Role of Antiplatelet Therapy in Patients Managed for Complex Aortic Aneurysms using Fenestrated or Branched Endovascular Repair.

OBJECTIVE: Despite the increasing number of fenestrated/branched endovascular aortic repair (f/bEVAR) procedures, evidence on post-operative antiplatelet therapy is lacking. This study aimed to investigate the role of single antiplatelet therapy (SAPT) vs. double antiplatelet therapy (DAPT) after f/bEVAR on 30 day and follow up outcomes. METHODS: A multicentre retrospective analysis was conducted, including f/bEVAR patients managed from 1 January 2018 to 31 December 2022. Comparative outcomes were assessed according to post-operative antiplatelet therapy. The cohort was divided into the SAPT group (acetylsalicylic acid [ASA] or clopidogrel) and DAPT group (ASA and clopidogrel). The duration of SAPT or DAPT was one to six months. Primary outcomes were 30 day death, and cardiovascular ischaemic and major haemorrhagic events. Secondary outcomes were survival and target vessel (TV) patency during follow up. RESULTS: A total of 1 430 patients were included: 955 under SAPT and 475 under DAPT. The 30 day mortality was similar (SAPT 2.1% vs. DAPT 1.5%; p = .42). Cardiovascular ischaemic events were lower in the DAPT group (SAPT 11.9% vs. DAPT 8.2%; p = .040), with DAPT being an independent protector for acute mesenteric (p = .009) and lower limb ischaemia (p = .020). No difference was found in 30 day major haemorrhagic events (SAPT 7.5% vs. DAPT 6.3%; p = .40). The mean follow up was 21.8 ± 2.9 months. Cox regression showed no cofounders on survival, with similar rates between groups (log rank p = .71). DAPT patients presented higher TV patency (SAPT 93.4%, standard error [SE] 0.7% vs. DAPT 96.6%, SE 0.7%; log rank p = .007) at thirty six months. Cox regression revealed bEVAR as a predictor of worse TV patency (hazard ratio 2.03, 95% confidence interval 1.36 - 3.03; p < .001). DAPT was related to higher patency within bEVAR patients (SAPT 87.2%, SE 2.1% vs. DAPT 94.9%, SE 1.9%; p < .001). CONCLUSIONS: DAPT after f/bEVAR was associated with lower risk of cardiovascular ischaemic events and higher TV patency, especially in bEVAR cases. No difference in major haemorrhagic events was observed at 30 days.

Assessment of volume flow rate in arteriovenous fistulas with a novel ultrasound Doppler device (earlybird): Trend analysis, comparison of methods, and inter- and intra-rater reliability.

BACKGROUND: An accessible tool is required to analyze volume flow trends in arteriovenous fistulas for hemodialysis. Earlybird, an easy-to-place ultrasound Doppler device, has shown comparable accuracy to duplex ultrasound. In this study, we compared volume flow measurements obtained with duplex ultrasound and the dilution technique to an enhanced earlybird device, featuring a dual Doppler probe system, eliminating the requirement for a known insonation angle. METHODS: Nine patients with a distal radiocephalic arteriovenous fistula were monitored for 12 months with regular volume flow measurements. Correlation and inter- and intra-class reliability analyses were conducted. RESULTS: An overall moderate correlation was observed between earlybird and duplex ultrasound or dilution technique (intraclass correlation coefficient = 0.606 (95% confidence interval 0.064, 0.721) and 0.581 (0.039, 0.739), respectively). Duplex ultrasound compared to dilution measurements, demonstrated an overall moderate correlation (0.725 (0.219, 0.843)). Correlation between earlybird and duplex ultrasound was stronger for the arteriovenous fistula (0.778 (0.016, 0.901)) than the brachial artery (0.381 (-0.062, 0.461)). For earlybird, inter-rater reliability was excellent for the arteriovenous fistula (0.907 (0.423, 0.930)) and poor for the brachial artery (0.430 (0.241, 0.716)). Duplex ultrasound showed a good inter-rater reliability (arteriovenous fistula: 0.843 (0.610, 0.871), brachial artery: 0.819 (0.477, 0.864)). The overall intra-rater reliability was good for duplex ultrasound (rater A: 0.893 (0.727, 0.911); rater B: 0.853 (0.710, 0.891)), while excellent for earlybird (rater A: 0.905 (0.819, 0.928); rater B: 0.921 (0.632, 0.969)). CONCLUSION: We observed a weaker correlation in the measurements of volume flow rates in arteriovenous fistulas when obtained using earlybird compared to dilution technique, unlike the comparison between duplex ultrasound and the dilution technique. However, inter-rater reliability for the arteriovenous fistula was excellent with earlybird and good with duplex ultrasound, indicating the potential of earlybird as a tool for frequent measurements, enabling trend surveillance and predicting adverse outcomes.

Increasing Use of Prophylactic Open Abdomen Therapy With Vacuum Assisted Wound Closure and Mesh Mediated Fascial Traction After Repair of Ruptured Abdominal Aortic Aneurysm.

OBJECTIVE: Open abdomen therapy (OAT) is commonly used to prevent or treat abdominal compartment syndrome (ACS) in patients with ruptured abdominal aortic aneurysms (rAAAs). This study aimed to evaluate the incidence, treatment, and outcomes of OAT after rAAA from 2006 to 2021. Investigating data on resuscitation fluid, weight gain, and cumulative fluid balance could provide a more systematic approach to determining the timing of safe abdominal closure. METHODS: This was a single centre observational cohort study. The study included all patients treated for rAAA followed by OAT from October 2006 to December 2021. RESULTS: Seventy-two of the 244 patients who underwent surgery for rAAA received OAT. The mean age was 72 ± 7.85 years, and most were male (n = 61, 85%). The most frequent comorbidities were cardiac disease (n = 31, 43%) and hypertension (n = 31, 43%). Fifty-two patients (72%) received prophylactic OAT, and 20 received OAT for ACS (28%). There was a 25% mortality rate in the prophylactic OAT group compared with the 50% mortality in those who received OAT for ACS (p = .042). The 58 (81%) patients who survived until closure had a median of 12 (interquartile range [IQR] 9, 16.5) days of OAT and 5 (IQR 4, 7) dressing changes. There was one case of colocutaneous fistula and two cases of graft infection. All 58 patients underwent successful abdominal closure, with 55 (95%) undergoing delayed primary closure. In hospital survival was 85%. Treatment trends over time showed the increased use of prophylactic OAT (p ≤ .001) and fewer ACS cases (p = .03) assessed by Fisher's exact test. In multivariable regression analysis fluid overload and weight reduction predicted 26% of variability in time to closure. CONCLUSION: Prophylactic OAT after rAAA can be performed safely, with a high rate of delayed primary closure even after long term treatment.

Early and mid-term results after endovascular repair of thoracoabdominal aortic aneurysms using the off-the-shelf multibranched t-Branch device: a national multi-center study.

Objective: The multibranched off-the-shelf Zenith® t-Branch (Cook Medical, Bloomington, IN) device is commonly chosen for endovascular repair of thoracoabdominal aortic aneurysms. The aim of this study was to report early and mid-term outcomes in all patients treated with the t-Branch in Norway; Design and Methods: A retrospective multicenter study with Norwegian centers performing complex endovascular aortic repair was undertaken. T-Branch patients from 2014 to 2020 were included. All postoperative computed tomography angiography images were reviewed, and demographic, anatomical, perioperative and follow-up data were analyzed; Results: Seventy patients were treated in a single-step (n = 55) or staged (n = 15) procedure. Symptomatic presentation was seen in 20 patients, six of which had a contained rupture. Technical success was 87% (n = 59), with failures caused by unsuccessful bridging of target vessels (n = 4), target vessel bleeding (n = 3), persisting type 1c endoleak (n = 1) and t-Branch malrotation (n = 1). 30-day mortality was 9% (n = 6) and was associated with high BMI (p = .038). The spinal cord ischemia rate was 21% (n = 15) and was associated with type II aneurysms (OR 5.4, 95% CI 1.1-26.7, p = .04), smoking (OR 6.0, 95% CI 1.3-27.6, p = .02) and intraoperative blood loss (OR 1.1, 95% CI 1.0-1.3, p = .01). Survival at one, two and three years was 84 ± 4%, 70 ± 6% and 67 ± 6%, respectively. Freedom from aortic-related reinterventions at one, two and three years was 80 ± 5%, 65 ± 7% and 50 ± 8%, respectively; Conclusion: The study showed low early mortality (9%) and satisfactory mid-term survival. Technical success was achieved in acceptable 87% of procedures. The rate of spinal cord ischemia was high, occurring in 21% of patients.

This paper provides a national experience of all TAAA patients treated with the multibranched t-Branch stent graft in Norway in a multi-center study. As we aimed at including all Norwegian patients operated with the device, the paper adds real-world data on t-Branch outcomes from four regional smaller-volume vascular centers.The paper provides technical and clinical mid-term results with several patients being followed up for >3 years.Technical success was achieved in 87% of procedures.The 30-day mortality rate was 9% and survival at one, two and three years was 85 ± 4%, 70 ± 6% and 67 ± 6%, respectively.Spinal cord ischemia was associated with Crawford type II aneurysms, smoking and intraoperative blood loss.

A method for treatment of deep and superficial enteroatmospheric fistulas in an open abdomen, ChimneyVAC: Ten years experience.

BACKGROUND: Leakage of intestinal fluid is a challenging event when it appears in an open abdomen (OA) and surgical deviation does not seem possible. Intestinal contents in the abdominal cavity maintain inflammation and drainage is there for essential. We have developed a method, ChimneyVAC, to treat both deep and superficial enteroatmospheric fistulas (EAF) AIMS: To describe this innovative surgical technique and our 10-year experience. MATERIAL & METHODS: This single-center observational cohort study included all 16 consecutive patients treated with ChimneyVAC. Seven women and 9 men; median age: 47; (interquartile range [IQR]:39-63) years, 15 with a small bowel fistula and 1 with a large bowel fistula. All except of the colonic fistula were classified as a high output fistula; 14 were deep and 2 superficial. In this technique, a negative-pressure source is applied directly above the fistula opening, in addition to negative pressure wound therapy for the OA. This controls the leakage of intestinal fluid by direct drainage into a vacuum system, thereby avoiding contamination of the abdomen. A controlled enterocutaneous fistula (ECF) then forms as the traction from the ChimneyVAC brings the fistula opening to skin level. RESULTS: In 14 patients, an ECF formed after a median of 42 (IQR:28-55) days and 12 (IQR:7-16) dressing changes. The median length of hospitalization was 103 (IQR:58-143) days. Two patients died of multiorgan failure and 14 initially survived. DISCUSSION: This study showed that 14 out of 16 patients survived the initial treatment for enteric leakage with the ChimneyVAC method. The outcome of ChimneyVAC treatment is a controlled ECF, which was then corrected after a median of six months. However, hospitalization is lengthy, the patients undergo several dressing changes and many needs additional parenteral nutrition until intestinal continuity is reestablished. CONCLUSION: ChimneyVAC is a feasible method for treatment of EAF in an OA, with favorable survival.

Peri-Operative Mortality and Survival After Repair of Abdominal Aortic Aneurysm in Advanced Age Patients: A National Study from the Norwegian Registry for Vascular Surgery Focused on Nonagenarians.

OBJECTIVE: Treatment of abdominal aortic aneurysm (AAA) in nonagenarians has become more frequent. This national observational cohort study aimed to investigate peri-operative mortality and survival after AAA surgery in nonagenarians in Norway. METHODS: All AAA repairs registered in the Norwegian Registry for Vascular Surgery from 2015 to 2021 were identified and stratified into nonagenarians > 90 years old (n = 77), octogenarians 80 - 89 years old (n = 1 362), and patients < 80 years old (n = 4 590). The patient characteristics and comorbidities were recorded, and the 30 and 90 day mortality rates were calculated. Kaplan-Meier analysis was performed to obtain the estimated median survival and survival curves. RESULTS: In the nonagenarians, the 30 day mortality rates were 2.5% in asymptomatic patients, 33.3% in symptomatic patients, and 59.1% in the patients with a ruptured AAA (rAAA). The estimated median survival (years) were 3.3 (95% confidence interval [CI] 1.95 - 4.59) for asymptomatic AAA, 2.9 (interquartile range [IQR] 2.82, 5.80) for symptomatic AAA, and 0.1 for rAAA (IQR 0.01, 3.04). For nonagenarians surviving the first 90 days, the estimated median survival (years) were 4.2 (95% CI 2.56 - 5.88) for asymptomatic AAA, 3.4 (IQR 2.86, 5.80) for symptomatic AAA, and 3.8 (IQR 1.49, 4.85) for rAAA. The 90 day mortality rates were 100.0%, 80.0%, and 62.5% for asymptomatic, symptomatic, and rAAA, respectively, after open surgical repair (OSR), and 5.1%, 10.0%, and 50.0%, respectively, after endovascular aortic repair (EVAR). CONCLUSION: Peri-operative mortality and survival results after AAA surgery in nonagenarians support treatment of selected asymptomatic patients. The 90 day survivors had an expected survival of more than three years, enabling balanced decision making regarding surgical vs. conservative treatment options in this challenging cohort. EVAR is the treatment method of choice for AAA in nonagenarians because most of them would probably live longer untreated than if treated by OSR.

Antithrombotic and Lipid Lowering Therapy is Associated With Improved Survival After Vascular Surgery: A Population Based Study From Norway.

OBJECTIVE: This population based retrospective cohort study aimed to investigate the association between combined treatment with lipid lowering drugs and antiplatelet or anticoagulation therapy and long term survival following vascular surgery in Norway. METHODS: The study included all patients who were registered for the treatment of carotid stenosis, abdominal aortic aneurysm (AAA), and atherosclerotic lower extremity arterial disease (LEAD) in the Norwegian Registry for Vascular Surgery between 2015 and 2019 and who were discharged alive. Clinical and medication details were retrieved from the register. Survival was assessed with Kaplan-Meier analysis and a multivariable Cox regression model. Stratification was according to treatment group, patient sex, and if patients received the recommended medications or not. Recommended medications were defined as lipid lowering drugs, usually statins, and antiplatelets, or sometimes anticoagulants, when comorbidity indicated anticoagulation therapy. RESULTS: In total, 15 810 patients had LEAD, 4 080 patients AAA, and 2 194 patients had carotid stenosis. In all treatment groups, survival was superior for patients who used the recommended medications upon discharge. The difference was greatest in patients with LEAD with mean survival periods of 4.33 (95% CI 4.29 - 4.36) and 3.7 (95% CI 3.64 - 3.77) years in patients discharged with and without the recommended medications, respectively (p < .001). The mean survival periods were 4.67 (95% CI 4.61 - 4.73) and 4.34 (95% CI 4.24 - 4.44) years in patients with AAA discharged with and without the recommended medications, respectively (p < .001). Cox regression analysis showed a statistically significantly lower mortality rate for patients discharged with the recommended medications for LEAD (HR 0.58; p < .001) and AAA (HR 0.57; p < .001). CONCLUSION: The recommended medications were associated with improved survival in all treatment groups and both sexes. The survival difference was statistically significant in patients with LEAD and AAA. Patients with LEAD had the greatest improvement; therefore, the recommended secondary prophylaxis is especially important in these patients.

A Retrospective Evaluation of Intra-Prosthetic Thrombus Formation After Endovascular Aortic Repair in Cook Zenith Alpha and Medtronic Endurant II Patients.

OBJECTIVE: To investigate the occurrence of limb graft occlusion (LGO) and intra-prosthetic thrombus (IPT) formation in Zenith Alpha and Endurant II stent graft limbs. METHODS: A single centre retrospective study was conducted on patients treated with the Zenith Alpha and Endurant II stent grafts between 2017 and 2019. All post-operative computed tomography angiography images were re-investigated for thrombus formation. Demographic, aneurysm, and stent graft data were collected and compared. LGO was defined as complete occlusion or significant stenosis (≥ 50% lumen diameter reduction). Logistic regression on pro-thrombotic risk factors was conducted. Freedom from LGO and overall limb IPT were compared using Kaplan-Meier analyses. RESULTS: Seventy-eight Zenith Alpha and eighty-six Endurant II patients were studied. The median follow up was 33 (IQR 25, 44) months for Zenith Alpha patients and 36 (IQR 22, 46) months for Endurant II patients (p = .53). LGO was seen in 15% (n = 12) of Zenith Alpha patients and 5% (n = 4) of Endurant II patients (p = .032), and freedom from LGO was significantly higher among Endurant II patients (p = .024). The Zenith Alpha stent graft was an independent risk factor for LGO (OR 3.9, 95% CI 1.1 - 13.4; p = .032). Among Zenith Alpha patients, limb flare compression within the main body gate was over represented in LGO patients (p = .011). There was no difference in freedom from overall limb IPT between the stent graft systems. For Endurant II limbs, IPT was significantly less common in the integrated ipsilateral limbs (without ETLW/ETEW stent graft limbs) (p = .044). Main endograft body IPT was correlated with overall limb IPT (p = .035). CONCLUSION: LGO was significantly more common among Zenith Alpha than Endurant II patients. Zenith Alpha limbs was an independent risk factor for LGO. There was no difference between stent grafts in overall limb IPT formation.

Midterm Outcomes for Endovascular Repair of Thoraco-Abdominal Aortic Aneurysms.

Objective: To investigate technical and clinical outcomes in patients with thoraco-abdominal aortic aneurysms treated with the multibranched off the shelf Zenith t-Branch stent graft or a custom made device (CMD). Methods: A retrospective study was conducted of patients operated on at a single tertiary vascular centre in Norway. Twenty eight t-Branch and 17 CMD patients were identified. Demographic, aneurysm, and peri-operative data were summarised and compared. Results: Thirty day mortality was 4% (2/45), with mortality rates of 7% (2/28) and 0 in t-Branch and CMD patients, respectively (p = .52). Technical success was 87% (39/45), with a non-significant difference between t-Branch and CMD procedures of 89% (25/28) and 82% (14/17), respectively (p = .63). Stent graft coverage was significantly longer in t-Branch patients (p = .020). Paraparesis or paraplegia developed in 18% (5/28) of t-Branch patients and 12% (2/17) of CMD patients (p = .69), and spinal cord ischaemia was associated with Crawford type II aneurysms (p = .010) and aortic coverage >400 mm (p = .050). The estimated survival at one and two years for t-Branch patients was 93% and 88%, and 100% and 92% for CMD patients. Freedom from re-intervention was estimated at 70% and 43% at one and two years for t-Branch patients, and 58% and 50% for CMD patients. Conclusion: The study showed low 30 day mortality rates, acceptable technical success rates, high medium term survival, and no statistically significant differences in clinically relevant outcomes between t-Branch and CMD patients.

The Effect of 12-Week Treatment with Intermittent Negative Pressure on Blood Flow Velocity and Flowmotion, Measured with a Novel Doppler Device (Earlybird). Secondary Outcomes from a Randomized Sham-Controlled Trial in Patients with Peripheral Arterial Disease.

BACKGROUND: Treatment with intermittent negative pressure (INP) is proposed as an adjunct to standard care in patients with peripheral arterial disease (PAD). The aims of this study were to evaluate the applicability of a novel ultrasound Dopplerdevice (earlybird) to assess blood flow characteristics in patients with PAD during a treatment session with INP, and whether certain flowproperties could determine who could benefit from INP treatment. METHODS: Secondary outcomes of data from a randomized sham-controlled trial were explored. Patients were randomized to 12 weeks of treatment with 40 mm Hg or 10 mm Hg INP, for one hour twice daily. Earlybird blood flow velocity recordings were made before and after the 12-week treatmentperiod and consists of a 5-min recording in rest, 3-min during INP treatment and 5-min recording after ended INP test-treatment. Mean blood flow velocity (vmean), relative changes in flow and frequency spectrum by Fourier-transform of the respective bandwidths of endothelial, sympathetic, and myogenic functions, were analyzed for the different series of blood flow measurements. RESULTS: In total, 62 patients were eligible for analysis, where 32 patients were treated with 40 mm Hg INP. The acquired recordings were of good quality and were used for descriptive analyses of flow characteristics. An immediate increase in vmean during the negative pressure periods of the INP test-treatment was observed in the 40 mm Hg INP treatment group at both pre- and post-test. There was a significant difference between the treatment groups, with a difference between the medians of 13.7 (P < 0.001) at pre-test and 10.7 (P < 0.001) at posttest. This finding was confirmed with spectrum analysis by Fourier-transform of the bandwidth corresponding to INP treatment. The change in amplitude corresponding to myogenic function after 12-weeks of treatment, was significantly different in favor of the 40 mm Hg INP treatment group. We were not able to detect the specific flow characteristics indicating who would benefit INP-treatment. CONCLUSIONS: Earlybird is an applicable tool for assessing blood flow velocity in patients with PAD. Analysis of the flow velocity recordings shows that INP induces an immediate increase in blood flow velocities during INP. The positive effects of INP may be attributed to recruitment of arterioles, and thereby, increasing blood flow. In these analyses, no flow characteristics were determined which could predict who would benefit INP treatment.

Validation of a novel ultrasound Doppler monitoring device (earlybird) for measurements of volume flow rate in arteriovenous fistulas for hemodialysis.

BACKGROUND: Controversy exists regarding surveillance of arteriovenous fistulas for hemodialysis to increase patency. A significant reduction in volume flow rate (VFR) should lead to diagnostic evaluation and eventually intervention. Several methods are available for VFR measurements, but all of them are associated with low reproducibility. VFR trend analysis is suggested as an improved solution. It is therefore a need to find user-friendly, cost and time-effective modalities. We present a novel Doppler ultrasound device (earlybird) which could bridge this gap. It includes an easy-to-use and light-weight single element transducer. METHODS: In an experimental and clinical setting, we compared earlybird to duplex ultrasound to assess VFR. In a closed circuit of blood-mimicking fluid, 36 paired calculations of calibrated, duplex ultrasound and earlybird VFR was measured. In addition, 23 paired recordings of duplex ultrasound and earlybird VFR was measured in 16 patients with underarm arteriovenous fistulas. Pearson correlation, intraclass correlation coefficient, root-mean-square and Bland-Altman plots were analyzed. RESULTS: Strong correlation (r = 0.991, p < 0.001), and excellent level of agreement (ICC = 0.970 (95% CI 0.932 - 0.985), p < 0.001) between earlybird and the calibrated VFR was found in the experimental setup. This was confirmed in the clinical setting, with a strong correlation (r = 0.781, p < 0.001) and moderate to good level of agreement (ICC = 0.750 (95% CI 0.502-0.885), p < 0.001) between earlybird and duplex ultrasound VFR measured at the arteriovenous fistulas outflow veins. In the Bland-Altman plot-analysis for the experimental setup, we found smaller limits of agreement, a smaller consistent and proportional bias, as well as greater accuracy of earlybird than DUS when compared to the calibrated VFR. CONCLUSION: Earlybird is a feasible tool for VFR measurements and could be a future promising device for easy assessment and surveillance of AVF for hemodialysis.

Effects of intermittent negative pressure treatment on circulating vascular biomarkers in patients with intermittent claudication.

The aim of this study was to investigate the effects of lower extremity intermittent negative pressure (INP) treatment for 1 hour twice daily for 12 weeks, on circulating vascular biomarkers in patients with intermittent claudication. Patients were randomized to treatment with -40 mmHg INP (treatment group), or -10 mmHg INP (sham control group). Venous blood samples were collected at baseline and after 12 weeks, and concentrations of vascular adhesion molecule-1 (VCAM-1), intracellular adhesion molecule-1 (ICAM-1), E-selectin, P-selectin, von Willebrand factor (vWF), l-arginine, asymmetric dimethylarginine (ADMA), and symmetric dimethylarginine (SDMA) were analyzed. A larger proportion of the patients in the treatment group (25/31) had a reduction in vWF levels after 12 weeks, compared to the sham control group (17/30) (p = 0.043). Within the treatment group there was a significant mean (SEM) reduction in the concentration of vWF of -11% (4) (p = 0.019), whereas there was no significant change in the levels of vWF in the sham control group (1% (6); p = 0.85). There were no significant differences in the change of any of the biomarker levels between the groups after 12 weeks of treatment. In conclusion, there were no differences in the change of the circulating levels of the measured biomarkers between the treatment group and the sham control group after 12 weeks of INP treatment. However, the observed changes in vWF might indicate a beneficial effect of INP treatment on endothelial activation and endothelial injury. Clinicaltrials.gov Identifier: NCT03640676.

Lower Extremity Intermittent Negative Pressure for Intermittent Claudication. Follow-Up after 24 Weeks of Treatment.

BACKGROUND: Treatment with lower extremity intermittent negative pressure (INP) of -40 mm Hg for one hour twice daily for 12 weeks, increases walking capacity in patients with intermittent claudication (IC). However, the effects of INP treatment beyond 12 weeks have not been elucidated. The aim of the present study was to investigate the clinical effects of INP treatment after 24 weeks in patients with IC. METHODS: This was a follow-up study after a randomized sham-controlled trial, where patients randomized to the active treatment group were offered to continue treatment for 12 additional weeks (24 weeks in total). Treatment with -40 mm Hg INP was applied in a pressure chamber sealed around the lower leg, and the patients were instructed to treat themselves at home one hour in the morning and one hour in the evening. Pain free walking distance (PWD), maximal walking distance (MWD), resting ankle-brachial index (ABI) and post exercise ABI were measured at baseline, after 12 and 24 weeks. RESULTS: Ten out of 32 patients (31%) from the active treatment group in the initial trial were included in this follow-up study. At baseline, PWD was (mean ±SD) 151 ± 91 m and MWD was 362 ±159 m. There was a significant increase in both PWD and MWD after 24 weeks of treatment, compared to baseline (ANOVA; P= 0.006 and P= 0.012, respectively). Post hoc tests revealed that PWD increased significantly from baseline to 12 weeks (mean 81 m; 95% CI [6, 156]; P = 0.032), and that MWD increased significantly from 12 to 24 weeks (mean 145 m; 95% CI [22, 268]; P = 0.018). There were no significant changes in resting ABI or post exercise ABI during the 24-week treatment period (ANOVA; P= 0.157 and P= 0.450, respectively). CONCLUSION: Both PWD and MWD improved after treatment with - 40 mm Hg INP for one hour twice daily for 24 weeks, compared to baseline. The main improvement in PWD occurred during the first 12 weeks of treatment, whereas the main improvement in MWD occurred between 12 and 24 weeks of treatment.

A randomized controlled trial of treatment with intermittent negative pressure for intermittent claudication.

OBJECTIVE: We investigated the effects of lower extremity intermittent negative pressure (INP) treatment for 1 hour two times daily for 12 weeks on the walking distance of patients with intermittent claudication (IC). METHODS: Patients with IC were randomized to treatment with -40 mm Hg INP (treatment group) or -10 mm Hg INP (sham control group). Pain-free walking distance (PWD) and maximal walking distance (MWD) on a treadmill, resting and postexercise ankle-brachial index, resting and postischemic blood flow (plethysmography), and quality of life (EQ-5D-5L and Vascuqol-6) were measured at baseline and after 12 weeks of treatment. RESULTS: A total of 72 patients were randomized, and 63 had data available for the intention-to-treat analyses. The between-group comparisons showed a significant change in the PWD, favoring the treatment group over the sham control group (estimated treatment effect, 50 m; 95% confidence interval [CI], 11-89; P = .014). The PWD had increased by 68 m (P < .001) in the treatment group and 18 m (P = .064) in the sham control group. No significant difference was found in the change in the MWD between the two groups (estimated treatment effect, 42 m; 95% CI, -14 to 97; P = .139). The MWD had increased by 62 m (P = .006) in the treatment group and 20 m (P = .265) in the sham control group. For patients with a baseline PWD of <200 m (n = 56), significant changes had occurred in both PWD and MWD between the two groups, favoring the treatment group (estimated treatment effect, 42 m; 95% CI, 2-83; P = .042; and estimated treatment effect, 62 m; 95% CI, 5-118; P = .032; respectively). Both overall and for the group of patients with a PWD <200 m, no significant differences were found in the changes in the resting and postexercise ankle-brachial index, resting and postischemic blood flow, or quality of life parameters between the two groups. CONCLUSIONS: Treatment with -40 mm Hg INP increased the PWD compared with sham treatment in patients with IC. For the patients with a baseline PWD of <200 m, an increase was found in both PWD and MWD compared with sham treatment.

Validation of a novel ultrasound Doppler monitoring device (earlybird) for detection of microvascular circulatory changes.

OBJECTIVE: In this proof-of-concept study we aim to validate a novel ultrasound Doppler monitoring device for evaluating microcirculation (earlybird) against LDF and pulsed Doppler. METHODS: In ten healthy subjects, we measured microcirculatory function at rest and during different autonomic tests (forced respiration, isometric exercise, Valsalva maneuver and cold pressor). Earlybird, LDF and pulsed Doppler were recorded simultaneously. We performed a ZNCC to determine correlation. RESULTS: The curves for earlybird and LDF or pulsed Doppler correlates visually well. Overall median ZNCC 0.87 (interquartile range 0.77 -0.91) between the LDF and earlybird measurements, and 0.90 (0.82 - 0.95) for pulsed Doppler and earlybird. Median ZNCC for baseline and each provocation test for earlybird against LDF and pulsed Doppler were calculated; baseline: LDF 0.87 (0.73 - 0.97) pulsed Doppler 0.91 (0.81 - 0.94), forced respiration: LDF 0.87 (0.28 - 0.90) pulsed Doppler 0.90 (0.85 - 0.96), isometric exercise: LDF 0.82 (0.59 - 0.90) pulsed Doppler 0.87 (0.68 - 0.94), Valsalva maneuver: LDF 0.88 (0.82 - 0.91) pulsed Doppler 0.94 (0.92 - 0.97) and cold pressor: LDF 0.90 (0.85 - 0.95) pulsed Doppler 0.89 (0.65 - 0.94). CONCLUSION: Earlybird records vasoconstrictions in healthy subjects as well as LDF and pulsed Doppler.

Steam ablation versus stripping of great saphenous varicose veins. / Vanndampbehandling versus stripping av vena saphena magna ved åreknuter.

BACKGROUND: Use of new technology can lead to changes in the treatment course for patients and in treatment costs for the health service. The aim of this study was to compare sickness absence and time to resumption of daily activities, as well as treatment costs, for two surgical treatments for varicose veins: endovenous steam ablation and vein stripping. MATERIAL AND METHOD: This prospective observational study included 46 patients treated with steam ablation and 37 treated with vein stripping in the period 2015-2016. The two groups were matched with respect to age, sex, occupational status and classification. After treatment, patients were interviewed every other week until daily activities had been resumed. Detailed information on expenditure related to personnel, equipment, premises and materials was used to calculate the cost of treatment. RESULTS: Patients treated with steam ablation resumed daily activities after a median of 0 (interquartile range 0-2) days versus 4 (2-7) days for vein stripping (p < 0.001), and sporting activities after 4 (2-9) days versus 11 (3-19) days (p < 0.004). For patients in employment, sickness absence after steam ablation was 2 (2-5) days versus 14 (6-21) for patients treated with vein stripping (p < 0.001). The estimated treatment cost for steam ablation was NOK 5 973, compared with NOK 10 109 for vein stripping. INTERPRETATION: Steam ablation led to shorter convalescence and sickness absence for the patient, and lower costs for the hospital. Reduced sickness absence also implies lower costs for society.

Open Abdomen Therapy with Vacuum and Mesh Mediated Fascial Traction After Aortic Repair: an International Multicentre Study.

OBJECTIVES: Open abdomen therapy may be necessary to prevent or treat abdominal compartment syndrome (ACS). The aim of the study was to analyse the primary delayed fascial closure (PDFC) rate and complications after open abdomen therapy with vacuum and mesh mediated fascial traction (VACM) after aortic repair and to compare outcomes between those treated with open abdomen after primary versus secondary operation. METHODS: This was a retrospective cohort, multicentre study in Sweden, Finland, and Norway, including consecutive patients treated with open abdomen and VACM after aortic repair at six vascular centres in 2006-2015. The primary endpoint was PDFC rate. RESULTS: Among 191 patients, 155 were men. The median age was 71 years (IQR 66-76). Ruptured abdominal aortic aneurysm (RAAA) occurred in 69.1%. Endovascular/hybrid and open repairs were performed in 49 and 142 patients, respectively. The indications for open abdomen were inability to close the abdomen (62%) at primary operation and ACS (80%) at secondary operation. Duration of open abdomen was 11 days (IQR 7-16) in 157 patients alive at open abdomen termination. The PDFC rate was 91.8%. Open abdomen initiated at primary (N=103), compared with secondary operation (N=88), was associated with less severe initial open abdomen status (p=.006), less intestinal ischaemia (p=.002), shorter duration of open abdomen (p=.007), and less renal replacement therapy (RRT, p<.001). In hospital mortality was 39.3%, and after entero-atmospheric fistula (N=9) was 88.9%. Seven developed graft infection within 6 months, 1 year mortality was 28.6%. Intestinal ischaemia (OR 3.71, 95% CI 1.55-8.91), RRT (OR 3.62, 95% CI 1.72-7.65), and age (OR 1.12, 95% CI 1.06-1.12), were independent factors associated with in hospital mortality, but not open abdomen initiated at primary versus secondary operation. CONCLUSIONS: VACM was associated with a high PDFC rate after prolonged open abdomen therapy following aortic repair. Patient outcomes seemed better when open abdomen was initiated at primary, compared with secondary operation but a selection effect is possible.

Bedside dressing changes for open abdomen in the intensive care unit is safe and time and staff efficient.

BACKGROUND: Patients with an open abdomen (OA) treated with temporary abdominal closure (TAC) need multiple surgical procedures throughout the hospital stay with repeated changes of the vacuum-assisted closure device (VAC changes). The aim of this study was to examine if using the intensive care unit (ICU) for dressing changes in OA patients was safe regarding bloodstream infections (BSI) and survival. Secondary aims were to evaluate saved time, personnel, and costs. METHODS: All patients treated with OA in the ICU from October 2006 to June 2014 were included. Data were retrospectively obtained from registered procedure codes, clinical and administrative patients' records and the OR, ICU, anesthesia and microbiology databases. Outcomes were 30-, 60- and 90-day survival, BSI, time used and saved personnel costs. RESULTS: A total of 113 patients underwent 960 surgical procedures including 443 VAC changes as a single procedure, of which 165 (37 %) were performed in the ICU. Nine patients died before the first scheduled dressing change and six patients were closed at the first scheduled surgery after established OA, leaving 98 patients for further analysis. The mean duration for the surgical team performing a VAC change in the ICU was 63.4 (60.4-66.4) minutes and in the OR 98.2 (94.6-101.8) minutes (p < 0.001). The mean duration for the anesthesia team in the OR was 115.5 minutes, while this team was not used in the ICU. Personnel costs were reduced by €682 per procedure when using the ICU. Forty-two patients had all the VAC changes done in the OR (VAC-OR), 22 in the ICU (VAC-ICU) and 34 in both OR and ICU (VAC-OR/ICU). BSI was diagnosed in eight (19 %) of the VAC-OR patients, seven (32 %) of the VAC-ICU and eight (24 %) of the VAC-OR/ICU (p = 0.509). Thirty-five patients (83 %) survived 30 days in the VAC-OR group, 17 in the VAC-ICU group (77 %) and 28 (82 %) in the VAC-OR/ICU group (p = 0.844). CONCLUSIONS: VAC change for OA in the ICU saved time for the OR team and the anesthesia team compared to using the OR, and it reduced personnel costs. Importantly, the use of ICU for OA dressing change seemed to be as safe as using the OR.