Implantable Defibrillator Insertion

What is an implantable defibrillator?

An implantable cardioverter defibrillator (ICD) is a small electronic device connected to
the heart. It is used to continuously monitor and help regulate potentially fast and life-
threatening electrical problems with the heart.

A transvenous or “traditional” ICD, about the size of a stopwatch, is implanted under the
skin just below the collarbone. It consists of a pulse generator and wires, called leads.
The pulse generator contains the battery and a tiny computer. One or more lead wires
connect the pulse generator to specific locations in the heart.

The ICD responds to irregular life-threatening heart rhythms from the lower chambers of
the heart with pacing that corrects a fast rhythm and promotes a normal heartbeat, or a
shock (defibrillation) that resets the heart rhythm to prevent sudden cardiac arrest. An
ICD also records and stores information about your heart rhythm and therapies
delivered by the ICD for your doctor to review.

Most people are unaware when the ICD is pacing the heart. But, a defibrillation shock is
described by many as feeling like a "kick in the chest."

An ICD can also be programmed to work as a basic pacemaker as needed. Sometimes

after a shock is delivered, the heart may beat too slowly. The ICD has a "back-up"
pacemaker, which can stimulate the heart to beat faster until the normal heart rhythm
returns. The ICD can act as a pacemaker any time the heart rate drops below a preset
rate.

For those patients who do not require either “back-up” pacing or Anti-Tachycardia
Pacing (ATP), a Subcutaneous Implantable Defibrillator (S-ICD) is available. It allows
for the delivery of high-energy shocks while avoiding the potential risks and
complications associated with leads that traverse the veins leading to the heart.

Why one might need an implantable defibrillator?

One may need an ICD if you have survived sudden cardiac arrest due to ventricular
fibrillation, or have fainted due to ventricular arrhythmia, or if you have certain inherited
heart conditions.

An ICD is generally needed for those at high risk of cardiac arrest due to a ventricular
arrhythmia. This includes people with heart failure who have problems with the
contraction of the heart, such as abnormal left ventricular ejection fraction.

There may be other reasons for your doctor to recommend an ICD.

What are the risks of an implantable defibrillator?
Possible risks of ICD insertion include:

 Bleeding from the incision or catheter insertion site

 Damage to the blood vessel at the catheter insertion site
 Infection of the incision or catheter site
 Tearing of the heart muscle
 Collapsed lung
 Dislodging of the leads requiring another procedure to reposition the leads

If one is pregnant or think that you could be, or are currently breastfeeding, tell your
healthcare provider.

If one is allergic to or sensitive to any medicines or latex, tell your healthcare provider.

Lying still on the procedure table for the length of the procedure may cause some
discomfort or pain.

There may be other risks depending on your specific medical condition. Be sure to
discuss any concerns with your healthcare provider before the procedure.

How is an implantable defibrillator implanted?

Having an ICD implanted may be done on an outpatient basis or as part of your stay in
a hospital. Procedures may vary depending on your condition and your doctor’s
practices.

Generally, an ICD insertion follows this process:

 You will be asked to remove any jewelry or other objects that may interfere with
the procedure.
 You will be asked to remove your clothing and will be given a gown to wear.
 You will be asked to empty your bladder before the procedure.
 An intravenous (IV) line will be started in your hand or arm for injection of
medicine and fluids, if needed.
 You will be placed on your back on the procedure table.
 You will be connected to an electrocardiogram (ECG) monitor that records the
electrical activity of the heart during the procedure using. Your vital signs (heart
rate, blood pressure, breathing rate, and oxygenation level) will be monitored
during the procedure.
 The surgical site is cleaned. In some cases, hair may be shaved or clipped.
 Large electrode pads will be placed on the front and back of the chest.
  You will receive a sedative in your IV before the procedure to help you relax.
However, you will likely remain awake during the procedure.
 The ICD insertion site will be cleansed with antiseptic soap.
 Sterile towels and a sheet will be placed around this area.
 A local anesthetic will be injected into the skin at the insertion site.
 Once the anesthetic has taken effect, the doctor will make a small incision at the
insertion site.
 A sheath, or introducer, is inserted into a blood vessel, usually under the
collarbone. The sheath is a plastic tube through which the ICD lead wire will be
inserted into the blood vessel and advanced into the heart.
 It will be very important for you to remain still during the procedure so that the
catheter does not move out of place and to prevent damage to the insertion site.
 The lead wire will be inserted through the introducer into the blood vessel. The
doctor will advance the lead wire through the blood vessel into the heart.
 Once the lead wire is inside the heart, it will be tested to verify proper location
and that it works. There may be 1, 2, or 3 lead wires inserted, depending on the
type of device your doctor has chosen for your condition. Fluoroscopy, (a special
type of X-ray that will be displayed on a TV monitor), will be used to position the
lead.
 For subcutaneous ICDs, one or two small incisions are made near the top and
bottom of the sternum or breast bone. The lead wire is then tunneled underneath
the skin next to the sternum and from the sternum to the incision on the left side
of the chest.
 The ICD generator will be slipped under the skin through the incision (just below
the collarbone for traditional ICDs and on the left side of the chest for S-ICDs)
after the lead wire is attached to the generator. Generally, if you are right-
handed, the device will be placed in your upper left chest. S-ICDs are implanted
on the left side of the chest near the heart. If you are left-handed, or have a
contraindication to a left-sided device a traditional ICD can be placed in your
upper right chest.
 The ECG will be observed to monitor ICD function. Certain tests may then be
done to assess the device function.
 The skin incision will be closed with sutures, adhesive strips, or special glue.
 A sterile bandage or dressing will be applied.

THE TOP 2 COMPANIES IN CARDIOVERTER DEFIBRILLATOR:

1. Medtronic PLC (Ireland)

 The company designs, manufactures, and sales
medical devices. The company offers its products under four operating business
segments i.e. cardiac and vascular group, minimally invasive therapies group,
restorative therapies group, and diabetes group.

The cardiac and vascular group segment offers, cardioverter defibrillators,

cardiac resynchronization therapy devices and implantable cardiac pacemakers.
The company has strong geographic presence in North America, Europe, Asia-
Pacific, Latin America, and Middle East & Africa with its 30 subsidiaries across
the globe.

2. Boston Scientific Corporation (U.S.)

Boston Scientific Corporation operates in developing,

manufacturing, and marketing medical devices for use in various interventional
medical specialties worldwide. The company operates into three operating
business segments i.e. Cardiovascular, Rhythm Management, and MedSurg.
Cardiovascular segment offers cardiac rhythm management devices, such as
implantable cardioverter defibrillator systems and implantable cardiac
resynchronization therapy pacemaker systems used to treat & detect abnormally
fast heart rhythms & heart failure.

With the strong distribution network and more than 35 subsidiaries including
Cardiac Pacemakers, Inc. and Boston Scientific Japan K.K; the company has a
strong geographic presence in North America, Europe, Asia-Pacific, Latin
America, and Middle East & Africa.

ADVANCES IN CADIOVERTER DEFIBRILLATOR TECHNOLOGY:

ICD trends include reducing inappropriate shocks, longer battery life, less
invasive installation and quadripolar leads
There have been several recent advancements in implantable cardioverter
defibrillator (ICD) technology  to extend battery life, improvements in patient
monitoring to avoid needless shocks, the introduction of quadripolar lead devices
to improve device programming and to improve therapy effectiveness, and
development of magnetic resonance imaging (MRI)-safe ICDs. 

ICDs are implanted in patients who are at high risk for sudden cardiac arrest
(SCA) due to sustained ventricular tachycardia or fibrillation. These devices also
are used to improve the heart’s pumping ability in heart failure patients   

INCREASED ICD BATTERY LIFE:

Battery longevity has long been an issue with ICDs. As patients live longer, they
may need to undergo surgical procedures every few years for regular battery
replacements. Increased device longevity can reduce the risk of infection and
other complications due to repeat replacement procedures and help minimize
out-of-pocket patient expenses for avoidable replacement procedures.

In February, Boston Scientific launched a line of extended longevity (EL) battery

ICDs, including the Dynagen EL and Inogen EL device models. The devices use
the EnduraLife battery, developed with high-performance chemistry and
advanced manufacturing capabilities to provide up to double the battery capacity
of other ICDs, the vendor said. Boston Scientific said the battery life is projected
to be about 12 years before a replacement is needed. The EnduraLife battery is
packaged in a device up to 11 percent smaller and 24 percent thinner than other
ICDs.

 "Battery longevity has a direct impact on patient outcomes and the cost of care,"
said Samir Saba, M.D,  who was the first to implant an EL ICD after FDA
approval at The University of Pittsburgh Medical Center. "The EL ICD is an
important advancement that can help minimize the frequency of avoidable
replacement procedures to help reduce costs and the potential for replacement-
related complications." 

  

MRI-SAFE ICDs: 

It is estimated that about 60 percent of ICD patients will need an MRI within 10
years of receiving a device. Until the availability of MR-conditional ICD systems,
patients with devices have been contraindicated from receiving MRI scans
because of potential interactions between the MRI and device function. There are
several MRI-compatible ICDs now available in Europe and two undergoing FDA
investigational device exemption (IDE) pivotal trials in the United States

The ProMRI trial is evaluating Biotronik’s DX ICD system, which gained CE mark
in Europe in 2011, becoming the first MRI-compatible ICD on the market. In May
2014, Medtronic announced the first U.S. trial implant of its Evera MRI SureScan
ICD system. Medtronic gained European CE mark approval for the device in April
2014.

REDUCING SHOCKS

Patients’ quality of life and faith in their ICDs can be significantly decreased if
their ICD shocks the patient needlessly. Some vendors now include technology
to help reduce inappropriate shocks. 

St. Jude Medical's Assura ICD and CRT portfolio features Secure Sense RV
Lead Noise Discrimination, an algorithm that expands St. Jude’s ShockGuard
technology and offers advanced sensing options designed to reduce the
incidence of inappropriate shocks. The algorithm provides advanced alerts as
well as more proactively lowering the risk of lead-related complications through
its ability to automatically withhold tachycardia therapy in the presence of lead
noise (over-sensing of electrical signals). The technology differentiates lead
noise from true ventricular tachycardia (VT) or ventricular fibrillation (VF)
episodes that require life-saving therapy.

In addition, ShockGuard technology features specific programming that

distinguishes between rhythms that require defibrillation therapy and those that
do not, such as benign arrhythmias. DecisionTx programming offers advanced
sensing technology designed to avoid sensing unwanted signals (T-waves) and
more anti-tachycardia pacing options, which can convert many fast ventricular
arrhythmias painlessly and avoid the need for high-voltage shocks. 

Medtronic’s Evera MRI includes SmartShock 2.0, a shock reduction algorithm

that enables the device to better differentiate between dangerous and harmless
heart rhythms. Medtronic said studies estimate about 20 percent of patients with
implantable defibrillators might experience inappropriate shocks in response to a
benign arrhythmia or electrical noise sensed by the device. 

Lead failure is another source of inappropriate shocks. In late 2013, Medtronic

gained FDA clearance for its Lead Integrity Alert (LIA) software for use with non-
Medtronic leads. LIA can report performance issues on Durata and Riata (St.
Jude Medical) and Endotak (Boston Scientific) defibrillator leads when connected
to a Medtronic device.

REDUCING IMPLANTED HARDWARE:

Biotronik’s Ilesto family of ICD/CRT-D devices includes the Ilesto DX. The
platform allows for a 15 percent size reduction and 29 percent fewer components
with no compromise in longevity or clinical features. It is the first defibrillator
system equipped to provide full atrial diagnostic information with just one
specialized defibrillator lead. The DX system offers an alternative with more
monitoring capability than a single-chamber device, and without additional leads
required for dual-chamber devices.

POWER SOURCES FOR IMPLANTABLE DEFIBRILLATOR:

The implantable cardioverter defibrillator (ICD) relies on a continuous supply of

electricity. Therefore, a long-term, extremely safe power source is critical in the
recharging of an ICD. Some of the power sources come from conventional batteries,
such as lithium cell, nuclear cell and bio-fuel cell however new methods have been
are being invested to recharge ICDs from outside of the human body. These emerging
innovations to recharge the implanted batteries, include electromagnetic energy
transmission, piezoelectric power generation, thermoelectric devices, ultrasonic power
motors, radio frequency recharging and optical recharging methods to name a few.

TYPICAL BATTERIES FOR ICDs

The first implanted lithium cell used to power a defibrillator was designed by an
Italian scientist in 1972. With the advent of lithium batteries, the longevity of an
implanted cardiac defibrillator had been extended to 10 years, and more than five
million people have benefited from such advancement so far. The lithium battery has
been widely adopted as the power source in ICDs, besides the implanted cardiac pace-
maker which has moved on to a safer Li/I2 battery that leak less than other liquid
batteries. The three typical ICDs utilizing lithium battery are Neuro-stimulators, drug
delivery system, and defibrillators.

The main reason why Li/I2 batteries take a dominant place in powering implantable
cardioverter defibrillator is their high discharge voltage and energy density.

Thermoelectric Devices
The thermoelectric power generator is a highly promising alternative to the typical
batteries. The human body has inherent temperature differences. The maximum
difference is between the body core and the skin surface at 8K which can be large
enough to generate electricity. Additionally, the human body naturally creates heat
energy which is typical released into the environment. Therefore, thermoelectric
power generators are environment-friendly. Although having perfect self-powering
capability by directly using the body heat, the thermoelectric generator has been far
from being fully developed.