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We assessed the impact of probiotics on outcomes related to caries in children and/or adolescents without underlying systemic diseases. We performed a comprehensive meta-analysis of randomised controlled trials (RCTs). Searches were performed in Embase, PubMed, Scopus and Web of Science until March 2023 for RCTs assessing probiotics with a minimum intake duration of 0.2 months vs. control (no treatment or placebo) and reporting at least one primary or secondary outcome. Primary outcomes were number of carious, Streptococcus mutans count, and Lactobacillus count; secondary outcomes were bacterial plaque index, gingival index, salivary pH, and bleeding index. We performed meta-analyses with random effects models and the inverse variance method. Effects were described as mean difference (MD) with their 95% confidence intervals (95%CI). The risk of bias was assessed with the RoB 2.0 tool. The GRADE methodology was used to assess the quality of evidence (QoE). Nineteen RCTs were included (n = 2622), with a follow-up range of 0.2 to 108 months. Probiotics had no effect on reduction of dental caries (MD -0.24 carious pieces, 95%CI -0.72 to 0.23; I2 = 52%, low QoE) or Lactobacillus count (MD -0.78 CFU/mL, 95%CI -1.65 to 0.09; I2= 52%, very low QoE) vs. control. However, probiotics probably reduced S. mutans count vs. control (MD -0.40 CFU/mL, 95%CI -0.57 to -0.24; I2 = 11%, moderate QoE). Probiotics had no effect on bacterial plaque index (MD 0.21 units of bacterial plaque, 95%CI -0. 55-0.96; I2 = 80%, very low QoE), gingival index (MD 0.04 units of gingival index, 95%CI -0.18 to 0.27; I2= 0%, low QoE), and salivary pH (MD -0.12 pH units, 95%CI -0.72 to 0.48; I2 = 92%, very low QoE) vs. control. Probiotics were found to likely reduce S. mutans counts. However, no significant effect of probiotics was observed in reducing other outcomes compared to the control group., Competing Interests: Conflict interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Clinician recognition of nonadherence is generally low. Tools that clinicians have used to assess medication adherence are self-reported adherence instruments that ask patients questions about their medication use experience. There is a need for more structured reviews that help clinicians comprehensively distinguish which tool might be most useful and valuable for their clinical setting and patient populations., Objectives: This systematic review aimed to (1) identify validated, self-reported medication adherence tools that are applicable to the primary care setting and (2) summarize selected features of the tools as an assessment of clinical feasibility and applicability., Methods: The investigators systematically reviewed MEDLINE via Ovid, Embase via Ovid, International Pharmaceutical Abstracts, and CINAHL from inception to December 1, 2020. Investigators independently screened 3394 citations, identifying 43 articles describing validation parameters for 25 unique adherence tools. After screening each tool, 17 tools met the inclusion criteria and were qualitatively summarized., Results: Findings highlight 25 various tool characteristics (i.e., descriptions, parameters and diseases, measures and validity comparators, and other information), which clinicians might consider when selecting a self-reported adherence tool with strong measurement validity that is practical to administer to patients. There was much variability about the nature and extent of adherence measurement. Considerable variation was noted in the objective measures used to correlate to the self-reported tools' measurements. There were wide ranges of correlation between self-reported and objective measures. Several included tools had relatively low to moderate criterion validities. Many manuscripts did not describe whether tools were associated with costs, had copyrights, and were available in other languages; how much time was required for patients to complete self-report tools; and whether patient input informed tool development., Conclusion: There is a critical need to ensure that adherence tool developers establish a key list of tool characteristics to report to help clinicians and researchers make practical comparisons among tools., (Copyright © 2022 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: There is conflicting evidence about the use of biomarkers to diagnose left atrial thrombus in patients with atrial fibrillation., Objective: The purpose of this study was to assess the diagnostic accuracy of D-dimer to detect left atrial thrombus in patients with atrial fibrillation., Methods: We searched 4 electronic databases from inception to December 16, 2020. The reference standard was left atrial thrombus detected by transesophageal echocardiography. Study quality was assessed with the Quality Assessment of Diagnostic Accuracy Studies 2 tool. We used a bivariate model to calculate the pooled sensitivity and specificity with their 95% confidence intervals (CIs). The optimal cutoff and predictive values were also estimated., Results: Eleven cross-sectional studies involving 4380 patients were included. The median prevalence of left atrial thrombus was 12%. In 7 studies, the pooled sensitivity of D-dimer at 500 ng/mL was 50% (95% CI 26%-74%) and the pooled specificity was 88% (95% CI 76%-95%). The pooled sensitivity of age-adjusted D-dimer was 36% (95% CI 14%-66%) and the pooled specificity was 99% (95% CI 96%-99%) in 2 studies. The optimal cutoff of D-dimer was 390 ng/mL in 10 studies with a pooled sensitivity of 68% (95% CI 44%-85%) and a pooled specificity of 73% (95% CI 54%-86%). The positive and negative predictive values were 21.8% and 95.4%, respectively. The risk of bias was low or unclear for all domains. Concerns about applicability were low for almost all studies., Conclusion: Our meta-analysis suggests that D-dimer has the potential to be useful to rule out left atrial thrombus in patients with atrial fibrillation., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: There is conflicting evidence about the efficacy of statin use in regard to clinical outcomes in patients with coronavirus disease 2019 (COVID-19). A systematic review and meta-analysis was performed to examine the effect of statin use on mortality in COVID-19 patients., Methods: The electronic databases were searched, from inception to March 3, 2021. Unadjusted and adjusted effect estimates with their 95% confidence intervals (95% CI) were pooled using random-effects models., Results: Twenty-five cohort studies involving 147 824 patients were included. The mean age of the patients ranged from 44.9 to 70.9 years; 57% of patients were male and 43% were female. The use of statins was not associated with mortality when applying the unadjusted risk ratio (uRR 1.16, 95% CI 0.86-1.57; 19 studies). In contrast, meta-analyses of the adjusted odds ratio (aOR 0.67, 95% CI 0.52-0.86; 11 studies) and adjusted hazard ratio (aHR 0.73, 95% CI 0.58-0.91; 10 studies) showed that statins were independently associated with a significant reduction in mortality. Subgroup analyses showed that only chronic use of statins significantly reduced mortality according to the adjusted models., Conclusions: The use of statins was found to be associated with a lower risk of mortality in COVID-19 patients based on adjusted effects of cohort studies. However, randomized controlled trials are still needed to confirm these findings., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Associations between dietary fats and mortality are unclear., Methods: We evaluated the relationship between quartiles of total fat, mono-unsaturated (MUFA), polyunsaturated (PUFA) and saturated fatty acid (SFA) consumption, and all-cause, coronary heart disease (CHD), stroke, and type 2 diabetes (T2D)-associated mortality in 24,144 participants from the National Health and Nutrition Examination Surveys (NHANES) 1999-2010. We added our results to a meta-analysis based on searches until November 2018., Results: In fully adjusted Cox-proportional hazard models in our prospective study, there was an inverse association between total fat (HR: 0.90, 95% confidence interval 0.82, 0.99, Q4 vs Q1) and PUFA (0.81, 0.78-0.84) consumption and all-cause mortality, whereas SFA were associated with the increased mortality (1.08, 1.04-1.11). In the meta-analysis of 29 prospective cohorts (n = 1,164,029) we found a significant inverse association between total fat (0.89, 0.82-0.97), MUFA (0.94, 0.89-0.99) and PUFA (0.89, 0.84-0.94) consumption and all-cause mortality. No association was observed between total fat and CVD (0.93, 0.80-1.08) or CHD mortality (1.03 0.99-1.09). A significant association between SFA intake and CHD mortality (1.10, 1.01-1.21) was observed. Neither MUFA nor PUFA were associated with CVD or CHD mortality. Inverse associations were observed between MUFA (0.80, 0.67-0.96) and PUFA (0.84, 0.80-0.90) intakes and stroke mortality., Conclusions: We showed differential associations of total fat, MUFA and PUFA with all-cause mortality, but not CVD or CHD mortalities. SFA was associated with higher all-cause mortality in NHANES and with CHD mortality in our meta-analysis. The type of fat intake appears to be associated with important health outcomes., (Copyright © 2020 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

When a review is performed following predefined steps (ie, systematically) and its results are quantitatively analyzed, it is called meta-analysis. Publication of meta-analyses has increased exponentially in pubmed.gov; using the key word "meta-analysis," 1,473 titles were yielded in 2007 and 176,704 on January 2020. Well-designed and reported meta-analyses provide valuable information for clinicians, researchers, and policymakers. The aim of this study was to provide CHEST peer reviewers, as well as authors and researchers in training, with tools that can help to improve the quality and timeliness of journal reviews, as well as the quality of the meta-analyses submitted. This article also is intended to be a practical guide to inform authors about the key features of meta-analyses to be considered when producing their review., (Copyright © 2020 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Maternal vitamin D deficiency has been associated with an increased risk for preeclampsia. Despite this, the current evidence regarding the efficacy of vitamin D supplementation in preventing preeclampsia is controversial. To assess the impact of vitamin D supplementation on the risk of preeclampsia, we performed a systematic review of the literature and a meta-analysis of the available randomized clinical trials (RCTs)., Methods: The primary outcome was preeclampsia. Subgroup analyses were carried out considering the timing of the supplementation, type of intervention and the study design. Meta-regression analysis, including the amount of vitamin D and maternal age, were planned to explore heterogeneity (PROSPERO database registration number: CRD42019119207)., Results: Data were pooled from 27 RCTs comprising 59 arms, which included overall 4777 participants, of whom 2487 were in the vitamin D-treated arm and 2290 in the control arm. Vitamin D administration in pregnancy was associated with a reduced risk of preeclampsia (odd ratio [OR] 0.37, 95% confidence interval [CI]: 0.26, 0.52; I 2  = 0%). If the vitamin D supplementation was started up to 20 weeks' gestation, the odds was a little lower (OR 0.35, 95% CI: 0.24, 0.50, p < 0.001). The effect was largely independent of the supplementation cessation (until delivery or not), type of intervention (vitamin D alone or in association with calcium), and study design. Increasing dose of vitamin D was associated with reduced incidence of preeclampsia (slope of log OR: -1.1, 95% CI: -1.73, -0.46; p < 0.001)., Conclusions: Results suggest that vitamin D supplementation may be useful in preventing preeclampsia. These data are especially useful for health-care providers who engage in the management of pregnant women at risk for preeclampsia. Our findings are a call for action to definitively address vitamin D supplementation as a possible intervention strategy in preventing preeclampsia in pregnancy., (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Turmeric extract or active component curcumin may have anti-inflammatory effects in people with chronic inflammatory diseases. The effect of turmeric or curcumin on a wide range of inflammatory markers has not been evaluated in a systematic review. We performed a systematic review of randomized controlled trials (RCTs) evaluating the effects of oral turmeric or curcumin on inflammatory markers (CRP, hsCRP, IL-1, IL-6, TNF) in patients with a wide range of chronic inflammatory diseases. Pubmed, EMBASE, Scopus, the Web of Science, and the Cochrane library were evaluated until June 2018. Random effects meta-analyses with inverse variance methods and stratified by turmeric or curcumin were performed. Effects were expressed as mean differences (MD) and their 95% confidence intervals (CI). Risk of bias of RCTs was evaluated with the Cochrane tool. Nineteen RCTs were identified; included patients had rheumatic diseases, advanced chronic kidney disease with hemodialysis, metabolic syndrome, and cardiovascular diseases. Turmeric was the intervention in 5 RCTs (n = 356) and curcumin/curcuminoids in 14 RCTs (n = 988). Follow up times ranged between 4 and 16 weeks. One RCT had high risk of bias. In comparison to controls, turmeric or curcumin did not significantly decrease levels of CRP (MD -2.71 mg/L, 95%CI -5.73 to 0.31, p = 0.08, 5 studies), hsCRP (MD -1.44 mg/L, 95%CI -2.94 to 0.06, p = 0.06, 6 studies), IL-1 beta (MD -4.25 pg/mL, 95%CI -13.32 to 4.82, p = 0.36, 2 studies), IL-6 (MD -0.71 pg/mL, 95%CI -1.68 to 0.25, p = 0.15), and TNF alpha (MD -1.23 pg/mL, 95%CI -3.01 to 0.55, p = 0.18, 7 studies). There were no differences between turmeric and curcumin interventions. High heterogeneity of effects was observed for all markers across studies, except hsCRP. Other inflammatory markers such as IL-1 alpha, TNF beta, IL-17, and IL-22 had scarce data. Turmeric or curcumin did not decrease several inflammatory markers in patients with chronic inflammatory diseases., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background & Aims: Several studies have examined the effect of vegetarian diets (VD) on metabolic syndrome (MetS) or its components, but findings have been inconsistent. The aim of this study was to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies to assess the association between VD and MetS or its components (systolic blood pressure [SBP], diastolic blood pressure [DBP], fasting glucose triglycerides, waist circumference [WC], HDL-cholesterol (HDL-C)) in adults., Methods: The Cochrane Library, EMBASE, PubMed, Web of Science, and Scopus were searched. RCTs, cohort studies and cross-sectional studies evaluating the effects of VD on MetS or its components in adults, with omnivore diet as control group, were included. Random effects meta-analyses stratified by study design were employed to calculate pooled estimates., Results: A total of 71 studies (n = 103 008) met the inclusion criteria (6 RCTs, 2 cohorts, 63 cross-sectional). VD were not associated with MetS in comparison to omnivorous diet (OR 0.96, 95% CI 0.50-1.85, p = 0.9) according to meta-analysis of five cross-sectional studies. Likewise, meta-analysis of RCTs and cohort studies indicated that consumption of VD were not associated with MetS components. Meta-analysis of cross-sectional studies demonstrated that VD were significantly associated with lower levels of SBP (mean difference [MD] -4.18 mmHg, 95%CI -5.57 to -2.80, p < 0.00001), DBP (MD -3.03 mmHg, 95% CI -4.93 to -1.13, p = 0.002), fasting glucose (MD -0.26 mmol/L, 95% CI -0.35to -0.17, p < 0.00001), WC (MD -1.63 cm, 95% CI -3.13 to -0.13, p = 0.03), and HDL-C (MD -0.05 mmol/L, 95% CI -0.07 to -0.03, p < 0.0001) in comparison to omnivorous diet. Heterogeneity of effects among cross-sectional studies was high. About, one-half of the included studies had high risk of bias., Conclusions: VD in comparison with omnivorous diet is not associated with a lower risk of MetS based on results of meta-analysis of cross-sectional studies. The association between VD and lower levels of SBP, DBP, HDL-C, and fasting glucose is uncertain due to high heterogeneity across the cross-sectional studies. Larger and controlled studies are needed to evaluate the association between VD and MetS and its components., (Copyright © 2018 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Introduction: Programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors show significant clinical activity in non-small-cell lung carcinoma (NSCLC). However, there is a relative lack of data on comparative efficacy of these drugs in the first-line setting versus chemotherapy-treated patients. We compared the efficacy and toxicity of these drugs in these 2 distinct groups of patients., Materials and Methods: Electronic databases (PubMed-Medline, EMBASE, Scopus) and major conference proceedings were systematically searched for all phase I to III clinical trials in NSCLC using PD-1/PD-L1 inhibitors. Objective response rate (ORR) and progression-free survival (PFS) data were collected and combined using DerSimonian and Laird random effects model meta-analysis. The I 2 statistic was used to assess heterogeneity., Results: Seventeen distinct trials (8 with treatment-naive patients [n = 937]; 14 with chemotherapy-treated patients [n = 3620]; 5 with separate treatment-naive and previously treated arms) were included. Treatment-naive patients had a statistically significant higher ORR (30.2%; 95% confidence interval [CI], 22.70-38.2) than patients previously treated with chemotherapy (ORR, 20.1%; 95% CI, 17.5-22.9; P = .02). No significant differences in PFS were observed between the 2 groups. Treatment-naive patients had statistically significant higher rates of all grade pneumonitis compared with previously treated patients (4.9%; 95% CI, 3.4-6.7 vs. 3.0%; 95% CI, 2.0-4.1; P = .04); however, no significant differences in any other immune-related adverse events were observed., Conclusion: PD-1/PD-L1 inhibitor therapy for advanced NSCLC has a significantly higher ORR and a higher rate of immune-mediated pneumonitis when used in the first-line setting compared with chemotherapy treated patients., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Smoking is an important risk factor for cardiovascular disease (CVD) morbidity and mortality. The impact of statin therapy on CVD risk by smoking status has not been fully investigated. Therefore we assessed the impact of statin therapy on CVD outcomes by smoking status through a systematic review of the literature and meta-analysis of available randomized controlled trials (RCTs). The literature search included EMBASE, ProQuest, CINAHL and PUBMED databases to 30 January 2016 to identify RCTs that investigated the effect of statin therapy on cumulative incidence of major CVD endpoints (e.g. non-fatal myocardial infarction, revascularization, unstable angina, and stroke). Relative risks (RR) ratios were calculated from the number of events in different treatment groups for both smokers and non-smokers. Finally 11 trials with 89,604 individuals were included. The number of smokers and non-smokers in the statin groups of the analyzed studies was 8826 and 36,090, respectively. The RR for major CV events was 0.73 (95% confidence interval [CI]: 0.67-0.81; p<0.001) in nonsmokers and 0.72 (95%CI: 0.64-0.81; p<0.001) in smokers. Moderate to high heterogeneity was observed both in non-smokers (I 2 =77.1%, p<0.001) and in smokers (I 2 =51.6%, p=0.024) groups. Smokers seemed to benefit slightly more from statins than non-smokers according to the number needed to treat (NNT) analysis (23.5 vs 26.8) based on RRs applied to the control event rates. The number of avoided events per 1000 individuals was 42.5 (95%CI: 28.9-54.6) in smokers and 37.3 (95%CI: 27.2-46.4) in non-smokers. In conclusion, this meta-analysis suggests that the effect of statins on CVD is similar for smokers and non-smokers, but in terms of NNTs and number of avoided events, smokers seem to benefit more although non-significantly., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Background: Programmed death 1 (PD-1) programmed death-ligand 1 (PD-L1) inhibitors show significant clinical activity in non-small cell lung carcinoma (NSCLC). However, they are often associated with potentially fatal immune-mediated pneumonitis. Preliminary reports of trials suggest a difference in the rate of pneumonitis with PD-1 and PD-L1 inhibitors. We sought to determine the overall incidence of pneumonitis and differences according to type of inhibitors and prior chemotherapy use., Methods: MEDLINE, Embase, and Scopus databases were searched up to November 2016. Rates of pneumonitis of any grade and grade ≥ 3 from all clinical trials investigating nivolumab, pembrolizumab, atezolizumab, durvalumab, and avelumab as single agents in NSCLC were collected. The incidence of pneumonitis across trials was calculated using DerSimonian-Laird random effects models. We compared incidences between PD-1 and PD-L1 inhibitors and between treatment naive and previously treated patients., Results: Nineteen trials (12 with PD-1 inhibitors [n = 3,232] and 7 with PD-L1 inhibitors [n = 1,806]) were identified. PD-1 inhibitors were found to have statistically significant higher incidence of any grade pneumonitis compared with PD-L1 inhibitors (3.6%; 95% CI, 2.4%-4.9% vs 1.3%; 95% CI, 0.8%-1.9%, respectively; P = .001). PD-1 inhibitors were also associated with higher incidence of grade 3 or 4 pneumonitis (1.1%; 95% CI, 0.6%-1.7% vs 0.4%; 95% CI, 0%-0.8%; P = .02). Treatment naive patients had higher incidence of grade 1 through 4 pneumonitis compared with previously treated patients (4.3%; 95% CI, 2.4%-6.3% vs 2.8%; 95% CI, 1.7%- 4%; P = .03)., Conclusions: There was a higher incidence of pneumonitis with use of PD-1 inhibitors compared with PD-L1 inhibitors. Higher rate of pneumonitis was more common in treatment naive patients., (Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

We aimed to elucidate the role of vitamin D supplementation on adipokines through a systematic review and a meta-analysis of randomized placebo-controlled trials (RCTs). The search included PUBMED, Scopus, Web of Science and Google Scholar through July 1st, 2015. Finally we identified 9 RCTs and 484 participants. Meta-analysis of data from 7 studies did not find a significant change in plasma adiponectin concentrations following vitamin D supplementation (mean difference [MD]: 4.45%, 95%CI: -3.04, 11.93, p=0.244; Q=2.18, I(2)=0%). In meta-regression, changes in plasma adiponectin concentrations following vitamin D supplementation were found to be independent of treatment duration (slope: 0.25; 95%CI: -0.69, 1.19; p=0.603) and changes in serum 25-hydroxy vitamin D [25(OH)D] levels (slope: -0.02; 95%CI: -0.15, 0.12; p=0.780). Meta-analysis of data from 6 studies did not find a significant change in plasma leptin concentrations following vitamin D supplementation (MD: -4.51%, 95%CI: -25.13, 16.11, p=0.668; Q=6.41, I(2)=21.97%). Sensitivity analysis showed that this effect size is sensitive to one of the studies; removing it resulted in a significant reduction in plasma leptin levels (MD: -12.81%, 95%CI: -24.33, -1.30, p=0.029). In meta-regression, changes in plasma leptin concentrations following vitamin D supplementation were found to be independent of treatment duration (slope: -1.93; 95%CI: -4.08, 0.23; p=0.080). However, changes in serum 25(OH)D were found to be significantly associated with changes in plasma leptin levels following vitamin D supplementation (slope: 1.05; 95%CI: 0.08, 2.02; p=0.033). In conclusion, current data did not indicate a significant effect of vitamin D supplementation on adiponectin and leptin levels., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Among patients with OSA, a higher number of medical morbidities are known to be associated with those who have obesity hypoventilation syndrome (OHS) compared with OSA alone. OHS can pose a higher risk of postoperative complications after elective noncardiac surgery (NCS) and often is unrecognized at the time of surgery. The objective of this study was to retrospectively identify patients with OHS and compare their postoperative outcomes with those of patients with OSA alone., Methods: Patients meeting criteria for OHS were identified within a large cohort with OSA who underwent elective NCS at a major tertiary care center. We identified postoperative outcomes associated with OSA and OHS as well as the clinical determinants of OHS (BMI, apnea-hypopnea index [AHI]). Multivariable logistic and linear regression models were used for dichotomous and continuous outcomes, respectively., Results: Patients with hypercapnia from definite or possible OHS and overlap syndrome are more likely to experience postoperative respiratory failure (OR, 10.9; 95% CI, 3.7-32.3; P < .0001), postoperative heart failure (OR, 5.4; 95% CI, 1.9-15.7; P = .002), prolonged intubation (OR, 3.1; 95% CI, 0.6-15.3; P = .2), postoperative ICU transfer (OR, 10.9; 95% CI, 3.7-32.3; P < .0001), and longer ICU (?-coefficient, 0.86; SE, 0.32; P = .009) and hospital (?-coefficient, 2.94; SE, 0.87; P = .0008) lengths of stay compared with patients with OSA. Among the clinical determinants of OHS, neither BMI nor AHI showed associations with any postoperative outcomes in univariable or multivariable regression., Conclusions: Better emphasis is needed on preoperative recognition of hypercapnia among patients with OSA or overlap syndrome undergoing elective NCS., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Studies suggest outpatient treatment or early discharge of patients with acute pulmonary embolism (aPE) is reasonable for those deemed to be at low risk of early mortality. We sought to determine clinical prediction rule accuracy for identifying patients with aPE at low risk for mortality., Methods: We performed a literature search of Medline and Embase from January 2000 to March 2014, along with a manual search of references. We included studies deriving/validating a clinical prediction rule for early post-aPE all-cause mortality and providing mortality data over at least the index aPE hospitalization but ≤ 90 days. A bivariate model was used to pool sensitivity and specificity estimates using a random-effects approach. Traditional random-effects meta-analysis was performed to estimate the weighted proportion of patients deemed at low risk for early mortality and their ORs for death compared with high-risk patients., Results: Forty studies (52 cohort-clinical prediction rule analyses) reporting on 11 clinical prediction rules were included. The highest sensitivities were observed with the Global Registry of Acute Coronary Events (0.99, 95% CI = 0.89-1.00), Aujesky 2006 (0.97, 95% CI = 0.95-0.99), simplified Pulmonary Embolism Severity Index (0.92, 95% CI = 0.89-0.94), Pulmonary Embolism Severity Index (0.89, 95% CI = 0.87-0.90), and European Society of Cardiology (0.88, 95% CI = 0.77-0.94) tools, with remaining clinical prediction rule sensitivities ranging from 0.41 to 0.82. Of these five clinical prediction rules with the highest sensitivities, none had a specificity > 0.48. They suggested anywhere from 22% to 45% of patients with aPE were at low risk and that low-risk patients had a 77% to 97% lower odds of death compared with those at high risk., Conclusions: Numerous clinical prediction rules for prognosticating early mortality in patients with aPE are available, but not all demonstrate the high sensitivity needed to reassure clinicians.

Background: Pulmonary embolism(PE)accounts for almost 40% of perioperative deaths after bariatric surgery.Placement of prophylactic inferior vena cava(IVC) filter before bariatric surgery to improve outcomes has shown varied results. We performed a meta-analysis to evaluate post- operative outcomes associated with the preoperative placement of IVC filters in these patients. Methods: A systematic review was conducted by three investigators independently in PubMed, EMBASE, the Web of Science and Scopus until February 28,2013.Our search was restricted to studies in adult patients undergoing bariatric surgery with and without IVC filters. Primary outcomes were postoperative deep vein thrombosis(DVT),pulmonary embolism (PE),and postoperative mortality. Meta-analysis used random effects models to account for heterogeneity,and Sidik- Jonkman method to account for scarcity of outcomes and studies. Associations are shown as Relative Risks(RR) and 95% Confidence Intervals(CI). Results: Seven observational studies were identified (n=102,767), with weighted average inci- dences of DVT(0.9%),PE(1.6%),and mortality(1.0%)for a follow-up ranging from 3 weeks to 3 months. Use of IVC filters was associated with an approximately 3-fold higher risk of DVT and death that was nominally significant for the former outcome, but not the latter (RR2.81,95%CI 1.33-5.97, p=0.007; and RR 3.27,95%CI0.78-13.64, p=0.1, respectively);there was no difference in the risk of PE(RR1.02,95%CI0.31-3.77,p=0.9). Moderate to high heterogeneity of effects was noted across studies. Conclusions: Placement of IVC filter before bariatric surgery Is associated with higher risk of postoperative DVT and mortality. A similar risk of PE inpatients with and without IVC filter placement cannot exclude a benefit, given the potential large imbalance in risk at baseline.Ran- domized trials are needed before IVC placement can be recommended. (SurgObesRelatDis 2015;11:268-269.) r 2015 American Society for Metabolic and Bariatric Surgery.

Background: While a positive family history (FH) is a known risk factor for developing an aneurysm, its association with the extent of disease has not been established. We evaluated the influence of a FH of aortic disease with respect to the pattern and distribution of aortic aneurysms in a given patient., Methods and Results: From November 1999 to November 2011, 1263 patients were enrolled in physician-sponsored endovascular device trials to treat aortic aneurysms. Of the 555 patients who were alive and returning for follow-up, we obtained 426 (77%) family histories. Three-dimensional imaging studies were used to identify the presence of aneurysms; 36% (155/426) of patients had a FH of aortic aneurysms and 5% (21/155) had isolated intracranial aneurysms. A logistic regression model was used to compare aortic morphology between patients with a positive or negative FH for aneurysms. Patients with a positive FH of aortic aneurysms were younger at their initial aneurysm (63 vs 70 years; P < .0001), more frequently had proximal aortic involvement (root: odds ratio [OR], 5.4; P < .0001; ascending: OR, 2.9; P < .001; thoracic: OR, 2.2; P = .01) with over 50% of FH patients ultimately developing suprarenal aortic involvement (P = .0001) and had a greater incidence of bilateral iliac artery aneurysm (OR, 1.8; P = .03)., Conclusions: FH is an important tool that provides insight into the expected behavior of the untreated aorta and has significant implications for the development of treatment strategies. These findings should be used to guide patient's management with regard to treatment, follow-up paradigms, genetic testing, and screening of other family members., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

In a systematic review and random-effects meta-analysis, we evaluated whether obesity is associated with postoperative atrial fibrillation (POAF) in patients undergoing cardiac operations. We selected 18 observational studies until December 2011 that excluded patients with preoperative AF (n=36,147). Obese patients had a modest higher risk of POAF compared with nonobese (odds ratio, 1.12; 95% confidence interval, 1.04 to 1.21; p=0.002). The association between obesity and POAF did not vary substantially by type of cardiac operation, study design, or year of publication. POAF was significantly associated with a higher risk of stroke, respiratory failure, and operative death., (Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Branched and fenestrated repair has been shown to be effective for treatment of complex aortic aneurysms. However, the long-term durability of branches is not well reported., Methods: Prospective data collected for all patients enrolled in a physician-sponsored investigational device exemption trial for branched and fenestrated endografts were analyzed. Retrospective review of imaging studies and electronic records was used to supplement the dataset. Incidences of branch stent secondary intervention, stent fracture, migration, branch-related rupture, and death were calculated. A time-to-event analysis was performed for secondary intervention for any branch. Univariable and multivariable analyses were performed to identify related variables. Branch instability, a composite outcome of any branch event, was reported as a function of exponential decay to capture the loss of freedom from complications over time., Results: Between the years 2001 and 2010, 650 patients underwent endovascular aortic repair with branched or fenestrated devices. Over 9 years of follow-up (mean [standard deviation], 3 [2.3] years), secondary procedures were performed for 0.6% of celiac, 4% of superior mesenteric artery (SMA), 6% of right renal artery, and 5% of left renal artery stents. Mean time to reintervention was 237 (354) days. The 30-day, 1-year, and 5-year freedom from branch intervention was 98% (95% confidence interval [CI], 96%-99%), 94% (95% CI, 92%-96%), and 84% (95% CI, 78%-90%), respectively. Death from branch stent complications occurred in three patients, two related to SMA thrombosis and one due to an unstented SMA scallop. Multivariable analysis revealed no factors as independent predictors of need for branch reintervention., Conclusions: Branches, after branched or fenestrated aortic repair, appear to be durable and are rarely the cause of patient death. The absence of long-term data on branch patency in open repair precludes comparison, yet the lower morbidity and mortality risk coupled with longer-term durability data will further alter the balance of repair options., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: This study determined the effect of pulmonary disease on outcomes after endovascular abdominal (EVAR) and endovascular thoracoabdominal aortic aneurysm (eTAAA) repair., Methods: A prospective study of high-risk patients undergoing EVAR and eTAAA repair between 1998 and 2009 was used to contrast clinical and endovascular outcomes between patients with (group 1) and without (group 2) chronic obstructive pulmonary disease (COPD). COPD patients were classified in accordance with the severity of their pulmonary disease using the Global Initiative for Chronic Obstructive Lung Disease criteria. Survival, morphologic changes, and complications were assessed using Cox models and life-table analyses. The cause and timing of deaths between the groups was compared., Results: Of 905 patients analyzed, 289 (32%) had COPD (group 1) and the remaining patients (group 2) did not have COPD. EVAR was performed in 334 patients (37%), and fenestrated or branched devices were used in the remaining 571 (63%). Group 1 patients were younger (73.5 ± 6.7 vs 75.6 ± 8.2 years), had a better glomerular filtration rate (67.8 ± 25.8 vs 61.0 ± 23.3 mL/min/1.73 m(2)), had higher hematocrits (41.6 ± 5.0 vs 40.5 ± 4.6), and had more extensive aneurysms. Mean follow-up was 39.5 ± 30.9 months. Early (3% vs 3%) and late (2% vs 1%) aneurysm-related deaths were similar between the two groups. Survival in group 1 depended on the severity of disease. Survival in patients with Global Initiative for Chronic Obstructive Lung Disease classification I and II was similar to group 2. Those with classifications III and IV demonstrated lower survival rates. Relevant pulmonary function test variables included a lower forced expiratory volume in 1 second and forced expiratory flow in the middle 50%, which were associated with decreased survival. Surrogate endovascular outcome analyses demonstrated that group 1 patients had fewer endoleaks (20% vs 25%; P = .05) and more rapid sac shrinkage rate (1.66 mm/y difference; P < .001)., Conclusions: The perioperative risk of death between COPD patients and non-COPD patients is eliminated when endovascular techniques are used. Long-term survival in COPD patients is most strongly related to the severity of their disease, and forced expiratory volume in 1 second and forced expiratory flow in the middle 50% are reasonable indicators of poor long-term outcomes. Morphologic changes after EVAR and eTAAA repair are more favorable in COPD patients, with a lower endoleak rate and faster sac shrinkage., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Proximal aortic dissections are life-threatening conditions that require immediate surgical intervention to avert an untreated mortality rate that approaches 50% at 48 hours. Advances in computed tomography (CT) imaging techniques have permitted increased characterization of aortic dissection that are necessary to assess the design and applicability of new treatment paradigms., Methods: All patients presenting during a 2-year period with acute proximal aortic dissections who underwent CT scanning were reviewed in an effort to establish a detailed assessment of their aortic anatomy. Imaging studies were assessed in an effort to document the location of the primary proximal fenestration, the proximal and distal extent of the dissection, and numerous morphologic measurements pertaining to the aortic valve, root, and ascending aorta to determine the potential for an endovascular exclusion of the ascending aorta., Results: During the study period, 162 patients presented with proximal aortic dissections. Digital high-resolution preoperative CT imaging was performed on 76 patients, and 59 scans (77%) were of adequate quality to allow assessment of anatomic suitability for treatment with an endograft. In all cases, the dissection plane was detectable, yet the primary intimal fenestration was identified in only 41% of the studies. Scans showed 24 patients (32%) appeared to be anatomically amenable to such a repair (absence of valvular involvement, appropriate length and diameter of proximal sealing regions, lack of need to occlude coronary vasculature). Of the 42 scans that were determined not to be favorable for endovascular repair, the most common exclusion finding was the absence of a proximal landing zone (n = 15; 36%)., Conclusions: Appropriately protocoled CT imaging provides detailed anatomic information about the aortic root and ascending aorta, allowing the assessment of which dissections have proximal fenestrations that may be amenable to an endovascular repair., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Endovascular repair of complex aortic aneurysms (CAAs) can be performed in high-risk individuals, yet is still associated with significant morbidity, including spinal cord ischemia, cardiac complications, and death. This analysis was undertaken to better define the cardiac risk for CAA., Methods: A prospective database of patients undergoing thoracoabdominal or juxtarenal aortic aneurysm repair with branched and fenestrated endografts was used to retrospectively determine the number of cardiac events, defined as myocardial infarction (MI), atrial fibrillation (AF), and ventricular arrhythmia (VA), that occurred ≤ 30 days of surgery. Postoperative serial troponin measurements were performed in 266 patients. Any additional available cardiac information, including preoperative echocardiography, physiologic stress tests, and history of cardiac disease, was obtained from medical records. The efficacy of preoperative stress testing and the association of various echo parameters were evaluated in the context of cardiac outcomes using univariable and multivariable logistic regression models., Results: Between August 2001 and December 2007, 395 patients underwent endovascular repair of a thoracoabdominal or juxtarenal aortic aneurysm. The incidence of AF, VA, and 30-day cardiac-related death was 9%, 3%, and 2%, respectively. Overall 30-day mortality was 6%. Univariable analysis showed the presence of mitral annulus calcification was associated with MI (odds ratio [OR], 3.5; 95% confidence interval [CI], 0.9-13.8; P = .07). Left atrium cavity area, ejection fraction, left ventricle mass, and left ventricular mass index were univariably associated with the presence of VA. Multivariable analysis showed only the left atrium cavity area was independently associated with VA (OR, 1.2; 95% CI, 1.0-1.5; P = .07). Stress test was done in 179 patients. Negative stress test results occurred in 152 (85%), of whom 9 (6%) sustained an MI during the 30-day perioperative course. MI occurred in 2 of the 27 patients (7%) who had a positive stress test result., Conclusions: Endovascular repair of CAA can be performed in high-risk individuals but is associated with significant cardiac risk. It remains difficult to risk stratify patients using preoperative stress testing. Echo evaluation may help to identify patients who may be more likely to develop ventricular arrhythmias in the postoperative period and thus warrant closer monitoring. Postoperative troponin monitoring of all patients undergoing repair of CAA is warranted given the overall risk of MI., (Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: In contrast to endovascular repair (EVAR), the absence of rigorous imaging follow-up after open surgical repair (OSR) has rendered the perception that late failure (LF) is rare. Better understanding of associated factors with LF will help define OSR follow-up paradigms and perhaps alter initial repair strategy to facilitate treatment of LF. The aim of this study is to evaluate aspects of LF requiring intervention after OSR., Methods: From 1998 to 2008, data were collected prospectively on 1097 patients who underwent an aortic endovascular repair. Patients undergoing intervention for LF contiguous with prior OSR were subjected to further analysis. The indication for reintervention was a maximal diameter >60 mm. Univariable and multivariable linear regression models were used to compare patients and disease variables (18 variables regarding age, comorbidities, family history, etiology, and extent) with time to LF., Results: LF of open surgical aneurysm repair was identified in 104 (9.5%) patients. Mean aneurysm diameter was 72 +/- 12 mm. Mean age at first repair and time between the two repairs were 61.4 +/- 10.0 and 10.8 +/- 6.0 years, respectively. When compared with the 993 other patients whose EVAR was their primary repair, LF patients were significantly younger at the time of their first repair (61.4 +/- 10.0 vs 74.1 +/- 9.6 years; P < .00001) and more frequently had a family history of aneurysms (20% vs 7%; P = .001). They were also more likely to have presented with dissection, renal insufficiency, and manifestations of atherosclerosis. On multivariable analysis, patients with an initial incomplete OSR (aneurysm located in another aortic segment but not treated at the time of the primary repair), more extensive aneurysms (those involving the descending thoracic or the thoracoabdominal aorta), and older patients experienced earlier LF (P < .00001, .002, and .001, respectively). Although we were incapable of determining the incidence of LF after OSR, 34% of patients presenting with LF were regional to our center., Conclusion: Aneurysmal disease is an ongoing process potentially involving the entire aorta. Segments that appear normal prior to OSR of EVAR may be vulnerable to LF. We identified several groups of patients following OSR who mandate more aggressive follow-up given their propensity to present with LF. The threshold and strategies guiding reintervention in the setting of LF is dependent upon many factors relating to the structure and the morphology of the aorta and implanted graft, the type of anastomosis, and patient comorbidities. Therefore, surgeons should consider LF treatment options when planning an aneurysm repair in an effort to optimize any later interventions, and have specifically tailored follow-up paradigms., (Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Long-term survival benefit contrasted with rupture risk should determine which patients are suitable for abdominal aortic aneurysm (AAA) intervention. Our aim was to develop a model capable of predicting long-term survival based on preoperative characteristics., Methods: A prospective cohort study using Cox regression modeling. We aimed to associate preoperative characteristics with long-term mortality, and create a predictive nomogram, which was then externally validated on an independent cohort (697 patients) who underwent endovascular abdominal aortic aneurysm (AAA) repair., Results: We pooled the results of 412 patients undergoing endovascular repair of infrarenal and juxtarenal aneurysm who were high risk (average Glasgow aneurysm scores of 72.8 [SD 10.4]). Despite anatomic differences, there were no statistically significant differences in perioperative or long-term outcomes between infrarenal and juxtarenal aneurysms (log rank test, P = .5). Data from this group (64% infrarenal aneurysms and 36% juxtarenal aneurysms) were randomly and evenly split into a model development and test group. Independent predictors of mortality included in the model are age, aneurysm diameter, history of peripheral artery disease, chronic obstructive pulmonary disease (COPD), or congestive heart failure, requirement for supplemental home oxygen, and use of salicylates. Internal validation reveals good calibration and discriminative ability (c-statistic 0.68 [95% confidence interval 0.65-0.71]). External validation confirms good calibration., Conclusions: In the context of acceptable perioperative results, long-term mortality risk can be predicted in endovascular AAA repair and must be balanced against risk of rupture to determine which patients should be offered treatment., (Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Inconsistent information exists about factors associated with daytime hypercapnia in obese patients with obstructive sleep apnea (OSA). We systematically evaluated these factors in this population., Methods: We included studies evaluating the association between clinical and physiologic variables and daytime hypercapnia (Paco(2), >or= 45 mm Hg) in obese patients (body mass index [BMI], >or= 30 kg/m(2)) with OSA (apnea-hypopnea index [AHI], >or= 5) and with a < 15% prevalence of COPD. Two investigators conducted independent literature searches using Medline, Web of Science, and Scopus until July 31, 2008. The association between individual factors and hypercapnia was expressed as the mean difference (MD). Random effects models were used to account for heterogeneity., Results: Fifteen studies (n = 4,250) fulfilled the selection criteria. Daytime hypercapnia was present in 788 patients (19%). Age and gender were not associated with hypercapnia. Patients with hypercapnia had higher BMI (MD, 3.1 kg/m(2); 95% confidence interval [CI], 1.9 to 4.4) and AHI (MD, 12.5; 95% CI, 6.6 to 18.4) than eucapnic patients. Patients with hypercapnia had lower percent predicted FEV(1) (MD, -11.2; 95% CI, -15.7 to -6.8), lower percent predicted vital capacity (MD, -8.1; 95% CI, -11.3 to -4.9), and lower percent predicted total lung capacity (MD, -6.4; 95% CI, -10.0 to -2.7). FEV(1)/FVC percent predicted was not different between hypercapnic and eucapnic patients (MD, -1.7; 95% CI, -4.1 to 0.8), but mean overnight pulse oximetric saturation was significantly lower in hypercapnic patients (MD, -4.9; 95% CI, -7.0 to -2.7)., Conclusions: In obese patients with OSA and mostly without COPD, daytime hypercapnia was associated with severity of OSA, higher BMI levels, and degree of restrictive chest wall mechanics. A high index of suspicion should be maintained in patients with these factors, as early recognition and appropriate treatment can improve outcomes.

Objectives: To assess outcomes and develop duplex scan criteria that will reliably determine the luminal status of covered and uncovered renal stents following fenestrated and branched endovascular repair., Methods: A prospective database of patients treated with fenestrated and branched endografts between 2001 and 2006 was reviewed. All patients with evidence of renal artery pathology including duplex scan assessed peak systolic velocity (PSV) <50 or >200 cm/s, renal aortic ratio (RAR) >3.5, elevation of the serum creatinine >30%, computed tomography (CT) evidence of renal stenosis underwent further analyses including medical chart review, and a review of CT and duplex scan imaging data. Correlations of ultrasound scan, CT, angiographic, and clinical outcomes were conducted and receiver operator curve (ROC) analysis was performed. Freedom from stenosis or occlusion was determined by Kaplan-Meier analysis with differences assessed by log rank tests., Results: A total of 518 renal arteries were treated with uncovered or covered renal stents (287 patients). Mean follow-up was 25 months. The estimated freedom from stenosis at 12, 24, and 36 months were 95% (95% confidence interval [CI] 93-98), 92% (89-96), and 89% (85-93) for uncovered stents, and 98% (96-100), 97% (95-100), and 95% (91-100) for covered stents (log rank P = .04). Secondary interventions were performed in 20% of the patients who developed stenoses. Only one of the detected stenoses that was not treated with a secondary intervention progressed to occlusion. Duplex scan criteria derived from ROC analysis correlating with curved planar reconstruction (CPR) from axial imaging data calculated a 60-99% in-stent stenosis to be associated with a PSV >280 cm/s or RAR >4.5. Occlusions were best identified by a mid renal artery PSV <57 cm/s in conjunction with an RAR <1.2., Conclusion: Revised ultrasound scan criteria have been developed to improve the sensitivity and specificity of non-invasive interrogation of renal stents following endovascular aneurysm repair (EVAR). Covered renal stents are associated with a lower incidence of in-stent stenosis and are thus recommended over uncovered stents for use in fenestrated or branched endografts.

Purpose: Aneurysms involving the supra-aortic vessels are rare but carry serious risk of embolization, thrombosis, and rupture. We describe our experience with the diagnosis, treatment strategies, and outcomes in patients with extended follow-up., Methods: Data during a 17-year period (January 1990 to December 2007) was analyzed. We assessed age, gender, presenting symptoms, localization, pathologic diagnosis, type of procedures, complications, and survival., Results: A total of 74 patients were treated for supra-aortic aneurysms. Of all aneurysms treated, 63% were degenerative, 24% iatrogenic, 8% traumatic, 3% genetic, and 1% mycotic. The subclavian artery was most commonly affected (50%, 2/3 in the right side), followed by the common carotid (36%), internal carotid (10%), innominate (3%), and vertebral (1%). At the time of diagnosis, 52 patients (70%) were asymptomatic, but of those symptomatic 68% had an embolic event as a presenting symptom. Embolic episodes were more common in patients with smaller aneurysms (P < .006). Open surgery was performed in 77% of all cases, and the use of endovascular techniques became the predominant treatment modality over the last 4 years. Survival at 30 days was 100%. Five- and 10-year survival rates were 87% and 43%, respectively., Conclusion: Most cases of supra-aortic aneurysm are asymptomatic and embolization as opposed to rupture represents the greatest risk to the patient. Most cases can be detected prior to symptoms. Endovascular repair is an emerging alternative of treatment and, with the current development of appropriate devices, will likely form the mainstay of therapy in the near future.

Objective: Little data exist to support the durability of thoracic endovascular repair during prolonged periods of follow-up. This study examines the durability and long-term results with the Zenith TX1 and TX2 thoracic devices (Cook Inc, Bloomington, Ind) in high-risk patients., Methods: Data were collected prospectively from 2001 to 2007 on high-risk patients who presented with thoracic aneurysms, chronic aortic dissection, or fistulas treated with a Zenith thoracic device. Surgical modifications of proximal or distal landing zones were performed when necessary. Computed tomography follow-up scans were performed before discharge, at 1, 6, and 12 months, and yearly thereafter. Three-dimensional reconstruction software with central line of flow measurements was used to assess aortic morphologic characteristics. Kaplan-Meier analysis was used to assess survival, freedom from reintervention, predictive factors of poor outcome, and morphologic changes, including aneurysm sac behavior., Results: A total of 160 patients (44% women; mean age, 70) were treated for 130 thoracic aneurysms, 25 aortic dissections with aneurysm, 2 fistulas, and 3 symptomatic or aortic ruptures, or both. Mean follow-up was 36 months, and aneurysm size was 67 mm. Seventy-five patients (47%) had undergone prior aortic aneurysm repair. Surgical modifications were required to create adequate landing zones in 33% patients, including 28 elephant trunk/arch reconstruction, 22 carotid-subclavian bypasses, and seven visceral vessel bypasses. Iliac conduits were required in 31 patients. Early mortality (<30 days) occurred in 11 patients (6.9%). Overall mortality at 1 year was 16%. Aneurysm sac increase (>5 mm) requiring intervention was observed only in one patient in the settings of component separation and type III endoleak that was treated; the sac is now stable. Twenty-seven endoleaks were detected in 25 patients: 15 primary endoleaks (9.4%) <30 days and 12 secondary endoleaks (7.5%) >30 days. Secondary interventions were required in 42 patients (26%)., Conclusion: Endovascular treatment of thoracic aortic pathologies with the Zenith TX1 and TX2 devices is feasible and durable. The mid- to long-term results are encouraging, with acceptable low reintervention rates and with good survival within high-risk patients.