Floor to Foothills: The Cadence of Healing

Tom Reed was 36 when he had a stroke. Cardiovascular technology and discipline helped chart his road to recovery.

Floor to Foothills: The Cadence of Healing
Healthy Heart | Jan. 24, 2023

Lub-dup. Lub-dup. Lub-dup.

Heel-toe. Heel-toe. Heel-toe.

Maddie-Harper. Maddie-Harper. Maddie-Harper.

The cadence of the heart, the run, and the loves of Tom Reed.

He was 36 in 2018, playing on the kitchen floor with 5-year-old Harper, having just put 2-year-old Maddie to bed when "something happened." There was no loss of consciousness, no pain. There was, however, that bewildered expression on his daughter's face which turned increasingly worried. He realized that while he thought he was speaking to her, no words came out.

"I stood up, walked around the kitchen, sat back down and thought I was talking to her, but again, nothing," Reed said. “She was asking, 'What's wrong, daddy?' I could see the reaction in her face and tears starting to well up. I went to my wife who was getting ready for bed and I still couldn't speak. She told me to lift my arms. I could raise my left arm but not the right."

His wife, a nurse practitioner, immediately recognized the problem and got him to the hospital as quickly as possible. The rhythm of that night accelerated as the staff rushed to diagnose and treat his condition. This young, active father who went to the gym regularly had experienced a stroke.

After medication was administered and the clot in his brain dissolved, the search was on for the cause.

A Long Time Coming

Ultimately, the culprit was revealed to be a patent foramen ovale (PFO), a hole in the heart that didn't close the way it should have after birth, decades earlier. The hole, which sits between the upper heart chambers, develops while in the womb and typically closes during infancy.

The condition occurs in about 25% of people, yet most don’t require treatment for it, or even know they have it.

Reed was not so fortunate. "My vascular surgeon gave me the diagnosis and explained that the PFO had not only caused the stroke but put me at risk for more of them," Reed said. "It was important to fix the hole and reduce that likelihood."

Fortunately, his surgeon believed he had just the tool for the job: Abbott’s PFO device (now available as the AmplatzerTM TalismanTM PFO Occluder), a big name for a small medical device designed specifically to repair the condition. This occluder -- one of several in the Structural Intervention portfolio at Abbott  -- sets the standard, pioneering treatment developed specifically for PFO closure to reduce the chance of recurring ischemic strokes.

And Reed was focused on doing everything he could to prevent another stroke. "All I could think about was Maddie and Harper growing up and how I needed to not just be there for them, but to make sure I was the healthiest I could be."

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When Words Can't Be Found

In the meantime, that optimal version of Tom Reed needed some work to get himself back into fighting trim. The first obstacle to overcome was being able to say, "fighting trim," out loud when he wanted. His stroke had caused a clot in the area of his brain that processed communication. The resulting condition, aphasia, left him with severely compromised speech and language skills.

While fortunate enough to have no long-term ambulatory effects from the stroke, Reed's communication issues were challenging. "I did speech therapy during the original hospitalization, followed by 3 pretty intensive months of 2-3 times per week, then 1-2 times per week for six months, finishing up with regular sessions about a full year post-stroke."

His communication skills have continued to improve consistently, though less dramatically, over the past couple years. "People say I sound so much better over time and that always feels good to hear," Reed said. "Lately, it's been pretty comforting that people I didn't know before don't seem to realize that I had a stroke."

But Reed's path to recovery has been neither easy nor short. In fact, it was the very challenges he faced post-stroke that inspired him to choose the extraordinarily long road that resulted in his current condition.

"Aphasia is for Life."

By the time 2018 was ending, Reed could safely categorize it as a rough year. His recovery, while strong for someone who had suffered a stroke, was still that of a stroke patient.

"Aphasia is for life," Reed said. "I still have the effect of that damage and it was worse back in 2018. I've learned ways to mitigate the impact, but sometimes I'll think I've written or said something and realize I haven't. My mind thinks the whole sentence, but it doesn't translate to the keyboard or in my speech. I sometimes have short-term memory loss. It can be frustrating."

These medical problems added layers of difficulty to his job as a metal industry sales professional, as well as his marriage, which ended the following year.

Reed needed a new path forward and chose a very long one.

"Before the stroke I didn't really care for distance running," Reed said. "I was a three times per week gym guy, who did some weights and worked on the cardio machines."

Then the breakthrough happened.

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The Road to Recovery is Long

"I realized that running can be therapeutic. It helped a bit physically but had a tremendous impact mentally and emotionally. It brought clarity to some thoughts that required more introspection while removing others that were just slowing me down. The more I found myself getting into the rhythm of the run, the more I felt I was getting back to controlling my life."

As his runs through the scenic Colorado foothills got longer, the benefits continued to accrue.

"Especially in 2018 when, frankly, I was going through a lot, I noticed that pushing myself harder helped, because if I could do this grueling thing, it wasn't that hard compared to all the other challenges I've met. It helped me realize that I could overcome things in my life that seemed overwhelming. Over time, it reset my confidence."

It also reset his life. First, there was the running club in Boulder, where distance devotees meet every Wednesday, followed by signing up for events including mini-marathons in locales both distant (including one in Indianapolis, near a boyhood home) and nearby (Denver).

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The Big Payback

Always one eager to pay it forward, Reed reached out to the American Heart Association (AHA) to contribute to their philanthropic efforts. As a survivor, he has spoken at several events and assists in frequent awareness-building and fundraising efforts. CycleNation, part of the AHA, has also taken advantage of Reed's passion for fitness and volunteer work through multiple events, with more to come.

He is grateful for the people in his life, none more than his growing daughters. Even the benefits he gets from the isolation of distance running are tied in with his desire to be part of a larger whole.

"There is a good kind of loneliness in running where you can be with just you and let in only what you want to," said Reed. "You have the rhythm of your own thoughts and that can make it easier to come up with solutions, think of ways to make life better or just remember what and who is important to you.

"My whole life, I've tried to see the positive. A lot of bad things have happened over the past few years, to me and my community. My stroke, the pandemic, wildfires destroyed over 1,000 homes in my town, including those across the street from mine … But I'm healthier than ever, I have my girls and I'm helping people. My attitude is when one door closes, another opens …"

As he steps through that door, Tom Reed feels that magical cadence that powers his life:

Lub-dup. Lub-dup. Lub-dup.

Heel-toe. Heel-toe. Heel-toe.

Maddie-Harper. Maddie-Harper. Maddie-Harper.

This story was originally published on Dec. 7, 2022, and updated on Jan. 24, 2023.

Important safety information

INDICATIONS FOR USE

The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.

CONTRAINDICATIONS

  • Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained.
  • Patients with intra-cardiac thrombus, mass, vegetation, or tumor.
  • Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.
  • Patients with anatomy in which the required Amplatzer™ Talisman™ PFO device size would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.
  • Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
  • Patients with active endocarditis or other untreated infections.
  • Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.

WARNINGS

  • Do not use an open or damaged pouch; do not use a damaged device.
  • Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO closure following standard of care.
  • The safety and effectiveness of the Amplatzer™ Talisman™ PFO Occluder has not been established in patients with a hypercoagulable state.
  • Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon and access to operating room.
  • Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
  • The Amplatzer™ Talisman™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.
  • Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.
  • Prior to device detachment, evaluate the position of the device relative to the free atrial wall and the aortic root using echocardiography.
  • Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic root.
  • Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or consider alternative treatments.
  • DO NOT use the Amplatzer™ Talisman™ PFO Occluder after the Use-by date stated on the package label.
  • This device was sterilized with ethylene oxide and is for single use only. Never reuse or re-sterilize the system. Use of expired, reused, or re-sterilized devices may result in infection.
  • This device should be used only by physicians who are trained in standard transcatheter techniques.

PRECAUTIONS FOR SPECIAL POPULATIONS

  • Pregnancy: The safety and effectiveness of this occluder has not been established during pregnancy. Fluoroscopic x-ray guidance is used during placement of the device. The risk of increased X-ray exposure for patients who are pregnant must be weighed against the potential benefits of this technique.
  • Nursing mother: The safety and effectiveness of this occluder has not been established in lactating mothers. There has been no quantitative assessment for the presence of leachables in breast milk.
  • Pediatric Population: The safety and effectiveness of this occluder has not been established in a pediatric population.

PRECAUTIONS

  • Aspirin (325 mg/day) (or alternative antiplatelet/anticoagulant, if patient has aspirin intolerance) is recommended to be started at least 24 hours prior to the procedure.
  • Antibiotics should be administered peri-procedurally.
  • Patients should be fully heparinized throughout the procedure using adequate dosing so as to keep the activated clotting time (ACT) greater than 200 seconds.

CAUTION: Intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE) is recommended as an aid in evaluating the PFO and placing the Amplatzer™ Talisman™ PFO Occluder. If TEE is used, the patient’s esophageal anatomy must be adequate for placement.

CAUTION: Be cautious when using fluoroscopic X-ray guidance, which may be used during placement of the device.

CAUTION: Do not use a power injection system to put contrast solution through the sheath.

The safety and effectiveness of the Amplatzer™ Talisman™ PFO Occluder has not been established in patients (with):

  • Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old
  • A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy
  • Unable to take antiplatelet therapy
  • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
  • Acute or recent (within 6 months) myocardial infarction or unstable angina
  • Left ventricular aneurysm or akinesis
  • Mitral valve stenosis or severe mitral regurgitation, irrespective of etiology
  • Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation
  • Mitral or aortic valve vegetation or prosthesis
  • Aortic arch plaques protruding greater than 4 mm into the aortic lumen
  • Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
  • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
  • Uncontrolled hypertension or uncontrolled diabetes mellitus
  • Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event
  • Arterial dissection as cause of stroke
  • Index stroke of poor outcome (modified Rankin score greater than 3)
  • Pregnancy at the time of implant
  • Multi-organ failure

PATIENT COUNSELING INFORMATION
Physicians should review the following information when counseling patients about the Amplatzer™ Talisman™ PFO Occluder and the implant procedure:

  • The safety and effectiveness of PFO closure with the Amplatzer™ Talisman™ PFO Occluder in combination with the required postimplant antiplatelet therapy.
  • PFO closure with the Amplatzer™ Talisman™ PFO Occluder can only reduce the risk for a recurrent stroke due to a paradoxical embolism through a PFO.
    - With aging, there is an increased likelihood that non-PFO related risks for stroke may develop and cause a recurrent ischemic stroke independent of PFO closure.
  • The procedural risks associated with Amplatzer™ Talisman™ PFO Occluder.
  • The need for adherence to a defined adjunctive antithrombotic therapy following implantation of the Amplatzer™ Talisman™ PFO Occluder.
  • Patients with a history of DVT or PE may benefit from continuation or resumption of anticoagulation therapy following implantation of the Amplatzer™ Talisman™ PFO Occluder to reduce the risk of recurrent DVT or PE.

It is recommended that the medical team (neurologist and cardiologist) and the patient engage in a shared decision-making process and discuss the risks and benefits of PFO closure in comparison to using antithrombotic therapy alone, while taking into account the patient’s values and preferences.

POTENTIAL ADVERSE EVENTS
Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to:

  • Air embolus
  • Allergic reaction/toxic effect due to: anesthesia, contrast media, medication, or metal
  • Arrhythmia
  • Arteriovenous fistulae
  • Bleeding
  • Cardiac perforation
  • Cardiac tamponade
  • Chest pain
  • Death
  • Deep vein thrombosis
  • Device embolization
  • Device erosion
  • Endocarditis
  • Esophagus injury
  • Fever
  • Headache/migraine
  • Hematoma
  • Hypertension/hypotension
  • Infection
  • Myocardial infarction
  • Pacemaker placement secondary to PFO device closure
  • Pain
  • Pericardial effusion
  • Pericarditis
  • Peripheral embolism
  • Pseudoaneurysm
  • Pulmonary embolism
  • Reintervention for residual shunt/device removal
  • Stroke
  • Transient ischemic attack
  • Thrombus formation
  • Valvular regurgitation
  • Vascular access site injury
  • Vessel perforation

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