Do gender differences exist in pacemaker implantation?--results of an obligatory external quality control program.

AIMS: The aim of the study was to evaluate the effects of patient gender onto primary pacemaker implantation, evaluating the database of the Institute of Quality Assurance Hessen in the federal state of Hessen, Germany. METHODS AND RESULTS: The database of the obligatory external quality control program for the years 2003-2006 was evaluated retrospectively. In 72 centres, 17 826 patients undergoing stationary primary pacemaker implantation have been registered. Male patients had more AV blocks when compared with women and less sick sinus syndrome and atrial fibrillation with bradycardia. In patients being 80 years and older, men received significantly more dual-chamber devices than women for the indications: AV block and sick sinus syndrome. In women, atrial pacing thresholds were significantly higher and P-wave amplitudes were significantly lower. Women had, independent from age or pacing system implanted, significantly more acute complications than men, with significant differences for pneumothorax and pocket haematoma. CONCLUSION: This large-scale real-life patient cohort of primary stationary pacemaker implantation showed that gender has an impact onto pacemaker implantation, with less favourable outcomes for women.

Do endoscopy capsules interfere with implantable cardioverter-defibrillators?

BACKGROUND AND STUDY AIMS: Capsule endoscopy is already an established diagnostic tool, and the newly introduced capsule PillCam COLON is now entering clinical studies. Because of the very limited clinical experience in patients with implantable cardioverter-defibrillators (ICDs), it is generally recommended that capsule endoscopy should not be used in these patients. Therefore, we investigated, in vitro, the possible interference between three different endoscopy capsules (Given Imaging and Olympus) and ICDs. MATERIALS AND METHODS: A total of 45 ICD devices were separately placed in a tank filled with a 0.9 % saline solution. With the help of pin jacks, the pacing pulses of ICDs were recorded and inhibiting signals could be coupled in. The capsules were placed in different positions near to the lead and the ICD device, and finally placed on the case of the device for 1 minute each. The function of each device was observed continuously. RESULTS: Even when the capsules were in closest proximity to the ICDs, no interference was observed. CONCLUSION: The clinical use of the three tested capsule devices is safe in patients with ICDs.

Capsule endoscopy and cardiac pacemakers: investigation for possible interference.

BACKGROUND AND STUDY AIMS: The diagnostic benefit of capsule endoscopy in suspected small-bowel disease is high and seems to be superior to that with conventional methods and scintigraphy. Because of the limited clinical experience in patients with cardiac pacemakers and other implanted electrical devices, it is recommended that capsule endoscopy should not be used in such cases. We investigated the potential for capsule endoscopy to interfere with cardiac pacemakers in vitro. MATERIAL AND METHODS: 21 different pacemakers and leads were positioned in a 0.9 % saline solution in a tank. Pin jacks were placed that were in contact with the solution. The pacemaker impulse was recorded and an inhibiting signal could be coupled in. The capsules (Given Imaging and Olympus) were placed in different positions relative to the cardiac pacemaker and finally placed on the case of the pacemaker, for 1 minute in each site. The functioning of the pacemaker was observed continuously. The effect on the pacemaker was noted particularly as inhibition, synchronization, or no effect. The pacemaker was then inhibited using a standard test signal. RESULTS: There was no interference between the video capsule and the cardiac pacemakers in our experiment in spite of the close proximity of the two devices. CONCLUSION: The clinical use of capsule endoscopy is unproblematic in patients with cardiac pacemakers.

Post-mortem evaluation of 415 pacemakers: in situ measurements and bench tests.

AIM: The hypothesis was that there is more undetected dysfunction of implanted pacemaker systems than that detected and corrected. This prompted a research project (sponsored by the German Research Foundation) to detect pacemaker abnormalities and evaluate their complications for patients, thus, proving or disproving the hypothesis. METHODS AND RESULTS: Four hundred and fifteen pacemakers of deceased patients were analyzed assessing their functionality by in situ measurements and bench tests including five measurements and one telemetric interrogation. Results were divided into four categories and statistically evaluated. Life-threatening abnormalities were found in 3.8%, potentially life-threatening in 3.7%, probably symptomatic, divided into atrial and ventricular problems, 13.3% and 2.8%, respectively, and premature exhaustion in 1.2%. Three of 179 bipolar ventricular leads and 2 of 131 bipolar atrial leads had insulation defects corresponding to 1.7% and 1.5%, respectively. The bipolar complication rate was 2.8 times higher than unipolar. CONCLUSION: The pacemaker patients investigated, living 4 years with their pacemaker on average, had a post-mortem evaluated complication rate of the category "life-threatening" of 3.8%. This result corresponds to an annual complication rate of 0.94% compared with a rate of only 0.39% in an earlier investigation.

Paradigm shift in lead design.

During the past 30 years there has been a tremendous development in electrode technology from bulky (90 mm2) to pin-sized (1.0 mm2) electrodes. Simultaneously, impedance has increased from 110 Ohms to >1 kOhms, which has been termed a "paradigm shift" in lead design. If current is responsible for stimulation, why is its impedance a key factor in saving energy? Further, what mechanism is behind this development based on experimental findings and what conclusion can be drawn from it to optimize electrode size? If it is assumed that there is always a layer of nonexcitable tissue between the electrode surface and excitable myocardium and that the electric field (potential gradient) produced by the electrode at this boundary is reaching threshold level, then a formula can be derived for the voltage threshold that completely describes the electrophysiology and electrophysics of a hemispherical electrode. Assuming that the mean chronic threshold for porous steroid-eluting electrodes is 0.6 V with 0.5-ms pulse duration, thickness of nonexcitable tissue can be estimated to be 1.5 mm. Taking into account this measure and the relationship between chronaxie and electrode area, voltage threshold, impedance, and energy as a function of surface area can be calculated. The lowest voltage for 0.5-ms pulse duration is reached with r(o) = 0.5 d, yielding a surface area of 4 mm2 and a voltage threshold of 0.62 V, an impedance of 1 kOhms, and an energy level of 197 nJ. It can be deduced from our findings that a further reduction of surface areas below 1.6 mm2 will not diminish energy threshold substantially, if pulse duration remains at 0.5 ms. Lowest energy is reached with t = chronaxie, yielding an energy level <100 nJ with surface areas < or =1.5 mm2. It is striking to see how well the theoretically derived results correspond to the experimental findings. It is also surprising that the hemispheric model so accurately approximates experimental results with differently shaped electrodes that it can be concluded that electrode shape seems to play a minor role in electrode efficiency. Further energy reduction can only be achieved by reducing the pulse duration to chronaxie. A real paradigm shift will occur only if the fundamentals of electrostimulation in combination with electrophysics are accepted by the pacing community.

[Calculation of internal from external electrical field strength and its effect on cardiac pacemaker patients]. / Berechnung der inneren aus der äusseren elektrischen Feldstärke und ihr Einfluss auf Herzschrittmacherpatienten.

What electric field strength is developed inside a person entering the electric field produced by, e.g., a high-voltage transmission line? This question may be of vital importance for a pacemaker patient. With the aim of finding an answer, known phenomena are combined in such a way that the mean current density within the thorax at the level of the heart can be determined. In this way it can be demonstrated that the internal electric field of a grounded person is twice that of an ungrounded person, that the internal field is 0.72 mV/m per 1 kV/m external field, and that the most sensitive pacemaker can be influenced by 2 kV/m. It is also clear that the field strength limit of 5 kV/m proposed by ICNIRP for the general public cannot be justified by the basic limit of 2 mA/m2.

[Effect of mobile phone on life-saving and life-sustaining systems]. / Einfluss von Mobilfunk auf lebensrettende und lebenserhaltende Systeme.

Since the beginning of the nineties there have been warnings not to use mobile phones in the vicinity of medical devices. Functional failures of dialysis machines, respirators and defibrillators prompted the banning of their use in many hospitals in Scandinavia, and then in other countries. Since we believe that a general ban in hospitals is problematic, we decided to investigate the influence of mobile telephone on life-saving and/or life-support systems, with the aim of establishing rules for its use in hospitals. We investigated available phones of varying power of the C-, D- and E-net, as also of a cordless phone meeting the DECT standard. The aim was to identify the devices susceptible to interference and determine the minimum distances at which interference occurred. A total of 224 devices classified into 23 types of devices were examined. Nine different sets of transmission conditions were applied, giving a total of 2016 tests. Our results permit the conclusion that the ban on mobile phones in hospitals is based not on actual events, but on theoretical considerations in the absence of any practical information on the actual susceptibility of devices and their reaction to the electromagnetic fields involved. The fact that hazardous situations are very rare is due firstly to the need for the simultaneous occurrence of four coincidences, and the fail-save feature of medical devices. We would therefore recommend that all life-saving and life-support systems that can also be used outside the hospital should be made mobile phone-proof. When apnoea monitors and respirators are protected from such interference, hazardous situations could be avoided by establishing the rule: "No portables, and mobile phones only at a distance of at least 1 metre from medical devices". With regard to emergency telephones, the minimum distance to medical devices should be at least 1.5 metres.