Overview of Pacemaker Functions
Overview of Pacemaker Functions
Percussive pacing
Percussive pacing, also known as transthoracic mechanical pacing, is the use of the closed
fist, usually on the left lower edge of the sternum over the right ventricle in the vena cava,
striking from a distance of 20–30 cm to induce a ventricular beat (the British Journal of
Anaesthesia suggests this must be done to raise the ventricular pressure to 10–15 mmHg to
induce electrical activity). This is an old procedure used only as a life-saving means until an
electrical pacemaker is brought to the patient.[7]
Transcutaneous pacing
Transcutaneous pacing (TCP), also called external pacing, is recommended for the initial
stabilization of hemodynamically significant bradycardias of all types. The procedure is
performed by placing two pacing pads on the patient's chest, either in the anterior/lateral
position or the anterior/posterior position. The rescuer selects the pacing rate, and gradually
increases the pacing current (measured in mA) until electrical capture (characterized by a
wide QRS complex with a tall, broad T wave on the ECG) is achieved, with a corresponding
pulse. Pacing artifact on the ECG and severe muscle twitching may make this determination
difficult. External pacing should not be relied upon for an extended period of time. It is an
emergency procedure that acts as a bridge until transvenous pacing or other therapies can be
applied.[8]
Epicardial pacing
Temporary epicardial pacing is used during open heart surgery should the surgical procedure
create atrio-ventricular block. The electrodes are placed in contact with the outer wall of the
ventricle (epicardium) to maintain satisfactory cardiac output until a temporary transvenous
electrode has been inserted.[9]
Permanent epicardial pacing leads can be implanted surgically and tunneled to the pulse
generator pocket. These leads are either passively touching the heart and sewn in place, or
have a screw mechanism to actively fix to the heart.
Transvenous pacing (temporary)
Transvenous pacing, when used for temporary pacing, is an alternative to transcutaneous
pacing. A pacemaker wire is placed into a vein, under sterile conditions, and then passed into
either the right atrium or right ventricle. The pacing wire is then connected to an external
pacemaker outside the body. Transvenous pacing is often used as a bridge to permanent
pacemaker placement. It can be kept in place until a permanent pacemaker is implanted or
until there is no longer a need for a pacemaker and then it is removed.
There are three basic types of permanent pacemakers, classified according to the number of
chambers involved and their basic operating mechanism:[10]
Single-chamber pacemaker. In this type, only one pacing lead is placed into a chamber of
the heart, either the atrium or the ventricle.[10]
Dual-chamber pacemaker. Here, wires are placed in two chambers of the heart. One lead
paces the atrium and one paces the ventricle. This type more closely resembles the natural
pacing of the heart by assisting the heart in coordinating the function between the atria and
ventricles.[10]
Biventricular pacemaker. This pacemaker has three wires placed in three chambers of the
heart. One in the atrium and two in either ventricle. It is more complicated to implant.[10]
Rate-responsive pacemaker. This pacemaker has sensors that detect changes in the
patient's physical activity and automatically adjust the pacing rate to fulfill the body's
metabolic needs.[10]
The pacemaker generator is a hermetically sealed device containing a power source, usually
a lithium battery, a sensing amplifier which processes the electrical manifestation of naturally
occurring heart beats as sensed by the heart electrodes, the computer logic for the
pacemaker and the output circuitry which delivers the pacing impulse to the electrodes.
Most commonly, the generator is placed below the subcutaneous fat of the chest wall, above
the muscles and bones of the chest. However, the placement may vary on a case-by-case
basis.
The outer casing of pacemakers is so designed that it will rarely be rejected by the body's
immune system. It is usually made of titanium, which is inert in the body.
Leadless pacing
Leadless pacemakers are devices that are as small as a capsule and are small enough to
allow the generator to be placed within the heart, therefore avoiding the need for pacing
leads.[11] As pacemaker leads can fail over time, a pacing system that avoids these
components offers theoretical advantages. Leadless pacemakers can be implanted into the
heart using a steerable catheter fed into the femoral vein via an incision in the groin.[11]
Basic function
Pacing modes
Modern pacemakers usually have multiple functions. The most basic form monitors the
heart's native electrical rhythm. When the pacemaker wire or "lead" does not detect heart
electrical activity in the chamber – atrium or ventricle – within a normal beat-to-beat time
period – most commonly one second – it will stimulate either the atrium or the ventricle with
a short low voltage pulse. If it does sense electrical activity, it will hold off stimulating. This
sensing and stimulating activity continues on a beat by beat basis and is called "demand
pacing". In the case of a dual-chamber device, when the upper chambers have a
spontaneous or stimulated activation, the device starts a countdown to ensure that in an
acceptable – and programmable – interval, there is an activation of the ventricle, otherwise
again an impulse will be delivered.
The more complex forms include the ability to sense and/or stimulate both the atrial and
ventricular chambers.
I II III IV V
Chamber(s) paced Chamber(s) sensed Response to sensing Rate modulation Multisite pacing
From this the basic ventricular "on demand" pacing mode is VVI or with automatic rate
adjustment for exercise VVIR – this mode is suitable when no synchronization with the atrial
beat is required, as in atrial fibrillation. The equivalent atrial pacing mode is AAI or AAIR which
is the mode of choice when atrioventricular conduction is intact but the sinoatrial node of the
natural pacemaker is unreliable – sinus node disease (SND) or sick sinus syndrome. Where
the problem is atrioventricular block (AVB) the pacemaker is required to detect (sense) the
atrial beat and after a normal delay (0.1–0.2 seconds) trigger a ventricular beat, unless it has
already happened – this is VDD mode and can be achieved with a single pacing lead with
electrodes in the right atrium (to sense) and ventricle (to sense and pace). These modes AAIR
and VDD are unusual in the US but widely used in Latin America and Europe.[13][14] The DDDR
mode is most commonly used as it covers all the options though the pacemakers require
separate atrial and ventricular leads and are more complex, requiring careful programming of
their functions for optimal results.
Automatic pacemakers are designed to be over-ridden by the heart's natural rate at any
moment that it gets back to a non-pathologic normal sinus rhythm and can reinitiate
influencing the electric activity in the heart when the pathologic event happens again.[15] A
"ventricular-demand pacemaker" produces a narrow vertical spike on the ECG, just before a
wide QRS. The spike of an "atrial-demand pacemaker" appears just before the P wave.[16]
Threshold
The heart is composed of an excitable tissue and an electrical pulse of a certain voltage is
needed to "capture" the myocardium to make the heart function. The minimum voltage to
achieve this is called the threshold. As this is a probabilistic property, the actual voltage used
is higher than the threshold (usually by a 50–100% margin). Additionally, the electrical pulse
has a time component and proper description of a threshold is a voltage and pulse width.
All electrical circuits require a complete connection between the cathode and the anode. For
some pacing leads, both connections to the heart are provided in a single lead ("bipolar") and
some only provide a single connection ("unipolar"). In unipolar, the second connection is
internally from the heart to the generator through the body (blood, tissue, etc).
Also important is the impedance. The lower the impedance, the more current is needed to
achieve the threshold voltage and lowers the battery life. The impedance is affected by the
integrity of the pacing lead and the electrode-tissue interface of the lead with the heart.
The minimum voltage to sense an event is called the sensitivity. The higher the sensitivity, the
less that is sensed, and vice-versa. Too low of a sensitivity can cause troubles with sensing P
waves, T waves, and noise; sensing these things is called "over sensing". A sensitivity too high
may result in missed sensing of P waves in the atria and QRS in the ventricles, and is called
"under sensing."
Biventricular pacing
Cardiac resynchronization therapy (CRT) is used for people with heart failure in whom the left
and right ventricles do not contract simultaneously (ventricular dyssynchrony), which occurs
in approximately 25–50% of heart failure patients. To achieve CRT, a biventricular pacemaker
(BVP) is used, which can pace both the septal and lateral walls of the left ventricle. By pacing
both sides of the left ventricle, the pacemaker can resynchronize the ventricular contractions.
CRT devices have at least two leads, one passing through the vena cava and the right atrium
into the right ventricle to stimulate the septum, and another passing through the vena cava
and the right atrium and inserted through the coronary sinus to pace the epicardial wall of the
left ventricle. Often, for patients in normal sinus rhythm, there is also a lead in the right atrium
to facilitate synchrony with the atrial contraction. Thus, the timing between the atrial and
ventricular contractions, as well as between the septal and lateral walls of the left ventricle
can be adjusted to achieve optimal cardiac function.
CRT devices have been shown to reduce mortality and improve quality of life in patients with
heart failure symptoms; a LV ejection fraction less than or equal to 35% and QRS duration on
EKG of 120 ms or greater.[18][19]
Biventricular pacing alone is referred to as CRT-P (for pacing). For selected patients at risk of
arrhythmias, CRT can be combined with an implantable cardioverter-defibrillator (ICD): such
devices, known as CRT-D (for defibrillation), also provide effective protection against life-
threatening arrhythmias.[20]
Conventional placement of ventricular leads in or around the tip or apex of the right ventricle,
or RV apical pacing, can have negative effects on heart function. It has been associated with
increased risk of atrial fibrillation, heart failure, weakening of the heart muscle and potentially
shorter life expectancy. His bundle pacing (HBP) and left bundle branch area pacing (LBBAP)
leads to a more natural or perfectly natural ventricular activation and has generated strong
research and clinical interest. By stimulating the His–Purkinje fiber network directly with a
special lead and placement technique, HBP causes a synchronized and therefore more
effective ventricular activation and avoids long-term heart muscle disease. HBP in some
cases can also correct bundle branch block patterns.[21][22]
Advancements in function
Dynamic pacemaking technology could also be applied to future artificial hearts. Advances in
transitional tissue welding would support this and other artificial organ/joint/tissue
replacement efforts. Stem cells may be of interest in transitional tissue welding.
Many advancements have been made to improve the control of the pacemaker once
implanted. Many of these have been made possible by the transition to microprocessor
controlled pacemakers. Pacemakers that control not only the ventricles but the atria as well
have become common. Pacemakers that control both the atria and ventricles are called dual-
chamber pacemakers. Although these dual-chamber models are usually more expensive,
timing the contractions of the atria to precede that of the ventricles improves the pumping
efficiency of the heart and can be useful in congestive heart failure.
Rate responsive pacing allows the device to sense the physical activity of the patient and
respond appropriately by increasing or decreasing the base pacing rate via rate response
algorithms.
The DAVID trials[24] have shown that unnecessary pacing of the right ventricle can exacerbate
heart failure and increases the incidence of atrial fibrillation. The newer dual-chamber devices
can keep the amount of right ventricle pacing to a minimum and thus prevent worsening of
the heart disease.
Considerations
Insertion
A pacemaker may be implanted whilst a person is awake using local anesthetic to numb the
skin with or without sedation, or asleep using a general anesthetic.[25] An antibiotic is usually
given to reduce the risk of infection.[25] Pacemakers are generally implanted in the front of the
chest in the region of the left or right shoulder. The skin is prepared by clipping or shaving any
hair over the implant site before cleaning the skin with a disinfectant such as chlorhexidine.
An incision is made below the collar bone and a space or pocket is created under the skin to
house the pacemaker generator. This pocket is usually created just above the pectoralis
major muscle (prepectoral), but in some cases the device may be inserted beneath the
muscle (submuscular).[26] The lead or leads are fed into the heart through a large vein guided
by X-ray imaging (fluoroscopy). The tips of the leads may be positioned within the right
ventricle, the right atrium, or the coronary sinus, depending on the type of pacemaker
required.[25] Surgery is typically completed within 30 to 90 minutes. Following implantation,
the surgical wound should be kept clean and dry until it has healed. Some movements of the
shoulder within a few weeks of insertion carry a risk of dislodging the pacemaker leads.[25]
The batteries within a pacemaker generator typically last 5 to 10 years. When the batteries are
nearing the end of life, the generator is replaced in a procedure that is usually simpler than a
new implant. Replacement involves making an incision to remove the existing device,
disconnecting the leads from the old device and reconnecting them to a new generator,
reinserting the new device and closing the skin.[25]
Sensing: the ability of the device to "see" intrinsic cardiac activity (atrial and ventricular
depolarization).
Impedance: A test to measure lead integrity. Large and/or sudden increases in impedance
can indicate a lead fracture, while large and/or sudden decreases in impedance can be
caused by insulation failure.
Threshold duration: The time that the device requires at the preset amplitude to reliably
pace the atrium or ventricle connected to the lead.
Percentage of pacing: The percentage of time that the pacemaker has been actively pacing
since the previous device interrogation, which shows how dependent the patient is on the
device.
Estimated battery life at current rate: As modern pacemakers are "on-demand" and only
pace when necessary, battery lifespan is affected by how much the pacemaker is utilized.
Other factors affecting battery life include programmed output and algorithms (features)
that use battery power.
Any events that were stored since the last follow-up, in particular arrhythmias such as atrial
fibrillation. These are typically stored based on specific criteria set by the physician and
specific to the patient. Some devices have the availability to display intracardiac
electrograms showing the onset of an event as well as the event itself, which helps to
diagnose its cause or origin.
The pacemaker patient may find that some types of everyday actions need to be modified.
For instance, the shoulder harness of a vehicle seatbelt may be uncomfortable if it falls across
the pacemaker insertion site. Women will not be able to wear bras for a while after the
operation, and later might have to wear bras with wide shoulder straps.
For some sports and physical activities, special pacemaker protection can be worn to prevent
possible injuries, or damage to the pacemaker leads.
Activities involving strong magnetic fields should be avoided. This includes activities such as
arc welding with certain types of equipment,[28] and maintaining heavy equipment that may
generate strong magnetic fields. Some medical procedures, particularly magnetic resonance
imaging (MRI), involve very strong magnetic fields or other conditions that may damage
pacemakers.
As of 2014 the five most commonly used cardiac pacing device manufacturers (covering
more than 99% of the US market) made FDA-approved MR-conditional pacemakers.[34] The
use of MRI may be ruled out by the patient having an older, non-MRI Conditional pacemaker,
or by having old pacing wires inside the heart, no longer connected to a pacemaker.
A 2008 US study found[35] that the magnetic field created by some headphones used with
portable music players or cellphones may cause interference if placed very close to some
pacemakers.
In addition, according to the American Heart Association, some home devices have the
potential to occasionally inhibit a single beat. Cellphones do not seem to damage pulse
generators or affect how the pacemaker works.[36] It is recommended that objects containing
magnets, or generating a significant magnetic field, should not be in close proximity to a
pacemaker. Induction cooktops, in particular, can pose a risk.[37]
Before medical procedures, the patient should inform all medical personnel that they have a
pacemaker. Having a pacemaker does not imply that a patient requires the use of antibiotics
to be administered before procedures such as dental work.[38]
Complications from having surgery to implant a pacemaker are uncommon (each 1–3%
approximately), but could include: infection where the pacemaker is implanted or in the
bloodstream; allergic reaction to the dye or anesthesia used during the procedure; swelling,
bruising or bleeding at the generator site, or around the heart, especially if the patient is taking
blood thinners, elderly, of thin frame or otherwise on chronic steroid use.[45]
It is important to consider leads as a potential nidus for thromboembolic events. The leads are
small-diameter wires from the pacemaker to the implantation site in the heart muscle, and are
usually placed intravenously through the subclavian vein in order to access the right atrium.
Placing a foreign object within the venous system in such a manner may disrupt blood-flow
and allow for thrombus formation. Therefore, patients with pacemakers may need to be
placed on anti-coagulation therapy to avoid potential life-threatening thrombosis or
embolus.[49][50]
These leads may also damage the tricuspid valve leaflets, either during placement or through
wear and tear over time. This can lead to tricuspid regurgitation and right-sided heart failure,
which may require tricuspid valve replacement.[51]
Sometimes leads will need to be removed. The most common reason for lead removal is
infection; however, over time, leads can degrade due to a number of reasons such as lead
flexing.[52] Changes to the programming of the pacemaker may overcome lead degradation
to some extent. However, a patient who has several pacemaker replacements over a decade
or two in which the leads were reused may require lead replacement surgery.
Lead replacement may be done in one of two ways. Insert a new set of leads without
removing the current leads (not recommended as it provides additional obstruction to blood
flow and heart valve function) or remove the current leads and then insert replacements. The
lead removal technique will vary depending on the surgeon's estimation of the probability that
simple traction will suffice to more complex procedures. Leads can normally be disconnected
from the pacemaker easily, which is why device replacement usually entails simple surgery to
access the device and replace it by simply unhooking the leads from the device to replace
and hooking the leads to the new device. The possible complications, such as perforation of
the heart wall, come from removing the lead{s} from the patient's body.
The free end of a pacemaker lead is actually implanted into the heart muscle with a miniature
screw or anchored with small plastic hooks called tines. The longer the leads have been
implanted (starting from a year or two), the more likely that they will have additional
attachments to the patient's body at various places in the pathway from device to heart
muscle, since the body tends to incorporate foreign devices into tissue. In some cases, for a
lead that has been inserted for a short amount of time, removal may involve simple traction to
pull the lead from the body. Removal in other cases is typically done with a laser or cutting
device which threads like a cannula with a cutting edge over the lead and is moved down the
lead to remove any organic attachments with tiny cutting lasers or similar device.[53][54]
Pacemaker lead malposition in various locations has been described in the literature.
Treatment varies, depending on the location of the pacer lead and symptoms.[55]
Another possible complication called twiddler's syndrome occurs when a patient manipulates
the pacemaker and causes the leads to be removed from their intended location and causes
possible stimulation of other nerves.
Overall life expectancy with pacemakers is excellent, and mostly depends upon underlying
diseases, presence of atrial fibrillation, age and sex at the time of first implantation.[56]
Other devices
I II III IV
Shock chamber Antitachycardia pacing chamber Tachycardia detection Antibradycardia pacing chamber
Origin
In 1889, John Alexander MacWilliam reported in the British Medical Journal (BMJ) of his
experiments in which application of an electrical impulse to the human heart in asystole
caused a ventricular contraction and that a heart rhythm of 60–70 beats per minute could be
evoked by impulses applied at spacings equal to 60–70/minute.[58]
In 1926, Mark C Lidwill of the Royal Prince Alfred Hospital of Sydney, supported by physicist
Edgar H. Booth of the University of Sydney, devised a portable apparatus which "plugged into
a lighting point" and in which "One pole was applied to a skin pad soaked in strong salt
solution" while the other pole "consisted of a needle insulated except at its point, and was
plunged into the appropriate cardiac chamber". "The pacemaker rate was variable from about
80 to 120 pulses per minute, and likewise the voltage variable from 1.5 to 120 volts".[59] In
1928, the apparatus was used to revive a stillborn infant at Crown Street Women's Hospital in
Sydney, whose heart continued "to beat on its own accord", "at the end of 10 minutes" of
stimulation.[60][61]
In 1932, American physiologist Albert Hyman, with the help of his brother, described an
electro-mechanical instrument of his own, powered by a spring-wound hand-cranked motor.
Hyman himself referred to his invention as an "artificial pacemaker", the term continuing in
use to this day.[62][63]
An apparent hiatus in the publication of research conducted between the early 1930s and
World War II may be attributed to the public perception of interfering with nature by "reviving
the dead".[64] For example, "Hyman did not publish data on the use of his pacemaker in
humans because of adverse publicity, both among his fellow physicians, and due to
newspaper reporting at the time. Lidwell may have been aware of this and did not proceed
with his experiments in humans".[61]
Transcutaneous
In 1950, Canadian electrical engineer John Hopps designed and built the first external
pacemaker based upon observations by cardio-thoracic surgeons Wilfred Gordon Bigelow
and John Callaghan at Toronto General Hospital.[65] The device was first tested on a dog at
the University of Toronto's Banting Institute.[66] A substantial external device using vacuum
tube technology to provide transcutaneous pacing, it was somewhat crude and painful to the
patient in use and, being powered from an AC wall socket, carried a potential hazard of
electrocution of the patient and inducing ventricular fibrillation.[67]
A number of innovators, including Paul Zoll, made smaller but still bulky transcutaneous
pacing devices from 1952 using a large rechargeable battery as the power supply.[68]
In 1957, William L. Weirich published the results of research performed at the University of
Minnesota. These studies demonstrated the restoration of heart rate, cardiac output and
mean aortic pressures in animal subjects with complete heart block through the use of a
myocardial electrode.[69]
In 1958 Colombian doctor Alberto Vejarano Laverde and Colombian electrical engineer Jorge
Reynolds Pombo constructed an external pacemaker, similar to those of Hopps and Zoll,
weighing 45 kg and powered by a 12 volt car lead–acid battery, but connected to electrodes
attached to the heart. This apparatus was successfully used to sustain a 70-year-old priest,
Gerardo Florez.[70]
The development of the silicon transistor and its first commercial availability in 1956 was the
pivotal event that led to the rapid development of practical cardiac pacemaking.[71]
Wearable
In 1958, engineer Earl Bakken of Minneapolis, Minnesota, produced the first wearable external
pacemaker for a patient of C. Walton Lillehei. This transistorized pacemaker, housed in a
small plastic box, had controls to permit adjustment of pacing heart rate and output voltage
and was connected to electrode leads which passed through the skin of the patient to
terminate in electrodes attached to the surface of the myocardium of the heart.
In the UK in the 1960s, Lucas Engineering in Birmingham was asked by Mr Abrams of The
Queen Elizabeth Hospital to produce a prototype for a transistorised replacement for the
electro-mechanical product. The team was headed by Roger Nolan, an engineer with the
Lucas Group Research Centre. Nolan designed and created the first blocking oscillator and
transistor-powered pacemaker. This pacemaker was worn on a belt and powered by a
rechargeable sealed battery, enabling users to live a more-normal life.
One of the earliest patients to receive this Lucas pacemaker device was a woman in her early
30s. The operation was carried out in 1964 by South African cardiac surgeon Alf
Gunning,[72][73] a student of Christiaan Barnard. This pioneering operation took place under
the guidance of cardiac consultant Peter Sleight at the Radcliffe Infirmary in Oxford and his
cardiac research team at St George's Hospital in London.[74][75]
Implantable
In 1959, temporary transvenous pacing was first demonstrated by Seymour Furman and John
Schwedel, whereby the catheter electrode was inserted via the patient's basilic vein.[78]
In February 1960, an improved version of the Swedish Elmqvist design was implanted by
Doctors Orestes Fiandra and Roberto Rubio in the Casmu 1 Hospital of Montevideo, Uruguay.
This pacemaker, the first implanted in the Americas, lasted until the patient died of other
ailments, nine months later. The early Swedish-designed devices used batteries recharged by
an induction coil from the outside.
The first use of transvenous pacing in conjunction with an implanted pacemaker was by
Parsonnet in the United States,[79][80][81] Lagergren in Sweden[82][83] and Jean-Jacques Welti
in France[84] in 1962–63. The transvenous, or pervenous, procedure involved incision of a
vein into which was inserted the catheter electrode lead under fluoroscopic guidance, until it
was lodged within the trabeculae of the right ventricle. This became the method of choice by
the mid-1960s.
Cardiothoracic surgeon Leon Abrams and medical engineer Ray Lightwood developed and
implanted the first patient-controlled variable-rate heart pacemaker in 1960 at the University
of Birmingham. The first implant took place in March 1960, with two further implants the
following month. These three patients made good recoveries and returned to a high quality of
life. By 1966, 56 patients had undergone implantation with one surviving for over 51⁄2
years.[85][86]
Lithium battery
The preceding implantable devices all suffered from the unreliability and short lifetime of the
available primary cell technology, mainly the mercury battery. In the late 1960s, several
companies, including ARCO in the US, developed isotope-powered pacemakers, but this
development was overtaken by the development in 1971 of the lithium iodide cell by Wilson
Greatbatch.[88] Lithium-iodide or lithium anode cells became the standard for pacemaker
designs.
A further impediment to the reliability of the early devices was the diffusion of water vapor
from body fluids through the epoxy resin encapsulation, affecting the electronic circuitry. This
phenomenon was overcome by encasing the pacemaker generator in a hermetically sealed
metal case, initially by Telectronics of Australia in 1969, followed by Cardiac Pacemakers, Inc.
of St. Paul, Minnesota in 1972. This technology, using titanium as the encasing metal, became
the standard by the mid-1970s.
On July 9, 1974, Manuel A. Villafaña and Anthony Adducci, the founders of Cardiac
Pacemakers, Inc. (Guidant), manufactured the world's first pacemaker with a lithium anode
and a lithium-iodide electrolyte solid-state battery. Lithium-iodide or lithium anode cells
increased the life of pacemakers from one year to as long as eleven years, and has become
the standard for pacemaker designs. They began designing and testing their implantable
cardiac pacemaker powered by a new longer-life lithium battery in 1971. The first patient to
receive a CPI pacemaker emerged from surgery in June 1973.[87][89]
Liza Morton was fitted with an implantable pacemaker at 11 days old in 1978, at Glasgow’s
Yorkhill hospital, Scotland. She was the youngest baby at the time.[90][91]
Intra-cardial
In 2013, several firms announced devices that could be inserted via a leg catheter rather than
invasive surgery. The devices are roughly the size and shape of a pill, much smaller than the
size of a traditional pacemaker. Once implanted, the device's prongs contact the muscle and
stabilize heartbeats. Development of this type of device was continuing.[92] In November
2014, Bill Pike of Fairbanks, Alaska, received a Medtronic Micra pacemaker in Providence St
Vincent Hospital in Portland, Oregon. D. Randolph Jones was the EP doctor. Also in 2014, St.
Jude Medical Inc. announced the first enrollments in the company's leadless Pacemaker
Observational Study evaluating the Nanostim leadless pacing technology. The Nanostim
pacemaker received European CE marking in 2013. Post-approval implant trials were carried
out in Europe.[93] The European study was stopped after reports of six perforations that led to
two patient deaths. After investigations, St Jude Medical restarted the study.[94] In the United
States, this therapy had not been approved by the FDA as of 2014.[95] While the St Jude
Nanostim and the Medtronic Micra are single-chamber pacemakers, it was anticipated that
leadless dual-chamber pacing for patients with atrioventricular block would become possible
with further development.[96]
Reusable pacemakers
Worldwide each year, in a simple procedure to avoid explosions, thousands of pacemakers
are removed from bodies to be cremated. Pacemakers with significant remaining battery life
are potentially life-saving devices for people in low- and middle-income countries
(LMICs).[97] The Institute of Medicine, a US non-governmental organization, has reported that
inadequate access to advanced cardiovascular technologies is a major contributor to
cardiovascular disease morbidity and mortality in LMICs. Ever since the 1970s, multiple
studies worldwide have reported on the safety and efficacy of pacemaker reuse. As of 2016,
widely acceptable standards for safe pacemaker and ICD reuse had not been developed, and
there continued to be legal and regulatory barriers to widespread adoption of medical device
reuse.[98]
In animals
Pacemakers have also been implanted in animals such as cats, dogs and horses.[99][100][101]
Manufacturers
Biotronik (Germany)
Intermedics (US)
Medtronic (US)
Sorin Group (Italy) (merged with Cyberonics to form LivaNova; in 2018, LivaNova sold its
cardiac rhythm management business unit to MicroPort for $190M[102] )
Abbott (US)
See also
Biological pacemaker
Button cell
Implantable cardioverter-defibrillator
Infective endocarditis
Pacemaker syndrome
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External links
Implantable Cardioverter Defibrillator from National Heart, Lung and Blood Institute (https://
[Link]/health/defibrillators)
Current indications for CRT-P and CRT-D: Webinar from the European Heart Rhythm
Association (EHRA) ([Link]
munities/EHRA/education/webinars/Pages/[Link])