Occurrence Of Major Adverse Events Research Articles

The Association Between Preoperative Hemoglobin A1C and Postoperative Glycemic Variability on 30-Day Major Adverse Outcomes Following Isolated Cardiac Valvular Surgery.

Preoperative hemoglobin A1c (HbA1c) and postoperative glycemic variability predict major adverse events (MAEs) after coronary artery bypass grafting in a protocolized glycemic control setting. However, the influence of preoperative HbA1c and postoperative glycemic variability in isolated cardiac valvular surgery is unknown. In this study, we sought to establish (a) whether preoperative HbA1c could identify patients at increased risk of MAEs and (b) whether postoperative glycemic variability was associated with MAEs after isolated cardiac valvular surgery. Patients >18 years of age undergoing isolated valve surgery from January 2008 to December 2013 were enrolled in this prospective, single-center, observational cohort study with IRB approval. Patient demographics, intraoperative data, and postoperative MAEs were extracted from the institutional Society of Thoracic Surgery (STS) database. The primary outcome, MAEs, was a composite of in-hospital death, myocardial infarction, reoperations, sternal infection, cardiac tamponade, pneumonia, stroke, or renal failure. Glycemic variability in the postoperative period was assessed by the coefficient of variation. Patents were stratified by HbA1c levels (<6.5% or ≥6.5%) and assessed using multivariable logistic regression. Of the enrolled 763 patients, 109 (14.3%) had a preoperative HbA1c level ≥6.5%. Patients with HbA1c ≥6.5% were older (70 [63-79] vs 66 [56-75], P < .001) and had a higher incidence of dyslipidemia (83.5% vs 57.0%, P < .001) and congestive heart failure (39.5% vs 27.8%, P = .01). The calculated STS risk score for morbidity and mortality was also statistically higher in this group (0.18 [0.13-0.27] vs 0.13 [0.09-0.21], P < .001). The occurrence of MAEs was similar between the 2 groups (13.8% in HbA1c ≥6.5% vs 11.0% in HbA1c <6.5%, P = .40). Multivariate logistic regression analysis revealed that neither preoperative HbA1c ≥ 6.5% (odds ratio [OR] 1.48, 95% confidence interval [CI]: 0.78-2.82; P = .23) nor postoperative glycemic variability (CV per quartile; OR 1.05, 95% CI: 0.85-1.30; P = .67) was found to be associated with MAEs. An HbA1c ≥ 6.5% was associated with the increased glycemic variability in the postoperative period (0.173 [0.129-0.217] vs 0.141 [0.106-0.178], P < .0001). This study did not show an association between preoperative HbA1c and postoperative glycemic variability with MAEs after isolated cardiac valvular surgery. Specifically, lack of association between postoperative glycemic variability and MAEs is noteworthy and is in contrast to our previous finding in CABG patients. Future studies should focus a targeted glycemic variability reduction in CABG patients and evaluate the reduction in MAEs, without risk of employing a one-size fits all approach when approaching other cardiac procedures.

Clinical Outcomes of Patients Undergoing Rotational Atherectomy Followed by Drug-eluting Stent Implantation: A Single-center Real-world Experience.

Background:Rotational atherectomy (RA) is used to improve procedural success of percutaneous catheter interventions (PCIs) of complex and heavily calcified coronary lesions. We report the clinical experience and outcomes in our institution with the use of RA, followed by drug-eluting stent implantation.Materials and Methods:Data of 81 patients treated with PCI and adjunctive RA were analyzed. Clinical follow-up for the occurrence of major adverse events (MAEs) was obtained in all patients and correlated with significant variables using multivariate Cox proportional hazards analysis.Results:Mean age was 67.9 ± 9.2 years, 61.7% had diabetes, 20.9% had chronic kidney disease, and 48.1% had previous acute coronary syndrome (ACS). Mean SYNTAX score was 29.8 ± 12.2, with a 92.5% angiographic success rate achieved. In-hospital MAEs rate was 7.4% while mortality rate was 8.6%. On median follow-up of 12.2 months, incidence of MAEs of 13.5% with a 75% free incidence from MAEs at 34 months. Multivariate analysis revealed that a history of previous ACS, ejection fraction, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, SYNTAX score, burr to artery ratio, and attainment of angiographic success were significant predictors of MAEs.Conclusion:RA followed by drug-eluting stent implantation is a safe and effective method in improving procedural success as well as short- and long-term outcomes of PCI in our center. A combination of clinical and procedural factors is predictive for the occurrence of MAEs and should be taken into account in the application of this technique.

One-Year Outcomes of Endovascular Aneurysm Repair in High-Risk Patients Using the Endurant Stent-Graft

Purpose: To evaluate the outcome and survival of patients with extensive comorbid conditions after endovascular aneurysm repair (EVAR) and objectify which of 2 medical comorbidity classifications is more accurate in predicting adverse outcomes. Methods: All 1263 patients (mean age 73.1 years; 1129 men) treated using the Endurant Stent Graft system and entered in the prospective global postmarketing ENGAGE registry ( ClinicalTrials.gov identifier NCT00870051) were grouped using the American Society of Anesthesiologists (ASA) classification and the Society for Vascular Surgery/American Association for Vascular Surgery (SVS/AAVS) medical comorbidity grading system. Patients assigned to ASA III and IV and SVS/AAVS 2 and 3 categories were considered high risk. Primary outcome was 1-year all-cause mortality. Secondary outcomes included technical and clinical success, major adverse events (MAE), aneurysm rupture, endoleaks, and secondary endovascular procedures. One-year follow-up of the entire ENGAGE cohort was the endpoint of the study. Results: A total of 1263 patients were included. The overall technical success rate was high, the lowest being 97.4% in the ASA I group. The overall 30-day and 1-year Kaplan-Meier survival estimates were 98.7% and 92.5%, respectively. All cause 1-year mortality was higher in the ASA III and IV groups, but this did not reach statistical significance (5.2% and 5.7% for ASA I and II vs 9.0% and 9.9% for ASA III and IV, p=0.12). In the SVS/AAVS groups, 1-year all-cause mortality significantly increased with the SVS/AAVS score to 11.3% in the SVS/AAVS 3 group (p=0.002). There were significantly more MAEs in the SVS/AAVS 3 group at 1 year (p<0.001 for group 1 vs 3 and group 2 vs 3). Conclusion: Endovascular aneurysm repair has evolved, and high technical success and low mortality and morbidity can be achieved in high-risk patients. When treating high-risk patients, the perioperative risks should always be weighed against the expected gains. In contrast to the ASA classification, the SVS/AAVS medical comorbidity grading system is a useful tool to predict occurrence of MAEs and 1-year survival in patients undergoing EVAR.

Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices.

The aim of this study was to assess predictors of adverse 1-week outcomes and determine the effect of left atrial appendage (LAA) morphology following LAA closure (LAAC) with Amplatzer devices. Percutaneous LAAC is a valuable treatment option for stroke prevention in patients with atrial fibrillation. Determinants of procedural safety events with Amplatzer occluders are not well established, and the possibly interrelating effect of LAA anatomy is unknown. Between 2009 and 2014, 500 consecutive patients with atrial fibrillation ineligible or at high risk for oral anticoagulation underwent LAAC using Amplatzer devices. Procedure- and device-related major adverse events (MAEs) were defined as the composite of death, stroke, major or life-threatening bleeding, serious pericardial effusion, device embolization, major access-site vascular complication, or need for cardiovascular surgery within 7 days following the intervention. Patients (mean age 73.9 ± 10.1 years) were treated with Amplatzer Cardiac Plug (n= 408 [82%]) or Amulet (n= 92 [18%]) devices. Early procedural success was 97.8%, and MAEs occurred in 29 patients (5.8%). Independent predictors of MAEs included device repositioning (odds ratio: 9.13; 95% confidence interval: 2.85 to 33.54; p< 0.001) and left ventricular ejection fraction<30% (odds ratio: 4.08; 95% confidence interval: 1.49 to 11.20; p= 0.006), with no effect of device type or size. Angiographic LAA morphology, characterized as cauliflower (33%), cactus (32%), windsock (20%), or chicken wing (15%), was not associated with procedural success (p= 0.51) or the occurrence of MAEs (p= 0.78). In this nonrandomized study, procedural success of LAAC using Amplatzer devices was high. MAEs within 7 days were predicted by patient- and procedure-related factors. Although LAA morphology displayed substantial heterogeneity, outcomes were comparable across the spectrum of LAA anatomies.

Magnetic resonance imaging in patients with cardiac implanted electronic devices: focus on contraindications to magnetic resonance imaging protocols.

Magnetic resonance imaging (MRI) has been reported to be safe in patients with cardiac implantable electronic devices (CIED) provided a specific protocol is followed. The objective of this study was to assess whether this is also true for patients excluded from published protocols. A total of 160 MRIs were obtained in 142 consecutive patients with CIEDs [106 patients had an implantable cardioverter defibrillator (ICD) and 36 had a pacemaker implanted] using an adapted, pre-specified protocol. A cardiac MRI was performed in 95 patients, and a spinal/brain MRI was performed in 47 patients. Forty-six patients (32%) had either abandoned leads (n = 10), and/or were pacemaker dependent with an implanted ICD (n = 19), had recently implanted CIEDs (n = 1), and/or had a CIED device with battery depletion (n = 2), and/or a component of the CIED was recalled or on advisory (n = 32). No major complications occurred. Some device parameters changed slightly, but significantly, right after or at 1-week post-MRI without requiring any reprogramming. In one patient with an ICD on advisory, the pacing rate changed inexplicably during one of his two MRIs from 90 to 50 b.p.m. Using a pre-specified protocol, cardiac and non-cardiac MRIs were performed in CIED patients with pacemaker dependency, abandoned leads, or depleted batteries without occurrence of major adverse events. Patients with devices on advisory need to be monitored carefully during MRI, especially if they are pacemaker dependent.

Adding a New Anticoagulant or Antiplatelet Agent for Patient Receiving Aspirin after an Acute Coronary Syndrome?--Results from a Pairwise and Network Meta-Analysis of Randomized-Controlled Trials

Objectives: To synthesize the efficacy and safety outcomes from randomized-controlled trials (RCTs) regarding new oral anticoagulant, protease-activated receptor-1 (PAR-1) antagonist, and warfarin adjunctive to aspirin for patients after acute coronary syndrome (ACS) via pair-wise and network meta-analyses. Methods: A comprehensive literature search was performed in Embase, Medline, Cochrane Library Web of Knowledge, and Scopus. The pair-wise meta-analysis was undertaken respectively to each agent/treatment category via Revmen 5.1. In order to estimate the relative efficacy of each agent/treatment category whilst preserving the randomized comparisons within each trial, a Bayesian network meta-analysis was conducted in WinBUGS using both fixed- and random-effects model. Covariate analysis was performed to explore the effects of length of follow-up and age of subject on the final results. Results: In total, 23 RCTs were included in the meta-analysis. As shown by the results (OR,95%CI) for the pair-wise meta-analysis, new oral anticoagulants (0.85, [0.78, 0.93] and 3.04, [2.21, 4.19]), PAR-1 antagonists (0.80, [0.52, 1.22] and 1.55, [1.25, 1.93]) and warfarin (0.87, [0.74, 1.02] and 1.77, [1.46, 2.14]) might be able to provide better outcome in the incidences of major adverse events (MAE) but with higher bleeding risk comparing to aspirin treatment alone. Based on the model fit assessment, the random-effects model was adopted. The network meta-analysis (treatment effect comparing to aspirin lone) identified ximelagatran (-0.3044, [-0.8601, 0.2502]), dabigatran (-0.2144, [-0.8666, 0.4525]), rivoroxaban (-0.2179, [-0.5986, 0.1628]) and vorapaxar (-0.2272, [-0.81, 0.1664]) produced better improvements in MAE incidences whereas vorapaxar (0.3764, [-0.4444, 1.124]), warfarin (0.663, [0.3375, 1.037]), ximelagatran (0.7509, [-0.4164, 2.002]) and apixaban (0.8594, [-0.0049, 1.7]) produced less major bleeding events. The indirect comparisons among drug category (difference in incidence comparing to aspirin lone) showed new oral anticoagulants (-0.1974, [-0.284, -0.111]) and PAR-1 antagonists (-0.1239, [-0.215, -0.033]) to besuperior to warfarin (-0.1004, [-0.166, -0.035]) in the occurrences of MAE whereas PAR-1 antagonists (0.4292, [0.2123, 0.6476]) afforded better outcomes in major bleeding events against warfarin (0.5742, [0.3889, 0.7619]) and new oral anticoagulants (1.169, [0.8667, 1.485]). Conclusion: Based on the study results, we cannot recommend the routine administration of new oral anticoagulant as add-on treatment for patients after ACS. However, for ACS patients comorbid with atrial fibrillation, new oral anticoagulant might be superior to warfarin in both efficacy and safety outcomes.

Cardiac magnetic resonance imaging findings predict major adverse events in apical hypertrophic cardiomyopathy.

The purpose of this study was to determine the prognostic significance of cardiac magnetic resonance imaging (MRI) findings in patients with apical hypertrophic cardiomyopathy (HCM). Cardiac MRI studies of 93 consecutive patients with apical HCM were retrospectively evaluated. Quantification of late gadolinium enhancement (LGE) was determined and expressed as a percentage of total left ventricular (LV) myocardial mass (%LGE). Morphologic features including presence of apical aneurysm, right ventricular hypertrophy, and LV thrombus were also assessed. Clinical data were collected during follow-up to assess for occurrence of major adverse events, defined as: heart failure, stroke, appropriate automatic implantable cardioverter defibrillator discharge, sustained ventricular tachycardia, aborted sudden cardiac death, and/or all-cause death. The mean age of the patients was 54.9±13.8 years, and 72.0% (n=67) were male. LGE, right ventricular hypertrophy, apical aneurysm, and LV thrombus were identified in 69.4%, 25.8%, 18.3%, and 4.3%, respectively. Mean %LGE was 10.8%±11.1%. Over 2.4±1.7 years of follow-up, 14 subjects (15.1%) experienced a major adverse event (event rate, 6.3%/y): heart failure (6.5%), stroke (6.5%), appropriate automatic implantable cardioverter defibrillator discharge (2.2%), sustained ventricular tachycardia (2.2%), aborted sudden cardiac death (1.1%), and all-cause death (0.0%). Presence of apical aneurysm and extent of LGE were significant predictors of major adverse events [odds ratio (OR) 4.6, P=0.015; and OR 1.4/5% LGE, P=0.030, respectively]. Patients with both apical aneurysm and >5% LGE were at highest risk for major adverse events (OR 6.7, P=0.004) and had shortest event-free survival (P=0.001). Within our population of apical HCM patients, the extent of LGE and the presence of an apical aneurysm identified by cardiac MRI were both significant predictors of major adverse clinical events.

Abstract 220: Technical Performance Scores Predict Outcomes Following Congenital Heart Surgery: Multicenter Validation

BACKGROUND: In previous work from a single center, Technical Performance Score (TPS), a tool that assesses technical adequacy of repair, has been shown to be strongly associated with outcomes in congenital cardiac surgery. We sought to validate the efficacy of TPS in a multicenter environment. METHODS: All patients (1 day to 62 years) who were discharged from January 1 to December 31, 2011; and who underwent 9 congenital cardiac procedures (Arterial switch operation [84], Bidirectional Glenn [75], Atrioventricular canal repair [135], Fontan [97], Arch repair on pump [58], Stage I Procedure [85], Pulmonary valve replacement [116], Tetralogy of Fallot repair [112], and Ventricular septal defect repair [163]); from 5 centers were included. Based on echocardiograms (echo) prior to discharge or death, and unplanned reinterventions at surgical site; TPS was assigned using previously established criteria. Case complexity was determined by RACHS-1 category. Outcomes included (a) major postoperative adverse events (AE) excluding unplanned reinterventions, (b) length of ventilation, and (c) postoperative hospital stay. Adjusted analysis used logistic/linear regression to determine odds ratio (OR) and regression coefficient (b) for each outcome. RESULTS: There were 925 hospital discharges: 418 (45%) were RACHS-1 category 2, 295 (32%) category 3, 85 (9%) category 4, 86 (9%) category 6 and the cohort included 41 (4%) adults. TPS were as follows: 491 (53%) class 1-optimal, 263 (28%) class 2-adequate, 131 (14%) class 3-inadequate and 40 (4%) had no TPS assigned because of a lack of or incomplete echos (NA). There were 26 (2.8%) deaths (81% of deaths were in class 3) and 105 (11%) adverse events. Occurrence of major adverse events, ventilation time and hospital length of stay were all significantly higher in class 3 (Figure). On multivariable analysis adjusting for age, RACHS-1, prematurity, and presence of non-cardiac anomalies; Class 3 TPS was associated with a higher odds of AE (OR 7.4, CI 4.1-13.2, p&lt;0.001), longer ventilation (b 1.9, CI 1.6-2.2, p&lt;0.001), and hospital stay (b 1.6, CI 1.4 to 1.8, p&lt;0.001). CONCLUSION: TPS predicts outcomes after congenital heart surgery in a multicenter cohort, and can serve as quality assessment tool. Outcomes may be favorably influenced by focusing on technical excellence.

Use of hypnotics in high risk patient groups

Treatment of insomnia with hypnotics often requires careful consideration by a physician treating a high-risk patient. This is particularly true for pregnant women, paediatric patients and elderly patients, in part because there are not always clear practice guidelines on what hypnotic could be chosen and how it should be administered, if at all. There are three principal groups of medication that have a hypnotic (soporific) effect - benzodiazepines and nonbenzodiazepine GABA agonists (Z-hypnotics), melatonin agonists and secondary hypnotics (neurotropic medication with a secondary hypnotic property). Review of recent literature suggests that the odds for major foetal malformations, serious complications in pregnant women and serious complications in the newborn, in situations when the mother is taking hypnotics during pregnancy, is comparable to odds of the naturally occurring adverse events. Large cohort studies suggest that the relative risk for occurrence of serious adverse events increases towards the third trimester. Use of hypnotics in paediatric patients also presents a challenge, this from a different perspective. Some of the hypnotics with the favourable profile, in terms of the pharmacokinetics and infrequent or mild adverse reactions, may aggravate conditions typically present in children, such is the case of Z-hypnotics and parasomnia. The adolescent population is even more difficult to treat because of the added caveats, mainly related to the increased risk of medication abuse and amplified adverse reactions, such as paradoxical psychomotor agitation or pronounced confusion and daytime somnolence as a result of the 'carry-over effect'. The large cohort studies show increased use of hypnotics in this group, mainly as a result of an increase of melatonin use. Elderly patients have an increased need for hypnotic use on one hand, and a higher incidence of adverse events as result of such practice on the other. Use of benzodiazepines may lead to an increased risk of falls and injuries; the risk is marginally lower with the use of Z-hypnotics. Use of alternative hypnotics may be a better option for this group of patients, mainly in the form of use of melatonin agonists and soporific non-tricyclic antidepressants. Generally, and particularly within the group of elderly patients, medical conditions such as renal, cardiac, hepatic and lung diseases, and recent hospitalization present the situation where the use of hypnotics, and principally benzodiazepines, comes with the highest risk for occurrence of major adverse events. At the end, the decision whether the hypnotic should be prescribed should not be governed by the unnecessary caution and based on unsubstantiated information - the failure to treat insomnia may result in serious consequences, and may negatively affects patient's every-day life and his well-being. Such decision should rather be made based on the scientific principles and established evidence, meaning that the physician must always stay current. It also means that the considerations should include all of the available modalities of insomnia treatment, including both the pharmacological and non-pharmacological therapy, and implementation of measures of good sleep hygiene.

The impact of saddle embolism on the major adverse event rate of patients with non-high-risk pulmonary embolism.

Wider application of CT angiography (CTA) improves the diagnosis of acute pulmonary embolism (PE). It also permits the visualisation of saddle embolism (SE), namely thrombi, which are located at the bifurcation of the main pulmonary artery. The aim of this study was to assess the prevalence of SE and whether SE predicts a complicated clinical course in patients with non-high-risk PE. In total, 297 consecutive patients with non-high-risk PE confirmed using CTA in the emergency department were studied. The presence of SE and its ability to predict the occurrence of major adverse events (MAEs) within 1 month were determined. Of the 297 patients, 27 (9.1%) had an SE. The overall mortality at 1 month was 12.5%; no significant difference was observed between the SE and non-SE groups (18.5% vs 11.9%, p=0.32). However, patients with SE were more likely to receive thrombolytic therapy (29.6% vs 8.1%, p<0.01) and had significantly more MAEs (59.3% vs 25.6%, p<0.01). At the time of diagnosis, SE, as determined using CTA, is associated with the development of MAE within 1 month. It may be a simple method for risk stratification of patients with non-high-risk PE. The prognosis of patients with SE, especially those who are haemodynamically stable, is unclear. This study shows that patients with SE, determined with CTA, is associated with the development of MAE.

Brief Report: Long‐term outcome of a randomized clinical trial comparing methotrexate to cyclophosphamide for remission induction in early systemic antineutrophil cytoplasmic antibody–associated vasculitis

The NORAM (Nonrenal Wegener's Granulomatosis Treated Alternatively with Methotrexate [MTX]) trial demonstrated that MTX can replace cyclophosphamide (CYC) as remission-inducing treatment for patients with newly diagnosed early systemic antineutrophil cytoplasmic antibody-associated vasculitis. Duration of relapse-free survival was longer among CYC-treated patients than among MTX-treated patients during short-term followup. The aim of the present study was to describe the long-term outcome in patients enrolled in the randomized clinical trial. Outcome questionnaires were sent to investigators who had recruited patients for the NORAM trial. Patients treated with MTX for induction of remission (n = 49) were compared to CYC-treated patients (n = 46) with respect to immunosuppressive therapy during followup, relapse-free survival, mortality, and occurrence of other clinical events. The median duration of followup was 6 years (range 0.1-10.8 years). One patient developed end-stage renal disease, and 11 died. The number of patients affected by serious infection, malignancy, or severe organ failure did not differ between treatment groups, and no difference in survival rate was observed. The duration of corticosteroid therapy was longer in the MTX group during the 18 months of the trial (P = 0.005). During subsequent followup, patients who were in the MTX group in the NORAM trial received corticosteroids, CYC, and other immunosuppressive agents (azathioprine, MTX, and/or mycophenolate mofetil) for longer periods than those who were in the CYC group (P = 0.004, P = 0.037, and P = 0.031, respectively). The cumulative relapse-free survival tended to be lower in the MTX group (P = 0.056). In the NORAM cohort, no difference in occurrence of major adverse events was observed between treatment groups during long-term followup. However, first-line treatment with MTX was associated with less effective disease control than CYC-based induction therapy.

Safety of pulmonary vein isolation and left atrial complex fractionated atrial electrograms ablation for atrial fibrillation with phased radiofrequency energy and multi-electrode catheters

Recently, a multi-electrode catheter system using phased radiofrequency (RF) energy was developed specifically for atrial fibrillation (AF) ablation: the pulmonary vein ablation catheter (PVAC), the multi-array septal catheter (MASC), and the multi-array ablation catheter (MAAC). Initial results of small trials have been promising: shorter procedure times and low adverse event rates. In a large single-centre registry, we evaluated the adverse events associated with multi-electrode ablation catheter procedures with PVAC alone, or combined with MASC and MAAC. In all, 634 consecutive patients with AF had 663 procedures with multi-electrode ablation catheters, 502 patients with the PVAC alone, 128 patients with PVAC/MASC/MAAC, 29 redo procedures with the PVAC or PVAC/MASC/MAAC, and 4 patients had a complicated transseptal puncture. Major and minor adverse events during 6 month follow-up were registered. In 15 cases (2.3%), major adverse events were seen within the first month after the procedure. These included complicated transseptal puncture (4), stroke (2), transient ischaemic attack (5), acute coronary syndrome (2), femoral pseudoaneurysm (1), and arteriovenous fistulae (1). Minor adverse events were seen in 10.7% at 6 months, mostly due to femoral haematoma (3.9%), and non-significant PV stenosis (5.2%). There was no difference in the occurrence of major adverse events between PVAC alone, or PVAC/MASC/MAAC ablation. Ablation with phased RF and multi-electrode catheters is accompanied by a major adverse event rate of 2.3% within 1 month and a minor event rate of 10.7% at 6 months.

Abstract 113: Technical Performance Scores as a quality assessment tool in Congenital Heart Surgery; preliminary analysis of validation data

BACKGROUND : In previous work from our institution, individual practitioner technical performance of surgical procedures has been shown to be an important contributor to outcome and resource utilization in selected congenital cardiac operations. We have developed a Technical Scoring System for evaluation of majority of congenital cardiac procedures and wish to validate its efficacy as a self assessment tool for quality improvement. METHODS : All patients who were discharged between Jan 1 2011 and Dec 31, 2011 were included in this study. Based on discharge echocardiograms, a technical performance score was assigned using previously designed criteria. Case complexity was determined by RACHS-I category, postoperative adverse events and mortality were prospectively monitored. Outcomes were analyzed by non parametric methods. RESULTS : There were a total of 842 discharges encompassing all ages from neonates to adults. 560 (67%) were in RACHS-1 categories 1 to 3 (low risk) and 130 (15%) were in RACHS-1 categories 4 to 6 (high risk) and 152 (18%) could not be categorized. Technical performance scores were as follows: 436 (52%) class 1-optimal, 242(29%) class 2-adequate, 96 (115) class 3-inadequate, and 68(8%) could not classified. Occurrence of major adverse events, mortality and length of stay were all significantly higher in class 3. CONCLUSION : Preliminary data validates the usefulness of the technical scoring system as a quality assessment tool.

No Differences in Perioperative Outcome between Symptomatic and Asymptomatic AAAs after EVAR: An Analysis from the ENGAGE Registry

AimThis study aimed to compare the differences in perioperative outcome after endovascular repair of symptomatic abdominal aneurysms (S-AAAs) and elective non-symptomatic AAAs (E-AAAs). Data from the ENGAGE Registry were used for the analysis. MethodsBetween March 2009 and December 2010, 1200 AAA patients were enrolled from 79 sites in 30 countries and treated with an Endurant Stent Graft. S-AAAs defined as AAAs accompanied by abdominal or back pain, without rupture, were present in 185 (15.4%) patients and E-AAAs in 1015 (84.6%) patients. Multivariate logistic regression was used to compare results. ResultsAt baseline, E-AAA patients had larger aneurysms on average (P = 0.006) and scored higher ASA classification more often (P = 0.001). Further analyses were corrected for baseline differences. Operation time and technical success were comparable, and S-AAAs were admitted to the Intensive Care Unit (ICU) as often as E-AAAs (35.7% vs. 33.4%, P = 0.479). Post-operative hospitalisation was similar (4.83 ± 5.29 in E-AAAs and 4.37 ± 3.49 in S-AAAs, P = 0.360). No differences in the occurrence of major adverse events, including mortality, within the 30-day post-implantation were seen between S-AAA and E-AAA patients, respectively, 3.2% and 4.2% (P = 0.572). ConclusionWith contemporary devices and technical proficiency, there is no difference in outcome between symptomatic AAA and elective non-symptomatic AAA patients if treated with endovascular techniques.

Renal artery stenosis predicts adverse cardiovascular and renal outcome in patients with peripheral artery disease

Patients with symptomatic peripheral artery disease (PAD) are considered cardiovascular high-risk patients. Our aim was to investigate whether incidental renal artery stenosis (RAS) increases the risk for adverse cardiovascular and renal outcomes in these patients. We prospectively enrolled 487 consecutive patients admitted for revascularization of symptomatic PAD and performed a renal overview angiogram categorizing RAS as absent (0-29%), moderate (30-59%) and severe (>or= 60%) respectively. Clinical follow-up was for median 15 months (IQR 12-22) for the occurrence of major adverse events [MAE: composite of death, myocardial infarction (MI), stroke, percutaneous coronary intervention, coronary bypass surgery, amputation and kidney failure]. Glomerular filtration rates (GFR) were obtained at 12 months to quantify the course of renal function. A severe RAS was found in 76 patients (15.6%). Overall MAE occurred in 121 patients (24.8%), the composite endpoint of MI, stroke, amputation and death occurred in 101 patients (20.7%). Patients with a severe RAS had a 1.87-fold increased adjusted risk for MAE (95% CI 1.12-3.12, P = 0.017), a 2.51-fold increased adjusted risk for occurrence of the composite endpoint of MI, stroke, amputation and death (95% CI 1.45-4.34, P = 0.001) and a 2.93-fold increased risk for death (95% CI 1.41-6.08, P = 0.004), compared to those of patients without RAS respectively. We observed a significant association between the decrease of GFR over the 12-month follow-up period and the severity of RAS by multivariable analysis (P = 0.044). Severe RAS in patients with symptomatic PAD is an independent predictor of major adverse cardiovascular events, adverse renal outcome and mortality.

Clinical Trial Results of a Modified Gore Excluder Endograft: Comparison with Open Repair and Original Device Design

A multicenter phase II clinical trial of aneurysm treatment was performed with the modified Gore Excluder bifurcated endoprosthesis (m-EBE, n = 193) and compared with previously reported results from the same group of the original unmodified device (EBE, n = 253) or standard open aneurysm exclusion (control, n = 99). Graft modifications were primarily related to the proximal attachment site and included an increase in the length of the external expanded polytetrafluoroethylene and modifications of the anchor configuration. Preprocedural characteristics, periprocedural clinical events, and postprocedural clinical and radiographic follow-up at 1, 6, 12, and 24 months were analyzed with univariate and multivariate statistics. Device placement was successful in all cases, and there were no aneurysm ruptures in any group. Survival to 2 years was similar in all groups. Early major adverse events with the m-EBE were similar to those with the EBE (14.5% vs. 14%, P = 0.9) and markedly reduced compared to the control group (60.6%, P < 0.0001). After 30 days, there was no significant difference in the occurrence of major adverse events between endoluminal treatment and open controls. The rates of documented endoleak and increased aneurysm size at each follow-up interval were not significantly different between the two endoluminal devices. However, there was a trend toward fewer reinterventions from 14 to 28 months with the m-EBE (2% vs. 6% with the EBE, P < 0.06). There were also significantly fewer major adverse events associated with the m-EBE compared to the EBE during 14- to 28-month follow-up (15.6% vs. 24.9%, P = 0.037), in part due to the difference in reinterventions. The safety and efficacy of the m-EBE are statistically similar to the original device, although there was a reduction in major late adverse events between the two iterations of the endograft. This difference appears to be related to increased operator experience and changing treatment algorithms. Compared with open aneurysm repair, endoluminal repair with the m-EBE offers advantages in the reduction of early major adverse events while maintaining similar survival and rupture-free outcomes in the intermediate term.

Follow-up results of carotid angioplasty with stenting as assessed by duplex ultrasound surveillance

Background Carotid artery stenting (CAS) has become an alternative modality to carotid endarterectomy (CEA) for the treatment of carotid occlusive disease. We report a retrospective review of our institution’s experience with CAS versus CEA. Methods Postprocedure surveillance duplex, recurrent symptoms, postprocedure strokes, progression of lesions, and rates of re-operation were analyzed in 46 patients who underwent CAS and 48 patients who underwent CEA. The mean length of follow-up evaluation was 13 months. All CAS procedures included neuroprotection devices. Results Statistically significant differences in progression to critical restenosis (2% vs 2%, P = 1.0), rate of subsequent symptoms or stroke (2% vs 10%, P = .1), or rate of re-interventions were not observed between CAS and CEA groups (2% vs 4%, P = .98). Total mortality (0% vs 2%, P = .33), and the occurrence of major adverse events (2% vs 10%, P = .18) also were not significantly different in the CAS compared with the CEA patients. The average rate of increase in internal carotid velocity at 6 to 12 months (−1% vs 1.1%, P = NS) and 12 to 24 months (−5% vs −6.5%, P = NS) also were equivalent. Conclusions Our observed results indicate that CAS may be performed with comparable clinical outcomes and durability of repair comparable with CEA.

Secondary conversion of the Gore Excluder to operative abdominal aortic aneurysm repair

Reports continue to document the occurrence of major adverse events after endovascular aortic aneurysm repair. Although many of these problems can be successfully managed through endovascular salvage, operative conversion with explantation of the endoprosthesis remains necessary in some patients. We report herein a review of all patients initially enrolled in multicenter US clinical trials of the Excluder endograft who underwent secondary conversion to open surgical repair. Clinical data and relevant medical records of patients enrolled in phase I and II multicenter US clinical trials of the Excluder endograft were retrospectively reviewed for adverse events and further narrowed to those patients who underwent secondary operative conversion. Hospital records, operative and anesthesia reports, and all imaging studies were analyzed at initial implantation and at the time of subsequent open surgical repair. Late open conversion was performed in 16 (2.7%) of the 594 patients enrolled in the Excluder clinical trials. Presumed endotension accounted for 8 of 16 of secondary conversions. In two of these patients, however, an endoleak was identified at the time of open surgical repair. Of the remaining eight patients, two underwent conversion for device infection, five for persistent endoleak, and one for aneurysm rupture. The overall 30-day mortality was 6.25% (1/16), with one death occurring in a patient with a ruptured aneurysm. Of patients who underwent conversion because of endotension, the maximal abdominal aortic aneurysm diameter (mean +/- SD) at the time of initial implantation and subsequent graft removal was 61 +/- 11 mm and 70 +/- 10 mm, respectively. The mean time to open conversion for treatment of endotension was 37 +/- 12 months (range, 20-50 months; median, 42 months). Freedom from conversion was 98.6% and 96.7% at 24 and 48 months, respectively. Endotension in the absence of a demonstrable endoleak has been a major indication for late surgical conversion in patients treated with the Excluder endograft. Given the potential presence of an undetected endoleak and the possible effects of progressive sac enlargement on long-term device stability, continued close surveillance of patients with assumed endotension is required. Should changes in device design eliminate endotension, a further reduction in the already low incidence of late open conversion of the Excluder endograft can be anticipated.