Novel Percutaneous Epicardial Autonomic Modulation in the Canine for Atrial Fibrillation: Results of an Efficacy and Safety Study.

BACKGROUND: Endocardial ablation of atrial ganglionated plexi (GP) has been described for treatment of atrial fibrillation (AF). Our objective in this study was to develop percutaneous epicardial GP ablation in a canine model using novel energy sources and catheters. METHODS: Phase 1: The efficacy of several modalities to ablate the GP was tested in an open chest canine model (n = 10). Phase 2: Percutaneous epicardial ablation of GP was done in six dogs using the most efficacious modality identified in phase 1 using two novel catheters. RESULTS: Phase 1: Direct current (DC) in varying doses (blocking [7-12 µA], electroporation [300-500 µA], ablation [3,000-7,500 µA]), radiofrequency ablation (25-50 W), ultrasound (1.5 MHz), and alcohol (2-5 mL) injection were successful at 0/8, 4/12, 5/7, 3/8, 1/5, and 5/7 GP sites. DC (500-5,000 µA) along with alcohol irrigation was tested in phase 2. Phase 2: Percutaneous epicardial ablation of the right atrium, oblique sinus, vein of Marshall, and transverse sinus GP was successful in 5/6 dogs. One dog died of ventricular fibrillation during DC ablation at 5,000 µA. Programmed stimulation induced AF in six dogs, preablation and no atrial arrhythmia in three, flutter in one, and AF in one postablation. Heart rate, blood pressure, effective atrial refractory period, and local atrial electrogram amplitude did not change significantly postablation. Microscopic examination showed elimination of GP, and minimal injury to atrial myocardium. CONCLUSION: Percutaneous epicardial ablation of GP using DC and novel catheters is safe and feasible and may be used as an adjunct to pulmonary vein isolation in the treatment of AF in order to minimize additional atrial myocardial ablation.

Diagnostic imaging of acute abdominal pain in adults.

Acute abdominal pain is a common presentation in the outpatient setting and can represent conditions ranging from benign to life-threatening. If the patient history, physical examination, and laboratory testing do not identify an underlying cause of pain and if serious pathology remains a clinical concern, diagnostic imaging is indicated. The American College of Radiology has developed clinical guidelines, the Appropriateness Criteria, based on the location of abdominal pain to help physicians choose the most appropriate imaging study. Ultrasonography is the initial imaging test of choice for patients presenting with right upper quadrant pain. Computed tomography (CT) is recommended for evaluating right or left lower quadrant pain. Conventional radiography has limited diagnostic value in the assessment of most patients with abdominal pain. The widespread use of CT raises concerns about patient exposure to ionizing radiation. Strategies to reduce exposure are currently being studied, such as using ultrasonography as an initial study for suspected appendicitis before obtaining CT and using low-dose CT rather than standard-dose CT. Magnetic resonance imaging is another emerging technique for the evaluation of abdominal pain that avoids ionizing radiation.

Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

Video review of family medicine resident clinical encounters: a tool for building emotional intelligence.

Video Review (VR) is a well established educational tool for developing the practice of patient-centered care in family medicine residents. There are a number of behaviorally-based checklists that can be use in both live observation as well as VR of clinical encounters to identify and promote behaviors associated with patient-centered care, most of which also overlap with behaviors associated with Emotional Intelligence (EI). We propose a VR that is structured less on a seek-and-find of clinician behaviors and more as a self-reflective exercise of how the clinician presents in the room alongside how they were feeling during that encounter. We believe that this exercise promotes the first two skills of EI (self-awareness and self-management) and then provides a foundation on which to build the second pair of skills (social awareness and relationship management). This perspective paper offers guidance, including stepwise instruction, on how to facilitate such a VR curriculum.

A randomized controlled trial of telephone-delivered cognitive-behavioral therapy for late-life anxiety disorders.

OBJECTIVES: Older adults face a number of barriers to receiving psychotherapy, such as a lack of transportation and access to providers. One way to overcome such barriers is to provide treatment by telephone. The purpose of this study was to examine the effects of cognitive behavioral therapy delivered by telephone (CBT-T) to older adults diagnosed with an anxiety disorder. DESIGN: Randomized controlled trial. SETTING: Participants' homes. PARTICIPANTS: Sixty participants age 60 and older with a diagnosis of generalized anxiety disorder, panic disorder, or anxiety disorder not otherwise specified. INTERVENTION: CBT-T versus information-only comparison. MEASUREMENTS: Coprimary outcomes included worry (Penn State Worry Questionnaire) and general anxiety (State Trait Anxiety Inventory). Secondary outcomes included clinician-rated anxiety (Hamilton Anxiety Rating Scale), anxiety sensitivity (Anxiety Sensitivity Index), depressive symptoms (Beck Depression Inventory), quality of life (SF-36), and sleep (Insomnia Severity Index). Assessments were completed prior to randomization, immediately upon completion of treatment, and 6 months after completing treatment. RESULTS: CBT-T was superior to information-only in reducing general anxiety (ES = 0.71), worry (ES = 0.61), anxiety sensitivity (ES = 0.85), and insomnia (ES = 0.82) at the posttreatment assessment; however, only the reductions in worry were maintained by the 6-month follow-up assessment (ES = 0.80). CONCLUSIONS: These results suggest that CBT-T may be efficacious in reducing anxiety and worry in older adults, but additional sessions may be needed to maintain these effects.

Opioid Use Disorder and Assessment of Patient Interactions Among Family Medicine Residents, Medical Students, and Physician Assistant Students.

Introduction: In light of the opioid overdose epidemic in the US and the necessity of developing training to conduct difficult conversations around opioid dependence, three case-based videos were created to demonstrate providers using motivational interviewing (MI) with patients who have opioid use disorder (OUD). These vignettes displayed a primary care provider interacting with a patient seeking opioids. Methods: Learners-including third-year medical and physician assistant (PA) students, and family medicine residents-viewed three videos set in a family medicine clinic and assessed clinician use of MI when interacting with patients with OUD. The patients were at different levels of acknowledging their need to change their opioid use behaviors and/or pursue treatment. Learners rated each video with an MI rating scale, and a facilitator debriefed strengths, weaknesses, and omissions regarding MI. Results: Medical and PA students, and resident family physicians provided 572 ratings. Analysis of variance of mean percent incorrect was lower in residents than in all groups combined, but failed to reach statistical significance (47% + 12.0 vs 53% + 15.0, p = .43). Discussion: These case-based videos with MI ratings afforded students and residents the opportunity to assess clinician use of MI techniques with patients with OUD. The MI rating scale had clinical significance (residents scored +5 points and had more training) despite lacking statistical significance. These scenarios allowed learners to recognize how to use MI when having a difficult conversation with patients who misuse opioids. We envision individual use or use for group discussion.

Insomnia in older adults with generalized anxiety disorder.

OBJECTIVES: The purposes of this study are to determine the frequency and severity of insomnia symptoms and related complaints experienced by older adults with Generalized Anxiety Disorder (GAD) and compare them with older adults without GAD; compare insomnia symptoms among older adults with GAD with and without comorbid depression; determine if there are age differences in insomnia severity among people with GAD; and determine if there are differences in insomnia severity between older adults with GAD and older adults diagnosed with insomnia. DESIGN: Cross-sectional. SETTING: Participants were recruited through primary care clinics, advertisements, and mass mailings. PARTICIPANTS: One hundred ten older adults; 31 with GAD, 25 with GAD and depression, 33 worried well, and 21 with no psychiatric diagnosis. MEASUREMENTS: Psychiatric diagnosis, sleep disturbance, and health. RESULTS: Participants with GAD with and without comorbid depression reported significantly greater sleep disturbance severity than participants with no psychiatric diagnosis and the worried well. There were no differences in sleep disturbances between older adults with GAD only and older adults with comorbid GAD and depression. The severity of sleep disturbance reported by older participants with GAD was greater than reports by young and middle-aged participants with GAD, and comparable with reports by older adults with a diagnosis of insomnia. CONCLUSIONS: Ninety percent of older adults with GAD report dissatisfaction with sleep and the majority report moderate to severe insomnia. These findings support the assessment of sleep disturbances within the context of late-life GAD.

Temporal Trends in Medical Student Burnout.

BACKGROUND AND OBJECTIVES: There is a paucity of longitudinal data documenting the temporal development of distress and burnout during medical school. The aim of this study was to examine trends and identify stressors associated with medical student distress over 4 years of medical education. METHODS: Medical students from the class of 2016 at a Liaison Committee on Medical Education-accredited medical school completed surveys nine times from orientation through after the residency match. Surveys included demographic variables and measured distress domains using the Medical Student Well-Being Index. The authors used Microsoft Excel to calculate the proportion of students screening positive for individual distress domains at each of the nine acquisition periods for descriptive analysis. RESULTS: Students completed 886 total surveys for an 85% response rate, which was relatively consistent across collection periods. Medical student distress and burnout increased from two (2%) to 12 (12%) respondents and from 19 (17%) to 37 (38%) respondents, respectively, from matriculation through after the residency match (P<0.01). Depersonalization increased from 15 (13%) to 34 (35%) respondents and emotional exhaustion increased from six (5%) to 22 (22%) respondents across 4 years of medical education (P<0.01). Emotional exhaustion peaked after medical school year 1, at 37 (45%), and year 3, at 45 (44%) respondents, with improvement after summer break and residency match. CONCLUSIONS: The results supported the literature demonstrating the development of burnout during medical school. Depersonalization increased early in the education process with minimal regression after development. Emotional exhaustion demonstrated a surprising increase after exposure to clinical clerkships. Further studies could support or refute the universality of these trends and evaluate prevention and intervention efforts targeting these key inflection points.

Age and racial differences in the presentation and treatment of Generalized Anxiety Disorder in primary care.

Despite the prevalence and impact of Generalized Anxiety Disorder (GAD) in the primary care setting, little is known about its presentation in this setting. The purpose of this study is to examine age and racial differences in the presentation and treatment of GAD in medical patients. Participants were recruited from one family medicine clinic and one internal medicine clinic. The prevalence of GAD was lowest for older adults. Age differences were found in the presentation of GAD, with young adults reporting greater cognitive symptoms of anxiety, negative affect, and depressive symptoms. African-Americans with GAD reported more positive affect and lower rates of treatment. The lower levels of negative affect and depressive symptoms reported among older adults may affect the recognition of GAD by primary care physicians. Further research is needed to better understand the causes of racial differences in treatment.

Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study.

BACKGROUND: One-year results of the VBLOC DM2 study found that intermittent vagal blocking (VBLOC therapy) was safe among subjects with obesity and type 2 diabetes mellitus (T2DM) and led to significant weight loss and improvements in glycemic parameters and cardiovascular risk factors. Longer-term data are needed to determine whether the results are sustained. METHODS: VBLOC DM2 is a prospective, observational study of 28 subjects with T2DM and body mass index (BMI) between 30 and 40 kg/m(2) to assess mid-term safety and weight loss and improvements in glycemic parameters, and other cardiovascular risk factors with VBLOC therapy. Continuous outcome variables are reported using mixed models. RESULTS: At 24 months, the mean percentage of excess weight loss was 22% (95% CI, 15 to 28, p < 0.0001) or 7.0% total body weight loss (95% CI, 5.0 to 9.0, p < 0.0001). Hemoglobin A1c decreased by 0.6 percentage points (95% CI, 0.2 to 1.0, p = 0.0026) on average from 7.8% at baseline. Fasting plasma glucose declined by 15 mg/dL (95% CI, 0 to 29, p = 0.0564) on average from 151 mg/dL at baseline. Among subjects who were hypertensive at baseline, systolic blood pressure declined 10 mmHg (95% CI, 2 to 19, p = 0.02), diastolic blood pressure declined by 6 mmHg (95% CI, 0 to 12, p = 0.0423), and mean arterial pressure declined 7 mmHg (95% CI, 2 to 13, p = 0.014). Waist circumference was significantly reduced by 7 cm (95% CI, 4 to 10, p < 0.0001) from a baseline of 120 cm. The most common adverse events were mild or moderate heartburn, implant site pain, and constipation. CONCLUSIONS: Improvements in obesity and glycemic control were largely sustained after 2 years of treatment with VBLOC therapy with a well-tolerated risk profile.

Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial.

BACKGROUND/OBJECTIVES: Vagal block therapy (vBloc) is effective for moderate to severe obesity at one year. SUBJECTS/METHODS: The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL) and total weight loss (%TWL) in intent-to-treat analyses. At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study. RESULTS: 18-month weight loss was 23% EWL (8.8% TWL) for vBloc and 10% EWL (3.8% TWL) for Sham (P < 0.0001). vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL). Sham regained over 40% of the 17% EWL (6.4% TWL) by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved. CONCLUSIONS: Weight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.

Percutaneous autonomic neural modulation: a novel technique to treat cardiac arrhythmia.

Ablation and anti-arrhythmic medications have shown promise but have been met with varying success and unwanted side effects such as myocardial injury, arrhythmias, and morbidity from invasive surgical intervention. The answer to improving efficacy of ablation may include modulation of the cardiac aspect of the autonomic nervous system. Our lab has developed a novel approach and device to navigate the oblique sinus and to use DC current and saline/alcohol irrigation to selectively stimulate and block the autonomic ganglia found on the epicardial side of the heart. This novel approach minimizes myocardial damage from thermal injury and provides a less invasive and targeted approach. For feasibility, proof-of-concept, and safety monitoring, we carried out canine studies to test this novel application. Our results suggest a safer and less invasive way of modulating arrhythmogenic substrate that may lead to improved treatment of AF in humans.

Hidden in plain sight: residency coordinators' social support of residents in family medicine residency programs.

BACKGROUND AND OBJECTIVES: Social support resources for family medicine residents have increased over the years in response to the challenges of residency training and Accreditation Council for Graduate Medical Education (ACGME) requirements. In all of the discussions of social support, the role of residency coordinators (RCs) has been overlooked. A national survey was conducted to expose and explore the contribution of RCs to the social support of family medicine residents. METHODS: A questionnaire was developed to identify the specific contributions to social support RCs might make and the amount of time dedicated to social support activities. The questionnaire was mailed to RCs at 459 US family medicine residencies, with a response rate of 69% (n=316). RESULTS: RCs report devoting on average approximately 6 hours a week (14% full-time equivalents) to the social support of residents. They provide ideas for solving personal and professional problems, opportunities for residents to express feelings, and emotional support. They frequently discuss resident issues with the residency director and others and often play a role in progress evaluations. CONCLUSIONS: RCs in family medicine residencies report playing an important yet often unacknowledged role in the social support of family medicine residents and often serving as a conduit for information between residents and the administration. This role raises issues concerning the recruitment, supervision, training, and job expectations of RCs.

Evaluation of acute abdominal pain in adults.

Acute abdominal pain can represent a spectrum of conditions from benign and self-limited disease to surgical emergencies. Evaluating abdominal pain requires an approach that relies on the likelihood of disease, patient history, physical examination, laboratory tests, and imaging studies. The location of pain is a useful starting point and will guide further evaluation. For example, right lower quadrant pain strongly suggests appendicitis. Certain elements of the history and physical examination are helpful (e.g., constipation and abdominal distension strongly suggest bowel obstruction), whereas others are of little value (e.g., anorexia has little predictive value for appendicitis). The American College of Radiology has recommended different imaging studies for assessing abdominal pain based on pain location. Ultrasonography is recommended to assess right upper quadrant pain, and computed tomography is recommended for right and left lower quadrant pain. It is also important to consider special populations such as women, who are at risk of genitourinary disease, which may cause abdominal pain; and the elderly, who may present with atypical symptoms of a disease.