Clinical experience with the use of bivalirudin in a large population undergoing endovascular abdominal aortic aneurysm repair

PURPOSE: To retrospectively evaluate the safety and effectiveness of the use of bivalirudin, a direct thrombin antagonist, compared with unfractionated heparin in endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Between March 1994 and September 2007, 740 consecutive patients (mean age, 75.7 y +/- 7.7; 69 women) underwent elective EVAR for infrarenal abdominal aortic aneurysm. Bivalirudin was used in 98 of these 740 (13.2%) and unfractioned heparin was used in the other 642 (86.8%). Complications were classified according to the Society of Vascular Surgery/International Society for Cardiovascular Surgery criteria. Major bleeding was defined as clinically overt blood loss resulting in a decrease of hemoglobin of more than 3 g/dL, any decrease in hemoglobin of more than 4 g/dL, transfusion of 2 U or more of red blood cells, or intracranial or retroperitoneal hemorrhage. RESULTS: Grade 1 major complications were observed in 161 of 642 patients (25.2%) in the heparin group and 12 of 98 patients (12.2%) in the bivalirudin group (P = .0046), whereas the incidences of grade 3 major complications were not significantly different between groups (P = .57). The rate of total complications was higher in the heparin group than in the bivalirudin group (247 of 642 [38.5%] vs 21 of 98 [21.4%]; P = .001). Major bleeding occurred in 10 of 98 patients (10.2%) receiving bivalirudin and in 91 of 642 patients (14.2%) receiving heparin (P = .34). One of 21 major complications (4.76%) in the bivalirudin group and 12 of 247 major complications (4.86%) in the heparin group were attributable to thrombosis (P = 1.0). CONCLUSIONS: Bivalirudin is a safe and feasible alternative to unfractionated heparin in patients undergoing EVAR.

Esophagus imaging for catheter ablation of atrial fibrillation: comparison of two methods with showing of esophageal movement

This study aims to evaluate whether visualization and integration of the computed tomography (CT) scan of the left atrium (LA) and the esophagus into the three-dimensional (3D) electroanatomical map the day before ablation is accurate compared with integration of an esophagus tag into the electroanatomic LA map visualizing the anatomic relationship during the radiofrequency ablation or whether esophagus movement prohibits esophagus visualization the day before ablation.

Association of increased tracheal mucus accumulation with poor willingness to perform in show-jumpers and dressage horses

The objective of this study was to examine the association of pharyngeal lymphoid hyperplasia (PLH), recurrent laryngeal neuropathy (RLN), mucus accumulation (MA) score and tracheobronchial secretion neutrophil percentage (TBS-N) with rider-assessed performance in sport horses. Airway endoscopy scores, tracheobronchial secretion cytology, rider-assessed general impression and willingness to perform were investigated in 171 top-level sport horses. Increased MA appears to be associated with poor willingness to perform in sport horses. Older horses had decreased PLH scores and increased TBS-N. Mucus accumulation scores > or =3 were associated with increased odds (mean 9.92; upper and lower 95% confidence intervals: 1.5-64.6) of poor rather than excellent willingness to perform. A TBS-N of 20-50% compared with <20% was associated with decreased odds (median 0.11; upper and lower 95% CI: 0.02-0.66) of poor rather than excellent willingness to perform. In addition, horses with an RLN grade > or =2 had significantly higher odds for giving a poorer general impression and willingness to perform. This finding, however, must be interpreted with caution, since only two horses had significant RLN (grade > or =3).

Oesophageal and gastric endoscopic foreign body removal: complications and follow-up of 102 dogs

OBJECTIVES: To assess complication rate, risk factors for complications and outcome in dogs with oesophageal and gastric endoscopic foreign body (FB) removal. METHODS: Medical records of 102 dogs undergoing endoscopic removal of oesophageal and/or gastric FBs from March 2001 to November 2006 were retrospectively reviewed. All owners were contacted by telephone to provide follow-up information. RESULTS: West Highland white terriers, Yorkshire terriers and Bernese mountain dogs were over-represented compared to the hospital population. Endoscopy alone was successful in 92/102 dogs (90.2 per cent), whereas gastrotomy (but no oesophagotomy) was required in 10 dogs (9.8 per cent). Complications in 13/102 dogs (12.7 per cent) were perforation (8), oesophageal stricture (1), oesophageal diverticula (1), perioesophageal abscess (1), pneumothorax and pleural effusion (1) and respiratory arrest (1). Six dogs (all weighing <10 kg) had complications resulting in death or euthanasia. Bone FBs, bodyweight of less than 10 kg, and oesophageal or gastric FB in place for more than three days were significant risk factors for complications. Of the dogs available for follow-up (75/96), 92 per cent had no complications after discharge. CLINICAL SIGNIFICANCE: Endoscopic FB removal is associated with a low overall complication rate with bone FBs and bodyweight of less than 10 kg as significant risk factors.

In vivo bisphenol-a release from dental pit and fissure sealants: a systematic review

OBJECTIVE To search the literature and assess the short- and long-term release of bisphenol-A (BPA) in human tissues after treatment with dental sealants. DATA Two review authors performed data extraction independently and in duplicate using data collection forms. Disagreements were resolved by discussion with an arbiter. SOURCES Electronic database searches of published and unpublished literature were performed. The following electronic databases with no language and publication date restrictions were searched: MEDLINE (via Ovid and Pubmed), EMBASE (via ovid), Cochrane Trials Register and CENTRAL. The reference lists of all eligible studies were hand-searched. STUDY SELECTION In the absence of RCTs, six interventional and two observational studies, examining in vivo BPA release in human salivary, blood and urinary samples, were included. Due to the heterogeneity in methodology and reporting, the main synthesis of the results was qualitative. The quantitative synthesis based on the weighted Z-test could only include two studies. BPA levels identified in saliva ranged from traces below the method's detection limit to 30 μg/ml. In urine, BPA quantities spanned from 0.17 mg/g to 45.4 mg/g. BPA was not traced in any blood sample at any point of time in the relevant studies. The quantitative analysis showed evidence of BPA release one hour after sealant placement compared to the amount traced before restoration (Stouffer's z trend: <0.001). CONCLUSIONS The available evidence on this topic derived from studies that represent a moderate level of evidence. Nevertheless, the available evidence supports that BPA is released in saliva after sealant placement. CLINICAL SIGNIFICANCE From the qualititative and quantitative synthesis of studies, it is reasonable to conclude that BPA is released after placement of some dental pit and fissure sealants in the oral cavity. The biggest quantities are detected in saliva immediately after or one hour after their placement.

Halitosis and tongue coating in patients with erosive gastroesophageal reflux disease versus nonerosive gastroesophageal reflux disease

OBJECTIVE The aim of this study was to investigate whether patients with diagnosed erosive gastroesophageal reflux disease (ERD) have an increased probability of halitosis and tongue coating compared to patients with nonerosive gastroesophageal reflux disease (NERD). MATERIALS AND METHODS Sixty-six patients (33 males and 33 females) were recruited for the study and received an upper gastrointestinal endoscopy. The presence of ERD (n = 31) and NERD (n = 35) was classified based on the Los Angeles classification for erosive changes in the esophagus. Additionally, the patients filled in a questionnaire regarding their subjective assessment of halitosis, and an organoleptic assessment of halitosis, a measurement of oral volatile sulfur compounds (VSC) with the Halimeter, and a tongue coating index were performed. ERD and NERD subjects were compared with regard to Halitosis-related clinical and anamnestic findings. RESULTS No statistically significant difference could be found between ERD and NERD patients regarding tongue coating index, organoleptic scores, and VSC values as well as self-perceived bad taste, tongue coating, and bad breath. CONCLUSIONS These data suggest that halitosis is not typically associated with erosive gastroesophageal reflux disease and the presence of esophageal mucosal damage (ERD patients). CLINICAL RELEVANCE The data of this investigation support the findings of interdisciplinary bad breath clinics that gastroesophageal reflux disease is not a leading cause for halitosis.

Mental health-care utilization in survivors of childhood cancer and siblings: the Swiss childhood cancer survivor study

PURPOSE We aimed to (1) describe the utilization of mental health-care in survivors and siblings, the association with severity of distress, and visits to other professionals in distressed survivors not utilizing mental health-care; and (2) identify factors associated with utilization of mental health-care in distressed survivors. METHODS Within the Swiss Childhood Cancer Survivor Study, we sent postal questionnaires to all participants aged <16 years at diagnosis (1976-2003), who survived ≥5 years after diagnosis and were aged ≥16 years at study. Survivors and siblings could indicate if they utilized mental health-care in the past year. Psychological distress was assessed with the Brief Symptom Inventory-18 (BSI-18). Participants with scores T ≥ 57 on two of three scales or the Global Severity Index were considered distressed. RESULTS We included 1,602 survivors and 703 siblings. Overall, 160 (10 %) and 53 (8 %), utilized mental health-care and 203 (14 %) and 127 (14 %) were considered distressed. Among these, 69 (34 %) survivors and 20 (24 %) siblings had utilized mental health-care. Participants with higher distress were more likely to utilize mental health-care. Distressed survivors not utilizing mental health-care were more likely to see a medical specialist than nondistressed. In the multivariable regression, factors associated with utilizing mental health-care were higher psychological distress and reporting late effects. CONCLUSIONS Our results underline the importance of developing interventional programs and implementing psychological screening in follow-up of survivors. It is also important to systematically address siblings' needs. In follow-up, patients at risk should be informed about existing possibilities or advised to visit mental health professionals.

Delay in diagnosis of eosinophilic esophagitis increases risk for stricture formation in a time-dependent manner

BACKGROUND & AIMS Development of strictures is a major concern for patients with eosinophilic esophagitis (EoE). At diagnosis, EoE can present with an inflammatory phenotype (characterized by whitish exudates, furrows, and edema), a stricturing phenotype (characterized by rings and stenosis), or a combination of these. Little is known about progression of stricture formation; we evaluated stricture development over time in the absence of treatment and investigated risk factors for stricture formation. METHODS We performed a retrospective study using the Swiss EoE Database, collecting data on 200 patients with symptomatic EoE (153 men; mean age at diagnosis, 39 ± 15 years old). Stricture severity was graded based on the degree of difficulty associated with passing of the standard adult endoscope. RESULTS The median delay in diagnosis of EoE was 6 years (interquartile range, 2-12 years). With increasing duration of delay in diagnosis, the prevalence of fibrotic features of EoE, based on endoscopy, increased from 46.5% (diagnostic delay, 0-2 years) to 87.5% (diagnostic delay, >20 years; P = .020). Similarly, the prevalence of esophageal strictures increased with duration of diagnostic delay, from 17.2% (diagnostic delay, 0-2 years) to 70.8% (diagnostic delay, >20 years; P < .001). Diagnostic delay was the only risk factor for strictures at the time of EoE diagnosis (odds ratio = 1.08; 95% confidence interval: 1.040-1.122; P < .001). CONCLUSIONS The prevalence of esophageal strictures correlates with the duration of untreated disease. These findings indicate the need to minimize delay in diagnosis of EoE.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document

OBJECTIVES The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. BACKGROUND A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. METHODS AND RESULTS Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. CONCLUSIONS This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair).

Trigger activity more than three years after left atrial linear ablation without pulmonary vein isolation in patients with atrial fibrillation.

OBJECTIVES The aim of this study was to analyze trigger activity in the long-term follow-up after left atrial (LA) linear ablation. BACKGROUND Interventional strategies for curative treatment of atrial fibrillation (AF) are targeted at the triggers and/or the maintaining substrate. After substrate modification using nonisolating linear lesions, the activity of triggers is unknown. METHODS With the LA linear lesion concept, 129 patients were treated using intraoperative ablation with minimal invasive surgical techniques. Contiguous radiofrequency energy-induced lesion lines involving the mitral annulus and the orifices of the pulmonary veins without isolation were placed under direct vision. RESULTS After a mean follow-up of 3.6 +/- 0.4 years, atrial ectopy, atrial runs, and reoccurrence of AF episodes were analyzed by digital 7-day electrocardiograms in 30 patients. Atrial ectopy was present in all patients. Atrial runs were present in 25 of 30 patients (83%), with a median number of 9 runs per patient/week (range 1 to 321) and a median duration of 1.2 s/run (range 0.7 to 25), without a significant difference in atrial ectopy and atrial runs between patients with former paroxysmal (n = 17) or persistent AF (n = 13). Overall, 87% of all patients were completely free from AF without antiarrhythmic drugs. CONCLUSIONS A detailed rhythm analysis late after specific LA linear lesion ablation shows that trigger activity remains relatively frequent but short and does not induce AF episodes in most patients. The long-term success rate of this concept is high in patients with paroxysmal or persistent AF.

Paraseptal accessory pathway in Wolff-Parkinson- White-Syndrom: ablation from the right, from the left or within the coronary sinus/middle cardiac vein?

AIMS In 1999 the consensus statement "living anatomy of the atrioventricular junctions" was published. With that new nomenclature the former posteroseptal accessory pathway (APs) are termed paraseptal APs. The aim of this study was to identify ECG features of manifest APs located in this complex paraseptal space. METHODS AND RESULTS ECG characteristics of all patients who underwent radiofrequency ablation of an AP during a 3 year period were analyzed. Of the 239 patients with one or more APs, 30 patients had a paraseptal AP with preexcitation. Compared to APs within the coronary sinus (CS) or the middle cardiac vein (MCV) the right sided paraseptal APs significantly more often showed an isoelectric delta wave in lead II and/or a negative delta wave in aVR. The left sided paraseptal APs presented a negative delta wave in II significantly more often compared to the right sided APs. CONCLUSIONS According to the site of radiofrequency ablation, paraseptal APs are classified into 4 subgroups: paraseptal right, paraseptal left, inside the CS or inside the MCV. Subtle differences in preexcitation patterns of the delta wave as well as of the QRS complex exist. However, the definitive localization of APs remains reserved to the periinterventional intracardiac electrogram analysis.

Late recurrent arrhythmias after ablation of atrial fibrillation: incidence, mechanisms, and treatment.

OBJECTIVES The aim of the study was to determine the incidence of atrial flutter and other arrhythmia recurrences (other than atrial fibrillation [AF]) during long-term follow-up after left atrial substrate modification by percutaneous radiofrequency (RF) ablation of AF. BACKGROUND RF ablation is an effective treatment for patients with AF. However, late recurrent arrhythmias may complicate the patient's course. METHODS One hundred fifty consecutive patients with paroxysmal or persistent AF were included in this prospective study. The incidence of arrhythmia recurrences after AF ablation was analyzed during long-term follow-up using repetitive 7-day ECG recording. RESULTS In 28 of 150 patients (18.7%), stable regular arrhythmias other than AF were detected during follow-up. Left atrial flutter observed in 10 patients (6.7%) was treated by recompletion of the ablation lines in all 10 patients. Left atrial flutter was associated with recurrence of AF in all 10 patients. Nine of 10 patients (90%) were free from atrial flutter and 6 of 10 patients were free from AF after the second intervention. Typical right atrial flutter occurred in 10 patients (6.7%) and was treated successfully by percutaneous RF ablation without recurrence in all patients. Additionally, atrial flutter was documented during follow-up in 7 patients (4.7%); however, invasive electrophysiologic evaluation was not performed due to various reasons. CONCLUSIONS Left atrial flutter is a relevant complication after RF catheter ablation of AF and was always associated with AF recurrence in our study population. Prevention of left atrial flutter can be achieved by induction of ablation lines as continuous and transmural as possible. However, left atrial flutter that does occur late after ablation is amenable to interventional treatment with good prospects of success.

Stable secondary arrhythmias late after intraoperative radiofrequency ablation of atrial fibrillation: incidence, mechanism, and treatment.

INTRODUCTION Intraoperative radiofrequency (RF) ablation is an effective treatment of atrial fibrillation (AF). However, secondary arrhythmias late after ablation may complicate the patient's course. We report on the incidence, mechanisms, and treatment of gap-related atrial flutter and other secondary arrhythmias during long-term follow-up. METHODS AND RESULTS In 129 patients who underwent intraoperative RF ablation with placement of left atrial linear lesions using minimally invasive surgical techniques, secondary arrhythmias were analyzed during long-term follow-up (20 +/- 6 months). Transient atrial arrhythmias during the first 3 postoperative months were excluded. In 8 (6.2%) of 129 patients, sustained stable secondary arrhythmias were documented. Left atrial, gap-related atrial flutter was observed in 4 patients (3.1%). The flutter was treated by percutaneous RF ablation in 3 patients (2.3%) and with drugs in 1 patient (0.8%). In 2 patients (1.6%), right atrial isthmus-dependent atrial flutter occurred and was treated successfully by percutaneous RF ablation. In 2 patients (1.6%), ectopic right atrial tachycardias occurred and were treated with percutaneous RF ablation. CONCLUSION Late after intraoperative RF ablation of atrial fibrillation, three types of stable secondary arrhythmias were observed in 6% of patients: left atrial gap-related atrial flutter, right atrial isthmus-dependent atrial flutter, and ectopic atrial tachycardia. Gaps after intraoperative RF ablation due to noncontinuous or nontransmural linear lesions may lead to stable left atrial macroreentrant tachycardias, requiring new interventional therapy.

Interdisciplinary Cardiovascular and Neurologic Outpatient Rehabilitation in Patients Surviving Transient Ischemic Attack or Stroke With Minor or No Residual Deficits

Objective To evaluate the feasibility and effectiveness of a comprehensive outpatient rehabilitation program combining secondary prevention and neurorehabilitation to improve vascular risk factors, neurologic functions, and health-related quality of life (HRQOL) in patients surviving a transient ischemic attack (TIA) or stroke with minor or no residual deficits. Design Prospective interventional single-center cohort study. Setting University hospital. Participants Consecutive consenting patients having sustained a TIA or stroke with 1 or more vascular risk factors (N=105) were included. Interventions Three-month hospital-based secondary prevention and neurorehabilitation outpatient program with therapeutic and educational sessions twice a week. Patients were evaluated at entry and program end. Main Outcome Measures Impact on vascular risk factors, neurological outcome, and HRQOL. Results A total of 105 patients entered the program and 95 patients completed it. Exercise capacity (P<.000), smoking status (P=.001), systolic (P=.001) and diastolic (P=.008) blood pressure, body mass index (P=.005), low-density lipoprotein cholesterol (P=.03), and triglycerides (P=.001) improved significantly. Furthermore, the 9-Hole-Peg-Test (P<.000), Six-minute Walking Test (P<.000), and One Leg Stand Test (P<.011) values as well as HRQOL improved significantly. The program could be easily integrated into an existing cardiovascular prevention and rehabilitation center and was feasible and highly accepted by patients. Conclusions Comprehensive combined cardiovascular and neurologic outpatient rehabilitation is feasible and effective to improve vascular risk factors, neurologic functions, and HRQOL in patients surviving TIA or stroke with minor or no residual deficits.

Long-term Results of a 12-Week Comprehensive Ambulatory Cardiac Rehabilitation Program

PURPOSE: To evaluate the long-term outcome of a 12-week outpatient cardiac rehabilitation (CR) program. METHODS: In a prospective single-center interventional cohort study, 201 consecutive patients (133 patients after acute coronary syndrome, 32 patients after heart surgery, and 36 patients with heart failure) attending a 12-week comprehensive outpatient CR program were evaluated for exercise capacity, cardiovascular risk factors (CvRFs), and quality of life at entry, end, and 1.4 years after completion of the program (followup). RESULTS: Physical exercise capacity improved significantly from program entry to program end and remained at this level at followup (P ≤ .006). CvRFs at followup were significantly reduced with regard to smoking prevalence and blood lipids (P < .001). At program end and followup, MacNew heart disease–specific emotional, physical, and social quality of life were improved significantly compared with those at program entry (P < .001). Use of cardioprotective medication remained equally high over the entire study period. However, significantly fewer patients reached blood pressure (<140/90 mm Hg, P = .034) and body mass index (<30 kg/m2, P = .017) goals at followup than at program end. CONCLUSION: The 12-week comprehensive outpatient CR program was successful at reducing important CvRFs long-term.