Lawrence Rosenthal

EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles

BACKGROUND There is a lack of prospective, randomized studies comparing the diagnostic yield and complication rates of 22-gauge and 25-gauge needles during EUS-FNA of solid pancreatic masses. OBJECTIVES Our primary aim was to compare the diagnostic yield of 22-gauge and 25-gauge needles. Secondary aims included determining the number of needle passes performed, ease of needle passage, and complications. DESIGN Prospective, randomized study. SETTING Tertiary referral centers at Yale University School of Medicine, New Haven, Connecticut, and Virginia Piper Cancer Institute, Minneapolis, Minnesota. PATIENTS Patients with a suspected solid pancreatic mass from February 2007 to June 2008 were enrolled. INTERVENTIONS Patients were randomized to EUS-FNA with a 22-gauge or 25-gauge needle. MAIN OUTCOME MEASUREMENTS A diagnostic result was defined as cytology findings positive for malignant cells. RESULTS A total of 131 patients were enrolled: EUS-FNA was performed with a 22-gauge needle in 64 patients and with a 25-gauge needle in 67 patients. Cytology was diagnostic in 120 (91.6%) of 131 patients overall: 56 (87.5%) of 64 with 22-gauge needles and 64 (95.5%) of 67 with 25-gauge needles (no statistically significant difference was found between the 2 groups; P=.18). A similar number of passes was performed in both arms (mean [SD] 2.6 [1.2] each; P=.96). There were no complications in either group. LIMITATION A larger number of patients is needed to determine small differences in diagnostic yield. CONCLUSIONS This is the first prospective, randomized trial comparing 22-gauge and 25-gauge needles in EUS-FNA of solid pancreatic masses. We achieved equally high diagnostic yields by using a similar number of passes, showing that 25-gauge needles are an effective alternative to 22-gauge needles.

ACUTE RADIATION DERMATITIS FOLLOWING RADIOFREQUENCY CATHETER ABLATION OF ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA

Radiation exposure during fluoroscopic imaging poses potential risks to patients and physicians, especially during protracted cardiovascular or radiological interventional procedures. We describe a woman with refractory paroxysmal supraventricular tachycardia who underwent radiofrequency catheter ablation of the slow pathway involved in atrioventricular nodal reentrant tachycardia. The patient subsequently returned 4 weeks later with acute radiation dermatitis that was retrospectively attributed to a malfunction in the fluoroscopy unit that lacked a maximum current output cut‐off switch. Using dose reconstruction studies and her estimated biological response, we determined that she received between 15 and 20 Gy (1 Gy = 100 rods) to the skin on her back during the procedure. The exposure will result in an increase in her lifelong risk of skin and lung cancer. This article underscores the potential for radiation‐induced injury during lengthy therapeutic procedures using x‐ray equipment.

Comparison of the Efficacy and Safety of Two Biphasic Defibrillator Waveforms for the Conversion of Atrial Fibrillation to Sinus Rhythm

The overall efficacy of transthoracic biphasic shocks delivered for conversion of atrial fibrillation (AF) has been demonstrated. We compared 2 different energy waveforms, either the biphasic rectilinear (BRL) waveform or the biphasic truncated exponential (BTE) waveform, in the conversion of AF to sinus rhythm. The relation between energy required for the conversion of AF, the type of biphasic waveform, and patient characteristics were examined. Serum levels of cardiac troponin I were measured before and after cardioversion, as well as postprocedural skin erythema and discomfort. In this prospective trial, 101 patients (mean age 61 +/- 15 years, 72 men [71%]) referred for elective electrical cardioversion of AF were randomized to either a BTE or a BRL device. Shocks were delivered in a step-up fashion beginning with 50 J (then 100 J, 200 J, repeat 200 J, and then crossover to 360 J). One hundred patients were successfully converted to sinus rhythm (99% success rate). There was no difference in efficacy at any energy level used, regardless of the duration of the arrhythmia. In addition, there was no difference in cumulative success. Troponin I did not significantly increase after cardioversion, regardless of the total energy used. A positive correlation between skin erythema and skin discomfort after shock (24 to 48 hours) was seen with increasing cumulative energies. There was also a positive trend toward increasing energy requirements as chest circumference and body mass index increased. Thus, biphasic waveforms are safe and effective at converting AF to sinus rhythm. In this study population, there was no clinical difference between the BRL and the BTE waveforms.

Brain Natriuretic Peptide Levels Fall Rapidly after Cardioversion of Atrial Fibrillation to Sinus Rhythm

Background: Brain natriuretic peptide (BNP) levels have been reported to fall following cardioversion of atrial fibrillation (AF). The mechanism for the fall in BNP has not been elucidated and the potential confounding effects of sedation have not been investigated. Sedation may alter BNP levels via its effects on loading conditions. Accordingly, we studied whether BNP levels change shortly after cardioversion and attempted to control for possible effects of sedation. Methods: BNP levels were obtained before and after cardioversion in patients with AF and in a control group of patients undergoing intravenous conscious sedation for transesophageal echocardiography. Results: BNP levels dropped (260 ± 255 vs. 190 ± 212 pg/ml, p < 0.05) 40 min after cardioversion, decreasing in 33 of 41 subjects who achieved sinus rhythm. By contrast, mean BNP did not fall in subjects in whom cardioversion was not successful. The change in BNP level was not related to the degree of change in heart rate. No control subject experienced a change in cardiac rhythm; BNP levels increased (195 ± 407 vs. 238 ± 458 pg/ml, p < 0.05) in 18/22 subjects after sedation. Baseline BNP levels were elevated in subjects with AF, and BNP levels were elevated in parallel with heart failure symptoms. Conclusions: The rapid fall in BNP after cardioversion (1) may reflect prompt hemodynamic improvement associated with rhythm change and (2) does not appear to be due to the effects of sedation.

Device diagnostics and long-term clinical outcome in patients receiving cardiac resynchronization therapy

AIMS This retrospective analysis sought to develop and validate a model using the measured diagnostic variables in cardiac resynchronization therapy (CRT) devices to predict mortality. METHODS AND RESULTS Data used in this analysis came from two CRT studies: Cardiac Resynchronization Therapy Registry Evaluating Patient Response with RENEWAL Family Devices (CRT RENEWAL) (n = 436) and Heart Failure-Heart Rate Variability (HF-HRV) (n = 838). Patients from CRT RENEWAL were used to create a model for risk of death using logistic regression and to create a scoring system that could be used to predict mortality. Results of both the logistic regression and the clinical risk score were validated in a cohort of patients from the HF-HRV study. Diagnostics significantly improved over time post-CRT implant (all P < 0.001) and were correlated with a trend of decreased risk of death. The regression model classified CRT RENEWAL patients into low (2.8%), moderate (6.9%), and high (13.8%) risk of death based on tertiles of their model predicted risk. The clinical risk score classified CRT RENEWAL patients into low (2.8%), moderate (10.1%), and high (13.4%) risk of death based on tertiles of their score. When both the regression model and the clinical risk score were applied to the HF-HRV study, each was able to classify patients into appropriate levels of risk. CONCLUSION Device diagnostics may be used to create models that predict the risk of death.

The Influence of Atrial and Ventricular Pacing on the Incidence of Atrial Fibrillation: A Meta-Analysis

Background:  The effect of atrial pacing on the incidence of atrial fibrillation (AF) is unknown. Furthermore, the threshold of ventricular pacing that is associated with a higher incidence of AF has yet to be determined. Thus, we set out to determine the optimal pacing modality in patients with sinus node dysfunction (SND) for the prevention of AF.

Reduced heart rate variability correlates with insulin resistance but not with measures of obesity in population undergoing laparoscopic Roux-en-Y gastric bypass

BACKGROUND Obesity is associated with a pathologic predominance of sympathetic over parasympathetic tone. With respect to the heart, this autonomic dysfunction presents as a decreased heart rate variability (HRV), which has been associated with increased cardiovascular morbidity. Gastric bypass (GB) reduces cardiovascular mortality, and, thus, could beneficially affect the HRV. We sought to identify the factors predictive of HRV in a severely obese population of undergoing GB at a university hospital in the United States. METHODS The data of all patients presenting for GB were included in a prospective database. The homeostatic model of assessment (HOMA) was used to calculate the insulin resistance and glucose disposition index. A 24-hour Holter monitor was used to assess the HRV. Measurements were repeated at 2 weeks and 6 months postoperatively. The correlations between variables were determined using linear mixed models. RESULTS We studied 30 patients undergoing GB. All exhibited some degree of reduced HRV that improved postoperatively. The HOMA-insulin resistance inversely correlated with the HRV, and the HOMA-glucose disposition index directly correlated with the parameters of HRV in our longitudinal models. Weight, body mass index, excess body weight, gender, and age did not correlate with HRV. Improvements in HRV correlated with reductions in the average heart rate, underscoring a postoperative increase in relative vagal tone. CONCLUSION HRV in the severely obese is better predicted by the degree of insulin resistance, than by the degree of obesity, age, or gender. GB led to an improvement in HRV, the magnitude of which correlated with the change in insulin resistance and glucose disposition index, but not with weight loss.

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions

BACKGROUND Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). OBJECTIVE The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions. METHODS The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead. Device interrogation was performed at enrollment, pre-MRI and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects (SADEs) through 1 month post-MRI, (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V), and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. RESULTS Two hundred twenty-six patients completed the MRI and 1-month post-MRI follow-up. No adverse events related to the implanted system and the MRI procedure occurred, resulting in an SADE-free rate of 100.0% (229/229, P <.001). Freedom from atrial and ventricular pacing threshold increase was 99.0% (189/191, P = .003) and 100% (217/217, P <.001), respectively. Freedom from P- and R- wave amplitude attenuation was 99.4% (167/168, P <.001) and 99.5% (193/194, P <.001), respectively. CONCLUSION The results of the ProMRI/ProMRI AFFIRM studies demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to head and lower lumbar MRI conditions.

Factors influencing pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CAPTURE Trial.

Objectives:  The CAPTURE study evaluated the accuracy of automated atrial and right ventricular (RV) threshold algorithms.

Inappropriate ICD Therapy Due to Proarrhythmic ICD Shocks and Hyperpolarization

A 50‐year‐old man with an ischemic cardiomyopathy underwent ICD implantation for inducible ventricular fibrillation (VF). Sixteen months later he experienced inappropriate ICD therapy due to atrial fibrillation with a rapid ventricular response. The initial shock resulted in the initiation of VF (proarrhythmia) and the patient received an additional shock converting his rhythm to an idioventricular rhythm with a cycle length of 490 ms (122 beats/min). Due to lead hyperpolarization, the device oversensed ventricular events and the patient subsequently received additional shocks. (PACE 2004; 27:415–416)