Marcus Wieczorek

A randomized comparison of transradial versus transfemoral approach for coronary angiography and angioplasty.

OBJECTIVES The aim of the study was to evaluate the safety, feasibility, and procedural variables by the transradial approach compared with the transfemoral access in a standard population of patients undergoing coronary catheterization. BACKGROUND Coronary catheterization is usually performed via the transfemoral approach. Transradial access may offer some advantages in comparison with transfemoral access especially under conditions of aggressive anticoagulation and antiplatelet treatment. METHODS Between July 2006 and January 2008, a total of 1,024 patients undergoing coronary catheterization were randomly assigned to the transradial or transfemoral approach. Patients with an abnormal Allens test, history of coronary artery bypass surgery, simultaneous right heart catheterization, chronic renal insufficiency, or known difficulties with the radial or femoral access were excluded. RESULTS Successful catheterization was achieved in 494 of 512 patients (96.5%) in the transradial and in 511 of 512 patients (99.8%) in the transfemoral group (p < 0.0001). Median procedural duration (37.0 min, interquartile range [IQR] 19.6 to 49.1 min vs. 40.2 min, IQR 24.3 to 50.8 min; p = 0.046) and median dose area product (38.2 Gycm(2), IQR 20.4 to 48.5 Gycm(2) vs. 41.9 Gycm(2), IQR 22.6 to 52.2 Gycm(2); p = 0.034) were significantly lower in the transfemoral group compared with the transradial access group. A median amount of contrast agent was similar among both groups. Vascular access site complications were higher in the transfemoral group (3.71%) than in the transradial group (0.58%; p = 0.0008) CONCLUSIONS The findings of the present study show that transradial coronary angiography and angioplasty are safe, feasible, and effective with similar results to those of the transfemoral approach. However, procedural duration and radiation exposure are higher using the transradial access. In contrast to the transfemoral route, the rate of major vascular complications was negligible using the transradial approach.

Results of Short-Term and Long-Term Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation Using Duty-Cycled Bipolar and Unipolar Radiofrequency Energy

PV Isolation Using Bipolar/Unipolar RF Energy. Background: Electrical disconnection of the pulmonary veins (PV) plays an important role in the ablation of paroxysmal atrial fibrillation (AF). Antral ablation using a conventional steerable ablation catheter often is technically challenging and time consuming.

Investigation into Causes of Abnormal Cerebral MRI Findings Following PVAC Duty-Cycled, Phased RF Ablation of Atrial Fibrillation

Asymptomatic Cerebral Lesions with Phased RF. Introduction: Left atrial catheter ablation of the pulmonary veins (PVs) is an established option for patients with atrial fibrillation (AF). Asymptomatic cerebral emboli (ACE) detected by diffusion weighted MRI (DW‐MRI) following AF ablation has been reported at varying rates. This variability may be linked to procedural variables and demographic risk factors. Animal studies with the multielectrode pulmonary vein ablation catheter (PVAC) have identified potential sources of emboli, including air introduced during PVAC introduction, inadequate anticoagulation, and high current densities when the distal (E1) and proximal (E10) electrodes are in contact. We sought to evaluate the incidence, size, and number of DW‐MRI findings with procedural modifications that potentially reduce the embolic load.

Does the number of simultaneously activated electrodes during phased RF multielectrode ablation of atrial fibrillation influence the incidence of silent cerebral microembolism

BACKGROUND Asymptomatic cerebral embolus (ACE) detected by diffusion-weighted magnetic resonance imaging (DW-MRI) following atrial fibrillation (AF) ablation has been reported at varying rates with different ablation techniques. OBJECTIVE To evaluate the incidence of ACE after phased radiofrequency ablation for AF with procedural modifications that potentially reduce the embolic load. METHODS One hundred twenty consecutive patients with AF underwent MRI before ablation, 24 hours after ablation, and at 4-6 weeks. In all patients, simultaneous activation of pulmonary vein ablation catheter electrode pairs 1 and 5 was forbidden. While in 60 group 1 patients, a maximum of 4 electrode pairs could be activated at a time, and in 60 group 2 patients, ablation was limited to a maximum of 2 pairs. All patients were on uninterrupted phenprocoumon, with an attempted activated clotting time of >300 seconds during ablation. RESULTS Both patient groups were comparable. A total of 28 DW-positive lesions were detected in 24 of 120 patients (20%). Seventeen group 1 patients (28.3%) were positive for new asymptomatic DW cerebral lesions compared with 7 group 2 patients (11.7%) (P = .039). During MRI follow-up, 3 patients (2.5%) were diagnosed with a small T2-positive asymptomatic glial scar. Procedure time was longer in group 2 patients than in group 1 patients (159 ± 39 vs 121 ± 15; P < .001). CONCLUSIONS Limiting the number of simultaneously activated electrode pairs to 2 significantly reduces the rate of ACE in patients treated with a multielectrode duty-cycled phased radiofrequency catheter system for AF. This reduction corresponds with a significant prolongation of the total procedure time.

Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial

Abstract Aims This prospective, multicentre study (PRECISION GOLD) evaluated the incidence of asymptomatic cerebral embolism (ACE) after pulmonary vein isolation (PVI) using a new gold multi-electrode radiofrequency (RF) ablation catheter, pulmonary vein ablation catheter (PVAC) GOLD. Also, procedural efficiency of PVAC GOLD was compared with ERACE. The ERACE study demonstrated that a low incidence of ACE can be achieved with a platinum multi-electrode RF catheter (PVAC) combined with procedural manoeuvres to reduce emboli. Methods and results A total of 51 patients with paroxysmal atrial fibrillation (AF) (age 57 ± 9 years, CHA2DS2-VASc score 1.4 ± 1.4) underwent AF ablation with PVAC GOLD. Continuous oral anticoagulation using vitamin K antagonists, submerged catheter introduction, and heparinization (ACT ≥ 350 s prior to ablation) were applied. Cerebral magnetic resonance imaging (MRI) scans were performed within 48 h before and 16–72 h post-ablation. Cognitive function assessed by the Mini-Mental State Exam at baseline and 30 days post-ablation. New post-procedural ACE occurred in only 1 of 48 patients (2.1%) and was not detectable on MRI after 30 days. The average number of RF applications per patient to achieve PVI was lower in PRECISION GOLD (20.3 ± 10.0) than in ERACE (28.8 ± 16.1; P = 0.001). Further, PVAC GOLD ablations resulted in significantly fewer low-power (<3 W) ablations (15 vs. 23%, 5 vs. 10% and 2 vs. 7% in 4:1, 2:1, and 1:1 bipolar:unipolar energy modes, respectively). Mini-Mental State Exam was unchanged in all patients. Conclusion Atrial fibrillation ablation with PVAC GOLD in combination with established embolic lowering manoeuvres results in a low incidence of ACE. Pulmonary vein ablation catheter GOLD demonstrates improved biophysical efficiency compared with platinum PVAC. Trial registration ClinicalTrials.gov NCT01767558.

Capsule Endoscopy in Patients with Cardiac Pacemakers and Implantable Cardioverter Defibrillators: (Re)evaluation of the Current State in Germany, Austria, and Switzerland 2010

Background and Aims. The study was a repeated evaluation of the experience of capsule endoscopy (CE) in patients with cardiac pacemaker or implantable cardioverter defibrillator (ICD). Patients and Methods. A standardized questionnaire was sent by the manufactors Given Imaging and Olympus to all centers in Germany, Austria, and Switzerland providing capsule endoscopy service. The questionnaire covers the number of examined patients, monitoring during CE, check of the electric implants before and after CE, occurrence of arrhythmia, quality of CE video, complications, indication of CE, and type of institution. Results. Overall 580 questionnaires were sent to the users. 26/5% (Germany/Austria + Switzerland) of the questionnaires were sent back anonymously to the authors. 114 centers (82 hospitals, 11 surgeries, 21 without specification) replied. In 58 centers (51%), patients with cardiac pacemaker (n = 300) and ICDs (n = 80) underwent uneventful capsule endoscopy. The predominant indication (patients with CP 97%, patients with ICD 100%) was mid gastrointestinal bleeding. Conclusion. The results of our inquiry show that in spite of formal contraindication CE is increasingly applied in bleeding patients with cardiac pacemakers/ICDs and seems to be safe even in a large cohort.

Capsule Endoscopy in Patients with Cardiac Pacemakers, Implantable Cardioverter Defibrillators, and Left Heart Devices: A Review of the Current Literature

Background and Study Aims. Capsule endoscopy is an established tool for investigation of the small intestine. Because of limited clinical experience in patients with cardiac devices, the Food and Drug Administration and the manufacturer recommended not to use capsule endoscopy in these patients. The vast majority of investigations did not reveal any interference between capsule endoscopy and cardiac devices. Methods. Studies investigating interference between CE and cardiac devices were analysed. For the review we considered studies published in English or German and indexed in Medline, as well as highly relevant abstracts. Results. In vitro and in vivo studies mainly revealed no interference between capsule endoscopy and cardiac devices. Technical data of capsule endoscopy (Given Imaging) reveal that interference with cardiac pacemakers and implantable cardioverter defibrillator is impossible. Telemetry can interfere with CE video. Conclusion. The clinical use of capsule endoscopy (Given Imaging) is unproblematic in patients with cardiac pacemakers.

Use of a novel needle wire in patients undergoing transseptal puncture associated with severe septal tenting

IntroductionAn increasing number of patients undergo left atrial ablation procedures, since several approaches have proven efficacy in the treatment of atrial fibrillation. Although transseptal catheterization was generally shown be a safe technique, it harbors the principal risk of cardiac injury. Therefore, there is a need for a safe and effective tool to enable transseptal puncture in difficult cases as well.Methods and ResultsIn 158 consecutive patients, a transseptal puncture was intended for mapping and ablation of left atrial tachycardias. In seven patients of this series transseptal puncture using different sheaths and needle designs, the operators failed to cross the interatrial septum as a result of severe tenting. Three patients were known to have a septal aneurysm; a redo procedure was performed in two patients. In the remaining patients, there was no obvious explanation for the difficulty in crossing the interatrial septum conventionally. In all seven patients, a 120-cm-long nitinol guidewire (“needle wire”) with a 0.014-inch diameter was used to cross the atrial septum with the following idea: after tenting the fossa ovalis with the transseptal dilator and the Brockenbrough needle positioned just inside the tip, effortless advancement of the needle wire perforates the membranous fossa. Unsupported by the needle and dilator, the tip of the wire immediately assumes a “J” shape, rendering it incapable of further tissue penetration after its entry into the left atrium. In all seven patients, the needle wire could be placed into a left pulmonary vein. In five patients, a single attempt was sufficient to reach the left atrium with the wire, two patients needed two and three attempts, respectively. No complications occurred.ConclusionsAdditional use of a needle wire to perform transseptal puncture in a subset of patients at higher risk for complications appears safe and effective.

Vermeidung von intermittierendem T-Wellen-Oversensing durch Programmierung

SummaryWe report the case of a 35-year-old man who was suffering from severe heart failure due to cardiomyopathy. He underwent heart transplantation years ago and developed complex ventricular arrhythmias in the following months in combination with recurrent episodes of syncope due to hypertrophic non-obstructive cardiomyopathy in the transplanted heart, so a dual chamber ICD was implanted. Months later repetitive episodes of intermittent T-wave oversensing with consecutive activation of the ICD could be observed. Surgical revision of the electrode was performed and the patient was closely followed up. One year later, further episodes of T-wave oversensing led to multiple inappropriate IDC-shocks.A very short AV-conduction time was programmed to allow ventricular capture whenever possible, because T-wave oversense after ventricular capture would be annotated as single ventricular ectopy not resulting in antitachycardia pacing. As a consequence, the patient was free from inappropriate ICD-shocks, but showed several shorter episodes of T-wave oversensing. They were all initiated by atrial activity that was seen in the refractory period, thus leading to a loss of AV synchrony. Programming a very short post ventricular atrial refractory period (PVARP) in addition to a short AV-delay led to the complete disappearance of T-wave oversensing in this patient. During a 9-month follow-up, no further tachycardia episodes were detected by the device.ZusammenfassungWir berichten über einen 35-jährigen Patienten, der sich bei primär dilatativer Kardiomyopathie und terminaler Herzinsuffizienz einer Herztransplantation unterzog. Monate später entwickelte der Patient komplexe ventrikuläre Tachyarrhythmien und rezidivierende Synkopen als Folge einer nicht vorbekannten hypertrophen nicht obstruktiven Kardiomyopathie im transplantierten Herzen, daher wurde ein im Zweikammerbetrieb arbeitender implantierbarer Cardioverter/Defibrillator (Zweikammer-ICD) implantiert.Wegen ICD-Entladungen infolge T-Wellen-Oversensings Monate postoperativ erfolgte nach Ausschluss einer extrakardialen korrigierbaren Ursache hierfür die Revision der Coil-Elektrode. Nach einem weiteren Jahr ohne klinische Ereignisse traten erneut ICD-Entladungen infolge T-Wellen-Oversensings auf. Die Umprogrammierung auf eine sehr kurze AV-Zeit sollte zu einer praktisch 100%igen ventrikulären Stimulation führen um sicherzustellen, dass T-Wellen-oversensing nach stimulierten QRS-Komplexen als ventrikuläre Ektopie und nicht als Tachykardie bewertet wird. In der Folge kam es hierdurch nicht mehr zu ICD-Entladungen, aber zu sporadischen refraktär wahrgenommenen atrialen Ereignissen mit nachfolgendem Unterlaufen der atrioventrikulären (AV-)Synchronität und konsekutivem T-Wellen-oversensing, was durch Verkürzung der postventrikulären atrialen Refraktärperiode (PVARP) auf den minimal möglichen Wert zuverlässig verhindert werden konnte. Der Patient ist seit 9 Monaten ereignisfrei, im Gerätespeicher sind keine weiteren inadäquaten Tachkardie-Episoden mehr registriert worden.

[Avoidance of intermittent T-wave oversensing with device programming].

SummaryWe report the case of a 35-year-old man who was suffering from severe heart failure due to cardiomyopathy. He underwent heart transplantation years ago and developed complex ventricular arrhythmias in the following months in combination with recurrent episodes of syncope due to hypertrophic non-obstructive cardiomyopathy in the transplanted heart, so a dual chamber ICD was implanted. Months later repetitive episodes of intermittent T-wave oversensing with consecutive activation of the ICD could be observed. Surgical revision of the electrode was performed and the patient was closely followed up. One year later, further episodes of T-wave oversensing led to multiple inappropriate IDC-shocks.A very short AV-conduction time was programmed to allow ventricular capture whenever possible, because T-wave oversense after ventricular capture would be annotated as single ventricular ectopy not resulting in antitachycardia pacing. As a consequence, the patient was free from inappropriate ICD-shocks, but showed several shorter episodes of T-wave oversensing. They were all initiated by atrial activity that was seen in the refractory period, thus leading to a loss of AV synchrony. Programming a very short post ventricular atrial refractory period (PVARP) in addition to a short AV-delay led to the complete disappearance of T-wave oversensing in this patient. During a 9-month follow-up, no further tachycardia episodes were detected by the device.ZusammenfassungWir berichten über einen 35-jährigen Patienten, der sich bei primär dilatativer Kardiomyopathie und terminaler Herzinsuffizienz einer Herztransplantation unterzog. Monate später entwickelte der Patient komplexe ventrikuläre Tachyarrhythmien und rezidivierende Synkopen als Folge einer nicht vorbekannten hypertrophen nicht obstruktiven Kardiomyopathie im transplantierten Herzen, daher wurde ein im Zweikammerbetrieb arbeitender implantierbarer Cardioverter/Defibrillator (Zweikammer-ICD) implantiert.Wegen ICD-Entladungen infolge T-Wellen-Oversensings Monate postoperativ erfolgte nach Ausschluss einer extrakardialen korrigierbaren Ursache hierfür die Revision der Coil-Elektrode. Nach einem weiteren Jahr ohne klinische Ereignisse traten erneut ICD-Entladungen infolge T-Wellen-Oversensings auf. Die Umprogrammierung auf eine sehr kurze AV-Zeit sollte zu einer praktisch 100%igen ventrikulären Stimulation führen um sicherzustellen, dass T-Wellen-oversensing nach stimulierten QRS-Komplexen als ventrikuläre Ektopie und nicht als Tachykardie bewertet wird. In der Folge kam es hierdurch nicht mehr zu ICD-Entladungen, aber zu sporadischen refraktär wahrgenommenen atrialen Ereignissen mit nachfolgendem Unterlaufen der atrioventrikulären (AV-)Synchronität und konsekutivem T-Wellen-oversensing, was durch Verkürzung der postventrikulären atrialen Refraktärperiode (PVARP) auf den minimal möglichen Wert zuverlässig verhindert werden konnte. Der Patient ist seit 9 Monaten ereignisfrei, im Gerätespeicher sind keine weiteren inadäquaten Tachkardie-Episoden mehr registriert worden.