in 95%, 1 patient had technical failure due to a postoperative myocardial infarction resulting in death. Mean follow-up was 22.8±15.2 months. During follow-up 1 patient had a type Ia endoleak, and 1 patient had a new type IIIa endoleak at an untreated location. There were 5 patients with aneurysm growth. Five patients underwent AAA-related reinterventions indications being: growth with type II endoleak (n=3), type Ia endoleak (n=1), and iliac aneurysm (n=1). At 1-year follow-up, the freedom from clinical failure was 77.5%, freedom from all-cause mortality 94.7%, freedom from aneurysm-related mortality 95%, and freedom from aneurysm-related reinterventions 93.8%. Conclusion: The EVAS relining can be safely performed to treat type III endoleaks with an acceptable technical success rate, a low 30-day mortality rate and no secondary ruptures at short-term follow-up. The relatively low clinical success rates, related to reinterventions and AAA enlargement, highlight the need for prolonged follow-up

Nationwide Experience with EVAS Relining of Previous Open or Endovascular AAA Treatment in The Netherlands

OBJECTIVE: Relining of a previously placed surgical graft or endograft for an abdominal aortic aneurysm (AAA) is a reintervention to treat progression of disease or failure of the primary (endo)graft. Endovascular Aneurysm Sealing (EVAS) relining is a technique with potential advantages due to the absence of a bifurcation, the possibility for a unilateral approach, and sealing concept of the endobags. The purpose of this study was to describe the nationwide experience with EVAS relining of previous AAA repair in the Netherlands. METHODS: A retrospective analysis of all patients who underwent EVAS relining in 7 high volume vascular centres in the Netherlands between 2014 and 2019 was performed. Primary outcomes were technical and clinical success. Secondary outcomes were perioperative outcomes, complications and survival. RESULTS: Thirty-three patients underwent EVAS relining of open (n = 10) or endovascular (n = 23) repair. 26 were elective cases, 5 were urgent and 2 were acute (ruptured). Mean time between primary treatment and EVAS relining was 99 ± 74 months. Indications after open repair were proximal progression of disease (n = 7) and graft defect (n = 3). Indications after EVAR were type IA (n = 10), type IB (n = 3), type IIIA (n = 4), type IIIB (n = 3) endoleak, and endotension (n = 3). 18 patients underwent regular EVAS, 4 unilateral EVAS and 11 chimney-EVAS. In-hospital mortality was 6% (both patients with rAAA). Technical success was achieved in 97%. Median follow-up after EVAS relining was 20 months (range 0-43). Freedom from reintervention at 1-year and 2-year were 83% and 61% and the estimated survival 79% and 71%, respectively. EVAS relining after open repair had a clinical success of 90% at 1-year and of 70% at latest follow-up, while after EVAR clinical success rates were 70% and 52%, respectively. CONCLUSION: EVAS relining of previous AAA repair is associated with high technical success, however with limited clinical success at median follow-up of 20 months. Clinical success was higher in patients with EVAS relining after open repair than after EVAR. In patients with failed AAA repair, EVAS relining should only be considered, when established techniques such as fenestrated repair or open conversion are not available or indicated

Nationwide Experience with EVAS Relining of Previous Open or Endovascular AAA Treatment in The Netherlands

Objective: Relining of a previously placed surgical graft or endograft for an abdominal aortic aneurysm (AAA) is a reintervention to treat progression of disease or failure of the primary (endo)graft. Endovascular Aneurysm Sealing (EVAS) relining is a technique with potential advantages due to the absence of a bifurcation, the possibility for a unilateral approach, and sealing concept of the endobags. The purpose of this study was to describe the nationwide experience with EVAS relining of previous AAA repair in the Netherlands. Methods: A retrospective analysis of all patients who underwent EVAS relining in 7 high volume vascular centres in the Netherlands between 2014 and 2019 was performed. Primary outcomes were technical and clinical success. Secondary outcomes were perioperative outcomes, complications and survival. Results: Thirty-three patients underwent EVAS relining of open (n = 10) or endovascular (n = 23) repair. 26 were elective cases, 5 were urgent and 2 were acute (ruptured). Mean time between primary treatment and EVAS relining was 99 ± 74 months. Indications after open repair were proximal progression of disease (n = 7) and graft defect (n = 3). Indications after EVAR were type IA (n = 10), type IB (n = 3), type IIIA (n = 4), type IIIB (n = 3) endoleak, and endotension (n = 3). 18 patients underwent regular EVAS, 4 unilateral EVAS and 11 chimney-EVAS. In-hospital mortality was 6% (both patients with rAAA). Technical success was achieved in 97%. Median follow-up after EVAS relining was 20 months (range 0-43). Freedom from reintervention at 1-year and 2-year were 83% and 61% and the estimated survival 79% and 71%, respectively. EVAS relining after open repair had a clinical success of 90% at 1-year and of 70% at latest follow-up, while after EVAR clinical success rates were 70% and 52%, respectively. Conclusion: EVAS relining of previous AAA repair is associated with high technical success, however with limited clinical success at median follow-up of 20 months. Clinical success was higher in patients with EVAS relining after open repair than after EVAR. In patients with failed AAA repair, EVAS relining should only be considered, when established techniques such as fenestrated repair or open conversion are not available or indicated

Vorapaxar in the secondary prevention of atherothrombotic events

Item does not contain fulltextBACKGROUND: Thrombin potently activates platelets through the protease-activated receptor PAR-1. Vorapaxar is a novel antiplatelet agent that selectively inhibits the cellular actions of thrombin through antagonism of PAR-1. METHODS: We randomly assigned 26,449 patients who had a history of myocardial infarction, ischemic stroke, or peripheral arterial disease to receive vorapaxar (2.5 mg daily) or matching placebo and followed them for a median of 30 months. The primary efficacy end point was the composite of death from cardiovascular causes, myocardial infarction, or stroke. After 2 years, the data and safety monitoring board recommended discontinuation of the study treatment in patients with a history of stroke owing to the risk of intracranial hemorrhage. RESULTS: At 3 years, the primary end point had occurred in 1028 patients (9.3%) in the vorapaxar group and in 1176 patients (10.5%) in the placebo group (hazard ratio for the vorapaxar group, 0.87; 95% confidence interval [CI], 0.80 to 0.94; P<0.001). Cardiovascular death, myocardial infarction, stroke, or recurrent ischemia leading to revascularization occurred in 1259 patients (11.2%) in the vorapaxar group and 1417 patients (12.4%) in the placebo group (hazard ratio, 0.88; 95% CI, 0.82 to 0.95; P=0.001). Moderate or severe bleeding occurred in 4.2% of patients who received vorapaxar and 2.5% of those who received placebo (hazard ratio, 1.66; 95% CI, 1.43 to 1.93; P<0.001). There was an increase in the rate of intracranial hemorrhage in the vorapaxar group (1.0%, vs. 0.5% in the placebo group; P<0.001). CONCLUSIONS: Inhibition of PAR-1 with vorapaxar reduced the risk of cardiovascular death or ischemic events in patients with stable atherosclerosis who were receiving standard therapy. However, it increased the risk of moderate or severe bleeding, including intracranial hemorrhage. (Funded by Merck; TRA 2P-TIMI 50 ClinicalTrials.gov number, NCT00526474.)