With MitraClip, a Long Life Kept Going

For nearly a decade after a heart scare, Kato Pomer lived the life she wanted, thanks to MitraClip.
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Healthy Heart | Nov. 17, 2017

NOTE TO READERS: Kato Pomer passed away on April 14, 2018. Abbott is grateful to have been a small part of her extraordinary life. We're proud to bring you her story and remember the impact she had on the lives of those who knew and loved her. We’ll never forget her.

Kato Pomer's life began in Holland at the close of the first World War. When she arrived in the United States as a WWII refugee in her 20s to complete her medical studies at Johns Hopkins University, the second World War was still raging.

She was moved by protests for civil rights and against the Vietnam War. And she was still caring for her patients in her 90s.

A long, productive work life wrought the fruits of her labors, including spending time during her retirement in Idyllwild, a tiny resort town nestled in southern California's San Jacinto Mountains.

It's a picturesque place where rugged mountains climb into an impossibly big sky, where old growth forests share their shade with those lucky enough to be there. In late summer of 2009, Pomer was lucky enough. She had just finished an art class.

The winds picked up, carrying with them smoke and ash from the Santa Clarita wildfires a few hundred miles away. Pomer fell very ill, very quickly. She was having a "terrible time breathing," she said. Her family feared the worst.

"They (doctors) told me her mitral valve had ruptured," Karen said. "They didn't know why and they needed to do something right away. But she was not a candidate for open heart surgery."

As Kato stabilized enough to get home to Los Angeles, doctors at two hospitals recommended Karen care for her mother by making her comfortable, calling hospice and preparing plans to say goodbye.

Karen Pomer was having none of it.

mitraclip

The Right Device at the Right Time

Perhaps no recorded century has been changed as much by creativity and innovation as these most recent 100 years.

Dr. Kato Pomer, first a pediatrician, and later, child psychiatrist, was born before women had the right to vote in the United States. She survived world war. She entered this world before the Soviet Union and outlived it by more than 25 years.

She was not quite a teen when Mickey Mouse took his first trip to the silver screen in "Steamboat Willie." She was in her prime when the Beatles debuted on "The Ed Sullivan Show."

She met Albert Einstein, Eleanor Roosevelt and Anna Freud. She witnessed humanity's first celestial steps on the moon.

But after that smoke blew into her chest that day in Idyllwild, Kato would have missed much of the last decade without another invention, this one of modern medicine.

First, the problem: Her ruptured mitral valve.

"The mitral valve separates the upper chambers from the lower chambers" in the heart, explained Dr. Saibal Kar, director of Cardiovascular Intervention Center Research at the Cedars-Sinai Heart Institute in Los Angeles, and Kato's interventional cardiologist. "And it prevents blood from going back to the upper chamber while the blood is being ejected out through the aorta."

Untreated, severe mitral valve leakage like Kato's can lead to progressive shortness of breath, fatigue and ultimately, heart failure. "And after several years of suffering, patients may actually die from the condition," said Dr. Kar, one of the world’s leading experts in mitral valve issues.

Kato was 92.

She was fighting an infection.

mitraclip

She was not a candidate for open-heart surgery. But they could try MitraClip, a small device implanted during a minimally invasive procedure through a vein in the leg.

MitraClip — which has now treated more than 50,000 people with mitral valve disease — allows the valve to continue to open and close on either side of the clip while reducing the backward flow of blood in the heart.

Once Karen learned what MitraClip could do for her mother, nothing was going to stand in the way.

"It's an Amazing Thing"

Kato was in bad shape.

"At that time, I had never had a patient who was so sick and so old," Dr. Kar said.

How'd it turn out?

"After my mother had MitraClip placed in her heart, she was back to her old self again," Karen said. “She was painting. She saw patients. She played with her grandchildren. She hung out with the dogs. She had a great time."

She has kept on having it. Kato recently celebrated her 100th birthday with family and friends gathered from around the country.

"It worked. I can function again," Kato said. "And have some fun. ... I can flirt. I'm very happy I did it because it saved my life."

Nobody lives forever. But who wouldn’t want to live their best life longer?

"At the time my mother had a MitraClip procedure, she was one of the highest risk, eldest patients to ever have one," Karen said. "The fact that she had one and survived helps save not just her life but other people’s lives who came after her."

"Who would have thought my mother was going to be turning 100 years old? It's an amazing thing. And it is a miracle."

"It was a miracle for our family," Kato said.

IMPORTANT SAFETY INFORMATION

MITRACLIP CLIP DELIVERY SYSTEMS

INDICATION FOR USE

The MitraClip™ NTR/XTR System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

The MitraClip™ NTR/XTR System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III  per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

CONTRAINDICATIONS

The MitraClip™ NTR/XTR System is contraindicated in patients with the following conditions:

Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen

Active endocarditis of the mitral valve

Rheumatic mitral valve disease

Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

WARNINGS

DO NOT use MitraClip™ outside of the labeled indication.

The MitraClip™ Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g., transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.

Read all instructions carefully.  Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the MitraClip™ System to avoid user injury.

Use of the MitraClip™ should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.

The Clip Delivery System is provided sterile and designed for single use only.  Cleaning, re-sterilization and / or reuse may result in infections, malfunction of the device or other serious injury or death.

Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClip™ in these patients has not been evaluated.

PRECAUTIONS

Note the product “Use by” date specified on the package.

Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.

Prohibitive Risk Primary (or degenerative) Mitral Regurgitation

Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:

30-day STS predicted operative mortality risk score of

≥8% for patients deemed likely to undergo mitral valve replacement or

≥6% for patients deemed likely to undergo mitral valve repair

Porcelain aorta or extensively calcified ascending aorta.

Frailty (assessed by in-person cardiac surgeon consultation).

Hostile chest

Severe liver disease / cirrhosis (MELD Score > 12)

Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)

Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.

Evaluable data regarding safety or effectiveness is not available for prohibitive risk DMR patients with an LVEF < 20% or an LVESD > 60 mm.  MitraClipTM should be used only when criteria for clip suitability for DMR have been met.

The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.

Secondary Mitral Regurgitation

Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.

The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClipTM procedure.

Death; Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudo-aneurysm; Arrhythmias; Atrial fibrillation; Atrial septal defect requiring intervention; Arterio-venous fistula; Bleeding; Cardiac arrest; Cardiac perforation; Cardiac tamponade / Pericardial Effusion; Chordal entanglement / rupture; Coagulopathy; Conversion to standard valve surgery; Deep venous thrombus (DVT); Dislodgement of previously implanted devices; Dizziness; Drug reaction to anti-platelet / anticoagulation agents / contrast media; Dyskinesia; Dyspnea; Edema; Emboli (air, thrombus, MitraClipTM Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClipTM to the intended site; Failure to retrieve MitraClipTM System components; Fever or hyperthermia; Gastrointestinal bleeding or infarct; Hematoma; Hemolysis; Hemorrhage requiring transfusion; Hypotension / hypertension; Infection; Injury to mitral valve complicating or preventing later surgical repair; Lymphatic complications; Mesenteric ischemia; MitraClipTM Implant erosion, migration or malposition; MitraClipTM Implant thrombosis; MitraClipTM System component(s) embolization; Mitral stenosis; Mitral valve injury; Multi-system organ failure; Myocardial infarction; Nausea / vomiting; Pain; Peripheral ischemia; Prolonged angina; Prolonged ventilation; Pulmonary congestion; Pulmonary thrombo-embolism; Renal insufficiency or failure; Respiratory failure / atelectasis / pneumonia; Septicemia; Shock, Anaphylactic or Cardiogenic; Single leaflet device attachment (SLDA); Skin injury or tissue changes due to exposure to ionizing radiation; Stroke or transient ischemic attack (TIA); Urinary tract infection; Vascular trauma, dissection or occlusion; Vessel spasm; Vessel perforation or laceration; Worsening heart failure; Worsening mitral regurgitation; Wound dehiscence

This patient testimonial relates 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.