With AVEIR DR, she found the pacemaker of her life

Our AVEIR DR dual chamber leadless pacemakers help Karen Pekowitz live life like she could never imagine before

At-a-glance:

Wellesley, Massachusetts, U.S.-native Karen Pekowitz, 50, had a complete, congenital heart block from birth that required a pacemaker from the time she was 17.
Her original pacemaker included traditional wires connecting the pacer to her heart. She says the wires were a “constant worry” for her.
In January 2024, she received our AVEIR DR dual chamber leadless pacemakers. It’s helped the elementary school English teacher live life like she hasn’t been able to before.

Abbott: How would you describe your life before receiving AVEIR DR?

Karen Pekowitz: About every seven years or so, I would have to have a procedure to replace my pacemaker’s battery and have to wait for it to heal. It was a bit of a drag to have to take the time off.

There were also a couple of times where my wires were not functioning properly. That would cause me to get lightheaded, dizzy. In 2001, I had to decide whether to remove one of the wires that was malfunctioning or leave it in. That was difficult: Do I take it out, with the risk of open-heart surgery? I decided — along with my mom — to just leave it in and hope that technology would improve in the future.

Karen reads a book to one of her students.

Abbott: What made you choose AVEIR DR?

KP: I had another malfunctioning wire, and we had to decide what to do. I didn’t really want to leave them in there because the more wires you put in, the more occluded your vein becomes. And the potential for infection becomes higher.

My cardiologist recommended the wires be extracted and that we put in wireless pacers in both chambers. Unfortunately, my batteries started to run out sooner than I expected. It was very scary. I wrote a letter to my children, just in case. My doctor said they had to leave a tiny little piece of a wire because it wouldn’t quite come out, but otherwise it went perfectly. Receiving AVEIR DR was super easy. They put a catheter in my groin and then put in the pacers. Those were certainly the easiest.

Karen solves a puzzle with her daughter at their family dining table.

Abbott: How would you describe your life since AVEIR DR?

KP: Unbelievable. I used to have to worry about raising my arms over my head when exercising, making sure that the pacemaker wasn’t jostled or moved. The more you move, the more potential for breaks in your wires, so it was always in the back of my head.

Now, I’m not aware of it. I’ve been feeling great. I can lift. I wasn’t allowed to do that. I’m a ferocious rower, I have to say.

It's mainly just the reassurance of mind that I’m not going to have to worry about those wires anymore. It was a constant worry. Just knowing I don’t have wires anymore is just very nice. When I go for my mammogram, there are no wires there. It’s amazing.

I went for my follow-up recently and they said, “One of your batteries has 17 years of power remaining and the other one has 12 years.” That’s so long! Now, I can concentrate on making sure I live a long life with exercise and diet. It’s not going to be the pacemaker! It just feels like it’s going to get better and better, the technology’s going to improve.

Abbott: What’s your advice for anyone considering AVEIR DR?

KP: Technology is not something to be afraid of. Sometimes, you just have to be brave and embrace new things. Abbott is making them for us; we have to use them. Just don’t be afraid.

This testimonial relays an account of an individual’s response to the treatment. This patient's account is genuine, typical, and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

Important safety information

AVEIR™ DR Dual Chamber 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 for Use: The AVEIR™ Leadless Pacemaker system is indicated for management of one or more of the following chronic clinical presentations: syncope, pre-syncope, fatigue, disorientation, and one or more of the indications which follow. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for patients exhibiting: sick sinus syndrome; chronic, symptomatic second- and third-degree AV block; recurrent Adams-Stokes syndrome; symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with: sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of AV block or sinus arrest, chronic atrial fibrillation. MR Conditional: The AVEIR Leadless Pacemaker is conditionally safe for use in the MRI environment and according to the instructions in the MRI-Ready Leadless System Manual.

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 and the right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.

The AVEIR™ Delivery Catheter 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 the Product Materials section of the 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 or dual chamber pacemakers with active fixation pacing leads including, but not limited to: cardiac perforation; cardiac tamponade; pericardial effusion; pericarditis; endocarditis; valve damage 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, contrast media, 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 capture, pacing or sensing (non-battery related); oversensing; increased capture threshold; inappropriate sensor response; corrupted, intermittent, or loss of i2i communications; 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, inability to release/re-dock of the LP from catheter, helix distortion); additional surgery or intervention; 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 dyspnea, respiratory failure, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.

™ Indicates a trademark of the Abbott group of companies.

‡ Indicates a third-party trademark, which is property of its respective owner.

With AVEIR DR, she found the pacemaker of her life

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