Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial.

BACKGROUND: Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias. METHODS: In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software. RESULTS: Acute PV isolation was achieved in 98% of PVs-using LICU-only in 77.3% (153/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12 months or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae. CONCLUSIONS: In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03639597.

Betting on CPR: a modern version of Pascal's Wager.

Many patients believe that cardiopulmonary resuscitation (CPR) is more likely to be successful than it really is in clinical practice. Even when working with accurate information, some nevertheless remain resolute in demanding maximal treatment. They maintain that even if survival after cardiac arrest with CPR is extremely low, the fact remains that it is still greater than the probability of survival after cardiac arrest without CPR (ie, zero). Without realising it, this line of reasoning is strikingly similar to Pascal's Wager, a Renaissance-era argument for accepting the proposition for God's existence. But while the original argument is quite logical-if not universally compelling-the modern variant makes several erroneous assumptions. The authors here present a case of a patient who unwittingly appeals to Pascal's Wager to explain his request for maximal treatment, in order to highlight the crucial divergences from the original Wager. In understanding the faulty assumptions inherent in the application of Pascal's Wager to code status decisions-and identifying the underlying motivations which the Wager serves to confirm-providers can better ensure that the true values and preferences of patients are upheld.

The Other Side of Medical Student Mistreatment: Teaching Cultural Competency Across the Generational Divide.

Introduction: Medical student mistreatment continues to be a significant problem despite increased awareness and longitudinal efforts to address the issue. Through audience discussions of a previously published film depicting learner mistreatment, we identified challenges created by student behaviors that negatively impact the learning environment. In addition, the need to address cultural competency in a multigenerational clinical environment became apparent. Methods: We created a film of three vignettes based on perspectives shared in focus groups by faculty, residents, nurses, and staff who work with medical students. We used this film to develop student and faculty curricula elucidating generational differences in behaviors and expectations while also exploring the learner's role in creating a more positive learning environment. Results: Our film was presented to medical education professionals at faculty development workshops and meetings, clerkship students at orientation sessions, residents as part of residents-as-teachers curricula, and faculty at departmental grand rounds. Evaluation data from 176 students and 42 faculty showed that a majority of our participants believed the film accurately reflected challenges they faced in the learning environment and felt better equipped to address them. Discussion: Film is an effective way to stimulate discussion about complex interactions in the clinical learning environment. Divergent perspectives on behaviors depicted in the film served as a stimulus to create targeted curricula for faculty and student education. Stimulating dialogue through film may enhance understanding and empathy among disparate groups, which is likely to be a necessary step for lasting change.

The Effectiveness of Standardized Patient Simulation in Training Hospital Ethics Committees.

Clinical simulation using standardized patients has become standard in medical education--and is now being incorporated into some graduate programs in bioethics--for both formative and summative evaluation. In most hospitals, though, clinical ethics consultation is done by the ethics committee (or a subset of it). This study is the first, to our knowledge, to examine the effectiveness of standardized patient simulation in training hospital ethics committees to deal with ethically complex and emotionally fraught clinical situations. Following a substantial revision of the institution's nonbeneficial treatment policy, ethics committee members underwent a simulation to determine whether a specific requested treatment should be withheld on the basis of futility. Pre- and post-intervention surveys showed improvement in all domains, although the small sample size limited the power of the study, with only one measure showing a statistically significant difference. An interesting incidental finding was that one-quarter of committee members voted against a determination of futility, even though the case clearly met the definition set forth in the policy. This highlights the emotional challenges in implementing an ethically rigorous, unanimously accepted policy that ultimately determines the timing and manner of a patient's death.

Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study.

BACKGROUND: Contact force (CF) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation. This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation. METHODS AND RESULTS: A total of 300 patients with symptomatic, drug-refractory, paroxysmal atrial fibrillation were enrolled in a prospective, multicenter, randomized, controlled trial and randomized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter (control). The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months. The primary safety end point included device-related serious adverse events. End points were powered to show noninferiority. All pulmonary veins were isolated in both groups. Effectiveness was achieved in 67.8% and 69.4% of subjects in the CF and control arms, respectively (absolute difference, -1.6%; lower limit of 1-sided 95% confidence interval, -10.7%; P=0.0073 for noninferiority). When the CF arm was stratified into optimal CF (≥90% ablations with ≥10 g) and nonoptimal CF groups, effectiveness was achieved in 75.9% versus 58.1%, respectively (P=0.018). The primary safety end point occurred in 1.97% and 1.40% of CF patients and control subjects, respectively (absolute difference, 0.57%; upper limit of 1-sided 95% confidence interval, 3.61%; P=0.0004 for noninferiority). CONCLUSIONS: The CF ablation catheter met the primary safety and effectiveness end points. Additionally, optimal CF was associated with improved effectiveness. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT01278953.

Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial.

BACKGROUND: To date no study has attempted to continuously evaluate changes in hemodynamics during delayed cord clamping in humans. We aimed to demonstrate 1. the feasibility of measurements of hemodynamics during delayed cord clamping and 2. to describe the changes that occur over each minute. RESULTS: After vaginal delivery, term infants (37(0)-41(6) weeks) were placed on a Life Start® bed 10-20 cm below the placenta. Transcutaneous sensors were placed on the neck and chest to determine heart rate, stroke volume and cardiac output at each beat. Once a signal was obtained, first 5 values (taken every beat) were averaged and the percent change for each subject from baseline was calculated. 20 infants were enrolled and all had a reliable signal obtained from transcutaneous sensors and had a delay in cord clamping for about 5 minutes. Cardiac output increased from 2 to 5 minutes of life (p = 0.008). For every minute of life the cord was kept unclamped, the stroke volume increased 13.1% ± 12.3 (p = 0.0001) and cardiac output increased 12.6% ± 6.3 from baseline (p < 0.0001). While the majority of infants continued to have an increase in cardiac output at 5 minutes of life, 7/20 infants reached their peak cardiac output at 188 ± 41 seconds of life. CONCLUSIONS: This study demonstrates that hemodynamic measures could be successfully obtained during the first five minutes of birth and while a newborn was receiving delayed cord clamping. This study also provides reference values for changes in cardiac output and stroke volume in well term infants during delayed cord clamping. TRIAL REGISTRATION: Clinical Trials.gov NCT02195037 Registered 17 July 2014.

The detection of premalignant colon polyps during colonoscopy is stable throughout the workday.

BACKGROUND: Recent studies have shown that colonoscopic polyp detection decreases as the workday progresses. This may reflect time-dependent factors such as colonoscopist fatigue and decreased colon cleanliness, which can be addressed through adaptations in colonoscopy practice. OBJECTIVE: To test for time-of-day differences in adenomatous polyp (AP) and sessile serrated polyp (SSP) detection in a practice that uses split-dose bowel preparation and moderated daily colonoscopist procedure loads. DESIGN: Retrospective chart review. SETTING: Community-based, group gastroenterology practice. PATIENTS: This study involved 2439 patients undergoing surveillance or screening colonoscopy. INTERVENTION: Colonoscopy. MAIN OUTCOME MEASUREMENTS: Detection rate of all premalignant polyps (PMPs), and of APs and SSPs, individually. RESULTS: A total of 1183 PMPs were identified in 1486 eligible patients (mean PMP/colonoscopy = 0.80; PMP detection rate = 47%). In univariate and multivariate analyses, PMP detection as well as detection of APs or SSPs individually did not vary significantly in relation to the hour of the day. In a binary comparison of morning (am) versus afternoon (pm) procedures, the total polyp detection rate was 67% and 66%, respectively. For PMPs, APs, SSPs, and hyperplastic polyps (HPs), the am and pm detection rates were 46% and 47%, 41% and 44%, 8% and 8%, and 27% and 24%, respectively. Bowel preparation quality was independent of time of day and was rated excellent or good in 86% to 87% of cases. LIMITATIONS: Retrospective, nonrandomized study. CONCLUSION: Stable PMP, AP, SSP, and HP detection rates throughout the workday occur under certain practice conditions, including the use of split-dose bowel preparation and/or moderated daily colonoscopist procedure loads.

Utilização da técnica Zanetti em implantodontia associada à técnica de moldeira individual aberta. Relato de caso clínico / The zanetti technique an alternative open tray transfer impression procedure in implant dentistry

O presente trabalho apresenta um caso clínico de reabilitação oral do arco superior por intermédio de implantes associados à prótese-fixa. A moldagem de transferência foi realizada utilizando-se a Técnica Zanetti para montagem em articulador semi-ajustável. Este procedimento objetivou demonstrar que essa técnica auxilia a montagem do arco superior em uma só etapa, evitando, desta forma, a incorporação de possíveis erros associados à sequência de montagem convencionais

Low-dose transdermal estradiol for symptomatic perimenopause.

OBJECTIVE: To determine whether low-dose transdermal estrogen therapy is associated with a reduction in vasomotor symptoms in women who continue to have menstrual cycles. DESIGN: An open-label, observational evaluation conducted over 12 months in 22 consecutive perimenopausal women with vasomotor symptoms. RESULTS: Improvement in vasomotor symptoms was reported by 16 (73%) of women evaluated. Of responders, 11 characterized symptom relief as complete and 6 as moderate. Fifteen (68%) of the women remained on transdermal estrogen at 12 months. No adverse health-related events were attributed to estrogen therapy. CONCLUSION: Low-dose transdermal estrogen is well tolerated and was associated with a reduction in complaints of vasomotor symptoms before menopause. The steady-state pharmacokinetics of transdermal delivery of unopposed estrogen may be advantageous in a population sensitive to fluctuations in circulating hormone levels.

Prevalence of sensing abnormalities in dual chamber implantable cardioverter defibrillators.

BACKGROUND: The clinical efficacy of ICD therapy depends on accurate sensing of intracardiac signals and sensing algorithms. We investigated the occurrence of sensing abnormalities in patients with dual chamber ICDs. METHODS: The study group consisted of all patients with dual chamber ICDs enrolled in the LESS trial and patients implanted with dual chamber ICDs at a single center between January 1997 and July 2000. Electrograms of spontaneous ventricular arrhythmias requiring device intervention were analyzed. RESULTS: A total of 48 patients met the criteria for enrollment. Among the 244 episodes, 215 (88%) were due to ventricular tachycardia and 29 (12%) were due to ventricular fibrillation. Overall undersensing was infrequent with 12 (20%) patients exhibiting on average 2.2 undersensed beats during 26 episodes of ventricular arrhythmias. There was no delay in therapy due to undersensing. Oversensing occurred in 5 (10%) patients resulting in 13 (2.7%) episodes of inappropriate therapy. None of the patients had any lead abnormalities and oversensing resolved after device reprogramming in 4 patients while 1 patient required a separate rate sensing lead. Among patients with oversensing, 4 out of 5 were pacing before the index event while among patients with no oversensing only 5 out of 42 were pacing (P<0.001). CONCLUSIONS: Dual chamber ICDs demonstrate outstanding accuracy of sensing. However, because of the selection of patient population requiring more frequent pacing, oversensing occurs with a significant frequency. Meticulous evaluation in such patients is necessary to minimize the likelihood of oversensing and inappropriate shocks.

An evaluation of bioequivalence of two 7-day 17beta-estradiol transdermal delivery systems by anatomical site.

An open-label, randomized, crossover study was conducted to assess the bioequivalence of two 7-day transdermal 17beta-estradiol delivery systems following application to the buttock in 42 postmenopausal women. The systems tested were a generic Estradiol Transdermal System (Mylan Pharmaceuticals, Inc.) and Climara (Berlex Laboratories, Inc.), the reference product. Each system was labeled to deliver 17beta-estradiol 0.1 mg/day and was applied for 7 days. Serial serum samples were assayed for estradiol, estrone, and estrone sulfate using validated assays. The bioequivalence confidence intervals for the ratio of log-transformed 17beta-estradiol Cmax values for the Estradiol Transdermal System and Climara were outside the interval of 0.80 to 1.25, indicating that the products were not bioequivalent. Application site reactions and skin irritation were more common with the Estradiol Transdermal System than with Climara. The odds of patch lifting or detachment were 6.95 times higher with the Estradiol Transdermal System than with Climara. Because these two transdermal delivery systems had been previously shown to be bioequivalent after application to the abdomen, the findings of this study suggest that bioequivalence at one anatomical site is not indicative of bioequivalence at another.

Implantes revestidos com hidroxiapatita: uma análise clínica retrospectiva de 5 anos / Coated implants with hidroxyapatite: a clinical analysis retrospective of 5 years

O objetivo deste estudo foi realizar uma análise clínica retrospectiva de 5 anos de 2095 implantes com cobertura de hidroxiapatita instalados em 680 pacientes. Os resultados clínicos demonstraram uma taxa de sobrevida de 97.14 por cento para implantes cilíndricos e 95.07 por cento para implantes em forma de parafuso. Pode-se concluir com base na revisão de literatura e nos resultados clínicos apresentados que implantes revestidos com hidroxiapatita vêm a ser uma alternativa de tratamento em casos selecionado de edentulismo

Procedimento de elevaçäo de piso de seio maxilar para instalaçäo de implantes endoósseos / Procedures of the maxillar sinus augumentation for endosseous implant instalation

O objetivo deste trabalho foi apresentar um caso de uma paciente classe II de Kennedy da regiäo superior posterior, onde a combinaçäo de enxertos ósseos xenógeno e alógeno para elevaçäo de piso de seio maxilar e implantes revestidos com hidroxiapatita foi empregada. Esse método permitiu a substituiçäo de uma prótese parcial removível por uma prótese fixa implanto-suportada

Elevação localizada de seio maxilar / Located suspension of maxillary sinus

O objetivo deste artigo é descrever o procedimento de instalação de implantes na região posterior da maxila em casos SA2 de Misch (1987) e discutir a correta indicação e as vantagens do emprego da técnica abordada em casos unitários onde existe necessidade de elevação de assoalho de seio maxilar com remanescente ósseo inferior a 10 mm

Implantes com cobertura de hidroxiapatita / Implants with hidroxiapatite coverage

O objetivo deste estudo clínico retrospectivo foi apresentar os resultados de 3 anos de uso de 904 implantes com cobertura de hidroxiapatita instalados em 339 pacientes da clínica de um dos autores. Os resultados demonstram uma taxa de sobrevida total de 96,59 por cento

Implantes com cobertura de hidroxiapatita: uma revisão / Implants with coverage of hidroxiapatites: a review

O objetivo deste artigo foi apresentar uma revisão de literatura e uma análise da previsibilidade clínica e indicações do emprego de implantes dentais com cobertura de hidroxiapatita

Implantes osseointegrados / Osseointegrated implants

O propósito deste artigo consistiu em apresentar um caso de paciente classe II de Kennedy resolvido por intermédio de prótese fixa sobre Implantes Osseointegrados e discutir noções científicas básicas da Implantologia Oral moderna

Osseointegração na clínica odontológica: implantes de Branemark / Osseointegration in dental clinic: Branemark's implants

O objetivo deste artigo é descrever os princípios clínicos e laboratoriais que regem a instalação de próteses osseointegradas. Um caso de edentulismo parcial restaurado através da técnica de osseointegração é apresentado, mostrando-se como uma alternativa ao tratamento protético convencional