bluuebunny/crossref_metadata_2025 huggingface dataset:
Induction of labour in nulliparous women with an unfavourable cervix: a randomised controlled trial comparing double and single balloon catheters and PGE2 gel
Authors: Pennell CE , Henderson JJ , O’Neill MJ , McCleery S , Doherty DA , Dickinson JE
Published: July 2009

Objective  To compare the efficacy and patient satisfaction of three methods of labour induction (double balloon catheters, single balloon catheters and prostaglandin gel) in term nulliparous women with unfavourable cervices.

Design  Randomised controlled trial.

Population  A total of 330 nulliparous women with unfavourable cervices induced at term.

Methods  Three cervical ripening study arms were used: double balloon catheter (107 women); 16F Foley catheter (110 women) and PGE2 gel (2 mg) (113 women).

Main outcome measures  Caesarean section, induction to delivery interval, adverse reactions and patient satisfaction.

Results  There was no difference in caesarean delivery rates between groups (double balloon 43%, single balloon 36%, PGE2 37%, P = 0.567). The induction to delivery interval was longer in the double balloon group (median 24.5; 95% CI 23.7, 30.6 hours) than the single balloon (23.2; 20.8, 25.8 hours) or PGE2 (23.8; 21.7, 26.8 hours) (P = 0.043). Uterine hyperstimulation occurred in 14% of the PGE2 group with none occurring with mechanical cervical ripening. Cord blood gases were worse in the PGE2 group: median arterial pH double balloon 7.26 (range 7.03–7.40); single balloon 7.26 (7.05–7.44); PGE2 7.25 (6.91–7.41) (P = 0.050). Cervical ripening with the single balloon catheter was associated with significantly less pain (pain score ≥4: double balloon 55%, single balloon 36%, PGE2 63%, P < 0.001).

Conclusions  Labour induction in nullipara with unfavourable cervices results in high caesarean delivery rates. Although all methods in this study had similar efficacy, the single balloon catheter offers the best combination of safety and patient comfort.
Surgery for menorrhagia within English regions: variation in rates of endometrial ablation and hysterectomy
Authors: Cromwell DA , Mahmood TA , Templeton A , van der Meulen JH
Published: July 2009

Objective  To examine variation between English regions in the use of surgery (endometrial ablation or hysterectomy) for the treatment of menorrhagia.

Design  Analysis of Hospital Episodes Statistics (HES) data to produce rates of surgery for English Strategic Health Authorities (SHAs) and Primary Care Trusts (PCTs).

Population  Women aged between 25 and 59 years who had endometrial ablation or hysterectomy for menorrhagia between April 2003 and March 2006 in English NHS hospitals.

Methods  Multilevel Poisson regression was used to determine the level of systematic variation in the regional rates of surgery and their association with regional characteristics (deprivation, service provision and mix of surgical procedures).

Main outcome measure  Age‐standardised annual rates of surgery.

Results  The English rate of surgery for menorrhagia was 143 procedures per 100 000 women. Surgical rates within SHAs ranged from 52 to 230 procedures per 100 000 women, while rates within PCTs ranged from 20 to 420 procedures per 100 000 women. While, 60% of all procedures were endometrial ablations, the proportion across SHAs varied, ranging from 46% to 75%. Surgery rates were associated with the regional characteristics, but only weakly, and risk adjustment reduced the amount of unexplained variation by <15% at both SHA and PCT levels.

Conclusion  Regional differences in surgical rates for menorrhagia have persisted despite changes in practice and improved evidence, suggesting there is scope for improving the management of menorrhagia within England.
Internal podalic version for neglected shoulder presentation with fetal demise
Authors: Mahajan NN , Gaikwad NL , Solomon MV , Mahajan KN , Kothari NP
Published: July 2009

In modern obstetrics, the role of internal podalic version (IPV) is limited to delivery of the second twin. A retrospective study was conducted to assess the efficacy of IPV in singleton neglected shoulder presentation with fetal demise. Women with live fetuses, previous CS or contracted pelvis were excluded. The procedure involved repositioning the prolapsed hand under anaesthetic followed by breech extraction. 12 women were identified over a 19 month period and all underwent successful IPV. One woman had a postpartum haemorrhage. We conclude that, in singleton pregnancies with a transverse lie, IPV has a role to play in the delivery of dead fetuses.
Garnet‐filled trails associated with carbonaceous matter mimicking microbial filaments in Archean basalt
Authors: LEPOT K. , PHILIPPOT P. , BENZERARA K. , WANG G.‐Y.
Published: July 2009

The study of the earliest traces of life on Earth can be complicated by abiotically formed biomorphs. We report here the finding of clustered micrometer‐sized filaments of iron‐ and calcium‐rich garnets associated with carbonaceous matter in an agate amygdale from a 2.7‐billion‐year‐old basalt of the Maddina Formation, Western Australia. The distribution of carbonaceous matter and the mineral phases composing the filaments were analyzed using a combination of confocal laser scanning microscopy, laser‐Raman micro‐spectroscopy, focused ion beam sectioning and transmission electron microscopy. The results allow consideration of possible biogenic and abiotic processes that produced the filamentous structures. The filaments have a range of sizes, morphologies and distributions similar to those of certain modern iron‐mineralized filamentous bacteria and some ancient filamentous structures interpreted as microfossils. They also share a high morphological similarity with tubular structures produced by microbial boring activity. However, the microstructures and the distribution of carbonaceous matter are more suggestive of an abiotic origin for the filaments. They are characteristic features of trails produced by the displacement of inclusions associated with local dissolution of their silica matrix. Organic compounds found in kerogen or bitumen inclusions may have contributed significantly to the dissolution of the quartz (or silica gel) matrix driving filamentous growth. Discriminating the products of such abiotic organic‐mediated processes from filamentous microfossils or microbial borings is important to the interpretation of the scarce Precambrian fossil record and requires investigation down to the nanoscale.
Experimental silicification of the extremophilic Archaea Pyrococcus abyssi and Methanocaldococcus jannaschii: applications in the search for evidence of life in early Earth and extraterrestrial rocks
Authors: ORANGE F. , WESTALL F. , DISNAR J.‐R. , PRIEUR D. , BIENVENU N. , LE ROMANCER M. , DÉFARGE CH.
Published: July 2009

Hydrothermal activity was common on the early Earth and associated micro‐organisms would most likely have included thermophilic to hyperthermophilic species. 3.5–3.3 billion‐year‐old, hydrothermally influenced rocks contain silicified microbial mats and colonies that must have been bathed in warm to hot hydrothermal emanations. Could they represent thermophilic or hyperthermophilic micro‐organisms and if so, how were they preserved? We present the results of an experiment to silicify anaerobic, hyperthermophilic micro‐organisms from the Archaea Domain Pyrococcus abyssi and Methanocaldococcus jannaschii, that could have lived on the early Earth. The micro‐organisms were placed in a silica‐saturated medium for periods up to 1 year. Pyrococcus abyssi cells were fossilized but the M. jannaschii cells lysed naturally after the exponential growth phase, apart from a few cells and cell remains, and were not silicified although their extracellular polymeric substances were. In this first simulated fossilization of archaeal strains, our results suggest that differences between species have a strong influence on the potential for different micro‐organisms to be preserved by fossilization and that those found in the fossil record represent probably only a part of the original diversity. Our results have important consequences for biosignatures in hydrothermal or hydrothermally influenced deposits on Earth, as well as on early Mars, as environmental conditions were similar on the young terrestrial planets and traces of early Martian life may have been similarly preserved as silicified microfossils.
Early worsening heart failure in patients admitted with acute heart failure – a new outcome measure associated with long‐term prognosis?
Authors: Weatherley Beth Davison , Milo‐Cotter Olga , Michael Felker G. , Uriel Nir , Kaluski Edo , Vered Zvi , O’Connor Christopher M. , Adams Kirkwood F. , Cotter Gad
Published: July 2009

A major limitation in acute heart failure (AHF) research has been the lack of an outcome measure paralleling re‐infarction in acute coronary syndromes. The aim of the present study was to assess the time course, prognostic factors and outcome of early worsening heart failure (WHF) in patients admitted for AHF to a community hospital. All AHF admissions between December 2003 and March 2004 in a regional medical center were recorded. Patients were followed through admission and for 6 months after discharge. Early WHF was defined as WHF occurring during the initial 7 days from admission. Study endpoints were cardiovascular mortality and WHF (defined as worsening or persistent signs or symptoms of AHF requiring rescue therapy or hospital readmission). Early WHF rate was 29% and was associated with markers of AHF severity on presentation (higher troponin I, lower oxygen saturation, need for mechanical ventilation, intravascular diuretics and inotropes). Early WHF was a powerful predictor of death during 6 months of follow up, with an age‐adjusted hazard ratio of 3.3 (95% confidence interval 1.7–6.3). Early WHF is a common adverse event in patients admitted with AHF, and is associated with AHF severity and excessive 6‐month mortality. WHF should be considered as a clinically important endpoint in AHF studies.
Cyclosporine and sirolimus pharmacokinetics and drug‐to‐drug interactions in kidney transplant recipients
Authors: Felipe Claudia R. , Park Sung‐In , Pinheiro‐Machado Paula G. , Garcia Riberto , Casarini Dulce E. , Moreira Silvia , Tedesco‐Silva Jr Helio , Medina‐Pestana Jose O.
Published: July 2009

This study was conducted to evaluate the pharmacokinetics (pk) and drug interactions between cyclosporine (CsA) and sirolimus (SRL) in kidney transplant recipients. The morning (a.m.) and evening (p.m.) pk of CsA (4–5 mg/kg/dose) and SRL (2 mg,n = 20; 5 mg,n = 33) were evaluated on day 7 (n = 53). CsA showed circadian variation when comparing a.m. and p.m. administration [AUC: 8066 vs. 6699,P < 0.001 (CI 970.9; 1763.6); C0: 272 vs. 245,P = 0.007 (CI 7.5; 46.1)]. SRL showed dose‐proportional pk. Significant and drug‐to‐drug concentration‐dependent pk interactions were observed within a narrow concentration range for both drugs. A fivefold increase in SRL AUC (from a mean of 130 to 538 ng h/mL) was associated with a 25% increase in mean a.m. CsA AUC [7021 to 8811 ng h/mL,P = 0.037, CI (−3461.2; −118.9)] and with a 42% increase in mean p.m. CsA AUC [5386–7639,P = 0.024, CI (−4164.4; −340.7)]. A twofold increase in a.m. CsA AUC (from 5860 to 10 974 ng h/mL) was associated with a 70% increase in mean SRL AUC [223 to 380 ng h/mL,P = 0.0026, CI (−291.7; −22.8)]. A twofold increase in p.m. CsA AUC (from 4573 to 9692 ng h/mL) was associated with a 63% increase in mean SRL AUC [246 to 400 ng h/mL,P = 0.032, CI (−290.7; −16.6)]. CSA shows circadian pk regardless of sirolimus dose or blood concentration. Significant drug‐to‐drug interactions occur within narrow blood drug concentrations. The magnitude of the effect of CsA on SRL blood concentration is higher than that of SRL on CsA blood concentrations. These findings emphasize the need for therapeutic drug monitoring using this drug combination.
Histamine: metabolism, physiology, and pathophysiology with applications in veterinary medicine
Authors: Peters Lisa J. , Kovacic Jan P.
Published: July 2009

Objective –To review the human and veterinary literature on histamine physiology and pathophysiology and potential applications for clinical use in veterinary critical care.

Data Sources –Human and veterinary clinical studies, reviews, texts, and recent research in histamine receptor and antagonist therapy.

Human Data Synthesis –Recent progress in molecular biology has led to a more complete understanding of the enzymes involved in histamine metabolism and histamine receptor physiology. The past decade of research has confirmed the role of histamine in theclassical functions(contraction of smooth muscle, increase in vascular permeability, and stimulation of gastric acid secretion) and has also elucidated newer ones that are now under investigation. Data on the roles of histamine in angiogenesis, circadian rhythm, bone marrow regeneration, bacterial eradication, and cancer are emerging in the literature. Newer histamine antagonists are currently in drug trials and are expected to advance the clinical field in treatment of allergic, gastrointestinal, and cognitive disorders.

Veterinary Data Synthesis –Veterinary histamine research is directed at identifying the effects of certain pharmacological agents on blood histamine concentrations and establishing the relevance in clinical disease states. Research demonstrates important species differences in regards to histamine receptor physiology and tissue response. Studies in the area of trauma, sepsis, anaphylaxis, allergy, and gastrointestinal disorders have direct applications to clinical veterinary medicine.

Conclusions –Histamine plays a key role in the morbidity and mortality associated with allergy, asthma, gastric ulcers, anaphylaxis, sepsis, hemorrhagic shock, anesthesia, surgery, cardiovascular disease, cancer, CNS disorders, and immune‐mediated disease. Histamine antagonism has been in common use to block its adverse effects. With recent advances in the understanding of histamine receptor physiology, pharmaceutical agents targeting these receptors have increased the therapeutic options.
Calcium Supplementation In Nulliparous Women For The Prevention Of Pregnancy‐Induced Hypertension, Preeclampsia And Preterm Birth: An Australian Randomized Irial
Authors: Crowther Caroline A. , Hiller Janet E. , Pridmore Brian , Bryce Robert , Duggan Paul , Hague William M. , Robinson Jeffrey S.
Published: July 2009

Summary: A multicentre, randomized controlled double‐blind trial in 5 maternity hospitals in Australia assessed the effect of a daily supplement of calcium (1.8g oral calcium or an oral placebo) taken daily until delivery, from less than 24 weeks' gestation, on the frequency of pregnancy‐induced hypertension, preeclampsia and preterm birth (< 37 weeks' gestation) in 456 nulliparas with a singleton pregnancy. Treatment with calcium reduced the risk of preeclampsia (relative risk 0.44 [95% CI, 0.21–0.90], p = 0.02) and the risk of preterm birth (relative risk 0.44 [95% CI, 0.21 ‐ 0.90], p = 0.02). No significant differences were seen between the 2 groups in the frequency of pregnancy‐induced hypertension, although the study only had statistical power to detect large differences in this outcome. An updated systematic review of the 9 randomized trials of calcium supplementation in pregnancy shows a significant reduction in the risk of hypertension and preeclampsia although no effect on preterm birth. Calcium supplementation during pregnancy reduced the risk of preeclampsia and preterm birth in this nulliparous population. The available evidence for systematic review of all the randomized trials of calcium supplementation shows benefit in reducing the risk of hypertension and preeclampsia.
A Survey of Parturients Using Epidural Analgesia During Labour. Considerations Relevant to Antenatal Educators
Authors: Paech M.J. , Gurrin L.C.
Published: July 2009

Summary: The use of epidural analgesia (EA) during labour is increasing in Australasia. This highlights the need for improved educational and resource materials, current factual information about EA, and identification of consumer attitudes towards EA. In this survey, 350 parturients who had recently used EA for labour pain relief in a single maternity unit were asked to complete a questionnaire about their expectations and experience. The response rate was 90%. Prepartum information was most commonly derived from hearsay and least commonly from medical health professionals, 56% of respondents wanted pain to be made tolerable and 34% wanted complete pain relief. Almost half considered unrestricted mobility and delivery without obstetric assistance important. A minority were concerned about possible effects of EA on the baby or labour outcome. Anticipated pain during epidural placement was significantly greater than that experienced. Satisfaction with EA was high, although 36% described unpleasant or annoying effects associated with EA. Parent educators and epidural service providers should be aided by knowledge of where parturients obtain information and of consumer views about EA.
The Impact of Leiomyomas on Pregnancy
Authors: Roberts William E. , Fulp Kari S. , MD John C. Morrison , Martin James N.
Published: July 2009

Summary: In this retrospective case control investigation, 51 pregnant patients who were diagnosed by ultrasound with uterine myomas were compared to 102 randomly selected control patients to determine if the ultrasound diagnosis of one or more leiomyoma is associated with increased untoward pregnancy outcomes compared to controls. Women with uterine myomas were older (p = 0.001), more likely to be African American (p = 0.001), and undergo Caesarean delivery (p = 0.03) than controls. However, when women who underwent abdominal delivery for previous myomectomy (n = 5) were excluded from analysis, there was no significant difference in the incidence of Caesarean delivery. Overall, there was no difference in the incidence of obstetric complications between groups even when the data was stratified for large and/or multiple leiomyomas. The discovery of uterine leiomyomas by gestational ultrasound does not appear to place the patient at increased risk for preterm labour, early delivery, or other untoward pregnancy outcomes.
Sexual Behaviour During Pregnancy
Authors: Oruç Semra , Esen Ayşen , Laçin Selman , Adigüzel Hakan , Uyar Yildiz , Koyuncu Faik
Published: July 2009

Summary: The effects of pregnancy on sexuality were studied in 158 pregnant women. They were surveyed by questionnaire about sociodemographic variables and sexual behaviour. Dyspareunia was common in our study group during pregnancy. Pregnancy had a negative effect on orgasmic quality. Dyspareunia and orgasmic quality influenced coital frequency. Coital frequency declined as the month of the pregnancy increased. Pregnancy is a potent influence on sexuality irrespective of an individual's conditioning.
The Introduction of a Woman‐Held Record into a Hospital Antenatal Clinic: The Bring Your Own Records Study
Authors: Homer Caroline S.E. , Davis Gregory K. , Everitt Louise S.
Published: July 2009

Summary: We report the introduction of a woman‐held record into an antenatal clinic in a NSW teaching hospital using a randomized controlled trial. In 1997, 150 women were randomized to either retaining their entire antenatal record through pregnancy (women‐held group) or to holding a small, abbreviated card, as was standard practice (control group). A questionnaire was distributed to women to measure sense of control, involvement in care and levels of communication. Availability of records at antenatal visits was also measured. Women in both groups were satisfied with their allocated method of record keeping, however, those in the women‐held group were significantly more likely to report feeling in ‘control’ during pregnancy. Women in the control group were more likely to feel anxious and helpless and less likely to have information on their records explained to them by their caregiver. The number of records available at each clinic was similar in both groups.
Hilus Cell Tumour of the Ovary in a Virilized, Premenopausal Woman. Case Report and Review of Hyperandrogenism of Ovarian Origin
Authors: Moore Amber , Permezel Michael , Mulvany Nicholas , Pepperell Roger J.
Published: July 2009

Summary: A 35 year‐old woman presented with virilization and was found to have elevated serum testosterone levels. Investigation revealed an 11 mm hilus cell tumour in the left ovary. After unilateral oophorectomy, serum testosterone levels rapidly returned to normal levels. The various ovarian tumours and conditions causing virilization are described and a clinical approach to the investigation of virilization is outlined.
Vulvar Vestibulitis Syndrome: An Often Unrecognized Cause of Dyspareunia
Authors: Pagano Ross
Published: July 2009

Summary: Vulvar vestibulitis syndrome (VVS) is an easily identifiable cause of entry dyspareunia. The aetiology is unknown although there is a strong association with Candida infection. The condition represents a focal area of hyperaesthesia within the vulvar vestibule. A management protocol for patients with this condition is presented; 230 patients with VVS were managed and followed‐up over a 5‐year period. Spontaneous resolution or improvement occurred in 21% of patients following initial explanation and use of simple local measures. In 21%, there were positive Candida cultures and long‐term antifungal therapy resulted in a 71% cure. In Candida‐negative patients, low‐dose amitriptyline was used (up to 75 mg daily) with a 60% positive response rate. Carbamazepine was of little benefit (13% response). Surgical vestibulectomy was offered when conservative measures failed and this was performed in 22 patients (10%) with a beneficial result in 20 patients (91%).
A Case of Aplastic Anaemia in Pregnancy
Authors: Ang H.Y. , Ho H.K. , Linn Y.C.
Published: July 2009

Summary: Aplastic anaemia in pregnancy is an extremely rare condition with high maternal morbidity and mortality rates. Intensive haematological support remains the mainstay of therapy and a successful obstetric outcome can be best accomplished with the close clinical collaboration of the haematologist and the obstetrician as occurred with our patient reported here.
Group B Streptococcus Infection, not Birth Asphyxia
Authors: Keogh John M. , Badawi Nadia , Kurinczuk Jennifer J. , Pemberton P.J. , Stanley F.J.
Published: July 2009

Summary: This case illustrates 2 main points. Firstly, fetal infection can mimic exactly both the immediate and delayed signs of perinatal asphyxia. Secondly, the placenta may hold the key to the diagnosis of sepsis which may be made difficult in the neonate by labour ward practices such as the use of intrapartum and immediate newborn antibiotics. We strongly support the recommendation that newborn blood and fetal membrane cultures should always be obtained in babies with a diagnosis of ‘intrapartum asphyxia and fetal distress’ (1). To this we would add the recommendation that placental histology be performed in these circumstances.
Rare Delivery Complication Caused by an Undiagnosed Uterine Septum
Authors: Banerjee Neelam , Kriplani Alka , Takkar Deep
Published: July 2009

Summary: The role of a uterine septum, and thus, metroplasty in an infertile woman is a debatable issue. A rare complication of fetal malpresentation and impaction in the uterine cavity due to undiagnosed uterine septum in a 24‐year‐old primigravida who conceived after 3 years of primary infertility is reported. This case highlights that uterine anomalies should be looked for in patients with infertility and reproductive failures, and should be corrected before conception by metroplasty in order to improve reproductive outcome.
Embolic Occlusion of the Blood Supply to Uterine Myomas: Report of 2 Cases
Authors: Kuhn Raphael , Mitchell Peter
Published: July 2009

Summary: Uterine myomas are the most common tumours of the female genital tract and with menorrhagia provide the most common indications for hysterectomy. Whilst myomectomy is a surgical alternative, it is associated with greater morbidity and a higher blood transfusion rate. Arterial embolization of myomas is a nonsurgical treatment option that can be performed as an outpatient procedure, is cheaper than myomectomy, permits preservation of reproductive potential, and may not only be associated with less morbidity than myomectomy but also may not cause adhesions which could compromise fertility. This paper details 2 cases treated by this technique.
Five‐layer Repair of Rectovaginal Fistula using a Vaginal Approach. A Case Report
Authors: Haylen Bernard T. , Cerqui Anthony J. , Meagher Alan P.
Published: July 2009

Summary: We present a case of a rectovaginal fistula which was revealed as an incidental finding at the time of posterior colporrhaphy. We describe a previously unreported 5‐layer repair through a vaginal approach in preference to the more frequently reported approaches of endoanal flap or conversion to a fourth degree tear. The diagnosis and management of rectovaginal fistulas is discussed.
ESTABLISHMENT OF MINIMAL AND MAXIMAL TRANSCRIPT LEVELS FOR NITRATE TRANSPORTER GENES FOR DETECTING NITROGEN DEFICIENCY IN THE MARINE PHYTOPLANKTON ISOCHRYSIS GALBANA (PRYMNESIOPHYCEAE) AND THALASSIOSIRA PSEUDONANA (BACILLARIOPHYCEAE)1
Authors: Kang Lee‐Kuo , Hwang Sheng‐Ping L. , Lin Hsing‐Juh , Chen Pei‐Chung , Chang Jeng
Published: July 2009

Nitrate transporter genes (Nrt2) encode high‐affinity nitrate transporters in marine phytoplankton, and their transcript levels are potential markers of nitrogen deficiency in eukaryotic phytoplankton. For the proper interpretation of measured Nrt2 transcript abundances, a relative expression assay was proposed and tested in Isochrysis galbana Parke (Prymnesiophyceae) and Thalassiosira pseudonana (Hust.) Hasle et Heimdal (Bacillariophyceae). The minimal transcript levels of Nrt2 genes were achieved by the addition of 100 μM ammonium, which led to a rapid decline in Nrt2 transcripts in 10–30 min. Experiments using a concentration series revealed that the effective dosage of ammonium to create a minimal transcript level of ∼1 μmol · mol−1 18S rRNA was ≥25 μM in both species. On the other hand, the addition of l‐methionine sulfoximine (MSX), an inhibitor of glutamine synthetase, enhanced the Nrt2 transcript level in I. galbana but did not affect that in T. pseudonana. Nitrogen deprivation was used as an alternative means to create maximal Nrt2 transcript levels. By transferring cells into N‐free medium for 24 h, Nrt2 transcript levels increased to ∼90 μmol · mol−1 18S rRNA in I. galbana, and to ∼800 μmol · mol−1 18S rRNA in T. pseudonana. The degree of nitrogen deficiency thus can be determined by comparing original Nrt2 transcript levels with the minimal and maximal levels.
Comparison of Cryoballoon and Radiofrequency Ablation of Pulmonary Veins in 40 Patients with Paroxysmal Atrial Fibrillation: A Case‐Control Study
Authors: LINHART MARKUS , BELLMANN BARBARA , MITTMANN‐BRAUN ERICA , SCHRICKEL JAN W. , BITZEN ALEXANDER , ANDRIÉ RENÉ , YANG ALEXANDER , NICKENIG GEORG , LICKFETT LARS , LEWALTER THORSTEN
Published: July 2009

Introduction: Ablation of pulmonary veins (PV) is an established therapeutic option for patients with symptomatic drug‐refractory paroxysmal atrial fibrillation (AF). Radiofrequency (RF) is currently the most widespread energy source for PV ablation. Cryothermal energy applied with a cryoballoon technique as an alternative has recently evolved.

Methods and Results: In a case‐control setting, we compared 20 patients with paroxysmal AF who underwent their first PV ablation with the cryoballoon technique to 20 matched patients with conventional RF ablation. In the case of persistent electrical potentials after cryoballoon ablation, it was combined with ablation with a conventional cryocatheter. All patients performed daily event recording for 3 months after ablation procedure. Ablation parameters and success rate after 3 and 6 months were compared. In the cryoballoon group, the overall success rate was 55% (50% in the cryoballoon only group [14 patients] and 66% in the combination group [6 patients]), as opposed to the RF group with 45%. AF episode burden was lower after cryoballoon ablation. There was no significant difference between cryoballoon and RF ablation regarding procedure parameters. In the cryoballoon group, 3 phrenic nerve palsies occurred using the 23 mm balloon that resolved spontaneously.

Conclusion: PV ablation with the cryoballoon technique is feasible and seems to have a similar success rate in comparison to RF ablation. Procedure‐ and fluoroscopy duration are not longer than in conventional RF ablation.
Catheter Ablation of Recurrent Scar‐Related Ventricular Tachycardia Using Electroanatomical Mapping and Irrigated Ablation Technology: Results of the Prospective Multicenter Euro‐VT‐Study
Authors: TANNER HILDEGARD , HINDRICKS GERHARD , VOLKMER MARIUS , FURNISS STEVE , KÜHLKAMP VOLKER , LACROIX DOMINIQUE , DE CHILLOU CHRISTIAN , ALMENDRAL JESÚS , CAPONI DOMENICO , KUCK KARL‐HEINZ , KOTTKAMP HANS
Published: July 2009

Catheter Ablation of Ventricular Tachycardia. Introduction: Ventricular tachycardia (VT) late after myocardial infarction is an important contributor to morbidity and mortality. This prospective multicenter study assessed the efficacy and safety of electroanatomical mapping in combination with open‐saline irrigated ablation technology for ablation of chronic recurrent mappable and unmappable VT in remote myocardial infarction.

Methods and Results: In 8 European institutions, 63 patients (89% males) were enrolled in the study. All patients had remote myocardial infarction and presented with a median number of 17 (range 1–380) VTs in the preceding 6 months. Incessant VT was present in 14 patients (22%). Left ventricular ejection fraction measured 30 ± 13%. A mean of 3 VTs were targeted per patient and 22% of all patients had only unmappable VT. The mean follow‐up period was 12 ± 3 months. A total of 164 VTs were targeted during catheter ablation. Ablation was acutely successful in 51 patients (81%). One patient (1.5%) experienced a major complication with degeneration of VT into ventricular fibrillation necessitating cardiopulmonary resuscitation maneuvers. However, no death occurred acutely or within the first 30 days after catheter ablation. During the follow‐up, 19 of the initially successful ablated patients (37%) and 31 of all ablated patients (49%) developed some type of VT recurrence.

Conclusions: The results of this multicenter study demonstrate the high acute success rate and a low complication rate of irrigated tip catheter ablation of all clinical relevant VTs in remote myocardial infarction. However, during the follow‐up a relevant number of recurrences occurred. (J Cardiovasc Electrophysiol, Vol. 21, pp. 47–53, January 2010)
Does the Risk‐Benefit Analysis Favor the Extraction of Failed, Sterile Pacemaker and Defibrillator Leads?
Authors: VENKATARAMAN GANESH , HAYES DAVID L. , STRICKBERGER S. ADAM
Published: July 2009

Transvenous pacemaker and defibrillator (PM‐D) lead failure is an important clinical problem. Lead extraction is routinely performed in patients with transvenous pacemaker and defibrillator (PM‐D) infections. The management of sterile PM‐D leads that have failed or are no longer required is less uniform. While extraction of excess or failed sterile PM‐D leads is often advocated, the risk of lead extraction must be weighed against the risk of abandoning these leads. There are no randomized trials comparing lead extraction with abandoning sterile leads in this setting. What then are the data that are used to advocate the extraction of excess or failed, sterile chronically implanted PM‐D leads, and are the data adequate to make this recommendation?
Radiofrequency Ablation Guided by Mechanical Termination of Idiopathic Ventricular Arrhythmias Originating in the Right Ventricular Outflow Tract
Authors: KÜHNE MICHAEL , SARRAZIN JEAN‐FRANCOIS , CRAWFORD THOMAS , EBINGER MATTHEW , GOOD ERIC , CHUGH AMAN , JONGNARANGSIN KRIT , PELOSI Jr. FRANK , ORAL HAKAN , MORADY FRED , BOGUN FRANK M.
Published: July 2009

Mapping of Idiopathic Ventricular Arrhythmias. Background: Termination of ventricular tachycardia (VT) by mechanical pressure has been described for fascicular and postinfarction VT. Mechanical interruption of idiopathic ventricular arrhythmias (VT/premature ventricular complexes [PVCs]) arising in the right ventricular outflow tract (RVOT) has not been described in systematic fashion.

Methods: Eighteen consecutive patients (13 females, age 49 ± 13 years, ejection fraction 0.55 ± 0.12) underwent mapping and ablation of RVOT VT or PVCs. In 7 patients, 9 distinct VTs (mean cycle length 440 ± 127 ms), and in 11 patients, 11 distinct PVCs originating in the RVOT were targeted. Mechanical termination was considered present if a reproducibly inducible VT was no longer inducible or if frequent PVCs suddenly ceased with the mapping catheter at a particular location. Endocardial activation time, electrogram characteristics, and pace‐mapping morphology were assessed at this location. Radiofrequency energy was delivered if mechanical termination was observed.

Results: All targeted arrhythmias were successfully ablated. In 7 of 18 patients (39%), catheter manipulation terminated the arrhythmia with the mapping catheter located at a particular site. Local endocardial activation time was earlier at sites of mechanical termination (−31 ± 7 ms) compared with effective sites without termination (−25 ± 3 ms, P = 0.04). The 10‐ms isochronal area was smaller in patients with mechanical interruption (0.35 ± 0.2 cm2) than in patients without mechanical termination (1.33 ± 0.9 cm2, P = 0.01). At all sites susceptible to mechanical trauma, the pace map displayed a match with the targeted VT/PVC. All sites where mechanical termination of VT or PVCs occurred were effective ablation sites.

Conclusions: Mechanical suppression at the site of origin of idiopathic RVOT arrhythmias frequently occurs during the mapping procedure and is a reliable indicator of effective ablation sites. Mechanical termination of RVOT arrhythmias may be indicative of a more localized arrhythmogenic substrate. (J Cardiovasc Electrophysiol, Vol. 21, pp. 42–46, January 2010)
The Optimal Automatic Algorithm for the Mapping of Complex Fractionated Atrial Electrograms in Patients With Atrial Fibrillation
Authors: TSAI WEN‐CHIN , LIN YENN‐JIANG , TSAO HSUAN‐MING , CHANG SHIH‐LIN , LO LI‐WEI , HU YU‐FENG , CHANG CHIEN‐JUNG , TANG WEI‐HUA , TUAN TA‐CHUN , UDYAVAR AMEYA R. , WANG JI‐HUNG , CHEN SHIH‐ANN
Published: July 2009

CFAEs and the Voltage. Introduction: Catheter ablation of atrial fibrillation (AF) can be guided by the identification of complex fractionated atrial electrograms (CFAEs). We aimed to study the prediction of the CFAEs defined by an automatic algorithm in different atrial substrates (high voltage areas vs low voltage areas).

Methods and Results: This study included 13 patients (age = 56 ± 12 years, paroxysmal AF = 8 and persistent AF = 5), who underwent mapping and catheter ablation of AF with a NavX system. High‐density voltage mapping of the left atrium (LA) was performed during sinus rhythm (SR) (248 ± 75 sites per patient) followed by that during AF (88 ± 24 sites per patient). The CFAE maps were based on the automatic‐detection algorithm. “Operator‐determined CFAEs” were defined according to Nademannee's criteria. A low‐voltage zone (LVZ) was defined as a bipolar voltage of less than 0.5 mV during SR. Among a total of 1150 mapping sites, 459 (40%) were categorized as “operator‐determined CFAE sites,” whereas 691 (60%) were categorized as “operator‐determined non‐CFAE sites.” The sensitivity and negative predictive value increased as the fractionated interval (FI) value of the automatic algorithm increased, but the specificity and positive predictive value decreased. The automatic CFAE algorithm exhibited the highest combined sensitivity and specificity with an FI of <60 ms for the sites inside the LVZ and FI < 70 ms for the sites outside the LVZ, when compared with a single threshold for both the high‐ and low‐voltage groups combined (i.e., no regard for voltage) (ROC: 0.89 vs 0.86).

Conclusions: The clinical relevance of the CFAE map would be improved if the calculated index values were accordingly scaled by the electrogram peak‐to‐peak amplitude. (J Cardiovasc Electrophysiol, Vol. 21, pp. 21–26, January 2010)
Safety and Efficacy of Bivalirudin in High‐risk Patients Admitted Through the Emergency Department
Authors: Miller Chadwick D. , Blomkalns Andra L. , Gersh Bernard J. , Pollack Charles V. , Brogan Gerard X. , Diercks Deborah B. , Frank Peacock W. , Stone Gregg W. , Hollander Judd E. , Manoukian Steven V. , Hoekstra James W. ,   on behalf of the ACUITY Investigators
Published: July 2009

Objectives:  The objective was to assess the safety and efficacy of bivalirudin monotherapy in patients with high‐risk acute coronary syndrome (ACS) presenting to the emergency department (ED).

Methods:  Data from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial were used to conduct a post hoc subgroup analysis of high‐risk ACS patients (cardiac biomarker elevation or ST‐segment deviation) who initially presented to the ED. The ACUITY trial randomized patients to receive heparin (unfractionated [UFH] or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Endpoints included composite ischemia, major bleeding (not coronary artery bypass graft (CABG) related), and net clinical outcome (major bleeding plus composite ischemia).

Results:  Of 13,819 participants in the ACUITY trial, 6,441 presented initially to the ED, met high‐risk criteria, and were included in the primary analysis. Bivalirudin alone when compared to heparin plus GPI, after adjusting for covariates, was associated with an improvement in net clinical outcome (12.3% vs. 14.3%, adjusted odds ratio [OR] = 0.81, 95% confidence interval [CI] = 0.66 to 0.99), similar composite ischemia (9.3% vs. 9.1%, adjusted OR = 0.98, 95% CI = 0.77 to 1.24), and less major bleeding (4.0% vs. 6.8%, adjusted OR = 0.57, 95% CI = 0.42 to 0.75). Bivalirudin plus GPI when compared to heparin plus GPI had similar net clinical outcome (13.8% vs. 14.3%, adjusted OR = 0.91, 95% CI = 0.75 to 1.11), composite ischemia (8.8% vs. 9.1%, adjusted OR = 0.87, 95% CI = 0.69 to 1.11), and major bleeding (6.8% vs. 6.8%, adjusted OR = 1.01, 95% CI = 0.79 to 1.30).

Conclusions:  Bivalirudin monotherapy decreases major bleeding while providing similar protection from ischemic events compared to heparin plus GPI in patients with high‐risk ACS admitted through the ED.
Perceived Challenges to Obtaining Informed Consent for a Time‐sensitive Emergency Department Study of Pediatric Status Epilepticus: Results of Two Focus Groups
Authors: Chamberlain James M. , Lillis Kathleen , Vance Cheryl , Brown Kathleen M. , Fawumi Olubunmi , Nichols Shari , Davis Colleen O. , Singh Tasmeen , Baren Jill M. ,   the Pediatric Emergency Care Applied Research Network (PECARN)
Published: July 2009

Objectives:  The objective was to describe the perspective of research personnel on issues of informed consent in a time‐sensitive clinical study under emergency circumstances.

Methods:  The authors convened concurrent focus groups of research staff and investigators involved in a pharmacokinetic study of lorazepam for status epilepticus (SE). Moderators led discussion with open‐ended questions on selected issues of parental consent, communication and understanding, patient assent, and comparison to other types of studies. Focus group transcripts were analyzed to identify themes and subthemes from the discussions.

Results:  Most themes and subthemes were identified in both research staff and investigator focus groups. Focus group discussion points were categorized into three main themes: barriers to and enablers of informed consent, barriers to and enablers of actual enrollment, and overall ethical concerns about the research. Many of the issues identified were unique to emergency research.

Conclusions:  From the perspectives of research staff and investigators enrolling patients in a time‐sensitive emergency department study, the authors identified several areas of concern that should be addressed when planning future emergency studies.
Emergency Physician High Pretest Probability for Acute Coronary Syndrome Correlates with Adverse Cardiovascular Outcomes
Authors: Chandra Abhinav , Lindsell Christopher J. , Limkakeng Alexander , Diercks Deborah B. , Hoekstra James W. , Hollander Judd E. , Douglas Kirk J. , Frank Peacock W. , Brian Gibler W. , Pollack Charles V. ,   on behalf of the EMCREG i*trACS Investigators
Published: July 2009

Objectives:  The value of unstructured physician estimate of risk for disease processes, other than acute coronary syndrome (ACS), has been demonstrated. The authors sought to evaluate the predictive value of unstructured physician estimate of risk for ACS in emergency department (ED) patients without obvious initial evidence of a cardiac event.

Methods:  This was a post hoc secondary analysis of the Internet Tracking Registry for Acute Coronary Syndromes (i*trACS), a prospectively collected multicenter data registry of patients over the age of 18 years presenting to the ED with symptoms of ACS between 1999 and 2001. In this registry, following patient history, physical exam, and electrocardiogram (ECG), the unstructured treating physician estimate of risk was recorded. A 30‐day follow‐up and a medical record review were used to determine rates of adverse cardiac events, death, myocardial infarction (MI), or revascularization procedure. The analysis included all patients with nondiagnostic ECG changes, normal initial biomarkers, and a non‐MI initial impression from the registry and excluded those without complete data or who were lost to follow‐up. Data were stratified by unstructured physician risk estimate: noncardiac, low risk, high risk, or unstable angina.

Results:  Of 15,608 unique patients in the registry, 10,145 met inclusion/exclusion criteria. Patients were defined as having unstable angina in 6.0% of cases; high risk, 23.5% of cases; low risk, 44.2%; and noncardiac, 26.3% of cases. Adverse cardiac event rates had an inverse relationship, decreasing from 22.0% (95% confidence interval [CI] = 18.8% to 25.6%) for unstable angina, 10.2% (95% CI = 9.0% to 11.5%) for those stratified as high risk, 2.2% (95% CI = 1.8% to 2.6%) for low risk, and to 1.8% (95% CI = 1.4% to 2.4%) for noncardiac. The relative risk (RR) of an adverse cardiac event for those with an initial label of unstable angina compared to those with a low‐risk designation was 10.2 (95% CI = 8.0 to 13.0). The RR of an event for those with a high‐risk initial impression compared to those with a low‐risk initial impression was 4.7 (95% CI = 3.8 to 5.9). The risk of an event among those with a low‐risk initial impression was the same as for those with a noncardiac initial impression (RR = 0.83, 95% CI = 0.6 to 1.2).

Conclusions:  In ED patients without obvious initial evidence of a cardiac event, unstructured emergency physician (EP) estimate of risk correlates with adverse cardiac outcomes.
Design and Implementation of a Controlled Clinical Trial to Evaluate the Effectiveness and Efficiency of Routine Opt‐out Rapid Human Immunodeficiency Virus Screening in the Emergency Department
Authors: Haukoos Jason S. , Hopkins Emily , Byyny Richard L. , Conroy Amy A. , Silverman Morgan , Eisert Sheri , Thrun Mark , Wilson Michael , Boyett Brian , Heffelfinger James D. ,   for the Denver ED HIV Opt‐Out Study Group
Published: July 2009

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt‐out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC’s recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi‐experimental equivalent time‐samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt‐out rapid HIV screening (intervention) to physician‐directed diagnostic rapid HIV testing (control) in a high‐volume urban ED. In addition, three nested observational studies were performed to evaluate the cost‐effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED‐based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED‐based health services research.
Validation of the AMPFℓSTR® MiniFilerTM PCR Amplification Kit for Use in Forensic Casework*
Authors: Luce Coral , Montpetit Shawn , Gangitano David , O’Donnell Patrick
Published: July 2009

Abstract:  The AmpFℓSTR® MiniFilerTM PCR Amplification Kit is designed to genotype degraded and/or inhibited DNA samples when the AmpFℓSTR® IdentifilerTM PCR Amplification Kit is incapable of generating a complete genetic profile. Validation experiments, following the SWGDAM guidelines, were designed to evaluate the performance of MiniFiler. Data obtained demonstrated that MiniFiler, when used in conjunction with Identifiler, provided an increased ability to obtain genetic profiles from challenged samples. The optimum template range was found to be between 0.2 and 0.6 ng, with 0.3 ng yielding the best results. Full concordance was achieved between the MiniFiler kit and Identifiler kit except in a single case of a null allele at locus D21S11. Numerous instances of severe heterozygous peak imbalance (<50%) were observed in single source samples amplified within the optimum range of input DNA suggesting that caution be taken when attempting to deduce component genotypes in a mixture.
Transforming Dissatisfaction With Services Into Self‐Determination: A Social Psychological Perspective on Community Program Effectiveness1
Authors: Macias Cathaleene , Aronson Elliot , Hargreaves William , Weary Gifford , Barreira Paul J. , Harvey John , Rodican Charles F. , Bickman Leonard , Fisher William
Published: July 2009

A field study of supported employment for adults with mental illness provided an experimental test of cognitive dissonance theory. We predicted that most work‐interested individuals randomly assigned to a non‐preferred program would reject services and lower their work aspirations. However, individuals who chose to pursue employment through a non‐preferred program were expected to resolve this dissonance through favorable service evaluations and strong efforts to succeed at work. Significant Work Interest × Service Preference interactions supported these predictions. Over 2 years, participants interested in employment who obtained work through a non‐preferred program stayed employed a median of 362 days vs. 108 days for those assigned to a preferred program; participants who obtained work through a non‐preferred program also had higher service satisfaction.