Steady. Precise. Works well under pressure.
Words that describe an expert marksman like Bob Eikey.
And the Aveir VR Leadless Pacemaker System that keeps his heart in rhythm, stabile and true.
It wasn't always that way.
In fact, until a few months ago, Eikey knew he needed a targeted solution to a long-standing and deteriorating condition, but neither he, nor his medical team, knew exactly where to aim.
Then, shortly after Eikey's lights went out, a light came on.
It turns out he received his wake-up call by passing out.
But we are getting ahead of ourselves.
A Sure Hand and Uncertain Heart
Eikey has always had the heart of a marksman. Literally.
"My heart rate was always low. It was usually about 55 beats per minute (BPM), which was great for when I was a competitive rifleman," Eikey said. "Having a lower heart rate is an advantage in most sports, but it's especially helpful when steadiness and calm are primary indicators of success."
Achievement in this sport came early and consistently to Eikey, who started competing in high school and continued in the military, winning numerous distinctions and expert ratings throughout his career.
His love for the sport never wavering, he walked-on to the rifle team at Ohio State in 1998 becoming, at 30, the oldest Division I athlete in the country at the time.
He went on to coach championship high school teams and continues to love the outdoors. He parlayed his Natural Resources (Wildlife Management) degree into a career as an environmental scientist, before starting his own landscaping firm. At 53, he is very active and very young at heart, but his body?
Not so much.
Broken Bones, Broken Heart?
"I break bones," Eikey said. "Broke my knee in the Coast Guard. Low back problems. Knee replacement. Spinal fusion in neck. In line for another spinal fusion. The list goes on."
But it was the irregular episodes he started having when he was 23 that felt the strangest.
"I was working in a bar and woke up on the floor. I was told it was dehydration. I joked, 'How can I be dehydrated when I drink a gallon of beer a day?' "
He was soon diagnosed with hypothyroidism, which can result in bradycardia, a slow heart rate.
These episodes continued in a seemingly random fashion for years.
There was no rhyme or reason to when they'd occur.
Any time of day, under any conditions.
"I would have 'gray-outs' where the lights would seem to dim and I’d feel like there was a fluttering in my chest. I wouldn't pass out, but it could be scary if I was driving or something similar."
After a particularly frightening episode behind the wheel, he was seen by a cardiologist who found nothing amiss on his EKG and suggested he was having panic attacks.
"First, I was dehydrated and now I was having panic attacks due to the chronic pain, combined with the hypothyroidism. It was a lot."
These overlapping concerns cast a considerable shadow over his diagnostic picture.
Not a great situation for marksman or physician.
A Target Coming into Focus
Strangely enough, it was blacking out in a home improvement store that shone the necessary light on the underlying cause of his problems: "I felt it coming on, literally stood straight up, and fell straight back onto the concrete, causing a concussion."
Concerned that he had done more damage to his neck, he waited to seek medical care until a prior scheduled neurosurgery visit at the VA hospital. Fortunately, Dr. Hamid Afshar — a board-certified cardiologist — took a holistic approach to Eikey, ordering a battery of tests, including his wearing a heart monitor.
The results were illuminating, the target coming into focus.
Eikey was diagnosed with an atrioventricular (AV) block, a partial or complete interruption of impulse transmission from the atria to the ventricles.
"I had no idea that this existed," Eikey said. "Apparently it had been going on my entire adult life, causing these random events."
He learned, for example, that when he was sleeping, his heart rate could drop to 20-25 BPM and his heart could stop beating for up to 3.5 seconds. Even the steadiest hands benefit from more cardiac activity than that. Afshar could now see the target. The next question was how best to hit it.
Enter Doctor and Device
"I am always looking for the most advanced technology for my patients, because they truly deserve the best," Afshar said. "We want to bring these innovations to the VA system."
Afshar was familiar with the Aveir VR Leadless Pacemaker System, designed to treat patients with slow heart rhythms, having recently completed training on the device. He thought it would be a good fit for Eikey, with several advantages:
Afshar pitched the technology to Eikey, focusing on an aspect near and dear to the patient's not-so-old heart: He was a relatively young man.
"I'm 53 and I'm always busy. I thought pacemakers were for old people," Eikey said. "I found out that my 75-year-old aunt had one and I saw a guy swimming with this clunky skin protrusion on his chest and I wasn’t excited about any of it. But Dr. Afshar explained why this device was different."
"I told him that if he were a member of my family, I’d recommend the Aveir leadless device," Afshar said. "He's young and he needed something that would last. With the leads of a traditional pacemaker there would be a lot of wear and tear over time.
"I wanted him to choose what was best for him and Aveir had several advantages like pacing could be adjusted, there was less chance of complications, like fractures in the leads or pocket infections, because there were no leads and no pocket, so those things were eliminated with this technology."
Decision Made and Precedent Set
After thorough discussion, Eikey's mind was made up.
Shortly thereafter, he became the first Texas patient to receive the Aveir VR Leadless Pacemaker. It did not take long before he understood that he had hit the bullseye.
"When I woke up in recovery, I felt great coming out of the gate," Eikey said. "I sort of geeked out over the science because that’s a passion of mine. I also appreciated the aesthetics, with no box sticking out of my chest. One of the first things I noticed was I didn't feel sluggish in the morning like I used to. I wake up bright-eyed and bushy tailed. I like that.
"I can tell when the pacemaker is doing its job. Once while tuning up, the pacemaker was set for 50 BPM when my heart rate dropped to 45 and the tech told me I’d feel it, and I felt a soft flutter that told me the pacemaker was doing its job. Before, I’d have an episode and be done for the day. Not anymore."
Afshar understands. "It's a very reassuring technology."
Bob Eikey is a busy man. He loves his business and his family but, "everything outdoors, from fishing to hunting to picking up turtles when they get too close to the road," is his passion. Go through a stack of pictures that include both Bob and any animal and you will find him smiling.
His marksman's eye is now set on the future and he's determined not to veer off target.
References
1 International Organization for Standardization (ISO) VVIR settings: 2.5V@0.4ms, 600 Ω, 60 bpm, 100% pacing.
IMPORTANT SAFETY INFORMATION
AVEIR LEADLESS PACEMAKER SYSTEM
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use
Indications: The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:
▪ Normal sinus rhythm with rare episodes of A-V block or sinus arrest
▪ Chronic atrial fibrillation
▪ Severe physical disability
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.
Intended Use: The Aveir™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.
The Aveir™ Delivery Catheter system is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.
Contraindications: Use of the Aveir™ Leadless Pacemaker is contraindicated in these cases:
Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.
Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.
Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.
Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.
Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in Product Materials section in IFU) contained in the device and a thorough history of allergies must be discussed.
Adverse Events: Potential complications associated with the use of the Aveir™ Leadless Pacemaker system are the same as with the use of single chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP (non-battery related), Loss of capture or sensing due to embolization or fibrotic tissue response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion), Death.
As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications (such as perforation, dissection, puncture, groin pain), Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage, General surgery risks and complications from comorbidities (such as hypotension, dyspnea, respiratory failure, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death)
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