EXTERNAL PACEMAKER AND RELATED SAFETY ISSUES

Introduction : To take a insight on the external pacemaker. Pacemaker are the name of cells naturally present in the Senoatrial Node (SA) within heart. Pacemaker is an electronic device which is used to prove and external electrical signal, which is used when the natural build-in pacemakers fails to provide a undisrupted intrinsic rhythm, which can be caused due to conditions like Bradycradia , heart block, etc. Pacemakers are also used for temporary treatment of arrhythmia such as after a medical procedure to cure arrhythmia also known as atrial fibrillation or long QT syndrome. (ESCHER, 1973) There are three types of artificial cardic pacemaker system which are commonly use clinically : 1) Single Chamber Pacemaker a) Ventricular Demand Pacemaker (VVI) - This is most commonly used. It captures the spontaneous ventricular impulse and paces ventricles only when it is mandatory. b) Atrial Demand Pacemaker (AAI) AAI is similar to VVI, except that it detects from the atria and paces it, so as to maintain the rhythm of atrial and ventricular contractions in a natural order. 2) Dual Chamber pacemaker a) AV Synchronous Pacemaker (VDD) - It detects from both atria and ventricular but only paces ventricles. b) AV Sequential Pacemaker (DVI) It detects from ventricles only, but paces both ventricles and atria only. c) Optimal Pacemaker (DDD) - It detects from both atrial and ventricular and paces both as required , either one or both according to as required by condition the heart is in. It si commonly referred as universal and physiologic too. 3) Biventricular pacemaker It uses 2 leads, two in ventricles one in each left and right and one in atrial. It is the latest type of pacemaker and is fairly complex when compared to other types in use Pacemaker can also be divided in 3 types based on the location of the device : 1) Implantable Pacemakers: These types of pacemaker with endo-cardial or myocardial electrodes to implanted in the heart, and are normally used for a long term or permanent. 2) External Pacemakers: External, Patient-portable pacemaker with exteriorized electrodes for temporary use. Such as after a surgery, or during one.

Working of External Pacemakers: Ion a normal heart the impulse will travel from the SA node going through out the heart into the atria and ventricles, through the bundle branches. In the case that natural pacemakers do not work or the signal traveling through the heart is somehow blocked, it is required to put an artificial pacemaker. Noninvasive Transcutaneous Cardiac Pacing (NTP) is a fast, easy and safe form of emergency cardiac pacing as it doesnt involve any type of invasion to the body, which might not be possible in an emergency case. NTP have hemodynamics similar to that of ventricular endocardial pacing. NTP is found to be effective in dealing with bradycardias and early cardiopulmonary resuscitation, Noninvasive external pacemaker consists of an electric cardiac pacemaker and a monitor with a paper recording. It detects the cardiac depolarizations amplitude and slew rate and displays it with the help of monitor and also paper if exceeds the limit, and also generates an alarm. It functions in the VVI mode, emitting the signal synchronized to the escaping rates up to 180 beats per minutes and amplitude to maximum of 140mA. It produces rectilinear design, constant current pulse of duration about 40msec stimuli. The received stimuli is first pre-amplified in the monitoring circuitry section is that it is clearly recognized and can be used for electrically stimulated origin. To set it, stimulating large electrodes of high impedance are placed on the back at about cardiac level between left scapula and spine, and other electrodes of same type is placed on the precordium. In the invasive type external pacemaker, different types of pacemakers work on closely same way but they differ on how they detect the signal from the heart and how and where they place the signal and electrode in the heart. Single Chamber Pacemaker consist of only one lead, which is either places in the atrium or the ventricle, such as VVI or AAI. It detects the signal from the same place and then delivers the impulse in the same place. In case of VVI it detects from either ventricles and send impulse to the same, this is the most commonly used type of pacemaker. In case of AAI it detects from the either of the atrium and then send impulse to the same. In early era of pacemakers, they only use to send the impulse in but as with the development, pacemakers are also able to listen to the heart and send the impulse to the heart only when required, both the things are done with the same lead. It is either used to treat atrium arrhythmia or Sick Sinus Syndrome. The VVI helps in pumping blood to the lungs and also treat problem with heart rate. Dual Chamber pacemakers have two invasive leads going to the heart. One of the leads is placed in the right ventricle and other in the right atrium. The pulse generator processor located in the pacemaker device is capable to detecting from either and send back impulse to other or both .This help improve the coordication between the two chambers of the heart, the

treatment to improve the contraction timing of each chamber is known as Cardiac Resynchronization Therapy (CRT) . It is an ideal pacemaker for the people suffering from heart failure. The latest development in the pacemaker technology is Biventricular pacemakers, with maximized the benefits to the CRT patients. This type of pacemakers has three invasive leads two going in each ventricle, one in right ventricle and other to the right and third lead to the right atrium. This type of pacemakers can help prevent pulmonary edema in the patients.

Risks and Safety issues associated with External Pacemakers : Pacemaker is a very sensitive device and prone to the interference from outside world, it can be of physical nature or radiation based interference, it can be from arc welding, cell phones (which are recommended to be kept at least 12 away from any type of pacemaker), radio to as small as 50 Hz interference from the electrical appliance in the regular household. One of the safety issue associated with pacemakers is oversensing. Oversensing is basically the happen when the pacemaker sense the signal from the wrong source or the not correctly sensing cardiac activity. This can be due to muscles activity or electromagnetic interference (EMI) or leakage in the lead due to breaking away of the lead insulation. Other risk associated with pacemaker is Failure to output. This can be due to many reasons, both external factors as well as internal factors. Crosstalk is one of the phenomenon which causes failure to output, this is referred to the condition when the lead in one chamber senses the contraction in other chamber and then fails to give impulse to the needed chamber when required. Few of the common reasons which leads to failure to output are battery failure ( which is easy to replace in the external pacemaker) , lead fracture, as mentioned before lead leakage sure to breakage in the insulation of the lead going into the body and poor connection to the lead of the pacemaker or pulse generator, which is a more common problem associated with the external pacemaker. Failure to capture is also a common problem associated with the pacemakers. This is a condition when the monitor in the pacemaker impulse is noted but it is not followed with an contraction. This can be due to breaking away of lead insulation as in failure to output case, lead fracture, elevated pacers threshold, poor lead connection to the generator and lead dislodgement. Pacemakers are also very much effected by the MRI (Magnetic Resonance Imaging). The effects of MRI:

1) Strong Static Magnetic field - reed switch closure resulting in asynchronous pacing. 2) Radiofrequency Fields This can cause the pacing rate to be altered. It also causes spurious tachyarrhythmia detection and also cause heating of the device components. 3) Time-varying magnetic gradient field - This can over pacing due the device reaching threshold as a result of induced voltage, this also cause the device to heat over a long time as well as reed switch closure. Environment affects the pacemaker largely, most of it is caused by electromagnetic interference, among the electromagnetic spectrum on the frequency between 0 to 10 9 Hz effect the pacemaker. This alters the current electricity supply and electro-cautery. In the condition of 109 and 1011 Hz pacemaker system behaves as antenna for EMI. Electromagnetic interference temporarily changes their modes to asynchronous mode. Cell phones operating at low frequency and low power do not pose much threat to the system, but more power phones such as satellite phones with higher frequency and high power signal does pose a threat to the pacemaker and recommended to be kept away from the pacemaker by the defined distance. Defibrillator, cardioversion, cautery/RF ablation cannot be used in the presence of pacemaker and as we well as radiation therapy also pose a threat to the pacemakers works beyond a given dosage. Another very common safety risk associated with the external pacemaker is accidental disconnection of cables, this is use to inadequate insecure connection of invasive external pacemaker. Different standards Associated with the Pacemakers: BS EN 60601-1 Is referred to the basic standards for any medical electrical equipment, which is justified as human body have a limited tolerance to the external current and can cause from small injury or even death in extreme, so it is very important to keep and safety check over any electrical equipment supplied. External pacemaker also falls under this category. BS EN 60601-2-31 is applicable to the implantable parts of external and internal pacemaker. This does not apply to the mains operated external pacemaker. ISO 14708-1 IEC 601-2-31 (98) It look over the safety of the external cardiac pacemaker with internal source. This is justified as the excess current supplied from the battery in the external pacemaker can cause possible injuries , as the leads are inserted inside the body and so there is low resistance path to the heart and so doesnt require that much amount of current as in case external electrode, where skin have a high resistance. Thus, it is importance to check safety of the devices before putting them in the market

BS ISO 14117 It apples to the implantable medical devices. It deals with their electromagnetic compatibility. It also says about the EMC test protocols for the implantable cardiac pacemaker or external pacemakers (invasive type), implantable cardioverter defibrillators and cardiac resynchronization devices. This is also justified as we read in the previous section of this report that electromagnetic interference largely effect the working of the pacemaker and also put them as a possible risk if they are in high frequency and how power electromagnetic fields. So it is justified to test them before use or making it available in the market. BS ISO 5841-2:2000 - It deals with cardiac pacemakers and method for reporting the clinical performance of the populations of the pulse generators. It is justify to have this standard as in external pacemaker, it is required to implant the leads into the heart. So it is very much required to keep check and report of the mass performance and statistics of the pulse generators in the general population. It have a international relationships with ISO 58412:1986 Identical.

Risk Minimization of External Cardiac pacing : External pacemaker is fairly safe device, except the external electromagnetic interference and accidentally disconnecting the cables. With respect to the electromagnetic interference, there is not much that can be just that that external leads can be shielded with grounded mash to stop the electromagnetic interference and leakage. For the breakage in the lead, standards can be applied to ensure better quality of material which does not break or crack under the conditions. For the part of misreading the different contraction in different chambers of heart, a better monitoring and filter of the signal can be applied in there pulse generator processor programming. For the part of external interference or meddling of the device externally or accidentally changing of modes and voltage threshold, and extra over cover can be applied and as well as a programmable lock can be applied to the system to ensure that if there parameters are changed then they have to be changed consciously and cannot be changed accidentally. Accidentally disconnection of wires can be avoided by ensuring that connection on temporary or external pacemaker are compatible and avoid using lead adaptors, use only the adapter that retention mechanism prevents accidental disconnection. Battery monitor can be incorporated in the monitoring device and a backup battery system can also be in external pacemaker to ensure that there no battery failure. By using a backup battery the probability of battery failure can decreased to very low values. A variable threshold filter and variable threshold limiter can be embedded into the device circuit arty to avoid any accidental low threshold or

high threshold. The high voltage circuitry can low voltage circuit arty can be separated electronically to ensure that there is no passage of high current into the body by any means.