Long-term outcome after implementation of endovascular-first strategy to treat acute mesenteric ischemia.

OBJECTIVE: To evaluate the rationale of an aggressive endovascular-first strategy to treat elderly patients with acute mesenteric ischemia (AMI) by studying long-term survival, readmissions, and patients' discharge to home vs nursing facility a decade after an episode of AMI. METHODS: The retrospective study cohort included 66 consecutive patients (all-comers) treated for arterial occlusive AMI between 2009 and 2013. Endovascular revascularization (EVR) was attempted in 50 patients (EVR+), whereas 16 patients were treated without attempted revascularization (EVR-). All patients were followed until death or September 2022. Studied outcomes included discharge status, long-term survival and cause of death and readmissions related to AMI. RESULTS: The mean age of all 66 patients was 78 ± 10 years: 79 ± 9 years in the EVR+ group and 76 ± 12 years in the EVR- group. EVR was technically successful in 44 patients (88%); three patients underwent subsequent open revascularization after EVR failure. One-third required bowel resection after EVR. The 30-day mortality for all patients was 44%; 32% in the EVR+ group and 81% in the EVR- group. Only two survivors were permanently institutionalized, whereas all others were discharged to the same place they lived prior to the AMI episode. There were four AMI-related readmissions during the follow-up; all were in the EVR+ group. Two patients underwent reinterventions for recurrent AMI. One-year survival was 52% for EVR+ and 19% for EVR- patients. Five-year survival rates were 18% and 13%, respectively. The causes of deaths were mesenteric ischemia in 22, other cardiovascular event in 21, and non-cardiovascular cause in 19 patients. Four patients were alive at the end of the follow-up. CONCLUSIONS: In this unselected elderly population with AMI, the aggressive strategy to attempt EVR resulted in a high revascularization rate and favorable outcomes. The high proportion of patients returning to their prior living status and low readmission rate after survival from AMI encourages active treatment of high-functioning elderly patients.

Percutaneous coronary intervention with drug-coated balloon-only strategy combined with single antiplatelet treatment in patients at high bleeding risk: Single center experience of a novel concept.

OBJECTIVES: At least 1 month of dual antiplatelet therapy is required after coronary stenting. The aim of this all-comers retrospective registry study was to assess the efficacy and safety of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) with single antiplatelet treatment (SAPT). METHODS: Between 2011 and 2020, 232 PCIs were performed in 172 patients using the DCB-only strategy and discharged with SAPT. RESULTS: The mean age of the patients was 75 ± 11 years and 59% were male. The clinical presentation was stable coronary artery disease (CAD) in 42% of the patients and acute coronary syndrome (ACS) in 58%. The lesions were mainly de novo (96%). The majority (58%) of treated lesions were in large coronary arteries (≥3.0 mm). Most (87%) of the patients were at high bleeding risk (HBR) with at least one major or two minor Academic Research Consortium (ARC) risk factors for bleeding. Periprocedural DAPT was used in 49% of the patients. The 12-month major adverse cardiac events (MACE, the composition of cardiovascular death, nonfatal myocardial infarction, and target-lesion revascularization) rate was 1.4% in stable CAD and 7.1% in ACS. The 12-month all-cause mortality after DBC only + SAPT strategy was 4.1% in stable CAD and 12.1% in ACS. The rate of ischemia-driven target lesion revascularisation (TLR) was 0% in stable CAD and 3.0% in ACS at 12 months. The 12-month rate of significant bleeding (BARC type 2-5) was 10.5%. There were no acute or subacute vessel closures. CONCLUSIONS: Despite the aged patient population with comorbidities, the TLR, MACE, and bleeding rates were low with DCB-only PCI combined with SAPT. This novel approach could reduce the post-PCI bleeding risk in patients with CAD and HBR compared to stenting.

Multivariable Analysis of Pre-operative Brain Atrophy as a Predictor of Long Term Mortality After Carotid Endarterectomy.

OBJECTIVE: Brain atrophy is associated with an increased mortality rate in elderly trauma patients and in patients treated with mechanical thrombectomy for acute ischaemic stroke. In the setting of ischaemic stroke, the association between brain atrophy and death is stronger than that of sarcopenia. It has previously been shown that lower masseter area, as a marker of sarcopenia, is linked to lower survival after carotid endarterectomy (CEA). The aim of this study was to investigate whether brain atrophy is also associated with long term mortality in patients undergoing CEA. METHODS: A cohort of patients treated with CEA between 2004 and 2010 was retrieved from the Tampere University Hospital vascular registry and those with available pre-operative computed tomography (CT) imaging were analysed retrospectively. CT images were evaluated for brain atrophy index (BAI) and masseter muscle surface area and density. The association between BAI and mortality was investigated with Cox regression. RESULTS: Two hundred and thirty-three patients with a median (interquartile range [IQR]) age of 71 years (64.0, 77.0) were included. Most patients were operated on for symptomatic stenosis (n = 203; 87.1%). The median (IQR) duration of follow up was 115.0 months (66.0, 153.0), and 155 patients (66.5%) died during follow up. BAI was statistically significantly correlated with age (r = .489), average masseter density (r = -.202), and smoking (r = -.186; all p <.005). Increased BAI was statistically significantly associated with overall mortality (hazard ratio [HR] 1.45, 95% confidence interval [CI] 1.25 - 1.68, per one standard deviation [SD] increase) in the univariable analysis, and the association remained (HR 1.23, 95% CI 1.04 - 1.46, per one SD increase) in the multivariable models. Age, peripheral artery disease, and chronic obstructive pulmonary disease were also independently associated with mortality. The optimal cutoff value for BAI was 0.133. CONCLUSION: Brain atrophy independently predicts the long term post-operative mortality rate after CEA in a cohort containing mainly symptomatic patients. Future studies are needed to validate the results in prospective settings and in asymptomatic patients.

Effect of patient frailty status on outcomes of fenestrated-branched endovascular aortic repair for complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: In the present study, we assessed the effects of patient frailty status on the early outcomes and late survival after fenestrated-branched endovascular aortic repair (FB-EVAR) for complex abdominal and thoracoabdominal aortic aneurysms. METHODS: We retrospectively reviewed the clinical data and outcomes of consecutive patients who had undergone elective FB-EVAR from 2007 to 2019 in a single institution. A previously validated 11-item modified frailty index (mFI-11) was derived from the comorbidity and preoperative functional status data. An mFI-11 <0.3 was defined as low risk, 0.3 to 0.5 as medium risk, and >0.5 as high risk. The studied outcomes were 90-day mortality, major adverse events (MAE), and long-term survival. Multivariate analyses were performed to identify the independent predictors of these outcomes. RESULTS: A total of 592 patients (155 women, mean age, 75 ± 8 years) had undergone FB-EVAR. Using the mFI-11, 310 patients (52%) were included in the low-risk, 199 (34%) in the medium-risk, and 83 (14%) in the high-risk group. The 90-day mortality was significantly higher in the high-risk group than in the medium- and low-risk groups (13%, 4%, and 3%, respectively; P < .01). The corresponding MAE rates were 27%, 18%, and 19% (P = .23). As a subgroup, 44 patients in the high-risk group had had chronic kidney disease (CKD). The 90-day mortality for these patients was as high as 23%, and 32% had experienced MAE. On multivariable analysis, the independent risk factors for 90-day mortality were CKD, respiratory disease, and a high mFI-11. The independent risk factors for MAE were female sex, CKD, larger aneurysm diameter, and the high-risk subgroup with CKD. The independent risk factors for long-term mortality were age, a low body mass index, CKD, larger aneurysm diameter, extent I-III thoracoabdominal aortic aneurysm, respiratory disease, congestive heart failure, a history of cerebrovascular problems, and higher mFI-11. The estimated survival at 1 year was 91% ± 2% in the low-risk, 88% ± 2% in the medium-risk, and 78% ± 5% in the high-risk group (P < .001). The corresponding 5-year survival estimates were 60% ± 4%, 52% ± 5%, and 32% ± 6%. The mean follow-up time was 2.9 ± 2.3 years. The patients treated during the first quartile of the study period were significantly more frail than were those in the later quartiles. Also, the outcomes of FB-EVAR had improved over time. CONCLUSIONS: Greater frailty was significantly associated with early mortality. Together with CKD, frailty was also associated with MAE and lower patient survival after FB-EVAR. The mFI-11 represents the accumulation of comorbidities and can be used to assist in better patient selection for FB-EVAR.

Use of paclitaxel-coated balloons in clinical setting is not associated with increased mortality compared with plain balloon angioplasty in femoropopliteal lesions.

OBJECTIVE: To investigate mortality and causes of death associated with the use of paclitaxel-coated balloon (PCB) compared with plain balloon (PB) angioplasty in the treatment of femoropopliteal artery lesions in real-world clinical setting. METHODS: This retrospective, single-center study included patients who underwent percutaneous femoropopliteal artery angioplasty without stenting between years 2014 and 2020. Patients were stratified into PCB and PB groups according to the index procedure. Those who had undergone any prior or subsequent intervention using drug-eluting technology were excluded from the PB group. Long-term survival was estimated up to 5 years using the Kaplan-Meier method, and risk factors for all-cause mortality were assessed in a multivariable analysis. Causes of death were retrieved from a national registry. RESULTS: The study included 139 patients treated with PB and 190 with PCB. Patients treated with PCB had a higher prevalence of chronic pulmonary disease (27% vs 17%; P = .02) and were less often on anticoagulant therapy (34% vs 48%; P = .01) compared with patients in the PB group. Those treated with PB were more likely to have chronic limb-threatening ischemia (CLTI; 82% vs 72%; P = .04). Ipsilateral perioperative amputation rate was significantly higher in the PB group (7% vs 1%; P = .01). There were no major differences in other 30-day outcomes between the groups and no differences in the rates of reinterventions and ipsilateral amputations during a mean follow-up time of 2.7 ± 1.9 years. Survival at 1 year in the PCB group was 83% ± 3% compared with 73% ± 4% in the PB group (P = .0001). The 5-year survival estimates were 56% ± 5% and 37% ± 5%, respectively. PCB use was independently associated with decreased risk of mortality (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.50-0.97). Independent risk factors for increased mortality were age (HR, 1.04 per year; 95% CI, 1.02-1.06), cardiac insufficiency (HR, 1.60; 95% CI, 1.12-2.27), chronic renal insufficiency (HR, 2.04; 95% CI, 1.47-2.85), anticoagulation therapy (HR, 1.65, 95% CI, 1.16-2.34), and CLTI (HR, 2.85; 95% CI, 1.51-5.39). In the PCB group, 63% of deaths were due to cardiovascular causes compared with 42% in the PB group (P < .01). CONCLUSIONS: The use of PCB is safe, and there is no concern of increased mortality after the procedure based on the 5-year survival estimates.

Radiographically quantified sarcopenia and traditional cardiovascular risk assessment in predicting long-term mortality after endovascular aortic repair.

OBJECTIVE: This study evaluated radiographically quantified sarcopenia and the patient's comorbidity burden based on traditional cardiovascular risk assessment as potential predictors of long-term mortality after endovascular aortic repair (EVAR). METHODS: The study included 480 patients treated with standard EVAR for intact infrarenal abdominal aortic aneurysms. Patient characteristics, comorbidities, aneurysm dimensions, and other preoperative risk factors were collected retrospectively. Preoperative computed tomography was used to measure psoas muscle area (PMA) at the L3 level. Patients were divided into three groups based on American Society of Anesthesiologists (ASA) score and PMA. In the high-risk group, patients had sarcopenia (PMA <8.0 cm2 for males and <5.5 cm2 for females) and an ASA score of 4. In the medium-risk group, patients had either sarcopenia or an ASA score of 4. Patients in the low-risk group had no sarcopenia and the ASA score was less than 4. Risk factors for long-term mortality were determined using multivariable analysis. Kaplan-Meier survival estimates were calculated for all-cause mortality. RESULTS: Patients in the high- and medium-risk groups were older than those in the low-risk group (77 ± 7, 76 ± 6, and 74 ± 8 years, respectively, P < .01). Patients in the high-risk group had higher prevalence of coronary artery disease, pulmonary disease, and chronic kidney disease. There were no differences in 30-day or 90-day mortality between the groups. The independent predictors of long-term mortality were age, ASA score, PMA, chronic kidney disease, and maximum aneurysm sac diameter. The estimated 1-year mortality rates were 5% ± 2% for the low-risk, 5% ± 2% for the medium-risk, and 18% ± 5% for the high-risk group (P < .01). Five-year mortality estimates were 23% ± 4%, 36% ± 3%, and 60% ± 6%, respectively (P < .01). The mean follow-up time was 5.0 ± 2.8 years. CONCLUSIONS: Both ASA and PMA were strong predictors of increased mortality after elective EVAR. The combination of these two can be used as a simple risk stratification tool to identify patients in whom aneurysm repair or the intensive long-term surveillance after EVAR may be unwarranted.

Discontinuing low-dose acetylsalicylic acid after gastrointestinal bleeding is associated with increased mortality.

BACKGROUND: Gastrointestinal bleeding is a common clinical problem in patients using low-dose acetylsalicylic acid (ASA). It is uncertain whether aspirin should continue to be used in patients who develop acute gastrointestinal bleeding during low-dose ASA therapy. AIMS: To assess whether ASA should be continued in patients who develop GI bleeding during low-dose ASA. METHODS: All patients admitted to an academic hospital for acute gastrointestinal bleeding between 2009 and 2011 were reviewed retrospectively. Clinical characteristics, comorbidities, medications and treatments were recorded from the patient records. Patients were divided into two groups based on continuing or discontinuing ASA after discharge. RESULTS: A total of 548 patients were included. ASA was continued in 282 (51.5%) (ASAc group) and discontinued in 266 (48.5%) patients (ASAd group). ASAc patients had more often coronary artery disease (57.8% vs. 42.5%, p < .001) and peripheral artery disease (17.4% vs. 9.0%, p = .004) than ASAd patients, whereas no differences were found in other comorbidities. There was no difference in 30-day all-cause mortality between ASAd and ASAc groups. However, after adjustment for age, gender and comorbidities, one-year all-cause mortality was double in the ASAd group (hazard ratio 2.16, 95% confidence interval 1.39-3.35). ASAd and ASAc groups did not differ with respect to cardiovascular mortality (4.9% vs. 5.3%, p = .811, respectively) or re-bleeding (10.2% vs. 9.2%, p = .713, respectively). CONCLUSION: Continuing low-dose ASA after gastrointestinal bleeding was associated with lower all-cause mortality during the first year without increasing the risk of re-bleeding.

Long-term symptom improvement and health-related quality of life after operative management of median arcuate ligament syndrome.

OBJECTIVE: To investigate long-term symptom improvement and health-related quality of life (HRQOL) after operative intervention for median arcuate ligament syndrome (MALS). METHODS: Clinical data of all consecutive patients treated by operative management of MALS from 1999 to 2018 were reviewed. A cross-sectional questionnaire using the Visick score, the Gastrointestinal Quality of Life Index, and Short Form (SF)-12v2 questionnaires was performed to assess long-term outcomes. The SF-12 HRQOL domains were compared between symptom-free and symptomatic patient groups and to averages for the US general population. Treatment failure was defined as no relief after surgery and Visick category 3 to 4 symptoms. Freedom from symptoms was estimated at 5 years. RESULTS: A total of 100 patients were treated for MALS (mean age, 38 ± 18 years; 75% female). Open surgical release was performed in 81 and laparoscopic release in 19 patients. The most common presenting symptom was abdominal pain in 99 patients with postprandial exacerbation in 85. There was no mortality. Major adverse events at 30 days had occurred in 21 patients (open 19, laparoscopic 2) including myocardial infarction (n = 1), pancreatitis (n = 2), respiratory failure (n = 4), estimated blood loss of more than 1 L (n = 8), and postoperative ileus (n = 8). One patient treated by laparoscopic release required conversion for an aortic injury, which was treated by primary repair and splenectomy. Forty-six patients responded to the questionnaire with a mean follow-up of 8 ± 4 years. Initial symptom resolution or improvement was reported by 38 patients (83%), whereas 8 patients (17%) reported treatment failure. Seven of the 38 patients (18%) with initial treatment success reported symptom recurrence. The estimated 5-year freedom from symptoms was 67 ± 7%. All SF-12 HRQOL domains were significantly lower and below the average population range in symptomatic patients compared with those who were symptom free, in which all domains were within the average population range. The Gastrointestinal Quality of Life Index scores were also significantly lower in symptomatic patients. Forty respondents (87%) reported that they would still undergo operative management if given the choice, including all respondents who reported symptom recurrence. CONCLUSIONS: The operative management of MALS can be performed with a low rate of complications. Approximately two-thirds of respondents were free of symptoms 5 years after the procedure. Treatment success in symptom-free patients was associated with an improved HRQOL on par with the population average compared with symptomatic patients. The vast majority of respondents would opt to have the operation again if given a choice. However, patients should be well-informed about the possibility of failure to relieve symptoms and symptom recurrence.

Psoas muscle area and attenuation are highly predictive of complications and mortality after complex endovascular aortic repair.

OBJECTIVE: The present study evaluated the psoas muscle area and attenuation (radiodensity), quantified by computed tomography, together with clinical risk assessment, as predictors of outcomes after fenestrated and branched endovascular aortic repair (FBEVAR). METHODS: The present single-center study included 504 patients who had undergone elective FBEVAR for pararenal or thoracoabdominal aortic aneurysms. The clinical risk assessment included age, sex, comorbidities, body mass index, glomerular filtration rate, aneurysm size and extent, cardiac stress test results, ejection fraction, and American Society of Anesthesiologists (ASA) score. Preoperative computed tomography was used to measure the psoas muscle area and attenuation at the L3 level. The lean psoas muscle area (LPMA; area in cm2 multiplied by attenuation in Hounsfield units [HU]) was calculated by multiplying the area by the attenuation. The risk factors for 90-day mortality, major adverse events (MAEs), and long-term mortality were determined using multivariable analysis. MAEs included 30-day or in-hospital death, acute kidney injury, myocardial infarction, respiratory failure, paraplegia, stroke, and bowel ischemia. A novel risk stratification method was proposed according to the strongest predictors of mortality and MAEs on multivariable analysis. RESULTS: The 30-day mortality, 90-day mortality, and MAE rates were 2.0%, 5.6%, and 20%, respectively. The independent predictors of 90-day mortality were chronic obstructive pulmonary disease, chronic kidney disease, ASA score, and LPMA. The independent predictors of MAEs were aneurysm diameter, glomerular filtration rate, and LPMA. For long-term mortality, the independent predictors were chronic kidney disease, congestive heart failure, extent I-III thoracoabdominal aortic aneurysms, ASA score, and LPMA. The patients were stratified into three groups according to the ASA score and LPMA: low risk, ASA score II or LPMA >350 cm2HU (n = 290); medium risk, ASA score III and LPMA ≤350 cm2HU (n = 181); and high risk, ASA score IV and LPMA ≤350 cm2HU (n = 33). The 90-day mortality and MAE rates were 1.7% and 16% in the low-, 7.2% and 24% in the medium-, and 30% and 33% in the high-risk patients, respectively (P < .001 and P = .02, respectively). Patients with ASA score IV and LPMA <200 cm2HU, indicating sarcopenia (n = 14) had a 43% risk of death within 90 days. The 3-year survival estimates were 80% ± 3% for the low-, 70% ± 4% for the medium-, and 35% ± 9% for the high-risk patients (P < .001). The mean follow-up time was 3.1 ± 2.3 years. CONCLUSIONS: LPMA was a strong predictor of outcomes and the only independent predictor of both mortality and MAEs after FBEVAR. A high muscle mass was protective against complications, regardless of the ASA score. Risk stratification based on the ASA score and LPMA can be used to identify patients at excessively high operative risk.

Impact of intentional accessory renal artery coverage on renal outcomes after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to evaluate the impact of intentional coverage of accessory renal arteries (ARAs) on renal outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) for pararenal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We analyzed the clinical data of 296 patients enrolled in a prospective nonrandomized study to evaluate outcomes of FB-EVAR between 2013 and 2018. Patients with solitary kidneys, intraoperative loss of main renal arteries, or pre-existing stage V chronic kidney disease were excluded. Two groups were analyzed: patients with intentional ARA coverage; and controls, who had complete preservation. End points included 30-day mortality; major adverse events; acute kidney injury (AKI), defined by RIFLE criteria (Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease); renal function deterioration (RFD), defined by >30% decline in baseline estimated glomerular filtration rate; and presence of renal infarcts. RESULTS: There were 254 patients (184 male; mean age, 75 ± 8 years) included in the study, 56 (22%) with intentional ARA coverage and 198 controls, of whom 16 had ARA preservation. ARA diameter was smaller in patients who had intentional coverage vs preservation (2.7 ± 0.9 mm vs 3.4 ± 0.2 mm; P < .001). There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. All ARAs intended to be incorporated were successfully stented. Patients with ARA coverage had a higher frequency of kidney infarction (75% vs 25%; P < .001). There were two (1%) deaths within 30 days, both among controls. Patients with ARA coverage had more major adverse events (32% vs 19%; P = .04) because of higher incidence of AKI (21% vs 9%; P = .02). None of the 16 patients who had ARA preservation developed AKI. At 3 years, freedom from RFD was lower for patients who had ARA coverage compared with controls (55% ± 9% vs 76% ± 5%; log-rank, P = .02). By multivariate analysis, predictors of AKI were ARA coverage (odds ratio, 2.8; 95% confidence interval [CI], 1.2-6.2; P = .01) and estimated blood loss >1 L (odds ratio, 3.8; 95% CI, 1.2-12.3; P = .03). Postoperative AKI (hazard ratio [HR], 4.4; 95% CI, 2.4-8.1; P < .001), renal reintervention for stenosis (HR, 3.2; 95% CI, 1.6-6.7; P = .002), aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.06; P < .001), and ARA coverage (HR, 2.0; 95% CI, 2.4-8.1; P = .02) were predictors of RFD. CONCLUSIONS: Intentional ARA coverage during FB-EVAR was associated with a threefold increase in AKI and with lower freedom from RFD. Factors associated with RFD included postoperative AKI, renal reinterventions for stenosis, and ARA coverage. Incorporation of ARAs during FB-EVAR, when it is technically feasible, helps decrease risk of AKI and RFD.

Perceptual Assessment and Acoustic Voice Analysis as Screening Tests for Vocal Fold Paresis After Thyroid or Parathyroid Surgery.

BACKGROUND: The aim of this study was to evaluate the reliability of clinician-based perceptual assessment of voice and computerized acoustic voice analysis as screening tests for vocal fold paresis or paralysis (VFP) after thyroid and parathyroid surgery. METHODS: This was a prospective study of 181 patients undergoing thyroid or parathyroid procedure with pre and postoperative laryngoscopic vocal fold inspection, perceptual voice assessment using grade, roughness, breathiness, asthenia, and strain (GRBAS) scale and acoustic voice analysis using the multi-dimensional voice program (MDVP). Patients were divided into 2 groups for comparison; those with new postoperative VFP and those without. Potential screening tools were evaluated using the receiving operating characteristic (ROC) analysis. RESULTS: Fourteen (6.6%) patients had a new postoperative VFP. Postoperative GRBAS scores were significantly (P < 0.05) higher in patients with VFP compared to those without. However, there were no statistically significant differences in MDVP values between the groups. Postoperative GRBAS grade score (cut off > 0) had the best sensitivity, 93%, for predicting VFP, but the specificity was only 50%. Postoperative jitter (cut off > 1.60) in MDVP had a good specificity, 90%, but only 50% sensitivity. Combining all the GRBAS and MDVP variables with P < 0.05 in the ROC analysis yielded a test with 100% sensitivity and 55% specificity. CONCLUSIONS: Physician-based perceptual voice assessment has a high sensitivity for detecting postoperative VFP, but the specificity is poor. The risk of VFP is low in patients with completely normal voice at discharge. However, routine laryngoscopy after thyroid and parathyroid surgery is still the most reliable exam for VFP screening.

Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial.

BACKGROUND: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. METHODS: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. FINDINGS: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. INTERPRETATIONS: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. FUNDING: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area.

Short-term outcomes of the t-Branch off-the-shelf multibranched stent graft for reintervention after previous infrarenal aortic repair.

OBJECTIVE: The purpose of this study was to evaluate the outcome of t-Branch (Cook Medical, Bloomington, Ind) stent graft for the treatment of thoracoabdominal and pararenal aortic aneurysms in patients who had previous infrarenal aortic repair. METHODS: A retrospective two-center study was undertaken. All consecutive patients who underwent endovascular repair using t-Branch stent graft after previous infrarenal aortic repair between January 2010 and August 2018 were included. Demographics, past medical history, cardiovascular risk factors, and intraoperative and perioperative details were recorded. Technical success and early (30-day) mortality, morbidity, target vessel patency, and presence of endoleak were analyzed. During the first year of follow-up, survival, freedom from reintervention, and patency rates were recorded. RESULTS: There were 32 patients (mean age, 74 ± 7 years; 81% male) included in the study; 24 (75%) patients had prior open surgical repair, and 8 (25%) patients had undergone standard endovascular aneurysm repair. The index operation was performed 9 ± 5 years earlier, including 10 ± 5 years for open surgical repair and 8 ± 6 years for endovascular aortic repair. The indication was progression of the disease in 26 patients (81%) and type IA endoleak in 6 patients (19%). The total number of target vessels incorporated was 117 arteries (3.8 ± 0.6 target vessels per patient). Eleven patients had only three vessels incorporated; celiac trunk was occluded in three patients, and eight patients had one functioning kidney. Technical success rate was 97% (31/32). There was a single technical failure in one patient who had a type IA endoleak after endovascular repair with suprarenal fixation. The stenotic right renal artery was not catheterized at the initial procedure, and retrograde access was achieved through a right subcostal incision 3 days later with successful completion of the repair. Early mortality rate was 13%, and spinal cord ischemia rate was 22% (7/32); four patients had permanent and three had transient neurologic deficits. Early target vessel patency was 100%, and the rate of any endoleak was 9% (3/32); two patients had type II endoleaks and one patient had type III endoleak. The mean follow-up was 5.4 ± 5.9 months. The cumulative survival rate was 82% and 73% at 6 and 12 months, respectively. The freedom from aorta-related mortality was 92% at 6 and 12 months. The cumulative freedom from reintervention during follow-up was 90% at 6 and 12 months. The overall target vessel patency rate was 100% and 97.5% at 6 and 12 months, respectively. CONCLUSIONS: The use of t-Branch off-the-shelf stent graft for the treatment of aortic disease in patients who had previous infrarenal aortic repair appears to be feasible, with acceptable early outcomes in terms of morbidity and mortality.

Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms.

OBJECTIVE: The objective of this study was to review the learning curve for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of 334 consecutive patients (255 males, mean age 75 ± 7 years) who underwent F-BEVAR between 2007 and 2016 in a single institution. Outcomes were analyzed in four quartiles of experience (Q1-Q4). Study outcomes included trends in patient characteristics, device design, procedural variables, 30-day mortality, and major adverse events (MAEs). RESULTS: There were 178 patients (53%) treated for pararenal aneurysms and 156 (47%) for TAAAs. During the study period, there was a statistically significant increase in the proportion of TAAAs and in the number of vessels incorporated. Despite this, there was a steady decrease in 30-day mortality (6% in Q1 to 0% in Q4; P < .04) and in the rate of MAEs (60% in Q1 to 29% in Q4; P<.001). By linear regression analysis, there was significant decline in estimated blood loss (1358 ± 1517 mL in Q1 to 486 ± 520 mL in Q4; P < .001), total operating time (325 ± 116 minutes in Q1 to 248 ± 92 minutes in Q4; P < .001), total fluoroscopy time (121 ± 59 minutes in Q1 to 85 ± 39 minutes in Q4; P < .001), contrast volume (201 ± 92 mL in Q1 to 160 ± 61 mL in Q4; P = .002), and radiation dose (4141 ± 2570 mGy in Q2 to 2543 ± 1895 mGy in Q4; P < .001). Independent predictors of MAEs were total operating time (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.3-1.8; P < .001), Society for Vascular Surgery total score (OR, 1.1; 95% CI, 1.02-1.2; P = .009), and quartile 1 (OR, 3.0; 95% CI, 1.7-5.2; P < .001). CONCLUSIONS: This study demonstrates significant improvement in perioperative mortality, MAEs, procedural variables, and secondary interventions in patients treated by F-BEVAR, despite the increase in complexity of aneurysm pathology during the study period. Also, better patient selection contributed to improve outcomes.

Outcomes of a novel upper extremity preloaded delivery system for fenestrated-branched endovascular repair of thoracoabdominal aneurysms.

OBJECTIVE: The aim of this study was to evaluate the feasibility and outcomes of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) using a novel low profile (LP) device with upper extremity preloaded guidewire system (PGS) and compare procedural metrics and outcomes with a standard multibranch stent graft (t-Branch; Cook Medical, Bloomington, Ind). METHODS: We reviewed the clinical data of 232 consecutive patients treated by fenestrated-branched endovascular aortic repair for TAAA and enrolled in a prospective nonrandomized trial between 2014 and 2017. Patients who had repair using t-Branch or patient-specific TAAA devices using upper extremity LP-PGS were included. End points were technical success, operative and fluoroscopic time, patient radiation exposure, time from arterial access to complete device deployment, total contrast volume, and 30-day rates of major adverse events (MAEs) and mortality. RESULTS: There were 54 patients, including 33 males (67%) and 21 females (33%), with a mean age of 73 ± 9 years old. Forty-nine patients (91%) had extent I-III and five patients (9%) had extent IV TAAAs. Device design was t-Branch in 24 patients (44%) and LP-PGS in 30 patients (56%). A total of 206 renal-mesenteric arteries were incorporated with no difference between groups (mean, 3.8 ± 0.6 target vessels/patient; P = .92). Patients treated by t-Branch device had larger mean aneurysm diameter (79 ± 16 vs 66 ± 10 mm; P = .0006). All patients had transbrachial approach. Technical success was achieved in all patients in both groups. Patients treated by LP-PGS devices had lower radiation dose (1250 ± 849 vs 3154 ± 2421 mGy; P = .003) and shorter operating time for complete device deployment (105 ± 42 vs 123 ± 34 minutes; P = .043). There was no difference in mean operative time (252 ± 69 vs 273 ± 56 minutes; P = .23), fluoroscopy time (82 ± 29 vs 96 ± 35 minutes; P = .08) or contrast volume (163 ± 59 vs 197 ± 75 mL; P = .07) comparing LP-PGS and t-Branch respectively. There was no 30-day or in-hospital mortality. There were no differences in MAEs, which occurred in 18 patients (33%) in both groups (P > .05). CONCLUSIONS: Endovascular TAAA repair using the standard or LP-PGS multibranch stent graft was associated with high technical success, no mortality, and a low rate of MAEs in this study. Patients treated by upper extremity LP-PGS had shorter time to complete device deployment, suggesting decreased technical demand with preloaded systems.

Outcomes of fenestrated-branched endovascular aortic repair in patients with a solitary functional kidney.

OBJECTIVE: The aim of this study was to evaluate outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal abdominal aortic aneurysms or thoracoabdominal aortic aneurysms (TAAAs) in patients with a solitary functional kidney (SFK). METHODS: We analyzed the outcomes of 287 consecutive patients (206 male; mean age, 74 ± 8 years old) enrolled in a prospective nonrandomized study to investigate use of F-BEVAR for treatment of patients with pararenal abdominal aortic aneurysms or TAAAs between 2013 and 2018. Outcomes were analyzed in patients with solitary kidney (functional or congenital) and compared with control patients who had two functioning kidneys. Acute kidney injury (AKI) was defined using Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease criteria, and renal function deterioration (RFD) was defined by a decline in estimated glomerular filtration the estimated glomerular filtration rate of more than 30% from baseline. End points included 30-day mortality and major adverse events, AKI, freedom from RFD, and patient survival. RESULTS: There where 30 patients (10%) with a SFK and 257 patients with two functioning kidneys. Patients with a SFK were younger and had significantly (P < .05) higher baseline creatinine (+0.3 mg/dL), lower estimated glomerular filtration rate (-16 mL/minute/1.73 m2) and more often had stage III to V chronic kidney disease (73% vs 43%). There were no differences in cardiovascular risk factors and aneurysm extent. Technical success was achieved in 98.9% of patients with SFK and in 99.8% of controls (P = .10). At 30 days, there was no significant differences in mortality (0% vs 1%) and major adverse events (40% vs 24%; P = .08), including rates of AKI (20% vs 12%) and new-onset dialysis (3% vs 1%) between patients with a SFK and the control group, respectively. Mean follow-up was 18 ± 15 months. At 2 years, there was no difference (P = .36) in patient survival (92 ± 5% vs 84 ± 3%) and freedom from RFD (100 ± 0% vs 84 ± 3%) for patients with SFK and controls, respectively. Presence of a SFK was not a predictor for AKI or RFD. By multivariable analysis, estimated blood loss of more than 1 L (odds ratio [OR], 2.9; P = .04) and total fluoroscopy time (OR, 1.8; P = .05) were predictors for AKI, and postoperative AKI (OR, 4.9; P < .001), renal branch occlusion/stenosis (OR, 3.1; P = .001), and Crawford extent II TAAA (OR, 2.4; P = .007) were predictors for RFD. CONCLUSIONS: Despite the worse baseline renal function, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK as compared with patients with two functioning kidneys. Development of postoperative AKI is the most important predictor for RFD.

Outcomes of target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to determine the incidence rate, outcomes, and risk factors of target vessel-related endoleaks after fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal aneurysms or thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed consecutive patients treated by F-BEVAR between 2007 and 2017. Target vessel endoleaks were identified by computed tomography angiography (CTA). Follow-up included CTA and duplex ultrasound before discharge, at 2 months, at 6 months, and annually thereafter. Primary endoleaks were detected by predismissal CTA; secondary endoleaks were absent on the first CTA and were identified during follow-up. End points were spontaneous resolution of primary endoleaks, secondary interventions, and aneurysm rupture. Multivariable analyses were performed for risk factors of target vessel endoleaks and predictors of spontaneous resolution. RESULTS: A total of 382 patients (mean age, 75 ± 8 years; 75% male) underwent F-BEVAR for 195 pararenal aneurysms and 187 TAAAs with 1204 renal-mesenteric arteries targeted by 981 fenestrations and 223 directional branches. Fifty-two target vessel endoleaks were identified in 41 patients; 41 were type IIIC (interattachment), 10 were type IC (distal bridging stent sealing zone), and 1 was type IIIB (bridging stent fabric tear). Thirty-three patients (9%) had primary target vessel endoleaks in 41 target vessels (3%). Eight patients (2%) developed 11 secondary target vessel endoleaks. Directional branches were more prone to primary endoleaks (13/223 [6%]) in comparison to fenestrations (28/981 [3%]; P = .03). However, branch endoleaks resolved more often spontaneously (11/14 [79%]) compared with fenestration endoleaks (14/38 [37%]; P = .008). Other risk factors for target vessel endoleaks included inner aortic diameter ≥30 mm at the target vessel origin, four or more targeted vessels, TAAA (for primary endoleaks), and physician-modified endograft (for secondary endoleaks). Four patients with primary endoleaks underwent successful reintervention before discharge, and 29 were observed with a mean follow-up of 24 ± 21 months. Of the 41 primary endoleaks, 25 resolved spontaneously in 20 patients (61%) at first follow-up with no recurrences. Of the observed endoleaks, 11 persisted in 9 patients, and 8 of those endoleaks were treated in 7 patients. All secondary target vessel endoleaks required reintervention. There was one possible aneurysm rupture attributed to persistent secondary target vessel endoleak. CONCLUSIONS: Target vessel endoleak on CTA at discharge occurs in 1 of 10 patients treated by F-BEVAR. Of these, two-thirds resolve spontaneously, especially those affecting directional branches. Among patients with a persistent endoleak, endovascular reintervention is usually successful and aneurysm rupture is rare.

Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The objective of this study was to evaluate outcomes of directional branches using self-expandable stent grafts (SESGs) or balloon-expandable stent grafts (BESGs) during fenestrated-branched endovascular aneurysm repair of thoracoabdominal aortic aneurysms. METHODS: Patients treated by fenestrated-branched endovascular aneurysm repair were enrolled in a prospective study from 2014 to 2018. We included in the analysis patients who had target vessels incorporated by directional branches using either SESG (Fluency [Bard, Covington Ga] or Gore Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) or BESG (Gore VBX). Target artery instability (TAI) was defined by a composite of any stent stenosis, separation, or type IC or type IIIC endoleak requiring reintervention and stent occlusion, aneurysm rupture, or death due to target artery complication. End points included technical success, target artery patency, freedom from TAI, freedom from type IC or type IIIC endoleak, and freedom from target artery reintervention. RESULTS: There were 126 patients (61% male; mean age, 73 ± 8 years) included in the study. A total of 335 renal-mesenteric arteries were targeted by directional branches using SESGs in 62 patients and 176 arteries or BESGs in 54 patients and 159 arteries. Patients in both groups had similar thoracoabdominal aortic aneurysm classification and aneurysm and target artery diameter, but SESG patients had significantly (P < .05) shorter stent length (-7 mm) and larger stent diameter (+1 mm) and more often had adjunctive bare-metal stents (72% vs 15%). Technical success was achieved in 99% of patients, with one 30-day death (0.7%). Mean follow-up was significantly longer among patients treated by SESGs compared with BESGs (23 ± 12 months vs 8±8 months; P < .0001). TAI occurred in 27 directional branches (8%), including 11 type IC endoleaks (2 SESGs, 9 BESGs), 10 stenoses (3 SESGs, 7 BESGs), 4 occlusions (3 SESGs, 1 BESGs), 4 type IIIC endoleaks (2 SESGs, 2 BESGs), and 1 stent separation (SESG), resulting in 20 target artery reinterventions in 16 patients (5 SESGs and 11 BESGs). At 1 year, SESGs had higher primary patency (97% ± 2% vs 96% ± 2%; P = .004), freedom from TAI (96% ± 2% vs 88% ± 3%; P < .0001), freedom from type IC or type IIIC endoleaks (98% ± 1% vs 92% ± 3%; P = .0004), and freedom from target artery reinterventions (98% ± 1% vs 88% ± 4%; P < .0001) compared with BESGs. There was no difference in secondary patency for SESGs and BESGs (98% ± 1% vs 99% ± 1%; P = .75). Factors associated with TAI were large stent diameter (odds ratio, 0.6; P < .0001) and use of VBX stent graft (odds ratio, 6.5; P < .0001). CONCLUSIONS: Directional branches were associated with high technical success and low rates of stent occlusion, independent of stent type. However, primary patency, freedom from TAI, and freedom from type IC or type IIIC endoleaks was lower for BESGs compared with SESGs.

Prospective nonrandomized study to evaluate cone beam computed tomography for technical assessment of standard and complex endovascular aortic repair.

OBJECTIVE: The objective of this study was to analyze the utility of cone beam computed tomography (CBCT) for technical assessment of standard and complex endovascular aneurysm repair (EVAR). METHODS: Data of consecutive patients who underwent standard or complex EVAR in 2016 and 2017 at our institution were entered into a prospective database and analyzed retrospectively. There were 154 patients (126 male; mean age, 74 ± 8 years) enrolled in a prospective study between 2016 and 2017. A total of 170 aortic procedures were investigated, including 85 fenestrated-branched EVARs (F-BEVARs), 42 abdominal and thoracic EVARs, 32 EVARs with iliac branch devices, and 11 aorta-related interventions. Technical assessment was done using CBCT with and without contrast enhancement, digital subtraction angiography (DSA), and computed tomography angiography (CTA). Patients with stage 3B or stage 4 chronic kidney disease had CBCT without contrast enhancement. Radiation exposure (mean dose-area product), effective dose (ED), and amount of iodine contrast agent were analyzed. End points were presence of any endoleak, positive findings warranting possible intervention (stent kink or compression, type I or type III endoleak, dissection, thrombus), and need for secondary intervention. RESULTS: Radiation exposure and amount of iodine contrast agent were significantly higher (P < .05) for F-BEVAR compared with other aortic procedures (174±101 Gy∙cm2 vs 1135±113 Gy∙cm2 and 144±60 mL vs 122±49 mL). ED averaged 74±36 mSv for the aortic procedure, 18 ± 18 mSv for fluoroscopy, 7 ± 7 mSv for DSA acquisition, 15±7 mSv for CBCT, and 34±17 mSv for CTA imaging (P < .001). Endoleak detection was significantly higher (P < .001) with CBCT (53%) compared with DSA (14%) and CTA (46%). CBCT identified 52 positive findings in 43 patients (28%), higher for F-BEVAR compared with other aortic procedures (35% vs 16%; P = .01). Positive findings included stent compression or kink in 29 patients (17%), type I or type III endoleak in 16 patients (10%), and arterial dissection or thrombus in 7 patients (5%). Of these, 28 patients (18%) had positive findings that prompted an intraoperative (17%) or delayed intervention (1%). Another 15 patients (10%) with minor positive findings were observed with no clinical consequence. DSA alone would not have detected positive findings in 34 of 43 patients (79%), including 21 patients (49%) who needed secondary interventions. CTA diagnosed two (1%) additional endoleaks requiring intervention (one type IC, one type IIIC) that were not diagnosed by CBCT. Replacing DSA and CTA by CBCT would have resulted in 53% ± 13% reduction in amount of iodine contrast agent and 55% ± 12% reduction in ED (P < .05). CONCLUSIONS: CBCT reliably detected positive findings prompting immediate revisions in nearly one of five patients, with the highest rates among F-BEVAR patients. Detection of any endoleak was higher with CBCT compared with DSA or CTA, but most endoleaks were observed. DSA alone failed to detect positive findings warranting revisions.

Cerebrospinal fluid drainage complications during first stage and completion fenestrated-branched endovascular aortic repair.

OBJECTIVE: To determine the rates and risk factors of complications related to cerebrospinal fluid drainage (CSFD) during first stage and completion fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms. METHODS: We reviewed the outcomes of 293 consecutive patients enrolled in a prospective, nonrandomized study to investigate outcomes of F-BEVAR between 2013 and 2018. Patients who received CSFD during first-stage thoracic endovascular aortic repair, index F-BEVAR, or completion of temporary aneurysm sac perfusion procedures were included in the analysis. CSFD complications were graded as severe or moderate if they were life threatening, escalated the level of care, or prolonged the hospital stay. Presence of substantial degenerative lumbar disease (DLD) was identified based on review of preoperative computed tomography. End points included technical difficulties during CSFD placement and CSFD-related complications. RESULTS: A total of 187 patients (mean age, 73 ± 8 years; 70% male) treated for 20 pararenal and 167 thoracoabdominal aortic aneurysms received CSFD in 240 procedures, including 51 first-stage thoracic endovascular aortic repairs, 184 index F-BEVARs, and 5 completion temporary aneurysm sac perfusion procedures. Nineteen patients (10%) had 22 CSFD-related complications after 21 aortic procedures (9%). Complications were graded as severe to moderate in 17 patients (9%). There were 12 patients (6%) with intracranial hypotension, including three (2%) who had intracranial hemorrhage and nine (5%) with post dural puncture headache requiring blood patches in six. Another six patients (3%) developed spinal hematomas resulting in paraplegia in two (1%) and transient paraparesis in two (1%). One patient had CSF leakage from the puncture site (no intervention required). Four patients had bleeding during attempted drain placement, which required postponement of F-BEVAR. Technical difficulties were experienced in 57 drain insertions (24%), more often in patients with DLD than in those without DLD (35/113 [31%] vs 22/121 [18%]; P = .03). Fluoroscopic guidance was used in 44 drain placements (18%) with a lower rate of technical difficulties compared with the blind approach (9% vs 28%; P = .01). There was a statistically nonsignificant trend toward more complications in patients with technical challenges (14% vs 7%; P = .10). Of 13 study patients who developed spinal cord injuries during aortic procedures, 4 (31%) were attributed to CSFD. CONCLUSIONS: Although CSFD is widely used to prevent ischemic spinal cord injury during complex aortic repair, the risk of major CSFD-related complications is not negligible and should be carefully weighed against its potential benefits. One-third of spinal cord injuries were caused by CSF drain placement. The use of fluoroscopic guidance may decrease the risk of CSFD-related complications.