Reversed Gore Excluder conformable main body as a conduit between branched stent graft limb, common iliac artery, and renal artery.

Renal artery access might not always be achieved due to anatomical reasons during the deployment of a branched stent graft in thoracoabdominal or juxtarenal abdominal aortic aneurysms. Renal perfusion is maintained through the aneurysm sac until the iliac limbs are deployed. To preserve renal perfusion, a branched iliac limb would be needed. Such limbs with a side branch, a narrow (12-14 mm) proximal end, and a wide (16-20 mm) distal end are not commercially available. Due to the nature of their deployment mechanism, Gore Excluder distal limbs (W.L. Gore & Associates) have been used outside the instructions for use in reversed position. A traditional Gore Excluder main body can be reversed; however, the smallest proximal diameter is 23 mm, which could be too large to be deployed in a typically 16- to 18-mm common iliac artery. However, the smallest Gore Excluder Conformable endoprosthesis (W.L. Gore & Associates, Inc) main body is 20 mm in diameter, and the distal limb is 14.5 mm. This allows for a perfect fit when deployed in reversed position between an 11-mm unibody limb (Cook Medical Inc) and the common iliac artery, resulting in access to the renal artery from the side branch. We used a Gore Excluder Conformable main body graft in two such cases successfully. In these two patients, the iliac limbs and renal artery have stayed patent during a follow-up of 24 and 3 months. A Gore Excluder Conformable graft can be deployed in reversed position, using it as a conduit between the branched stent graft limb, common iliac artery, and renal artery.

The Effect of a Suspended Radiation Protection System on Occupational Radiation Doses During Infrarenal EVAR Procedures: A Randomised Controlled Study.

OBJECTIVE: To compare the protective effect of Zero Gravity (ZG) with conventional radiation protection during endovascular aneurysm repair (EVAR). Secondly, user experience was surveyed with a questionnaire on ergonomics. METHODS: This was a single centre, prospective, randomised, two arm trial where 71 consecutive elective infrarenal EVAR procedures were randomised into two groups: (1) operator using ZG and assistant using conventional protection (n = 36), and (2) operator and assistant using conventional radiation protection (n = 35). A movable floor unit ZG system consists of a lead shield (1.0 mm Pb equivalent) for the front of the body and 0.5 mm Pb equivalent acrylic shielding for the head and neck. The ZG also includes arm flaps of 0.5 mm Pb equivalent covering the arm up to the elbow. Deep dose equivalent values, Hp(10) were measured with direct ion storage dosimeters (DIS) placed on various anatomical regions of the operator (axilla, chest, abdomen, and lower leg). Personal dose equivalent values, Hp(3) to eye lenses were measured in the operating and assisting surgeon using thermoluminescence dosimeters. The study was registered at the US National Institute of Health #NCT04078165. RESULTS: Protection with the standard protection was superior in chest (0.0 vs. 0.1 µSv), abdomen (0.0 vs. 0.6 µSv), and lower leg (0.4 vs. 2.2 µSv) (p < .001). On the other hand, the ZG system yielded better shielding for the axilla (1.5 vs. 0.0 µSv) and eyes (6.3 vs. 1.1 µSv) of the operator. The use of ZG hampered the deployment of ancillary shields, which is particularly relevant for protection of the assisting surgeon. Users found ZG more cumbersome than conventional garments, it also impaired communication and reduced field of view. CONCLUSION: Both ZG and conventional radiation protection reduced radiation exposure. Conventional protection allows better manoeuvrability at the price of wider exposure of the upper arm and axilla. ZG indirectly impaired protection of the assistant.

Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial.

BACKGROUND: Contemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascular aortic repair (TEVAR) are balanced against the potential for rupture, complex surgery, and death. Improved aortic morphology following TEVAR is documented, but evidence for improved overall survival is lacking. The costs and impact on quality of life are also needed. METHODS: The trial is a randomized, open-label, superiority clinical trial with parallel assignment of subjects at 23 clinical sites in Denmark, Norway, Sweden, Finland, and Iceland. Eligibility includes patients aged ≥ 18 with uTBAD of < 4 weeks duration. Recruited subjects will be randomized to either standard medical therapy (SMT) or SMT + TEVAR, where TEVAR must be performed between 2-12 weeks from the onset of symptoms. DISCUSSION: This trial will evaluate the primary question of whether early TEVAR improves survival at 5 years among uTBAD patients. Moreover, the costs and the impact on quality of life should provide sorely needed data on other factors that play a role in treatment strategy decisions. The common Nordic healthcare model, with inclusion of all aortic centers, provides a favorable setting for carrying out this trial, while the robust healthcare registries ensure data validity. TRIAL REGISTRATION: ClinicalTrials.gov NCT05215587. Registered on January 31, 2022.

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease.

BACKGROUND: No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. OBJECTIVES: This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. METHODS: Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. RESULTS: A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). CONCLUSIONS: These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.

Routine Inferior Mesenteric Artery Embolisation is Unnecessary Before Endovascular Aneurysm Repair.

OBJECTIVE: A type II endoleak is the most common complication during surveillance after endovascular aneurysm repair (EVAR), and a patent inferior mesenteric artery (IMA) is a known risk factor for an endoleak. The effect of routine IMA embolisation prior to EVAR on overall outcome is unknown. The aim of the study was to compare two strategies: routine attempted IMA embolisation prior to EVAR (strategy in centre A) and leaving the IMA untouched (strategy in centre B). METHODS: Patients were treated with EVAR in two centres during the period 2005 - 2015, and the data were reviewed retrospectively. The primary endpoints were re-intervention rate due to type II endoleaks and the late IMA embolisation rate. Secondary endpoints included EVAR related re-intervention, sac enlargement, aneurysm rupture, and open conversion rates. RESULTS: Strategy A was used to treat 395 patients. The IMA was patent in 268 (67.8%) patients, and embolisation was performed in 164 (41.5%). The corresponding figures for strategy B were 337 patients with 279 (82.8%) patent IMAs, two (0.6%) of which were embolised. The mean duration of follow up was 70 months for strategy A and 68.2 months for strategy B. The re-intervention rates due to a type II endoleak were 12.9% and 10.4%, respectively (p = .29), with no significant difference in the rate of re-interventions to occlude a patent IMA (2.0% and 4.7%, respectively; p = .039). The EVAR related re-intervention rate was similar, regardless of strategy (24.1% and 24.6%, respectively; p = .93). Significant sac enlargement was seen in 20.3% of cases treated with strategy A and in 19.6% treated with strategy B (p = .82). The rupture and conversion rates were 2.5% and 2.1% (p = .69) and 1.0% and 1.5% (p = .40), respectively. CONCLUSION: The strategy of routinely embolising the IMA does not seem to yield any significant clinical benefit and should therefore be abandoned.

Editor's Choice - Risk of Major Amputation Following Application of Paclitaxel Coated Balloons in the Lower Limb Arteries: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD). METHOD: This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed. RESULTS: In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I2 = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies. CONCLUSION: There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.

The implementation of a pathway and care bundle for the management of acute occlusive arterial mesenteric ischemia reduced mortality.

BACKGROUND: Acute mesenteric ischemia (AMI) is a disease with high mortality and requires a multidisciplinary approach for effective management. A pathway and care bundle were developed and implemented with the objective to reduce mortality. The aim of this retrospective comparative study was to analyze the effects of the pathway on patient management and outcome. METHODS: All consecutive patients operated in a secondary and tertiary referral center because of occlusive arterial AMI were identified between 2014 and April 2020. The pathway aimed to increase overall awareness, and hasten and improve diagnostics and management. Patients treated before implementation of the pathway (pregroup, years 2014-2017) were compared with patients treated using the pathway (postgroup, May 2018 to April 2020). Univariate and multivariate analyses were used to compare the groups. RESULTS: There were 78 patients in the pregroup and 67 patients in the postgroup with comparable baseline characteristics and disease acuity. The postgroup was more often diagnosed with contrast-enhanced computed tomography (58 [74%] vs. 63 [94%], p = 0.001) and had shorter mean in-hospital delay to operating room (7 hours [interquartile range, 3.5-12.5] vs. 3 hours [interquartile range, 2-11], p = 0.023). Revascularization was done more often in the postgroup (53 [68%] vs. 56 [84%], p = 0.030) especially using endovascular treatment (26 [33%] vs. 43 [64%], p < 0.001). Thirty-day mortality was lower in the postgroup (23 [51%] vs. 17 [25%], p = 0.001). Being managed in the postgroup remained as a protective factor (odds ratio, 0.32; 95% confidence interval, 0.14-0.75; p = 0.008) for 30-day mortality in the multivariate analysis. CONCLUSION: Implementing a pathway and care bundle resulted in enhanced regional and in-hospital awareness of AMI, more appropriate computed tomography imaging, shorter in-hospital delays, increased number of revascularizations, and, hence, lower mortality. LEVEL OF EVIDENCE: Therapeutic/Care Management, level IV.

No Difference in Mid-term and Long-Term Mortality After Vascular Paclitaxel Exposure.

BACKGROUND: Concern has been raised over potential paclitaxel-related increase in mortality following treatment with drug-coated balloons. We report mid-term and long-term patient-level mortality in three trials from our institution. METHODS: Patient data from the DRECOREST I and II trials, as well as the FINNPTX-trial, were included for analysis. The DRECOREST I involved patients with stenosis in a bypass vein graft, and the DRECOREST II included patients with stenosis in a dialysis fistula. The FINNPTX-trial randomized patients to either a prosthetic bypass or drug-eluting stent for long femoropopliteal lesions. Since the present retrospective study addressed mortality related to intravascular paclitaxel exposure and population data in Finland are comprehensive, we were able to include all patients exposed to paclitaxel in the three trials. Mortality data were extracted from the population registry, as well as patient records. Survival rates were analyzed for all trials pooled and separately. Late mortality was retrospectively analyzed and cross-referenced with national registry data. RESULTS: A total of 142 patients were included, 76 treated with paclitaxel-eluting device, and 66 without. The mean follow-up time for survivors was 3.9 years. Overall all-cause mortality was 31.7% during follow-up. In the DRECOREST I-trial, 35.5% of patients died in the paclitaxel group and 37.9% in the control group (P = 0.84). In the DRECOREST II, overall mortality was 55.6% in the paclitaxel group and 44.4% in the control group (P = 0.51). In the FINNPTX-trial 22.2% died in the paclitaxel group and 10.5% in the control group during follow-up (P = 0.30). No single cause of death was overrepresented. The most common causes of death in both groups were cardiovascular death, 59.3% in the paclitaxel group and 52.4% in the control group (P = 0.733), followed by malignancy (14.8% vs. 14.3% in the groups respectively). CONCLUSIONS: No significant difference was seen in the overall analysis between the paclitaxel and the control group. A statistically nonsignificant elevated late mortality in the FINNPTX-trial after paclitaxel exposure was observed. However, the numbers in the individual trials are small and should be interpreted in the context of future patient-level meta-analysis.

En bloc resection of visceral aorta and right kidney due to aortic sarcoma using temporary extracorporeal bypass grafting.

Aortic sarcomas have not been linked to Lynch syndrome in humans, although other soft tissue malignancies have been. We report the case of a 31-year-old man with Lynch syndrome, who presented with abdominal pain and severe claudication. The clinical and diagnostic workup revealed near occlusion of the infrarenal aorta due to aortic angiosarcoma. En bloc resection of the visceral and infrarenal aorta with right nephrectomy was performed, facilitated by temporary extracorporeal bypass to the visceral arteries. The aorta was reconstructed with a bifurcated Dacron graft. At the 24-month follow-up examination, the patient was free of disease but was experiencing chronic diarrhea.

Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study).

BACKGROUND: Stenosis is a known complication in bypass vein grafts for peripheral arterial disease. The aim of this study was to evaluate the effect of drug-coated balloons (DCBs) in the treatment of vein graft stenoses. DCBs may prevent restenosis in arterial lesions. One small prospective and larger retrospective and registry studies have failed to show benefit from DCBs in vein grafts. Prospective data are scarce. METHODS: Sixty patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to DCB (n = 30) or standard balloon angioplasty (BA) (n = 30). Follow-up was 1 year. The primary outcome measure was target lesion revascularization (TLR). Secondary outcome measures were assisted primary patency and secondary patency and graft occlusion. RESULTS: Fifty-seven patients were analyzed. Three patients were excluded due to primary technical failure (2 DCB, 1 BA). Overall TLR rate was 34.5% and 46.4% in the DCB and BA groups, respectively (P = 0.33). Five (8.8%) grafts occluded during follow-up (1 DCB, 4 BA). Assisted primary patency was 93.1% (DCB) versus 85.7% (BA) (P = 0.362) and secondary patency was 100% (DCB) versus 89.3% (BA) (P = 0.076). Subgroup analysis showed a significant benefit from DCB in the treatment of primary stenosis (TLR rate 15.0% vs. 18.9%, P = 0.03). CONCLUSION: There was no significant benefit from DCBs for treatment of vein graft stenosis compared to BA, although a trend in favor of DCBs could be seen. TRIAL REGISTRATION: ClinicalTrials.govNCT03023098.

Drug-Eluting Stent Shows Similar Patency Results as Prosthetic Bypass in Patients with Femoropopliteal Occlusion in a Randomized Trial.

BACKGROUND: Claudication and critical limb threatening ischemia are significant causes of mortality in the elderly. The gold standard of superficial femoral artery (SFA) revascularization is thus far considered to be the femoropopliteal bypass. The aim of this study was to compare mid-term patency between drug-eluting stents (DESs) and prosthetic bypass grafts (BSX). Studies have reported comparable results for both the methods. METHODS: Forty-six patients with claudication or rest pain due to a 5-25 cm SFA occlusion were randomized between DES and BSX groups. The follow-up period was 24 months, and the primary outcome measure was overall patency. Secondary outcome measures were primary and primary assisted patency, change in ankle-brachial index (ABI), and amputation-free survival. RESULTS: Forty-one patients were eventually analyzed. Six-month secondary patency was 91% (DES) versus 83% (BSX) (P = 0.450). The corresponding numbers at 12 months in the DES and BSX groups were 74% and 80% (P = 0.750), respectively. At 24 months, the respective numbers were 56% and 71% (P = 0.830). There were no statistically significant differences in primary or assisted primary patency at 1, 6, or 12 months. CONCLUSION: There were no demonstrable differences in patency rates or clinical outcomes such as ABI or major amputations between DES and BSX. Although underpowered, the results suggest noninferiority of the DES compared with prosthetic bypass surgery. TRIAL REGISTRATION: The trial was preregistered at ClinicalTrials.org (NCT01450722).

A randomized prospective controlled study with 5-year follow-up of cross-pin femoral fixation versus metal interference screw fixation in anterior cruciate ligament reconstruction.

PURPOSE: The purpose of this study was to determine and compare mid- to long-term results of cross-pin versus metal interference screw fixation of ACL graft. METHODS: In a prospective trial, 62 patients were randomized into two groups based on method of fixation. Transtibial drilling technique was used in the cross-pin and outside-in femoral drilling in the interference screw fixation group. Clinical and radiographical outcomes were assessed 2 and 5 years postoperatively. RESULTS: The study showed no clinically significant difference with respect to method of graft fixation. Mean anteroposterior side-to-side instrumented laxity difference was 2.4 mm in the cross-pin group and 2.5 mm in the screw group (n.s.). Median Tegner and mean Lysholm scores at 5 years were 6 (range 3-9) and 92.2 (range 69-100) in the screw group and 7 (3-10) and 93.3 (82-100), respectively, in the cross-pin group. Radiographical osteoarthritis increased in both groups from 2 to 5 years after reconstruction (p < 0.05), especially in the medial and patellofemoral joint spaces. Widening of the drill tunnels continued from 2 to 5 years without clinical significance. CONCLUSIONS AND CLINICAL RELEVANCE: The method of graft fixation did not yield a difference in clinical or radiographical outcome at 5 years. Results were excellent in both groups. LEVEL OF EVIDENCE: I.

Bilateral hemodynamic responses to auditory stimulation in newborn infants.

We studied hemodynamic auditory evoked responses of 20 healthy full-term neonates with near-infrared spectroscopy. The instrument used allows the measurements to be performed simultaneously above both auditory cortices. The stimulation consisted of 5-s trains of sound (700-ms interstimulus interval) with a 25-s silent interval. In response to the stimulation, a significant increase in concentration of oxygenated hemoglobin was detected in 14 out of 21 measurements. The mean latency of the largest response was 9.63+/-2.20 s (mean+/-SD) and the mean amplitude was 1.02+/-0.53 microM. The response amplitude was significantly larger in active (1.28+/-0.59 microM) than in quiet sleep (0.76+/-0.32 microM). The latency of the oxygenated hemoglobin concentration response was significantly shorter (r=-0.70 and p=0.0023) for infants with higher gestational age.