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Biomedical subjects

R Ammer

Publications and source records attributed to R Ammer.

12 recordsLinked to original sources
PubMed2006

Bioequivalence of a methylphenidate hydrochloride extended-release preparation: comparison of an intact capsule and an opened capsule sprinkled on applesauce.

OBJECTIVE: To assess bioequivalence between an intact capsule and the content of a capsule sprinkled on applesauce. MATERIALS: Medikinet retard 20 mg capsules were obtained from Medice (Iserlohn, Germany). METHODS: This was a single-center, completely randomized, open, 2-period, 2-sequence, balanced crossover study with a washout period of 1 week between administrations, in 12 healthy male and female subjects, aged 18-45 years. Blood samples were collected over 24 hours and methylphenidate plasma concentration-time data were used to calculate pharmacokinetic parameters for both administrations. The main parameters were (confirmatory) AUC0-tz (extent of BA), Cmax, tmax (rate of BA) and (descriptively) AUC0-infinity and t1/2. Equivalence was concluded if the 90% confidence interval (CI) for the ratio between test and reference was 0.80-1.25 (AUC0-tz). RESULTS: All 12 dosed subjects finished both treatment periods and were included in pharmacokinetic and safety analyses. 90% geometric confidence intervals for AUC0-tz and Cmax data were well within accepted bioequivalence limits. The study has shown that both treatment modes lead to similar pattern of absorption and elimination following single-dose administration in the fed state. The test treatment (content of capsule sprinkled over 15 ml applesauce) is bioequivalent to the reference treatment (intact capsule) in terms of extent and rate of absorption. CONCLUSION: Data collected from this study demonstrate that Medikinet retard capsules can be opened and the content sprinkled on a tablespoon of applesauce without influencing the rate and extent of bioavailability.

Adolescent↗
PubMed1999

Marked reduction in atrial defibrillation thresholds with repeated internal cardioversion.

OBJECTIVES: This study was performed to assess the atrial defibrillation threshold in patients with recurrent atrial fibrillation (AF) using repeated internal cardioversion. BACKGROUND: Previous studies in patients with chronic AF undergoing internal cardioversion have shown this method to be effective and safe. However, current energy requirements might preclude patients with longer-lasting AF from being eligible for an implantable atrial defibrillator. METHODS: Internal shocks were delivered via defibrillation electrodes placed in the right atrium (cathode) and the coronary sinus (anode) or the right atrium (cathode) and the left pulmonary artery. After cardioversion, patients were orally treated with sotalol (mean 189 +/- 63 mg/day). Eighty consecutive patients with chronic AF (mean duration 291 +/- 237 days) underwent internal cardioversion, and sinus rhythm was restored in 74 patients. Eighteen patients underwent repeated internal cardioversion using the same electrode position and shock configuration after recurrence of AF (mean duration 34 +/- 25 days). RESULTS: In these 18 patients, the overall mean defibrillation threshold was 6.67 +/- 3.09 J for the first cardioversion and 3.83 +/- 2.62 J for the second (p = 0.003). Mean lead impedance was 55.6 +/- 5.1 ohms and 57.1 +/- 3.7 ohms, respectively (not significant). For sedation, 6.7 +/- 2.9 mg and 3.9 +/- 2.2 mg midazolam were administered intravenously (p = 0.003), and the pain score (0 = not felt, 10 = intolerable) was 5.1 +/- 1.9 and 2.7 +/- 1.8 (p = 0.001). Uni- and multivariate analyses revealed only the duration of AF before cardioversion to be of relevance, lasting 175 +/- 113 days before the first and 34 +/- 25 days before the second cardioversion in these 18 patients (p = 0.002). CONCLUSIONS: If the duration of AF is reduced, a significant reduction in defibrillation energy requirements for internal cardioversion ensues. This might extend the group of patients eligible for an implantable atrial defibrillator despite relatively high initial defibrillation thresholds.

Adult↗
PubMed1998

Unexpected recurrence of sinus rhythm in chronic atrial fibrillation due to sick sinus disease.

A 60-years old patient with symptomatic sick sinus disease was implanted a dual-chamber pacemaker that did well during the following 13 years. Thereafter, the pacemaker had to be explanted because of a systemic infection, with the patient in constant chronic atrial fibrillation in the meantime. After another asymptomatic year, 6 arrhythmogenic syncopes occurred, apparently due to pre-automatic pauses prior to spontaneous conversions to sinus rhythm. Subsequently, the patient was implanted a VVI pacemaker, whereupon he did well henceforth. This case demonstrates the possibility of recurrence of sinus rhythm even after long-standing chronic atrial fibrillation.

Arrhythmia, Sinus↗
PubMed1998

Efficacy of a new balloon catheter for internal cardioversion of chronic atrial fibrillation without anaesthesia.

OBJECTIVE: To compare a new internal cardioversion system incorporated into a balloon guided catheter with a conventional two electrode system in patients with atrial fibrillation (AF). DESIGN: Prospective study. PATIENTS: 74 patients with chronic AF treated by internal cardioversion. MATERIALS: A 7.5 F balloon catheter with high energy electrode arrays each consisting of six 0.5 cm platinum rings. Brachial vein access enables one electrode array to be placed in the left pulmonary artery (distal pole) and the other at the lateral right atrial wall (proximal pole). The conventional two electrode system consists of 6 F electrodes placed in the proximal left pulmonary artery (anode) and the lower right atrium. INTERVENTIONS: Internal cardioversion was performed by shocks delivered in 40 V incremental steps from an external defibrillator. Shocks were applied by the new device to 32 patients (group A) and by the conventional system to 42 patients (group B). RESULTS: The groups differed with respect to system positioning (9.2 (7.3) upsilon 12.3 (8.1) minutes, p < 0.05) and fluoroscopy times (1.7 (1.0) v 3.3 (2.1) minutes, p < 0.01). Sinus rhythm was restored in 30 patients of group A and in 39 of group B (NS) with mean (SD) energy requirements of 8.4 (3.1) J and 7.2 (3.1) J, respectively (NS). CONCLUSIONS: This new method of internal cardioversion has comparably high primary success rates and low sedation requirements with single and two lead systems.

Adult↗
PubMed1997

Effect of electrode position on outcome of low-energy intracardiac cardioversion of atrial fibrillation.

The aim of this study was to evaluate the new method of low-energy, catheter-based intracardiac cardioversion in patients with chronic atrial fibrillation (AF) and to compare 2 different lead positions. Accordingly, we prospectively studied 80 consecutive patients with chronic AF (9.8 +/- 7.9 months) who were randomly assigned to undergo internal cardioversion either via defibrillation electrodes placed in the right atrium and coronary sinus (coronary sinus group) or via defibrillation electrodes placed in the right atrium and left pulmonary artery (pulmonary artery group). Intracardiac shocks were delivered by an external defibrillator synchronized to the QRS complex. After conversion, all patients were treated orally with sotalol (mean daily dose, 189 +/- 63 mg/day). For conversion to sinus rhythm, the overall mean energy requirement was 5.6 +/- 3.1 J. In the coronary sinus group, cardioversion was achieved in 35 of 38 patients at a mean energy level of 4.1 +/- 2.3 J (range 1.0 to 9.9), and in the pulmonary artery group in 39 of 42 patients with 7.2 +/- 3.1 J (range 2.5 to 14.8). Although there was no difference with regard to success rate, the energy differed significantly between the 2 groups (p < 0.01). Mean lead impedance was 56.4 +/- 7.0 omega and 54.6 +/- 8.5 omega, respectively (p = NS). No serious complications were observed in either lead group. At a mean follow-up of 14.2 +/- 7.0 months, 54% and 56%, respectively, of patients who had been converted successfully remained in sinus rhythm. Thus, low-energy biphasic shocks delivered between the right atrium and coronary sinus or pulmonary artery are equally effective for cardioversion of patients with chronic AF. The energy requirements for conversion from a pulmonary artery electrode position are higher than for the coronary sinus position.

Administration, Oral↗
PubMed1997

Patient characteristics and underlying heart disease as predictors of recurrent atrial fibrillation after internal and external cardioversion in patients treated with oral sotalol.

The aim of this study was to identify predictors for recurrent atrial fibrillation after internal and external cardioversion in 157 patients. After cardioversion, patients were treated orally with sotalol (174 +/- 54 mg/day). Univariate predictors for recurrence included coronary artery disease (p < 0.05) and advanced age (p < 0.05). Multivariate adjusted risk for relapse increased with the presence of coronary artery disease (odds ratio [OR] 3.4, 95% confidence interval [CI] 1.6 to 8.0), presence of atrial fibrillation > 2 months before cardioversion (OR 2.3; 95% CI 1.4 to 4.5), left atrial diameter > 60 mm (OR 2.1; 95% CI 1.2 to 3.1), and age > 65 years (OR 1.6; 95% CI 1.3 to 3.3). In 26% of patients with lone atrial fibrillation, recurrence was observed compared with 51% of patients with underlying structural heart disease (p < 0.05). The mode of conversion, internal or external, had no impact on the recurrence rate. These findings might be useful for selection of the most appropriate therapy for the individual patient.

Administration, Oral↗
PubMed1997

A comparison of treatment of atrial fibrillation with low-energy intracardiac cardioversion and conventional external cardioversion.

AIM: Low-energy (1 to 15 J), catheter-based intracardiac cardioversion was compared with transthoracic external cardioversion (360 J) in a prospective, cross-over clinical trial. METHODS AND RESULTS: In 187 consecutive patients with chronic atrial fibrillation, over a period of a mean of 10.0 +/- 7.3 (SD) months, 217 cardioversion attempts were made. Intracardiac shocks were randomly applied between two 6-F catheters located in either the right atrium and coronary sinus or between the right atrium and left pulmonary artery. When a cardioversion attempt with one method failed, the other method was implemented. After cardioversion, all patients were treated orally with sotalol with a mean daily dose of 174 +/- 54 mg. Internal cardioversion was more effective than external cardioversion (65/70 = 93% vs 92/117 = 79%, P < 0.01). The mean energy for successful cardioversion was 5.8 +/- 3.2 J for the internal and 313 +/- 71 J for the external cardioversion group. At a mean follow-up of 12.5 +/- 6.4 months, 48% (38%) of the patients treated with internal (external) cardioversion were in sinus rhythm (P < 0.05). In 22 of 25 patients in whom external cardioversion failed, sinus rhythm was restored with internal cardioversion at a mean energy of 6.5 +/- 3.0 J. Overweight patients had twice the risk of unsuccessful external cardioversion. CONCLUSIONS: Internal cardioversion is effective in restoring sinus rhythm. It might be indicated in patients in whom external cardioversion had failed or in whom external cardioversion is assumed to be difficult or even contraindicated.

Adult↗
PubMed1997

Pain threshold for low energy intracardiac cardioversion of atrial fibrillation with low or no sedation.

UNLABELLED: Recent studies have shown that internal cardioversion of atrial fibrillation is safe and effective. In this randomized prospective study, we have tried to evaluate the influence of different waveforms on the perception of pain during internal cardioversion in patients with chronic atrial fibrillation. METHODS: Internal cardioversion was performed with minimal or no sedation in 31 consecutive patients. R wave triggered, biphasic shocks of 6 ms/6 ms or 3 ms/3 ms duration (randomly selected) and approximately 65% tilt were used starting with a 50-V test shock. The shock intensity was increased in 40-V steps up to a maximum voltage of 520 V Shocks were applied via two custom-made catheters (Elecath, Rahway, NJ). In 16 patients (3 females, age 61 +/- 11 years, left atrium diameter 58 +/- 5 mm, duration of atrial fibrillation 4 +/- 4 months), 6/6 waveforms were used, and in 15 patients (1 female, age 62 +/- 5 years, left atrium diameter 59 +/- 4 mm, duration of atrial fibrillation 5 +/- 2 months), 3/3 waveforms were used. After cardioversion, each patient was asked to quantify their pain on a scale from 0-10 (0 = no pain, 10 = intolerable). Fourteen of the 15 patients in the 3/3 ms and 15 of the 16 patients in the 6/6 ms group were successfully cardioverted. Patients from the 6/6 waveform group were cardioverted with a lower mean voltage of 254/92 versus 355/127 V (P < 0.02), at lower pain score 1.8 +/- 1.3 versus 4.2 +/- 2.2 (P < 0.05) with equivalent energy (6.8 +/- 2.8 versus 6.2 +/- 1.5 J, n.s.) and required lower doses of midazolam of 2.2 +/- 1.9 versus 4.0 +/- 1.8 mg IV (P < 0.02). The waveform used in internal cardioversion seems to have a major impact on the patients' perception of pain. These results imply that energy determines the success of a shock, but voltage determines the pain perceived by the patient. The use of waveforms that deliver greater energy at lower peak voltages offers the possibility of internal cardioversion with less sedation and greater patient tolerance.

Atrial Fibrillation↗
PubMed1997

Evaluation of a new treadmill exercise protocol.

STUDY OBJECTIVES: To confirm that a newly drafted treadmill exercise protocol designed on a theoretical basis to span a range of 0 to 200 W with approximately 25-W increments by alteration of either speed or grade from one stage to the next should correspond to a standard bicycle protocol consisting of 25-W steps. DESIGN: Randomized, crossover study to compare both exercise test modes. STUDY PARTICIPANTS: Twenty-one consecutive healthy volunteers. INTERVENTIONS: Subjects underwent both exercise tests until either exhaustion or completion of the respective protocol, and cardiopulmonary exercise parameters were assessed during either of them. For comparison, correlation coefficients (r) were calculated. RESULTS: Exercise tolerance time was 9% higher on the treadmill (p<0.05). Ten subjects completed the bicycle program, whereas 18 subjects did so on the treadmill. With both protocols, there were comparably linear increases in heart rate (r=0.885), oxygen uptake (r=0.925), oxygen uptake per body weight (r=0.944), carbon dioxide output (r=0.937), and minute ventilation (r=0.914). For the 2-min stage duration, a plateau in oxygen uptake was achieved with neither protocol. The ventilatory equivalent for oxygen, which is not linear, showed its minimum at comparable workloads, at the point of surpassing the anaerobic threshold. Correlation of oxygen pulse was fair (r=0.896). CONCLUSIONS: There was an excellent correlation of the parameters with respect to both measured values at identical workloads and slopes of both protocols, thus enabling comparability of treadmill and bicycle ergometry. Due to its practical handling, the new protocol may facilitate acceptance, especially when used for elderly or disabled patients.

Adult↗
PubMed1996

Low energy intracardiac cardioversion after failed conventional external cardioversion of atrial fibrillation.

OBJECTIVES: This study was designed to evaluate the efficacy of intracardiac cardioversion in patients with chronic atrial fibrillation after unsuccessful external cardioversion. BACKGROUND: Previous studies in patients with atrial fibrillation undergoing intracardiac cardioversion have suggested that intracardiac cardioversion is highly effective and safe. However, the characteristics of patients who benefit most from this invasive technique are unknown. METHODS: We prospectively studied 25 consecutive patients with chronic atrial fibrillation (11 +/- 9 months). All patients had undergone at least three attempts at conventional external transthoracic cardioversion by means of paddles in an anteroposterolateral position applying energies up to 360 J without success. Intracardiac shocks were delivered by an external defibrillator through defibrillation electrodes placed in the right atrium and coronary sinus or in the right atrium and left pulmonary artery. After conversion, all patients were treated orally with sotalol (mean 194 +/- 63 mg/day). RESULTS: Internal cardioversion was successful in 22 of 25 patients at a mean defibrillation threshold of 6.5 +/- 3.0 J. Mean lead impedance was 56.4 +/- 7.4 omega. No severe complications were observed. At a mean follow-up of 15 +/- 12 months, 12 (55%) of the patients treated successfully remained in sinus rhythm. CONCLUSIONS: In patients with failed external cardioversion, internal cardioversion offers a new option for restoring sinus rhythm. Intracardiac cardioversion is an effective and safe method and can be easily performed in patients with minimal sedation.

Adult↗
PubMed1996

Improving accelerometer-based rate adaptive pacing by means of second-generation signal processing.

Accelerometer-based rate adaptive pacing has gained widespread clinical use. Limitations exist for the distinction between walking upstairs and downstairs. It was the aim of this study to evaluate a new signal processing algorithm for more physiological rate adaptation. A custom-made pacemaker incorporating an accelerometer was randomly fixed to the left or right chest of 16 pacemaker patients (7 females, age: 64 +/- 11 years), 18 elderly study participants (6 females, age: 62 +/- 11 years), and 15 students (7 females age: 23 +/- 2 years). Study participants walked on level ground, upstairs and downstairs at five different step rates (72, 84, 96, 108, and 120 steps/min) controlled by an acoustic quartz metronome. The accelerometer signals, recorded on a portable data recorder, were analyzed with respect to frequency content, peak average of the mean acceleration, and morphology characteristics of the acceleration signal above and below zero baseline. By calculating the quotient of the signal's duration above and below zero baseline, a reliable discrimination between walking upstairs and downstairs was possible. A correction of the Leaky integrator signal by the new quotient yielded a more adequate rate adaptation to walking up and downstairs to represent at the patient's daily life activities. A more physiological rate adaptation can be achieved when using not only the accelerometer signal's amplitude, but applying additionally the morphology criterium of the acceleration signal's content in the positive and negative direction.

Acceleration↗