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Johannes Brachmann

Publications and source records attributed to Johannes Brachmann.

15 recordsLinked to original sources
PubMed2006

Results of the first clinical study of adjunctive CAldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial Infarction: the randomized multicentre CASTEMI study.

AIMS: To examine the safety and efficacy of intravenous caldaret in patients with large acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: STEMI patients (n=387) with > or =10 mm summed ST-deviation on electrocardiogram were randomized to receive a 48 h infusion of caldaret 57.5 mg [lower dose (LD)], caldaret 172.5 mg [higher dose (HD)], or placebo, starting before PCI. Both HD and LD were well tolerated. In 247 patients with pre-PCI TIMI 0/1, there was no effect of HD or LD on single photon emission computed tomography infarct size or ejection fraction assessed at Day 7 and Day 30. Subgroup analyses suggest that future work in patients with anterior MI might be warranted. CONCLUSION: This first human experience with caldaret prior to direct PCI for large STEMI shows a good safety profile. No evidence of efficacy was discerned. Subgroup analyses in anterior MI patients showed some effects in endpoints studied, however, these findings require confirmation in a further study if a drug effect is to be established.

Angioplasty, Balloon, Coronary↗
PubMed2006

A new method to investigate the response to the morphology discrimination algorithm in patients with ICD.

BACKGROUND: Inappropriate therapy for supraventricular tachyarrhythmia is still a major problem in implantable cardioverter defibrillators (ICD). The morphology discrimination algorithm compares the morphology of a tachycardia electrogram with a stored template on a beat-to-beat basis. However, algorithm responders could not yet be identified prior to the occurrence of first tachycardia episodes. We analyzed whether rapid atrial pacing and/or exercise testing can be used for identification of responders and compared the results with ICD detected tachycardia. METHODS: 22 patients (16 male, 61+/-14 years) with dual-chamber ICDs have been enrolled. Patients underwent a standardized bicycle exercise testing and an atrial pacing protocol. For both tests, morphology match scores of 8 consecutive beats were analyzed for each 10-bpm-step increment above sinus rhythm. Patients were categorized as responders, if morphology match was > or = 90% of tested heart rates. During follow-up, ICD stored episodes with morphology discrimination activated were evaluated. RESULTS: There were no significant differences between morphology match (85+/-29% vs. 84+/-27%) and linear regression slope B (-0.19+/-0.87 vs. -0.20+/-0.48) during exercise testing and atrial pacing. 16 patients (73%) were classified as responders. During follow-up (739+/-338 days) 121 sustained supraventricular (n=88) and ventricular tachycardia (n=33) were detected in 10 patients (45%). Specificity for tachycardia discrimination was 78% overall, 100% in responders and 22% in non-responders. CONCLUSION: Exercise testing and atrial pacing were equally suitable for identification of patients who seem to respond to the morphology discrimination algorithm with a high specificity for ventricular tachycardia discrimination. Thus, morphology match tests are suggested to optimize tachycardia discrimination and to reduce inadequate therapies.

Algorithms↗
PubMed2005

Response of atrial fibrillation to pulmonary vein antrum isolation is directly related to resumption and delay of pulmonary vein conduction.

BACKGROUND: The role of pulmonary vein (PV) isolation in ablative treatment of atrial fibrillation (AF) has been debated in conflicting reports. We sought to compare PV conduction in patients who had no AF recurrence (group I), patients who could maintain sinus rhythm on antiarrhythmic medication (group II), and patients who had recurrent AF despite antiarrhythmic medication (group III) after PV antrum isolation (PVAI). METHODS AND RESULTS: PV conduction was examined in consecutive patients undergoing second PVAI for AF recurrence. We also recruited some patients cured of AF to undergo a repeat, limited electrophysiological study at >3 months after PVAI. All patients underwent PVAI with an intracardiac echocardiography (ICE)-guided approach with complete isolation of all 4 PV antra (PVA). The number of PVs with recurrent conduction and the shortest atrial to PV (A-PV) conduction delay was measured with the use of consistent Lasso positions defined by ICE. Late AF recurrence was defined as AF >2 months after PVAI with the patient off medications. Patients in groups I (n=26), II (n=37), and III (n=44) did not differ at baseline (38% permanent AF; ejection fraction 53+/-6%). Recurrence of PV-left atrial (LA) conduction was seen in 1.7+/-0.8 and 2.2+/-0.8 PVAs for groups II and III but only in 0.2+/-0.4 for group I (P=0.02). In patients with recurrent PV-LA conduction, the A-PV delay increased from the first to second procedure by 69+/-47% for group III, 267+/-110% for group II, and 473+/-71% for group I (P<0.001). When pacing was at a faster rate, A-PV block developed in all 5 of the group I patients with recurrent PV-LA conduction. CONCLUSIONS: The majority of patients with drug-free cure show no PV-LA conduction recurrence. Substantial A-PV delay is seen in patients able to maintain sinus rhythm on antiarrhythmic medication or cured of AF compared with patients who fail PVAI.

Anticoagulants↗
PubMed2005

Assessment of temperature, proximity, and course of the esophagus during radiofrequency ablation within the left atrium.

BACKGROUND: Left atrioesophageal fistula is a devastating complication of atrial fibrillation ablation. There is no standard approach for avoiding this complication, which is caused by thermal injury during ablation. The objectives of this study were to evaluate the course of the esophagus and the temperature within the esophagus during pulmonary vein antrum isolation (PVAI) and correlate these data with esophagus tissue damage. METHODS AND RESULTS: Eight-one patients presenting for PVAI underwent esophagus evaluation that included temperature probe placement. Esophagus course was obtained with computed tomography, 3D imaging (NAVX), or intracardiac echocardiography. For each lesion, the power, catheter and esophagus temperature, location, and presence of microbubbles were recorded. Lesion location and esophagus course were defined with 6 predetermined left atrial anatomic segments. Endoscopy evaluated tissue changes during and after PVAI. Of 81 patients, the esophagus coursed near the right pulmonary veins in 23 (28.4%), left pulmonary veins in 31 (38.3%), and mid-posterior wall in 27 (33%). Esophagus temperature was significantly higher during left atrial lesions along its course than with lesions elsewhere (38.9+/-1.4 degrees C, 36.8+/-0.5 degrees C, P<0.01). Lesions that generated microbubbles had higher esophagus temperatures than those without (39.3+/-1.5 degrees C, 38.5+/-0.9 degrees C, P<0.01). Power was not predictive of esophagus temperatures. Distance between the esophagus and left atrium was 4.4+/-1.2 mm. CONCLUSIONS: Lesions near the course of the esophagus that generated microbubbles significantly increased esophagus temperature compared with lesions that did not. Power did not correlate with esophagus temperatures. Esophagus variability makes the avoidance of lesions along its course difficult. Rather than avoiding posterior lesions, emphasis could be placed on better esophagus monitoring for creation of safer lesions.

Adult↗
PubMed2005

Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial.

CONTEXT: Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation (AF). Pulmonary vein isolation (PVI) with radiofrequency ablation may cure AF, obviating the need for antiarrhythmic drugs and anticoagulation. OBJECTIVE: To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF. DESIGN, SETTING, AND PARTICIPANTS: A multicenter prospective randomized study conducted from December 31, 2001, to July 1, 2002, of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs. INTERVENTION: Patients were randomized to receive either PVI using radiofrequency ablation (n=33) or antiarrhythmic drug treatment (n=37), with a 1-year follow-up. MAIN OUTCOME MEASURES: Recurrence of AF, hospitalization, and quality of life assessment. RESULTS: Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up. At the end of 1-year follow-up, 22 (63%) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 (13%) of 32 patients who received PVI (P<.001). Hospitalization during 1-year follow-up occurred in 19 (54%) of 35 patients in the antiarrhythmic drug group compared with 3 (9%) of 32 in the PVI group (P<.001). In the antiarrhythmic drug group, the mean (SD) number of AF episodes decreased from 12 (7) to 6 (4), after initiating therapy (P = .01). At 6-month follow-up, the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey. There were no thromboembolic events in either group. Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 (6%) of 32 patients in the PVI group. CONCLUSION: Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF. Larger studies are needed to confirm its safety and efficacy.

Anti-Arrhythmia Agents↗
PubMed2005

Effectiveness and safety of sirolimus-eluting stents in the treatment of restenosis after coronary stent placement.

BACKGROUND: In-stent restenosis is notoriously difficult to treat by repeat catheter intervention because of its propensity for aggressive recurrent neointimal formation. This study sought to assess the effectiveness and safety of the sirolimus-eluting stent in the treatment of in-stent restenosis. METHODS AND RESULTS: The study was designed as a prospective multicenter registry. We included 162 patients with in-stent restenosis of a native coronary artery who had a clinical indication for repeat intervention. Patients were scheduled for follow-up angiography at 6 months. The primary end point was in-lesion late loss. Follow-up angiography was performed in 155 patients. We obtained an in-lesion late loss of 0.08+/-0.49 mm and a binary restenosis rate of 9.7% (15/155), which prompted reintervention in 7.4% (12/162) at 9 months. The 9-month rate of death was 1.2% (2/162) and that of nonfatal myocardial infarction was 1.2% (2/162). CONCLUSIONS: Sirolimus-eluting stents were highly efficacious and safe in the treatment of in-stent restenosis. Our study provides rationale for the use of sirolimus-eluting stents in the treatment of in-stent restenosis.

Aged↗
PubMed2005

Design of the SHock Inhibition Evaluation with Azimilide (SHIELD) study: a novel method to assess antiarrhythmic drug effect in patients with an implantable cardioverter-defibrillator.

This report presents the rationale and study design details of the SHock Inhibition Evaluation with Azimilide study, which is recruiting 624 patients with implantable cardioverter-defibrillators (ICDs) who are at risk for life-threatening ventricular arrhythmia, randomized to azimilide 75 mg, azimilide 125 mg, or placebo and followed for 1 year. The objective of this study is to determine the effect of azimilide versus placebo on the symptomatic ventricular arrhythmia burden using a unique statistical analysis based on the unusual temporal distribution of symptomatic ICD therapies. The primary efficacy end points are time to all-cause shocks and time to all-cause shocks plus symptomatic ventricular arrhythmic events triggering antitachycardia pacing measured from randomization.

Anti-Arrhythmia Agents↗
PubMed2005

Embolic events and char formation during pulmonary vein isolation in patients with atrial fibrillation: impact of different anticoagulation regimens and importance of intracardiac echo imaging.

UNLABELLED: Thromboembolic events are important complications of pulmonary vein isolation (PVI) procedures, occurring in up to 2.8% of patients. In this study, we report the incidence of char formation and embolic events with different anticoagulation protocols prospectively changed to reduce such complication. METHODS: A total of 785 patients (mean age: 54 years, 83.5% male) underwent catheter-based PVI for treatment of drug refractory, symptomatic atrial fibrillation (AF). PVI was performed utilizing different strategies including radiofrequency (RF) using temperature control energy delivery and RF using intracardiac echocardiography (ICE)-guided power titration. Patients were divided based on the anticoagulation protocol into three groups: in group 1 (194 patients), activation coagulation time (ACT) was maintained between 250 and 300 seconds; in group 2 (180 patients), ACT was maintained between 300 and 350 seconds plus the IV infusion of eptifibatide (135 microg/kg bolus + 0.5 microg/kg/min); and in group 3 (411 patients), ACT was maintained between 350 and 400 seconds. RESULTS: Char formation was detected in 69 patients of group 1, 5 of group 2, and 8 of group 3. An embolic event was observed in 7 patients of group 1, 3 of group 2, and 2 of group 3 (P = 0.01; group 1 vs group 3). Higher degree of anticoagulation with heparin was associated with a reduced incidence of embolic events even after removing the patients undergoing ICE-guided ablation (P = 0.04). CONCLUSION: More aggressive anticoagulation with heparin reduced periprocedural embolic events. The use of platelet inhibition does not have incremental beneficial effect. None of the anticoagulation protocol abolished char formation.

Anticoagulants↗
PubMed2004

Placebo-controlled, randomized clinical trial of azimilide for prevention of ventricular tachyarrhythmias in patients with an implantable cardioverter defibrillator.

BACKGROUND: Although implanted cardioverter defibrillators (ICDs) effectively treat sustained ventricular tachyarrhythmias, up to 50% of ICD recipients eventually require concomitant antiarrhythmic drug therapy to prevent symptomatic arrhythmia recurrences and hence reduce the number of device therapies. METHODS AND RESULTS: A total of 633 ICD recipients were enrolled in a randomized, double-blind, placebo-controlled study to evaluate the effect of daily doses of 75 or 125 mg of azimilide on recurrent symptomatic ventricular tachyarrhythmias and ICD therapies. Total all-cause shocks plus symptomatic ventricular tachycardia (VT) terminated by antitachycardia pacing (ATP) were significantly reduced by azimilide, with relative risk reductions of 57% (hazard ratio [HR]=0.43, 95% CI 0.26 to 0.69, P=0.0006) and 47% (HR=0.53, 95% CI 0.34 to 0.83, P=0.0053) at 75- and 125-mg doses, respectively. The reductions in all-cause shocks with both doses of azimilide did not achieve statistical significance. The incidence of all appropriate ICD therapies (shocks or ATP-terminated VT) was reduced significantly among patients taking 75 mg of azimilide (HR=0.52, 95% CI 0.30 to 0.89, P=0.017) and those taking 125 mg of azimilide (HR=0.38, 95% CI 0.22 to 0.65, P=0.0004). Five patients in the azimilide groups and 1 patient in the placebo group had torsade de pointes; all were successfully treated by the device. One patient taking 75 mg of azimilide had severe but reversible neutropenia. CONCLUSIONS: Azimilide significantly reduced the recurrence of VT or ventricular fibrillation terminated by shocks or ATP in ICD patients, thereby reducing the burden of symptomatic ventricular tachyarrhythmia.

Anti-Arrhythmia Agents↗
PubMed2004

Mode of initiation and ablation of ventricular fibrillation storms in patients with ischemic cardiomyopathy.

OBJECTIVES: We report on the initiation of ventricular fibrillation (VF) storm in patients with ischemic cardiomyopathy (ICM) and the results of targeted ablation to treat VF storm. BACKGROUND: Monomorphic premature ventricular contractions (PVCs) have been shown to initiate VF in patients without structural heart disease. METHODS: A total of 29 patients with ICM and documented VF initiation were identified. In 21 patients, VF storm was controlled with antiarrhythmic drugs and/or treatment of heart failure. Eight patients with VF (mean 52 +/- 25 episodes) refractory to medical management required ablation. All patients underwent three-dimensional electroanatomical mapping using CARTO (Biosense-Webster Inc., Diamond Bar, California), and PVCs were mapped when present. Scarred areas were identified using voltage mapping. RESULTS: Monomorphic PVCs initiated VF in all 29 identified patients. Five of eight patients requiring ablation had frequent PVCs that allowed PVC mapping. The earliest activation site was consistently located in the scar border zone. The PVCs were always preceded by a Purkinje-like potential (PLP). Ablation was successfully performed at these sites. In three patients, infrequent PVCs prevented mapping, but PLPs were recorded around the scar border. Ablation targeting these potentials along the scar border was successfully performed. During follow-up (10 +/- 6 months), one patient had a single VF episode and another developed sustained, monomorphic ventricular tachycardia. There was no recurrence of VF storm. CONCLUSIONS: Ventricular fibrillation in ICM is triggered by monomorphic PVCs originating from the scar border zone with preceding PLPs; targeting these PVCs may prevent VF recurrence. In the absence of PVCs, both substrate mapping and ablation appear to be equally effective.

Aged↗
PubMed2004

Immediate Risk-Stratification Improves Survival (IRIS): study protocol.

BACKGROUND: To date, the implantable cardioverter-defibrillator (ICD) has been shown to be effective for primary prevention of sudden cardiac death only in selected groups of patients in the chronic phase after myocardial infarction. METHODS AND RESULTS: The Immediate Risk-Stratification Improves Survival (IRIS) Study compares ICD therapy with no ICD therapy in selected high risk patients early after myocardial infarction. Special emphasis is placed on optimal acute and long term medical therapy in all patients including metoprolol CR/ZOK. The hypothesis is tested that use of the ICD reduces overall mortality. For that purpose, consecutive acute ST elevation or non-ST elevation myocardial infarction patients are collected in a registry. From this denominator, patients are screened, and enrolled early after myocardial infarction (day 5 to day 31) if they exhibit both a reduced left ventricular ejection fraction < or =40% and a heart rate > or =100 bpm on the first available electrocardiogram (criterion I), or non-sustained ventricular tachycardia at a rate > or =150 bpm during Holter (criterion II). CONCLUSIONS: IRIS is a large scale prospective, randomized trial to evaluate the benefit of ICD therapy for reduction of total mortality in patients considered at high risk of sudden death early after acute myocardial infarction.

Clinical Protocols↗
PubMed2003

Relationship between selected overdrive parameters and the therapeutic outcome and tolerance of atrial overdrive pacing.

There is a paucity of information on the influence of selected overdrive parameters on the clinical efficacy and tolerance of atrial overdrive algorithms to suppress atrial tachyarrhythmias. Data from a completed clinical trial investigating a new DDD+ overdrive algorithm implemented in a permanent pacemaker were analyzed. One-hundred patients with standard pacing indications and atrial tachyarrhythmias were enrolled and followed for 6 months in DDD and 6 months in DDD+ mode in a randomized, crossover fashion. The overdrive step size was programmed at the discretion of the investigators between 4 and 12 beats/min, overdrive plateau length between 10 and 32 beats, and maximum overdrive rate between 100 and 160 beats/min. The effects of DDD+ versus DDD mode on burden and incidence of atrial tachyarrhythmias stored in the mode switch memory were examined as a function of the programmed overdrive parameters. An overdrive step size between 7 and 12 beats/min, and higher a maximum overdrive rate between 121 and 160 beats/min were slightly more effective than lower programmed values, though > 500 randomized, crossover observations would have been necessary to verify statistical significance. Overdrive pacing related symptoms mandated early manual deactivation of overdrive pacing in 4.7% of 85 evaluated patients. Overdrive was disabled without testing tolerability of less aggressive overdrive values. There was no link between patient symptoms and programmed overdrive step size or overdrive plateau length values.

Aged↗
PubMed2003

The influence of concomitant drug therapy on the efficacy of atrial overdrive stimulation for prevention of atrial tachyarrhythmias.

Data from the completed "Suppression of Atrial Fibrillation by DDD+ Overdrive Pacing with Inos2 CLS (closed-loop system) Pacemakers" multicenter trial were retrospectively evaluated to examine the influence of concomitant antiarrhythmic drugs on the clinical success of conventional single site right atrial overdrive pacing compared with DDD pacing. The DDD+ overdrive algorithm provided > 90% atrial pacing at a rate slightly above the intrinsic atrial rate. Seventy-five patients with conventional pacing indications and paroxysmal, recurrent atrial tachyarrhythmia have completed the study. They were randomized to 6 months of DDD or DDD+ pacing, followed by mode crossover and an additional 6-month follow-up in the alternate mode. The incidence of atrial tachyarrhythmia during each period was compared using data on sustained (> 60 s) mode switch episodes stored in the pacemaker memory. A stable antiarrhythmic drug regimen was allowed during the study. beta-Adrenergic blockers and Class III antiarrhythmics, prescribed to 54.7% and 40.0% of patients respectively, were linked to minimal or no benefit of overdrive pacing compared with DDD pacing. In contrast, patients untreated with beta-adrenergic blockers or Class III drugs had a significant reduction in atrial tachyarrhythmia burden of > 5 hours/patient per week (P < 0.05) during overdrive. Changes with Class I and Class IV antiarrhythmic drugs, prescribed to 18.7% and 13.3% of patients, respectively, were insignificant. Our data indicate that clinical trials that prohibit the use of beta-adrenergic blockers may record more favorable outcomes with dynamic atrial overdrive algorithms versus conventional DDDR pacing, than studies allowing concomitant beta-adrenergic blockade.

Adrenergic beta-Antagonists↗
PubMed2003

Mortality, morbidity, and complications in 3344 patients with implantable cardioverter defibrillators: results fron the German ICD Registry EURID.

ICDs are the therapy of choice in patients with life-threatening ventricular arrhythmias. Mortality, morbidity, and complication rates including appropriate and inappropriate therapies are unknown when ICDs are used in routine medical care and not in well-defined patients included in multicenter trials. Therefore, the data of 3,344 patients (61.1 +/- 12.1 years; 80.2% men; CAD 64.6%, dilated cardiomyopathy 18.9%; NYHA Class I-III: 19.1%, 54.3%, 20.1%, respectively; LVEF > 0.50: 0.234, LVEF 0.30-0.50: 0.472, LVEF < 0.30: 0.293, respectively) implanted in 62 German hospitals between January 1998 and October 2000 were prospectively collected and analyzed as a part of the European Registry of Implantable Defibrillators (EURID Germany). The 1-year survival rate was 93.5%. Patients in NYHA Class III and aLVEF < 0.30 had a lower survival rate than patients in NYHA Class I and a preserved LVEF (0.852 vs 0.975,P = 0.0001). Including the 1-year follow-up, 49.5% of patients had an intervention by the ICD, 39.8% had appropriate ICD therapies, 16.2% had inappropriate therapies. Overall, 1,691 hospital readmissions were recorded. The main causes for hospital readmissions were ventricular arrhythmias (61.3%) and congestive heart failure symptoms (12.9%). Thus, demographic data and mortality of patients treated with an ICD in conditions of standard medical care seems to be comparable and based on, or congruent with, the large secondary preventions trials. When ICDs are used in standard medical care, the 1-year survival rate is high, especially in patients with NYHA Class I and preserved LVEF. However, nearly half of all patients suffer from ICD intervention.

Defibrillators, Implantable↗