Paclitaxel in real-life data is not associated with reduced survival but has limited benefit in preventing amputation.

BACKGROUND: Recent meta-analysis of randomized-controlled trials reported an increased risk of long-term mortality in patients treated with paclitaxel-coated devices (PCD) for femoropopliteal arteries (FP) lesions. However, real-life data on the subject is contradictory and data from CLTI patients is missing. The authors aim to evaluate the impact of PCD for the treatment of FP lesions on long-term mortality and amputation on a real-life cohort up to 5 years. METHODS: All patients treated for FP lesions with endovascular devices from January 2013 to December 2016 were included, irrespective of clinical presentation. Primary endpoint is overall survival. Secondary endpoints are freedom-from major amputation and amputation-free survival. Survival estimates were obtained using Kaplan-Meier plots and a multivariable model was constructed to correct for relevant baseline differences. RESULTS: From 2013 to 2016, 351 patients with FP lesions were treated, 250 with uncoated devices (nPCD) and 101 with PCD. Patients treated with nPCD were significantly older, more often female and with more severe degrees of ischemia. Median follow-up was 55(20-71) months. Overall survival and amputation-free survival were significantly higher in patients treated with PCD. Survival at one-year was 79% vs. 92%, at two-years 69% vs. 79% and at five-years 50% vs. 65% (P=0.02). AFS was 43% vs. 57% at 5-years (P=0.016). Freedom-from major amputation was similar between groups. After correction for relevant baseline differences on multivariable analysis, the survival advantage for patients treated with PCD was lost at 2 and 5 years. CONCLUSIONS: Our results do not confirm the findings of increased mortality associated with PCD. However, no improvement in amputation rate was found. For the time, our institutional data does not support withholding PCD to reduce mortality but suggests that the benefit in preventing amputation is not significant.

Total Luminal Volume Predicts Risk after Endovascular Aneurysm Repair.

OBJECTIVE: Large aneurysm diameter represents a well known predictor of late complications after endovascular aneurysm repair (EVAR). However, the role of the thrombus free lumen inside the abdominal aortic aneurysm (AAA) sac is not clear. It was hypothesised that greater luminal volume represents a relevant risk factor for late complications after EVAR. METHODS: A retrospective cohort analysis was performed including all patients undergoing EVAR from 2005 to 2016 at a tertiary referral institution. Pre-operative AAA lumen volume was measured in centre lumen line reconstructions and patients were stratified into quartiles according to luminal volume. The primary endpoint was freedom from AAA related complications. Secondary endpoints were freedom from neck events (type 1A endoleak, migration >5 mm or any pre-emptive neck related intervention), iliac related events (type 1B endoleak or pre-emptive iliac related intervention), and overall survival. RESULTS: Four hundred and four patients were included: 101 in the first quartile (Q1; <61 cm3). Patients with higher luminal volumes had wider, shorter, and more angulated proximal necks. There were more ruptured AAAs, more aorto-uni-iliac implanted devices and patients outside neck instructions for use in the 4th quartile. Five year freedom from AAA related complications was 79%, 66%, 58% and 56%, respectively (p = .007). At five years, freedom from neck related events was 86%, 84%, 73%, and 71%, respectively, for the four groups (p = .009), and freedom from iliac related events was 96%, 91%, 88%, and 88%, respectively (p = .335). On multivariable analysis, luminal volume was an independent predictor of late complications (Q4 vs. Q1 - hazard ratio: 1.91, 95% confidence interval 1.01-3.6, p = .046). Overall survival at five years was not affected by lumen volume (p = .75). CONCLUSION: AAA luminal volume represents an important risk factor for AAA related complications. This information may be considered when deciding tailoring surveillance protocols after EVAR. However, larger studies are needed to validate this hypothesis.

Vascular Trauma in Children-Review from a Major Paediatric Center.

BACKGROUND: Traumatic noniatrogenic vascular injuries in children are rare and rarely discussed in literature. Pediatric vascular injuries pose a set of challenges mainly because of continued growth and development in a child or adolescent. The purpose of the study is to characterize management strategies and outcomes in these cases. METHODS: This is a single-center retrospective review of patients less than age 18 years (pediatric age) with acute, noniatrogenic traumatic vascular injuries between January 2009 and December 2015. Patient's demographics, injury characteristics, surgical management, complications, and follow-up were analyzed. RESULTS: From 2009 to 2015, 3277 children with traumatic injuries were treated, of which 21 (0.6%) had 23 significant vascular injuries: 17 arterial and 6 venous injuries. The majority were males (n = 16), and the median age was 14 years (range 1 to 16 years). Penetrating injuries were the predominant mechanism (n = 21), mainly by glass (n = 13). At presentation, 4 patients were hemodynamically unstable, 3 of them in hypovolemic shock. All patients were managed operatively. Operations for arterial injuries included 5 primary arterial repairs, 4 repairs using vein grafts and 8 ligations. The following adjunct procedures were necessary: one 4-compartment leg fasciotomy due to associated soft tissue trauma, 8 tendon repairs, and 11 nerve repairs. Operations for venous injuries included 4 ligations and 2 primary repairs. There were no intraoperative or postoperative deaths, major complications, or limb loss. The median length of stay in the hospital was 6 days (range: 2-23 days). The median time of follow-up was 52 months (range: 20-94 months). Ten patients did not have any sequelae, and 11 patients reported impaired mobility and/or decreased sensation, which was transitory in most cases and related to associated neurological or muscle tendon injuries. All reconstructions remained patent over the course of follow-up. No limb asymmetry was observed. CONCLUSIONS: Noniatrogenic pediatric vascular trauma is uncommon. Penetrating mechanism is more common than blunt and extremities are more frequently affected. Overall complications come from associated injuries to tendons and nerves.

One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft.

OBJECTIVE: The Endurant (Medtronic, Minneapolis, Minn) is a new stent graft specifically designed to make more patients anatomically eligible for endovascular aneurysm (EVAR). This study presents the 1-year results of 100 consecutive patients with abdominal aortic aneurysms (AAAs) treated with the Endurant stent graft in real-life practice. METHODS: All clinical preoperative, operative, postoperative, and 1-year follow-up data of patients with the Endurant stent graft from three tertiary centers were prospectively collected. Patients underwent computed tomographic angiography (CTA) preoperatively, at 1 month, and at 1-year post-EVAR. The first 100 patients with an implantation date at least 1 year before our date of analysis and complete information were included. Clinical data, AAA characteristics, presence of endoleaks, graft migration, and other EVAR-related complications were noted. All values are stated as mean ± SD (range). RESULTS: This study included 100 patients with AAAs (88 men) with a mean age of 73 ± 8 years (47 to 87 years), an AAA size of 61 ± 10 mm (31 to 93 mm), an AAA volume of 210 ± 122 mL (69 to 934 mL), a proximal neck length of 33 ± 14 mm (9 to 82 mm), and an infrarenal angulation of 44 ± 25° (0°-108°). Nineteen of the 100 included patients had at least one anatomic characteristic that was considered a violation of the instructions for use (IFU) of the Endurant stent graft. A primary technical success was achieved in 98% of the patients (one additional stent placement in renal artery was required; one unplanned aorto-uni-iliac device placed), with no primary type I or III endoleaks or conversions. A secondary technical success was achieved in all cases. The 30-day mortality was 2% and the first postoperative CTA documented 16 endoleaks (16%; 16 type II). One-year follow-up showed three iliac limb occlusions (3%), one infected stent graft (causing a type Ia endoleak), and five endovascular reinterventions (5%; three to treat iliac limb occlusions, one proximal extension cuff; and one stent in the renal artery). The 1-year all-cause mortality rate was 12% (12 patients) and the AAA-related mortality was 3%. The mean AAA size was significantly smaller after 1 year (diameter, 54 ± 11.8 [32-80] mm; P < .01; volume, 173 ± 119 [42-1028] mL; P < .01), and one graft migration >5 mm and 13 endoleaks were noted (12 type II, 1 type I [neck dilatation]). CONCLUSION: The treatment of patients with AAAs with the Endurant stent graft seems to be successful and durable during the first year after EVAR. Despite the wider inclusion criteria for the Endurant, and with 19% of our patients treated outside the IFU, the AAA-related mortality, number of type I or III endoleaks, and reintervention rates are comparable to the results of other stent grafts.