Indications and Usage

ELA Medical pacemakers system are indicated for:

Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and /or activity.

The accepted patient conditions warranting chronic cardiac pacing which include, but are not restricted to :


  • symptomatic paroxysmal or permanent second- or third –degree AV block ;

  • symptomatic bilateral bundle branch block ;

  • symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders ;

  • bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias ;

  • vasovagal syndromes or hypersensitive carotid sinus syndromes.


ELA dual chamber pacemakers are also indicated for dual-chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony which include :

  • various degrees of AV block to maintain the atrial contribution to cardiac output ;

  • VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.


Contraindications:

  • ELA pacemakers are contraindicated in patients co-implanted with an implanted cardioverter-defibrillator because these devices revert to unipolar polarity in standby mode, which may cause unwanted delivery of ICD therapy.

  • Dual-chamber and single-chamber atrial pacing are contraindicated in patients with chronic refractory atrial tachyarrhythmias.

  • Asynchronous pacing (DOO/VOO/AOO) may be proarrhythmic in the presence (or likelihood) of competition between pace and intrinsic rhythms.


Warnings and Precautions:
Hospital equipment including mechanical ventilators, magnetic resonance imaging, diathermy, electrosurgical cautery, lithotripsy, external defibrillation, high radiation sources, and radio frequency ablation can damage the pacemakers or cause them to be inhibited or to pace at inappropriate rates. Equipment in the home or in occupational environments including high voltage power lines, high power communication transmitters, arc or resistance welders, induction furnaces, retail theft prevention systems, ungrounded home appliances and cellular phones may cause inappropriate sensing or therapy.


Do not use combined or minute ventilation pacing for abdominal or epicardial implants. Certain diagnostic modes provide no pacing. Do not resterilize or reuse. Use only IS-1 compatible leads. Do not use a unipolar atrial lead with Talent II if rate response is required. Do not enable ventricular autothreshold when using high polarization leads. Minute ventilation pacing may be inappropriate for patients with respiration rates greater than 48 breaths per minute.


Side Effects:
Observed adverse events included oversensing, loss of sensing, loss of capture, lead connector problems, lead dislodgment, phrenic nerve stimulation, irritation at implant site, hemo and pneumothorax, minute ventilation noise, overpacing protection, programming errors, medication induced threshold elevation, and pacemaker syndrome. Refer to the physicians’manual for a complete listing of indications, contraindications, precautions and warnings.