Connectivity Series: A look at Electrophysiology

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Did you know that 2% of people under 65 and 9% of people over 65 struggle with atrial fibrillation? Did you also know that many people with atrial fibrillation are unaware of the condition until it gets discovered during a physical examination? There are many possible causes of atrial fibrillation, also called Afib, but many times the cause is unclear. With heart rhythm disorder rates expecting to double by 2035, a substantial increase in demand for Electrophysiology (EP) device equipment is expected. As a result, the race to develop the safest and most efficient way to treat the condition is on for the major medical device manufacturers and even many emerging, more specialized electrophysiology device companies.

                So what is Electrophysiology anyway? In essence, it tests the electrical activity of cells and tissues and electrical pathways in the heart to find an abnormal heartbeat or arrythmia. Although Electrophysiology may seem like a difficult process due to the complexity of its name it is a surprisingly safe and inexpensive procedure that can save money for the patient and hospital. By inserting catheters and custom wire electrodes, which measure electrical activity through blood vessels that enter the heart, doctors are able to assess the heart’s electrical system more accurately than traditional surgery.

A typical EP procedure would include the following steps:

  1. Electrodes will be placed on your chest and back to connect you to the array of monitors placed around the operating table.
  2. Local anesthetic will be administered to the areas where the catheter will be inserted – either the neck or groin. You may feel a slight pinch!
  3. Several long, thin, flexible wire catheters are inserted into your veins. The catheters will then be guided to your heart as they are monitored on a screen.
  4. A mapping catheter is used to determine where the arrythmia is taking place and then the catheter tips apply either extreme heat or cold to ablate these spots.
  5. Once the procedure is completed the catheters will be removed and you must remain still for four to six hours as to let the catheter sites seal.
  6. Depending on the procedure site the wire catheters could be reprocessed so they must have a biocompatible surface finish that can be sterilized or appropriately decontaminated.
  7. Get lots of bed rest and limit your mobility for the next week. Did someone say Netflix and nap?

With an aging population and a movement toward less invasive procedures, the global EP equipment market is expected to reach $8.27 billion by 2022, while growing at a CAGR of 13.4%. This rapid growth rate has already rocketed ablation catheters to the #1 treatment device for atrial fibrillation, ahead of ICDs, pacemakers, medications, and coronary bypass surgery. With EP Mapping and Navigation devices expected to reach $1.4B by 2024 and with EP Ablation to reach $3.3B the future looks bright for this field changing technology.

Whether a device manufacturer is focusing on mapping systems, mapping catheters, ablation catheters or perhaps the full suite of electrophysiology devices, each one will need reliable power and data transmission capability.

Some of the cable features required by the EP market include:

  • Highly flexible solution for surgeon’s effortless manipulation
  • Mechanical strength to withstand the twists and turns of surgery
  • A biocompatible surface finish for doctor and patient safety and comfort
  • Solutions that can be sterilized or appropriately decontaminated

Northwire has been partnering with contract manufacturers and medical device companies for decades in the design and manufacture of customized cable and wire for the Healthcare industry, including:

  • Solutions that are compatible with steam, H202, gamma, and ETO sterilization
  • Cable materials compliant to ISO 10993-5 and ISO 10993-10
  • An experienced design team in direct contact with customers
  • BioCompatible materials including a USP Class VI silicone alternative with superior cut, crush, and abrasion resistance

Why is there so much attention around this technology? Before Electrophysiological testing Doctors would typically rely on simple heart rate monitors leading to an educated guess for what the causes of the irregular heartbeat could be. This would involve placing a Holter monitor or Event monitor on the outside of the patient’s heart to record their heartbeat throughout the day. To ensure that patients experienced an array of different arrhythmias a stress test would be administered involving exercise on a treadmill or bicycle. However, these tests only led to educated guesses that are based on the data obtained from former patients who experienced heart arrhythmia.  Thankfully, with Electrophysiology test and mapping we can receive the most accurate information in real time in order to more quickly and effectively treat the arrythmia.

Current alternatives for Electrophysiology

Vagal Maneuvers: The at home remedy for fast heartbeats hasn’t been popular since the early 1900’s, VM requires the patient to hold their breathe for long periods of time, dunking their face in freezing ice water, or simply coughing in order to slow down the heart rate. However, VM doesn’t work for all types of arrhythmias.

Medications: Although effective, medications for irregular heart rhythms are only meant to be a short-term solution. Doctors will typically prescribe blood-thinning medications to help keep dangerous blood clots from forming around the heart.

Cardioversion: A form of shock therapy this procedure is only used in unique cases of arrhythmia. Will require multiple unsuccessful attempts which can be a burden to the consumer.

Coronary Bypass Surgery & Pacemakers: Both being solutions legendary cartoon characters Krusty the Clown and Homer Simpson used to treat their heart arrhythmias, CPS and Pacemakers are just as outdated as their cartoon counterparts.  Pacemakers being an implanted device near the collarbone during a minor surgery helps control abnormal heart rhythms by detecting abnormal heartbeats. If this is detected the device emits an electrical impulse that stimulates the heart to beat at a normal rate. In season 1 of The Simpsons, everyone’s favorite clown Krusty is arrested for a crime that he didn’t commit. In order to prove his innocence, the main characters explain that the crime was committed near a microwave oven that would have disrupted his pacemaker resulting in serious injury. Sadly, this is more fact than fiction for many with pacemakers as they are forced to avoid prolonged contact with electrical devices with strong magnetic fields such as cellphones, household appliances, high-tension wires, metal detectors, industrial welders, and electrical generators.

When compared to the alternatives, it is clear why Electrophysiology has experienced so much growth, which is projected to continue into the foreseeable future. With experienced designers on hand to guide your cable design and rapid prototyping, Northwire is an ideal partner in the development of cable and assembly solutions tailored to the EP market.

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